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Issue 5

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Where our team of guest writers discuss what they think about the current NGP US Issues.

Peter Duncan
Director of Business Development

Can digital pathology save drug development?

Peter Duncan of Definiens discusses the potential of digital pathology.
07 Jul 2010

Improving Employee Performance

Clarkston Consulting | www.clarkstonconsulting.com

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Imagine you are an executive at a leading pharmaceutical firm. Your manufacturing facility has the most up-to-date production machinery and laboratory equipment, including well-documented procedures on how to use each piece of equipment. You are comfortable in the fact that you have a sufficient number of employees to handle the production schedule; in fact, you have suspicions that you have more resources than are really necessary.

You have the people and the procedures, the material and the machinery. So why are you unable to produce the numbers you need to meet market demands? Why is there so much waste? Why are there so many contamination issues? Most importantly, why is the FDA inspector implying you don’t know what is really happening in your facility?

Chances are your employees are not sufficiently trained to do the work to which they are assigned. The manifestation of these issues may arise from two underlying sources: the employees’ lack of understanding of the overall process, and ineffective training methods on the procedures themselves.

Investments made in developing the best manufacturing practices, acquiring the most advanced machines and then implementing the newest software programs could all prove worthless if your employees are not using them correctly. Process-based training development and delivery helps to ensure employees’ learning is internalized and successful. This learning methodology readies employees for changes in the workplace, remains flexible for use with various presentation methods, and is a repeatable process for easy maintenance.

What is process-based learning?

It is possible your employees have been instructed to push this button and pull that lever, but when that doesn’t produce the expected result, their only remediation is to… push this button and pull that lever. They are not aware of what happened to the product before it arrived at their station, nor do they understand what happens further down the line. In most cases, there is not sufficient knowledge of the entire product development lifecycle.

Process-based learning focuses not only on what content should be taught, but how that content will be best understood and subsequently utilized in the workplace.

Step-by-step procedures to operate a certain piece of machinery are necessary, but if employees are to most effectively perform the documented procedures and investigate root causes of failures, trainers should help employees understand the overall processes. This type of training clarifies the inter-relationships among jobs, systems, processes and business goals.

Notice this learning method is referred to as process-based training, not simply process training. It is not sufficient to train employees on the overall process, and then leave them to their own defenses to understand the step-by-step procedures that make up that process. The methods used to train the details are equally important to an employee’s success, but just as with the process, the details cannot stand in isolation. Including procedural training with process training fosters a greater understanding of where and how the details fit into the overall picture.

How process-based training is structured

Make it personal and consistent: Employees need to know up front why they are being trained. Openly tackle such questions as: “What is being trained? Why am I in training? And what will be expected of me?” Create a template to use across modules that consistently addresses these questions and makes clear that each participant is accountable for his/her learning.
Paint a picture of the process: Take that literally. Use pictorial process flows to exhibit a high-level overview of a process. This will frequently require several levels of understanding: a very high level, connecting customers and suppliers to the company; a mid-level view, connecting departments within the company; and a low-level flow showing inputs, outputs, and individuals associated with a process.
Conduct step-by-step procedural training: Once there is an understanding of a process, it is time to dive into the details. An effective method to incorporate is the “tell me, show me, let me, help me” technique. Review the procedure verbally, give a visual example, allow the participants try it for themselves, help them to fill in any gaps and answer any questions. By engaging multiple learning styles, your employees have a greater chance of learning the procedure.
Assess learners’ understanding: Would you gladly hand over the car keys to a teenager who claims to know how to drive? No, you wouldn’t. You would demand proof of their abilities. Organizations want the same assurance, particularly when an employee is responsible for using a multi-million dollar piece of equipment, or will have access to vital company data in an enterprise resource planning system. Evaluate learners upon completion of training and track their learning to determine process qualification. Tracking and benchmarking employees’ learning is an advantage to the employees as well, when it provides documentation that coincides with their career development plans.

Benefits of process-based training applications

Process-based learning has applications in all layers of training. Instructor-led courses are discussed throughout this paper. In addition, as an organization may move toward computer-based or web-based training, objects within the high-level flow can be used to ‘drill down’ into more detailed information at the employee’s own pace. It can also be utilized across and outside the organization.

The high-level process information can be used to orient new employees, customers, vendors, and even executives who are being questioned about processes by that fastidious FDA inspector.

