NCMRs and its relation to CAPA

#1
I work in a med device company. As part of our MRB process, the NCMR requires a written justification if we are NOT going to issue a CAPA (or SCAR) for all material rejections and dispositions. Is this common? I've been with a number of med device companies in my 4 decades of work, including a Class III device maker, and I haven't seen this requirement. Any feedback would be welcome.
 
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chris1price

Trusted Information Resource
#2
There isn't a specific regulatory requirement related to NCR and CAPA, but ISO13485, 8.3.1 does say "Records of the nature of the nonconformities and any subsequent action taken, including the evaluation, any investigation and the rationale for decisions shall be maintained". It may be good practice to document the rationale for not performing a CAPA. 21CFR820.90 has similar language.
 

blackholequasar

Involved In Discussions
#3
I used to work in pharma and in contact lenses, which are considered a Class II device - and we had to provide justification why an NCMR did not require a corrective/preventive action. It was just how they did business as a result of having auditors look at their documents and ask them WHY. "Why didn't you look into root cause and do an analysis on this?" If you have justification, it helps. But most of all looking into that also helps your processes. You've detected something that is non-conforming, that could be a symptom of a larger process breakdown somewhere else.

But as far as being a requirement? It's only required if your company says it is.
 

Bev D

Heretical Statistician
Staff member
Super Moderator
#4
Do you write NCMRs (non conforming material reports?) for all nonconforming things from incoming material and components as well as your products that fail your QC/release testing?

Do you write NCMRs for each individual part or do you group parts that all fail at the same time?

Do you have a lot of nonconforming events (not perfect yields) or are these fairly rare events?
 

indubioush

Quite Involved in Discussions
#5
Justification is not required. I am used to having an "other actions" section that lists checkboxes for CAPA, ECO, SCAR, Advisory Notice, Rework form, No further action required. Form has been audited by a notified body, and it was fine. Usually there is a company policy that if there are three similar NCMRs opened, a CAPA is required as this would indicate a systemic issue.
 

somashekar

Staff member
Super Moderator
#6
There isn't a specific regulatory requirement related to NCR and CAPA, but ISO13485, 8.3.1 does say "Records of the nature of the nonconformities and any subsequent action taken, including the evaluation, any investigation and the rationale for decisions shall be maintained". It may be good practice to document the rationale for not performing a CAPA. 21CFR820.90 has similar language.
This is a straight and perfect response from Chris....except that it is a 'shall' requirement of the standard, and therefore the rationale or written justification has to be present and the same authorised by your responsible manager in your NCMR.
 

indubioush

Quite Involved in Discussions
#7
Let' reel it back a bit. This section of the standard does not mention corrective action, and when it is talking about "actions" it is talking about disposition of product. If an auditor told me I needed a justification for not doing a CAPA, I would fight that finding. I think the NCMR procedure should clearly define when an NCMR should be escalated to a CAPA. There is no requirement to have this type of justification in every NCMR record. You can have it in there if you want, but you will be writing "Not a systemic issue" a lot.
On the other hand, you do have to document the rationale for whatever disposition you chose for your product.
 

somashekar

Staff member
Super Moderator
#8
Records of the nature of the nonconformities and any subsequent action taken, including the evaluation, any investigation and the rationale for decisons shall be maintained .......
so says the standard 13485 at 8.3.1
The NCMR record therefore has to be complete in itself.
 
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