September-October 1999

PDA Journal of
Pharmaceutical Science and Technology
EDITOR: Joseph B. Schwartz

Competency-based Training Program Design

by
David Gallup, Ed.D.
Katherine Beauchemin, Ed.D.
Marge Gillis, RN, MSN

Training and Communications Group, Inc.

1137 Lancaster Avenue
Berwyn, PA 19312
610-296-2171 (phone) 610-296-2163 (fax)

The Road to Performance Excellence

September-October 1999

Competency-based Training Program Design

DAVID GALLUP, KATHERINE BEAUCHEMIN and MARGE GILLIS

Training and Communications Group, Inc., Berwyn, Pennsylvania

Job Skills and Competency-Based Training

In the healthcare manufacturing industry each employee needs job- Correspondence address: 1137 Lancaster Ave., Berwyn, PA 19312.

specific training in technical skills, SOPs, and awareness of the GMP The plant had recently undergone a redesign that was not achieving
regulations (see article A Comprehensive Approach to Compliance the results anticipated. The achievement of this plants corporate
Training in a Pharmaceutical Manufacturing Facility in the previous objective of increasing the speed and number of new product
issue of this journal). To satisfy this requirement, companies must adopt a introductions was impacted by several critical factors.
systematic approach to training design, development, and implemen-
tation. Planned product introductions required more complex processes
FDA commentary suggests that training programs should be than those currently in use.
competency-based-that is, based on the knowledge and skills an Highly skilled operators needed to be involved at the R&D level to
employee must possess to perform successfully in the job. For example, speed the scale-up process from lab to pilot to production scale.
if an employee needs to know how to perform each step in the operation Qualified operators were needed in numbers sufficient to continue
of a certain machine, the steps are competencies the employee needs to operations through lunch and breaks on all shifts.
demonstrate. Another definition of competency-based training is training One million dollars in nonconformances, 60% of which were
in which required behaviors or competencies and performance standards operator-related, was inconsistent with plant goals.
are stated in advance of instruction. Facility-wide analysis showed a deficiency in technical training
Effective competency-based training programs do not just happen; methodology. Training was based on the buddy system, Follow
rather, they are the result of applying a systematic process to training Joe around until he feels you are capable of doing the job. Lack of
program design. This process involves following certain well-defined cross-training meant skilled operators could not move between
steps in a methodical way to develop a training program that meets both operations. This deficiency often meant a poor use of human
the trainees and the organizations needs. resources and an inability to leverage existing technical skills within
departments.
The Training Program Design Model
Using the Model
The most reliable method of training and qualifying employees in the
safe and effective performance of technical skills is by using an The facility followed these steps to address training issues:
instructional system de sign model. One such model, the Training
Program Design Model (TPDM) developed by Gallup and Griffin is I. Conducting a Needs Analysis
shown in Figure 1.
The use of this model in developing a competency-based training A training needs analysis is aimed at revealing the differences
program is presented in a step-by-step discussion in the case study that between the current situation and the desired situationand whether
follows: trainin g will correct the deficiency. For example, a team leader may state
a problem this way:
A Case Study My group isnt meeting quality standards. During the needs analysis
we learn what quality standards the group is meeting, the standards the
This case study involves a single facility within a multi-facility group should be meeting and why the discrepancy exists. Then we decide
pharmaceutical manufacturer (ABC Company). Management at a 350 whether training is required to correct the deficiency.
employee facility wished to develop training to assist in achieving plant A needs analysis is typically conducted using one or more of the
goals. methods listed in Figure 2.
The ABC facility was the company leader in speed and in the number At the ABC facility, the needs analysis was based on key
of new product introductions. Its goal was to broaden its manufacturing consultations with managers, reviewing production records and reports,
capabilities to accommodate more planned product launches to leverage evaluating recent changes in procedures and equipment, and group
their fast -track approach. discussions with team leaders and operators that suggested procedures
required standardization. Findings included: I) no competency-based
training existed; 2) no qualified trainers existed; 3) some SOPs were
Poster Session at the PDA Spring Meeting, San Diego, CA, March 1998.

