Failure mode and effects analysis (FMEA) for the Space Shuttle solid rocket motor

NASA Technical Reports Server (NTRS)

Russell, D. L.; Blacklock, K.; Langhenry, M. T.

1988-01-01

The recertification of the Space Shuttle Solid Rocket Booster (SRB) and Solid Rocket Motor (SRM) has included an extensive rewriting of the Failure Mode and Effects Analysis (FMEA) and Critical Items List (CIL). The evolution of the groundrules and methodology used in the analysis is discussed and compared to standard FMEA techniques. Especially highlighted are aspects of the FMEA/CIL which are unique to the analysis of an SRM. The criticality category definitions are presented and the rationale for assigning criticality is presented. The various data required by the CIL and contribution of this data to the retention rationale is also presented. As an example, the FMEA and CIL for the SRM nozzle assembly is discussed in detail. This highlights some of the difficulties associated with the analysis of a system with the unique mission requirements of the Space Shuttle.

Risk Based Reliability Centered Maintenance of DOD Fire Protection Systems

DTIC Science & Technology

1999-01-01

2.2.3 Failure Mode and Effect Analysis ( FMEA )............................ 2.2.4 Failure Mode Risk Characterization...Step 2 - System functions and functional failures definition Step 3 - Failure mode and effect analysis ( FMEA ) Step 4 - Failure mode risk...system). The Interface Location column identifies the location where the FMEA of the fire protection system began or stopped. For example, for the fire

Failure Mode and Effects Analysis: views of hospital staff in the UK.

PubMed

Shebl, Nada; Franklin, Bryony; Barber, Nick; Burnett, Susan; Parand, Anam

2012-01-01

To explore health care professionals' experiences and perceptions of Failure Mode and Effects Analysis (FMEA), a team-based, prospective risk analysis technique. Semi-structured interviews were conducted with 21 operational leads (20 pharmacists, one nurse) in medicines management teams of hospitals participating in a national quality improvement programme. Interviews were transcribed, coded and emergent themes identified using framework analysis. Themes identified included perceptions and experiences of participants with FMEA, validity and reliability issues, and FMEA's use in practice. FMEA was considered to be a structured but subjective process that helps health care professionals get together to identify high risk areas of care. Both positive and negative opinions were expressed, with the majority of interviewees expressing positive views towards FMEA in relation to its structured nature and the use of a multidisciplinary team. Other participants criticised FMEA for being subjective and lacking validity. Most likely to restrict its widespread use were its time consuming nature and its perceived lack of validity and reliability. FMEA is a subjective but systematic tool that helps identify high risk areas, but its time consuming nature, difficulty with the scores and perceived lack of validity and reliability may limit its widespread use.

Fuzzy-based failure mode and effect analysis (FMEA) of a hybrid molten carbonate fuel cell (MCFC) and gas turbine system for marine propulsion

NASA Astrophysics Data System (ADS)

Ahn, Junkeon; Noh, Yeelyong; Park, Sung Ho; Choi, Byung Il; Chang, Daejun

2017-10-01

This study proposes a fuzzy-based FMEA (failure mode and effect analysis) for a hybrid molten carbonate fuel cell and gas turbine system for liquefied hydrogen tankers. An FMEA-based regulatory framework is adopted to analyze the non-conventional propulsion system and to understand the risk picture of the system. Since the participants of the FMEA rely on their subjective and qualitative experiences, the conventional FMEA used for identifying failures that affect system performance inevitably involves inherent uncertainties. A fuzzy-based FMEA is introduced to express such uncertainties appropriately and to provide flexible access to a risk picture for a new system using fuzzy modeling. The hybrid system has 35 components and has 70 potential failure modes, respectively. Significant failure modes occur in the fuel cell stack and rotary machine. The fuzzy risk priority number is used to validate the crisp risk priority number in the FMEA.

Independent Orbiter Assessment (IOA): Assessment of the landing/deceleration (LDG/DEC) subsystem FMEA/CIL

NASA Technical Reports Server (NTRS)

Odonnell, R. A.; Weissinger, D.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Landing/Deceleration (LDG/DEC) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter LDG/DEC hardware. The IOA product for the LDG/DEC analysis consisted of 259 failure mode worksheets that resulted in 124 potential critical items being identified. Comparison was made to the NASA baseline which consisted of 267 FMEA's and 120 CIL items. This comparison produced agreement on all but 75 FMEA's which caused differences in 51 CIL items.

Effectiveness and cost of failure mode and effects analysis methodology to reduce neurosurgical site infections.

PubMed

Hover, Alexander R; Sistrunk, William W; Cavagnol, Robert M; Scarrow, Alan; Finley, Phillip J; Kroencke, Audrey D; Walker, Judith L

2014-01-01

Mercy Hospital Springfield is a tertiary care facility with 32 000 discharges and 15 000 inpatient surgeries in 2011. From June 2009 through January 2011, a stable inpatient elective neurosurgery infection rate of 2.15% was observed. The failure mode and effects analysis (FMEA) methodology to reduce inpatient neurosurgery infections was utilized. Following FMEA implementation, overall elective neurosurgery infection rates were reduced to 1.51% and sustained through May 2012. Compared with baseline, the post-FMEA deep-space and organ infection rate was reduced by 41% (P = .052). Overall hospital inpatient clean surgery infection rates for the same time frame did not decrease to the same extent, suggesting a specific effect of the FMEA. The study team believes that the FMEA interventions resulted in 14 fewer expected infections, $270 270 in savings, a 168-day reduction in expected length of stay, and 22 fewer readmissions. Given the serious morbidity and cost of health care-associated infections, the study team concludes that FMEA implementation was clinically cost-effective. © 2013 by the American College of Medical Quality.

Availability Estimate of a Conceptual ESM System.

DTIC Science & Technology

1979-06-01

affect mission operation.t A functional block level failure modes and effects analysis ( FMEA ) performed on the filter resulted in an assessed failure rate...is based on an FMEA of failures that disable the function (see Appendix A). A further 29 examination of the filter piece-parts reveals that the driver...Digital-to-analog converter DC Direct current DF Direction finding ESM Electronic Support Measures FMEA Failure modes and effects analysis FMPO

Project Recon

DTIC Science & Technology

2012-06-14

Management tool • Current Risk Recon functionality • Issues Recon & Opportunity Recon – Launching Fall 2012 • FMEA and Lessons Learned – Planned Future...Lessons learned UNCLASSIFIED Integrated Risk Management FMEA Failure Mode and Effects Analysis Risk Recon Fields from FMEA software pre...populate Risk Info sheet. Risk Mitigation from Risk Recon trace back and populate FMEA , new RPN numbers. Issues Recon When a risk becomes an issue

Independent Orbiter Assessment (IOA): Assessment of the remote manipulator system FMEA/CIL

NASA Technical Reports Server (NTRS)

Tangorra, F.; Grasmeder, R. F.; Montgomery, A. D.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Remote Manipulator System (RMS) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were than compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. The results of that comparison for the Orbiter RMS hardware are documented. The IOA product for the RMS analysis consisted of 604 failure mode worksheets that resulted in 458 potential critical items being identified. Comparison was made to the NASA baseline which consisted of 45 FMEAs and 321 CIL items. This comparison produced agreement on all but 154 FMEAs which caused differences in 137 CIL items.

Independent Orbiter Assessment (IOA): Assessment of the guidance, navigation, and control subsystem FMEA/CIL

NASA Technical Reports Server (NTRS)

Trahan, W. H.; Odonnell, R. A.; Pietz, K. C.; Drapela, L. J.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Guidance, Navigation, and Control System (GNC) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. The results of that comparison for the Orbiter GNC hardware is documented. The IOA product for the GNC analysis consisted of 141 failure mode worksheets that resulted in 24 potential critical items being identified. Comparison was made to the NASA baseline which consisted of 148 FMEAs and 36 CIL items. This comparison produced agreement on all but 56 FMEAs which caused differences in zero CIL items.

Independent Orbiter Assessment (IOA): Assessment of the body flap subsystem FMEA/CIL

NASA Technical Reports Server (NTRS)

Wilson, R. E.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Body Flap (BF) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter BF hardware. The IOA product for the BF analysis consisted of 43 failure mode worksheets that resulted in 19 potential critical items being identified. Comparison was made to the NASA baseline which consisted of 34 FMEAs and 15 CIL items. This comparison produced agreement on all CIL items. Based on the Pre 51-L baseline, all non-CIL FMEAs were also in agreement.

Failure mode and effects analysis outputs: are they valid?

PubMed

Shebl, Nada Atef; Franklin, Bryony Dean; Barber, Nick

2012-06-10

Failure Mode and Effects Analysis (FMEA) is a prospective risk assessment tool that has been widely used within the aerospace and automotive industries and has been utilised within healthcare since the early 1990s. The aim of this study was to explore the validity of FMEA outputs within a hospital setting in the United Kingdom. Two multidisciplinary teams each conducted an FMEA for the use of vancomycin and gentamicin. Four different validity tests were conducted: Face validity: by comparing the FMEA participants' mapped processes with observational work. Content validity: by presenting the FMEA findings to other healthcare professionals. Criterion validity: by comparing the FMEA findings with data reported on the trust's incident report database. Construct validity: by exploring the relevant mathematical theories involved in calculating the FMEA risk priority number. Face validity was positive as the researcher documented the same processes of care as mapped by the FMEA participants. However, other healthcare professionals identified potential failures missed by the FMEA teams. Furthermore, the FMEA groups failed to include failures related to omitted doses; yet these were the failures most commonly reported in the trust's incident database. Calculating the RPN by multiplying severity, probability and detectability scores was deemed invalid because it is based on calculations that breach the mathematical properties of the scales used. There are significant methodological challenges in validating FMEA. It is a useful tool to aid multidisciplinary groups in mapping and understanding a process of care; however, the results of our study cast doubt on its validity. FMEA teams are likely to need different sources of information, besides their personal experience and knowledge, to identify potential failures. As for FMEA's methodology for scoring failures, there were discrepancies between the teams' estimates and similar incidents reported on the trust's incident database. Furthermore, the concept of multiplying ordinal scales to prioritise failures is mathematically flawed. Until FMEA's validity is further explored, healthcare organisations should not solely depend on their FMEA results to prioritise patient safety issues.

Independent Orbiter Assessment (IOA): Assessment of the main propulsion subsystem FMEA/CIL, volume 3

NASA Technical Reports Server (NTRS)

Holden, K. A.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Main Propulsion System (MPS) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to available data from the Rockwell Downey/NASA JSC FMEA/CIL review. Volume 3 continues the presentation of IOA worksheets and includes the potential critical items list.

Independent Orbiter Assessment (IOA): Assessment of the main propulsion subsystem FMEA/CIL, volume 2

NASA Technical Reports Server (NTRS)

Holden, K. A.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Main Propulsion System (MPS) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were than compared to available data from the Rockwell Downey/NASA JSC FMEA/CIL review. Volume 2 continues the presentation of IOA worksheets for MPS hardware items.

Sensor Technology Baseline Study for Enabling Condition Based Maintenance Plus in Army Ground Vehicles

DTIC Science & Technology

2012-03-01

for enabling condition based maintenance plus in Army ground vehicles. The sensor study was driven from Failure Mode Effects Analysis ( FMEA ...of Tables Table 1. Sensor technology baseline study based on engine FMEA report. ...................................5 Table 2. Sensor technology...baseline study based on transmission FMEA report. .........................8 Table 3. Sensor technology baseline study based on alternator FMEA report

SU-F-T-246: Evaluation of Healthcare Failure Mode And Effect Analysis For Risk Assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Harry, T; University of California, San Diego, La Jolla, CA; Manger, R

Purpose: To evaluate the differences between the Veteran Affairs Healthcare Failure Modes and Effect Analysis (HFMEA) and the AAPM Task Group 100 Failure and Effect Analysis (FMEA) risk assessment techniques in the setting of a stereotactic radiosurgery (SRS) procedure were compared respectively. Understanding the differences in the techniques methodologies and outcomes will provide further insight into the applicability and utility of risk assessments exercises in radiation therapy. Methods: HFMEA risk assessment analysis was performed on a stereotactic radiosurgery procedure. A previous study from our institution completed a FMEA of our SRS procedure and the process map generated from this workmore » was used for the HFMEA. The process of performing the HFMEA scoring was analyzed, and the results from both analyses were compared. Results: The key differences between the two risk assessments are the scoring criteria for failure modes and identifying critical failure modes for potential hazards. The general consensus among the team performing the analyses was that scoring for the HFMEA was simpler and more intuitive then the FMEA. The FMEA identified 25 critical failure modes while the HFMEA identified 39. Seven of the FMEA critical failure modes were not identified by the HFMEA and 21 of the HFMEA critical failure modes were not identified by the FMEA. HFMEA as described by the Veteran Affairs provides guidelines on which failure modes to address first. Conclusion: HFMEA is a more efficient model for identifying gross risks in a process than FMEA. Clinics with minimal staff, time and resources can benefit from this type of risk assessment to eliminate or mitigate high risk hazards with nominal effort. FMEA can provide more in depth details but at the cost of elevated effort.« less

Modeling Hydraulic Components for Automated FMEA of a Braking System

DTIC Science & Technology

2014-12-23

Modeling Hydraulic Components for Automated FMEA of a Braking System Peter Struss, Alessandro Fraracci Tech. Univ. of Munich, 85748 Garching...Germany struss@in.tum.de ABSTRACT This paper presents work on model-based automation of failure-modes-and-effects analysis ( FMEA ) applied to...the hydraulic part of a vehicle braking system. We describe the FMEA task and the application problem and outline the foundations for automating the

A comparative critical study between FMEA and FTA risk analysis methods

NASA Astrophysics Data System (ADS)

Cristea, G.; Constantinescu, DM

2017-10-01

Today there is used an overwhelming number of different risk analyses techniques with acronyms such as: FMEA (Failure Modes and Effects Analysis) and its extension FMECA (Failure Mode, Effects, and Criticality Analysis), DRBFM (Design Review by Failure Mode), FTA (Fault Tree Analysis) and and its extension ETA (Event Tree Analysis), HAZOP (Hazard & Operability Studies), HACCP (Hazard Analysis and Critical Control Points) and What-if/Checklist. However, the most used analysis techniques in the mechanical and electrical industry are FMEA and FTA. In FMEA, which is an inductive method, information about the consequences and effects of the failures is usually collected through interviews with experienced people, and with different knowledge i.e., cross-functional groups. The FMEA is used to capture potential failures/risks & impacts and prioritize them on a numeric scale called Risk Priority Number (RPN) which ranges from 1 to 1000. FTA is a deductive method i.e., a general system state is decomposed into chains of more basic events of components. The logical interrelationship of how such basic events depend on and affect each other is often described analytically in a reliability structure which can be visualized as a tree. Both methods are very time-consuming to be applied thoroughly, and this is why it is oftenly not done so. As a consequence possible failure modes may not be identified. To address these shortcomings, it is proposed to use a combination of FTA and FMEA.

Application of Failure Mode and Effect Analysis (FMEA), cause and effect analysis, and Pareto diagram in conjunction with HACCP to a corn curl manufacturing plant.

PubMed

Varzakas, Theodoros H; Arvanitoyannis, Ioannis S

2007-01-01

The Failure Mode and Effect Analysis (FMEA) model has been applied for the risk assessment of corn curl manufacturing. A tentative approach of FMEA application to the snacks industry was attempted in an effort to exclude the presence of GMOs in the final product. This is of crucial importance both from the ethics and the legislation (Regulations EC 1829/2003; EC 1830/2003; Directive EC 18/2001) point of view. The Preliminary Hazard Analysis and the Fault Tree Analysis were used to analyze and predict the occurring failure modes in a food chain system (corn curls processing plant), based on the functions, characteristics, and/or interactions of the ingredients or the processes, upon which the system depends. Critical Control points have been identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram, and the fishbone diagram). Finally, Pareto diagrams were employed towards the optimization of GMOs detection potential of FMEA.

Independent Orbiter Assessment (IOA): Assessment of the electrical power generation/power reactant storage and distribution subsystem FMEA/CIL

NASA Technical Reports Server (NTRS)

Ames, B. E.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) is presented. The IOA effort first completed an analysis of the Electrical Power Generation/Power Reactant Storage and Distribution (EPG/PRSD) subsystem hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baselines with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. The results of that comparison are documented for the Orbiter EPG/PRSD hardware. The comparison produced agreement on all but 27 FMEAs and 9 CIL items. The discrepancy between the number of IOA findings and NASA FMEAs can be partially explained by the different approaches used by IOA and NASA to group failure modes together to form one FMEA. Also, several IOA items represented inner tank components and ground operations failure modes which were not in the NASA baseline.

Independent Orbiter Assessment (IOA): Assessment of the rudder/speed brake subsystem FMEA/CIL

NASA Technical Reports Server (NTRS)

Wilson, R. E.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Rudder/Speed Brake (RSB) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline along with the proposed Post 51-L CIL updates included. A resolution of each discrepancy from the comparison was provided through additional analysis as required. This report documents the results of that comparison for the Orbiter RSB hardware. The IOA product for the RSB analysis consisted of 38 failure mode worksheets that resulted in 27 potential critical items being identified. Comparison was made to the NASA baseline which consisted of 34 FMEAs and 18 CIL items. This comparison produced agreement on all CIL items. Based on the Pre 51-L baseline, all non-CIL FMEAs were also in agreement.

Independent Orbiter Assessment (IOA): Assessment of the manned maneuvering unit

NASA Technical Reports Server (NTRS)

Huynh, M.; Duffy, R. E.; Saiidi, M. J.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Manned Maneuvering Unit (MMU) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contain within the NASA FMEA/CIL documentation. The IOA results were then compared to the proposed Martin Marietta FMEA/CIL Post 51-L updates. A discussion of each discrepancy from the comparison is provided through additional analysis as required. These discrepancies were flagged as issues, and recommendations were made based on the FMEA data available at the time. The results of this comparison for the Orbiter MMU hardware are documented. The IOA product for the MMU analysis consisted of 204 failure mode worksheets that resulted in 95 potential critical items being identified. Comparison was made to the NASA baseline which consisted of 179 FMEAs and 110 CIL items. This comparison produced agreement on all 121 FMEAs which caused differences in 92 CIL items.

Independent Orbiter Assessment (IOA): Assessment of the ascent thrust vector control actuator subsystem FMEA/CIL

NASA Technical Reports Server (NTRS)

Wilson, R. E.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Ascent Thrust Vector Control Actuator (ATVD) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter ATVC hardware. The IOA product for the ATVC actuator analysis consisted of 25 failure mode worksheets that resulted in 16 potential critical items being identified. Comparison was made to the NASA baseline which consisted of 21 FMEAs and 13 CIL items. This comparison produced agreement on all CIL items. Based on the Pre 51-L baseline, all non-CIL FMEAs were also in agreement.

Independent Orbiter Assessment (IOA): Assessment of the data processing system FMEA/CIL

NASA Technical Reports Server (NTRS)

Lowery, H. J.; Haufler, W. A.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Data Processing System (DPS) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. The results of that comparison is documented for the Orbiter DPS hardware.

Independent Orbiter Assessment (IOA): Assessment of the atmospheric revitalization pressure control subsystem FMEA/CIL

NASA Technical Reports Server (NTRS)

Saiidi, M. J.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the atmospheric Revitalization Pressure Control Subsystem (ARPCS) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL proposed Post 51-L updates based upon the CCB/PRCB presentations and an informal criticality summary listing. A discussion of each discrepancy from the comparison is provided through additional analysis as required. These discrepancies were flagged as issues, and recommendations were made based on the FMEA data available at the time. This report documents the results of that comparison for the Orbiter ARPCS hardware.

Risk analysis of analytical validations by probabilistic modification of FMEA.

PubMed

Barends, D M; Oldenhof, M T; Vredenbregt, M J; Nauta, M J

2012-05-01

Risk analysis is a valuable addition to validation of an analytical chemistry process, enabling not only detecting technical risks, but also risks related to human failures. Failure Mode and Effect Analysis (FMEA) can be applied, using a categorical risk scoring of the occurrence, detection and severity of failure modes, and calculating the Risk Priority Number (RPN) to select failure modes for correction. We propose a probabilistic modification of FMEA, replacing the categorical scoring of occurrence and detection by their estimated relative frequency and maintaining the categorical scoring of severity. In an example, the results of traditional FMEA of a Near Infrared (NIR) analytical procedure used for the screening of suspected counterfeited tablets are re-interpretated by this probabilistic modification of FMEA. Using this probabilistic modification of FMEA, the frequency of occurrence of undetected failure mode(s) can be estimated quantitatively, for each individual failure mode, for a set of failure modes, and the full analytical procedure. Copyright © 2012 Elsevier B.V. All rights reserved.

Independent Orbiter Assessment (IOA): Assessment of the life support and airlock support systems, volume 1

NASA Technical Reports Server (NTRS)

Arbet, J. D.; Duffy, R. E.; Barickman, K.; Saiidi, M. J.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Life Support and Airlock Support Systems (LSS and ALSS) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. The discrepancies were flagged for potential future resolution. This report documents the results of that comparison for the Orbiter LSS and ALSS hardware. The IOA product for the LSS and ALSS analysis consisted of 511 failure mode worksheets that resulted in 140 potential critical items. Comparison was made to the NASA baseline which consisted of 456 FMEAs and 101 CIL items. The IOA analysis identified 39 failure modes, 6 of which were classified as CIL items, for components not covered by the NASA FMEAs. It was recommended that these failure modes be added to the NASA FMEA baseline. The overall assessment produced agreement on all but 301 FMEAs which caused differences in 111 CIL items.

Independent Orbiter Assessment (IOA): Assessment of the EPD and C/remote manipulator system FMEA/CIL

NASA Technical Reports Server (NTRS)

Robinson, W. W.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Electrical Power Distribution and Control (EPD and C)/Remote Manipulator System (RMS) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA analysis of the EPD and C/RMS hardware initially generated 345 failure mode worksheets and identified 117 Potential Critical Items (PCIs) before starting the assessment process. These analysis results were compared to the proposed NASA Post 51-L baseline of 132 FMEAs and 66 CIL items.

Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool.

PubMed

Zimmermann, Hartmut F; Hentschel, Norbert

2011-01-01

With the publication of the quality guideline ICH Q9 "Quality Risk Management" by the International Conference on Harmonization, risk management has already become a standard requirement during the life cycle of a pharmaceutical product. Failure mode and effect analysis (FMEA) is a powerful risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to biopharmaceutical processes brings about some difficulties. The proposal presented here is intended to serve as a brief but nevertheless comprehensive and detailed guideline on how to conduct a biopharmaceutical process FMEA. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. The application for such a biopharmaceutical process FMEA is widespread. It can be useful whenever a biopharmaceutical manufacturing process is developed or scaled-up, or when it is transferred to a different manufacturing site. It may also be conducted during substantial optimization of an existing process or the development of a second-generation process. According to their resulting risk ratings, process parameters can be ranked for importance and important variables for process development, characterization, or validation can be identified. Health authorities around the world ask pharmaceutical companies to manage risk during development and manufacturing of pharmaceuticals. The so-called failure mode and effect analysis (FMEA) is an established risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to pharmaceutical processes that use modern biotechnology (biopharmaceutical processes) brings about some difficulties, because those biopharmaceutical processes differ from processes in mechanical and electrical industries. The proposal presented here explains how a biopharmaceutical process FMEA can be conducted. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. With the help of this guideline, different details of the manufacturing process can be ranked according to their potential risks, and this can help pharmaceutical companies to identify aspects with high potential risks and to react accordingly to improve the safety of medicines.

Independent Orbiter Assessment (IOA): Assessment of the electrical power generation/fuel cell powerplant subsystem FMEA/CIL

NASA Technical Reports Server (NTRS)

Brown, K. L.; Bertsch, P. J.

1987-01-01

Results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Electrical Power Generation/Fuel Cell Powerplant (EPG/FCP) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the proposed Post 51-L NASA FMEA/CIL baseline. A resolution of each discrepancy from the comparison was provided through additional analysis as required. This report documents the results of that comparison for the Orbiter EPG/FCP hardware.

Independent Orbiter Assessment (IOA): Assessment of the hydraulics/water spray boiler subsystem

NASA Technical Reports Server (NTRS)

Bynum, M. C.; Duval, J. D.; Parkman, W. E.; Davidson, W. R.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Hydraulics/Water Spray Boiler (HYD/WSB) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter HYD/WSB hardware. The IOA product for the HYD/WSB analysis consisted of 447 failure mode worksheets that resulted in 183 potential critical items being identified. Comparison was made to the NASA baseline which consisted of 364 FMEAs and 111 CIL items. This comparison produced agreement on all but 68 FMEAs which caused differences in 23 CIL items.

Independent Orbiter Assessment (IOA): Assessment of the Electrical Power Distribution and Control/Electrical Power Generation (EPD and C/EPG) FMEA/CIL

NASA Technical Reports Server (NTRS)

Mccants, C. N.; Bearrow, M.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Electrical Power Distribution and Control/Electrical Power Generation (EPD and C/EPG) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison was provided through additional analysis as required. The results of that comparison is documented for the Orbiter EPD and C/EPG hardware. The IOA product for the EPD and C/EPG analysis consisted of 263 failure mode worksheets that resulted in 42 potential critical items being identified. Comparison was made to the NASA baseline which consisted of 211 FMEA and 47 CIL items.

Independent Orbiter Assessment (IOA): Assessment of the auxiliary power unit

NASA Technical Reports Server (NTRS)

Barnes, J. E.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Auxiliary Power Unit (APU) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter APU hardware. The IOA product for the APU analysis, covering both APU hardware and APU electrical components, consisted of 344 failure mode worksheets that resulted in 178 potential critical items being identified. A comparison was made of the IOA product to the NASA APU hardware FMEA/CIL baseline which consisted of 184 FMEAs and 57 CIL items. The comparison identified 72 discrepancies.

Safety Management of a Clinical Process Using Failure Mode and Effect Analysis: Continuous Renal Replacement Therapies in Intensive Care Unit Patients.

PubMed

Sanchez-Izquierdo-Riera, Jose Angel; Molano-Alvarez, Esteban; Saez-de la Fuente, Ignacio; Maynar-Moliner, Javier; Marín-Mateos, Helena; Chacón-Alves, Silvia

2016-01-01

The failure mode and effect analysis (FMEA) may improve the safety of the continuous renal replacement therapies (CRRT) in the intensive care unit. We use this tool in three phases: 1) Retrospective observational study. 2) A process FMEA, with implementation of the improvement measures identified. 3) Cohort study after FMEA. We included 54 patients in the pre-FMEA group and 72 patients in the post-FMEA group. Comparing the risks frequencies per patient in both groups, we got less cases of under 24 hours of filter survival time in the post-FMEA group (31 patients 57.4% vs. 21 patients 29.6%; p < 0.05); less patients suffered circuit coagulation with inability to return the blood to the patient (25 patients [46.3%] vs. 16 patients [22.2%]; p < 0.05); 54 patients (100%) versus 5 (6.94%) did not get phosphorus levels monitoring (p < 0.05); in 14 patients (25.9%) versus 0 (0%), the CRRT prescription did not appear on medical orders. As a measure of improvement, we adopt a dynamic dosage management. After the process FMEA, there were several improvements in the management of intensive care unit patients receiving CRRT, and we consider it a useful tool for improving the safety of critically ill patients.

Model 0A wind turbine generator FMEA

NASA Technical Reports Server (NTRS)

Klein, William E.; Lalli, Vincent R.

1989-01-01

The results of Failure Modes and Effects Analysis (FMEA) conducted for the Wind Turbine Generators are presented. The FMEA was performed for the functional modes of each system, subsystem, or component. The single-point failures were eliminated for most of the systems. The blade system was the only exception. The qualitative probability of a blade separating was estimated at level D-remote. Many changes were made to the hardware as a result of this analysis. The most significant change was the addition of the safety system. Operational experience and need to improve machine availability have resulted in subsequent changes to the various systems which are also reflected in this FMEA.

Failure mode and effects analysis outputs: are they valid?

PubMed Central

2012-01-01

Background Failure Mode and Effects Analysis (FMEA) is a prospective risk assessment tool that has been widely used within the aerospace and automotive industries and has been utilised within healthcare since the early 1990s. The aim of this study was to explore the validity of FMEA outputs within a hospital setting in the United Kingdom. Methods Two multidisciplinary teams each conducted an FMEA for the use of vancomycin and gentamicin. Four different validity tests were conducted: · Face validity: by comparing the FMEA participants’ mapped processes with observational work. · Content validity: by presenting the FMEA findings to other healthcare professionals. · Criterion validity: by comparing the FMEA findings with data reported on the trust’s incident report database. · Construct validity: by exploring the relevant mathematical theories involved in calculating the FMEA risk priority number. Results Face validity was positive as the researcher documented the same processes of care as mapped by the FMEA participants. However, other healthcare professionals identified potential failures missed by the FMEA teams. Furthermore, the FMEA groups failed to include failures related to omitted doses; yet these were the failures most commonly reported in the trust’s incident database. Calculating the RPN by multiplying severity, probability and detectability scores was deemed invalid because it is based on calculations that breach the mathematical properties of the scales used. Conclusion There are significant methodological challenges in validating FMEA. It is a useful tool to aid multidisciplinary groups in mapping and understanding a process of care; however, the results of our study cast doubt on its validity. FMEA teams are likely to need different sources of information, besides their personal experience and knowledge, to identify potential failures. As for FMEA’s methodology for scoring failures, there were discrepancies between the teams’ estimates and similar incidents reported on the trust’s incident database. Furthermore, the concept of multiplying ordinal scales to prioritise failures is mathematically flawed. Until FMEA’s validity is further explored, healthcare organisations should not solely depend on their FMEA results to prioritise patient safety issues. PMID:22682433

A streamlined failure mode and effects analysis.

PubMed

Ford, Eric C; Smith, Koren; Terezakis, Stephanie; Croog, Victoria; Gollamudi, Smitha; Gage, Irene; Keck, Jordie; DeWeese, Theodore; Sibley, Greg

2014-06-01

Explore the feasibility and impact of a streamlined failure mode and effects analysis (FMEA) using a structured process that is designed to minimize staff effort. FMEA for the external beam process was conducted at an affiliate radiation oncology center that treats approximately 60 patients per day. A structured FMEA process was developed which included clearly defined roles and goals for each phase. A core group of seven people was identified and a facilitator was chosen to lead the effort. Failure modes were identified and scored according to the FMEA formalism. A risk priority number,RPN, was calculated and used to rank failure modes. Failure modes with RPN > 150 received safety improvement interventions. Staff effort was carefully tracked throughout the project. Fifty-two failure modes were identified, 22 collected during meetings, and 30 from take-home worksheets. The four top-ranked failure modes were: delay in film check, missing pacemaker protocol/consent, critical structures not contoured, and pregnant patient simulated without the team's knowledge of the pregnancy. These four failure modes had RPN > 150 and received safety interventions. The FMEA was completed in one month in four 1-h meetings. A total of 55 staff hours were required and, additionally, 20 h by the facilitator. Streamlined FMEA provides a means of accomplishing a relatively large-scale analysis with modest effort. One potential value of FMEA is that it potentially provides a means of measuring the impact of quality improvement efforts through a reduction in risk scores. Future study of this possibility is needed.

Model-OA wind turbine generator - Failure modes and effects analysis

NASA Technical Reports Server (NTRS)

Klein, William E.; Lali, Vincent R.

1990-01-01

The results failure modes and effects analysis (FMEA) conducted for wind-turbine generators are presented. The FMEA was performed for the functional modes of each system, subsystem, or component. The single-point failures were eliminated for most of the systems. The blade system was the only exception. The qualitative probability of a blade separating was estimated at level D-remote. Many changes were made to the hardware as a result of this analysis. The most significant change was the addition of the safety system. Operational experience and need to improve machine availability have resulted in subsequent changes to the various systems, which are also reflected in this FMEA.

A novel approach for evaluating the risk of health care failure modes.

PubMed

Chang, Dong Shang; Chung, Jenq Hann; Sun, Kuo Lung; Yang, Fu Chiang

2012-12-01

Failure mode and effects analysis (FMEA) can be employed to reduce medical errors by identifying the risk ranking of the health care failure modes and taking priority action for safety improvement. The purpose of this paper is to propose a novel approach of data analysis. The approach is to integrate FMEA and a mathematical tool-Data envelopment analysis (DEA) with "slack-based measure" (SBM), in the field of data analysis. The risk indexes (severity, occurrence, and detection) of FMEA are viewed as multiple inputs of DEA. The practicality and usefulness of the proposed approach is illustrated by one case of health care. Being a systematic approach for improving the service quality of health care, the approach can offer quantitative corrective information of risk indexes that thereafter reduce failure possibility. For safety improvement, these new targets of the risk indexes could be used for management by objectives. But FMEA cannot provide quantitative corrective information of risk indexes. The novel approach can surely overcome this chief shortcoming of FMEA. After combining DEA SBM model with FMEA, the two goals-increase of patient safety, medical cost reduction-can be together achieved.

Fuzzy Risk Evaluation in Failure Mode and Effects Analysis Using a D Numbers Based Multi-Sensor Information Fusion Method.

PubMed

Deng, Xinyang; Jiang, Wen

2017-09-12

Failure mode and effect analysis (FMEA) is a useful tool to define, identify, and eliminate potential failures or errors so as to improve the reliability of systems, designs, and products. Risk evaluation is an important issue in FMEA to determine the risk priorities of failure modes. There are some shortcomings in the traditional risk priority number (RPN) approach for risk evaluation in FMEA, and fuzzy risk evaluation has become an important research direction that attracts increasing attention. In this paper, the fuzzy risk evaluation in FMEA is studied from a perspective of multi-sensor information fusion. By considering the non-exclusiveness between the evaluations of fuzzy linguistic variables to failure modes, a novel model called D numbers is used to model the non-exclusive fuzzy evaluations. A D numbers based multi-sensor information fusion method is proposed to establish a new model for fuzzy risk evaluation in FMEA. An illustrative example is provided and examined using the proposed model and other existing method to show the effectiveness of the proposed model.

Fuzzy Risk Evaluation in Failure Mode and Effects Analysis Using a D Numbers Based Multi-Sensor Information Fusion Method

PubMed Central

Deng, Xinyang

2017-01-01

Failure mode and effect analysis (FMEA) is a useful tool to define, identify, and eliminate potential failures or errors so as to improve the reliability of systems, designs, and products. Risk evaluation is an important issue in FMEA to determine the risk priorities of failure modes. There are some shortcomings in the traditional risk priority number (RPN) approach for risk evaluation in FMEA, and fuzzy risk evaluation has become an important research direction that attracts increasing attention. In this paper, the fuzzy risk evaluation in FMEA is studied from a perspective of multi-sensor information fusion. By considering the non-exclusiveness between the evaluations of fuzzy linguistic variables to failure modes, a novel model called D numbers is used to model the non-exclusive fuzzy evaluations. A D numbers based multi-sensor information fusion method is proposed to establish a new model for fuzzy risk evaluation in FMEA. An illustrative example is provided and examined using the proposed model and other existing method to show the effectiveness of the proposed model. PMID:28895905

Independent Orbiter Assessment (IOA): Assessment of the extravehicular mobility unit, volume 2

NASA Technical Reports Server (NTRS)

Raffaelli, Gary G.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort performed an independent analysis of the Extravehicular Mobility Unit (EMU) hardware and system, generating draft failure modes criticalities and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the most recent proposed Post 51-L NASA FMEA/CIL baseline. A resolution of each discrepancy from the comparison was provided through additional analysis as required. This report documents the results of that comparison for the Orbiter EMU hardware. Volume 2 continues the presentation of IOA analysis worksheets and contains the potential critical items list and NASA FMEA to IOA worksheet cross references and recommendations.

Failure Modes and Effects Analysis (FMEA) Assistant Tool Feasibility Study

NASA Technical Reports Server (NTRS)

Flores, Melissa; Malin, Jane T.

2013-01-01

An effort to determine the feasibility of a software tool to assist in Failure Modes and Effects Analysis (FMEA) has been completed. This new and unique approach to FMEA uses model based systems engineering concepts to recommend failure modes, causes, and effects to the user after they have made several selections from pick lists about a component s functions and inputs/outputs. Recommendations are made based on a library using common failure modes identified over the course of several major human spaceflight programs. However, the tool could be adapted for use in a wide range of applications from NASA to the energy industry.

Failure Modes and Effects Analysis (FMEA) Assistant Tool Feasibility Study

NASA Astrophysics Data System (ADS)

Flores, Melissa D.; Malin, Jane T.; Fleming, Land D.

2013-09-01

An effort to determine the feasibility of a software tool to assist in Failure Modes and Effects Analysis (FMEA) has been completed. This new and unique approach to FMEA uses model based systems engineering concepts to recommend failure modes, causes, and effects to the user after they have made several selections from pick lists about a component's functions and inputs/outputs. Recommendations are made based on a library using common failure modes identified over the course of several major human spaceflight programs. However, the tool could be adapted for use in a wide range of applications from NASA to the energy industry.

WE-G-BRC-02: Risk Assessment for HDR Brachytherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mayadev, J.

2016-06-15

Failure Mode and Effects Analysis (FMEA) originated as an industrial engineering technique used for risk management and safety improvement of complex processes. In the context of radiotherapy, the AAPM Task Group 100 advocates FMEA as the framework of choice for establishing clinical quality management protocols. However, there is concern that widespread adoption of FMEA in radiation oncology will be hampered by the perception that implementation of the tool will have a steep learning curve, be extremely time consuming and labor intensive, and require additional resources. To overcome these preconceptions and facilitate the introduction of the tool into clinical practice, themore » medical physics community must be educated in the use of this tool and the ease in which it can be implemented. Organizations with experience in FMEA should share their knowledge with others in order to increase the implementation, effectiveness and productivity of the tool. This session will include a brief, general introduction to FMEA followed by a focus on practical aspects of implementing FMEA for specific clinical procedures including HDR brachytherapy, physics plan review and radiosurgery. A description of common equipment and devices used in these procedures and how to characterize new devices for safe use in patient treatments will be presented. This will be followed by a discussion of how to customize FMEA techniques and templates to one’s own clinic. Finally, cases of common failure modes for specific procedures (described previously) will be shown and recommended intervention methodologies and outcomes reviewed. Learning Objectives: Understand the general concept of failure mode and effect analysis Learn how to characterize new equipment for safety Be able to identify potential failure modes for specific procedures and learn mitigation techniques Be able to customize FMEA examples and templates for use in any clinic.« less

WE-G-BRC-01: Risk Assessment for Radiosurgery

DOE Office of Scientific and Technical Information (OSTI.GOV)

Kim, G.

2016-06-15

Failure Mode and Effects Analysis (FMEA) originated as an industrial engineering technique used for risk management and safety improvement of complex processes. In the context of radiotherapy, the AAPM Task Group 100 advocates FMEA as the framework of choice for establishing clinical quality management protocols. However, there is concern that widespread adoption of FMEA in radiation oncology will be hampered by the perception that implementation of the tool will have a steep learning curve, be extremely time consuming and labor intensive, and require additional resources. To overcome these preconceptions and facilitate the introduction of the tool into clinical practice, themore » medical physics community must be educated in the use of this tool and the ease in which it can be implemented. Organizations with experience in FMEA should share their knowledge with others in order to increase the implementation, effectiveness and productivity of the tool. This session will include a brief, general introduction to FMEA followed by a focus on practical aspects of implementing FMEA for specific clinical procedures including HDR brachytherapy, physics plan review and radiosurgery. A description of common equipment and devices used in these procedures and how to characterize new devices for safe use in patient treatments will be presented. This will be followed by a discussion of how to customize FMEA techniques and templates to one’s own clinic. Finally, cases of common failure modes for specific procedures (described previously) will be shown and recommended intervention methodologies and outcomes reviewed. Learning Objectives: Understand the general concept of failure mode and effect analysis Learn how to characterize new equipment for safety Be able to identify potential failure modes for specific procedures and learn mitigation techniques Be able to customize FMEA examples and templates for use in any clinic.« less

WE-G-BRC-03: Risk Assessment for Physics Plan Review

DOE Office of Scientific and Technical Information (OSTI.GOV)

Parker, S.

2016-06-15

Failure Mode and Effects Analysis (FMEA) originated as an industrial engineering technique used for risk management and safety improvement of complex processes. In the context of radiotherapy, the AAPM Task Group 100 advocates FMEA as the framework of choice for establishing clinical quality management protocols. However, there is concern that widespread adoption of FMEA in radiation oncology will be hampered by the perception that implementation of the tool will have a steep learning curve, be extremely time consuming and labor intensive, and require additional resources. To overcome these preconceptions and facilitate the introduction of the tool into clinical practice, themore » medical physics community must be educated in the use of this tool and the ease in which it can be implemented. Organizations with experience in FMEA should share their knowledge with others in order to increase the implementation, effectiveness and productivity of the tool. This session will include a brief, general introduction to FMEA followed by a focus on practical aspects of implementing FMEA for specific clinical procedures including HDR brachytherapy, physics plan review and radiosurgery. A description of common equipment and devices used in these procedures and how to characterize new devices for safe use in patient treatments will be presented. This will be followed by a discussion of how to customize FMEA techniques and templates to one’s own clinic. Finally, cases of common failure modes for specific procedures (described previously) will be shown and recommended intervention methodologies and outcomes reviewed. Learning Objectives: Understand the general concept of failure mode and effect analysis Learn how to characterize new equipment for safety Be able to identify potential failure modes for specific procedures and learn mitigation techniques Be able to customize FMEA examples and templates for use in any clinic.« less

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

Failure Mode and Effects Analysis (FMEA) originated as an industrial engineering technique used for risk management and safety improvement of complex processes. In the context of radiotherapy, the AAPM Task Group 100 advocates FMEA as the framework of choice for establishing clinical quality management protocols. However, there is concern that widespread adoption of FMEA in radiation oncology will be hampered by the perception that implementation of the tool will have a steep learning curve, be extremely time consuming and labor intensive, and require additional resources. To overcome these preconceptions and facilitate the introduction of the tool into clinical practice, themore » medical physics community must be educated in the use of this tool and the ease in which it can be implemented. Organizations with experience in FMEA should share their knowledge with others in order to increase the implementation, effectiveness and productivity of the tool. This session will include a brief, general introduction to FMEA followed by a focus on practical aspects of implementing FMEA for specific clinical procedures including HDR brachytherapy, physics plan review and radiosurgery. A description of common equipment and devices used in these procedures and how to characterize new devices for safe use in patient treatments will be presented. This will be followed by a discussion of how to customize FMEA techniques and templates to one’s own clinic. Finally, cases of common failure modes for specific procedures (described previously) will be shown and recommended intervention methodologies and outcomes reviewed. Learning Objectives: Understand the general concept of failure mode and effect analysis Learn how to characterize new equipment for safety Be able to identify potential failure modes for specific procedures and learn mitigation techniques Be able to customize FMEA examples and templates for use in any clinic.« less

Using failure mode and effects analysis to plan implementation of smart i.v. pump technology.

PubMed

Wetterneck, Tosha B; Skibinski, Kathleen A; Roberts, Tanita L; Kleppin, Susan M; Schroeder, Mark E; Enloe, Myra; Rough, Steven S; Hundt, Ann Schoofs; Carayon, Pascale

2006-08-15

Failure mode and effects analysis (FMEA) was used to evaluate a smart i.v. pump as it was implemented into a redesigned medication-use process. A multidisciplinary team conducted a FMEA to guide the implementation of a smart i.v. pump that was designed to prevent pump programming errors. The smart i.v. pump was equipped with a dose-error reduction system that included a pre-defined drug library in which dosage limits were set for each medication. Monitoring for potential failures and errors occurred for three months postimplementation of FMEA. Specific measures were used to determine the success of the actions that were implemented as a result of the FMEA. The FMEA process at the hospital identified key failure modes in the medication process with the use of the old and new pumps, and actions were taken to avoid errors and adverse events. I.V. pump software and hardware design changes were also recommended. Thirteen of the 18 failure modes reported in practice after pump implementation had been identified by the team. A beneficial outcome of FMEA was the development of a multidisciplinary team that provided the infrastructure for safe technology implementation and effective event investigation after implementation. With the continual updating of i.v. pump software and hardware after implementation, FMEA can be an important starting place for safe technology choice and implementation and can produce site experts to follow technology and process changes over time. FMEA was useful in identifying potential problems in the medication-use process with the implementation of new smart i.v. pumps. Monitoring for system failures and errors after implementation remains necessary.

Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct.

PubMed

Lee, Howard; Lee, Heechan; Baik, Jungmi; Kim, Hyunjung; Kim, Rachel

2017-01-01

Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting. A multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later. A total of 114 failure modes were identified with an RPN score ranging 3-378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively. FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes.

Minimizing treatment planning errors in proton therapy using failure mode and effects analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zheng, Yuanshui, E-mail: yuanshui.zheng@okc.procure.com; Johnson, Randall; Larson, Gary

Purpose: Failure mode and effects analysis (FMEA) is a widely used tool to evaluate safety or reliability in conventional photon radiation therapy. However, reports about FMEA application in proton therapy are scarce. The purpose of this study is to apply FMEA in safety improvement of proton treatment planning at their center. Methods: The authors performed an FMEA analysis of their proton therapy treatment planning process using uniform scanning proton beams. The authors identified possible failure modes in various planning processes, including image fusion, contouring, beam arrangement, dose calculation, plan export, documents, billing, and so on. For each error, the authorsmore » estimated the frequency of occurrence, the likelihood of being undetected, and the severity of the error if it went undetected and calculated the risk priority number (RPN). The FMEA results were used to design their quality management program. In addition, the authors created a database to track the identified dosimetric errors. Periodically, the authors reevaluated the risk of errors by reviewing the internal error database and improved their quality assurance program as needed. Results: In total, the authors identified over 36 possible treatment planning related failure modes and estimated the associated occurrence, detectability, and severity to calculate the overall risk priority number. Based on the FMEA, the authors implemented various safety improvement procedures into their practice, such as education, peer review, and automatic check tools. The ongoing error tracking database provided realistic data on the frequency of occurrence with which to reevaluate the RPNs for various failure modes. Conclusions: The FMEA technique provides a systematic method for identifying and evaluating potential errors in proton treatment planning before they result in an error in patient dose delivery. The application of FMEA framework and the implementation of an ongoing error tracking system at their clinic have proven to be useful in error reduction in proton treatment planning, thus improving the effectiveness and safety of proton therapy.« less

Minimizing treatment planning errors in proton therapy using failure mode and effects analysis.

PubMed

Zheng, Yuanshui; Johnson, Randall; Larson, Gary

2016-06-01

Failure mode and effects analysis (FMEA) is a widely used tool to evaluate safety or reliability in conventional photon radiation therapy. However, reports about FMEA application in proton therapy are scarce. The purpose of this study is to apply FMEA in safety improvement of proton treatment planning at their center. The authors performed an FMEA analysis of their proton therapy treatment planning process using uniform scanning proton beams. The authors identified possible failure modes in various planning processes, including image fusion, contouring, beam arrangement, dose calculation, plan export, documents, billing, and so on. For each error, the authors estimated the frequency of occurrence, the likelihood of being undetected, and the severity of the error if it went undetected and calculated the risk priority number (RPN). The FMEA results were used to design their quality management program. In addition, the authors created a database to track the identified dosimetric errors. Periodically, the authors reevaluated the risk of errors by reviewing the internal error database and improved their quality assurance program as needed. In total, the authors identified over 36 possible treatment planning related failure modes and estimated the associated occurrence, detectability, and severity to calculate the overall risk priority number. Based on the FMEA, the authors implemented various safety improvement procedures into their practice, such as education, peer review, and automatic check tools. The ongoing error tracking database provided realistic data on the frequency of occurrence with which to reevaluate the RPNs for various failure modes. The FMEA technique provides a systematic method for identifying and evaluating potential errors in proton treatment planning before they result in an error in patient dose delivery. The application of FMEA framework and the implementation of an ongoing error tracking system at their clinic have proven to be useful in error reduction in proton treatment planning, thus improving the effectiveness and safety of proton therapy.

Validating FMEA output against incident learning data: A study in stereotactic body radiation therapy.

PubMed

Yang, F; Cao, N; Young, L; Howard, J; Logan, W; Arbuckle, T; Sponseller, P; Korssjoen, T; Meyer, J; Ford, E

2015-06-01

Though failure mode and effects analysis (FMEA) is becoming more widely adopted for risk assessment in radiation therapy, to our knowledge, its output has never been validated against data on errors that actually occur. The objective of this study was to perform FMEA of a stereotactic body radiation therapy (SBRT) treatment planning process and validate the results against data recorded within an incident learning system. FMEA on the SBRT treatment planning process was carried out by a multidisciplinary group including radiation oncologists, medical physicists, dosimetrists, and IT technologists. Potential failure modes were identified through a systematic review of the process map. Failure modes were rated for severity, occurrence, and detectability on a scale of one to ten and risk priority number (RPN) was computed. Failure modes were then compared with historical reports identified as relevant to SBRT planning within a departmental incident learning system that has been active for two and a half years. Differences between FMEA anticipated failure modes and existing incidents were identified. FMEA identified 63 failure modes. RPN values for the top 25% of failure modes ranged from 60 to 336. Analysis of the incident learning database identified 33 reported near-miss events related to SBRT planning. Combining both methods yielded a total of 76 possible process failures, of which 13 (17%) were missed by FMEA while 43 (57%) identified by FMEA only. When scored for RPN, the 13 events missed by FMEA ranked within the lower half of all failure modes and exhibited significantly lower severity relative to those identified by FMEA (p = 0.02). FMEA, though valuable, is subject to certain limitations. In this study, FMEA failed to identify 17% of actual failure modes, though these were of lower risk. Similarly, an incident learning system alone fails to identify a large number of potentially high-severity process errors. Using FMEA in combination with incident learning may render an improved overview of risks within a process.

Application of Failure Mode and Effect Analysis (FMEA) and cause and effect analysis in conjunction with ISO 22000 to a snails (Helix aspersa) processing plant; A case study.

PubMed

Arvanitoyannis, Ioannis S; Varzakas, Theodoros H

2009-08-01

Failure Mode and Effect Analysis (FMEA) has been applied for the risk assessment of snails manufacturing. A tentative approach of FMEA application to the snails industry was attempted in conjunction with ISO 22000. Preliminary Hazard Analysis was used to analyze and predict the occurring failure modes in a food chain system (snails processing plant), based on the functions, characteristics, and/or interactions of the ingredients or the processes, upon which the system depends. Critical Control points have been identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram, and fishbone diagram). In this work a comparison of ISO22000 analysis with HACCP is carried out over snails processing and packaging. However, the main emphasis was put on the quantification of risk assessment by determining the RPN per identified processing hazard. Sterilization of tins, bioaccumulation of heavy metals, packaging of shells and poisonous mushrooms, were the processes identified as the ones with the highest RPN (280, 240, 147, 144, respectively) and corrective actions were undertaken. Following the application of corrective actions, a second calculation of RPN values was carried out leading to considerably lower values (below the upper acceptable limit of 130). It is noteworthy that the application of Ishikawa (Cause and Effect or Tree diagram) led to converging results thus corroborating the validity of conclusions derived from risk assessment and FMEA. Therefore, the incorporation of FMEA analysis within the ISO22000 system of a snails processing industry is considered imperative.

Risk analysis by FMEA as an element of analytical validation.

PubMed

van Leeuwen, J F; Nauta, M J; de Kaste, D; Odekerken-Rombouts, Y M C F; Oldenhof, M T; Vredenbregt, M J; Barends, D M

2009-12-05

We subjected a Near-Infrared (NIR) analytical procedure used for screening drugs on authenticity to a Failure Mode and Effects Analysis (FMEA), including technical risks as well as risks related to human failure. An FMEA team broke down the NIR analytical method into process steps and identified possible failure modes for each step. Each failure mode was ranked on estimated frequency of occurrence (O), probability that the failure would remain undetected later in the process (D) and severity (S), each on a scale of 1-10. Human errors turned out to be the most common cause of failure modes. Failure risks were calculated by Risk Priority Numbers (RPNs)=O x D x S. Failure modes with the highest RPN scores were subjected to corrective actions and the FMEA was repeated, showing reductions in RPN scores and resulting in improvement indices up to 5.0. We recommend risk analysis as an addition to the usual analytical validation, as the FMEA enabled us to detect previously unidentified risks.

Independent Orbiter Assessment (IOA): Assessment of the crew equipment subsystem

NASA Technical Reports Server (NTRS)

Saxon, H.; Richard, Bill; Sinclair, S. K.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Crew Equipment hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter Crew Equipment hardware. The IOA product for the Crew Equipment analysis consisted of 352 failure mode worksheets that resulted in 78 potential critical items being identified. Comparison was made to the NASA baseline which consisted of 351 FMEAs and 82 CIL items.

Independent Orbiter Assessment (IOA): FMEA/CIL assessment

NASA Technical Reports Server (NTRS)

Hinsdale, L. W.; Swain, L. J.; Barnes, J. E.

1988-01-01

The McDonnell Douglas Astronautics Company (MDAC) was selected to perform an Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL). Direction was given by the Orbiter and GFE Projects Office to perform the hardware analysis and assessment using the instructions and ground rules defined in NSTS 22206. The IOA analysis featured a top-down approach to determine hardware failure modes, criticality, and potential critical items. To preserve independence, the analysis was accomplished without reliance upon the results contained within the NASA and Prime Contractor FMEA/CIL documentation. The assessment process compared the independently derived failure modes and criticality assignments to the proposed NASA post 51-L FMEA/CIL documentation. When possible, assessment issues were discussed and resolved with the NASA subsystem managers. Unresolved issues were elevated to the Orbiter and GFE Projects Office manager, Configuration Control Board (CCB), or Program Requirements Control Board (PRCB) for further resolution. The most important Orbiter assessment finding was the previously unknown stuck autopilot push-button criticality 1/1 failure mode. The worst case effect could cause loss of crew/vehicle when the microwave landing system is not active. It is concluded that NASA and Prime Contractor Post 51-L FMEA/CIL documentation assessed by IOA is believed to be technically accurate and complete. All CIL issues were resolved. No FMEA issues remain that have safety implications. Consideration should be given, however, to upgrading NSTS 22206 with definitive ground rules which more clearly spell out the limits of redundancy.

A streamlined failure mode and effects analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ford, Eric C., E-mail: eford@uw.edu; Smith, Koren; Terezakis, Stephanie

Purpose: Explore the feasibility and impact of a streamlined failure mode and effects analysis (FMEA) using a structured process that is designed to minimize staff effort. Methods: FMEA for the external beam process was conducted at an affiliate radiation oncology center that treats approximately 60 patients per day. A structured FMEA process was developed which included clearly defined roles and goals for each phase. A core group of seven people was identified and a facilitator was chosen to lead the effort. Failure modes were identified and scored according to the FMEA formalism. A risk priority number,RPN, was calculated and usedmore » to rank failure modes. Failure modes with RPN > 150 received safety improvement interventions. Staff effort was carefully tracked throughout the project. Results: Fifty-two failure modes were identified, 22 collected during meetings, and 30 from take-home worksheets. The four top-ranked failure modes were: delay in film check, missing pacemaker protocol/consent, critical structures not contoured, and pregnant patient simulated without the team's knowledge of the pregnancy. These four failure modes hadRPN > 150 and received safety interventions. The FMEA was completed in one month in four 1-h meetings. A total of 55 staff hours were required and, additionally, 20 h by the facilitator. Conclusions: Streamlined FMEA provides a means of accomplishing a relatively large-scale analysis with modest effort. One potential value of FMEA is that it potentially provides a means of measuring the impact of quality improvement efforts through a reduction in risk scores. Future study of this possibility is needed.« less

Failure mode and effects analysis using intuitionistic fuzzy hybrid weighted Euclidean distance operator

NASA Astrophysics Data System (ADS)

Liu, Hu-Chen; Liu, Long; Li, Ping

2014-10-01

Failure mode and effects analysis (FMEA) has shown its effectiveness in examining potential failures in products, process, designs or services and has been extensively used for safety and reliability analysis in a wide range of industries. However, its approach to prioritise failure modes through a crisp risk priority number (RPN) has been criticised as having several shortcomings. The aim of this paper is to develop an efficient and comprehensive risk assessment methodology using intuitionistic fuzzy hybrid weighted Euclidean distance (IFHWED) operator to overcome the limitations and improve the effectiveness of the traditional FMEA. The diversified and uncertain assessments given by FMEA team members are treated as linguistic terms expressed in intuitionistic fuzzy numbers (IFNs). Intuitionistic fuzzy weighted averaging (IFWA) operator is used to aggregate the FMEA team members' individual assessments into a group assessment. IFHWED operator is applied thereafter to the prioritisation and selection of failure modes. Particularly, both subjective and objective weights of risk factors are considered during the risk evaluation process. A numerical example for risk assessment is given to illustrate the proposed method finally.

Application of ISO22000 and Failure Mode and Effect Analysis (fmea) for Industrial Processing of Poultry Products

NASA Astrophysics Data System (ADS)

Varzakas, Theodoros H.; Arvanitoyannis, Ioannis S.

Failure Mode and Effect Analysis (FMEA) model has been applied for the risk assessment of poultry slaughtering and manufacturing. In this work comparison of ISO22000 analysis with HACCP is carried out over poultry slaughtering, processing and packaging. Critical Control points and Prerequisite programs (PrPs) have been identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram and fishbone diagram).

Independent Orbiter Assessment (IOA): Assessment of the mechanical actuation subsystem, volume 2

NASA Technical Reports Server (NTRS)

Bradway, M. W.; Slaughter, W. T.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine draft failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the proposed Post 51-L NASA FMEA/CIL baseline that was available. A resolution of each discrepancy from the comparison was provided through additional analysis as required. These discrepancies were flagged as issues, and recommendations were made based on the FMEA data available at the time. This report documents the results of that comparison for the Orbiter Mechanical Actuation System (MAS) hardware. Specifically, the MAS hardware consists of the following components: Air Data Probe (ADP); Elevon Seal Panel (ESP); External Tank Umbilical (ETU); Ku-Band Deploy (KBD); Payload Bay Doors (PBD); Payload Bay Radiators (PBR); Personnel Hatches (PH); Vent Door Mechanism (VDM); and Startracker Door Mechanism (SDM). Criticality was assigned based upon the severity of the effect for each failure mode. Volume 2 continues the presentation of IOA analysis worksheets and contains the potential critical items list, detailed analysis, and NASA FMEA/CIL to IOA worksheet cross reference and recommendations.

Product Quality Improvement Using FMEA for Electric Parking Brake (EPB)

NASA Astrophysics Data System (ADS)

Dumitrescu, C. D.; Gruber, G. C.; Tişcă, I. A.

2016-08-01

One of the most frequently used methods to improve product quality is complex FMEA. (Failure Modes and Effects Analyses). In the literature various FMEA is known, depending on the mode and depending on the targets; we mention here some of these names: Failure Modes and Effects Analysis Process, or analysis Failure Mode and Effects Reported (FMECA). Whatever option is supported by the work team, the goal of the method is the same: optimize product design activities in research, design processes, implementation of manufacturing processes, optimization of mining product to beneficiaries. According to a market survey conducted on parts suppliers to vehicle manufacturers FMEA method is used in 75%. One purpose of the application is that after the research and product development is considered resolved, any errors which may be detected; another purpose of applying the method is initiating appropriate measures to avoid mistakes. Achieving these two goals leads to a high level distribution in applying, to avoid errors already in the design phase of the product, thereby avoiding the emergence and development of additional costs in later stages of product manufacturing. During application of FMEA method using standardized forms; with their help will establish the initial assemblies of product structure, in which all components will be viewed without error. The work is an application of the method FMEA quality components to optimize the structure of the electrical parking brake (Electric Parching Brake - E.P.B). This is a component attached to the roller system which ensures automotive replacement of conventional mechanical parking brake while ensuring its comfort, functionality, durability and saves space in the passenger compartment. The paper describes the levels at which they appealed in applying FMEA, working arrangements in the 4 distinct levels of analysis, and how to determine the number of risk (Risk Priority Number); the analysis of risk factors and established authors who have imposed measures to reduce / eliminate risk completely exploiting this complex product.

Independent Orbiter Assessment (IOA): Assessment of the nose wheel steering subsystem

NASA Technical Reports Server (NTRS)

Mediavilla, Anthony Scott

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Nose Wheel Steering (NWS) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the proposed NASA post 51-L FMEA/CIL baseline. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter NWS hardware.

Independent Orbiter Assessment (IOA): Assessment of the active thermal control system

NASA Technical Reports Server (NTRS)

Sinclair, S. K.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Active Thermal Control System (ATCS) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the available NASA FMEA/CIL data. Discrepancies from the comparison were documented, and where enough information was available, recommendations for resolution of the discrepancies were made. This report documents the results of that comparison for the Orbiter ATCS hardware. The IOA product for the ATCS independent analysis consisted of 310 failure mode worksheets that resulted in 101 potential critical items (PCI) being identified. A comparison was made to the available NASA data which consisted of 252 FMEAs and 109 CIL items.

Independent Orbiter Assessment (IOA): Assessment of the electrical power distribution and control subsystem, volume 3

NASA Technical Reports Server (NTRS)

Schmeckpeper, K. R.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA first completed an analysis of the Electrical Power Distribution and Control (EPD and C) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter EPD and C hardware. Volume 3 continues the presentation of IOA worksheets and contains the potential critical items list and the NASA FMEA to IOA worksheet cross reference and recommendations.

Independent Orbiter Assessment (IOA): FMEA/CIL assessment

NASA Technical Reports Server (NTRS)

Saiidi, Mo J.; Swain, L. J.; Compton, J. M.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. Direction was given by the Orbiter and GFE Projects Office to perform the hardware analysis and assessment using the instructions and ground rules defined in NSTS 22206. The IOA analysis features a top-down approach to determine hardware failure modes, criticality, and potential critical items. To preserve independence, the anlaysis was accomplished without reliance upon the results contained within the NASA and prime contractor FMEA/CIL documentation. The assessment process compares the independently derived failure modes and criticality assignments to the proposed NASA Post 51-L FMEA/CIL documentation. When possible, assessment issues are discussed and resolved with the NASA subsystem managers. The assessment results for each subsystem are summarized. The most important Orbiter assessment finding was the previously unknown stuck autopilot push-button criticality 1/1 failure mode, having a worst case effect of loss of crew/vehicle when a microwave landing system is not active.

Independent Orbiter Assessment (IOA): Assessment of the orbital maneuvering subsystem, volume 2

NASA Technical Reports Server (NTRS)

Haufler, W. A.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Orbital Maneuvering System (OMS) hardware and electrical power distribution and control (EPD and C), generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the proposed Post 51-L NASA FMEA/CIL baseline. This report documents the results of that comparison for the Orbiter OMS hardware and EPD and C systems. Volume 2 continues the presentation of IOA worksheets and contains the critical items list and the NASA FMEA to IOA worksheet cross reference and recommendations.

Failure mode and effects analysis: an empirical comparison of failure mode scoring procedures.

PubMed

Ashley, Laura; Armitage, Gerry

2010-12-01

To empirically compare 2 different commonly used failure mode and effects analysis (FMEA) scoring procedures with respect to their resultant failure mode scores and prioritization: a mathematical procedure, where scores are assigned independently by FMEA team members and averaged, and a consensus procedure, where scores are agreed on by the FMEA team via discussion. A multidisciplinary team undertook a Healthcare FMEA of chemotherapy administration. This included mapping the chemotherapy process, identifying and scoring failure modes (potential errors) for each process step, and generating remedial strategies to counteract them. Failure modes were scored using both an independent mathematical procedure and a team consensus procedure. Almost three-fifths of the 30 failure modes generated were scored differently by the 2 procedures, and for just more than one-third of cases, the score discrepancy was substantial. Using the Healthcare FMEA prioritization cutoff score, almost twice as many failure modes were prioritized by the consensus procedure than by the mathematical procedure. This is the first study to empirically demonstrate that different FMEA scoring procedures can score and prioritize failure modes differently. It found considerable variability in individual team members' opinions on scores, which highlights the subjective and qualitative nature of failure mode scoring. A consensus scoring procedure may be most appropriate for FMEA as it allows variability in individuals' scores and rationales to become apparent and to be discussed and resolved by the team. It may also yield team learning and communication benefits unlikely to result from a mathematical procedure.

MO-G-BRE-09: Validating FMEA Against Incident Learning Data: A Study in Stereotactic Body Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yang, F; Cao, N; Young, L

2014-06-15

Purpose: Though FMEA (Failure Mode and Effects Analysis) is becoming more widely adopted for risk assessment in radiation therapy, to our knowledge it has never been validated against actual incident learning data. The objective of this study was to perform an FMEA analysis of an SBRT (Stereotactic Body Radiation Therapy) treatment planning process and validate this against data recorded within an incident learning system. Methods: FMEA on the SBRT treatment planning process was carried out by a multidisciplinary group including radiation oncologists, medical physicists, and dosimetrists. Potential failure modes were identified through a systematic review of the workflow process. Failuremore » modes were rated for severity, occurrence, and detectability on a scale of 1 to 10 and RPN (Risk Priority Number) was computed. Failure modes were then compared with historical reports identified as relevant to SBRT planning within a departmental incident learning system that had been active for two years. Differences were identified. Results: FMEA identified 63 failure modes. RPN values for the top 25% of failure modes ranged from 60 to 336. Analysis of the incident learning database identified 33 reported near-miss events related to SBRT planning. FMEA failed to anticipate 13 of these events, among which 3 were registered with severity ratings of severe or critical in the incident learning system. Combining both methods yielded a total of 76 failure modes, and when scored for RPN the 13 events missed by FMEA ranked within the middle half of all failure modes. Conclusion: FMEA, though valuable, is subject to certain limitations, among them the limited ability to anticipate all potential errors for a given process. This FMEA exercise failed to identify a significant number of possible errors (17%). Integration of FMEA with retrospective incident data may be able to render an improved overview of risks within a process.« less

Failure Mode and Effect Analysis (FMEA) may enhance implementation of clinical practice guidelines: An experience from the Middle East.

PubMed

Babiker, Amir; Amer, Yasser S; Osman, Mohamed E; Al-Eyadhy, Ayman; Fatani, Solafa; Mohamed, Sarar; Alnemri, Abdulrahman; Titi, Maher A; Shaikh, Farheen; Alswat, Khalid A; Wahabi, Hayfaa A; Al-Ansary, Lubna A

2018-02-01

Implementation of clinical practice guidelines (CPGs) has been shown to reduce variation in practice and improve health care quality and patients' safety. There is a limited experience of CPG implementation (CPGI) in the Middle East. The CPG program in our institution was launched in 2009. The Quality Management department conducted a Failure Mode and Effect Analysis (FMEA) for further improvement of CPGI. This is a prospective study of a qualitative/quantitative design. Our FMEA included (1) process review and recording of the steps and activities of CPGI; (2) hazard analysis by recording activity-related failure modes and their effects, identification of actions required, assigned severity, occurrence, and detection scores for each failure mode and calculated the risk priority number (RPN) by using an online interactive FMEA tool; (3) planning: RPNs were prioritized, recommendations, and further planning for new interventions were identified; and (4) monitoring: after reduction or elimination of the failure mode. The calculated RPN will be compared with subsequent analysis in post-implementation phase. The data were scrutinized from a feedback of quality team members using a FMEA framework to enhance the implementation of 29 adapted CPGs. The identified potential common failure modes with the highest RPN (≥ 80) included awareness/training activities, accessibility of CPGs, fewer advocates from clinical champions, and CPGs auditing. Actions included (1) organizing regular awareness activities, (2) making CPGs printed and electronic copies accessible, (3) encouraging senior practitioners to get involved in CPGI, and (4) enhancing CPGs auditing as part of the quality sustainability plan. In our experience, FMEA could be a useful tool to enhance CPGI. It helped us to identify potential barriers and prepare relevant solutions. © 2017 John Wiley & Sons, Ltd.

Independent Orbiter Assessment (IOA): Assessment of the orbital maneuvering system FMEA/CIL, volume 1

NASA Technical Reports Server (NTRS)

Prust, Chet D.; Haufler, W. A.; Marino, A. J.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Orbital Maneuvering System (OMS) hardware and Electrical Power Distribution and Control (EPD and C), generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the proposed Post 51-L NASA FMEA/CIL baseline. This report documents the results of that comparison for the Orbiter OMS hardware. The IOA analysis defined the OMS as being comprised of the following subsystems: helium pressurization, propellant storage and distribution, Orbital Maneuvering Engine, and EPD and C. The IOA product for the OMS analysis consisted of 284 hardware and 667 EPD and C failure mode worksheets that resulted in 160 hardware and 216 EPD and C potential critical items (PCIs) being identified. A comparison was made of the IOA product to the NASA FMEA/CIL baseline which consisted of 101 hardware and 142 EPD and C CIL items.

Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct

PubMed Central

Baik, Jungmi; Kim, Hyunjung; Kim, Rachel

2017-01-01

Background Failure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting. Methods A multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later. Results A total of 114 failure modes were identified with an RPN score ranging 3–378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively. Conclusions FMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes. PMID:29089745

Application of ISO 22000 and Failure Mode and Effect Analysis (FMEA) for industrial processing of salmon: a case study.

PubMed

Arvanitoyannis, Ioannis S; Varzakas, Theodoros H

2008-05-01

The Failure Mode and Effect Analysis (FMEA) model was applied for risk assessment of salmon manufacturing. A tentative approach of FMEA application to the salmon industry was attempted in conjunction with ISO 22000. Preliminary Hazard Analysis was used to analyze and predict the occurring failure modes in a food chain system (salmon processing plant), based on the functions, characteristics, and/or interactions of the ingredients or the processes, upon which the system depends. Critical Control points were identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram and fishbone diagram). In this work, a comparison of ISO 22000 analysis with HACCP is carried out over salmon processing and packaging. However, the main emphasis was put on the quantification of risk assessment by determining the RPN per identified processing hazard. Fish receiving, casing/marking, blood removal, evisceration, filet-making cooling/freezing, and distribution were the processes identified as the ones with the highest RPN (252, 240, 210, 210, 210, 210, 200 respectively) and corrective actions were undertaken. After the application of corrective actions, a second calculation of RPN values was carried out resulting in substantially lower values (below the upper acceptable limit of 130). It is noteworthy that the application of Ishikawa (Cause and Effect or Tree diagram) led to converging results thus corroborating the validity of conclusions derived from risk assessment and FMEA. Therefore, the incorporation of FMEA analysis within the ISO 22000 system of a salmon processing industry is anticipated to prove advantageous to industrialists, state food inspectors, and consumers.

FMEA: a model for reducing medical errors.

