IATF 16949 7.1.5.3.2 FAQ #7 Audit Finding - External Calibration Laboratory

Bran

Starting to get Involved
#1
Hello! Long time lurker to this forum, decided it was finally time to get my feet wet by sharing a recent experience.

IATF FAQ #7 for External Laboratory states:

QUESTION 1: When can the equipment manufacturer be used to calibrate inspection and test equipment? If an accredited laboratory exists but is very remote and/or expensive and the inspection or test equipment manufacturer is nearby and available can they be used (even if they are not accredited to ISO/IEC 17025)?

ANSWER 1: The inspection or test equipment manufacturer developed the methodology to maintain and adjust the equipment to meet calibration requirements as part of the design and manufacture of the inspection or test equipment. Therefore, the original equipment manufacturer of the inspection and test equipment is qualified to calibrate the equipment they designed and manufactured.

The organization shall obtain customer approval before using any original equipment manufacturer for calibration services.

--

My organization recently went through a Stage 2 IATF audit. The auditor came across one of our OEM calibration suppliers who is not ISO 17025 accredited, and we had no record of any customer approval to use this OEM for calibration services. Naturally the conversation went to the section discussing OEMs, needing to meet the requirements listed in 7.1.5.3.1, from which there was evidence to show, such as the lab's scope document, their ISO 9001 cert, etc.

We still ended up with a finding against IATF 7.1.5.3.2 because there was no record of customer approval of the OEM calibration service. The auditor based his decision on the FAQ #7 comment (in red above), which reads like an IATF requirement.

This FAQ forces customer approval to use OEMs providing calibration services. Was this always the requirement and I was misinterpreting the intention, or does the FAQ add the requirement of customer approval?
 
Elsmar Forum Sponsor

morteza

Trusted Information Resource
#2
Hello! Long time lurker to this forum, decided it was finally time to get my feet wet by sharing a recent experience.

IATF FAQ #7 for External Laboratory states:

QUESTION 1: When can the equipment manufacturer be used to calibrate inspection and test equipment? If an accredited laboratory exists but is very remote and/or expensive and the inspection or test equipment manufacturer is nearby and available can they be used (even if they are not accredited to ISO/IEC 17025)?

ANSWER 1: The inspection or test equipment manufacturer developed the methodology to maintain and adjust the equipment to meet calibration requirements as part of the design and manufacture of the inspection or test equipment. Therefore, the original equipment manufacturer of the inspection and test equipment is qualified to calibrate the equipment they designed and manufactured.

The organization shall obtain customer approval before using any original equipment manufacturer for calibration services.

--

My organization recently went through a Stage 2 IATF audit. The auditor came across one of our OEM calibration suppliers who is not ISO 17025 accredited, and we had no record of any customer approval to use this OEM for calibration services. Naturally the conversation went to the section discussing OEMs, needing to meet the requirements listed in 7.1.5.3.1, from which there was evidence to show, such as the lab's scope document, their ISO 9001 cert, etc.

We still ended up with a finding against IATF 7.1.5.3.2 because there was no record of customer approval of the OEM calibration service. The auditor based his decision on the FAQ #7 comment (in red above), which reads like an IATF requirement.

This FAQ forces customer approval to use OEMs providing calibration services. Was this always the requirement and I was misinterpreting the intention, or does the FAQ add the requirement of customer approval?
Hi Bran,
Good Question,

At first I should mention that this FAQ has added a new requirement to clause 7.1.5.3.2 (like a SI, but we know that FAQ only clear the current requirement without adding any new requirement. So, one of the reasons that can justify your auditor finding is the following requirement in IATF 16949 clause 7.1.5.3.2:

- there shall be evidence that the external laboratory is acceptable to the customer.

If we accept that this requirement also apply to the following requirement of clause 7.1.5.3.2:

Calibration services may be performed by the equipment manufacturer when a qualified laboratory is not available for a given piece of equipment.

The FAQ would be right. but we know that IATF only requires the organization to ensure that the requirements listed in Section 7.1.5.3.1 have been met.

Another justification would be that in the case of FAQ#7, there is an accredited laboratory exists but is very remote and/or expensive. Based on clause 7.1.5.3.2 the organization is allowed to use the equipment manufacturer for calibration service when a qualified laboratory is not available for a given piece of equipment. When there is a laboratory, it should meet at least one of the following conditions:
- accreditation to ISO/SEC 17025 or national equivalent
- Customer approval
for this reason FAQ#7 has required the organization to obtain customer approval.


Anyway, I think this question has the potential to be answered by IATF oversight offices.
 

Golfman25

Trusted Information Resource
#3
It's a "clarification" (i.e, rewrite) of the requirement. Not much you can do but get customer approval. Good luck.
 

Bran

Starting to get Involved
#4
Thank you both for your input.

