Nonconformance Training in Best Practices

[uhohraggy]

Does anyone know of any training courses, or webinars on nonconformance management best practices?

We are having a few debates within my organization.
1) Do nonconformances require a corrective action as part of the NCMR process?

2) Do NCMR's need to be closed prior to allowing this shipping of the product?


Our current process and most (almost all) of the experience in our organization is that corrective actions must be part of the NCMR process and only escalate to a CAPA for systemic issues. Since the NCMR cannot close until the CA is completed, the NCMR does not need to be closed in order to ship the material as long as the correction to the material has been approved by the MRB and completed (if in fact a correction is needed). Of course we have one approver that believes this is completely wrong. Hoping a best practices reference or training can align people.

 

[Marcelo]

1) Do nonconformances require a corrective action as part of the NCMR process?

NCs requires corrections (action to eliminate a detected nonconformity), then it needs to be analyzed to verify of there?s a need for corrective actions (to deal with root causes which are related to processes).

2) Do NCMR's need to be closed prior to allowing this shipping of the product?

They need to be corrected.

Does anyone know of any training courses, or webinars on nonconformance management best practices?

No, sorry.

 

[uhohraggy]

If nonconformances only need to be corrected how are you ensuring compliance with 21CFR100

(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;
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I've seen this as an audit finding many times.

 

[Marcelo]

(3) Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems;

Sorry, you are right, I should have said that the NCs might need correction, or a related actions such as be thrown away.

However, the escalation for a corrective action is to be analyzed after the first action.

The correction acts on the detected NC, CA acts on the root cause of the process.

For you to ship, you need to correct or whatever the particular problem. You may need to change the process, but you do not need that to ship.

 

[TWA - not the airline]

Muddy waters here...

Marcelo, scrapping faulty parts is also a correction just like e.g. reworking the parts. Unfortunately the wording of 21 CFR 820.100 is a bit misleading in my opinion: a) actions needed to correct = correction, b) actions needed to prevent (the same) non-conformity from occuring again = corrective action, c) actions to prevent other quality problems = preventive action.
And "identify the action(s) needed" means an assessment and this could result in "no action required", e.g. if it was a singular event that cannot happen again...

 

[John Broomfield]

uhohraggy,

Please bear in mind that the following dispositions of nonconforming product are design changes and should be reviewed and approved or not approved as such:

1. Use as is, and
2. Repair.

Many organizations say rework when they mean repair and vice versa.

Rework is not a design change because the nonconforming product is reworked to conform to the original specification.

Repairs do not conform to the original design unless, of course, the designer also specified approved repairs for common nonconformities.

Naturally, for your customer to continue the business relationship, you will be expected to determine actions to stop recurrence.

But determining these actions should not stop shipment of product verified as meeting the original or changed requirements.

This subject should be taught thoroughly in any certified lead auditor class.

But it is too small to command its own course except, perhaps, on YouTube.

John

 

[TWA - not the airline]

John,

but rework still would need to be considered a kind of change even though design = specifications would stay the same, right?. Rework involves additional process steps that are not part of the initial DMR and therefore 820.90 b(2) requires an evaluation of "any adverse effect from the rework upon the product".

 

[John Broomfield]

John,

but rework still would need to be considered a kind of change even though design = specifications would stay the same, right?. Rework involves additional process steps that are not part of the initial DMR and therefore 820.90 b(2) requires an evaluation of "any adverse effect from the rework upon the product".

TWA,

Yes, but they are covering all bases including cases where the supplier misnames repair as rework.

John

 

[Reg Morrison]

Just to remind people that not always a nonconformity can be corrected. For example, a late delivery to a customer. Even if the supplier agrees to a credit back to the customer for a late delivery, that issue can not be fixed from the perspective that the product would have gotten to the customer late.

A potential late delivery can be "corrected" with expedited shipment, expedited production, etc.

Certainly, if there is a systemic issue of late deliveries, a corrective action could be justified.

As to the OP challenge, when a regulatory auditor requires corrective action for issues that are prone to happen again, such as typos, for example, the solution is: you pretend you do corrective action and they pretend to believe that will never happen again. And they live happily ever after....

 

[John Broomfield]

Reg,

Yes, there's something to be said for designing service processes according to their opportunity and risk - or at least validating them as we do for special processes.

And all companies deliver services with or without products.

John