PubMed

Chiozza, Maria Laura; Ponzetti, Clemente

2009-06-01

Patient safety is a management issue, in view of the fact that clinical risk management has become an important part of hospital management. Failure Mode and Effect Analysis (FMEA) is a proactive technique for error detection and reduction, firstly introduced within the aerospace industry in the 1960s. Early applications in the health care industry dating back to the 1990s included critical systems in the development and manufacture of drugs and in the prevention of medication errors in hospitals. In 2008, the Technical Committee of the International Organization for Standardization (ISO), licensed a technical specification for medical laboratories suggesting FMEA as a method for prospective risk analysis of high-risk processes. Here we describe the main steps of the FMEA process and review data available on the application of this technique to laboratory medicine. A significant reduction of the risk priority number (RPN) was obtained when applying FMEA to blood cross-matching, to clinical chemistry analytes, as well as to point-of-care testing (POCT).

Application of ISO22000, failure mode, and effect analysis (FMEA) cause and effect diagrams and pareto in conjunction with HACCP and risk assessment for processing of pastry products.

PubMed

Varzakas, Theodoros H

2011-09-01

The Failure Mode and Effect Analysis (FMEA) model has been applied for the risk assessment of pastry processing. A tentative approach of FMEA application to the pastry industry was attempted in conjunction with ISO22000. Preliminary Hazard Analysis was used to analyze and predict the occurring failure modes in a food chain system (pastry processing plant), based on the functions, characteristics, and/or interactions of the ingredients or the processes, upon which the system depends. Critical Control points have been identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram, and fishbone diagram). In this work a comparison of ISO22000 analysis with HACCP is carried out over pastry processing and packaging. However, the main emphasis was put on the quantification of risk assessment by determining the Risk Priority Number (RPN) per identified processing hazard. Storage of raw materials and storage of final products at -18°C followed by freezing were the processes identified as the ones with the highest RPN (225, 225, and 144 respectively) and corrective actions were undertaken. Following the application of corrective actions, a second calculation of RPN values was carried out leading to considerably lower values (below the upper acceptable limit of 130). It is noteworthy that the application of Ishikawa (Cause and Effect or Tree diagram) led to converging results thus corroborating the validity of conclusions derived from risk assessment and FMEA. Therefore, the incorporation of FMEA analysis within the ISO22000 system of a pastry processing industry is considered imperative.

Clinical risk analysis with failure mode and effect analysis (FMEA) model in a dialysis unit.

PubMed

Bonfant, Giovanna; Belfanti, Pietro; Paternoster, Giuseppe; Gabrielli, Danila; Gaiter, Alberto M; Manes, Massimo; Molino, Andrea; Pellu, Valentina; Ponzetti, Clemente; Farina, Massimo; Nebiolo, Pier E

2010-01-01

The aim of clinical risk management is to improve the quality of care provided by health care organizations and to assure patients' safety. Failure mode and effect analysis (FMEA) is a tool employed for clinical risk reduction. We applied FMEA to chronic hemodialysis outpatients. FMEA steps: (i) process study: we recorded phases and activities. (ii) Hazard analysis: we listed activity-related failure modes and their effects; described control measures; assigned severity, occurrence and detection scores for each failure mode and calculated the risk priority numbers (RPNs) by multiplying the 3 scores. Total RPN is calculated by adding single failure mode RPN. (iii) Planning: we performed a RPNs prioritization on a priority matrix taking into account the 3 scores, and we analyzed failure modes causes, made recommendations and planned new control measures. (iv) Monitoring: after failure mode elimination or reduction, we compared the resulting RPN with the previous one. Our failure modes with the highest RPN came from communication and organization problems. Two tools have been created to ameliorate information flow: "dialysis agenda" software and nursing datasheets. We scheduled nephrological examinations, and we changed both medical and nursing organization. Total RPN value decreased from 892 to 815 (8.6%) after reorganization. Employing FMEA, we worked on a few critical activities, and we reduced patients' clinical risk. A priority matrix also takes into account the weight of the control measures: we believe this evaluation is quick, because of simple priority selection, and that it decreases action times.

Independent Orbiter Assessment (IOA): Assessment of the life support and airlock support systems, volume 2

NASA Technical Reports Server (NTRS)

Barickman, K.

1988-01-01

The McDonnell Douglas Astronautics Company (MDAC) was selected in June 1986 to perform an Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL). The IOA effort first completed an analysis of the Life Support and Airlock Support Systems (LSS and ALSS) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. The discrepancies were flagged for potential future resolution. This report documents the results of that comparison for the Orbiter LSS and ALSS hardware. Volume 2 continues the presentation of IOA worksheets and contains the critical items list and NASA FMEA to IOA worksheet cross reference and recommendations.

Independent Orbiter Assessment (IOA): Assessment of the reaction control system, volume 5

NASA Technical Reports Server (NTRS)

Prust, Chet D.; Hartman, Dan W.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the aft and forward Reaction Control System (RCS) hardware and Electrical Power Distribution and Control (EPD and C), generating draft failure modes and potential critical items. The IOA results were then compared to the proposed Post 51-L NASA FMEA/CIL baseline. This report documents the results of that comparison for the Orbiter RCS hardware and EPD and C systems. Volume 5 contains detailed analysis and superseded analysis worksheets and the NASA FMEA to IOA worksheet cross reference and recommendations.

Independent Orbiter Assessment (IOA): Assessment of the communication and tracking subsystem, volume 3

NASA Technical Reports Server (NTRS)

Long, W. C.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed and analysis of the Communication and Tracking hardware, generating draft failure modes and potential critical items. The IOA results were then compared to the NASA FMEA/CIL baseline. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter Communication and Tracking hardware. Volume 3 continues the presentation of IOA worksheets and contains the potential critical items list, detailed analysis, and the NASA FMEA to IOA worksheet cross reference and recommendations.

Independent Orbiter Assessment (IOA): Assessment of the extravehicular mobility unit, volume 1

NASA Technical Reports Server (NTRS)

Raffaelli, Gary G.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort performed an independent analysis of the Extravehicular Mobility Unit (EMU) hardware and system, generating draft failure modes criticalities and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were than compared to the most recent proposed Post 51-L NASA FMEA/CIL baseline. A resolution of each discrepancy from the comparison was provided through additional analysis as required. This report documents the results of that comparison for the Orbiter EMU hardware.

Composable Framework Support for Software-FMEA Through Model Execution

NASA Astrophysics Data System (ADS)

Kocsis, Imre; Patricia, Andras; Brancati, Francesco; Rossi, Francesco

2016-08-01

Performing Failure Modes and Effect Analysis (FMEA) during software architecture design is becoming a basic requirement in an increasing number of domains; however, due to the lack of standardized early design phase model execution, classic SW-FMEA approaches carry significant risks and are human effort-intensive even in processes that use Model-Driven Engineering.Recently, modelling languages with standardized executable semantics have emerged. Building on earlier results, this paper describes framework support for generating executable error propagation models from such models during software architecture design. The approach carries the promise of increased precision, decreased risk and more automated execution for SW-FMEA during dependability- critical system development.

Independent Orbiter Assessment (IOA): Assessment of the communication and tracking subsystem, volume 1

NASA Technical Reports Server (NTRS)

Long, W. C.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed and analysis of the Communication and Tracking hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter Communication and Tracking hardware. The IOA product for the Communication and Tracking consisted of 1,108 failure mode worksheets that resulted in 298 critical items being identified. Comparison was made to the NASA baseline which consists of 697 FMEAs and 239 CIL items. The comparison determined if there were any results which had been found by IOA but were not in the NASA baseline. This comparison produced agreement on all but 407 FMEAs which caused differences in 294 CIL items. Volume 1 contains the subsystem description, assessment results, ground rules and assumptions, and some of the IOA worksheets.

TU-FG-201-11: Evaluating the Validity of Prospective Risk Analysis Methods: A Comparison of Traditional FMEA and Modified Healthcare FMEA

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lah, J; Manger, R; Kim, G

Purpose: To examine the ability of traditional Failure mode and effects analysis (FMEA) and a light version of Healthcare FMEA (HFMEA), called Scenario analysis of FMEA (SAFER) by comparing their outputs in terms of the risks identified and their severity rankings. Methods: We applied two prospective methods of the quality management to surface image guided, linac-based radiosurgery (SIG-RS). For the traditional FMEA, decisions on how to improve an operation are based on risk priority number (RPN). RPN is a product of three indices: occurrence, severity and detectability. The SAFER approach; utilized two indices-frequency and severity-which were defined by a multidisciplinarymore » team. A criticality matrix was divided into 4 categories; very low, low, high and very high. For high risk events, an additional evaluation was performed. Based upon the criticality of the process, it was decided if additional safety measures were needed and what they comprise. Results: Two methods were independently compared to determine if the results and rated risks were matching or not. Our results showed an agreement of 67% between FMEA and SAFER approaches for the 15 riskiest SIG-specific failure modes. The main differences between the two approaches were the distribution of the values and the failure modes (No.52, 54, 154) that have high SAFER scores do not necessarily have high FMEA RPN scores. In our results, there were additional risks identified by both methods with little correspondence. In the SAFER, when the risk score is determined, the basis of the established decision tree or the failure mode should be more investigated. Conclusion: The FMEA method takes into account the probability that an error passes without being detected. SAFER is inductive because it requires the identification of the consequences from causes, and semi-quantitative since it allow the prioritization of risks and mitigation measures, and thus is perfectly applicable to clinical parts of radiotherapy.« less

Independent Orbiter Assessment (IOA): Assessment of the electrical power distribution and control subsystem, volume 1

NASA Technical Reports Server (NTRS)

Schmeckpeper, K. R.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA first completed an analysis of the Electrical Power Distribution and Control (EPD and C) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter EPD and C hardware. The IOA product for the EPD and C analysis consisted of 1671 failure mode analysis worksheets that resulted in 468 potential critical items being identified. Comparison was made to the proposed NASA Post 51-L baseline which consisted of FMEAs and 158 CIL items. Volume 1 contains the EPD and C subsystem description, analysis results, ground rules and assumptions, and some of the IOA worksheets.

The role of failure modes and effects analysis in showing the benefits of automation in the blood bank.

PubMed

Han, Tae Hee; Kim, Moon Jung; Kim, Shinyoung; Kim, Hyun Ok; Lee, Mi Ae; Choi, Ji Seon; Hur, Mina; St John, Andrew

2013-05-01

Failure modes and effects analysis (FMEA) is a risk management tool used by the manufacturing industry but now being applied in laboratories. Teams from six South Korean blood banks used this tool to map their manual and automated blood grouping processes and determine the risk priority numbers (RPNs) as a total measure of error risk. The RPNs determined by each of the teams consistently showed that the use of automation dramatically reduced the RPN compared to manual processes. In addition, FMEA showed where the major risks occur in each of the manual processes and where attention should be prioritized to improve the process. Despite no previous experience with FMEA, the teams found the technique relatively easy to use and the subjectivity associated with assigning risk numbers did not affect the validity of the data. FMEA should become a routine technique for improving processes in laboratories. © 2012 American Association of Blood Banks.

A comparison of two prospective risk analysis methods: Traditional FMEA and a modified healthcare FMEA.

PubMed

Rah, Jeong-Eun; Manger, Ryan P; Yock, Adam D; Kim, Gwe-Ya

2016-12-01

To examine the abilities of a traditional failure mode and effects analysis (FMEA) and modified healthcare FMEA (m-HFMEA) scoring methods by comparing the degree of congruence in identifying high risk failures. The authors applied two prospective methods of the quality management to surface image guided, linac-based radiosurgery (SIG-RS). For the traditional FMEA, decisions on how to improve an operation were based on the risk priority number (RPN). The RPN is a product of three indices: occurrence, severity, and detectability. The m-HFMEA approach utilized two indices, severity and frequency. A risk inventory matrix was divided into four categories: very low, low, high, and very high. For high risk events, an additional evaluation was performed. Based upon the criticality of the process, it was decided if additional safety measures were needed and what they comprise. The two methods were independently compared to determine if the results and rated risks matched. The authors' results showed an agreement of 85% between FMEA and m-HFMEA approaches for top 20 risks of SIG-RS-specific failure modes. The main differences between the two approaches were the distribution of the values and the observation that failure modes (52, 54, 154) with high m-HFMEA scores do not necessarily have high FMEA-RPN scores. In the m-HFMEA analysis, when the risk score is determined, the basis of the established HFMEA Decision Tree™ or the failure mode should be more thoroughly investigated. m-HFMEA is inductive because it requires the identification of the consequences from causes, and semi-quantitative since it allows the prioritization of high risks and mitigation measures. It is therefore a useful tool for the prospective risk analysis method to radiotherapy.

A Proposal of Operational Risk Management Method Using FMEA for Drug Manufacturing Computerized System

NASA Astrophysics Data System (ADS)

Takahashi, Masakazu; Nanba, Reiji; Fukue, Yoshinori

This paper proposes operational Risk Management (RM) method using Failure Mode and Effects Analysis (FMEA) for drug manufacturing computerlized system (DMCS). The quality of drug must not be influenced by failures and operational mistakes of DMCS. To avoid such situation, DMCS has to be conducted enough risk assessment and taken precautions. We propose operational RM method using FMEA for DMCS. To propose the method, we gathered and compared the FMEA results of DMCS, and develop a list that contains failure modes, failures and countermeasures. To apply this list, we can conduct RM in design phase, find failures, and conduct countermeasures efficiently. Additionally, we can find some failures that have not been found yet.

EVALUATION OF SAFETY IN A RADIATION ONCOLOGY SETTING USING FAILURE MODE AND EFFECTS ANALYSIS

PubMed Central

Ford, Eric C.; Gaudette, Ray; Myers, Lee; Vanderver, Bruce; Engineer, Lilly; Zellars, Richard; Song, Danny Y.; Wong, John; DeWeese, Theodore L.

2013-01-01

Purpose Failure mode and effects analysis (FMEA) is a widely used tool for prospectively evaluating safety and reliability. We report our experiences in applying FMEA in the setting of radiation oncology. Methods and Materials We performed an FMEA analysis for our external beam radiation therapy service, which consisted of the following tasks: (1) create a visual map of the process, (2) identify possible failure modes; assign risk probability numbers (RPN) to each failure mode based on tabulated scores for the severity, frequency of occurrence, and detectability, each on a scale of 1 to 10; and (3) identify improvements that are both feasible and effective. The RPN scores can span a range of 1 to 1000, with higher scores indicating the relative importance of a given failure mode. Results Our process map consisted of 269 different nodes. We identified 127 possible failure modes with RPN scores ranging from 2 to 160. Fifteen of the top-ranked failure modes were considered for process improvements, representing RPN scores of 75 and more. These specific improvement suggestions were incorporated into our practice with a review and implementation by each department team responsible for the process. Conclusions The FMEA technique provides a systematic method for finding vulnerabilities in a process before they result in an error. The FMEA framework can naturally incorporate further quantification and monitoring. A general-use system for incident and near miss reporting would be useful in this regard. PMID:19409731

Independent Orbiter Assessment (IOA): Assessment of the mechanical actuation subsystem, volume 1

NASA Technical Reports Server (NTRS)

Bradway, M. W.; Slaughter, W. T.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine draft failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the proposed Post 51-L NASA FMEA/CIL baseline that was available. A resolution of each discrepancy from the comparison was provided through additional analysis as required. These discrepancies were flagged as issues, and recommendations were made based on the FMEA data available at the time. This report documents the results of that comparison for the Orbiter Mechanical Actuation System (MAS) hardware. Specifically, the MAS hardware consists of the following components: Air Data Probe (ADP); Elevon Seal Panel (ESP); External Tank Umbilical (ETU); Ku-Band Deploy (KBD); Payload Bay Doors (PBD); Payload Bay Radiators (PBR); Personnel Hatches (PH); Vent Door Mechanism (VDM); and Startracker Door Mechanism (SDM). Criticality was assigned based upon the severity of the effect for each failure mode.

Benchmarking Commercial Reliability Practices.

DTIC Science & Technology

1995-07-01

companies (70% of total), and to actually receive completed survey forms from 40 companies ( 60 % of participants, 40% of total identified). Reliability...E -20 -30 - A B C D E F G H I J KL MN OP Q R -40 - A = FMEA , B = FTA, C =Thermal Analysis, D = Sneak Circuit Analysis, E = Worst-Case Circuit Analysis...Failure Modes and Effects Analysis ( FMEA ), will be conducted. c. Commercial companies specify the environmental conditions for their products. In doing

Independent Orbiter Assessment (IOA): FMEA/CIL instructions and ground rules

NASA Technical Reports Server (NTRS)

Traves, S. T.

1986-01-01

The McDonnell Douglas Astronautics Company was selected to conduct an independent assessment of the Orbiter Failure Mode and Effects Analysis/Critical Items List (FMEA/CIL). Part of this effort involved an examination of the FMEA/CIL preparation instructions and ground rules. Assessment objectives were to identify omissions and ambiguities in the ground rules that may impede the identification of shuttle orbiter safety and mission critical items, and to ensure that ground rules allow these items to receive proper management visibility for risk assessment. Assessment objectives were followed during the performance of the assessment without being influenced by external considerations such as effects on budget, schedule, and documentation growth. Assessment personnel were employed who had a strong reliability background but no previous space shuttle FMEA/CIL experience to ensure an independent assessment would be achieved. The following observations were made: (1) not all essential items are in the CIL for management visibility; (2) ground rules omit FMEA/CIL coverage of items that perform critical functions; (3) essential items excluded from the CIL do not receive design justification; and (4) FMEAs/CILs are not updated in a timely manner. In addition to the above issues, a number of other issues were identified that correct FMEA/CIL preparation instruction omissions and clarify ambiguities. The assessment was successful in that many of the issues have significant safety implications.

Independent Orbiter Assessment (IOA): Assessment of the Orbiter Experiment (OEX) subsystem

NASA Technical Reports Server (NTRS)

Compton, J. M.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Orbiter Experiments (OEX) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. The results of that comparison for the Orbiter OEX hardware are documented. The IOA product for the OEX analysis consisted of 82 failure mode worksheets that resulted in two potential critical items being identified.

Preventing blood transfusion failures: FMEA, an effective assessment method.

PubMed

Najafpour, Zhila; Hasoumi, Mojtaba; Behzadi, Faranak; Mohamadi, Efat; Jafary, Mohamadreza; Saeedi, Morteza

2017-06-30

Failure Mode and Effect Analysis (FMEA) is a method used to assess the risk of failures and harms to patients during the medical process and to identify the associated clinical issues. The aim of this study was to conduct an assessment of blood transfusion process in a teaching general hospital, using FMEA as the method. A structured FMEA was recruited in our study performed in 2014, and corrective actions were implemented and re-evaluated after 6 months. Sixteen 2-h sessions were held to perform FMEA in the blood transfusion process, including five steps: establishing the context, selecting team members, analysis of the processes, hazard analysis, and developing a risk reduction protocol for blood transfusion. Failure modes with the highest risk priority numbers (RPNs) were identified. The overall RPN scores ranged from 5 to 100 among which, four failure modes were associated with RPNs over 75. The data analysis indicated that failures with the highest RPNs were: labelling (RPN: 100), transfusion of blood or the component (RPN: 100), patient identification (RPN: 80) and sampling (RPN: 75). The results demonstrated that mis-transfusion of blood or blood component is the most important error, which can lead to serious morbidity or mortality. Provision of training to the personnel on blood transfusion, knowledge raising on hazards and appropriate preventative measures, as well as developing standard safety guidelines are essential, and must be implemented during all steps of blood and blood component transfusion.

Failure mode and effects analysis of witnessing protocols for ensuring traceability during IVF.

PubMed

Rienzi, Laura; Bariani, Fiorenza; Dalla Zorza, Michela; Romano, Stefania; Scarica, Catello; Maggiulli, Roberta; Nanni Costa, Alessandro; Ubaldi, Filippo Maria

2015-10-01

Traceability of cells during IVF is a fundamental aspect of treatment, and involves witnessing protocols. Failure mode and effects analysis (FMEA) is a method of identifying real or potential breakdowns in processes, and allows strategies to mitigate risks to be developed. To examine the risks associated with witnessing protocols, an FMEA was carried out in a busy IVF centre, before and after implementation of an electronic witnessing system (EWS). A multidisciplinary team was formed and moderated by human factors specialists. Possible causes of failures, and their potential effects, were identified and risk priority number (RPN) for each failure calculated. A second FMEA analysis was carried out after implementation of an EWS. The IVF team identified seven main process phases, 19 associated process steps and 32 possible failure modes. The highest RPN was 30, confirming the relatively low risk that mismatches may occur in IVF when a manual witnessing system is used. The introduction of the EWS allowed a reduction in the moderate-risk failure mode by two-thirds (highest RPN = 10). In our experience, FMEA is effective in supporting multidisciplinary IVF groups to understand the witnessing process, identifying critical steps and planning changes in practice to enable safety to be enhanced. Copyright © 2015 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Application of failure mode and effect analysis in an assisted reproduction technology laboratory.

PubMed

Intra, Giulia; Alteri, Alessandra; Corti, Laura; Rabellotti, Elisa; Papaleo, Enrico; Restelli, Liliana; Biondo, Stefania; Garancini, Maria Paola; Candiani, Massimo; Viganò, Paola

2016-08-01

Assisted reproduction technology laboratories have a very high degree of complexity. Mismatches of gametes or embryos can occur, with catastrophic consequences for patients. To minimize the risk of error, a multi-institutional working group applied failure mode and effects analysis (FMEA) to each critical activity/step as a method of risk assessment. This analysis led to the identification of the potential failure modes, together with their causes and effects, using the risk priority number (RPN) scoring system. In total, 11 individual steps and 68 different potential failure modes were identified. The highest ranked failure modes, with an RPN score of 25, encompassed 17 failures and pertained to "patient mismatch" and "biological sample mismatch". The maximum reduction in risk, with RPN reduced from 25 to 5, was mostly related to the introduction of witnessing. The critical failure modes in sample processing were improved by 50% in the RPN by focusing on staff training. Three indicators of FMEA success, based on technical skill, competence and traceability, have been evaluated after FMEA implementation. Witnessing by a second human operator should be introduced in the laboratory to avoid sample mix-ups. These findings confirm that FMEA can effectively reduce errors in assisted reproduction technology laboratories. Copyright © 2016 Reproductive Healthcare Ltd. Published by Elsevier Ltd. All rights reserved.

Comprehensive protocol of traceability during IVF: the result of a multicentre failure mode and effect analysis.

PubMed

Rienzi, L; Bariani, F; Dalla Zorza, M; Albani, E; Benini, F; Chamayou, S; Minasi, M G; Parmegiani, L; Restelli, L; Vizziello, G; Costa, A Nanni

2017-08-01

Can traceability of gametes and embryos be ensured during IVF? The use of a simple and comprehensive traceability system that includes the most susceptible phases during the IVF process minimizes the risk of mismatches. Mismatches in IVF are very rare but unfortunately possible with dramatic consequences for both patients and health care professionals. Traceability is thus a fundamental aspect of the treatment. A clear process of patient and cell identification involving witnessing protocols has to be in place in every unit. To identify potential failures in the traceability process and to develop strategies to mitigate the risk of mismatches, previously failure mode and effects analysis (FMEA) has been used effectively. The FMEA approach is however a subjective analysis, strictly related to specific protocols and thus the results are not always widely applicable. To reduce subjectivity and to obtain a widespread comprehensive protocol of traceability, a multicentre centrally coordinated FMEA was performed. Seven representative Italian centres (three public and four private) were selected. The study had a duration of 21 months (from April 2015 to December 2016) and was centrally coordinated by a team of experts: a risk analysis specialist, an expert embryologist and a specialist in human factor. Principal investigators of each centre were first instructed about proactive risk assessment and FMEA methodology. A multidisciplinary team to perform the FMEA analysis was then formed in each centre. After mapping the traceability process, each team identified the possible causes of mistakes in their protocol. A risk priority number (RPN) for each identified potential failure mode was calculated. The results of the FMEA analyses were centrally investigated and consistent corrective measures suggested. The teams performed new FMEA analyses after the recommended implementations. In each centre, this study involved: the laboratory director, the Quality Control & Quality Assurance responsible, Embryologist(s), Gynaecologist(s), Nurse(s) and Administration. The FMEA analyses were performed according to the Joint Commission International. The FMEA teams identified seven main process phases: oocyte collection, sperm collection, gamete processing, insemination, embryo culture, embryo transfer and gamete/embryo cryopreservation. A mean of 19.3 (SD ± 5.8) associated process steps and 41.9 (SD ± 12.4) possible failure modes were recognized per centre. A RPN ≥15 was calculated in a mean of 6.4 steps (range 2-12, SD ± 3.60). A total of 293 failure modes were centrally analysed 45 of which were considered at medium/high risk. After consistent corrective measures implementation and re-evaluation, a significant reduction in the RPNs in all centres (RPN <15 for all steps) was observed. A simple and comprehensive traceability system was designed as the result of the seven FMEA analyses. The validity of FMEA is in general questionable due to the subjectivity of the judgments. The design of this study has however minimized this risk by introducing external experts for the analysis of the FMEA results. Specific situations such as sperm/oocyte donation, import/export and pre-implantation genetic testing were not taken into consideration. Finally, this study is only limited to the analysis of failure modes that may lead to mismatches, other possible procedural mistakes are not accounted for. Every single IVF centre should have a clear and reliable protocol for identification of patients and traceability of cells during manipulation. The results of this study can support IVF groups in better recognizing critical steps in their protocols, understanding identification and witnessing process, and in turn enhancing safety by introducing validated corrective measures. This study was designed by the Italian Society of Embryology Reproduction and Research (SIERR) and funded by the Italian National Transplant Centre (CNT) of the Italian National Institute of Health (ISS). The authors have no conflicts of interest. N/A. © The Author 2017. Published by Oxford University Press on behalf of the European Society of Human Reproduction and Embryology. All rights reserved. For Permissions, please e-mail: journals.permissions@oup.com

Application of Risk Assessment Tools in the Continuous Risk Management (CRM) Process

NASA Technical Reports Server (NTRS)

Ray, Paul S.

2002-01-01

Marshall Space Flight Center (MSFC) of the National Aeronautics and Space Administration (NASA) is currently implementing the Continuous Risk Management (CRM) Program developed by the Carnegie Mellon University and recommended by NASA as the Risk Management (RM) implementation approach. The four most frequently used risk assessment tools in the center are: (a) Failure Modes and Effects Analysis (FMEA), Hazard Analysis (HA), Fault Tree Analysis (FTA), and Probabilistic Risk Analysis (PRA). There are some guidelines for selecting the type of risk assessment tools during the project formulation phase of a project, but there is not enough guidance as to how to apply these tools in the Continuous Risk Management process (CRM). But the ways the safety and risk assessment tools are used make a significant difference in the effectiveness in the risk management function. Decisions regarding, what events are to be included in the analysis, to what level of details should the analysis be continued, make significant difference in the effectiveness of risk management program. Tools of risk analysis also depends on the phase of a project e.g. at the initial phase of a project, when not much data are available on hardware, standard FMEA cannot be applied; instead a functional FMEA may be appropriate. This study attempted to provide some directives to alleviate the difficulty in applying FTA, PRA, and FMEA in the CRM process. Hazard Analysis was not included in the scope of the study due to the short duration of the summer research project.

A failure modes and effects analysis study for gynecologic high-dose-rate brachytherapy.

PubMed

Mayadev, Jyoti; Dieterich, Sonja; Harse, Rick; Lentz, Susan; Mathai, Mathew; Boddu, Sunita; Kern, Marianne; Courquin, Jean; Stern, Robin L

2015-01-01

To improve the quality of our gynecologic brachytherapy practice and reduce reportable events, we performed a process analysis after the failure modes and effects analysis (FMEA). The FMEA included a multidisciplinary team specifically targeting the tandem and ring brachytherapy procedure. The treatment process was divided into six subprocesses and failure modes (FMs). A scoring guideline was developed based on published FMEA studies and assigned through team consensus. FMs were ranked according to overall and severity scores. FM ranking >5% of the highest risk priority number (RPN) score was selected for in-depth analysis. The efficiency of each existing quality assurance to detect each FM was analyzed. We identified 170 FMs, and 99 were scored. RPN scores ranged from 1 to 192. Of the 13 highest-ranking FMs with RPN scores >80, half had severity scores of 8 or 9, with no mode having severity of 10. Of these FM, the originating process steps were simulation (5), treatment planning (5), treatment delivery (2), and insertion (1). Our high-ranking FM focused on communication and the potential for applicator movement. Evaluation of the efficiency and the comprehensiveness of our quality assurance program showed coverage of all but three of the top 49 FMs ranked by RPN. This is the first reported FMEA process for a comprehensive gynecologic brachytherapy procedure overview. We were able to identify FMs that could potentially and severely impact the patient's treatment. We continue to adjust our quality assurance program based on the results of our FMEA analysis. Published by Elsevier Inc.

Independent Orbiter Assessment (IOA): Assessment of the Electrical Power Distribution and Control Subsystem, Volume 2

NASA Technical Reports Server (NTRS)

Schmeckpeper, K. R.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA first completed an analysis of the Electrical Power Distribution and Control (EPD and C) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter EPD and C hardware. Volume 2 continues the presentation of IOA worksheets.

Laser Beam Failure Mode Effects and Analysis (FMEA) of the Solid State Heat Capacity Laser (SSHCL)

DOE Office of Scientific and Technical Information (OSTI.GOV)

King, J.

2015-09-07

A laser beam related FMEA of the SSHCL was performed to determine potential personnel and equipment safety issues. As part of the FMEA, a request was made to test a sample of the drywall material used for walls in the room for burn-through. This material was tested with a full power beam for five seconds. The surface paper material burned off and the inner calcium carbonate turned from white to brown. The result of the test is shown in the photo below.

Failure mode and effect analysis oriented to risk-reduction interventions in intraoperative electron radiation therapy: the specific impact of patient transportation, automation, and treatment planning availability.

PubMed

López-Tarjuelo, Juan; Bouché-Babiloni, Ana; Santos-Serra, Agustín; Morillo-Macías, Virginia; Calvo, Felipe A; Kubyshin, Yuri; Ferrer-Albiach, Carlos

2014-11-01

Industrial companies use failure mode and effect analysis (FMEA) to improve quality. Our objective was to describe an FMEA and subsequent interventions for an automated intraoperative electron radiotherapy (IOERT) procedure with computed tomography simulation, pre-planning, and a fixed conventional linear accelerator. A process map, an FMEA, and a fault tree analysis are reported. The equipment considered was the radiance treatment planning system (TPS), the Elekta Precise linac, and TN-502RDM-H metal-oxide-semiconductor-field-effect transistor in vivo dosimeters. Computerized order-entry and treatment-automation were also analyzed. Fifty-seven potential modes and effects were identified and classified into 'treatment cancellation' and 'delivering an unintended dose'. They were graded from 'inconvenience' or 'suboptimal treatment' to 'total cancellation' or 'potentially wrong' or 'very wrong administered dose', although these latter effects were never experienced. Risk priority numbers (RPNs) ranged from 3 to 324 and totaled 4804. After interventions such as double checking, interlocking, automation, and structural changes the final total RPN was reduced to 1320. FMEA is crucial for prioritizing risk-reduction interventions. In a semi-surgical procedure like IOERT double checking has the potential to reduce risk and improve quality. Interlocks and automation should also be implemented to increase the safety of the procedure. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Failure Modes and Effects Analysis (FMEA): A Bibliography

NASA Technical Reports Server (NTRS)

2000-01-01

Failure modes and effects analysis (FMEA) is a bottom-up analytical process that identifies process hazards, which helps managers understand vulnerabilities of systems, as well as assess and mitigate risk. It is one of several engineering tools and techniques available to program and project managers aimed at increasing the likelihood of safe and successful NASA programs and missions. This bibliography references 465 documents in the NASA STI Database that contain the major concepts, failure modes or failure analysis, in either the basic index of the major subject terms.

Preliminary Failure Modes and Effects Analysis of the US DCLL Test Blanket Module

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee C. Cadwallader

2010-06-01

This report presents the results of a preliminary failure modes and effects analysis (FMEA) of a small tritium-breeding test blanket module design for the International Thermonuclear Experimental Reactor. The FMEA was quantified with “generic” component failure rate data, and the failure events are binned into postulated initiating event families and frequency categories for safety assessment. An appendix to this report contains repair time data to support an occupational radiation exposure assessment for test blanket module maintenance.

Preliminary Failure Modes and Effects Analysis of the US DCLL Test Blanket Module

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lee C. Cadwallader

2007-08-01

This report presents the results of a preliminary failure modes and effects analysis (FMEA) of a small tritium-breeding test blanket module design for the International Thermonuclear Experimental Reactor. The FMEA was quantified with “generic” component failure rate data, and the failure events are binned into postulated initiating event families and frequency categories for safety assessment. An appendix to this report contains repair time data to support an occupational radiation exposure assessment for test blanket module maintenance.

Independent Orbiter Assessment (IOA): Assessment of the backup flight system FMEA/CIL

NASA Technical Reports Server (NTRS)

Prust, E. E.; Ewell, J. J., Jr.; Hinsdale, L. W.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Backup Flight System (BFS) hardware, generating draft failure modes and Potential Critical Items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the proposed NASA Post 51-L FMEA/CIL baseline. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter BFS hardware. The IOA product for the BFS analysis consisted of 29 failure mode worksheets that resulted in 21 Potential Critical Items (PCI) being identified. This product was originally compared with the proposed NASA BFS baseline and subsequently compared with the applicable Data Processing System (DPS), Electrical Power Distribution and Control (EPD and C), and Displays and Controls NASA CIL items. The comparisons determined if there were any results which had been found by the IOA but were not in the NASA baseline. The original assessment determined there were numerous failure modes and potential critical items in the IOA analysis that were not contained in the NASA BFS baseline. Conversely, the NASA baseline contained three FMEAs (IMU, ADTA, and Air Data Probe) for CIL items that were not identified in the IOA product.

Study Of The Risks Arising From Natural Disasters And Hazards On Urban And Intercity Motorways By Using Failure Mode Effect Analysis (FMEA) Methods

NASA Astrophysics Data System (ADS)

DELİCE, Yavuz

2015-04-01

Highways, Located in the city and intercity locations are generally prone to many kind of natural disaster risks. Natural hazards and disasters that may occur firstly from highway project making to construction and operation stages and later during the implementation of highway maintenance and repair stages have to be taken into consideration. And assessment of risks that may occur against adverse situations is very important in terms of project design, construction, operation maintenance and repair costs. Making hazard and natural disaster risk analysis is largely depending on the definition of the likelihood of the probable hazards on the highways. However, assets at risk , and the impacts of the events must be examined and to be rated in their own. With the realization of these activities, intended improvements against natural hazards and disasters will be made with the utilization of Failure Mode Effects Analysis (FMEA) method and their effects will be analyzed with further works. FMEA, is a useful method to identify the failure mode and effects depending on the type of failure rate effects priorities and finding the most optimum economic and effective solution. Although relevant measures being taken for the identified risks by this analysis method , it may also provide some information for some public institutions about the nature of these risks when required. Thus, the necessary measures will have been taken in advance in the city and intercity highways. Many hazards and natural disasters are taken into account in risk assessments. The most important of these dangers can be listed as follows; • Natural disasters 1. Meteorological based natural disasters (floods, severe storms, tropical storms, winter storms, avalanches, etc.). 2. Geological based natural disasters (earthquakes, tsunamis, landslides, subsidence, sinkholes, etc) • Human originated disasters 1. Transport accidents (traffic accidents), originating from the road surface defects (icing, signaling caused malfunctions and risks), fire or explosion etc.- In this study, with FMEA method, risk analysis of the urban and intercity motorways against natural disasters and hazards have been performed and found solutions were brought against these risks. Keywords: Failure Modes Effects Analysis (FMEA), Pareto Analyses (PA), Highways, Risk Management.

Failure mode and effects analysis and fault tree analysis of surface image guided cranial radiosurgery.

PubMed

Manger, Ryan P; Paxton, Adam B; Pawlicki, Todd; Kim, Gwe-Ya

2015-05-01

Surface image guided, Linac-based radiosurgery (SIG-RS) is a modern approach for delivering radiosurgery that utilizes optical stereoscopic imaging to monitor the surface of the patient during treatment in lieu of using a head frame for patient immobilization. Considering the novelty of the SIG-RS approach and the severity of errors associated with delivery of large doses per fraction, a risk assessment should be conducted to identify potential hazards, determine their causes, and formulate mitigation strategies. The purpose of this work is to investigate SIG-RS using the combined application of failure modes and effects analysis (FMEA) and fault tree analysis (FTA), report on the effort required to complete the analysis, and evaluate the use of FTA in conjunction with FMEA. A multidisciplinary team was assembled to conduct the FMEA on the SIG-RS process. A process map detailing the steps of the SIG-RS was created to guide the FMEA. Failure modes were determined for each step in the SIG-RS process, and risk priority numbers (RPNs) were estimated for each failure mode to facilitate risk stratification. The failure modes were ranked by RPN, and FTA was used to determine the root factors contributing to the riskiest failure modes. Using the FTA, mitigation strategies were formulated to address the root factors and reduce the risk of the process. The RPNs were re-estimated based on the mitigation strategies to determine the margin of risk reduction. The FMEA and FTAs for the top two failure modes required an effort of 36 person-hours (30 person-hours for the FMEA and 6 person-hours for two FTAs). The SIG-RS process consisted of 13 major subprocesses and 91 steps, which amounted to 167 failure modes. Of the 91 steps, 16 were directly related to surface imaging. Twenty-five failure modes resulted in a RPN of 100 or greater. Only one of these top 25 failure modes was specific to surface imaging. The riskiest surface imaging failure mode had an overall RPN-rank of eighth. Mitigation strategies for the top failure mode decreased the RPN from 288 to 72. Based on the FMEA performed in this work, the use of surface imaging for monitoring intrafraction position in Linac-based stereotactic radiosurgery (SRS) did not greatly increase the risk of the Linac-based SRS process. In some cases, SIG helped to reduce the risk of Linac-based RS. The FMEA was augmented by the use of FTA since it divided the failure modes into their fundamental components, which simplified the task of developing mitigation strategies.

Consistency of FMEA used in the validation of analytical procedures.

PubMed

Oldenhof, M T; van Leeuwen, J F; Nauta, M J; de Kaste, D; Odekerken-Rombouts, Y M C F; Vredenbregt, M J; Weda, M; Barends, D M

2011-02-20

In order to explore the consistency of the outcome of a Failure Mode and Effects Analysis (FMEA) in the validation of analytical procedures, an FMEA was carried out by two different teams. The two teams applied two separate FMEAs to a High Performance Liquid Chromatography-Diode Array Detection-Mass Spectrometry (HPLC-DAD-MS) analytical procedure used in the quality control of medicines. Each team was free to define their own ranking scales for the probability of severity (S), occurrence (O), and detection (D) of failure modes. We calculated Risk Priority Numbers (RPNs) and we identified the failure modes above the 90th percentile of RPN values as failure modes needing urgent corrective action; failure modes falling between the 75th and 90th percentile of RPN values were identified as failure modes needing necessary corrective action, respectively. Team 1 and Team 2 identified five and six failure modes needing urgent corrective action respectively, with two being commonly identified. Of the failure modes needing necessary corrective actions, about a third were commonly identified by both teams. These results show inconsistency in the outcome of the FMEA. To improve consistency, we recommend that FMEA is always carried out under the supervision of an experienced FMEA-facilitator and that the FMEA team has at least two members with competence in the analytical method to be validated. However, the FMEAs of both teams contained valuable information that was not identified by the other team, indicating that this inconsistency is not always a drawback. Copyright © 2010 Elsevier B.V. All rights reserved.

Defining hazards of supplemental oxygen therapy in neonatology using the FMEA tool.

PubMed

van der Eijk, Anne Catherine; Rook, Denise; Dankelman, Jenny; Smit, Bert Johan

2013-01-01

To prospectively evaluate hazards in the process of supplemental oxygen therapy in very preterm infants hospitalized in a Dutch NICU. A Failure Mode and Effects Analysis (FMEA) was conducted by a multidisciplinary team. This team identified, evaluated, and prioritized hazards of supplemental oxygen therapy in preterm infants. After accrediting "hazard scores" for each step in this process, recommendations were formulated for the main hazards. Performing the FMEA took seven meetings of 2 hours. The top 10 hazards could all be categorized into three main topics: incorrect adjustment of the fraction of inspired oxygen (FiO2), incorrect alarm limits for SpO2, and incorrect pulse-oximetry alarm limits on patient monitors for temporary use. The FMEA culminated in recommendations in both educational and technical directions. These included suggestions for (changes in) protocols on alarm limits and manual FiO2 adjustments, education of NICU staff on hazards of supplemental oxygen, and technical improvements in respiratory devices and patient monitors. The FMEA prioritized flaws in the process of supplemental oxygen therapy in very preterm infants. Thanks to the structured approach of the analysis by a multidisciplinary team, several recommendations were made. These recommendations are currently implemented in the study's center.

SU-E-T-421: Failure Mode and Effects Analysis (FMEA) of Xoft Electronic Brachytherapy for the Treatment of Superficial Skin Cancers

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hoisak, J; Manger, R; Dragojevic, I

Purpose: To perform a failure mode and effects analysis (FMEA) of the process for treating superficial skin cancers with the Xoft Axxent electronic brachytherapy (eBx) system, given the recent introduction of expanded quality control (QC) initiatives at our institution. Methods: A process map was developed listing all steps in superficial treatments with Xoft eBx, from the initial patient consult to the completion of the treatment course. The process map guided the FMEA to identify the failure modes for each step in the treatment workflow and assign Risk Priority Numbers (RPN), calculated as the product of the failure mode’s probability ofmore » occurrence (O), severity (S) and lack of detectability (D). FMEA was done with and without the inclusion of recent QC initiatives such as increased staffing, physics oversight, standardized source calibration, treatment planning and documentation. The failure modes with the highest RPNs were identified and contrasted before and after introduction of the QC initiatives. Results: Based on the FMEA, the failure modes with the highest RPN were related to source calibration, treatment planning, and patient setup/treatment delivery (Fig. 1). The introduction of additional physics oversight, standardized planning and safety initiatives such as checklists and time-outs reduced the RPNs of these failure modes. High-risk failure modes that could be mitigated with improved hardware and software interlocks were identified. Conclusion: The FMEA analysis identified the steps in the treatment process presenting the highest risk. The introduction of enhanced QC initiatives mitigated the risk of some of these failure modes by decreasing their probability of occurrence and increasing their detectability. This analysis demonstrates the importance of well-designed QC policies, procedures and oversight in a Xoft eBx programme for treatment of superficial skin cancers. Unresolved high risk failure modes highlight the need for non-procedural quality initiatives such as improved planning software and more robust hardware interlock systems.« less

Independent Orbiter Assessment (IOA): Assessment of the purge, vent and drain subsystem

NASA Technical Reports Server (NTRS)

Bynum, M. C., III

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Purge, Vent and Drain (PV and D) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the NASA FMEA/CIL baseline with proposed Post 51-L updates included. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter PV and D hardware. The PV and D Subsystem controls the environment of unpressurized compartments and window cavities, senses hazardous gases, and purges Orbiter/ET disconnect.

AGOR 28: SIO Shipyard Representative Bi-Weekly Progress Report

DTIC Science & Technology

2013-05-10

WATERMAN SUPPLY)(R/ASR) 368/0 AGOR27 A035- 09 STD Report - FAILURE MODE EFFECT ANALYSIS ( FMEA ) AND DESIGN VERIFCATION TEST PROCEDURE (DVTP) (DI-035-09... FMEA & DVTP - Multidrives)(R/ASR) 4/0 AGOR27 A006- 08 STD Report - PURCHASE ORDER (PO) INDEX ( PO INDEX 4-26- 13) 37/0 AGOR28 A006- 08 STD

White Paper: A Defect Prioritization Method Based on the Risk Priority Number

DTIC Science & Technology

2013-11-01

adapted The Failure Modes and Effects Analysis ( FMEA ) method employs a measurement technique called Risk Priority Number (RPN) to quantify the...Up to an hour 16-60 1.5 Brief Interrupt 0-15 1 Table 1 – Time Scaling Factors In the FMEA formulation, RPN is a product of the three categories

Knowledge Repository for Fmea Related Knowledge

NASA Astrophysics Data System (ADS)

Cândea, Gabriela Simona; Kifor, Claudiu Vasile; Cândea, Ciprian

2014-11-01

This paper presents innovative usage of knowledge system into Failure Mode and Effects Analysis (FMEA) process using the ontology to represent the knowledge. Knowledge system is built to serve multi-projects work that nowadays are in place in any manufacturing or services provider, and knowledge must be retained and reused at the company level and not only at project level. The system is following the FMEA methodology and the validation of the concept is compliant with the automotive industry standards published by Automotive Industry Action Group, and not only. Collaboration is assured trough web-based GUI that supports multiple users access at any time

An Independent Evaluation of the FMEA/CIL Hazard Analysis Alternative Study

NASA Technical Reports Server (NTRS)

Ray, Paul S.

1996-01-01

The present instruments of safety and reliability risk control for a majority of the National Aeronautics and Space Administration (NASA) programs/projects consist of Failure Mode and Effects Analysis (FMEA), Hazard Analysis (HA), Critical Items List (CIL), and Hazard Report (HR). This extensive analytical approach was introduced in the early 1970's and was implemented for the Space Shuttle Program by NHB 5300.4 (1D-2. Since the Challenger accident in 1986, the process has been expanded considerably and resulted in introduction of similar and/or duplicated activities in the safety/reliability risk analysis. A study initiated in 1995, to search for an alternative to the current FMEA/CIL Hazard Analysis methodology generated a proposed method on April 30, 1996. The objective of this Summer Faculty Study was to participate in and conduct an independent evaluation of the proposed alternative to simplify the present safety and reliability risk control procedure.

Failure mode and effect analysis: improving intensive care unit risk management processes.

PubMed

Askari, Roohollah; Shafii, Milad; Rafiei, Sima; Abolhassani, Mohammad Sadegh; Salarikhah, Elaheh

2017-04-18

Purpose Failure modes and effects analysis (FMEA) is a practical tool to evaluate risks, discover failures in a proactive manner and propose corrective actions to reduce or eliminate potential risks. The purpose of this paper is to apply FMEA technique to examine the hazards associated with the process of service delivery in intensive care unit (ICU) of a tertiary hospital in Yazd, Iran. Design/methodology/approach This was a before-after study conducted between March 2013 and December 2014. By forming a FMEA team, all potential hazards associated with ICU services - their frequency and severity - were identified. Then risk priority number was calculated for each activity as an indicator representing high priority areas that need special attention and resource allocation. Findings Eight failure modes with highest priority scores including endotracheal tube defect, wrong placement of endotracheal tube, EVD interface, aspiration failure during suctioning, chest tube failure, tissue injury and deep vein thrombosis were selected for improvement. Findings affirmed that improvement strategies were generally satisfying and significantly decreased total failures. Practical implications Application of FMEA in ICUs proved to be effective in proactively decreasing the risk of failures and corrected the control measures up to acceptable levels in all eight areas of function. Originality/value Using a prospective risk assessment approach, such as FMEA, could be beneficial in dealing with potential failures through proposing preventive actions in a proactive manner. The method could be used as a tool for healthcare continuous quality improvement so that the method identifies both systemic and human errors, and offers practical advice to deal effectively with them.

Independent Orbiter Assessment (IOA): Assessment of the orbiter main propulsion system FMEA/CIL, volume 1

NASA Technical Reports Server (NTRS)

Slaughter, B. C.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the Main Propulsion System (MPS) hardware, generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to available data from the Rockwell Downey/NASA JSC FMEA/CIL review. The Orbiter MPS is composed of the Propellant Management Subsystem (PMS) consisting of the liquid oxygen (LO2) and liquid hydrogen (LH2) subsystems and the helium subsystem. The PMS is a system of manifolds, distribution lines, and valves by which the liquid propellants pass from the External Tank to the Space Shuttle Main Engine (SSME). The helium subsystem consists of a series of helium supply tanks and their associated regulators, control valves, and distribution lines. Volume 1 contains the MPS description, assessment results, ground rules and assumptions, and some of the IOA worksheets.

A practical guide to failure mode and effects analysis in health care: making the most of the team and its meetings.

PubMed

Ashley, Laura; Armitage, Gerry; Neary, Maria; Hollingsworth, Gillian

2010-08-01

Failure Mode and Effects Analysis (FMEA) is a proactive risk assessment tool used to identify potential vulnerabilities in complex, high-risk processes and to generate remedial actions before the processes result in adverse events. FMEA is increasingly used to proactively assess and improve the safety of complex health care processes such as drug administration and blood transfusion. A central feature of FMEA is that it is undertaken by a multidisciplinary team, and because it entails numerous analytical steps, it takes a series of several meetings. Composing a team of busy health care professionals with the appropriate knowledge, skill mix, and logistical availability for regular meetings is, however, a serious challenge. Despite this, information and advice on FMEA team assembly and meetings scheduling are scarce and diffuse and often presented without the accompanying rationale. Assemble an eight-member team composed of clinically active health care staff, from every profession involved in delivery of the process-and who regularly perform it; staff from a range of seniority levels; outsider(s) to the process-and perhaps even to health care; a leader (and facilitator); and researchers. Plan for 10-15 hours of team meeting time for first-time, narrowly defined FMEAs, scheduled as four to six meetings lasting 2 to 3 hours each, spaced weekly to biweekly. Meet in a venue that seats the team around one table and is off the hospital floor but within its grounds. FMEA, generally acknowledged to be a useful addition to the patient safety toolkit, is a meticulous and time- and resource-intensive methodology, and its successful completion is highly dependent on the team members' aptitude and on the facility's and team members' commitment to hold regular, productive meetings.

Independent Orbiter Assessment (IOA): Analysis of the pyrotechnics subsystem

NASA Technical Reports Server (NTRS)

Robinson, W. W.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Orbiter Pyrotechnics hardware. The IOA analysis process utilized available pyrotechnics hardware drawings and schematics for defining hardware assemblies, components, and hardware items. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode.

SU-E-T-192: FMEA Severity Scores - Do We Really Know?

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tonigan, J; Johnson, J; Kry, S

2014-06-01

Purpose: Failure modes and effects analysis (FMEA) is a subjective risk mitigation technique that has not been applied to physics-specific quality management practices. There is a need for quantitative FMEA data as called for in the literature. This work focuses specifically on quantifying FMEA severity scores for physics components of IMRT delivery and comparing to subjective scores. Methods: Eleven physical failure modes (FMs) for head and neck IMRT dose calculation and delivery are examined near commonly accepted tolerance criteria levels. Phantom treatment planning studies and dosimetry measurements (requiring decommissioning in several cases) are performed to determine the magnitude of dosemore » delivery errors for the FMs (i.e., severity of the FM). Resultant quantitative severity scores are compared to FMEA scores obtained through an international survey and focus group studies. Results: Physical measurements for six FMs have resulted in significant PTV dose errors up to 4.3% as well as close to 1 mm significant distance-to-agreement error between PTV and OAR. Of the 129 survey responses, the vast majority of the responders used Varian machines with Pinnacle and Eclipse planning systems. The average years of experience was 17, yet familiarity with FMEA less than expected. Survey reports perception of dose delivery error magnitude varies widely, in some cases 50% difference in dose delivery error expected amongst respondents. Substantial variance is also seen for all FMs in occurrence, detectability, and severity scores assigned with average variance values of 5.5, 4.6, and 2.2, respectively. Survey shows for MLC positional FM(2mm) average of 7.6% dose error expected (range 0–50%) compared to 2% error seen in measurement. Analysis of ranking in survey, treatment planning studies, and quantitative value comparison will be presented. Conclusion: Resultant quantitative severity scores will expand the utility of FMEA for radiotherapy and verify accuracy of FMEA results compared to highly variable subjective scores.« less

[Failure mode and effects analysis (FMEA) of insulin in a mother-child university-affiliated health center].

PubMed

Berruyer, M; Atkinson, S; Lebel, D; Bussières, J-F

2016-01-01

Insulin is a high-alert drug. The main objective of this descriptive cross-sectional study was to evaluate the risks associated with insulin use in healthcare centers. The secondary objective was to propose corrective measures to reduce the main risks associated with the most critical failure modes in the analysis. We conducted a failure mode and effects analysis (FMEA) in obstetrics-gynecology, neonatology and pediatrics. Five multidisciplinary meetings occurred in August 2013. A total of 44 out of 49 failure modes were analyzed. Nine out of 44 (20%) failure modes were deemed critical, with a criticality score ranging from 540 to 720. Following the multidisciplinary meetings, everybody agreed that an FMEA was a useful tool to identify failure modes and their relative importance. This approach identified many corrective measures. This shared experience increased awareness of safety issues with insulin in our mother-child center. This study identified the main failure modes and associated corrective measures. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

Hazards/Failure Modes and Effects Analysis MK 1 MOD 0 LSO-HUD Console System.

DTIC Science & Technology

1980-03-24

AsI~f~ ! 127 = 3gc Z Isre -0 -q ~sI I I 𔃻~~~ ~ _ _ 3_______ II! -0udC Z Z’ P4 12 d-U * ~s ’:i~i42 S- 60 -, Uh ~ U3l I OM -C ~ . - U 4~ dcd 8U-q Ali...8 VI SCOPE AND METHODOLOGY OF ANALYSIS ........ 1O FIGURE 1: H/ FMEA /(SSA) WORK SHEET FORMAT ........... 14 APPENDIX A: HAZARD/FAILURE MODES AND...EFFECTS ANALYSIS (H/ FMEA ) -- WORK SHEETS ......... 15(A-O) TABLE: SUBSYSTEM: UNIT I Heads-Up Display Console .............. 17(A-1) UNIT 2 Auxiliary

Use of failure mode effect analysis (FMEA) to improve medication management process.

PubMed

Jain, Khushboo

2017-03-13

Purpose Medication management is a complex process, at high risk of error with life threatening consequences. The focus should be on devising strategies to avoid errors and make the process self-reliable by ensuring prevention of errors and/or error detection at subsequent stages. The purpose of this paper is to use failure mode effect analysis (FMEA), a systematic proactive tool, to identify the likelihood and the causes for the process to fail at various steps and prioritise them to devise risk reduction strategies to improve patient safety. Design/methodology/approach The study was designed as an observational analytical study of medication management process in the inpatient area of a multi-speciality hospital in Gurgaon, Haryana, India. A team was made to study the complex process of medication management in the hospital. FMEA tool was used. Corrective actions were developed based on the prioritised failure modes which were implemented and monitored. Findings The percentage distribution of medication errors as per the observation made by the team was found to be maximum of transcription errors (37 per cent) followed by administration errors (29 per cent) indicating the need to identify the causes and effects of their occurrence. In all, 11 failure modes were identified out of which major five were prioritised based on the risk priority number (RPN). The process was repeated after corrective actions were taken which resulted in about 40 per cent (average) and around 60 per cent reduction in the RPN of prioritised failure modes. Research limitations/implications FMEA is a time consuming process and requires a multidisciplinary team which has good understanding of the process being analysed. FMEA only helps in identifying the possibilities of a process to fail, it does not eliminate them, additional efforts are required to develop action plans and implement them. Frank discussion and agreement among the team members is required not only for successfully conducing FMEA but also for implementing the corrective actions. Practical implications FMEA is an effective proactive risk-assessment tool and is a continuous process which can be continued in phases. The corrective actions taken resulted in reduction in RPN, subjected to further evaluation and usage by others depending on the facility type. Originality/value The application of the tool helped the hospital in identifying failures in medication management process, thereby prioritising and correcting them leading to improvement.

The use of failure mode and effects analysis to construct an effective disposal and prevention mechanism for infectious hospital waste

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ho, Chao Chung, E-mail: ho919@pchome.com.tw; Liao, Ching-Jong

Highlights: > This study is based on a real case in a regional teaching hospital in Taiwan. > We use Failure mode and effects analysis (FMEA) as the evaluation method. > We successfully identify the risk factors of infectious waste disposal. > We propose plans for the detection of exceptional cases of infectious waste. - Abstract: In recent times, the quality of medical care has been continuously improving in medical institutions wherein patient-centred care has been emphasized. Failure mode and effects analysis (FMEA) has also been promoted as a method of basic risk management and as part of total qualitymore » management (TQM) for improving the quality of medical care and preventing mistakes. Therefore, a study was conducted using FMEA to evaluate the potential risk causes in the process of infectious medical waste disposal, devise standard procedures concerning the waste, and propose feasible plans for facilitating the detection of exceptional cases of infectious waste. The analysis revealed the following results regarding medical institutions: (a) FMEA can be used to identify the risk factors of infectious waste disposal. (b) During the infectious waste disposal process, six items were scored over 100 in the assessment of uncontrolled risks: erroneous discarding of infectious waste by patients and their families, erroneous discarding by nursing staff, erroneous discarding by medical staff, cleaning drivers pierced by sharp articles, cleaning staff pierced by sharp articles, and unmarked output units. Therefore, the study concluded that it was necessary to (1) provide education and training about waste classification to the medical staff, patients and their families, nursing staff, and cleaning staff; (2) clarify the signs of caution; and (3) evaluate the failure mode and strengthen the effects.« less

Risk management of key issues of FPSO

NASA Astrophysics Data System (ADS)

Sun, Liping; Sun, Hai

2012-12-01

Risk analysis of key systems have become a growing topic late of because of the development of offshore structures. Equipment failures of offloading system and fire accidents were analyzed based on the floating production, storage and offloading (FPSO) features. Fault tree analysis (FTA), and failure modes and effects analysis (FMEA) methods were examined based on information already researched on modules of relex reliability studio (RRS). Equipment failures were also analyzed qualitatively by establishing a fault tree and Boolean structure function based on the shortage of failure cases, statistical data, and risk control measures examined. Failure modes of fire accident were classified according to the different areas of fire occurrences during the FMEA process, using risk priority number (RPN) methods to evaluate their severity rank. The qualitative analysis of FTA gave the basic insight of forming the failure modes of FPSO offloading, and the fire FMEA gave the priorities and suggested processes. The research has practical importance for the security analysis problems of FPSO.

Independent Orbiter Assessment (IOA): Analysis of the communication and tracking subsystem

NASA Technical Reports Server (NTRS)

Gardner, J. R.; Robinson, W. M.; Trahan, W. H.; Daley, E. S.; Long, W. C.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Orbiter Communication and Tracking hardware. The IOA analysis process utilized available Communication and Tracking hardware drawings and schematics for defining hardware assemblies, components, and hardware items. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode.

[Failure mode and effects analysis on computerized drug prescriptions].

PubMed

Paredes-Atenciano, J A; Roldán-Aviña, J P; González-García, Mercedes; Blanco-Sánchez, M C; Pinto-Melero, M A; Pérez-Ramírez, C; Calvo Rubio-Burgos, Miguel; Osuna-Navarro, F J; Jurado-Carmona, A M

2015-01-01

To identify and analyze errors in drug prescriptions of patients treated in a "high resolution" hospital by applying a Failure mode and effects analysis (FMEA).Material and methods A multidisciplinary group of medical specialties and nursing analyzed medical records where drug prescriptions were held in free text format. An FMEA was developed in which the risk priority index (RPI) was obtained from a cross-sectional observational study using an audit of the medical records, carried out in 2 phases: 1) Pre-intervention testing, and (2) evaluation of improvement actions after the first analysis. An audit sample size of 679 medical records from a total of 2,096 patients was calculated using stratified sampling and random selection of clinical events. Prescription errors decreased by 22.2% in the second phase. FMEA showed a greater RPI in "unspecified route of administration" and "dosage unspecified", with no significant decreases observed in the second phase, although it did detect, "incorrect dosing time", "contraindication due to drug allergy", "wrong patient" or "duplicate prescription", which resulted in the improvement of prescriptions. Drug prescription errors have been identified and analyzed by FMEA methodology, improving the clinical safety of these prescriptions. This tool allows updates of electronic prescribing to be monitored. To avoid such errors would require the mandatory completion of all sections of a prescription. Copyright © 2014 SECA. Published by Elsevier Espana. All rights reserved.

Use of Failure Mode and Effects Analysis to Improve Emergency Department Handoff Processes.

PubMed

Sorrentino, Patricia

2016-01-01

The purpose of this article is to describe a quality improvement process using failure mode and effects analysis (FMEA) to evaluate systems handoff communication processes, improve emergency department (ED) throughput and reduce crowding through development of a standardized handoff, and, ultimately, improve patient safety. Risk of patient harm through ineffective communication during handoff transitions is a major reason for breakdown of systems. Complexities of ED processes put patient safety at risk. An increased incidence of submitted patient safety event reports for handoff communication failures between the ED and inpatient units solidified a decision to implement the use of FMEA to identify handoff failures to mitigate patient harm through redesign. The clinical nurse specialist implemented an FMEA. Handoff failure themes were created from deidentified retrospective reviews. Weekly meetings were held over a 3-month period to identify failure modes and determine cause and effect on the process. A functional block diagram process map tool was used to illustrate handoff processes. An FMEA grid was used to list failure modes and assign a risk priority number to quantify results. Multiple areas with actionable failures were identified. A majority of causes for high-priority failure modes were specific to communications. Findings demonstrate the complexity of transition and handoff processes. The FMEA served to identify and evaluate risk of handoff failures and provide a framework for process improvement. A focus on mentoring nurses to quality handoff processes so that it becomes habitual practice is crucial to safe patient transitions. Standardizing content and hardwiring within the system are best practice. The clinical nurse specialist is prepared to provide strong leadership to drive and implement system-wide quality projects.

Failure-Modes-And-Effects Analysis Of Software Logic

NASA Technical Reports Server (NTRS)

Garcia, Danny; Hartline, Thomas; Minor, Terry; Statum, David; Vice, David

1996-01-01

Rigorous analysis applied early in design effort. Method of identifying potential inadequacies and modes and effects of failures caused by inadequacies (failure-modes-and-effects analysis or "FMEA" for short) devised for application to software logic.

Failure mode and effects analysis: too little for too much?

PubMed

Dean Franklin, Bryony; Shebl, Nada Atef; Barber, Nick

2012-07-01

Failure mode and effects analysis (FMEA) is a structured prospective risk assessment method that is widely used within healthcare. FMEA involves a multidisciplinary team mapping out a high-risk process of care, identifying the failures that can occur, and then characterising each of these in terms of probability of occurrence, severity of effects and detectability, to give a risk priority number used to identify failures most in need of attention. One might assume that such a widely used tool would have an established evidence base. This paper considers whether or not this is the case, examining the evidence for the reliability and validity of its outputs, the mathematical principles behind the calculation of a risk prioirty number, and variation in how it is used in practice. We also consider the likely advantages of this approach, together with the disadvantages in terms of the healthcare professionals' time involved. We conclude that although FMEA is popular and many published studies have reported its use within healthcare, there is little evidence to support its use for the quantitative prioritisation of process failures. It lacks both reliability and validity, and is very time consuming. We would not recommend its use as a quantitative technique to prioritise, promote or study patient safety interventions. However, the stage of FMEA involving multidisciplinary mapping process seems valuable and work is now needed to identify the best way of converting this into plans for action.

SU-E-T-627: Failure Modes and Effect Analysis for Monthly Quality Assurance of Linear Accelerator

DOE Office of Scientific and Technical Information (OSTI.GOV)

Xie, J; Xiao, Y; Wang, J

2014-06-15

Purpose: To develop and implement a failure mode and effect analysis (FMEA) on routine monthly Quality Assurance (QA) tests (physical tests part) of linear accelerator. Methods: A systematic failure mode and effect analysis method was performed for monthly QA procedures. A detailed process tree of monthly QA was created and potential failure modes were defined. Each failure mode may have many influencing factors. For each factor, a risk probability number (RPN) was calculated from the product of probability of occurrence (O), the severity of effect (S), and detectability of the failure (D). The RPN scores are in a range ofmore » 1 to 1000, with higher scores indicating stronger correlation to a given influencing factor of a failure mode. Five medical physicists in our institution were responsible to discuss and to define the O, S, D values. Results: 15 possible failure modes were identified and all RPN scores of all influencing factors of these 15 failue modes were from 8 to 150, and the checklist of FMEA in monthly QA was drawn. The system showed consistent and accurate response to erroneous conditions. Conclusion: The influencing factors of RPN greater than 50 were considered as highly-correlated factors of a certain out-oftolerance monthly QA test. FMEA is a fast and flexible tool to develop an implement a quality management (QM) frame work of monthly QA, which improved the QA efficiency of our QA team. The FMEA work may incorporate more quantification and monitoring fuctions in future.« less

Identification and assessment of common errors in the admission process of patients in Isfahan Fertility and Infertility Center based on "failure modes and effects analysis".

PubMed

Dehghan, Ashraf; Abumasoudi, Rouhollah Sheikh; Ehsanpour, Soheila

2016-01-01

Infertility and errors in the process of its treatment have a negative impact on infertile couples. The present study was aimed to identify and assess the common errors in the reception process by applying the approach of "failure modes and effects analysis" (FMEA). In this descriptive cross-sectional study, the admission process of fertility and infertility center of Isfahan was selected for evaluation of its errors based on the team members' decision. At first, the admission process was charted through observations and interviewing employees, holding multiple panels, and using FMEA worksheet, which has been used in many researches all over the world and also in Iran. Its validity was evaluated through content and face validity, and its reliability was evaluated through reviewing and confirmation of the obtained information by the FMEA team, and eventually possible errors, causes, and three indicators of severity of effect, probability of occurrence, and probability of detection were determined and corrective actions were proposed. Data analysis was determined by the number of risk priority (RPN) which is calculated by multiplying the severity of effect, probability of occurrence, and probability of detection. Twenty-five errors with RPN ≥ 125 was detected through the admission process, in which six cases of error had high priority in terms of severity and occurrence probability and were identified as high-risk errors. The team-oriented method of FMEA could be useful for assessment of errors and also to reduce the occurrence probability of errors.

Application of failure mode and effects analysis to intracranial stereotactic radiation surgery by linear accelerator.

PubMed

Masini, Laura; Donis, Laura; Loi, Gianfranco; Mones, Eleonora; Molina, Elisa; Bolchini, Cesare; Krengli, Marco

2014-01-01

The aim of this study was to analyze the application of the failure modes and effects analysis (FMEA) to intracranial stereotactic radiation surgery (SRS) by linear accelerator in order to identify the potential failure modes in the process tree and adopt appropriate safety measures to prevent adverse events (AEs) and near-misses, thus improving the process quality. A working group was set up to perform FMEA for intracranial SRS in the framework of a quality assurance program. FMEA was performed in 4 consecutive tasks: (1) creation of a visual map of the process; (2) identification of possible failure modes; (3) assignment of a risk probability number (RPN) to each failure mode based on tabulated scores of severity, frequency of occurrence and detectability; and (4) identification of preventive measures to minimize the risk of occurrence. The whole SRS procedure was subdivided into 73 single steps; 116 total possible failure modes were identified and a score of severity, occurrence, and detectability was assigned to each. Based on these scores, RPN was calculated for each failure mode thus obtaining values from 1 to 180. In our analysis, 112/116 (96.6%) RPN values were <60, 2 (1.7%) between 60 and 125 (63, 70), and 2 (1.7%) >125 (135, 180). The 2 highest RPN scores were assigned to the risk of using the wrong collimator's size and incorrect coordinates on the laser target localizer frame. Failure modes and effects analysis is a simple and practical proactive tool for systematic analysis of risks in radiation therapy. In our experience of SRS, FMEA led to the adoption of major changes in various steps of the SRS procedure.

Utility of Failure Mode and Effect Analysis to Improve Safety in Suctioning by Orotracheal Tube.

PubMed

Vázquez-Valencia, Agustín; Santiago-Sáez, Andrés; Perea-Pérez, Bernardo; Labajo-González, Elena; Albarrán-Juan, Maria Elena

2017-02-01

The objective of the study was to use the Failure Mode and Effect Analysis (FMEA) tool to analyze the technique of secretion suctioning on patients with an endotracheal tube who were admitted into an intensive care unit. Brainstorming was carried out within the service to determine the potential errors most frequent in the process. After this, the FMEA was applied, including its stages, prioritizing risk in accordance with the risk prioritization number (RPN), selecting improvement actions in which they have an RPN of more than 300. We obtained 32 failure modes, of which 13 surpassed an RPN of 300. After our result, 21 improvement actions were proposed for those failure modes with RPN scores above 300. FMEA allows us to ascertain possible failures so as to later propose improvement actions for those which have an RPN of more than 300. Copyright © 2016 American Society of PeriAnesthesia Nurses. Published by Elsevier Inc. All rights reserved.

Independent Orbiter Assessment (IOA): Assessment of the communication and tracking subsystem, volume 2

NASA Technical Reports Server (NTRS)

Long, W. C.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed and analysis of the Communication and Tracking hardware, generating draft failure modes and potential critical items. The IOA results were then compared to the NASA FMEA/CIL baseline. A resolution of each discrepancy from the comparison is provided through additional analysis as required. This report documents the results of that comparison for the Orbiter Communication and Tracking hardware. Volume 2 continues the presentation of IOA worksheets.

Failure mode and effects analysis: A community practice perspective.

PubMed

Schuller, Bradley W; Burns, Angi; Ceilley, Elizabeth A; King, Alan; LeTourneau, Joan; Markovic, Alexander; Sterkel, Lynda; Taplin, Brigid; Wanner, Jennifer; Albert, Jeffrey M

2017-11-01

To report our early experiences with failure mode and effects analysis (FMEA) in a community practice setting. The FMEA facilitator received extensive training at the AAPM Summer School. Early efforts focused on department education and emphasized the need for process evaluation in the context of high profile radiation therapy accidents. A multidisciplinary team was assembled with representation from each of the major department disciplines. Stereotactic radiosurgery (SRS) was identified as the most appropriate treatment technique for the first FMEA evaluation, as it is largely self-contained and has the potential to produce high impact failure modes. Process mapping was completed using breakout sessions, and then compiled into a simple electronic format. Weekly sessions were used to complete the FMEA evaluation. Risk priority number (RPN) values > 100 or severity scores of 9 or 10 were considered high risk. The overall time commitment was also tracked. The final SRS process map contained 15 major process steps and 183 subprocess steps. Splitting the process map into individual assignments was a successful strategy for our group. The process map was designed to contain enough detail such that another radiation oncology team would be able to perform our procedures. Continuous facilitator involvement helped maintain consistent scoring during FMEA. Practice changes were made responding to the highest RPN scores, and new resulting RPN scores were below our high-risk threshold. The estimated person-hour equivalent for project completion was 258 hr. This report provides important details on the initial steps we took to complete our first FMEA, providing guidance for community practices seeking to incorporate this process into their quality assurance (QA) program. Determining the feasibility of implementing complex QA processes into different practice settings will take on increasing significance as the field of radiation oncology transitions into the new TG-100 QA paradigm. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

Independent Orbiter Assessment (IOA): Analysis of the crew equipment subsystem

NASA Technical Reports Server (NTRS)

Sinclair, Susan; Graham, L.; Richard, Bill; Saxon, H.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical (PCIs) items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The independent analysis results coresponding to the Orbiter crew equipment hardware are documented. The IOA analysis process utilized available crew equipment hardware drawings and schematics for defining hardware assemblies, components, and hardware items. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. Of the 352 failure modes analyzed, 78 were determined to be PCIs.

