Need advice in streamlining antiquated 21 CFR 820 compliant QMS

[DrMarioQAMD]

Hello All,

I am looking to perhaps receive some advice regarding 21 CFR 820 compliance and developing. The company I recently started working for is registered with the FDA and our quality system while it is sufficient in meeting regulatory standards is antiquated. It was developed in the early 80's and as the company has grown, additions have been made to comply with areas we're deficient. 30+ years later, we are still compliant but now are in possession of a QMS that's all over the place and bulky. It DOES serve its purpose, but I'm looking to streamline it to set us up for the future, which may include ISO certification and future 510k submissions.
At this point I realize that gap analysis from a 3rd party auditor will tell us where we're deficient, not help guide us in hitting the "reset" button. Any advice on how we can go about starting this huge undertaking? Would a template QMS help out by picking from our system and reclassifying to this? Maybe a service we can look into to help us along with this? Any help and advise will be greatly appreciated!

 

[Mark Meer]

Here's my suggestion (basically just a simplified description of generic change-controls):

First: is there a problem that actually needs fixing? Sure, an overly "bulky" system is undesirable, but is the present "bulkiness" of the system actually creating problems, or lending itself to potential problems? Doing a system overhaul is a big undertaking...be sure you've weighed the cost/benefits, and that management is on board.

Second: Create a plan. Document what's being changed and why. Include a impact/risk assessment of potential effects of "streamlining" (which presumably means removal/modifications to current controls), and gap analysis of how modified processes deviate from current practices (and hence what kind of (re)training will be required, and how current practices will be affected).

Third: Develop drafts of new docs, and demonstrate that these new documents continue to meet your Quality System requirements (21 CFR 820, ISO...), and do not conflict with other established documents.

Fourth: Implement new docs & retrain as necessary.

Depending on how your current system is structured, it may be simplest to tackle individual processes one-at-a-time, rather than the entire system at once.

Bottom Line: Go through your change control, which should include documented consideration and evidence that whatever changes you make meet your quality system requirements and don't adversely affect product or the rest of the system.

Good luck!

 

[DrMarioQAMD]

Thank you for the feedback Mark! Much appreciated.