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5 Key Steps in the Calibration Optimization Journey

Mr. John Cummins, CPIP
Article

With over 13 years’ experience in the pharmaceutical and bio-pharmaceutical industry, John works with clients in both Ireland & the US to help them achieve a state of Calibration & Maintenance Program Excellence

Here John talks us through the 5 Key Steps needed to begin your Calibration Optimization Journey.

1. Review How You Classify Your Instrumentation
In many facilities, outdated methodologies are used to classify instrumentation. The overly conservative approach of making everything “critical” so that nothing will be missed is at best, time consuming, and at worst, a demonstration of a lack of confidence in your own process. There are clear guidelines now—particularly within the Life Science industries—of how to simplistically classify an instrument based on its impact to the product and process. You should be aiming for only 40% of your instruments to be classified as critical.

2. Make Calibration Frequency Decisions Based on Data
You must use real data to make decisions on calibration frequencies. The results of this can be astounding. In one project I worked on, when reclassification of instrumentation was combined with statistical analysis of historical calibration data, an annual reduction of 51.67% in annual calibration tasks was achieved. What would that kind of reduction do for your engineering budget?

3. Determine Risk and Rigor for the Instruments Most Critical to Your Process
Now that you have confidence in the classification of your instrumentation and their associated calibration frequencies, the next step is to ensure that the level of risk and rigor applied to them is proportionate to their impact on your product and process. For example, running a statistical analysis process is an excellent step in the Cal OpEx journey, but you must ensure that you have properly risk assessed the action of extending the frequency of the critical instruments. Instruments not considered critical would not be subject to the same level of analysis and effort.

4. Level Your Workload
Having 800 tasks in May and 400 tasks in June with the same workforce is not good business in any industry. The same goes for calibration and maintenance activity. As part of your Cal OpEx journey, forecast your planned activity over the next 12–18 months and see what your work load level distribution looks like. The value in this exercise is gained from analyzing the data at the granular level. For example, you may have a perfect balance of approximately 500 tasks per month, but have you taken into account the vacation time in summer or winter when your resource levels might be low? Have you accounted for scheduled plant shutdowns? Do you know your average level of on-demand requests and their impact on your resources? Knowing this information far ahead of time prevents chaotic months and makes for a much happier workplace.

5. Recognize and Reward Employee Ideation
This is probably the most important part of the Cal OpEx journey. A drive towards an optimized calibration and maintenance department (or any department for that matter) will not be realized without the support of the people who deliver the service. Utilize the experience and the talents within your department and document, reward and recognize the ideas that can take your department—and your company—to the next level.