PV (Production Validation) test plan responsibility

Mr Skeleton

Starting to get Involved
#1
Hello,

This is my first post here, so want to start with a thank you! I've been using Elsmar Cove since 2002 when I started my 1st (post Uni) job as a graduate quality engineer. Over the years I've never had to post a question - always found the answer I needed with a search. I'm now an STA/SQA Manager for an Automotive OEM and I'm back for some help with a project but can't find what I'm looking for. I know if anyone can help, it's the guys and girls at Elsmar Cove! So thank you for your support and enlightenment over the years and I look forward to hearing your experiences and opinions with my current topic: PV test planning

How to lay this out. I guess my problem statement / customer verbatim is something to the effect of:
"PV test plans are ineffective and inefficient. They are created with little or no respect for the PFMEA and therefor the risk inherent in the process so are ineffective and wasteful".​

This is clearly specific to my situation but I'd hazard a guess that more than a few of you recognise this complaint.

A little more detail:
In my place of work the Lead Product Development Engineer is responsible for setting the DV and PV test plan. The result is normally a PV test plan based on replication of previous plans (photocopy engineering) or just a repeat of DV. My STA seniors are quire happy to leave this to the PD tea but I'm sure I recall, in previous employment (6 years ago now), the STA team created the PV test plan based on PFMEA detection and recommended actions.

I've been reflecting on this for a few years now. I think there would be several benefits to having STA set the PV test plan:
  • PD engineering not able to use PV testing as a "safety blanket" or to "top up" DV testing (pens down boys!)
  • Test plan developed targeting only the risks that can't be controlled to acceptable level through measurement and in-process techniques therefore controlling cost
  • test samples selected with understanding of the process variation factors and risk profile which could improve test effectiveness.
  • Re-validation testing requirements better designed, more clearly understood and justified as part of the PFMEA and CP
This thought experiment rolls on to suggest that DV test planning should be born out of DFMEA but I've not explored that.

Am I on to something? In your experience who's responsibility was PV test planning? Is there / can there ever be a pure link between PFMEA and the PV test plan?

Please wade in with your questions and comments.

Thanks, Mr Skeleton
 
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Jim Wynne

Staff member
Admin
#2
Welcome. :bigwave: It would be a good idea for you to spell out the abbreviations on first use in your post for the benefit of those who might not be familiar with them.

You wrote, "PV test plans are ineffective and inefficient. They are created with little or no respect for the PFMEA and therefor the risk inherent in the process so are ineffective and wasteful". Where did this statement come from? Is it accurate in your view?
 

Mr Skeleton

Starting to get Involved
#3
They are my words :) and yes, that is my firmly held belief from 6 years in STA at an OEM, mainly responsible for trim parts (could be different in other commodity teams).

I feel like I'm the customer when Product Development Engineering are defining the plan and I'm ensuring it is delivered, but they can't tell me on what basis the plan is created only "that's what we did last time".

I've seen many warranty claims (normally early life) where defects should have / could have been found during PV, except the sample wasn't properly designed to represent the variation expected from the process etc.
 

Jim Wynne

Staff member
Admin
#5
They are my words :) and yes, that is my firmly held belief from 6 years in STA at an OEM, mainly responsible for trim parts (could be different in other commodity teams).

I feel like I'm the customer when Product Development Engineering are defining the plan and I'm ensuring it is delivered, but they can't tell me on what basis the plan is created only "that's what we did last time".

I've seen many warranty claims (normally early life) where defects should have / could have been found during PV, except the sample wasn't properly designed to represent the variation expected from the process etc.
Once again, please tell us what the abbreviations in your initial post stand for.
 

Mr Skeleton

Starting to get Involved
#6
Good point about abbreviations (y)

STA / SQA = Supplier Technical Assistance / Supplier Quality Engineer
OEM = Original End manufacturer
PV = Production Validation
DV = Design Verification
PFMEA = Process Failure Mode & Effects Analysis
CP = Control Plan

Yes, I guess I'm a little confused by the meaning of PV :unsure:

I'll check back into my processes a little but what I'm gunning for is a test plan that validates the process - where we wish to improve detection of potential failure modes by gaining confidence that the process delivers important characteristics.

