Documentation Approvals Frequency


Trusted Information Resource
During an internal audit, we found some work instructions that were last approved since 2008,by people who are no longer in the company, and they claim that these instructions are still valid till now.
Did you use the internal audit as an opportunity to confirm the work instructions are valid?

If they are valid, don't worry. If they are not valid, I would look and see if there is a policy to review documents, and if the policy is not being met.

If there is not a policy, and the documents are NOT effective, you may have found a root cause.

Mike S.

Happy to be Alive
Trusted Information Resource
In my current company it would be a Non-Conformity due to our Documental Information Procedure for the QMS.

Documents are only approved at every version change, but must be validated every 12 months by the Process Owner. The Process Owner must always be a current employee.

So, in your scenario: Nothing wrong with a document last updated and approved in 2008 by someone no longer in the company... the process may still be the same but that should have been validated by the currently responsible person.

Thats per our policy of course, although I think in ISO 9001 terms.... 7.5.2 c) When creating and updating documented information, the organisation shall ensure appropriate review and approval for suitability and adequacy,
What's your validation process? Does it have to be documented?

Ed Panek

QA RA Small Med Dev Company
Super Moderator
With 9001:2015 almost all of our documents were revised to be in line with a risk based approach. If we referenced the 9001:2008 standard by number almost all of the bumped up one digit in 2015.

For example
9001:2008 _______________________________________________________________9001:2015
6.1 Provision of Resources​
7.1 Resources, 7.1.1 General​
6.2 Human Resources​
7.1.2 People, 7.2 Competence, 7.3 Awareness​
6.3 Infrastructure​
7.1.3 Infrastructure​
6.4 Work Environment​
7.1.4 Environment for the operation of processes​
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