Introduction

Process failure mode effects analysis (PFMEA) is part of advanced quality planning (AQP) or advanced product quality planning (APQP), whose purpose is to plan quality into the product realization process. It seeks to anticipate trouble in advance, in the form of failure modes, failure causes (also known as failure mechanisms), and failure effects. It then seeks to implement controls that prevent generation of nonconforming product, or at least detect and stop it before it can reach an internal or external customer. It is required by the IATF 16949:2016 standard for automotive quality management systems (clause 8.3.5.2 (g)) and highly recommended for ISO 9001 users.

This is a 90-minute overview of AIAG/VDA’s newest approach to process failure mode effects analysis, with additional information on (1) the role of FMEA in advanced quality planning (AQP), and (2) the control plan that can be appended to a PFMEA to create a dynamic control plan.

(Design FMEA will not be addressed, except for its role in AQP, due to time limitations and because some manufacturing organizations do not have design in the scope of their quality management systems.)

Area Covered In The Webinar

  • FMEA is a proactive process to identify, assess, and then remove or mitigate, risks associated with a product design, process, or monitoring and system response (MSR). This presentation focuses on process FMEA. FMEA is part of advanced quality planning (AQP) or Advanced Production Quality Planning (APQP), and is synergistic with other quality system activities such as CAPA and control plans. It supports quality management systems such as ISO 9001:2015 and IATF 16949:2016.
  • FMEA basics; FMEAs should be updated in response to changes that could affect quality and/or safety.
  • Step 1: Planning deliverables: scope, baseline FMEA, FMEA headers. Quality, safety, and continuity of operations all fall within the scope of the process FMEA.
  • Step 2: Structure analysis deliverables include a structure tree with the process steps and the process elements that might affect the operations. This is synergistic with the process flowchart.
  • Step 3: Function Analysis deliverables include definition of what each process step is supposed to do. We will see later that failure effects can include failure of the process step to perform its intended function. Process characteristics are generally subject to prevention controls (i.e. they can be measured and adjusted during product realization) while product characteristics are generally subject to detection controls as they are usually measured after product realization. This is not however a hard and fast rule as some product characteristics can be measured during realization. Prevention controls also include error-proofing methods that make the failure impossible.
  • Step 4: Failure analysis deliverables include the failure effect (consequences of the failure), failure mode (how it happens), and failure cause (formerly the mechanism) which is why it happens. The failure effect is "what happens that shouldn't" or "what doesn't happen that should." The new approach applies something similar to a cause and effect diagram (process work elements) that helps identify potential failure causes.
  • Step 5: Risk analysis deliverables include, for each failure mode, the prevention and detection controls along with the Severity, Occurrence, and Detection ratings. The Occurrence rating is now based on the nature of the prevention controls, and the Detection rating on the detection controls. This removes the need to estimate quantitative likelihoods of occurrence and detection of the failure mode. These lead in turn to an Action Priority of Low, Medium, or High with the greatest weight being given to the Severity rating, with the Occurrence rating second. This replaces the Risk Priority Number which is the product of three ordinal numbers, which has obvious drawbacks.
  • Step 6: Optimization deliverables include actions to reduce or mitigate the risk, such as better prevention and/or detection controls.
  • Step 7: Documentation deliverables include quality records and also deployment of lessons learned to related processes. This also addresses what CQI-20 calls the systemic root cause of a problem, or why the planning system didn't identify the issue before it happened. This could include failure to deploy lessons learned from one activity to a similar one.
  • Occupational health and safety example based on a real improvement that reduced injuries from daily to zero
  • Manufacturing example based on a Shigeo Shingo case study
  • Control plans, which can be appended to process FMEAs as dynamic control plans. These are synergistic with the FMEA because they also address process and product characteristics, as well as the relevant prevention and detection controls along with (where applicable) sample sizes and frequencies, and reaction plans when problems are detected.

Why should you attend?

The AIAG/VDA (Automotive Industry Action Group/ German Association of the Automotive Industry) manual for failure mode effects analysis (FMEA) is the most advanced guidance for FMEA. Critical developments include replacement of the risk priority number (RPN) with an Action Priority rating, as well as definition of occurrence and detection ratings according to the process' prevention and detection controls. This eliminates the need to estimate the failure mode's occurrence frequency which was not always possible. 

The new approach is also synergistic with AIAG's CQI-20, Effective Problem Solving, because a failure mode's occurrence root cause (why it happened) reflects a failure in a prevention control. The failure mode's escape root cause (why it was not detected before it reached an internal or external customer) reflects similarly an inadequacy in a detection control.  This makes FMEA and CAPA (corrective and preventive action) mutually reinforcing and supporting. The overall result is a far more user-friendly and also more effective approach to FMEA than existed in the past.

Who Will Benefit

Quality managers, engineers, and technicians, and others with responsibility for advanced quality planning (AQP) or PPAP

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Bill Levinson, P.E., FASQ, is the principal of Levinson Productivity Systems PC which specializes in industrial statistics, quality management, and lean manufacturing. He is a leading authority on He Know More

William Levinson