IATF 16949:2016 Major NC pertaining to Calibration/verification records

Sidney Vianna

Post Responsibly
It has really put us in a bind.
The referenced SI stipulates: "...the organization is responsible to ensure that there is evidence that the laboratory has been evaluated and meets the requirements of Section of IATF 16949..."

A simple self declaration by your customer confirming their calibration lab complies with the above suffices.

:tunnel: Auditor is happy


On Holiday
Since the customer provides the equipment AND the calibration, I content it’s not an “external lab” in the conventional sense that IATF 16949 considers it to be.


Quite Involved in Discussions
Since the customer provides the equipment AND the calibration, I content it’s not an “external lab” in the conventional sense that IATF 16949 considers it to be.

@codya24 This is a great case study.

I agree here with FB. However, take it a step further to tie all the bows.

First off, the clause about "External Lab" most certainly does not apply (assuming I understand the process here based on Cody(OP)): The customer manages the equipment they keep on Cody's site. The only thing that Cody's site does, is send the equipment when due. Call this an SLA with the customer. So Cody's org is not sending to an "External Lab". In turn, they are not responsible for that lab.

The clause that is in play is 8.5.3 - Cody's site needs to care for customers' property. So the SLA to send the equipment when due is part of that "care". Cody's site is doing their job.

Cody's site should be responsible for the 10% of the equipment that is theirs.

I would tell the CB and Auditor - This is the customer's property; we are caring for it per 8.5.3. This finding is invalid; please remove.


Quite Involved in Discussions
The calibration for inspection , measuring & testing equipment are relevant for measuring & gauges used for the fixtures checks ; therefore you should receive the following evidences from your customer :

1- reports of all check points of their owned fixtures & the relevant measuring devices references used to check/ measure the parameters ;
2- copies of all calibration certificates which covering the relevant references ;
3- your internal check form which used as incoming fixtures -they should verify that the relevant references stated in certificates have traced to int./N Standard ;
4- the Cert. have accreditation logo " ISO IEC 17025" covering the scope of measuring ;
5- the essential evidences for appropriate competency of Lab. if they haven't the accreditations ;
6- the written process & formal terms of your customer regarding FIX. checks ; including contracts ; any CSR & relevant records issues accordingly


Quite Involved in Discussions
The below Requirement should be considered with essential evidences of controls: Management of production tooling and manufacturing, test, inspection tooling and equipment;
* 1-provide resources for tool and gauge design, fabrication, and verification activities;
*2-system for production tooling management, whether owned by the organization or the customer, including:----etc

The organization shall verify that customer-owned tools, manufacturing equipment, and test/inspection equipment are permanently marked in a visible location so that the ownership and application of each item can be determined.

The organization shall implement a system to monitor these activities if any work is outsourced.
Top Bottom