:confused:

We had a non-conformance logged following a TS16949 Stage 2 audit.
Engineering assure me that they considered warranty/historical issues but neglected to tick a box on the Feasibility Review form. I.e. no evidence. Our auditor wants to see a control plan in place for the APQP process before recommending our qualification for the standard.
Does anyone have an example of a Control Plan for the Customer Order Progression Process and/or APQP. At this stage in the process I cannot see how we can define measurables and have got a mental block or am having a senior moment as my partner would describe it?
The problem is that I cannot think of the measurables I would detail at this stage in the production process. We are not manufacturing parts but considering history & feasibility.
Do I just detail the process and the forms engineering complete that require them to review the BOS & SPC charts and discuss warranty issues with Quality ? Para 7.5.1.1. seems to require measurables.

(In my place of work we design add-ons for vehicles, sub the manufacturing and then we fit those parts upon reciept. The parts we make are very low volume e.g. 5 cages for police dog vehicles in a month)

Thanks in anticipation,
Anthonyl

:confused:

We had a non-conformance logged following a TS16949 Stage 2 audit.
Engineering assure me that they considered warranty/historical issues but neglected to tick a box on the Feasibility Review form. I.e. no evidence. Our auditor wants to see a control plan in place for the APQP process before recommending our qualification for the standard.
Does anyone have an example of a Control Plan for the Customer Order Progression Process and/or APQP. At this stage in the process I cannot see how we can define measurables and have got a mental block or am having a senior moment as my partner would describe it?
The problem is that I cannot think of the measurables I would detail at this stage in the production process. We are not manufacturing parts but considering history & feasibility.
Do I just detail the process and the forms engineering complete that require them to review the BOS & SPC charts and discuss warranty issues with Quality ? Para 7.5.1.1. seems to require measurables.

(In my place of work we design add-ons for vehicles, sub the manufacturing and then we fit those parts upon reciept. The parts we make are very low volume e.g. 5 cages for police dog vehicles in a month)

Thanks in anticipation,
Anthonyl

It helps immensely in answering questions about audit findings if you can post the exact wording of the finding, including the auditor's citation of the part of the standard that was (allegedly) violated.

16949 does not include requirements for control plans for business processes--control plan requirements are applicable to manufacturing processes--thus your statement that that the auditor " ...wants to see a control plan in place for the APQP process..." leads me to believe that the auditor is asking for something that isn't required.

Thank you Jim,
I am new to this as you have gathered.
BSI auditor remarks were as follows:-

The process for the flow of information from the PFMEA to control plan fails to capture all actions (Para7.5.1.1 quoted)

then.....

The organisation shall have a control plan for pre-launch and production that takes into account the design FMEA ........etc.

We did not have a control plan for the pre-launch just production so when the FMEA is completed the engineers just tick boxes and take appropriate actions as in APQP. Hence my question.

Thank you Jim,
I am new to this as you have gathered.
BSI auditor remarks were as follows:-

The process for the flow of information from the PFMEA to control plan fails to capture all actions (Para7.5.1.1 quoted)

then.....

The organisation shall have a control plan for pre-launch and production that takes into account the design FMEA ........etc.

We did not have a control plan for the pre-launch just production so when the FMEA is completed the engineers just tick boxes and take appropriate actions as in APQP. Hence my question.

So the finding was for lack of a pre-launch CP for a certain product? I'm still having trouble understanding what your question is. If my question about the finding is correct, you'll need to explain (in answering the finding) what's been done about the specific problem, and what's been done to prevent it from happening again.

It appears that you don't have a DFMEA in place, however you are designing vehicle add ons, anyone designing anything must have a DFMEA which usually provides the metrics for a control plan. There must be some type of decison gates in the design life cycle that would include some type of simulation or characterization metrics for the DFMEA and control plan. I am new at this too and could be way off, but as soon as I hear the word design, DFMEA pops up right away and it sounds as though you only have a PFMEA after the fact. Am I as clear as mud? ;)

It appears that you don't have a DFMEA in place, however you are designing vehicle add ons, anyone designing anything must have a DFMEA which usually provides the metrics for a control plan.

Product (not process, usually) specifications are part of DFMEA output, and the DFMEA should be used as PFMEA input, but the control plan is not normally considered part of DFMEA output--it comes after the PFMEA in the APQP process.

We've had to show the evaluation methods/controls for design characteristics in the DFMEA correlated and (transferred) to the PFMEA and Control plan. In other words, the outputs of the design fema were the inputs for the process fema which in turn transfered to the control plans.

We've had to show the evaluation methods/controls for design characteristics in the DFMEA correlated and (transferred) to the PFMEA and Control plan. In other words, the outputs of the design fema were the inputs for the process fema which in turn transfered to the control plans.

