I am hoping someone can give me some insight as to what they are looking for in 7.3.4.1 Monitoring: Measurements at specified stages of design and development shall be difined, analyzed and reported with summary results as an input to management review. Note: These measurements include quality risks, costs, lead-times, critical paths and others, as appropriate.

We do not do design work here so does this apply for my company????

Any feedback would be greatly appreciated!

:thanks:

I am hoping someone can give me some insight as to what they are looking for in 7.3.4.1 Monitoring: Measurements at specified stages of design and development shall be difined, analyzed and reported with summary results as an input to management review. Note: These measurements include quality risks, costs, lead-times, critical paths and others, as appropriate.

We do not do design work here so does this apply for my company????

Any feedback would be greatly appreciated!

:thanks:

Hello Laurie,

You may not do design work (I assume product design?), but you are still manufacturing process design responsible. You are expected to track progress against a time line (a timing chart or program management software) and submit that information for Mgt Review. The intent of this requirement is to ensure that Top Management is aware of the progress made and intervene when necessary.

Hope this helps a little.

Stijloor.

Thank You for your input. Is this just for monitoring of "new" programs?

Thank You for your input. Is this just for monitoring of "new" programs?

Hi Laurie,

Yes. Any time you would launch a new program for your customer, and this launch would require a new process or a significant modification, that requirement applies. If you launch a new program utilizing an existing manufacturing process, you would still review your PFMEA, Control Plans, etc.
You want to sure that the new program runs better than the previous one.
Continual Improvement.............

Hope this helps.

Stijloor.