Help,

I always love when I get a new SQA from my customer! We recently submitted a new PPAP for approval and the SQA rejected it because he said we did not submit a lab scope (no phone call just rejection, nice).

I have to admit I'm confused, we are not A2LA or ISO 17025 certified and the only thing we do in our lab/QA inspection area is measurements and minor calibrations on hand tools with NIST traceable gage blocks/pins etc.

So what in the world do I need to submit? I asked what he was looking for and he said "our lab scope". Technically we are not a lab even though we refer to our inspection room as our QA Lab.

Anyone have any ideas?

Help,

I always love when I get a new SQA from my customer! We recently submitted a new PPAP for approval and the SQA rejected it because he said we did not submit a lab scope (no phone call just rejection, nice).

I have to admit I'm confused, we are not A2LA or ISO 17025 certified and the only thing we do in our lab/QA inspection area is measurements and minor calibrations on hand tools with NIST traceable gage blocks/pins etc.

So what in the world do I need to submit? I asked what he was looking for and he said "our lab scope". Technically we are not a lab even though we refer to our inspection room as our QA Lab.

Anyone have any ideas?

The AIAG PPAP manual, 4th Edition, page 10 (2..2.12 Qualified Laboratory Documentation) says, in part:
Inspection and testing for PPAP shall be performed by a qualified laboratory as defined by customer requirements (e.g., an accredited laboratory). The qualified laboratory (internal or external to the organization) shall have a laboratory scope and documentation showing that the laboratory is qualified for the type of measurements or tests conducted. Emphasis in the original.

Does your customer have a documented requirement for PPAP testing/inspection to be performed by a "qualified laboratory"? If so, then you're obliged to meet the requirements. If not, then you need to ask your SQA to refer you to the source of the requirement he's trying to hold you to.

You didn't say if you were TS 16949, but it also requires you to have a lab scope. 7.6.3.1

We are TS registered. They do not require us to be a certified lab.

I'm just don't know what he wants when he says lab scope.

We are TS registered. They do not require us to be a certified lab.

I'm just don't know what he wants when he says lab scope.

Ask him where the requirement is documented.

Please read TS169449 section 3.1.4 and 3.1.5.

We developed these because we have in house calibration, and off line physical testing. Not hard to do, you don't need to be certified to any other standard. This has been discussed here in the 'Cove" in the last few days

7.6.3.1
An organization's internal lab. facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services.

Now, most of our customers do not require that we submit the lab scope, but if your customer wants it as part of their requirement, and your TS certified, you should have one, to meet the above requirement.

What concerns me more is Ralph's comment. Does an internal lab that does testing (reliability) and calibration need to have ISO17025 if the customer requirements state "the supplier shall follow or align to the AIAG blue book requirements"?

What concerns me more is Ralph's comment. Does an internal lab that does testing (reliability) and calibration need to have ISO17025 if the customer requirements state "the supplier shall follow or align to the AIAG blue book requirements"?

Does your customer actually say "...AIAG blue book requirements"? Like I said earlier, the PPAP "blue book" says that "Inspection and testing for PPAP shall be performed by a qualified laboratory as defined by customer requirements..." (Emphasis added). If the customer requirements don't define requirements for laboratory qualification, then there are no requirements as far as PPAP is concerned.

What concerns me more is Ralph's comment. Does an internal lab that does testing (reliability) and calibration need to have ISO17025 if the customer requirements state "the supplier shall follow or align to the AIAG blue book requirements"?


I don't recall anything in the AIAG blue books that requires your internal lab to conform to ISO17025. When I first went thru QS9000 and the blue books, the registrar stated that we needed an interrnal lab scope because we did off line testing. Currently our physical test lab for the heat treat dept. is required to conform to Ford WHTX, and the new CQI-9.

So if we don't have to be certified then what do have to say.

That the scope of my lab has the equipment that has the capability of measuring product within your specified blueprint requirements?

Strange, I was going to attach a copy of our internal lab scope as an example for you but the "attach files" option isn't available. If you still need an example, send me a private message and I will send it to you.

Dave

[QUOTE=jkittle;179335]
I have to admit I'm confused, we are not A2LA or ISO 17025 certified and the only thing we do in our lab/QA inspection area is measurements and minor calibrations on hand tools with NIST traceable gage blocks/pins etc.

QUOTE]

One other point.....the folks here have much better answers regarding TS, so I defer to them.....

But don't confuse accreditation to ANS/ISO/IEC 17025 as being the same as accredited by A2LA.....

ANS/ISO/IEC 17025 is an accreditation Standard, A2LA is an organization, and one of several that offers that accreditation in the U.S.

Hope this helps.

Hershal

So what in the world do I need to submit? I asked what he was looking for and he said "our lab scope". Technically we are not a lab even though we refer to our inspection room as our QA Lab. Anyone have any ideas?

