Improving Calibration and Maintenance by Design

Design of Your Systems Can Affect Calibration

The design of the system can affect the consistency, reliability, and effectiveness of calibration and maintenance. This simple example illustrates the potential benefits of some planning during implementation.
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Well designed validated CMMS software allows you to meet compliance requirements for your calibration, validation, and maintenance scheduling with a minimum cost and effort in maintaining the system. This software is also available on line, so you can be up and running quickly with a 21CFR11 and Annex 11 compliant system.

Calibration and maintenance are critical to keeping equipment running in a manner to support its intended use. However, calibration and maintenance do not ensure that the equipment is ready for use. The design of the equipment and the manner in which the calibration and maintenance programs are put into practice can have an even greater effect, and may even defeat the intent of the work performed.

A simple example (hardware): Calibration of a Differential Pressure Gauge
Gauges used to monitor the differential pressure across an entry door to a cleanroom are calibrated to ensure that they remain within an acceptable tolerance. It is typical to see multiple gauges in a single panel that displays all the differential pressures for the area. Typically, these are calibrated on an annual basis, often by a contractor that may not be entirely familiar with the facility. The calibration is not difficult, with the proper equipment, but the design of the system can make all the difference in determining whether the completed calibration achieves the desired result of accurate measurement of each room differential pressure.

If the system is designed such that the person performing the calibration is required to disconnect and reconnect the tubing to the gauges, and the tubing is unmarked, then there is the risk that while the gauges may be calibrated correctly, multiple disconnects and reconnects of tubing may result in the readings not reflecting the correct room differentials. So from the front of the panel one can see that the calibrations are complete, when, in fact, the displayed information may be entirely incorrect. This situation can easily occur and is a simple example of how system design can affect performance.
Some guidelines to avoid these types of problems include:
– Maintain accurate system drawings
– Identify all systems and components with ID numbers that match drawings
– Identify wires, tubing, and other connections uniquely to avoid confusion
– Identify ports and terminals for connections
– Provide easy access for calibration and maintenance to minimize system disruption
– Familiarize personnel performing work with the system and its purpose
– Check work carefully after it is completed to reduce potential issues

If the above are performed, there is a much better chance that the person doing the work AND the customer will be much happier with the results.

A simple example (software): Validated CMMS System
A validated calibration and maintenance management software (CMMS) system is used to track validation and maintenance for a facility. As a validated system, the user can have a high degree of confidence that the software will perform as designed. So if the data are entered correctly, and the work is scheduled as indicated, the calibration and maintenance program should ensure that all systems are maintained in good running order (assuming issues in the above examples are not a problem).

Even a validated CMMS system cannot keep a calibration or maintenance program running smoothly unless it is used correctly. Data entry errors, misunderstandings of the functionality, delayed data entry, inadequate training and/or follow up, and approved procedures that are not correctly followed can all lead to having a calibration or maintenance program that finds itself out of compliance. For cGMP systems, this can result in audit observations, in addition to undesired operation of equipment.

Some guidelines to avoid these types of problems include:
– Ensure there is a written and approved calibration and/or maintenance program
– Select a validated CMMS system that is easy to use and requires minimal data entry to minimize errors and improve timeliness of entry
– Ensure that any operators with access fully understand the data entry, reporting, and scheduling functions
– Perform training and develop standard operating procedures
– Provide adequate resources for data entry and administration
– Ensure that data are reviewed before entering
– Maintain some hardcopy records of certificates/work orders as a reference

A well designed validated CMMS system will allow you to perform required functions with a minimal data entry burden and provide clear reports to guide activities including scheduling, work performed, tracking non-conformance. In addition, it will always be current because, of course, you will be keeping up with the easy data entry and not getting bogged down by entering data that doesn’t benefit your compliance.