ISO Calibration Procedures

I'm curious of what everyone's experience is with ISO Calibration procedures for instruments. I'm in the food industry and the company I just started working for is struggling with this. Currently they have all instruments on this list, but I wonder if it should be only critical instruments?

Also, they are required to be calibrated once per year, but this year, downtime didn't allow access to all instruments, so as the year ends, they are struggling to figure out how to address the remaining items on the list.

We are thinking we can modify our calibration standards to provide for a year when the plant is not down, and require downtime the following year.

Any thoughts?

Back in the day when I was involved with this, we would annually certify the instruments that were kept in the inspection room and most of what was out on the floor we would mark as reference only and periodically check against the calibrated stuff.

Hi,

First point normaly it's accepted that you only take the critical intruments into account. But.. Critical Instruments or defined by yourself. We define our critical instruments according the Hazop, risk analyzes and production importance.

It's not such a big problem if you didn't do all the calibrations, but you need to have a recovery plan ready what is saying how you're gona cope with this no conformity.
When I had that problem we replanned our preventive maintenace program and put those of lost year first. It's also good to show that you have planned additional people to do the calibration faster to catch up.

It's also good to keep a record of the calibrations of the instruments. Because you can decide according historical data that you do could extend a calibration with one year based on that historical calibration information.

Rudi

We have a QA Queen that said everything must be calibrated; she wouldn’t even listen to the toolmakers about what was important.

You only need to calibrate what you say needs calibration.

Thanks for the replies so far.

It sounds like this system is more customer driven than anything. To impress the customers, we've been telling them we calibrate everything every 365 days max. That had to change when we may schedule downtime in May of one year, then August the next. Now it is every calendar year. However, the past year was a crunch because of sales/ production issues.

The concern is making sure our standards are still held intact, and allow situations like this to be responded to, but not that calibration and quality don't fall by the wayside to making money

What is important

The ISO certification is based on whether you have a procedure and do you actually follow your written procedure.

We calibrate those instruments which have a direct effect on product quality measurements. Everything else is labeled "calibration not required". The periodicity is determined by your procedure. Of course, it should be reasonable...

Bob O said:

We have a QA Queen that said everything must be calibrated; she wouldn’t even listen to the toolmakers about what was important.

You only need to calibrate what you say needs calibration.

Click to expand...

This is exactly what ISO is all about. "You say what you do and you do what you say." ... and you proove it with archives and procedures.

Its not about educating your client on what "should" be done.

If he does not know anything about your product, you could tell this client the dumbest things in your ISO quality book and it will be OK.

In fact it often is that way.

I have read many of them books only to find a lot of irrelevant stuff.

So if you, "The Expert" in this production tell them you need to calibrate these things once every 50 years and this is what you do, its OK.

Now, you will need to adress the quality issue and its improvement in another section of the all mighty ISO philosophy.

The knowledgable client will read the book and see that you are not serious BUT if your price are good and he can live with this "once per 50 years" issue then he will purchase from you, getting exactly what you say you will give him.

ISO cuts a lot of bull out of the sales people pitch. Now this bull is writen into specs.