Simple Representation for Scope of DFMEA and PFMEA

v9991

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This is a typical pharma development & operations, and apart from other things, people are unable to distinguish failure modes to be considered at various stages of FMEA.
I have come up with following broad-outline to help focus performing assessment.
This is actually backed up by detailed SOP, but here I want to hear from Risk-Gurus on approach.
 

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JaxQC

dFMEA should address the materials selection, component interface, manufacturability, production assembly error proofing and the print dimensions since this is where the specs and GD&T originate. It should also address service needs as evidenced by my need to all but drop my engine to replace my car battery.

pFMEA should address manufacturing error proofing, insuring conformance to specs (material & dimensional) & how to achieve every GD&T item / spec requirement on the print.

After doing Automotive & Medical… look into the AIAG “bluebooks” for FMEA’s as a good starting training reference.
 
M

mayank_thkkr

Typically Design FMEA is used to analyze products before they are released to production. It focuses on potential failure mode associated with FUNCTION of a product caused by DESIGN.

Process FMEA is used to analyze manufacturing and assembly processes, It focuses on potential failure modes associated with the FUNCTIONS of a process caused by DESIGN and OPERATION.

Just for further clarification:
Take example of shaft, for which desired function is to transfer the energy from one form to another.

FUNCTION : The characteristics which can only be realized after the application. i.e. Intended function after application (How well it fulfills the requirements after use)

PRODUCT CH. The Characteristics which can be realized (or measured) only after manufacturing but before final application. i.e Length, height, Width etc

PROCESS CH. The Characteristics which can be realized only during the manufacturing process. i.e Speed, Feed rate, Coolant Concentration,

This is how we use this methodology in Mechanical Industries, I am not sure about applicability to your organization / Process
 

v9991

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can anyone share examples of dfmea and pfmea for any process. (i would prefer any chemical/pharma processing activity, however any engineering examples are very much welcome)

thank you
 
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