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Dynamic control plan combines FMEA and the control plan

Event Details

Dynamic control plan combines FMEA and the control plan

Time: February 20, 2018 from 1pm to 2pm
Location: 26468 E Walker Dr, Aurora, Colorado 80016-6104
Street: 26468 E Walker Dr, Aurora, Colorado 80016-6104
City/Town: Aurora
Website or Map:
Phone: 7209961616
Event Type: online, webinar
Organized By: Training Doyens
Latest Activity: Jan 25, 2018

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Event Description


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.


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.


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.


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


For more detail please click on this below link:



Toll Free: +1-888-300-8494

Tel: +1-720-996-1616

Fax: +1-888-909-1882

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