The Cove Business Standards Discussion Forums
Go Back   The Elsmar Cove Business Systems and Standards Discussion Forums > > >
Forum Username

Elsmar Cove Forum Visitor Notice(s)

Wooden Line

When should a note-to-file be used in a QMS vs Deviation 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
deviations from a print or requirement, note to file, qms (quality management system)
Reply
 
Thread Tools Search this Thread Rate Thread Content Display Modes
  Post Number #1  
Old 10th August 2018, 09:54 AM
snoopy2017

 
 
Total Posts: 91
Question When should a note-to-file be used in a QMS vs Deviation Report

Hi everyone,

When should a note-to-file be used in a QMS? When should a deviation report be filed?

Thanks.

Sponsored Links
  Post Number #2  
Old 11th August 2018, 05:58 PM
Ajit Basrur's Avatar
Ajit Basrur

 
 
Total Posts: 6,222
Re: When should a note-to-file be used in a QMS vs Deviation Report

Quote:
In Reply to Parent Post by snoopy2017 View Post

Hi everyone,

When should a note-to-file be used in a QMS? When should a deviation report be filed?

Thanks.
As a tool, Quality Risk Management (QRM) has always been part of the analysis process linked to the handling of events and deviations. See the attached guidance document from World Health Organization (WHO) that proposes a possible strategy to differentiate non-significant events which actually do not affect the product’s quality or violate any norm or defined procedure, from actual deviations which could impact on the product´s quality.

I am not sure if your "note-to-file" document is an official document. Take a look at the attachment and see if it fits your QMS needs.
.
Attached Files: 1. Scan for viruses before opening, 2. Please report any 'bad' files by Reporting this post, 3. Use at your Own Risk.
File Type: pdf WHO - Deviation Handling.pdf (651.5 KB, 31 views)
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
Can anyone share an Note to File for justifying postponement of Internal Audits ? kellascat Quality Manager and Management Related Issues 5 13th January 2014 04:06 PM
Manufacturing Process Deviation linked to DMR (Discrepant Material Report)? todayssunny 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3 31st August 2012 12:16 PM
AAR (Appearance Approval Report) with general note for Grain vardar3 APQP and PPAP 1 12th March 2012 06:00 PM
Handling Calibration Postponement - just a note/deviation report/others? Quality Priest General Measurement Device and Calibration Topics 7 24th April 2008 08:23 AM
Bug Report Thread 070418 --> NOTE: Testing new advertisement layouts Marc Old Forum News and Issues Threads Archive 17 18th April 2007 04:18 PM



The time now is 03:18 AM. All times are GMT -4.
Your time zone can be changed in your UserCP --> Options.



Misc. Internal Links


NOTE: This forum uses "Cookies"