Document Approval Requirements in an ISO 13485 and FDA System

In an ISO 13485 and FDA system, is a Quality Manager part of a technical document approval workflow ? Or a project manager is enough for DMR documents?

Second question, is optional reviewing can be acceptable in a approval workflow, I mean that the document approval can be done without all the reviewing process done (if this case is correctly described in QMS procedures) ?

Thanks in advance.

Arnaudl,

If your 1st question is related to a possibility of QM be a part of the technical review documentation, than the answer can be "yes", as long as QM is an independant reviewer.

Please provide more information for Q#2 because optional reviewer(?) is acceptable, however all of the process must be completed.
How can you review documentation if process is not completed?

Just to piggy-back off of Michael's reply, the regulations do not specify WHO has to review or approve documents. That's up to your company.

Regarding your second question, if I understand correctly, you're asking if a document can be approved without it being reviewed by some of the (assigned) reviewers. If that's the case, then it's likely you have deeper systemic issues. Why aren't the reviewers able to complete their reviews in the allotted time? Presuming there's good rationale for all required reviewers, if they don't conduct the review, necessary inputs may be lacking and you increase the risk of product failures / deficiencies. Many times, a company will over-specify the list of required reviewers and the process gets bogged down when "uninterested" reviewers put off the review. There are sound business reasons to conduct the review so you shouldn't short-change it.

Ok, so is there a rational to fix or explain the number of reviewers ? Should this be written in a procedure for each document type ?

In my case the reviewers list is defined in the document workflow of a electronic DMS, which allows us to (easily) add or remove a reviewer even during the reviewing process (for example if someone is on leave). It is acceptable to operate in this way ?

On a more general way, do you agree to say that FDA expects more (written) details for example on how documents are managed (for a 510(k) submission) that what a ISO auditor would check and listen?

I've seen a number of ways to define who reviews and approves. The bottom line is that YOU define who reviews and approves documents. As long as it doesn't appear ad hoc, is consistent, and is reasonable (i.e., mechanical is not the only reviewer of a sw spec), it's generally accepted. So don't worry about as much about what you think the FDA expects or what an ISO auditor would want to see. Define what makes best sense for your operations, ensuring appropriate stakeholders review and approve, and you should be fine. It never hurts to document the minimal roles for who should review and approve.

arnaudl said:

Is optional reviewing can be acceptable in a approval workflow, I mean that the document approval can be done without all the reviewing process done (if this case is correctly described in QMS procedures)?

Click to expand...

There are two situations where this can happen...below two can be suitably described in respective SOPs

1) During change control review; you can terminate/conclude the change control initiated for revising the document based on few reviews/feedback (it may not be required to complete reviews from all proposed; however a justification/note must be added for concluding w/o those few rev.comments );

2) For documents where changes are not proposed, usually, document control systems allow for validity-extension, (SOP might have prescribed a set review process; but it is superseded by the above condition whereby the doc is extended for implementation)

Are there specific descriptions about approver qualifications or about what is allowed in approving? I specifically need to know if someone should ever approve their own work, even if they are part of a group of functional approvers looking at the changes from a functional aspect.

Like what Yodon has said.....

"YOU define who reviews and approves documents. As long as it doesn't appear ad hoc, is consistent, and is reasonable

Click to expand...

"
as far as "definition and implementation" meet the actual intent of requirement of operation, I believe it must be acceptable;

Having said that, it is not encouraged as a general practice......
there is definite discretion required in allowing 'who(role) or which conditions/activities in which ' same person can review and approve his own work...