Product Design vs. Manufacturing Process Design

[rui12524]

7.3 requirements regarding manufactoring process design:

Houdy,
We are an injection-moulding factory, with capacity to do injection moulds. These moulds are built and used in house to produce plastic parts for our customers.
The question that hit’s me is the following: we consider that the mould building is part of our productive process, so we exclude design and development activities; BUT as far as manufactoring process design, I have some doubts about what the ISO TS 16949:2002 draft “want’s”! I understand “manufactoring process design” applied to companys that make machines that will make products in their customers (ex. Injection moulding machines); our case, although we do have project management activities, I think we do not have or need “manufactoring process design” in the sense I explain earlier.
Can anybody give me a hint about this?

Best
RMC

 

[frank-h]

Probably safer if you do?

We are currently ISO1994 and QS9000, we are gearing up for the new stuff as we speak.

My concern would be how far an auditor pushes the thoughts of:
How does this effect Quality?
How does the lack of control effect on time shipments due to the fact that your designs may not be consistant from job to job?
How do you production based on the fact that you have no prior history of how your designs work?
Continous improvement of your operation......

These are some of my thoughts as that I'm also an auditor.
I know there is a gray line, but we will push it if we don't feel warm and fuzzy inside about Quality.

 

[Marc]

One of the things you have to consider is that your paradigm of what design is may be too narrow. Read through https://elsmar.com/elsmarqualityforum/threads/2691/ for some thoughts on what design is. Traditionally, folks have thought of design with respect to - for example - designing a widget - a physical item. This is why service companies used to be able to get away without addressing design ("We don't do design.") If you look closely, even service companies 'design' their services.

A process is no different. I would say your project management activities are a form of manufacturing process design.

Just some thoughts.

 

[rui12524]

Ok, I am a bit confused with this two “designs”: we are a injection moulding plant with capability to do tools for internal use; although the customer sends a purchase order for the tool, the product that he wants is a plastic part. So, we say that we don’t have “product design”, but have “Manufacturing Process Design” (tool making + injection process)… the problem is that I can’t exclude the items of “Product Design”, so the way I chose was that of including “Product Design” and adjust the requirements of TS 16949:2002, so I could have a logical approach. Looking at what is done, I think that there is a big mix between requirements regarding “Product Design” and “Manufacturing Process Design”. Can anybody provide some light about these issues?

 

[Howard Atkins]

7.3 Design and development
NOTE The requirements of 7.3 include product and manufacturing process design and development, and focus on error prevention rather than detection.

TS 16949

IMHO in the "old days" pre ISO9001:2000 you could have got away with out design of the tools, but today you cannot ignore this. Your customer pays for the tool and it is his property, you use the tool to produce parts that he wants.
Ask yourself "who designs the tool?"
If the tool is not designed properly then you will not have correct parts to supply or you will be involved in extra costs ( an anathema to the industry).
You must have a design control system for the design and building of the mold and the design and implementation of the process.

 

[TQCon]

As recently pointed out by a TS Auditor, the last statements in Sub-Clause 1.0 of the TS states "The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development. Permitted exclusions do not include manufacturing process design."

My question then, is what sub-clause should best be referenced to provide the documentation? We provided a flowmap of how a new product is processed, including developing a process design step by Engineering. We called it a 7.3 item, even tho we didn't address all of the Product Design requirements.

Do people agree with this methodology? Thanks.

TQCon

 

[Jim Wynne]

As recently pointed out by a TS Auditor, the last statements in Sub-Clause 1.0 of the TS states "The only permitted exclusions for this Technical Specification relate to 7.3 where the organization is not responsible for product design and development. Permitted exclusions do not include manufacturing process design."

My question then, is what sub-clause should best be referenced to provide the documentation? We provided a flowmap of how a new product is processed, including developing a process design step by Engineering. We called it a 7.3 item, even tho we didn't address all of the Product Design requirements.

Do people agree with this methodology? Thanks.

TQCon

Welcome to the Cove, TQCon.

You don't need to reference the standard in your documentation. You need relevant documentation for the requirements of your process design system, and associated controls. You will probably need more detail than just a process flow diagram, though.

 

[TQCon]

The reason I'm looking for a TS reference sub-clause is that our numbering system for documents using it as nomenclature. It seems to help everyone get familiar with it.

TQCon

 

[Stijloor]

The reason I'm looking for a TS reference sub-clause is that our numbering system for documents using it as nomenclature. It seems to help everyone get familiar with it.

TQCon

Hello TQCon,

I strongly recommend that you take Jim Wynne's advise to heart. Aligning your documentation with the clauses in ISO/TS is a bad habit stemming from the old QS-9000 days. It may lead to audits per clause rather than audit per process. Please keep that in mind.

Now, if you still want to do what you asked about, you can refer to 7.3 even though you do not address all sub-clauses because you are not product design responsible. I consider that number (or any number) just a label. And numbering is not even required.

One last appeal....align your documents with the PROCESS they support.

Hope this helps.

Stijloor.