Changing material without a granted change request, ISO 9001

[Pudge 72]

PPAP has become a glorified term for items that should be required from any vendor / supplier by an ISO or TS company. It just makes good business sense. If they are not automotive, require the items individually in the PO - Process Flow Diagram, Gage R&R, Control Plan, Capability Studies and FMEA. Big deal - remember PPAP is not really an elusive Automotive wizard guys. These tools should be familiar to anyone who has half a brain in the Quality circle of life.
I have been in the Automotive industry and now have moved on to medical device industry, the terms are different, but the principles always stay the same.

 

[AndyN]

PPAP has become a glorified term for items that should be required from any vendor / supplier by an ISO or TS company. It just makes good business sense. If they are not automotive, require the items individually in the PO - Process Flow Diagram, Gage R&R, Control Plan, Capability Studies and FMEA. Big deal - remember PPAP is not really an elusive Automotive wizard guys. These tools should be familiar to anyone who has half a brain in the Quality circle of life.
I have been in the Automotive industry and now have moved on to medical device industry, the terms are different, but the principles always stay the same.

Agreed! However, one vital point is missing - who's going to pay for the PPAP to be done?..............

Unless an organization is mature (or has 'half a brain, as you put it) about some of these things, then price alone will prevail..............

 

[Stijloor]

PPAP has become a glorified term for items that should be required from any vendor / supplier by an ISO or TS company. It just makes good business sense. If they are not automotive, require the items individually in the PO - Process Flow Diagram, Gage R&R, Control Plan, Capability Studies and FMEA. Big deal - remember PPAP is not really an elusive Automotive wizard guys. These tools should be familiar to anyone who has half a brain in the Quality circle of life.
I have been in the Automotive industry and now have moved on to medical device industry, the terms are different, but the principles always stay the same.

Hello Pudge 72,

Excellent points! You've hit the nail right on the head!

Stijloor.

 

[Stijloor]

Agreed! However, one vital point is missing - who's going to pay for the PPAP to be done?..............

Andy, you know from your audit and training experience that a "smart" company already does most of the things that PPAP requires. The "cost" of providing the evidence (that already should exist) would not be that high. A customer could even ask for electronic transmittals of the required documents.

Just some thoughts....

Stijloor.

 

[Pudge 72]

I can agree with you there - however, I have a bit of a different spin on this than some of my colleagues also.
I have found that a lot of places are charging in excess of $750.00 USD for the "PPAP" Package. However, considering that a Root Cause Analysis and subsequent issued CAR because of poor front end metric identification will usually cost a minumum of 3X more than that. Isn't it worth it to bite the bullet and have yourself armed for battle regardless of who pays for the "PPAP" package? This is my usual justification explanation to management - it has not failed me yet.
My opinion is - make the submission package a culture rather than a cost & incorporate it into qualification of whatever you are submitting to your customer or receiving from your supplier (work with your supplier to understand what is required). In most instances, after doing this, they don't even charge me because they are so happy that the expectations and processes are so well defined!! I found that this gives them a warm fuzzy feeling also, and, in the end - the ROI will be well worth the initial investment of time and resource.

 

[somerqc]

I take some offense to the "half a brain" comment.

Why? As with most quality professionals, I know what a PPAP is and did "practice" ones when doing my training; but, since I avoid the automotive industry (yes, I could make more $$ but my family life is too important to sacrifice) I have not had to do a PPAP since 1999!! Why? It is only recently that non-automotive (or non-aerospace for that matter) have started requiring PPAP's. Why? My customers haven't demanded it yet.

Do I disagree with this movement? No. Just stating that unless you are in the automotive or linked industry the likelihood of needing a PPAP is slim.

John

 

[Pudge 72]

The half - a - brain comment was meant to be an eye opener, not offend.
The other point is - forget the term PPAP. That is all it is - we have become too dependent on acronyms.

Do you do Gage R&R? Do you do FMEA? Do you do Control Plans? Do you do capability studies? Do you make In-Process Inspection Plans and Process Flow Diagrams?

Then you do PPAP!!! People (especially the medical device industry which is where I am at now) think that any term developed in the Automotive Industry or by it is dirty - well, guess what, as much as we can disdain some automotive practices, they have the best system for submission and process definition guys! IQ, OQ, PQ is essentially the same thing in a different industry, and, it still does not match the level of what gets incorporated into a PPAP.
The whole point here is, it is a culture, a system, a by-product of what your business believes, and, we know all of the tools that are utilized, forget the term and worry about the content.

 

[vanputten]

Does 7.2.3 apply to this situation? Did the supplier do 7.2.3a?

Does the organization have a requirement with the supplier to communicate changes? If so,then 5.2 and 6.1b, 7.2.1, 7.2.2, 7.2.3 apply to the supplier.

Regards,

Dirk

 

[chaosweary]

I think the PO is the right way to go. Using ISO 9001 you would be reaching. You don't even need a PPAP if the PO is strong enough. If your PO states you want rev. xx and states no change in form, fit, function, material, design, or mfg location then you could reject the product very easily.

 

[CarolX]

Hi

We have a problem with a supplier with ISO 9000 certification that has made a material change without a granted change request. I am used to TS 16949 from my former work and almost gets allergic reactions to this changes.

Is there anything within the ISO 9000 requirements that I can use to emphasize their wrong doing?

Best regards
Fredrik

Fredrick - really hard to tell from your post. What are you purchasing from this supplier? Who holds design authority is really the question - if you supplier does - not much you can do.

To the rest of the group ----

Please start a new thread if you want to discuss the merits of PPAP. Thanks!!!!!!!!!