If a company is doing some of it's calibration internally, such as calibrating calipers, ofcourse we must know the measurement uncertainty on the calibration proces and also have traceability.
But do we also need a Laboratory Scope, as we are TS16949 certified?

Yes, please see ISO/TS 16949, 7.6.3.1. The first sentnce speaks of the requirement for a defined scope. I am surprised (no, actually, I'm not) that this was not seen on your registration audit.

Yes, please see ISO/TS 16949, 7.6.3.1. The first sentnce speaks of the requirement for a defined scope. I am surprised (no, actually, I'm not) that this was not seen on your registration audit.

Yes, indeed! Ditto the above comments:agree1:
Andy

If a company is doing some of it's calibration internally, such as calibrating calipers, ofcourse we must know the measurement uncertainty on the calibration proces and also have traceability.
But do we also need a Laboratory Scope, as we are TS16949 certified?

What brought you to ask this? Was there a question from an auditor or what?

I'm curious about your specific situation. How long has your company been TS 16949 registered?

Thanks for the fast feedback and interest from you all. My company have been certified since february '06 (I was hired in january to help push things further). Did all calibration external until now, as we do not have a measurement dep. or the like this was the best solution. I started to analyze requirements to our measurement equipment in production. Mapping tolerances, procesvariation, measurement methods and comparing them to the approval limits for calibration. Found out that for calipers, we could ease up requirements if necessary, and do calibration ourselfes if we wanted to (many advantages including flexibility, hands on knowledge and economics). We have not started yet. First have to make calibration procedures, secure traceability, estimate uncertainty and so on..... and make a LAB scope I can see now.

I will rely on others to say whether TS calls the calibration function a lab, but I can tell you with certainty that ANS/ISO/IEC 17025 does consider it a lab.....

If the TS view is the same, then the next question is whether you must seek accreditation.....if so, that comes under ANS/ISO/IEC 17025.....

One word of caution, NEVER put money on an accreditation application until you check with ALL the accrediting bodies!

Oh, as for calibration.....I always recommend having an accredited calibration provider take care of your calibration support.....after all, using Metrology professionals for your calibration is no different than using a machinist to program/run your CNC machine.....and NOT using Metrology professionals is the same as using a non-machinery professional to program/run your CNC machine.....

Hershal

I will rely on others to say whether TS calls the calibration function a lab, but I can tell you with certainty that ANS/ISO/IEC 17025 does consider it a lab.....

If the TS view is the same, then the next question is whether you must seek accreditation.....if so, that comes under ANS/ISO/IEC 17025.....

Hershal:
Happily, ISO/TS 16949 doesn't require accreditation of internal facilities. :cool:

Andy

This may be slightly off topic. But my organisation does inhouse calibration/verification of the simpler items such as Calipers, Micrometers and various gauges, using gauge blocks as a basis. This is included in a lab scope.
Our auditor recently found a minor non-conformance in that there was "No objective evidence of qualification/competence of personel performing in-house calibration" I am the only person in our (small) organisation doing this work. For qualification I can produce suitable Engineering qualifications and measurement experience. But I am not so sure how I can demonstrate competence.

(Moderator, please move response if desired for new thread..)

Gary, there seems to be a littany of posts questioning the finding of auditors. So, I have a couple of questions.

The auditor states no ojective evidence of competence. It seems the auditor should be interested in obtaining evidence of incompetence. To me, there is a difference. Did the auditor observe a problem? Observe a weakness?

1. Do you have procedures of how to calibrate your devices, and training records where individuals are trained? Do you have appropriate traceability?

2. What about a gauge R&R study? Have you performed one?

3. Did the auditor observe (or find documentation) that individuals are not following the procedures, or substantial inconsistency?

There is a middle ground that should be achieved. On one hand, "anybody can do calibrations" is very dangerous, and can lead to problems. On the other, is having everything go to NIST, which is extremely costly with substantial downtime! In practice, many organizations have competent labs to calibrate those items which competency cannot be supported in-house.

I guess I ask you: do you have objective evidence to support the contrary; that you are competent?

Thanks for your reply Brad.
The auditor ( TS16949 by the way) did not seem to be looking at any problem area's when he noticed this and I don't think there were any problems pointing in this direction. He arrived at the question by simply goint through the process. ie "what do you calibrate?", "who does the calibration?"

1. We have procedures for calibration.
2. I would immediately use R&R but it is a bit wishy washy with just one appraiser. Perhaps I could use an analysis of historic results of relatively stable devices.
3. No faults were found with the actual calibrations performed.

My main problem is how to go about demonstrating my competance. Then again maybe not knowing how to do it demonstrates my incompetance.

If a company is doing some of it's calibration internally, such as calibrating calipers, ofcourse we must know the measurement uncertainty on the calibration proces and also have traceability.
But do we also need a Laboratory Scope, as we are TS16949 certified?

Going back to morten's initial query, as its already clarified, a complete lab manual with scope will need to be prepared. But that will be an internal document.

If the discussion is regarding whether lab is required to be included in the scope of TS certification, the answer is NO.

This may be slightly off topic. But my organisation does inhouse calibration/verification of the simpler items such as Calipers, Micrometers and various gauges, using gauge blocks as a basis. This is included in a lab scope.
Our auditor recently found a minor non-conformance in that there was "No objective evidence of qualification/competence of personel performing in-house calibration" I am the only person in our (small) organisation doing this work. For qualification I can produce suitable Engineering qualifications and measurement experience. But I am not so sure how I can demonstrate competence.

The observation of your auditor relates to clause 6.2, rather than clause 7.6 Please go through the clause in detail, starting with
a. have you determined the competence requirement of someone doig calibration. to
c. Have you assessed effectiveness of yourself as a calibrator. to
e. Do you have appropriate records of the actions taken?

