Control of Nonconforming product (5.10 API Q1)

Hi All,

I'm still quite new to the Quality Management world. Could someone give me some advice with regards to control of nonconforming product (5.10 API Q1) and improvement (6.4). Does anyone out there use one form to address both of these subjects or do you split them. I was intending on having an NCR form purely for nonconforming product and a preventative and corrective action form purely for quality management issues. However, the more I do, the more I realise that the two can go hand in hand, in that product non conformities are sometimes down to quality management issues.
Any help will be most appreciated.

David.

Re: Control of Nonconforming product

I keep corrective actions, preventive actions, and nonconforming reports separate. When first setting up our QMS I was unsuccessful when I tried to combine them in different ways.

Which certification are you with?

Re: Control of Nonconforming product

Hi David,

It is standard practice to keep NCR form and CAPA form separate. Even though they go hand by hand sometime, still it is advisable to keep them independent. As you might not issue corrective actions for all the NCR's. However, on the CAPA form you can add the NCR details for traceability.

Vik

Re: Control of Nonconforming product

Eredhel said:

I keep corrective actions, preventive actions, and nonconforming reports separate. When first setting up our QMS I was unsuccessful when I tried to combine them in different ways.

Which certification are you with?

Click to expand...

Nothing at the moment, were working towards API Q1