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Changing revision status of a reviewed document

#1
When reviewing a document for periodic review, I was taught that the document should be reved even if no changes have occurred, just so there is an audit trail of the periodic review. Does anyone have a reg that points to this?

thank you
 
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Johnny Quality

Quite Involved in Discussions
#3
If an auditor asks if a document has been reviewed, how will you prove it?

Revising the document to a new level and documenting the review is one way, @brandieb1230 's way is another.

Whichever suits your organization best.
 

Mike S.

Happy to be Alive
Trusted Information Resource
#4
Who/what says that you have to periodically review your documents?

If your procedures say you have to review the documents every X months/years, also state if/how you will create a record of the review. Make it easy on yourself.

Maybe keep a simple review log in Excel.

Maybe send yourself an email saying "on this date I reviewed document ABC123 Rev C and found it acceptable as-is". There! You have a record.
 

Jim Wynne

Staff member
Admin
#5
I agree with Mike S. The revision status of a document should be changed only when the document has actually been changed/revised, and for this reason I think that the record of review should be kept separate from the document itself.
 
#6
Who/what says that you have to periodically review your documents?

If your procedures say you have to review the documents every X months/years, also state if/how you will create a record of the review. Make it easy on yourself.

Maybe keep a simple review log in Excel.

Maybe send yourself an email saying "on this date I reviewed document ABC123 Rev C and found it acceptable as-is". There! You have a record.
I had the same question. For document control we have a 3 year review of documents that have not been revised to confirm whether it is still Active-Approved, Active-Changes Required, or can be made Obsolete.

Currently, it was requested that a note is placed in the revision history that the document was reviewed and Active-Approved (if no changes were necessary).

Normally, I would handle the Review Date by placing it under the effective date (example below)
Effective Date: 06/10/2018
Reviewed Date: 06/10/2021

This way the effective and revision date remains the same.

I was wondering if many others add the reviewed date information to the revision history in addition to it being stated as I have above? Do you roll the revision? I stood strong on not rolling a revision because that would put extra work on training required, new print for manuals, archiving the old revision etc.....
 

Mike S.

Happy to be Alive
Trusted Information Resource
#7
I do not add a reviewed date to the revision history, and do not roll the revision simply because it was reviewed.

If what you do works efficiently for your company, that's great.
 

Tidge

Trusted Information Resource
#8
This topic is one that I've seen diverse organizations deal with in different ways, some group are 'better' at it than others. The need to periodically review procedures has not been (in my experience) specifically called out in 'regulations' (although I wouldn't be surprised to learn that some have done this explicitly) but it commonly comes up as the most obvious solution to address other elements of regulations. For example, it used to be the case (I no longer have any direct experience) that in order to maintain A2LA lab accreditation labs would commonly have to demonstrate that they are periodically reviewing their internal procedures. In many fields 'periodic review' is the implemented manner by which organizations 'maintain' (appropriate) procedures.

For certain institutions which PUBLISH standards, it is often the case that the periodic review of a recognized (and still useful) standard requires no revision, so the 'revision' (typically year of release) remains the same but the published standard will identify date of original approval along with any dates of recent 're-approval' (planned and scheduled by a specific committee). ASTM used to do this, I haven't reviewed ASTM standards/test methods in a while. Most manufacturing organizations don't do this... quite frankly there would be too much overhead involved (including all sorts of procedural requirements) for almost everyone, and without the weight of a major organization with diverse stakeholders 3rd party auditors would almost certainly have a field day.

Some organizations take the simplest approach to simply 'casually approve the next revision'. This is typically always a waste of resources, but there are some pretty simple-minded 3rd-party auditors and pretty simple-minded quality managers out there that don't want to implement (or cannot guarantee) a more comprehensive system to address this. I have seen all the variations of this: the auditor that lacks critical thinking skills, the pendantic auditor, the malicious auditor who is toying with a naive quality manager, the quality manager who lacks critical thinking, the frustrated quality manager who can't get people to follow the implemented process... I can sense @Jim Wynne 's temperature rising.

I prefer the approach that has someone (typically a 'quality' role) keeping track of periodic review status, and a document control system that allows for the recording of periodic review results to be archived alongside the (released) document under (periodic) review. This can be slightly tricky to implement because there is both a monitoring/scheduling element (the human factor, someone has to have this job) and a need to be able to routinely archive supporting data alongside documents that have already entered the 'released' phase of their life cycle.
 

Thee Bouyyy

Involved In Discussions
#9
When reviewing a document for periodic review, I was taught that the document should be reved even if no changes have occurred, just so there is an audit trail of the periodic review. Does anyone have a reg that points to this?

thank you
What did you write about this alteration in your procedure? You must follow if you have indicated that you must roll the revision if no changes have occurred. Who instructed you on this? Inquire with him as to where it is written in the standard.

I just recommend keeping track of revision records on a separate sheet and avoiding rolling revisions that aren't essential.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#10
If you conduct a management review per ISO 13485 this should cover you.

5.6.1 General The organization shall document procedures for management review. Top management shall review the organization’s quality management system at documented planned intervals to ensure its continuing suitability, adequacy and effectiveness. The review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives

In your minutes' state documents related to the QMS were included in the overall review as a result of their outputs.
 
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