Complaint / Non-Conforming Product / CAPA Procedures - Please share your experience


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We need to tighten up our control of non-conforming product procedure. From the beginning - customer complaint to the corrective action validation.

Please share your experience and samples.

Where one ends and another begins?

Your input will be greatly appreciated.

M. :thanx:
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Re: Complaint / Non-Conforming Product / CAPA Procedures - Please share your experien

A quick "Bump". My Thanks in advance to anyone who will share their experience and/or examples.

Mike S.

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Re: Complaint / Non-Conforming Product / CAPA Procedures - Please share your experien

Are you taking about dealing with "escapes" -- where nonconforming material has reached your customer, and they complain?

Maybe you can ask your question more specifically.

Also, did you search for the term "nonconforming" - you will get tons of hits on this forum.


Re: Complaint / Non-Conforming Product / CAPA Procedures - Please share your experien

I agree with Mike S. What you are asking is pretty vague. I can tell you some key points that if your CAPA procedures do NOT have, you will be in a world of hurt.

1) 8Ds or A3s or PPS - the documentation. Develop the habit of addressing EVERY problem with an 8D. People think this is a pain. They CAN be - IF your 8D gets out of control. Keep them simple and use the steps. You don't HAVE to have a fishbone in your 8D, a fishbone is one (of many) root cause tools. Like a 3x5 why - another tool. It's not a MUST have. A good 8D is simply a container that all the steps have been done. "But they are a pain to fill out the form ...." Whine whine whine. If this is the case, your form sucks. The INFORMATION that goes in the form, you're going to answer anyway. Just get into the habit of filling the thing out instead of emailing everything around. Do this, get into the habit, and in a few months, you will realize that in truth, they aren't bad at all and keep you organized.

2) FIFO. I cannot say this enough. Take it seriously. Many "repeat issues" are actually FIFO breaches where a pallet of parts sat in the corner for months. And we do this poorly EVERYWHERE. I don't know why we make it so hard. Go to a primary school. When a teacher moves a class from location to location, she keeps count of the kids to not lose one. Why logistics cannot do this with barcodes and scanners, I don't know. Should be easy peasy with technology today. And yet.....

3) Traceability - parts should have traceability marks wherever possible. This should be ON the part AND the range of parts should be tied to the dunnage. So if you DO have to put a rope around suspect parts, this is as easy as possible.

4) In your face DMR areas. One of my pet peeves. Nobody likes when people see scrap. It doesn't "show" well. So the DMR area gets put in the back corner of the factory. And, consequently, it gets ignored and parts to be dispositioned age out. They will either be scrapped because nobody can remember what the defect was (red tags are ALWAYS complete, amirite?) OR they will get passed and you will get a repeat issue. The DMR should be right inside the damn lobby door so ALL the engineers and leaders are tripping over the pile of parts if it gets too large. You don't like the way the junk pile looks? Then you properly process it and make it go away the RIGHT way. To me, I LIKE an "in your face" DMR area. Most do not. Because people don't like seeing scrap. C'mon, we are all IN manufacturing, we know it happens.

5) Layered Audits - Worth their weight in gold. Your CAPA system should add a line for a period of time to your layered audit so that people are CHECKING that your corrective action worked. Plenty of corrective actions make total sense on the 8D, then, in practice, don't work because of something unforseen. The issue should NOT be closed when the customer accepts the 8D, it should live on for a period of time on your layered audit. (Unless you LIKE getting a bloody nose for a repeat issue). If you don't have layered audits, GET THEM.

6) A well lit, well stocked sort and early containment area. You need an area where you handle special cases. Many plant managers don't like this. They say it creates a culture that special cases are OK when they should not be. Hogwash. If that's your culture, you need a plant manager who knows how to lead. We all know that a good PRODUCTION work area helps quality: well let, tools at the ready, arranged in a way that makes sense. By this exact same logic your spill and early containment area needs the same things. Too many plants set the area up as needed. This burns energy in setup every time that COULD be spent on root cause.

Just off the top of my head .... but this is what I see that works.
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