Can you exclude ISO 9001 Clause 7.3 completely from QMS?

[lrsiyer]

Hi!

I am a quality enigneer in an automobile facility. I have a basic doubt. I get drawing from my OEM for making components. I make components as per drawing. Initially the customer approves the process and product (PPAP) and I carry on with production. Am I not responsible to validate the process and product as per the drawing and PPAP? Am I not responsible to determine the criteria when should I validate the process and product?

My question is in one way or other organisation is involved in proving the design either during the developement stage or during the PPAP stage, in such times is it possible to exclude 7.3 completely?

 

[Howard Atkins]

Hi!

I am a quality enigneer in an automobile facility. I have a basic doubt. I get drawing from my OEM for making components. I make components as per drawing. Initially the customer approves the process and product (PPAP) and I carry on with production. Am I not responsible to validate the process and product as per the drawing and PPAP? Am I not responsible to determine the criteria when should I validate the process and product?

My question is in one way or other organisation is involved in proving the design either during the developement stage or during the PPAP stage, in such times is it possible to exclude 7.3 completely?

If you are talking about ISO 9001 then you can but if it is ISO/TS then you can't.
You design the process and the PPAP that you submit is in fact the validation of that process. The criteria to validate the process is the customer requirements.

 

[lrsiyer]

Hi!

If that is the case we all talk much about customer requirements loud in 9K. One of the requirements is PPAP. I need to make and implement the PPAP in the production process and include the same in 9K also. Now it becomes automatically applicaple for 9K also?

 

[Helmut Jilling]

Hi!

If that is the case we all talk much about customer requirements loud in 9K. One of the requirements is PPAP. I need to make and implement the PPAP in the production process and include the same in 9K also. Now it becomes automatically applicaple for 9K also?

Remember, PPAP is a specific format for product validation and approval. It is a customer specific requirement of certain customers. Otherwise, ISO only requires product validation and approval in an appropriate format. The process also becomes validated during this activity, by default.

 

[Howard Atkins]

Hi!

If that is the case we all talk much about customer requirements loud in 9K. One of the requirements is PPAP. I need to make and implement the PPAP in the production process and include the same in 9K also. Now it becomes automatically applicaple for 9K also?

You only perform PPAP once and document it once.
If you have ISO 9001 then it does not need to be in the QMS but if you want ISO/TS 16949 then 7.3 must apply to process development.
Whether it is excluded or not in the QMS in practice you do develop and design the process.

 

[potdar]

Hi!

If that is the case we all talk much about customer requirements loud in 9K. One of the requirements is PPAP. I need to make and implement the PPAP in the production process and include the same in 9K also. Now it becomes automatically applicaple for 9K also?

In 9K if your normal scope of activity does not include 7.3, you can very well claim exemption. Meeting customer specific requirements is a separate issue. After you have your system up and going, defined, certified if a customer asks you to stand on your head or do a samba; and you agree; you do it. You dont even bother to modify your QMS for this purpose - just demonstrate that the requirements are effectively communicated and met.

However, if all your customers are automotive and you plan to include PPAP as a part of your QMS, then obviously your system does consist of 7.3. No exemptions.

 

[fireonce]

If you are talking about ISO 9001 then you can but if it is ISO/TS then you can't.
You design the process and the PPAP that you submit is in fact the validation of that process. The criteria to validate the process is the customer requirements.

Yes,I think so.

 

[lrsiyer]

Dear Potdar,

Now the question is not automobile client or non automobile client. When the standard is taking about customer equirements (stated and implied), one has to implement the PPAP as the part of QMS.
One cannot seperate meeting customer requirements from QMS since the primary objective of QMS is same(That is what I understand). If you don't do samba before certification by implementing 7.3 and PPAP requirements then aim for deep dive.
I hpoe my understanding is clear and you also agree with me?

 

[lrsiyer]

Dear Howard,

PPAP is done once. I agree. You give a confidence to your customer that the processes are designed in such a way that product shall be measured and conforming product shall be produced at the end of the process.
PPAP criteria says whenever there is a change in design, material, man, machine (which includes capital overhaul), and methods the PPAP needs to be validated apart from routine validation.
More over you cannot seperate customer requirements from the QMS. If one of the requirements is PPAP and your customer is a TS certified industry then you have to include PPAP in your QMS.

 

[potdar]

Dear Howard,

PPAP is done once. I agree. You give a confidence to your customer that the processes are designed in such a way that product shall be measured and conforming product shall be produced at the end of the process.
PPAP criteria says whenever there is a change in design, material, man, machine (which includes capital overhaul), and methods the PPAP needs to be validated apart from routine validation.
More over you cannot seperate customer requirements from the QMS. If one of the requirements is PPAP and your customer is a TS certified industry then you have to include PPAP in your QMS.

LRS

Firstly, PPAP is not something thats done once and forgotten. You have to keep doing it again and again as and when required.

Secondly, Customer requirements are and will always remain a part of the QMS. But is PPAP a general customer requirement? To decide that you have to look at your scope. i shall explain with an example.

I happen to be a fabricator. I am certified for ISO 9001 as one. I dont design my products. I have claimed 7.3 as an exclusion. Now an automotive customer comes along. He demands a PPAP. I give him one. He approves it. I get the order. I execute it. I get the money. I am happy. My customer is happy.

To give my customer a PPAP I dont modify my QMS. I just ask him what he wants. He tells me. I give it to him. The whole operation is taken care of by my statement in the QMS saying, "I will take care of my customer's requirements (stated and unstated)".

An auditor comes along. He looks at the records. He asks about what exactly I have done while doing this thing called PPAP. The why and how. I show him the guidance I have received from the customer. Some stated, some unstated. I show him the evidence that I have met the customer's requirements not covered in my QMS (this is known in other words as customer specific requirements). I even show him some records of my people being trained by the customer on how to do PPAP and being declared as competent.

You are the auditor. If you believe there is a non-conformance to the system in what I have described, please state it. Remember. I am a fabricator. I am not a fabricator of automotive parts.