Failure Mode and Effects Analysis: A Community Practice Perspective

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

doi:10.1016/j.ijrobp.2016.06.1985

Cited by 7 publications

(12 citation statements)

References 0 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…23 For a general external beam process with support from a trained facilitator, total FMEA including analysis was estimated at 75 h. 15 Three centers exploring FMEA for radiosurgery identified 104-135 failure modes but completed the process over a period of 2-6 months. 10 The most extensive example of an FMEA might be that offered by Schuller et al 12 who identified a total of 409 failure modes, applied analysis to all modes and required an estimated total of 258 h, equivalent to 34 and a half working days. Variation and uncertainty in resource requirements could potentially act as a barrier to a center considering FMEA-based risk assessment for new or existing services and prevent more widespread practical implementation.…”

Section: D | Resource Implicationsmentioning

confidence: 99%

“…The resource requirements for conducting an FMEA are under reported in the literature with relatively few papers providing timings. 12,13,15,23 Reported timings range from 30 23 to 258 12 h, dependent on methodology. For a radiotherapy center considering adopting FMEA this information is particularly important, as there is cost associated with embarking on convoluted and lengthy risk assessments, particularly when considering an active service.…”

Section: E | Resource Requirements Of Fmeamentioning

confidence: 99%

“…Identifying potential errors and risks within a complex multistep process can be an exhaustive process and limited conclusions can be drawn from the available literature. Considering examples published on radiosurgery, the number of failure modes identified ranged from 86 11 to 409 12 . For more general radiotherapy, papers have been presented by several groups 13‐15 with failure modes identified ranging from 52 to 127 with a variety of treatment planning and delivery platforms, and variable discussion of the scope of FMEA (i.e., including acceptance/commissioning as well as routine use).…”

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Evaluation of failure modes and effect analysis for routine risk assessment of lung radiotherapy at a UK center

Gilmore

Rowbottom

2021

J Applied Clin Med Phys

View full text Add to dashboard Cite

Purpose: Explore the feasibility of adopting failure modes and effects analysis (FMEA) for risk assessment of a high volume clinical service at a UK radiotherapy center. Compare hypothetical failure modes to locally reported incidents.Method: An FMEA for a lung radiotherapy service was conducted at a hospital that treats~350 lung cancer patients annually with radical radiotherapy. A multidisciplinary team of seven people was identified including a nominated facilitator. A process map was agreed and failure modes identified and scored independently, final failure modes and scores were then agreed at a face-to-face meeting. Risk stratification methods were explored and staff effort recorded. Radiation incidents related to lung radiotherapy reported locally in a 2-year period were analyzed to determine their relation to the identified failure modes. The final FMEA was therefore a combination of prospective evaluation and retrospective analysis from an incident learning system.Results: Thirty-six failure modes were identified for the pre-existing clinical service.The top failure modes varied according to the ranking method chosen. The process required 30 h of combined staff time. Over the 2-year period chosen, 38 voluntarily reported incidents were identified as relating to lung radiotherapy. Of these, 13 were not predicted by the identified failure modes, with six relating to delays in the process, three issues with appointment times, one communication error, two instances of a failure to image, and one technical fault deemed unpredictable by the manufacturer. Four additional failure modes were added to the FMEA following the incident analysis. Conclusion:FMEA can be effectively applied to an established high volume service as a risk assessment method. Facilitation by an individual familiar with the FMEA process can reduce resource requirement. Prospective evaluation of risks should be combined with an incident reporting and learning system to produce a more comprehensive analysis of risk.

show abstract

Section: D | Resource Implicationsmentioning

confidence: 99%

Section: E | Resource Requirements Of Fmeamentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 1 more Smart Citation

Evaluation of failure modes and effect analysis for routine risk assessment of lung radiotherapy at a UK center

Gilmore

Rowbottom

2021

J Applied Clin Med Phys

View full text Add to dashboard Cite

show abstract

“…What qualifies as high‐risk is highly arbitrary and is dependent on the number of risks involved in the process and their RPN scores. Some studies cite a lower threshold for high‐risk activities and classify all failure modes with RPNs greater than 100 or severity scores of 9 or 10 as high‐risk . However, as in Figure , if most failure modes lie above this RPN threshold, we suggest targeting the largest one or two RPNs calculated.…”

