Hi Group,

The company I work for recently received for:

RR Audit NCR 2012-01-4.2.3
-- Not having sufficient Statutory & Regulatory Procedures for its Design & Development processes

RR Audit NCR 2012-02- 7.3.2
-- Having many procedures or templates that were over 2 years old for its Design & Development processes

I haven't been with the company that long, but they assigned me to complete the Non-Compliance Reports (NCRs).

Has anyone else been a similar situation & more importantly, how did you rectify the situation & complete these forms to satisfy the ISO auditors?

Any examples of completed forms would be appreciative (without showing company info.)

Thanks

what standard are you being audited against ? ISO 9001 ??

if the standard requires procedures are updated every two years, then pretty much that's what you have to do. maybe it's enough to reissue the procedure docs every two years, maybe get someone who hasn't been with the company long to review them ! ('cause everyone else is too busy !!) at best this could be an opportunity to find out how your company does things, and why ('cause that's how we've always done it !); at worst a paper-exercise (which is what it sounds like if they're asking you to review design and development procedures).

contact the auditing agency, they'll document what's being looked for, and go from there

Hi rb1957 & hacksaw,

Thanks for responding. The company is primarily tying to comply to ISO 4.2 - Documentation Requirements & ISO's 7.3 series - Design & Development.

From what I understand, my manger gave the ISO auditor the run-around because there was "no" sufficient documentation to demonstrate to the ISO auditor that they had a good process & documentation control. Back then, they received a major non-compliance.

With the recent demonstration of my documentation, it was a drastic improvement, but still areas to improve. On some of my documents I had "Form TBD" for templates I developed. According to this auditor & even though it demonstrated other necessary requirements, because the Form was not approved or did not have a Form #, the process was not valid, even they he liked it.

With these recent NCRs, we're suppose to develop the root cause of being non-compliant, but more importantly, have a proposed action plan. One of the primary reasons & even though (somewhat) justifiable, there's been a high production demand, with less focus with formal documentation or processes.

Has anyone here dealt with a similar situation & how did you or the company rectify the issue?

Thanks

Frankly, sounds like a silly waste of time. Why do you need to comply with those ISO's? customer requirement?