Design and development outputs

[Howard Atkins]

I have been through the various comments on the exclusions for non product design and the reasons for excluding clauses such as 7.3.3.1 and 7.3.2.1 and I have a question:

7.3.3 says

Design and development outputs shall
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d) specify the characteristics of the product that are essential for its safe and proper use.
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It is accepted that 7.3.3 can not be excluded.

How can you meet this requirement.

Also despite the fact that 7.3.2.1 can be exclded

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7.3.2.1 Product design input​

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[/font]The organization shall identify, document and review the product design inputs requirements, including the following:​

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• customer requirements (contract review) such as special characteristics (see 7.3.2.3), identification,traceability and packaging;​

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This is an agreed part of all production planning inputs.​

Any one have any comments​

 

[p_tww]

I have been through the various comments on the exclusions for non product design and the reasons for excluding clauses such as 7.3.3.1 and 7.3.2.1 and I have a question:

7.3.3 saysIt is accepted that 7.3.3 can not be excluded.

How can you meet this requirement.

Also despite the fact that 7.3.2.1 can be exclded
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This is an agreed part of all production planning inputs.​

Any one have any comments​

IMO, one of process design input was product design output.
What you said is included in the customer provided product design output.

 

[Sam]

I have been through the various comments on the exclusions for non product design and the reasons for excluding clauses such as 7.3.3.1 and 7.3.2.1 and I have a question:

7.3.3 saysIt is accepted that 7.3.3 can not be excluded.

How can you meet this requirement.

Also despite the fact that 7.3.2.1 can be exclded
[/left]
[/list]

This is an agreed part of all production planning inputs.​

Any one have any comments​

IMO;
#1- 7.3.3, Since you are not design responsible, this information should already be provided in the design records. You need only to review the design records and insert the appropriate information in your control plan and PFMEA in order to meet the requirements.

#2- 7.3.2.1, same as above,however there may be additional documents to review,i.e., P.O., SOW.

 

[Tom W]

IMO;
#1- 7.3.3, Since you are not design responsible, this information should already be provided in the design records. You need only to review the design records and insert the appropriate information in your control plan and PFMEA in order to meet the requirements.

#2- 7.3.2.1, same as above,however there may be additional documents to review,i.e., P.O., SOW.

I agree with this, however working at a service provider, it is rare that we ever get design records, we request them but almost never get them. This makes it very difficult to ensure proper process design, although we work with the customer documents that we get, usually just a specification that they want met. Again, we don't re-create heat treating so it does not impact us as much as a manufacturing company that has to actually create a product from a design.

 

[Don Wood - 2011]

We tell auditors that the only clauses that can be entirely excluded are 7.3.2.1 - Product Design Input) and 7.3.3.1 - Product Design Output. The base ISO clauses, 7.3.2 and 7.3.3 are applicable to BOTH product and process, thus exlcuding them is a no-no. Auditors should mentally substitute "process" for "product" when looking at non-product design responsible orgs.

Sam's thought process is a good way to look at it - how is your manufacturing process assuring that product requirements are being fulfilled?
DW