posted 06 September 1999 06:30 AM               

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.

posted 07 September 1999 10:56 AM               

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

Others' thoughts?

posted 07 September 1999 03:18 PM               

Regards,

posted 08 September 1999 05:30 AM               

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.

posted 08 September 1999 09:00 AM               

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?

posted 08 September 1999 10:56 AM               

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.

posted 13 September 1999 02:18 PM               

Let me try to explain with an example.

posted 14 September 1999 01:42 PM               

1999 - You manufacture a widget. You have made it for 100 years. Way before the folks who thought up QS9000 were born. You now do QS9000. You 'grandfather' the design aspect of the product (no design FMEA necessary). You still have to do a Process FMEA, Control Plan, Process Flow Diagram and 'Appropriate' manufacturing (work) instructions.

The only question I know of that comes into play is if you do design changes POST-QS9000 registration, does that necessarily trigger a Design FMEA to be originated and as I understand it, it does.....

Now - that said - if you are referring to widget STOCK that was produced prior to your QS9000 registration the question becomes an issue between you and your customer. I would expect that if you HAVE BEEN supplying the part for a year or more before your QS9000 registration, there would be no problem. But I am *ASSUMING* you have a continuing dialogue with your customer and that they knew you were going for the QS9000 registration. They were accepting the parts on some basis before which was obviously less than QS9000.

If you made the widgets, then did QS9000 registration dance, and AFTER your QS registration you get an order for widgets and you are wanting to use up the stock made BEFORE your registration, I would *ASSUME* you would discuss this with your potential customer and you would together come to an agreement on whether they will accept the parts made before registration.