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dfmea (design fmea), fmea - failure modes and effects analysis, pfmea (process fmea), pharmaceuticals and pharmaceutical industry, process fmea
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Old 28th December 2011, 11:52 AM
v9991 v9991 is offline
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Please Help! Simple Representation for Scope of DFMEA and PFMEA

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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Last edited by Stijloor; 28th December 2011 at 04:22 PM. Reason: Typo.

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  #2  
Old 29th December 2011, 04:40 AM
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Re: Simple Representation for Scope of DFMEA and PFMEA

A Quick Bump!

Feedback? Comments?

Thank you very much!

Stijloor.
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Old 3rd January 2012, 12:48 PM
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Re: Simple Representation for Scope of DFMEA and PFMEA

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.
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Old 16th January 2012, 07:17 AM
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Re: Simple Representation for Scope of DFMEA and PFMEA

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
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Old 20th April 2012, 11:20 AM
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Please Help! Re: Simple Representation for Scope of DFMEA and PFMEA

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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