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By Karen Dixon

EAS is pleased to introduce a new column in our EAS-e-News called Ask the Expert. Each month our expert consultants and Senior Directors will answer one question sent in by readers (edited if applicable to remove identifying information). If you’d like to submit a question, please use the “contact us” link on our website.

This month’s Ask the Expert question is on training requirements in a manufacturing facility is answered by EAS Independent Consultant, Karen Dixon.

Karen has a strong focus on the development and implementation of FDA readiness programs including processes, compliance considerations, and integration within all levels of an organization. Her unique combination of expertise in operations, training systems, finance, product quality, Quality Management Systems, regulatory affairs, and ISO-9001-2015 makes her a valuable asset to EAS clients. She has held positions such as Manager, Quality Management System at Altria and Philip Morris USA and is a Certified Quality Auditor (CQA) with the American Society for Quality.

Question: How can I ensure our company offers effective training for all levels of employees at our manufacturing facility?

Dixon: In an FDA regulated manufacturing environment, the importance of a solid training program is critical to meeting your quality system requirements. Most manufacturing companies are faced with ‘doing more with less’ and often training is a burden. There are several solutions that can address training efficiencies and enhance the overall knowledge base of your employees. After all, your employees are your most important asset.

First, no training program should be one-size fits all program. Your procedure/process should be designed for flexibility in training delivery while ensuring you meet critical requirements. Developing a level or class system within your training SOP will aid the manufacturing process when there are competing opportunities. For example, a level 1 could be defined as the employees’ immediate job function and the work instructions associated with it. Level 2 would be your ‘read to understand’ material, and/or quality procedures designed for understanding. Level 3 training could be those materials and/or courses developed to enhance employees’ capability, i.e. business writing classes. This categorization would allow the firm to focus priority. Training an employee in their immediate process in order to produce a quality product is more pressing than a continuing education class for example.

For your infrastructure, implement a training procedure with these requirements clearly defined.

  • Type of training (Level 1, 2, 3)
  • Platform (i.e., computer-based, classroom, on-the-job or read-to-understand)
  • Trainer (i.e., buddy system, subject matter expert, certified trainer)
  • Record keeping requirement (roster, training assessment)

It is important to remember that the FDA Inspector will want to see evidence that an employee has been provided the appropriate training for the tasks they are performing; therefore, good documentation is imperative. There are a number of training options, of course. One is a “canned” Learning Management Systems (LMS). Another is attending public courses to meet your training requirements. Depending on the topic, some public courses have been vetted and certified to offer continuing education units (such as EAS Consulting Group’s Food Labeling Compliance Seminar), others, though not providing specific CEUs meet the training requirements required by FDA, (such as EAS’ Dietary Supplement Good Manufacturing Practices Seminar). Still, a third option is to bring outside trainers into your facility to provide a customized approach to your specific business and training needs. Customized programs offer an opportunity to bring in experts familiar with your type of business as well as the federal, state and industry regulations with which you must comply so that those in-house programs developed to meet your needs exactly.

Steps to Achieving Effective Manufacturing Training

No matter the type of learning environment, online, public or in-house, there are some basic steps needed to achieve optimum adult learning:

Here are a few points to consider about each step:

Design: During this phase of development, you should focus on the need for the training or conducting a ‘needs analysis’. Considering the business goals or metrics behind the topic of the training. Create clear learning objectives to uncover topics that are influencing the training.

Develop: Points to consider under development: 1) stay true to the plan developed during the Design phase, don’t drift into another topic or focus area, 2) Gather credible sources of information for the training. Use facts, input from Subject Matter Experts, and guidance from seasoned employees.

Deliver: Consider your audience through a leaner-centric approach. Delivering learner-centric material means you are delivering to adult learners who learn very differently than adolescents. Clients should consider investing in a full-time training developer who has been trained in adult learning principles. Most clients already have an employee or employees dedicated to training, even as part of a job. There are many inexpensive courses available that would enhance their ability on understanding adult learning. Investing in a two to the three-day course would bring a return on investment quickly.

Evaluate / Continuous Improvement: Your training program will never be complete. Continuously evaluating the health of your program through metrics is important. Whether it is a simple measure of percent complete trained, evaluation of non-conforming product incidents, or waste percentages there is always a way to measure the health of your training program. Revisit your initial training material and improve as needed.

To learn more about training design and developing a flexible training program, contact EAS Consulting Group. Our independent consultants can provide a perspective your company needs to ensure processes and procedures are accurately in place to support full compliance with current and future FDA requirements while also providing counsel on how your infrastructure can work for you in meeting production goals.

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