QMS Overload

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Maybe approach it like a triage center near a disaster. Sort the patients out based on risk and start working.
 

Mike S.

Happy to be Alive
Trusted Information Resource
Of course they have been going along all these years with no QMS and "crappy" parts, so I am not convinced the the risk is there.
Who said "crappy" parts? You.

I'm not convinced risk is there, either, that's why I said "it depends". But it should be considered.

Sometimes the risk comes from unexpected places. Not every nonconforming part has the risk to life and subsequent notoriety of the 737 door that blew out or the inferior steel used on navy subs of a few years back.

Consider a widget built and sold for years with some percentage slightly out of spec but the Production Mgr and QA Manager felt that "little NC" shouldn't cause a late delivery so they just repeatedly fudged the data and shipped them. No actual harm came to anyone. But one day a disgruntled former employee blows the whistle and the reputation of the company is destroyed in no time flat. Any risk there?
 

Golfman25

Trusted Information Resource
Maybe approach it like a triage center near a disaster. Sort the patients out based on risk and start working.
That's what I am saying. If OP starts red tagging everything and shuts the place down, he's going to have issues. Focus on the big ones first.
 

DesantisJ

Registered
I have been using the term "non-conformance" a bit loosely. Also, my background is more in the manufacturing field than documentation. But I also have plenty of experience in writing, reviewing, and auditing process documentation.
I have been using the term "non-conformance" to mean failed dimensional inspection, functional testing, and also customer returns (typically in the form of functional issues).
I am confident that the parts we manufacture are not "crappy". Our standard 3 decimal tolerancing is ±.002", and many of our detail parts have flatness and parallelism callouts of .0001. As you can guess, it is very difficult to machine to these tight of tolerances and my inspector ends up failing upwards of 80%, but dimensional rejections have been accepted or rejected by the manufacturing manager based on his tribal knowledge of what can work further down. In my mind, this is issue number 1 to correct and it will cause production to slow down if dispositions take too long, and also cause more work for engineering to correct documents. But I would rather spend a few hours fixing the cause than continue doing the same things and expecting different results.
I also want to say, thank you all. Having a place for me to talk these things out is such a blessing. It really helps to hear that I need to stop thinking "ISO certified" and instead just focus on needs.
 

Miner

Forum Moderator
Leader
Admin
... but dimensional rejections have been accepted or rejected by the manufacturing manager based on his tribal knowledge of what can work further down.
Are these internal specifications rather than customer specifications? If so, maybe some loosening of the internal specifications is in order.
 

Golfman25

Trusted Information Resource
I have been using the term "non-conformance" a bit loosely. Also, my background is more in the manufacturing field than documentation. But I also have plenty of experience in writing, reviewing, and auditing process documentation.
I have been using the term "non-conformance" to mean failed dimensional inspection, functional testing, and also customer returns (typically in the form of functional issues).
I am confident that the parts we manufacture are not "crappy". Our standard 3 decimal tolerancing is ±.002", and many of our detail parts have flatness and parallelism callouts of .0001. As you can guess, it is very difficult to machine to these tight of tolerances and my inspector ends up failing upwards of 80%, but dimensional rejections have been accepted or rejected by the manufacturing manager based on his tribal knowledge of what can work further down. In my mind, this is issue number 1 to correct and it will cause production to slow down if dispositions take too long, and also cause more work for engineering to correct documents. But I would rather spend a few hours fixing the cause than continue doing the same things and expecting different results.
I also want to say, thank you all. Having a place for me to talk these things out is such a blessing. It really helps to hear that I need to stop thinking "ISO certified" and instead just focus on needs.
First "crappy" is a term of art. And my point is your parts seem to be working good enough to keep you in business, so there's that. But youre manufacturing manager's situation is exactly what I am talking about. The part may be "no good" but it's actually usable. Conceivably, you could handle all of those first -- revise the prints to expand the .0001 flatness without stopping a thing. Good luck.
 

DesantisJ

Registered
Are these internal specifications rather than customer specifications? If so, maybe some loosening of the internal specifications is in order.
These are internal specifications. But we do have a specific customer that requires parallelism of .05mm at the top level, so I am left to assume that requirement was passed along to all other similar products. Unfortunately, I am also left with no evidence that past shipments have met this requirement, as first article inspections are only performed upon customer request.
 

Golfman25

Trusted Information Resource
These are internal specifications. But we do have a specific customer that requires parallelism of .05mm at the top level, so I am left to assume that requirement was passed along to all other similar products. Unfortunately, I am also left with no evidence that past shipments have met this requirement, as first article inspections are only performed upon customer request.
Sounds like you might want to start with a basic inspection program -- setup, in-process, and final. Keeping it as simple as possible, of course.
 

outdoorsNW

Quite Involved in Discussions
Focus on the actual requirements. Just because one part has a .05mm requirement does not mean others do. If you check, you may find many "nonconforming" parts may conform to the requirements for the specific part. Even so, you probably should proceed with care and make sure your customer has not gotten used to you always delivering better than the print requires and will be upset if you start delivering parts using more of the allowed tolerance range.
 

mindytanner

Starting to get Involved
Hello all,
I am a new Quality Manager for a company. This is my first job "quality" job, my other experience is as a manufacturing engineer. I was a trained AS9100 internal auditor for my past job and was often tasked with reviewing and revising many process documents, so I am familiar with reviewing QMSs.
My situation is this: My new company is not ISO certified nor do they have what I would define as a Quality Management System. The owner has expressed a desire to be certified but has also shown it not to be a top priority since our customers have not requested it of us. I want to help this company to succeed, but this task is currently too daunting for me to decide where to step first. I've found un-released procedures that attempted to align with ISO9001:2008, but they were never implemented.
My boss is hoping to see results in the form of reduction of non-conformances. My brain is telling me to start with a receiving inspection procedure, but there are a lot of holes in the process before we've ever received these parts, both in-house and out-sourced machined parts.
My question is, where do I even start with this project? I know the best way to eat an elephant is 1 bite at a time, but would you start at the snout or the tail?
You start at his feet, of course! Then he can't get away!! :)
The best way to start is keep a notebook & pen with you everywhere you go. Every time someone preforms a task, ask them how they do it, and document it. Example, contact a Supplier to inform them of defective material. Then you document it in some way. I prefer flow charts. Next, compare what is being done to what the standard requires. This will help you build a gap audit while also learning the processes at your new company. I started doing that at my job. The plant was slated for closure. Senior leadership changed and the facility did not close. However, they had let their certificate expire. I show up and there is no evidence of a QMS so, rather than totally recreate the wheel, this is what I am doing. Some of these team members have been here doing same thing for over 25 years. If something is required but not being done, I only have to ask them to change that one thing. That is a much easier sell than to totally write a QMS just from the standard. :)
 
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