Design falling outside ISO scope

[lisap]

I work for a large corporate that includes several brands under the same group.

I worked for years for the largest brand, ISO certified, that had its own design team, and I recently moved to the global group structure, not certified.

Now, due to some political internal adjustments the entire Engineering and Design authority has moved from the individual brand “to group”.
This means that the whole new product development process has fallen outside ISO scope for most if the brands.
So design validation and verification are now carried autonomously by the engineering authority.

As a result of this, they are rewriting their new product development process without taking into account barely any quality requirement (for example at none of the various design review gates a QA member is ever considered a stakeholder, not even at production readiness).

I am in a role where I have no power of direct action, other than highlighting the risks of cutting the supply sites entirely out of the process. Even the supplier selection has been strategically moved under the same Engineering Authority.

As there is no formal auditing on the “global” part of the business, should the individual brands treat the Engineering Authority as a supplier and set a list of requirements for design validation and verification before accepting to start production?

But what if the Engineering authority and Product Management are allowed to launch a product that hasn’t been fully validated yet?
Without in fact ever being subject to NC or held accountable?

I hope I’ve explained myself clearly enough.

 

[Randy]

You're saying that everyone is manufacturing to a supplied specification they have no involvement in or control over? OK no big deal, design & development is not applicable, I see it nearly every day.

(The catch is, is there a mechanism to bounce customer dissatisfaction for correction and any other problems back to whoever controls design so things can be improved/corrected?)

 

[Tagin]

should the individual brands treat the Engineering Authority as a supplier and set a list of requirements for design validation and verification before accepting to start production?

From a risk perspective, I would treat them as I would a supplier of those services.

But what if the Engineering authority and Product Management are allowed to launch a product that hasn’t been fully validated yet?
Without in fact ever being subject to NC or held accountable?

Is Product Mgmt within your brand/ISO scope? Or is it another "group" function outside of your control? Can it force your brand to carry a product? I don't understand the relationship.

 

[lisap]

You're saying that everyone is manufacturing to a supplied specification they have no involvement in or control over? OK no big deal, design & development is not applicable, I see it nearly every day.

(The catch is, is there a mechanism to bounce customer dissatisfaction for correction and any other problems back to whoever controls design so things can be improved/corrected?)

That’s exactly the issue. The CAPA system can bounce customer dissatisfaction or internal waste to the engineering authority, however the latter doesn’t have to do anything as after product launch they’re not responsible anymore.

There’s a complete governance and QA void between the global level and the operational level.

So typically the Quality Engineers will collaborate with suppliers/production engineers to fix the issue. This often has a high cost in terms of resources/time and also wasted material and reputation. Meanwhile the stakeholders involved in New Product Development process is never formally made accountable

 

[lisap]

From a risk perspective, I would treat them as I would a supplier of those services.



Is Product Mgmt within your brand/ISO scope? Or is it another "group" function outside of your control? Can it force your brand to carry a product? I don't understand the relationship.

Hi, no they also are a “group” function. They cannot force the brand to carry the product per se but they have direct influence on the executive functions that do make the final decision.
More often than not, quality related risks are completely omitted in the reviews and only commercial risks are discussed.
This is primarily due to a lack of commitment to quality and secondarily due to no QA stakeholders to question the current process.

In reality what happens is that the factory is pushed to manufacture a product that hasn’t been fully validated (the components are non-conforming to the design requirements).
So QA/QC take charge of full components validation and guide the suppliers to improve their processes. This obviously takes time and requires a few rounds of trials.
QA/QC become the blame-monkey for holding up components and delaying sales.

But all can be seen at “group” and executive level is that the product has been launched on time (so well done new product development teams) and “the supply sites are late with deliveries”.

 

[indubioush]

It sounds like the "Brand" is no longer operating under the processes and procedures that were compliant to ISO standards. If this is true (the processes are not compliant), the ISO certification should no longer be applicable, and you should notify your customers that this is the case. If the only customer is the parent company, and the parent company is not certified, there is no reason to be certified.

 

[lisap]

It sounds like the "Brand" is no longer operating under the processes and procedures that were compliant to ISO standards. If this is true (the processes are not compliant), the ISO certification should no longer be applicable, and you should notify your customers that this is the case. If the only customer is the parent company, and the parent company is not certified, there is no reason to be certified.

The process is out of scope now, and the factory, that is the direct supplier to the customers, is taking action to prevent non-conforming products reaching the customers.

However, this is causing high levels of waste internally that goes entirely unnoticed at the “group” level and therefore the process that causes the issues is not seen as faulty, quite the opposite in fact.

I’m not sure I understood why you think the ISO certification shouldn’t be applicable, can you clarify please?
I think there should be maybe a formal way to assess the output of the design process that is now out of scope.

 

[indubioush]

What is the scope statement on your ISO cert? Is the statement still correct? If not, you need to notify your registrar of the change. You will need to notify your customers as well.

 

[Sidney Vianna]

As there is no formal auditing on the “global” part of the business, should the individual brands treat the Engineering Authority as a supplier and set a list of requirements for design validation and verification before accepting to start production?

Assuming these are not regulated products, otherwise, I don't know how they could be introduced in the marketplace without proper V&V, you have touched on an issue that even ISO TC 176 does not know how to tackle. In a very old document (ISO/TC 176/SC 2/N 524R6), from 2008, Example No. 10 resembles your current scenario. Years later, ISO had another paper (that I can't find now) mentioning that the Production site would have to treat the Design & Development (D&D) process as an outsourced process and ensure the corporate function, responsible for D&D was "compliant with the applicable requirements of ISO 9001. Naiveté since we all know the pecking order in the corporate world and there is no way a manufacturing site can demand much from a global corporate function.

The bit about the design reviews not including site quality stakeholders is very telling of a corporate dysfunction.

Good luck.

 

[lisap]

What is the scope statement on your ISO cert? Is the statement still correct? If not, you need to notify your registrar of the change. You will need to notify your customers as well.

That’s right, the statement needs changing, I believe the Quality Manager is aware because we discussed it on several occasions.