Inquiry about the number of changes in a document

TarKEpa

Registered
Hi all, :)

I work for a Pharmaceutical company and in our last audit we had that comment in the inspection report

* Number of changes in the documents after which reissuing takes place is not determined

just wanted to understand :frust: this item and what it means?

Thank you so much, Love this site,

TarKEpa
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Re: Inquiry about No. of changes in a document ?

That is a pretty cryptic write up. It seems to me like a document revision control comment.
 

Wes Bucey

Prophet of Profit
Hi all, :)

I work for a Pharmaceutical company and in our last audit we had that comment in the inspection report

Quote:
* Number of changes in the documents after which reissuing takes place is not determined
just wanted to understand :frust: this item and what it means?

Thank you so much, Love this site,

TarKEpa
I would "guess" this auditor was struck by looking at "redlined" documents (documents where changes are added to an existing document and then initialed by approving entities) and wondered [opportunity for improvement] why the changes weren't incorporated into a revised document which was then reissued (a clean document without all the markups.) The comment appears to aim at creating an "organization policy" for maintaining clear documentation.

But why guess? Call or email the auditor who wrote the comment and ask for a clarification. In the future, try to ask such questions at the closing meeting, but do not feel "stupid" if a question arises in interpretation after the auditor has left the building. Auditees cannot be expected to read the mind of an auditor and have every right (even responsibility) to ensure they understand the comment and the basis for the comment (often called the "show me the shall" in referring to a citation against a Standard or a company policy.)
 
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TarKEpa

Registered
I would "guess" this auditor was struck by looking at "redlined" documents (documents where changes are added to an existing document and then initialed by approving entities) and wondered [opportunity for improvement] why the changes weren't incorporated into a revised document which was then reissued (a clean document without all the markups.) The comment appears to aim at creating an "organization policy" for maintaining clear documentation.


hi Mr. Wes

Did it aim at making a "change control table" in all SOPs mentioned in it the No. of changes + the reissued date ?
 

JoCam

Trusted Information Resource
Hi TarKEpa,

I read from this that the Auditor is stating that the changes made to documents and presented to document control for up-issue are not highlighted. For example, insertions in green and strike through of omissions. These changes need to be highlighted to assist approvers of the amended documents, and ensure full traceability of amendments in the doument history.

I may be wrong, but it is another way of intepreting the statement.

Hope this helps,

Jo
 
M

mzeeshanz

Dear TarKEpa,

IMO, you should consider the best suggestion as made by Wes Bucey (Call or email the auditor who wrote the comment and ask for a clarification.)

The guess of
Wes Bucey is also "well-guessed". If auditor's clarification would be similar to this guess, then you should simply have to add a piece of text in you procedure of document control that describe your procedure of handwritten changes. The text to be added may be like this:

"Handwritten changes followed by review and approval from authorized personnel are allowed. In such cases formal procedure for reissuing is not followed but XYZ (designated personnel) ensures that all distributed copies of particular document are updated accordingly. After NN (number of) changes, particular document is formally reviewed, approved and distributed with new issue number."

Hope it helps.

Regards:
Zeeshan
 

raghu_1968

Involved In Discussions
Dear TarKEpa,

Hope that auditor is looking for the revision history of the document. The revision history shall contain:

1. S.No.
2. Revision number
3. Description of the change (With change control form no.)
4. Effective date of the particular revision.

This revision history should be part of the each procedure.

Regards / Raghu
 
D

DrM2u

TarKEpa,

Follow Wes Bucey's advice: contact your auditor for clarification! As you can see so far, there are many interpretations of the same statement.

I am going to assume that you are following ISO 13485, being a pharmaceutical organization. If that is the case, there is no requirement in the standard to determine the "number of changes in the documents after which reissuing takes place [...]" (see clause 4.3 for requirements). Therefore the auditor' comment cannot be more that an opportunity for improvement for your procedure and/or document control process. At this point you can ignore it (if the system is suitable and compliant) or take action (if you see the opportunity as well). Whatever you decide to do, and at the risk of repeating myslef, contact your auditor for clarification first!!!
 
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