The Cove Business Standards Discussion Forums
Manufacturing Process Deviation linked to DMR (Discrepant Material Report)?
Please read this thread...
Software update
Manufacturing Process Deviation linked to DMR (Discrepant Material Report)?
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

Manufacturing Process Deviation linked to DMR (Discrepant Material Report)?

Monitor the Elsmar Forum
Courtesy Quick Links


Links Elsmar Cove visitors will find useful in the quest for knowledge and support:

Jennifer Kirley's
Conway Business Services


Howard's
International Quality Services


Marcelo Antunes'
SQR Consulting, and
Medical Devices Expert Forum


Bob Doering
Bob Doering's Blogs and,
Correct SPC - Precision Machining


Ajit Basrur
Claritas Consulting, LLC



International Standards Bodies - World Wide Standards Bodies

AIAG - Automotive Industry Action Group

ASQ - American Society for Quality

International Organization for Standardization - ISO Standards and Information

NIST's Engineering Statistics Handbook

IRCA - International Register of Certified Auditors

SAE - Society of Automotive Engineers

Quality Digest

IEST - Institute of Environmental Sciences and Technology


Some Related Topic Tags
dmr (discrepant material report), fda (food and drug administration), manufacturing processes
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 30th August 2012, 11:29 AM
todayssunny

 
 
Total Posts: 4
Please Help! Manufacturing Process Deviation linked to DMR (Discrepant Material Report)?

Hi All,

Imagine I have a devation in the manufacturing process in place.
The deviation was requested and approved before the work order was started. a) It is applicable for a defined period of time only.
or
b) ... applicable for a certain number of lots/batches.

How is FDA expecting me to link such a deviation to the DMR?
Some consultants adviced us to get rid of the deviation process as for the time of the deviation in place, we do not manufacture according to the approved DMR.

Any reply is highly appreciated...

---------------------------------

just for clarification... by DMR I mean Device Master Record (Medical Devices) --> sorry for any confusion caused

Last edited by todayssunny; 31st August 2012 at 03:22 AM. Reason: clarification

Sponsored Links
  Post Number #2  
Old 31st August 2012, 03:05 AM
Stijloor's Avatar
Stijloor

 
 
Total Posts: 15,334
Re: Manufacturing Process Deviation linked to DMR (Discrepant Material Report)?

A Quick Bump!

Can someone help?

Thank you very much!!
  Post Number #3  
Old 31st August 2012, 11:59 AM
yodon

 
 
Total Posts: 1,158
Re: Manufacturing Process Deviation linked to DMR (Discrepant Material Report)?

For right or wrong, I don't 'link' it to the DMR - I include the deviation as part of the DHR. (Note: the deviation is linked to a specific revision of the DMR.) This allows me to know that the device / lot / batch was built according to the DMR + the approved deviation(s).
  Post Number #4  
Old 31st August 2012, 12:16 PM
isoalchemist

 
 
Total Posts: 230
Re: Manufacturing Process Deviation linked to DMR (Discrepant Material Report)?

The deviation itself should clearly state if it is a time period or a specific number of lots/batches so that you can maintain tracability of the materials that were produced under that deviation. I've used both approaches ( time or lot) depending on the reason for the deviation.

For the DMR I had a section for deviations that I added as a roadmap if questions came up we could go find them. It was rare I needed to deviate (thankfully), but we could trace it. I didn't put a copy of each deviation in the DMR, but pointed to where any deviations could be found. Make sure a copy of the deviation is in each DHF for the lots manufactured under that deviation regarless of the time/lot question.
Thanks to isoalchemist for your informative Post and/or Attachment!
Reply

Lower Navigation Bar
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > > >

Bookmarks



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
Emoticons 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
Format for Discrepant Material Report (DMR) - Nonconformance Report (NCR) biju-joseph Document Control Systems, Procedures, Forms and Templates 1 6th March 2012 12:42 AM
How to Capture Discrepant Material identified at Supplier in NC system Beauclan Nonconformance and Corrective Action 6 4th February 2011 06:05 PM
Material Review Board Process in a small plastic manufacturing company lgoeke ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10 30th April 2008 09:48 AM
Incoming Material Inspection Plan - Drawing CTQ (Critical to Quality) features linked FC Larson Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5 18th November 2007 06:14 AM
Concession/ Deviation for change in manufacturing process Andrews IATF 16949 - Automotive Quality Systems Standard 1 20th August 2005 09:04 AM



The time now is 08:14 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"