The Road to Performance Excellence

September-October 1999

Figure 3Methodology for conducting a Job Inventory Task

Analysis.
characteristics that can affect how training should be designed.
It also identifies where the training will be conducted,
availability of classroom space, personnel, the number of
facilities involved, and available equipmentincluding access to
the manufacturing suite and computer terminals.
The situation analysis at the ABC facility identified limited
availability of equipment and qualified OJT instructors.
Budgeting restraints and the need for quick and easy revision of
not current in areas where the greatest amount of rework or lost materials were also limiting factors. Section 5 discusses how the
product occurred. situation analysis impacts the training program design process.
The training needs analysis further revealed that granulation
led in nonconformances. It was also the most complex 3. Job Inventory/Task Analysis
technology. Training program design for operator certification
began in this area. The next step in designing a training program is to identify job
Because of the time commitments and constraints on in-house requirements in terms of skill and knowledge. This is done by
resources, it was decided the project would require help from conducting a job inventory or task analysis of each job.
outside training professionals to work with in-house management This process involves studying ajob to subdivide or break it
to analyze operators skills and knowledge, and develop the into discrete units to use as a basis for training program design.
curriculum. The job inventory helps identify the competencies (areas of skill
and knowledge) needed to be focused on during the training.
2. Situation Analysis Figure 3 presents a methodology for conducting a Job
Inventory/Task Analysis.
A situation analysis focuses on profiling the audience and the In the Task Analysis, all the departments in the organization
training resources within the facility. It determines who and how and all the jobs within each department were identified. The
many will be trained, their level of education training program design effort began with the Granulation
including previous job training, computer skills and other Department, where a high number of operator-related errors were
occurring.
Beginning with the Job Descriptionfor example, Perform
steps in the granulation process, we identified major duties in
the process operation. In this case one duty would be set up the
line. Then we broke each duty into tasks. For set up the line,
for example, a task might be turn power on. The next step was
to divide tasks into elements and sub-elements: locate power
switches on right side of machine; set switches to on position.

240 PDA Journal of Pharmaceutical Science & Technology

September-October 1999
To be sure all important aspects of ajob are covered, each of the the Batch Record requirements including in-process product
following duties were analyzed as to their tasks elements and testing results.
sub-elements: 3.11 In-Process Product Testing: This covers tasks
involved in product sampling and inspection required to ensure
Process Overview product is meeting specifications as to weight, size, quality,
Safety labeling, etc.
Set-Up
Pre-Start-Up 4. Specifying Behavioral Objectives
Start-Up
Normal Operations
Abnormal Operations The next step is to develop behavioral objectives. They
Shutdown specify the exact competencies operators will demonstrate after
Cleaning in Place completing the training programthat is, what they will know or
Completing Batch Records be able to do. The program content trains to these objectives.
In-Process Product Testing Behavioral objectives also guide the development of evaluation
instrumentsthe written tests and performance demonstration
A brief description of what was included under each duty checklists used to determine whether operators acquired the
follows: competencies identified in the job inventory/task analysis.
3.1 Process Overview: This describes the process or The following objectives are examples from the Granulation
equipment with a tour highlighting features, purpose of System Overview Module.
equipment, and how it fits into the overall production process.
3.2 Safety: Covers general safety rules and requirements that 1. Identify the major components of the Granulation System.
may apply to the equipment or process, such as proper personal 2. State the function of each component.
protective equipment. In addition, it includes safety issues 3. Describe how each component works to produce granulated
pertinent to a specific process such as pinch points, guarding product.
considerations, or lifting considerations. Safety issues are 4. Define key terms related to topics covered in this unit.
covered again in the modules that deal with specific process
areas. 5. Selecting, Designing and Producing Training Materials
3.3 Set-Up: Covers getting the machine ready to operate or
getting a process ready to run.
3.4 Pre-Start-Up: This module addresses all ancillary Selecting, designing and producing training methods and
equipment necessary to a support process; e.g. bins are in place to materials is the next step in the TPDM.
collect product, and feed stocks ready. 5.1 Selecting Training Methods: Training methods are the
3.5 Start-Up: This pertains to the first time the machine is ways in which training is deliveredclassroom instruction, self-
turned on, and how to evaluate overall function of equipment instruction, on-the-job instruction, or a combination of these
before you move to normal operation. methods. Training methods are chosen based on several factors
3.6 Normal Operations: Covers tasks necessary to ensure included in the situation analysis such as, availability of
that equipment is operating appropriately, including in-process classroom space, personnel, and equipment, as well as the
testing. Testing is also covered under the In-Process Product subject matter and needs of the training audience. We chose
Testing module. some classroom instruction combined with a strong hands-on
3.7 Abnormal Operations: Addresses tasks involved in: component to maximize effeciency in training program delivery.
These methods were judged best in terms of outlining
Responding to alarms specific to the process and/or equipment outcomes, cost, and speed of development. Classroom instruction
and equipment shutdowns. provides an environment for process experts to present
Troubleshooting to correct problems. information while participants take notes in their guidebooks.
Determining whether a mechanic needs to be called or if the The participant is able to raise questions and gain additional
problem is within scope of operator. insight through group interaction. Classroom training does not
interfere with equipment scheduling. On-the-job training
3.8 Shutdown (Partial and Total Shutdown): Includes all provides the hands-on experience necessary to gain the technical
steps integral to the following scenarios: skills of the required granulation operator both through direct
observation of an expert, and hands-on experience.
Material or ingredient shortage or changeover. Experienced workers served as trainers because they could
Routine maintenance. communicate and demonstrate correct procedures. Having a
Complete changeover to different product or different size mentor to both observe and coach the trainees affords the learner
package. hands-on experience in an actual work situation making it ideal
for skill training. One limitation of on-the-job training is that
3.9 Cleaning in Place (CIP): This involves complete mentors may not have formal training backgrounds and may
cleaning, including shutdown and changeover. require special training and program development. We addressed
3.10 Batch Records: This deals with how to read and follow this by including a

