Comments on: NonConformance Report: 4 Key Things To Consider http://currentquality.com/blog/nonconformance-report-4-key-things-to-consider/ Advancing Your Quality Assurance Knowledge Sat, 13 Nov 2010 22:34:55 +0000 hourly 1 http://wordpress.org/?v=3.3.1 By: Sandra Gauvin http://currentquality.com/blog/nonconformance-report-4-key-things-to-consider/comment-page-1/#comment-82 Sandra Gauvin Mon, 07 Dec 2009 12:24:03 +0000 http://currentquality.com/blog/?p=9#comment-82 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 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

]]> By: Venice http://currentquality.com/blog/nonconformance-report-4-key-things-to-consider/comment-page-1/#comment-81 Venice Mon, 07 Dec 2009 08:16:42 +0000 http://currentquality.com/blog/?p=9#comment-81 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. 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.

]]> By: Sandra Gauvin http://currentquality.com/blog/nonconformance-report-4-key-things-to-consider/comment-page-1/#comment-71 Sandra Gauvin Fri, 28 Aug 2009 15:45:14 +0000 http://currentquality.com/blog/?p=9#comment-71 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 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

]]> By: Edward Fisher http://currentquality.com/blog/nonconformance-report-4-key-things-to-consider/comment-page-1/#comment-70 Edward Fisher Thu, 20 Aug 2009 00:22:10 +0000 http://currentquality.com/blog/?p=9#comment-70 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 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

]]> By: KrisBelucci http://currentquality.com/blog/nonconformance-report-4-key-things-to-consider/comment-page-1/#comment-58 KrisBelucci Wed, 03 Jun 2009 06:14:52 +0000 http://currentquality.com/blog/?p=9#comment-58 Great post! Just wanted to let you know you have a new subscriber- me! Great post! Just wanted to let you know you have a new subscriber- me!

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