Combined Procedure - Control of Non-conforming Product, Corrective and Preventive

[heartlyn]

Hello,

This is my 2nd time to post a query. I just want to know if it is okay to have these procedures combined in one - Control of Non-conforming Product, Corrective and Preventive action. I have attached here our procedure and I hope you could help me on reviewing it. We are only starting implementing the ISO 9001:2008 in the company.

I appreciate any advise or suggestions you could give. Thanks in advance.

 

[somashekar]

It is OK... for a short answer
Please address how your company will meet the standard's requirements in both these within the procedure.
While one is about the NC in your product (How a NC product is controlled)., the CA is about process and product NC's .. add customer complaints too.
I am more comfortable in a CA + PA procedure.


(Note: I have not read your attached procedure)

 

[heartlyn]

Thanks Somashekar. I was actually planning to separate them but then we have already that combined procedure which is attached so if it is okay, I would just revised them with the good suggestions. I'm still hoping one could give me a clear understanding on this matter.

 

[AndyN]

Don't do it - plus you have made it a requirement to treat NC Product by taking corrective action. You will bring the place to a halt! Even ISO 9001 allows you to simply fix the issue. By combining procedures you are missing vitally important steps - can I ask if you understand completely how these ISO requirements are supposed to work. They are completely separate "entities" and can be linked, by example, through "data analysis"...

 

[heartlyn]

That's what I thought. In my previous company, we have separate procedures & when I came here, they have it combined already. I am not that expert in ISO though but I am trying to understand.

 

[Project Man]

I agree with AndyN.
Control of non-conforming product and your CAPA need to be separate procedures.
Non-conforming product needs to be able to follow a path that easily (but clearly) allows it to either be reworked or scrapped. Yes, this process has similarities to the CAPA process but is definitely not the same thing.

 

[Bev D]

control of nonconforming product, corrective action and preventive action are separate processes. as another responder mentioned you can certainly move from one to the other through data analysis but they also can - and should - be initiated from independent events.

These separate processes can be combined in a single document but that approach does present additional complications that are not present if you created 3 separate documents...

 

[Vthouta]

Independent procedures would be really helpful for the ISO. For example: When you need to update the procedure everytime, you need to verify both the sections. Importantly, when you have an external audit, the auditor would be reviewing the revision history of the document and there is more room to ask for questions and investigate why these were combined, even though it might be correct. In other words, just inviting trouble and making easy for auditors.

Vik

 

[heartlyn]

Thank you everyone. I have decided to separate them now to avoid complications. I have already completed the Control of Non-conforming Product Procedure, now I am going to start doing the CAPA. Thank you for the suggestions.

 

[SheiLaJP]

That's true. It is better to separate them. Coz here we do separate, corrective & preventive action & handling of non-conformance. in that manner, you'll be able to create a process correctly and efficiently.





SheiLaJP