AIAG FMEA Manual: The Benchmark 4th Edition of Industry Standards Understanding how PFMEA, Process Flow, and Control Plan activities are connected will help you ensure that potential risk is mitigated effectively so defects will not be sent downstream or to customers.By R.Dan Reidrns with the effectiveness of FMEA implementation in the supply chain.This may be due to a number of factors, e.g., inadequate resources, or lack of or ineffective training of new quality practitioners.To supplement the existing FMEA training, AIAG has developed a new workshop, PFMEA in Context. This class shows how FMEA and other Advanced Product Quality Planning (APQP) deliverables fit into the bigger system of product quality planning and realization (see AIAGs Advanced Product Quality Planningwith Control Plan Reference pitfalls to avoid and best practices documented by automakers, suppliers, and auditors.Look what people are saying bout the class:FMEA BackgroundThe AIAG FMEA manual defines FMEA as an analytical methodology used to ensurethat potential problems have been considered and addressed throughout the product and process development process (APQP).FMEAs are an effective tool to quantify risk so it can be analyzed, prioritized, mitigated, and/or eliminated. FMEAs can be appliedall types of organizations, including manufacturing and service.FMEAs should be completed by a crossfunctional team during product or process development as part of the APQP process.Appendix C in the FMEA manual offers other alternative risk analysis criteria.
One alternative is called SOD or SD.It is a nonarithmeticcombination of the ratings above.For example, for Severity = 6; Occurrence = 3; and Detection = 7, the SOD rating would be 637.
The SD calculation is the same, excluding the Occurrence value.
So the SD rating for the above example would be 67.The various SOD ratings would then be sorted in numerical descending order to
get the highest Severity scenarios at the top of the list.Appendix D lists some alternative techniques to FMEA for analyzing risk.These include Failure Mode, Effect and Criticality Analysis (FMECA); Design Review Based on Failure Modes (DRBFM); and Fault Tree Analysis (FTA).Examples of some these are provided in the Appendix.FMEA ScopeThe FMEA Manual indicates that the FMEA scope establishes the boundary of the FMEA analysis. The scope can be system, subsystem, or component.
A system consists of many subsystems, which consist of many components.
The linkages and interactions among parts within the scope, as well as with other subsystems or systems also have to be addressed.The FMEA Manual lists a number of tools that can help define the appropriate scope, which should dictate the appropriate team membership.These include: block diagrams, process flow charts, schematics, and bills of material
.Other FMEA Manual GuidanceThe FMEA Manual also contains an Index and list of helpful references.It also adds numerous examples and diagrams to provide helpfulguidance.There is a section on linkage of FMEAs to other documents, including the block diagram and the Design Verification Plan and Report (DVP&R).FMEA Acceptance CriteriaWhat constitutes an acceptable FMEA? A good FMEA should:Be completed across to the right side, which is the area for recomputing 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 errorproof the design and/or process [see AIAGs Guideline to Effective ErrorProofing (CQI18)]; 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 TogetherOnce thecharacteristics 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 QS9000, ISO Technical Specification S) 16949, ISO 9001:2000, the first ISO International Workshop Agreement (IWA 1), and its replacement, AIAGs Business Operating Systems for Healthcare Organizations (HF2).For additional information on this topic, please contact the AIAG Program Manager Dan Reid, firstname.lastname@example.org..