The RCA for this gave actions to address the "systemic issue" by:
(1) identifying all OEM calibration suppliers we use (I believe this number may be 15-30 for my organization)
(2) contacting each of our automotive customers (close to 100 for us...) to get their approval to use each of the OEM suppliers listed above

Problem here is obviously getting this done within the time frame for the IATF CAR.

--

I could understand getting customer approval for new line setup, or new business, but many of the calibration OEMs we use have been in use by my organization for decades and we have been supplying customers up to this point with no history of issues. Also, a good number of these calibration OEMs do not have anything to do with product measurement devices; for example we have many EHS-related devices in place, or other devices to meet internal requirements.

For most IATF items up to this point I have been able to make a business case, showing how the new requirement would benefit either my organization or the customer. This one I'm struggling with. If each customer does not approve a calibration OEM, there is no alternative equipment or source. The equipment is too specialized and/or antiquated to the point where we're already locked into using the OEM. Even if replacement or upgrade of equipment (in order to make it serviceable by a 17025 accredited lab) was an option, this would be cost prohibitive in almost all cases.
 

Golfman25

Trusted Information Resource
#5
Thank you both for your input.

The RCA for this gave actions to address the "systemic issue" by:
(1) identifying all OEM calibration suppliers we use (I believe this number may be 15-30 for my organization)
(2) contacting each of our automotive customers (close to 100 for us...) to get their approval to use each of the OEM suppliers listed above

Problem here is obviously getting this done within the time frame for the IATF CAR.

--

I could understand getting customer approval for new line setup, or new business, but many of the calibration OEMs we use have been in use by my organization for decades and we have been supplying customers up to this point with no history of issues. Also, a good number of these calibration OEMs do not have anything to do with product measurement devices; for example we have many EHS-related devices in place, or other devices to meet internal requirements.

For most IATF items up to this point I have been able to make a business case, showing how the new requirement would benefit either my organization or the customer. This one I'm struggling with. If each customer does not approve a calibration OEM, there is no alternative equipment or source. The equipment is too specialized and/or antiquated to the point where we're already locked into using the OEM. Even if replacement or upgrade of equipment (in order to make it serviceable by a 17025 accredited lab) was an option, this would be cost prohibitive in almost all cases.
All true. And your customers will be shaking their heads asking why they have to do this. But it is what it is. Make up a letter and see if you can get some approvals to close it out. Then work on the rest before the next audit. Good luck.
 
#6
Hi Bran,

I am curious how did it go with closing this non-conformity? We received the same one and we are in similar situation, however only have two customers.

Thank you.
 

Bran

Starting to get Involved
#7
Hi Bran,

I am curious how did it go with closing this non-conformity? We received the same one and we are in similar situation, however only have two customers.

Thank you.
I sent an email to the customers which included a list our OEMs performing calibration services, asking for approval to use the OEMs. I limited the email distribution to only those customers who were on our CSR matrix, so only those customers that are either IATF subscribing or have a CSR document per the IATF definition (these would be most visible to our auditors).

Surprisingly, I did get approval email responses from most on the list within a week or two. Only 1 of the "big 3" questioned a single item on the list - the SQE didn't agree that only the OEM could perform calibration for one of the devices, he challenged us to find an alternative calibration lab. I explained that moving away would take much longer than the time I had to close out the finding, eventually he agreed.

Our CSR matrix has changed since the time of the audit, so I will need to send a few more emails to capture approvals of the new customers added prior to the next audit.
 
