The GMP Training Matrix: A Game Plan for Consistent Compliance

Mapping training plans to role-based training matrices sets a foundation for inspection readiness and consistent compliance.

Training leaders often ask me about best practices for developing a training matrix. It’s an important topic because delivering the right content to the right people at the right time is the ultimate goal to ensure each individual is qualified while improving learner engagement. It also has a critical compliance impact on organizations in highly regulated industries. 

Unfortunately, the frameworks we've used over the last three decades have yet to change or evolve into a set of best practices that can be easily referenced or applied by any organization. There is no “one-size-fits-all” approach to GxP training excellence, as it depends on each company’s history, goals, and focus. 

Recently, I had the opportunity to explore this topic with three industry experts: Nicole Donovan, SPHR, SHRM-SCP, director of organizational development at Tolmar; Christian Torstensson, director of learning and development for Sanofi; and John Constantine, senior vice president at Orchestrall, Inc..

The following are key lessons learned and best practices from our discussion. 

Training plans and matrices must evolve together

As Nicole defines them, training matrices are logically organized collections of curricula with training content that summarize the skills and knowledge each employee must master. These matrices are linked to various training plans, which prioritize activities so that everyone in the organization — from employees and supervisors to managers and business leaders — understands top priorities and the sequence in which training needs to be completed for specific qualifications. Ideally, training plans and matrices evolve together. 

However, Christian says many pharma training departments still approach the process reactively, prioritizing plan development and keeping it separate from matrix development until a problem comes up. As a result, plans may remain hidden in an LMS until they’re pulled out and used to define matrices after, for example, a manufacturing challenge. Ideally, training teams should start with matrices and roll them out into individual training plans.

Proactive inspection readiness and annual report building

John says that linking plans and matrices makes it easier to take a strategic, proactive approach to improve GMP inspection readiness. With a reactive approach, staff responds to an inspector’s request by pulling a report from an LMS and extracting data from it. Having robust training matrices in place would allow a more proactive approach, with each matrix serving as an inspection playbook, making it easier to drill down and find requested data.

This benefit also extends to the annual reporting required by the FDA and recommended by ICH. Matrices ensure the information needed for yearly manufacturing reports is correct and up-to-date. John recalls his experience helping large pharma companies prepare annual reports and the difficulties of pulling matrix data from 400–500 role-based training curricula. “If you don’t have a matrix to figure out all that information, it is almost impossible to track,” he says.

But matrices are equally crucial for small companies. For one small innovative organization, John says, they enabled role-based training assignments and a matrix to be developed as new software was being implemented and moved the company away from manual processes. This should be a consistent best practice – refactoring training to develop a matrix in conjunction with the move to digital systems. 

Who should create the matrices?

Ultimately, success requires focused training on what is directly related to each individual’s role and the procedures they are responsible for on the manufacturing floor. It should never be one individual’s responsibility, Nicole says. 

At Tolmar, training and development leaders generally establish priorities and structure for training in close collaboration with the company’s quality department. Ownership belongs with the individual’s department, she says, within the overall structure that is in place. Ultimately, department managers are responsible for ensuring that those on their team have the training they need.

For small organizations that do not have a formal training department, John suggests that each business function owns the content that needs to be taught, while the training department takes responsibility for compiling a governing matrix and executing training programs.

For most small to mid-sized companies, creating a small but dedicated training group is the best way to ensure that individuals in different functions are properly qualified. Setting up such groups is easier than it sounds. At some companies, five people in five different locations may spend a fraction of their work time on training because someone needs it. They can be brought together to form the inaugural training group, which would scale over time as the company grows.

Keeping it simple

Training experts emphasize the need to avoid getting caught up in terminology. After all, Christian notes, qualifications, roles, and skills are just terminology buckets that describe different aspects of GxP training. If training leaders try to shoehorn training into just one of those buckets, a task that would be better suited to another bucket will come up. A better approach, he says, is to figure out which buckets best describe the most impactful way to create job readiness relative to a specific task or SOP. 

He suggests allowing workers to choose the most relevant buckets, using simple questions to focus results, such as: "Are you based at Site X? Do you work in the cleaning space? What functions do you perform?" Christian says time and thought spent optimizing the questions will be well spent.

Simplicity is key, John agrees. "The more complex you make things, the sooner you will reach the point of diminishing returns and create new compliance risks rather than mitigating them all. If you've kept your training plan simple and followed the spirit of regulatory guidance, i.e., to ensure your people are qualified and stick to your plan, you're doing well."

Here is the recording of our discussion. Watch it to learn more.