Attached is the form we use to answer the "lab scope" issue. Competency requirements are defined in personnel training records. First, we identified all our lab equipment, then defined which tests were performed. The procedure says (I have removed bullet 1 from the attachment):

At a minimum, each laboratory scope includes the following information:

title and location of the laboratory in which the scope applies.
specific tests, evaluations, and calibrations that the laboratory has the ability and competency to perform.
identification of the equipment used to conduct the defined tests and calibrations.
identification of the standards and methods used to perform the defined tests and calibrations.

You could add a column to identify the instruction for that specific test. We didn't as everything is electronically linked.

I copy pasted our internal lab scope so you can se what we have used for TS
I could not attache it due to our fire wall, so it is a little out of alignment ,but you can get the basics below:

1.0 INTERNAL LABORATORY SCOPE

2.0 SCOPE:
This procedure is to define the Internal Laboratory Scope
3.0 QUALITY PROCEDURE:
Heat Treat Laboratory Scope – Ref. Clause 7.6.3.1
Technical Capability:
Feature measured Range Equipment
Inclusion Content Pax analysis tools Leeco Software
Grain size 50,100,200,400 Olympus PME-3
Fiber flow Visual Metallograph
Microstructure 5x, 10x, 20x, 40x Objective Lens
Surface hardness HRB & HRC scales Mitutoyo ARK-600
Core hardness convert to all scales Mitutoyo ATK-F2000
Effective Case Depth HV Indention traverse to HV 513 Leco 300AT
Indirect surface hardness convert to all scales FM700
All testing equipment and performed tests are in compliance with applicable ASTM, HES and W-HTX standards. Reference standards are as follows:
• ASTM E-112 Determine Grain Size ASTM E-407 Micro etching Metals and Alloys
• ASTM E3-01 Preparation of Metallographic Specimens ASTM E92-82 Vickers Hardness of Metallic Materials
• ASTM E140-02 Conversion Tables ASTM E2014-99 Metallographic Laboratory Safety
• HES C 008-99 Steels Machine Use HES A 0001-99A Hardness Conversion Table
• HES A 1010-99A Hardness Meter Selection Standards HES A 3013-91 Heat Treatment
• HES A 3014-99A Standards for Carburized Hardening of Case Hardened Steel
• HES C 001-99 Hardness and Structure Standards for steel Normalizing and Annealing
• HES C 006-01 Steels for Machine use JIS G 0553 Macrostructure Detecting for steel
• Q101 Ford Quality Standard W-HTX -1 Ford Manufacturing Standard
• W-HTX-12 Ford Manufacturing Standard SAE J423 Measuring of Case Depth
• SAE J864 Testing with files ISO 1024 Hardness Testing
• ISO 4970 Determination of Total and Effective Case ISO 6508 Testing materials
• ISO 2639 Determination and Verification of the effective depth of carburized and hardened cases.
_____________________________________________________________________
Calibrations and Master Verification:
Annual calibrations and daily master verifications are performed as specified in:
• ASTM E-18 for Rockwell testers
• ASTM E-384 for microvickers testers
• ASTM E-1951 for microscopes
All hardness measuring devices are verified daily by the use of N.I.S.T. traceable standard blocks.
Daily verifications are logged in Master Verification Log Book in Heat Treat department.
M.S.C. Heat Treat laboratory uses a certified inspector for annual calibration of all optical measuring
devices. Leco optical service calibrations are accredited to ISO 17025 by A2LA.Calibration records and Laboratory scopes for external lab are kept on file in the Gage Control section of Quality Control.
Test Methods and Specifications:
All characteristics tested have guidelines and specifications provided in the customer drawings located in the Quality Control area and listed on Operator Process Instructions.
Personnel trained on the operation of testing equipment are specified in the Heat Treat department Training Skill Map Matrix.


Quality Control Dimensional Laboratory Scope

Technical Capability:
Feature measured Equipment
All dimensional checks Mitutoyo CMM
Crysta- Appex-C
Contours, Angles, Radius Mitutoyo Form Tracer
Surface Roughness


Basic Dimensional measuring

Calipers
Micrometers
Gleason
Height Gauges
Dial Indicators


Calibrations and Master Verification:

All testing equipment and performed annually and tests are in compliance with ISO 10360-2:2001 –National Institute of Standards and Technology.


Test Methods and Specifications:
All characteristics tested have guidelines and specifications provided in the customer drawings located in the Quality Control area and listed on Operator Process Instructions.
Personnel trained on the operation of testing equipment are specified in the QC department Training Skill Map Matrix.

Thanks everyone I think I've got it now.

This site is great; there is so much experience here

A lab scope is not difficult to construct. I used excel - and I went a couple of steps above what was really needed to make it a living working document.
It tells anyone who cares to look: gage types, accuracies, calibration frequencies, if they are outsourced or done internally, if internally - what is used to perform the calibration, if outsourced - who is approved and accredited, is the outsource an OEM etc. I also added a code for additional information such as: "gage is replaced at this frequency" or "non-production gage" (which explains why there is a larger frequency).
I have taken most of our gages out (left a few commone types) and also removed our supplier names so that I could attach a brief sample for you.
Feel free to modify and use according to your needs if you'd like.

I hope you find this helpful.
Jane