Imagine driving the wrong direction for hundreds of miles after a wrong turn, simply because you didn’t notice missing the exit. Overlooked deviations can cause a lot of frustration, whether during a drive or while executing a batch of pharmaceuticals.
Detecting and recognizing a deviation or other problem while in process is called review by exception (RBE) and it can be done live. This is the main point of my article in the September/October issue of InTech. RBE drives significant competitive advantage for manufacturers that use it. Analyzing batch manufacturing data after the batch is completed might take days or weeks, during which time good, life-saving product takes up space in inventory, or a bad batch proceeds to waste disposal.
One manufacturer started using RBE analysis tools built on a digital platform to get results in real time, resulting in substantial improvements.
Digitalization of the review process has allowed the QA team to safely auto-release 50–60 percent of batches immediately after completion. Average batch release time went from four weeks to six hours. The organization saved millions of dollars in finished goods inventory, and QA personnel gained more time to focus on manufacturing performance and product quality.
RBE provides plant personnel with situational awareness. Operators and quality personnel can see a problem while it’s happening and intervene well before the batch runs to completion.
One way to get the most value out of an RBE system is to choose one that natively interfaces with both the distributed control system (DCS) and manufacturing execution system (MES) in the plant.
Choosing a solution specifically designed to work with the existing MES and DCS benefited the team in several ways. It required no additional complex engineering, because it seamlessly integrated with the organization’s MES and DCS. This reduced the project time and made the RBE system easier to maintain over its life cycle. The team also pulled alarms and OPC exceptions into the RBE system in real time, helping them stay better informed.
Emerson offers just this kind of tool, Syncade Quality Review Manager, which reduces the time and effort required to identify, review, and resolve process exceptions. Delivered as part of the Syncade manufacturing execution system, this product supports a review-by-exception methodology, allowing quality and manufacturing personnel to release batches faster, resulting in a reduction in inventory and time required to release product to patients, while continuing to promote quality.
RBE technologies operate directly at the intersection of automation and personnel to help plants make the efficiency gains necessary to improve processes and dramatically cut release times. When an RBE system empowers personnel and smoothly integrates with existing tools, operators not only perform their tasks with more confidence, but also have the process history and task flexibility to focus on other critical issues affecting performance and quality. In addition, digitalized production boosts morale and increases collaboration among plant personnel, improving the overall plant experience for operators, QA team members, and other plant staff.
Visit the Lifecycle Services Pages at Emerson.com for more on technologies and solutions for pharmaceutical and batch manufacturing QA and content evaluation. You can also connect and interact with other engineers in the Life Sciences Group at the Emerson Exchange 365 community or share your comments below.
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