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Skipping Document Revision Levels

D

DocGuy

#1
I want to throw out a question to the forum regarding skipping revisions on documentation.

Issue is that this part is currently at Rev A, and on of my collegues checked it out in January to rev it to B. That change is on hold, and not sure when or if it will be resolved.

Another collegue made revisions but also included the changes from A to B but had parts made to C before the document change was approved formerly through our Change Process.

How do other Medical Device companies or other industries handle this. I only skip I,O,Q and it's written in a procedure.

Would a memo to file be sufficient, would that hold up in an FDA audit?

Thanks,
Kevin
 
J

JaneB

#3
What's the common sense solution? It sounds as though rev. C has been approved and released, yes?

In that case, I'd write a File Note/similar to explain why the version jumped from Rev A to C. Naturally, I'd include in the File Note that the changes from A to B were also reviewed and approved via the release of version C.

Cannot answer the question of an FDA audit - someone else probably can - but this would satisfy any reasonable external auditor.

I don't understand what you mean about rev B still being 'on hold' - that one has to now be cancelled. Any further changes MUST be to revC as normal (and taken up to D).
 
A

Al Dyer

#4
Sounds like total disregard for a document control system that should be in place and the total process revision aspect of an entire manufacturing system. Discuss with us why or how you think this happened?????

Al...
 

harry

Super Moderator
#5
FDA or not, the expectation of a perfect record is a myth. What is more important is having a system that is able to demonstrate or prove that nonconformances or breaches can be detected and acted upon.

Is this an isolated incident or were there similar issues previously? Set the relevant provisions in your system into motion and take appropriate actions as provided.
 
K

Ka Pilo

#6
FDA or not, the expectation of a perfect record is a myth. What is more important is having a system that is able to demonstrate or prove that nonconformances or breaches can be detected and acted upon.

Is this an isolated incident or were there similar issues previously? Set the relevant provisions in your system into motion and take appropriate actions as provided.
I agree with Harry. If there is nonconformity to the Control of Documents Procedure, you need to record such non-conformity thru your CPAR/CAPA, determine the root causes of non-conformity and corrective action with corresponding timelines, implement action plans and review effectiveness, follow up implemented action plan.

Make your Corrective Action Procedure works for you.
 
J

JaneB

#7
FDA or not, the expectation of a perfect record is a myth. What is more important is having a system that is able to demonstrate or prove that nonconformances or breaches can be detected and acted upon..
Yes, I agree totally Harry.

That's the real purpose.
 
J

JaneB

#8
If there is nonconformity to the Control of Documents Procedure, you need to record such non-conformity thru your CPAR/CAPA, determine the root causes of non-conformity and corrective action with corresponding timelines, implement action plans and review effectiveness, follow up implemented action plan.

Make your Corrective Action Procedure works for you.
Sorry, I disagree with this also. While I do agree that one's CA procedure should work for one, I definitely don't want to use a sledgehammer to crack a nut. After all, we are merely talking about ONE single instance of a breach here.

Are you seriously saying that you would move straight into issuing a formal NC on the basis of one single, solitary instance, without even taking any time to find out a bit more about how/why it occurred? Without having any more evidence than that? :confused:

I would not. To me, that's pretty much a recipe for making the name of Quality a dirty word and overly extreme action for one single instance.
 
K

Ka Pilo

#9
Sorry, I disagree with this also. While I do agree that one's CA procedure should work for one, I definitely don't want to use a sledgehammer to crack a nut. After all, we are merely talking about ONE single instance of a breach here.

Are you seriously saying that you would move straight into issuing a formal NC on the basis of one single, solitary instance, without even taking any time to find out a bit more about how/why it occurred? Without having any more evidence than that? :confused:

I would not. To me, that's pretty much a recipe for making the name of Quality a dirty word and overly extreme action for one single instance.
Your reasoning is sound and fair.
 
D

DocGuy

#10
Thank you all,

The procedure describes the process for engineering changes to a released production level part. The problem is Engineering didn't follow the procedure.

The document control system is manual and when someone wants to revise a part or document there is no communication with document control.

Revision B is on a change document and the package is stalled sitting on someone's desk, another engineer went into the engineering system and made a change to the same part and the engineering system forces the revision to change to C.

The change to revision C is now in a new change package. Revision B was never released in the documentation system.

I so wish my company could afford to buy an electronic document control system, working a manual system is so frustrating and plain tiring.
 
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