Skipping Document Revision Levels

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#11
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.
Was Revision B ever going to come out?

Let us step back from this and look at the reason for not skipping revisions. It is about risk. If Revision C came out and then was replaced by Revision B, the changes in Revision C would be lost. I have seen this happen - it can be messy. It is important to find a way to avoid it.

If the changes in Revision B are now being included in Revision C, I would note that in the document's history for the sole purpose of explaining a missing Revision B years down the road.
 
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M

MIREGMGR

#12
My observation of FDA practices as revealed by Warning Letters is that they are less concerned with device makers having an orderly system than an effective one that assuredly delivers safe devices.

My take is that it's fine to have systematic discrepancies, odd situations and judgment calls as long as it's very clear that they're contemporaneously understood, intelligently managed so as to remain in control, justifiably handled as a special case rather than through a system change, and documented so that they're auditable at a later date.
 
J

JaneB

#13
My observation of FDA practices as revealed by Warning Letters is that they are less concerned with device makers having an orderly system than an effective one that assuredly delivers safe devices.
I'm very pleased to hear it and applaud their good judgement in that case.

My take is that it's fine to have systematic discrepancies, odd situations and judgment calls as long as it's very clear that they're contemporaneously understood, intelligently managed so as to remain in control, justifiably handled as a special case rather than through a system change, and documented so that they're auditable at a later date.
Yes, exactly. Well put.
 
J

JaneB

#14
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.
I agree EDC is better, but from a pragmatic and risk point of view (as Jennifer points out) there's very strong reasons to build in reasonable controls into your manual system.

You say there's 'no communication' with document control. Bad Thing. (Why so?)
You say 'engineering didn't follow procedure'. Ditto. (Why didn't they?)
Both = risk.

I'd seriously consider revising the procedure to hopefully avoid recurrence. For example
* could you flag the file for the existing current document in some way as 'under revision'?
* could you set up a 'Drafts under revision' folder and have the process work on new drafts only in that folder?
etc.
 
K

Ka Pilo

#15
Based from the responses, it seems to me that when someone sees an area where there is nonconformity, shouldn’t necessarily be reported in a formal CPAR/CAPA even if Control of Nonconforming Product Procedure or Corrective Action Procedure says so provided that the nonconformity is isolated or just a minor deviation to the procedure.
 
A

AliInMo

#16
I'm a bit confused. How can someone revise a document if there is no communication with document control? If you have control of the documents then shouldn't you have the only copy that can can be altered (eg: the Word version vs. a PDF which anyone can read)? Our system is also manual at the moment. (I'm still trying to find a good yet inexpensive EDMS.) I have an Excel master log of all controlled documents and one of the columns is for check-out. If someone wishes to revise a document I check it out to them (noted in master log), give them access to a copy that can be changed and they have 2 weeks to make those changes. If someone else wants to check out that document during those 2 weeks they are referred to the person who originally requested the document and they can work together to make the necessary changes. In this way, no document can be under revision by two different people at the same time.
 
D

DocGuy

#17
Engineering has a program called Solid Works that they use, I have no access to the program and Document Control has never been given engineering documentation.

This is part of my frustration.
 
J

JaneB

#18
Engineering has a program called Solid Works that they use, I have no access to the program and Document Control has never been given engineering documentation.

This is part of my frustration.
I empathise.
Solidworks or no, 'Engineering' needs to get with the program and have good control.
OK, they use a CAD type program (of course) and some of those have certain 'preferences' built in as to where the files are stored and how managed.
All fine BUT regardless of that there still HAS to be a good, robust procedure for controlling such files/documents. Is it possible to devolve responsiblity to the Engineering Manager and work with them to ensure a good system? Because otherwise this kind of thing is bound to happen again. And 'Document Control' (whoever they are) cannot possibility have the responsi bility for this if they have no access to it, nor authority.

Perhaps the idea of treating it as a formal NC is not such a bad one. Either way, I'd definitely be putting this very high on my priorities for internal audit - to get in there and see whether it really was simply an isolated instance. Or not.
 
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M

Monica Kelpin

#19
Hello Jane,
Hello to everybody in the Cove,

I am since just a few days member in the Cove. I work in a small engineering company and since a few months I am familiarising with the Quality issues. In the short time I learned very much from the Cove forum, I found here many ideas which I could make us of.

"And 'Document Control' (whoever they are) cannot possibility have the responsi bility for this if they have no access to it, nor authority."

I agree totally with Jane. Maybe I am a control freak, as some colleagues are laughing (I am comming from the document control side into Quality). But the Document Control Center should own the files in original, and gives a document free to be edited when the Project Manager decides that.

"Perhaps the idea of treating it as a formal NC is not such a bad one. Either way, I'd definitely be putting this very high on my priorities for internal audit - to get in there and see whether it really was simply an isolated instance. Or not."

It does not look like an isolated case, but the common practice. :(
It would be interesting to know what the document control procedure foresees for the engineering documents control?

Regards,
Monica
 

Wes Bucey

Quite Involved in Discussions
#20
As a guy who lived and worked with manual document control systems for more than 30 years before workable electronic (computerized) systems were available, I'm curious about TWO things in this thread:
  1. We learn the hangup on final approval of Rev B was because "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." How long was it sitting there? How can ANY system leap to Rev. C if there is no formal issuance and approval of Rev. B? How is it that Rev C was approved and manufactured before Rev B? Didn't a change document have to be issued for Rev C? Did the guy with Rev B sitting on his desk ignore it [lose it?] and sign off on Rev C?
  2. Is the issue merely one of correcting records? If so, it seems that circulating a change document for Rev. C and including in that document that "Rev B is superseded since it was never approved for production" should serve as a viable fix to restore order to the "appearance of the documents as being in order." In aerospace (a notoriously fussy industry for record keeping), for example, it is common practice for engineers and others to "redline" existing versions of documents with changes and then go ahead with implementing the changes in production BEFORE the formal approval process takes place, but there is an informal approval process (phone calls, emails, face-to-face, etc.) whereby the pertinent parties agree the change is necessary and they will affix formal approval when the new document incorporating the redline changes is circulated. It seems to me the important thing to consider is the root cause of WHY anyone thought it OK to suspend either formal or informal approval process and go ahead. In every well-run organization I have been acquainted with, the person or department in charge of record-keeping [document control?] is NEVER left out of the loop when redlining is in operation.
 
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