In most instances, PFMEAs and control plans done by suppliers are done without ever seeing a DFMEA, and are based solely on specifications. As you suggest, the process might be different for design-responsible companies who will naturally have access to their own DFMEAs. In those cases there should be some measure of continuity.

Just taking into account the finding, "The organisation shall have a control plan for pre-launch and production that takes into account the design FMEA ........etc." Sounds an awful lot like the auditor wants a control plan at the DFMEA level and the PFMEA level. Currently we are only pre TS 16949 and do control plans whereever a customer wants one. So I am used to seeing them growing in the wild.

Just taking into account the finding, "The organisation shall have a control plan for pre-launch and production that takes into account the design FMEA ........etc." Sounds an awful lot like the auditor wants a control plan at the DFMEA level and the PFMEA level. Currently we are only pre TS 16949 and do control plans whereever a customer wants one. So I am used to seeing them growing in the wild.

Well, there should be pre-launch and production control plans (actually it's possible for the document to remain unchanged through each stage, except for the designation). When the standard says (in 7.5.1.1) that the control plan must take "...into account the design FMEA and manufacturing process FMEA outputs," it doesn't necessarily mean that the production control plan must somehow directly reflect DFMEA output. It means that there should be a traceable, logical progression from the DFMEA to the specifications to the PFMEA to the control plan.

From Anthonyl (by e-mail):

Thanks for the advise Jim. Apart from the resolution to problem with the pre launch CP and the preventative actions our understanding of what was required was that we needed a CP that covered the process of deciding whether we would take on a customer order or not. I think that the real answer is for me to contact the auditor as I am also unclear as too what he really is after. The remarks are, to me, open to interpretation. Thank you anyway.

From Anthonyl (by e-mail):

Thanks for the advise Jim. Apart from the resolution to problem with the pre launch CP and the preventative actions our understanding of what was required was that we needed a CP that covered the process of deciding whether we would take on a customer order or not. I think that the real answer is for me to contact the auditor as I am also unclear as too what he really is after. The remarks are, to me, open to interpretation. Thank you anyway.

It sounds like the auditor is confused. What he seems to be saying is that you need some means of control over the contract review process, which is not the same thing as a "control plan" as it's described in the standard.

Boy you lot know your stuff. Thank you all for your help and input.

In this case we had no design input, we rarely do, we are simply adding customer supplied product onto their vehicle.

To answer our auditor our engineering dept. have raised a PFMEA & Production Control Plan and we have revised our feasibility review questionnaire to include this requirement for future projects and obviously reflected the process changes in the flow maps and document records. (in addition to what was already in place)

I've learnt a lot reading your mail and it makes me appreciate how simple my life is in not having to work with parts per million nor design to a large extent. Our normal order may be for anywhere from 1 - 200 conversions. We might simply have to design a bracket to guard cables leading to a light cluster on 1 vehicle for instance and even with the QS9000 this could lead to protracted discussions with our auditor with regard to time, expense etc.

My difficulty is in complying with the requirements of the standard, that incidently our customer tell us we must have before we can do business with them. If your trying to encourage your smaller suppliers to go for ISO9001:2000, as I now have too, you will know just how frustrating that can be. I.e. We are going for it because we have too. Having said that there is no denying there are benefits to our business. It is just difficult for us to fit the mold.

Thank you all again,
Anthonyl

It is just difficult for us to fit the mold.

But as a boss of mine used to be fond of saying, "If it were easy, anyone could do it.":D

Thank you all again,


You're welcome:agree1:

Boy you lot know your stuff. Thank you all for your help and input.

In this case we had no design input, we rarely do, we are simply adding customer supplied product onto their vehicle.

To answer our auditor our engineering dept. have raised a PFMEA & Production Control Plan and we have revised our feasibility review questionnaire to include this requirement for future projects and obviously reflected the process changes in the flow maps and document records. (in addition to what was already in place)

I've learnt a lot reading your mail and it makes me appreciate how simple my life is in not having to work with parts per million nor design to a large extent. Our normal order may be for anywhere from 1 - 200 conversions. We might simply have to design a bracket to guard cables leading to a light cluster on 1 vehicle for instance and even with the QS9000 this could lead to protracted discussions with our auditor with regard to time, expense etc.

My difficulty is in complying with the requirements of the standard, that incidently our customer tell us we must have before we can do business with them. If your trying to encourage your smaller suppliers to go for ISO9001:2000, as I now have too, you will know just how frustrating that can be. I.e. We going for it because we have too. Having said that there is no denying there are benefits to our business. It is just difficult for us to fit the mold.

Thank you all again,
Anthonyl

It seems to me the auditors was looking for evidence that you have control plansfor both Pre-launch and production stage. PFMEA should be available too for both pre-launch and production stage.

Johnson :bigwave: