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/ Henry Mossi

3 Tips for an Effective Quality Management System (QMS) Training Program

Many Life Science and Medical Device organizations struggle with how to align training compliance with business strategy, resulting in reactive and often overwhelming training without any real value, which can lead to poor product quality and services. An effective training program must be a proactive and integral part of a business’s quality processes and strategy. In our experience with dozens of organizations and their QMS, we've noticed one thing: all successful business organizations share a common training culture focused on quality process improvements, as well as an effective training program for their workforce.

Training compliance is not just a “checkbox” for new hires and employees changing roles within an organization. Leading organizations have proven, effective training programs that translate to a knowledgeable and efficient workforce. For those working in regulated healthcare and environmental safety such as the European Commission and the U.S. Food and Drug Administration (FDA), the need to train effectively is even greater as per the U.S. FDA 211.25 - CFR - Code of Federal Regulations Title 21 - Personnel Qualification.

As we've become a trusted business partner for many leading Life Science and Medical Device organizations, we've identified three areas in particular that lead to effective training programs:

  1. Individual Training Assessments
    All individual training courses must be assessed to determine target audiences, training delivery methodology and the need for post-training evaluation. The training assessment ensures that a particular training offering is only delivered to the target audience. This means less memorization, information retention, and knowing when and where to get information as needed. By assessing the delivery methodology, organizations will also be able to determine whether a training course should be an independent self-study, an instructor-led classroom or an on-the-job training (OJT) session. A post-training evaluation assesses key training takeaways and drives the need for quizzes or a comprehensive trainee evaluation by a qualified trainer.

  2. Post-Training Accessibility
    Since everyone has a different learning curve, there is a chance that some information will get lost along the way. An organization that provides a central repository where employees can easily access required information such as quick references guides, job aids or user manuals, increases employee productivity. Employees do not need to memorize everything; they need to know where to find information very quickly when they really need it. An effective training program ensures that everyone knows the one-stop centralized training content resource where information can be accessed quickly and whenever it is needed.

  3. Learning Metrics
    Post-training metrics are key for continuous training improvement. These metrics are achieved by assessing the trainee’s productivity and overall product quality and services. Quality products or services are those far from defects and recalls. Poor services, product defects and recalls can significantly impact a company’s reputation and bottom line. If a person can retain and recall information, apply applicable principles, and have easy access to the required information to accomplish day-to-day tasks, productivity and quality standards tend to increase, keeping product quality at the forefront of business results.

Understanding the audience is one of the keys to delivering effective training. Once you understand how to train targeted individuals within a role, it becomes easier to measure how effective a particular training course or program is in achieving a goal. 

Regulatory requirements require training to be conducted by qualified personnel. The qualified personnel must not only be area subject matter experts; they must have excellent interpersonal and communication skills for maximum effectiveness. The more effective the training is, the more competent employees will be, resulting in better quality product, services and business profit. Inadequate and ineffective training leads to an incompetent workforce, which results in poor product quality and services, an impact on business profit, and most importantly on a company’s reputation.