242 PDA Journal of Pharmaceutical Science & Technology

September-October 1999

comprenensive train-me-trainer session for the technical trainers.

5.2 Selecting Training Media:
Training media can either support or deliver the training.
Media can include:

Printed Materials
Flipcharts
Overheads
Videotapes
Computer-Based Instruction
Simulations
Real Objects

To meet the objectives of a single training program, we mix and

match training methods and media. This mixing and matching
was based on adult learning theory, behavioral program
objectives, and the results of the situation analysis. Technical
skill objectives cannot be easily reached or evaluated without materials.
some type of hands-on experience. Also to be considered is cost,
the size of the audience, the availability of hardware and software
or other electronic equipment, and the development timetable. Evaluations must be based on program objectives, with each
A decision was made to use leaders guides and trainees program objective tested. In competency-based training the
guides with overhead transparencies for classroom instruction trainee is required to demonstrate proficiency (competency) in an
and checklists for on-the-job training. These materials were the area, often by being observed performing a task and using a
least expensive and quickest to produce, easy to edit and update. performance checklist, to verify successful demonstration of key
They were well-suited to reach audiences of 510 trainees who competencies.
needed access to process experts, as well as hands-on experience 6.2 Reaction: What did the trainees feel about the program?
with process equipment. Evaluation of trainees reactions to training are usually conducted
5.3 Designing Training Materials: The Job Inventory/ Task by questionnaires administered immediately after the program
Analysis itself provided the basis for developing the ends, although we can also measure reaction by observing
comprehensive training program materials. The Job Description trainees in class or interviewing them later.
gave us the title of the training program: Granulation Operator This type of evaluation usually measures these areas:
Training Course. The duties we identified in the task analysis
formed the training topics, whereas the tasks, elements, and sub- Were the objectives of the training program clear?
elements gave us the content of the training program. Were the objectives appropriate?
In our case, consultants created material that was reviewed by Were the objectives of the training program met?
supervisors and expert operators serving as the Subject Matter Did the program design support the objectives?
Experts (SMEs). The development process also involved How valuable was the program content in supporting the
reaching consensus on best practices when disagreement arose objectives of the program and the job need of the
among SMEs or when SOPs were too vague to be a deciding participants?
factor. As a result of the work done with SMEs, the SOPs were
revised or updated. 6.3 Results: Did the training pay off? Was the training
5.4 Producing Training Materials: In this step the training validthat is, did it do what it was supposed to do? We should
materials were actually produced by the training program design never forget that a primary objective ofjob training is to ensure
team. on-the-job results.
This type of evaluation can be difficult to design, administer
6. Selecting, Designing, and Producing Evaluation Materials and validate, which is why it is so seldom performed in industry.
But it is wise to measure on-the-job behavior and productivity
What is it exactly that we are evaluating when we collect data results to formulate a picture of the training and to build
about training programs? Most specialist agree that we are credibility for the training program.
evaluating three areas, all of which were assessed in the training.
6.1 Competencies: What competenciesareas of knowledge Did the trainees peers, subordinates, or superiors notice
or skillsdid trainees acquire as a result of the training? We changes in behavior? For example, application of new
usually evaluate what trainees learned by administering a written knowledge or use of new skills?
test or observing performance. Did the quality of the work change?
Figure 4Basis for developing the comprehens ive training program

