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

[Kevin_Emmrich]

Another vote to keep them separate. Now, of course, the control of the NC material will many times lead to a CAPA, so that is where the tow process will come together.

 

[Sudhamadhuri]

Dear Sir,

Please give me ISO 9001 2008 clause number for rejected material at stores.

 

[somashekar]

Dear Sir,

Please give me ISO 9001 2008 clause number for rejected material at stores.

Greetings and Welcome to the COVE Sudhamadhuri ~~~
Can you be more specific. The ISO 9001 clause numbers just identify major processes that one has to consider in developing a QMS.
What exactly would you like to know...

 

[dsanabria]

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.

WAIT - before you get excited and start separating the documents read ISO 9001:2015 -

"One of the key purposes of a quality management system is to act as a preventive tool. Consequently, this International Standard does not have a separate clause or sub-clause titled 'Preventive action’. The concept of preventive action is expressed through a risk-based approach to formulating quality management system requirements."

Most of the opinions that I am reading is to keep the separate. In reality that is what is called old school thinking - nothing wrong with it but there is a better way.

Keep the documents as one and make sure that you incorporate the requirements of CAPA. (8.5.2 & 8.5.3). Remember that what ever you corrected take credit under 8.5.1 Continuous Improvement because you just corrected and prevented future issues. 8.4 Analysis of Data should not be used with CAPA - it has another purpose.

Start thinking Risk Process and minimize bureaucracy.

 

[dsanabria]

Dear Sir,

Please give me ISO 9001 2008 clause number for rejected material at stores.

First - Start with Clause 8.2.3

"8.2.3 Monitoring and Measurement of Processes

The organization shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate."

Second if you need to get customer input or decision - go to 8.3

"8.3 Control of Nonconforming Product

The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. A documented procedure shall be established to define the controls and related responsibilities and authorities for dealing with nonconforming product."

third - the requirements to document a non conformance are in clause 8.5.2

"8.5.2 Corrective Action

The organization shall take action to eliminate the causes of non-conformities in order to prevent recurrence. Corrective actions shall be appropriate to the effects of the non-conformities encountered."

Finally, if during this process you improved the process or the product - take credit under 8.5.1 - Continuous Improvement.