The benefits of process-based learning are to the employees and in turn, the organization. By understanding the entire process (including inputs, outputs, handoffs, and resources involved), this method of training helps empower employees to look for the underlying causes of problems rather than just the symptoms. It creates a learning environment that is focused on business objectives and maximizes employee readiness for change in a dynamic environment.

An added bonus of process-based training is the ease of maintenance when there is a change in procedure, especially when compared with role-based training materials. If training materials are organized by job role, there is a good chance that a single procedure is used across multiple roles. Therefore, when a procedure changes, the training materials for all related roles must also be updated. Generally speaking, a procedure is found in one overall process, so updates need only occur in one set of training materials. Process-based materials consider not only the first round of training, but also how changes and enhancements will be handled in the future.

Process-based training best practices

Strive for consistency: Communicate your organization’s message to learners by ensuring your company’s vision and your training department’s goals are reflected in all of your training. This will give your employees a sense of uniformity and even familiarity, particularly when there are other organizational changes connected with the training.
Select and train the right people to conduct the training: Just because someone is an expert on a process, he or she is not necessarily the right person to train other employees. Select and prepare individuals who will foster an open learning environment, engage the participants and be an agent of change.
Utilize images, charts and diagrams: Don’t underestimate the power of a picture. It’s one thing to tell someone how a process works; it is quite another to give someone a visual representation.
Insist on active participation: Make sure participants know they are responsible for what they take away from the training and be clear on the long-term training requirements for their career development.
Be redundant: Studies show that people typically retain one-third of what they hear. As you go through the details of a procedure, be sure to reference back to the overall process: where the procedure fits in, what led up to it and what will be happening next.
Vary assessments and training methods: Tests and quizzes aren’t the only way to ensure your participants are learning. Utilize training games, puzzles, and contests to reinforce the content of the training. This also helps keep participants from falling into a boredom-induced coma. The sanitization process isn’t exactly action-packed.
Evaluate, evaluate, evaluate: Assess the effectiveness of the training including the materials, instructors, and environment. Create an atmosphere of continuous improvement.
Centralize training and development: Training materials should be customized for each audience group. However, all training within an organization – particularly during a change initiative – should carry a consistent message and pattern and reflect the organization’s goals and core values. This is much easier to achieve if there is a central training and development strategy. In addition, a central repository for all training materials will facilitate training documentation maintenance when a process or procedure is changed.

Process-based training enables organizations to create training programs that focus on employee and company performance. Getting products to market in today’s demand driven market place depends on employees who understand the entire product development lifecycle approval process and how their individual responsibilities contribute to the overall success of the company. Incorporating diverse learning styles in a collaborative learning environment will help the entire organization meet and exceed their go-to-market goals. Centralizing and creating repeatable, measurable, and adjustable training programs engages employees at all levels to be committed to the company’s product launches and manufacturing.

Process-based training success story

An international vaccines manufacturer had several site-wide instances of contamination, resulting in a FDA investigation and subsequent revocation of the manufacturing license. It was sited in two official communications from the FDA that employees were not following written procedures; an inadequate training program for those procedures was identified as one of the root causes of the contamination issues. In the existing training program, an employee would receive a hardcopy of a documented standard operating procedure (SOP), with instruction to read the document and sign a form when complete. There was no assessment, no follow-up, no interaction with a trainer or process expert, and nothing to connect that procedure to an overall process. The employee was then expected to perform tasks correctly and investigate failures for their root causes.

Clarkston Consulting worked with the client’s internal training department to implement a new learning strategy as part of a multifaceted effort to restore the license to produce vaccines within four months. The new program consisted of: flexible, reusable training modules, organized by process; training activities, walk-throughs, pictures, job-aids and/or process flows within each module; expert trainers in relevant processes, leading
interactive sessions; and an assessment process that included questions for each SOP, to be answered both in class and during on-the-job training.

The manufacturing license was restored on schedule. Inspectors recognized the new training as a model program that encouraged compliance by:

• Raising participant accountability with increased knowledge of overall manufacturing processes.
• Allowing for changes in an efficient and accurate manner.
• Increasing program sustainability with actions for continuous improvement.

Recognized by corporate leadership for its excellence, the details of the new training program were reviewed with other international manufacturing sites to determine global rollout throughout the organization.


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