FMEA and consideration of real work situations for safer design of production systems.

PubMed

Lux, Aurélien; Mawo De Bikond, Johann; Etienne, Alain; Quillerou-Grivot, Edwige

2016-12-01

Production equipment designers must ensure the health and safety of future users; in this regard, they augment requirements for standardizing and controlling operator work. This contrasts with the ergonomic view of the activity, which recommends leaving operators leeway (margins for manoeuvre) in performing their task, while safeguarding their health. Following a brief analysis of design practices in the car industry, we detail how the Failure Modes and Effects Analysis (FMEA) approach is implemented in this sector. We then suggest an adaptation that enables designers to consider real work situations. This new protocol, namely, work situation FMEA, allows experience feedback to be used to defend the health standpoint during designer project reviews, which usually only address quality and performance issues. We subsequently illustrate the advantage of this approach using two examples of work situations at car parts manufacturers: the first from the literature and the second from an in-company industrial project.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cheong, S-K; Kim, J

Purpose: The aim of the study is the application of a Failure Modes and Effects Analysis (FMEA) to access the risks for patients undergoing a Low Dose Rate (LDR) Prostate Brachytherapy Treatment. Methods: FMEA was applied to identify all the sub processes involved in the stages of identifying patient, source handling, treatment preparation, treatment delivery, and post treatment. These processes characterize the radiation treatment associated with LDR Prostate Brachytherapy. The potential failure modes together with their causes and effects were identified and ranked in order of their importance. Three indexes were assigned for each failure mode: the occurrence rating (O),more » the severity rating (S), and the detection rating (D). A ten-point scale was used to score each category, ten being the number indicating most severe, most frequent, and least detectable failure mode, respectively. The risk probability number (RPN) was calculated as a product of the three attributes: RPN = O X S x D. The analysis was carried out by a working group (WG) at UPMC. Results: The total of 56 failure modes were identified including 32 modes before the treatment, 13 modes during the treatment, and 11 modes after the treatment. In addition to the protocols already adopted in the clinical practice, the prioritized risk management will be implanted to the high risk procedures on the basis of RPN score. Conclusion: The effectiveness of the FMEA method was established. The FMEA methodology provides a structured and detailed assessment method for the risk analysis of the LDR Prostate Brachytherapy Procedure and can be applied to other radiation treatment modes.« less

A FMEA clinical laboratory case study: how to make problems and improvements measurable.

PubMed

Capunzo, Mario; Cavallo, Pierpaolo; Boccia, Giovanni; Brunetti, Luigi; Pizzuti, Sante

2004-01-01

The authors have experimented the application of the Failure Mode and Effect Analysis (FMEA) technique in a clinical laboratory. FMEA technique allows: a) to evaluate and measure the hazards of a process malfunction, b) to decide where to execute improvement actions, and c) to measure the outcome of those actions. A small sample of analytes has been studied: there have been determined the causes of the possible malfunctions of the analytical process, calculating the risk probability index (RPI), with a value between 1 and 1,000. Only for the cases of RPI > 400, improvement actions have been implemented that allowed a reduction of RPI values between 25% to 70% with a costs increment of < 1%. FMEA technique can be applied to the processes of a clinical laboratory, even if of small dimensions, and offers a high potential of improvement. Nevertheless, such activity needs a thorough planning because it is complex, even if the laboratory already operates an ISO 9000 Quality Management System.

Independent Orbiter Assessment (IOA): Assessment of the reaction control system, volume 1

NASA Technical Reports Server (NTRS)

Prust, Chet D.; Hartman, Dan W.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the aft and forward Reaction Control System (RCS) hardware, and Electrical Power Distribution and Control (EPD and C), generating draft failure modes and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The IOA results were then compared to the proposed Post 51-L NASA FMEA/CIL baseline. This report documents the results of that comparison for the Orbiter RCS hardware and EPD and C systems. The IOA product for the RCS analysis consisted of 208 hardware and 2064 EPD and C failure mode worksheets that resulted in 141 hardware and 449 EPD and C potential critical items (PCIs) being identified. A comparison was made of the IOA product to the NASA FMEA/CIL baseline. After comparison and discussions with the NASA subsystem manager, 96 hardware issues, 83 of which concern CIL items or PCIs, and 280 EPD and C issues, 158 of which concern CIL items or PCIs, and 280 EPD and C issues, 158 of which concern CIL items or PCIs, remain unresolved. Volume 1 contains the subsystem description, assessment results, and some of the IOA worksheets.

Spaceflight Ground Support Equipment Reliability & System Safety Data

NASA Technical Reports Server (NTRS)

Fernandez, Rene; Riddlebaugh, Jeffrey; Brinkman, John; Wilkinson, Myron

2012-01-01

Presented were Reliability Analysis, consisting primarily of Failure Modes and Effects Analysis (FMEA), and System Safety Analysis, consisting of Preliminary Hazards Analysis (PHA), performed to ensure that the CoNNeCT (Communications, Navigation, and Networking re- Configurable Testbed) Flight System was safely and reliably operated during its Assembly, Integration and Test (AI&T) phase. A tailored approach to the NASA Ground Support Equipment (GSE) standard, NASA-STD-5005C, involving the application of the appropriate Requirements, S&MA discipline expertise, and a Configuration Management system (to retain a record of the analysis and documentation) were presented. Presented were System Block Diagrams of selected GSE and the corresponding FMEA, as well as the PHAs. Also discussed are the specific examples of the FMEAs and PHAs being used during the AI&T phase to drive modifications to the GSE (via "redlining" of test procedures, and the placement of warning stickers to protect the flight hardware) before being interfaced to the Flight System. These modifications were necessary because failure modes and hazards were identified during the analysis that had not been properly mitigated. Strict Configuration Management was applied to changes (whether due to upgrades or expired calibrations) in the GSE by revisiting the FMEAs and PHAs to reflect the latest System Block Diagrams and Bill Of Material. The CoNNeCT flight system has been successfully assembled, integrated, tested, and shipped to the launch site without incident. This demonstrates that the steps taken to safeguard the flight system when it was interfaced to the various GSE were successful.

WE-G-BRA-09: Microsphere Brachytherapy Failure Mode and Effects Analysis in a Dual-Vendor Environment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Younge, K C; Lee, C I; Feng, M

2015-06-15

Purpose: To improve the safety and quality of a dual-vendor microsphere brachytherapy program with failure mode and effects analysis (FMEA). Methods: A multidisciplinary team including physicists, dosimetrists, a radiation oncologist, an interventional radiologist, and radiation safety personnel performed an FMEA for our dual-vendor microsphere brachytherapy program employing SIR-Spheres (Sirtex Medical Limited, Australia) and Theraspheres (BTG, England). We developed a program process tree and step-by-step instructions which were used to generate a comprehensive list of failure modes. These modes were then ranked according to severity, occurrence rate, and detectability. Risk priority numbers (RPNs) were calculated by multiplying these three scores together.more » Three different severity scales were created: one each for harmful effects to the patient, staff, or the institution. Each failure mode was ranked on one or more of these scales. Results: The group identified 164 failure modes for the microsphere program. 113 of these were ranked using the patient severity scale, 52 using the staff severity scale, and 50 using the institution severity scale. The highest ranked items on the patient severity scale were an error in the automated dosimetry worksheet (RPN = 297.5), and the incorrect target specified on the planning study (RPN = 135). Some failure modes ranked differently between vendors, especially those corresponding to dose vial preparation because of the different methods used. Based on our findings, we made several improvements to our QA program, including documentation to easily identify which product is being used, an additional hand calculation during planning, and reorganization of QA steps before treatment delivery. We will continue to periodically review and revise the FMEA. Conclusion: We have applied FMEA to our dual-vendor microsphere brachytherapy program to identify potential key weaknesses in the treatment chain. Our FMEA results were used to improve the effectiveness of our overall microsphere program.« less

Life Cost Based FMEA Manual: A Step by Step Guide to Carrying Out a Cost-based Failure Modes and Effects Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rhee, Seung; Spencer, Cherrill; /Stanford U. /SLAC

2009-01-23

Failure occurs when one or more of the intended functions of a product are no longer fulfilled to the customer's satisfaction. The most critical product failures are those that escape design reviews and in-house quality inspection and are found by the customer. The product may work for a while until its performance degrades to an unacceptable level or it may have not worked even before customer took possession of the product. The end results of failures which may lead to unsafe conditions or major losses of the main function are rated high in severity. Failure Modes and Effects Analysis (FMEA)more » is a tool widely used in the automotive, aerospace, and electronics industries to identify, prioritize, and eliminate known potential failures, problems, and errors from systems under design, before the product is released (Stamatis, 1997). Several industrial FMEA standards such as those published by the Society of Automotive Engineers, US Department of Defense, and the Automotive Industry Action Group employ the Risk Priority Number (RPN) to measure risk and severity of failures. The Risk Priority Number (RPN) is a product of 3 indices: Occurrence (O), Severity (S), and Detection (D). In a traditional FMEA process design engineers typically analyze the 'root cause' and 'end-effects' of potential failures in a sub-system or component and assign penalty points through the O, S, D values to each failure. The analysis is organized around categories called failure modes, which link the causes and effects of failures. A few actions are taken upon completing the FMEA worksheet. The RPN column generally will identify the high-risk areas. The idea of performing FMEA is to eliminate or reduce known and potential failures before they reach the customers. Thus, a plan of action must be in place for the next task. Not all failures can be resolved during the product development cycle, thus prioritization of actions must be made within the design group. One definition of detection difficulty (D) is how well the organization controls the development process. Another definition relates to the detectability of a particular failure in the product when it is in the hands of the customer. The former asks 'What is the chance of catching the problem before we give it to the customer'? The latter asks 'What is the chance of the customer catching the problem before the problem results in a catastrophic failure?' (Palady, 1995) These differing definitions confuse the FMEA users when one tries to determine detection difficulty. Are we trying to measure how easy it is to detect where a failure has occurred or when it has occurred? Or are we trying to measure how easy or difficult it is to prevent failures? Ordinal scale variables are used to rank-order industries such as, hotels, restaurants, and movies (Note that a 4 star hotel is not necessarily twice as good as a 2 star hotel). Ordinal values preserve rank in a group of items, but the distance between the values cannot be measured since a distance function does not exist. Thus, the product or sum of ordinal variables loses its rank since each parameter has different scales. The RPN is a product of 3 independent ordinal variables, it can indicate that some failure types are 'worse' than others, but give no quantitative indication of their relative effects. To resolve the ambiguity of measuring detection difficulty and the irrational logic of multiplying 3 ordinal indices, a new methodology was created to overcome these shortcomings, Life Cost-Based FMEA. Life Cost-Based FMEA measures failure/risk in terms of monetary cost. Cost is a universal parameter that can be easily related to severity by engineers and others. Thus, failure cost can be estimated using the following simplest form: Expected Failure Cost = {sup n}{Sigma}{sub i=1}p{sub i}c{sub i}, p: Probability of a particular failure occurring; c: Monetary cost associated with that particular failure; and n: Total number of failure scenarios. FMEA is most effective when there are inputs into it from all concerned disciplines of the product development team. However, FMEA is a long process and can become tedious and won't be effective if too many people participate. An ideal team should have 3 to 4 people from: design, manufacturing, and service departments if possible. Depending on how complex the system is, the entire process can take anywhere from one to four weeks working full time. Thus, it is important to agree to the time commitment before starting the analysis else, anxious managers might stop the procedure before it is completed.« less

A Case Study of a Combat Aircraft’s Single Hit Vulnerability

DTIC Science & Technology

1986-09-01

Survivability Life Cycle 21 3.2 Interfaces of the FMECA Process 27 3.3 Example FMEA Format 29 3.4 Example DMEA Matrix 33 3.5 Example Disablement Diagram 34...Typical Hi-Hi/Hi-Hi Mission 58 5.5 A-20 Conceptual Tactics 60 7.1 A-20 Fuel System 73 7.2 A-20 Hydraulics System 75 7.3 A-20 Flight Controls System 77 7.4...effect severity. The FMECA procedure is performed in two steps, (1) a Fail- ure Mode and Effects Analysis ( FMEA ) and (2) a Damage Mode and Effects

Failure mode effect analysis and fault tree analysis as a combined methodology in risk management

NASA Astrophysics Data System (ADS)

Wessiani, N. A.; Yoshio, F.

2018-04-01

There have been many studies reported the implementation of Failure Mode Effect Analysis (FMEA) and Fault Tree Analysis (FTA) as a method in risk management. However, most of the studies usually only choose one of these two methods in their risk management methodology. On the other side, combining these two methods will reduce the drawbacks of each methods when implemented separately. This paper aims to combine the methodology of FMEA and FTA in assessing risk. A case study in the metal company will illustrate how this methodology can be implemented. In the case study, this combined methodology will assess the internal risks that occur in the production process. Further, those internal risks should be mitigated based on their level of risks.

Demonstration Advanced Avionics System (DAAS), Phase 1

NASA Technical Reports Server (NTRS)

Bailey, A. J.; Bailey, D. G.; Gaabo, R. J.; Lahn, T. G.; Larson, J. C.; Peterson, E. M.; Schuck, J. W.; Rodgers, D. L.; Wroblewski, K. A.

1981-01-01

Demonstration advanced anionics system (DAAS) function description, hardware description, operational evaluation, and failure mode and effects analysis (FMEA) are provided. Projected advanced avionics system (PAAS) description, reliability analysis, cost analysis, maintainability analysis, and modularity analysis are discussed.

Failure mode and effects analysis as a performance improvement tool in trauma.

PubMed

Day, Suzanne; Dalto, Joseph; Fox, Jolene; Turpin, Melinda

2006-01-01

Performance improvement (PI) in the multiple systems injured patient frequently highlights areas for improvement in overall hospital care processes. Failure mode effects analysis (FMEA) is an effective tool to assess and prioritize areas of risk in clinical practice. Failure mode effects analysis is often initiated by a "near-miss" or concern for risk as opposed to a root cause analysis that is initiated solely after a sentinel event. In contrast to a root cause analysis, the FMEA looks more broadly at processes involved in the delivery of care. The purpose of this abstract was to demonstrate the usefulness of FMEA as a PI tool by describing an event and following the event through the healthcare delivery PI processes involved. During routine chart abstraction, a trauma registrar found that an elderly trauma patient admitted with a subdural hematoma inadvertently received heparin during the course of a dialysis treatment. Although heparin use was contraindicated in this patient, there were no sequelae as a result of the error. This case was reviewed by the trauma service PI committee and the quality improvement team, which initiated FMEA. An FMEA of inpatient dialysis process was conducted following this incident. The process included physician, nursing, and allied health representatives involved in dialysis. As part of the process, observations of dialysis treatments and staff interviews were conducted. Observation revealed that nurses generally left the patient's room and did not involve themselves in the dialysis process. A formal patient "pass-off" report was not done. Nurses did not review dialysis orders or reevaluate the treatment plan before treatment. We found that several areas of our current practice placed our patients at risk. 1. The nephrology consult/dialysis communication process was inconsistent. 2. Scheduling of treatments for chronic dialysis patients could occur without a formal consult or order. 3. RNs were not consistently involved in dialysis scheduling, setup, or treatment. 4. Dialysis technicians may exceed scope of practice (taking telephone orders) when scheduling of treatment occurred before consult and written orders. Near-miss events may be overlooked as opportunities for improvement in cases where no harm has come to the patient. As a result of our FMEA investigation, the following recommendations were made to improve hospital care delivery in those trauma patients who require inpatient dialysis: 1. Education of RNs about the dialysis process. 2. Implementation of a formal reporting process between the RN and the dialysis technician before the procedure is initiated. 3. RN supervision of dialysis treatments. 4. Use of a preprinted inpatient dialysis form. 5. Education of dialysis technicians regarding their scope of practice. 6. Improve notification process for scheduling dialysis procedures between units and dialysis coordinator (similar to x-ray scheduling). Our performance improvement focus has broadened to include all reported "near-miss" events in order to improve our healthcare delivery process before an event with sequelae occurs. We have found that using FMEA has greatly increased our ability to facilitate change across all services and departments within the hospital.

Independent Orbiter Assessment (IOA): Assessment of the reaction control system, volume 3

NASA Technical Reports Server (NTRS)

Prust, Chet D.; Hartman, Dan W.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the aft and forward Reaction Control System (RCS) hardware and Electrical Power Distribution and Control (EPD and C), generating draft failure modes and potential critical items. The IOA results were then compared to the proposed Post 51-L NASA FMEA/CIL baseline. This report documents the results of that comparison for the Orbiter RCS hardware and EPD and C systems. Volume 3 continues the presentation of IOA worksheets.

Independent Orbiter Assessment (IOA): Assessment of the reaction control system, volume 2

NASA Technical Reports Server (NTRS)

Prust, Chet D.; Hartman, Dan W.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the aft and forward Reaction Control System (RCS) hardware and Electrical Power Distribution and Control (EPD and C), generating draft failure modes and potential critical items. The IOA results were then compared to the proposed Post 51-L NASA FMEA/CIL baseline. This report documents the results of that comparison for the Orbiter RCS hardware and EPD and C systems. Volume 2 continues the presentation of IOA worksheets.

Independent Orbiter Assessment (IOA): Analysis of the life support and airlock support subsystems

NASA Technical Reports Server (NTRS)

Arbet, Jim; Duffy, R.; Barickman, K.; Saiidi, Mo J.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Orbiter Life Support System (LSS) and Airlock Support System (ALSS). Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. The LSS provides for the management of the supply water, collection of metabolic waste, management of waste water, smoke detection, and fire suppression. The ALSS provides water, oxygen, and electricity to support an extravehicular activity in the airlock.

Independent Orbiter Assessment (IOA) CIL issues resolution report, volume 3

NASA Technical Reports Server (NTRS)

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. This report contains IOA assessment workshets showing resolution of outstanding IOA CIL issues that were summarized in the IOA FMEA/CIL Assessment Interim Report, dated 9 March 1988. Each assessment worksheet has been updated with CIL issue rsolution and rationale. Volume 3 contains the worksheets for the Reaction Control Subsystem and the Communications and Tracking Subsystem.

Risk, Issues and Lessons Learned: Maximizing Risk Management in the DoD Ground Domain

DTIC Science & Technology

2011-10-01

Carnegie Mellon University “Risk Management Overview for TACOM” Benefits of Risk Management include: • Risk is a proactive approach - preventing... Chili (no beans) 13 • Hot dog sub-assy Unclassified How does the FMEA work? Execute the analysis and discover the potential failures and effects...34 - --· . -· A c u i.rition Benefits of FMEAs • Prevent major risks, reduce failures, minimize cost and reduce development time - Do it right the first time

The use of failure mode and effect analysis in a radiation oncology setting: the Cancer Treatment Centers of America experience.

PubMed

Denny, Diane S; Allen, Debra K; Worthington, Nicole; Gupta, Digant

2014-01-01

Delivering radiation therapy in an oncology setting is a high-risk process where system failures are more likely to occur because of increasing utilization, complexity, and sophistication of the equipment and related processes. Healthcare failure mode and effect analysis (FMEA) is a method used to proactively detect risks to the patient in a particular healthcare process and correct potential errors before adverse events occur. FMEA is a systematic, multidisciplinary team-based approach to error prevention and enhancing patient safety. We describe our experience of using FMEA as a prospective risk-management technique in radiation oncology at a national network of oncology hospitals in the United States, capitalizing not only on the use of a team-based tool but also creating momentum across a network of collaborative facilities seeking to learn from and share best practices with each other. The major steps of our analysis across 4 sites and collectively were: choosing the process and subprocesses to be studied, assembling a multidisciplinary team at each site responsible for conducting the hazard analysis, and developing and implementing actions related to our findings. We identified 5 areas of performance improvement for which risk-reducing actions were successfully implemented across our enterprise. © 2012 National Association for Healthcare Quality.

Failure mode and effective analysis ameliorate awareness of medical errors: a 4-year prospective observational study in critically ill children.

PubMed

Daverio, Marco; Fino, Giuliana; Luca, Brugnaro; Zaggia, Cristina; Pettenazzo, Andrea; Parpaiola, Antonella; Lago, Paola; Amigoni, Angela

2015-12-01

Errors in are estimated to occur with an incidence of 3.7-16.6% in hospitalized patients. The application of systems for detection of adverse events is becoming a widespread reality in healthcare. Incident reporting (IR) and failure mode and effective analysis (FMEA) are strategies widely used to detect errors, but no studies have combined them in the setting of a pediatric intensive care unit (PICU). The aim of our study was to describe the trend of IR in a PICU and evaluate the effect of FMEA application on the number and severity of the errors detected. With this prospective observational study, we evaluated the frequency IR documented in standard IR forms completed from January 2009 to December 2012 in the PICU of Woman's and Child's Health Department of Padova. On the basis of their severity, errors were classified as: without outcome (55%), with minor outcome (16%), with moderate outcome (10%), and with major outcome (3%); 16% of reported incidents were 'near misses'. We compared the data before and after the introduction of FMEA. Sixty-nine errors were registered, 59 (86%) concerning drug therapy (83% during prescription). Compared to 2009-2010, in 2011-2012, we noted an increase of reported errors (43 vs 26) with a reduction of their severity (21% vs 8% 'near misses' and 65% vs 38% errors with no outcome). With the introduction of FMEA, we obtained an increased awareness in error reporting. Application of these systems will improve the quality of healthcare services. © 2015 John Wiley & Sons Ltd.

Application of failure mode and effect analysis in managing catheter-related blood stream infection in intensive care unit

PubMed Central

Li, Xixi; He, Mei; Wang, Haiyan

2017-01-01

Abstract In this study, failure mode and effect analysis (FMEA), a proactive tool, was applied to reduce errors associated with the process which begins with assessment of patient and ends with treatment of complications. The aim of this study is to assess whether FMEA implementation will significantly reduce the incidence of catheter-related bloodstream infections (CRBSIs) in intensive care unit. The FMEA team was constructed. A team of 15 medical staff from different departments were recruited and trained. Their main responsibility was to analyze and score all possible processes of central venous catheterization failures. Failure modes with risk priority number (RPN) ≥100 (top 10 RPN scores) were deemed as high-priority-risks, meaning that they needed immediate corrective action. After modifications were put, the resulting RPN was compared with the previous one. A centralized nursing care system was designed. A total of 25 failure modes were identified. High-priority risks were “Unqualified medical device sterilization” (RPN, 337), “leukopenia, very low immunity” (RPN, 222), and “Poor hand hygiene Basic diseases” (RPN, 160). The corrective measures that we took allowed a decrease in the RPNs, especially for the high-priority risks. The maximum reduction was approximately 80%, as observed for the failure mode “Not creating the maximal barrier for patient.” The averaged incidence of CRBSIs was reduced from 5.19% to 1.45%, with 3 months of 0 infection rate. The FMEA can effectively reduce incidence of CRBSIs, improve the security of central venous catheterization technology, decrease overall medical expenses, and improve nursing quality. PMID:29390515

Beyond FMEA: the structured what-if technique (SWIFT).

PubMed

Card, Alan J; Ward, James R; Clarkson, P John

2012-01-01

Although it is probably the best-known prospective hazard analysis (PHA) tool, failure mode and effects analysis (FMEA) is far from the only option available. This article introduces one of the alternatives: The structured what-if technique (SWIFT). SWIFT is a flexible, high-level risk identification technique that can be used on a stand-alone basis, or as part of a staged approach to make more efficient use of bottom-up methods like FMEA. In this article we describe the method, assess the evidence related to its use in healthcare with the use of a systematic literature review, and suggest ways in which it could be better adapted for use in the healthcare industry. Based on the limited evidence available, it appears that healthcare workers find it easy to learn, easy to use, and credible. Especially when used as part of a staged approach, SWIFT appears capable of playing a useful role as component of the PHA armamentarium. © 2012 American Society for Healthcare Risk Management of the American Hospital Association.

[THE FAILURE MODES AND EFFECTS ANALYSIS FACILITATES A SAFE, TIME AND MONEY SAVING OPEN ACCESS COLONOSCOPY SERVICE].

PubMed

Gingold-Belfer, Rachel; Niv, Yaron; Horev, Nehama; Gross, Shuli; Sahar, Nadav; Dickman, Ram

2017-04-01

Failure modes and effects analysis (FMEA) is used for the identification of potential risks in health care processes. We used a specific FMEA - based form for direct referral for colonoscopy and assessed it for procedurerelated perforations. Ten experts in endoscopy evaluated and computed the entire referral process, modes of preparation for the endoscopic procedure, the endoscopic procedure itself and the discharge process. We used FMEA assessing for likelihood of occurrence, detection and severity and calculated the risk profile number (RPN) for each of the above points. According to the highest RPN results we designed a specific open access referral form and then compared the occurrence of colonic perforations (between 2010 and 2013) in patients who were referred through the open access arm (Group 1) to those who had a prior clinical consultation (non-open access, Group 2). Our experts in endoscopy (5 physicians and 5 nurses) identified 3 categories of failure modes that, on average, reached the highest RPNs. We identified 9,558 colonoscopies in group 1, and 12,567 in group 2. Perforations were identified in three patients from the open access group (1:3186, 0.03%) and in 10 from group 2 (1:1256, 0.07%) (p = 0.024). Direct referral for colonoscopy saved 9,558 pre-procedure consultations and the sum of $850,000. The FMEA tool-based specific referral form facilitates a safe, time and money saving open access colonoscopy service. Our form may be adopted by other gastroenterological clinics in Israel.

Quality by design I: Application of failure mode effect analysis (FMEA) and Plackett-Burman design of experiments in the identification of "main factors" in the formulation and process design space for roller-compacted ciprofloxacin hydrochloride immediate-release tablets.

PubMed

Fahmy, Raafat; Kona, Ravikanth; Dandu, Ramesh; Xie, Walter; Claycamp, Gregg; Hoag, Stephen W

2012-12-01

As outlined in the ICH Q8(R2) guidance, identifying the critical quality attributes (CQA) is a crucial part of dosage form development; however, the number of possible formulation and processing factors that could influence the manufacturing of a pharmaceutical dosage form is enormous obviating formal study of all possible parameters and their interactions. Thus, the objective of this study is to examine how quality risk management can be used to prioritize the number of experiments needed to identify the CQA, while still maintaining an acceptable product risk profile. To conduct the study, immediate-release ciprofloxacin tablets manufactured via roller compaction were used as a prototype system. Granules were manufactured using an Alexanderwerk WP120 roller compactor and tablets were compressed on a Stokes B2 tablet press. In the early stages of development, prior knowledge was systematically incorporated into the risk assessment using failure mode and effect analysis (FMEA). The factors identified using FMEA were then followed by a quantitative assessed using a Plackett-Burman screening design. Results show that by using prior experience, literature data, and preformulation data the number of experiments could be reduced to an acceptable level, and the use of FMEA and screening designs such as the Plackett Burman can rationally guide the process of reducing the number experiments to a manageable level.

The Shuttle processing contractors (SPC) reliability program at the Kennedy Space Center - The real world

NASA Astrophysics Data System (ADS)

McCrea, Terry

The Shuttle Processing Contract (SPC) workforce consists of Lockheed Space Operations Co. as prime contractor, with Grumman, Thiokol Corporation, and Johnson Controls World Services as subcontractors. During the design phase, reliability engineering is instrumental in influencing the development of systems that meet the Shuttle fail-safe program requirements. Reliability engineers accomplish this objective by performing FMEA (failure modes and effects analysis) to identify potential single failure points. When technology, time, or resources do not permit a redesign to eliminate a single failure point, the single failure point information is formatted into a change request and presented to senior management of SPC and NASA for risk acceptance. In parallel with the FMEA, safety engineering conducts a hazard analysis to assure that potential hazards to personnel are assessed. The combined effort (FMEA and hazard analysis) is published as a system assurance analysis. Special ground rules and techniques are developed to perform and present the analysis. The reliability program at KSC is vigorously pursued, and has been extremely successful. The ground support equipment and facilities used to launch and land the Space Shuttle maintain an excellent reliability record.

Independent Orbiter Assessment (IOA): CIL issues resolution report, volume 1

NASA Technical Reports Server (NTRS)

Urbanowicz, Kenneth J.; Hinsdale, L. W.; Barnes, J. E.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. This report contains IOA assessment worksheets showing resolution of outstanding IOA CIL issues that were summarized in the IOA FMEA/CIL Assessment Interim Report, dated 9 March 1988. Each assessment worksheet has been updated with CIL issue resolution and rationale. The NASA and Prime Contractor post 51-L FMEA/CIL documentation assessed is believed to be technically accurate and complete. No assessment issues remain that has safety implications. Volume 1 contain worksheets for the following sybsystems: Landing and Deceleration Subsystem; Purge, Vent and Drain Subsystem; Active Thermal Control and Life Support Systems; Crew Equipment Subsystem; Instrumentation Subsystem; Data Processing Subsystem; Atmospheric Revitalization Pressure Control Subsystem; Hydraulics and Water Spray Boiler Subsystem; and Mechanical Actuation Subsystem.

Defective Reduction in Frozen Pie Manufacturing Process

NASA Astrophysics Data System (ADS)

Nooted, Oranuch; Tangjitsitcharoen, Somkiat

2017-06-01

The frozen pie production has a lot of defects resulting in high production cost. Failure mode and effect analysis (FMEA) technique has been applied to improve the frozen pie process. Pareto chart is also used to determine the major defects of frozen pie. There are 3 main processes that cause the defects which are the 1st freezing to glazing process, the forming process, and the folding process. The Risk Priority Number (RPN) obtained from FMEA is analyzed to reduce the defects. If RPN of each cause exceeds 45, the process will be considered to be improved and selected for the corrective and preventive actions. The results showed that RPN values decreased after the correction. Therefore, the implementation of FMEA technique can help to improve the performance of frozen pie process and reduce the defects approximately 51.9%.

Independent Orbiter Assessment (IOA): Assessment of the reaction control system, volume 4

NASA Technical Reports Server (NTRS)

Prust, Chet D.; Hartman, Dan W.

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA effort first completed an analysis of the aft and forward Reaction Control System (RCS) hardware and Electrical Power Distribution and Control (EPD and C), generating draft failure modes and potential critical items. The IOA results were then compared to the proposed Post 51-L NASA FMEA/CIL baseline. This report documents the results of that comparison for the Orbiter RCS hardware and EPD and C systems. Volume 4 continues the presentation of IOA worksheets and contains the potential critical items list.

Independent Orbiter Assessment (IOA): Analysis of the atmospheric revitalization pressure control subsystem

NASA Technical Reports Server (NTRS)

Saiidi, M. J.; Duffy, R. E.; Mclaughlin, T. D.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis/Critical Items List (FMEA/CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The independent analysis results corresponding to the Orbiter Atmospheric Revitalization and Pressure Control Subsystem (ARPCS) are documented. The ARPCS hardware was categorized into the following subdivisions: (1) Atmospheric Make-up and Control (including the Auxiliary Oxygen Assembly, Oxygen Assembly, and Nitrogen Assembly); and (2) Atmospheric Vent and Control (including the Positive Relief Vent Assembly, Negative Relief Vent Assembly, and Cabin Vent Assembly). The IOA analysis process utilized available ARPCS hardware drawings and schematics for defining hardware assemblies, components, and hardware items. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode.

Independent Orbiter Assessment (IOA): Analysis of the mechanical actuation subsystem

NASA Technical Reports Server (NTRS)

Bacher, J. L.; Montgomery, A. D.; Bradway, M. W.; Slaughter, W. T.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Orbiter Mechanical Actuation System (MAS) hardware. Specifically, the MAS hardware consists of the following components: Air Data Probe (ADP); Elevon Seal Panel (ESP); External Tank Umbilical (ETU); Ku-Band Deploy (KBD); Payload Bay Doors (PBD); Payload Bay Radiators (PBR); Personnel Hatches (PH); Vent Door Mechanism (VDM); and Startracker Door Mechanism (SDM). The IOA analysis process utilized available MAS hardware drawings and schematics for defining hardware assemblies, components, and hardware items. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode.

SU-F-P-07: Applying Failure Modes and Effects Analysis to Treatment Planning System QA

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mathew, D; Alaei, P

2016-06-15

Purpose: A small-scale implementation of Failure Modes and Effects Analysis (FMEA) for treatment planning system QA by utilizing methodology of AAPM TG-100 report. Methods: FMEA requires numerical values for severity (S), occurrence (O) and detectability (D) of each mode of failure. The product of these three values gives a risk priority number (RPN). We have implemented FMEA for the treatment planning system (TPS) QA for two clinics which use Pinnacle and Eclipse TPS. Quantitative monthly QA data dating back to 4 years for Pinnacle and 1 year for Eclipse have been used to determine values for severity (deviations from predeterminedmore » doses at points or volumes), and occurrence of such deviations. The TPS QA protocol includes a phantom containing solid water and lung- and bone-equivalent heterogeneities. Photon and electron plans have been evaluated in both systems. The dose values at multiple distinct points of interest (POI) within the solid water, lung, and bone-equivalent slabs, as well as mean doses to several volumes of interest (VOI), have been re-calculated monthly using the available algorithms. Results: The computed doses vary slightly month-over-month. There have been more significant deviations following software upgrades, especially if the upgrade involved re-modeling of the beams. TG-100 guidance and the data presented here suggest an occurrence (O) of 2 depending on the frequency of re-commissioning the beams, severity (S) of 3, and detectability (D) of 2, giving an RPN of 12. Conclusion: Computerized treatment planning systems could pose a risk due to dosimetric errors and suboptimal treatment plans. The FMEA analysis presented here suggests that TPS QA should immediately follow software upgrades, but does not need to be performed every month.« less

Failure modes and effects analysis for ocular brachytherapy.

PubMed

Lee, Yongsook C; Kim, Yongbok; Huynh, Jason Wei-Yeong; Hamilton, Russell J

The aim of the study was to identify potential failure modes (FMs) having a high risk and to improve our current quality management (QM) program in Collaborative Ocular Melanoma Study (COMS) ocular brachytherapy by undertaking a failure modes and effects analysis (FMEA) and a fault tree analysis (FTA). Process mapping and FMEA were performed for COMS ocular brachytherapy. For all FMs identified in FMEA, risk priority numbers (RPNs) were determined by assigning and multiplying occurrence, severity, and lack of detectability values, each ranging from 1 to 10. FTA was performed for the major process that had the highest ranked FM. Twelve major processes, 121 sub-process steps, 188 potential FMs, and 209 possible causes were identified. For 188 FMs, RPN scores ranged from 1.0 to 236.1. The plaque assembly process had the highest ranked FM. The majority of FMs were attributable to human failure (85.6%), and medical physicist-related failures were the most numerous (58.9% of all causes). After FMEA, additional QM methods were included for the top 10 FMs and 6 FMs with severity values > 9.0. As a result, for these 16 FMs and the 5 major processes involved, quality control steps were increased from 8 (50%) to 15 (93.8%), and major processes having quality assurance steps were increased from 2 to 4. To reduce high risk in current clinical practice, we proposed QM methods. They mainly include a check or verification of procedures/steps and the use of checklists for both ophthalmology and radiation oncology staff, and intraoperative ultrasound-guided plaque positioning for ophthalmology staff. Copyright © 2017 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Failure Mode/Mechanism Distributions

DTIC Science & Technology

1991-09-01

circuits , hybrids, discrete semiconductors, microwave devices, optoelectronics and nonelectronic parts employed in military, space, industrial and...FMEA may be performed as a hardware analysis, a functional analysis, or a combination analysis and is ideally initiated at the part, circuit or...by a single replaceable module , a separate FMEA could be performed on the internal functions of the module , viewing the module as a system. The level

FMEA of manual and automated methods for commissioning a radiotherapy treatment planning system.

PubMed

Wexler, Amy; Gu, Bruce; Goddu, Sreekrishna; Mutic, Maya; Yaddanapudi, Sridhar; Olsen, Lindsey; Harry, Taylor; Noel, Camille; Pawlicki, Todd; Mutic, Sasa; Cai, Bin

2017-09-01

To evaluate the level of risk involved in treatment planning system (TPS) commissioning using a manual test procedure, and to compare the associated process-based risk to that of an automated commissioning process (ACP) by performing an in-depth failure modes and effects analysis (FMEA). The authors collaborated to determine the potential failure modes of the TPS commissioning process using (a) approaches involving manual data measurement, modeling, and validation tests and (b) an automated process utilizing application programming interface (API) scripting, preloaded, and premodeled standard radiation beam data, digital heterogeneous phantom, and an automated commissioning test suite (ACTS). The severity (S), occurrence (O), and detectability (D) were scored for each failure mode and the risk priority numbers (RPN) were derived based on TG-100 scale. Failure modes were then analyzed and ranked based on RPN. The total number of failure modes, RPN scores and the top 10 failure modes with highest risk were described and cross-compared between the two approaches. RPN reduction analysis is also presented and used as another quantifiable metric to evaluate the proposed approach. The FMEA of a MTP resulted in 47 failure modes with an RPN ave of 161 and S ave of 6.7. The highest risk process of "Measurement Equipment Selection" resulted in an RPN max of 640. The FMEA of an ACP resulted in 36 failure modes with an RPN ave of 73 and S ave of 6.7. The highest risk process of "EPID Calibration" resulted in an RPN max of 576. An FMEA of treatment planning commissioning tests using automation and standardization via API scripting, preloaded, and pre-modeled standard beam data, and digital phantoms suggests that errors and risks may be reduced through the use of an ACP. © 2017 American Association of Physicists in Medicine.

Application of failure mode and effect analysis in managing catheter-related blood stream infection in intensive care unit.

PubMed

Li, Xixi; He, Mei; Wang, Haiyan

2017-12-01

In this study, failure mode and effect analysis (FMEA), a proactive tool, was applied to reduce errors associated with the process which begins with assessment of patient and ends with treatment of complications. The aim of this study is to assess whether FMEA implementation will significantly reduce the incidence of catheter-related bloodstream infections (CRBSIs) in intensive care unit.The FMEA team was constructed. A team of 15 medical staff from different departments were recruited and trained. Their main responsibility was to analyze and score all possible processes of central venous catheterization failures. Failure modes with risk priority number (RPN) ≥100 (top 10 RPN scores) were deemed as high-priority-risks, meaning that they needed immediate corrective action. After modifications were put, the resulting RPN was compared with the previous one. A centralized nursing care system was designed.A total of 25 failure modes were identified. High-priority risks were "Unqualified medical device sterilization" (RPN, 337), "leukopenia, very low immunity" (RPN, 222), and "Poor hand hygiene Basic diseases" (RPN, 160). The corrective measures that we took allowed a decrease in the RPNs, especially for the high-priority risks. The maximum reduction was approximately 80%, as observed for the failure mode "Not creating the maximal barrier for patient." The averaged incidence of CRBSIs was reduced from 5.19% to 1.45%, with 3 months of 0 infection rate.The FMEA can effectively reduce incidence of CRBSIs, improve the security of central venous catheterization technology, decrease overall medical expenses, and improve nursing quality. Copyright © 2017 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.

[Failure mode and effects analysis to improve quality in clinical trials].

PubMed

Mañes-Sevilla, M; Marzal-Alfaro, M B; Romero Jiménez, R; Herranz-Alonso, A; Sanchez Fresneda, M N; Benedi Gonzalez, J; Sanjurjo-Sáez, M

The failure mode and effects analysis (FMEA) has been used as a tool in risk management and quality improvement. The objective of this study is to identify the weaknesses in processes in the clinical trials area, of a Pharmacy Department (PD) with great research activity, in order to improve the safety of the usual procedures. A multidisciplinary team was created to analyse each of the critical points, identified as possible failure modes, in the development of clinical trial in the PD. For each failure mode, the possible cause and effect were identified, criticality was calculated using the risk priority number and the possible corrective actions were discussed. Six sub-processes were defined in the development of the clinical trials in PD. The FMEA identified 67 failure modes, being the dispensing and prescription/validation sub-processes the most likely to generate errors. All the improvement actions established in the AMFE were implemented in the Clinical Trials area. The FMEA is a useful tool in proactive risk management because it allows us to identify where we are making mistakes and analyze the causes that originate them, to prioritize and to adopt solutions to risk reduction. The FMEA improves process safety and quality in PD. Copyright © 2018 SECA. Publicado por Elsevier España, S.L.U. All rights reserved.

Evaluating the application of failure mode and effects analysis technique in hospital wards: a systematic review

PubMed Central

Asgari Dastjerdi, Hoori; Khorasani, Elahe; Yarmohammadian, Mohammad Hossein; Ahmadzade, Mahdiye Sadat

2017-01-01

Abstract: Background: Medical errors are one of the greatest problems in any healthcare systems. The best way to prevent such problems is errors identification and their roots. Failure Mode and Effects Analysis (FMEA) technique is a prospective risk analysis method. This study is a review of risk analysis using FMEA technique in different hospital wards and departments. Methods: This paper has systematically investigated the available databases. After selecting inclusion and exclusion criteria, the related studies were found. This selection was made in two steps. First, the abstracts and titles were investigated by the researchers and, after omitting papers which did not meet the inclusion criteria, 22 papers were finally selected and the text was thoroughly examined. At the end, the results were obtained. Results: The examined papers had focused mostly on the process and had been conducted in the pediatric wards and radiology departments, and most participants were nursing staffs. Many of these papers attempted to express almost all the steps of model implementation; and after implementing the strategies and interventions, the Risk Priority Number (RPN) was calculated to determine the degree of the technique’s effect. However, these papers have paid less attention to the identification of risk effects. Conclusions: The study revealed that a small number of studies had failed to show the FMEA technique effects. In general, however, most of the studies recommended this technique and had considered it a useful and efficient method in reducing the number of risks and improving service quality. PMID:28039688

SU-F-T-245: The Investigation of Failure Mode and Effects Analysis and PDCA for the Radiotherapy Risk Reduction

DOE Office of Scientific and Technical Information (OSTI.GOV)

Xie, J; Wang, J; P, J

2016-06-15

Purpose: To optimize the clinical processes of radiotherapy and to reduce the radiotherapy risks by implementing the powerful risk management tools of failure mode and effects analysis(FMEA) and PDCA(plan-do-check-act). Methods: A multidiciplinary QA(Quality Assurance) team from our department consisting of oncologists, physicists, dosimetrists, therapists and administrator was established and an entire workflow QA process management using FMEA and PDCA tools was implemented for the whole treatment process. After the primary process tree was created, the failure modes and Risk priority numbers(RPNs) were determined by each member, and then the RPNs were averaged after team discussion. Results: 3 of 9 failuremore » modes with RPN above 100 in the practice were identified in the first PDCA cycle, which were further analyzed to investigate the RPNs: including of patient registration error, prescription error and treating wrong patient. New process controls reduced the occurrence, or detectability scores from the top 3 failure modes. Two important corrective actions reduced the highest RPNs from 300 to 50, and the error rate of radiotherapy decreased remarkably. Conclusion: FMEA and PDCA are helpful in identifying potential problems in the radiotherapy process, which was proven to improve the safety, quality and efficiency of radiation therapy in our department. The implementation of the FMEA approach may improve the understanding of the overall process of radiotherapy while may identify potential flaws in the whole process. Further more, repeating the PDCA cycle can bring us closer to the goal: higher safety and accuracy radiotherapy.« less

Using failure mode and effects analysis to improve the safety of neonatal parenteral nutrition.

PubMed

Arenas Villafranca, Jose Javier; Gómez Sánchez, Araceli; Nieto Guindo, Miriam; Faus Felipe, Vicente

2014-07-15

Failure mode and effects analysis (FMEA) was used to identify potential errors and to enable the implementation of measures to improve the safety of neonatal parenteral nutrition (PN). FMEA was used to analyze the preparation and dispensing of neonatal PN from the perspective of the pharmacy service in a general hospital. A process diagram was drafted, illustrating the different phases of the neonatal PN process. Next, the failures that could occur in each of these phases were compiled and cataloged, and a questionnaire was developed in which respondents were asked to rate the following aspects of each error: incidence, detectability, and severity. The highest scoring failures were considered high risk and identified as priority areas for improvements to be made. The evaluation process detected a total of 82 possible failures. Among the phases with the highest number of possible errors were transcription of the medical order, formulation of the PN, and preparation of material for the formulation. After the classification of these 82 possible failures and of their relative importance, a checklist was developed to achieve greater control in the error-detection process. FMEA demonstrated that use of the checklist reduced the level of risk and improved the detectability of errors. FMEA was useful for detecting medication errors in the PN preparation process and enabling corrective measures to be taken. A checklist was developed to reduce errors in the most critical aspects of the process. Copyright © 2014 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Morphological features (defects) in fuel cell membrane electrode assemblies

NASA Astrophysics Data System (ADS)

Kundu, S.; Fowler, M. W.; Simon, L. C.; Grot, S.

Reliability and durability issues in fuel cells are becoming more important as the technology and the industry matures. Although research in this area has increased, systematic failure analysis, such as a failure modes and effects analysis (FMEA), are very limited in the literature. This paper presents a categorization scheme of causes, modes, and effects related to fuel cell degradation and failure, with particular focus on the role of component quality, that can be used in FMEAs for polymer electrolyte membrane (PEM) fuel cells. The work also identifies component defects imparted on catalyst-coated membranes (CCM) by manufacturing and proposes mechanisms by which they can influence overall degradation and reliability. Six major defects have been identified on fresh CCM materials, i.e., cracks, orientation, delamination, electrolyte clusters, platinum clusters, and thickness variations.

Risk analysis of a biomass combustion process using MOSAR and FMEA methods.

PubMed

Thivel, P-X; Bultel, Y; Delpech, F

2008-02-28

Thermal and chemical conversion processes that convert in energy the sewage sludge, pasty waste and other pre-processed waste are increasingly common, for economic and ecological reasons. Fluidized bed combustion is currently one of the most promising methods of energy conversion, since it burns biomass very efficiently, and produces only very small quantities of sulphur and nitrogen oxides. The hazards associated with biomass combustion processes are fire, explosion and poisoning from the combustion gases (CO, etc.). The risk analysis presented in this paper uses the MADS-MOSAR methodology, applied to a semi-industrial pilot scheme comprising a fluidization column, a conventional cyclone, two natural gas burners and a continuous supply of biomass. The methodology uses a generic approach, with an initial macroscopic stage where hazard sources are identified, scenarios for undesired events are recognized and ranked using a grid of SeverityxProbability and safety barriers suggested. A microscopic stage then analyzes in detail the major risks identified during the first stage. This analysis may use various different tools, such as HAZOP, FMEA, etc.: our analysis is based on FMEA. Using MOSAR, we were able to identify five subsystems: the reactor (fluidized bed and centrifuge), the fuel and biomass supply lines, the operator and the environment. When we drew up scenarios based on these subsystems, we found that malfunction of the gas supply burners was a common trigger in many scenarios. Our subsequent microscopic analysis, therefore, focused on the burners, looking at the ways they failed, and at the effects and criticality of those failures (FMEA). We were, thus, able to identify a number of critical factors such as the incoming gas lines and the ignition electrode.

Independent Orbiter Assessment (IOA): Analysis of the reaction control system, volume 3

NASA Technical Reports Server (NTRS)

Burkemper, V. J.; Haufler, W. A.; Odonnell, R. A.; Paul, D. J.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results for the Reaction Control System (RCS). The RCS is situated in three independent modules, one forward in the orbiter nose and one in each OMS/RCS pod. Each RCS module consists of the following subsystems: Helium Pressurization Subsystem; Propellant Storage and Distribution Subsystem; Thruster Subsystem; and Electrical Power Distribution and Control Subsystem. Volume 3 continues the presentation of IOA analysis worksheets and the potential critical items list.

Independent Orbiter Assessment (IOA): CIL issues resolution report, volume 2

NASA Technical Reports Server (NTRS)

1988-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes And Effects Analysis (FMEA) and Critical Items List (CIL) are presented. This report contains IOA assessment worksheets showing resolution of outstanding IOA CIL issues that were summarized in the IOA FMEA/CIL Assessment Interim Report, dated 9 March 1988. Each assessment worksheet has been updated with CIL issue resolution and rationale. Volume 2 contains the worksheets for the following subsystems: Nose Wheel Steering Subsystem; Remote Manipulator Subsystem; Atmospheric Revitalization Subsystem; Extravehicular Mobility Unit Subsystem; Power Reactant Supply and Distribution Subsystem; Main Propulsion Subsystem; and Orbital Maneuvering Subsystem.

A Framework for Creating a Function-based Design Tool for Failure Mode Identification

NASA Technical Reports Server (NTRS)

Arunajadai, Srikesh G.; Stone, Robert B.; Tumer, Irem Y.; Clancy, Daniel (Technical Monitor)

2002-01-01

Knowledge of potential failure modes during design is critical for prevention of failures. Currently industries use procedures such as Failure Modes and Effects Analysis (FMEA), Fault Tree analysis, or Failure Modes, Effects and Criticality analysis (FMECA), as well as knowledge and experience, to determine potential failure modes. When new products are being developed there is often a lack of sufficient knowledge of potential failure mode and/or a lack of sufficient experience to identify all failure modes. This gives rise to a situation in which engineers are unable to extract maximum benefits from the above procedures. This work describes a function-based failure identification methodology, which would act as a storehouse of information and experience, providing useful information about the potential failure modes for the design under consideration, as well as enhancing the usefulness of procedures like FMEA. As an example, the method is applied to fifteen products and the benefits are illustrated.

Design Process Improvement for Electric CAR Harness

NASA Astrophysics Data System (ADS)

Sawatdee, Thiwarat; Chutima, Parames

2017-06-01

In an automobile parts design company, the customer satisfaction is one of the most important factors for product design. Therefore, the company employs all means to focus its product design process based on the various requirements of customers resulting in high number of design changes. The objective of this research is to improve the design process of the electric car harness that effects the production scheduling by using Fault Tree Analysis (FTA) and Failure Mode and Effect Analysis (FMEA) as the main tools. FTA is employed for root cause analysis and FMEA is used to ranking a High Risk Priority Number (RPN) which is shows the priority of factors in the electric car harness that have high impact to the design of the electric car harness. After the implementation, the improvements are realized significantly since the number of design change is reduced from 0.26% to 0.08%.

Identification and assessment of common errors in the admission process of patients in Isfahan Fertility and Infertility Center based on “failure modes and effects analysis”

PubMed Central

Dehghan, Ashraf; Abumasoudi, Rouhollah Sheikh; Ehsanpour, Soheila

2016-01-01

Background: Infertility and errors in the process of its treatment have a negative impact on infertile couples. The present study was aimed to identify and assess the common errors in the reception process by applying the approach of “failure modes and effects analysis” (FMEA). Materials and Methods: In this descriptive cross-sectional study, the admission process of fertility and infertility center of Isfahan was selected for evaluation of its errors based on the team members’ decision. At first, the admission process was charted through observations and interviewing employees, holding multiple panels, and using FMEA worksheet, which has been used in many researches all over the world and also in Iran. Its validity was evaluated through content and face validity, and its reliability was evaluated through reviewing and confirmation of the obtained information by the FMEA team, and eventually possible errors, causes, and three indicators of severity of effect, probability of occurrence, and probability of detection were determined and corrective actions were proposed. Data analysis was determined by the number of risk priority (RPN) which is calculated by multiplying the severity of effect, probability of occurrence, and probability of detection. Results: Twenty-five errors with RPN ≥ 125 was detected through the admission process, in which six cases of error had high priority in terms of severity and occurrence probability and were identified as high-risk errors. Conclusions: The team-oriented method of FMEA could be useful for assessment of errors and also to reduce the occurrence probability of errors. PMID:28194208

Independent Orbiter Assessment (IOA): Analysis of the auxiliary power unit

NASA Technical Reports Server (NTRS)

Barnes, J. E.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Orbiter Auxiliary Power Unit (APU). The APUs are required to provide power to the Orbiter hydraulics systems during ascent and entry flight phases for aerosurface actuation, main engine gimballing, landing gear extension, and other vital functions. For analysis purposes, the APU system was broken down into ten functional subsystems. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. A preponderance of 1/1 criticality items were related to failures that allowed the hydrazine fuel to escape into the Orbiter aft compartment, creating a severe fire hazard, and failures that caused loss of the gas generator injector cooling system.

Independent Orbiter Assessment (IOA): Analysis of the electrical power generation/fuel cell powerplant subsystem

NASA Technical Reports Server (NTRS)

Brown, K. L.; Bertsch, P. J.

1986-01-01

Results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Orbiter Electrical Power Generation (EPG)/Fuel Cell Powerplant (FCP) hardware. The EPG/FCP hardware is required for performing functions of electrical power generation and product water distribution in the Orbiter. Specifically, the EPG/FCP hardware consists of the following divisions: (1) Power Section Assembly (PSA); (2) Reactant Control Subsystem (RCS); (3) Thermal Control Subsystem (TCS); and (4) Water Removal Subsystem (WRS). The IOA analysis process utilized available EPG/FCP hardware drawings and schematics for defining hardware assemblies, components, and hardware items. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode.

Independent Orbiter Assessment (IOA): Analysis of the orbital maneuvering system

NASA Technical Reports Server (NTRS)

Prust, C. D.; Paul, D. J.; Burkemper, V. J.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The independent analysis results for the Orbital Maneuvering System (OMS) hardware are documented. The OMS provides the thrust to perform orbit insertion, orbit circularization, orbit transfer, rendezvous, and deorbit. The OMS is housed in two independent pods located one on each side of the tail and consists of the following subsystems: Helium Pressurization; Propellant Storage and Distribution; Orbital Maneuvering Engine; and Electrical Power Distribution and Control. The IOA analysis process utilized available OMS hardware drawings and schematics for defining hardware assemblies, components, and hardware items. Each level of hardware was evaluted and analyzed for possible failure modes and effects. Criticality was asigned based upon the severity of the effect for each failure mode.

Independent Orbiter Assessment (IOA): Analysis of the Electrical Power Distribution and Control Subsystem, Volume 2

NASA Technical Reports Server (NTRS)

Schmeckpeper, K. R.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Orbiter Electrical Power Distribution and Control (EPD and C) hardware. The EPD and C hardware performs the functions of distributing, sensing, and controlling 28 volt DC power and of inverting, distributing, sensing, and controlling 117 volt 400 Hz AC power to all Orbiter subsystems from the three fuel cells in the Electrical Power Generation (EPG) subsystem. Volume 2 continues the presentation of IOA analysis worksheets and contains the potential critical items list.

16 CFR 1211.5 - General testing parameters.

Code of Federal Regulations, 2010 CFR

2010-01-01

... condition flow chart shown in figure 1 shall be used: (1) To conduct a failure-mode and effect analysis (FMEA); (2) In investigating the performance during the Environmental Stress Tests; and (3) During the...

Failure analysis in the identification of synergies between cleaning monitoring methods.

PubMed

Whiteley, Greg S; Derry, Chris; Glasbey, Trevor

2015-02-01

The 4 monitoring methods used to manage the quality assurance of cleaning outcomes within health care settings are visual inspection, microbial recovery, fluorescent marker assessment, and rapid ATP bioluminometry. These methods each generate different types of information, presenting a challenge to the successful integration of monitoring results. A systematic approach to safety and quality control can be used to interrogate the known qualities of cleaning monitoring methods and provide a prospective management tool for infection control professionals. We investigated the use of failure mode and effects analysis (FMEA) for measuring failure risk arising through each cleaning monitoring method. FMEA uses existing data in a structured risk assessment tool that identifies weaknesses in products or processes. Our FMEA approach used the literature and a small experienced team to construct a series of analyses to investigate the cleaning monitoring methods in a way that minimized identified failure risks. FMEA applied to each of the cleaning monitoring methods revealed failure modes for each. The combined use of cleaning monitoring methods in sequence is preferable to their use in isolation. When these 4 cleaning monitoring methods are used in combination in a logical sequence, the failure modes noted for any 1 can be complemented by the strengths of the alternatives, thereby circumventing the risk of failure of any individual cleaning monitoring method. Copyright © 2015 Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.

[FMEA applied to the radiotherapy patient care process].

PubMed

Meyrieux, C; Garcia, R; Pourel, N; Mège, A; Bodez, V

2012-10-01

Failure modes and effects analysis (FMEA), is a risk analysis method used at the Radiotherapy Department of Institute Sainte-Catherine as part of a strategy seeking to continuously improve the quality and security of treatments. The method comprises several steps: definition of main processes; for each of them, description for every step of prescription, treatment preparation, treatment application; identification of the possible risks, their consequences, their origins; research of existing safety elements which may avoid these risks; grading of risks to assign a criticality score resulting in a numerical organisation of the risks. Finally, the impact of proposed corrective actions was then estimated by a new grading round. For each process studied, a detailed map of the risks was obtained, facilitating the identification of priority actions to be undertaken. For example, we obtain five steps in patient treatment planning with an unacceptable level of risk, 62 a level of moderate risk and 31 an acceptable level of risk. The FMEA method, used in the industrial domain and applied here to health care, is an effective tool for the management of risks in patient care. However, the time and training requirements necessary to implement this method should not be underestimated. Copyright © 2012 Société française de radiothérapie oncologique (SFRO). Published by Elsevier SAS. All rights reserved.

Failure mode and effects analysis to reduce risk of anticoagulation levels above the target range during concurrent antimicrobial therapy.

PubMed

Daniels, Lisa M; Barreto, Jason N; Kuth, John C; Anderson, Jeremy R; Zhang, Beilei; Majka, Andrew J; Morgenthaler, Timothy I; Tosh, Pritish K

2015-07-15

A failure mode and effects analysis (FMEA) was conducted to analyze the clinical and operational processes leading to above-target International Normalized Ratios (INRs) in warfarin-treated patients receiving concurrent antimicrobial therapy. The INRs of patients on long-term warfarin therapy who received a course of trimethoprim-sulfamethoxazole, metronidazole, fluconazole, miconazole, or voriconazole (highly potentiating antimicrobials, or HPAs) between September 1 and December 31, 2011, were compared with patients on long-term warfarin therapy who did not receive any antimicrobial during the same period. A multidisciplinary team of physicians, pharmacists, and a systems analyst was then formed to complete a step-by-step outline of the processes involved in warfarin management and concomitant HPA therapy, followed by an FMEA. Patients taking trimethoprim-sulfamethoxazole, metronidazole, or fluconazole demonstrated a significantly increased risk of having an INR of >4.5. The FMEA identified 134 failure modes. The most common failure modes were as follows: (1) electronic medical records did not identify all patients receiving warfarin, (2) HPA prescribers were unaware of recommended warfarin therapy when HPAs were prescribed, (3) HPA prescribers were unaware that a patient was taking warfarin and that the drug interaction is significant, and (4) warfarin managers were unaware that an HPA had been prescribed for a patient. An FMEA determined that the risk of adverse events caused by concomitantly administering warfarin and HPAs can be decreased by preemptively identifying patients receiving warfarin, having a care process in place, alerting providers about the patient's risk status, and notifying providers at the anticoagulation clinic. Copyright © 2015 by the American Society of Health-System Pharmacists, Inc. All rights reserved.

Application of Failure Mode and Effects Analysis to Intraoperative Radiation Therapy Using Mobile Electron Linear Accelerators

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ciocca, Mario, E-mail: mario.ciocca@cnao.it; Cantone, Marie-Claire; Veronese, Ivan

2012-02-01

Purpose: Failure mode and effects analysis (FMEA) represents a prospective approach for risk assessment. A multidisciplinary working group of the Italian Association for Medical Physics applied FMEA to electron beam intraoperative radiation therapy (IORT) delivered using mobile linear accelerators, aiming at preventing accidental exposures to the patient. Methods and Materials: FMEA was applied to the IORT process, for the stages of the treatment delivery and verification, and consisted of three steps: 1) identification of the involved subprocesses; 2) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system,more » based on the product of three parameters (severity, frequency of occurrence and detectability, each ranging from 1 to 10); 3) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. Results: Twenty-four subprocesses were identified. Ten potential failure modes were found and scored, in terms of RPN, in the range of 42-216. The most critical failure modes consisted of internal shield misalignment, wrong Monitor Unit calculation and incorrect data entry at treatment console. Potential causes of failure included shield displacement, human errors, such as underestimation of CTV extension, mainly because of lack of adequate training and time pressures, failure in the communication between operators, and machine malfunctioning. The main effects of failure were represented by CTV underdose, wrong dose distribution and/or delivery, unintended normal tissue irradiation. As additional safety measures, the utilization of a dedicated staff for IORT, double-checking of MU calculation and data entry and finally implementation of in vivo dosimetry were suggested. Conclusions: FMEA appeared as a useful tool for prospective evaluation of patient safety in radiotherapy. The application of this method to IORT lead to identify three safety measures for risk mitigation.« less

Risk assessment as standard work in design.

PubMed

Morrill, Patricia W

2013-01-01

This case study article examines a formal risk assessment as part of the decision making process for design solutions in high risk areas. The overview of the Failure Modes and Effects Analysis (FMEA) tool with examples of its application in hospital building projects will demonstrate the benefit of those structured conversations. This article illustrates how two hospitals used FMEA when integrating operational processes with building projects: (1) adjacency decision for Intensive Care Unit (ICU); and (2) distance concern for handling of specimens from Surgery to Lab. Both case studies involved interviews that exposed facility solution concerns. Just-in-time studies using the FMEA followed the same risk assessment process with the same workshop facilitator involving structured conversations in analyzing risks. In both cases, participants uncovered key areas of risk enabling them to take the necessary next steps. While the focus of this article is not the actual design solution, it is apparent that the risk assessment brought clarity to the situations resulting in prompt decision making about facility solutions. Hospitals are inherently risky environments; therefore, use of the formal risk assessment process, FMEA, is an opportunity for design professionals to apply more rigor to design decision making when facility solutions impact operations in high risk areas. Case study, decision making, hospital, infection control, strategy, work environment.

Failure mode and effect analysis-based quality assurance for dynamic MLC tracking systems

PubMed Central

Sawant, Amit; Dieterich, Sonja; Svatos, Michelle; Keall, Paul

2010-01-01

Purpose: To develop and implement a failure mode and effect analysis (FMEA)-based commissioning and quality assurance framework for dynamic multileaf collimator (DMLC) tumor tracking systems. Methods: A systematic failure mode and effect analysis was performed for a prototype real-time tumor tracking system that uses implanted electromagnetic transponders for tumor position monitoring and a DMLC for real-time beam adaptation. A detailed process tree of DMLC tracking delivery was created and potential tracking-specific failure modes were identified. For each failure mode, a risk probability number (RPN) was calculated from the product of the probability of occurrence, the severity of effect, and the detectibility of the failure. Based on the insights obtained from the FMEA, commissioning and QA procedures were developed to check (i) the accuracy of coordinate system transformation, (ii) system latency, (iii) spatial and dosimetric delivery accuracy, (iv) delivery efficiency, and (v) accuracy and consistency of system response to error conditions. The frequency of testing for each failure mode was determined from the RPN value. Results: Failures modes with RPN≥125 were recommended to be tested monthly. Failure modes with RPN<125 were assigned to be tested during comprehensive evaluations, e.g., during commissioning, annual quality assurance, and after major software∕hardware upgrades. System latency was determined to be ∼193 ms. The system showed consistent and accurate response to erroneous conditions. Tracking accuracy was within 3%–3 mm gamma (100% pass rate) for sinusoidal as well as a wide variety of patient-derived respiratory motions. The total time taken for monthly QA was ∼35 min, while that taken for comprehensive testing was ∼3.5 h. Conclusions: FMEA proved to be a powerful and flexible tool to develop and implement a quality management (QM) framework for DMLC tracking. The authors conclude that the use of FMEA-based QM ensures efficient allocation of clinical resources because the most critical failure modes receive the most attention. It is expected that the set of guidelines proposed here will serve as a living document that is updated with the accumulation of progressively more intrainstitutional and interinstitutional experience with DMLC tracking. PMID:21302802

Introducing a change in hospital policy using FMEA methodology as a tool to reduce patient hazards.

PubMed

Ofek, Fanny; Magnezi, Racheli; Kurzweil, Yaffa; Gazit, Inbal; Berkovitch, Sofia; Tal, Orna

2016-01-01

Intravenous potassium chloride (IV KCl) solutions are widely used in hospitals for treatment of hypokalemia. As ampoules of concentrated KCL must be diluted before use, critical incidents have been associated with its preparation and administration. Currently, we have introduced ready-to-use diluted KCl infusion solutions to minimize the use of high-alert concentrated KCl. Since this process may be associated with considerable risks, we embraced a proactive hazard analysis as a tool to implement a change in high-alert drug usage in a hospital setting. Failure mode and effect analysis (FMEA) is a systematic tool to analyze and identify risks in system operations. We used FMEA to examine the hazards associated with the implementation of the ready-to-use solutions. A multidisciplinary team analyzed the risks by identifying failure modes, conducting a hazard analysis and calculating the criticality index (CI) for each failure mode. A 1-day survey was performed as an evaluation step after a trial run period of approximately 4 months. Six major possible risks were identified. The most severe risks were prioritized and specific recommendations were formulated. Out of 28 patients receiving IV KCl on the day of the survey, 22 received the ready-to-use solutions and 6 received the concentrated solutions as instructed. Only 1 patient received inappropriate ready-to-use KCl. Using the FMEA tool in our study has proven once again that by creating a gradient of severity of potential vulnerable elements, we are able to proactively promote safer and more efficient processes in health care systems. This article presents a utilization of this method for implementing a change in hospital policy regarding the routine use of IV KCl.

SU-D-201-07: A Survey of Radiation Oncology Residents’ Training and Preparedness to Lead Patient Safety Programs in Clinics

DOE Office of Scientific and Technical Information (OSTI.GOV)

Spraker, M; Nyflot, M; Ford, E

Purpose: Safety and quality has garnered increased attention in radiation oncology, and physicians and physicists are ideal leaders of clinical patient safety programs. However, it is not clear whether residency programs incorporate formal patient safety training and adequately equip residents to assume this leadership role. A national survey was conducted to evaluate medical and physics residents’ exposure to safety topics and their confidence with the skills required to lead clinical safety programs. Methods: Radiation oncology residents were identified in collaboration with ARRO and AAPM. The survey was released in February 2016 via email using REDCap. This included questions about exposuremore » to safety topics, confidence leading safety programs, and interest in training opportunities (i.e. workshops). Residents rated their exposure, skills, and confidence on 4 or 5-point scales. Medical and physics residents responses were compared using chi-square tests. Results: Responses were collected from 56 of 248 (22%) physics and 139 of 690 (20%) medical residents. More than two thirds of all residents had no or only informal exposure to incident learning systems (ILS), root cause analysis (RCA), failure mode and effects analysis (FMEA), and the concept of human factors engineering (HFE). Likewise, 63% of residents had not heard of RO-ILS. Response distributions were similar, however more physics residents had formal exposure to FMEA (p<0.0001) and felt they were adequately trained to lead FMEAs in clinic (p<0.001) than medical residents. Only 36% of residents felt their patient safety training was adequate, and 58% felt more training would benefit their education. Conclusion: These results demonstrate that, despite increasing desire for patient safety training, medical and physics residents’ exposure to relevant concepts is low. Physics residents had more exposure to FMEA than medical residents, and were more confident in leading FMEA. This suggests that increasing resident exposure to specific topics may increase their confidence.« less

SU-E-T-419: Workflow and FMEA in a New Proton Therapy (PT) Facility

DOE Office of Scientific and Technical Information (OSTI.GOV)

Cheng, C; Wessels, B; Hamilton, H

2014-06-01

Purpose: Workflow is an important component in the operational planning of a new proton facility. By integrating the concept of failure mode and effect analysis (FMEA) and traditional QA requirements, a workflow for a proton therapy treatment course is set up. This workflow serves as the blue print for the planning of computer hardware/software requirements and network flow. A slight modification of the workflow generates a process map(PM) for FMEA and the planning of QA program in PT. Methods: A flowchart is first developed outlining the sequence of processes involved in a PT treatment course. Each process consists of amore » number of sub-processes to encompass a broad scope of treatment and QA procedures. For each subprocess, the personnel involved, the equipment needed and the computer hardware/software as well as network requirements are defined by a team of clinical staff, administrators and IT personnel. Results: Eleven intermediate processes with a total of 70 sub-processes involved in a PT treatment course are identified. The number of sub-processes varies, ranging from 2-12. The sub-processes within each process are used for the operational planning. For example, in the CT-Sim process, there are 12 sub-processes: three involve data entry/retrieval from a record-and-verify system, two controlled by the CT computer, two require department/hospital network, and the other five are setup procedures. IT then decides the number of computers needed and the software and network requirement. By removing the traditional QA procedures from the workflow, a PM is generated for FMEA analysis to design a QA program for PT. Conclusion: Significant efforts are involved in the development of the workflow in a PT treatment course. Our hybrid model of combining FMEA and traditional QA program serves a duo purpose of efficient operational planning and designing of a QA program in PT.« less

Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System

PubMed Central

Rossi, Elio G.; Picchi, Marco; Baccetti, Sonia; Monechi, Maria Valeria; Vuono, Catia; Sabatini, Federica; Traversi, Antonella; Di Stefano, Mariella; Firenzuoli, Fabio; Albolino, Sara; Tartaglia, Riccardo

2017-01-01

Aim: To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM) and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA) and failure modes and effects analysis (FMEA). Methods: SEA is the selected tool for studying adverse events (AE) and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS). This requires the active participation of all the actors and external experts to validate the analysis. FMEA is a proactive risk assessment tool involving the selection of the clinical process, the input of a multidisciplinary group of experts, description of the process, identification of the failure modes (FMs) for each step, estimates of the frequency, severity, and detectability of FMs, calculation of the risk priority number (RPN), and prioritized improvement actions to prevent FMs. Results: In homeopathy, the greatest risk depends on the decision to switch from allopathic to homeopathic therapy. In acupuncture, major problems can arise, mainly from delayed treatment and from the modalities of needle insertion. Conclusions: The combination of SEA and FMEA can reveal potential risks for patients and suggest actions for safer and more reliable services in CM. PMID:29258191

Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System.

PubMed

Rossi, Elio G; Bellandi, Tommaso; Picchi, Marco; Baccetti, Sonia; Monechi, Maria Valeria; Vuono, Catia; Sabatini, Federica; Traversi, Antonella; Di Stefano, Mariella; Firenzuoli, Fabio; Albolino, Sara; Tartaglia, Riccardo

2017-12-16

Aim: To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM) and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA) and failure modes and effects analysis (FMEA). Methods: SEA is the selected tool for studying adverse events (AE) and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS). This requires the active participation of all the actors and external experts to validate the analysis. FMEA is a proactive risk assessment tool involving the selection of the clinical process, the input of a multidisciplinary group of experts, description of the process, identification of the failure modes (FMs) for each step, estimates of the frequency, severity, and detectability of FMs, calculation of the risk priority number (RPN), and prioritized improvement actions to prevent FMs. Results: In homeopathy, the greatest risk depends on the decision to switch from allopathic to homeopathic therapy. In acupuncture, major problems can arise, mainly from delayed treatment and from the modalities of needle insertion. Conclusions: The combination of SEA and FMEA can reveal potential risks for patients and suggest actions for safer and more reliable services in CM.

