Document Control

Milas

Involved In Discussions
Hi

Couple of quick questions.

with regards to periodic review of documents, should the review be documented , i.e. create a form which shows a specific document was reviewed at a specific date and the action taken ?

Thanks
 

Tidge

Trusted Information Resource
with regards to periodic review of documents, should the review be documented , i.e. create a form which shows a specific document was reviewed at a specific date and the action taken ?

The review absolutely should be documented, otherwise there is no evidence that the review occurred. The recorded details should be sufficient to
  1. Provide evidence of who did the review
  2. Provide evidence of what was reviewed
  3. Provide evidence of when the review occurred
  4. Recommendations/outcomes of the review (I'm assuming the "review criteria" are specified somewhere as well)
A form works well for this sort of documentation, as forms can drive consistency. Where the form gets stored is another one of those questions with a lot of different answers.
 

Hi_Its_Matt

Involved In Discussions
With regards to periodic review of documents, should the review be documented?
What type of documents are you talking about? "Documented procedures" (i.e., SOPs, WIs, etc.)? Product-related documents (i.e., design documentation, risk management documents, etc.)?
I'm assuming you mean the former, but want to confirm.

ISO 13485 states:
A documented procedure shall define the controls needed to:
a) review and approve documents for adequacy prior to issue;
b) review, update as necessary and re-approve documents;
...
and
The organization shall ensure that changes to documents are reviewed and approved

So there is nothing explicitly requiring that organizations perform formal, documented, periodic reviews of their documents. It certainly does expect/require that the documents remain accurate. If documents aren't maintained (i.e., they become inaccurate), the deficiencies will likely show up in audits, complaint and NCR investigations, etc.

In the spirit of continuous improvement, your documents should really be "reviewed" (at least informally) every time they are utilized. If someone notices a deficiency, they should bring them up, and there should be processes in place to correct them. Mandating a formal, periodic review by a particular group or individual is certainly a possibility, but I don't see it as a requirement within 13485.

Having said all that, if your organization has chosen to mandate such a review, then you should absolutely keep records of them. Afterall, 4.2.5 requires that "Records shall be maintained to provide evidence of conformity to requirements and of the effective operation of the quality management system."
 

Chrisx

Quite Involved in Discussions
I'm not sure that every auditor would agree that a periodic review is not a requirement. It's so common place that every document management system I used had a provision to manage periodic reviews in the software. This also has the advantage that the software updates the review date each time the document is revised.
 

Miner

Forum Moderator
Leader
Admin
There are a number of ways that you can document the review. A separate form is not a requirement. If you have a revision history, either separate or in the document itself, you can note the review there. You can also set up a review system similar to a calibration system or PM system in software and manage it from there.
 

ChrisM

Quite Involved in Discussions
Further to Miner's post above, my experience in the field of medical devices is that there is an intention that all procedures, WI's etc should be reviewed at least once every 3 years if they have not been updated in that timeframe. If no change is deemed necessary, you can simply update the document one level and add in the revision history words along the lines of "reviewed and re-issued without any change". This provides an auditor with evidence that the document was reviewed.
 
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