Our last post focused on how to assess the robustness of your training program. Today, we want to discuss elements that make for a strong foundation for such a program.  Remember the goal is to maintain compliance while ensuring employees efficiently master required techniques and current operating procedures and protocols.

1) Consider your Audience for Training

When training people to perform assigned functions, different groups need different types and methods. Below are examples of certain audiences and what approach best meets their needs:

• New hires – Onboarding training includes good documentation practices (GDP), training program training, IT security processes, and core quality assurance (QA) processes, which are usually document management related. Job-specific training should be completed within the first two weeks after hire, with other modules introduced later, after the employee has been in the position for one to three months.
• Existing staff – Skills training (a.k.a. on-the-job training) is another important element of an ongoing training program. Do individuals performing complex tasks in a laboratory, manufacturing, labelling, or other capacity have a high risk of impacting patient/subject safety or the quality of the product? How can you best ensure their tasks are successfully implemented to mitigate risk? Steps should include:
  • Reading a procedure,
  • Observing a subject matter expert (SME) performing the task,
  • Performing the task while an SME observes, and
  • Performing the task independently.

• Contractors – This training can include signature records, GDP, training on the training program, and any core QA and/or skills-based training necessary to do their job.
• Training trainers – SMEs who either want to become trainers or are asked to become trainers must demonstrate proper schooling and certification and/or pass a “presentation assessment.” The presentation should focus on relevant subject matter, be presented to peers and/or other SMEs, and be evaluated based on clarity, content, presentation organization and style, communication of concepts and content, and the ability to answer questions. Such assessment allows individuals to become trainers based on their competency of a developed curriculum and their teaching skills.

2) Use Role-Based Curricula

Establishing role-based (rather than an employee-based) curricula for training allows you to effectively correlate roles and responsibilities delineated in standard operating procedures (SOPs) and training. While it can be a challenge to first ensure the roles within the organization are extremely clear and well understood, this type of structure allows for a more balanced (and less excessive) training regimen.

3) Develop Ongoing Employee Monitoring and Assessment

Assessments are one of the key foundational building blocks of a robust training program. While not every document needs to have an assessment, there must be a minimum of monitoring to ensure proper assessment of completed training. For example, “read-only” training is effective in demonstrating compliance only if someone can monitor and assess that people are reading the materials. Here is what can happen if that is not done regularly. Early in my career, I was completing a read-only training task when I couldn’t open a document in the Learning Management System (LMS). Since it was a training task that didn’t require an assessment, I could have signed and continued. However, in case there was some sort of “operator error,” I notified my training coordinator.

Not only did the coordinator discover a document rendering issue in the system, furthermore, they were aghast to discover that more than 200 people had been “trained on” this “unable-to-be-opened” document. Making students accountable with meaningful assessments (e.g., minimum passing grades, ongoing training involvement, or due dates to complete training) is just as important as reviewing materials at regular intervals to ensure people are completing training requirements, and you have accurate information for your benchmark values or metrics.

4) Implement Continuous Training, Documenting, And Monitoring

Business environments evolve constantly; your training efforts should evolve constantly, as well. Implement continuous training tactics (e.g., lunch and learns, annual GxP training, and quarterly internal audits or surprise FDA drills) so training becomes part of the company culture and employees come to expect it.

5) Remember that Training Is Vital to a Voluntary QA (VQA) Culture

Employee training impacts performance; when employees perform better, there is a reduction in compliance issues. Investing in the proper thinking, approach, and resources is the best way to bulletproof your quality training programs so you can operate in a more proactive “prevention” mode vs. a reactive “inspection” mode. Everyone in your company is part of Quality. A VQA culture involves trust, collaboration, and ownership among many people and across many departments. Training is fundamental for employees to learn and understand that quality is not what you must do at your company, but rather what we can do as a team.