Is Design required for a manufacturing site?

[DaveB88]

Hi everyone! I have a couple questions maybe you can help me better understand.

I have searched and have not found the answer to this question, although it has related posts.

1. I am wondering if design is provided from our R&D at a location several hundred miles away from our manufacturing site and we only include the manufacturing in our scope whether Design is required? We really don't design at the manufacturing site, so some believe we can leave that out of our scope. There are some that believe we can just manage the implementation of the design into production. Is that reasonable or not?

2. Relative to KPI's, do you have to have a KPI for each process in the ISO 9001 2015 standard?

Thanks

 

[Golfman25]

Do some searching on the KPI issue. There are several discussions about them. My take is to use the same KPI/Measurement for multiple processes where possible.

 

[Randy]

Short answers ....NOPE for design and NOPE for KPI's

 

[DaveB88]

Do some searching on the KPI issue. There are several discussions about them. My take is to use the same KPI/Measurement for multiple processes where possible.

Was that a nope for leaving Design out of our scope or it's reasonable to get away with?

 

[Jim Wynne]

Was that a nope for leaving Design out of our scope or it's reasonable to get away with?

Did you quote the wrong post?

 

[Randy]

Was that a nope for leaving Design out of our scope or it's reasonable to get away with?

Do you do design there or not? YES or NO?

 

[DaveB88]

We do not do design at the manufacturing location.

 

[Randy]

We do not do design at the manufacturing location.

Then 8.3 is not Applicable and you can claim that. Make sure you document the fact and provide justification evidence. I see it all the time (NBD).

 

[Big Jim]

Some people seem to confuse the engineering done to determine how to produce something falls into design. Indeed, it does for automotive, but not for ISO 9001. What you do to determine how to make something, including designing fixtures and programming CNC machines, falls under element 8.1, Operation Planning and Control or as in prior versions of the standard, Production Planning. Product design falls under 8.3.

 

[Milton0323]

We exclude design in our scope. Our parent company is responsible for R&D. They are at a separate location. They are treated like a customer, as our scope defines this location only. We have not ever had an issue with it in 30 years. But they do need to adhere to our requirements for a customer. (we also do contract mfg). Where there is a difference in a process, we note it in the procedure.