Document Control Newbie - Control of Nonconforming / Returns Log

J

Jcornett344

Okay, so.

This is probably a question some of you may laugh or scoff at.
However I simply do not have the answer nor do I know anyone with the answer.

In regards to revision control, I want to know how often it is necessary to update revision number if you are simply adding information to a log.

Specifically, I am referring to our Nonconforming / Returns Log. Purely a list of past customer returns, to which gets added to every time we file one. Simply lists the Non-Con number, customer, date, and disposition.

Even though the format remains the same, must I update the revision status?

i.e. our first revision is Rev. 0, then Rev. 1, then Rev. 2 etc.

So if i add the latest nonconformity to the log, must i up the Rev. from Rev. 7 to Rev. 8? Or will the revision remain the same?

I know this is probably a goofy ass question. Just help a newb trying to be successful.
 
Last edited:

Ninja

Looking for Reality
Trusted Information Resource
You log is your log. It is a living document...no rev control.

Trying to rev a living document every time it 'breathes' is a great way to start hating your QMS...don't go there.

FWIW, I would suggest keeping that log in XL...its just easier...
 

Coury Ferguson

Moderator here to help
Trusted Information Resource
Okay, so.

This is probably a question some of you may laugh or scoff at.
However I simply do not have the answer nor do I know anyone with the answer.

In regards to revision control, I want to know how often it is necessary to update revision number if you are simply adding information to a log.

Specifically, I am referring to our Nonconforming / Returns Log. Purely a list of past customer returns, to which gets added to every time we file one. Simply lists the Non-Con number, customer, date, and disposition.

Even though the format remains the same, must I update the revision status?

i.e. our first revision is Rev. 0, then Rev. 1, then Rev. 2 etc.

So if i add the latest nonconformity to the log, must i up the Rev. from Rev. 7 to Rev. 8? Or will the revision remain the same?

I know this is probably a goofy ass question. Just help a newb trying to be successful.

I agree with everyone that it is a living document (at least the data) and doesn't need a revision. However, if you change the input format, or form format, you would need to change the revision level in my opinion.

Rule of thumb from my point of view:

Anytime the format, form information required to complete, is modified or changed, change the revision level and maintain the obsoleted form (with previous data) in a separate folder identifying it as obsolete forms and/or procedure.

Just my take on it
 

Ron Rompen

Trusted Information Resource
Just to echo what everyone else has said, you do NOT need to change the revision of the document when you record information in it. You change the rev level when you change the format of the document, the method of inputting data, or something that affects the document structure.

And it definitely was NOT a stupid question - at least you are smart enough to realize you don't have all the answers, and aren't afraid to ask for input from others.:agree1::applause::cool::notme:
 

QAengineer13

Quite Involved in Discussions
I am in agreement with everyone that the revision does not need to be up rev'ed but I believe that Log is a forma of a record which captured data as a snapshot of time which needs to follow the document control procedure of your QMS for records (i.e) who review/approve the log, what interval.
 
Q

QAMTY

Regarding to QAengineer13 comment:

The opinion of most of the users, is that is a live document and is not needed
to change the revision.

But I question, really the info contained in the format is by far more important then the
format which needs control, maybe is data of production in a big manufacturing company, who, how and when such important info was captured and how to trust in that if is not controlled at all?
could someone clarify this point?

Thanks
 

Mark Meer

Trusted Information Resource
But I question, really the info contained in the format is by far more important then the format which needs control, maybe is data of production in a big manufacturing company, who, how and when such important info was captured and how to trust in that if is not controlled at all?
could someone clarify this point?

I think, in such cases, "control" is usually established by restricting access somehow.

In the case of smaller organizations, or exclusive responsibilities, this could be as simple as the responsible party being the owner of the document (maybe it's maintained locally on their computer, or paper records filed by them), and hence (in principle) the only persons who can access/update.

Another possibility is ensuring training on who has authority to update, and perhaps including an initial/date field as a confirmation of who does the specific updates.

And yet another option (which is working well for us) is to adopt a software solution that automatically maintains a revision history (logging who does updates and when). For example a wiki. Such systems also allow control of access by user/account permissions...

