7.1.5.3.1 Internal Lab Scope

sfuller

Registered
We just had our IATF audit and we received one minor non-conformance.
We are a machine shop and we have gages such as Thread gages (and NPTF) Ring & Plug, Calipers, Micrometers, pin gages, height stands, snap gages etc. Key Inspection is Oasis, Comparator, CMM, and Keyence.

Our minor was our lab scope does not meet the requirements:
Nonconformity observed in process Calibration
Standard clause 7.1.5.3.1
Internal laboratory
Requirement
An organization's internal laboratory facility shall have a 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 a 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 the related records.
Statement of nonconformity
The system for identifying process standards for testing is not completely effective.
Objective evidence
Their Lab Scope is in Doc-002-OT rev C and it does not make reference capability to perform these services correctly, traceable to the relevant
process standard (such as ASTM, EN, etc.).
Justification for classification
This is a Minor because their internal procedure does refer to some reference standards. This did not directly affect the customer.

The auditor gave me an example of an external lab cert that has an attached page to the cert of each what the place calibrates and the standard in which they use. We send out most of gages to be calibrated. We do have some set masters. I am really having a hard time setting up this updated scope. Does anyone have some examples close to a machine shop that they could send me?
 

Ashland78

Quite Involved in Discussions
If you are doing simple calibrations, this is relatively easy. I was once wrote up for the same thing. I would be willing to try to find the scope I saved but I would rather send to only you.
 

sfuller

Registered
I asked the auditor if we needed one due to us doing "some" in house calibration and he said no, we needed it due to checking customer samples.
 

Ashland78

Quite Involved in Discussions
I asked the auditor if we needed one due to us doing "some" in house calibration and he said no, we needed it due to checking customer samples.
I think it would more than benefit you to have something in case it comes up again. Pm me and I will get you what I have that worked when we had this as a finding.
 

sfuller

Registered
Could you please pm me? I try to pm and it says that I am not allowed, and it may be due to not being registered. I am registered and logged in.
 

Crimpshrine13

Involved In Discussions
We got dinged on the similar issue some years ago. Ours was that I didn't have the method of calibration standard on the lab scope. Adding the standard method of calibration and measurement in comment section cleared the issue.

Example:
Length Measurement / Digimatic Caliper / Range (0 - 150) mm / Best Uncertainty ± 0.02 mm (L ≤ 50) / Comments: ASME B89.1.14-2018
Calibration - Digimatic Caliper / Range (0 - 20) mm / Maximum Permissive Error ± 0.02 mm (L ≤ 50) / Comments: ASME B89.1.14-2018 Use gage blocks traceable to ISO 17025
 

sfuller

Registered
We do not do any in-house calibration, only verification. We need one for inspection. What do you put in the comments box if you send them for outside calibration?
 
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