Be completed across to the right side, which is the area for re-computing Risk after initial efforts have been
taken to reduce the initial high risk rating, e.g. RPN;
List multiple effects for each mode and multiple causes for each effect. Generally there is not a 1:1
relationship, as any given failure mode could have many effects;
List actions taken on high severity and high RPN, or other risk ratings, aimed at preventing the occurrence of
a potential failure. Responsibility for the actions taken should be assigned and tracked to completion;
Include efforts to error-proof the design and/or process [see AIAGs Guideline to Effective Error-Proofing
(CQI-18)];
Ensure that measurement uncertainty is known and acceptable for applicable metrics;
Identify characteristics which should be designated as special or critical on the Control Plan so actions can
be planned and implemented to mitigate the effects of the potential failure;
Carefully consider all the risk, e.g. safety, quality, equipment, and resource, as well as efficiency of methods
used, actions taken, and contingency planning;
Consider the major types of design failures: materials, processes, costs; OR;
Consider the major types of process failures: too much, too little, missing, or wrong.
Tying It Together
Once the characteristics that need to be handled with extra care are identified in the FMEA and Control Plan, this
information should be used to develop understandable Work Instructions for manufacturing, assembly, and
verification activities to ensure that potential risk is mitigated effectively and so defects will not be sent downstream or
to customers. Where risk is still significant as identified on the FMEA, additional verification activities may need to be
implemented from the original plan.
FMEA is a living document. When problems arise that were not previously identified, the FMEA and Control Plan
should be revisited to include provisions to prevent recurrence. These actions should be deployed as preventive
actions for other applicable processes. These activities require resource allocation from top management to provide
practitioners with the time needed to complete these important activities.
R. Dan Reid, AIAG program manager - quality, is best known as an author of QS-9000, ISO Technical Specification
(TS) 16949, ISO 9001:2000, the first ISO International Workshop Agreement (IWA 1), and its replacement, AIAGs
Business Operating Systems for Healthcare Organizations (HF-2).
For additional information on this topic, please contact the AIAG Program Manager Dan Reid, dreid@aiag.org.