Safety and feasibility of STAT RAD: Improvement of a novel rapid tomotherapy-based radiation therapy workflow by failure mode and effects analysis.

PubMed

Jones, Ryan T; Handsfield, Lydia; Read, Paul W; Wilson, David D; Van Ausdal, Ray; Schlesinger, David J; Siebers, Jeffrey V; Chen, Quan

2015-01-01

The clinical challenge of radiation therapy (RT) for painful bone metastases requires clinicians to consider both treatment efficacy and patient prognosis when selecting a radiation therapy regimen. The traditional RT workflow requires several weeks for common palliative RT schedules of 30 Gy in 10 fractions or 20 Gy in 5 fractions. At our institution, we have created a new RT workflow termed "STAT RAD" that allows clinicians to perform computed tomographic (CT) simulation, planning, and highly conformal single fraction treatment delivery within 2 hours. In this study, we evaluate the safety and feasibility of the STAT RAD workflow. A failure mode and effects analysis (FMEA) was performed on the STAT RAD workflow, including development of a process map, identification of potential failure modes, description of the cause and effect, temporal occurrence, and team member involvement in each failure mode, and examination of existing safety controls. A risk probability number (RPN) was calculated for each failure mode. As necessary, workflow adjustments were then made to safeguard failure modes of significant RPN values. After workflow alterations, RPN numbers were again recomputed. A total of 72 potential failure modes were identified in the pre-FMEA STAT RAD workflow, of which 22 met the RPN threshold for clinical significance. Workflow adjustments included the addition of a team member checklist, changing simulation from megavoltage CT to kilovoltage CT, alteration of patient-specific quality assurance testing, and allocating increased time for critical workflow steps. After these modifications, only 1 failure mode maintained RPN significance; patient motion after alignment or during treatment. Performing the FMEA for the STAT RAD workflow before clinical implementation has significantly strengthened the safety and feasibility of STAT RAD. The FMEA proved a valuable evaluation tool, identifying potential problem areas so that we could create a safer workflow. Copyright © 2015 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Risk Assessment Planning for Airborne Systems: An Information Assurance Failure Mode, Effects and Criticality Analysis Methodology

DTIC Science & Technology

2012-06-01

Visa Investigate Data Breach March 30, 2012 Visa and MasterCard are investigating whether a data security breach at one of the main companies that...30). MasterCard and Visa Investigate Data Breach . New York Times . Stamatis, D. (2003). Failure Mode Effect Analysis: FMEA from Theory to Execution

A Comparison of Two Approaches to Safety Analysis Based on Use Cases

NASA Astrophysics Data System (ADS)

Stålhane, Tor; Sindre, Guttorm

Engineering has a long tradition in analyzing the safety of mechanical, electrical and electronic systems. Important methods like HazOp and FMEA have also been adopted by the software engineering community. The misuse case method, on the other hand, has been developed by the software community as an alternative to FMEA and preliminary HazOp for software development. To compare the two methods misuse case and FMEA we have run a small experiment involving 42 third year software engineering students. In the experiment, the students should identify and analyze failure modes from one of the use cases for a commercial electronic patient journals system. The results of the experiment show that on the average, the group that used misuse cases identified and analyzed more user related failure modes than the persons using FMEA. In addition, the persons who used the misuse cases scored better on perceived ease of use and intention to use.

Foresight begins with FMEA. Delivering accurate risk assessments.

PubMed

Passey, R D

1999-03-01

If sufficient factors are taken into account and two- or three-stage analysis is employed, failure mode and effect analysis represents an excellent technique for delivering accurate risk assessments for products and processes, and for relating them to legal liability. This article describes a format that facilitates easy interpretation.

Creating and evaluating a data-driven curriculum for central venous catheter placement.

PubMed

Duncan, James R; Henderson, Katherine; Street, Mandie; Richmond, Amy; Klingensmith, Mary; Beta, Elio; Vannucci, Andrea; Murray, David

2010-09-01

Central venous catheter placement is a common procedure with a high incidence of error. Other fields requiring high reliability have used Failure Mode and Effects Analysis (FMEA) to prioritize quality and safety improvement efforts. To use FMEA in the development of a formal, standardized curriculum for central venous catheter training. We surveyed interns regarding their prior experience with central venous catheter placement. A multidisciplinary team used FMEA to identify high-priority failure modes and to develop online and hands-on training modules to decrease the frequency, diminish the severity, and improve the early detection of these failure modes. We required new interns to complete the modules and tracked their progress using multiple assessments. Survey results showed new interns had little prior experience with central venous catheter placement. Using FMEA, we created a curriculum that focused on planning and execution skills and identified 3 priority topics: (1) retained guidewires, which led to training on handling catheters and guidewires; (2) improved needle access, which prompted the development of an ultrasound training module; and (3) catheter-associated bloodstream infections, which were addressed through training on maximum sterile barriers. Each module included assessments that measured progress toward recognition and avoidance of common failure modes. Since introducing this curriculum, the number of retained guidewires has fallen more than 4-fold. Rates of catheter-associated infections have not yet declined, and it will take time before ultrasound training will have a measurable effect. The FMEA provided a process for curriculum development. Precise definitions of failure modes for retained guidewires facilitated development of a curriculum that contributed to a dramatic decrease in the frequency of this complication. Although infections and access complications have not yet declined, failure mode identification, curriculum development, and monitored implementation show substantial promise for improving patient safety during placement of central venous catheters.

The Utility of Failure Modes and Effects Analysis of Consultations in a Tertiary, Academic, Medical Center.

PubMed

Niv, Yaron; Itskoviz, David; Cohen, Michal; Hendel, Hagit; Bar-Giora, Yonit; Berkov, Evgeny; Weisbord, Irit; Leviron, Yifat; Isasschar, Assaf; Ganor, Arian

Failure modes and effects analysis (FMEA) is a tool used to identify potential risks in health care processes. We used the FMEA tool for improving the process of consultation in an academic medical center. A team of 10 staff members-5 physicians, 2 quality experts, 2 organizational consultants, and 1 nurse-was established. The consultation process steps, from ordering to delivering, were computed. Failure modes were assessed for likelihood of occurrence, detection, and severity. A risk priority number (RPN) was calculated. An interventional plan was designed according to the highest RPNs. Thereafter, we compared the percentage of completed computer-based documented consultations before and after the intervention. The team identified 3 main categories of failure modes that reached the highest RPNs: initiation of consultation by a junior staff physician without senior approval, failure to document the consultation in the computerized patient registry, and asking for consultation on the telephone. An interventional plan was designed, including meetings to update knowledge of the consultation request process, stressing the importance of approval by a senior physician, training sessions for closing requests in the patient file, and reporting of telephone requests. The number of electronically documented consultation results and recommendations significantly increased (75%) after intervention. FMEA is an important and efficient tool for improving the consultation process in an academic medical center.

Failure Mode and Effect Analysis for Delivery of Lung Stereotactic Body Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Perks, Julian R., E-mail: julian.perks@ucdmc.ucdavis.edu; Stanic, Sinisa; Stern, Robin L.

2012-07-15

Purpose: To improve the quality and safety of our practice of stereotactic body radiation therapy (SBRT), we analyzed the process following the failure mode and effects analysis (FMEA) method. Methods: The FMEA was performed by a multidisciplinary team. For each step in the SBRT delivery process, a potential failure occurrence was derived and three factors were assessed: the probability of each occurrence, the severity if the event occurs, and the probability of detection by the treatment team. A rank of 1 to 10 was assigned to each factor, and then the multiplied ranks yielded the relative risks (risk priority numbers).more » The failure modes with the highest risk priority numbers were then considered to implement process improvement measures. Results: A total of 28 occurrences were derived, of which nine events scored with significantly high risk priority numbers. The risk priority numbers of the highest ranked events ranged from 20 to 80. These included transcription errors of the stereotactic coordinates and machine failures. Conclusion: Several areas of our SBRT delivery were reconsidered in terms of process improvement, and safety measures, including treatment checklists and a surgical time-out, were added for our practice of gantry-based image-guided SBRT. This study serves as a guide for other users of SBRT to perform FMEA of their own practice.« less

Independent Orbiter Assessment (IOA): Analysis of the active thermal control subsystem

NASA Technical Reports Server (NTRS)

Sinclair, S. K.; Parkman, W. E.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical (PCIs) items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The independent analysis results corresponding to the Orbiter Active Thermal Control Subsystem (ATCS) are documented. The major purpose of the ATCS is to remove the heat, generated during normal Shuttle operations from the Orbiter systems and subsystems. The four major components of the ATCS contributing to the heat removal are: Freon Coolant Loops; Radiator and Flow Control Assembly; Flash Evaporator System; and Ammonia Boiler System. In order to perform the analysis, the IOA process utilized available ATCS hardware drawings and schematics for defining hardware assemblies, components, and hardware items. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. Of the 310 failure modes analyzed, 101 were determined to be PCIs.

Independent Orbiter Assessment (IOA): Analysis of the hydraulics/water spray boiler subsystem

NASA Technical Reports Server (NTRS)

Duval, J. D.; Davidson, W. R.; Parkman, William E.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items (PCIs). To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results for the Orbiter Hydraulics/Water Spray Boiler Subsystem. The hydraulic system provides hydraulic power to gimbal the main engines, actuate the main engine propellant control valves, move the aerodynamic flight control surfaces, lower the landing gear, apply wheel brakes, steer the nosewheel, and dampen the external tank (ET) separation. Each hydraulic system has an associated water spray boiler which is used to cool the hydraulic fluid and APU lubricating oil. The IOA analysis process utilized available HYD/WSB hardware drawings, schematics and documents for defining hardware assemblies, components, and hardware items. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. Of the 430 failure modes analyzed, 166 were determined to be PCIs.

Independent Orbiter Assessment (IOA): Analysis of the remote manipulator system

NASA Technical Reports Server (NTRS)

Tangorra, F.; Grasmeder, R. F.; Montgomery, A. D.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items (PCIs). To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The independent analysis results for the Orbiter Remote Manipulator System (RMS) are documented. The RMS hardware and software are primarily required for deploying and/or retrieving up to five payloads during a single mission, capture and retrieve free-flying payloads, and for performing Manipulator Foot Restraint operations. Specifically, the RMS hardware consists of the following components: end effector; displays and controls; manipulator controller interface unit; arm based electronics; and the arm. The IOA analysis process utilized available RMS hardware drawings, schematics and documents for defining hardware assemblies, components and hardware items. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. Of the 574 failure modes analyzed, 413 were determined to be PCIs.

Independent Orbiter Assessment (IOA): Analysis of the electrical power distribution and control/electrical power generation subsystem

NASA Technical Reports Server (NTRS)

Patton, Jeff A.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Orbiter Electrical Power Distribution and Control (EPD and C)/Electrical Power Generation (EPG) hardware. The EPD and C/EPG hardware is required for performing critical functions of cryogenic reactant storage, electrical power generation and product water distribution in the Orbiter. Specifically, the EPD and C/EPG hardware consists of the following components: Power Section Assembly (PSA); Reactant Control Subsystem (RCS); Thermal Control Subsystem (TCS); Water Removal Subsystem (WRS); and Power Reactant Storage and Distribution System (PRSDS). The IOA analysis process utilized available EPD and C/EPG hardware drawings and schematics for defining hardware assemblies, components, and hardware items. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode.

Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report

PubMed Central

Lago, Paola; Bizzarri, Giancarlo; Scalzotto, Francesca; Parpaiola, Antonella; Amigoni, Angela; Putoto, Giovanni; Perilongo, Giorgio

2012-01-01

Objective Administering medication to hospitalised infants and children is a complex process at high risk of error. Failure mode and effect analysis (FMEA) is a proactive tool used to analyse risks, identify failures before they happen and prioritise remedial measures. To examine the hazards associated with the process of drug delivery to children, we performed a proactive risk-assessment analysis. Design and setting Five multidisciplinary teams, representing different divisions of the paediatric department at Padua University Hospital, were trained to analyse the drug-delivery process, to identify possible causes of failures and their potential effects, to calculate a risk priority number (RPN) for each failure and plan changes in practices. Primary outcome To identify higher-priority potential failure modes as defined by RPNs and planning changes in clinical practice to reduce the risk of patients harm and improve safety in the process of medication use in children. Results In all, 37 higher-priority potential failure modes and 71 associated causes and effects were identified. The highest RPNs related (>48) mainly to errors in calculating drug doses and concentrations. Many of these failure modes were found in all the five units, suggesting the presence of common targets for improvement, particularly in enhancing the safety of prescription and preparation of endovenous drugs. The introductions of new activities in the revised process of administering drugs allowed reducing the high-risk failure modes of 60%. Conclusions FMEA is an effective proactive risk-assessment tool useful to aid multidisciplinary groups in understanding a process care and identifying errors that may occur, prioritising remedial interventions and possibly enhancing the safety of drug delivery in children. PMID:23253870

Use of FMEA analysis to reduce risk of errors in prescribing and administering drugs in paediatric wards: a quality improvement report.

PubMed

Lago, Paola; Bizzarri, Giancarlo; Scalzotto, Francesca; Parpaiola, Antonella; Amigoni, Angela; Putoto, Giovanni; Perilongo, Giorgio

2012-01-01

Administering medication to hospitalised infants and children is a complex process at high risk of error. Failure mode and effect analysis (FMEA) is a proactive tool used to analyse risks, identify failures before they happen and prioritise remedial measures. To examine the hazards associated with the process of drug delivery to children, we performed a proactive risk-assessment analysis. Five multidisciplinary teams, representing different divisions of the paediatric department at Padua University Hospital, were trained to analyse the drug-delivery process, to identify possible causes of failures and their potential effects, to calculate a risk priority number (RPN) for each failure and plan changes in practices. To identify higher-priority potential failure modes as defined by RPNs and planning changes in clinical practice to reduce the risk of patients harm and improve safety in the process of medication use in children. In all, 37 higher-priority potential failure modes and 71 associated causes and effects were identified. The highest RPNs related (>48) mainly to errors in calculating drug doses and concentrations. Many of these failure modes were found in all the five units, suggesting the presence of common targets for improvement, particularly in enhancing the safety of prescription and preparation of endovenous drugs. The introductions of new activities in the revised process of administering drugs allowed reducing the high-risk failure modes of 60%. FMEA is an effective proactive risk-assessment tool useful to aid multidisciplinary groups in understanding a process care and identifying errors that may occur, prioritising remedial interventions and possibly enhancing the safety of drug delivery in children.

Poster - Thur Eve - 38: Review of couch parameters using an FMEA.

PubMed

Larouche, R; Doucet, R; Rémy, E; Filion, A; Poirier, L

2012-07-01

To improve patient safety during positioning, we undertook a systematic review of the processes used by our center to obtain couch positions. We used a Failure Mode and Effects Analysis (FMEA) framework and fifteen different possible failures were identified and rated. The three major failures were 1) Loss of planned couch position and bias from the previous day's couch position, 2) DICOM origin or isocenter is different between two plans (imaging or treatment), and 3) Patient shift in opposite direction than intended. The main effect of these failures was to cause an override of couch parameters. Based on these results, we modified our processes, introduced new QA and software checks and developed new tolerance tables so as to improve system robustness and increase our success rate at catching failures before they can affect the patient. It has been a year since we made these modifications. Based on our results, we have reduced the number of overrides at our center from a maximum of 20.5% to a maximum of 6.3%, with an average at 4% of daily treatments. Our results suggest that FMEA is an effective tool in improving treatment quality that could be used in other centers. © 2012 American Association of Physicists in Medicine.

Independent Orbiter Assessment (IOA): Analysis of the guidance, navigation, and control subsystem

NASA Technical Reports Server (NTRS)

Trahan, W. H.; Odonnell, R. A.; Pietz, K. C.; Hiott, J. M.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) is presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The independent analysis results corresponding to the Orbiter Guidance, Navigation, and Control (GNC) Subsystem hardware are documented. The function of the GNC hardware is to respond to guidance, navigation, and control software commands to effect vehicle control and to provide sensor and controller data to GNC software. Some of the GNC hardware for which failure modes analysis was performed includes: hand controllers; Rudder Pedal Transducer Assembly (RPTA); Speed Brake Thrust Controller (SBTC); Inertial Measurement Unit (IMU); Star Tracker (ST); Crew Optical Alignment Site (COAS); Air Data Transducer Assembly (ADTA); Rate Gyro Assemblies; Accelerometer Assembly (AA); Aerosurface Servo Amplifier (ASA); and Ascent Thrust Vector Control (ATVC). The IOA analysis process utilized available GNC hardware drawings, workbooks, specifications, schematics, and systems briefs for defining hardware assemblies, components, and circuits. Each hardware item was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode.

Independent Orbiter Assessment (IOA): Analysis of the nose wheel steering subsystem

NASA Technical Reports Server (NTRS)

Mediavilla, Anthony Scott

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The independent analysis results for the Orbiter Nose Wheel Steering (NWS) hardware are documented. The NWS hardware provides primary directional control for the Orbiter vehicle during landing rollout. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. The original NWS design was envisioned as a backup system to differential braking for directional control of the Orbiter during landing rollout. No real effort was made to design the NWS system as fail operational. The brakes have much redundancy built into their design but the poor brake/tire performance has forced the NSTS to upgrade NWS to the primary mode of directional control during rollout. As a result, a large percentage of the NWS system components have become Potential Critical Items (PCI).

[Reliability theory based on quality risk network analysis for Chinese medicine injection].

PubMed

Li, Zheng; Kang, Li-Yuan; Fan, Xiao-Hui

2014-08-01

A new risk analysis method based upon reliability theory was introduced in this paper for the quality risk management of Chinese medicine injection manufacturing plants. The risk events including both cause and effect ones were derived in the framework as nodes with a Bayesian network analysis approach. It thus transforms the risk analysis results from failure mode and effect analysis (FMEA) into a Bayesian network platform. With its structure and parameters determined, the network can be used to evaluate the system reliability quantitatively with probabilistic analytical appraoches. Using network analysis tools such as GeNie and AgenaRisk, we are able to find the nodes that are most critical to influence the system reliability. The importance of each node to the system can be quantitatively evaluated by calculating the effect of the node on the overall risk, and minimization plan can be determined accordingly to reduce their influences and improve the system reliability. Using the Shengmai injection manufacturing plant of SZYY Ltd as a user case, we analyzed the quality risk with both static FMEA analysis and dynamic Bayesian Network analysis. The potential risk factors for the quality of Shengmai injection manufacturing were identified with the network analysis platform. Quality assurance actions were further defined to reduce the risk and improve the product quality.

Independent Orbiter Assessment (IOA): Analysis of the electrical power generation/power reactant storage and distribution subsystem

NASA Technical Reports Server (NTRS)

Gotch, S. M.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NAA FMEA/CIL documentation. The independent analysis results corresponding to the Orbiter Electrical Power Generation (EPG)/Power Reactants Storage and Distribution (PRSD) System Hardware is documented. The EPG/PRSD hardware is required for performing critical functions of cryogenic hydrogen and oxygen storage and distribution to the Fuel Cell Powerplants (FCP) and Atmospheric Revitalization Pressure Control Subsystem (ARPCS). Specifically, the EPG/PRSD hardware consists of the following: Hydryogen (H2) tanks; Oxygen (O2) tanks; H2 Relief Valve/Filter Packages (HRVFP); O2 Relief Valve/Filter Packages (ORVFP); H2 Valve Modules (HVM); O2 Valve Modules (OVM); and O2 and H2 lines, components, and fittings.

SU-F-T-247: Collision Risks in a Modern Radiation Oncology Department: An Efficient Approach to Failure Modes and Effects Analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Schubert, L; Westerly, D; Vinogradskiy, Y

Purpose: Collisions between treatment equipment and patients are potentially catastrophic. Modern technology now commonly involves automated remote motion during imaging and treatment, yet a systematic assessment to identify and mitigate collision risks has yet to be performed. Failure modes and effects analysis (FMEA) is a method of risk assessment that has been increasingly used in healthcare, yet can be resource intensive. This work presents an efficient approach to FMEA to identify collision risks and implement practical interventions within a modern radiation therapy department. Methods: Potential collisions (e.g. failure modes) were assessed for all treatment and simulation rooms by teams consistingmore » of physicists, therapists, and radiation oncologists. Failure modes were grouped into classes according to similar characteristics. A single group meeting was held to identify implementable interventions for the highest priority classes of failure modes. Results: A total of 60 unique failure modes were identified by 6 different teams of physicists, therapists, and radiation oncologists. Failure modes were grouped into four main classes: specific patient setups, automated equipment motion, manual equipment motion, and actions in QA or service mode. Two of these classes, unusual patient setups and automated machine motion, were identified as being high priority in terms severity of consequence and addressability by interventions. The two highest risk classes consisted of 33 failure modes (55% of the total). In a single one hour group meeting, 6 interventions were identified. Those interventions addressed 100% of the high risk classes of failure modes (55% of all failure modes identified). Conclusion: A class-based approach to FMEA was developed to efficiently identify collision risks and implement interventions in a modern radiation oncology department. Failure modes and interventions will be listed, and a comparison of this approach against traditional FMEA methods will be presented.« less

WE-G-BRA-08: Failure Modes and Effects Analysis (FMEA) for Gamma Knife Radiosurgery

DOE Office of Scientific and Technical Information (OSTI.GOV)

Xu, Y; Bhatnagar, J; Bednarz, G

2015-06-15

Purpose: To perform a failure modes and effects analysis (FMEA) study for Gamma Knife (GK) radiosurgery processes at our institution based on our experience with the treatment of more than 13,000 patients. Methods: A team consisting of medical physicists, nurses, radiation oncologists, neurosurgeons at the University of Pittsburgh Medical Center and an external physicist expert was formed for the FMEA study. A process tree and a failure mode table were created for the GK procedures using the Leksell GK Perfexion and 4C units. Three scores for the probability of occurrence (O), the severity (S), and the probability of no detectionmore » (D) for failure modes were assigned to each failure mode by each professional on a scale from 1 to 10. The risk priority number (RPN) for each failure mode was then calculated (RPN = OxSxD) as the average scores from all data sets collected. Results: The established process tree for GK radiosurgery consists of 10 sub-processes and 53 steps, including a sub-process for frame placement and 11 steps that are directly related to the frame-based nature of the GK radiosurgery. Out of the 86 failure modes identified, 40 failure modes are GK specific, caused by the potential for inappropriate use of the radiosurgery head frame, the imaging fiducial boxes, the GK helmets and plugs, and the GammaPlan treatment planning system. The other 46 failure modes are associated with the registration, imaging, image transfer, contouring processes that are common for all radiation therapy techniques. The failure modes with the highest hazard scores are related to imperfect frame adaptor attachment, bad fiducial box assembly, overlooked target areas, inaccurate previous treatment information and excessive patient movement during MRI scan. Conclusion: The implementation of the FMEA approach for Gamma Knife radiosurgery enabled deeper understanding of the overall process among all professionals involved in the care of the patient and helped identify potential weaknesses in the overall process.« less

[Improving the continuous care process in primary care during weekends and holidays: redesigning and FMEA].

PubMed

Cañada Dorado, A; Cárdenas Valladolid, J; Espejo Matorrales, F; García Ferradal, I; Sastre Páez, S; Vicente Martín, I

2010-01-01

To describe a project carried out in order to improve the process of Continuous Health Care (CHC) on Saturdays and bank holidays in Primary Care, area number 4, Madrid. The aim of this project was to guarantee a safe and error-free service to patients receiving home health care on weekends. The urgent need for improving CHC process was identified by the Risk Management Functional Unit (RMFU) of the area. In addition, some complaints had been received from the nurses involved in the process as well as from their patients. A SWOT (Strengths, Weaknesses, Opportunities and Threats) analysis performed in 2009 highlighted a number of problems with the process. As a result, a project for improvement was drawn up, to be implemented in the following stages: 1. Redesigning and improving the existing process. 2. Application of failure mode and effect analysis (FMEA) to the new process. 3. Follow up, managing and leading the project. 4. Nurse training. 5. Implementing the process in the whole area. 6. CHC nurse satisfaction surveys. After carrying out this project, the efficiency and level of automation improved considerably. Since implementation of the process enhancement measures, no complaints have been received from patients and surveys show that CHC nurse satisfaction has improved. By using FMEA, errors were given priority and enhancement steps were taken in order to: Inform professionals, back-up personnel and patients about the process. Improve the specialist follow-up report. Provide training in ulcer patient care. The process enhancement, and especially its automation, has resulted in a significant step forward toward achieving greater patient safety. FMEA was a useful tool, which helped in taking some important actions. Finally, CHC nurse satisfaction has clearly improved. Copyright © 2009 SECA. Published by Elsevier Espana. All rights reserved.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rusu, I; Thomas, T; Roeske, J

Purpose: To identify areas of improvement in our liver stereotactic body radiation therapy (SBRT) program, using failure mode and effect analysis (FMEA). Methods: A multidisciplinary group consisting of one physician, three physicists, one dosimetrist and two therapists was formed. A process map covering 10 major stages of the liver SBRT program from the initial diagnosis to post treatment follow-up was generated. A total of 102 failure modes, together with their causes and effects, were identified. The occurrence (O), severity (S) and lack of detectability (D) were independently scored. The ranking was done using the risk probability number (RPN) defined asmore » the product of average O, S and D numbers for each mode. The scores were normalized to remove inter-observer variability, while preserving individual ranking order. Further, a correlation analysis on the overall agreement on rank order of all failure modes resulted in positive values for successive pairs of evaluators. The failure modes with the highest RPN value were considered for further investigation. Results: The average normalized RPN values for all modes were 39 with a range of 9 to 103. The FMEA analysis resulted in the identification of the top 10 critical failures modes as: Incorrect CT-MR registration, MR scan not performed in treatment position, patient movement between CBCT acquisition and treatment, daily IGRT QA not verified, incorrect or incomplete ITV delineation, OAR contours not verified, inaccurate normal liver effective dose (Veff) calculation, failure of bolus tracking for 4D CT scan, setup instructions not followed for treatment and plan evaluation metrics missed. Conclusion: The application of FMEA to our liver SBRT program led to the identification and possible improvement of areas affecting patient safety.« less

Independent Orbiter Assessment (IOA): Analysis of the manned maneuvering unit

NASA Technical Reports Server (NTRS)

Bailey, P. S.

1986-01-01

Results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items (PCIs). To preserve indepedence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Manned Maneuvering Unit (MMU) hardware. The MMU is a propulsive backpack, operated through separate hand controllers that input the pilot's translational and rotational maneuvering commands to the control electronics and then to the thrusters. The IOA analysis process utilized available MMU hardware drawings and schematics for defining hardware subsystems, assemblies, components, and hardware items. Final levels of detail were evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the worst case severity of the effect for each identified failure mode. The IOA analysis of the MMU found that the majority of the PCIs identified are resultant from the loss of either the propulsion or control functions, or are resultant from inability to perform an immediate or future mission. The five most severe criticalities identified are all resultant from failures imposed on the MMU hand controllers which have no redundancy within the MMU.

Practical Implementation of Failure Mode and Effects Analysis for Safety and Efficiency in Stereotactic Radiosurgery

DOE Office of Scientific and Technical Information (OSTI.GOV)

Younge, Kelly Cooper, E-mail: kyounge@med.umich.edu; Wang, Yizhen; Thompson, John

2015-04-01

Purpose: To improve the safety and efficiency of a new stereotactic radiosurgery program with the application of failure mode and effects analysis (FMEA) performed by a multidisciplinary team of health care professionals. Methods and Materials: Representatives included physicists, therapists, dosimetrists, oncologists, and administrators. A detailed process tree was created from an initial high-level process tree to facilitate the identification of possible failure modes. Group members were asked to determine failure modes that they considered to be the highest risk before scoring failure modes. Risk priority numbers (RPNs) were determined by each group member individually and then averaged. Results: A totalmore » of 99 failure modes were identified. The 5 failure modes with an RPN above 150 were further analyzed to attempt to reduce these RPNs. Only 1 of the initial items that the group presumed to be high-risk (magnetic resonance imaging laterality reversed) was ranked in these top 5 items. New process controls were put in place to reduce the severity, occurrence, and detectability scores for all of the top 5 failure modes. Conclusions: FMEA is a valuable team activity that can assist in the creation or restructuring of a quality assurance program with the aim of improved safety, quality, and efficiency. Performing the FMEA helped group members to see how they fit into the bigger picture of the program, and it served to reduce biases and preconceived notions about which elements of the program were the riskiest.« less

The Application of Failure Modes and Effects Analysis Methodology to Intrathecal Drug Delivery for Pain Management

PubMed Central

Patel, Teresa; Fisher, Stanley P.

2016-01-01

Objective This study aimed to utilize failure modes and effects analysis (FMEA) to transform clinical insights into a risk mitigation plan for intrathecal (IT) drug delivery in pain management. Methods The FMEA methodology, which has been used for quality improvement, was adapted to assess risks (i.e., failure modes) associated with IT therapy. Ten experienced pain physicians scored 37 failure modes in the following categories: patient selection for therapy initiation (efficacy and safety concerns), patient safety during IT therapy, and product selection for IT therapy. Participants assigned severity, probability, and detection scores for each failure mode, from which a risk priority number (RPN) was calculated. Failure modes with the highest RPNs (i.e., most problematic) were discussed, and strategies were proposed to mitigate risks. Results Strategic discussions focused on 17 failure modes with the most severe outcomes, the highest probabilities of occurrence, and the most challenging detection. The topic of the highest‐ranked failure mode (RPN = 144) was manufactured monotherapy versus compounded combination products. Addressing failure modes associated with appropriate patient and product selection was predicted to be clinically important for the success of IT therapy. Conclusions The methodology of FMEA offers a systematic approach to prioritizing risks in a complex environment such as IT therapy. Unmet needs and information gaps are highlighted through the process. Risk mitigation and strategic planning to prevent and manage critical failure modes can contribute to therapeutic success. PMID:27477689

Application of failure mode and effects analysis (FMEA) to pretreatment phases in tomotherapy.

PubMed

Broggi, Sara; Cantone, Marie Claire; Chiara, Anna; Di Muzio, Nadia; Longobardi, Barbara; Mangili, Paola; Veronese, Ivan

2013-09-06

The aim of this paper was the application of the failure mode and effects analysis (FMEA) approach to assess the risks for patients undergoing radiotherapy treatments performed by means of a helical tomotherapy unit. FMEA was applied to the preplanning imaging, volume determination, and treatment planning stages of the tomotherapy process and consisted of three steps: 1) identification of the involved subprocesses; 2) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system; and 3) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. A total of 74 failure modes were identified: 38 in the stage of preplanning imaging and volume determination, and 36 in the stage of planning. The threshold of 125 for RPN was exceeded in four cases: one case only in the phase of preplanning imaging and volume determination, and three cases in the stage of planning. The most critical failures appeared related to (i) the wrong or missing definition and contouring of the overlapping regions, (ii) the wrong assignment of the overlap priority to each anatomical structure, (iii) the wrong choice of the computed tomography calibration curve for dose calculation, and (iv) the wrong (or not performed) choice of the number of fractions in the planning station. On the basis of these findings, in addition to the safety strategies already adopted in the clinical practice, novel solutions have been proposed for mitigating the risk of these failures and to increase patient safety.

AADL Fault Modeling and Analysis Within an ARP4761 Safety Assessment

DTIC Science & Technology

2014-10-01

Analysis Generator 27 3.2.3 Mapping to OpenFTA Format File 27 3.2.4 Mapping to Generic XML Format 28 3.2.5 AADL and FTA Mapping Rules 28 3.2.6 Issues...PSSA), System Safety Assessment (SSA), Common Cause Analysis (CCA), Fault Tree Analysis ( FTA ), Failure Modes and Effects Analysis (FMEA), Failure...Modes and Effects Summary, Mar - kov Analysis (MA), and Dependence Diagrams (DDs), also referred to as Reliability Block Dia- grams (RBDs). The

Exploring the delivery of antiretroviral therapy for symptomatic HIV in Swaziland: threats to the successful treatment and safety of outpatients attending regional and district clinics.

PubMed

Armitage, Gerry; Hodgson, Ian; Wright, John; Bailey, Kerry; Mkhwana, Estel

2011-01-01

To examine the safety and acceptability of providing antiretroviral therapy (ART) in a resource poor setting. Two-stage observational and qualitative study. Rural hospital in Southern Africa. Structured observation using failure modes and effects analysis (FMEA) of the drug supply, dispensing, prescribing and administration processes. The findings from the FMEA were explored further in qualitative interviews with eight health professionals involved in the delivery of ART. To obtain a patient perspective, a stratified sample of 14 patients receiving ART was also interviewed. Key vulnerabilities in the process of ART provision include supply problems, poor packaging and labelling, inadequate knowledge among staff and lack of staff. Key barriers to successful patient adherence include transport inconsistency in supply and personal financial difficulties. There is, however, strong evidence of patient commitment and adherence. IMPLICATIONS AND CONCLUSION: Medication safety is relatively unexplored in the developing world. This study reveals an encouraging resilience in the health system and adherence among patients in the delivery of complex ART. The vulnerabilities identified, however, undermine patient safety and effectiveness of ART. There are implications for drug manufacturers; international aid agencies funding and supplying ART; and local practitioners. FMEA can help identify potential vulnerabilities and inform safety improvement interventions.

Analysis of failure and maintenance experiences of motor operated valves in a Finnish nuclear power plant

NASA Astrophysics Data System (ADS)

Simola, Kaisa; Laakso, Kari

1992-01-01

Eight years of operating experiences of 104 motor operated closing valves in different safety systems in nuclear power units were analyzed in a systematic way. The qualitative methods used were Failure Mode and Effect Analysis (FMEA) and Maintenance Effects and Criticality Analysis (MECA). These reliability engineering methods are commonly used in the design stage of equipment. The successful application of these methods for analysis and utilization of operating experiences was demonstrated.

Engaging staff to improve quality and safety in an austere medical environment: a case-control study in two Sierra Leonean hospitals.

PubMed

Rosen, Michael A; Chima, Adaora M; Sampson, John B; Jackson, Eric V; Koka, Rahul; Marx, Megan K; Kamara, Thaim B; Ogbuagu, Onyebuchi U; Lee, Benjamin H

2015-08-01

Inadequate observance of basic processes in patient care such as patient monitoring and documentation practices are potential impediments to the timely diagnoses and management of patients. These gaps exist in low resource settings such as Sierra Leone and can be attributed to a myriad of factors such as workforce and technology deficiencies. In the study site, only 12.4% of four critical vital signs were documented in the pre-intervention period. Implement a failure mode and effects analysis (FMEA) to improve documentation of four patient vital signs: temperature, blood pressure, pulse rate and respiratory rate. FMEA was implemented among a subpopulation of health workers who are involved in monitoring and documenting patient vital signs. Pre- and post-FMEA monitoring and documentation practice were compared with a control site. Participants identified a four-step process to monitoring and documenting vital signs, three categories of failure modes and four potential solutions. Based on 2100 patient days of documentation compliance data from 147 patients between July and November 2012, staff members at the study site were 1.79 times more likely to document all four patient vital signs in the post-implementation period (95% CI [1.35, 2.38]). FMEA is a feasible and effective strategy for improving quality and safety in an austere medical environment. Documentation compliance improved at the intervention facility. To evaluate the scalability and sustainability of this approach, programs targeting the development of these types of process improvement skills in local staff should be evaluated. © The Author 2015. Published by Oxford University Press in association with the International Society for Quality in Health Care; all rights reserved.

Independent Orbiter Assessment (IOA): Analysis of the electrical power distribution and control/remote manipulator system subsystem

NASA Technical Reports Server (NTRS)

Robinson, W. W.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the Electrical Power Distribution and Control (EPD and C)/Remote Manipulator System (RMS) hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained in the NASA FMEA/CIL documentation. This report documents the results of the independent analysis of the EPD and C/RMS (both port and starboard) hardware. The EPD and C/RMS subsystem hardware provides the electrical power and power control circuitry required to safely deploy, operate, control, and stow or guillotine and jettison two (one port and one starboard) RMSs. The EPD and C/RMS subsystem is subdivided into the four following functional divisions: Remote Manipulator Arm; Manipulator Deploy Control; Manipulator Latch Control; Manipulator Arm Shoulder Jettison; and Retention Arm Jettison. The IOA analysis process utilized available EPD and C/RMS hardware drawings and schematics for defining hardware assemblies, components, and hardware items. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based on the severity of the effect for each failure mode.

Independent Orbiter Assessment (IOA): Analysis of the displays and controls subsystem

NASA Technical Reports Server (NTRS)

Trahan, W. H.; Prust, E. E.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Orbiter Displays and Controls (D and C) subsystem hardware. The function of the D and C hardware is to provide the crew with the monitor, command, and control capabilities required for management of all normal and contingency mission and flight operations. The D and C hardware for which failure modes analysis was performed consists of the following: Acceleration Indicator (G-METER); Head Up Display (HUD); Display Driver Unit (DDU); Alpha/Mach Indicator (AMI); Horizontal Situation Indicator (HSI); Attitude Director Indicator (ADI); Propellant Quantity Indicator (PQI); Surface Position Indicator (SPI); Altitude/Vertical Velocity Indicator (AVVI); Caution and Warning Assembly (CWA); Annunciator Control Assembly (ACA); Event Timer (ET); Mission Timer (MT); Interior Lighting; and Exterior Lighting. Each hardware item was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode.

Conceptual design study of Fusion Experimental Reactor (FY86 FER): Safety

NASA Astrophysics Data System (ADS)

Seki, Yasushi; Iida, Hiromasa; Honda, Tsutomu

1987-08-01

This report describes the study on safety for FER (Fusion Experimental Reactor) which has been designed as a next step machine to the JT-60. Though the final purpose of this study is to have an image of design base accident, maximum credible accident and to assess their risk or probability, etc., as FER plant system, the emphasis of this years study is placed on fuel-gas circulation system where the tritium inventory is maximum. The report consists of two chapters. The first chapter summarizes the FER system and describes FMEA (Failure Mode and Effect Analysis) and related accident progression sequence for FER plant system as a whole. The second chapter of this report is focused on fuel-gas circulation system including purification, isotope separation and storage. Probability of risk is assessed by the probabilistic risk analysis (PRA) procedure based on FMEA, ETA and FTA.

Independent Orbiter Assessment (IOA): Analysis of the landing/deceleration subsystem

NASA Technical Reports Server (NTRS)

Compton, J. M.; Beaird, H. G.; Weissinger, W. D.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Orbiter Landing/Deceleration Subsystem hardware. The Landing/Deceleration Subsystem is utilized to allow the Orbiter to perform a safe landing, allowing for landing-gear deploy activities, steering and braking control throughout the landing rollout to wheel-stop, and to allow for ground-handling capability during the ground-processing phase of the flight cycle. Specifically, the Landing/Deceleration hardware consists of the following components: Nose Landing Gear (NLG); Main Landing Gear (MLG); Brake and Antiskid (B and AS) Electrical Power Distribution and Controls (EPD and C); Nose Wheel Steering (NWS); and Hydraulics Actuators. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. Due to the lack of redundancy in the Landing/Deceleration Subsystems there is a high number of critical items.

Independent Orbiter Assessment (IOA): Analysis of the ascent thrust vector control actuator subsystem

NASA Technical Reports Server (NTRS)

Wilson, R. E.; Riccio, J. R.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The independent analysis results for the Ascent Thrust Vector Control (ATVC) Actuator hardware are documented. The function of the Ascent Thrust Vector Control Actuators (ATVC) is to gimbal the main engines to provide for attitude and flight path control during ascent. During first stage flight, the SRB nozzles provide nearly all the steering. After SRB separation, the Orbiter is steered by gimbaling of its main engines. There are six electrohydraulic servoactuators, one pitch and one yaw for each of the three main engines. Each servoactuator is composed of four electrohydraulic servovalve assemblies, one second stage power spool valve assembly, one primary piston assembly and a switching valve. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. Critical failures resulting in loss of ATVC were mainly due to loss of hydraulic fluid, fluid contamination and mechanical failures.

Independent Orbiter Assessment (IOA): Analysis of the elevon subsystem

NASA Technical Reports Server (NTRS)

Wilson, R. E.; Riccio, J. R.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results for the Orbiter Elevon system hardware. The elevon actuators are located at the trailing edge of the wing surface. The proper function of the elevons is essential during the dynamic flight phases of ascent and entry. In the ascent phase of flight, the elevons are used for relieving high wing loads. For entry, the elevons are used to pitch and roll the vehicle. Specifically, the elevon system hardware comprises the following components: flow cutoff valve; switching valve; electro-hydraulic (EH) servoactuator; secondary delta pressure transducer; bypass valve; power valve; power valve check valve; primary actuator; primary delta pressure transducer; and primary actuator position transducer. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. Of the 25 failure modes analyzed, 18 were determined to be PCIs.

Supply chain analysis of e-tailing versus retailing operation - a case study

NASA Astrophysics Data System (ADS)

Kumar, Sameer; Tiffany, Maryellen; Vaidya, Salil

2016-07-01

The swift growth of e-commerce or e-tailing as a consumer retail channel has made it a serious competitor to traditional retail channels and is changing consumers' purchasing behaviour. The purpose of this case study, based on Target and Amazon.com, is to analyse the attributes of traditional retailing, e-tailing, and hybrid supply chain models to form conclusions about the feasibility of an idealised supply chain model for the future. An integrated and generalised modelling framework is used that incorporates Six Sigma - define, measure, analyse, improve, control methodology leveraging various tools, including process flow maps, cause and effect diagram, performance efficiency metrics, failure mode and effects analysis (FMEA), and Monte Carlo simulation. Based on this analysis and research, the conclusion is that the idealised supply chain of the future may evolve into a hybrid supply chain, which includes both e-tail and retail channels. The main recommendations from this study include assessing the risks of migrating to such a hybrid supply chain and to leverage the recommended actions provided in the hybrid FMEA. To facilitate more effective and mature processes, this study can guide researchers in exhaustive empirical evaluations of hybrid supply chains, gather experiences and lessons learned for practitioners.

Process-based quality management for clinical implementation of adaptive radiotherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Noel, Camille E.; Santanam, Lakshmi; Parikh, Parag J.

Purpose: Intensity-modulated adaptive radiotherapy (ART) has been the focus of considerable research and developmental work due to its potential therapeutic benefits. However, in light of its unique quality assurance (QA) challenges, no one has described a robust framework for its clinical implementation. In fact, recent position papers by ASTRO and AAPM have firmly endorsed pretreatment patient-specific IMRT QA, which limits the feasibility of online ART. The authors aim to address these obstacles by applying failure mode and effects analysis (FMEA) to identify high-priority errors and appropriate risk-mitigation strategies for clinical implementation of intensity-modulated ART. Methods: An experienced team of twomore » clinical medical physicists, one clinical engineer, and one radiation oncologist was assembled to perform a standard FMEA for intensity-modulated ART. A set of 216 potential radiotherapy failures composed by the forthcoming AAPM task group 100 (TG-100) was used as the basis. Of the 216 failures, 127 were identified as most relevant to an ART scheme. Using the associated TG-100 FMEA values as a baseline, the team considered how the likeliness of occurrence (O), outcome severity (S), and likeliness of failure being undetected (D) would change for ART. New risk priority numbers (RPN) were calculated. Failures characterized by RPN ≥ 200 were identified as potentially critical. Results: FMEA revealed that ART RPN increased for 38% (n = 48/127) of potential failures, with 75% (n = 36/48) attributed to failures in the segmentation and treatment planning processes. Forty-three of 127 failures were identified as potentially critical. Risk-mitigation strategies include implementing a suite of quality control and decision support software, specialty QA software/hardware tools, and an increase in specially trained personnel. Conclusions: Results of the FMEA-based risk assessment demonstrate that intensity-modulated ART introduces different (but not necessarily more) risks than standard IMRT and may be safely implemented with the proper mitigations.« less

Process-based quality management for clinical implementation of adaptive radiotherapy

PubMed Central

Noel, Camille E.; Santanam, Lakshmi; Parikh, Parag J.; Mutic, Sasa

2014-01-01

Purpose: Intensity-modulated adaptive radiotherapy (ART) has been the focus of considerable research and developmental work due to its potential therapeutic benefits. However, in light of its unique quality assurance (QA) challenges, no one has described a robust framework for its clinical implementation. In fact, recent position papers by ASTRO and AAPM have firmly endorsed pretreatment patient-specific IMRT QA, which limits the feasibility of online ART. The authors aim to address these obstacles by applying failure mode and effects analysis (FMEA) to identify high-priority errors and appropriate risk-mitigation strategies for clinical implementation of intensity-modulated ART. Methods: An experienced team of two clinical medical physicists, one clinical engineer, and one radiation oncologist was assembled to perform a standard FMEA for intensity-modulated ART. A set of 216 potential radiotherapy failures composed by the forthcoming AAPM task group 100 (TG-100) was used as the basis. Of the 216 failures, 127 were identified as most relevant to an ART scheme. Using the associated TG-100 FMEA values as a baseline, the team considered how the likeliness of occurrence (O), outcome severity (S), and likeliness of failure being undetected (D) would change for ART. New risk priority numbers (RPN) were calculated. Failures characterized by RPN ≥ 200 were identified as potentially critical. Results: FMEA revealed that ART RPN increased for 38% (n = 48/127) of potential failures, with 75% (n = 36/48) attributed to failures in the segmentation and treatment planning processes. Forty-three of 127 failures were identified as potentially critical. Risk-mitigation strategies include implementing a suite of quality control and decision support software, specialty QA software/hardware tools, and an increase in specially trained personnel. Conclusions: Results of the FMEA-based risk assessment demonstrate that intensity-modulated ART introduces different (but not necessarily more) risks than standard IMRT and may be safely implemented with the proper mitigations. PMID:25086527

Process-based quality management for clinical implementation of adaptive radiotherapy.

PubMed

Noel, Camille E; Santanam, Lakshmi; Parikh, Parag J; Mutic, Sasa

2014-08-01

Intensity-modulated adaptive radiotherapy (ART) has been the focus of considerable research and developmental work due to its potential therapeutic benefits. However, in light of its unique quality assurance (QA) challenges, no one has described a robust framework for its clinical implementation. In fact, recent position papers by ASTRO and AAPM have firmly endorsed pretreatment patient-specific IMRT QA, which limits the feasibility of online ART. The authors aim to address these obstacles by applying failure mode and effects analysis (FMEA) to identify high-priority errors and appropriate risk-mitigation strategies for clinical implementation of intensity-modulated ART. An experienced team of two clinical medical physicists, one clinical engineer, and one radiation oncologist was assembled to perform a standard FMEA for intensity-modulated ART. A set of 216 potential radiotherapy failures composed by the forthcoming AAPM task group 100 (TG-100) was used as the basis. Of the 216 failures, 127 were identified as most relevant to an ART scheme. Using the associated TG-100 FMEA values as a baseline, the team considered how the likeliness of occurrence (O), outcome severity (S), and likeliness of failure being undetected (D) would change for ART. New risk priority numbers (RPN) were calculated. Failures characterized by RPN ≥ 200 were identified as potentially critical. FMEA revealed that ART RPN increased for 38% (n = 48/127) of potential failures, with 75% (n = 36/48) attributed to failures in the segmentation and treatment planning processes. Forty-three of 127 failures were identified as potentially critical. Risk-mitigation strategies include implementing a suite of quality control and decision support software, specialty QA software/hardware tools, and an increase in specially trained personnel. Results of the FMEA-based risk assessment demonstrate that intensity-modulated ART introduces different (but not necessarily more) risks than standard IMRT and may be safely implemented with the proper mitigations.

Strategies to increase patient safety in Hemodialysis: Application of the modal analysis system of errors and effects (FEMA system).

PubMed

Arenas Jiménez, María Dolores; Ferre, Gabriel; Álvarez-Ude, Fernando

Haemodialysis (HD) patients are a high-risk population group. For these patients, an error could have catastrophic consequences. Therefore, systems that ensure the safety of these patients in an environment with high technology and great interaction of the human factor is a requirement. To show a systematic working approach, reproducible in any HD unit, which consists of recording the complications and errors that occurred during the HD session; defining which of those complications could be considered adverse event (AE), and therefore preventable; and carrying out a systematic analysis of them, as well as of underlying real or potential errors, evaluating their severity, frequency and detection; as well as establishing priorities for action (Failure Mode and Effects Analysis system [FMEA systems]). Retrospective analysis of the graphs of all HD sessions performed during one month (October 2015) on 97 patients, analysing all recorded complications. The consideration of these complications as AEs was based on a consensus among 13 health professionals and 2 patients. The severity, frequency and detection of each AE was evaluated by the FMEA system. We analysed 1303 HD treatments in 97 patients. A total of 383 complications (1 every 3.4 HD treatments) were recorded. Approximately 87.9% of them was deemed AEs and 23.7% complications related with patients' underlying pathology. There was one AE every 3.8 HD treatments. Hypertension and hypotension were the most frequent AEs (42.7 and 27.5% of all AEs recorded, respectively). Vascular-access related AEs were one every 68.5 HD treatments. A total of 21 errors (1 every 62 HD treatments), mainly related to the HD technique and to the administration of prescribed medication, were registered. The highest risk priority number, according to the FMEA, corresponded to errors related to patient body weight; dysfunction/rupture of the catheter; and needle extravasation. HD complications are frequent. Consideration of some of them as AEs could improve safety by facilitating the implementation of preventive measures. The application of the FMEA system allows stratifying real and potential errors in dialysis units and acting with the appropriate degree of urgency, developing and implementing the necessary preventive and improvement measures. Copyright © 2017 Sociedad Española de Nefrología. Published by Elsevier España, S.L.U. All rights reserved.

A new state evaluation method of oil pump unit based on AHP and FCE

NASA Astrophysics Data System (ADS)

Lin, Yang; Liang, Wei; Qiu, Zeyang; Zhang, Meng; Lu, Wenqing

2017-05-01

In order to make an accurate state evaluation of oil pump unit, a comprehensive evaluation index should be established. A multi-parameters state evaluation method of oil pump unit is proposed in this paper. The oil pump unit is analyzed by Failure Mode and Effect Analysis (FMEA), so evaluation index can be obtained based on FMEA conclusions. The weights of different parameters in evaluation index are discussed using Analytic Hierarchy Process (AHP) with expert experience. According to the evaluation index and the weight of each parameter, the state evaluation is carried out by Fuzzy Comprehensive Evaluation (FCE) and the state is divided into five levels depending on status value, which is inspired by human body health. In order to verify the effectiveness and feasibility of the proposed method, a state evaluation of oil pump used in a pump station is taken as an example.

A Case Study on Improving Intensive Care Unit (ICU) Services Reliability: By Using Process Failure Mode and Effects Analysis (PFMEA)

PubMed Central

Yousefinezhadi, Taraneh; Jannesar Nobari, Farnaz Attar; Goodari, Faranak Behzadi; Arab, Mohammad

2016-01-01

Introduction: In any complex human system, human error is inevitable and shows that can’t be eliminated by blaming wrong doers. So with the aim of improving Intensive Care Units (ICU) reliability in hospitals, this research tries to identify and analyze ICU’s process failure modes at the point of systematic approach to errors. Methods: In this descriptive research, data was gathered qualitatively by observations, document reviews, and Focus Group Discussions (FGDs) with the process owners in two selected ICUs in Tehran in 2014. But, data analysis was quantitative, based on failures’ Risk Priority Number (RPN) at the base of Failure Modes and Effects Analysis (FMEA) method used. Besides, some causes of failures were analyzed by qualitative Eindhoven Classification Model (ECM). Results: Through FMEA methodology, 378 potential failure modes from 180 ICU activities in hospital A and 184 potential failures from 99 ICU activities in hospital B were identified and evaluated. Then with 90% reliability (RPN≥100), totally 18 failures in hospital A and 42 ones in hospital B were identified as non-acceptable risks and then their causes were analyzed by ECM. Conclusions: Applying of modified PFMEA for improving two selected ICUs’ processes reliability in two different kinds of hospitals shows that this method empowers staff to identify, evaluate, prioritize and analyze all potential failure modes and also make them eager to identify their causes, recommend corrective actions and even participate in improving process without feeling blamed by top management. Moreover, by combining FMEA and ECM, team members can easily identify failure causes at the point of health care perspectives. PMID:27157162

Independent Orbiter Assessment (IOA): Analysis of the reaction control system, volume 1

NASA Technical Reports Server (NTRS)

Burkemper, V. J.; Haufler, W. A.; Odonnell, R. A.; Paul, D. J.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results for the Reaction Control System (RCS). The purpose of the RCS is to provide thrust in and about the X, Y, Z axes for External Tank (ET) separation; orbit insertion maneuvers; orbit translation maneuvers; on-orbit attitude control; rendezvous; proximity operations (payload deploy and capture); deorbit maneuvers; and abort attitude control. The RCS is situated in three independent modules, one forward in the orbiter nose and one in each OMS/RCS pod. Each RCS module consists of the following subsystems: Helium Pressurization Subsystem; Propellant Storage and Distribution Subsystem; Thruster Subsystem; and Electrical Power Distribution and Control Subsystem. Of the failure modes analyzed, 307 could potentially result in a loss of life and/or loss of vehicle.

MO-D-213-02: Quality Improvement Through a Failure Mode and Effects Analysis of Pediatric External Beam Radiotherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gray, J; Lukose, R; Bronson, J

2015-06-15

Purpose: To conduct a failure mode and effects analysis (FMEA) as per AAPM Task Group 100 on clinical processes associated with teletherapy, and the development of mitigations for processes with identified high risk. Methods: A FMEA was conducted on clinical processes relating to teletherapy treatment plan development and delivery. Nine major processes were identified for analysis. These steps included CT simulation, data transfer, image registration and segmentation, treatment planning, plan approval and preparation, and initial and subsequent treatments. Process tree mapping was utilized to identify the steps contained within each process. Failure modes (FM) were identified and evaluated with amore » scale of 1–10 based upon three metrics: the severity of the effect, the probability of occurrence, and the detectability of the cause. The analyzed metrics were scored as follows: severity – no harm = 1, lethal = 10; probability – not likely = 1, certainty = 10; detectability – always detected = 1, undetectable = 10. The three metrics were combined multiplicatively to determine the risk priority number (RPN) which defined the overall score for each FM and the order in which process modifications should be deployed. Results: Eighty-nine procedural steps were identified with 186 FM accompanied by 193 failure effects with 213 potential causes. Eighty-one of the FM were scored with a RPN > 10, and mitigations were developed for FM with RPN values exceeding ten. The initial treatment had the most FM (16) requiring mitigation development followed closely by treatment planning, segmentation, and plan preparation with fourteen each. The maximum RPN was 400 and involved target delineation. Conclusion: The FMEA process proved extremely useful in identifying previously unforeseen risks. New methods were developed and implemented for risk mitigation and error prevention. Similar to findings reported for adult patients, the process leading to the initial treatment has an associated high risk.« less

Application of failure mode and effects analysis (FMEA) to pretreatment phases in tomotherapy

PubMed Central

Broggi, Sara; Cantone, Marie Claire; Chiara, Anna; Muzio, Nadia Di; Longobardi, Barbara; Mangili, Paola

2013-01-01

The aim of this paper was the application of the failure mode and effects analysis (FMEA) approach to assess the risks for patients undergoing radiotherapy treatments performed by means of a helical tomotherapy unit. FMEA was applied to the preplanning imaging, volume determination, and treatment planning stages of the tomotherapy process and consisted of three steps: 1) identification of the involved subprocesses; 2) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system; and 3) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. A total of 74 failure modes were identified: 38 in the stage of preplanning imaging and volume determination, and 36 in the stage of planning. The threshold of 125 for RPN was exceeded in four cases: one case only in the phase of preplanning imaging and volume determination, and three cases in the stage of planning. The most critical failures appeared related to (i) the wrong or missing definition and contouring of the overlapping regions, (ii) the wrong assignment of the overlap priority to each anatomical structure, (iii) the wrong choice of the computed tomography calibration curve for dose calculation, and (iv) the wrong (or not performed) choice of the number of fractions in the planning station. On the basis of these findings, in addition to the safety strategies already adopted in the clinical practice, novel solutions have been proposed for mitigating the risk of these failures and to increase patient safety. PACS number: 87.55.Qr PMID:24036868

Leveraging electronic health record documentation for Failure Mode and Effects Analysis team identification

PubMed Central

Carson, Matthew B; Lee, Young Ji; Benacka, Corrine; Mutharasan, R. Kannan; Ahmad, Faraz S; Kansal, Preeti; Yancy, Clyde W; Anderson, Allen S; Soulakis, Nicholas D

2017-01-01

Objective: Using Failure Mode and Effects Analysis (FMEA) as an example quality improvement approach, our objective was to evaluate whether secondary use of orders, forms, and notes recorded by the electronic health record (EHR) during daily practice can enhance the accuracy of process maps used to guide improvement. We examined discrepancies between expected and observed activities and individuals involved in a high-risk process and devised diagnostic measures for understanding discrepancies that may be used to inform quality improvement planning. Methods: Inpatient cardiology unit staff developed a process map of discharge from the unit. We matched activities and providers identified on the process map to EHR data. Using four diagnostic measures, we analyzed discrepancies between expectation and observation. Results: EHR data showed that 35% of activities were completed by unexpected providers, including providers from 12 categories not identified as part of the discharge workflow. The EHR also revealed sub-components of process activities not identified on the process map. Additional information from the EHR was used to revise the process map and show differences between expectation and observation. Conclusion: Findings suggest EHR data may reveal gaps in process maps used for quality improvement and identify characteristics about workflow activities that can identify perspectives for inclusion in an FMEA. Organizations with access to EHR data may be able to leverage clinical documentation to enhance process maps used for quality improvement. While focused on FMEA protocols, findings from this study may be applicable to other quality activities that require process maps. PMID:27589944

Fuzzy Failure Analysis: A New Approach to Service Quality Analysis in Higher Education Institutions (Case Study: Vali-e-asr University of Rafsanjan-Iran)

ERIC Educational Resources Information Center

Takalo, Salim Karimi; Abadi, Ali Reza Naser Sadr; Vesal, Seyed Mahdi; Mirzaei, Amir; Nawaser, Khaled

2013-01-01

In recent years, concurrent with steep increase in the growth of higher education institutions, improving of educational service quality with an emphasis on students' satisfaction has become an important issue. The present study is going to use the Failure Mode and Effect Analysis (FMEA) in order to evaluate the quality of educational services in…

Mod 1 wind turbine generator failure modes and effects analysis

NASA Technical Reports Server (NTRS)

1979-01-01

A failure modes and effects analysis (FMEA) was directed primarily at identifying those critical failure modes that would be hazardous to life or would result in major damage to the system. Each subsystem was approached from the top down, and broken down to successive lower levels where it appeared that the criticality of the failure mode warranted more detail analysis. The results were reviewed by specialists from outside the Mod 1 program, and corrective action taken wherever recommended.

Independent Orbiter Assessment (IOA): Analysis of the body flap subsystem

NASA Technical Reports Server (NTRS)

Wilson, R. E.; Riccio, J. R.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items (PCIs). To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The independent analysis results for the Orbiter Body Flap (BF) subsystem hardware are documented. The BF is a large aerosurface located at the trailing edge of the lower aft fuselage of the Orbiter. The proper function of the BF is essential during the dynamic flight phases of ascent and entry. During the ascent phase of flight, the BF trails in a fixed position. For entry, the BF provides elevon load relief, trim control, and acts as a heat shield for the main engines. Specifically, the BF hardware comprises the following components: Power Drive Unit (PDU), rotary actuators, and torque tubes. The IOA analysis process utilized available BF hardware drawings and schematics for defining hardware assemblies, components, and hardware items. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. Of the 35 failure modes analyzed, 19 were determined to be PCIs.

Failure mode and effects analysis: a comparison of two common risk prioritisation methods.

PubMed

McElroy, Lisa M; Khorzad, Rebeca; Nannicelli, Anna P; Brown, Alexandra R; Ladner, Daniela P; Holl, Jane L

2016-05-01

Failure mode and effects analysis (FMEA) is a method of risk assessment increasingly used in healthcare over the past decade. The traditional method, however, can require substantial time and training resources. The goal of this study is to compare a simplified scoring method with the traditional scoring method to determine the degree of congruence in identifying high-risk failures. An FMEA of the operating room (OR) to intensive care unit (ICU) handoff was conducted. Failures were scored and ranked using both the traditional risk priority number (RPN) and criticality-based method, and a simplified method, which designates failures as 'high', 'medium' or 'low' risk. The degree of congruence was determined by first identifying those failures determined to be critical by the traditional method (RPN≥300), and then calculating the per cent congruence with those failures designated critical by the simplified methods (high risk). In total, 79 process failures among 37 individual steps in the OR to ICU handoff process were identified. The traditional method yielded Criticality Indices (CIs) ranging from 18 to 72 and RPNs ranging from 80 to 504. The simplified method ranked 11 failures as 'low risk', 30 as medium risk and 22 as high risk. The traditional method yielded 24 failures with an RPN ≥300, of which 22 were identified as high risk by the simplified method (92% agreement). The top 20% of CI (≥60) included 12 failures, of which six were designated as high risk by the simplified method (50% agreement). These results suggest that the simplified method of scoring and ranking failures identified by an FMEA can be a useful tool for healthcare organisations with limited access to FMEA expertise. However, the simplified method does not result in the same degree of discrimination in the ranking of failures offered by the traditional method. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

Failure Mode and Effect Analysis (FMEA) Applications to Identify Iron Sand Reject and Losses in Cement Industry : A Case Study

NASA Astrophysics Data System (ADS)

Helia, V. N.; Wijaya, W. N.

2017-06-01

One of the main raw materials required in the manufacture of cement is iron sand. Data from the Procurement Department on XYZ Company shows that the number of defective iron sand (reject) fluctuates every month. Iron sand is an important raw material in the cement production process, so that the amount of iron sand reject and losses got financial and non-financial impact. This study aims to determine the most dominant activity as the cause of rejection and losses of iron sands and suggest improvements that can be made by using the approach of FMEA (Failure Mode and Effect Analysis). Data collection techniques in this study was using the method of observation, interviews, and focus group discussion (FGD) as well as the assessment of the experts to identify it. Results from this study is there are four points of the most dominant cause of the defect of iron sand (mining activities, acceptance, examination and delivery). Recommendation for overcoming these problem is presented (vendor improvement).

Independent Orbiter Assessment (IOA): Analysis of the extravehicular mobility unit

NASA Technical Reports Server (NTRS)

Raffaelli, Gary G.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items (PCIs). To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Extravehicular Mobility Unit (EMU) hardware. The EMU is an independent anthropomorphic system that provides environmental protection, mobility, life support, and communications for the Shuttle crewmember to perform Extravehicular Activity (EVA) in Earth orbit. Two EMUs are included on each baseline Orbiter mission, and consumables are provided for three two-man EVAs. The EMU consists of the Life Support System (LSS), Caution and Warning System (CWS), and the Space Suit Assembly (SSA). Each level of hardware was evaluated and analyzed for possible failure modes and effects. The majority of these PCIs are resultant from failures which cause loss of one or more primary functions: pressurization, oxygen delivery, environmental maintenance, and thermal maintenance. It should also be noted that the quantity of PCIs would significantly increase if the SOP were to be treated as an emergency system rather than as an unlike redundant element.

Reliability and Maintainability Analysis of Fluidic Back-Up Flight Control System and Components.

DTIC Science & Technology

1981-09-01

industry. 2 r ~~m~ NADC 80227- 60 Maintainability Review of FMEA worksheets indicates that the standard hydraulic components of the servoactuator will...achieved. Procedures for conducting the FMEA and evaluating the 6 & | I NADC 80227- 60 severity of each failure mode are included as Appendix A...KEYSER N62269-81-M-3047 UNCLASSIFIED NADC-80227- 60 NL 66 11111.5 .4 11 6 MICROCOPY RESOLUTION TEST CHART N~ATIONAL BUR[AU Of STANDARDS 1%3A, REPORT

Independent Orbiter Assessment (IOA): Analysis of the orbiter main propulsion system

NASA Technical Reports Server (NTRS)

Mcnicoll, W. J.; Mcneely, M.; Holden, K. A.; Emmons, T. E.; Lowery, H. J.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items (PCIs). To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The independent analysis results for the Orbiter Main Propulsion System (MPS) hardware are documented. The Orbiter MPS consists of two subsystems: the Propellant Management Subsystem (PMS) and the Helium Subsystem. The PMS is a system of manifolds, distribution lines and valves by which the liquid propellants pass from the External Tank (ET) to the Space Shuttle Main Engines (SSMEs) and gaseous propellants pass from the SSMEs to the ET. The Helium Subsystem consists of a series of helium supply tanks and their associated regulators, check valves, distribution lines, and control valves. The Helium Subsystem supplies helium that is used within the SSMEs for inflight purges and provides pressure for actuation of SSME valves during emergency pneumatic shutdowns. The balance of the helium is used to provide pressure to operate the pneumatically actuated valves within the PMS. Each component was evaluated and analyzed for possible failure modes and effects. Criticalities were assigned based on the worst possible effect of each failure mode. Of the 690 failure modes analyzed, 349 were determined to be PCIs.

Probabilistic Risk Assessment: A Bibliography

NASA Technical Reports Server (NTRS)

2000-01-01

Probabilistic risk analysis is an integration of failure modes and effects analysis (FMEA), fault tree analysis and other techniques to assess the potential for failure and to find ways to reduce risk. This bibliography references 160 documents in the NASA STI Database that contain the major concepts, probabilistic risk assessment, risk and probability theory, in the basic index or major subject terms, An abstract is included with most citations, followed by the applicable subject terms.

Sensemaking of patient safety risks and hazards.

PubMed

Battles, James B; Dixon, Nancy M; Borotkanics, Robert J; Rabin-Fastmen, Barbara; Kaplan, Harold S

2006-08-01

In order for organizations to become learning organizations, they must make sense of their environment and learn from safety events. Sensemaking, as described by Weick (1995), literally means making sense of events. The ultimate goal of sensemaking is to build the understanding that can inform and direct actions to eliminate risk and hazards that are a threat to patient safety. True sensemaking in patient safety must use both retrospective and prospective approach to learning. Sensemaking is as an essential part of the design process leading to risk informed design. Sensemaking serves as a conceptual framework to bring together well established approaches to assessment of risk and hazards: (1) at the single event level using root cause analysis (RCA), (2) at the processes level using failure modes effects analysis (FMEA) and (3) at the system level using probabilistic risk assessment (PRA). The results of these separate or combined approaches are most effective when end users in conversation-based meetings add their expertise and knowledge to the data produced by the RCA, FMEA, and/or PRA in order to make sense of the risks and hazards. Without ownership engendered by such conversations, the possibility of effective action to eliminate or minimize them is greatly reduced.

Sensemaking of Patient Safety Risks and Hazards

PubMed Central

Battles, James B; Dixon, Nancy M; Borotkanics, Robert J; Rabin-Fastmen, Barbara; Kaplan, Harold S

2006-01-01

In order for organizations to become learning organizations, they must make sense of their environment and learn from safety events. Sensemaking, as described by Weick (1995), literally means making sense of events. The ultimate goal of sensemaking is to build the understanding that can inform and direct actions to eliminate risk and hazards that are a threat to patient safety. True sensemaking in patient safety must use both retrospective and prospective approach to learning. Sensemaking is as an essential part of the design process leading to risk informed design. Sensemaking serves as a conceptual framework to bring together well established approaches to assessment of risk and hazards: (1) at the single event level using root cause analysis (RCA), (2) at the processes level using failure modes effects analysis (FMEA) and (3) at the system level using probabilistic risk assessment (PRA). The results of these separate or combined approaches are most effective when end users in conversation-based meetings add their expertise and knowledge to the data produced by the RCA, FMEA, and/or PRA in order to make sense of the risks and hazards. Without ownership engendered by such conversations, the possibility of effective action to eliminate or minimize them is greatly reduced. PMID:16898979

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mossahebi, S; Feigenberg, S; Nichols, E

Purpose: GammaPod™, the first stereotactic radiotherapy device for early stage breast cancer treatment, has been recently installed and commissioned at our institution. A multidisciplinary working group applied the failure mode and effects analysis (FMEA) approach to perform a risk analysis. Methods: FMEA was applied to the GammaPod™ treatment process by: 1) generating process maps for each stage of treatment; 2) identifying potential failure modes and outlining their causes and effects; 3) scoring the potential failure modes using the risk priority number (RPN) system based on the product of severity, frequency of occurrence, and detectability (ranging 1–10). An RPN of highermore » than 150 was set as the threshold for minimal concern of risk. For these high-risk failure modes, potential quality assurance procedures and risk control techniques have been proposed. A new set of severity, occurrence, and detectability values were re-assessed in presence of the suggested mitigation strategies. Results: In the single-day image-and-treat workflow, 19, 22, and 27 sub-processes were identified for the stages of simulation, treatment planning, and delivery processes, respectively. During the simulation stage, 38 potential failure modes were found and scored, in terms of RPN, in the range of 9-392. 34 potential failure modes were analyzed in treatment planning with a score range of 16-200. For the treatment delivery stage, 47 potential failure modes were found with an RPN score range of 16-392. The most critical failure modes consisted of breast-cup pressure loss and incorrect target localization due to patient upper-body alignment inaccuracies. The final RPN score of these failure modes based on recommended actions were assessed to be below 150. Conclusion: FMEA risk analysis technique was applied to the treatment process of GammaPod™, a new stereotactic radiotherapy technology. Application of systematic risk analysis methods is projected to lead to improved quality of GammaPod™ treatments. Ying Niu and Cedric Yu are affiliated with Xcision Medical Systems.« less

40 CFR Appendix B to Subpart G of... - Substitutes Subject to Use Restrictions and Unacceptable Substitutes

Code of Federal Regulations, 2013 CFR

2013-07-01

... inches) and right-hand thread direction for CO2 refrigerant service containers.3 Manufacturers should... Failure Mode and Effect Analysis in Manufacturing and Assembly Process [Process FMEA] on the MVAC as... submitted to demonstrate it can be used safely in this end-use. CFC-11, CFC-12, R-502 Industrial Process...

40 CFR Appendix B to Subpart G of... - Substitutes Subject to Use Restrictions and Unacceptable Substitutes

Code of Federal Regulations, 2014 CFR

2014-07-01

... inches) and right-hand thread direction for CO2 refrigerant service containers.3 Manufacturers should... Failure Mode and Effect Analysis in Manufacturing and Assembly Process [Process FMEA] on the MVAC as... submitted to demonstrate it can be used safely in this end-use. CFC-11, CFC-12, R-502 Industrial Process...

Clinical implementation and failure mode and effects analysis of HDR skin brachytherapy using Valencia and Leipzig surface applicators.

