By necessity, pharmaceutical manufacturing must be highly controlled. When excursions, or any event that falls outside of normal operation, take place during the manufacturing process, a chain of evaluation must occur to ensure the proper response and control takes place. As such, an excursion can have a severe impact on the process, including delays in lot release, loss of batches, or receipts of non-compliance.
New England Controls has developed an automated excursion management solution that uses Emerson’s Logbooks software in conjunction with a manufacturing execution system (MES) and a distributed control system (DCS). By working together, Logbooks, the MES, and the DCS make the process of identifying, classifying, and correcting excursions much easier. The automated excursion management system monitors events that have been classified as excursions, and when these events occur, they are automatically passed to the automated excursion management system. Automated entry of these items prevents users from needing to interpret what is important at the time of the excursion and removes the possibility of transcription errors.
The automated excursion management system drives a resolution workflow involving several individuals or groups within the organization. The number of groups involved is based on the classified severity of the excursion which is introduced to prevent Quality from reviewing low impact items that don’t require Quality input. These groups include:
- Manufacturing Operator – An operator who witnessed the excursion occur is responsible for performing an initial review, where he or she provides additional information to the automatically collected Information.
- Manufacturing Supervisor – A manufacturing supervisor ensures that the proper information was recorded and/or can resolve excursions classified as being owned by manufacturing. This prevents a Quality representative from having to review low impact excursions.
- Manufacturing Sciences – A manufacturing sciences representative can optionally be involved in the review process for specifically evaluating the science behind the change in the process caused by the excursion.
- Quality Representative – The quality representative will review the most severe excursions and take necessary action, which might include attaching justification documents or acknowledging that the issue requires further investigation, which he or she does by creating a CAPA. Quality only is involved in excursions classified as requiring quality or for unassigned excursions that are too generic to classify.
The automated excursion management system queries the MES and DCS at a high frequency to retrieve excursions as they take place. The MES and DCS record events as they occur, and some of the events are classified as excursions depending upon their characteristics. These excursions are loaded into Logbooks where the manufacturing employee who observed the excursion will enter additional context around the excursion. Then, it is escalated to a manufacturing supervisor to approve or escalate through the process, depending on the severity of the excursion they are working on resolving.
One of the benefits of an automated excursion management system is that the excursion can be reviewed in almost real-time, which increases the awareness of the initial impact of the excursion and reduces the risk of forward processing. In fact, the goal is to use this real-time collection and resolution process to have zero unresolved excursions by the time the batch is ready to forward process. By collecting all excursions into the excursion management system, lots can be released quicker, because it will be possible to close out the batch closer to when it was completed, if not almost immediately after it is completed.
Download New England Controls’ whitepaper to learn more about this solution.