As a manager of your company’s calibration and/or maintenance management system (CMMS), part of your responsibility is to ensure that you are as prepared as practical for any review of the systems by management, regulatory agencies, customers, or business partners. The following is a list of some issues that can come up during such audits. These general principles can apply equally well to calibration, validation, or maintenance management systems.
No Written/Approved CMMS Program
Every serious CMMS system should have a written, approved procedure that defines the calibration and maintenance management system including responsibilities, the manner in which equipment and instrumentation are assessed and tracked, the manner in which tolerances and intervals are managed, document management, and how out of tolerance conditions are managed. If there is no written program, the meeting is not likely to go well.
Inadequate Tracking System
A validated CMMS software package (such as GxPReady! Suite) will make this part of the problem go away more easily than other systems. Validation provides documented evidence that the system meets your requirements and is appropriate for the intended use. If you have a non-validated or manual system, questions will arise as to how the system is managed and how you can have confidence that the system adequately tracks work, schedules, and equipment items. Further, if the system has no audit trail, questions will arise about how changes are managed and what written procedures and controls are in place to ensure that the information is accurate and secure. In FDA regulated industries, it is likely that both cGMP and 21CFR11 requirements apply to the CMMS system, depending on its intended use.
Procedures Not Followed
Written procedures that are in place for the management of your calibration and maintenance program must be followed. If there is a validated CMMS system in place, it is likely that there will be fewer required procedures than a non-validated or manual system because the CMMS software has controls in place and reports that have already been qualified. Manual systems rely more on individuals to ensure that procedures are followed. For example, maintenance of a spreadsheet or logbook can be difficult to control procedurally and increases the likelihood of errors when a significant number of people have access or there are a significant number of instruments/equipment. Get a system that is easy to use and maintain. You will stay on top of your schedule and have confidence in your program.
Inadequate Assessment of Equipment/Instruments
The manner in which it is determined which equipment requires calibration and maintenance is likely to be a key topic, but you will have a procedure in place to clarify that, of course. What are the criteria and how does a person in the field identify calibrated equipment from non-calibrated equipment? Where is this decision documented for each piece of equipment. Are the criteria applied consistently?
Inadequate Justification for Tolerance/Intervals
How are the tolerances and intervals assigned? The manufacturer recommendations are a starting point, but the intended use is key as well. The manufacturer cannot account for how the equipment/instrument will be used and if it is appropriate for the task. This is managed by written procedures that identify your approach.
Of course, there are other issues that are important in any CMMS program, but these items are near the top of the auditors list in many cases. Furthermore, if you have these blocks in place, it will likely mean that you have most other bases covered in the process of putting these together. Then, you can avoid having that blank look when answering an auditor that our friend in the above image is modelling.