Dynamic control plan combines FMEA and the control plan

OVERVIEW

Advanced quality planning (AQP) includes quality function deployment (QFD, house of quality), design FMEA, process FMEA, and the control plan. All these activities are interrelated. The outputs of QFD are inputs to the design FMEA, the design FMEA's outputs are inputs to the process FMEA, and the process FMEA's outputs define the requirements of the control plan.

The control plan governs operations that affect the critical to quality product characteristics and it includes, for example, sampling plans, metrology, and measurement systems analysis (MSA). As the process FMEA defines the critical operations and their failure modes—that is, how a deficiency in the operation can cause nonconformances—it is natural to extend the FMEA to include the control plan itself. The result is a dynamic control plan, a living document that evolves in response to process improvements, and thus drives continual improvement.

The webinar will cover additional considerations for FMEA, including the often-overlooked effect of frequency of exposure to a risk, and the concurrent need for engineering controls (poka-yoke, error proofing) that make nonconformances physically impossible.

WHY SHOULD YOU ATTEND

Failure mode effects analysis (FMEA) is a mandatory element of AQP and APQP, and the textbook methods are well known. Attendees will learn, however, considerations that go well beyond calculation of the traditional risk priority number (RPN). Drawbacks of RPN include the fact that it is the product of three ordinal numbers which means that a smaller RPN does not necessarily mean a lower risk. Failure modes with catastrophic severity ratings always require attention regardless of RPN, and the occurrence rating does not account for the frequency with which we are exposed to a risk. The Army's Risk Management Process does account for frequency of exposure, and this free off the shelf resource is worthy of consideration.

The issue of frequency of exposure, whether in terms of the number of times a job is performed or the number of parts that are produced, also underscores the need for engineering controls that make nonconformances impossible, in contrast to administrative controls that rely on worker vigilance. Shigeo Shingo case studies that begin with language like "errors were avoided through worker vigilance" always involved errors—not because workers aren't vigilant but because mistakes are inevitable given (1) any finite probability of occurrence and (2) enough opportunities. Consideration of this issue increases the effectiveness of FMEA.

Extension of the FMEA to include the control plan then creates a dynamic control plan that addresses the product's critical to quality characteristics and the risks associated with them.

AREAS COVERED

• Know the key elements of advanced quality planning: QFD, design FMEA, process FMEA, and the control plan. The importance of designing quality into the product cannot be overemphasized; Henry Ford said to design the product so it can be most easily made, i.e. for manufacture.
• Know the definition of critical characteristics (these affect safety and/or compliance with government regulations) and significant characteristics, which affect customer satisfaction. These are known generically as critical to quality (CTQ) characteristics for which quality planning and controls are mandatory.
• Recognize that the control plan must address the CTQ characteristics through appropriate measurements and controls, which can include gages and instruments, sample plans, calibration schedules, and measurement systems analysis (MSA, gage reproducibility and repeatability). Controls can also, however, include error-proofing (poka-yoke) and automatic feedback process controls.
• Know the definition of failure modes (what goes wrong) and failure mechanisms (how it goes wrong).
• Know how to define severity, occurrence, and detection ratings, and multiply these to get a risk priority number in FMEA. Also, however, give priority to high severity ratings regardless of RPN, and recognize that the occurrence rating does not inherently recognize frequency of exposure to the risk.
• Army Techniques Publication (ATP) 5-19, "Risk Management," as a simpler alternative to FMEA when it is difficult to quantify the exact probability of occurrence and/or non-detection.
• Extend the columns of the FMEA to include the control plan, and thus create a dynamic control plan.

LEARNING OBJECTIVES

The dynamic control plan is a natural extension of the columns of a traditional process failure mode effects analysis (FMEA) to include the control plan for the operations that affect the critical to quality (CTQ) product characteristics. This supports advanced quality planning (AQP) or advanced product quality planning (APQP) as required by IATF 16949.

WHO WILL BENEFIT

Manufacturing and design professionals with responsibilities for AQP or APQP (automotive).

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Learn the aspects of the dynamic control plan that  is a natural extension of the columns of a traditional process failure mode effects analysis (FMEA)

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