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.

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