New Process Failure Mode Effects Analysis and Control Plan

Why Should You Attend:

The prevailing approach to process failure mode effects analysis (PFMEA) has some drawbacks including (1) the need to estimate the nonconforming fraction or defect rate to get the Occurrence rating and (2) the Risk Priority Number (RPN), which is the product of three ordinal numbers: The Severity, Occurrence, and Detection ratings [1].

As an example, suppose there are two failure modes. The first has a Severity of 10, an Occurrence of 3, and a Detection of 5. The second has a Severity of 3, an Occurrence of 5, and a Detection of 10. The RPN for both is 150. While the second will reach the customer more often than the first, it can at most annoy the customer as opposed to causing death or serious injury.

The AIAG/VDA approach is synergistic with AIAG's Effective Problem-Solving process (CQI-20) which cites three root causes for any problem. The Occurrence root cause, which is the traditional focus of corrective and preventive action (CAPA), is why the trouble happened. The Escape root cause is why the problem reached an internal or external customer (if it did escape), and the Systemic root cause relates to failures in the planning process, such as failure to apply lessons learned, that did not identify the problem ahead of time. The AIAG/VDA approach uses the nature of the prevention controls, as opposed to any estimate of the nonconforming fraction, to determine the Occurrence rating. The nature of the detection controls is used similarly to determine the Detection rating.

The AIAG/VDA approach also addresses not just quality, the traditional focus of FMEA, but also continuity of operations (e.g. could the problem idle an internal or external customer's production line?) and safety. The deliverable is an Action Priority of Low, Medium, or High as a function of the Severity, Occurrence, and Detection ratings in place of the Risk Priority Number. This takes care of the issue of the RPN as the product of three ordinal numbers.

The structure of the FMEA allows a control plan to be appended to create a dynamic control plan. The control plan identifies the prevention and detection controls whose respective purposes is to disable the occurrence root cause and to prevent poor quality from reaching a customer.

Areas Covered in the Webinar:

1. Role of FMEA in Advanced Quality Policy (AQP) or Advanced Production Quality Planning (APQP). FMEA can also be leveraged to reduce the cost of poor quality.
2. FMEA Basics
• Foundation FMEAs are synergistic with group technology in which a family of parts can be realized by the same process.
• Know that any change in a potential process factor (the same factors that are considered in a cause and effect diagram) creates a risk of undesirable and unforeseen consequences.
3. Six Step Process
• Planning and preparation
• Structure analysis is synergistic with the process flowchart, a basic planning tool. Identify the process item (what the process is supposed to accomplish) and the process steps that are intended to deliver it.
• The process step is the location of the failure mode, which is the starting point of the analysis of the failure chain.
• The consequence of the failure mode is the failure effect, which affects the process item.
• The failure cause (previously known as the failure mechanism) is what causes the failure mode. This is synergistic with the cause and effect diagram, as reflected by the process work elements.
• Function analysis identifies what each process step is supposed to do.
• Failure effect = what happens that shouldn't, or doesn't happen that should
• Failure mode = how it happens
• Failure cause (formerly the mechanism) = why it happens
• This step also identifies product characteristics that are generally subject to detection controls (such as measurements and inspections) and process characteristics that are generally subject to prevention controls.
• Control factors also may be identified at this stage, which is consistent with the control plan.
• Failure analysis: Identify the failure causes (formerly known as mechanisms), failure modes, and failure effects. The failure mode is the starting point of the assessment. Consider occupational safety and continuity of operations as well as quality.
• Risk analysis assesses the Severity, Occurrence, and Detection ratings for the failure modes that were identified in the previous step.
• The Occurrence rating now depends on the nature of the prevention controls whose purpose is to disable the failure cause. Engineering or technical controls are generally superior to administrative controls that rely on vigilance and compliance.
• The Detection rating depends similarly on the nature of the detection controls whose purpose is to disable the escape root cause and ideally stop the process to prevent generation of additional nonconforming product. This is the function of jidoka or autonomation.
• The deliverable is an Action Priority of Low, Medium, or High, with the Severity rating having the greatest weight and the Occurrence rating having the second greatest weight as it is better to prevent the poor quality than to detect it once it is produced. This eliminates the drawbacks associated with the Risk Priority Number.
• Optimization means the selection and implementation of actions to reduce the Severity, Occurrence, and/or Detection ratings to reduce the Action Priority for the failure mode in question.
• Best: eliminate the failure effect entirely
• Next: reduce the Occurrence rating. If the Occurrence rating can be reduced to 1 (best possible), the Action Priority will be Low regardless of the other two ratings.
• Next: reduce the Detection rating.
• Document the FMEA and deploy lessons learned to related processes.
4. Quality and occupational health and safety examples will be provided.
5. A control plan is required under IATF 16949 (automotive users) and can be easily appended to the FMEA. It includes the control method (how the process and product characteristics are controlled) and the reaction plan which tells the production workers what to do in the event of a problem.

Who Will Benefit:

• Quality managers, engineers, and technicians, and others with responsibility for advanced quality planning (AQP) or APQP
Instructor Profile:



William Levinson
Principal Consultant, Levinson Productivity Systems

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.

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