7.3.1 Design & Development Planning related to Process Design

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Bigfoot

How are others handling the Design & Development Planning related to process design, in organizations that are not product design responsible.

I recently heard that registrars are being pushed to scrutinize this clause within the context of it being an input for 7.3.2.2 Manufacturing Process Design Inputs. Have any others heard this? Or those of you who perform External Audits been pushed toward this?
 

qusys

Trusted Information Resource
How are others handling the Design & Development Planning related to process design, in organizations that are not product design responsible.

I recently heard that registrars are being pushed to scrutinize this clause within the context of it being an input for 7.3.2.2 Manufacturing Process Design Inputs. Have any others heard this? Or those of you who perform External Audits been pushed toward this?

If an organization is not responsible of product design and development, it can exclude but they cannot exclude process design and development. It applies to the manufacturing process design for incoming to shipping thorugh production according to the process flow.
Could you plase be more specific, because I am not sure if I understood well.
 
R

rickmcq

How are others handling the Design & Development Planning related to process design, in organizations that are not product design responsible.

I recently heard that registrars are being pushed to scrutinize this clause within the context of it being an input for 7.3.2.2 Manufacturing Process Design Inputs. Have any others heard this? Or those of you who perform External Audits been pushed toward this?

We are not design responsible and are excluded from 7.3.1, 7.3.2, 7.3.2.1, 7.3.3 and 7.3.3.1. We make product according to part drawings and any other information given during quotation.

The only thing I can think of when you say "scrutinize the clause in the context of being an input" is if you are helping your customer design their product. If it's not that then all you can do is verify that you have met all of the requirements that were given to you and not worry about it.
 

John Broomfield

Leader
Super Moderator
How are others handling the Design & Development Planning related to process design, in organizations that are not product design responsible.

I recently heard that registrars are being pushed to scrutinize this clause within the context of it being an input for 7.3.2.2 Manufacturing Process Design Inputs. Have any others heard this? Or those of you who perform External Audits been pushed toward this?

Bigfoot,

Surely it makes sense to plan the design of your manufacturing processes. Then everyone concerned can be informed, help with the design inputs and with the design reviews (FMEAs)?

You could end up with manufacturing processes so well designed they may even be mistake-proofed and need less time and money wasted on product inspection (per 7.5.2).

John
 
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