CIP (Corrective Action) requirements - ISO 9001 clause 10.2

raul1122

Starting to get Involved
Question on a topic that i was advised on by my QMS help desk person. So we had a finding on Clause 10.2 stating that corrective actions (CIP)s do not always have evidence of investigation and cause analysis results recorded. Now if one was just no plating on parts that required plating. Having a request - coordination- action - action verification isn't sufficient if the customer complaint file is attached to the report?
 

Randy

Super Moderator
OK so how are you going to provide a permanent fix to a problem if you don't determine what caused it to begin with and how you determined the cause?

Next time this problem happens are you going to reinvent the wheel figuring out what happened and why or will you have a record to look back on that you can say "Hey looky here, this happened before and here's how it was fixed"

Solving problems without recording the why's, how's and wherefore's put you right in the middle of a mobius loop of correction.
 

raul1122

Starting to get Involved
OK so how are you going to provide a permanent fix to a problem if you don't determine what caused it to begin with and how you determined the cause?

Next time this problem happens are you going to reinvent the wheel figuring out what happened and why or will you have a record to look back on that you can say "Hey looky here, this happened before and here's how it was fixed"

Solving problems without recording the why's, how's and wherefore's put you right in the middle of a mobius loop of correction.
Thank you, if its not too much to ask could i Message you my reply to the findings to get some feed back? This is my first time ever having to deal with the auditors
 

Randy

Super Moderator
Thank you, if its not too much to ask could i Message you my reply to the findings to get some feed back? This is my first time ever having to deal with the auditors
Sure go ahead but I have to be honest up front, all I do is 3rd party audits just like them.
 

Kronos147

Trusted Information Resource
Does it need to be a PM? We could all give feedback if you hide the names to protect the innocent.

Though Randy knows his stuff.
 

raul1122

Starting to get Involved
No it doesnt here it is
 

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AndyN

Moved On
Question on a topic that i was advised on by my QMS help desk person. So we had a finding on Clause 10.2 stating that corrective actions (CIP)s do not always have evidence of investigation and cause analysis results recorded. Now if one was just no plating on parts that required plating. Having a request - coordination- action - action verification isn't sufficient if the customer complaint file is attached to the report?

This example should have been simply corrected. Is the real issue you are using corrective actions when simple corrections are all that's really necessary?
 

Big Jim

Admin
Andy is right. This was clarified in the 2015 version of the standard. It is up to the organization to determine if it is necessary to go beyond "correction".

It helps to pay attention to the definitions of "correction" and "corrective action" as provided in ISO 9000 (not ISO 9001). Paraphrasing for emphasis. Correction - action taken to over come a nonconformance. Corrective action - action taken to overcome the CAUSE of a nonconformance.

Lets take a look at 9001:2015 10.2.1

When a nonconformity occurs, including any arising from complaints, the organization shall:
a) react to the nonconformity and, as applicable:
1) take action to control and correct it;
2) deal with the consequences;

The above, 10.2.1a is the correction.

back to the standard -

b) EVALUATE THE NEED FOR ACTION TO ELIMINATE THE CAUSE(S) OF THE NONCONFORMITY . . .

(emphasis added)

This should make it crystal clear that not all nonconformances need go further than correction. Since it says "evaluate the need" that puts the evaluation in the hands of the organization, NOT AUDITORS.

More, much more, could be said about handling of nonconformances but his much is pertinent to the current conversation.
 
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