Ineffective Training Programs

This week, I will address the eighth of nine common CGMP Quality System shortcomings; Ineffective Training Programs.

A routine part of any inspection or audit is to evaluate the training program.

Managing a training program is a monumental task. Consequently, I have found few training programs to be well managed and/or effective. Most training programs have a structure in place, but the effective implementation of that structure is often left to each Area Supervisor, who, in turn, may defer the training burden to their subordinates. This training program methodology very seldom works effectively.

In addition, training programs can become a check-in-the-box requirement. This becomes very evident, when re-training operators is a recurring corrective action for non-conformance investigations. I can appreciate the difficulty in effectively training the huge number of people need to perform the very complicated process of drug manufacturing, but a well managed and effective training program that minimizes human error is a critical element in any Quality System.

In reality, ill-trained operators can nullify some in-process controls.

To overcome this shortcoming, the Quality Units should routinely monitor the training program by correlating training effectiveness to encountered nonconformances and deviations.