PubMed

Sayler, Elaine; Eldredge-Hindy, Harriet; Dinome, Jessie; Lockamy, Virginia; Harrison, Amy S

2015-01-01

The planning procedure for Valencia and Leipzig surface applicators (VLSAs) (Nucletron, Veenendaal, The Netherlands) differs substantially from CT-based planning; the unfamiliarity could lead to significant errors. This study applies failure modes and effects analysis (FMEA) to high-dose-rate (HDR) skin brachytherapy using VLSAs to ensure safety and quality. A multidisciplinary team created a protocol for HDR VLSA skin treatments and applied FMEA. Failure modes were identified and scored by severity, occurrence, and detectability. The clinical procedure was then revised to address high-scoring process nodes. Several key components were added to the protocol to minimize risk probability numbers. (1) Diagnosis, prescription, applicator selection, and setup are reviewed at weekly quality assurance rounds. Peer review reduces the likelihood of an inappropriate treatment regime. (2) A template for HDR skin treatments was established in the clinic's electronic medical record system to standardize treatment instructions. This reduces the chances of miscommunication between the physician and planner as well as increases the detectability of an error. (3) A screen check was implemented during the second check to increase detectability of an error. (4) To reduce error probability, the treatment plan worksheet was designed to display plan parameters in a format visually similar to the treatment console display, facilitating data entry and verification. (5) VLSAs are color coded and labeled to match the electronic medical record prescriptions, simplifying in-room selection and verification. Multidisciplinary planning and FMEA increased detectability and reduced error probability during VLSA HDR brachytherapy. This clinical model may be useful to institutions implementing similar procedures. Copyright © 2015 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Independent Orbiter Assessment (IOA): Analysis of the Orbiter Experiment (OEX) subsystem

NASA Technical Reports Server (NTRS)

Compton, J. M.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Orbiter Experiments hardware. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. The Orbiter Experiments (OEX) Program consists of a multiple set of experiments for the purpose of gathering environmental and aerodynamic data to develop more accurate ground models for Shuttle performance and to facilitate the design of future spacecraft. This assessment only addresses currently manifested experiments and their support systems. Specifically this list consists of: Shuttle Entry Air Data System (SEADS); Shuttle Upper Atmosphere Mass Spectrometer (SUMS); Forward Fuselage Support System for OEX (FFSSO); Shuttle Infrared Laced Temperature Sensor (SILTS); Aerodynamic Coefficient Identification Package (ACIP); and Support System for OEX (SSO). There are only two potential critical items for the OEX, since the experiments only gather data for analysis post mission and are totally independent systems except for power. Failure of any experiment component usually only causes a loss of experiment data and in no way jeopardizes the crew or mission.

Risk assessment of failure modes of gas diffuser liner of V94.2 siemens gas turbine by FMEA method

NASA Astrophysics Data System (ADS)

Mirzaei Rafsanjani, H.; Rezaei Nasab, A.

2012-05-01

Failure of welding connection of gas diffuser liner and exhaust casing is one of the failure modes of V94.2 gas turbines which are happened in some power plants. This defect is one of the uncertainties of customers when they want to accept the final commissioning of this product. According to this, the risk priority of this failure evaluated by failure modes and effect analysis (FMEA) method to find out whether this failure is catastrophic for turbine performance and is harmful for humans. By using history of 110 gas turbines of this model which are used in some power plants, the severity number, occurrence number and detection number of failure determined and consequently the Risk Priority Number (RPN) of failure determined. Finally, critically matrix of potential failures is created and illustrated that failure modes are located in safe zone.

Improving Reliability of Service Operation Using FMEA Review and New Opportunity for Investigations

NASA Astrophysics Data System (ADS)

Sutrisno, Agung; Gunawan, Indra

2016-01-01

Despite its growing contribution to the global economy, investigation on the application status of service FMEA study to support realization of reliable service operation is very limited in literature. Motivated by such situation, the paper presented an initial survey on the status and research gaps in developing and applying FMEA in service sectors. Systematic preliminary survey using specific criteria are undertaken. Our study indicated that development and application of service FMEA are partially addressing the characteristics of service operations and it is still applied into the good deed and profit oriented operations. Opportunities for further investigation pertaining to advancement of its decision supporting tool for service risk appraisal, its modification to cope with sustainability related requirements and application of service FMEA in not for profit oriented operations are presented as new avenues for further investigation

Multi-institutional application of Failure Mode and Effects Analysis (FMEA) to CyberKnife Stereotactic Body Radiation Therapy (SBRT).

PubMed

Veronese, Ivan; De Martin, Elena; Martinotti, Anna Stefania; Fumagalli, Maria Luisa; Vite, Cristina; Redaelli, Irene; Malatesta, Tiziana; Mancosu, Pietro; Beltramo, Giancarlo; Fariselli, Laura; Cantone, Marie Claire

2015-06-13

A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to assess the risks for patients undergoing Stereotactic Body Radiation Therapy (SBRT) treatments for lesions located in spine and liver in two CyberKnife® Centres. The various sub-processes characterizing the SBRT treatment were identified to generate the process trees of both the treatment planning and delivery phases. This analysis drove to the identification and subsequent scoring of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system. Novel solutions aimed to increase patient safety were accordingly considered. The process-tree characterising the SBRT treatment planning stage was composed with a total of 48 sub-processes. Similarly, 42 sub-processes were identified in the stage of delivery to liver tumours and 30 in the stage of delivery to spine lesions. All the sub-processes were judged to be potentially prone to one or more failure modes. Nineteen failures (i.e. 5 in treatment planning stage, 5 in the delivery to liver lesions and 9 in the delivery to spine lesions) were considered of high concern in view of the high RPN and/or severity index value. The analysis of the potential failures, their causes and effects allowed to improve the safety strategies already adopted in the clinical practice with additional measures for optimizing quality management workflow and increasing patient safety.

An Intelligent Hierarchical Decision Architecture for Operational Test and Evaluation

DTIC Science & Technology

1996-05-01

Results .......................................... 60 3.4 CONTRIBUTION...FCM Fuzzy Cognitive Map FMEA Failure Modes and Effects Analysis HWIL Hardware-in-the-Loop IBL Increase in Break Locks xiv IDA Institute for Defense... 60 .5 .40 3 .25 0.21 0.26 Figure 8 PROD-ALL COMMFFY Compositional Method .65 . 7 5 . 60 M 0.67 Figure 9 PROD-MAX COMMFFY Compositional Method 49

Independent Orbiter Assessment (IOA): Analysis of the instrumentation subsystem

NASA Technical Reports Server (NTRS)

Howard, B. S.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The independent analysis results for the Instrumentation Subsystem are documented. The Instrumentation Subsystem (SS) consists of transducers, signal conditioning equipment, pulse code modulation (PCM) encoding equipment, tape recorders, frequency division multiplexers, and timing equipment. For this analysis, the SS is broken into two major groupings: Operational Instrumentation (OI) equipment and Modular Auxiliary Data System (MADS) equipment. The OI equipment is required to acquire, condition, scale, digitize, interleave/multiplex, format, and distribute operational Orbiter and payload data and voice for display, recording, telemetry, and checkout. It also must provide accurate timing for time critical functions for crew and payload specialist use. The MADS provides additional instrumentation to measure and record selected pressure, temperature, strain, vibration, and event data for post-flight playback and analysis. MADS data is used to assess vehicle responses to the flight environment and to permit correlation of such data from flight to flight. The IOA analysis utilized available SS hardware drawings and schematics for identifying hardware assemblies and components and their interfaces. Criticality for each item was assigned on the basis of the worst-case effect of the failure modes identified.

MO-E-9A-01: Risk Based Quality Management: TG100 In Action

DOE Office of Scientific and Technical Information (OSTI.GOV)

Huq, M; Palta, J; Dunscombe, P

2014-06-15

One of the goals of quality management in radiation therapy is to gain high confidence that patients will receive the prescribed treatment correctly. To accomplish these goals professional societies such as the American Association of Physicists in Medicine (AAPM) has published many quality assurance (QA), quality control (QC), and quality management (QM) guidance documents. In general, the recommendations provided in these documents have emphasized on performing device-specific QA at the expense of process flow and protection of the patient against catastrophic errors. Analyses of radiation therapy incidents find that they are most often caused by flaws in the overall therapymore » process, from initial consult through final treatment, than by isolated hardware or computer failures detectable by traditional physics QA. This challenge is shared by many intrinsically hazardous industries. Risk assessment tools and analysis techniques have been developed to define, identify, and eliminate known and/or potential failures, problems, or errors, from a system, process and/or service before they reach the customer. These include, but are not limited to, process mapping, failure modes and effects analysis (FMEA), fault tree analysis (FTA), and establishment of a quality management program that best avoids the faults and risks that have been identified in the overall process. These tools can be easily adapted to radiation therapy practices because of their simplicity and effectiveness to provide efficient ways to enhance the safety and quality of treatment processes. Task group 100 (TG100) of AAPM has developed a risk-based quality management program that uses these tools. This session will be devoted to a discussion of these tools and how these tools can be used in a given radiotherapy clinic to develop a risk based QM program. Learning Objectives: Learn how to design a process map for a radiotherapy process. Learn how to perform a FMEA analysis for a given process. Learn what Fault tree analysis is all about. Learn how to design a quality management program based upon the information obtained from process mapping, FMEA and FTA.« less

HFE (Human Factors Engineering) Technology for Navy Weapon System Acquisition.

DTIC Science & Technology

1979-07-01

requirements 2-31 to electrical components using: Failure Modes and Effects Analysis ( FMEA ) and LOR data, component design requirements and a selected...3- 60 * ,.- .- I; L , , _ m m _ --- : " I. I ._ . - I- The use of SAINT can specify various outputs of the simulation, histograms, plots, summary...Electro Safety . 60 .98 .95 .65 .92 .70 .42 .62 Personnel Relationships .74 .70 .79 .63 .40 .77 .85 .80 Electro Circuit Analysis .63 .90 .95 .58 .40

Breakdown Cause and Effect Analysis. Case Study

NASA Astrophysics Data System (ADS)

Biały, Witold; Ružbarský, Juraj

2018-06-01

Every company must ensure that the production process proceeds without interferences. Within this article, the author uses the term "interferences" in reference to unplanned stoppages caused by breakdowns. Unfortunately, usually due to machine operators' mistakes, machines break, which causes stoppages thus generating additional costs for the company. This article shows a cause and effect analysis of a breakdown in a production process. The FMEA as well as quality management tools: the Ishikawa diagram and Pareto chart were used for the analysis. Correction measures were presented which allowed for a significant reduction in the number of stoppages caused by breakdowns.

[Process management in the hospital pharmacy for the improvement of the patient safety].

PubMed

Govindarajan, R; Perelló-Juncá, A; Parès-Marimòn, R M; Serrais-Benavente, J; Ferrandez-Martí, D; Sala-Robinat, R; Camacho-Calvente, A; Campabanal-Prats, C; Solà-Anderiu, I; Sanchez-Caparrós, S; Gonzalez-Estrada, J; Martinez-Olalla, P; Colomer-Palomo, J; Perez-Mañosas, R; Rodríguez-Gallego, D

2013-01-01

To define a process management model for a hospital pharmacy in order to measure, analyse and make continuous improvements in patient safety and healthcare quality. In order to implement process management, Igualada Hospital was divided into different processes, one of which was the Hospital Pharmacy. A multidisciplinary management team was given responsibility for each process. For each sub-process one person was identified to be responsible, and a working group was formed under his/her leadership. With the help of each working group, a risk analysis using failure modes and effects analysis (FMEA) was performed, and the corresponding improvement actions were implemented. Sub-process indicators were also identified, and different process management mechanisms were introduced. The first risk analysis with FMEA produced more than thirty preventive actions to improve patient safety. Later, the weekly analysis of errors, as well as the monthly analysis of key process indicators, permitted us to monitor process results and, as each sub-process manager participated in these meetings, also to assume accountability and responsibility, thus consolidating the culture of excellence. The introduction of different process management mechanisms, with the participation of people responsible for each sub-process, introduces a participative management tool for the continuous improvement of patient safety and healthcare quality. Copyright © 2012 SECA. Published by Elsevier Espana. All rights reserved.

Utilization of Failure Mode and Effects Analysis (FMEA) Method in Increasing the Revenue of Emergency Department; a Prospective Cohort Study.

PubMed

Shahrami, Ali; Rahmati, Farhad; Kariman, Hamid; Hashemi, Behrooz; Rahmati, Majid; Baratloo, Alireza; Forouzanfar, Mohammad Mehdi; Safari, Saeed

2013-01-01

The balance between revenue and cost of an organization/system is essential to maintain its survival and quality of services. Emergency departments (ED) are one of the most important parts of health care delivery system. Financial discipline of EDs, by increasing the efficiency and profitability, can directly affect the quality of care and subsequently patient satisfaction. Accordingly, the present study attempts to investigate failure mode and effects analysis (FMEA) method in identifying the problems leading to the loss of ED revenue and offer solutions to help fix these problems. This prospective cohort study investigated the financial records of ED patients and evaluated the effective errors in reducing the revenue in ED of Imam Hossein hospital, Tehran, Iran, from October 2007 to November 2009. The whole department was divided into one main system and six subsystems, based on FMEA. The study was divided into two phases. In the first phase, the problems leading to the loss of revenue in each subsystem were identified and weighted into four groups using risk priority number (RPN), and the solutions for fixing them were planned. Then, in the second phase, discovered defects in the first phase were fixed according to their priority. Finally, the impact of each solution was compared before and after intervention using the repeated measure ANOVA test. 100 financial records of ED patients were evaluated during the first phase of the study. The average of ED revenue in the six months of the first phase was 73.1±3.65 thousand US dollars/month. 12 types of errors were detected in the predefined subsystems. ED revenue rose from 73.1 to 153.1, 207.06, 240, and 320 thousand US dollars/month after solving first, second, third, and fourth priority problems, respectively (337.75% increase in two years) (p<0.001). 111.0% increase in the ED revenue after solving of first priority problems revealed that they were extremely indispensable in decreasing the revenue (p<0.0001). The findings of the present study revealed that FMEA could be considered as an efficient model for increasing the revenue of emergency department. According to this model, not recording the services by the nursing unit, and lack of specific identifying code for the patients moving from ED to any other department, were the two first priority problems in decreasing our ED revenue.

Utilization of Failure Mode and Effects Analysis (FMEA) Method in Increasing the Revenue of Emergency Department; a Prospective Cohort Study

PubMed Central

Shahrami, Ali; Rahmati, Farhad; Kariman, Hamid; Hashemi, Behrooz; Rahmati, Majid; Baratloo, Alireza; Forouzanfar, Mohammad Mehdi; Safari, Saeed

2013-01-01

Introduction: The balance between revenue and cost of an organization/system is essential to maintain its survival and quality of services. Emergency departments (ED) are one of the most important parts of health care delivery system. Financial discipline of EDs, by increasing the efficiency and profitability, can directly affect the quality of care and subsequently patient satisfaction. Accordingly, the present study attempts to investigate failure mode and effects analysis (FMEA) method in identifying the problems leading to the loss of ED revenue and offer solutions to help fix these problems. Methods: This prospective cohort study investigated the financial records of ED patients and evaluated the effective errors in reducing the revenue in ED of Imam Hossein hospital, Tehran, Iran, from October 2007 to November 2009. The whole department was divided into one main system and six subsystems, based on FMEA. The study was divided into two phases. In the first phase, the problems leading to the loss of revenue in each subsystem were identified and weighted into four groups using risk priority number (RPN), and the solutions for fixing them were planned. Then, in the second phase, discovered defects in the first phase were fixed according to their priority. Finally, the impact of each solution was compared before and after intervention using the repeated measure ANOVA test. Results: 100 financial records of ED patients were evaluated during the first phase of the study. The average of ED revenue in the six months of the first phase was 73.1±3.65 thousand US dollars/month. 12 types of errors were detected in the predefined subsystems. ED revenue rose from 73.1 to 153.1, 207.06, 240, and 320 thousand US dollars/month after solving first, second, third, and fourth priority problems, respectively (337.75% increase in two years) (p<0.001). 111.0% increase in the ED revenue after solving of first priority problems revealed that they were extremely indispensable in decreasing the revenue (p<0.0001). Conclusion: The findings of the present study revealed that FMEA could be considered as an efficient model for increasing the revenue of emergency department. According to this model, not recording the services by the nursing unit, and lack of specific identifying code for the patients moving from ED to any other department, were the two first priority problems in decreasing our ED revenue. PMID:26495327

Integrated HTA-FMEA/FMECA methodology for the evaluation of robotic system in urology and general surgery.

PubMed

Frosini, Francesco; Miniati, Roberto; Grillone, Saverio; Dori, Fabrizio; Gentili, Guido Biffi; Belardinelli, Andrea

2016-11-14

The following study proposes and tests an integrated methodology involving Health Technology Assessment (HTA) and Failure Modes, Effects and Criticality Analysis (FMECA) for the assessment of specific aspects related to robotic surgery involving safety, process and technology. The integrated methodology consists of the application of specific techniques coming from the HTA joined to the aid of the most typical models from reliability engineering such as FMEA/FMECA. The study has also included in-site data collection and interviews to medical personnel. The total number of robotic procedures included in the analysis was 44: 28 for urology and 16 for general surgery. The main outcomes refer to the comparative evaluation between robotic, laparoscopic and open surgery. Risk analysis and mitigation interventions come from FMECA application. The small sample size available for the study represents an important bias, especially for the clinical outcomes reliability. Despite this, the study seems to confirm the better trend for robotics' surgical times with comparison to the open technique as well as confirming the robotics' clinical benefits in urology. More complex situation is observed for general surgery, where robotics' clinical benefits directly measured are the lowest blood transfusion rate.

Improving the treatment planning and delivery process of Xoft electronic skin brachytherapy.

PubMed

Manger, Ryan; Rahn, Douglas; Hoisak, Jeremy; Dragojević, Irena

2018-05-14

To develop an improved Xoft electronic skin brachytherapy process and identify areas of further improvement. A multidisciplinary team conducted a failure modes and effects analysis (FMEA) by developing a process map and a corresponding list of failure modes. The failure modes were scored for their occurrence, severity, and detectability, and a risk priority number (RPN) was calculated for each failure mode as the product of occurrence, severity, and detectability. Corrective actions were implemented to address the higher risk failure modes, and a revised process was generated. The RPNs of the failure modes were compared between the initial process and final process to assess the perceived benefits of the corrective actions. The final treatment process consists of 100 steps and 114 failure modes. The FMEA took approximately 20 person-hours (one physician, three physicists, and two therapists) to complete. The 10 most dangerous failure modes had RPNs ranging from 336 to 630. Corrective actions were effective at addressing most failure modes (10 riskiest RPNs ranging from 189 to 310), yet the RPNs were higher than those published for alternative systems. Many of these high-risk failure modes remained due to hardware design limitations. FMEA helps guide process improvement efforts by emphasizing the riskiest steps. Significant risks are apparent when using a Xoft treatment unit for skin brachytherapy due to hardware limitations such as the lack of several interlocks, a short source lifespan, and variability in source output. The process presented in this article is expected to reduce but not eliminate these risks. Copyright © 2018 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.

Failure mode and effect analysis in blood transfusion: a proactive tool to reduce risks.

PubMed

Lu, Yao; Teng, Fang; Zhou, Jie; Wen, Aiqing; Bi, Yutian

2013-12-01

The aim of blood transfusion risk management is to improve the quality of blood products and to assure patient safety. We utilize failure mode and effect analysis (FMEA), a tool employed for evaluating risks and identifying preventive measures to reduce the risks in blood transfusion. The failure modes and effects occurring throughout the whole process of blood transfusion were studied. Each failure mode was evaluated using three scores: severity of effect (S), likelihood of occurrence (O), and probability of detection (D). Risk priority numbers (RPNs) were calculated by multiplying the S, O, and D scores. The plan-do-check-act cycle was also used for continuous improvement. Analysis has showed that failure modes with the highest RPNs, and therefore the greatest risk, were insufficient preoperative assessment of the blood product requirement (RPN, 245), preparation time before infusion of more than 30 minutes (RPN, 240), blood transfusion reaction occurring during the transfusion process (RPN, 224), blood plasma abuse (RPN, 180), and insufficient and/or incorrect clinical information on request form (RPN, 126). After implementation of preventative measures and reassessment, a reduction in RPN was detected with each risk. The failure mode with the second highest RPN, namely, preparation time before infusion of more than 30 minutes, was shown in detail to prove the efficiency of this tool. FMEA evaluation model is a useful tool in proactively analyzing and reducing the risks associated with the blood transfusion procedure. © 2013 American Association of Blood Banks.

MO-G-BRE-05: Clinical Process Improvement and Billing in Radiation Oncology: A Case Study of Applying FMEA for CPT Code 77336 (continuing Medical Physics Consultation)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Spirydovich, S; Huq, M

2014-06-15

Purpose: The improvement of quality in healthcare can be assessed by Failure Mode and Effects Analysis (FMEA). In radiation oncology, FMEA, as applied to the billing CPT code 77336, can improve both charge capture and, most importantly, quality of the performed services. Methods: We created an FMEA table for the process performed under CPT code 77336. For a given process step, each member of the assembled team (physicist, dosimetrist, and therapist) independently assigned numerical values for: probability of occurrence (O, 1–10), severity (S, 1–10), and probability of detection (D, 1–10) for every failure mode cause and effect combination. The riskmore » priority number, RPN, was then calculated as a product of O, S and D from which an average RPN was calculated for each combination mentioned above. A fault tree diagram, with each process sorted into 6 categories, was created with linked RPN. For processes with high RPN recommended actions were assigned. 2 separate R and V systems (Lantis and EMR-based ARIA) were considered. Results: We identified 9 potential failure modes and corresponding 19 potential causes of these failure modes all resulting in unjustified 77336 charge and compromised quality of care. In Lantis, the range of RPN was 24.5–110.8, and of S values – 2–10. The highest ranking RPN of 110.8 came from the failure mode described as “end-of-treatment check not done before the completion of treatment”, and the highest S value of 10 (RPN=105) from “overrides not checked”. For the same failure modes, within ARIA electronic environment with its additional controls, RPN values were significantly lower (44.3 for end-of-treatment missing check and 20.0 for overrides not checked). Conclusion: Our work has shown that when charge capture was missed that also resulted in some services not being performed. Absence of such necessary services may result in sub-optimal quality of care rendered to patients.« less

Combining System Safety and Reliability to Ensure NASA CoNNeCT's Success

NASA Technical Reports Server (NTRS)

Havenhill, Maria; Fernandez, Rene; Zampino, Edward

2012-01-01

Hazard Analysis, Failure Modes and Effects Analysis (FMEA), the Limited-Life Items List (LLIL), and the Single Point Failure (SPF) List were applied by System Safety and Reliability engineers on NASA's Communications, Navigation, and Networking reConfigurable Testbed (CoNNeCT) Project. The integrated approach involving cross reviews of these reports by System Safety, Reliability, and Design engineers resulted in the mitigation of all identified hazards. The outcome was that the system met all the safety requirements it was required to meet.

The engine fuel system fault analysis

NASA Astrophysics Data System (ADS)

Zhang, Yong; Song, Hanqiang; Yang, Changsheng; Zhao, Wei

2017-05-01

For improving the reliability of the engine fuel system, the typical fault factor of the engine fuel system was analyzed from the point view of structure and functional. The fault character was gotten by building the fuel system fault tree. According the utilizing of fault mode effect analysis method (FMEA), several factors of key component fuel regulator was obtained, which include the fault mode, the fault cause, and the fault influences. All of this made foundation for next development of fault diagnosis system.

Obseving Nurse Interaction With Infusion Pump Technologies

DTIC Science & Technology

2005-01-01

24 Observations of the medication administration process , as described below, were performed to provide data to the FMEA team on nursing practice...involves an FMEA of the medication administration process using the observation data as input into the assessment process .29 One use of the...invaluable to the FMEA team in many ways. First, it allowed for an unbiased and nonjudgmental look at the actual nursing processes in place, as

A survey of residents' experience with patient safety and quality improvement concepts in radiation oncology.

PubMed

Spraker, Matthew B; Nyflot, Matthew; Hendrickson, Kristi; Ford, Eric; Kane, Gabrielle; Zeng, Jing

The safety and quality of radiation therapy have recently garnered increased attention in radiation oncology (RO). Although patient safety guidelines expect physicians and physicists to lead clinical safety and quality improvement (QI) programs, trainees' level of exposure to patient safety concepts during training is unknown. We surveyed active medical and physics RO residents in North America in February 2016. Survey questions involved demographics and program characteristics, exposure to patient safety topics, and residents' attitude regarding their safety education. Responses were collected from 139 of 690 (20%) medical and 56 of 248 (23%) physics RO residents. More than 60% of residents had no exposure or only informal exposure to incident learning systems (ILS), root cause analysis, failure mode and effects analysis (FMEA), and the concepts of human factors engineering. Medical residents had less exposure to FMEA than physics residents, and fewer medical than physics residents felt confident in leading FMEA in clinic. Only 27% of residents felt that patient safety training was adequate in their program. Experiential learning through practical workshops was the most desired educational modality, preferred over web-based learning. Residents training in departments with ILS had greater exposure to patient safety concepts and felt more confident leading clinical patient safety and QI programs than residents training in departments without an ILS. The survey results show that most residents have no or only informal exposure to important patient safety and QI concepts and do not feel confident leading clinical safety programs. This represents a gaping need in RO resident education. Educational programs such as these can be naturally developed as part of an incident learning program that focuses on near-miss events. Future research should assess the needs of RO program directors to develop effective RO patient safety and QI training programs. Copyright © 2016 American Society of Radiation Oncology. Published by Elsevier Inc. All rights reserved.

WE-H-BRC-01: Failure Mode and Effects Analysis of Skin Electronic Brachytherapy Using Esteya Unit

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ibanez-Rosello, B; Bautista-Ballesteros, J; Bonaque, J

Purpose: A failure mode and effect analysis (FMEA) of skin lesions treatment process using Esteya™ device (Elekta Brachyterapy, Veenendaal, The Netherlands) was performed, with the aim of increasing the quality of the treatment and reducing the likelihood of unwanted events. Methods: A multidisciplinary team with experience in the treatment process met to establish the process map, which outlines the flow of various stages for such patients undergoing skin treatment. Potential failure modes (FM) were identified and the value of severity (S), frequency of occurrence (O), and lack of detectability (D) of the proposed FM were scored individually, each on amore » scale of 1 to 10 following TG-100 guidelines of the AAPM. These failure modes were ranked according to our risk priority number (RPN) and S scores. The efficiency of existing quality management tools was analyzed through a reassessment of the O and D made by consensus. Results: 149 FM were identified, 43 of which had RPN ≥ 100 and 30 had S ≥ 7. After introduction of the tools of quality management, only 3 FM had RPN ≥ 100 and 22 FM had RPN ≥ 50. These 22 FM were thoroughly analyzed and new tools for quality management were proposed. The most common cause of highest RPN FM was associated with the heavy patient workload and the continuous and accurate applicator-patient skin contact during the treatment. To overcome this second item, a regular quality control and setup review by a second individual before each treatment session was proposed. Conclusion: FMEA revealed some of the FM potentials that were not predicted during the initial implementation of the quality management tools. This exercise was useful in identifying the need of periodic update of the FMEA process as new potential failures can be identified.« less

SU-C-BRD-02: A Team Focused Clinical Implementation and Failure Mode and Effects Analysis of HDR Skin Brachytherapy Using Valencia and Leipzig Surface Applicators

DOE Office of Scientific and Technical Information (OSTI.GOV)

Sayler, E; Harrison, A; Eldredge-Hindy, H

Purpose: and Leipzig applicators (VLAs) are single-channel brachytherapy surface applicators used to treat skin lesions up to 2cm diameter. Source dwell times can be calculated and entered manually after clinical set-up or ultrasound. This procedure differs dramatically from CT-based planning; the novelty and unfamiliarity could lead to severe errors. To build layers of safety and ensure quality, a multidisciplinary team created a protocol and applied Failure Modes and Effects Analysis (FMEA) to the clinical procedure for HDR VLA skin treatments. Methods: team including physicists, physicians, nurses, therapists, residents, and administration developed a clinical procedure for VLA treatment. The procedure wasmore » evaluated using FMEA. Failure modes were identified and scored by severity, occurrence, and detection. The clinical procedure was revised to address high-scoring process nodes. Results: Several key components were added to the clinical procedure to minimize risk probability numbers (RPN): -Treatments are reviewed at weekly QA rounds, where physicians discuss diagnosis, prescription, applicator selection, and set-up. Peer review reduces the likelihood of an inappropriate treatment regime. -A template for HDR skin treatments was established in the clinical EMR system to standardize treatment instructions. This reduces the chances of miscommunication between the physician and planning physicist, and increases the detectability of an error during the physics second check. -A screen check was implemented during the second check to increase detectability of an error. -To reduce error probability, the treatment plan worksheet was designed to display plan parameters in a format visually similar to the treatment console display. This facilitates data entry and verification. -VLAs are color-coded and labeled to match the EMR prescriptions, which simplifies in-room selection and verification. Conclusion: Multidisciplinary planning and FMEA increased delectability and reduced error probability during VLA HDR Brachytherapy. This clinical model may be useful to institutions implementing similar procedures.« less

An improved method for risk evaluation in failure modes and effects analysis of CNC lathe

NASA Astrophysics Data System (ADS)

Rachieru, N.; Belu, N.; Anghel, D. C.

2015-11-01

Failure mode and effects analysis (FMEA) is one of the most popular reliability analysis tools for identifying, assessing and eliminating potential failure modes in a wide range of industries. In general, failure modes in FMEA are evaluated and ranked through the risk priority number (RPN), which is obtained by the multiplication of crisp values of the risk factors, such as the occurrence (O), severity (S), and detection (D) of each failure mode. However, the crisp RPN method has been criticized to have several deficiencies. In this paper, linguistic variables, expressed in Gaussian, trapezoidal or triangular fuzzy numbers, are used to assess the ratings and weights for the risk factors S, O and D. A new risk assessment system based on the fuzzy set theory and fuzzy rule base theory is to be applied to assess and rank risks associated to failure modes that could appear in the functioning of Turn 55 Lathe CNC. Two case studies have been shown to demonstrate the methodology thus developed. It is illustrated a parallel between the results obtained by the traditional method and fuzzy logic for determining the RPNs. The results show that the proposed approach can reduce duplicated RPN numbers and get a more accurate, reasonable risk assessment. As a result, the stability of product and process can be assured.

Comprehensive reliability allocation method for CNC lathes based on cubic transformed functions of failure mode and effects analysis

NASA Astrophysics Data System (ADS)

Yang, Zhou; Zhu, Yunpeng; Ren, Hongrui; Zhang, Yimin

2015-03-01

Reliability allocation of computerized numerical controlled(CNC) lathes is very important in industry. Traditional allocation methods only focus on high-failure rate components rather than moderate failure rate components, which is not applicable in some conditions. Aiming at solving the problem of CNC lathes reliability allocating, a comprehensive reliability allocation method based on cubic transformed functions of failure modes and effects analysis(FMEA) is presented. Firstly, conventional reliability allocation methods are introduced. Then the limitations of direct combination of comprehensive allocation method with the exponential transformed FMEA method are investigated. Subsequently, a cubic transformed function is established in order to overcome these limitations. Properties of the new transformed functions are discussed by considering the failure severity and the failure occurrence. Designers can choose appropriate transform amplitudes according to their requirements. Finally, a CNC lathe and a spindle system are used as an example to verify the new allocation method. Seven criteria are considered to compare the results of the new method with traditional methods. The allocation results indicate that the new method is more flexible than traditional methods. By employing the new cubic transformed function, the method covers a wider range of problems in CNC reliability allocation without losing the advantages of traditional methods.

TARDEC FMEA TRAINING: Understanding and Evaluating Failure Mode and Effects Analyses (FMEA)

DTIC Science & Technology

2012-06-07

Tip Brass 1 1.1.2.1.3 Ball Tungsten Carbide 1 1.1.2.1.4 Blue Ink Ink .1 grams 1.1.2.2 Steel 1 1.1.3 ABS/PP 1 Ink/Spring Assembly Ink Tube Spring Nib...does not meet airflow (8) voltage circuit analy sis of vehic le - New Yuma - test requirements (6 in. WCtJ.P -Blown fuse control c ircuit vehicle...1500 CFM for XXXX) - Broken wire - Compare fuse capacity to in-rush current and stall current during high ambient temperature conditions - Review

Revised Risk Priority Number in Failure Mode and Effects Analysis Model from the Perspective of Healthcare System

PubMed Central

Rezaei, Fatemeh; Yarmohammadian, Mohmmad H.; Haghshenas, Abbas; Fallah, Ali; Ferdosi, Masoud

2018-01-01

Background: Methodology of Failure Mode and Effects Analysis (FMEA) is known as an important risk assessment tool and accreditation requirement by many organizations. For prioritizing failures, the index of “risk priority number (RPN)” is used, especially for its ease and subjective evaluations of occurrence, the severity and the detectability of each failure. In this study, we have tried to apply FMEA model more compatible with health-care systems by redefining RPN index to be closer to reality. Methods: We used a quantitative and qualitative approach in this research. In the qualitative domain, focused groups discussion was used to collect data. A quantitative approach was used to calculate RPN score. Results: We have studied patient's journey in surgery ward from holding area to the operating room. The highest priority failures determined based on (1) defining inclusion criteria as severity of incident (clinical effect, claim consequence, waste of time and financial loss), occurrence of incident (time - unit occurrence and degree of exposure to risk) and preventability (degree of preventability and defensive barriers) then, (2) risks priority criteria quantified by using RPN index (361 for the highest rate failure). The ability of improved RPN scores reassessed by root cause analysis showed some variations. Conclusions: We concluded that standard criteria should be developed inconsistent with clinical linguistic and special scientific fields. Therefore, cooperation and partnership of technical and clinical groups are necessary to modify these models. PMID:29441184

Reliability Growth Testing Effectiveness.

DTIC Science & Technology

1984-01-01

interface boundaries. f. Test facility and equipment descriptions and requirements. g. Procedures and timing for corrective acticns. Uh . Blocks of tme and...apporLionment, FMEA and stress analysis. Instead, reiiability "growth management provides a means of viewing all the reliability program activities in an...A VENDOR SURVEILLANCE 8 A A R GROWTH ESTING. A R PROGRAM4 C B A A NORMALIZED INCREASE 0 2.5% 25% 60 % IN ACQUISITION COST RELATIVE CHANGE IN 1:1 4:1

Independent Orbiter Assessment (IOA): Analysis of the rudder/speed brake subsystem

NASA Technical Reports Server (NTRS)

Wilson, R. E.; Riccio, J. R.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. The independent analysis results for the Orbiter Rudder/Speedbrake Actuation Mechanism is documented. The function of the Rudder/Speedbrake (RSB) is to provide directional control and to provide a means of energy control during entry. The system consists of two panels on a vertical hinge mounted on the aft part of the vertical stabilizer. These two panels move together to form a rudder but split apart to make a speedbrake. The Rudder/Speedbrake Actuation Mechanism consists of the following elements: (1) Power Drive Unit (PDU) which is composed of hydraulic valve module and a hydraulic motor-powered gearbox which contains differentials and mixer gears to provide PDU torque output; (2) four geared rotary actuators which apply the PDU generated torque to the rudder/speedbrake panels; and (3) ten torque shafts which join the PDU to the rotary actuators and interconnect the four rotary actuators. Each level of hardware was evaluated and analyzed for possible failures and causes. Criticality was assigned based upon the severity of the effect for each failure mode. Critical RSB failures which result in potential loss of vehicle control were mainly due to loss of hydraulic fluid, fluid contaminators, and mechanical failures in gears and shafts.

Medication Safety of Five Oral Chemotherapies: A Proactive Risk Assessment

PubMed Central

Weingart, Saul N.; Spencer, Justin; Buia, Stephanie; Duncombe, Deborah; Singh, Prabhjyot; Gadkari, Mrinalini; Connor, Maureen

2011-01-01

Purpose: Oral chemotherapies represent an emerging risk area in ambulatory oncology practice. To examine the hazards associated with five oral chemotherapies, we performed a proactive risk assessment. Methods: We convened interdisciplinary teams and conducted failure mode and effects analyses (FMEAs) for five oral chemotherapy agents: capecitabine, imatinib, temozolomide, 6-mercaptopurine, and an investigational agent. This involved the creation of process maps for each medication, identification of failure modes, selection of high-risk failure modes, and development of recommendations to mitigate these risks. We analyzed the number of steps and types of failure modes and compared this information across the study drugs. Results: Key vulnerabilities include patient education about drug handling and adverse effects, prescription writing, patient self-administration and medication adherence, and failure to monitor and manage toxicities. Many of these failure modes were common across the five oral chemotherapies, suggesting the presence of common targets for improvement. Streamlining the FMEA itself may promote the dissemination of this method. Conclusion: Each stage of the medication process poses risks to the safe use of oral chemotherapies. FMEAs may identify opportunities to improve medication safety and reduce the risk of patient harm. PMID:21532801

Independent Orbiter Assessment (IOA): Analysis of the electrical power distribution and control subsystem, volume 1

NASA Technical Reports Server (NTRS)

Schmeckpeper, K. R.

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Orbiter Electrical Power Distribution and Control (EPD and C) hardware. The EPD and C hardware performs the functions of distributing, sensing, and controlling 28 volt DC power and of inverting, distributing, sensing, and controlling 117 volt 400 Hz AC power to all Orbiter subsystems from the three fuel cells in the Electrical Power Generation (EPG) subsystem. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. Of the 1671 failure modes analyzed, 9 single failures were determined to result in loss of crew or vehicle. Three single failures unique to intact abort were determined to result in possible loss of the crew or vehicle. A possible loss of mission could result if any of 136 single failures occurred. Six of the criticality 1/1 failures are in two rotary and two pushbutton switches that control External Tank and Solid Rocket Booster separation. The other 6 criticality 1/1 failures are fuses, one each per Aft Power Control Assembly (APCA) 4, 5, and 6 and one each per Forward Power Control Assembly (FPCA) 1, 2, and 3, that supply power to certain Main Propulsion System (MPS) valves and Forward Reaction Control System (RCS) circuits.

Reliability studies of Integrated Modular Engine system designs

NASA Technical Reports Server (NTRS)

Hardy, Terry L.; Rapp, Douglas C.

1993-01-01

A study was performed to evaluate the reliability of Integrated Modular Engine (IME) concepts. Comparisons were made between networked IME systems and non-networked discrete systems using expander cycle configurations. Both redundant and non-redundant systems were analyzed. Binomial approximation and Markov analysis techniques were employed to evaluate total system reliability. In addition, Failure Modes and Effects Analyses (FMEA), Preliminary Hazard Analyses (PHA), and Fault Tree Analysis (FTA) were performed to allow detailed evaluation of the IME concept. A discussion of these system reliability concepts is also presented.

System safety in Stirling engine development

NASA Technical Reports Server (NTRS)

Bankaitis, H.

1981-01-01

The DOE/NASA Stirling Engine Project Office has required that contractors make safety considerations an integral part of all phases of the Stirling engine development program. As an integral part of each engine design subtask, analyses are evolved to determine possible modes of failure. The accepted system safety analysis techniques (Fault Tree, FMEA, Hazards Analysis, etc.) are applied in various degrees of extent at the system, subsystem and component levels. The primary objectives are to identify critical failure areas, to enable removal of susceptibility to such failures or their effects from the system and to minimize risk.

Reliability studies of integrated modular engine system designs

NASA Technical Reports Server (NTRS)

Hardy, Terry L.; Rapp, Douglas C.

1993-01-01

A study was performed to evaluate the reliability of Integrated Modular Engine (IME) concepts. Comparisons were made between networked IME systems and non-networked discrete systems using expander cycle configurations. Both redundant and non-redundant systems were analyzed. Binomial approximation and Markov analysis techniques were employed to evaluate total system reliability. In addition, Failure Modes and Effects Analyses (FMEA), Preliminary Hazard Analyses (PHA), and Fault Tree Analysis (FTA) were performed to allow detailed evaluation of the IME concept. A discussion of these system reliability concepts is also presented.

Reliability studies of integrated modular engine system designs

NASA Astrophysics Data System (ADS)

Hardy, Terry L.; Rapp, Douglas C.

1993-06-01

A study was performed to evaluate the reliability of Integrated Modular Engine (IME) concepts. Comparisons were made between networked IME systems and non-networked discrete systems using expander cycle configurations. Both redundant and non-redundant systems were analyzed. Binomial approximation and Markov analysis techniques were employed to evaluate total system reliability. In addition, Failure Modes and Effects Analyses (FMEA), Preliminary Hazard Analyses (PHA), and Fault Tree Analysis (FTA) were performed to allow detailed evaluation of the IME concept. A discussion of these system reliability concepts is also presented.

Reliability studies of Integrated Modular Engine system designs

NASA Astrophysics Data System (ADS)

Hardy, Terry L.; Rapp, Douglas C.

1993-06-01

A study was performed to evaluate the reliability of Integrated Modular Engine (IME) concepts. Comparisons were made between networked IME systems and non-networked discrete systems using expander cycle configurations. Both redundant and non-redundant systems were analyzed. Binomial approximation and Markov analysis techniques were employed to evaluate total system reliability. In addition, Failure Modes and Effects Analyses (FMEA), Preliminary Hazard Analyses (PHA), and Fault Tree Analysis (FTA) were performed to allow detailed evaluation of the IME concept. A discussion of these system reliability concepts is also presented.

Quality control process improvement of flexible printed circuit board by FMEA

NASA Astrophysics Data System (ADS)

Krasaephol, Siwaporn; Chutima, Parames

2018-02-01

This research focuses on the quality control process improvement of Flexible Printed Circuit Board (FPCB), centred around model 7-Flex, by using Failure Mode and Effect Analysis (FMEA) method to decrease proportion of defective finished goods that are found at the final inspection process. Due to a number of defective units that were found at the final inspection process, high scraps may be escaped to customers. The problem comes from poor quality control process which is not efficient enough to filter defective products from in-process because there is no In-Process Quality Control (IPQC) or sampling inspection in the process. Therefore, the quality control process has to be improved by setting inspection gates and IPCQs at critical processes in order to filter the defective products. The critical processes are analysed by the FMEA method. IPQC is used for detecting defective products and reducing chances of defective finished goods escaped to the customers. Reducing proportion of defective finished goods also decreases scrap cost because finished goods incur higher scrap cost than work in-process. Moreover, defective products that are found during process can reflect the abnormal processes; therefore, engineers and operators should timely solve the problems. Improved quality control was implemented for 7-Flex production lines from July 2017 to September 2017. The result shows decreasing of the average proportion of defective finished goods and the average of Customer Manufacturers Lot Reject Rate (%LRR of CMs) equal to 4.5% and 4.1% respectively. Furthermore, cost saving of this quality control process equals to 100K Baht.

Identification of priorities for medication safety in neonatal intensive care.

PubMed

Kunac, Desireé L; Reith, David M

2005-01-01

Although neonates are reported to be at greater risk of medication error than infants and older children, little is known about the causes and characteristics of error in this patient group. Failure mode and effects analysis (FMEA) is a technique used in industry to evaluate system safety and identify potential hazards in advance. The aim of this study was to identify and prioritize potential failures in the neonatal intensive care unit (NICU) medication use process through application of FMEA. Using the FMEA framework and a systems-based approach, an eight-member multidisciplinary panel worked as a team to create a flow diagram of the neonatal unit medication use process. Then by brainstorming, the panel identified all potential failures, their causes and their effects at each step in the process. Each panel member independently rated failures based on occurrence, severity and likelihood of detection to allow calculation of a risk priority score (RPS). The panel identified 72 failures, with 193 associated causes and effects. Vulnerabilities were found to be distributed across the entire process, but multiple failures and associated causes were possible when prescribing the medication and when preparing the drug for administration. The top ranking issue was a perceived lack of awareness of medication safety issues (RPS score 273), due to a lack of medication safety training. The next highest ranking issues were found to occur at the administration stage. Common potential failures related to errors in the dose, timing of administration, infusion pump settings and route of administration. Perceived causes were multiple, but were largely associated with unsafe systems for medication preparation and storage in the unit, variable staff skill level and lack of computerised technology. Interventions to decrease medication-related adverse events in the NICU should aim to increase staff awareness of medication safety issues and focus on medication administration processes.

Independent Orbiter Assessment (IOA): Analysis of the purge, vent and drain subsystem

NASA Technical Reports Server (NTRS)

Bynum, M. C., III

1987-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis (FMEA) and Critical Items List (CIL) are presented. The IOA approach features a top-down analysis of the hardware to determine failure modes, criticality, and potential critical items. To preserve independence, this analysis was accomplished without reliance upon the results contained within the NASA FMEA/CIL documentation. This report documents the independent analysis results corresponding to the Orbiter PV and D (Purge, Vent and Drain) Subsystem hardware. The PV and D Subsystem controls the environment of unpressurized compartments and window cavities, senses hazardous gases, and purges Orbiter/ET Disconnect. The subsystem is divided into six systems: Purge System (controls the environment of unpressurized structural compartments); Vent System (controls the pressure of unpressurized compartments); Drain System (removes water from unpressurized compartments); Hazardous Gas Detection System (HGDS) (monitors hazardous gas concentrations); Window Cavity Conditioning System (WCCS) (maintains clear windows and provides pressure control of the window cavities); and External Tank/Orbiter Disconnect Purge System (prevents cryo-pumping/icing of disconnect hardware). Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. Four of the sixty-two failure modes analyzed were determined as single failures which could result in the loss of crew or vehicle. A possible loss of mission could result if any of twelve single failures occurred. Two of the criticality 1/1 failures are in the Window Cavity Conditioning System (WCCS) outer window cavity, where leakage and/or restricted flow will cause failure to depressurize/repressurize the window cavity. Two criticality 1/1 failures represent leakage and/or restricted flow in the Orbiter/ET disconnect purge network which prevent cryopumping/icing of disconnect hardware. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode.

Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy

PubMed Central

2013-01-01

Background A multidisciplinary and multi-institutional working group applied the Failure Mode and Effects Analysis (FMEA) approach to the actively scanned proton beam radiotherapy process implemented at CNAO (Centro Nazionale di Adroterapia Oncologica), aiming at preventing accidental exposures to the patient. Methods FMEA was applied to the treatment planning stage and consisted of three steps: i) identification of the involved sub-processes; ii) identification and ranking of the potential failure modes, together with their causes and effects, using the risk probability number (RPN) scoring system, iii) identification of additional safety measures to be proposed for process quality and safety improvement. RPN upper threshold for little concern of risk was set at 125. Results Thirty-four sub-processes were identified, twenty-two of them were judged to be potentially prone to one or more failure modes. A total of forty-four failure modes were recognized, 52% of them characterized by an RPN score equal to 80 or higher. The threshold of 125 for RPN was exceeded in five cases only. The most critical sub-process appeared related to the delineation and correction of artefacts in planning CT data. Failures associated to that sub-process were inaccurate delineation of the artefacts and incorrect proton stopping power assignment to body regions. Other significant failure modes consisted of an outdated representation of the patient anatomy, an improper selection of beam direction and of the physical beam model or dose calculation grid. The main effects of these failures were represented by wrong dose distribution (i.e. deviating from the planned one) delivered to the patient. Additional strategies for risk mitigation, easily and immediately applicable, consisted of a systematic information collection about any known implanted prosthesis directly from each patient and enforcing a short interval time between CT scan and treatment start. Moreover, (i) the investigation of dedicated CT image reconstruction algorithms, (ii) further evaluation of treatment plan robustness and (iii) implementation of independent methods for dose calculation (such as Monte Carlo simulations) may represent novel solutions to increase patient safety. Conclusions FMEA is a useful tool for prospective evaluation of patient safety in proton beam radiotherapy. The application of this method to the treatment planning stage lead to identify strategies for risk mitigation in addition to the safety measures already adopted in clinical practice. PMID:23705626

Failure modes and effects analysis (FMEA) for Gamma Knife radiosurgery.

PubMed

Xu, Andy Yuanguang; Bhatnagar, Jagdish; Bednarz, Greg; Flickinger, John; Arai, Yoshio; Vacsulka, Jonet; Feng, Wenzheng; Monaco, Edward; Niranjan, Ajay; Lunsford, L Dade; Huq, M Saiful

2017-11-01

Gamma Knife radiosurgery is a highly precise and accurate treatment technique for treating brain diseases with low risk of serious error that nevertheless could potentially be reduced. We applied the AAPM Task Group 100 recommended failure modes and effects analysis (FMEA) tool to develop a risk-based quality management program for Gamma Knife radiosurgery. A team consisting of medical physicists, radiation oncologists, neurosurgeons, radiation safety officers, nurses, operating room technologists, and schedulers at our institution and an external physicist expert on Gamma Knife was formed for the FMEA study. A process tree and a failure mode table were created for the Gamma Knife radiosurgery procedures using the Leksell Gamma Knife Perfexion and 4C units. Three scores for the probability of occurrence (O), the severity (S), and the probability of no detection for failure mode (D) were assigned to each failure mode by 8 professionals on a scale from 1 to 10. An overall risk priority number (RPN) for each failure mode was then calculated from the averaged O, S, and D scores. The coefficient of variation for each O, S, or D score was also calculated. The failure modes identified were prioritized in terms of both the RPN scores and the severity scores. The established process tree for Gamma Knife radiosurgery consists of 10 subprocesses and 53 steps, including a subprocess for frame placement and 11 steps that are directly related to the frame-based nature of the Gamma Knife radiosurgery. Out of the 86 failure modes identified, 40 Gamma Knife specific failure modes were caused by the potential for inappropriate use of the radiosurgery head frame, the imaging fiducial boxes, the Gamma Knife helmets and plugs, the skull definition tools as well as other features of the GammaPlan treatment planning system. The other 46 failure modes are associated with the registration, imaging, image transfer, contouring processes that are common for all external beam radiation therapy techniques. The failure modes with the highest hazard scores are related to imperfect frame adaptor attachment, bad fiducial box assembly, unsecured plugs/inserts, overlooked target areas, and undetected machine mechanical failure during the morning QA process. The implementation of the FMEA approach for Gamma Knife radiosurgery enabled deeper understanding of the overall process among all professionals involved in the care of the patient and helped identify potential weaknesses in the overall process. The results of the present study give us a basis for the development of a risk based quality management program for Gamma Knife radiosurgery. © 2017 The Authors. Journal of Applied Clinical Medical Physics published by Wiley Periodicals, Inc. on behalf of American Association of Physicists in Medicine.

The development of control and monitoring system on marine current renewable energy Case study: strait of Toyapakeh - Nusa Penida, Bali

NASA Astrophysics Data System (ADS)

Arief, I. S.; Suherman, I. H.; Wardani, A. Y.; Baidowi, A.

2017-05-01

Control and monitoring system is a continuous process of securing the asset in the Marine Current Renewable Energy. A control and monitoring system is existed each critical components which is embedded in Failure Mode Effect Analysis (FMEA) method. As the result, the process in this paper developed through a matrix sensor. The matrix correlated to critical components and monitoring system which supported by sensors to conduct decision-making.

Life prediction and reliability assessment of lithium secondary batteries

NASA Astrophysics Data System (ADS)

Eom, Seung-Wook; Kim, Min-Kyu; Kim, Ick-Jun; Moon, Seong-In; Sun, Yang-Kook; Kim, Hyun-Soo

Reliability assessment of lithium secondary batteries was mainly considered. Shape parameter (β) and scale parameter (η) were calculated from experimental data based on cycle life test. We also examined safety characteristics of lithium secondary batteries. As proposed by IEC 62133 (2002), we had performed all of the safety/abuse tests such as 'mechanical abuse tests', 'environmental abuse tests', 'electrical abuse tests'. This paper describes the cycle life of lithium secondary batteries, FMEA (failure modes and effects analysis) and the safety/abuse tests we had performed.

Automated Generation of Fault Management Artifacts from a Simple System Model

NASA Technical Reports Server (NTRS)

Kennedy, Andrew K.; Day, John C.

2013-01-01

Our understanding of off-nominal behavior - failure modes and fault propagation - in complex systems is often based purely on engineering intuition; specific cases are assessed in an ad hoc fashion as a (fallible) fault management engineer sees fit. This work is an attempt to provide a more rigorous approach to this understanding and assessment by automating the creation of a fault management artifact, the Failure Modes and Effects Analysis (FMEA) through querying a representation of the system in a SysML model. This work builds off the previous development of an off-nominal behavior model for the upcoming Soil Moisture Active-Passive (SMAP) mission at the Jet Propulsion Laboratory. We further developed the previous system model to more fully incorporate the ideas of State Analysis, and it was restructured in an organizational hierarchy that models the system as layers of control systems while also incorporating the concept of "design authority". We present software that was developed to traverse the elements and relationships in this model to automatically construct an FMEA spreadsheet. We further discuss extending this model to automatically generate other typical fault management artifacts, such as Fault Trees, to efficiently portray system behavior, and depend less on the intuition of fault management engineers to ensure complete examination of off-nominal behavior.

Mission safety evaluation report for STS-35: Postflight edition

NASA Technical Reports Server (NTRS)

Hill, William C.; Finkel, Seymour I.

1991-01-01

Space Transportation System 35 (STS-35) safety risk factors that represent a change from previous flights that had an impact on this flight, and factors that were unique to this flight are discussed. While some changes to the safety risk baseline since the previous flight are included to highlight their significance in risk level change, the primary purpose is to insure that changes which were too late too include in formal changes through the Failure Modes and Effects Analysis/Critical Items List (FMEA/CIL) and Hazard Analysis process are documented along with the safety position, which includes the acceptance rationale.

Aircraft Transparency Failure and Logistical Cost Analysis. Volume I. Program Summary

DTIC Science & Technology

1978-12-01

Hours liv LIST OF ABBREVIATIONS (Continued) SFMC Field Maintenance Cost FMEA Failure Modes and Effect Analysis SFMS Field Maintenance Squadron FSN...3, CH-53, AND UH -1 Figure 3. Study Aircraft 10 I. 1. WINDSHIELDS 2. CANOPIES 3. WINDOWS INTERACTIVE SUPPORT SYSTEMS 1. ANTI-ICING 2. DEFOGGING 3...52,947 13,761 UH /TH-1F, 1P 73,431 73,640 Total helicopters 339,690 113,492 2.99 Bombers B-S2G 138,348 64,431 B-S2P 93,000 36,936 B-57 34,527 19,552

Application of a risk analysis method to different technologies for producing a monoclonal antibody employed in hepatitis B vaccine manufacturing.

PubMed

Milá, Lorely; Valdés, Rodolfo; Tamayo, Andrés; Padilla, Sigifredo; Ferro, Williams

2012-03-01

CB.Hep-1 monoclonal antibody (mAb) is used for a recombinant Hepatitis B vaccine manufacturing, which is included in a worldwide vaccination program against Hepatitis B disease. The use of this mAb as immunoligand has been addressed into one of the most efficient steps of active pharmaceutical ingredient purification process. Regarding this, Quality Risk Management (QRM) provides an excellent framework for the risk management use in pharmaceutical manufacturing and quality decision-making applications. Consequently, this study sought applying a prospective risk analysis methodology Failure Mode Effects Analysis (FMEA) as QRM tool for analyzing different CB.Hep-1 mAb manufacturing technologies. As main conclusions FMEA was successfully used to assess risks associated with potential problems in CB.Hep-1 mAb manufacturing processes. The severity and occurrence of risks analysis evidenced that the percentage of very high severe risks ranged 31.0-38.7% of all risks and the huge majority of risks have a very low occurrence level (61.9-83.3%) in all assessed technologies. Finally, additive Risk Priority Number, was descending ordered as follow: transgenic plants (2636), ascites (2577), transgenic animals (2046) and hollow fiber bioreactors (1654), which also corroborated that in vitro technology, should be the technology of choice for CB.Hep-1 mAb manufacturing in terms of risks and mAb molecule quality. Copyright © 2011 The International Alliance for Biological Standardization. Published by Elsevier Ltd. All rights reserved.

Ground Operations Autonomous Control and Integrated Health Management

NASA Technical Reports Server (NTRS)

Figueroa, Fernando; Walker, Mark; Wilkins, Kim; Johnson, Robert; Sass, Jared; Youney, Justin

2014-01-01

An intelligent autonomous control capability has been developed and is currently being validated in ground cryogenic fluid management operations. The capability embodies a physical architecture consistent with typical launch infrastructure and control systems, augmented by a higher level autonomous control (AC) system enabled to make knowledge-based decisions. The AC system is supported by an integrated system health management (ISHM) capability that detects anomalies, diagnoses causes, determines effects, and could predict future anomalies. AC is implemented using the concept of programmed sequences that could be considered to be building blocks of more generic mission plans. A sequence is a series of steps, and each executes actions once conditions for the step are met (e.g. desired temperatures or fluid state are achieved). For autonomous capability, conditions must consider also health management outcomes, as they will determine whether or not an action is executed, or how an action may be executed, or if an alternative action is executed instead. Aside from health, higher level objectives can also drive how a mission is carried out. The capability was developed using the G2 software environment (www.gensym.com) augmented by a NASA Toolkit that significantly shortens time to deployment. G2 is a commercial product to develop intelligent applications. It is fully object oriented. The core of the capability is a Domain Model of the system where all elements of the system are represented as objects (sensors, instruments, components, pipes, etc.). Reasoning and decision making can be done with all elements in the domain model. The toolkit also enables implementation of failure modes and effects analysis (FMEA), which are represented as root cause trees. FMEA's are programmed graphically, they are reusable, as they address generic FMEA referring to classes of subsystems or objects and their functional relationships. User interfaces for integrated awareness by operators have been created.

Failure Modes and Effects Analysis of bilateral same-day cataract surgery

PubMed Central

Shorstein, Neal H.; Lucido, Carol; Carolan, James; Liu, Liyan; Slean, Geraldine; Herrinton, Lisa J.

2017-01-01

PURPOSE To systematically analyze potential process failures related to bilateral same-day cataract surgery toward the goal of improving patient safety. SETTING Twenty-one Kaiser Permanente surgery centers, Northern California, USA. DESIGN Retrospective cohort study. METHODS Quality experts performed a Failure Modes and Effects Analysis (FMEA) that included an evaluation of sterile processing, pharmaceuticals, perioperative clinic and surgical center visits, and biometry. Potential failures in human factors and communication (modes) were identified. Rates of endophthalmitis, toxic anterior segment syndrome (TASS), and unintended intraocular lens (IOL) implantation were assessed in eyes having bilateral same-day surgery from 2010 through 2014. RESULTS The study comprised 4754 eyes. The analysis identified 15 significant potential failure modes. These included lapses in instrument processing and compounding error of intracameral antibiotic that could lead to endophthalmitis or TASS and ambiguous documentation of IOL selection by surgeons, which could lead to unintended IOL implantation. Of the study sample, 1 eye developed endophthalmitis, 1 eye had unintended IOL implantation (rates, 2 per 10 000; 95% confidence intervals [CI] 0.1–12.0 per 10 000), and no eyes developed TASS (upper 95% CI, 8 per 10 000). Recommendations included improving oversight of cleaning and sterilization practices, separating lots of compounded drugs for each eye, and enhancing IOL verification procedures. CONCLUSIONS Potential failure modes and recommended actions in bilateral same-day cataract surgery were determined using a FMEA. These findings might help improve the reliability and safety of bilateral same-day cataract surgery based on current evidence and standards. PMID:28410711

IDA/OSD(Institute for Defense Analyses/Office of the Secretary of Defense) Reliability and Maintainability Study. Volume 3. Case Study Analysis.

DTIC Science & Technology

1983-11-01

Isolation FIT Fault Isolation Test FMC Fully Mission Capable FMEA Failure Modes and Effects Analysis FMECA Failure Modes, Effects and Criticality...8217 ..* ,/- " , " A ’’"""¢ 9 % ’ k " . " ~ .[:, .- v," . , , .’ % , o4,o 100 92 88 0 80 76 PERCENT -- __ OF F-16 60 FLIGHTS WITHOUT NATO NATO RADAR HILL BASE BASE...to manage a growth program adequately. 822/1-13 IV-13 %. - 70 60 F-ill 50 F-1 5 40- CL. C.c 30 - IF-1 S20 ICIC p 10 I~* -. -. - - -____ F-5E -4 -3 -2

Modeling and Fault Simulation of Propellant Filling System

NASA Astrophysics Data System (ADS)

Jiang, Yunchun; Liu, Weidong; Hou, Xiaobo

2012-05-01

Propellant filling system is one of the key ground plants in launching site of rocket that use liquid propellant. There is an urgent demand for ensuring and improving its reliability and safety, and there is no doubt that Failure Mode Effect Analysis (FMEA) is a good approach to meet it. Driven by the request to get more fault information for FMEA, and because of the high expense of propellant filling, in this paper, the working process of the propellant filling system in fault condition was studied by simulating based on AMESim. Firstly, based on analyzing its structure and function, the filling system was modular decomposed, and the mathematic models of every module were given, based on which the whole filling system was modeled in AMESim. Secondly, a general method of fault injecting into dynamic system was proposed, and as an example, two typical faults - leakage and blockage - were injected into the model of filling system, based on which one can get two fault models in AMESim. After that, fault simulation was processed and the dynamic characteristics of several key parameters were analyzed under fault conditions. The results show that the model can simulate effectively the two faults, and can be used to provide guidance for the filling system maintain and amelioration.

Clinical Risk Assessment in Intensive Care Unit

PubMed Central

Asefzadeh, Saeed; Yarmohammadian, Mohammad H.; Nikpey, Ahmad; Atighechian, Golrokh

2013-01-01

Background: Clinical risk management focuses on improving the quality and safety of health care services by identifying the circumstances and opportunities that put patients at risk of harm and acting to prevent or control those risks. The goal of this study is to identify and assess the failure modes in the ICU of Qazvin's Social Security Hospital (Razi Hospital) through Failure Mode and Effect Analysis (FMEA). Methods: This was a qualitative-quantitative research by Focus Discussion Group (FDG) performed in Qazvin Province, Iran during 2011. The study population included all individuals and owners who are familiar with the process in ICU. Sampling method was purposeful and the FDG group members were selected by the researcher. The research instrument was standard worksheet that has been used by several researchers. Data was analyzed by FMEA technique. Results: Forty eight clinical errors and failure modes identified, results showed that the highest risk probability number (RPN) was in respiratory care “Ventilator's alarm malfunction (no alarm)” with the score 288, and the lowest was in gastrointestinal “not washing the NG-Tube” with the score 8. Conclusions: Many of the identified errors can be prevented by group members. Clinical risk assessment and management is the key to delivery of effective health care. PMID:23930171

Enhancement of LEEDS Decision Tools for E-Craft

DTIC Science & Technology

2012-03-13

software tool was conducted to determine how to best incorporate RCM into the FMEA process already a part of LEEDS. Plans were made to enhance the...as opposed to implementing a strictly scheduled and costly equipment maintenance program. Utilizing the FMEA process already a part of LEEDS

NASA Taxonomies for Searching Problem Reports and FMEAs

NASA Technical Reports Server (NTRS)

Malin, Jane T.; Throop, David R.

2006-01-01

Many types of hazard and risk analyses are used during the life cycle of complex systems, including Failure Modes and Effects Analysis (FMEA), Hazard Analysis, Fault Tree and Event Tree Analysis, Probabilistic Risk Assessment, Reliability Analysis and analysis of Problem Reporting and Corrective Action (PRACA) databases. The success of these methods depends on the availability of input data and the analysts knowledge. Standard nomenclature can increase the reusability of hazard, risk and problem data. When nomenclature in the source texts is not standard, taxonomies with mapping words (sets of rough synonyms) can be combined with semantic search to identify items and tag them with metadata based on a rich standard nomenclature. Semantic search uses word meanings in the context of parsed phrases to find matches. The NASA taxonomies provide the word meanings. Spacecraft taxonomies and ontologies (generalization hierarchies with attributes and relationships, based on terms meanings) are being developed for types of subsystems, functions, entities, hazards and failures. The ontologies are broad and general, covering hardware, software and human systems. Semantic search of Space Station texts was used to validate and extend the taxonomies. The taxonomies have also been used to extract system connectivity (interaction) models and functions from requirements text. Now the Reconciler semantic search tool and the taxonomies are being applied to improve search in the Space Shuttle PRACA database, to discover recurring patterns of failure. Usual methods of string search and keyword search fall short because the entries are terse and have numerous shortcuts (irregular abbreviations, nonstandard acronyms, cryptic codes) and modifier words cannot be used in sentence context to refine the search. The limited and fixed FMEA categories associated with the entries do not make the fine distinctions needed in the search. The approach assigns PRACA report titles to problem classes in the taxonomy. Each ontology class includes mapping words - near-synonyms naming different manifestations of that problem class. The mapping words for Problems, Entities and Functions are converted to a canonical form plus any of a small set of modifier words (e.g. non-uniformity NOT + UNIFORM.) The report titles are parsed as sentences if possible, or treated as a flat sequence of word tokens if parsing fails. When canonical forms in the title match mapping words, the PRACA entry is associated with the corresponding Problem, Entity or Function in the ontology. The user can search for types of failures associated with types of equipment, clustering by type of problem (e.g., all bearings found with problems of being uneven: rough, irregular, gritty ). The results could also be used for tagging PRACA report entries with rich metadata. This approach could also be applied to searching and tagging failure modes, failure effects and mitigations in FMEAs. In the pilot work, parsing 52K+ truncated titles (the test cases that were available), has resulted in identification of both a type of equipment and type of problem in about 75% of the cases. The results are displayed in a manner analogous to Google search results. The effort has also led to the enrichment of the taxonomy, adding some new categories and many new mapping words. Further work would make enhancements that have been identified for improving the clustering and further reducing the false alarm rate. (In searching for recurring problems, good clustering is more important than reducing false alarms). Searching complete PRACA reports should lead to immediate improvement.

Research on Application of FMECA in Missile Equipment Maintenance Decision

NASA Astrophysics Data System (ADS)

Kun, Wang

2018-03-01

Fault mode effects and criticality analysis (FMECA) is a method widely used in engineering. Studying the application of FMEA technology in military equipment maintenance decision-making, can help us build a better equipment maintenance support system, and increase the using efficiency of weapons and equipment. Through Failure Modes, Effects and Criticality Analysis (FMECA) of equipment, known and potential failure modes and their causes are found out, and the influence on the equipment performance, operation success, personnel security are determined. Furthermore, according to the synthetical effects of the severity of effects and the failure probability, possible measures for prevention and correction are put forward. Through replacing or adjusting the corresponding parts, corresponding maintenance strategy is decided for preventive maintenance of equipment, which helps improve the equipment reliability.

A Automated Tool for Supporting FMEAs of Digital Systems

DOE Office of Scientific and Technical Information (OSTI.GOV)

Yue,M.; Chu, T.-L.; Martinez-Guridi, G.

2008-09-07

Although designs of digital systems can be very different from each other, they typically use many of the same types of generic digital components. Determining the impacts of the failure modes of these generic components on a digital system can be used to support development of a reliability model of the system. A novel approach was proposed for such a purpose by decomposing the system into a level of the generic digital components and propagating failure modes to the system level, which generally is time-consuming and difficult to implement. To overcome the associated issues of implementing the proposed FMEA approach,more » an automated tool for a digital feedwater control system (DFWCS) has been developed in this study. The automated FMEA tool is in nature a simulation platform developed by using or recreating the original source code of the different module software interfaced by input and output variables that represent physical signals exchanged between modules, the system, and the controlled process. For any given failure mode, its impacts on associated signals are determined first and the variables that correspond to these signals are modified accordingly by the simulation. Criteria are also developed, as part of the simulation platform, to determine whether the system has lost its automatic control function, which is defined as a system failure in this study. The conceptual development of the automated FMEA support tool can be generalized and applied to support FMEAs for reliability assessment of complex digital systems.« less

Interoperability-oriented Integration of Failure Knowledge into Functional Knowledge and Knowledge Transformation based on Concepts Mapping

NASA Astrophysics Data System (ADS)

Koji, Yusuke; Kitamura, Yoshinobu; Kato, Yoshikiyo; Tsutsui, Yoshio; Mizoguchi, Riichiro

In conceptual design, it is important to develop functional structures which reflect the rich experience in the knowledge from previous design failures. Especially, if a designer learns possible abnormal behaviors from a previous design failure, he or she can add an additional function which prevents such abnormal behaviors and faults. To do this, it is a crucial issue to share such knowledge about possible faulty phenomena and how to cope with them. In fact, a part of such knowledge is described in FMEA (Failure Mode and Effect Analysis) sheets, function structure models for systematic design and fault trees for FTA (Fault Tree Analysis).

Reliability Practice at NASA Goddard Space Flight Center

NASA Technical Reports Server (NTRS)

Pruessner, Paula S.; Li, Ming

2008-01-01

This paper describes in brief the Reliability and Maintainability (R&M) Programs performed directly by the reliability branch at Goddard Space Flight Center (GSFC). The mission assurance requirements flow down is explained. GSFC practices for PRA, reliability prediction/fault tree analysis/reliability block diagram, FMEA, part stress and derating analysis, worst case analysis, trend analysis, limit life items are presented. Lessons learned are summarized and recommendations on improvement are identified.

