The Elsmar Cove Wiki More Free Files The Elsmar Cove Forums Discussion Thread Index Post Attachments Listing Failure Modes Services and Solutions to Problems Elsmar cove Forums Main Page Elsmar Cove Home Page
Miner's MSA (Measurement Systems Analysis) Blog 
Go Back   The Elsmar Cove Forum > Common Quality Assurance Processes and Tools > FMEA and Control Plans
Forum Username

Wooden Line

Simple Representation for Scope of DFMEA and PFMEA

Wooden Line
Search the Elsmar Cove
Search Elsmar
Monitor the Elsmar Forum
Follow Marc & Elsmar
Elsmar Cove Forum RSS Feed  Marc Smith's Google+ Page  Marc Smith's Linked In Page   Marc Smith's Elsmar Cove YouTube Page  Marc Smith's Facebook Page  Elsmar Cove Twitter Feed
Elsmar Cove Groups
Elsmar Cove Google+ Group  Elsmar Cove LinkedIn Group  Elsmar Cove Facebook Group
Donate and $ Contributor Forum Access
Courtesy Quick Links

Links that Elsmar Cove visitors will find useful in your quest for knowledge:

International Quality Services
Marcelo Antunes'
SQR Consulting
Bob Doering's
Correct SPC - Precision Machining

NIST's Engineering Statistics Handbook
IRCA - International Register of Certified Auditors
SAE - Society of Automotive Engineers
Quality Digest Portal
IEST - Institute of Environmental Sciences and Technology
ASQ - American Society for Quality

Related Topic Tags
dfmea (design fmea), fmea - failure modes and effects analysis, pfmea (process fmea), pharmaceuticals and pharmaceutical industry, process fmea
Thread Tools Search this Thread Rating: Thread Rating: 1 votes, 5.00 average. Display Modes
Old 28th December 2011, 11:52 AM

Posts: 803
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.
Attached Thumbnails

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

Sponsored Links
Old 29th December 2011, 04:40 AM
Stijloor's Avatar

Posts: 14,639
Re: Simple Representation for Scope of DFMEA and PFMEA

A Quick Bump!

Feedback? Comments?

Thank you very much!

Sponsored Links

Old 3rd January 2012, 12:48 PM

Posts: 210
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.
Old 16th January 2012, 07:17 AM

Posts: 26
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
Old 20th April 2012, 11:20 AM

Posts: 803
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

Lower Navigation Bar
Go Back   The Elsmar Cove Forum > Common Quality Assurance Processes and Tools > FMEA and Control Plans

Do you find this discussion thread helpful and informational?


Visitors Currently Viewing this Thread: 1 (0 Registered Visitors (Members) and 1 Unregistered Guest Visitors)
Thread Tools Search this Thread
Search this Thread:

Advanced Forum Search
Display Modes Rate Thread Content
Rate Thread Content:

Forum Posting Settings
You may not post new threads
You may not post replies
You may not post attachments
You may not edit your posts

BB code is On
Smilies are On
[IMG] code is On
HTML code is Off

Similar Discussion Threads
Discussion Thread Title Thread Starter Forum Replies Last Post or Poll Vote
IQRM PFMEA/DFMEA Software engineer11 FMEA and Control Plans 17 9th April 2013 03:54 AM
DFMEA & PFMEA Lead Responsibility KWB64 FMEA and Control Plans 10 3rd April 2010 11:40 AM
The difference between DFMEA and PFMEA Garfield_01 - 2011 FMEA and Control Plans 4 20th December 2006 09:38 PM
Connection between DFMEA and PFMEA - What must be transferred to the PFMEA? mahoc FMEA and Control Plans 9 1st September 2006 09:29 AM
PFMEA - Is having the DFMEA An Absolute Requirement when doing a PFMEA Amex FMEA and Control Plans 19 23rd June 2005 07:54 AM

The time now is 07:16 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.


Marc Timothy Smith -
8466 LeSourdsville-West Chester Road, Olde West Chester, Ohio 45069-1929
513 341-6272
NOTE: This forum uses "cookies".