Beyond Compliance: How a Training Module Optimizes Quality

Training Management in QMS

Compliance with industry regulations is often the focal point in discussions about quality management systems (QMS). That’s not surprising since adherence to standards and regulations is an existential issue for any pharma company. However, another element of QMS systems that deserves more attention is how a complete QMS can drive teams to very high levels of performance. And the key to that is the training component of a QMS.

Imagine an America’s Cup sailboat racing team—a model of precision, synergy, and peak performance. Each team member knows their role, how to perform it with precision and perfect timing, and how their tasks interact with the actions of their teammates.

In this blog post, we’ll explore how the training module of a QMS can help a team in a manufacturing environment accomplish the same level of performance.

The Necessity of Compliance

Compliance with industry standards and regulations is, of course, of paramount importance and is a key catalyst for implementing a QMS system. For compliance, a QMS ensures that processes are completed and documented in accordance with regulatory requirements. By having batch records collected, deviations documented, and CAPAs executed, an organization is ensuring they meet the expectations of Good Manufacturing Practices. However, a training model is vital to going beyond compliance to drive improvements in both quality and performance.

When it comes to training, pharmaceutical manufacturers must comply with a number of regulatory requirements. These requirements ensure that employees have the skills and knowledge to perform their jobs safely and effectively. Some of the key regulatory requirements for employee training in the pharmaceutical manufacturing industry include:

  • The Food and Drug Administration (FDA) 21 CFR Part 211: This regulation requires pharmaceutical manufacturers to have a training program in place for all employees who perform activities that directly impact the product’s quality.
  • The European Medicines Agency (EMA) GMP Guide for Human Medicinal Products: This guide requires pharmaceutical manufacturers to have a training program in place for all employees who are involved in the manufacturing or quality control of medicinal products.

In both cases, the training program must ensure that employees have the knowledge and skills to perform their jobs correctly. But compliance with regulatory requirements, while critical, is a baseline. A training module in a QMS goes further, driving team performance.

The Training Module Ensures Everyone Knows their Role

Let’s go back to the sailing team. Compliance with the rules is critical – they must know the race rules and avoid penalties. But what makes them exceptional is the meticulous training and coordination that allows them to perform at their peak. So they need a set of plays they know how to execute flawlessly.

In the QMS world, the training module is the crew’s playbook. It equips staff with the skills, knowledge, and clarity they need to excel in their roles. It ensures they know what is expected of their roles and how to execute the tasks associated with their roles with precision.

By documenting each role and process and ensuring that every person is fully trained on the requirements of their role, the team as a whole is less likely to make errors or create deviations. This minimizes quality issues and reduces wasted time and wasted materials.

Much like each sailing crew member must know “the ropes” as they relate to their assignment, every employee must have a clear and exact understanding of their roles and tasks. By ensuring they have received training on each aspect of their role, the training module ensures they know not just what to do but why it matters. And that every time a change in a procedure occurs, their training is updated.

The Training Module Enables Continuous Improvement and Organizational Learning

Top-tier sailing teams don’t stop at the basics. They constantly train to improve their skills. Similarly, a training module ensures that employees are updated with evolving best practices and quality standards and, in that way, engenders a culture of continuous improvement.

The training module of a QMS acts as a repository of best practices for the organization. By capturing the proven best way to complete a task, the training module ensures that knowledge does not leave the organization when a person departs. Instead, it is retained and distributed to anyone placed in that role.

The Training Component of a QMS Standardizes Processes Across the Organization

Another key benefit of a training module is that it can be used to create training programs across multiple sites. This allows pharmaceutical manufacturers to deliver the same training to employees at all of their sites, regardless of their location, and results in standardization of processes.

For example, a pharmaceutical manufacturer could create a training program on the latest manufacturing procedures and link it to all of its manufacturing sites. This would ensure that employees at all of the sites are trained on the same procedures.

Training Modules Help You Go Beyond Compliance

In a sailing race, failures in execution cost seconds and result in lost races. In pharma manufacturing, errors result in wasted time, wasted materials, and the risk of warning letters or worse. Any QMS software system plays a crucial role in avoiding those outcomes and ensuring compliance. But it is the training module that, by ensuring everyone knows their role, is fully trained, and is up-to-date on every change, ensures a level of quality and performance that goes far beyond compliance. It drives the organization to new performance levels and helps them win their race to deliver the highest quality products.

PS. We have some exciting news coming for Scigeniq’s new Training Management System. Reach out if you’re interested in learning more ahead of its release.