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IATF 16949 M&TE Laboratory scope

#1
Hi all, during last IATF audit, our auditor identified that our M & TE lab scope (created several years ago) did not refer to any national standards with regards to internal verification or usage of M & TE. The Lab Scope in it's current form includes M & TE called out on our Quality Plan but also includes numerous other M & TE in-house but not used in mass production. These "other" M & TE might only be used by R & D or in some sort of investigative fashion. Since IATF primarily focuses on Mas Pro requirements (Quality Plans, etc.) should we/can we remove the M & TE items not listed on our Mass Pro Quality Documentation? I appreciate everyone's thoughts.
 
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malasuerte

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#2
Just to clarify, Are you Design responsible?

Regardless, I guess I would ask what is the problem you would like to solve here?

It seems you are asking to remove the requirements/documentation for equipment used in R&D? Why? That doesn't sound like it solves a problem.

However, the idea that M&TE for design is not subject to the standard or as you say "focuses on Mas pro....", does not seem right. It seems, any M&TE used would be in scope. Although, some equip. could be "For Reference Only".

Hence, I don't think it would be correct to just 'scope out' the equip. used on the R&D side of the house.

----------

Ok...Now I will take a stab at what may be the actual problem. Problem Statement: In the audit, a non-conformance was written because the lab scope did not reference the standards used by your labs. Is this correct?

If so, why don't you just revise the Lab Scope to provide how M&TE 'aligns' to some sort of standard? The problem is not a HVM vs.. R&D - it is simply that the scope statement doesn't explain what standards are used.

71531 says "...national or international standard...OR....the organization shall define...."
 
#3
Thanks for responding. We are not design responsible. Many IATF auditors are currently scrutinizing the compliance of Lab Scopes to the 17025 standard. Previous years that has not been the case as much. Most 17025 compliant labs are independent testing or calibration labs. Our internal lab is merely to support the manufacturing processes within our facility. The IATF standard normally addresses M & TE that is used to verify manufactured parts compliance to specifications. These M & TE are identified on the Quality Control Plan which is the "procedure" on how to manufacture good parts. R&D M & TE is not used to verify Mass Production parts. If R & D has a particular test that they have designed it may not necessarily match an ASTM or other standardized test method, therefore it is difficult to identify a standard as matching the particular test. We are merely trying to have a lab scope to satisfy the IATF standard but is not inclusive of unnecessary documentation. If you identify an ASTM or similar standard on your scope you must have the standard which can get extremely costly. There are no problems with who we use for calibrations....all are 17025 accreduted.
 

malasuerte

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#4
Thanks for responding. We are not design responsible. Many IATF auditors are currently scrutinizing the compliance of Lab Scopes to the 17025 standard. Previous years that has not been the case as much. Most 17025 compliant labs are independent testing or calibration labs. Our internal lab is merely to support the manufacturing processes within our facility. The IATF standard normally addresses M & TE that is used to verify manufactured parts compliance to specifications. These M & TE are identified on the Quality Control Plan which is the "procedure" on how to manufacture good parts. R&D M & TE is not used to verify Mass Production parts. If R & D has a particular test that they have designed it may not necessarily match an ASTM or other standardized test method, therefore it is difficult to identify a standard as matching the particular test. We are merely trying to have a lab scope to satisfy the IATF standard but is not inclusive of unnecessary documentation. If you identify an ASTM or similar standard on your scope you must have the standard which can get extremely costly. There are no problems with who we use for calibrations....all are 17025 accreduted.

Sorry....I may be confusing things here. The clause is pretty clear; it is one of the better clauses detailing what is required. The auditor "scrutinizing" the Lab scope is irrelevant. The requirements are clear and in 'D' it clearly states the options. Your Internal Lab does not need to be 17025 compliant; however, if it is not, you must have the documentation of your methodology and of course, it needs to make sense.

An organization's internal laboratory facility shall have defined scope that includes its capability to perform the required inspection, test, or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement, as minimum, requirements for:
a) adequacy of the laboratory technical procedures;
b) competency of the laboratory personnel;
c) testing of the product;
d) capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.) when no national or international standard(s) is available, the organization shall define and implement a methodology to verify measurement system capability;
e) customer requirements, if any;
f) review of related records.

I go back to the problem statement as I understand it. Your Scope statement does not meet the requirements. FYI: It also sounds like you are confusing the word "Scope", because you say "the Lab Scope in it's current form includes M & TE called out on our Quality Plan but also includes numerous other M & TE in-house but not used in mass production."

The clause tells you what the Scope statement needs to be. It's not about what equipment you have or use....you certainly could add that.

I apologize if I am missing things....but here is what I would have for your Lab Scope as an example:

The company xxx internal lab provides inspection, test and calibration services for all M&TE equipment used in the "mass production" of company xxx products.

The labs capability to perform the required inspection, test or calibration services are assured through:
  • our technical procedures which have been written by technical experts and benchmarked against industry standards
  • education, on-the-job training, experience and continuing development of all lab personnel
  • appropriate testings requirements for product as outlined in Spec 0000000XXX
  • initial and continual capability studies to verify measurement system capability as defined in Spec 1111111XXX
  • all customer requirements are documented and addressed where applicable
  • etc
  • etc
  • etc
Anyways...something like that...that is off the top of my head while eating a messy sandwich. :)

hope that helps...looking forward to your response.
 
#5
No, what you state makes sense to me. Whoever constructed our scope numerous years ago included items like "Straight Edge" and "123 blocks" which I have never seen listed as M & TE before (and is certainly not on the Quality Plan or used for Mass Pro inspection). I want to remove all irrelevant items (those not utilized to measure or determine ok/ng of mass production and also not on Quality Plans) but my colleagues/supervisors are thinking that we should keep scope as is and try to identify standards or work instructions to qualify every single item on the scope. I absolutely want to meet the standard but why spend money and energy for extra documentation? My bosses think we will be compliant in the eyes of the IATF auditor if we only connect WIs and standards to Mass Pro gaging but leave other items (123 blocks) on scope without standards or WIs. I think the auditor will say All items listed on the scope must meet the bullet points you identified above.
 
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