An effective training programme for a strong QMS

Companies in the life sciences industry must ensure they have the systems and tools to be able to consistently provide a product that is safe and effective and that is delivered in a timely manner to meet the needs of customers, in addition to an efficient and agile support system for resolution of unexpected situations.

These elements strongly resonate with having a robust quality management system (QMS) in place, i.e. a system to manage the quality of your products, as well as having an effective training programme for personnel on the policies and procedures that make up the QMS. You cannot have one without the other. Let’s expand on how these two ideas are interconnected.

A QMS is defined as a formalised structure that documents the processes, procedures, and responsibilities for achieving quality policies and objectives. A robust QMS is the vehicle that allows organisations to coordinate and direct the activities that will meet customer and regulatory requirements. Those regulatory requirements are translated into policies and procedures to ensure that every time a process is performed, the same information, methods, skills, and controls are used and applied in a consistent manner. However, policies and procedures won’t do your organisation any good if your employees don’t follow and understand them, and that is where training enters the picture.

How an effective training programme is key to having a strong QMS

Training expectations and requirements are explicitly mentioned in FDA 21 CFR 211.25, which states:

• Each person engaged in the manufacture, processing, packing, or holding of a drug product shall have education, training, and experience, or any combination thereof, to enable that person to perform the assigned functions. Training shall be in the particular operations that the employee performs and in current good manufacturing practice (including the cGMP regulations in this chapter and written procedures required by these regulations) as they relate to the employee's functions. Training in cGMP shall be conducted by qualified individuals on a continuing basis and with sufficient frequency to assure that employees remain familiar with the cGMP requirements applicable to them.
• Each person responsible for supervising the manufacture, processing, packing, or holding of a drug product shall have the education, training, and experience, or any combination thereof, to perform assigned functions in such a manner as to provide assurance that the drug product has the safety, identity, strength, quality, and purity that it purports or is represented to possess.
• There shall be an adequate number of qualified personnel to perform and supervise the manufacture, processing, packing, or holding of each drug product.

Whenever deficiencies are found during an FDA inspection related to training of personnel working in management, production, quality assurance, and quality control, it is the above section of the Code of Federal Regulations that was not followed. This, by itself, is the first justification for having an effective training programme.

Moving beyond the compliance aspects and regulatory expectations, once the impact that an effective training programme has on critical quality metrics and objectives is understood, the results include ending up with a strong QMS.

Policies and procedures provide a roadmap for day-to-day operations. They ensure compliance with laws and regulations, give guidance for decision-making, and assist in streamlining internal processes. Employees need to be trained on the policies and procedures of a company’s QMS to achieve quality goals. However, what’s more important is the appropriate training of the employees on the procedures to obtain their buy-in of quality objectives. There are many other benefits an organisation gets when everyone is following, understanding, and applying policies and procedures correctly. These benefits include efficient use of time and resources, consistent processes and structures, and the increasing ability to identify deviations and areas of improvement in your processes. This is where an effective training programme complements a QMS and strengthens it. Moreover, when employees follow procedures and have a clear understanding of them, they perform tasks correctly and provide consistent customer service, which, in turn, results in enhancing the quality of an organisation’s products and services.

Training supports many areas of a company. For example, one of the most targeted areas of a regulatory audit is the training records. Likewise, when an incident occurs, the corrective action is often training and more training. Another instance in which training is brought into the picture is when companies get a regulatory agency citation, with one of the most common action items proposed to address it being to provide more training to the employees.

But has the company determined how many of the quality deviations or non-conformities are caused by human error? And do they know if these errors were isolated or recurrent events? If the data points out that a significant number of deviations are caused by human error or if the data analysis shows events are recurrent, these may be signs of not having an effective training programme in place. Then the question becomes, is the company certain the root cause of events is not tied to the training programme itself?

Making sure your employees read policies and procedures is the first step towards ensuring compliance, but this alone is not enough, as it does not guarantee that every employee will truly understand them. Also, employees may not entirely know how to put procedures into practice and that is a key aspect a training programme should cover. Companies must ensure they are not focusing only on getting people trained, but on how they are training them, on what the substance of the procedures is and, moreover, what their application is in real situations, so that they really get people to learn. It cannot be merely “checking a box” that says they read the procedure. An employee may sign off on a document without fully understanding it and, in the long run, this will be reflected in an increased number of quality events.

