Should You Ever Reopen a Closed Non Conformance Report?

by Sandra Gauvin

Photo: Help Key by Petr Kratochvil

You know that dreaded feeling, when you realize that you forgot to put key information in a non conformance report that’s since closed and product has been released?  Do you reopen the report or not bother?

Every time you reopen a closed non conformance report, you’re putting your company at risk from a compliance and maybe even a liability perspective.  That’s because an auditor would begin to question the integrity and thoroughness of the investigation.  S/he would want to know, was the investigation cut short because the focus was on releasing product and not finding root cause? If the missing information were available at the time of the investigation, would the product still have been released?  And if you’re FDA regulated, did you put patients at risk because non conforming product may have been released?

Once an auditor questions the integrity of an investigation, all investigations are then questioned and they’ll start looking for trends to support their suspicions…it’s like opening pandora’s box! And keep in mind that if you have an electronic system, the audit trail will document when and how often a record was opened, and what information was added, so it’s even more obvious to a savvy auditor.

To minimize your risk, you’ll first need to know how often records have been reopened in the past.  If you have an electronic system, then you should be able to quickly run a report.  For paper systems, you’ll unfortunately have to manually look through each report.  Any reopened records found will have to be re-evaluated through the eyes of an auditor to determine the severity of the situation.

For example, was the record reopened to fix grammar and typo errors or were lot numbers affected by the non conformance not included in the initial investigation?  Either way, you’ll need to know how you’ll handle the situation should an auditor ask questions.  Moving forward, you should consider how you’ll control the reopening of closed non conformance reports and write a procedure documenting the control…this applies even to companies that provide a service as opposed to a manufactured product.

{ 4 comments… read them below or add one }

Stephen August 6, 2010 at 11:47 pm

Thanks for your latest newsletter. I always find them informative and practical – a good combination.

Non conformances, system improvement and document control are all high on the list of challenges for most management systems I’ve seen.

Risk management also seems to be getting a lot more attention in the past year or two.

You mention the use of electronic systems for logging non-conformances. What systems have you seen that are effective for a small or medium sized business?
eg. for a (service or manufacturing) business with up to 50 staff?

– Stephen

Sandra Gauvin August 7, 2010 at 3:27 pm

Stephen,
You’re very welcome…I’m glad that you enjoy the newsletter. I’ve used TrackWise by Sparta Systems in the past to track non-conformances and more (planned deviations, corrective and preventive actions, change controls, etc.). Most biotech companies use it because it’s 21 CFR Part 11 compliant, but the company also has software for non-biotech industries…you can check out their website at http://tinyurl.com/335pjul.

Sandra

Stephen August 9, 2010 at 12:05 am

Thanks Sandra.

I’ll take a look TrackWise and see how closely it aligns with possible applications here.

Stephen

Sandra Gauvin August 9, 2010 at 10:36 am

Stephen,
Let me know how you make out.

Sandra

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