Nonconforming Product & Validations

[wiseman119]

My company manufactures FDA Class I / MDR Class IIa medical devices that are difficult to manufacture in a repeatable way. Its 'expected' if not necessarily acceptable to see 30-50% fallout for some lines due to the nature of the manufacturing process. Currently the way our QMS / ERP software works, if any pieces fallout during manufacturing, a nonconformance is automatically opened, but as nearly every workorder generates some fallout and therefore a nonconformance, 95% of these 'nonconformances' do not get RCA'd / Investigated or anything like that. The parts are marked as scrapped and we all move on.

Obviously, the true issues that are the result of abnormalities in the process that generate fallout above what is expected or normal are investigated and corrected.
My question is: I have a heck of a time explaining that we accept such a high fallout rate during production despite continuous improvement efforts.
Further, when attempting to 'validate' a process I find myself writing test plans / protocols that are extremely vague, because I know we cannot meet our own system specs. Especially when we expect so much fallout.

Any thoughts on redefining things to make our system more palatable to auditors and passing validations in a reasonable way? Especially with efforts to move towards MDR in the future?

 

[Bev D]

Well you can always lie and falsify the records. <—this is sarcasm

OR just be honest about fact that your processes are not perfect, focus on validating your inspection, measurement and test processes as being highly effective in catching NC parts such that you don’t ship NC and non functioning parts. Focus on proving reliability annd quality of shipped parts. And write your test protocols to be robust and specific. It is your Business choice (literally) to make difficult parts and take a high scrap rate.

Then you can focus on process and product improvements….

 

[wiseman119]

Well you can always lie and falsify the records. <—this is sarcasm

OR just be honest about fact that your processes are not perfect, focus on validating your inspection, measurement and test processes as being highly effective in catching NC parts such that you don’t ship NC and non functioning parts. Focus on proving reliability annd quality of shipped parts. And write your test protocols to be robust and specific. It is your Business choice (literally) to make difficult parts and take a high scrap rate.

Then you can focus on process and product improvements….

Thanks for your reply Bev, this fairly well matches our current philosophy and strategy. The difficulty comes in when we have to explain to an auditor why we have 1000s of 'nonconformances' (tried to redefine as "issues", but no dice), that are not fully investigated. Our inspections will catch the expected fallout, and a nonconformance is opened to record how many defective parts, but the parts are then simply dispositioned as scrap and the nonconformance closed out...

 

[Bev D]

I'm not sure that an auditor has a valid position against many NCs as long as the proper disposition is made, the inspections are highly effective and the NCs can be explained by an immature or difficult process - such as something cutting edge. but we would need to know what the product is and what processes are used.

Have you received any findings for this? or do they just give you grief?

 

[wiseman119]

I'm not sure that an auditor has a valid position against many NCs as long as the proper disposition is made, the inspections are highly effective and the NCs can be explained by an immature or difficult process - such as something cutting edge. but we would need to know what the product is and what processes are used.

Have you received any findings for this? or do they just give you grief?

We've received findings and observations, but dispositions haven't always been clean due to the quantity.

It is relieving to know that we at least have some ground to stand on though.

 

[outdoorsNW]

Do you classify non-conformances by type, process, or some other category so you can investigate what appears to be the large contributors or high risk contributors to fallout?

Do you investigate orders with the largest fallout to see if you can figure out why the fallout happened?

In other words, are you using defendable criteria for what you do and do not investigate?

 

[Bev D]

@wiseman119 can you post the text and referenced sections of the findings? This will also help us help you.

 

[Tidge]

The difficulty comes in when we have to explain to an auditor why we have 1000s of 'nonconformances' (tried to redefine as "issues", but no dice), that are not fully investigated. Our inspections will catch the expected fallout, and a nonconformance is opened to record how many defective parts, but the parts are then simply dispositioned as scrap and the nonconformance closed out...

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)

 

[wiseman119]

Here's the text of the finding:
"Disposition of Non conforming product is not recorded effectively

Evidence:

a) 4 of 4 NCM reports observed have no record of disposition.
b) 2 of 4 NCM does not recorded description of the Nonconformance."
Finding against 8.3.1 of 13485

 

[Bev D]

This isn’t a finding about the number of nonconforming parts or type of nonconformance. It is simply a finding about inadequate description and disposition of some NCs. Certainly you can do better here.

It would still be helpful to answer the other questions if you want more help…