In 2015, 30 percent of the 40 GMP warning letters issued by the FDA for data integrity deficiencies referenced training issues or requirements.1
There are a number of challenges hindering effective training in life sciences. For example, most companies use one system to manage standard operating procedures (SOPs) and other documents, and a different application to manage training, creating a barrier between two aligned activities.
Tolmar, a specialty pharmaceutical company, built a custom application to manage and track compliance-based training requirements while using a cloud-based system to administer various other training types. The in-house learning management system (LMS) required extensive configuration and integration, as well as ongoing validation support.
“We have around 1,600 documents that 700 employees across the organization need to be trained on. Managing this workload across two applications—our cloud-based document management system and in-house LMS—is complex and requires a lot of overhead,” said Joe Miller, VP of information technology at Tolmar.
Similar challenges make it difficult for companies to link training outcomes to business objectives, such as reducing manufacturing-related deviations or other quality events. But an effective training program can have a direct impact on critical quality metrics by bringing together training with quality goals. As a result, more life sciences organizations are rethinking training as a strategic part of the business in quality.
Companies are modernizing training to unify processes across quality, content, and training systems for improved quality management. In an end-to-end quality process, companies identify and revise the documents impacted by a deviation, then the quality event automatically triggers and assigns training tasks to the right people. Training is connected to document versions, change control processes, and quality events, helping support organizational goals to improve quality metrics.
Here are five steps to make training a strategic asset.
Step 1: Attach Trainable Behaviors to Quality Metrics with Bill of Learning
Bridging the gap between a business goal and training starts with a bill of learning—a breakdown of the goal into discrete, measurable learning objectives for a specific skill set. Educational initiatives are tied to a company’s strategic direction, helping improve critical metrics. Also, a bill of learning can help demonstrate the impact of training on the business.
“A bill of learning provides significant benefits to the learners by helping them gain the proper knowledge, skills, and behaviors they need to be successful,” said Karl Kapp, director of the Institute for Interactive Technologies and professor of instructional technology at Bloomsburg University. “It addresses questions like, ‘Why am I learning this?’ or ‘How does it relate strategically to what I do on-the-job every day?’ Linking the strategic objective to the quality process allows learners to see training in the context of their everyday jobs.”
In this bill of learning [Figure 1], the objective to decrease deviations is divided into the actions needed to meet this goal, such as implementing the correct manufacturing process. Then, to implement the right manufacturing process, knowledge of how to properly perform the assembly process is reinforced through training. Ultimately, the bill of learning makes it easy to understand the impact of not following proper SOPs, which helps reinforce the importance of following approved processes without deviation.
“The idea is that companies can break a strategic objective into specific learning components and link the learning outcomes back to the organization,” said Kapp. “In doing this, companies effectively connect quality and compliance, gathering metrics that can be measured against corporate objectives to continuously improve quality processes.”
A single solution for training and quality management in the cloud allows nationally or globally dispersed organizations to bring together SOPs, quality processes, and training with complete transparency. For example, companies identify the gaps in documentation that resulted in a deviation and build training around those gaps. With a bill of learning, training is attached to a corporate objective to ensure alignment across internal and external stakeholders.
“At Tolmar, one of our quality goals is ‘do it right the first time,’ and a cloud-based training solution provides a strong foundation for this goal,” said Miller. “Many pharmaceutical companies have a program or process for SOP training, but most are inefficient. A training system in the cloud that’s connected to quality processes and content helps streamline our training, so we are more confident that critical documents have been read and understood.”
Step 2: Define Learner Roles for Role-based Training
Once a bill of learning is established, the next step is to specify learner roles—the foundation for role-based training. Modern role-based training uses a combination of job responsibility, function, and level in the department or organization.
With legacy technologies, learner roles are often exclusively tied to a specific job title or job ID, limiting the ability to deliver precise content to each person. People are often undertrained or placed in more than one group and over-trained. Both situations present compliance risks. Without the ability to deliver appropriate, contextual content, it is almost impossible to build a flexible and scalable training program while ensuring compliance.
Defining learner roles is a critical first step in implementing a role-based curriculum, and it starts by asking questions like, “Is each role specific to one department, job, or function, or combination of these attributes?” or “Which roles are applicable to the behaviors identified in a bill of learning?” The answers will help teams tailor training programs to ensure the right content reaches the right people, to do the right job, at the right time.
Modern training solutions connect training to learner roles in an end-to-end process within the quality system. A quality document is tagged as required training and, in the event of a deviation, the content is revised via change control. The revised document is then automatically reassigned to learners as a training task. As a result, companies deliver the right content to more precise audiences without over- or under-training, increasing efficiency and compliance.
“The ability to track a user’s training status or assessment for any training document enables management to ensure only those qualified to perform a particular operation can do so,” said Miller. “For example, if someone is out for the day, it’s easy to find other qualified employees to perform a task, helping minimize compliance risk and improve daily operations.”