242 PDA Journal of Pharmaceutical Science & Technology

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did productivity or profits change in any of these ways? training programs and make it critical that we improve training
Reduction in direct costs on an ongoing basis.
Increased productivity of trained vs. untrained empl oyee It is only by constant evaluation and revision that our training
s programand therefore our employeesare the best that they
Increased productivity after vs. before training can be.
Improved quality of work 8.1 The Case Study: How long did this process take in our
Fewer accidents case study? We spent 350450 person hours per course in
Reduced absenteeism conducting the task analysis and developing the training
Lower turnover rates materials. This included working with SMEs, revising SOPs as
needed, establishing procedural agreement among operators, and
Careful design of evaluation instruments is important; it is the piloting the program. One reason the number of hours was
only way to be sure that your training program is validthat is, substantial was because this was groundbreaking work. Although
accomplishing its objectives. revising SOPs is not considered part of actual training program
development, in many cases SOPs need to be revisited to
7. Implementation accommodate actual procedures and ensure the validity of
training.
The first presentation of the program is usually referred to as After 50-plus months of sustained effort, the ABC facility now
the pilot program. This lets everyone know at least some has training programs that cover each operating process in their
program adjustments are expected. For this program that had a facility. Each training program takes trainees six to ten days to
significant impact on operations; we engaged in true pilot complete. They contain about 20% classroom training to ensure
testingthat is, testing on participants who actually need the that trainees have the knowledge needed to begin working with
training. For some programs, however, it is simply too expensive equipment. The rest of the time is devoted to hands-on activities,
to put that time and effort into such testing. In these cases, you including tours, demonstrations, and participating in training.
will be piloting the program on the first group to be ready for Each program contains the following:
the training. Trainers Guide. A comprehensive package designed for
senior operators without training backgrounds. Included are
8. Refining professional objectives.

Even the best training programs can be made more effective if 1. Detailed Outlines/Lesson Plans
they are revised or modified. The pilot program evaluations will 2. Program Schedule
tell you where you can improve the training program. 3. Support Materials
Refining, the final stage in training program design, has two 4. Pre-Test of Knowledge
components: 5. Post-Test of Knowledge
6. Performance Checklists for use as pre- and posttraining.
Analyzing the training program evaluations to see where (Pre-Test can be used to test out of courses; post-tests are
revision is needed. used for certification.)
Revising, re-implementing, and re-evaluating the training 7. Final Certification. Opportunity to demonstrate qualifi-
program to correct problems identified. cations for a specific job.
8. Performance Demonstration Guides. Steps necessary to
Revising the training program may mean incorporating new perform a specific task. Each job may have multiple guides.
material to help the program meet its objectives, or it may mean 9. Support Materials:
revising the objectives themselves, based on input from trainees Photographs
or managers. In any case, though, you will follow the steps you Slides
used to develop the training program as you refine it. Video clips depicting important areas or processes

First, make sure the revisions are designed to support Trainees Guide. All information required passing the written
specific, measurable objectives. and performance-based tests. Included are copies of objectives,
Second, follow the appropriate steps to select, design or handouts, and diagrams with room for notes to serve as trainees
produce training materials to support those revisions. personal reference manuals.
Finally, re-implement, reevaluate, and refine the revised Qualification and certification pathway for each job.
program to see if further modifications are necessary. Each program has individual modules that are associated with a
list of knowledge and skills. Trainees are required to pass a
In other words, you will follow the same process you used to knowledge test before they may complete a performance
design the program as you revised to meet the objectives you set. evaluation. Failure response is included in this document. If
In a sense, the refining process never ends because we are trainees arc unable to pass knowledge and performance tests after
always looking for ways to update, revise, and modify the a certain number of exposures, then they are reassigned until able
training programs we design. Developments in technology, to satisfy knowledge and performance requirements.
changes in skills and knowledge among trainees, new Train-the-Trainer. Program designed for SMEs assigned to
marketplace demands, and a variety of other factors impact our lead the training. Developed to train people without training
244 PDA Journal of Pharmaceutical Science & Technology
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backgrounds who are experts in the process on

