“Training?, “Yes, we have training records.” This often hollow response is given, almost automatically, by auditees, particularly when being interviewed by a FDA investigator. There are many different ways to meet the training requirements of the cGMPs and an equal number of training processes to maintain. But what is training? Just how should employees be trained to perform tasks, competencies assessed, and skills maintained?  How should training be recorded and tracked?

New employees in the regulated pharmaceutical industry start their careers with a wide range of qualifications, experience, and training. However, having high-level qualifications and many years of relevant experience, does not necessarily, indeed must not automatically, be assumed to mean that the employee meets the training requirements for their new position. What is required is a comprehensive training plan for each individual and/or job that encompasses company procedures, cGMP requirements, job, and career needs. This is a combination of both on-and-off-the-job training. This enables the new hire to become initiated in company ethos. On-the-job training develops competence at the work place. Then a combination of these training methods reflects an individual’s specific competence and career development requirements.

Most companies now have compulsory new starter orientation sessions which cover basic company policies, procedures, and conditions of employment. These sessions start all operational and lower management personnel with the same foundation training in company quality standards and philosophies. This quality orientation training is essential for al staff levels if management expectations of compliance are to be fulfilled.  Other essential procedures, health and safety laws, and “gatekeepers”  restrict unsupervised entry to sensitive areas, such as sterile facilities, biological, and other high hazard areas without prior demonstration of competence or supplementary background training.

SOPs generally define the basic requirements of an introductory session. These are followed by periodic updates, which maintain training and compliance with the “c” in cGMPs. Reading company policies, guidelines, SOPs, and documenting these events has for several years been deemed, in some cases, as adequate training. The records usually read something along the lines of, “I have read and understood the following SOP’s”. They may have read and understood them, but are they trained? Do they have sufficient experience to be able to perform the required duties either under supervision or alone? Due to business pressures, the pathway for a new hire becoming a fully active employee in the process is sometimes shorter and less defined than in an ideal situation.

Unfortunately, the path doesn’t get easier as the employee is integrated into the company, and soon there are newer hire who know less about company workings. The other employee now feels relatively more qualified in the company business, but may, in practice, be no more trained and qualified than the new hire. This read-only training has an inherent and significant risk of inadequacy. To protect company standards, and even its legal position, it is better to positively train and access. A proactive rather than reactive approach to situations is the position sometimes taken by companies.  We are all familiar with the term “Build in the quality, don’t test it into compliance.” The same could be said for training. Sufficient training for a new employee establishes a sound foundation.1

In a product efficiency driven world of metrics and timelines, how much pre-job activity training is done, and is it enough?  What should and does occur in some companies is a complete overall training process. This requires adequate finances, resources, people, and time ken away from the actual job function to fulfill its objections. Senior management and the company must be committed to the implementation and maintenance of the training program.

After this orientation is complete, a training program relevant to the new employee’s job is initiated for their specific area responsibilities, i.e., a different matrix for laboratory, manufacturing, or packaging areas.  These introductory procedures contain two (2) categories of training. The first is a set of predefined core procedures standard to that work area, e.g., laboratories, balances, behavior, and dress code, and a second variable set of SOPs relevant to the specific job., e.g., HPLC analysis. No one is allowed to execute and hands-on procedures without adequate confirming training and demonstrated competence, unless they are being supervised as part of their training program.

Certification by an experienced trainer of an individual in performing a task according to predetermine acceptance criteria is essential. A degree of responsibility is shared between the supervisor and the individual to manage their own training. In the meantime, existing staff may be already performing tasks based on their previous experience but without the necessary formal documented training in what may be a newly written procedure. These staff members must also be brought into the formal training framework by thorough observation and assessment by their supervisor or suitably qualified individual. Individuals who demonstrate competency from previous experience may be grandfathered in without going through a formal training process. Care must be exercised here that grandfathering is not just a rubber-stamping into the compliance process.  In particular, new hires with reputed skills in a process must be monitored during their initial stages to ensure that requirements are fulfilled. At a minimum, competency and reading / understanding the relevant SOPs must be documented by a supervisor or other suitably qualified person.

All training documentation must record, as a minimum, the event title e.g., SOP reference number, version, date(s) of training, trainer’s name and signature, and trainee’s name and signature.  The record should include an assessment of competence either from the trainer’s observation alone or supplemented via a written or verbal examination. The content of the training sessions must be retained ad include copies of slides and overheads, with reference to the version of a procedure. This is by no means an indication of the depth of the training performed.

A competency demonstration is required to be proven on more than one occasion, depending on the company’s approach and complexity of the task or procedure. The assessed competence is agreed to by the trainee to ensure they feel confident, appreciated in their role, and are not being pushed beyond safe operating levels. This agreement also offers some protection to the company in the event of any subsequent failure or accident whereby the operator could otherwise deny responsibility through lack of training.

It is crucial to the process that competence is not just a record of attendance at a training session, as some trainees may require additional training to be determined by the trainer as meeting minimum requirements.

Effective training programs must include a period for refresher training, although this is flexible in reflecting the type and complexity of work involved, i.e., a regular operation of a simple process may further negate training, as it is an ongoing part of the job function. Infrequent and complex processes should be subject to regular updates. It is the supervisor’s responsibility to remain aware of their workforce’s needs and requirements.

There is a calculated risk in discovering training inadequacies. The consequences may require a significant input of resources to meet expectations. Combined with other observations, this may become the central focus of an inspection, resulting in a significant delay in approval of an application.

In the second part in this series we will examine training competency levels and explore the many different ways to record and track training.