NonConformance Report: 4 Key Things To Consider

by Sandra Gauvin

Write A Good Problem Statement
I’ve learned over the years that writing a good problem statement in your NonConformance Report is probably the most important part of any investigation.  If the problem isn’t stated clearly, then it becomes too easy to misinterpret the problem and lead the investigation in the wrong direction.  A Good problem statement should tell someone ‘who, what, where, and when’….the ‘why’ will be addressed in the actual investigation.

Start Your Investigation Immediately
Every investigation has an assigned timeframe (specified in your Standard Operating Procedure) in which it must be completed….that means approved and closed out.  So the day the NonConformance Report is initiated, the clock starts ticking.  If you wait until you have very little time left before you begin, then you most likely won’t complete a through investigation and may find yourself revisiting the issue.  Set up a timeline that will include milestones along the way so that you are working on the investigation  little-by-little….before you know it your NonConformance Report will be completed and on-time!

Consider All Possibilities When Determining Root Cause
In your NonConformance Report, you want to make sure that you consider everything that may be contributing to the problem and rule each one out until you’ve gotten to the most likely root cause(s)….yes there can be more than one root cause.  Sometimes our workload gets a bit crazy and it becomes too easy to quickly jump to a premature conclusion.

Verify That Your Corrective Action Was Effective
Give yourself enough time to evaluate whether or not the the problem has truly been corrected.  For example, if the problem used to occur whenever you manufactured product X, then you would want to make sure you have at least three cycles of making product X after your corrective action has been implemented.  If the problem hasn’t occurred during the three cycles, then you most likely got to the root cause.

Let me know what your experience has been with NonConformance Reports and if this post has been helpful.

Thanks,
Sandra




{ 5 comments… read them below or add one }

KrisBelucci June 3, 2009 at 6:14 am

Great post! Just wanted to let you know you have a new subscriber- me!

Edward Fisher August 20, 2009 at 12:22 am

Sandra I have read your post and agree completely with you. I do struggle with trying to get the NCR’s completed and to have people focus on the problem. I think the information in the report is critical to getting something positive out of the process

Sandra Gauvin August 28, 2009 at 3:45 pm

Ed,
Sometimes senior management has the tendency to focus on the on-time closure rates for NCR’s, which at times conflicts with conducting a thorough investigation.

Sandra

Venice December 7, 2009 at 8:16 am

Hi Sandra,
I’ve three sets of non conformance report of three different products which happened the same date, same root cause and findings. I do not know how to close the NC. And this had happened before and the NC had closed. According to my superior, we shouldn’t face the same problems again which have been closed for few weeks ago. From your professional point of view, what should we do to prevent query from Auditor? Thanks.

Sandra Gauvin December 7, 2009 at 12:24 pm

If you’re facing the same problem after a nonconformance investigation has closed, then you didn’t get to the actual root cause (assuming you did a root cause analysis to begin with). Part of your RCA is to take action (i.e. corrective action) to fix the problem. So whenever you implement a corrective action, you need to keep the CA open until you have objective evidence that you got to root cause, otherwise the problem may recur. Because I don’t know the details of the problem (i.e. severity) or what industry you work in (i.e. biotech), it’s difficult to provide advice. For example, did you release the product that was involved in the NC? Does recurring nonconformace’s happen often so that an auditor could easily spot a trend? If you’d like to discuss this futher and provide more details, please use the ‘email Sandra’ tab.

Sandra

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