These are just a few possibilities...
MM
 
Thread starter Similar threads Forum Replies Date
A Can a Form Template be altered in a 13485 document control system? ISO 13485:2016 - Medical Device Quality Management Systems 4
J Document Control Requirements within Oracle System Document Control Systems, Procedures, Forms and Templates 1
T Document Approver System AS9100 Doc Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
T Terms & Conditions Document Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
A Introducing a document control system benefits Document Control Systems, Procedures, Forms and Templates 13
A Digital Document Control - Revision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
A Document control system for QMS in Google Drive? Document Control Systems, Procedures, Forms and Templates 6
E Do anyone have document of automotive production risk and control of risk? Lean in Manufacturing and Service Industries 1
J Document Control of Online Management Software ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
W Document control Document Control Systems, Procedures, Forms and Templates 10
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
qualprod Sheets into a spreadsheet document control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Document Control - Applying Suitable Identification to Obsolete Documents ISO 13485:2016 - Medical Device Quality Management Systems 7
D Document Control Question involving DocuSign US Food and Drug Administration (FDA) 6
M Document Control ISO and FDA ISO 13485:2016 - Medical Device Quality Management Systems 7
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 5
dpenbert AS9100 7.5.3 - Manual Document Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Help in document control procedure Document Control Systems, Procedures, Forms and Templates 14
J Training on the importance of Document Control Document Control Systems, Procedures, Forms and Templates 3
M ISO 13485 and document control for programs ISO 13485:2016 - Medical Device Quality Management Systems 6
K ASME, ANSI, ASTM and similar specifications and their requirements for document control. Inspection, Prints (Drawings), Testing, Sampling and Related Topics 8
J Document Control Metrics Document Control Systems, Procedures, Forms and Templates 3
I Document Control Software Document Control Systems, Procedures, Forms and Templates 2
T Controlling Expandable Forms in Paper-Based Document Control System Document Control Systems, Procedures, Forms and Templates 10
shimonv Document Control Procedure Header Content Document Control Systems, Procedures, Forms and Templates 4
L How to add exemption or statement to control of document procedure? ISO 13485:2016 - Medical Device Quality Management Systems 5
I Document Control on Log Files ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q Tracking Procedure Revisions (Document Control) Document Control Systems, Procedures, Forms and Templates 9
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
I Control of Documentation Distribution - Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Control of downloaded document copies by employees Document Control Systems, Procedures, Forms and Templates 3
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
O Vendor vs Engineering Document Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A ISO9001:2015 Document control and training aids ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
GreatNate Document Control info - What is required on a controlled form/document for ISO 9001: 2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J Document Control Software Needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Document Control - Revision Number in Document Names Document Control Systems, Procedures, Forms and Templates 4
I First Time Implementing Document Control for ISO-9001 - how far back do you go? Document Control Systems, Procedures, Forms and Templates 15
I Document Control Workflow Document Control Systems, Procedures, Forms and Templates 2
D ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions Document Control Systems, Procedures, Forms and Templates 51
R Changing Document Control software. Must I transfer EVERYTHING? Document Control Systems, Procedures, Forms and Templates 3
B Referencing to Supplier Outputs within our Document Control System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Sidney Vianna IAF Mandatory Document #23 - Control of CB Franchisees and Agents Registrars and Notified Bodies 3
C Document Control - old revision vs new revision Document Control Systems, Procedures, Forms and Templates 22
D Software for advancing with Document Control Quality Assurance and Compliance Software Tools and Solutions 4
L IATF 16949 Cl. 7.1 - Lotus Notes for Document Control IATF 16949 - Automotive Quality Systems Standard 0
A Removing purchase order form from document control - should it be done? Document Control Systems, Procedures, Forms and Templates 9
I Video under Document Control SOP ISO 13485:2016 - Medical Device Quality Management Systems 2
S Change Control Form vs. Document Change Notification ISO 13485:2016 - Medical Device Quality Management Systems 3
S Document control for tooling drawings (Document control clause 7.5.3) IATF 16949 - Automotive Quality Systems Standard 5

Similar threads

Top Bottom