7.3.7 Control of Design & Dev. Changes

[Willbwell]

Since our customers are responsible for design of product we manufacture, we have exclded 7.3 thru 7.3.6. in our QM. Our consultant advises to exclude 7.3.7 also. My question...would it not be best to retain and address 7.3.7 since we must deal with changes that originate with the customers as well as changes resulting from product improvements that we may suggest for customer approval?

Thanks for your help!!!

Willbwell

 

[Chris May]

Keep 7.3.7

I would most definitely keep in 7.3.7.

I would suggest this so that you can maintain document control at the point of product realisation.

Any change from your customer could have an impact upon your realisation processes, purchasing processes etc;

In fact, the more I think of it, your customer design changes will have an impact on a majority of the clauses of 9K2K.

So yes, keep with it.

Regards,

Chris

 

[M Greenaway]

Willbwell

My view on this would be that all you need to consider is the document control element of this 'external' design.

Clause 7.3.7 is primarily concerned with the proper evaluation of design changes, and as such should be undertaken by the design authority, whether they are internal or external. Even if you play a significant part in the developement of the design I would imagine that you only undertake work against 'approved' design and design changes from the external design authority.

So at first glance of your situation I would agree that clause 7.3.7 does not apply to your organisation.

 

[HFowler]

Willbwell,

I agree with M Greenaway (sort of). In my opinion, clause 7.3.7 requires the organization responsible for design and design changes to maintain documented control. You really don't care how much the design changes until you get an order for that product. Where you should be concerned about changes is during "Contract Review". See the last sentence of clause 7.2.2.

As I said, this is my opinion. Read on for the views of others.

Best Regards,
Hank Fowler

 

[akin]

I realy want to know that is necessary to maintain the paper document for design review.. is it okay in MSN messanger, Pls. suggest us

 

[Willbwell]

Aikn,

I believe you are asking if electronic records are acceptable in-lieu of hardcopy. Although it is not specifically stated in 4.2.4 (Control of Records), I believe electronic records are acceptable. ISO 9002-1994, 4.16 specifically stated that electronic media was acceptable.