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Advice on how to reduce overhead of handling non-conforming material

#1
Hi

I would very much appreciate any advice on how to reduce overhead and streamline our process for handling non-conforming material (NCM).

A little background for context:
Our QMS needs to comply with international medical quality system regulation (e.g. ISO 13485:2016, FDA QSR)

Non conformities are identified in the following situations (mostly):
- Material that past QC inspection but turned out to be defective later on in the assembly process.
- NCM received from supplier
- Products returning from customers as defective

Our current process is facilitated by a form that includes the following sections in order:
1. Identification and description of NC
2. Root cause analysis
3. Effect on existing inventory / product already delivered
4. Effect on risk associated with product
5. Disposition decision: Accept as is / Rework / Reject + justification for decision (to verify compliance with specification / regulatory compliance)
8. CAPA required (yes/no) + justification if not (CAPA is expected to be opened 100% of the time, unless relevant CAPA is in process).
9. MRB approval (signatures required at this point)
10. Verification of disposition (added later by QA).

This entire process is applied to every non-conforming material report regardless of severity or number of occurrences (can be 10th repetition of non NC that already has known disposition decision + CAPA in process). Essentially it means that every NC is escalated to QA and gets a full report.
Looking for ways to simplify and streamline the process. possibly even enabling some NC to be dealt with by production supervisor and only be reported to QA after the fact for trend and follow-up.

Thanks for reading so far. Many many thanks in advance for any advice

S
 
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Tagin

Trusted Information Resource
#2
My interpretation is that it seems as though your process is skipping this step of 8.3.1:
The evaluation of nonconformity shall include a determination of the need for an investigation...
That is, by requiring a RCA on all n/c's you are jumping right into an investigation, without first determining if that investigation is warranted.
 

outdoorsNW

Quite Involved in Discussions
#3
Simone,

You idea to not always so a full report for something with a known cause and corrective action is basically a good one. The only caution is how to make sure the second occurrence has the same root cause as the first.
 
#4
Thank you @Tagin and @outdoorsNW. Combing both comments, I worry that we decide not to investigate on certain NC and then:
1. What may seem as a reoccurrence is not
2. What may seem as minor / isolated event is not

I was considering maybe reducing the process and doing the following:
1. NC reported (either from production or returned product via customer complaint)
2. Risk assessment (to be performed by QA, not involving entire MRB at this point).
3. Determine effect on Inventory / product already delivered.
4. Check if there had been similar NC recently and what the status of the CA is.
5. Decide on disposition.
6. Determine (based on risk, effect, occurrence) if investigation and root cause analysis required. If yes, initiate CAPA and investigate as part of the CAPA process.

=> if the effect is local, the risk is low, and it is an isolate event, the NC can be closed at this point with QA approval only (unless part needs to be accepted not according to original specifications in which case MRB decision is required). The MRB will receive periodical updates on all these "minor" issues and if any concerns are raised action can be taken at this point.
=> if the effect is not local, risk is high and/or this is not isolated event, the NC is escalated to MRB, and MRB need to approve and sign the NC report.

My concerns are that this overcomplicates rather than simplifies, may lead to missing important non-conformities, and puts us at risk of non-compliance with quality regulations.
I am less concerned about risk escaping because the only decisions that can be made without MRB is "reject" or "rework" so that part is returned to its original specification.

Any thoughts, ideas, comments, references are greatly appreciated
 

Tagin

Trusted Information Resource
#5
Thank you @Tagin and @outdoorsNW. Combing both comments, I worry that we decide not to investigate on certain NC and then:
1. What may seem as a reoccurrence is not
2. What may seem as minor / isolated event is not

I was considering maybe reducing the process and doing the following:
1. NC reported (either from production or returned product via customer complaint)
2. Risk assessment (to be performed by QA, not involving entire MRB at this point).
3. Determine effect on Inventory / product already delivered.
4. Check if there had been similar NC recently and what the status of the CA is.
5. Decide on disposition.
6. Determine (based on risk, effect, occurrence) if investigation and root cause analysis required. If yes, initiate CAPA and investigate as part of the CAPA process.

=> if the effect is local, the risk is low, and it is an isolate event, the NC can be closed at this point with QA approval only (unless part needs to be accepted not according to original specifications in which case MRB decision is required). The MRB will receive periodical updates on all these "minor" issues and if any concerns are raised action can be taken at this point.
=> if the effect is not local, risk is high and/or this is not isolated event, the NC is escalated to MRB, and MRB need to approve and sign the NC report.
I'm not clear what step 2 (risk assessment) would involve; to me, steps 3 & 4 would be part of a risk assessment.
 
#6
Good point, so if I understand correctly, I could probably combine all 3 steps into one matrix/decision tree?
taking into account the severity (potential harm to user), frequency and whether or not we have defective parts/products currently in inventory)?

in step 2 I was thinking of the severity, as in, what would be the potential harm to the user if the non-conforming product would have escaped? its not exactly the same as step 3, because the severity could be negligible (inconvenience for example) but the business risk could be high if there are multiple defective parts in inventory or worse in the field leading to multiple complaints. Of course, if the severity is high, then whether or not a non-conforming product may have escaped has an entirely different meaning and implications and this type of case would need to be escalated further then the MRB scope.

The more I think about this, its seems to me that I am overcomplicating this more and more. There seem to be too many forks in the road...
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#7
Simone, you are, obviously, an intelligent person and intent in doing the right thing. Kudos.

The one thing I would like to point out is about the question not asked and not being addressed. If there are too many instances of nonconformities to be processed in an expeditiously manner, much more important than to optimize the review process is to address why so many problems are happening.

If suppliers are allowing too many escapes to reach you, there is a problem with supplier qualification and monitoring. If you are allowing defective products to be shipped, there are serious shortcomings in your QMS.

Some people, for not knowing any different, believe their paradigm of having to deal with copious volumes of defects is "normal". It isn't. The organization culture needs to shift to one that despises defects, instead of having more friendly processes to deal with them.

I wish you very good luck.
 
#8
Thank you @Sidney Vianna, that is a very important question. The company culture here is definitely one that depsides defects and the goal is to minimize them as much as possible and handle each with the appropriate attention. However, I think that to get there we need an efficient process to begin with, one that will free up resources to deal with the major issues with higher priority.
I know that I lack the experience and knowledge as I am still a newbie in QA, but it doesn't seem to me that the amount of NC we are dealing with at the moment is unusually large, maybe we are just very meticulous in reporting them :). I would like to keep that rate of reporting everything so nothing gets missed or slips under our attention but at the same time enable us to focus on the more important ones.

So, my goal behind having a more friendlier process for dealing with defects is two fold: free up resources to deal with the major and "heavy" problems with a higher priority and implement solutions, and second, make it more accessible to operational and production team, getting them more involved.
and thanks for the kind words !!!
 
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