ISO 9001, NC’s & B&E

Help!

I am a newish QA manager seeking advice concerning issues that technically warrant an NC according to ISO 9001.

My organization will occasionally have an internal issue or a customer complaint that has a high effort but low benefit to correct on our end. Addressing some of these issues also cause contention with my team.

Am I required to initiate a CA every time or could I build “exceptions” such as low customer impact, high cost correction, low risk, etc into my policy? If so, I would love some pointers.

To add, some of these issues are on our radar but we have higher priority tasks on our plate at the moment.

 

You don't need to initiate corrective action every time, no. If we did that for every minor non-conformance, we'd never get any where. Fix the immediate issue and move on.

ISO 9001:2015 Clause 10.2.1 b is quite clear regarding the need for corrective action, stating "evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere."

I think you seem to already have this figured out though, dependant upon the criteria you've mentioned. I'm sure others will have other criteria for you to consider.

You don't really need to document the criteria for escalation to corrective action either, there's no such requirement. It's up to you.

 

These don't seem to line up.

Setting the standard requirements a side for a bit, how do you know if these are repeat nonconformities? If they are repeating and you are spending time and $$ fixing each time, maybe corrective action is warranted.

 

If the issue keeps on repeating, then it's either the corrective actions were poorly determined/implemented or the causes are ineliminable. Corrective actions intend to prevent recurrence. However, if the causes are factors that cannot be eliminated, you can refer to the guidance provided by clause 10.2.1 of ISO/TS 9002:2016 where it specifies:

"When evaluating the action needed for a nonconformity the organization could consider that there might be instances where the cause of a nonconformity cannot be eliminated, therefore, the organization should consider taking actions to be able to detect and minimize the effects of the nonconformity if it were to occur again."​

I agree with @MonsterEnergy22. Internal issues, complaints, even nonconformities, do not automatically require corrective actions. There's an ISO standard that specifies guidance on developing management system standards (i.e. Annex SL Appendix 2. Harmonized structure for MSS with guidance for use). According to section 10.2 of this standard:

"In formulating any discipline-specific requirements, MSS writers should be aware of the following:
⎯ the difference between “correction” (“action to eliminate a detected nonconformity” – see ISO 9000) and “corrective action” (“action to eliminate the cause(s) of a nonconformity and to prevent recurrence” – see 3.17);
⎯ it is not always possible, technically feasible, or cost effective to identify or fully eliminate the cause, and this is not required by 10.2 in all cases; “the organization shall evaluate the need for action” and “corrective actions shall be appropriate to the effects of the nonconformities encountered”​

 

Morning Tony, What standard is this that you're referencing?

 

You can click the link in the paragraph specifying "Appendix 2", then you can download the version you would prefer in this link https://committee.iso.org/home/jtcg