Clause 7.1.5.3 Laboratory Requirements

We, as a Distributor, are attempting to be compliant with IATF 16949:2016 standards. Our goal is to get a letter of compliance when audited. We have our parts manufactured by factories that have a valid IATF 16949:2016 certificate.

We inspect the items once they arrive on our site, using Calipers, Micrometers, and CMM. What is the best strategy for us to be compliant with Clause 7.1.5.3? We currently calibrate some tools using masters and standards in house.

 

Good day @Terry Teter ;

First a question if I may. You state...."...get a letter of compliance when audited". Who will be doing said audit? (i.e. 3rd party registrar, customer, ????) What is the goal in regard to receiving a "letter of compliance/conformance" ? What request or implied requirement is your organization attempting to satisfy?

To answer your question, please be sure to consider the terms within the standard as follows...
1- Inspection:
" Determination of conformity" (ISO 9000:2015 3.11.7)
Generally assumed in the context of product/service (output) conformity)

2- Verification:
In the context of 7.1.5.3, it is used to describe confirming that the evidence that results of an inspection meets specified requirements (e.g. for example, checking a caliper against a NIST traceable gage block to show that it is measuring properly prior to inspecting product).
NOTE: the standard describes both VERIFICATION and CALIBRATION in the context of measurement tools. It does NOT prescribe one over the other and they are not the same thing.

3- Calibration:
This is not the same as simply verification..and often includes multiple ranges and calculations. It is unlikely that your organization is performing actual 'calibration' (most likely simply verification?)
NOTE: the standard describes both VERIFICATION and CALIBRATION in the context of measurement tools. It does NOT prescribe one over the other and they are not the same thing.

I point out "inspection" (item "1") because of clause 7.1.5.1.1 . This (MSA) is likely the biggest challenge to your organization. In short, it is your organization's method of providing a statistical analysis has been done to confirm the proper tool is used for measuring/verifying the product. (e.g. to make sure we are not using a yardstick to measure a surface ground precision width with a 0.0001" tolerance)

Also, keep in mind that 7.1.5.3.1 is not talking only about the measurement equipment but also the inspection that is taking place. Therefore, your scope must identify the methods/standards and measurement tools used for the inspections (on product) employed by your organization.

Summary:
The terms above are distinctly different and that should be considered in response to your original question (i.e. the original question over simplifies).

I hope this information proves helpful. Don't hesitate to expound and/or continue the conversation. (BTW: I see @Andy Nichols has provided some good food for thought....as to 'why" any of this.).

Be well.

 

We hold the patent. We don't manufacture them, we contract overseas factories to do that for us. We bring in the parts, store and ship as needed. We supply to tier 2 suppliers. They want us to at the least be compliant with the standard. Our Registrar says we can be audited by not registered, a letter of compliance can be issued.

I was wondering if we, as John states in point 3, if we are just performing a verification. Thanks John, that is helpful.

Yes, Andy complicated beyond common sense.

 

Hi Andy, if you don't mind, I am just going to stick to the topic question today. one step at a time. 162/110 is my record today.