Monitoring the Calibration Process

[Houcka]

I manage the calibration program for my company and it occured to me the only means of monitoring the process, as far as I can tell, is through the use of internal audits. While this seems to satisfy my third party auditor, it doesn't sit well with me.

I also manage the internal audit program and very recently implemented a new approach to our process, moving from a compliance audit to a process audit. With this, I know first hand how ineffective our previous audit program was at identifying real oppurtunities for improvement and monitoring the effectiveness of each process.

So I have to ask if there's a better way to monitor the success of the calibration process. I know we have calibration program, and I know we have had it for years, but how can I definitively show there's been an improvement to the process over the years?

Thank you in advance for any feedback.

 

[AndyN]

Are you checking the calibration data (as found conditions) for trends in wear etc. which might indicate the frequency needs to be changed? Are you looking at an aging list of calibrations past due to see if anything can be pushed out or for some other reason the cal's not getting done?

 

[BradM]

Along with Andy's good thoughts, is the calibration program providing the needed resources for the process?

Have there been process requirements that were not fulfilled due to something in the calibration program? Was a customer's request not fulfilled because of a deficiency in the program?

Otherwise, if all the needs are being met (throughout the organization), then the calibration program is effective to that extent.

However, Andy's points are valid, when assessing the calibration program within the program. Are you calibrating instruments at the right time interval? Can you manage the calibration failures more effectively? Are there adequate safeguards to minimize external failures based on a potential calibration failure?

I would start with Andy's suggestion-analyze the data; see how things are going. That can give you a good idea of how/where to start.

 

[howste]

It looks like you've had some good feedback from Andy and Brad.

When monitoring or measuring any process, you need to consider who are the customers of the process, and what do they need. I imagine that the primary things (outputs) that customers of this process need would be trusted equipment available when they need it without excessive costs.

Here's a rough swag at a few things that could be tracked (some already mentioned above):

Trusted equipment
Track the rate of equipment found out-of-tolerance at the time of calibration (failure rate - hopefully this = 0%).
Track the rate of equipment that was found within X% of tolerance limit at the time of calibration (near-miss rate).
Track R&R values of gaging, particularly for key characteristics based on risk management.
Track wear or drift on individual equipment as mentioned by Andy.

Available when they need it
Track downtime of other processes due to calibrated equipment not being available (out for calibration).
Track on-time calibration rate (hopefully 100%).
Track calibration workload for stability over time. (If many items are due at the same time, calibrations may be missed, key equipment may not be available when needed, or overtime may be necessary.)
Track standard times for calibrating items that require downtime. (Is the furnace down for two days for calibration instead of 2 hours?)

Without excessive costs
Track periodic (monthly?) cost of calibrations. (Can we adjust calibration frequencies to reduce costs? Are we replacing cheap gages frequently or repairing worn-out equipment instead of buying new, quality gages? Can we calibrate in-house instead of sending out?)
Track overtime of calibration personnel.

 

[20110525R]

I manage the calibration program for my company and it occured to me the only means of monitoring the process, as far as I can tell, is through the use of internal audits. While this seems to satisfy my third party auditor, it doesn't sit well with me.

I also manage the internal audit program and very recently implemented a new approach to our process, moving from a compliance audit to a process audit. With this, I know first hand how ineffective our previous audit program was at identifying real oppurtunities for improvement and monitoring the effectiveness of each process.

So I have to ask if there's a better way to monitor the success of the calibration process. I know we have calibration program, and I know we have had it for years, but how can I definitively show there's been an improvement to the process over the years?

Thank you in advance for any feedback.

