Avoiding a deviation - a real-life story

In the GMP environment of Pharmaceutical Manufacturing, receiving a deviation can mean a lot work for many people. Someone of the Life Sciences Industry (LSI) once told me that it can add up to 2 man-weeks (a translated expression we use in Germany) of work to get a deviation closed out in the GMP and Quality documentation. In other words, it is a lot of work!

When asking ChatGPT the answer about what it requires to close out a deviation in LSI the answer looks like this:

1. Nature and Severity of the Deviation:If the missing calibration poses a significant risk to product quality or patient safety, there may be an urgency to address the deviation promptly. The impact on product quality and compliance will determine the level of priority assigned to closing out the deviation.
2. Regulatory Requirements:Regulatory agencies, such as the FDA, may have specific guidelines and timelines for addressing and closing out deviations. Compliance with these timelines is crucial to maintain regulatory compliance. The pharmaceutical manufacturer will need to follow their internal procedures while ensuring alignment with regulatory expectations.
3. Quality Management System:The effectiveness of the company's quality management system plays a role. If the company has robust procedures in place for handling deviations, the process may be more streamlined. Some companies have established deviation management processes that include predefined timelines for investigation, root cause analysis, corrective action implementation, and closure.
4. Root Cause Analysis:The time required for a thorough root cause analysis can vary. Identifying the underlying cause of the missing calibration is crucial to prevent recurrence. Depending on the complexity of the issue, the root cause analysis process may take more or less time.
5. Corrective Actions and Preventive Measures:Once the root cause is identified, implementing corrective actions and preventive measures is the next step. This could involve recalibration of the master device, updating procedures, providing additional training, etc. The time required to implement these actions depends on their complexity and the resources available.
6. Verification and Effectiveness Checks:Before closing out a deviation, it's common practice to verify that corrective actions have been implemented and are effective. This step may involve additional testing, verification activities, or documentation reviews.
7. Documentation and Reporting:Pharmaceutical manufacturers are typically required to document the deviation investigation, root cause analysis, corrective actions, and verification activities. The time required for thorough documentation can vary.
8. Communication with Regulatory Authorities:If the deviation is reportable to regulatory authorities, additional time may be needed to prepare and submit the required documentation.

This supports the understanding of what type of issue and work a deviation can mean for a pharmaceutical manufacturer and why they try hard to avoid them.

Therefore, I am even more delighted that our E+H team could support the Affiliate of a global European Manufacturer in Singapore, who sent their Master Flowmeter back to our flow factory in Switzerland for the most accurate calibration on this device. (A Master Flowmeter is being used for many onsite calibrations throughout the year, which makes it an important reference for the in-process measurements.)

As it turned out, our factory is currently heavily loaded with recalibration jobs from customers around the world, so a backlog is inevitable. This backlog situation and its natural delay with first-in / first-out in executing calibrations led to an urgent request from our customer to our local team in Singapore, from there to our Service Hub in Germany all the way to the Strategic Account Manager - because the planned calibration date of the Master Flowmeter, including all possible shortcuts in the system, would be September 20th, 2023 on the calibration certificate. That being said, the calibration certificate from last year asked for a calibration by September 19th,.........Singapore time!

Now, I hope that our Management stops reading this article at this point, since meeting the customer's request meant for our team in Reinach bypassing several of our internal well-established processes and workflows that were implemented for many good reasons and to have a smooth workflow in recalibrations.

Well, it is the people who make the business and although some of our involved teammates did maybe not do much, but all these little individual actions of many summed up to getting the device calibrated in time before midnight of September 19th, 2023 (Singapore Time) - with that being documented on the calibration certificate. And by getting this done, they helped the customer avoiding a deviation.

The cherry on the top is, that the Master Flowmeter, which left the factory in July 2016, was calibrated successfully.

A big Thank You to our team at E+H Flow, who once again impressed me heavily.

Another learning of this nice little story could also lead to the conclusion, that time-based calibrations as they are out there for decades, can today be improved with smart instruments. These indicate the need for calibration automatically and can support significant expansion of time-based calibration cycles as we know them (e.g., 1x per year) .

;-)