Scope of ISO 9001 clause 10.2 in the product life cycle

[J.R. Strickland]

I'm looking for some guidance on a practical approach to applying 10.2, particularly in design and development. We recently completed an internal audit on this process and one of the auditors raised this as a finding because each item on their project issues list did not have all/most of the typical fields found in a formal CAR. One hypothetical example might be when bringing up a new product design and it fails to achieve a desired output. The engineer, when evaluating the first sample built on his/her bench, determines that a resistor value needs to be 10K ohms vs. 1k ohms. (This is where everyone typically wants to wade off into change control, but that is not my question. It is strictly about the requirement to document the issue per 10.2.) It seems to me that it is impractical to ask engineers that are in the process of designing a product to go through a whole 10.2 documentation process for all of the issues they encounter. Thoughts?

 

[yodon]

First, it would probably be helpful if you posted the complete text of the finding. Having that often helps to craft the best response.

If I understand, though, it sounds like the they're still working out the details of the design. If so, I even agree that it's premature to even get into change control much less triggering a NC. On the surface, it seems the design has not yet been asserted to be complying. Now if the current design represents a 'contract' between that and another design aspect, and the change affects that contract, then I'd think change control is in order but, still, not a NC.

 

[J.R. Strickland]

First, it would probably be helpful if you posted the complete text of the finding. Having that often helps to craft the best response.

If I understand, though, it sounds like the they're still working out the details of the design. If so, I even agree that it's premature to even get into change control much less triggering a NC. On the surface, it seems the design has not yet been asserted to be complying. Now if the current design represents a 'contract' between that and another design aspect, and the change affects that contract, then I'd think change control is in order but, still, not a NC.

Thanks for the reply. I have been on vacation for a week and am getting caught up on things. Your understanding is correct in that the design is still being evaluated/verified for compliance. There is no "contract" as you put it between this design and another design aspect. Your initial thoughts are in line with my current sentiments on the subject. Also, it seems while I was gone, there was some additional discussion on this and I have a meeting later this week on this topic. I'll post an update and some additional context after that.