Unreleased Controlled Document Use

[Wyatml01]

Brief context - ISO 13485/9001/14001 IVD manufacturer. The 99.9% of what we manufacture falls under our ISO 9001 cert. A project to update our validation procedure has been in limbo for over a year now, with the updated procedure and protocol template still being unreleased at this time.

We've been following the released validation process for new equipment and updated processes, but every single validation our engineering team tries to release is being stonewalled at final quality approval because the quality management team states we need to use the updated, but unreleased and unapproved template and procedure. To my knowledge, using those documents violates our document control procedure b/c they're unapproved and unreleased.

How would you approach this issue, especially if called into an audit to explain why we used an unreleased procedure and template?

 

[John Predmore]

I am curious why the updated, but unapproved, template and procedure are still unreleased after over a year in limbo. Are there specific objections to the procedure as written? Is someone working to address these objections?

One idea which occurs to me is to ask the document authority (and customer, depending on the nature and risk of the changes) to allow the updated procedure on a limited pilot basis. Very often, a QMS includes a temporary deviation procedure, sometimes called a waiver process.

If there are any kinks in the procedure as written, the pilot is an opportunity to uncover and address shortcomings. Once your group demonstrates successful deployment of the new procedure in the pilot, perhaps that experience will help convince the naysayers to approve widescale adoption of the new procedure.

 

[Tidge]

Unless the Quality Management has some previously approved plan that is authorizing the use of non-approved templates, only the approved templates are to be used.

 

[Enternationalist]

This is a great time to use the quality management system for its intended purpose! It can and should give you the tools to absolutely shut down this kind of anti-quality behavior. You've observed a non-conformance of personnel with the requirements of procedures - file a complaint, non-conformance, or preventive action (following the procedure to the T!) that lists every single requirement you can find they are violating by doing this, and then watch the quality manager squirm. Say things like "it appears they are not aware of how their work can affect product quality" and "management appears unwilling to allocate the resources needed to maintain the quality system".

A 13485 process more or less forces them to follow through on an assessment if you're careful about how you present it - either they realize that what they're doing is absurd, or they are setting themselves up to be absolutely crucified at any external audit. Document it, make clear recommendations. Do it in a way that requires the initial issue be captured as a record even if they dismiss it as "not needing attention". Complaints can be a great way to do this, normally they need to be kept on file. I'd also quietly let a member of upper management know the issues in a matter-of-fact and non-accusatory way, being clear about the requirements, and gently request that they observe how the quality team handles your issue.

Then, when audit times comes, you've done your due diligence and then some.