If a batch record process relies on paper forms that must be physically passed between multiple employees, it is simply not possible to efficiently catalog the large amounts of data required to support these analytic and diagnostic activities. As a result, the ability to track manufacturing changes, identify quality events and take corrective actions is limited.
Example: Limited Awareness of Quality Events and Delayed Corrective Actions
Batch record data is used for more than just anticipating and implementing deviation plans. It’s also essential for monitoring the output of each step in a manufacturing process and using this data, in turn, to analyze the quality of intermediate products. Batch reports are the most important source for this data and can include:
- Ingredient information: Certificate of Analysis (CoA) supplied with raw materials, test method procedures and yields, as well as the source of the ingredients, the quantity used, and any notes from the original manufacturer may all have implications for the quality of the product being manufactured.
- Observed values: The measurements, weights and properties that line workers input as part of their material process actions are an integral part of the batch report and can be useful for diagnosing or anticipating quality problems that may arise from human error or oversight.
These capabilities are especially important in drug manufacturing, where seemingly small quality issues can quickly cause serious problems, up to and including a need to discard an entire batch in production. Furthermore, these issues are time sensitive when chemical processes are involved, meaning that QA engineers need immediate access to process data in order to signal quality events and initiate corrective action as soon as possible.
Solution: Robust Quality Reporting and Corrective Action Potential
Until now, companies have had to make do with the time delays and practical limitations inherent to manual batch record processes, closing the door to significant gains in efficiency, speed and accuracy. Manual processes are simply not fast, accurate or comprehensive enough to surface the observations that engineers and QA teams need to make real-time decisions about deviations, quality events and corrective actions.
This functionality can best be achieved with an EBR system. When batch record documents are filed electronically, the data contained in these documents is immediately available to relevant teams and to other parts of the manufacturing toolchain, such as an ERP solution.
An EBR solution improves QA’s ability to report quality events and initiate corrective action procedures in two ways:
- Right first time. Because batch record documents are filed electronically, it’s possible to set the range of valid entries that can be made. This means that any document that is marked complete will have valid data that QA teams can use immediately.
- Fast accessibility of data. Rather than waiting hours or days for batch record updates to change hands across teams, and for data to be entered into an accessible database or repository, the data is available seconds after a batch record entry or document is completed on the floor.
Pain Point 3: Disconnected Systems
There is no one system that can guarantee manufacturing success or control every aspect of a complex, multifaceted manufacturing process. Instead, manufacturers rely on a set of systems that monitor, collect and aggregate data, such as ERP, MES or SCADA systems that surface observations from multiple business areas for use in manufacturing, purchasing and other activities.
The necessity of interfacing with multiple systems poses a potentially serious problem for companies that use paper-based batch reporting processes because these processes cannot connect with electronic systems, are subject to human error and scale poorly.
While a lack of communication between systems is by no means unique to batch record development processes, it is an enduring challenge in the manufacturing field. But because the batch record is at the heart of the manufacturing process as a whole, limitations here can have wide-ranging impacts throughout a company’s operations.
Example: Poor Collaboration Among Users and Quality/Manufacturing Departments
Manufacturing is an integrated process that relies on interoperability between multiple business areas. A disconnected, manual batch record system interferes with physical operations, but also with collaboration between team members and employees in different departments. There are many scenarios in which this could be an issue, for example:
- Quality and manufacturing: As discussed earlier, QA teams must have access to manufacturing data in order to initiate quality events and recommend corrective action. Conversely, manufacturing teams must be able to report data to not only their supervisors, but also directors and engineers in QA.
- Manufacturing and operations: Operations-based departments such as human resources, procurement, legal and sales require access to manufacturing data in order to surface relevant observations and reports for stakeholders throughout the company, as well as for clients and customers.
While these connections are certainly possible using a manual batch record system, the challenges resulting from poor synchronization and time-consuming data entry can seriously limit the throughput between manufacturing and other critical business areas.