Thread starter Similar threads Forum Replies Date
D IATF 16949 FAQ 24 (8.4.2.2 Countries of Destination) - How is this actually being interpreted? IATF 16949 - Automotive Quality Systems Standard 3
U IATF 16949 8.4.2.2 FAQ 24 - Countries of destination IATF 16949 - Automotive Quality Systems Standard 3
H New FAQ & SI -IATF 16949 - Effect in april and june 2018 IATF 16949 - Automotive Quality Systems Standard 0
S Thoughts on managing ISO 9001, 13485, IATF 16949 and 17025 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 33
P IATF 16949 requirement - error-proofing in control plan IATF 16949 - Automotive Quality Systems Standard 3
R IATF 16949 - Outsourcing of internal audits Internal Auditing 10
eule del ayre Documented Information - Periodic Review of Documents? IATF 16949:2016 / ISO 9001:2015 IATF 16949 - Automotive Quality Systems Standard 34
Crimpshrine13 Laboratory Scope - Calibration vs. Test Methods - IATF 16949 IATF 16949 - Automotive Quality Systems Standard 3
earl62 What is the best way to control special characteristics in Control plan? Is it Mandatory to have SPC for IATF 16949? IATF 16949 - Automotive Quality Systems Standard 7
L IATF 16949 certification costs IATF 16949 - Automotive Quality Systems Standard 3
B FCA US Customer Specific IATF 16949- Critical Characteristics 8.6.2 Customer and Company Specific Requirements 0
B IATF 16949 News Six month extension on all valid IATF 16949 certs IATF 16949 - Automotive Quality Systems Standard 10
earl62 IATF 16949 Clause 9.1.1.1 - What is the batch conformance to specification method? IATF 16949 - Automotive Quality Systems Standard 3
B FCA US IATF 16949 Customer Requirements updates Customer and Company Specific Requirements 3
S Can assembly manufacturing sub-supplier be certified IATF 16949? IATF 16949 - Automotive Quality Systems Standard 6
D IATF 16949 Requirement for CMMI in a Global Company Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 0
M Tips on preparing for IATF 16949 Internal Lead Auditor exam Manufacturing and Related Processes 1
A IATF 16949 4.3.1 - Determining the scope of the quality management system - supplemental IATF 16949 - Automotive Quality Systems Standard 9
S Definition of "worldwide" in view of IATF 16949 and Product conformity IATF 16949 - Automotive Quality Systems Standard 3
R Where does IATF 16949 address Process mapping? IATF 16949 - Automotive Quality Systems Standard 3
A Document "Correspondence IATF 16949 vs ISO13485" available? IATF 16949 - Automotive Quality Systems Standard 0
H Remote product audits in Coivd-19 - IATF 16949 9.2.2.4 IATF 16949 - Automotive Quality Systems Standard 3
S IATF 16949 - Partial traceability of Aftermarket products IATF 16949 - Automotive Quality Systems Standard 5
M IATF 16949 8.5.1.3 Verification of job set-ups - Do we need secondary check? IATF 16949 - Automotive Quality Systems Standard 7
C Industrial scales and MSA (IATF 16949 requirement 7.1.5.1.1) IATF 16949 - Automotive Quality Systems Standard 30
V Generic IATF 16949 Audit Checklist wanted IATF 16949 - Automotive Quality Systems Standard 3
M Scope of Combined ISO 9001 and IATF 16949 QMS - Non-automotive customers ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
D Postpone IATF 16949 audit due to COVID-19 IATF 16949 - Automotive Quality Systems Standard 41
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
T Reaction Plan To Drive suppliers to IATF 16949 registration IATF 16949 - Automotive Quality Systems Standard 4
B IATF 16949 - Is a Deviation required for sample components in a prototype build? IATF 16949 - Automotive Quality Systems Standard 13
C IATF 16949 - Scope or not? IATF 16949 - Automotive Quality Systems Standard 2
L "IATF-Compliant" IATF 16949:2016 certification? What does this mean? IATF 16949 - Automotive Quality Systems Standard 13
B Go Beyond ISO 9001 WITH IATF 16949 (January 28) [Paid] Training - Internal, External, Online and Distance Learning 1
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
S Can we provide training plan as corrective action for IATF 16949 Non conformity? IATF 16949 - Automotive Quality Systems Standard 9
C Design and implementation of process audits as defined within IATF 16949 IATF 16949 - Automotive Quality Systems Standard 2
Q VDA 6.3 questions vs IATF 16949 clauses VDA Standards - Germany's Automotive Standards 0
N IATF 16949:2016 7.1.5.3.2 External Laboratory - How to approve the Testing Laboratory without accreditation scope IATF 16949 - Automotive Quality Systems Standard 2
M IATF 16949 (6.1.1 - Planning and Risk Analysis for a remote site) Process Maps, Process Mapping and Turtle Diagrams 5
Jimmy123 What is the difference between Error Proofing and Controls? ISO/IATF 16949 - Control Plans FMEA and Control Plans 16
P IATF 16949 8.4.2.4 Supplier Monitoring IATF 16949 - Automotive Quality Systems Standard 2
V IATF 16949 9.2.2.1 Internal Audit Program - "Process Changes" IATF 16949 - Automotive Quality Systems Standard 11
Sidney Vianna IATF 16949 News Presentations from the latest IATF Stakeholder Event - Expectation that IATF 16949 certification should equate with product quality. Misguided? IATF 16949 - Automotive Quality Systems Standard 7
C IATF 16949 8.3 Exclusion - Manufacturing process design and development IATF 16949 - Automotive Quality Systems Standard 5
J IATF 16949 8.4.1.2 Supplier selection process IATF 16949 - Automotive Quality Systems Standard 4
M IATF 16949 CAPITULO 7.3.2 IATF 16949 - Automotive Quality Systems Standard 3
Casana IATF 16949 7.1.5.3.2 External Laboratory - On Site Calibration IATF 16949 - Automotive Quality Systems Standard 8
M IATF 16949 7.2.3 Internal Auditor Competency - Trainer's competency Internal Auditing 7
P IATF 16949 Clause 8.4.2.3 - Justification for non-certified suppliers IATF 16949 - Automotive Quality Systems Standard 14

Similar threads

Top Bottom