Section: What Is Fmea?mentioning

confidence: 99%

Targeting specimen misprocessing safety events with failure modes and effects analysis

Stravitz¹,

Cibas²,

Heher³

2019

Cancer Cytopathology

View full text Add to dashboard Cite

“…In this study, we apply the American Association of Physicists in Medicine (AAPM) Task Group 100 (TG-100) Failure Modes and Effects Analysis (FMEA) methodology 22 to apply modern risk-based analysis techniques to IGCSAI, as it has been done for a number of other medical physics applications. [22][23][24][25][26][27][28][29][30][31][32][33][34][35] In the process, we propose a new process map specific to IGCSAI that changes the paradigm from individual errors in radiation delivery, to groups that are highlighted in a proposed new severity table. We also perform a preliminary FMEA survey based on expert opinion from SARRP operators.…”

Section: Introductionmentioning

confidence: 99%

A failure modes and effects analysis quality management framework for image‐guided small animal irradiators: A change in paradigm for radiation biology

et al. 2020

View full text Add to dashboard Cite

Purpose: Image-guided small animal irradiators (IGSAI) are increasingly being adopted in radiation biology research. These animal irradiators, designed to deliver radiation with submillimeter accuracy, exhibit complexity similar to that of clinical radiation delivery systems, including image guidance, robotic stage motion, and treatment planning systems. However, physics expertise and resources are scarcer in radiation biology, which makes implementation of conventional prescriptive QA infeasible. In this study, we apply the failure modes and effect analysis (FMEA) popularized by the AAPM task group 100 (TG-100) report to IGSAI and radiation biological research. Methods: Radiation biological research requires a change in paradigm where small errors to large populations of animals are more severe than grievous errors that only affect individuals. To this end, we created a new adverse effects severity table adapted to radiation biology research based on the original AAPM TG-100 severity table. We also produced a process tree which outlines the main components of radiation biology studies performed on an IGSAI, adapted from the original clinical IMRT process tree from TG-100.Using this process tree, we created and distributed a preliminary survey to eight expert IGSAI operators in four institutions. Operators rated proposed failure modes for occurrence, severity, and lack of detectability, and were invited to share their own experienced failure modes. Risk probability numbers (RPN) were calculated and used to identify the failure modes which most urgently require intervention. Results: Surveyed operators indicated a number of high (RPN >125) failure modes specific to small animal irradiators. Errors due to equipment breakdown, such as loss of anesthesia or thermal control, received relatively low RPN (12-48) while errors related to the delivery of radiation dose received relatively high . Errors identified could either be improved by manufacturer intervention (e.g., electronic interlocks for filter/collimator) or physics oversight (errors related to tube calibration or treatment planning system commissioning). Operators identified a number of failure modes including collision between the collimator and the stage, misalignment between imaging and treatment isocenter, inaccurate robotic stage homing/translation, and incorrect SSD applied to hand calculations. These were all relatively highly rated , indicating a possible bias in operators towards reporting high RPN failure modes. Conclusions: The first FMEA specific to radiation biology research was applied to image-guided small animal irradiators following the TG-100 methodology. A new adverse effects severity table and a process tree recognizing the need for a new paradigm were produced, which will be of great use to future investigators wishing to pursue FMEA in radiation biology research. Future work will focus on expanding scope of user surveys to users of all commercial IGSAI and collaborating with manufacturers to increase the breadth of surveyed expert operato...

show abstract

Failure Mode and Effects Analysis: A Community Practice Perspective

Cited by 7 publications

References 0 publications

Evaluation of failure modes and effect analysis for routine risk assessment of lung radiotherapy at a UK center

Evaluation of failure modes and effect analysis for routine risk assessment of lung radiotherapy at a UK center

Targeting specimen misprocessing safety events with failure modes and effects analysis

A failure modes and effects analysis quality management framework for image‐guided small animal irradiators: A change in paradigm for radiation biology

Contact Info

Product

Resources

About