ISO/TS 16949 Clause 7.6.3.1 - Internal Laboratory - Requirements

[Mikey324]

The way you describe it, I think the auditor is correct (at least from my experience). However, why wouldn't your current "lab" scope cover it. I assume you already use the standard gages you listed to make dimensional checks. And your currently have calibration requirements, etc. If not, you simply need to add them to your current "lab" scope -- doesn't need to be real complicated. And don't get caught up in the word "lab" -- stampers "labs" are usually their shop floor. Good luck.

I wonder that too. we do have instructions with scope for calibration. the operator intructions and reference to inspect sheets detail the measurement and criteria. and yes our "lab" is the plant floor, thats why we didnt consider it.

 

[vanputten]

Mikey324

Are any measuring tools calibrated internally regardless if the measurement is for in process or final production?

 

[Mikey324]

Mikey324

Are any measuring tools calibrated internally regardless if the measurement is for in process or final production?

yes, we verify digital calipers and digital micrometers with externally calibrated gage blocks.

 

[vanputten]

Then I would say 7.6.3 .1 applies to the "verification" of the digital caliper and micrometer measuring tools. A lot of people get hung up on the word "laboratory" because they think it means a physical room.

 

[jelly1921]

The same situation happened in China.
My question is how to describe the analysis of root cause about this NC?

 

[Mikey324]

The same situation happened in China.
My question is how to describe the analysis of root cause about this NC?

My plan is to be honest.

Based on previous operations, shop floor inspection areas were not considered as an internal lab. Instruction/Procedures for calibration and test methods were difined, but int. lab scope was not documented as per requirement...

 

[Sebastian]

Conclusion ?

Due to definition of 3.1.4, requirements of 7.6.3.1 are related to each control listed in control plan ?
No matter product characteristics or manufacturing process parameters ?

 

[Mikey324]

From my new understanding, if you calibrate the equipment you use in house then you need to include the lab scope. It might be a good idea to document a lab scope in any case to as a preventive measure for this potential NC. Myabe others have a better idea, but i guess it couldnt hurt. Creates more documents (and another chance to shoot yourself in the foot!)

 

[tongxiaozhi]

TS doesn't specify that calibration Must be done in the lab. It can done by anyone qualified to perform internal calibration

 

[Penny Treadwell]

I also have a question regarding a Internal lab scope statement. Does the "uncertainties" column in a chemical laboratory scope need to be identified? I have seen several and they vary.