SU-E-T-105: An FMEA Survey of Intensity Modulated Radiation Therapy (IMRT) Step and Shoot Dose Delivery Failure Modes

DOE Office of Scientific and Technical Information (OSTI.GOV)

Faught, J Tonigan; Johnson, J; Stingo, F

2015-06-15

Purpose: To assess the perception of TG-142 tolerance level dose delivery failures in IMRT and the application of FMEA process to this specific aspect of IMRT. Methods: An online survey was distributed to medical physicists worldwide that briefly described 11 different failure modes (FMs) covered by basic quality assurance in step- and-shoot IMRT at or near TG-142 tolerance criteria levels. For each FM, respondents estimated the worst case H&N patient percent dose error and FMEA scores for Occurrence, Detectability, and Severity. Demographic data was also collected. Results: 181 individual and three group responses were submitted. 84% were from North America.more » Most (76%) individual respondents performed at least 80% clinical work and 92% were nationally certified. Respondent medical physics experience ranged from 2.5–45 years (average 18 years). 52% of individual respondents were at least somewhat familiar with FMEA, while 17% were not familiar. Several IMRT techniques, treatment planning systems and linear accelerator manufacturers were represented. All FMs received widely varying scores ranging from 1–10 for occurrence, at least 1–9 for detectability, and at least 1–7 for severity. Ranking FMs by RPN scores also resulted in large variability, with each FM being ranked both most risky (1st ) and least risky (11th) by different respondents. On average MLC modeling had the highest RPN scores. Individual estimated percent dose errors and severity scores positively correlated (p<0.10) for each FM as expected. No universal correlations were found between the demographic information collected and scoring, percent dose errors, or ranking. Conclusion: FMs investigated overall were evaluated as low to medium risk, with average RPNs less than 110. The ranking of 11 FMs was not agreed upon by the community. Large variability in FMEA scoring may be caused by individual interpretation and/or experience, thus reflecting the subjective nature of the FMEA tool.« less

Using the failure mode and effects analysis model to improve parathyroid hormone and adrenocorticotropic hormone testing

PubMed Central

Magnezi, Racheli; Hemi, Asaf; Hemi, Rina

2016-01-01

Background Risk management in health care systems applies to all hospital employees and directors as they deal with human life and emergency routines. There is a constant need to decrease risk and increase patient safety in the hospital environment. The purpose of this article is to review the laboratory testing procedures for parathyroid hormone and adrenocorticotropic hormone (which are characterized by short half-lives) and to track failure modes and risks, and offer solutions to prevent them. During a routine quality improvement review at the Endocrine Laboratory in Tel Hashomer Hospital, we discovered these tests are frequently repeated unnecessarily due to multiple failures. The repetition of the tests inconveniences patients and leads to extra work for the laboratory and logistics personnel as well as the nurses and doctors who have to perform many tasks with limited resources. Methods A team of eight staff members accompanied by the Head of the Endocrine Laboratory formed the team for analysis. The failure mode and effects analysis model (FMEA) was used to analyze the laboratory testing procedure and was designed to simplify the process steps and indicate and rank possible failures. Results A total of 23 failure modes were found within the process, 19 of which were ranked by level of severity. The FMEA model prioritizes failures by their risk priority number (RPN). For example, the most serious failure was the delay after the samples were collected from the department (RPN =226.1). Conclusion This model helped us to visualize the process in a simple way. After analyzing the information, solutions were proposed to prevent failures, and a method to completely avoid the top four problems was also developed. PMID:27980440

Use of failure modes and effects analysis in design of the tracker system for the HET wide-field upgrade

NASA Astrophysics Data System (ADS)

Hayes, Richard; Beets, Tim; Beno, Joseph; Booth, John; Cornell, Mark; Good, John; Heisler, James; Hill, Gary; Kriel, Herman; Penney, Charles; Rafal, Marc; Savage, Richard; Soukup, Ian; Worthington, Michael; Zierer, Joseph

2012-09-01

In support of the Hobby-Eberly Telescope Dark Energy Experiment (HETDEX), the Center for Electromechanics at The University of Texas at Austin was tasked with developing the new Tracker and control system to support the HETDEX Wide-Field Upgrade. The tracker carries the 3,100 kg Prime Focus Instrument Package and Wide Field Corrector approximately 13 m above the 10 m diameter primary mirror. Its safe and reliable operation by a sophisticated control system, over a 20 year life time is a paramount requirement for the project. To account for all potential failures and potential hazards, to both the equipment and personnel involved, an extensive Failure Modes and Effects Analysis (FMEA) was completed early in the project. This task required participation of all the stakeholders over a multi-day meeting with numerous follow up exchanges. The event drove a number of significant design decisions and requirements that might not have been identified this early in the project without this process. The result is a system that has multiple layers of active and passive safety systems to protect the tens of millions of dollars of hardware involved and the people who operate it. This paper will describe the background of the FMEA process, how it was utilized on HETDEX, the critical outcomes, how the required safety systems were implemented, and how they have worked in operation. It should be of interest to engineers, designers, and managers engaging in complex multi-disciplinary and parallel engineering projects that involve automated hardware and control systems with potentially hazardous operating scenarios.

TU-FG-201-12: Designing a Risk-Based Quality Assurance Program for a Newly Implemented Y-90 Microspheres Procedure

DOE Office of Scientific and Technical Information (OSTI.GOV)

Vile, D; Zhang, L; Cuttino, L

2016-06-15

Purpose: To create a quality assurance program based upon a risk-based assessment of a newly implemented SirSpheres Y-90 procedure. Methods: A process map was created for a newly implemented SirSpheres procedure at a community hospital. The process map documented each step of this collaborative procedure, as well as the roles and responsibilities of each member. From the process map, different potential failure modes were determined as well as any current controls in place. From this list, a full failure mode and effects analysis (FMEA) was performed by grading each failure mode’s likelihood of occurrence, likelihood of detection, and potential severity.more » These numbers were then multiplied to compute the risk priority number (RPN) for each potential failure mode. Failure modes were then ranked based on their RPN. Additional controls were then added, with failure modes corresponding to the highest RPNs taking priority. Results: A process map was created that succinctly outlined each step in the SirSpheres procedure in its current implementation. From this, 72 potential failure modes were identified and ranked according to their associated RPN. Quality assurance controls and safety barriers were then added for failure modes associated with the highest risk being addressed first. Conclusion: A quality assurance program was created from a risk-based assessment of the SirSpheres process. Process mapping and FMEA were effective in identifying potential high-risk failure modes for this new procedure, which were prioritized for new quality assurance controls. TG 100 recommends the fault tree analysis methodology to design a comprehensive and effective QC/QM program, yet we found that by simply introducing additional safety barriers to address high RPN failure modes makes the whole process simpler and safer.« less

Incident Learning and Failure-Mode-and-Effects-Analysis Guided Safety Initiatives in Radiation Medicine

PubMed Central

Kapur, Ajay; Goode, Gina; Riehl, Catherine; Zuvic, Petrina; Joseph, Sherin; Adair, Nilda; Interrante, Michael; Bloom, Beatrice; Lee, Lucille; Sharma, Rajiv; Sharma, Anurag; Antone, Jeffrey; Riegel, Adam; Vijeh, Lili; Zhang, Honglai; Cao, Yijian; Morgenstern, Carol; Montchal, Elaine; Cox, Brett; Potters, Louis

2013-01-01

By combining incident learning and process failure-mode-and-effects-analysis (FMEA) in a structure-process-outcome framework we have created a risk profile for our radiation medicine practice and implemented evidence-based risk-mitigation initiatives focused on patient safety. Based on reactive reviews of incidents reported in our departmental incident-reporting system and proactive FMEA, high safety-risk procedures in our paperless radiation medicine process and latent risk factors were identified. Six initiatives aimed at the mitigation of associated severity, likelihood-of-occurrence, and detectability risks were implemented. These were the standardization of care pathways and toxicity grading, pre-treatment-planning peer review, a policy to thwart delay-rushed processes, an electronic whiteboard to enhance coordination, and the use of six sigma metrics to monitor operational efficiencies. The effectiveness of these initiatives over a 3-years period was assessed using process and outcome specific metrics within the framework of the department structure. There has been a 47% increase in incident-reporting, with no increase in adverse events. Care pathways have been used with greater than 97% clinical compliance rate. The implementation of peer review prior to treatment-planning and use of the whiteboard have provided opportunities for proactive detection and correction of errors. There has been a twofold drop in the occurrence of high-risk procedural delays. Patient treatment start delays are routinely enforced on cases that would have historically been rushed. Z-scores for high-risk procedures have steadily improved from 1.78 to 2.35. The initiatives resulted in sustained reductions of failure-mode risks as measured by a set of evidence-based metrics over a 3-years period. These augment or incorporate many of the published recommendations for patient safety in radiation medicine by translating them to clinical practice. PMID:24380074

General Template for the FMEA Applications in Primary Food Processing.

PubMed

Özilgen, Sibel; Özilgen, Mustafa

Data on the hazards involved in the primary steps of processing cereals, fruit and vegetables, milk and milk products, meat and meat products, and fats and oils are compiled with a wide-ranging literature survey. After determining the common factors from these data, a general FMEA template is offered, and its use is explained with a case study on pasteurized milk production.

SU-F-P-33: Combining Research and Professional Practice in the Clinical Setting: A Medical Physicist Personal Experience

DOE Office of Scientific and Technical Information (OSTI.GOV)

Lopez-Tarjuelo, J

Purpose: To initiate a discussion on the current and evolving role of Medical Physicists based on author’s professional and research experience in patient safety and quality control. Methods: Several professionals of the departments of Medical Physics and Radiation Oncology, chiefly devoted to clinical tasks, began a research program on patient safety and quality control in a framework provided by the implementation of intraoperative radiotherapy (IORT). We performed studies on virtual simulation for IORT, in vivo dosimetry, failure mode and effect analysis (FMEA), statistical process control (SPC), and receiver operating characteristics of dosimetric equipment. This was done with the support ofmore » our research foundation and different grants while continuing with our departmental clinical routine involving about 1600 annual treatments with two linacs and different brachytherapy techniques. Results: We published 5 papers in international journals in the last two years. This author conducted a doctoral research which resulted in a dissertation in 2015. The extra time spent after treatments was essential to succeed. Funding and support achieved via our foundation played a crucial role; but this would have not been possible without punctual external mentoring and partnership. FMEA conclusions were able to be implemented only with staff commitment; however, conclusions concerning equipment cannot be easily communicated to manufacturers. These tasks required extra training in the appropriated methods. Conclusion: Research needed the support of a dedicated foundation, which would have been very difficult to obtain with the sole participation of our departments. FMEA and SPC results may need engagement of staff and manufacturers, respectively, hard to achieve without strong recommendations or even a regulatory framework. All these fields need evolution of Medical Physicists’ roles and additional training. Devotion to both clinical tasks and research could be unfeasible for Medical Physicists in the clinical setting without the appropriate rearrangement of their schedules and tasks. Supported by grants IPT-300000-2010-3 and PI11/01659. ERDF funds and Spanish Government.« less

Risk management in medical product development process using traditional FMEA and fuzzy linguistic approach: a case study

NASA Astrophysics Data System (ADS)

Kirkire, Milind Shrikant; Rane, Santosh B.; Jadhav, Jagdish Rajaram

2015-12-01

Medical product development (MPD) process is highly multidisciplinary in nature, which increases the complexity and the associated risks. Managing the risks during MPD process is very crucial. The objective of this research is to explore risks during MPD in a dental product manufacturing company and propose a model for risk mitigation during MPD process to minimize failure events. A case study approach is employed. The existing MPD process is mapped with five phases of the customized phase gate process. The activities during each phase of development and risks associated with each activity are identified and categorized based on the source of occurrence. The risks are analyzed using traditional Failure mode and effect analysis (FMEA) and fuzzy FMEA. The results of two methods when compared show that fuzzy approach avoids the duplication of RPNs and helps more to convert cognition of experts into information to get values of risk factors. The critical, moderate, low level and negligible risks are identified based on criticality; risk treatments and mitigation model are proposed. During initial phases of MPD, the risks are less severe, but as the process progresses the severity of risks goes on increasing. The MPD process should be critically designed and simulated to minimize the number of risk events and their severity. To successfully develop the products/devices within the manufacturing companies, the process risk management is very essential. A systematic approach to manage risks during MPD process will lead to the development of medical products with expected quality and reliability. This is the first research of its kind having focus on MPD process risks and its management. The methodology adopted in this paper will help the developers, managers and researchers to have a competitive edge over the other companies by managing the risks during the development process.

SU-E-T-128: Applying Failure Modes and Effects Analysis to a Risk-Based Quality Management for Stereotactic Radiosurgery in Brazil

DOE Office of Scientific and Technical Information (OSTI.GOV)

Teixeira, F; Universidade do Estado do Rio de Janeiro, Rio De Janeiro, RJ; Almeida, C de

2015-06-15

Purpose: The goal of the present work was to evaluate the process maps for stereotactic radiosurgery (SRS) treatment at three radiotherapy centers in Brazil and apply the FMEA technique to evaluate similarities and differences, if any, of the hazards and risks associated with these processes. Methods: A team, consisting of professionals from different disciplines and involved in the SRS treatment, was formed at each center. Each team was responsible for the development of the process map, and performance of FMEA and FTA. A facilitator knowledgeable in these techniques led the work at each center. The TG100 recommended scales were usedmore » for the evaluation of hazard and severity for each step for the major process “treatment planning”. Results: Hazard index given by the Risk Priority Number (RPN) is found to range from 4–270 for various processes and the severity (S) index is found to range from 1–10. The RPN values > 100 and severity value ≥ 7 were chosen to flag safety improvement interventions. Number of steps with RPN ≥100 were found to be 6, 59 and 45 for the three centers. The corresponding values for S ≥ 7 are 24, 21 and 25 respectively. The range of RPN and S values for each center belong to different process steps and failure modes. Conclusion: These results show that interventions to improve safety is different for each center and it is associated with the skill level of the professional team as well as the technology used to provide radiosurgery treatment. The present study will very likely be a model for implementation of risk-based prospective quality management program for SRS treatment in Brazil where currently there are 28 radiotherapy centers performing SRS. A complete FMEA for SRS for these three radiotherapy centers is currently under development.« less

Reliability and quality assurance on the MOD 2 wind system

NASA Technical Reports Server (NTRS)

Mason, W. E. B.; Jones, B. G.

1981-01-01

The Safety, Reliability, and Quality Assurance (R&QA) approach developed for the largest wind turbine generator, the Mod 2, is described. The R&QA approach assures that the machine is not hazardous to the public or to the operating personnel, is operated unattended on a utility grid, demonstrates reliable operation, and helps establish the quality assurance and maintainability requirements for future wind turbine projects. The significant guideline consisted of a failure modes and effects analysis (FMEA) during the design phase, hardware inspections during parts fabrication, and three simple documents to control activities during machine construction and operation.

Experience with modified aerospace reliability and quality assurance method for wind turbines

NASA Technical Reports Server (NTRS)

Klein, W. E.

1982-01-01

The SR&QA approach assures that the machine is not hazardous to the public or operating personnel, can operate unattended on a utility grid, demonstrates reliability operation, and helps establish the quality assurance and maintainability requirements for future wind turbine projects. The approach consisted of modified failure modes and effects analysis (FMEA) during the design phase, minimal hardware inspection during parts fabrication, and three simple documents to control activities during machine construction and operation. Five years experience shows that this low cost approach works well enough that it should be considered by others for similar projects.

DfM requirements and ROI analysis for system-on-chip

NASA Astrophysics Data System (ADS)

Balasinski, Artur

2005-11-01

DfM (Design-for-Manufacturability) has become staple requirement beyond 100 nm technology node for efficient generation of mask data, cost reduction, and optimal circuit performance. Layout pattern has to comply to many requirements pertaining to database structure and complexity, suitability for image enhancement by the optical proximity correction, and mask data pattern density and distribution over the image field. These requirements are of particular complexity for Systems-on-Chip (SoC). A number of macro-, meso-, and microscopic effects such as reticle macroloading, planarization dishing, and pattern bridging or breaking would compromise fab yield, device performance, or both. In order to determine the optimal set of DfM rules applicable to the particular designs, Return-on-Investment and Failure Mode and Effect Analysis (FMEA) are proposed.

TH-E-19A-01: Quality and Safety in Radiation Therapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ford, E; Ezzell, G; Miller, B

2014-06-15

Clinical radiotherapy data clearly demonstrate the link between the quality and safety of radiation treatments and the outcome for patients. The medical physicist plays an essential role in this process. To ensure the highest quality treatments, the medical physicist must understand and employ modern quality improvement techniques. This extends well beyond the duties traditionally associated with prescriptive QA measures. This session will review the current best practices for improving quality and safety in radiation therapy. General elements of quality management will be reviewed including: what makes a good quality management structure, the use of prospective risk analysis such as FMEA,more » and the use of incident learning. All of these practices are recommended in society-level documents and are incorporated into the new Practice Accreditation program developed by ASTRO. To be effective, however, these techniques must be practical in a resource-limited environment. This session will therefore focus on practical tools such as the newly-released radiation oncology incident learning system, RO-ILS, supported by AAPM and ASTRO. With these general constructs in mind, a case study will be presented of quality management in an SBRT service. An example FMEA risk assessment will be presented along with incident learning examples including root cause analysis. As the physicist's role as “quality officer” continues to evolve it will be essential to understand and employ the most effective techniques for quality improvement. This session will provide a concrete overview of the fundamentals in quality and safety. Learning Objectives: Recognize the essential elements of a good quality management system in radiotherapy. Understand the value of incident learning and the AAPM/ASTRO ROILS incident learning system. Appreciate failure mode and effects analysis as a risk assessment tool and its use in resource-limited environments. Understand the fundamental principles of good error proofing that extends beyond traditional prescriptive QA measures.« less

Reduction of Defects in Jewelry Manufacturing

NASA Astrophysics Data System (ADS)

Ayudhya, Phitchaya Phanomwan na; Tangjitsitcharoen, Somkiat

2017-06-01

The aim of this research was to reduce the defects of gem bracelet found during manufacturing process at a jewelry company. It was found that gem bracelet product has the highest rejects compared to the rejects found in ring, earring, and pendant products. Types of defect were classified by using Pareto Diagram consisting of gem falling, seam, unclean casting, impinge, and deformation. The causes of defect were analyzed by Cause and Effect Diagram and applied Failure Mode and Effects Analysis (FMEA) was applied during manufacturing processes. This research found that the improvement of manufacturing process could reduce the Risk Priority Number (RPN) and total of all defects by 48.70% and 48.89%, respectively.

Defective Reduction in Automotive Headlining Manufacturing Process

NASA Astrophysics Data System (ADS)

Rittichai, Saranya; Chutima, Parames

2016-05-01

In an automobile parts manufacturing company, currently the headlining process has a lot of wastes resulting in a high cost of quality per year. In this paper, the Six Sigma method is used to reduce the defects in the headlining process. Cause-and-effect matrix and failure mode and effect analysis (FMEA) were adopted to screen the factors that affect the quality of headlining. The 2k-1 fractional factorials design was also use to determine the potential preliminary root causes. The full factorial experiments was conducted to identify appropriate settings of the significant factors. The result showed that the process can reduce the defects of headlining from 12.21% to 6.95%

Accessibility of insulin pumps for blind and visually impaired people.

PubMed

Uslan, Mark M; Burton, Darren M; Chertow, Bruce S; Collins, Ronda

2004-10-01

Continuous subcutaneous insulin infusion using an insulin pump (IP) more closely mimics the normal pancreas than multiple insulin injections. It is an effective, and often a preferred, means of maintaining normal blood glucose levels, but IPs were not designed to be fully accessible to blind or visually impaired people. This study will identify accessibility issues related to the design of IPs and focus on the key improvements required in the user interface to provide access for people who are blind or visually impaired. IPs that are commercially available were evaluated, and features and functions such as operating procedures, user interface design, and user manuals were tabulated and analyzed. Potential failures and design priorities were identified through a Failure Modes and Effects Analysis (FMEA). Although the IPs do provide some limited audio output, in general, it was found to be of minimal use to people who are blind or visually impaired. None of the IPs uses high-contrast displays with consistently large fonts preferred by people who are visually impaired. User manuals were also found to be of minimal use. Results of the FMEA emphasize the need to focus design improvements on communicating and verifying information so that errors and failures can be detected and corrected. The most important recommendation for future IP development is speech output capability, which, more than any other improvement, would break down accessibility barriers and allow blind and visually impaired people to take advantage of the benefits of IP technology.

Application of Fuzzy Logic to Matrix FMECA

NASA Astrophysics Data System (ADS)

Shankar, N. Ravi; Prabhu, B. S.

2001-04-01

A methodology combining the benefits of Fuzzy Logic and Matrix FMEA is presented in this paper. The presented methodology extends the risk prioritization beyond the conventional Risk Priority Number (RPN) method. Fuzzy logic is used to calculate the criticality rank. Also the matrix approach is improved further to develop a pictorial representation retaining all relevant qualitative and quantitative information of several FMEA elements relationships. The methodology presented is demonstrated by application to an illustrative example.

Matrix Failure Modes and Effects Analysis as a Knowledge Base for a Real Time Automated Diagnosis Expert System

NASA Technical Reports Server (NTRS)

Herrin, Stephanie; Iverson, David; Spukovska, Lilly; Souza, Kenneth A. (Technical Monitor)

1994-01-01

Failure Modes and Effects Analysis contain a wealth of information that can be used to create the knowledge base required for building automated diagnostic Expert systems. A real time monitoring and diagnosis expert system based on an actual NASA project's matrix failure modes and effects analysis was developed. This Expert system Was developed at NASA Ames Research Center. This system was first used as a case study to monitor the Research Animal Holding Facility (RAHF), a Space Shuttle payload that is used to house and monitor animals in orbit so the effects of space flight and microgravity can be studied. The techniques developed for the RAHF monitoring and diagnosis Expert system are general enough to be used for monitoring and diagnosis of a variety of other systems that undergo a Matrix FMEA. This automated diagnosis system was successfully used on-line and validated on the Space Shuttle flight STS-58, mission SLS-2 in October 1993.

Introduction to Concurrent Engineering: Electronic Circuit Design and Production Applications

DTIC Science & Technology

1992-09-01

STD-1629. Failure mode distribution data for many different types of parts may be found in RAC publication FMD -91. FMEA utilizes inductive logic in a...contrasts with a Fault Tree Analysis ( FTA ) which utilizes deductive logic in a "top down" approach. In FTA , a system failure is assumed and traced down...Analysis ( FTA ) is a graphical method of risk analysis used to identify critical failure modes within a system or equipment. Utilizing a pictorial approach

SU-F-T-248: FMEA Risk Analysis Implementation (AAPM TG-100) in Total Skin Electron Irradiation Technique

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ibanez-Rosello, B; Bautista-Ballesteros, J; Bonaque, J

2016-06-15

Purpose: Total Skin Electron Irradiation (TSEI) is a radiotherapy treatment which involves irradiating the entire body surface as homogeneously as possible. It is composed of an extensive multi-step technique in which quality management requires high consumption of resources and a fluid communication between the involved staff, necessary to improve the safety of treatment. The TG-100 proposes a new perspective of quality management in radiotherapy, presenting a systematic method of risk analysis throughout the global flow of the stages through the patient. The purpose of this work has been to apply TG-100 approach to the TSEI procedure in our institution. Methods:more » A multidisciplinary team specifically targeting TSEI procedure was formed, that met regularly and jointly developed the process map (PM), following TG-100 guidelines of the AAPM. This PM is a visual representation of the temporal flow of steps through the patient since start until the end of his stay in the radiotherapy service. Results: This is the first stage of the full risk analysis, which is being carried out in the center. The PM provides an overview of the process and facilitates the understanding of the team members who will participate in the subsequent analysis. Currently, the team is implementing the analysis of failure modes and effects (FMEA). The failure modes of each of the steps have been identified and assessors are assigning a value of severity (S), frequency of occurrence (O) and lack of detection (D) individually. To our knowledge, this is the first PM made for the TSEI. The developed PM can be useful for those centers that intend to implement the TSEI technique. Conclusion: The PM of TSEI technique has been established, as the first stage of full risk analysis, performed in a reference center in this treatment.« less

Failure mode and effects analysis of skin electronic brachytherapy using Esteya® unit

PubMed Central

Bautista-Ballesteros, Juan Antonio; Bonaque, Jorge; Celada, Francisco; Lliso, Françoise; Carmona, Vicente; Gimeno-Olmos, Jose; Ouhib, Zoubir; Rosello, Joan; Perez-Calatayud, Jose

2016-01-01

Purpose Esteya® (Nucletron, an Elekta company, Elekta AB, Stockholm, Sweden) is an electronic brachytherapy device used for skin cancer lesion treatment. In order to establish an adequate level of quality of treatment, a risk analysis of the Esteya treatment process has been done, following the methodology proposed by the TG-100 guidelines of the American Association of Physicists in Medicine (AAPM). Material and methods A multidisciplinary team familiar with the treatment process was formed. This team developed a process map (PM) outlining the stages, through which a patient passed when subjected to the Esteya treatment. They identified potential failure modes (FM) and each individual FM was assessed for the severity (S), frequency of occurrence (O), and lack of detection (D). A list of existing quality management tools was developed and the FMs were consensually reevaluated. Finally, the FMs were ranked according to their risk priority number (RPN) and their S. Results 146 FMs were identified, 106 of which had RPN ≥ 50 and 30 had S ≥ 7. After introducing the quality management tools, only 21 FMs had RPN ≥ 50. The importance of ensuring contact between the applicator and the surface of the patient’s skin was emphasized, so the setup was reviewed by a second individual before each treatment session with periodic quality control to ensure stability of the applicator pressure. Some of the essential quality management tools are already being implemented in the installation are the simple templates for reproducible positioning of skin applicators, that help marking the treatment area and positioning of X-ray tube. Conclusions New quality management tools have been established as a result of the application of the failure modes and effects analysis (FMEA) treatment. However, periodic update of the FMEA process is necessary, since clinical experience has suggested occurring of further new possible potential failure modes. PMID:28115958

Magnetic Fields on the National Ignition Facility (MagNIF)

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mason, D.; Folta, J.

2016-08-12

A magnetized target capability on the National Ignition Facility (NIF) at Lawrence Livermore National Laboratory (LLNL) has been investigated. Stakeholders’ needs and project feasibility analysis were considered in order to down-select from a wide variety of different potential magnetic field magnitudes and volumes. From the large range of different target platforms, laser configurations, and diagnostics configurations of interest to the stakeholders, the gas-pipe platform has been selected for the first round of magnetized target experiments. Gas pipe targets are routinely shot on the NIF and provide unique value for external collaborators. High-level project goals have been established including an experimentallymore » relevant 20Tesla magnetic field magnitude. The field will be achieved using pulsed power-driven coils. A system architecture has been proposed. The pulsed power drive system will be located in the NIF target bay. This decision provides improved maintainability and mitigates equipment safety risks associated with explosive failure of the drive capacitor. High-level and first-level subsystem requirements have been established. Requirements have been included for two distinct coil designs – full solenoid and quasi-Helmholtz. A Failure Modes and Effects Analysis (FMEA) has been performed and documented. Additional requirements have been derived from the mitigations included in the FMEA document. A project plan is proposed. The plan includes a first phase of electromagnetic simulations to assess whether the design will meet performance requirements, then a second phase of risk mitigation projects to address the areas of highest technical risk. The duration from project kickoff to the first magnetized target shot is approximately 29 months.« less

European Extremely Large Telescope (E-ELT) availability stochastic model: integrating failure mode and effect analysis (FMEA), influence diagram, and Bayesian network together

NASA Astrophysics Data System (ADS)

Verzichelli, Gianluca

2016-08-01

An Availability Stochastic Model for the E-ELT has been developed in GeNIE. The latter is a Graphical User Interface (GUI) for the Structural Modeling, Inference, and Learning Engine (SMILE), originally distributed by the Decision Systems Laboratory from the University of Pittsburgh, and now being a product of Bayes Fusion, LLC. The E-ELT will be the largest optical/near-infrared telescope in the world. Its design comprises an Alt-Azimuth mount reflecting telescope with a 39-metre-diameter segmented primary mirror, a 4-metre-diameter secondary mirror, a 3.75-metre-diameter tertiary mirror, adaptive optics and multiple instruments. This paper highlights how a Model has been developed for an earlier on assessment of the Telescope Avail- ability. It also describes the modular structure and the underlying assumptions that have been adopted for developing the model and demonstrates the integration of FMEA, Influence Diagram and Bayesian Network elements. These have been considered for a better characterization of the Model inputs and outputs and for taking into account Degraded-based Reliability (DBR). Lastly, it provides an overview of how the information and knowledge captured in the model may be used for an earlier on definition of the Failure, Detection, Isolation and Recovery (FDIR) Control Strategy and the Telescope Minimum Master Equipment List (T-MMEL).

Reliability Investigation of Low Noise GaAs FETs.

DTIC Science & Technology

1981-07-01

measured by switching its input to the 10 GHz sweep oscillator signal and its output to the microwave power meter. The measured noise figure Fmeas and...associated gain Ga are then used to calculate the minimum noise figure Fmin of the FET: F -IF. zF o Frmin = Fmeas a where F is the measured noise figure...stayed within specification longer. As a matter of interest, Table 5-2 shows that the vast majority of temperature induced failures, that is, ( 60 + 33

Risk assessment and quality improvement of liquid waste management in Taiwan University chemical laboratories.

PubMed

Ho, Chao-Chung; Chen, Ming-Shu

2018-01-01

The policy of establishing new universities across Taiwan has led to an increase in the number of universities, and many schools have constructed new laboratories to meet students' academic needs. In recent years, there has been an increase in the number of laboratory accidents from the liquid waste in universities. Therefore, how to build a safety system for laboratory liquid waste disposal has become an important issue in the environmental protection, safety, and hygiene of all universities. This study identifies the risk factors of liquid waste disposal and presents an agenda for practices to laboratory managers. An expert questionnaire is adopted to probe into the risk priority procedures of liquid waste disposal; then, the fuzzy theory-based FMEA method and the traditional FMEA method are employed to analyze and improve the procedures for liquid waste disposal. According to the research results, the fuzzy FMEA method is the most effective, and the top 10 potential disabling factors are prioritized for improvement according to the risk priority number (RNP), including "Unclear classification", "Gathering liquid waste without a funnel or a drain pan", "Lack of a clearance and transport contract", "Liquid waste spill during delivery", "Spill over", "Decentralized storage", "Calculating weight in the wrong way", "Compatibility between the container material and the liquid waste", "Lack of dumping and disposal tools", and "Lack of a clear labels for liquid waste containers". After tracking improvements, the overall improvement rate rose to 60.2%. Copyright © 2017 Elsevier Ltd. All rights reserved.

Failure Mode Identification Through Clustering Analysis

NASA Technical Reports Server (NTRS)

Arunajadai, Srikesh G.; Stone, Robert B.; Tumer, Irem Y.; Clancy, Daniel (Technical Monitor)

2002-01-01

Research has shown that nearly 80% of the costs and problems are created in product development and that cost and quality are essentially designed into products in the conceptual stage. Currently, failure identification procedures (such as FMEA (Failure Modes and Effects Analysis), FMECA (Failure Modes, Effects and Criticality Analysis) and FTA (Fault Tree Analysis)) and design of experiments are being used for quality control and for the detection of potential failure modes during the detail design stage or post-product launch. Though all of these methods have their own advantages, they do not give information as to what are the predominant failures that a designer should focus on while designing a product. This work uses a functional approach to identify failure modes, which hypothesizes that similarities exist between different failure modes based on the functionality of the product/component. In this paper, a statistical clustering procedure is proposed to retrieve information on the set of predominant failures that a function experiences. The various stages of the methodology are illustrated using a hypothetical design example.

40 CFR Appendix B to Subpart G of... - Substitutes Subject to Use Restrictions and Unacceptable Substitutes

Code of Federal Regulations, 2012 CFR

2012-07-01

... Analysis in Manufacturing and Assembly Processes (Process FMEA). Revised January 2009. SAE International. 3... submitted to demonstrate it can be used safely in this end-use. CFC-11, CFC-12, R-502 Industrial Process... Outside diameter of 20.955 +0/−0.127 mm (0.825 +0/−0.005 inches) and right-hand thread direction for CO2...

An FMEA evaluation of intensity modulated radiation therapy dose delivery failures at tolerance criteria levels.

PubMed

Faught, Jacqueline Tonigan; Balter, Peter A; Johnson, Jennifer L; Kry, Stephen F; Court, Laurence E; Stingo, Francesco C; Followill, David S

2017-11-01

The objective of this work was to assess both the perception of failure modes in Intensity Modulated Radiation Therapy (IMRT) when the linac is operated at the edge of tolerances given in AAPM TG-40 (Kutcher et al.) and TG-142 (Klein et al.) as well as the application of FMEA to this specific section of the IMRT process. An online survey was distributed to approximately 2000 physicists worldwide that participate in quality services provided by the Imaging and Radiation Oncology Core - Houston (IROC-H). The survey briefly described eleven different failure modes covered by basic quality assurance in step-and-shoot IMRT at or near TG-40 (Kutcher et al.) and TG-142 (Klein et al.) tolerance criteria levels. Respondents were asked to estimate the worst case scenario percent dose error that could be caused by each of these failure modes in a head and neck patient as well as the FMEA scores: Occurrence, Detectability, and Severity. Risk probability number (RPN) scores were calculated as the product of these scores. Demographic data were also collected. A total of 181 individual and three group responses were submitted. 84% were from North America. Most (76%) individual respondents performed at least 80% clinical work and 92% were nationally certified. Respondent medical physics experience ranged from 2.5 to 45 yr (average 18 yr). A total of 52% of individual respondents were at least somewhat familiar with FMEA, while 17% were not familiar. Several IMRT techniques, treatment planning systems, and linear accelerator manufacturers were represented. All failure modes received widely varying scores ranging from 1 to 10 for occurrence, at least 1-9 for detectability, and at least 1-7 for severity. Ranking failure modes by RPN scores also resulted in large variability, with each failure mode being ranked both most risky (1st) and least risky (11th) by different respondents. On average MLC modeling had the highest RPN scores. Individual estimated percent dose errors and severity scores positively correlated (P < 0.01) for each FM as expected. No universal correlations were found between the demographic information collected and scoring, percent dose errors or ranking. Failure modes investigated overall were evaluated as low to medium risk, with average RPNs less than 110. The ranking of 11 failure modes was not agreed upon by the community. Large variability in FMEA scoring may be caused by individual interpretation and/or experience, reflecting the subjective nature of the FMEA tool. © 2017 American Association of Physicists in Medicine.

Insertion Demonstrations of Digital Gallium Arsenide. OBP-80 Final Technical Report. Volume 1. Chip Set Schematics

DTIC Science & Technology

1992-01-01

In First Out FMEA Failure Mode Effects Analysis EDM Engineering Development Model GALU Generic Arithmetic Logic Unit GaAs Gallium Arsenide GTE Ground...Bl B>55 * 1585/IS1/B1 = B56 I$11146/I$3/B1 B= 57 I$2S146/I$2/B1 B= 58 * $1146/1$1/81 =>B59 * 1590/IS3/Bl B= 60 *1$590/IS2/Bl== B61 * 1590/IS1/B1 - B62...vote circuitry. It is known that only 60 fC of charge is needed to upset the latch elements. It is interesting to speculate how much charge is required

SU-F-T-243: Major Risks in Radiotherapy. A Review Based On Risk Analysis Literature

DOE Office of Scientific and Technical Information (OSTI.GOV)

López-Tarjuelo, J; Guasp-Tortajada, M; Iglesias-Montenegro, N

Purpose: We present a literature review of risk analyses in radiotherapy to highlight the most reported risks and facilitate the spread of this valuable information so that professionals can be aware of these major threats before performing their own studies. Methods: We considered studies with at least an estimation of the probability of occurrence of an adverse event (O) and its associated severity (S). They cover external beam radiotherapy, brachytherapy, intraoperative radiotherapy, and stereotactic techniques. We selected only the works containing a detailed ranked series of elements or failure modes and focused on the first fully reported quartile as much.more » Afterward, we sorted the risk elements according to a regular radiotherapy procedure so that the resulting groups were cited in several works and be ranked in this way. Results: 29 references published between 2007 and February 2016 were studied. Publication trend has been generally rising. The most employed analysis has been the Failure mode and effect analysis (FMEA). Among references, we selected 20 works listing 258 ranked risk elements. They were sorted into 31 groups appearing at least in two different works. 11 groups appeared in at least 5 references and 5 groups did it in 7 or more papers. These last sets of risks where choosing another set of images or plan for planning or treating, errors related with contours, errors in patient positioning for treatment, human mistakes when programming treatments, and planning errors. Conclusion: There is a sufficient amount and variety of references for identifying which failure modes or elements should be addressed in a radiotherapy department before attempting a specific analysis. FMEA prevailed, but other studies such as “risk matrix” or “occurrence × severity” analyses can also lead professionals’ efforts. Risk associated with human actions ranks very high; therefore, they should be automated or at least peer-reviewed.« less

Ground Vehicle Condition Based Maintenance

DTIC Science & Technology

2010-10-04

Diagnostic Process Map 32 FMEAs Developed : • Diesel Engine • Transmission • Alternators Analysis : • Identify failure modes • Derive design factors and...S&T Initiatives  TARDEC P&D Process Map  Component Testing  ARL CBM Research  AMSAA SDC & Terrain Modeling UNCLASSIFIED 3 CBM+ Overview...UNCLASSIFIED 4 RCM and CBM are core processes for CBM+ System Development • Army Regulation 750-1, 20 Sep 2007, p. 79 - Reliability Centered Maintenance (RCM

A Systematic Approach of Employing Quality by Design Principles: Risk Assessment and Design of Experiments to Demonstrate Process Understanding and Identify the Critical Process Parameters for Coating of the Ethylcellulose Pseudolatex Dispersion Using Non-Conventional Fluid Bed Process.

PubMed

Kothari, Bhaveshkumar H; Fahmy, Raafat; Claycamp, H Gregg; Moore, Christine M V; Chatterjee, Sharmista; Hoag, Stephen W

2017-05-01

The goal of this study was to utilize risk assessment techniques and statistical design of experiments (DoE) to gain process understanding and to identify critical process parameters for the manufacture of controlled release multiparticulate beads using a novel disk-jet fluid bed technology. The material attributes and process parameters were systematically assessed using the Ishikawa fish bone diagram and failure mode and effect analysis (FMEA) risk assessment methods. The high risk attributes identified by the FMEA analysis were further explored using resolution V fractional factorial design. To gain an understanding of the processing parameters, a resolution V fractional factorial study was conducted. Using knowledge gained from the resolution V study, a resolution IV fractional factorial study was conducted; the purpose of this IV study was to identify the critical process parameters (CPP) that impact the critical quality attributes and understand the influence of these parameters on film formation. For both studies, the microclimate, atomization pressure, inlet air volume, product temperature (during spraying and curing), curing time, and percent solids in the coating solutions were studied. The responses evaluated were percent agglomeration, percent fines, percent yield, bead aspect ratio, median particle size diameter (d50), assay, and drug release rate. Pyrobuttons® were used to record real-time temperature and humidity changes in the fluid bed. The risk assessment methods and process analytical tools helped to understand the novel disk-jet technology and to systematically develop models of the coating process parameters like process efficiency and the extent of curing during the coating process.

Reliability modelling and analysis of thermal MEMS

NASA Astrophysics Data System (ADS)

Muratet, Sylvaine; Lavu, Srikanth; Fourniols, Jean-Yves; Bell, George; Desmulliez, Marc P. Y.

2006-04-01

This paper presents a MEMS reliability study methodology based on the novel concept of 'virtual prototyping'. This methodology can be used for the development of reliable sensors or actuators and also to characterize their behaviour in specific use conditions and applications. The methodology is demonstrated on the U-shaped micro electro thermal actuator used as test vehicle. To demonstrate this approach, a 'virtual prototype' has been developed with the modeling tools MatLab and VHDL-AMS. A best practice FMEA (Failure Mode and Effect Analysis) is applied on the thermal MEMS to investigate and assess the failure mechanisms. Reliability study is performed by injecting the identified defaults into the 'virtual prototype'. The reliability characterization methodology predicts the evolution of the behavior of these MEMS as a function of the number of cycles of operation and specific operational conditions.

Independent Orbiter Assessment (IOA): Analysis of the DPS subsystem

NASA Technical Reports Server (NTRS)

Lowery, H. J.; Haufler, W. A.; Pietz, K. C.

1986-01-01

The results of the Independent Orbiter Assessment (IOA) of the Failure Modes and Effects Analysis/Critical Items List (FMEA/CIL) is presented. The IOA approach features a top-down analysis of the hardware to independently determine failure modes, criticality, and potential critical items. The independent analysis results corresponding to the Orbiter Data Processing System (DPS) hardware are documented. The DPS hardware is required for performing critical functions of data acquisition, data manipulation, data display, and data transfer throughout the Orbiter. Specifically, the DPS hardware consists of the following components: Multiplexer/Demultiplexer (MDM); General Purpose Computer (GPC); Multifunction CRT Display System (MCDS); Data Buses and Data Bus Couplers (DBC); Data Bus Isolation Amplifiers (DBIA); Mass Memory Unit (MMU); and Engine Interface Unit (EIU). The IOA analysis process utilized available DPS hardware drawings and schematics for defining hardware assemblies, components, and hardware items. Each level of hardware was evaluated and analyzed for possible failure modes and effects. Criticality was assigned based upon the severity of the effect for each failure mode. Due to the extensive redundancy built into the DPS the number of critical items are few. Those identified resulted from premature operation and erroneous output of the GPCs.

Safety Strategies in an Academic Radiation Oncology Department and Recommendations for Action

PubMed Central

Terezakis, Stephanie A.; Pronovost, Peter; Harris, Kendra; DeWeese, Theodore; Ford, Eric

2013-01-01

Background Safety initiatives in the United States continue to work on providing guidance as to how the average practitioner might make patients safer in the face of the complex process by which radiation therapy (RT), an essential treatment used in the management of many patients with cancer, is prepared and delivered. Quality control measures can uncover certain specific errors such as machine dose mis-calibration or misalignments of the patient in the radiation treatment beam. However, they are less effective at uncovering less common errors that can occur anywhere along the treatment planning and delivery process, and even when the process is functioning as intended, errors still occur. Prioritizing Risks and Implementing Risk-Reduction Strategies Activities undertaken at the radiation oncology department at the Johns Hopkins Hospital (Baltimore) include Failure Mode and Effects Analysis (FMEA), risk-reduction interventions, and voluntary error and near-miss reporting systems. A visual process map portrayed 269 RT steps occurring among four subprocesses—including consult, simulation, treatment planning, and treatment delivery. Two FMEAs revealed 127 and 159 possible failure modes, respectively. Risk-reduction interventions for 15 “top-ranked” failure modes were implemented. Since the error and near-miss reporting system’s implementation in the department in 2007, 253 events have been logged. However, the system may be insufficient for radiation oncology, for which a greater level of practice-specific information is required to fully understand each event. Conclusions The “basic science” of radiation treatment has received considerable support and attention in developing novel therapies to benefit patients. The time has come to apply the same focus and resources to ensuring that patients safely receive the maximal benefits possible. PMID:21819027

Failure mode and effects analysis based risk profile assessment for stereotactic radiosurgery programs at three cancer centers in Brazil.

PubMed

Teixeira, Flavia C; de Almeida, Carlos E; Saiful Huq, M

2016-01-01

The goal of this study was to evaluate the safety and quality management program for stereotactic radiosurgery (SRS) treatment processes at three radiotherapy centers in Brazil by using three industrial engineering tools (1) process mapping, (2) failure modes and effects analysis (FMEA), and (3) fault tree analysis. The recommendations of Task Group 100 of American Association of Physicists in Medicine were followed to apply the three tools described above to create a process tree for SRS procedure for each radiotherapy center and then FMEA was performed. Failure modes were identified for all process steps and values of risk priority number (RPN) were calculated from O, S, and D (RPN = O × S × D) values assigned by a professional team responsible for patient care. The subprocess treatment planning was presented with the highest number of failure modes for all centers. The total number of failure modes were 135, 104, and 131 for centers I, II, and III, respectively. The highest RPN value for each center is as follows: center I (204), center II (372), and center III (370). Failure modes with RPN ≥ 100: center I (22), center II (115), and center III (110). Failure modes characterized by S ≥ 7, represented 68% of the failure modes for center III, 62% for center II, and 45% for center I. Failure modes with RPNs values ≥100 and S ≥ 7, D ≥ 5, and O ≥ 5 were considered as high priority in this study. The results of the present study show that the safety risk profiles for the same stereotactic radiotherapy process are different at three radiotherapy centers in Brazil. Although this is the same treatment process, this present study showed that the risk priority is different and it will lead to implementation of different safety interventions among the centers. Therefore, the current practice of applying universal device-centric QA is not adequate to address all possible failures in clinical processes at different radiotherapy centers. Integrated approaches to device-centric and process specific quality management program specific to each radiotherapy center are the key to a safe quality management program.

A practical implementation of physics quality assurance for photon adaptive radiotherapy.

PubMed

Cai, Bin; Green, Olga L; Kashani, Rojano; Rodriguez, Vivian L; Mutic, Sasa; Yang, Deshan

2018-03-14

The fast evolution of technology in radiotherapy (RT) enabled the realization of adaptive radiotherapy (ART). However, the new characteristics of ART pose unique challenges for efficiencies and effectiveness of quality assurance (QA) strategies. In this paper, we discuss the necessary QAs for ART and introduce a practical implementation. A previously published work on failure modes and effects analysis (FMEA) of ART is introduced first to explain the risks associated with ART sub-processes. After a brief discussion of QA challenges, we review the existing QA strategies and tools that might be suitable for each ART step. By introducing the MR-guided online ART QA processes developed at our institute, we demonstrate a practical implementation. The limitations and future works to develop more robust and efficient QA strategies are discussed at the end. Copyright © 2018. Published by Elsevier GmbH.

Failure Analysis of a Complex Learning Framework Incorporating Multi-Modal and Semi-Supervised Learning

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pullum, Laura L; Symons, Christopher T

2011-01-01

Machine learning is used in many applications, from machine vision to speech recognition to decision support systems, and is used to test applications. However, though much has been done to evaluate the performance of machine learning algorithms, little has been done to verify the algorithms or examine their failure modes. Moreover, complex learning frameworks often require stepping beyond black box evaluation to distinguish between errors based on natural limits on learning and errors that arise from mistakes in implementation. We present a conceptual architecture, failure model and taxonomy, and failure modes and effects analysis (FMEA) of a semi-supervised, multi-modal learningmore » system, and provide specific examples from its use in a radiological analysis assistant system. The goal of the research described in this paper is to provide a foundation from which dependability analysis of systems using semi-supervised, multi-modal learning can be conducted. The methods presented provide a first step towards that overall goal.« less

Contamination Sources Effects Analysis (CSEA) - A Tool to Balance Cost/Schedule While Managing Facility Availability

NASA Technical Reports Server (NTRS)

Wilcox, Margaret

2008-01-01

A CSEA is similar to a Failure Modes Effects Analysis (FMEA). A CSEA tracks risk, deterrence, and occurrence of sources of contamination and their mitigation plans. Documentation is provided spanning mechanical and electrical assembly, precision cleaning, thermal vacuum bake-out, and thermal vacuum testing. These facilities all may play a role in contamination budgeting and reduction ultimately affecting test and flight. With a CSEA, visibility can be given to availability of these facilities, test sequencing and trade-offs. A cross-functional team including specialty engineering, contamination control, electrostatic dissipation, manufacturing, testing, and material engineering participate in an exercise that identifies contaminants and minimizes the complexity of scheduling these facilities considering their volatile schedules. Care can be taken in an efficient manner to insure correct cleaning processes are employed. The result is reduction in cycle time ("schedule hits"), reduced cost due to rework, reduced risk and improved communication and quality while achieving adherence to the Contamination Control Plan.

TH-EF-BRC-02: FMEA

DOE Office of Scientific and Technical Information (OSTI.GOV)

Huq, M.

2016-06-15

This Hands-on Workshop will be focused on providing participants with experience with the principal tools of TG 100 and hence start to build both competence and confidence in the use of risk-based quality management techniques. The three principal tools forming the basis of TG 100’s risk analysis: Process mapping, Failure-Modes and Effects Analysis and fault-tree analysis will be introduced with a 5 minute refresher presentation and each presentation will be followed by a 30 minute small group exercise. An exercise on developing QM from the risk analysis follows. During the exercise periods, participants will apply the principles in 2 differentmore » clinical scenarios. At the conclusion of each exercise there will be ample time for participants to discuss with each other and the faculty their experience and any challenges encountered. Learning Objectives: To review the principles of Process Mapping, Failure Modes and Effects Analysis and Fault Tree Analysis. To gain familiarity with these three techniques in a small group setting. To share and discuss experiences with the three techniques with faculty and participants. Director, TreatSafely, LLC. Director, Center for the Assessment of Radiological Sciences. Occasional Consultant to the IAEA and Varian.« less

Modeling Off-Nominal Behavior in SysML

NASA Technical Reports Server (NTRS)

Day, John; Donahue, Kenny; Ingham, Mitch; Kadesch, Alex; Kennedy, Kit; Post, Ethan

2012-01-01

Fault Management is an essential part of the system engineering process that is limited in its effectiveness by the ad hoc nature of the applied approaches and methods. Providing a rigorous way to develop and describe off-nominal behavior is a necessary step in the improvement of fault management, and as a result, will enable safe, reliable and available systems even as system complexity increases... The basic concepts described in this paper provide a foundation to build a larger set of necessary concepts and relationships for precise modeling of off-nominal behavior, and a basis for incorporating these ideas into the overall systems engineering process.. The simple FMEA example provided applies the modeling patterns we have developed and illustrates how the information in the model can be used to reason about the system and derive typical fault management artifacts.. A key insight from the FMEA work was the utility of defining failure modes as the "inverse of intent", and deriving this from the behavior models.. Additional work is planned to extend these ideas and capabilities to other types of relevant information and additional products.

Improvement of the safety of the red pepper spice with FMEA and post processing EWMA quality control charts.

PubMed

Ozilgen, Sibel; Bucak, Seyda; Ozilgen, Mustafa

2013-06-01

Although there are numerous decades-old studies drawing attention to the presence of aflatoxins in spices, and particularly in red pepper spice, the problem has not been eradicated. In the present study, information presented in the literature, about production method of red pepper spice, its contamination with aflatoxin, and the uncertainty about the data are assessed to find out the points where improvement may be achieved. Failure Mode and Effect Analysis (FMEA) are performed to assess the risk. The highest total risk attributable to chemical plus physical plus biological causes is associated with the washing stage (RPN=363), which is followed by the receiving (RPN=342) and the storage (RPN=342) stages. The highest risk attributable to biological causes (RPN=180) is associated with microbial growth and aflatoxin production due to insufficient control of drying conditions. The highest chemical risk (RPN=144) is found for the presence of unintentional food additives, such as pesticides, herbicides, hormones, and heavy metals in fresh red pepper fruits. EWMA (exponentially weighted average) charts are employed to monitor aflatoxin production during storage. They successfully distinguished between the batches, which turned to be unsafe. Risk associated with unintentional additives may be reduced by using certified additives only. Better drying control will definitely reduce the risk associated with the drying process. Codex Alimentarius plan has worldwide acceptance for assessing safety of the nuts. Risk of accepting the batches contaminated with aflatoxin may be eliminated by applying the Codex Alimentarius sampling plan before putting the dry pulverized red pepper into the storage facility.

Comprehension and retrieval of failure cases in airborne observatories

NASA Technical Reports Server (NTRS)

Alvarado, Sergio J.; Mock, Kenrick J.

1995-01-01

This paper describes research dealing with the computational problem of analyzing and repairing failures of electronic and mechanical systems of telescopes in NASA's airborne observatories, such as KAO (Kuiper Airborne Observatory) and SOFIA (Stratospheric Observatory for Infrared Astronomy). The research has resulted in the development of an experimental system that acquires knowledge of failure analysis from input text, and answers questions regarding failure detection and correction. The system's design builds upon previous work on text comprehension and question answering, including: knowledge representation for conceptual analysis of failure descriptions, strategies for mapping natural language into conceptual representations, case-based reasoning strategies for memory organization and indexing, and strategies for memory search and retrieval. These techniques have been combined into a model that accounts for: (a) how to build a knowledge base of system failures and repair procedures from descriptions that appear in telescope-operators' logbooks and FMEA (failure modes and effects analysis) manuals; and (b) how to use that knowledge base to search and retrieve answers to questions about causes and effects of failures, as well as diagnosis and repair procedures. This model has been implemented in FANSYS (Failure ANalysis SYStem), a prototype text comprehension and question answering program for failure analysis.

Comprehension and retrieval of failure cases in airborne observatories

NASA Astrophysics Data System (ADS)

Alvarado, Sergio J.; Mock, Kenrick J.

1995-05-01

This paper describes research dealing with the computational problem of analyzing and repairing failures of electronic and mechanical systems of telescopes in NASA's airborne observatories, such as KAO (Kuiper Airborne Observatory) and SOFIA (Stratospheric Observatory for Infrared Astronomy). The research has resulted in the development of an experimental system that acquires knowledge of failure analysis from input text, and answers questions regarding failure detection and correction. The system's design builds upon previous work on text comprehension and question answering, including: knowledge representation for conceptual analysis of failure descriptions, strategies for mapping natural language into conceptual representations, case-based reasoning strategies for memory organization and indexing, and strategies for memory search and retrieval. These techniques have been combined into a model that accounts for: (a) how to build a knowledge base of system failures and repair procedures from descriptions that appear in telescope-operators' logbooks and FMEA (failure modes and effects analysis) manuals; and (b) how to use that knowledge base to search and retrieve answers to questions about causes and effects of failures, as well as diagnosis and repair procedures. This model has been implemented in FANSYS (Failure ANalysis SYStem), a prototype text comprehension and question answering program for failure analysis.

Photovoltaic power system reliability considerations

NASA Technical Reports Server (NTRS)

Lalli, V. R.

1980-01-01

An example of how modern engineering and safety techniques can be used to assure the reliable and safe operation of photovoltaic power systems is presented. This particular application is for a solar cell power system demonstration project designed to provide electric power requirements for remote villages. The techniques utilized involve a definition of the power system natural and operating environment, use of design criteria and analysis techniques, an awareness of potential problems via the inherent reliability and FMEA methods, and use of fail-safe and planned spare parts engineering philosophy.

Photovoltaic power system reliability considerations

NASA Technical Reports Server (NTRS)

Lalli, V. R.

1980-01-01

This paper describes an example of how modern engineering and safety techniques can be used to assure the reliable and safe operation of photovoltaic power systems. This particular application was for a solar cell power system demonstration project in Tangaye, Upper Volta, Africa. The techniques involve a definition of the power system natural and operating environment, use of design criteria and analysis techniques, an awareness of potential problems via the inherent reliability and FMEA methods, and use of a fail-safe and planned spare parts engineering philosophy.

Production Time Loss Reduction in Sauce Production Line by Lean Six Sigma Approach

NASA Astrophysics Data System (ADS)

Ritprasertsri, Thitima; Chutima, Parames

2017-06-01

In all industries, time losses, which are incurred in processing are very important. As a result, losses are incurred in productivity and cost. This research aimed to reduce lost time that occurs in sauce production line by using the lean six sigma approach. The main objective was to reduce the time for heating sauce which causes a lot of time lost in the production line which affects productivity. The methodology was comprised of the five-phase improvement model of Six Sigma. This approach begins with defining phase, measuring phase, analysing phase, improving phase and controlling phase. Cause-and-effect matrix and failure mode and effect analysis (FMEA) were adopted to screen the factors which affect production time loss. The results showed that the percentage of lost time from heating sauce reduced by 47.76%. This increased productivity to meet the plan.

Tools for developing a quality management program: proactive tools (process mapping, value stream mapping, fault tree analysis, and failure mode and effects analysis).

PubMed

Rath, Frank

2008-01-01

This article examines the concepts of quality management (QM) and quality assurance (QA), as well as the current state of QM and QA practices in radiotherapy. A systematic approach incorporating a series of industrial engineering-based tools is proposed, which can be applied in health care organizations proactively to improve process outcomes, reduce risk and/or improve patient safety, improve through-put, and reduce cost. This tool set includes process mapping and process flowcharting, failure modes and effects analysis (FMEA), value stream mapping, and fault tree analysis (FTA). Many health care organizations do not have experience in applying these tools and therefore do not understand how and when to use them. As a result there are many misconceptions about how to use these tools, and they are often incorrectly applied. This article describes these industrial engineering-based tools and also how to use them, when they should be used (and not used), and the intended purposes for their use. In addition the strengths and weaknesses of each of these tools are described, and examples are given to demonstrate the application of these tools in health care settings.

Parts and Components Reliability Assessment: A Cost Effective Approach

NASA Technical Reports Server (NTRS)

Lee, Lydia

2009-01-01

System reliability assessment is a methodology which incorporates reliability analyses performed at parts and components level such as Reliability Prediction, Failure Modes and Effects Analysis (FMEA) and Fault Tree Analysis (FTA) to assess risks, perform design tradeoffs, and therefore, to ensure effective productivity and/or mission success. The system reliability is used to optimize the product design to accommodate today?s mandated budget, manpower, and schedule constraints. Stand ard based reliability assessment is an effective approach consisting of reliability predictions together with other reliability analyses for electronic, electrical, and electro-mechanical (EEE) complex parts and components of large systems based on failure rate estimates published by the United States (U.S.) military or commercial standards and handbooks. Many of these standards are globally accepted and recognized. The reliability assessment is especially useful during the initial stages when the system design is still in the development and hard failure data is not yet available or manufacturers are not contractually obliged by their customers to publish the reliability estimates/predictions for their parts and components. This paper presents a methodology to assess system reliability using parts and components reliability estimates to ensure effective productivity and/or mission success in an efficient manner, low cost, and tight schedule.

SU-E-T-87: A TG-100 Approach for Quality Improvement of Associated Dosimetry Equipment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Manger, R; Pawlicki, T; Kim, G

2015-06-15

Purpose: Dosimetry protocols devote so much time to the discussion of ionization chamber choice, use and performance that is easy to forget about the importance of the associated dosimetry equipment (ADE) in radiation dosimetry - barometer, thermometer, electrometer, phantoms, triaxial cables, etc. Improper use and inaccuracy of these devices may significantly affect the accuracy of radiation dosimetry. The purpose of this study is to evaluate the risk factors in the monthly output dosimetry procedure and recommend corrective actions using a TG-100 approach. Methods: A failure mode and effects analysis (FMEA) of the monthly linac output check procedure was performed tomore » determine which steps and failure modes carried the greatest risk. In addition, a fault tree analysis (FTA) was performed to expand the initial list of failure modes making sure that none were overlooked. After determining the failure modes with the highest risk priority numbers (RPNs), 11 physicists were asked to score corrective actions based on their ease of implementation and potential impact. The results were aggregated into an impact map to determine the implementable corrective actions. Results: Three of the top five failure modes were related to the thermometer and barometer. The two highest RPN-ranked failure modes were related to barometric pressure inaccuracy due to their high lack-of-detectability scores. Six corrective actions were proposed to address barometric pressure inaccuracy, and the survey results found the following two corrective actions to be implementable: 1) send the barometer for recalibration at a calibration laboratory and 2) check the barometer accuracy against the local airport and correct for elevation. Conclusion: An FMEA on monthly output measurements displayed the importance of ADE for accurate radiation dosimetry. When brainstorming for corrective actions, an impact map is helpful for visualizing the overall impact versus the ease of implementation.« less

Integrated System Health Management (ISHM) for Test Stand and J-2X Engine: Core Implementation

NASA Technical Reports Server (NTRS)

Figueroa, Jorge F.; Schmalzel, John L.; Aguilar, Robert; Shwabacher, Mark; Morris, Jon

2008-01-01

ISHM capability enables a system to detect anomalies, determine causes and effects, predict future anomalies, and provides an integrated awareness of the health of the system to users (operators, customers, management, etc.). NASA Stennis Space Center, NASA Ames Research Center, and Pratt & Whitney Rocketdyne have implemented a core ISHM capability that encompasses the A1 Test Stand and the J-2X Engine. The implementation incorporates all aspects of ISHM; from anomaly detection (e.g. leaks) to root-cause-analysis based on failure mode and effects analysis (FMEA), to a user interface for an integrated visualization of the health of the system (Test Stand and Engine). The implementation provides a low functional capability level (FCL) in that it is populated with few algorithms and approaches for anomaly detection, and root-cause trees from a limited FMEA effort. However, it is a demonstration of a credible ISHM capability, and it is inherently designed for continuous and systematic augmentation of the capability. The ISHM capability is grounded on an integrating software environment used to create an ISHM model of the system. The ISHM model follows an object-oriented approach: includes all elements of the system (from schematics) and provides for compartmentalized storage of information associated with each element. For instance, a sensor object contains a transducer electronic data sheet (TEDS) with information that might be used by algorithms and approaches for anomaly detection, diagnostics, etc. Similarly, a component, such as a tank, contains a Component Electronic Data Sheet (CEDS). Each element also includes a Health Electronic Data Sheet (HEDS) that contains health-related information such as anomalies and health state. Some practical aspects of the implementation include: (1) near real-time data flow from the test stand data acquisition system through the ISHM model, for near real-time detection of anomalies and diagnostics, (2) insertion of the J-2X predictive model providing predicted sensor values for comparison with measured values and use in anomaly detection and diagnostics, and (3) insertion of third-party anomaly detection algorithms into the integrated ISHM model.

The robust corrective action priority-an improved approach for selecting competing corrective actions in FMEA based on principle of robust design

NASA Astrophysics Data System (ADS)

Sutrisno, Agung; Gunawan, Indra; Vanany, Iwan

2017-11-01

In spite of being integral part in risk - based quality improvement effort, studies improving quality of selection of corrective action priority using FMEA technique are still limited in literature. If any, none is considering robustness and risk in selecting competing improvement initiatives. This study proposed a theoretical model to select risk - based competing corrective action by considering robustness and risk of competing corrective actions. We incorporated the principle of robust design in counting the preference score among corrective action candidates. Along with considering cost and benefit of competing corrective actions, we also incorporate the risk and robustness of corrective actions. An example is provided to represent the applicability of the proposed model.

HACCP-Based Programs for Preventing Disease and Injury from Premise Plumbing: A Building Consensus

PubMed Central

McCoy, William F.; Rosenblatt, Aaron A.

2015-01-01

Thousands of preventable injuries and deaths are annually caused by microbial, chemical and physical hazards from building water systems. Water is processed in buildings before use; this can degrade the quality of the water. Processing steps undertaken on-site in buildings often include conditioning, filtering, storing, heating, cooling, pressure regulation and distribution through fixtures that restrict flow and temperature. Therefore, prevention of disease and injury requires process management. A process management framework for buildings is the hazard analysis and critical control point (HACCP) adaptation of failure mode effects analysis (FMEA). It has been proven effective for building water system management. Validation is proof that hazards have been controlled under operating conditions and may include many kinds of evidence including cultures of building water samples to detect and enumerate potentially pathogenic microorganisms. However, results from culture tests are often inappropriately used because the accuracy and precision are not sufficient to support specifications for control limit or action triggers. A reliable negative screen is based on genus-level Polymerase Chain Reaction (PCR) for Legionella in building water systems; however, building water samples with positive results from this test require further analysis by culture methods. PMID:26184325

HACCP-Based Programs for Preventing Disease and Injury from Premise Plumbing: A Building Consensus.

PubMed

McCoy, William F; Rosenblatt, Aaron A

2015-07-09

Thousands of preventable injuries and deaths are annually caused by microbial, chemical and physical hazards from building water systems. Water is processed in buildings before use; this can degrade the quality of the water. Processing steps undertaken on-site in buildings often include conditioning, filtering, storing, heating, cooling, pressure regulation and distribution through fixtures that restrict flow and temperature. Therefore, prevention of disease and injury requires process management. A process management framework for buildings is the hazard analysis and critical control point (HACCP) adaptation of failure mode effects analysis (FMEA). It has been proven effective for building water system management. Validation is proof that hazards have been controlled under operating conditions and may include many kinds of evidence including cultures of building water samples to detect and enumerate potentially pathogenic microorganisms. However, results from culture tests are often inappropriately used because the accuracy and precision are not sufficient to support specifications for control limit or action triggers. A reliable negative screen is based on genus-level Polymerase Chain Reaction (PCR) for Legionella in building water systems; however, building water samples with positive results from this test require further analysis by culture methods.

Life Forecasting as a Logistics Technique.

DTIC Science & Technology

1982-01-01

Two examples of RCM applications were investigated directly by the MIT project team: the T53-L-13B engine for the UH -lH Helicopter and the M- 60 Tank...for RCM activities. The candidate systems and the respective 4 readiness commands were the UH -lH helicopter (TSARCOM), TOY Weapon System (MIRCOM), M...have capability for developing Failure Modes and Effects Analyses ( FMEA ). 5. Accurate and dependable field or test data are generally not available. 6

C3I (Command, Control, Communications and Intelligence) Teradata Study.

DTIC Science & Technology

1986-03-01

data storage capacity of one trillion bytes. The largest configuration currently built consists of 60 processors and 60 disks. .--. ,[ -... "I i The DBC... FMEA ) was developed to l indicate potential points of failure in the configuration and their - effects on total system operation. -"ince the contract did...number or IrPs and AMPs Int is the Integer function Thus, for a maximum configuration (see Section 3.3) of 1024 processors, there are ten tiers in Uhe

Space Shuttle Main Engine Quantitative Risk Assessment: Illustrating Modeling of a Complex System with a New QRA Software Package

NASA Technical Reports Server (NTRS)

Smart, Christian

1998-01-01

During 1997, a team from Hernandez Engineering, MSFC, Rocketdyne, Thiokol, Pratt & Whitney, and USBI completed the first phase of a two year Quantitative Risk Assessment (QRA) of the Space Shuttle. The models for the Shuttle systems were entered and analyzed by a new QRA software package. This system, termed the Quantitative Risk Assessment System(QRAS), was designed by NASA and programmed by the University of Maryland. The software is a groundbreaking PC-based risk assessment package that allows the user to model complex systems in a hierarchical fashion. Features of the software include the ability to easily select quantifications of failure modes, draw Event Sequence Diagrams(ESDs) interactively, perform uncertainty and sensitivity analysis, and document the modeling. This paper illustrates both the approach used in modeling and the particular features of the software package. The software is general and can be used in a QRA of any complex engineered system. The author is the project lead for the modeling of the Space Shuttle Main Engines (SSMEs), and this paper focuses on the modeling completed for the SSMEs during 1997. In particular, the groundrules for the study, the databases used, the way in which ESDs were used to model catastrophic failure of the SSMES, the methods used to quantify the failure rates, and how QRAS was used in the modeling effort are discussed. Groundrules were necessary to limit the scope of such a complex study, especially with regard to a liquid rocket engine such as the SSME, which can be shut down after ignition either on the pad or in flight. The SSME was divided into its constituent components and subsystems. These were ranked on the basis of the possibility of being upgraded and risk of catastrophic failure. Once this was done the Shuttle program Hazard Analysis and Failure Modes and Effects Analysis (FMEA) were used to create a list of potential failure modes to be modeled. The groundrules and other criteria were used to screen out the many failure modes that did not contribute significantly to the catastrophic risk. The Hazard Analysis and FMEA for the SSME were also used to build ESDs that show the chain of events leading from the failure mode occurence to one of the following end states: catastrophic failure, engine shutdown, or siccessful operation( successful with respect to the failure mode under consideration).

Improving FMEA risk assessment through reprioritization of failures

NASA Astrophysics Data System (ADS)

Ungureanu, A. L.; Stan, G.

2016-08-01

Most of the current methods used to assess the failure and to identify the industrial equipment defects are based on the determination of Risk Priority Number (RPN). Although conventional RPN calculation is easy to understand and use, the methodology presents some limitations, such as the large number of duplicates and the difficulty of assessing the RPN indices. In order to eliminate the afore-mentioned shortcomings, this paper puts forward an easy and efficient computing method, called Failure Developing Mode and Criticality Analysis (FDMCA), which takes into account the failures and the defect evolution in time, from failure appearance to a breakdown.

Dynamic safety assessment of natural gas stations using Bayesian network.

PubMed

Zarei, Esmaeil; Azadeh, Ali; Khakzad, Nima; Aliabadi, Mostafa Mirzaei; Mohammadfam, Iraj

2017-01-05

Pipelines are one of the most popular and effective ways of transporting hazardous materials, especially natural gas. However, the rapid development of gas pipelines and stations in urban areas has introduced a serious threat to public safety and assets. Although different methods have been developed for risk analysis of gas transportation systems, a comprehensive methodology for risk analysis is still lacking, especially in natural gas stations. The present work is aimed at developing a dynamic and comprehensive quantitative risk analysis (DCQRA) approach for accident scenario and risk modeling of natural gas stations. In this approach, a FMEA is used for hazard analysis while a Bow-tie diagram and Bayesian network are employed to model the worst-case accident scenario and to assess the risks. The results have indicated that the failure of the regulator system was the worst-case accident scenario with the human error as the most contributing factor. Thus, in risk management plan of natural gas stations, priority should be given to the most probable root events and main contribution factors, which have identified in the present study, in order to reduce the occurrence probability of the accident scenarios and thus alleviate the risks. Copyright © 2016 Elsevier B.V. All rights reserved.

Engineering and Safety Partnership Enhances Safety of the Space Shuttle Program (SSP)

NASA Technical Reports Server (NTRS)

Duarte, Alberto

2007-01-01

Project Management must use the risk assessment documents (RADs) as tools to support their decision making process. Therefore, these documents have to be initiated, developed, and evolved parallel to the life of the project. Technical preparation and safety compliance of these documents require a great deal of resources. Updating these documents after-the-fact not only requires substantial increase in resources - Project Cost -, but this task is also not useful and perhaps an unnecessary expense. Hazard Reports (HRs), Failure Modes and Effects Analysis (FMEAs), Critical Item Lists (CILs), Risk Management process are, among others, within this category. A positive action resulting from a strong partnership between interested parties is one way to get these documents and related processes and requirements, released and updated in useful time. The Space Shuttle Program (SSP) at the Marshall Space Flight Center has implemented a process which is having positive results and gaining acceptance within the Agency. A hybrid Panel, with equal interest and responsibilities for the two larger organizations, Safety and Engineering, is the focal point of this process. Called the Marshall Safety and Engineering Review Panel (MSERP), its charter (Space Shuttle Program Directive 110 F, April 15, 2005), and its Operating Control Plan emphasizes the technical and safety responsibilities over the program risk documents: HRs; FMEA/CILs; Engineering Changes; anomalies/problem resolutions and corrective action implementations, and trend analysis. The MSERP has undertaken its responsibilities with objectivity, assertiveness, dedication, has operated with focus, and has shown significant results and promising perspectives. The MSERP has been deeply involved in propulsion systems and integration, real time technical issues and other relevant reviews, since its conception. These activities have transformed the propulsion MSERP in a truly participative and value added panel, making a difference for the safety of the Space Shuttle Vehicle, its crew, and personnel. Because of the MSERP's valuable contribution to the assessment of safety risk for the SSP, this paper also proposes an enhanced Panel concept that takes this successful partnership concept to a higher level of 'true partnership'. The proposed panel is aimed to be responsible for the review and assessment of all risk relative to Safety for new and future aerospace and related programs.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Teixeira, Flavia C., E-mail: flavitiz@gmail.com; Almeida, Carlos E. de; Saiful Huq, M.

