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

[Big Jim]

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?

This isn't my intrepretation. It is the intrepretation of the CB that I work with. I only apply it as directed.

The standard does not use the term "design responsible". That term is an intrepretation. Why are you so shocked that their could be other intrepretations?

 

[Big Jim]

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.

You are right, there should be no exception. Job shops that participate in design should not be able to claim the entirety of 7.3 as an exclusion. The call to headquarters would happpen if the auditee protested the finding. This speaks to the scope of registration and the CB needs to be informed when something is found that is in conflict to the agreed scope.

Do you not contact the CB when you find a varience from the stated scope statement?

 

[Jim Wynne]

You are right, there should be no exception. Job shops that participate in design should not be able to claim the entirety of 7.3 as an exclusion. The call to headquarters would happpen if the auditee protested the finding. This speaks to the scope of registration and the CB needs to be informed when something is found that is in conflict to the agreed scope.

Do you not contact the CB when you find a varience from the stated scope statement?

A CB that insists on this kind of silliness would never have gotten my business to begin with.

 

[Big Jim]

A CB that insists on this kind of silliness would never have gotten my business to begin with.

It seems like I heard the same comments when we were told to start doing process based auditing and quite relying entirely on a checklist. Also when were were told to start asking clients how their processes were performing based on the KPI.

 

[AndyN]

I still don't see an answer to the question about why no-one but your CB does this Jim? The CB you work for, if this is their formal documented approach to certification to ISO 9001 is completely out of step with the market.

I'm also interested to know that if you audit companies who participate in partial design activities, are you checking to see if their participants are competent to do this? What types of records of participation do they have to keep? Are they internally auditing this design activity? Is it reported at management review? Do they have any quality objectives tied to the partial design activity? How do they work to improve this?

Your answers are eagerly awaited!

BTW - Let's not trade terminology about responsibility for design since the word is used in context of 1.2 of the standard, regarding exclusions!

 

[Sidney Vianna]

What puzzles me: Big Jim seems to believe that the CB in question is 100% correct in their interpretation; so why not PROUDLY disclose the CB's identity here? What are we hiding? If we are so much smarter than the competition, I would like potential clients to know who I am, so they flock in droves to my services.

Such an unorthodox and creative interpretation should be publicly displayed in their website and available to other interested parties.

 

[Big Jim]

I still don't see an answer to the question about why no-one but your CB does this Jim? The CB you work for, if this is their formal documented approach to certification to ISO 9001 is completely out of step with the market.

I'm also interested to know that if you audit companies who participate in partial design activities, are you checking to see if their participants are competent to do this? What types of records of participation do they have to keep? Are they internally auditing this design activity? Is it reported at management review? Do they have any quality objectives tied to the partial design activity? How do they work to improve this?

Your answers are eagerly awaited!

BTW - Let's not trade terminology about responsibility for design since the word is used in context of 1.2 of the standard, regarding exclusions!

Oh but let us do look at 1.2.

Responsibility is a word used there, but not in the context of being responsible for design. In context it is used in the context of providing product that meets customer requirements.

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

As for what I look for in companies that claim partial design, it depends on what portion of design they claim to participate in. If they claim to make suggestions when they discover either opportunities for improvement or mistakes when reviewing customer specifications, that is where I look.

I have no idea why other CB's don't include partial design in their registration scheme. Perhaps you should ask them.

 

[Sidney Vianna]

I have no idea why other CB's don't include partial design in their registration scheme. Perhaps you should ask them.

Probably because we understand the intent and proper application of the standard?

Look at this document. It is an application form for CB's that want to attain AS9110 accreditation from ANAB.

Section 5 – Initial Witness Assessment

(reference: AS9104, 5.3)

A full system AS9110 assessment at a suitable organization is required to be witnessed by ANAB. An upgrade from AS9100 to AS9110 (per AS9104, 8.2.5) is not considered a suitable audit for ANAB to witness for AS9110 initial accreditation.

A suitable organization may be design responsible and shall be subject to prime contractor flowed-down requirements or to FAA Requirements (Title 14 CFR Part 21 or 145).
Note: If a design responsible organization is not available, an organization that is not design responsible may be used, however the scope of accreditation will be limited to AS9110 for non-design responsible organizations until such time as ANAB has witnessed the CB assessing the design control processes of a suitable organization’s quality system.​

Do you read where it says design responsibility? It does not state design involvement. Your CB interpretation is simply stupid. If I participate in a focus group suggesting to Volkswagen what new features I would like to see in a car, does that make me part of VW's design team? NO. ISO 9001 requires the organization RESPONSIBLE for the product design to evaluate inputs to determine their adequacy. Just because someone suggests something, it does not mean that they are part of the design team or process.​

Let's go: name the CB. Why would they be concerned of being associated with such interpretation, if it is so brilliant?​

 

[Big Jim]

What puzzles me: Big Jim seems to believe that the CB in question is 100% correct in their interpretation; so why not PROUDLY disclose the CB's identity here? What are we hiding? If we are so much smarter than the competition, I would like potential clients to know who I am, so they flock in droves to my services.

Such an unorthodox and creative interpretation should be publicly displayed in their website and available to other interested parties.

Sidney,

I would prefer to respond to you privately, but your private message feature has been turned off. So I guess that I will not be able to respond.

I have learned a lot while participating here at the Cove. You are one of the contributors that I have found most helpful. I am not trying to flaunt a unique intrepretation, I have only defended it once it came up.

 

[Big Jim]

Probably because we understand the intent and proper application of the standard?

Look at this document. It is an application form for CB's that want to attain AS9110 accreditation from ANAB.

Do you read where it says design responsibility? It does not state design involvement. Your CB interpretation is simply stupid. If I participate in a focus group suggesting to Volkswagen what new features I would like to see in a car, does that make me part of VW's design team? NO. ISO 9001 requires the organization RESPONSIBLE for the product design to evaluate inputs to determine their adequacy. Just because someone suggests something, it does not mean that they are part of the design team or process.​

Let's go: name the CB. Why would they be concerned of being associated with such interpretation, if it is so brilliant?​

Sidney,

Why would you go back and edit your post so it has a very different question than the one I already answered?

I looked at the web site for the CB that you are associated with. I did not find anything about design or no design concerning registration. So you expect other CBs to live to a higher standard?