Obsolete Documents vs. Inactive Documents

Q

QualityClimber

We are a licensed medical device manufacturer and ISO 13485 compliant company. We have been debating the definitions of "inactive documents" vs "obsolete documents". How do my fellow Covers define these? How do you differentiate the two? Do you handle them differently?
Our issue is this: Thru the regular document control procedures, old/previous revisions of documents are moved from the current document store to an archive file. We think of these as "obsolete." However, there are documents in the current document store, that have become inactive for some reason. For example, an assembly instruction for an item we aren't currently manufacturing and we are not likely to make this item again.

Thanks and I look forward to your take on this!
 

AndyN

Moved On
Re: Obsolete vs Inactive Documents

From what you've written, I believe you have the correct interpretation! Obsolete = previous version(s). Inactive = latest version, not utilized.

Can't imagine anyone would have an equally valid alternative!
 
Q

QualityClimber

Re: Obsolete vs Inactive Documents

Thanks for the quick reply, ANdy. Do you monitor or handle "inactive documents" any different than any other documents? My thought is if an auditor sees a document that hasn't been reviewed or updated in three years, and they ask the question, "why hasn't this changed in three years?" Do you make some denotation that the document is not "currently utilized?"

Thanks again!
 
C

Craig H.

Re: Obsolete vs Inactive Documents

Thanks for the quick reply, ANdy. Do you monitor or handle "inactive documents" any different than any other documents? My thought is if an auditor sees a document that hasn't been reviewed or updated in three years, and they ask the question, "why hasn't this changed in three years?" Do you make some denotation that the document is not "currently utilized?"

Thanks again!

Even if the document has not been used in a while it should still be subject to periodic (annual) review in case it is used. At that time a decision may be made to make the document obsolete, and removing it from the review cycle.

Of course records of the review should be kept, the same way that they are kept for active documents.
 

AndyN

Moved On
Re: Obsolete vs Inactive Documents

Thanks for the quick reply, ANdy. Do you monitor or handle "inactive documents" any different than any other documents? My thought is if an auditor sees a document that hasn't been reviewed or updated in three years, and they ask the question, "why hasn't this changed in three years?" Do you make some denotation that the document is not "currently utilized?"

Thanks again!

No problem. If we are talking about preparing for some odd ball auditor question, I believe that that's a different subject.

Personally, I wouldn't have a problem with your explanation of inactive documents vs obsolete, if I were the auditor. Often those documents which have become obsolete through revision, are clearly marked as such. It should be too difficult for a reasonable auditor to get comfrtable that inactive documents won't be marked and won't be available during 'current' production. You can't be reasonably expected to have a system so watertight it can withstand any goofy question. It sounds like you have a robust process, so just stick to that.

Added in edit: I also don't see any reason for dragging out documents, when a product may not have been made, just to review them! What context could there be for doing that? In ISO/IEC 17025 there's a requirement to do this, and I know others have previously posted that they do this review. Personally, I couldn't justify why I'd expend resources doing that.

I'm not speaking from a particular background in a specific industry, just 20+ years of implementation across the board in many industries - "the song remains the same"
 
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C

Craig H.

Re: Obsolete vs Inactive Documents

Added in edit: I also don't see any reason for dragging out documents, when a product may not have been made, just to review them! What context could there be for doing that? In ISO/IEC 17025 there's a requirement to do this, and I know others have previously posted that they do this review. Personally, I couldn't justify why I'd expend resources doing that.

I'm not speaking from a particular background in a specific industry, just 20+ years of implementation across the board in many industries - "the song remains the same"

Andy, my thinking on this is that if a document (and a process) are inactive, that means that there is a chance that it would be reactivated at some time. If the document has not been reviewed for 3 years (or however long) then there should be a review at some point before the document is reactivated. It seems to me that in most cases it would be better to continue to follow the existing review procedure, instead of instituting another procedure for inactive documents.

However, if there are a LOT of inactive documents, then it would make sense to have a "review before use" policy.

Just MHO.
 

AndyN

Moved On
I agree Craig! I tend to think of that as being a function of the 'Quality Planning' requirements, rather than a specific document control issue, if you get my p.o.v.
 
A

amanbhai

There are obsolete documents in ISO 9001 however there is nothing for inactive documents or.......I am missing something?
 
N

neelu

Re: Obsolete vs Inactive Documents

Thanks for the quick reply, ANdy. Do you monitor or handle "inactive documents" any different than any other documents? My thought is if an auditor sees a document that hasn't been reviewed or updated in three years, and they ask the question, "why hasn't this changed in three years?" Do you make some denotation that the document is not "currently utilized?"

Thanks again!
In respect of ISO 9001, there is no requirement that periodicity of revision should be mentioned. But I have seen that some orgs. mention the periodicity in their procedure for documentation control and that creates the problem as in the case that you mentioned. It would be prudent to mention that 'documents will be reviewed as and when required.' In that case you can explain to the auditor what you mean by that in your org.
 

Helmut Jilling

Auditor / Consultant
Re: Obsolete vs Inactive Documents

In respect of ISO 9001, there is no requirement that periodicity of revision should be mentioned. But I have seen that some orgs. mention the periodicity in their procedure for documentation control and that creates the problem as in the case that you mentioned. It would be prudent to mention that 'documents will be reviewed as and when required.' In that case you can explain to the auditor what you mean by that in your org.


I don't think it creates any "problem." If a document is "inactive," it should be put out of the way and people (including auditors) would not normally come across it. Thus, it is not in use, inactive, and does not need to be monitored or reviewed. If it is not put out of the way, then apparently it is not really inactive.
 
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