Purpose: The goal of this study was to evaluate the safety and quality management program for stereotactic radiosurgery (SRS) treatment processes at three radiotherapy centers in Brazil by using three industrial engineering tools (1) process mapping, (2) failure modes and effects analysis (FMEA), and (3) fault tree analysis. Methods: The recommendations of Task Group 100 of American Association of Physicists in Medicine were followed to apply the three tools described above to create a process tree for SRS procedure for each radiotherapy center and then FMEA was performed. Failure modes were identified for all process steps and values of riskmore » priority number (RPN) were calculated from O, S, and D (RPN = O × S × D) values assigned by a professional team responsible for patient care. Results: The subprocess treatment planning was presented with the highest number of failure modes for all centers. The total number of failure modes were 135, 104, and 131 for centers I, II, and III, respectively. The highest RPN value for each center is as follows: center I (204), center II (372), and center III (370). Failure modes with RPN ≥ 100: center I (22), center II (115), and center III (110). Failure modes characterized by S ≥ 7, represented 68% of the failure modes for center III, 62% for center II, and 45% for center I. Failure modes with RPNs values ≥100 and S ≥ 7, D ≥ 5, and O ≥ 5 were considered as high priority in this study. Conclusions: The results of the present study show that the safety risk profiles for the same stereotactic radiotherapy process are different at three radiotherapy centers in Brazil. Although this is the same treatment process, this present study showed that the risk priority is different and it will lead to implementation of different safety interventions among the centers. Therefore, the current practice of applying universal device-centric QA is not adequate to address all possible failures in clinical processes at different radiotherapy centers. Integrated approaches to device-centric and process specific quality management program specific to each radiotherapy center are the key to a safe quality management program.« less

The integration methods of fuzzy fault mode and effect analysis and fault tree analysis for risk analysis of yogurt production

NASA Astrophysics Data System (ADS)

Aprilia, Ayu Rizky; Santoso, Imam; Ekasari, Dhita Murita

2017-05-01

Yogurt is a product based on milk, which has beneficial effects for health. The process for the production of yogurt is very susceptible to failure because it involves bacteria and fermentation. For an industry, the risks may cause harm and have a negative impact. In order for a product to be successful and profitable, it requires the analysis of risks that may occur during the production process. Risk analysis can identify the risks in detail and prevent as well as determine its handling, so that the risks can be minimized. Therefore, this study will analyze the risks of the production process with a case study in CV.XYZ. The method used in this research is the Fuzzy Failure Mode and Effect Analysis (fuzzy FMEA) and Fault Tree Analysis (FTA). The results showed that there are 6 risks from equipment variables, raw material variables, and process variables. Those risks include the critical risk, which is the risk of a lack of an aseptic process, more specifically if starter yogurt is damaged due to contamination by fungus or other bacteria and a lack of sanitation equipment. The results of quantitative analysis of FTA showed that the highest probability is the probability of the lack of an aseptic process, with a risk of 3.902%. The recommendations for improvement include establishing SOPs (Standard Operating Procedures), which include the process, workers, and environment, controlling the starter of yogurt and improving the production planning and sanitation equipment using hot water immersion.

Six sigma tools for a patient safety-oriented, quality-checklist driven radiation medicine department.

PubMed

Kapur, Ajay; Potters, Louis

2012-01-01

The purpose of this work was to develop and implement six sigma practices toward the enhancement of patient safety in an electronic, quality checklist-driven, multicenter, paperless radiation medicine department. A quality checklist process map (QPM), stratified into consultation through treatment-completion stages was incorporated into an oncology information systems platform. A cross-functional quality management team conducted quality-function-deployment and define-measure-analyze-improve-control (DMAIC) six sigma exercises with a focus on patient safety. QPM procedures were Pareto-sorted in order of decreasing patient safety risk with failure mode and effects analysis (FMEA). Quantitative metrics for a grouped set of highest risk procedures were established. These included procedural delays, associated standard deviations and six sigma Z scores. Baseline performance of the QPM was established over the previous year of usage. Data-driven analysis led to simplification, standardization, and refinement of the QPM with standard deviation, slip-day reduction, and Z-score enhancement goals. A no-fly policy (NFP) for patient safety was introduced at the improve-control DMAIC phase, with a process map interlock imposed on treatment initiation in the event of FMEA-identified high-risk tasks being delayed or not completed. The NFP was introduced in a pilot phase with specific stopping rules and the same metrics used for performance assessments. A custom root-cause analysis database was deployed to monitor patient safety events. Relative to the baseline period, average slip days and standard deviations for the risk-enhanced QPM procedures improved by over threefold factors in the NFP period. The Z scores improved by approximately 20%. A trend for proactive delays instead of reactive hard stops was observed with no adverse effects of the NFP. The number of computed potential no-fly delays per month dropped from 60 to 20 over a total of 520 cases. The fraction of computed potential no-fly cases that were delayed in NFP compliance rose from 28% to 45%. Proactive delays rose to 80% of all delayed cases. For potential no-fly cases, event reporting rose from 18% to 50%, while for actually delayed cases, event reporting rose from 65% to 100%. With complex technologies, resource-compromised staff, and pressures to hasten treatment initiation, the use of the six sigma driven process interlocks may mitigate potential patient safety risks as demonstrated in this study. Copyright © 2012 American Society for Radiation Oncology. Published by Elsevier Inc. All rights reserved.

Quantification of phytochelatins in Chlamydomonas reinhardtii using ferrocene-based derivatization.

PubMed

Bräutigam, Anja; Bomke, Susanne; Pfeifer, Thorben; Karst, Uwe; Krauss, Gerd-Joachim; Wesenberg, Dirk

2010-08-01

A method for the identification and quantification of canonic and isoforms of phytochelatins (PCs) from Chlamydomonas reinhardtii was developed. After disulfide reduction with tris(2-carboxyethyl)phosphine (TCEP) PCs were derivatized with ferrocenecarboxylic acid (2-maleimidoyl)ethylamide (FMEA) in order to avoid oxidation of the free thiol functions during analysis. Liquid chromatography (LC) coupled to electrospray mass spectrometry (ESI-MS) and inductively coupled plasma-mass spectrometry (ICP-MS) was used for rapid and quantitative analysis of the precolumn derivatized PCs. PC(2-4), CysGSH, CysPC(2-4), CysPC(2)desGly, CysPC(2)Glu and CysPC(2)Ala were determined in the algal samples depending on the exposure of the cells to cadmium ions.

Risk management for outsourcing biomedical waste disposal – Using the failure mode and effects analysis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Liao, Ching-Jong; Ho, Chao Chung, E-mail: ho919@pchome.com.tw

Highlights: • This study is based on a real case in hospital in Taiwan. • We use Failure Mode and Effects Analysis (FMEA) as the evaluation method. • We successfully identify the evaluation factors of bio-medical waste disposal risk. - Abstract: Using the failure mode and effects analysis, this study examined biomedical waste companies through risk assessment. Moreover, it evaluated the supervisors of biomedical waste units in hospitals, and factors relating to the outsourcing risk assessment of biomedical waste in hospitals by referring to waste disposal acts. An expert questionnaire survey was conducted on the personnel involved in waste disposalmore » units in hospitals, in order to identify important factors relating to the outsourcing risk of biomedical waste in hospitals. This study calculated the risk priority number (RPN) and selected items with an RPN value higher than 80 for improvement. These items included “availability of freezing devices”, “availability of containers for sharp items”, “disposal frequency”, “disposal volume”, “disposal method”, “vehicles meeting the regulations”, and “declaration of three lists”. This study also aimed to identify important selection factors of biomedical waste disposal companies by hospitals in terms of risk. These findings can serve as references for hospitals in the selection of outsourcing companies for biomedical waste disposal.« less

Failure mode and effects analysis of the universal anaesthesia machine in two tertiary care hospitals in Sierra Leone

PubMed Central

Rosen, M. A.; Sampson, J. B.; Jackson, E. V.; Koka, R.; Chima, A. M.; Ogbuagu, O. U.; Marx, M. K.; Koroma, M.; Lee, B. H.

2014-01-01

Background Anaesthesia care in developed countries involves sophisticated technology and experienced providers. However, advanced machines may be inoperable or fail frequently when placed into the austere medical environment of a developing country. Failure mode and effects analysis (FMEA) is a method for engaging local staff in identifying real or potential breakdowns in processes or work systems and to develop strategies to mitigate risks. Methods Nurse anaesthetists from the two tertiary care hospitals in Freetown, Sierra Leone, participated in three sessions moderated by a human factors specialist and an anaesthesiologist. Sessions were audio recorded, and group discussion graphically mapped by the session facilitator for analysis and commentary. These sessions sought to identify potential barriers to implementing an anaesthesia machine designed for austere medical environments—the universal anaesthesia machine (UAM)—and also engaging local nurse anaesthetists in identifying potential solutions to these barriers. Results Participating Sierra Leonean clinicians identified five main categories of failure modes (resource availability, environmental issues, staff knowledge and attitudes, and workload and staffing issues) and four categories of mitigation strategies (resource management plans, engaging and educating stakeholders, peer support for new machine use, and collectively advocating for needed resources). Conclusions We identified factors that may limit the impact of a UAM and devised likely effective strategies for mitigating those risks. PMID:24833727

Improving Quality of Seal Leak Test Product using Six Sigma

NASA Astrophysics Data System (ADS)

Luthfi Malik, Abdullah; Akbar, Muhammad; Irianto, Dradjad

2016-02-01

Seal leak test part is a polyurethane material-based product. Based on past data, defect level of this product was 8%, higher than the target of 5%. Quality improvement effort was done using six sigma method that included phases of define, measure, analyse, improve, and control. In the design phase, a Delphi method was used to identify factors that were critical to quality. In the measure phase, stability and process capability was measured. Fault tree analysis (FTA) and failure mode and effect analysis (FMEA) were used in the next phase to analize the root cause and to determine the priority issues. Improve phase was done by compiling, selecting, and designing alternative repair. Some improvement efforts were identified, i.e. (i) making a checklist for maintenance schedules, (ii) making written reminder form, (iii) modifying the SOP more detail, and (iv) performing a major service to the vacuum machine. To ensure the continuity of improvement efforts, some control activities were executed, i.e. (i) controlling, monitoring, documenting, and setting target frequently, (ii) implementing reward and punishment system, (iii) adding cleaning tool, and (iv) building six sigma organizational structure.

Development and Assessment of a Medication Safety Measurement Program in a Long-Term Care Pharmacy.

PubMed

Hertig, John B; Hultgren, Kyle E; Parks, Scott; Rondinelli, Rick

2016-02-01

Medication errors continue to be a major issue in the health care system, including in long-term care facilities. While many hospitals and health systems have developed methods to identify, track, and prevent these errors, long-term care facilities historically have not invested in these error-prevention strategies. The objective of this study was two-fold: 1) to develop a set of medication-safety process measures for dispensing in a long-term care pharmacy, and 2) to analyze the data from those measures to determine the relative safety of the process. The study was conducted at In Touch Pharmaceuticals in Valparaiso, Indiana. To assess the safety of the medication-use system, each step was documented using a comprehensive flowchart (process flow map) tool. Once completed and validated, the flowchart was used to complete a "failure modes and effects analysis" (FMEA) identifying ways a process may fail. Operational gaps found during FMEA were used to identify points of measurement. The research identified a set of eight measures as potential areas of failure; data were then collected on each one of these. More than 133,000 medication doses (opportunities for errors) were included in the study during the research time frame (April 1, 2014, and ended on June 4, 2014). Overall, there was an approximate order-entry error rate of 15.26%, with intravenous errors at 0.37%. A total of 21 errors migrated through the entire medication-use system. These 21 errors in 133,000 opportunities resulted in a final check error rate of 0.015%. A comprehensive medication-safety measurement program was designed and assessed. This study demonstrated the ability to detect medication errors in a long-term pharmacy setting, thereby making process improvements measureable. Future, larger, multi-site studies should be completed to test this measurement program.

Overall uncertainty measurement for near infrared analysis of cryptotanshinone in tanshinone extract

NASA Astrophysics Data System (ADS)

Xue, Zhong; Xu, Bing; Shi, Xinyuan; Yang, Chan; Cui, Xianglong; Luo, Gan; Qiao, Yanjiang

2017-01-01

This study presented a new strategy of overall uncertainty measurement for near infrared (NIR) quantitative analysis of cryptotanshinone in tanshinone extract powders. The overall uncertainty of NIR analysis from validation data of precision, trueness and robustness study was fully investigated and discussed. Quality by design (QbD) elements, such as risk assessment and design of experiment (DOE) were utilized to organize the validation data. An "I × J × K" (series I, the number of repetitions J and level of concentrations K) full factorial design was used to calculate uncertainty from the precision and trueness data. And a 27-4 Plackett-Burmann matrix with four different influence factors resulted from the failure mode and effect analysis (FMEA) analysis was adapted for the robustness study. The overall uncertainty profile was introduced as a graphical decision making tool to evaluate the validity of NIR method over the predefined concentration range. In comparison with the T. Saffaj's method (Analyst, 2013, 138, 4677.) for overall uncertainty assessment, the proposed approach gave almost the same results, demonstrating that the proposed method was reasonable and valid. Moreover, the proposed method can help identify critical factors that influence the NIR prediction performance, which could be used for further optimization of the NIR analytical procedures in routine use.

Post-Challenger evaluation of space shuttle risk assessment and management

NASA Technical Reports Server (NTRS)

1988-01-01

As the shock of the Space Shuttle Challenger accident began to subside, NASA initiated a wide range of actions designed to ensure greater safety in various aspects of the Shuttle system and an improved focus on safety throughout the National Space Transportation System (NSTS) Program. Certain specific features of the NASA safety process are examined: the Critical Items List (CIL) and the NASA review of the Shuttle primary and backup units whose failure might result in the loss of life, the Shuttle vehicle, or the mission; the failure modes and effects analyses (FMEA); and the hazard analysis and their review. The conception of modern risk management, including the essential element of objective risk assessment is described and it is contrasted with NASA's safety process in general terms. The discussion, findings, and recommendations regarding particular aspects of the NASA STS safety assurance process are reported. The 11 subsections each deal with a different aspect of the process. The main lessons learned by SCRHAAC in the course of the audit are summarized.

Generating Options for Active Risk Control (GO-ARC): introducing a novel technique.

PubMed

Card, Alan J; Ward, James R; Clarkson, P John

2014-01-01

After investing significant amounts of time and money in conducting formal risk assessments, such as root cause analysis (RCA) or failure mode and effects analysis (FMEA), healthcare workers are left to their own devices in generating high-quality risk control options. They often experience difficulty in doing so, and tend toward an overreliance on administrative controls (the weakest category in the hierarchy of risk controls). This has important implications for patient safety and the cost effectiveness of risk management operations. This paper describes a before and after pilot study of the Generating Options for Active Risk Control (GO-ARC) technique, a novel tool to improve the quality of the risk control options generation process. The quantity, quality (using the three-tiered hierarchy of risk controls), variety, and novelty of risk controls generated. Use of the GO-ARC technique was associated with improvement on all measures. While this pilot study has some notable limitations, it appears that the GO-ARC technique improved the risk control options generation process. Further research is needed to confirm this finding. It is also important to note that improved risk control options are a necessary, but not sufficient, step toward the implementation of more robust risk controls. © 2013 National Association for Healthcare Quality.

Analysis of a risk prevention document using dependability techniques: a first step towards an effectiveness model

NASA Astrophysics Data System (ADS)

Ferrer, Laetitia; Curt, Corinne; Tacnet, Jean-Marc

2018-04-01

Major hazard prevention is a main challenge given that it is specifically based on information communicated to the public. In France, preventive information is notably provided by way of local regulatory documents. Unfortunately, the law requires only few specifications concerning their content; therefore one can question the impact on the general population relative to the way the document is concretely created. Ergo, the purpose of our work is to propose an analytical methodology to evaluate preventive risk communication document effectiveness. The methodology is based on dependability approaches and is applied in this paper to the Document d'Information Communal sur les Risques Majeurs (DICRIM; in English, Municipal Information Document on Major Risks). DICRIM has to be made by mayors and addressed to the public to provide information on major hazards affecting their municipalities. An analysis of law compliance of the document is carried out thanks to the identification of regulatory detection elements. These are applied to a database of 30 DICRIMs. This analysis leads to a discussion on points such as usefulness of the missing elements. External and internal function analysis permits the identification of the form and content requirements and service and technical functions of the document and its components (here its sections). Their results are used to carry out an FMEA (failure modes and effects analysis), which allows us to define the failure and to identify detection elements. This permits the evaluation of the effectiveness of form and content of each components of the document. The outputs are validated by experts from the different fields investigated. Those results are obtained to build, in future works, a decision support model for the municipality (or specialised consulting firms) in charge of drawing up documents.

Technology Readiness Assessment (TRA) Deskbook

DTIC Science & Technology

2003-09-01

be certified as being compliant with the FMEA by the Under Secretary of Defense (Comptroller) (USD(C)). B.3 A COMMENT ON THE TRA PROCESS The Interim...I-2 1.4 Acquisition Process Overview...II-6 2.2.3 Processing the TRA Results .......................................................... II-6 2.3 Component Acquisition Executive (CAE

TU-B-304-02: Quantitative FMEA of TG-142

DOE Office of Scientific and Technical Information (OSTI.GOV)

O’Daniel, J.

2015-06-15

Although published in 2009, the AAPM TG-142 report on accelerator quality assurance still proves a challenge for full clinical implementation. The choice of methodologies to satisfy TG-142 requirements is critical to a successful application. Understanding the philosophy of TG-142 can help in creating an institution-specific QA practice that is both efficient and effective. The concept of maintaining commissioned beam profiles is still found confusing. The physicist must also consider technologies not covered by TG-142 (i.e. arc therapy techniques). On the horizon is TG-198 report on implementing TG-142. Although the community still lacks a final TG-100 report, performing a failure-mode -and-effectsmore » analysis and statistical process control analysis to determine the institution-specific clinical impact of each TG-142 test may be useful for identifying trends for pro-active surveillance. Learning Objectives: To better understand the confusing and controversial aspects of TG-142. To understand what is still missing from TG-142 and how to account for these tests in clinical practice To describe which QA tests in TG-142 yield the largest potential clinical result if not discovered.« less

A Study of Technical Engineering Peer Reviews at NASA

NASA Technical Reports Server (NTRS)

Chao, Lawrence P.; Tumer, Irem Y.; Bell, David G.

2003-01-01

This report describes the state of practices of design reviews at NASA and research into what can be done to improve peer review practices. There are many types of reviews at NASA: required and not, formalized and informal, programmatic and technical. Standing project formal reviews such as the Preliminary Design Review and Critical Design Review are a required part of every project and mission development. However, the technical, engineering peer reviews that support teams' work on such projects are informal, some times ad hoc, and inconsistent across the organization. The goal of this work is to identify best practices and lessons learned from NASA's experience, supported by academic research and methodologies to ultimately improve the process. This research has determined that the organization, composition, scope, and approach of the reviews impact their success. Failure Modes and Effects Analysis (FMEA) can identify key areas of concern before or in the reviews. Product definition tools like the Project Priority Matrix, engineering-focused Customer Value Chain Analysis (CVCA), and project or system-based Quality Function Deployment (QFD) help prioritize resources in reviews. The use of information technology and structured design methodologies can strengthen the engineering peer review process to help NASA work towards error-proofing the design process.

Application of Six Sigma methodology to a cataract surgery unit.

PubMed

Taner, Mehmet Tolga

2013-01-01

The article's aim is to focus on the application of Six Sigma to minimise intraoperative and post-operative complications rates in a Turkish public hospital cataract surgery unit. Implementing define-measure-analyse-improve and control (DMAIC) involves process mapping, fishbone diagrams and rigorous data-collection. Failure mode and effect analysis (FMEA), pareto diagrams, control charts and process capability analysis are applied to redress cataract surgery failure root causes. Inefficient skills of assistant surgeons and technicians, low quality of IOLs used, wrong IOL placement, unsystematic sterilisation of surgery rooms and devices, and the unprioritising network system are found to be the critical drivers of intraoperative-operative and post-operative complications. Sigma level was increased from 2.60 to 3.75 subsequent to extensive training of assistant surgeons, ophthalmologists and technicians, better quality IOLs, systematic sterilisation and air-filtering, and the implementation of a more sophisticated network system. This article shows that Six Sigma measurement and process improvement can become the impetus for cataract unit staff to rethink their process and reduce malpractices. Measuring, recording and reporting data regularly helps them to continuously monitor their overall process and deliver safer treatments. This is the first Six Sigma ophthalmology study in Turkey.

Orbit transfer rocket engine technology program. Phase 2: Advanced engine study

NASA Technical Reports Server (NTRS)

Erickson, C.; Martinez, A.; Hines, B.

1987-01-01

In Phase 2 of the Advanced Engine Study, the Failure Modes and Effects Analysis (FMEA) maintenance-driven engine design, preliminary maintenance plan, and concept for space operable disconnects generated in Phase 1 were further developed. Based on the results of the vehicle contractors Orbit Transfer Vehicle (OTV) Concept Definition and System Analysis Phase A studies, minor revisions to the engine design were made. Additional refinements in the engine design were identified through further engine concept studies. These included an updated engine balance incorporating experimental heat transfer data from the Enhanced Heat Load Thrust Chamber Study and a Rao optimum nozzle contour. The preliminary maintenance plan of Phase 1 was further developed through additional studies. These included a compilation of critical component lives and life limiters and a review of the Space Shuttle Main Engine (SSME) operations and maintenance manual in order to begin outlining the overall maintenance procedures for the Orbit Transfer Vehicle Engine and identifying technology requirements for streamlining space-based operations. Phase 2 efforts also provided further definition to the advanced fluid coupling devices including the selection and preliminary design of a preferred concept and a preliminary test plan for its further development.

NASA GRC Technology Development Project for a Stirling Radioisotope Power System

NASA Technical Reports Server (NTRS)

Thieme, Lanny G.; Schreiber, Jeffrey G.

2000-01-01

NASA Glenn Research Center (GRC), the Department of Energy (DOE), and Stirling Technology Company (STC) are developing a Stirling convertor for an advanced radioisotope power system to provide spacecraft on-board electric power for NASA deep space missions. NASA GRC is conducting an in-house project to provide convertor, component, and materials testing and evaluation in support of the overall power system development. A first characterization of the DOE/STC 55-We Stirling Technology Demonstration Convertor (TDC) under the expected launch random vibration environment was recently completed in the NASA GRC Structural Dynamics Laboratory. Two TDCs also completed an initial electromagnetic interference (EMI) characterization at NASA GRC while being tested in a synchronized, opposed configuration. Materials testing is underway to support a life assessment of the heater head, and magnet characterization and aging tests have been initiated. Test facilities are now being established for an independent convertor performance verification and technology development. A preliminary Failure Mode Effect Analysis (FMEA), initial finite element analysis (FEA) for the linear alternator, ionizing radiation survivability assessment, and radiator parametric study have also been completed. This paper will discuss the status, plans, and results to date for these efforts.

Quality-by-Design II: Application of Quantitative Risk Analysis to the Formulation of Ciprofloxacin Tablets.

PubMed

Claycamp, H Gregg; Kona, Ravikanth; Fahmy, Raafat; Hoag, Stephen W

2016-04-01

Qualitative risk assessment methods are often used as the first step to determining design space boundaries; however, quantitative assessments of risk with respect to the design space, i.e., calculating the probability of failure for a given severity, are needed to fully characterize design space boundaries. Quantitative risk assessment methods in design and operational spaces are a significant aid to evaluating proposed design space boundaries. The goal of this paper is to demonstrate a relatively simple strategy for design space definition using a simplified Bayesian Monte Carlo simulation. This paper builds on a previous paper that used failure mode and effects analysis (FMEA) qualitative risk assessment and Plackett-Burman design of experiments to identity the critical quality attributes. The results show that the sequential use of qualitative and quantitative risk assessments can focus the design of experiments on a reduced set of critical material and process parameters that determine a robust design space under conditions of limited laboratory experimentation. This approach provides a strategy by which the degree of risk associated with each known parameter can be calculated and allocates resources in a manner that manages risk to an acceptable level.

SU-F-T-226: QA Management for a Large Institution with Multiple Campuses for FMEA

DOE Office of Scientific and Technical Information (OSTI.GOV)

Tang, G; Chan, M; Lovelock, D

2016-06-15

Purpose: To redesign our radiation therapy QA program with the goal to improve quality, efficiency, and consistency among a growing number of campuses at a large institution. Methods: A QA committee was established with at least one physicist representing each of our six campuses (22 linacs). Weekly meetings were scheduled to advise on and update current procedures, to review end-to-end and other test results, and to prepare composite reports for internal and external audits. QA procedures for treatment and imaging equipment were derived from TG Reports 142 and 66, practice guidelines, and feedback from ACR evaluations. The committee focused onmore » reaching a consensus on a single QA program among all campuses using the same type of equipment and reference data. Since the recommendations for tolerances referenced to baseline data were subject to interpretation in some instances, the committee reviewed the characteristics of all machines and quantified any variations before choosing between treatment planning system (i.e. treatment planning system commissioning data that is representative for all machines) or machine-specific values (i.e. commissioning data of the individual machines) as baseline data. Results: The configured QA program will be followed strictly by all campuses. Inventory of available equipment has been compiled, and additional equipment acquisitions for the QA program are made as needed. Dosimetric characteristics are evaluated for all machines using the same methods to ensure consistency of beam data where possible. In most cases, baseline data refer to treatment planning system commissioning data but machine-specific values are used as reference where it is deemed appropriate. Conclusion: With a uniform QA scheme, variations in QA procedures are kept to a minimum. With a centralized database, data collection and analysis are simplified. This program will facilitate uniformity in patient treatments and analysis of large amounts of QA data campus-wide, which will ultimately facilitate FMEA.« less

Automation for System Safety Analysis

NASA Technical Reports Server (NTRS)

Malin, Jane T.; Fleming, Land; Throop, David; Thronesbery, Carroll; Flores, Joshua; Bennett, Ted; Wennberg, Paul

2009-01-01

This presentation describes work to integrate a set of tools to support early model-based analysis of failures and hazards due to system-software interactions. The tools perform and assist analysts in the following tasks: 1) extract model parts from text for architecture and safety/hazard models; 2) combine the parts with library information to develop the models for visualization and analysis; 3) perform graph analysis and simulation to identify and evaluate possible paths from hazard sources to vulnerable entities and functions, in nominal and anomalous system-software configurations and scenarios; and 4) identify resulting candidate scenarios for software integration testing. There has been significant technical progress in model extraction from Orion program text sources, architecture model derivation (components and connections) and documentation of extraction sources. Models have been derived from Internal Interface Requirements Documents (IIRDs) and FMEA documents. Linguistic text processing is used to extract model parts and relationships, and the Aerospace Ontology also aids automated model development from the extracted information. Visualizations of these models assist analysts in requirements overview and in checking consistency and completeness.

Flexible multielectrodes can resolve multiple muscles in an insect appendage.

PubMed

Spence, Andrew J; Neeves, Keith B; Murphy, Devon; Sponberg, Simon; Land, Bruce R; Hoy, Ronald R; Isaacson, Michael S

2007-01-15

Research into the neuromechanical basis of behavior, either in biomechanics, neuroethology, or neuroscience, is frequently limited by methods of data collection. Two of the most pressing needs are for methods with which to (1) record from multiple neurons or muscles simultaneously and (2) perform this recording in intact, behaving animals. In this paper we present the fabrication and testing of flexible multielectrode arrays (fMEAs) that move us significantly towards these goals. The fMEAs were used to record the activity of several distinct units in the coxa of the cockroach Blaberus discoidalis. The devices fabricated here address the first goal in two ways: (1) their flexibility allows them to be inserted into an animal and guided through internal tissues in order to access distinct groups of neurons and muscles and (2) their recording site geometry has been tuned to suit the anatomy under study, yielding multichannel spike waveforms that are easily separable under conditions of spike overlap. The flexible nature of the devices simultaneously addresses the second goal, in that it is less likely to interfere with the natural movement of the animal.

Application of quality by design (QbD) to formulation and processing of naproxen pellets by extrusion-spheronization.

PubMed

Wang, Junlin; Kan, Shuling; Chen, Tong; Liu, Jianping

2015-03-01

The aim of this research was to apply quality by design (QbD) to the development of naproxen loaded core pellets which can be used as the potential core for colon-specific pellets. In the early stages of this study, prior knowledge and preliminary studies were systematically incorporated into the risk assessment using failure mode and effect analysis (FMEA) and fishbone diagram. Then Plackett-Burman design was used to screen eight potential high risk factors (spheronization speed, spheronization time, extrusion speed, drying method, CCMC-Na concentration, lactose concentration, water concentration and Tween 80 concentration) obtained from the above risk assessment. It was discovered that out of the eight potential high risk factors only three factors (spheronization speed, extrusion speed and CCMC-Na concentration) had significant effects on the quality of the pellets. This allowed the use of Box-Behnken design (BBD) to fully elucidate the relationship between the variables and critical quality attribute (CQA). Finally, the final control space was established within which the quality of the pellets can meet the requirement of colon-specific drug delivery system. This study demonstrated that naproxen loaded core pellets were successfully designed using QbD principle.

Orbit transfer rocket engine technology program: Advanced engine study

NASA Technical Reports Server (NTRS)

Erickson, C. M.

1992-01-01

In Task D.6 of the Advanced Engine Study, three primary subtasks were accomplished: (1) design of parametric data; (2) engine requirement variation studies; and (3) vehicle study/engine study coordination. Parametric data were generated for vacuum thrusts ranging from 7500 lbf to 50,000 lbf, nozzle expansion ratios from 600 to 1200, and engine mixture ratios from 5:1 to 7:1. Failure Modes and Effects Analysis (FMEA) was used as a departure point for these parametric analyses. These data are intended to assist in definition and trade studies. In the Engine Requirements Variation Studies, the individual effects of increasing the throttling ratio from 10:1 to 20:1 and requiring the engine to operate at a maximum mixture ratio of 12:1 were determined. Off design engine balances were generated at these extreme conditions and individual component operating requirements analyzed in detail. Potential problems were identified and possible solutions generated. In the Vehicle Study/Engine Study coordination subtask, vehicle contractor support was provided as needed, addressing a variety of issues uncovered during vehicle trade studies. This support was primarily provided during Technical Interchange Meetings (TIM) in which Space Exploration Initiative (SEI) studies were addressed.

Multisite Parent-Centered Risk Assessment to Reduce Pediatric Oral Chemotherapy Errors

PubMed Central

Walsh, Kathleen E.; Mazor, Kathleen M.; Roblin, Douglas; Biggins, Colleen; Wagner, Joann L.; Houlahan, Kathleen; Li, Justin W.; Keuker, Christopher; Wasilewski-Masker, Karen; Donovan, Jennifer; Kanaan, Abir; Weingart, Saul N.

2013-01-01

Purpose: Observational studies describe high rates of errors in home oral chemotherapy use in children. In hospitals, proactive risk assessment methods help front-line health care workers develop error prevention strategies. Our objective was to engage parents of children with cancer in a multisite study using proactive risk assessment methods to identify how errors occur at home and propose risk reduction strategies. Methods: We recruited parents from three outpatient pediatric oncology clinics in the northeast and southeast United States to participate in failure mode and effects analyses (FMEA). An FMEA is a systematic team-based proactive risk assessment approach in understanding ways a process can fail and develop prevention strategies. Steps included diagram the process, brainstorm and prioritize failure modes (places where things go wrong), and propose risk reduction strategies. We focused on home oral chemotherapy administration after a change in dose because prior studies identified this area as high risk. Results: Parent teams consisted of four parents at two of the sites and 10 at the third. Parents developed a 13-step process map, with two to 19 failure modes per step. The highest priority failure modes included miscommunication when receiving instructions from the clinician (caused by conflicting instructions or parent lapses) and unsafe chemotherapy handling at home. Recommended risk assessment strategies included novel uses of technology to improve parent access to information, clinicians, and other parents while at home. Conclusion: Parents of pediatric oncology patients readily participated in a proactive risk assessment method, identifying processes that pose a risk for medication errors involving home oral chemotherapy. PMID:23633976

The STEP database through the end-users eyes--USABILITY STUDY.

PubMed

Salunke, Smita; Tuleu, Catherine

2015-08-15

The user-designed database of Safety and Toxicity of Excipients for Paediatrics ("STEP") is created to address the shared need of drug development community to access the relevant information of excipients effortlessly. Usability testing was performed to validate if the database satisfies the need of the end-users. Evaluation framework was developed to assess the usability. The participants performed scenario based tasks and provided feedback and post-session usability ratings. Failure Mode Effect Analysis (FMEA) was performed to prioritize the problems and improvements to the STEP database design and functionalities. The study revealed several design vulnerabilities. Tasks such as limiting the results, running complex queries, location of data and registering to access the database were challenging. The three critical attributes identified to have impact on the usability of the STEP database included (1) content and presentation (2) the navigation and search features (3) potential end-users. Evaluation framework proved to be an effective method for evaluating database effectiveness and user satisfaction. This study provides strong initial support for the usability of the STEP database. Recommendations would be incorporated into the refinement of the database to improve its usability and increase user participation towards the advancement of the database. Copyright © 2015 Elsevier B.V. All rights reserved.

a New Quantitative Method for the Rapid Evaluation of Buildings against Earthquakes

NASA Astrophysics Data System (ADS)

Mahmoodzadeh, Amir; Mazaheri, Mohammad Mehdi

2008-07-01

At the present time there exist numerous weak buildings which are not able to withstand earthquakes. At the same time, both private and public developers are trying to use scientific methods to prioritize and allocate budget in order to reinforce the above mentioned structures. This is because of the limited financial resources and time. In the recent years the procedure of seismic assessment before rehabilitation of vulnerable buildings has been implemented in many countries. Now, it seems logical to reinforce the existing procedures with the mass of available data about the effects caused by earthquakes on buildings. The main idea is driven from FMEA (Failure Mode and Effect Analysis) in quality management where the main procedure is to recognize the failure, the causes, and the priority of each cause and failure. Specifying the causes and effects which lead to a certain shortcoming in structural behavior during earthquakes, an inventory is developed and each building is rated through a yes-or-no procedure. In this way, the rating of the structure is based on some standard forms which along with relative weights are developed in this study. The resulted criteria by rapid assessment will indicate whether the structure is to be demolished, has a high, medium or low vulnerability or is invulnerable.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Mahmoodzadeh, Amir; Mazaheri, Mohammad Mehdi

At the present time there exist numerous weak buildings which are not able to withstand earthquakes. At the same time, both private and public developers are trying to use scientific methods to prioritize and allocate budget in order to reinforce the above mentioned structures. This is because of the limited financial resources and time. In the recent years the procedure of seismic assessment before rehabilitation of vulnerable buildings has been implemented in many countries. Now, it seems logical to reinforce the existing procedures with the mass of available data about the effects caused by earthquakes on buildings. The main ideamore » is driven from FMEA (Failure Mode and Effect Analysis) in quality management where the main procedure is to recognize the failure, the causes, and the priority of each cause and failure. Specifying the causes and effects which lead to a certain shortcoming in structural behavior during earthquakes, an inventory is developed and each building is rated through a yes-or-no procedure. In this way, the rating of the structure is based on some standard forms which along with relative weights are developed in this study. The resulted criteria by rapid assessment will indicate whether the structure is to be demolished, has a high, medium or low vulnerability or is invulnerable.« less

Risk based approach for design and optimization of stomach specific delivery of rifampicin.

PubMed

Vora, Chintan; Patadia, Riddhish; Mittal, Karan; Mashru, Rajashree

2013-10-15

The research envisaged focuses on risk management approach for better recognizing the risks, ways to mitigate them and propose a control strategy for the development of rifampicin gastroretentive tablets. Risk assessment using failure mode and effects analysis (FMEA) was done to depict the effects of specific failure modes related to respective formulation/process variable. A Box-Behnken design was used to investigate the effect of amount of sodium bicarbonate (X1), pore former HPMC (X2) and glyceryl behenate (X3) on percent drug release at 1st hour (Q1), 4th hour (Q4), 8th hour (Q8) and floating lag time (min). Main effects and interaction plots were generated to study effects of variables. Selection of the optimized formulation was done using desirability function and overlay contour plots. The optimized formulation exhibited Q1 of 20.9%, Q4 of 59.1%, Q8 of 94.8% and floating lag time of 4.0 min. Akaike information criteria and Model selection criteria revealed that the model was best described by Korsmeyer-Peppas power law. The residual plots demonstrated no existence of non-normality, skewness or outliers. The composite desirability for optimized formulation computed using equations and software were 0.84 and 0.86 respectively. FTIR, DSC and PXRD studies ruled out drug polymer interaction due to thermal treatment. Copyright © 2013 Elsevier B.V. All rights reserved.

Blood specimen labelling errors: Implications for nephrology nursing practice.

PubMed

Duteau, Jennifer

2014-01-01

Patient safety is the foundation of high-quality health care, as recognized both nationally and worldwide. Patient blood specimen identification is critical in ensuring the delivery of safe and appropriate care. The practice of nephrology nursing involves frequent patient blood specimen withdrawals to treat and monitor kidney disease. A critical review of the literature reveals that incorrect patient identification is one of the major causes of blood specimen labelling errors. Misidentified samples create a serious risk to patient safety leading to multiple specimen withdrawals, delay in diagnosis, misdiagnosis, incorrect treatment, transfusion reactions, increased length of stay and other negative patient outcomes. Barcode technology has been identified as a preferred method for positive patient identification leading to a definitive decrease in blood specimen labelling errors by as much as 83% (Askeland, et al., 2008). The use of a root cause analysis followed by an action plan is one approach to decreasing the occurrence of blood specimen labelling errors. This article will present a review of the evidence-based literature surrounding blood specimen labelling errors, followed by author recommendations for completing a root cause analysis and action plan. A failure modes and effects analysis (FMEA) will be presented as one method to determine root cause, followed by the Ottawa Model of Research Use (OMRU) as a framework for implementation of strategies to reduce blood specimen labelling errors.

Quality Tools and TRIZ Based Quality Improvement Case Study at PT ‘X’ A Plastic Moulding Manufacturing Industry

NASA Astrophysics Data System (ADS)

Wirawan, Christina; Chandra, Fory

2016-02-01

Theory of Inventive Problem Solving (TRIZ) is a creative encouraging problem solving method. TRIZ is prepared by Altshuller for product design. Altshuller prepared contradiction matrix and suggestion to solve contradictions usually occur in product design. This paper try to combine TRIZ with quality tools such as Pareto and Fault Tree Analysis (FTA) to solve contradiction in quality improvement problem, neither than product design problem. Pareto used to identify defect priority, FTA used to analysis and identify root cause of defect. When there is contradiction in solving defect causes, TRIZ used to find creative problem solving. As a case study, PT ’X’, a plastic molding manufacturing industry was taken. PT ‘X’ using traditional press machine to produce plastic thread cone. There are 5 defect types that might occur in plastic thread cone production, incomplete form, dirty, mottle, excessive form, rugged. Research about quality improvement effort using DMAIC at PT ‘X’ have been done by Fory Candra. From this research, defect types, priority, root cause from FTA, recommendation from FMEA. In this research, from FTA reviewed, contradictions found among causes troublesome quality improvement efforts. TRIZ used to solve the contradictions and quality improvement effort can be made effectively.

High Reliability and the Evaluation of ATC System Configuration by Communizing Resources

NASA Astrophysics Data System (ADS)

Yamamoto, Masanori

Automatic Train Control (ATC) in the railway signalling system is required high safety, high availability, reduction of unit, energy saving and cost reduction. This paper described the resources communization redundancy of the ATC system that shared the redundant units in preparation for common use units in order to accommodate with this issue by keeping safety and availability in the same level of conventional ATC. It was evaluated on N+2 redundant system which established 2 spares for the common use system N piece in transmission division. It was done the safety evaluation of the N+2 redundant system by way of hazard analysis of FTA method and safety issue was confirmed by FMEA. The new redundant system concludes that 19% of downsizing and 36% of the energy saving are surely possible.

55th Annual Fuze Conference

DTIC Science & Technology

2011-05-26

concrete plate and compact soil Confirmation: Complete Success both tests The TDD functioned as programmed; traces show entry and exit from each...concrete target and difference in deceleration levels between concrete and soil configuration The final exit & fire signals were generated as planned...Technical Data Package • Determine Process Capability • FMEA Manufacturing • Determine process capability • Cp = ( USL -LSL)/(6*Sigma) • Cpl

Information Extraction for System-Software Safety Analysis: Calendar Year 2008 Year-End Report

NASA Technical Reports Server (NTRS)

Malin, Jane T.

2009-01-01

This annual report describes work to integrate a set of tools to support early model-based analysis of failures and hazards due to system-software interactions. The tools perform and assist analysts in the following tasks: 1) extract model parts from text for architecture and safety/hazard models; 2) combine the parts with library information to develop the models for visualization and analysis; 3) perform graph analysis and simulation to identify and evaluate possible paths from hazard sources to vulnerable entities and functions, in nominal and anomalous system-software configurations and scenarios; and 4) identify resulting candidate scenarios for software integration testing. There has been significant technical progress in model extraction from Orion program text sources, architecture model derivation (components and connections) and documentation of extraction sources. Models have been derived from Internal Interface Requirements Documents (IIRDs) and FMEA documents. Linguistic text processing is used to extract model parts and relationships, and the Aerospace Ontology also aids automated model development from the extracted information. Visualizations of these models assist analysts in requirements overview and in checking consistency and completeness.

Optimization of a Coupling Process for Insulin Degludec According to a Quality by Design (QbD) Paradigm.

PubMed

Nie, Lei; Hu, Mingming; Yan, Xu; Guo, Tingting; Wang, Haibin; Zhang, Sheng; Qu, Haibin

2018-05-03

This case study described a successful application of the quality by design (QbD) principles to a coupling process development of insulin degludec. Failure mode effects analysis (FMEA) risk analysis was first used to recognize critical process parameters (CPPs). Five CPPs, including coupling temperature (Temp), pH of desB30 solution (pH), reaction time (Time), desB30 concentration (Conc), and molar equivalent of ester per mole of desB30 insulin (MolE), were then investigated using a fractional factorial design. The curvature effect was found significant, indicating the requirement of second-order models. Afterwards, a central composite design was built with an augmented star and center points study. Regression models were developed for the CPPs to predict the purity and yield of predegludec using above experimental data. The R 2 and adjusted R 2 were higher than 96 and 93% for the two models respectively. The Q 2 values were more than 80% indicating a good predictive ability of models. MolE was found to be the most significant factor affecting both yield and purity of predegludec. Temp, pH, and Conc were also significant for predegludec purity, while Time appeared to remarkably influence the yield model. The multi-dimensional design space and normal operating region (NOR) with a robust setpoint were determined using a probability-based Monte-Carlo simulation method. The verified experimental results showed that the design space was reliable and effective. This study enriches the understanding of acetylation process and is instructional to other complicated operations in biopharmaceutical engineering.

Advanced uncertainty modelling for container port risk analysis.

PubMed

Alyami, Hani; Yang, Zaili; Riahi, Ramin; Bonsall, Stephen; Wang, Jin

2016-08-13

Globalization has led to a rapid increase of container movements in seaports. Risks in seaports need to be appropriately addressed to ensure economic wealth, operational efficiency, and personnel safety. As a result, the safety performance of a Container Terminal Operational System (CTOS) plays a growing role in improving the efficiency of international trade. This paper proposes a novel method to facilitate the application of Failure Mode and Effects Analysis (FMEA) in assessing the safety performance of CTOS. The new approach is developed through incorporating a Fuzzy Rule-Based Bayesian Network (FRBN) with Evidential Reasoning (ER) in a complementary manner. The former provides a realistic and flexible method to describe input failure information for risk estimates of individual hazardous events (HEs) at the bottom level of a risk analysis hierarchy. The latter is used to aggregate HEs safety estimates collectively, allowing dynamic risk-based decision support in CTOS from a systematic perspective. The novel feature of the proposed method, compared to those in traditional port risk analysis lies in a dynamic model capable of dealing with continually changing operational conditions in ports. More importantly, a new sensitivity analysis method is developed and carried out to rank the HEs by taking into account their specific risk estimations (locally) and their Risk Influence (RI) to a port's safety system (globally). Due to its generality, the new approach can be tailored for a wide range of applications in different safety and reliability engineering and management systems, particularly when real time risk ranking is required to measure, predict, and improve the associated system safety performance. Copyright © 2016 Elsevier Ltd. All rights reserved.

Superconducting Magnet Power Supply and Hard-Wired Quench Protection at Jefferson Lab for 12 GeV Upgrade

DOE Office of Scientific and Technical Information (OSTI.GOV)

Ghoshal, Probir K.; Bachimanchi, Ramakrishna; Fair, Ruben J.

The superconducting magnet system in Hall B being designed and built as part of the Jefferson Lab 12 GeV upgrade requires powering two conduction cooled superconducting magnets - a torus and a solenoid. The torus magnet is designed to operate at 3770 A and solenoid at 2416 A. Failure Modes and Effects Analysis (FMEA) determined that voltage level thresholds and dump switch operation for magnet protection should be tested and analyzed before incorporation into the system. The designs of the quench protection and voltage tap sub-systems were driven by the requirement to use a primary hard-wired quench detection sub-system togethermore » with a secondary PLC-based protection. Parallel path voltage taps feed both the primary and secondary quench protection sub-systems. The PLC based secondary protection is deployed as a backup for the hard-wired quench detection sub-system and also acts directly on the dump switch. Here, we describe a series of tests and modifications carried out on the magnet power supply and quench protection system to ensure that the superconducting magnet is protected for all fault scenarios.« less

Superconducting Magnet Power Supply and Hard-Wired Quench Protection at Jefferson Lab for 12 GeV Upgrade

DOE PAGES

Ghoshal, Probir K.; Bachimanchi, Ramakrishna; Fair, Ruben J.; ...

2017-10-05

The superconducting magnet system in Hall B being designed and built as part of the Jefferson Lab 12 GeV upgrade requires powering two conduction cooled superconducting magnets - a torus and a solenoid. The torus magnet is designed to operate at 3770 A and solenoid at 2416 A. Failure Modes and Effects Analysis (FMEA) determined that voltage level thresholds and dump switch operation for magnet protection should be tested and analyzed before incorporation into the system. The designs of the quench protection and voltage tap sub-systems were driven by the requirement to use a primary hard-wired quench detection sub-system togethermore » with a secondary PLC-based protection. Parallel path voltage taps feed both the primary and secondary quench protection sub-systems. The PLC based secondary protection is deployed as a backup for the hard-wired quench detection sub-system and also acts directly on the dump switch. Here, we describe a series of tests and modifications carried out on the magnet power supply and quench protection system to ensure that the superconducting magnet is protected for all fault scenarios.« less

Achievements in the development of the Water Cooled Solid Breeder Test Blanket Module of Japan to the milestones for installation in ITER

NASA Astrophysics Data System (ADS)

Tsuru, Daigo; Tanigawa, Hisashi; Hirose, Takanori; Mohri, Kensuke; Seki, Yohji; Enoeda, Mikio; Ezato, Koichiro; Suzuki, Satoshi; Nishi, Hiroshi; Akiba, Masato

2009-06-01

As the primary candidate of ITER Test Blanket Module (TBM) to be tested under the leadership of Japan, a water cooled solid breeder (WCSB) TBM is being developed. This paper shows the recent achievements towards the milestones of ITER TBMs prior to the installation, which consist of design integration in ITER, module qualification and safety assessment. With respect to the design integration, targeting the detailed design final report in 2012, structure designs of the WCSB TBM and the interfacing components (common frame and backside shielding) that are placed in a test port of ITER and the layout of the cooling system are presented. As for the module qualification, a real-scale first wall mock-up fabricated by using the hot isostatic pressing method by structural material of reduced activation martensitic ferritic steel, F82H, and flow and irradiation test of the mock-up are presented. As for safety milestones, the contents of the preliminary safety report in 2008 consisting of source term identification, failure mode and effect analysis (FMEA) and identification of postulated initiating events (PIEs) and safety analyses are presented.

Use of modeling to identify vulnerabilities to human error in laparoscopy.

PubMed

Funk, Kenneth H; Bauer, James D; Doolen, Toni L; Telasha, David; Nicolalde, R Javier; Reeber, Miriam; Yodpijit, Nantakrit; Long, Myra

2010-01-01

This article describes an exercise to investigate the utility of modeling and human factors analysis in understanding surgical processes and their vulnerabilities to medical error. A formal method to identify error vulnerabilities was developed and applied to a test case of Veress needle insertion during closed laparoscopy. A team of 2 surgeons, a medical assistant, and 3 engineers used hierarchical task analysis and Integrated DEFinition language 0 (IDEF0) modeling to create rich models of the processes used in initial port creation. Using terminology from a standardized human performance database, detailed task descriptions were written for 4 tasks executed in the process of inserting the Veress needle. Key terms from the descriptions were used to extract from the database generic errors that could occur. Task descriptions with potential errors were translated back into surgical terminology. Referring to the process models and task descriptions, the team used a modified failure modes and effects analysis (FMEA) to consider each potential error for its probability of occurrence, its consequences if it should occur and be undetected, and its probability of detection. The resulting likely and consequential errors were prioritized for intervention. A literature-based validation study confirmed the significance of the top error vulnerabilities identified using the method. Ongoing work includes design and evaluation of procedures to correct the identified vulnerabilities and improvements to the modeling and vulnerability identification methods. Copyright 2010 AAGL. Published by Elsevier Inc. All rights reserved.

A comparative presentation of implementation of ISO 22000 versus HACCP and FMEA in a small size Greek factory producing smoked trout: a case study.

PubMed

Arvanitoyannis, Ioannis S; Palaiokostas, Christos; Panagiotaki, Panagiota

2009-02-01

ISO 22000 is the new standard bound to replace HACCP on issues related to food safety. Although several companies, especially the big ones, have either implemented or are on the point of implementing ISO 22000, there are many others which are rather timid and/or reluctant to implement it. The main reason behind that is the lack of information and the fear that the new standard is too demanding in terms of bureaucratic work. This paper aims at making a comparative presentation of how the two systems can be applied to a small smoked salmon producing company thereby facilitating the emergence of the differences. The main difference is that in ISO 22000 systems like Good Manufacturing Practice and Good Hygiene Practice are prerequisites thus leading to lower number of CCPs. In this case study for example, the number of CCPs dropped from eight (8) in HACCP to four (4) in ISO 22000. Furthermore, the Failure Mode and Effect Analysis was applied to the smoked trout manufacturing process in an attempt to calculate quantitatively the Risk Priority Number (RPN) and to find out whether it can be effectively correlated to ISO 22000 and/or HACCP. RPN was found to be higher than 130 for eight steps, in close agreement with HACCP, thereby indicating that corrective actions will have to be undertaken.

QbD for pediatric oral lyophilisates development: risk assessment followed by screening and optimization.

PubMed

Casian, Tibor; Iurian, Sonia; Bogdan, Catalina; Rus, Lucia; Moldovan, Mirela; Tomuta, Ioan

2017-12-01

This study proposed the development of oral lyophilisates with respect to pediatric medicine development guidelines, by applying risk management strategies and DoE as an integrated QbD approach. Product critical quality attributes were overviewed by generating Ishikawa diagrams for risk assessment purposes, considering process, formulation and methodology related parameters. Failure Mode Effect Analysis was applied to highlight critical formulation and process parameters with an increased probability of occurrence and with a high impact on the product performance. To investigate the effect of qualitative and quantitative formulation variables D-optimal designs were used for screening and optimization purposes. Process parameters related to suspension preparation and lyophilization were classified as significant factors, and were controlled by implementing risk mitigation strategies. Both quantitative and qualitative formulation variables introduced in the experimental design influenced the product's disintegration time, mechanical resistance and dissolution properties selected as CQAs. The optimum formulation selected through Design Space presented ultra-fast disintegration time (5 seconds), a good dissolution rate (above 90%) combined with a high mechanical resistance (above 600 g load). Combining FMEA and DoE allowed the science based development of a product with respect to the defined quality target profile by providing better insights on the relevant parameters throughout development process. The utility of risk management tools in pharmaceutical development was demonstrated.

Minimization of Defective Products in The Department of Press Bridge & Rib Through Six Sigma DMAIC Phases

NASA Astrophysics Data System (ADS)

Rochman, YA; Agustin, A.

2017-06-01

This study proposes the DMAIC Six Sigma approach of Define, Measure, Analyze, Improve/Implement and Control (DMAIC) to minimizing the number of defective products in the bridge & rib department. There are 5 types of defects were the most dominant are broken rib, broken sound board, strained rib, rib sliding and sound board minori. The imperative objective is to improve the quality through the DMAIC phases. In the define phase, the critical to quality (CTQ) parameters was identified minimization of product defects through the pareto chart and FMEA. In this phase, to identify waste based on the current value stream mapping. In the measure phase, the specified control limits product used to maintain the variations of the product, the calculation of the value of DPMO (Defect Per Million Opportunities) and the calculation of the value of sigma level. In analyze phase, determine the type of defect of the most dominant and identify the causes of defective products. In the improve phase, the existing design was modified through various alternative solutions by conducting brainstorming sessions. In this phase, the solution was identified based on the results of FMEA. Improvements were made to the seven priority causes of disability based on the highest RPN value. In the control phase, focusing on improvements to be made. Proposed improvements include making and define standard operating procedures, improving the quality and eliminate waste defective products.

SU-E-T-635: Process Mapping of Eye Plaque Brachytherapy

DOE Office of Scientific and Technical Information (OSTI.GOV)

Huynh, J; Kim, Y

Purpose: To apply a risk-based assessment and analysis technique (AAPM TG 100) to eye plaque brachytherapy treatment of ocular melanoma. Methods: The role and responsibility of personnel involved in the eye plaque brachytherapy is defined for retinal specialist, radiation oncologist, nurse and medical physicist. The entire procedure was examined carefully. First, major processes were identified and then details for each major process were followed. Results: Seventy-one total potential modes were identified. Eight major processes (corresponding detailed number of modes) are patient consultation (2 modes), pretreatment tumor localization (11), treatment planning (13), seed ordering and calibration (10), eye plaque assembly (10),more » implantation (11), removal (11), and deconstruction (3), respectively. Half of the total modes (36 modes) are related to physicist while physicist is not involved in processes such as during the actual procedure of suturing and removing the plaque. Conclusion: Not only can failure modes arise from physicist-related procedures such as treatment planning and source activity calibration, but it can also exist in more clinical procedures by other medical staff. The improvement of the accurate communication for non-physicist-related clinical procedures could potentially be an approach to prevent human errors. More rigorous physics double check would reduce the error for physicist-related procedures. Eventually, based on this detailed process map, failure mode and effect analysis (FMEA) will identify top tiers of modes by ranking all possible modes with risk priority number (RPN). For those high risk modes, fault tree analysis (FTA) will provide possible preventive action plans.« less

Degradation analysis of anode-supported intermediate temperature-solid oxide fuel cells under various failure modes

NASA Astrophysics Data System (ADS)

Lee, Tae-Hee; Park, Ka-Young; Kim, Ji-Tae; Seo, Yongho; Kim, Ki Buem; Song, Sun-Ju; Park, Byoungnam; Park, Jun-Young

2015-02-01

This study focuses on mechanisms and symptoms of several simulated failure modes, which may have significant influences on the long-term durability and operational stability of intermediate temperature-solid oxide fuel cells (IT-SOFCs), including fuel/oxidation starvation by breakdown of fuel/air supply components and wet and dry cycling atmospheres. Anode-supported IT-SOFCs consisting of a Ba0.5Sr0.5Co0.8Fe0.2O3-δ (BSCF)-Nd0.1Ce0.9O2-δ (NDC) composite cathode with an NDC electrolyte on a Ni-NDC anode substrate are fabricated via dry-pressings followed by the co-firing method. Comprehensive and systematic research based on the failure mode and effect analysis (FMEA) of anode-supported IT-SOFCs is conducted using various electrochemical and physiochemical analysis techniques to extend our understanding of the major mechanisms of performance deterioration under SOFC operating conditions. The fuel-starvation condition in the fuel-pump failure mode causes irreversible mechanical degradation of the electrolyte and cathode interface by the dimensional expansion of the anode support due to the oxidation of Ni metal to NiO. In contrast, the BSCF cathode shows poor stability under wet and dry cycling modes of cathode air due to the strong electroactivity of SrO with H2O. On the other hand, the air-depletion phenomena under air-pump failure mode results in the recovery of cell performance during the long-term operation without the visible microstructural transformation through the reduction of anode overvoltage.

Improving Quality of Shoe Soles Product using Six Sigma

NASA Astrophysics Data System (ADS)

Jesslyn Wijaya, Athalia; Trusaji, Wildan; Akbar, Muhammad; Ma’ruf, Anas; Irianto, Dradjad

2018-03-01

A manufacture in Bandung produce kind of rubber-based product i.e. trim, rice rollers, shoe soles, etc. After penetrating the shoe soles market, the manufacture has met customer with tight quality control. Based on the past data, defect level of this product was 18.08% that caused the manufacture’s loss of time and money. Quality improvement effort was done using six sigma method that included phases of define, measure, analyse, improve, and control (DMAIC). In the design phase, the object’s problem and definition were defined. Delphi method was also used in this phase to identify critical factors. In the measure phase, the existing process stability and sigma quality level were measured. Fishbone diagram and failure mode and effect analysis (FMEA) were used in the next phase to analyse the root cause and determine the priority issues. Improve phase was done by designing alternative improvement strategy using 5W1H method. Some improvement efforts were identified, i.e. (i) modifying design of the hanging rack, (ii) create pantone colour book and check sheet, (iii) provide pedestrian line at compound department, (iv) buying stop watch, and (v) modifying shoe soles dies. Some control strategies for continuous improvement were proposed such as SOP or reward and punishment system.

Investigation of improving MEMS-type VOA reliability

NASA Astrophysics Data System (ADS)

Hong, Seok K.; Lee, Yeong G.; Park, Moo Y.

2003-12-01

MEMS technologies have been applied to a lot of areas, such as optical communications, Gyroscopes and Bio-medical components and so on. In terms of the applications in the optical communication field, MEMS technologies are essential, especially, in multi dimensional optical switches and Variable Optical Attenuators(VOAs). This paper describes the process for the development of MEMS type VOAs with good optical performance and improved reliability. Generally, MEMS VOAs have been fabricated by silicon micro-machining process, precise fibre alignment and sophisticated packaging process. Because, it is composed of many structures with various materials, it is difficult to make devices reliable. We have developed MEMS type VOSs with many failure mode considerations (FMEA: Failure Mode Effect Analysis) in the initial design step, predicted critical failure factors and revised the design, and confirmed the reliability by preliminary test. These predicted failure factors were moisture, bonding strength of the wire, which wired between the MEMS chip and TO-CAN and instability of supplied signals. Statistical quality control tools (ANOVA, T-test and so on) were used to control these potential failure factors and produce optimum manufacturing conditions. To sum up, we have successfully developed reliable MEMS type VOAs with good optical performances by controlling potential failure factors and using statistical quality control tools. As a result, developed VOAs passed international reliability standards (Telcodia GR-1221-CORE).

Investigation of improving MEMS-type VOA reliability

NASA Astrophysics Data System (ADS)

Hong, Seok K.; Lee, Yeong G.; Park, Moo Y.

2004-01-01

MEMS technologies have been applied to a lot of areas, such as optical communications, Gyroscopes and Bio-medical components and so on. In terms of the applications in the optical communication field, MEMS technologies are essential, especially, in multi dimensional optical switches and Variable Optical Attenuators(VOAs). This paper describes the process for the development of MEMS type VOAs with good optical performance and improved reliability. Generally, MEMS VOAs have been fabricated by silicon micro-machining process, precise fibre alignment and sophisticated packaging process. Because, it is composed of many structures with various materials, it is difficult to make devices reliable. We have developed MEMS type VOSs with many failure mode considerations (FMEA: Failure Mode Effect Analysis) in the initial design step, predicted critical failure factors and revised the design, and confirmed the reliability by preliminary test. These predicted failure factors were moisture, bonding strength of the wire, which wired between the MEMS chip and TO-CAN and instability of supplied signals. Statistical quality control tools (ANOVA, T-test and so on) were used to control these potential failure factors and produce optimum manufacturing conditions. To sum up, we have successfully developed reliable MEMS type VOAs with good optical performances by controlling potential failure factors and using statistical quality control tools. As a result, developed VOAs passed international reliability standards (Telcodia GR-1221-CORE).

A review for identification of initiating events in event tree development process on nuclear power plants

NASA Astrophysics Data System (ADS)

Riyadi, Eko H.

2014-09-01

Initiating event is defined as any event either internal or external to the nuclear power plants (NPPs) that perturbs the steady state operation of the plant, if operating, thereby initiating an abnormal event such as transient or loss of coolant accident (LOCA) within the NPPs. These initiating events trigger sequences of events that challenge plant control and safety systems whose failure could potentially lead to core damage or large early release. Selection for initiating events consists of two steps i.e. first step, definition of possible events, such as by evaluating a comprehensive engineering, and by constructing a top level logic model. Then the second step, grouping of identified initiating event's by the safety function to be performed or combinations of systems responses. Therefore, the purpose of this paper is to discuss initiating events identification in event tree development process and to reviews other probabilistic safety assessments (PSA). The identification of initiating events also involves the past operating experience, review of other PSA, failure mode and effect analysis (FMEA), feedback from system modeling, and master logic diagram (special type of fault tree). By using the method of study for the condition of the traditional US PSA categorization in detail, could be obtained the important initiating events that are categorized into LOCA, transients and external events.

AMSEC Users Guide.

DTIC Science & Technology

1976-11-01

Hardware • System functional configuration characteristics • Component aging mechanisms (engineering) • Subsystem/component FMEAs • Subsystem...modified to fit the specific mission(s) under investigation. 60 — .- m. • •. mi . ui ••_!!•»•••’ i • .. ••Mil ’’•^•^••BWW^WlWi^Wi...8217 / t / / / s y / ’ / / * y hO | -;-; • / / 1, r T ", 60 / / / • f tl’Jt, s s 1 / ’ • Mode 7 B=4.0 ^ / 7 / 0 Mode 8

The safer clinical systems project in renal care.

PubMed

Weale, Andy R

2013-09-01

Current systems in place in healthcare are designed to detect harm after it has happened (e.g critical incident reports) and make recommendations based on an assessment of that event. Safer Clinical Systems, a Health Foundation funded project, is designed to proactively search for risk within systems, rather than being reactive to harm. The aim of the Safer Clinical Systems project in Renal Care was to reduce the risks associated with shared care for patients who are undergoing surgery but are looked after peri-operatively by nephrology teams on nephrology wards. This report details our findings of the diagnostic phase of Safer Clinical Systems: the proactive search for risk. We have evaluated the current system of care using a set of risk evaluation and process mapping tools (Failure Modes and Effects Analysis (FMEA) and Hierarchical Task Analysis HTA). We have engaged staff with the process mapping and risk assessment tools. We now understand our system and understand where the highest risk tasks are undertaken during a renal in-patient stay during which a patient has an operation. These key tasks occur across the perioperaive period and are not confined to one aspect of care. A measurement strategy and intervention plan have been designed around these tasks. Safer Clinical Systems has identified high risk, low reliability tasks in our system. We look forward to fully reporting these data in 2014. © 2013 European Dialysis and Transplant Nurses Association/European Renal Care Association.

PDA survey of quality risk management practices in the pharmaceutical, devices, & biotechnology industries.

PubMed

Ahmed, Ruhi; Baseman, Harold; Ferreira, Jorge; Genova, Thomas; Harclerode, William; Hartman, Jeffery; Kim, Samuel; Londeree, Nanette; Long, Michael; Miele, William; Ramjit, Timothy; Raschiatore, Marlene; Tomonto, Charles

2008-01-01

In July 2006 the Parenteral Drug Association's Risk Management Task Force for Aseptic Processes, conducted an electronic survey of PDA members to determine current industry practices regarding implementation of Quality Risk Management in their organizations. This electronic survey was open and publicly available via the PDA website and targeted professionals in our industry who are involved in initiating, implementing, or reviewing risk management programs or decisions in their organizations. One hundred twenty-nine members participated and their demographics are presented in the sidebar "Correspondents Profile". Among the major findings are: *The "Aseptic Processing/Filling" operation is the functional area identified as having the greatest need for risk assessment and quality risk management. *The most widely used methodology in industry to identify risk is Failure Mode and Effects Analysis (FMEA). This tool was most widely applied in assessing change control and for adverse event, complaint, or failure investigations. *Despite the fact that personnel training was identified as the strategy most used for controlling/minimizing risk, the largest contributors to sterility failure in operations are still "Personnel". *Most companies still rely on "Manufacturing Controls" to mitigate risk and deemed the utilization of Process Analytical Technology (PAT) least important in this aspect. *A majority of correspondents verified that they did not periodically assess their risk management programs. *A majority of the correspondents desired to see case studies or examples of risk analysis implementation (as applicable to aseptic processing) in future PDA technical reports on risk management.

Addressing Uniqueness and Unison of Reliability and Safety for a Better Integration

NASA Technical Reports Server (NTRS)

Huang, Zhaofeng; Safie, Fayssal

2016-01-01

Over time, it has been observed that Safety and Reliability have not been clearly differentiated, which leads to confusion, inefficiency, and, sometimes, counter-productive practices in executing each of these two disciplines. It is imperative to address this situation to help Reliability and Safety disciplines improve their effectiveness and efficiency. The paper poses an important question to address, "Safety and Reliability - Are they unique or unisonous?" To answer the question, the paper reviewed several most commonly used analyses from each of the disciplines, namely, FMEA, reliability allocation and prediction, reliability design involvement, system safety hazard analysis, Fault Tree Analysis, and Probabilistic Risk Assessment. The paper pointed out uniqueness and unison of Safety and Reliability in their respective roles, requirements, approaches, and tools, and presented some suggestions for enhancing and improving the individual disciplines, as well as promoting the integration of the two. The paper concludes that Safety and Reliability are unique, but compensating each other in many aspects, and need to be integrated. Particularly, the individual roles of Safety and Reliability need to be differentiated, that is, Safety is to ensure and assure the product meets safety requirements, goals, or desires, and Reliability is to ensure and assure maximum achievability of intended design functions. With the integration of Safety and Reliability, personnel can be shared, tools and analyses have to be integrated, and skill sets can be possessed by the same person with the purpose of providing the best value to a product development.

Plastic Injection Quality Controlling Using the Lean Six Sigma and FMEA Method

NASA Astrophysics Data System (ADS)

Mansur, A.; Mu'alim; Sunaryo

2016-01-01

PT. Yogya Presisi Teknikatama Industri (PT. YPTI) is a mold, precision part, and plastic injection maker company. One of the obstacles faced by the company is the high level of nonconformity on its production results. The waste on production process can be identified and classified into four types, i.e.: a). during the process of injection molding machines, b). finishing and cutting processes, c). quality control process and d). the packaging process. The objectives of this research are minimizing the defective goods and reducing the waste using Lean Six Sigma and FMEA approaches, especially for Bush product. From the analysis result, defective types on Bush product can be classified into bubble, speckle, short shoot, sunken, sink mark, over-cut, flashing, and discolor. Based on the attributes data on Bush product, the DPMO score is 988.42 or the sigma level is 4.6, While the DPMO score on the variable data on each dimension i.e.: a). Slit width on the bottom side has DPMO score of 30119 (sigma level 3.37), b). Diameter of the circle on the top side has DPMO score of 392294 (sigma level 1.77), c). Product thickness on the top side has DPMO score of 70474 (sigma level 2.97), d). Product height has DPMO score of 82107 (sigma level 2.89), product thickness on the bottom side has DPMO score of 24448 (sigma level 3.47), and f). Diameter of the circle on the bottom side has DPMO score of 24448 (sigma level 3.47). The highest RPN score on the dominant types of product defects which needs improvement are the defective goods of bubble type has RPN score of 729, flashing and the molten material out on the heating channel has RPN score of 384, over cutting has RPN score of 324 and sink mark has RPN score of 270. The recommendations for improvement that can be given from this research are making checklist for maintenance and production monitoring, enhancing work supervision and inspection, as well as improving the environment and work stations.

Enhancing the management of the noise level using six sigma method: a case study on the machining industry

NASA Astrophysics Data System (ADS)

Rimantho, D.; Hanantya, M. W.

2017-12-01

The hearing disorder is caused by noises in the workplace, it has been a concern for numerous researchers. This study aims to improve the performance of the management of the noise level by applying the six sigma method. Data collection is done directly by using a sound level meter. In addition, several key informants also used in order to gather information related to the problem. The results showed the values of Cp and Cpk on the entire department are still below the recommended value. Moreover, the results also showed the potential failure (DPMO) approximately 115,260.6 and equivalent to the Sigma value is approximately 2.70. Furthermore, the highest value of the RPN in FMEA analysis is the workers not wear factor of earplug which is about 56. Thus, it is necessary to make enhancements to the process of managing the noise level in the framework of continuous improvement.

Present status of the liquid lithium target facility in the international fusion materials irradiation facility (IFMIF)

NASA Astrophysics Data System (ADS)

Nakamura, Hiroo; Riccardi, B.; Loginov, N.; Ara, K.; Burgazzi, L.; Cevolani, S.; Dell'Orco, G.; Fazio, C.; Giusti, D.; Horiike, H.; Ida, M.; Ise, H.; Kakui, H.; Matsui, H.; Micciche, G.; Muroga, T.; Nakamura, Hideo; Shimizu, K.; Sugimoto, M.; Suzuki, A.; Takeuchi, H.; Tanaka, S.; Yoneoka, T.

2004-08-01

During the three year key element technology phase of the International Fusion Materials Irradiation Facility (IFMIF) project, completed at the end of 2002, key technologies have been validated. In this paper, these results are summarized. A water jet experiment simulating Li flow validated stable flow up to 20 m/s with a double reducer nozzle. In addition, a small Li loop experiment validated stable Li flow up to 14 m/s. To control the nitrogen content in Li below 10 wppm will require surface area of a V-Ti alloy getter of 135 m 2. Conceptual designs of diagnostics have been carried out. Moreover, the concept of a remote handling system to replace the back wall based on `cut and reweld' and `bayonet' options has been established. Analysis by FMEA showed safe operation of the target system. Recent activities in the transition phase, started in 2003, and plan for the next phase are also described.

Quality risk management of top spray fluidized bed process for antihypertensive drug formulation with control strategy engendered by Box-behnken experimental design space.

PubMed

Mukharya, Amit; Patel, Paresh U; Shenoy, Dinesh; Chaudhary, Shivang

2013-01-01

Lacidipine (LCDP) is a very low soluble and highly biovariable calcium channel blocker used in the treatment of hypertension. To increase its apparent solubility and to reduce its biovariability, solid dispersion fluid bed processing technology was explored, as it produces highly dispersible granules with a characteristic porous structure that enhances dispersibility, wettability, blend uniformity (by dissolving and spraying a solution of actives), flow ability and compressibility of granules for tableting and reducing variability by uniform drug-binder solution distribution on carrier molecules. Main object of this quality risk management (QRM) study is to provide a sophisticated "robust and rugged" Fluidized Bed Process (FBP) for the preparation of LCDP tablets with desired quality (stability) and performance (dissolution) by quality by design (QbD) concept. THIS STUDY IS PRINCIPALLY FOCUSING ON THOROUGH MECHANISTIC UNDERSTANDING OF THE FBP BY WHICH IT IS DEVELOPED AND SCALED UP WITH A KNOWLEDGE OF THE CRITICAL RISKS INVOLVED IN MANUFACTURING PROCESS ANALYZED BY RISK ASSESSMENT TOOLS LIKE: Qualitative Initial Risk-based Matrix Analysis (IRMA) and Quantitative Failure Mode Effective Analysis (FMEA) to identify and rank parameters with potential to have an impact on In Process/Finished Product Critical Quality Attributes (IP/FP CQAs). These Critical Process Parameters (CPPs) were further refined by DoE and MVDA to develop design space with Real Time Release Testing (RTRT) that leads to implementation of a control strategy to achieve consistent finished product quality at lab scale itself to prevent possible product failure at larger manufacturing scale.

[Application of quality by design in granulation process for Ginkgo leaf tablet (Ⅲ)： process control strategy based on design space].

