How to Improve Manufacturing Operations with Review by Exception
As the pharmaceutical industry grows ever more competitive, operations are continuously looking for ways to reduce overhead and production costs- without compromising quality and safety. Quality assurance (QA) plays a key role in ensuring that only products which meet acceptable criteria are produced and measures are taken to ensure proper documentation. Such a system requires a highly trained and meticulous quality management team and system. Modern production environments must augment QA activities with computer assisted functionality to meet such goals. “Review by Exception” is an essential function to improve the quality and efficiency of pharmaceutical manufacturing operations.
Here, we look at the benefits of this innovative computer assisted functionality which greatly increases the efficiency of the process, while simultaneously cutting costs.
We will define what Review by Exception is and discuss how its implementation increases quality control while significantly reducing quality and manufacturing review cycles and costs.
What is Review by Exception?
Review by Exception is a process designed to leverage computer assisted review and checks to and streamline human review. Exceptions are created automatically or manually when pre-defined events occur. For example when a process deviation occurs, the system flags the deviation as an exception. The exception may prompt the operator to correct the issue in real time, or require review at a later time. Enabling Review by Exception allows plant supervisors or QA personnel to focus only on events with flags, as opposed to searching for events manually, post-mortem. Comments can be manually logged by an operator/user or enforced automatically by the system due to any parameter entry failing validation of set limits. This way, substantial review savings are achieved.
As the old saying goes, “If it ain’t broke, don’t fix it!”. This concept is exemplified in the Review by Exception process, directing attention towards areas where potential problems have been identified rather than exploring areas without evidence of opportunity.
What are the Highlights of Review by Exception?
Reduced QA costs. Review by Exception ensures QA and manufacturing effort is targeted where it’s needed. The time previously utilized on manual or paper review is no longer required.
Historical data. Review trends over time to evaluate QA performance. This ensures a culture of continuous improvement that will go a long way towards meeting your objectives.
Ultimately, adopting Review by Exception ensures your QA resources are deployed where they’re going to have the biggest impact. If you are looking for ways to deliver a high ROI when it comes to reducing production overheads, the introduction of Review by Exception functionality is a must.
Which Industries are Particularly Suited for Review by Exception?
Review by Exception techniques can work in any environment where intensive QA is employed. It is particularly suited for the pharmaceutical and biomedical industries, where meticulous and thorough process review is essential. Historically, businesses involved in the production of pharmaceuticals, medical equipment and similar products invest heavily in QA due to the importance of delivering exemplary products and regulatory compliance.
If you are involved in the pharmaceutical, biotech, or life sciences sector, Review by Exception, built standard into OpsTrakker, could have a considerable savings in your quality organization. OpsTrakker decreases execution errors, allowing QA to focus only on review in case of exceptions, thereby improving manufacturing operations. The system itself acts as a reviewer so a separate Supervisor/QA review is no longer required.
Get in touch to find out more about Review by Exception and the other benefits that the OpsTrakker Platform provides to manufacturing operations.