The minor quality event in pharmaceutical manufacturing could be perceived as something relatively insignificant on its own. The event could include some kind of problem with the equipment, documentation issue, handling of materials, or some process interruption. While on their own, they do not necessarily warrant a full-fledged investigation. When they occur repeatedly, however, they could provide a clue to underlying issues that might be hard to detect when considered separately.
This is the importance of trend analysis of quality events. With the help of the trend analysis, organizations will be able to detect patterns regarding the equipment, process, material, documentation, department, or location.
Individual Events Are Only Partial of the Whole Picture
Suppose there is an equipment-related issue that happens once, gets investigated, documented, and finally solved. The same kind of equipment problem might happen after several weeks. In this case, the problem still seems to be under control. However, when it happens for the third or fourth time, it no longer becomes about "what" happened, but about "why" it keeps on happening.
What Should Be Trended?
Organizations need to classify events by relevant data, for example:
- Type of the event
- Department/Location
- Equipment/Process
- Involved material
- Date/Recurrence Frequency
- Risk Level
- Category of the root cause
- Recurrence
- Correction
It is necessary to be consistent since it is impossible to make a proper comparison of the data in case of the difference in classification of the same type of event.
Implementing the Risk-Based Approach
The trend is not necessarily a reason for a major deviation. Instead, it is possible to apply the criteria to choose an appropriate approach based on risks.
They might include product impact, patients' safety, GMP importance, recurrence, magnitude, equipment history, traceability, and efficacy of correction measures performed before.
Using Technology for Increased Visibility
Spreadsheets and siloed quality records can make it hard to perform trend analysis. Integrated manufacturing systems may provide integrated information related to the equipment, materials, people, processes, and manufacturing events.
IoT sensors, RFID, BLE, industrial gateways, edge computing, databases, and analytics software can be used to provide additional context to the analysis process. These tools will not replace quality judgments, but they could help the investigator find relationships and ask better questions.
A Simplified Workflow
There are six key components in the trending process:
- Record the event consistently.
- Classify it according to the quality system.
- Evaluate the risk and potential impact.
- Trend it by comparing it to past events.
- Find the recurring patterns.
- Act based on monitoring, corrective actions, or investigations
The goal is not to stop every small event that happens. The objective is to recognize when many small events create a bigger problem that needs to be addressed before the situation worsens.
Quality records, consistent classification, accessible history, and proper analysis lead to good quality decisions.
Track the events. Trend the data. Find the patterns. Take an appropriate action.
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