OVERVIEW

Webinar - Process Failure Mode Effects Analysis: the Newest Approach is organized by Global Wizdom (GW) and will be heldon Apr 28, 2020.

Overview:
Failure mode effects analysis (FMEA) has long been part of advanced quality planning (AQP), a set of activities whose purpose is to plan quality into a product and its manufacturing process. The Automotive Industry Action Group’s (AIAG’s) and German Association of the Automotive Industry’s (VDA’s) newest manual (2019) improves significantly on the previous methods. It includes a very logical and comprehensive process that identifies potential failure modes, their causes (previously mechanisms), and effects. It improves on the previous approach to the Severity, Occurrence, and Detection ratings, with the latter depending on the nature of the process’ prevention and detection controls.

The Action Priority rating is from a tabulated matrix that gives the most weight to the failure mode’s Severity rating and then to its Occurrence rating. This is superior to the risk priority number (RPN) which is the product of three ordinal numbers [1].

Why Should You Attend:
FMEA has been around for decades, but the older methods have drawbacks including the need for quantitative information (probability of failure) to determine the Occurrence rating. While this can be estimated from a process capability study, one is not always available. In addition, the risk priority number, as the product of three ordinal numbers, is not always a good indicator of the actual risk associated with a failure mode.

The AIAG/VDA manual is the newest and best approach to FMEA. Its seven-step process is a very straightforward, rational, and powerful approach to the identification of potential failure modes, their causes, and their effects, as well as an assessment of the Occurrence and Detection ratings from the nature of the associated prevention and detection controls. Engineering or machine-based controls are superior to administrative controls that rely on human judgment and vigilance. The Action Priority rating meanwhile overcomes the drawbacks associated with the RPN. The webinar will also cite the synergy of PFMEA with the organization’s corrective and preventive action (CAPA) process and the control plan; the latter can be appended to the PFMEA to create a dynamic control plan.

It is recommended that attendees purchase this manual not only for reference but also because the complete tables (including the action priority matrix) are not available elsewhere. The Severity tables address not only quality but also the continuity of operations as well as occupational health and safety (OH&S) issues. The Occurrence and Detection tables meanwhile discuss prevention and detection controls.https://www.aiag.org/store/publications/details?ProductCode=FMEAAV-1

Areas Covered in the Session:
Role of PFMEA in Advanced Quality Planning
Seven step PFMEA process
• Planning and preparation; include the scope of the PFMEA which can include safety as well as quality and continuity of operations. Foundation or generic PFMEAs are previously completed PFMEAs for the same product family, which takes advantage of group technology (a common set of tools and process steps for a related group of parts).
• Structure analysis; identification of the overall process and its objectives (process item), process steps (operations), and process work elements (factors that affect the process steps); the latter are similar to the categories in a cause and effect diagram.
• Function analysis identifies the functions of the process item, process steps, and process work elements. This lays the foundation for failure analysis.
• Failure analysis begins with the failure mode (how the process step fails to achieve its function) which results in the failure effect (what happens that should not happen, or does not happen that should). The failure cause, formerly known as the failure mechanism, is why the failure mode occurs.
• Risk analysis determines the Severity, Occurrence, and Detection ratings for each failure mode. Failure modes can affect the continuity of operations and safety as well as quality. The Action Priority is then obtained from the table in the manual. Prevention controls, which relate to the Occurrence rating, have a greater influence than Detection controls. Engineering or machine-based controls are meanwhile preferable to administrative controls that rely on compliance and vigilance for their effectiveness.
• Optimization seeks to eliminate the failure effect and/or implement better prevention and detection controls, all of which can reduce the action priority.
• Documentation means the PFMEA becomes a quality record that supports organizational knowledge. It is important to share the lessons learned with similar processes (read-across/replicate the process, or best practice deployment).

Regards,
Events Team
Global Wizdom
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