If training is being conducted just to keep records as evidence of compliance, then the need for an effective training programme becomes imperative. Training performed without a subsequent evaluation of the results is inadequate and weakens the performance of a QMS, whereas trained and qualified employees are an indication of quality and continuous improvement in all processes. Thus, a formal assessment plan that determines the effectiveness of the training programme and the corresponding action(s) to improve it where needed becomes a must.

It may be challenging for companies to link training outcomes to business objectives, such as reducing the number of quality events or manufacturing deviations, but an effective training programme can have a direct impact on critical quality metrics and objectives when combined with quality goals. As a result, rethinking training as a strategic part of the quality side of the business, as well as correlating training results to quality objectives, will allow companies to make more informed decisions that will not only improve the overall productivity and the quality of products and services, but will also ensure compliance.

A well-defined training programme is likely to be effective

Before assessing the training programme effectiveness, it is important to have a plan that clearly defines its goals and purpose, including the purpose of each training event. In other words, start with a well-defined and robust programme. The plan should also consider an understanding of the team needs (strengths and gaps), as well as a definition of the skills that need to be developed in the training. Having this plan in place will assist in analysing whether the skills and knowledge were effectively acquired. This is the training programme effectiveness assessment.

Other considerations to have in mind when developing a robust training programme:

1. Question the training event

• Ask yourself: What is the training trying to accomplish?
• Determine if the training is related to a procedure in a process that requires ensuring consistent execution. If that is the case, was the process correctly described in the procedure? Are the trainees correctly identified?
• Are the trainers “content experts” on the matter being taught?

2. Tackle the assessment at two time points

• Manufacturing processes are complex and require a lot of attention from operators. Test the knowledge of the trainees after completing the training session, but also consider doing spot checks to test that knowledge during one-on-one meetings or even on the manufacturing floor, when they are executing the procedure.

3. Training should be on-going for all employees

• It all starts with a thorough onboarding process, but training should remain a living process, and include employees who have been working for the company for a long time, as training provides an opportunity to improve skills.

Evaluating the effectiveness of training

If a manufacturing process doesn't produce the desired quality product on a consistent basis, most companies would proceed to evaluate and identify what changes are needed to improve it. The same principle should then be applied to a training programme if, of course, it is being evaluated.

Training is still the primary method through which employees become qualified to perform their assigned tasks. Like other aspects of manufacturing and quality processes, training should also be evaluated to determine areas of improvement if it is not proving effective. When this is done, a company gains both compliance and productivity benefits and has greater assurance of a strong QMS performance.

In the assessment of the training programme effectiveness, there are many methods a company can adopt. The fact that each organisation works differently should be considered when selecting the method(s) that will work best for the company. Some methods used to evaluate training effectiveness are:

1. Testing
This is the most common method and a simple one if done properly. When using it, be sure to specify a minimum score as required to classify the test as a “Pass”. The testing method can be written tests with questions on the subject, or practical tests that involve the execution of a process or task that was taught during training.

One important consideration when using this method is to apply the test before and after the training is conducted, to ensure a more accurate evaluation. This will help determine if the employees increased their knowledge on the subject. You may also want to build knowledge or skill assessment into the training, such as quizzes, questions, or observations. This can provide evaluation data and reinforce learning at the same time.

2. Feedback from trainees
It could be as simple as asking the individual who was trained, “How do you think the training went?” This method could also consider asking the trainee to submit a short “report” summarising the procedure or attended training session.

3. On-going Review of Process and quality metrics
This method can be easily combined with all other QMS programme initiatives. It requires developing indicators and meaningful metrics that can be used to measure the achievement of training goals and reviewing compliance with those metrics frequently.

For example, if the training provided is related to a manufacturing process, and the number of quality deviations or recurrent events keeps increasing, an evaluation of the procedure and training event is appropriate. It is important to make sure we do not fall into claiming effective training through the absence of deviations, product defects, or complaints - especially if no one is formally looking at metrics. Use the data generated and assessed in mechanisms such as the Internal Audit Programme and Management Review Process to evaluate your training programme.

Having a competent, professional workforce is essential to having a strong QMS and meeting regulatory expectations. An effective training programme can ensure the quality of your processes.

About the author

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Limaris Alvarado Mercado is currently leading the Quality Management and Compliance division of PharmaLex US. She has over 25 years’ experience working for various biopharmaceutical companies. Her educational background includes a Bachelor of Science in Mechanical Engineering and a Master of Science in Manufacturing of Pharmaceutical Products from the University of Puerto Rico. Mercado also completed an accelerated programme at Stanford University Graduate School of Business.