A few years ago, I decided to validate and test our calibration program (automated recall system) and check usage and wear of tooling used for acceptance. It was a small company, with about 150 pieces of acceptance tooling and the costs of calibrating the tooling seemed high to me for the amount of useage of certain tooling. I decided to track daily, weekly usage of the tooling that showed relatively little wear between calibration cycles. I started tracking about 50 items that had calibrations over a 2 year period by having them signed out on a daily log sheet for each use. I trended this after about one month. I followed up again 2 months later with the same tracking of the same tools on another sign out sheet. I found that the calibration recall system (by a records review) did it's job and recalled tooling when it was due for recalibration, but found that 19 items (high dollar tools) were rarely (1 or 2 times of use during the cycle) used during the cycle before they were due for recalibration.
I then went about looking for alternatives to these tools and other methods based on costs and cycle times. Between myself and a very sharp engineer, we came up with an alternative approach to replace these tools with a different type of tool and method for acceptance testing the products. It turned out, we were able to use other tooling and methods to replace 10 of the tools with methods that were more accurate and yielded better results for the acceptance of the product, and we also placed the new methods (and a few less expensive indicators and gauges) in the machining area to check the parts before they came into the QA Lab. One of the things I also did, was put in-process machining check sheets out on the floor so I could trend the machining output real time. Turned out great, we took those 10 tools out of service and saved over $2100 per year in in calibration and repairs (people dropped tools and broke them alot, so we stopped all the handling of the tooling).
The main difference was, we used the Calibration system to develop some new in-process methods, that were a great improvement to us and a cost savings. We later studied a few other tools, and were able to extend the life and calibration intervals of several other tools. Sometimes we forget to look at alternative methods of measuring products and don't look at new and improved. Not sure this is what you were going for, but we saved money and processing by looking at how and what we were doing, and eliminating a lot of movement of tooling from the QA Lab to the floor and back and eliminating some high dollar tooling.

 

[vanputten]

Related to calibration, what do you manage?

If internal audits can monitor calibration, why can't you?

 

[SriVish]

I also administer and manage the calibration process and as an internal auditor, ask your technicians to demonstrate the process of calibration and compare it as documented in the SOP. In this process, identify the areas where in the deviations occur and re do the exercise. If you feel that there are better ways to improve the performance, write a change control and implement such methods. For example, interfacing standards used in calibration can be automated used various software components which will eliminate the possible human errors of entering the data manually. Overall, such practice will improve the performance and confidence among the staff to demonstrate the capabilities during internal/external aduits.

 

[Ka Pilo]

I manage the calibration program for my company and it occured to me the only means of monitoring the process, as far as I can tell, is through the use of internal audits. While this seems to satisfy my third party auditor, it doesn't sit well with me.

I also manage the internal audit program and very recently implemented a new approach to our process, moving from a compliance audit to a process audit. With this, I know first hand how ineffective our previous audit program was at identifying real oppurtunities for improvement and monitoring the effectiveness of each process.

So I have to ask if there's a better way to monitor the success of the calibration process. I know we have calibration program, and I know we have had it for years, but how can I definitively show there's been an improvement to the process over the years?

Thank you in advance for any feedback.

What is the frequency of internal audit? If the instrument/equipment is found to be out of calibration before the internal audit, what would you do? How do you train internal auditors to do it and what do you train them against?

 

[AndyN]

What is the frequency of internal audit? If the instrument/equipment is found to be out of calibration before the internal audit, what would you do? How do you train internal auditors to do it and what do you train them against?

The internal audit process can't be used in the manner the OP is asking about. Calibration - just like equipment maintenance - has to be monitored for effectiveness. The audits, verify the process as effective, as a feedback on the process. I understand from another post that you haven't taken any formal training in ISO implementation. This is the kind of valuable information you could learn at a course!

 

[SriVish]

The frequency of internal audits can be set to quarterly and audit at least one or few of the 17025 clause for its compliance during a quick monthly meeting. This helps in your internal auditors in understanding the complete process and to be in compliance in the event of an external audit. Do you have an OOT procedure for an equipment found out of tolerance? If the As Found of the equipment under investigation is not failed, it is not that significant. However, if it failed, perform analysis on what could have been affected on the calibration process and write a deviation report.