Retro fitting QS9k requirements

[Martin Rudkin]

Can anyone offer any advice with regards the retrofitting of QS9k requirements on current approved parts?

We have many parts which are currently approved by our customers (including automotive) where the full QS9k requirements have not been met (some parts in excess of 7 years old). Do we have to revisit these parts ensuring that all sections of the QS9k requirements are completed or not?

Would it be sufficient to ensure that 'live' documents are in-keeping with the QS9k requirements? (e.g. Control Plans, FMEA, etc)
Also would all parts have to be brought in line initially our would it be possible to update parts as and when they are required by production.


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[ALM]

Well, I cannot say with 100% assurance, but I'd like to believe that you could "grandfather-in" the existing parts (those that existed prior to "official" implementation of your new quality system).

Going forward, you would update those parts as now required by your system.

Others' thoughts?

ALM

 

[Kevin Mader]

You may want to get a waiver from your Customer. This way you could demonstrate to your registrar that you aren't obligated to provide all the expected QS9000 and support manual items.

Regards,

Kevin

 

[Marc]

From having to deal with this in implemenmtations, this is the scoop as I have experienced it.

For current parts, you must have everything except the design FMEA. And you have to explain that the part came online before your QS9000 registration. What must you have?

Process FMEA
Process Flow Diagram
Process Control Plan
'Appropriate' manufacturing (work) instructions

If you did your FMEAs and Control Plans by equipment instead of by product, you should have no work to do except the flow diagram for the product.

Yes - you can have 'active parts' which are scheduled for future production where you do not have they FMEA, etc. done - with the stipulation that before you produce them again you will have the appropriate documents in place.

I have not had a client ask for a waiver so I don't know about that aspect.

 

[Martin Rudkin]

Thanks for your reply.

With regards your comments on implementing Control Plans and FMEAs by equipment, would it be possible to list them by product groups instead? Then make reference to the document which would have the m/c type, tool number etc listed.

e.g. If we have a product type - metal pressing, degreased and pack - could we have a generic Control Plan, making reference to the Works Route Card as the source of information re: tool number, machine type, etc?




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[Marc]

You could do them by product group as well. I push clients to use the equipment approach as they save time in the long run. Since several products (or more) can run through each machine, an FMEA and control plan by machine makes bringing new products on board simple and easy. Of course, there is always cut and paste but remember if you update the control plan / FMEA for a machine in product oriented system, you will most likely have to change each of all the others.

The point is that for each step in the flow of the product there has to be a control plan or piece of a larger control plan (same with a process FMEA) to address it.

Yes - referencing one document in another is quiter acceptable.

 

[Sam]

Existing parts,like training for example can be "grandfathered in".

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Sam Goody

 

[Marc]

While I know you can 'grandfather' training, you still have to have a training record for the grandfathered individual.

Please - more detail on the grandfathering of parts. My experience with QS implementations was that Process FMEA, Process Flow Diagram, Process Control Plan and 'Appropriate' manufacturing (work) instructions are required for Current parts. Exactly what can you 'get out of' by grandfathering a part? All I know of is the Design FMEA.

 

[barb butrym]

I'm with Marc..absolutely

 

[Sam]

I may be looking at the quesstion from the wrong perspective ......

Let me try to explain with an example.

Company X makes widgets for twenty years, then decides to become QS registered. At the registration audit he should have some evidence of compliance to the standard. The question is "how much and covering what time frame";six months, maybe a year,certainly not 5,10 or 20 years.
IMO ISO/QS is a regulator of the process , with the parts being a by-product of the process, therefore, it's not possible to consider existing parts when they were not produced in a QS9000 process.
I think ALM put it a little more straight- forward than I did.