equipment. Covers how to prepare to train in the classroom and enthusiastic about participating in the training. As one
OJT, as well as how to test and conduct performance experienced operator put it: Ive
observations. been doing things my way tor 20 years. INow b see there are
better ways to do some of those things. And what were doing is
9. Operator Cert ifi cation/Qualification making the process more consistent. All in all, the training has
been a plus for us.
Competency-based training programs are designed to certify
or qualify employees to ensure they are able to perform their The Outcome: Measurable Results
assigned functions. Operator qualification or certification is the
final step in completing competency-based training. This final The effort that began with the needs analysis resulted in a
step demonstrates that each trainee has acquired the competency-based, operator qualification program made up of
competencies defined in the training program. classroom and on-the-job training. Trainers were selected from
Certification means that someonesupervisor, senior the plants expert operators. The consultant conducted a train-the-
operator, lead operator, trainerhas observed the employee trainer for the selected trainers to qualify them to perform the
performing the tasks associated with the job. The observer operator training for this facility. Training was implemented with
certifies the trainee through an observation checklist to cooperation from the entire facility. Results after 24 months and
demonstrate that the person performed the job correctly and 95% of granulation operators trained were as follows:
produced a quality outcome. The formal certification process for
any company should be part of the written Standard Operating Total Process-Related Destruct Order Costs
Procedures.
Careful design of evaluation instruments is important; it is the
Year I, $692,000; Year 2, $325,000; Reduction, 53%. Process
only way to be sure that your training program is validthat is,
accomplishing its objectives.
Operator-Related Destruct Order Costs

Implementation Challenges

Before the ABC facility actually began training people, some Year 1, $215,000; Year 2, $160,000; Reduction, 74%. Total
issues had to be taken into account. For instance, because of
production requirements, scheduling trainers and trainees was a Waste Costs
challenge. Managers were understandably reluctant to release
people for training when they were at full production. Added to
this was the availability, or lack of availability of processing Year 1, $2,500,000; Year 2, $2,100,000; Reduction, 16%.
equipment and classrooms. Another challenge involved Additional highlights from this training program include
employees perceptions of the large-scale curriculum. the following one-year performance enhancements:
Experienced operators wondered whether they would be tested
and perhaps found deficient in skills they had been using for 19% Reduction in Non-Conformances
decades. $50,000 Reduction in Landfill Costs
To counter the first issues, the ABC facility worked hard to 10%15% Increase in Planning Values
accommodate training to production schedules and classroom
and equipment availability. This meant training was done only Also reported were increases in employee moral and facility-
when release time could be justified and equipment was wide recognition of the value of training in job performance.
accessible. It also meant some false starts and not a few The process used to develop the competency-based training
frustrations for schedulers and trainers alike. Fortunately, once programs begins with a needs analysis.
managers began to see the benefits of training, they became more Perhaps the best endorsement of the program came from the
enthusiastic about sending employees to the session, and Facility Manager, who noticed measurable increases in
scheduling became less of a problem. productivity in areas where training had been conducted. This
The next challenge involved reassuring employees that their resulted in continued organizational commitment.
jobs were not in jeopardy. This was done by ensuring
experienced workers had input into both program development ROI
and pilot programs. Experienced employees were asked to help
test the program, refine it, and validate evaluation instruments. Training is many times viewed as a cost of doing business. A
The goal was to come up with the best possible programs, and principle incentive for approving training budgets in the past has
the input of experienced operators and line tenders was essential been FDA regulations. As management experienced firsthand,
to meeting that goal. the bottom-line benefits of competency-based training and the
As time passed it became clear that training and certification incentive to expand the training budget became an understanding
were not being used as a means of downsizing personnel, and of the ROI, which these expenses generate.
this issue resolved itself. In fact, once the element of anxiety was A 10% increase in the book value of capital stock is
removed from the process, employees, like managers, became associated with a 2.6% increase in manufacturing facilities
244 PDA Journal of Pharmaceutical Science & Technology
September-October 1999
output ..compared to capital stock increase, the boost to
. workers within a manufacturing establishment results in a 6.2%
productivity associated with increased years of schooling is more increase in outputor greater than twice the improvement that
dramatic would result from a similar increase in capital stock.
In other words, a 10% increase in the amount of training

Vol. 53, No. 5 / September-October 1999 245