Design & Development Clause 7.3, Applicable or not, What is rule?

[charanjit singh]

I am sorry I cannot agree with Big Jim.

Participating in customer's design reviews/meetings or giving advice to the customer does not constitute or imply responsibility for the whole or a part of the design process. You are only assisting the customer by giving suggestions/design inputs that the customer may or may not find acceptable fully or partially in his overall view of the design process. The ultimate responsibility for the design remains with the customer. You have no responsibility for any of the subclauses of 7.3 either.

 

[Big Jim]

I am sorry I cannot agree with Big Jim.

Participating in customer's design reviews/meetings or giving advice to the customer does not constitute or imply responsibility for the whole or a part of the design process. You are only assisting the customer by giving suggestions/design inputs that the customer may or may not find acceptable fully or partially in his overall view of the design process. The ultimate responsibility for the design remains with the customer. You have no responsibility for any of the subclauses of 7.3 either.

Agree of don't, but that is the position of at least one major CB.

And if you really think about it, it does make sense. The standard does not say anything about who is responsible for design. It only talks about design activity. If you participate in design, you should not be claiming full exemption.

 

[AndyN]

Agree of don't, but that is the position of at least one major CB.

And if you really think about it, it does make sense. The standard does not say anything about who is responsible for design. It only talks about design activity. If you participate in design, you should not be claiming full exemption.

Maybe it makes sense to the one CB, 'major' (whatever that means) or not. Plenty of clients would love to have the word "design" appear in their scope (for no extra cash), but that doesn't make it an appropriate scope or certification!

Based on what all the other CB's do, it doesn't makes sense to them, clearly.......and I rather doubt the customers of an organization claiming 'partial design' would be impressed, either!

I'd suggest that the tie breaker would be the limitation of culpability in a mega buck product liability law suit, where the product design was found to be at fault! I bet you wouldn't see a lot of 'partial design' suppliers for dust........

 

[Big Jim]

Maybe it makes sense to the one CB, 'major' (whatever that means) or not. Plenty of clients would love to have the word "design" appear in their scope (for no extra cash), but that doesn't make it an appropriate scope or certification!

Based on what all the other CB's do, it doesn't makes sense to them, clearly.......and I rather doubt the customers of an organization claiming 'partial design' would be impressed, either!

I'd suggest that the tie breaker would be the limitation of culpability in a mega buck product liability law suit, where the product design was found to be at fault! I bet you wouldn't see a lot of 'partial design' suppliers for dust........

It only shows up in the exclusion statement. It does not show up on the certificate.

I guess you must feel that it is OK to claim exemption to design when a company is involved with design?

Take another look at 1.2

"Where any requirements(s) cannot be applied due to the nature of an organization and its product, this can be considered for exclusion."

If a company is involved in design, how can they claim it for exclusion?

". . . and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements."

Some of my partial design clients feel that they would compromise their ability to provide product that meets their customer expectations.

My partial design clients tell me that their customers ARE impressed that they are willing to make suggestions when they see opportunities for improvement.

I believe that there is so much resistance to this concept is that it runs contrary to your experience, but if you stop and read the standard you can see that it is appropriate.

 

[Sidney Vianna]

I believe that there is so much resistance to this concept is that it runs contrary to your experience, but if you stop and read the standard you can see that it is appropriate.

That reminds me of the joke:

As a senior citizen was driving down the freeway, his car phone rang. Answering, he heard his wife's voice urgently warning him, "Herman, I just heard on the news that there's a car going the wrong way on 280. Please be careful!"

"Hell," said Herman, "It's not just one car. It's hundreds of them!"

Once and for all: The standard is about design responsibility, not design involvement. When ALL CB's but one agree on something, it should give you a hint.

 

[Jim Wynne]

It only shows up in the exclusion statement. It does not show up on the certificate.

I guess you must feel that it is OK to claim exemption to design when a company is involved with design?

Take another look at 1.2

"Where any requirements(s) cannot be applied due to the nature of an organization and its product, this can be considered for exclusion."

If a company is involved in design, how can they claim it for exclusion?

". . . and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements."

Some of my partial design clients feel that they would compromise their ability to provide product that meets their customer expectations.

My partial design clients tell me that their customers ARE impressed that they are willing to make suggestions when they see opportunities for improvement.

I believe that there is so much resistance to this concept is that it runs contrary to your experience, but if you stop and read the standard you can see that it is appropriate.

At what point does "partial design" become a factor? If a job shop excludes design responsibility from their QMS scope, and they get a call one day from a customer's design engineer asking about whether a given dimensional tolerance is realistic, is the shop "partial design" responsible? Tell us where the line is between no design responsibility and "partial" design responsibility.

Where the line actually is in authority for developing new designs, and changing old ones. If you can't unilaterally change a product design, you're not design responsible.

 

[Big Jim]

That reminds me of the joke:

Once and for all: The standard is about design responsibility, not design involvement. When ALL CB's but one agree on something, it should give you a hint.

Not all models are perfect, but most are useful. Your model doesn't fit.

Another model that doesn't fit is "if salmon didn't swim upstream, there would be no salmon".

 

[Big Jim]

At what point does "partial design" become a factor? If a job shop excludes design responsibility from their QMS scope, and they get a call one day from a customer's design engineer asking about whether a given dimensional tolerance is realistic, is the shop "partial design" responsible? Tell us where the line is between no design responsibility and "partial" design responsibility.

Where the line actually is in authority for developing new designs, and changing old ones. If you can't unilaterally change a product design, you're not design responsible.

I have not encountered something as trivial as that yet. If I do, I'll call the CB and ask what they want to do.

A job shop that routinely makes suggestions on how to improve design when they review specifications are indeed participating in design. If it is a rare event, and I came accross it, I would talk to the CB.

 

[AndyN]

I have not encountered something as trivial as that yet. If I do, I'll call the CB and ask what they want to do.

A job shop that routinely makes suggestions on how to improve design when they review specifications are indeed participating in design. If it is a rare event, and I came accross it, I would talk to the CB.

I would suggest that if it's necessary to make a call 'back to base' for an auditor to determine what's in scope or not indicates a fundamental accreditation issue. I have heard from others about having to seek this kind of sanctioning from 'HQ' and found that it's often incosistently applied.

I'd be interested to know what ANAB, UKAS and RvA would answer if they were questioned about the validity of certification based on 'partial design'.......

As Sidney says, Jim, if this is such a great idea, that it's a reasonable interpretation of 'design responsibility', how come the more experienced, longer serving CB's (I'm guessing yours isn't one of the earlier CB's to be accredited) haven't be doing what you propose?

 

[Jim Wynne]

I have not encountered something as trivial as that yet. If I do, I'll call the CB and ask what they want to do.

A job shop that routinely makes suggestions on how to improve design when they review specifications are indeed participating in design. If it is a rare event, and I came accross it, I would talk to the CB.

The question isn't about participating in design--if that were the case, there would be no exclusions for job shops, ever. You yourself have just characterized a hypothetical instance of "design participation" as "trivial."
I don't care what a single misguided CB says--it's about design responsibility, not design participation. In your view of "partial" design participation, a job shop would have to refuse all requests for information related to design from their customers in order to maintain an exclusion. That makes no sense on any level.