Qualified Laboratory Documentation and Customer Specific Requirements

Hi Ladies & Gentlemen,

I need help.

This is my first time doing a PPAP documentation.

What do you think I should put into the section titled "Qualified Laboratory Documentation" and "Customer-Specific Requirements"?

Please enlightened me.

For the section Qualified Laboratory Documentation, We don't really have laboratories. Its just some measuring and testing equipments in a room. Should I have some documents of the equipments to be in the section?

As for the section Customer Specific Requirements, is it on the product specifications/requirements itself? or the customer's company requirements?

Thanks in advance for your help!

Hi Toffee and welcome to the Cove

"Qualified Laboratory Documentation" , I would think, would be stuff like your Certificate of Registration (QS, TS, or ISO), any required certifications and Scopes of Accredtation for testing of your product by outside labs, any material or testing specifications and their results. I would put my material certification and the Restricted & Reportable Substances report in this "section" as well.

"Customer Specific Requirements" - I don't have a specific "section" in my PPAP submissions for this. Typically, they are found in the Supplier Quality Manual (or some such document issued by your customer) and the requirements are dispersed throughout the "sections" in my submission booklet (I have 13 "sections" - pretty much based on the list in the AIAG PPAP manual (3rd ed.) on page 16.

Hope that helps you out a little,

Bill

Hi Bill,

I'm really apprecative of your advise.

Does that mean that in your PPAP booklet, you have leave out the last section (Customer Specifec Requirements)?

Do you think my PPAP will be rejected if I leave out Qualified Laboratory Documentation and Customer Specific Requirements?

The main problem is that this project is actually thru an agent. I have no chance to actually communicate with the customer regarding the PPAP requirements. Everything questions I put forward, will be thru this agent and this agent is not very responive. Therefore, I will need to go thru all this by myself....

Looking forward to your advise.

Best Regards

Poky

hello ,
for customer specific requirements, all are based on which customer and what level of submission , is it interim level , initial and or specific change , and if you are involve in IMDS submision also, ??
about qualified labs the requirements are very clear, if you are doing the dimensional result internally in your lab., your tooling and fixture you are using to validate the result shall be certify with traceable standards or the institution is certified by rab with ISO 17025 or A2LA,however if you need anything in specific i'll be happy to help you

In QS9000 , the QS9000 certification gives you the right to use your own facilities for your own products without any further qualification.
In general the Laboratory clause in PPAP is for external laboratories.
If you do not use external labs then you do not need this.

I think the question is what is a lab. For your own measurement and testing I think that this is not a Lab in the meaning of the standards. We tend to use the word Lab when we mean a measuring facility.

Customer specifics, the booklet for PPAP refers specificaly to Section II, and inmy opionion refers to the parts or the PPAP only.

Toffee

I don't understand "thru an agent". Does that mean the agent is your customer?

Do you think my PPAP will be rejected if I leave out Qualified Laboratory Documentation

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If you don't get rejected, you could probably expect a delay in an approval until you get the documentation. Most customers are not very flexible on this point.

Here is what my submissions "look like" with the 13 sections:
Cover Sheet - explains, briefly, what the submission is for.

PPAP Checklist - I use a generic list unless a customer has a specific one they want used.

Part Submission Warrant - As implied this has the PSW. I also put any interim and deviation requests here, "behind" the PSW.

Design Record - All part drawings and any customer approved deviations that may be in affect.

Dimensional Results sheets

Process Flow Diagram

PFMEA

Control Plan(s)

Gage R&Rs - On all gages or types of gages used in the Control Plan.

Capability Studies - Summary page, Histograms, Control Charts, Data page.

Test Results - Lab and Mat'l Certs - This is my "catch-all" section. I start off with Chemical certification, "Restricted and Reportable Substances" report (in the customer's format - might be just an IMDS reference number), any Test Results we are responsible for, our Certificate of Registration to TS, copies of any/all specifications/procedures referenced on part drawings. If I have any components we assemble into our castings, their PPAP info is in this section. Required information regarding any outside services (impregnation, painting, heat treating, etc.) is in this section, also. Sometimes these outside services (as well as, a component supplier) need to use an outside laboratory to meet some of the requirements. Those accreditations are put in this section, also.

Appearance Approval Report - If not required, I put a piece of paper in stating so.

DFMEA - This always has a piece of paper stating "Not Required" (if I use the tab) as I don't get DFMEAs from my customers.

This is just my approach to PPAP submissions and has worked very well with all my customers. More and more customers are requiring Run@Rates included in submissions (even for replacement tooling). I will normally "white out" the DFMEA tab and relabel as Run@Rate with the results in there.

Bill

Thanks Gentlemen for your valuable advice.

Bill > Thru an agent. In another words, they are kinda like middleman.

I have just received a checklist from this customer. Please advise your thoughts on my attachment.

Must I have every applicable item in 'ok' status? Will any items that fall in red results my PPAP to be rejected?

AS can be seen from the form attached by you there is a column N/A.
For example

number 80
If minority owned business, copy of MMBDC certificate or equivalent?

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I don't know if you are but it does not matter,if you are not put N/A and it is OK, except if there was a customer requirement that you are
If your part is not defined as an appearance part again N/A.
To return to your laboratory problems, if you are QS then all testing that you did yourself is OK.
If you used an outside Lab then you have to show that it is qualified.

If you are worried, and even if not, I recommend talking to the customer, as you said this is through the agent, the agent should be as interested as you for the PPAP to be approved, try to use leaverage from the marketing people.

Well, to be frank, I'm really worried and pressured by this. I starting to have sleepless nites!

Under my customer's checklist, do you think I should submit the section "checking aids". I understand from the PPAP manual that it is not required to submit to my customer but to actually retained at my location.

Best Regards

Toffee,
They say exactly what they want:

Have job instructions been included in PPAP?
Documentation showing engineering sign-off on all tooling and gaging?
Have gage instructions been included in PPAP?
Have predictive maintenance procedures or plan been included in PPAP?

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You should have these documents and they want to see them.
You don't need to send the gauge.
I would suggest that you also submit drawings.

Try to get some sleep, or cause others to lose sleep as well