In the pharmaceutical manufacturing industry, when the Corrective Action Preventative Action (CAPA) process labels employees as the root cause of a problem, the first question to be asked is, “What training is needed to improve performance?” Thus, the focus of the ensuing actions is directed toward improving human performance through training or retraining interventions. Inadvertently, training is often viewed as a solution rather than one of the many tools/interventions available to address problems found in the CAPA process.
WHAT IS A CAPA?
According to the FDA, CAPA is a systematic procedure of collecting and analyzing information in order to identify and investigate product or quality problems within a good manufacturing practice (GMP) environment. The main purpose of the CAPA process is to identify potential solutions to correct and prevent recurrence of product nonconformity or quality problems in the workplace. As the name suggests, CAPA success is best measured by the results of the actions taken rather than the completion of the CAPA process.
If training is determined to be the appropriate action, the focus of the ensuing interventions should be to realize measurable on-the-job performance outcomes as outlined in the CAPA. But, how do we go about designing a training that measures CAPA success?
STEP 1: KNOW YOUR AUDIENCE
The first step to effective training as a CAPA is to clearly define the target audience for your intervention. For example, let’s say the CAPA process has identified improper hand sanitization by Manufacturing Associates within the drug product manufacturing area. Then, the focus of the intervention should be to train Manufacturing Associates on the relevant skills needed to successfully perform proper hand sanitization in the affected areas.
Knowing your specific audience will help you design effective and efficient training intervention. In addition, defining your audience will help you to determine the desired performance outcomes and the criteria to measure success.
STEP 2: CLEARLY STATE DESIRED OUTCOMES
The second step is to determine outcomes. The measure of success should be based on achieving the desired performance outcomes outlined in the CAPA. For example, associates will be able to perform a 5 step hand sanitization procedure with a 100% accuracy after the training. But a more important consideration is how associates performance will impact desired CAPA outcomes.
In this case, the desired outcomes of the CAPA is to reduce and prevent bioburden observations caused by improper hand sanitization. Thus, the most significant measure of success is the reduction of bioburdens in affected areas. The training program should state both the desired CAPA and performance outcomes. Your stated outcomes will determine your measures of success.
STEP 3: CLEARLY DEFINE THE MEASURES OF SUCCESS
Consider the following outcomes and think about what they are measuring:
- At the end of training, Manufacturing Associates will be able to perform 5 steps hand sanitization procedures required in classified areas for drug product manufacturing area with 100% accuracy. (Performance outcome)
- Correctly performing 5 steps hand sanitization procedures will result in reduction of bioburden observations in classified areas for drug product manufacturing area by 80%, after two weeks. (CAPA outcome)
Let me explain. If the CAPA identified improper hand sanitization as the cause of increased bioburden observations in classified areas for manufacturing, then, we should expect proper hand sanitization procedures to reduce bioburdens. Stated in learning outcome language, performing 5 step hand sanitization procedures after every 30 minutes in classified areas will reduce bioburden by 50 % in the first week and 100% by the end of the second week. This example outlines the expected time frame and metrics to be used to measure progress and success. So, what goes into and comes out of an effective training as a CAPA?
TRAINING INPUTS AND OUTPUTS
There are many elements that contribute to successful training intervention. Inputs are elements that can be manipulated to produce specific outputs. For example, on-the-job training (OJT), instructor-led training, skills demonstrations, simulations, knowledge etc.
Regrettably, these training inputs are unintentionally used as measures of CAPA success. Specifically, trainee completion and performance assessment records. Although these are legitimate measures of success, they do not address the specific outcomes outlined in the CAPA. They only measures what the training department is doing rather than CAPA success.
On the other hand, outputs are the results of training inputs. One way to effectively meet CAPA outcomes is to consider integrating continuous improvement learning opportunities such as monitoring of bioburdens as part of the training design. These learning opportunities can provide valuable information to help you determine whether the intervention is working.
WHAT TRAINING MEASURES HAVE IMPACT ON CAPA?
In this case, the significant measure of training success is proper hand sanitization and reduction and prevention of bioburdens observations in classified areas. In other words, training success should be measured by the outcomes of corrective and preventative actions taken to reduce further observations.
In conclusion, defining the outcomes and measures of success are key steps towards successfully designing training as a CAPA. Although not everything can be measured, training metrics provide accountability and data to measure success of the training interventions. As Peter Drucker rightly put it, “You can’t manage what you can’t measure.”
U.S. Food and Drug Administration. 2020. Corrective And Preventive Actions (CAPA). [online] Available at: <https://www.fda.gov/corrective-and-preventive-actions-capa> [Accessed 8 March 2020].
William ‘Will’ Kanyi is a learning and development professional who is passionate about improving human performance through lifelong learning. Will is also doctoral candidate at Indiana University School of Education pursuing a degree in Instructional Systems Technology. His career and research interests are in eLearning design, Competency Based Training (CBT), Adult Education, Learning Technologies, Multimedia Learning, Human Performance Technology/Improvement (HPT/HPI), Digital/Open Badges, and Open Educational Resources (OER/OEP).