If we do not perform design activitiy does my manual still have to address 7.3.1.1 "Multidisciplinary Approach", 7.3.2.2 "Manufacturing Process Design Input", 7.3.2.3 "Special Characteristics", 7.3.3.2 "Manufacturing Process Design Output", 7.3.4.1 "Monitoring" and 7.3.6.3 "Product Approval Process" or can I take exclusion to section 7.3 and all subsections ?

Abody

If we do not perform design activitiy does my manual still have to address 7.3.1.1 "Multidisciplinary Approach", 7.3.2.2 "Manufacturing Process Design Input", 7.3.2.3 "Special Characteristics", 7.3.3.2 "Manufacturing Process Design Output", 7.3.4.1 "Monitoring" and 7.3.6.3 "Product Approval Process" or can I take exclusion to section 7.3 and all subsections ?

AbodyWelcome to The Cove! This is a good first question because there's a fair amount of confusion about excluding design.

I take it you are referring to TS16949? If so, do you design your processes? The notes help point out the sections that deal with both product and process design.

7.3 to 7.3.3.1 involve product design and its related activities.

However:

- 7.3.3.2 involves design of processes too. Unless you have someone external telling how to do everything, 7.3.3.2 probably applies to you.
- The note to 7.3.4 says it includes process design.
- 7.3.4.1 does not specifically involve both, but is a really good idea IMO
- Note 2 below 7.3.6 says 7.3.5 and 7.3.6 include process design, and 7.3.6.3 refers to both manufacturing product and processes

I hope this helps!

Jennifer has it!

Regardless of your responsibility for product design, it is expected that you apply the same design process criteria to the design of the process!

You should also plan on practically following 7.3.2.3 for product characteristics that are customer generated and for your own process characteristics that might tie to those critical customer characteristics. See also: Identification of Special Characteristics - Cl 7.3.2.3 Interpretation (http://elsmar.com/Forums/showthread.php?t=28868) I know that technically 7.2.1.1 covers customer generated special characteristics, but in practice they're asking for the details laid out in 7.3.2.3.

Ray

Thanks Ray