Audit Finding - CAPA, Improvement Initiatives not filed in CAR System

Adaym

Involved In Discussions
#1
In an Internal Audit it was observed that different operation teams have taken appropriate corrective actions / preventive actions and even few improvement initiatives as a result of their analysis of re-occurring issues, monthly quality objectives not meeting and so on. The records of these are available in email (minutes meeting, monthly meeting, progress updates ), HRMS systems but it is not filed internal CAR system as per their internal stated procedure.

I believe this is an observation rather than a non-conformity in the standard it is not a requirement to have a CAR system in place accept it should satisfy steps as required under 10.2. Am I correct? Can I say that internal CPAR system is not effective -

Please guide me appropriate Audit Finding statement.

Finding: Observation
Internal CPAR system is not being used for filing corrective / preventive actions and improvement initiatives.

Requirement: Internal Continual Improvement procedure

Impact:
* Lack of management visibility
* inaccurate trending results
What else ?

Evidence :
Email Dated time from to . for the action _____ as a result of _______.
 
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Randy

Super Moderator
#2
1st and very important...What does their corrective action process require? Does it require that every NC be formalized into a Corrective action Yes or No?

Look at what 10.2 actually says (in fact it's pretty much what's always been required and nobdy noticed..

10.2.1 When a nonconformity occurs, including any arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable:


b) evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by:

c) implement any action needed;

So essentiality an organization has the right to prioritize inconsistancies (nonconformities) and take the action they deem necessary and appropriate, taking into consideration the risks posed and do something like fix it and move on or make formal corrrection doing everthing it entails.

Non every nonconformity requires formal corrective action unless the organization shoots themself in the foot by requiring it in their own process/procedure.
 

Kronos147

Trusted Information Resource
#3
Finding: Observation
Internal CPAR system is not being used for filing corrective / preventive actions and improvement initiatives.

Requirement: Internal Continual Improvement procedure
I find the requirement to be one of the more important items on an NCR. Does the internal procedure say to log the event? Then not logging is a non-conformance, not an observation.


Example:
Requirement: Internal Procedure 123 Rev. A states in para 4. "maintain underwater basketweaving statistics on form ABC Rev. 6."

Nonconformance: The process of maintaining underwater basketweaving statisticsis not effective.

Objective Evidence: Underwater basketweaving statistics presented during the audit were not logged on form ABC Rev. 6 as per Internal Procedure 123 Rev. A.
 
Last edited:
#4
Hi Randy,
Is there a difference between 8.7 "Control of nonconforming outputs" and 10.2"nonconformity and corrective actions"? Does 8.7 apply only to final products?

You also mentioned not all nonconformance requires a corrective action, but do all corrective actions require preventative actions?

Sorry to veer slightly off topic, but didn't se other posts that covered this.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#5
Hi Randy,
Is there a difference between 8.7 "Control of nonconforming outputs" and 10.2"nonconformity and corrective actions"? Does 8.7 apply only to final products?

You also mentioned not all nonconformance requires a corrective action, but do all corrective actions require preventative actions?

Sorry to veer slightly off topic, but didn't se other posts that covered this.
Let us observe that 8.7 Control of nonconforming outputs is in the Operations clause group, which means process outputs that do not meet expectations will be addressed. The idea is to not wait until the end, when the issues affect other processes or products go further on down the line before problems are noticed, which can be very expensive for an organization. (Cost of poor quality)

Let us also notice the second paragraph, which says "...This shall also apply to nonconforming products and services..." which stresses the point that the definition of "outputs" in this clause are not limited to products are services. It is also for support processes. That is clarified in ISO 9000:2015:
3.7.5
output
result of a process (3.4.1)
10.2 talks to nonconformity in general. From ISO 9000:2015:
3.6.9
nonconformity
non-fulfilment of a requirement (3.6.4)
Let us notice 10.2 in ISO 9001:2015 is packed with "weasel words" like as applicable, and if necessary, and lastly appropriate. This is meant to avoid locking people in to regimented, one-size-fits-all approaches to addressing nonconformity.

I hope this helps!
 

Mike S.

Happy to be Alive
Trusted Information Resource
#6
The records of these are available in email (minutes meeting, monthly meeting, progress updates ), HRMS systems but it is not filed internal CAR system as per their internal stated procedure.
I believe you answered your own question here.

If the CAR procedure says CARs shall be documented on blue paper in red ink, then if they are documented on white paper in red ink there is a nonconformance, not an observation, IMO.
 
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