Nonconforming Product & Validations


My instincts are telling me several things:
  • Thousands of non-conformances are not doing your NCR process any favors. That number, by itself, is an indication that your company likely has issues... describing any of the NCRs as "not fully investigated" is a serious compliance risk. (*1)
  • The process in question should probably be "refactored" so that it is more like a process with known/predicted yields and test/inspection/sort processes to end with a product/component that meets specifications.
The second point is probably the direction you will want to go.... these shouldn't be production "issues" but instead would just be a process that has a terrible yield and a humongous amount of waste. If this happened "offsite" I suspect it would be controlled in a different way.

(*1) From just this small bit of info, I don't know that the company could pass the red-faced test for questions like:
  1. You have thousands of NCRs. How many associates do you have to process, investigate and disposition the NCRs?
  2. You have thousands of NCRs that don't get much TLC. Which of your other NCRs also don't get TLC?
  3. Why is handling of NCRs ad hoc?
  4. Is there a difference between producer's risk and consumer's risk at this company? (not related to NCRs, but a place my mind went to)
NCRs are dispositioned by the quality inspectors and are always just scrapped out.
2-3. Valid point, our system was set up to handle three different industries with medical device being just one piece of that pie. Most of our products are extremely custom, low volume devices where each nonconformance is fully investigated and one nonconformance will be linked to typically 1-3 parts made in that lot. For medical device, all products are extremely high volume, lower yield processes. So when our QMS software automatically generates nonconformances its impossible to follow up on all reported NCRs. Definitely a case of one size does not fit all, when it comes to systems and software.
4. Not sure what you mean by producer's risk, but I will say 99% of our rejected parts are either appearance defects or very slight effectivity reduction. We know the MDs using the devices are just extremely unforgiving for any appearance related defects (not a bad thing) making it hard to have a process that can repeatably make parts to the end user requirements...

What you're saying makes sense though.

Bev D

Heretical Statistician
Super Moderator
I’ve worked in organizations where many NC parts could be made. In these cases we issued a single NCR for the lot, documenting how many defective parts were found and what the disposition was, including whether or not the whole lot was scrapped or it was screened. Look into a way to write a single NC for a lot of material.
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