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Process Failure Mode Effects Analysis: the Newest Approach
1.Role of FMEA in AQP and APQP
2.Seven step process for a PFMEA
- Planning and preparation take advantage of group technology and product families with foundation or generic PFMEAs. The scope of the PFMEA can include continuity of operations, and occupational health and safety (OH&S) as well as quality
- Structure analysis uses the process approach and process flowchart to define the process item, the process steps or operations, and the process work elements (factors that can affect the process steps). The deliverable is a structure tree that is very similar to a cause and effect diagram for each process step
- Function analysis identifies the functions of the process item, the process steps, and the process work elements. Failure to achieve the function, or the negative of the function, is the failure mode, cause, or effect
- Risk analysis includes identification of the prevention and detection controls, assessment of Severity, Occurrence, and Detection ratings, and determination of the Action Priority. This step makes it clear that engineering controls (or machine-based or technical controls) are superior to administrative (or behavioral) controls that rely on worker vigilance
- Optimization includes testing and confirmation of actions to reduce or eliminate the failure effect and/or implement superior prevention or detection controls
- Documentation: the PFMEA becomes a quality record and part of organizational knowledge (ISO 9001:2015 clause 7.1.6), and the lessons learned are deployed to similar processes that might benefit from the knowledge
- Failure analysis identifies the failure modes, causes, and effects. The failure mode is the focus element or starting point; it is how the process step can fail to perform its function. The failure effect is the consequence for the process item or objective the process is supposed to achieve. It is what does not happen that should, or what happens that should not. The failure cause is why, in terms of failure by a process work element (Manpower, Machine, Material, Environment, and possibly Method or Measurement), the failure mode occurs. This, in turn, invites application of the Five Whys to identify the root cause of the failure cause. (Note; the failure cause was known previously as the failure mechanism.)
3.PFMEA controls are synergistic with Shigeo Shingo's Zero Quality Control [2]. Vertical source inspection seeks to prevent the introduction of nonconforming parts into the process. Prevention controls seek to avoid production of a defect, while detection controls stop the defect from reaching the next process if one is produced. The webinar will discuss a couple of Shingo case studies in which improved controls were implemented to achieve one or more of these goals, and also an OH&S case study in which the Ford Motor Company eliminated totally two sources of workplace injuries roughly 100 years ago
4.A control plan can be appended to the PFMEA to create a dynamic control plan
Overview of the webinar
Failure mode effects analysis (FMEA) play s an important role in advanced quality planning (AQP) or, in the automotive industry, advanced product quality planning (APQP). It is a structured and disciplined approach for planning quality into a product design (DFMEA) and the product realization process (PFMEA), with the latter as the focus of this webinar. The newest approach improves on formerly-used methods with a seven-step process that helps ensure discovery of potential failure modes and their causes, and focuses more heavily on the nature of the prevention and detection controls for the failures in question. This is in turn consistent with the control plan which can be appended onto a PFMEA to create a dynamic control plan.
Who should attend?
- Quality Managers
- Engineers
- Technicians
- Others with responsibility for advanced quality planning (AQP) or PPAP
Why should you attend?
Failure Mode Effects Analysis (FMEA) is a well-established technique for the identification of risks in a manufacturing process. The Automotive Industry Action Group's (AIAG's) and German Association of the Automotive Industry's (VDA's) newest FMEA manual (2019) is, however, a considerable improvement on the older processes. It offers a seven-step process that helps ensure that failure modes and their associated causes will be recognized, and also clear direction on how to establish Occurrence (O) and Detection (D) ratings.
The prior method required an estimate of the probability of failure (ranging from less than 1 in 1.5 million to more than 50%) to define the Occurrence rating, and this kind of information is not always available. The new method defines the O and D ratings qualitatively, on the basis of the prevention and detection controls that are built into the process.
Another improvement is elimination of the risk priority number (RPN), a problematic metric that, as the product of three ordinal numbers (Severity, Occurrence, and Detection) does not always reflect the actual relative risk of a given failure mode [1]. The new method uses an Action Priority (Low, Medium, or High) with the most weight given to the Severity rating, followed by the Occurrence rating.
Attendees will learn the basics of the new approach's most important features including how to identify failure modes, effects, and causes (formerly mechanisms) as well as controls that mitigate or eliminate them. It is recommended that attendees buy AIAG/VDA, 2019, Failure Mode and Effects Analysis Handbook because it contains the necessary complete tables for Severity, Occurrence, Detection, and Action Priority, and these tables are not available elsewhere. While this webinar will focus on process failure mode effects analysis (PFMEA), the manual also addresses design FMEA and monitoring and system response (FMEA-MSR).
Faculty - Mr.William A. Levinson
William A. Levinson, P.E., is the principal of Levinson Productivity Systems, P.C. He is an ASQ Fellow, Certified Quality Engineer, Quality Auditor, Quality Manager, Reliability Engineer and Six Sigma Black Belt. He is also the author of several books on quality, productivity and management, of which the most recent is The Expanded and Annotated My Life and Work: Henry Ford's Universal Code for World-Class Success.