PubMed

Cui, Xiang-Long; Xu, Bing; Sun, Fei; Dai, Sheng-Yun; Shi, Xin-Yuan; Qiao, Yan-Jiang

2017-03-01

In this paper, under the guidance of quality by design (QbD) concept, the control strategy of the high shear wet granulation process of the ginkgo leaf tablet based on the design space was established to improve the process controllability and product quality consistency. The median granule size (D50) and bulk density (Da) of granules were identified as critical quality attributes (CQAs) and potential critical process parameters (pCPPs) were determined by the failure modes and effect analysis (FMEA). The Plackeet-Burmann experimental design was used to screen pCPPs and the results demonstrated that the binder amount, the wet massing time and the wet mixing impeller speed were critical process parameters (CPPs). The design space of the high shear wet granulation process was developed within pCPPs range based on the Box-Behnken design and quadratic polynomial regression models. ANOVA analysis showed that the P-values of model were less than 0.05 and the values of lack of fit test were more than 0.1, indicating that the relationship between CQAs and CPPs could be well described by the mathematical models. D₅₀ could be controlled within 170 to 500 μm, and the bulk density could be controlled within 0.30 to 0.44 g•cm⁻³ by using any CPPs combination within the scope of design space. Besides, granules produced by process parameters within the design space region could also meet the requirement of tensile strength of the ginkgo leaf tablet.. Copyright© by the Chinese Pharmaceutical Association.

Quality risk management of top spray fluidized bed process for antihypertensive drug formulation with control strategy engendered by Box-behnken experimental design space

PubMed Central

Mukharya, Amit; Patel, Paresh U; Shenoy, Dinesh; Chaudhary, Shivang

2013-01-01

Introduction: Lacidipine (LCDP) is a very low soluble and highly biovariable calcium channel blocker used in the treatment of hypertension. To increase its apparent solubility and to reduce its biovariability, solid dispersion fluid bed processing technology was explored, as it produces highly dispersible granules with a characteristic porous structure that enhances dispersibility, wettability, blend uniformity (by dissolving and spraying a solution of actives), flow ability and compressibility of granules for tableting and reducing variability by uniform drug-binder solution distribution on carrier molecules. Materials and Methods: Main object of this quality risk management (QRM) study is to provide a sophisticated “robust and rugged” Fluidized Bed Process (FBP) for the preparation of LCDP tablets with desired quality (stability) and performance (dissolution) by quality by design (QbD) concept. Results and Conclusion: This study is principally focusing on thorough mechanistic understanding of the FBP by which it is developed and scaled up with a knowledge of the critical risks involved in manufacturing process analyzed by risk assessment tools like: Qualitative Initial Risk-based Matrix Analysis (IRMA) and Quantitative Failure Mode Effective Analysis (FMEA) to identify and rank parameters with potential to have an impact on In Process/Finished Product Critical Quality Attributes (IP/FP CQAs). These Critical Process Parameters (CPPs) were further refined by DoE and MVDA to develop design space with Real Time Release Testing (RTRT) that leads to implementation of a control strategy to achieve consistent finished product quality at lab scale itself to prevent possible product failure at larger manufacturing scale. PMID:23799202

A quality by design approach using artificial intelligence techniques to control the critical quality attributes of ramipril tablets manufactured by wet granulation.

PubMed

Aksu, Buket; Paradkar, Anant; de Matas, Marcel; Özer, Özgen; Güneri, Tamer; York, Peter

2013-02-01

Quality by design (QbD) is an essential part of the modern approach to pharmaceutical quality. This study was conducted in the framework of a QbD project involving ramipril tablets. Preliminary work included identification of the critical quality attributes (CQAs) and critical process parameters (CPPs) based on the quality target product profiles (QTPPs) using the historical data and risk assessment method failure mode and effect analysis (FMEA). Compendial and in-house specifications were selected as QTPPs for ramipril tablets. CPPs that affected the product and process were used to establish an experimental design. The results thus obtained can be used to facilitate definition of the design space using tools such as design of experiments (DoE), the response surface method (RSM) and artificial neural networks (ANNs). The project was aimed at discovering hidden knowledge associated with the manufacture of ramipril tablets using a range of artificial intelligence-based software, with the intention of establishing a multi-dimensional design space that ensures consistent product quality. At the end of the study, a design space was developed based on the study data and specifications, and a new formulation was optimized. On the basis of this formulation, a new laboratory batch formulation was prepared and tested. It was confirmed that the explored formulation was within the design space.

A review for identification of initiating events in event tree development process on nuclear power plants

DOE Office of Scientific and Technical Information (OSTI.GOV)

Riyadi, Eko H., E-mail: e.riyadi@bapeten.go.id

2014-09-30

Initiating event is defined as any event either internal or external to the nuclear power plants (NPPs) that perturbs the steady state operation of the plant, if operating, thereby initiating an abnormal event such as transient or loss of coolant accident (LOCA) within the NPPs. These initiating events trigger sequences of events that challenge plant control and safety systems whose failure could potentially lead to core damage or large early release. Selection for initiating events consists of two steps i.e. first step, definition of possible events, such as by evaluating a comprehensive engineering, and by constructing a top level logicmore » model. Then the second step, grouping of identified initiating event's by the safety function to be performed or combinations of systems responses. Therefore, the purpose of this paper is to discuss initiating events identification in event tree development process and to reviews other probabilistic safety assessments (PSA). The identification of initiating events also involves the past operating experience, review of other PSA, failure mode and effect analysis (FMEA), feedback from system modeling, and master logic diagram (special type of fault tree). By using the method of study for the condition of the traditional US PSA categorization in detail, could be obtained the important initiating events that are categorized into LOCA, transients and external events.« less

Defining process design space for monoclonal antibody cell culture.

PubMed

Abu-Absi, Susan Fugett; Yang, LiYing; Thompson, Patrick; Jiang, Canping; Kandula, Sunitha; Schilling, Bernhard; Shukla, Abhinav A

2010-08-15

The concept of design space has been taking root as a foundation of in-process control strategies for biopharmaceutical manufacturing processes. During mapping of the process design space, the multidimensional combination of operational variables is studied to quantify the impact on process performance in terms of productivity and product quality. An efficient methodology to map the design space for a monoclonal antibody cell culture process is described. A failure modes and effects analysis (FMEA) was used as the basis for the process characterization exercise. This was followed by an integrated study of the inoculum stage of the process which includes progressive shake flask and seed bioreactor steps. The operating conditions for the seed bioreactor were studied in an integrated fashion with the production bioreactor using a two stage design of experiments (DOE) methodology to enable optimization of operating conditions. A two level Resolution IV design was followed by a central composite design (CCD). These experiments enabled identification of the edge of failure and classification of the operational parameters as non-key, key or critical. In addition, the models generated from the data provide further insight into balancing productivity of the cell culture process with product quality considerations. Finally, process and product-related impurity clearance was evaluated by studies linking the upstream process with downstream purification. Production bioreactor parameters that directly influence antibody charge variants and glycosylation in CHO systems were identified.

Collaborative engineering and design management for the Hobby-Eberly Telescope tracker upgrade

NASA Astrophysics Data System (ADS)

Mollison, Nicholas T.; Hayes, Richard J.; Good, John M.; Booth, John A.; Savage, Richard D.; Jackson, John R.; Rafal, Marc D.; Beno, Joseph H.

2010-07-01

The engineering and design of systems as complex as the Hobby-Eberly Telescope's* new tracker require that multiple tasks be executed in parallel and overlapping efforts. When the design of individual subsystems is distributed among multiple organizations, teams, and individuals, challenges can arise with respect to managing design productivity and coordinating successful collaborative exchanges. This paper focuses on design management issues and current practices for the tracker design portion of the Hobby-Eberly Telescope Wide Field Upgrade project. The scope of the tracker upgrade requires engineering contributions and input from numerous fields including optics, instrumentation, electromechanics, software controls engineering, and site-operations. Successful system-level integration of tracker subsystems and interfaces is critical to the telescope's ultimate performance in astronomical observation. Software and process controls for design information and workflow management have been implemented to assist the collaborative transfer of tracker design data. The tracker system architecture and selection of subsystem interfaces has also proven to be a determining factor in design task formulation and team communication needs. Interface controls and requirements change controls will be discussed, and critical team interactions are recounted (a group-participation Failure Modes and Effects Analysis [FMEA] is one of special interest). This paper will be of interest to engineers, designers, and managers engaging in multi-disciplinary and parallel engineering projects that require coordination among multiple individuals, teams, and organizations.

Optimisation of maintenance concept choice using risk-decision factor - a case study

NASA Astrophysics Data System (ADS)

Popovic, Vladimir M.; Vasic, Branko M.; Rakicevic, Branislav B.; Vorotovic, Goran S.

2012-10-01

The design of maintenance system and the corresponding logistic support is a very complex process, during which the aim is to find the compromise solutions regarding the relations among different maintenance procedures and the ways of their implementation. As a result of this, various solutions can be adopted, since this is conditioned by a series of important factors and criteria, which can be contradictory sometimes. There are different perspectives on ways of solving practical maintenance problems, that is dilemmas when it comes to the choice of maintenance concept. The principal dilemma is how and when to decide on carrying out maintenance procedures. Should the decision be based on theoretical grounds or experience, how does one reconcile those two extremes, who is to decide upon this? In this article we have offered one, basically new solution as a possibility for maintenance concept choice, based on a significant modification of the widely used failure modes and effects analysis (FMEA) method. This solution is risk-decision factor (RDF). This is a result of seven parameters (of different importance and weight) that have the key impact on the process of production and logistic support. The application of this factor is illustrated by the example of planning, organisation and functioning of the maintenance system applied in The Institute for Manufacturing Banknotes and Coins (ZIN) in Belgrade.

High Reliability Prototype Quadrupole for the Next Linear Collider

NASA Astrophysics Data System (ADS)

Spencer, C. M.

2001-01-01

The Next Linear Collider (NLC) will require over 5600 magnets, each of which must be highly reliable and/or quickly repairable in order that the NLC reach its 85/ overall availability goal. A multidiscipline engineering team was assembled at SLAC to develop a more reliable electromagnet design than historically had been achieved at SLAC. This team carried out a Failure Mode and Effects Analysis (FMEA) on a standard SLAC quadrupole magnet system. They overcame a number of longstanding design prejudices, producing 10 major design changes. This paper describes how a prototype magnet was constructed and the extensive testing carried out on it to prove full functionality with an improvement in reliability. The magnet's fabrication cost will be compared to the cost of a magnet with the same requirements made in the historic SLAC way. The NLC will use over 1600 of these 12.7 mm bore quadrupoles with a range of integrated strengths from 0.6 to 132 Tesla, a maximum gradient of 135 Tesla per meter, an adjustment range of 0 to -20/ and core lengths from 324 mm to 972 mm. The magnetic center must remain stable to within 1 micron during the 20/ adjustment. A magnetic measurement set-up has been developed that can measure sub-micron shifts of a magnetic center. The prototype satisfied the center shift requirement over the full range of integrated strengths.

Probabilistic Risk Assessment Procedures Guide for NASA Managers and Practitioners (Second Edition)

NASA Technical Reports Server (NTRS)

Stamatelatos,Michael; Dezfuli, Homayoon; Apostolakis, George; Everline, Chester; Guarro, Sergio; Mathias, Donovan; Mosleh, Ali; Paulos, Todd; Riha, David; Smith, Curtis;

WE-B-BRC-02: Risk Analysis and Incident Learning

DOE Office of Scientific and Technical Information (OSTI.GOV)

Fraass, B.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

Aerospace Safety Advisory Panel

NASA Technical Reports Server (NTRS)

1989-01-01

This report provides findings, conclusions and recommendations regarding the National Space Transportation System (NSTS), the Space Station Freedom Program (SSFP), aeronautical projects and other areas of NASA activities. The main focus of the Aerospace Safety Advisory Panel (ASAP) during 1988 has been monitoring and advising NASA and its contractors on the Space Transportation System (STS) recovery program. NASA efforts have restored the flight program with a much better management organization, safety and quality assurance organizations, and management communication system. The NASA National Space Transportation System (NSTS) organization in conjunction with its prime contractors should be encouraged to continue development and incorporation of appropriate design and operational improvements which will further reduce risk. The data from each Shuttle flight should be used to determine if affordable design and/or operational improvements could further increase safety. The review of Critical Items (CILs), Failure Mode Effects and Analyses (FMEAs) and Hazard Analyses (HAs) after the Challenger accident has given the program a massive data base with which to establish a formal program with prioritized changes.

Reliability and Maintainability Analysis for the Amine Swingbed Carbon Dioxide Removal System

NASA Technical Reports Server (NTRS)

Dunbar, Tyler

2016-01-01

I have performed a reliability & maintainability analysis for the Amine Swingbed payload system. The Amine Swingbed is a carbon dioxide removal technology that has gone through 2,400 hours of International Space Station on-orbit use between 2013 and 2016. While the Amine Swingbed is currently an experimental payload system, the Amine Swingbed may be converted to system hardware. If the Amine Swingbed becomes system hardware, it will supplement the Carbon Dioxide Removal Assembly (CDRA) as the primary CO2 removal technology on the International Space Station. NASA is also considering using the Amine Swingbed as the primary carbon dioxide removal technology for future extravehicular mobility units and for the Orion, which will be used for the Asteroid Redirect and Journey to Mars missions. The qualitative component of the reliability and maintainability analysis is a Failure Modes and Effects Analysis (FMEA). In the FMEA, I have investigated how individual components in the Amine Swingbed may fail, and what the worst case scenario is should a failure occur. The significant failure effects are the loss of ability to remove carbon dioxide, the formation of ammonia due to chemical degradation of the amine, and loss of atmosphere because the Amine Swingbed uses the vacuum of space to regenerate the Amine Swingbed. In the quantitative component of the reliability and maintainability analysis, I have assumed a constant failure rate for both electronic and nonelectronic parts. Using this data, I have created a Poisson distribution to predict the failure rate of the Amine Swingbed as a whole. I have determined a mean time to failure for the Amine Swingbed to be approximately 1,400 hours. The observed mean time to failure for the system is between 600 and 1,200 hours. This range includes initial testing of the Amine Swingbed, as well as software faults that are understood to be non-critical. If many of the commercial parts were switched to military-grade parts, the expected mean time to failure would be 2,300 hours. Both calculated mean times to failure for the Amine Swingbed use conservative failure rate models. The observed mean time to failure for CDRA is 2,500 hours. Working on this project and for NASA in general has helped me gain insight into current aeronautics missions, reliability engineering, circuit analysis, and different cultures. Prior my internship, I did not have a lot knowledge about the work being performed at NASA. As a chemical engineer, I had not really considered working for NASA as a career path. By engaging in interactions with civil servants, contractors, and other interns, I have learned a great deal about modern challenges that NASA is addressing. My work has helped me develop a knowledge base in safety and reliability that would be difficult to find elsewhere. Prior to this internship, I had not thought about reliability engineering. Now, I have gained a skillset in performing reliability analyses, and understanding the inner workings of a large mechanical system. I have also gained experience in understanding how electrical systems work while I was analyzing the electrical components of the Amine Swingbed. I did not expect to be exposed to as many different cultures as I have while working at NASA. I am referring to both within NASA and the Houston area. NASA employs individuals with a broad range of backgrounds. It has been great to learn from individuals who have highly diverse experiences and outlooks on the world. In the Houston area, I have come across individuals from different parts of the world. Interacting with such a high number of individuals with significantly different backgrounds has helped me to grow as a person in ways that I did not expect. My time at NASA has opened a window into the field of aeronautics. After earning a bachelor's degree in chemical engineering, I plan to go to graduate school for a PhD in engineering. Prior to coming to NASA, I was not aware of the graduate Pathways program. I intend to apply for the graduate Pathways program as positions are opened up. I would like to pursue future opportunities with NASA, especially as my engineering career progresses.

The reliability-quality relationship for quality systems and quality risk management.

PubMed

Claycamp, H Gregg; Rahaman, Faiad; Urban, Jason M

2012-01-01

Engineering reliability typically refers to the probability that a system, or any of its components, will perform a required function for a stated period of time and under specified operating conditions. As such, reliability is inextricably linked with time-dependent quality concepts, such as maintaining a state of control and predicting the chances of losses from failures for quality risk management. Two popular current good manufacturing practice (cGMP) and quality risk management tools, failure mode and effects analysis (FMEA) and root cause analysis (RCA) are examples of engineering reliability evaluations that link reliability with quality and risk. Current concepts in pharmaceutical quality and quality management systems call for more predictive systems for maintaining quality; yet, the current pharmaceutical manufacturing literature and guidelines are curiously silent on engineering quality. This commentary discusses the meaning of engineering reliability while linking the concept to quality systems and quality risk management. The essay also discusses the difference between engineering reliability and statistical (assay) reliability. The assurance of quality in a pharmaceutical product is no longer measured only "after the fact" of manufacturing. Rather, concepts of quality systems and quality risk management call for designing quality assurance into all stages of the pharmaceutical product life cycle. Interestingly, most assays for quality are essentially static and inform product quality over the life cycle only by being repeated over time. Engineering process reliability is the fundamental concept that is meant to anticipate quality failures over the life cycle of the product. Reliability is a well-developed theory and practice for other types of manufactured products and manufacturing processes. Thus, it is well known to be an appropriate index of manufactured product quality. This essay discusses the meaning of reliability and its linkages with quality systems and quality risk management.

Analysis of design tool attributes with regards to sustainability benefits

NASA Astrophysics Data System (ADS)

Zain, S.; Ismail, A. F.; Ahmad, Z.; Adesta, E. Y. T.

2018-01-01

The trend of global manufacturing competitiveness has shown a significant shift from profit and customer driven business to a more harmonious sustainability paradigm. This new direction, which emphasises the interests of three pillars of sustainability, i.e., social, economic and environment dimensions, has changed the ways products are designed. As a result, the roles of design tools in the product development stage of manufacturing in adapting to the new strategy are vital and increasingly challenging. The aim of this paper is to review the literature on the attributes of design tools with regards to the sustainability perspective. Four well-established design tools are selected, namely Quality Function Deployment (QFD), Failure Mode and Element Analysis (FMEA), Design for Six Sigma (DFSS) and Design for Environment (DfE). By analysing previous studies, the main attributes of each design tool and its benefits with respect to each sustainability dimension throughout four stages of product lifecycle are discussed. From this study, it is learnt that each of the design tools contributes to the three pillars of sustainability either directly or indirectly, but they are unbalanced and not holistic. Therefore, the prospective of improving and optimising the design tools is projected, and the possibility of collaboration between the different tools is discussed.

Probabilistic Risk Assessment (PRA): A Practical and Cost Effective Approach

NASA Technical Reports Server (NTRS)

Lee, Lydia L.; Ingegneri, Antonino J.; Djam, Melody

2006-01-01

The Lunar Reconnaissance Orbiter (LRO) is the first mission of the Robotic Lunar Exploration Program (RLEP), a space exploration venture to the Moon, Mars and beyond. The LRO mission includes spacecraft developed by NASA Goddard Space Flight Center (GSFC) and seven instruments built by GSFC, Russia, and contractors across the nation. LRO is defined as a measurement mission, not a science mission. It emphasizes the overall objectives of obtaining data to facilitate returning mankind safely to the Moon in preparation for an eventual manned mission to Mars. As the first mission in response to the President's commitment of the journey of exploring the solar system and beyond: returning to the Moon in the next decade, then venturing further into the solar system, ultimately sending humans to Mars and beyond, LRO has high-visibility to the public but limited resources and a tight schedule. This paper demonstrates how NASA's Lunar Reconnaissance Orbiter Mission project office incorporated reliability analyses in assessing risks and performing design tradeoffs to ensure mission success. Risk assessment is performed using NASA Procedural Requirements (NPR) 8705.5 - Probabilistic Risk Assessment (PRA) Procedures for NASA Programs and Projects to formulate probabilistic risk assessment (PRA). As required, a limited scope PRA is being performed for the LRO project. The PRA is used to optimize the mission design within mandated budget, manpower, and schedule constraints. The technique that LRO project office uses to perform PRA relies on the application of a component failure database to quantify the potential mission success risks. To ensure mission success in an efficient manner, low cost and tight schedule, the traditional reliability analyses, such as reliability predictions, Failure Modes and Effects Analysis (FMEA), and Fault Tree Analysis (FTA), are used to perform PRA for the large system of LRO with more than 14,000 piece parts and over 120 purchased or contractor built components.

Evaluation of Computer Software in an Operational Environment.

DTIC Science & Technology

1980-08-01

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Application of telecom planar lightwave circuits for homeland security sensing

NASA Astrophysics Data System (ADS)

Veldhuis, Gert J.; Elders, Job; van Weerden, Harm; Amersfoort, Martin

2004-03-01

Over the past decade, a massive effort has been made in the development of planar lightwave circuits (PLCs) for application in optical telecommunications. Major advances have been made, on both the technological and functional performance front. Highly sophisticated software tools that are used to tailor designs to required functional performance support these developments. In addition extensive know-how in the field of packaging, testing, and failure mode and effects analysis (FMEA) has been built up in the struggle for meeting the stringent Telcordia requirements that apply to telecom products. As an example, silica-on-silicon is now a mature technology available at several industrial foundries around the world, where, on the performance front, the arrayed-waveguide grating (AWG) has evolved into an off-the-shelf product. The field of optical chemical-biological (CB) sensors for homeland security application can greatly benefit from the advances as described above. In this paper we discuss the currently available technologies, device concepts, and modeling tools that have emerged from the telecommunications arena and that can effectively be applied to the field of homeland security. Using this profound telecom knowledge base, standard telecom components can readily be tailored for detecting CB agents. Designs for telecom components aim at complete isolation from the environment to exclude impact of environmental parameters on optical performance. For sensing applications, the optical path must be exposed to the measurand, in this area additional development is required beyond what has already been achieved in telecom development. We have tackled this problem, and are now in a position to apply standard telecom components for CB sensing. As an example, the application of an AWG as a refractometer is demonstrated, and its performance evaluated.

QbD-enabled systematic development of gastroretentive multiple-unit microballoons of itopride hydrochloride.

PubMed

Bansal, Sanjay; Beg, Sarwar; Asthana, Abhay; Garg, Babita; Asthana, Gyati Shilakari; Kapil, Rishi; Singh, Bhupinder

2016-01-01

The objectives of present studies were to develop the systematically optimized multiple-unit gastroretentive microballoons, i.e. hollow microspheres of itopride hydrochloride (ITH) employing quality by design (QbD)-based approach. Initially, the patient-centric QTPP and CQAs were earmarked, and preliminary studies were conducted to screen the suitable polymer, solvent, solvent ratio, pH and temperature conditions. Microspheres were prepared by non-aqueous solvent evaporation method employing Eudragit S-100. Risk assessment studies carried out by constructing Ishikawa cause-effect fish-bone diagram, and techniques like risk estimation matrix (REM) and failure mode effect analysis (FMEA) facilitated the selection of plausible factors affecting the drug product CQAs, i.e. percent yield, entrapment efficiency (EE) and percent buoyancy. A 3(3) Box-Behnken design (BBD) was employed for optimizing CMAs and CPPs selected during factor screening studies employing Taguchi design, i.e. drug-polymer ratio (X1), stirring temperature (X2) and stirring speed (X3). The hollow microspheres, as per BBD, were evaluated for EE, particle size and drug release characteristics. The optimum formulation was embarked upon using numerical desirability function yielding excellent floatation characteristics along with adequate drug release control. Drug-excipient compatibility studies employing FT-IR, DSC and powder XRD revealed absence of significant interaction among the formulation excipients. The SEM studies on the optimized formulation showed hollow and spherical nature of the prepared microspheres. In vivo X-ray imaging studies in rabbits confirmed the buoyant nature of the hollow microspheres for 8 h in the upper GI tract. In a nutshell, the current investigations report the successful development of gastroretentive floating microspheres for once-a-day administration of ITH.

WE-B-BRC-01: Current Methodologies in Risk Assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rath, F.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

WE-B-BRC-03: Risk in the Context of Medical Imaging

DOE Office of Scientific and Technical Information (OSTI.GOV)

Samei, E.

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

WE-B-BRC-00: Concepts in Risk-Based Assessment

DOE Office of Scientific and Technical Information (OSTI.GOV)

NONE

Prospective quality management techniques, long used by engineering and industry, have become a growing aspect of efforts to improve quality management and safety in healthcare. These techniques are of particular interest to medical physics as scope and complexity of clinical practice continue to grow, thus making the prescriptive methods we have used harder to apply and potentially less effective for our interconnected and highly complex healthcare enterprise, especially in imaging and radiation oncology. An essential part of most prospective methods is the need to assess the various risks associated with problems, failures, errors, and design flaws in our systems. Wemore » therefore begin with an overview of risk assessment methodologies used in healthcare and industry and discuss their strengths and weaknesses. The rationale for use of process mapping, failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by TG-100 will be described, as well as suggestions for the way forward. This is followed by discussion of radiation oncology specific risk assessment strategies and issues, including the TG-100 effort to evaluate IMRT and other ways to think about risk in the context of radiotherapy. Incident learning systems, local as well as the ASTRO/AAPM ROILS system, can also be useful in the risk assessment process. Finally, risk in the context of medical imaging will be discussed. Radiation (and other) safety considerations, as well as lack of quality and certainty all contribute to the potential risks associated with suboptimal imaging. The goal of this session is to summarize a wide variety of risk analysis methods and issues to give the medical physicist access to tools which can better define risks (and their importance) which we work to mitigate with both prescriptive and prospective risk-based quality management methods. Learning Objectives: Description of risk assessment methodologies used in healthcare and industry Discussion of radiation oncology-specific risk assessment strategies and issues Evaluation of risk in the context of medical imaging and image quality E. Samei: Research grants from Siemens and GE.« less

Development of the Functional Flow Block Diagram for the J-2X Rocket Engine System

NASA Technical Reports Server (NTRS)

White, Thomas; Stoller, Sandra L.; Greene, WIlliam D.; Christenson, Rick L.; Bowen, Barry C.

2007-01-01

The J-2X program calls for the upgrade of the Apollo-era Rocketdyne J-2 engine to higher power levels, using new materials and manufacturing techniques, and with more restrictive safety and reliability requirements than prior human-rated engines in NASA history. Such requirements demand a comprehensive systems engineering effort to ensure success. Pratt & Whitney Rocketdyne system engineers performed a functional analysis of the engine to establish the functional architecture. J-2X functions were captured in six major operational blocks. Each block was divided into sub-blocks or states. In each sub-block, functions necessary to perform each state were determined. A functional engine schematic consistent with the fidelity of the system model was defined for this analysis. The blocks, sub-blocks, and functions were sequentially numbered to differentiate the states in which the function were performed and to indicate the sequence of events. The Engine System was functionally partitioned, to provide separate and unique functional operators. Establishing unique functional operators as work output of the System Architecture process is novel in Liquid Propulsion Engine design. Each functional operator was described such that its unique functionality was identified. The decomposed functions were then allocated to the functional operators both of which were the inputs to the subsystem or component performance specifications. PWR also used a novel approach to identify and map the engine functional requirements to customer-specified functions. The final result was a comprehensive Functional Flow Block Diagram (FFBD) for the J-2X Engine System, decomposed to the component level and mapped to all functional requirements. This FFBD greatly facilitates component specification development, providing a well-defined trade space for functional trades at the subsystem and component level. It also provides a framework for function-based failure modes and effects analysis (FMEA), and a rigorous baseline for the functional architecture.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Wijesooriya, K; Seitter, K; Desai, V

Purpose: To present our single institution experience on catching errors with trajectory log file analysis. The reported causes of failures, probability of occurrences (O), severity of effects (S), and the probability of the failures to be undetected (D) could be added to guidelines of FMEA analysis. Methods: From March 2013 to March 2014, 19569 patient treatment fields/arcs were analyzed. This work includes checking all 131 treatment delivery parameters for all patients, all treatment sites and all treatment delivery fractions. TrueBeam trajectory log files for all treatment field types as well as all imaging types were accessed, read in every 20ms,more » and every control point (total of 37 million parameters) compared to the physician approved plan in the planning system. Results: Couch angle outlier occurrence: N= 327, range = −1.7 −1.2 deg; gantry angle outlier occurrence: N =59, range = 0.09 – 5.61 deg, collimator angle outlier occurrence: N = 13, range = −0.2 – 0.2 deg. VMAT cases have slightly larger variations in mechanical parameters. MLC: 3D single control point fields have a maximum deviation of 0.04 mm, 39 step and shoot IMRT cases have MLC −0.3 – 0.5 mm deviations, all (1286) VMAT cases have −0.9 – 0.7 mm deviations. Two possible serious errors were found: 1) A 4 cm isocenter shift for the PA beam of an AP-PA pair, under-dosing a portion of PTV by 25%. 2) Delivery with MLC leaves abutted behind the jaws as opposed to the midline as planned, leading to a under-dosing of a small volume of the PTV by 25%, by just the boost plan. Due to their error origin, neither of these errors could have been detected by pre-treatment verification. Conclusion: Performing Trajectory Log file analysis could catch typically undetected errors to avoid potentially adverse incidents.« less

Final Report: Modifications and Optimization of the Organic Rankine Cycle to Improve the Recovery of Waste Heat

DOE Office of Scientific and Technical Information (OSTI.GOV)

Guillen, Donna Post; Zia, Jalal

2013-09-01

This research and development (R&D) project exemplifies a shared public private commitment to advance the development of energy efficient industrial technologies that will reduce the U.S. dependence upon foreign oil, provide energy savings and reduce greenhouse gas emissions. The purpose of this project was to develop and demonstrate a Direct Evaporator for the Organic Rankine Cycle (ORC) for the conversion of waste heat from gas turbine exhaust to electricity. In conventional ORCs, the heat from the exhaust stream is transferred indirectly to a hydrocarbon based working fluid by means of an intermediate thermal oil loop. The Direct Evaporator accomplishes preheating,more » evaporation and superheating of the working fluid by a heat exchanger placed within the exhaust gas stream. Direct Evaporation is simpler and up to 15% less expensive than conventional ORCs, since the secondary oil loop and associated equipment can be eliminated. However, in the past, Direct Evaporation has been avoided due to technical challenges imposed by decomposition and flammability of the working fluid. The purpose of this project was to retire key risks and overcome the technical barriers to implementing an ORC with Direct Evaporation. R&D was conducted through a partnership between the Idaho National Laboratory (INL) and General Electric (GE) Global Research Center (GRC). The project consisted of four research tasks: (1) Detailed Design & Modeling of the ORC Direct Evaporator, (2) Design and Construction of Partial Prototype Direct Evaporator Test Facility, (3) Working Fluid Decomposition Chemical Analyses, and (4) Prototype Evaluation. Issues pertinent to the selection of an ORC working fluid, along with thermodynamic and design considerations of the direct evaporator, were identified. The FMEA (Failure modes and effects analysis) and HAZOP (Hazards and operability analysis) safety studies performed to mitigate risks are described, followed by a discussion of the flammability analysis of the direct evaporator. A testbed was constructed and the prototype demonstrated at the GE GRC Niskayuna facility.« less

Risk, Issues and Lessons Learned: Maximizing Risk Management in the DoD Ground Domain

DTIC Science & Technology

2011-09-01

mpor an r s s e ore ey urn n o ssues . - Carnegie Mellon University “Risk Management Overview for TACOM” Benefits of Risk Management include: • Risk...min 10 inch  length) • Ketchup (Heinz) •Mustard (yellow) • Onions (chopped) • Chili (no beans)      • Hot dog sub‐assy Unclassified How does FMEA work...risk early SAVES MONEY! ARE YOU USING FMEA?  CAN YOU AFFORD NOT TO? How can we use FMEA to our  benefit ? Use it proactively  to prevent failures Use it

FMEA on the superconducting torus for the Jefferson Lab 12 GeV accelerator upgrade

DOE PAGES

Ghoshal, Probir K.; Biallas, George H.; Fair, Ruben J.; ...

2015-01-16

As part of the Jefferson Lab 12GeV accelerator upgrade project, Hall B requires two conduction cooled superconducting magnets. One is a magnet system consisting of six superconducting trapezoidal racetrack-type coils assembled in a toroidal configuration and the second is an actively shielded solenoidal magnet system consisting of 5 coils. Both magnets are to be wound with Superconducting Super Collider-36 NbTi strand Rutherford cable soldered into a copper channel. This paper describes the various failure modes in torus magnet along with the failure modes that could be experienced by the torus and its interaction with the solenoid which is located inmore » close proximity.« less

Implementation of Quality by Design for Formulation of Rebamipide Gastro-retentive Tablet.

PubMed

Ha, Jung-Myung; Seo, Jeong-Woong; Kim, Su-Hyeon; Kim, Ju-Young; Park, Chun-Woong; Rhee, Yun-Seok; Park, Eun-Seok

2017-11-01

The purpose of the present study was to develop a rebamipide (RBM) gastro-retentive (GR) tablet by implementing quality by design (QbD). RBM GR tablets were prepared using a sublimation method. Quality target product profile (QTPP) and critical quality attributes (CQAs) of the RBM GR tablets were defined according to the preliminary studies. Factors affecting the CQAs were prioritized using failure mode and effects analysis (FMEA). Design space and optimum formulation were established through a mixture design. The validity of the design space was confirmed using runs within the area. The QTPP of the RBM GR tablets was the orally administered GR tablet containing 300 mg of RBM taken once daily. Based on the QTPP, dissolution rate, tablet friability, and floating property were chosen as CQAs. According to the risk assessment, the amount of sustained-release agent, sublimating material, and diluent showed high-risk priority number (RPN) values above 40. Based on the RPN, these factors were further investigated using mixture design methodology. Design space of formulations was depicted as an overlaid contour plot and the optimum formulation to satisfy the desired responses was obtained by determining the expected value of each response. The similarity factor (f2) of the release profile between predicted response and experimental response was 89.463, suggesting that two release profiles are similar. The validity of the design space was also confirmed. Consequently, we were able to develop the RBM GR tablets by implementing the QbD concept. These results provide useful information for development of tablet formulations using the QbD.

Reliability analysis in the Office of Safety, Environmental, and Mission Assurance (OSEMA)

NASA Astrophysics Data System (ADS)

Kauffmann, Paul J.

1994-12-01

The technical personnel in the SEMA office are working to provide the highest degree of value-added activities to their support of the NASA Langley Research Center mission. Management perceives that reliability analysis tools and an understanding of a comprehensive systems approach to reliability will be a foundation of this change process. Since the office is involved in a broad range of activities supporting space mission projects and operating activities (such as wind tunnels and facilities), it was not clear what reliability tools the office should be familiar with and how these tools could serve as a flexible knowledge base for organizational growth. Interviews and discussions with the office personnel (both technicians and engineers) revealed that job responsibilities ranged from incoming inspection to component or system analysis to safety and risk. It was apparent that a broad base in applied probability and reliability along with tools for practical application was required by the office. A series of ten class sessions with a duration of two hours each was organized and scheduled. Hand-out materials were developed and practical examples based on the type of work performed by the office personnel were included. Topics covered were: Reliability Systems - a broad system oriented approach to reliability; Probability Distributions - discrete and continuous distributions; Sampling and Confidence Intervals - random sampling and sampling plans; Data Analysis and Estimation - Model selection and parameter estimates; and Reliability Tools - block diagrams, fault trees, event trees, FMEA. In the future, this information will be used to review and assess existing equipment and processes from a reliability system perspective. An analysis of incoming materials sampling plans was also completed. This study looked at the issues associated with Mil Std 105 and changes for a zero defect acceptance sampling plan.

Reliability analysis in the Office of Safety, Environmental, and Mission Assurance (OSEMA)

NASA Technical Reports Server (NTRS)

Kauffmann, Paul J.

1994-01-01

The technical personnel in the SEMA office are working to provide the highest degree of value-added activities to their support of the NASA Langley Research Center mission. Management perceives that reliability analysis tools and an understanding of a comprehensive systems approach to reliability will be a foundation of this change process. Since the office is involved in a broad range of activities supporting space mission projects and operating activities (such as wind tunnels and facilities), it was not clear what reliability tools the office should be familiar with and how these tools could serve as a flexible knowledge base for organizational growth. Interviews and discussions with the office personnel (both technicians and engineers) revealed that job responsibilities ranged from incoming inspection to component or system analysis to safety and risk. It was apparent that a broad base in applied probability and reliability along with tools for practical application was required by the office. A series of ten class sessions with a duration of two hours each was organized and scheduled. Hand-out materials were developed and practical examples based on the type of work performed by the office personnel were included. Topics covered were: Reliability Systems - a broad system oriented approach to reliability; Probability Distributions - discrete and continuous distributions; Sampling and Confidence Intervals - random sampling and sampling plans; Data Analysis and Estimation - Model selection and parameter estimates; and Reliability Tools - block diagrams, fault trees, event trees, FMEA. In the future, this information will be used to review and assess existing equipment and processes from a reliability system perspective. An analysis of incoming materials sampling plans was also completed. This study looked at the issues associated with Mil Std 105 and changes for a zero defect acceptance sampling plan.

The report of Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management

PubMed Central

Huq, M. Saiful; Fraass, Benedick A.; Dunscombe, Peter B.; Gibbons, John P.; Mundt, Arno J.; Mutic, Sasa; Palta, Jatinder R.; Rath, Frank; Thomadsen, Bruce R.; Williamson, Jeffrey F.; Yorke, Ellen D.

2016-01-01

The increasing complexity of modern radiation therapy planning and delivery challenges traditional prescriptive quality management (QM) methods, such as many of those included in guidelines published by organizations such as the AAPM, ASTRO, ACR, ESTRO, and IAEA. These prescriptive guidelines have traditionally focused on monitoring all aspects of the functional performance of radiotherapy (RT) equipment by comparing parameters against tolerances set at strict but achievable values. Many errors that occur in radiation oncology are not due to failures in devices and software; rather they are failures in workflow and process. A systematic understanding of the likelihood and clinical impact of possible failures throughout a course of radiotherapy is needed to direct limit QM resources efficiently to produce maximum safety and quality of patient care. Task Group 100 of the AAPM has taken a broad view of these issues and has developed a framework for designing QM activities, based on estimates of the probability of identified failures and their clinical outcome through the RT planning and delivery process. The Task Group has chosen a specific radiotherapy process required for “intensity modulated radiation therapy (IMRT)” as a case study. The goal of this work is to apply modern risk-based analysis techniques to this complex RT process in order to demonstrate to the RT community that such techniques may help identify more effective and efficient ways to enhance the safety and quality of our treatment processes. The task group generated by consensus an example quality management program strategy for the IMRT process performed at the institution of one of the authors. This report describes the methodology and nomenclature developed, presents the process maps, FMEAs, fault trees, and QM programs developed, and makes suggestions on how this information could be used in the clinic. The development and implementation of risk-assessment techniques will make radiation therapy safer and more efficient. PMID:27370140

The report of Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management

DOE Office of Scientific and Technical Information (OSTI.GOV)

Huq, M. Saiful, E-mail: HUQS@UPMC.EDU

The increasing complexity of modern radiation therapy planning and delivery challenges traditional prescriptive quality management (QM) methods, such as many of those included in guidelines published by organizations such as the AAPM, ASTRO, ACR, ESTRO, and IAEA. These prescriptive guidelines have traditionally focused on monitoring all aspects of the functional performance of radiotherapy (RT) equipment by comparing parameters against tolerances set at strict but achievable values. Many errors that occur in radiation oncology are not due to failures in devices and software; rather they are failures in workflow and process. A systematic understanding of the likelihood and clinical impact ofmore » possible failures throughout a course of radiotherapy is needed to direct limit QM resources efficiently to produce maximum safety and quality of patient care. Task Group 100 of the AAPM has taken a broad view of these issues and has developed a framework for designing QM activities, based on estimates of the probability of identified failures and their clinical outcome through the RT planning and delivery process. The Task Group has chosen a specific radiotherapy process required for “intensity modulated radiation therapy (IMRT)” as a case study. The goal of this work is to apply modern risk-based analysis techniques to this complex RT process in order to demonstrate to the RT community that such techniques may help identify more effective and efficient ways to enhance the safety and quality of our treatment processes. The task group generated by consensus an example quality management program strategy for the IMRT process performed at the institution of one of the authors. This report describes the methodology and nomenclature developed, presents the process maps, FMEAs, fault trees, and QM programs developed, and makes suggestions on how this information could be used in the clinic. The development and implementation of risk-assessment techniques will make radiation therapy safer and more efficient.« less

The report of Task Group 100 of the AAPM: Application of risk analysis methods to radiation therapy quality management.

PubMed

Huq, M Saiful; Fraass, Benedick A; Dunscombe, Peter B; Gibbons, John P; Ibbott, Geoffrey S; Mundt, Arno J; Mutic, Sasa; Palta, Jatinder R; Rath, Frank; Thomadsen, Bruce R; Williamson, Jeffrey F; Yorke, Ellen D

2016-07-01

The increasing complexity of modern radiation therapy planning and delivery challenges traditional prescriptive quality management (QM) methods, such as many of those included in guidelines published by organizations such as the AAPM, ASTRO, ACR, ESTRO, and IAEA. These prescriptive guidelines have traditionally focused on monitoring all aspects of the functional performance of radiotherapy (RT) equipment by comparing parameters against tolerances set at strict but achievable values. Many errors that occur in radiation oncology are not due to failures in devices and software; rather they are failures in workflow and process. A systematic understanding of the likelihood and clinical impact of possible failures throughout a course of radiotherapy is needed to direct limit QM resources efficiently to produce maximum safety and quality of patient care. Task Group 100 of the AAPM has taken a broad view of these issues and has developed a framework for designing QM activities, based on estimates of the probability of identified failures and their clinical outcome through the RT planning and delivery process. The Task Group has chosen a specific radiotherapy process required for "intensity modulated radiation therapy (IMRT)" as a case study. The goal of this work is to apply modern risk-based analysis techniques to this complex RT process in order to demonstrate to the RT community that such techniques may help identify more effective and efficient ways to enhance the safety and quality of our treatment processes. The task group generated by consensus an example quality management program strategy for the IMRT process performed at the institution of one of the authors. This report describes the methodology and nomenclature developed, presents the process maps, FMEAs, fault trees, and QM programs developed, and makes suggestions on how this information could be used in the clinic. The development and implementation of risk-assessment techniques will make radiation therapy safer and more efficient.

The key incident monitoring and management system - history and role in quality improvement.

PubMed

Badrick, Tony; Gay, Stephanie; Mackay, Mark; Sikaris, Ken

2018-01-26

The determination of reliable, practical Quality Indicators (QIs) from presentation of the patient with a pathology request form through to the clinician receiving the report (the Total Testing Process or TTP) is a key step in identifying areas where improvement is necessary in laboratories. The Australasian QIs programme Key Incident Monitoring and Management System (KIMMS) began in 2008. It records incidents (process defects) and episodes (occasions at which incidents may occur) to calculate incident rates. KIMMS also uses the Failure Mode Effects Analysis (FMEA) to assign quantified risk to each incident type. The system defines risk as incident frequency multiplied by both a harm rating (on a 1-10 scale) and detection difficulty score (also a 1-10 scale). Between 2008 and 2016, laboratories participating rose from 22 to 69. Episodes rose from 13.2 to 43.4 million; incidents rose from 114,082 to 756,432. We attribute the rise in incident rate from 0.86% to 1.75% to increased monitoring. Haemolysis shows the highest incidence (22.6% of total incidents) and the highest risk (26.68% of total risk). "Sample is suspected to be from the wrong patient" has the second lowest frequency, but receives the highest harm rating (10/10) and detection difficulty score (10/10), so it is calculated to be the 8th highest risk (2.92%). Similarly, retracted (incorrect) reports QI has the 10th highest frequency (3.9%) but the harm/difficulty calculation confers the second highest risk (11.17%). TTP incident rates are generally low (less than 2% of observed episodes), however, incident risks, their frequencies multiplied by both ratings of harm and discovery difficulty scores, concentrate improvement attention and resources on the monitored incident types most important to manage.

Design and optimization of a chromatographic purification process for Streptococcus pneumoniae serotype 23F capsular polysaccharide by a Design of Experiments approach.

PubMed

Ji, Yu; Tian, Yang; Ahnfelt, Mattias; Sui, Lili

2014-06-27

Multivalent pneumococcal vaccines were used worldwide to protect human beings from pneumococcal diseases. In order to eliminate the toxic organic solutions used in the traditional vaccine purification process, an alternative chromatographic process for Streptococcus pneumoniae serotype 23F capsular polysaccharide (CPS) was proposed in this study. The strategy of Design of Experiments (DoE) was introduced into the process development to solve the complicated design procedure. An initial process analysis was given to review the whole flowchart, identify the critical factors of chromatography through FMEA and chose the flowthrough mode due to the property of the feed. A resin screening study was then followed to select candidate resins. DoE was utilized to generate a resolution IV fractional factorial design to further compare candidates and narrow down the design space. After Capto Adhere was selected, the Box-Behnken DoE was executed to model the process and characterize all effects of factors on the responses. Finally, Monte Carlo simulation was used to optimize the process, test the chosen optimal conditions and define the control limit. The results of three scale-up runs at set points verified the DoE and simulation predictions. The final results were well in accordance with the EU pharmacopeia requirements: Protein/CPS (w/w) 1.08%; DNA/CPS (w/w) 0.61%; the phosphorus content 3.1%; the nitrogen 0.315% and the Methyl-pentose percentage 47.9%. Other tests of final pure CPS also met the pharmacopeia specifications. This alternative chromatographic purification process for pneumococcal vaccine without toxic organic solvents was successfully developed by the DoE approach and proved scalability, robustness and suitability for large scale manufacturing. Copyright © 2014 Elsevier B.V. All rights reserved.

Machinery safety of lathe machine using SHARP-systemic human action reliability procedure: a pilot case study in academic laboratory

NASA Astrophysics Data System (ADS)

Suryoputro, M. R.; Sari, A. D.; Sugarindra, M.; Arifin, R.

2017-12-01

This research aimed to understand the human reliability analysis, to find the SHARP method with its functionality on case study and also emphasize the practice in Lathe machine, continued with identifying improvement that could be made to the existing safety system. SHARP comprises of 7 stages including definition, screening, breakdown, representation, impact assessment, quantification and documentation. These steps were combined and analysed using HIRA, FTA and FMEA. HIRA analysed the lathe at academic laboratory showed the level of the highest risk with a score of 9 for the activities of power transmission parts and a score of 6 for activities which shall mean the moving parts required to take action to reduce the level of risk. Hence, the highest RPN values obtained in the power transmission activities with a value of 18 in the power transmission and then the activities of moving parts is 12 and the activities of the operating point of 8. Thus, this activity has the highest risk of workplace accidents in the operation. On the academic laboratory the improvement made on the engineering control initially with a machine guarding and completed with necessary administrative controls (SOP, work permit, training and routine cleaning) and dedicated PPEs.

Enhancement of Efficiency and Reduction of Grid Thickness Variation on Casting Process with Lean Six Sigma Method

NASA Astrophysics Data System (ADS)

Witantyo; Setyawan, David

2018-03-01

In a lead acid battery industry, grid casting is a process that has high defect and thickness variation level. DMAIC (Define-Measure-Analyse-Improve-Control) method and its tools will be used to improve the casting process. In the Define stage, it is used project charter and SIPOC (Supplier Input Process Output Customer) method to map the existent problem. In the Measure stage, it is conducted a data retrieval related to the types of defect and the amount of it, also the grid thickness variation that happened. And then the retrieved data is processed and analyzed by using 5 Why’s and FMEA method. In the Analyze stage, it is conducted a grid observation that experience fragile and crack type of defect by using microscope showing the amount of oxide Pb inclusion in the grid. Analysis that is used in grid casting process shows the difference of temperature that is too high between the metal fluid and mold temperature, also the corking process that doesn’t have standard. The Improve stage is conducted a fixing process which generates the reduction of grid variation thickness level and defect/unit level from 9,184% to 0,492%. In Control stage, it is conducted a new working standard determination and already fixed control process.

A Comparison of Functional Models for Use in the Function-Failure Design Method

NASA Technical Reports Server (NTRS)

Stock, Michael E.; Stone, Robert B.; Tumer, Irem Y.

2006-01-01

When failure analysis and prevention, guided by historical design knowledge, are coupled with product design at its conception, shorter design cycles are possible. By decreasing the design time of a product in this manner, design costs are reduced and the product will better suit the customer s needs. Prior work indicates that similar failure modes occur with products (or components) with similar functionality. To capitalize on this finding, a knowledge base of historical failure information linked to functionality is assembled for use by designers. One possible use for this knowledge base is within the Elemental Function-Failure Design Method (EFDM). This design methodology and failure analysis tool begins at conceptual design and keeps the designer cognizant of failures that are likely to occur based on the product s functionality. The EFDM offers potential improvement over current failure analysis methods, such as FMEA, FMECA, and Fault Tree Analysis, because it can be implemented hand in hand with other conceptual design steps and carried throughout a product s design cycle. These other failure analysis methods can only truly be effective after a physical design has been completed. The EFDM however is only as good as the knowledge base that it draws from, and therefore it is of utmost importance to develop a knowledge base that will be suitable for use across a wide spectrum of products. One fundamental question that arises in using the EFDM is: At what level of detail should functional descriptions of components be encoded? This paper explores two approaches to populating a knowledge base with actual failure occurrence information from Bell 206 helicopters. Functional models expressed at various levels of detail are investigated to determine the necessary detail for an applicable knowledge base that can be used by designers in both new designs as well as redesigns. High level and more detailed functional descriptions are derived for each failed component based on NTSB accident reports. To best record this data, standardized functional and failure mode vocabularies are used. Two separate function-failure knowledge bases are then created aid compared. Results indicate that encoding failure data using more detailed functional models allows for a more robust knowledge base. Interestingly however, when applying the EFDM, high level descriptions continue to produce useful results when using the knowledge base generated from the detailed functional models.

A risk assessment methodology using intuitionistic fuzzy set in FMEA

NASA Astrophysics Data System (ADS)

Chang, Kuei-Hu; Cheng, Ching-Hsue

2010-12-01

Most current risk assessment methods use the risk priority number (RPN) value to evaluate the risk of failure. However, conventional RPN methodology has been criticised as having five main shortcomings as follows: (1) the assumption that the RPN elements are equally weighted leads to over simplification; (2) the RPN scale itself has some non-intuitive statistical properties; (3) the RPN elements have many duplicate numbers; (4) the RPN is derived from only three factors mainly in terms of safety; and (5) the conventional RPN method has not considered indirect relations between components. To address the above issues, an efficient and comprehensive algorithm to evaluate the risk of failure is needed. This article proposes an innovative approach, which integrates the intuitionistic fuzzy set (IFS) and the decision-making trial and evaluation laboratory (DEMATEL) approach on risk assessment. The proposed approach resolves some of the shortcomings of the conventional RPN method. A case study, which assesses the risk of 0.15 µm DRAM etching process, is used to demonstrate the effectiveness of the proposed approach. Finally, the result of the proposed method is compared with the listing approaches of risk assessment methods.

[High Pressure Gas Tanks

NASA Technical Reports Server (NTRS)

Quintana, Rolando

2002-01-01

Four high-pressure gas tanks, the basis of this study, were especially made by a private contractor and tested before being delivered to NASA Kennedy Space Center. In order to insure 100% reliability of each individual tank the staff at KSC decided to again submit the four tanks under more rigorous tests. These tests were conducted during a period from April 10 through May 8 at KSC. This application further validates the predictive safety model for accident prevention and system failure in the testing of four high-pressure gas tanks at Kennedy Space Center, called Continuous Hazard Tracking and Failure Prediction Methodology (CHTFPM). It is apparent from the variety of barriers available for a hazard control that some barriers will be more successful than others in providing protection. In order to complete the Barrier Analysis of the system, a Task Analysis and a Biomechanical Study were performed to establish the relationship between the degree of biomechanical non-conformities and the anomalies found within the system on particular joints of the body. This relationship was possible to obtain by conducting a Regression Analysis to the previously generated data. From the information derived the body segment with the lowest percentage of non-conformities was the neck flexion with 46.7%. Intense analysis of the system was conducted including Preliminary Hazard Analysis (PHA), Failure Mode and Effect Analysis (FMEA), and Barrier Analysis. These analyses resulted in the identification of occurrences of conditions, which may be becoming hazardous in the given system. These conditions, known as dendritics, may become hazards and could result in an accident, system malfunction, or unacceptable risk conditions. A total of 56 possible dendritics were identified. Work sampling was performed to observe the occurrence each dendritic. The out of control points generated from a Weighted c control chart along with a Pareto analysis indicate that the dendritics "Personnel not Wearing Proper Protective and Hose/tubing located in high-traffic area" which account for 59.18% of total dendritic frequency need to be addressed to reduce the chance of a hazard from occurring. However, the occurrences of some dendritics are more important than others. As a result immediate, from a Weighted c perspective, corrective action should be taken to ameliorate the cause of the Class A dendritic "Personnel located under suspended or moving loads" rather than just the most commonly occurring dendritics. In any case the vast majority of data obtained indicates that testing operations possess a relatively high degree of safety.

De-blending deep Herschel surveys: A multi-wavelength approach

NASA Astrophysics Data System (ADS)

Pearson, W. J.; Wang, L.; van der Tak, F. F. S.; Hurley, P. D.; Burgarella, D.; Oliver, S. J.

2017-07-01

Aims: Cosmological surveys in the far-infrared are known to suffer from confusion. The Bayesian de-blending tool, XID+, currently provides one of the best ways to de-confuse deep Herschel SPIRE images, using a flat flux density prior. This work is to demonstrate that existing multi-wavelength data sets can be exploited to improve XID+ by providing an informed prior, resulting in more accurate and precise extracted flux densities. Methods: Photometric data for galaxies in the COSMOS field were used to constrain spectral energy distributions (SEDs) using the fitting tool CIGALE. These SEDs were used to create Gaussian prior estimates in the SPIRE bands for XID+. The multi-wavelength photometry and the extracted SPIRE flux densities were run through CIGALE again to allow us to compare the performance of the two priors. Inferred ALMA flux densities (FinferALMA), at 870 μm and 1250 μm, from the best fitting SEDs from the second CIGALE run were compared with measured ALMA flux densities (FmeasALMA) as an independent performance validation. Similar validations were conducted with the SED modelling and fitting tool MAGPHYS and modified black-body functions to test for model dependency. Results: We demonstrate a clear improvement in agreement between the flux densities extracted with XID+ and existing data at other wavelengths when using the new informed Gaussian prior over the original uninformed prior. The residuals between FmeasALMA and FinferALMA were calculated. For the Gaussian priors these residuals, expressed as a multiple of the ALMA error (σ), have a smaller standard deviation, 7.95σ for the Gaussian prior compared to 12.21σ for the flat prior; reduced mean, 1.83σ compared to 3.44σ; and have reduced skew to positive values, 7.97 compared to 11.50. These results were determined to not be significantly model dependent. This results in statistically more reliable SPIRE flux densities and hence statistically more reliable infrared luminosity estimates. Herschel is an ESA space observatory with science instruments provided by European-led Principal Investigator consortia and with important participation from NASA.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Grabaskas, David; Brunett, Acacia J.; Passerini, Stefano

GE Hitachi Nuclear Energy (GEH) and Argonne National Laboratory (Argonne) participated in a two year collaboration to modernize and update the probabilistic risk assessment (PRA) for the PRISM sodium fast reactor. At a high level, the primary outcome of the project was the development of a next-generation PRA that is intended to enable risk-informed prioritization of safety- and reliability-focused research and development. A central Argonne task during this project was a reliability assessment of passive safety systems, which included the Reactor Vessel Auxiliary Cooling System (RVACS) and the inherent reactivity feedbacks of the metal fuel core. Both systems were examinedmore » utilizing a methodology derived from the Reliability Method for Passive Safety Functions (RMPS), with an emphasis on developing success criteria based on mechanistic system modeling while also maintaining consistency with the Fuel Damage Categories (FDCs) of the mechanistic source term assessment. This paper provides an overview of the reliability analyses of both systems, including highlights of the FMEAs, the construction of best-estimate models, uncertain parameter screening and propagation, and the quantification of system failure probability. In particular, special focus is given to the methodologies to perform the analysis of uncertainty propagation and the determination of the likelihood of violating FDC limits. Additionally, important lessons learned are also reviewed, such as optimal sampling methodologies for the discovery of low likelihood failure events and strategies for the combined treatment of aleatory and epistemic uncertainties.« less

Intelligent system for a remote diagnosis of a photovoltaic solar power plant

NASA Astrophysics Data System (ADS)

Sanz-Bobi, M. A.; Muñoz San Roque, A.; de Marcos, A.; Bada, M.

2012-05-01

Usually small and mid-sized photovoltaic solar power plants are located in rural areas and typically they operate unattended. Some technicians are in charge of the supervision of these plants and, if an alarm is automatically issued, they try to investigate the problem and correct it. Sometimes these anomalies are detected some hours or days after they begin. Also the analysis of the causes once the anomaly is detected can take some additional time. All these factors motivated the development of a methodology able to perform continuous and automatic monitoring of the basic parameters of a photovoltaic solar power plant in order to detect anomalies as soon as possible, to diagnose their causes, and to immediately inform the personnel in charge of the plant. The methodology proposed starts from the study of the most significant failure modes of a photovoltaic plant through a FMEA and using this information, its typical performance is characterized by the creation of its normal behaviour models. They are used to detect the presence of a failure in an incipient or current form. Once an anomaly is detected, an automatic and intelligent diagnosis process is started in order to investigate the possible causes. The paper will describe the main features of a software tool able to detect anomalies and to diagnose them in a photovoltaic solar power plant.

Seguridad del paciente en Radioterapia Intraoperatoria: Impacto de los elementos controlados por el Radiofisico

NASA Astrophysics Data System (ADS)

Tarjuelo, Juan Lopez

Introduccion: En la administracion de la radioterapia intervienen profesionales y equipos de tratamiento, por lo que existe el riesgo de error y se precisa que dicho equipamiento funcione conforme a lo esperado. A los radiofisicos les corresponde participar en las actividades de garantia o aseguramiento de la calidad, incluyendo el control de calidad de los equipos, y en la evaluacion de los riesgos asociados. La radioterapia intraoperatoria (RIO) es una tecnica radioterapica de intensificacion de dosis, altamente selectiva, dirigida a volumenes anatomicos restringidos durante el tratamiento quirurgico oncologico, basada en la administracion de una dosis absorbida alta por medio de un haz de electrones tras el examen visual directo del lecho tumoral. Como incorporar los ultimos avances en el refuerzo de la seguridad en radioterapia es una tarea ambiciosa y compleja, resulta mas concreta y de inmediata aplicacion su introduccion en la RIO. El objetivo es analizar los elementos que reducen los riesgos y aumentan la seguridad en la RIO y su dosimetria, y valorar la funcion del radiofisico en esta labor. Material y metodos: Se emplearon el planificador Radiance de GMV y el acelerador lineal de los tratamientos de RIO Elekta Precise, controlado con el verificador diario de haces Daily QA Check 1090 y medido con las camaras de ionizacion PPC 40, FC65-G y FC65-P de PTW-Freiburg, a su vez verificadas con fuentes radiactivas adecuadas de estroncio-90 modelos CDP y CDC de IBA Dosimetry. Se realizo un analisis de modos de fallo y efectos (failure mode and effect analysis, FMEA) con el fin de identificar los elementos que forman la RIO y aplicar las herramientas necesarias para la minimizacion de los riesgos y la mejora de la seguridad en la tecnica. Se estudiaron las verificaciones diarias de dicho acelerador Precise con el control estadistico de procesos (statistical process control, SPC) y se simularon intervenciones para devolverlo al estado llamado en control. El SPC tambien se uso para estudiar la estabilidad de las camaras de ionizacion mencionadas. Se realizo la dosimetria in vivo en 45 pacientes con MOSFET reforzados mobile TN-502RDM-H, pelicula radiocromica Gafchromic MD-55-2, y se elaboro un modelo teorico para explicar los datos. Por ultimo, al precisarse el uso en RIO de la simulacion virtual y del calculo de la dosis absorbida en el paciente virtual, se ha ilustrado este apartado con la aceptacion y el estado de referencia inicial del planificador de tratamientos modulados con calculo de Monte Carlo Elekta Monaco. Para ello se utilizaron la camara de ionizacion TW31016-0104 y la matriz seven29 de PTW-Freiburg, pelicula radiocromica Gafchromic EBT-2, y diferentes maniquies. Resultados: El FMEA identifico 57 modos de fallo y efectos potenciales. No se experimentaron sucesos relativos a una administracion inadecuada de la dosis absorbida. Se identificaron las revisiones dobles y por un par como claves para reducir los riesgos asociados al equipo de profesionales involucrado en la RIO. Se identificaron tambien oportunidades de mejora con el uso de la automatizacion y el enclavamiento. En cuanto al SPC, los indices de capacidad del proceso abarcaron de 1,6 a 9,3 para un nivel de especificaciones del +/-2%. Las intervenciones simuladas alcanzaron del 2% al 34% de las sesiones de medida. Las camaras de ionizacion Farmer derivaron en direcciones opuestas en un periodo de 6 anos; aunque ello no se aprecio en los informes de calibracion del laboratorio acreditado. No derivo la camara PPC-40. En la dosimetria in vivo, las medidas de los MOSFET no se desviaron significativamente de las medidas con pelicula. Los valores centrales de las dosis absorbidas quedaron entre la dosis absorbida prescrita y la maxima, con lo que indicaron un tratamiento correcto del lecho tumoral. Las anchuras de los intervalos de confianza de las dosis absorbidas esperadas segun el modelo teorico al nivel del 95% abarcaron del 8,6% al 14,7%. Las verificaciones de Monaco resultaron satisfactorias excepto en el caso de la transferencia de datos, que obligo a cambiar el flujo de trabajo. Conclusiones: El FMEA es crucial para priorizar las intervenciones reductoras del riesgo. Tipos diferentes de procesos fallidos se pueden eliminar o paliar con tipos diferentes de tales intervenciones. El SPC puede evaluar la variabilidad inherente del procedimiento monitorizador de haces de electrones, indica cuando intervenir para devolver un proceso al estado de control y si un proceso es capaz con respecto a unas especificaciones o requisitos establecidos. Es viable realizar dosimetria in vivo con un acelerador convencional fijo y obtener resultados satisfactorios en cada localizacion estudiada a pesar de su variabilidad. El modelo teorico desarrollado puede describir con exito resultados globales, aunque no puede explicar todos los datos experimentales. Se ha mostrado que un planificador puede funcionar correctamente en condiciones de laboratorio o trabajando solo; pero puede fallar cuando se conecta con otros equipos de radioterapia. Todos estos aspectos presentados y evaluados aqui constituyen competencias actuales o futuras, y deseables, de los radiofisicos, tanto en el campo de la RIO como en la extension a la radioterapia en su conjunto.

Development of biopolymers based interpenetrating polymeric network of capecitabine: A drug delivery vehicle to extend the release of the model drug.

PubMed

Upadhyay, Mansi; Adena, Sandeep Kumar Reddy; Vardhan, Harsh; Yadav, Sarita K; Mishra, Brahmeshwar

2018-04-27

The research aims the development and optimization of capecitabine loaded interpenetrating polymeric network by ionotropic gelation method using polymers locust bean gum and sodium alginate by QbD approach. FMEA was performed to recognize the risks influencing CQAs. BBD was applied to study the effect of factors (polymer ratio, amount of cross-linker and curing time) on responses (particle size, % drug entrapment and % drug release). Polynomial equations and 3-D graphs were plotted to relate between factors and responses. The results of the optimized batch viz. particle size (457.92 ± 1.6 μm), % drug entrapment (74.11 ± 3.1%) and % drug release (90.23 ± 2.1%) were close to the predicted values generated by Minitab® 17. Characterization techniques SEM, EDX, FTIR, DSC and XRD were also performed for the optimized batch. To study the water transport inside IPN microbeads, swelling study was done. In vitro drug release of optimized batch showed controlled drug release for 12 h. Pharmacokinetic study carried out following oral administration in Albino Wistar rats exhibited that optimized microbeads had better PK parameters than free drug. In vitro cytotoxicity against HT-29 cells revealed significant reduction of the cell growth when treated with optimized formulation indicating IPN microbeads as effective dosage form for treating colon cancer. Copyright © 2018. Published by Elsevier B.V.

IMEKO TC1-TC7 Symposium in London: The assurance as a result of blood chemical analysis by ISO-GUM and QE

NASA Astrophysics Data System (ADS)

Iwaki, Y.

2010-07-01

The Quality Assurance (QA) of measurand has been discussed over many years by Quality Engineering (QE). It is need to more discuss about ISO standard. It is mining to find out root fault element for improvement of measured accuracy, and it remove. The accuracy assurance needs to investigate the Reference Material (RM) for calibration and an improvement accuracy of data processing. This research follows the accuracy improvement in field of data processing by how to improve of accuracy. As for the fault element relevant to measurement accuracy, in many cases, two or more element is buried exist. The QE is to assume the generating frequency of fault state, and it is solving from higher ranks for fault factor first by "Failure Mode and Effects Analysis (FMEA)". Then QE investigate the root cause over the fault element by "Root Cause Analysis (RCA)" and "Fault Tree Analysis (FTA)" and calculate order to the generating element of assume specific fault. These days comes, the accuracy assurance of measurement result became duty in the Professional Test (PT). ISO standard was legislated by ISO-GUM (Guide of express Uncertainty in Measurement) as guidance of an accuracy assurance in 1993 [1] for QA. Analysis method of ISO-GUM is changed into Exploratory Data Analysis (EDA) from Analysis of Valiance (ANOVA). EDA calculate one by one until an assurance performance is obtained according to "Law of the propagation of uncertainty". If the truth value was unknown, ISO-GUM is changed into reference value. A reference value set up by the EDA and it does check with a Key Comparison (KC) method. KC is comparing between null hypothesis and frequency hypothesis. It performs operation of assurance by ISO-GUM in order of standard uncertainty, the combined uncertainty of many fault elements and an expansion uncertain for assurance. An assurance value is authorized by multiplying the final expansion uncertainty [2] by K of coverage factor. K-value is calculated from the Effective Free Degree (EFD) which thought the number of samples is important. Free degree is based on maximum likelihood method of an improved information criterion (AIC) for a Quality Control (QC). The assurance performance of ISO-GUM is come out by set up of the confidence interval [3] and is decided. The result of research of "Decided level/Minimum Detectable Concentration (DL/MDC)" was able to profit by the operation. QE has developed for the QC of industry. However, these have been processed by regression analysis by making frequency probability of a statistic value into normalized distribution. The occurrence probability of the statistics value of a fault element which is accompanied element by a natural phenomenon becomes an abnormal distribution in many cases. The abnormal distribution needs to obtain an assurance value by other method than statistical work of type B in ISO-GUM. It is tried fusion the improvement of worker by QE became important for reservation of the reliability of measurement accuracy and safety. This research was to make the result of Blood Chemical Analysis (BCA) in the field of clinical test.

Digital I and C system upgrade integration technique

DOE Office of Scientific and Technical Information (OSTI.GOV)

Huang, H. W.; Shih, C.; Wang, J. R.

2012-07-01

This work developed an integration technique for digital I and C system upgrade, the utility can replace the I and C systems step by step systematically by this method. Inst. of Nuclear Energy Research (INER) developed a digital Instrumentation and Control (I and C) replacement integration technique on the basis of requirement of the three existing nuclear power plants (NPPs), which are Chin-Shan (CS) NPP, Kuo-Sheng (KS) NPP, and Maanshan (MS) NPP, in Taiwan, and also developed the related Critical Digital Review (CDR) Procedure. The digital I and C replacement integration technique includes: (I) Establishment of Nuclear Power Plant Digitalmore » Replacement Integration Guideline, (2) Preliminary Investigation on I and C System Digitalization, (3) Evaluation on I and C System Digitalization, and (4) Establishment of I and C System Digitalization Architectures. These works can be a reference for performing I and C system digital replacement integration of the three existing NPPs of Taiwan Power Company (TPC). A CDR is the review for a critical system digital I and C replacement. The major reference of this procedure is EPRI TR- 1011710 (2005) 'Handbook for Evaluating Critical Digital Equipment and Systems' which was published by the Electric Power Research Inst. (EPRI). With this document, INER developed a TPC-specific CDR procedure. Currently, CDR becomes one of the policies for digital I and C replacement in TPC. The contents of this CDR procedure include: Scope, Responsibility, Operation Procedure, Operation Flow Chart, CDR review items. The CDR review items include the comparison of the design change, Software Verification and Validation (SVandV), Failure Mode and Effects Analysis (FMEA), Evaluation of Diversity and Defense-in-depth (D3), Evaluation of Watchdog Timer, Evaluation of Electromagnetic Compatibility (EMC), Evaluation of Grounding for System/Component, Seismic Evaluation, Witness and Inspection, Lessons Learnt from the Digital I and C Failure Events. A solid review can assure the quality of the digital I and C system replacement. (authors)« less

Risk Assessment Integrated QbD Approach for Development of Optimized Bicontinuous Mucoadhesive Limicubes for Oral Delivery of Rosuvastatin.

PubMed

Javed, Md Noushad; Kohli, Kanchan; Amin, Saima

2018-04-01

Statins are widely prescribed for hyperlipidemia, cancer, and Alzheimer's disease but are facing some inherent challenges such as low solubility and drug loading, higher hepatic metabolism, as well as instability at gastric pH. So, relatively higher circulating dose, required for exerting the therapeutic benefits, leads to dose-mediated severe toxicity. Furthermore, due to low biocompatibility, high toxicity, and other regulatory caveats such as product conformity, reproducibility, and stability of conventional formulations as well as preferentially higher bioabsorption of lipids in their favorable cuboidal geometry, enhancement in in vivo biopharmaceutical performance of Rosuvastatin could be well manifested in Quality by Design (QbD) integrated cuboidal-shaped mucoadhesive microcrystalline delivery systems (Limicubes). Here, quality-target-product-profile (QTPPs), critical quality attributes (CQAs), Ishikawa fishbone diagram, and integration of risk management through risk assessment matrix for failure mode and effects analysis (FMEA) followed by processing of Plackett-Burman design matrix using different statistical test for the first time established an approach to substantiate the claims that controlling levels of only these three screened out independent process variables, i.e., Monoolein (B = 800-1100 μL), Poloxamer (C = 150-200 mg), and stirring speed (F = 700-1000 rpm) were statistically significant to modulate and improve the biopharmaceutical performance affecting key attributes, viz., average particle size (Y 1  = 1.40-2.70 μ), entrapment efficiency (Y 2  = 62.60-88.80%), and drug loading (Y 3  = 0.817-1.15%), in QbD-enabled process. The optimal performance of developed Limicubes exhibited an average particle size of 1.8 ± 0.2 μ, entrapment efficiency 80.32 ± 2.88%, and drug loading 0.93 ± 0.08% at the level of 1100 μL (+ 1), 200 mg (+ 1), and 700 rpm (- 1) for Monoolein, Poloxamer, and stirring speed, respectively.