Non-conformance logged following a TS16949 Stage 2 audit - APQP Control Plan

[Anthonyl]

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

 

[Jim Wynne]

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.

 

[Anthonyl]

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.

 

[Jim Wynne]

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.

 

[qualityboi]

Product Design is the key

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?

 

[Jim Wynne]

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.

 

[sblair]

Outputs

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.

 

[Jim Wynne]

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.

 

[qualityboi]

Control Plans

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.

 

[Jim Wynne]

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.