Step 3: Connect Critical Content to Learner Roles with Microlearning
After determining learner roles, organizations can apply microlearning techniques to develop hyper-focused content for their role-based training programs. If many deviations are associated with an SOP, companies divide the SOP into smaller, targeted learning assets to help learners hone in on skills. Since each task is connected to a larger instructional objective, microlearning reinforces the right behaviors for better performance that improve strategic quality objectives.
“Performance support and learning are inextricably linked,” said Kapp. “In any organization, we learn because we want a certain outcome. We want learners to perform an action correctly. So microlearning can really be an invaluable tool for supporting improved performance.”
Microlearning in a unified quality system helps formulate an end-to-end learning journey, not just one learning event. Once a quality procedure is revised, the system automatically re-assigns training for that SOP based on the pre-determined learner roles. Modern learning frameworks like microlearning help ensure that learners are not only reading and understanding documents, but also applying that knowledge to their daily tasks effectively.
“We want to expand our program to go beyond simply training on SOPs and see if specific training has a real impact on an individual’s performance,” said Miller. “With our cloud-based application, we can use concrete evidence, such as results from on-the-job training, to assess an employee’s comprehension. Doing it right the first time will help us avoid rework and costly errors.”
Step 4: Deploy Training in the Flow of Work
Microlearning is only as effective as when, where, and how it is deployed. Companies can expect better results from training programs by shifting from individual, content-driven events to learning that is deeply contextual, social, and embedded into real work.2
Considering how much information is consumed via technology every day, meeting learners where they learn best—in the flow of their work and day-to-day life—is crucial. The average person checks their smartphone nine times an hour and gives content less than seven seconds to hold their attention.3 In fact, smartphones dominate as learning technology, with 70 percent using their mobile devices to learn.
Where and when learning takes place should also be considered when deploying training materials. A large percentage of learning happens during the workday with 27 percent of learners consuming content during the work commute and 42 percent at work. Also, since more than half of individuals learn at the point of need, microlearning can greatly impact learning objectives by delivering learning events more rapidly and frequently.
“When a learner needs to retrain on the appropriate steps to execute an action, they access training in the flow of their work when they need it most, without delay or interruption,” said Kapp. “This is an example of how microlearning and the strategic goals of an organization can come together to create the right learning environment.”
One solution for training enables both learners and trainers to focus on the right content, at the right time, across devices. By connecting learners with training content at the time of need and according to their learning habits, companies can better change behaviors to decrease quality events.
Step 5: Generate Insight and Take Action to Realize Measurable Impact
Many organizations have encountered difficulties generating comprehensive reports around training or qualification tasks and how they are related to compliance. Training tasks live in a different place than the training content, such as in a document management system, email, or in multiple learning platforms, reducing visibility.
End-to-end insight in a unified cloud system enables companies to understand how training is related to quality objectives to make better, more informed decisions. Once a training initiative is complete, teams generate reports that include which critical content and version are associated with deviations when corresponding training materials linked to a deviation were consumed, and if the number of deviations decreased as a result.
With quality processes, documentation, and training unified in one solution, quality teams can effectively report on strategic metrics and the ROI of the training program. A bill of learning in a unified system provides a direct correlation from the discovery of an issue to the deployment of training and a tangible process improvement.
“Direct integration between our training, documents, and processes allows us to measure the impact of training and determine if training is helping us meet strategic goals,” said Miller. “We can schedule training for new and revised documents, link quality events like CAPAs to training tasks, and measure the results. These new capabilities, only possible with a unified platform, will eliminate manual processes and allow us to stay dynamic and better align our processes with quality objectives.”
What’s Possible Now: Strategic Training to Improve Quality Metrics
Corporate learning in life sciences has the potential to be more than simply a program to improve productivity and reduce errors. It also can be an important source of strategic, competitive advantage.4 By continually breaking down a strategic objective into specific learning components, companies teach to those components and apply the outcomes to the organization. At the conclusion of the process, individual teams provide metrics that measure improvement and lead to the development of better quality programs around a specific learning objective.
The key is to connect all the pieces of the puzzle together, aligning training to specific quality goals.
The cloud is enabling the industry to bring training and quality processes together and transform quality management. The results of doing so include saving time by accelerating internal audit preparation and onboarding team members faster, as well as improving compliance as more quality professionals can execute their jobs better. Correlating training results to quality objectives will enable organizations to make more informed decisions and rethink training as a critical business strategy.
By connecting quality management and training in a single application and applying modern learning techniques, life sciences companies can create an effective training program that’s measurable across the organization.
About the Author
Kent Malmros is senior director of Vault Training at Veeva Systems. He has spent the majority of his career delivering technology-enabled training solutions to life sciences, holding leadership positions at leading companies such as AdMed, ClearPoint (Red Nucleus), UL EduNeering (UL), and now Veeva Systems.