Calibration Questions

Good Afternoon,

I'm brand new to this forum and looking for some guidance and wisdom from other quality-minded individuals. I've recently been tasked with getting my small company through their first ISO 9001 audit, there is a debate over measuring equipment calibration/verification I'd like some guidance on.

We use vernier's, micrometres, slip gauges for example, I am of the mind that all of these used on the products must be calibrated in order to pass an ISO 9001 audit, but my colleagues are suggesting that we mark up the majority of the equipment as ''reference only'' and have a final inspection area where the equipment is calibrated to perform final checks before the products are delivered. I know that from reading other posts this is often ''frowned upon'' but in theory is it enough to get us through an audit? There doesn't seem to be much movement on having everything calibrated angle.

The other issue is that we have a historical customer, who don't ask us for any real inspection of any kind, they simply ''trust'' us and as long as the part fits and is given a quick ''look over'' before going out of the door it is deemed acceptable. If we are to adopt ISO 9001, am I correct in saying that if we were audited and we weren't following the same procedures as our more stringent customers, we would fail?

I guess what I'm asking is, should I be saying ''No we cannot treat our historical customer differently or give them special treatment?''

There are financial concerns here that I think are coming into consideration with the calibration etc, my company don't want to charge more for the inspection/calibration part of the work to their historical customer.

I hope this makes some sort of sense, I think I know the answer but some affirmation would be helpful? Any guidance on how a smaller company can navigate their first audit?

 

Good day @MorganHelios and welcome to the site . Let's look at these one at a time...
1- am of the mind that all of these used on the products must be calibrated
A- ISO 9001 does not mandate what equipment , if any, is calibrated or verified UNLESS....
"...traceability is a requirement, or is considered by the organization to be an essential
part of providing confidence in the validity of measurement results..."

2-in order to pass an ISO 9001 audit
A- I counsel that your organization (within the mandates set forth by the standard), prioritizes your organization and your customers (i.e. what practices best protect your organization and its customers), and not put "get through ....audit" /"...to pass an ISO 9001 audit" as the forethought.

3- "suggesting that we mark up the majority of the equipment as ''reference only'' ...
A- IF it is possible to segregate and maintain the 'reference only' from the later mentioned 'final inspection, AND this approach is determined by your organization to protect your organization and its customers.....then..... there is nothing in the standard that would prevent this approach (in my experience this only causes confusion about 'which' calipers and also sends a message to your teams that some measurements are important and some are not).

4- on having everything calibrated
A- again, unless traceability is required by your customers or "considered by the organization to be an essential....", there is no requirement. Remember, CALIBRATE is not the same as VERIFY. One or both of these options may have merit/provide benefit to your organization.

5- a historical customer, who don't ask us for any real inspection of any kind, they simply ''trust'' us and as long as the part fits and is given a quick ''look over'' before going out of the door it is deemed acceptable
A- See my response "1" above.


6- if we were audited and we weren't following the same procedures as our more stringent customers, we would fail?
A- ONLY if your organization has its own internal requirement ('procedure'), that states ...with no exceptions...that calibration and/or verification are being performed).
See my response "1" above.


7- There are financial concerns here that I think are coming into consideration with the calibration
A-
a) Calibration is one approach....also verification which generally has very little cost associated with it. Reminder that these two are potential options and NOT the same.
b) How do these financial concerns compare with cost of quality /cost of poor quality ...
i. if in process material is not good and is found at final inspection?
ii. if material received by the customer is determined to be not good?
(historically these costs grow exponentially the further from the process the not good condition is discovered and are generally MUCH higher than prevention and/or early detection.)

Hope this helps.
Be well.

 

While calibration isn't specifically mandated, the lazy auditor standard says you may have a problem with no calibration/verification at all as it is a common practice. You'll need to be able to justify your way out of it, IMO. With that said, no reason to make calibration anymore than it needs to be. How many instruments are you talking about? How long of calibration interval can you use? We are a small company and probably have 50 or so things that we calibrate/verify. We use 6 month intervals for the hand gages. 1 year for the CMM. 5+ years for surface plates and things that are hardly used. So it's not that burdensome for us.

As for you "historical customer" you are required to meet their requirements. If they don't expect a measured part check, then you don't need to do it. If a quick "look over" is all that you need, then you're good. Just make sure your production planning and control documentation covers the "look over" -- you're doing what you say you do, and what your customer requires.