TS 16949 - Laboratory Scope - Injection Molding

[giacomo]

Hello everybody.

I am a new member, and an "almost newcomer" to the TS world.

I browsed the forum for some time before registering, and I already know I will spend a lot of time here, but now it's time to pass to active posting!

I start with a simple question, that may have important consequences on my system.

What exactly is included in the definition of "internal lab"?

We are a manufacturing company (injection moulding), we have what we call a lab, with controlled temperature, CMMs, gage blocks, and two trained technicians that spend 100% of their time measuring parts (mainly PPAP phase) and calibrating measuring instruments.

In addition to that we have the various instruments we use at machine side for daily inspections (plug gages, micromoters etc.). Are also this instruments part of the lab? Are machine operators that use those gages part of lab personnel?

Thanks in advance for your help

 

[Douglas E. Purdy]

For What it's worth!

What exactly is included in the definition of "internal lab"?

We are a manufacturing company (injection moulding), we have what we call a lab, with controlled temperature, CMMs, gage blocks, and two trained technicians that spend 100% of their time measuring parts (mainly PPAP phase) and calibrating measuring instruments.

In addition to that we have the various instruments we use at machine side for daily inspections (plug gages, micromoters etc.). Are also this instruments part of the lab? Are machine operators that use those gages part of lab personnel?

Thanks in advance for your help

I cannot answer your questions, but I can share theoretically how I have attempted to help identify / establish internal laboratories for Quality Management Systems. The attached graphic shows how a Pyramid Scheme is used to show the relationship between the two entities, something that I believe is required if one was to establish a laboratory quality management system to ISO 17025. [First suggestion: use ISO 17025 standards in determining / establishing an internal laboratory] Then determine what processes the two entities will share and what processes are unique to the management of the laboratory.

I could share more if this is what you are wanting, just let me know.

Doug

 

[Sidney Vianna]

What exactly is included in the definition of "internal lab"?

We are a manufacturing company (injection moulding), we have what we call a lab, with controlled temperature, CMMs, gage blocks, and two trained technicians that spend 100% of their time measuring parts (mainly PPAP phase) and calibrating measuring instruments.

In addition to that we have the various instruments we use at machine side for daily inspections (plug gages, micromoters etc.). Are also this instruments part of the lab? Are machine operators that use those gages part of lab personnel?

After I read the definition of a laboratory in the TS 16949 document, it is my understanding that what you described as the environmentally (temperature) controled room is your (internal) lab. The instruments and operators working on the shop floor are not part of the lab.
That is my understanding.

 

[MikeL]

Certificate for Customer

I have had a similar situation with two companies. A nice building with people with white coats and similar testing equipment on shop floor.

What we ended up with and agreed with assessor was that the laboratory produced a certificate of quality that went to the customer, all other equipment and testing was process control.

We put together a Laboratory Manual that covered just those tests that appeared on COQ.

 

[Kevin H]

Giacomo - Welcome. I'll agree with the folks who have posted so far. We're registered to ISO/TS through LRQA, and are a bulk material producer. We have a lab that generates c of a's for our customers. Some of the same types of equipment are in use throughout our plant in process control by manufacturing personnel. Our laboratory scope covers the activities in the lab related to generating c of a's. The balance of the testing comes gets covered under process control and calibration, not the lab scope.

 

[giacomo]

Dear all,

thanks for your incredibly fast replies.
I think this approach seems logical to me: the lab is the part of the company that "produces" tests and measurements.
This enlarges a little bit the scope I had initially imagined, but at least excludes 90% of production floor equipment, which in fact will never be used to issue a certificate to the customer.

Of course the matter requires some more thinking from my side, but I have now a better idea of what may be a sound criteria.

 

[Morcs74]

If you dont have an internal lab as such, but for your approvals parts may go to an external lab for testing, then in youre quality manual, it is sufficient to just state that you do not have an internal lab, but you use an external one, put in their details

 

[debbieola]

More than one type of lab

courier new
I have a question about a situation that I have not seen discussed before.
We have two production divisions Safety Systems and Interior Exterior which are each self controlled. Each of these has a "lab" that performs daily measurements. We also have a Performance Testing Lab that does preproduction; PPAP and other part validation. How would we cover all of these groups under ISo17025

 

[Ken K]

Each of these has a "lab" that performs daily measurements.

Could you let us know what these measurements are used for?


As far as the labs go, you can either group them under one certificate or do each separately. Obviously, if you do them separate, your looking at three times the cost. It really depends on which type of testing each lab performs and if you do calibrations in-house.

 

[Kevin H]

Hi Debbie, Welcome to the Cove.
I have to agree with Ken, regarding a little better understanding of how the measurements are being used.
My experience is that ISO/TS 16949 does not require a lab to be certified to ISO Guide 17025, and that only labs providing results to customers may require certificaiton if for example, you had a customer specifically requiring it.

With that said, I felt that certification of the mechanical testing lab I ran at my prior employer to ISO Guide 25 (17025's predecessor) by A2LA did improve our operation. At that location we had 4 laboratories - 3 providing results to customers and 1 providing internal process test results. We chose to have the 3 labs providing test results independently certified. It was a steel mil producing stainless and electrical steels. The certified labs were: Chemical, Mechanical Testing (including Metallography) and Electrical properties. All 4 labs had scopes of testing that were documented within the quality system. We were a tier 1 supplier to the auto industry.

My current employer is registered to ISO/TS 16949, and we are a tier 2 supplier to the auto industry. We have labs at 2 different manufacturing sites, and the scope of the lab tests at each site is covered/addressed by our quality system. Both sites provide data used to prepare certificates of analysis for our customers. We have chosen to certify neither site to ISO Guide 17025.

One other point - for ISO Guide 17025 your assessor/s (A2LA didn't like the term auditor) needs to have practical experience in the test methods/measurements that will be part of the scope of your accreditation. If the 3 labs present an unusaul mix of test methods you might find it hard to find a qualified assessor for them, and it might be easier to go with 3 separate registrations.