Calibration and Maintenance: Keeping it Real

validated cmms

A solid calibration and maintenance management system helps maintain consistent performance.

There are several elements to putting together such a calibration and maintenance program that can help you to direct your resources to where they will do the most benefit.  The following are some keys to putting together a solid program:

  • Keep it Simple:  The key is to scale it to your operation.  Focus on the most important items if resources are limited.  A simple program that is followed and that you can defend is much better than a program that bogs down in complexity.
  • Written Program:  Your calibration and maintenance programs should be written, of course, and they should be approved by QA.  Consider including the following:
    • Equipment Assessment and Identification:  Assess of each piece of equipment item to determine if it is important enough to be calibrated and/or requires maintenance.  You will probably find much of your instrumentation is not used for a critical (e.g. GMP) purpose and can be designated as non-calibrated.  Each item should have an ID assigned to allow tracking of the maintenance and/or calibration status.
    • Labeling:  Label calibrated and non-calibrated equipment so that a user can determine if any item is past the calibration date, or is for informational use only and may not be calibrated.
    • Scheduling System:  Get a reliable and validated CMMS (like GxPReady! Suite) to track when equipment is due for calibration or maintenance.  This way it is easy to stay on top of it.
    •  Tolerance Assignment:  If you decide to calibrate an instrument, consider what kind of accuracy you actually need from the equipment/instrument.  A common rule of thumb is that the instrument should be at least 4 times more accurate than your process specification, but there are several ways to manage this.
    • Interval Assignments:   Manufacturer recommendations are based on certain conditions.  If you use the equipment more or less often than “normal” use, consider adjusting the interval between calibrations or maintenance, but keep the interval short enough so that if you did get an out of tolerance (OOT), you wouldn’t have too much research to do of historical work performed using the instrument since the last passing calibration.
    •  Training:  Personnel that use the equipment should be trained on its use and not to use equipment that is not calibrated for critical measurements.  Also, anyone performing calibration and/or maintenance should be qualified to do so.

Put a program in place as soon as you start acquiring significant equipment so that keep things running smoothly and avoid costly repairs and quality control problems, and to get a validated CMMS system that can grow with your organization.  Don’t fall into the trap of assuming equipment will keep running just because it has run flawlessly for months or years.

There are many bad results that can come of mismanaged calibration and/or maintenance including the following (not that these apply to regulated and non-regulated companies):

Unscheduled Downtime:  A critical piece of equipment goes down.  Production stops, and you are forced to schedule repairs ASAP.  You pay premium prices for parts and labor, because the need is urgent.  Some parts may have long lead times, or not be available.  You may suffer reputational costs with customers waiting for delivery.

Out of Specification (OOS) Product:  Quality control may indicate that product is not maintaining its historically high quality.  If you have no calibration and maintenance program in place, tracking down the problem is substantially more difficult if you don’t have confidence in the readings that may be indicating that there is a problem.

Root Cause Analysis (RCA):  Suppose you find product that is out of specification and you are trying to determine the cause.  If there is no calibration and maintenance program in place, it is far more difficult to pinpoint changes that may have affected your production system.  This can cause a very significant impact on your ability to correct the problem and regain your historical quality standards of production.

A dependable calibration and maintenance program using a validated CMMS system can go a long way to keeping your production and quality testing running.  Alternatively, an inappropriate system can bog you down with paperwork, delays, unpredictable performance, and myriad other problems.   Take care of your equipment and relax, knowing your management will be happy with the consistent quality that they have become accustomed to.