Calibrated measurement tools on shop floor discussion

brownie

Registered
Hi all,

Long time reader of the forum, but first time posting - not quite sure if this is the right section to open this discussion

I'm looking for some advice - we are an ISO 9001:2015 certified manufacturing shop, and we are in the process of ramping up production with one of our bigger medical industry customers (FDA + ISO 13485) in mind.

The upper management of this shop is cheap, and I am feeling the effects of it as the quality manager. Here is my conundrum:

We are rebuilding our calibration system to be more well equipped to handle the larger production quantities
(New asset tagging/tracking, and will be sending tools out for NIST traceable calibration as they do not want to purchase the standards to bring the process to an internal system)

The upper management team is arguing with me that all of the shop tools do not need calibration, and can/should be reference only, as QA is what controls final acceptance of the lots of parts moving through.

I disagree with this, as the machinists that are checking their work need to be able to verify the accuracy of their measurements by using calibrated tools. The argument I have received to this point is that the tools will be damaged regardless, and the machinists are untrained operators whose measurements can not be trusted.

I'd like to get some opinions from others to see what the general consensus is, and if there is any validity to the upper management team's approach.


This is all driven based on cost of outside calibration, which was the preferred option after they learned the cost of NIST traceable standards.

Thank you!!!
 

Jen Kirley

Quality and Auditing Expert
Leader
Admin
Congratulations on your first post brownie!

This seems like the time for some math. I used to work for a machine shop that sent out all their calipers for calibration monthly (that frequency was needed due to the work environment and constant use). They would box up the calipers, send them out and in 2 weeks receive them back with little certificates. All good! But I did a little math and found that after this action 4 or 5 times, they could have bought new calipers. We purchased two sets of gage blocks (one for regular use and a master set for standby), which paid themselves back very soon. And that was just for calipers. Then there were the plunger dial indicators, micrometers etc.

Management speaks the language of money, some don't much appreciate qualitative terms. Have you tried math?
 

Golfman25

Trusted Information Resource
Assuming you’re talking about basic hand gages, mics, calipers and such. Those are easily verified/calibrated in house. All you need is a set of masters to check to. If you’re doing any type of machining at all it will be the cost of one or two bad parts. While I agree that QA has the final sign off, having good production gages helps a lot. We calibrate ours twice per year.
 

ChrisM

Quite Involved in Discussions
Measurement items in use in a machine shop etc do not need to be sent out for calibration, only those used for verification (QA/Inspection Department) need to be formally calibrated. But.... as Jen has said, you need to do a cost-benefit assessment. As Golfman has said you can also internally check/calibrate the measuring equipment used in the production facility in-house
 

dwperron

Trusted Information Resource
The upper management team is arguing with me that all of the shop tools do not need calibration, and can/should be reference only, as QA is what controls final acceptance of the lots of parts moving through.

I disagree with this, as the machinists that are checking their work need to be able to verify the accuracy of their measurements by using calibrated tools. The argument I have received to this point is that the tools will be damaged regardless, and the machinists are untrained operators whose measurements can not be trusted.

I'd like to get some opinions from others to see what the general consensus is, and if there is any validity to the upper management team's approach.
Since you are certified to ISO 9001, then let's look at what that says:

"7.1.5.2 Measurement traceability
When measurement traceability is a requirement, or is considered by the organization to be an essential
part of providing confidence in the validity of measurement results, measuring equipment shall be:
a) calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards
traceable to international or national measurement standards"


If your contracts require that your tools be calibrated then they must be calibrated. That takes care of the easy situation.

If there is no requirement placed on you to calibrate then it is up to "the organization" to decide what needs to be calibrated. What determines what "needs calibration"?
7.1.5.1 General
The organization shall determine and provide the resources needed to ensure valid and reliable results
when monitoring or measuring is used to verify the conformity of products and services to requirements"

If your final acceptance is not discovering nonconformity in the products then it is hard to disagree with upper management's position.
 

BrokenProbe

Registered
Hi all,

Long time reader of the forum, but first time posting - not quite sure if this is the right section to open this discussion

I'm looking for some advice - we are an ISO 9001:2015 certified manufacturing shop, and we are in the process of ramping up production with one of our bigger medical industry customers (FDA + ISO 13485) in mind.

The upper management of this shop is cheap, and I am feeling the effects of it as the quality manager. Here is my conundrum:

We are rebuilding our calibration system to be more well equipped to handle the larger production quantities
(New asset tagging/tracking, and will be sending tools out for NIST traceable calibration as they do not want to purchase the standards to bring the process to an internal system)

The upper management team is arguing with me that all of the shop tools do not need calibration, and can/should be reference only, as QA is what controls final acceptance of the lots of parts moving through.

I disagree with this, as the machinists that are checking their work need to be able to verify the accuracy of their measurements by using calibrated tools. The argument I have received to this point is that the tools will be damaged regardless, and the machinists are untrained operators whose measurements can not be trusted.

I'd like to get some opinions from others to see what the general consensus is, and if there is any validity to the upper management team's approach.

This is all driven based on cost of outside calibration, which was the preferred option after they learned the cost of NIST traceable standards.

Thank you!!!
Had a similar issue at a shop I worked at. Our solution was to buy a set of standards that went from 1-12". The same standards you get when you buy a set of micrometers to check those to. Set those up on a "calibration tree" out in the shop. basically zip tied those to a piece of sheet metal. The machinist would then use the tree to check the calibration of their tools to be used that day to those standards and if it was out would bring those tools to us in QC to be adjusted or scrapped. The biggest hurdle is training employees to use the calibration tree every day.
 

Golfman25

Trusted Information Resource
This statement bothers me. If this is what management thinks, or worse yet if it is true, you have big problems.
Maybe, maybe not. The issue to me would be if they are relying on these un-trusted operator measurements.

I would never trust our operators to measure parts. Their work areas and skill levels aren't up to it. Thus, we use supervisors and independent inspectors to do the heavy lifting for measurements. It works for us.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Has your customer audited your production processes? What is their opinion?
 

Mike S.

Happy to be Alive
Trusted Information Resource
Maybe, maybe not. The issue to me would be if they are relying on these un-trusted operator measurements.

I would never trust our operators to measure parts. Their work areas and skill levels aren't up to it. Thus, we use supervisors and independent inspectors to do the heavy lifting for measurements. It works for us.
I'm not talking running a CMM or air gauging within a ten-thousandth. But if your "machinists are untrained" and they can't make accurate basic measurements with calipers and mics, I don't wanna buy anything from you. (They're also not machinists IMO.) I've worked dozens of years in various companies with machine shops and never was this the case in any of them.
 
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