An example : We laminate a cover stock onto a substrate using a robotised spray glue system, with a full form press tool to apply heat and pressure to fix. We can check the glue pattern, the glue flow rate at the nozzle, the time, temp, pressure in the press etc but is the press form good? is the glue coverage consistently acceptable in different production conditions (e.g. when just cleaned, just before cleaning, high humidity, low temp etc)? for these failure modes, we need to test some product... in this way, the PV test plan is informed by the process. So we test the laminate performance (to the design spec std test) but with a sample designed with reference to the PFMEA and the process risks. This is the kind of PV test plan I want
 
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Jim Wynne

Staff member
Admin
#7
In my experience (I worked as a supplier quality engineer for a vehicle manufacturer), the process should go something like this:
  1. Design concept
  2. Manufacturing feasibility
  3. DFMEA
  4. Design documentation (including drawings and specifications)
  5. Prototype development
  6. Design verification
  7. Release to manufacturing.
These steps may be different under different circumstances and in different companies, but the idea is that each step feeds into the next one and #7 doesn't happen until the other six have been successfully completed. Production people, suppliers and just about anyone with significant interest in the project should be involved where appropriate, such that the finished design doesn't just get thrown over the wall by the design people.
 

Jim Wynne

Staff member
Admin
#8
An example : We laminate a cover stock onto a substrate using a robotised spray glue system, with a full form press tool to apply heat and pressure to fix. We can check the glue pattern, the glue flow rate at the nozzle, the time, temp, pressure in the press etc but is the press form good? is the glue coverage consistently acceptable in different production conditions (e.g. when just cleaned, just before cleaning, high humidity, low temp etc)? for these failure modes, we need to test some product... in this way, the PV test plan is informed by the process. So we test the laminate performance (to the design spec std test) but with a sample designed with reference to the PFMEA and the process risks. This is the kind of PV test plan I want
It happens that I have direct experience (working with a tier-one automotive supplier) with the type of process you describe. It's a different from working as the OEM, but the idea is that testing is developed during the design process, not subsequent to it. Not only that, but the proposed testing should be validated before release to manufacturing. I had an awful experience where we were working on a General Motors project and the parts successfully passed all of the prescribed environmental testing. The problem was that one of the tests was not adequate and there was a pretty significant field failure. The operation was a success but the patient died. We should be able to expect that testing adequately represents what the product will "see" in end use. That's a job for the design people.

I don't see this as being an item for the PFMEA--it should be addressed in the DFMEA, or the output of the DFMEA. If there is concern that subsequent manufacturing processing might have an effect on things, that's a different story, but that sort of thing should also be considered in the design phase (#2 in the list I posted earlier).
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#9
DV = Design Verification
Here's where things get dicey with abbreviations - DV = Design Verification, but also can be Design Validation. Thus our query.

First - Responsibilities for anything are always dependent upon the company and how they define them internally.

So we test the laminate performance (to the design spec std test)
This is Design Validation. Design Verification vs. Validation - What is YOUR definition? - Note that for some products design validation can only be done through the actual use of the product, an example of which is elevator cabs.

but is the press form good? is the glue coverage consistently acceptable in different production conditions (e.g. when just cleaned, just before cleaning, high humidity, low temp etc)? for these failure modes, we need to test some product...
This is process validation. In @Jim Wynne 's list, it would be another step - Step 8. (Design Validation would be Prototype testing.) Assuming that's all good, release to production and proceed to Process Validation. That's relatively standard and typically a requirement prior to the actual start of "real" production.

For example - Let's say I have an assembly line for brake cylinder assemblies. First the line is designed. Then the line is built. Usually there is a run-off at the line equipment manufacturers facility to make sure everything works correctly. Then the assembly equipment is shipped to the plant. Another run-off is done after the line is installed. Once that is done, Process Validation is done to prove that the process is capable, whether dimensionally, and/or in your case with respect to performance.

the idea is that each step feeds into the next one and #7 doesn't happen until the other six have been successfully completed.
Well, some times there are things running in parallel with overlap, but in general I agree.
the idea is that testing is developed during the design process
I fully agree.

I don't see this as being an item for the PFMEA--it should be addressed in the DFMEA, or the output of the DFMEA.
Yup - Exactly.

I keep coming back to this recently:

APQP Timeline.jpg

Noting that the DFMEA is an input to the PFMEA.
 

Mr Skeleton

Starting to get Involved
#10
The definition of PV from my business process is "Product Validation testing" but the element of APQP taken from Ford's APQP guideline is "Production Validation Testing". This is relevant because my business's processes are derived from Fords
 
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