Slide 20 of 161

Where and Why

• Automotive

  QS9000 paragraph 4.2
  
  Cited in the AIAG APQP Manual

• Process Safety Management Act (PSM)

  CFR 1910.119999999 lists the process FMEA as one of about 6 methods to evaluate hazards
  
  Example: ICI Explosives - Hazardous Operability Studies

• FDA - GMPs

  One of several methods that should be used to verify a new design (21CFR Part 820). Inspector’s check list questions cover use of the Design FMEA.
  

• ISO 9001/2

  Requires Preventative Actions. The utilization of FMEAs is one continuous improvement tool which can satisfy the requirement (ISO9001, Section 4.14)
  

• ISO14000

  Can be used to evaluate potential hazards and their accompanying risks.
  

The Juran Trilogy	The Deming PDCA Cycle	QMS Implementation	FMEA Information	APQP Information
Auditing Information	8-D Problem Solving	Statistics	Error Proofing (Poka Yoke)	Brainstorming
Identifying Waste	Pull Systems	Lead Time Reduction	Planned Maintenance	Quick Setup
Discovering Change	Process Capability - Cp vs. Cpk	Histogram Animation	Process Loop Animation	Taguchi Loss Function
		Fishbone / Cause and Effects Animation

All Y'All Come Back Now, Y' Hear?

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