Supplier Laboratory Requirements - 4.10.6 - Requirements for an In-House Laboratory

M

mniem

#1
#1
We don't really have a lab, just do dimensional measurements with a CMM. ? Lab is not a controlled area, other than the walls around it. They have procedues for what they do, but nothing as in-depth as the standarad states. Can I just refer to their measurements as inspection and testing process and say that the lab requirements do not apply to us? If I say they do not apply do I have to get a waiver from our customers, or is this between the registrar auditor and me?
 
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D

Dan De Yarman

#2
#2
We also have an inspection department with a CMM. All that is performed is dimensional verification, with the exception of our hardness tester. I was recently told that we would have to consider ourselves having a lab because of the hardness tester. IS THIS TRUE?!! All we use the hardness tester for is to check how hard something we had heat treated is, after it breaks (just to see how hard the piece is). Other than that we occasionally test copper to see if it is 110 or what have you. This is sometimes done before machining and sometimes after machining. It is tested after machining if the machinist suspects the copper isn't as hard as it should be.

If I have to become a lab because of one hardness tester, that is ridiculous. I will get rid of the hardness tester or use it for R&D purposes if this is the case. Is there anything else that can be done in this situation?

Dan
 
R

Rich S.

#3
#3
This is from the AIAG website, and is guiding our compliance development (i.e scope statement, generic operations manual, operator qualifications):

Labs and Calibration
4.10.6 - Requirements for an In-House Laboratory
Compliance to ISO Guide 25 is not required per se
Compliance to QS-9000 Requirements, including 4.10.6.1 - 4.10.6.6, is required
What is a lab? A facility, a building, a special room, a designated area, etc., that facilitates (makes possible) an activity where testing is done.

What isn't a lab? Places where testing occurs as a part of a process, which are within the parameters of that process. In other words, if testing is adequately controlled by in-process testing and inspection, and the items to be tested are not taken out of the process to a "facility," the in-house laboratory requirement does not apply.
Lab requirements:

Scope - answers the questions:
-What is the reason for the activity?
-What are the elements/rules/laws/procedures that will be included in the activity?
-Who or what is affected by the activity?

More specifically, the definition from QS-9000: A quality record (see 4.16) containing the following:
1) the specific tests, evaluations and calibrations a supplier laboratory has the ability and competency to perform,
2) a list of the equipment used to perform the above,
3) a list of the methods and standards to which it performs the above.

Lab personnel - professional judgments require theoretical and practical experience.

Test samples - must be retained and/or disposed of by procedures.

Environment controls - must be adequate.

Methods - must meet the needs of the customer and meet current standards. The lab must verify its capability to perform to standard specifications.

Statistics - must be appropriate to the work done.
 
L

louie

#4
#4
Additional Clarification please

Do I need "lab" facilities in which to "certify" my calibrated items?

If I have my micrometers, calipers, etc. calibrated by an outside lab once a year, can I certify that they are still within acceptable range using calibrated gage blocks, without having a true lab?
 
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