Football games cannot be won without solid blocking and tackling. These are fundamentals, and that’s why solid defense is taught and expected by coaches from pee-wee all the way on through to the professional ranks. It is hard work and requires discipline day in and day out by every member of the team. Blocking and tackling isn’t glamorous or pretty, but it’s absolutely essential as is solid procedurals—policies, standards, SOPs (standard operating procedures)—based training for winning compliance.

Although there have been many advances in the use of sophisticated technologies in pharmaceutical manufacturing, companies still depend on people to install, assemble, calibrate, maintain and operate the equipment, instruments and systems. To do this properly day in and day out while avoiding errors, companies need to ensure that they are providing solid procedure-based training to their employees. This makes good business sense, and it is a fundamental requirement of FDA regulations that companies have well-defined written procedures and that employees are trained to perform these procedures as prescribed.

Not adhering to company procedures is pure folly. Yet, to this day, 25 years after GMPs officially went into effect, the most frequently observed deviation within companies and those cited in 483s during facility inspections is “operator error” caused by “failure to follow procedures.”

In today’s highly competitive market, no company can continue to tolerate such errors caused because of not adhering to procedures. Besides the obvious benefit of improving compliance and product quality, reduced operator error impacts the bottom line of companies by reducing waste, improving cycle-time and increasing productivity.

This calls for a solid procedural based training system that requires hard work and discipline. There are several key steps for implementing a solid procedural based training system and they include the following:

Mapping Procedures to Tasks/Positions

Mapping SOPs, standards and policies to the various job tasks and positions is an important first step because it clearly establishes the company’s required procedure-based curriculum for training purposes. With procedures mapped, management will now know what procedures are required not only for individual job positions (e.g., oral solid dosage operator) but also for specific tasks (e.g., tablet press operation).

Sequence Learning Progression

Sequencing the procedures, or what will eventually become the course content based on a logical learning progression, provides structure or the architecture according to which employee training and development should ideally progress (e.g., company ethics policy, quality systems standard, documentation practices and SOPs). The learning progression identifies the order in which training should be completed. Sequencing rationale should be:

• Logical to maximize learning—i.e., broad, easy-to-understand concepts first, followed by more complex details;

• Timely to reflect or be aligned to job tasks required to be performed within near future—delayed application of training concepts on the job usually results in employees forgetting most of what was learned originally, leading to errors; and

• Aligned to work and resource needs of the company—companies should ask how they should develop employees to ensure they are adequately trained and qualified employees to perform the work demands of the company.

Developing Written Course Instructions

Instruction for training courses is a written plan that explains how the training is to be presented in order to meet the learning objectives and provide consistency of delivery. The traditional and antiquated way of giving procedural training by simply cramming a bunch of employees in a room and then reading through SOPs on an overhead projector has been long viewed as ineffective. The purpose of training is not just to complete a check-list to satisfy GMPs; it is to develop the competence of employees to enable them to perform essential job tasks on a consistent basis without error. To achieve the latter requires effort, discipline and commitment from upper management.

Course instructions for instructor-led training must be in writing and should include learning objectives, content (e.g., SOP), methodologies (e.g., demonstration) and specific instructions for the trainer. Instruction for interactive, online, Web-based training can be built into the course, automatically providing consistency of training across the entire organization, thereby eliminating instructor variability. Both course instructions should be reviewed and approved by the applicable departments, the training organization and QA department to assure the appropriateness of the content and methodologies in meeting the learning objectives.

Using Qualified Trainers

While written instructions may certainly help ensure a consistent approach to providing training, it is not a substitute for assuring that only qualified trainers present the training. Qualified trainers must have the education, training and experience in the subject matter of the training being presented. Companies should strive to free up their subject matter experts, for they are often the company’s top performers. While the company may lose some short-term productivity, there is a huge gain with employees learning from the best, thereby driving consistency and exemplary performance.

The benefit of using computers will automatically provide consistency of training across the entire organization and eliminate instructor variability. Also, top performing subject matter experts are not required to lead the training, saving otherwise lost productivity.

Assessing Comprehension

The days of FDA accepting employee sign-offs signifying that they read and understood the contents of an SOP are long gone. Today, FDA expects that companies assess employee comprehension following completion of training to assure and provide proof that they have not only completed the required training, but most importantly, have met the learning objectives. Companies should embrace this concept as being critical to ensuring that their employees have the knowledge essential for performing their assigned job tasks.

Managing the manual completion of employee assessments for each training course is very error-prone, labor-intensive and costly. Many companies have discovered this and have moved to computer-based interventions for procedural training that include preprogrammed assessments which can be effectively and efficiently completed, graded and tracked automatically via a learning management system (LMS).

Training Completion and Assessments

As the saying goes, “what gets measured gets done.” Without an effective means to measure completion of required training and comprehension, companies will most likely not achieve success with their procedural training. Most companies have literally thousands of individual procedures in the form of policies, standards and SOPs. Individual employees may be required to know and understand 50 SOPs or more as part of their job. With so many records to track, it is no longer a luxury to have an electronic LMS or training documentation system; it is an absolute necessity.

An LMS enables companies to quickly, easily and accurately track and run a variety of reports to verify the status of required training and assessments. The ability to report this information is important for several reasons. It makes required training completion records visible to employees and their management alike so the training is much more likely to get done. When training deficiencies are observed, management is more likely to implement corrective action to bring employee training into compliance. Most importantly, management will be able to make more appropriate work assignments because they’ll know which employees possess the critical knowledge for specified work tasks, thus reducing the possibility of errors.

For companies to achieve winning compliance, they have to be good at basic blocking and tackling otherwise they won’t be able to stay in the game. And, implementing a solid procedural based training system, though being hard work and requiring consistent discipline, is absolutely essential if you want to score with winning compliance. n

Mike Starke is director of GMP Education at EduNeering, Inc. (Princeton, N.J.) and former president of GMP Training and Education Association. Reach Starke at mgstarke@comcast.net.