In my opinion, THAT is the objective evidence your auditor is looking for.

2. I would immediately use R&R but it is a bit wishy washy with just one appraiser. Perhaps I could use an analysis of historic results of relatively stable devices.
My main problem is how to go about demonstrating my competance. Then again maybe not knowing how to do it demonstrates my incompetance.

Let's see.....I would not do an R&R, I would recommend a thorough uncertainty study which is far more descriptive and tells you about what the actual measurement is doing.

Potdar has a good point about what your auditor is seeking. In the accreditation world as an example, there is competent or not competent (means technically proficient), there is no incompetent. The best thing is to pick up both ANS/ISO/IEC 17025 and measurement uncertainty training.....whether you go for accreditation or not, then you have some evidence of training, and supported by continued records should have more evidence than your auditor needs.

Hope this helps.

Hershal

But do we also need a Laboratory Scope, as we are TS16949 certified?If you are TS registered and you make measurements of ANY kind, you need a scope statement for your internal laboratory. I know this is necessary from personal experience.
Lab Scope:
TS 7.6.3.1: The organization's internal laboratory facility shall have a defined scope that includes its capability to perform the required inspection, test or calibration services.
TS 3.1.5 (Definitions): Laboratory scope: a controlled document containing
-Specific tests, evaluations and calibrations that a laboratory is qualified to perform,
- List of the equipment which it uses to perform the work above, and
- List of methods and standards to which it performs the above.

See this thread (http://elsmar.com/Forums/showthread.php?t=13747), starting at post #10 for a complete breakdown on how to answer a lab scope finding.

Icy do you have a lab scope example that you could share? :D

Ok, more questions for me than answers.

I will take Hershals comment that "incompetent" is not proper lingo in the industry. I will take note of this, and use "not competent". :thanks:

Hershal, are you stating, that given the need to establish uncertainty, that it is better to perform no R&R, than with one person R&R? While the user error should remain fixed (same person), it would seem you could establish the system uncertainty will a little more accuracy (equipment, material, etc.). If this is way off, please correct me.

( ISO / TS 16949 Clause 6.2.2.2 Training )

The organization shall establish and maintain documented procedures for identifying training needs and achieving competence of all personnel performing activities affecting product quality.


I may have a different perspective of this, but an auditor is not Crime Scene Investigation, to keep digging/searching until they find something (there's a dead body; we need to find who dunnit). They audit against a standard, and the organization is compliant or not, to that standard. They were hired by the client to do one thing: audit against what they asked.

Citing "no objective evidence of competence", with no accompanied objective evidence, is not very helpful.

Observing insufficient (or no records) training records, no resume or competency modules of any kind, finding competency gaps in the procedures, etc.; that's evidence to me. But that should be specified in the nonconformance documentation. It should be clear where the lapse occurred; no questions of where to improve.

It's just seems like to be gstewart is having to struggle with a non-conformance that he shouldn't have to be. If the auditor did their job, an individual should not have to go searching for how to respond to a non-conformance. No one should be left wondering.

Actually, I was referring to the usual interpretation of a Gage R&R, my bad in the comment part. The regular R&R will give you what you need for Type A, and so it actually is done. But then you need to go after the Type B uncertainties also. That was what I meant to say.....I should have re-read before I sent. My apologies for the mis-understanding there.

Hope this helps.

Hershal

Sample of our Lab Scope. I removed a few things but most of it is intact. Just include the items Icy mentioned for TS 3.1.5.

Icy do you have a lab scope example that you could share? :DBad, qualityboi, we weren't paying attention in class today:D
To repeat:
See this thread, starting at post #10 for a complete breakdown on how to answer a lab scope finding. (http://elsmar.com/Forums/showthread.php?t=13747) Any entire lab scope is developed from scratch with comments from other Covers. It just doesn't get any better than that.

Thanks this works! By the way what does PDCP stand for?

Thanks this works! By the way what does PDCP stand for?Product Development Control Process. We already had a long-standing process in place to cover the Product Realization stuff in the 7.1, 7.2, & 7.3 sections of 9k2k before we started the registration process. It's far more detailed and also covers us for TS16949. Rather that rewrite it to fit the standard(s), our procedures manual is shot through with references to "the PDCP" so that auditors can connect the dots.

P.S. - I see by your signature that the second time usually works!:lol:

Icy you seem pretty knowledgeable concerning the labs portion of the TS. What does this line mean?


The laboratory shall be accredited to ISO/IEC 17025 or national equivalent.

I know what the first part means, but what is "national equivalent" do you have an example?

Never mind I found this here: http://elsmar.com/Forums/showthread.php?t=12094

Look, guys, let us understand this.....even though EVERYONE knows I support using accredited calibration laboratories..... LET'S GET REAL..... If the standard does not require it, it does not require it - SO - If you consider this a need for an accredited lab - THEN - The requirement is for a laboratory accredited to ANS/ISO/IEC 17025 by an accrediting body recognized by ILAC.....

That means IAS, NVLAP, SCC/CLAS, EMA.....

Any more detailed questions in that respect, then off-line message me......

Hershal

TS16949 references to look at ISO 10012 'Measurement Management System"
Within ISO10012 it recommends that outsourced calibration be 17025 accreditated. the key word is "Recommends"

Please note that ISO10012 has a 2003 verision


Ford Motor issued a letter November 2003
"Commerical/Independent calibration labs shall be approved prior to use. The acceptance criteria should be based on ISO/IEC 17025 or National Equivalent" which would be ANSI/NCSL Z540 for the USA.

Hi guys, :thanx:
thank you very much for sharing inputs on Company Internal Calibration, as I am starting to create procedures for this.
Again, thank you very much.
best regards,
raffy :cool: