Medical Device & Diagnostic Industry Magazine
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An MD&DI August 1997 Column

HELP DESK

Clarence Semple, president of Sigma Four (Redondo Beach, CA), a usability engineering firm, explains how to best design, develop, and evaluate a cost-effective manufacturing training program.

How can one define training requirements for manufacturing departments, determine who is a qualified trainer, and fully document that an employee is trained and qualified to perform a manufacturing task?

Effective manufacturing training supports shortened learning curves, increased production rates, increased production quality standards, and enhanced profitability. The objective of training is to instill, effectively and efficiently, job-required skills, knowledge, and attitudes to support the manufacturing process.

Training design, development, fielding, and evaluation is a systems engineering process. Accordingly, well-designed training includes objectives, content, methods and media, measurable outcomes, standards of performance, and an evaluation of the process. The principles and methods of instructional system development (ISD) are widely accepted as a cost-beneficial way to develop highly efficient and effective training.

A job-centered task analysis is the training process foundation. Each job is divided into major behavioral tasks--structures describing the manufacturing job's main components--that workers must perform. Tasks are further analyzed into their component elements or steps. Tasks and elements new to the worker are singled out for further training analysis. Procedures to perform each selected task or element are listed, including cognitive (mental) procedures, such as recalling details from memory, and visual perception associated with worker inspections to assess meeting work standards.

Each task and its elements are analyzed for learning content including the prerequisite skills and knowledge workers must bring with them to the learning situation; skills, knowledge, and attitudes needed to effectively perform each task and element; standards of acceptable performance; special tools and equipment; personal safety issues; and manufacturing mistakes that may occur and their likely consequences for subsequent manufacturing operations, such as rework requirements. Design and manufacturing engineers, manufacturing supervisors, skilled production workers, and, in some cases, component vendors are valuable sources of task-analysis information.

The training should be designed around the behavioral and cognitive components to be performed and their standards of acceptable performance. The technical content also stresses how to recognize and correct common mistakes, use special equipment, and deal with safety issues in performing each job activity. Worker attitude is important to both productivity and quality control and is discussed in the context of job safety needs and the effects of undetected or unreported manufacturing mistakes on subsequent manufacturing operations and, more importantly, on end-users of the product.

Look for similar, but not identical, behaviors the worker may be familiar with from other manufacturing operations. The goal is to identify existing worker skills and knowledge that may interfere with the learning of new tasks. Such opportunities for negative transfer of training should be emphasized and discussed during instruction and closely monitored during training and initial on-the-job performance.

Training methods should be tailored to the particular skill, knowledge, and attitude to be learned. Lectures with discussion are common. Videos or demonstrations of skilled personnel performing the desired behaviors provide realistic models for learners to emulate. Hands-on training may involve mock-ups or actual equipment that can be either reused or economically discarded.

Trainers must have knowledge of and the ability to demonstrate all of the skills, knowledge, and attitudes to be taught. Their levels of attainment can be measured using the same test and evaluation methods used for students. Effectiveness in answering questions is another way to assess trainer competence, as are learner ratings. Trainers must possess a general knowledge of how people learn, how to teach, and how to motivate. They must understand that learner errors and initial lack of speed are normal steps in the learning process and are tools to be used constructively to guide learners to desired performance standards.

Consistent performance deficiencies suggest the need to modify training. When consistent deficiencies are eliminated and job performance is acceptable, the training has been content validated because the person demonstrates the needed job skills, knowledge, and attitudes.

A central ISD concept is that training results, including intermediate points in the learning process, must be measured objectively. Written and oral tests provide skill and knowledge measurement opportunities, as do standardized observations and measurements of training work samples. Observation and dialogue with workers provide assessments of whether safety and productivity attitudes are being learned. Having learners demonstrate that they meet or exceed required performance standards documents their qualifications and is used for quality control.

Most learning occurs somewhat erratically and along a curve. Thus, even learners who demonstrate required performance during and at the end of training should be monitored until supervisors are fully satisfied with the quality and speed of their work. Supervisor monitoring and criticism must not be intimidating, since this will only reduce worker willingness to ask questions. Manufacturing problems should be documented and analyzed so constructive feedback can eliminate the problems, often through refinements to the basic training program as well as highly focused remedial training.

"Help Desk" solicits questions about the design, manufacture, regulation, and sale of medical products and refers them to appropriate experts in the field. A list of topics previously covered can be found in our Help Desk Archives. Send questions to Help Desk, MD&DI, 11444 W. Olympic Blvd., Ste. 900, Los Angeles, CA 90064, fax 310/445-4299, e-mail [email protected]. You can also use our on-line query form.

Although every effort is made to ensure the accuracy of this column, neither the experts nor the editors can guarantee the accuracy of the solutions offered. They also cannot ensure that the proposed answers will work in every situation.

Readers are also encouraged to send comments on the published questions and answers.

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