Workflow for Biopharmaceutical Excursions

In the biopharmaceutical manufacturing world, the term excursion strikes fear in the hearts of almost everyone. Why? Because simply defined, an excursion is when the manufacturing operation leaves the normal path of the manufacturing process – it takes a step in the wrong direction.

Excursions lead to deviations and to scrapped batches, rework, reprocessing, long delays in releasing batches, long and costly investigations, and mounds of paperwork. An excursion can be as simple as using a different than expected lot of raw material or as potentially complex as a batch failing a series of quality tests or a batch not completing successfully.

For many, what’s scary is the real possibility of having to proceed with a manufacturing process knowing there’s some risk but not being able to quantify or qualify that risk to determine the immediate or long-term compliance impact. Without the proper management of change (MOC) process or workflow to handle excursions and deviations, the potential for risks increases, leading to noncompliance issues and even costly fines.

The Paper Trail

Many biopharmaceutical companies do not have formal processes to manage excursions, because most excursion detection, investigation, and resolution practices are incomplete, inconsistent, highly manual, often paper-based and don’t use the latest technology. Meaning that to even detect excursions, someone must wade through a lot of meaningless information to determine if an excursion exists before deciding whether they need to launch an investigation.

For example, the comments found in many paper-based, batch documents tend to be too long and include irrelevant information. They are extremely time consuming to read, but every reviewer must still read them. Buried among these long comments, however, are often some very important comments that may go unnoticed because they typically don’t have enough detail. Under these circumstances, paper-based systems are costly as time must be spent to verify the comments to ensure Food and Drug Administration (FDA) and current good manufacturing practice (cGMP) regulations are met.

When it comes to excursion detection, the investigation and MOC process is just as long, just as manual, and just as fraught with peril. Thus, when an excursion is detected, the investigation team – usually the manufacturing, quality and sometimes engineering departments – tend to be buried in paperwork from the batch, which means the review process is usually hours or days later for each department. If the engineering department gets involved, more time is needed to approve and complete the MOC, which takes time and increases costs.

In these instances, companies must rely on highly-skilled, seasoned individuals or teams, who perform these tasks well, despite the long and costly process. The most experienced people can’t be everywhere at once, however, and they can’t personally investigate every excursion. What’s worse is when they retire and take their many years of operational knowledge with them. It’s important to capture that tribal knowledge, combine it with best practices and translate it into intelligent action plans for any excursion. Think of it as a work process or a workflow management system focused on handling excursions.

Real-Time Detection

By integrating some business process changes with off-the-shelf technology tools, it’s possible to establish rules so individual teams can quickly detect an excursion and collect the data associated with the excursion in real time. This newly defined process eliminates the need to manually record the data on paper. Instead, it links the data directly to the batch as part of the electronic batch records.

The result is a new MOC workflow system that makes it easy for the investigation and disposition teams to handle excursions quickly and as painlessly as possible. It gets the right data to the right people in a timely fashion – saving time, batches, compliance and a lot of money. It also removes the fear and dread out of excursions for good.

To this end, operations, quality and manufacturing teams should have step-by-step instructions to help them quickly detect, investigate and disposition excursions, all while delivering the real-time data needed to keep tabs on the investigation and disposition progress, and later even refine future workflows for optimal effectiveness. Once the data collection processes are in place, it’s possible to track specific conditions and trends to help prevent excursions from happening. The idea here is to make sure the team has the right response to every excursion, every time.

Key Workflow Elements

Workflows can and should include many elements, such as the rules to detect the excursion in the first place and then ensure the right information gets to the right people in real time. In this way, the quality and manufacturing teams can review the data, perform their initial impact assessment, correctly classify the excursion, and determine the proper course of action. All as quickly as possible, with the necessary data at hand.

A key element of the workflow is the entire excursion resolution process. Some of the first steps in the workflow process will be to determine:

  • The severity of the excursion
  • The owners of the excursion
  • The team of people or departments that need to get involved

Defining these processes in the workflow is important to get an initial review completed to verify that the right people or departments are assigned. Some excursions can be handled just by the quality team or just by the manufacturing team; some require both quality and manufacturing; and some require quality and manufacturing with the engineering team involved.

The initial review and triage must be performed as quickly as possible, making the real-time data collection and the real-time process management through the workflow almost mandatory. After the initial review, the manufacturing review can be thought of as a real-time equivalent to the post-batch manufacturing review. Likewise, the quality review is the real-time equivalent of the post-batch quality review. In both review processes, emphasis is placed on real time.

Again, to make all this work, real-time data collection is critical. Details such as batch, order, and operator comments along with batch operations, batch phases, and batch steps provide both the information and the information context to allow the excursion to be properly identified, classified and assigned for investigation and processing.

The result is a workflow-based excursion management system that:

  • Provides real-time excursion detection
  • Gets the right information to the right people in real time
  • Defines step-by-step instructions for excursion investigation
  • Has mobile-ready access for on-the-go monitoring and execution
  • Allows real-time reporting for insight into the excursion processes
  • Includes historical records for ensuring compliance and recording of data in audit trails

Such a system offers tremendous benefits, including:

  • Fewer rejected batches
  • Less rework and reprocessing
  • Quicker batch release
  • Reduced operating costs
  • Reduced paperwork
  • More accurate batch records
  • Product lifecycle management

All in all, having a real-time workflow-based excursion management system in place means handling excursions becomes routine. It’s just part of doing business. It means the right people have the right information and the excursion processes are handled like clockwork. It saves time, batches, and money – a lot of money. There’s nothing to fear or dread about that. People can find other things to worry about. A real-time, workflow-based excursion management system is well worth taking a good, long look at to keep your manufacturing operations on the right path.

John Clemons

John Clemons

is Director of Manufacturing IT at MAVERICK Technologies with over 30
years’ experience implementing manufacturing information technology in
FDA-regulated industries.

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ABOUT THE AUTHORS

John Clemons

John Clemons is Director of Manufacturing IT at MAVERICK Technologies with over 30 years’ experience implementing manufacturing information technology in FDA-regulated industries.


John Clemons

Rick Mondragon is Industry Manager for the Life Sciences industry at MAVERICK Technologies with 30 years of industrial process automation experience, including 20 years delivering, marketing and selling compliant solutions to biopharmaceutical customers. He has extensive experience with biopharmaceutical manufacturing processes, change control and cGMP production.

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