It’s no secret that employees are the building blocks of any organisation. Despite rapidly growing proclivity towards digitisation and advanced technology applications, pharma and biotech industry continues to remain highly dependent on human competences. Review of the regulatory citations of recent past suggests, a major chunk of non-compliances is still due to knowledge or skill gaps – which can be directly or indirectly attributed to training ineffectiveness, even though they are not so explicitly mentioned in the observations. Unfortunately, many pharma manufacturers don’t realise the importance of talent development in the true sense and fail to implement a robust training programme for their employees in cGMP operations. Many times, the judgment of skill levels go wrong while recruiting or deploying an employee on a specific job role. From an outsider’s perspective, one might be curious- why a university graduate or a young industry beginner from another company can’t be directly assigned on a core pharma operations role, soon after their joining? But the reality is the gap between academic courses and the practical applications of the same in the industry, and the need for accuracy in the business of ‘saving lives’, makes it nearly impossible.
So, what are the critical success factors?
Leadership outlook towards employee development is paramount: The most important factor for success is the leadership vision in an enterprise. Does the company leadership view it as a cost, or as an investment? Cost of failure due to poor quality of execution always outweighs the cost of right-first-time execution through well-groomed employees. Some corporate leaders are hesitant to train and develop their employees due to the fear of losing them to competitors, hence prefer to get experienced employees from outside organisations who are supposedly fit-for-purpose. This not only hinders the growth of the employees but also of the corporation in the long run. It has a much larger impact on the morale of the employees and the overall engagement level in the organisation.
As Zig Ziglar says, “The only thing worse than training your people and losing them is not training them and keeping them.”
Training can’t be an auxiliary function in the organisation: Many organisations fail to understand the scope of training in today’s pharma setup, and they attach it as an additional responsibility of any mainstream function like manufacturing, quality assurance or HR, with few inexperienced resources managing it. We are often mistaken by equating ‘subject matter expertise’ with ‘trainer’s expertise’, and push the subject matter experts without enough qualities of a trainer, to a critical process training. This results in a lack of engagement of the trainees in the session which ultimately defeats the purpose.
Training is not a checkbox exercise to satisfy regulatory audits: As soon as an employee joins an organisation, the line function is in a hurry to place him in the vacant position to ease the pressure on rest of the team. This occasionally results in training becoming an administrative expediency than serving any higher purpose. Same is the case for refresher training, as resources are always limited and sparing employees for training is considered as an additional burden. Thus, trainees are overloaded with a pile of training topics to be finished within a short duration in rigorous day(s)-long training sessions. This usually tests the limit of trainees’ ability to absorb and retain all the information provided to them. The enthusiasm of managers for training his employees plays a vital role here, which ultimately shows up its colours at the shop floor.
Do the employees have enough foundation to be trained in operating procedures?
People miss the contents from the training session due to lack of focus, or inability of the trainer to engage the participants. Else, many times participants don’t have basic foundational knowledge, because no one assessed them before nominating for a training session. Say for example, training on microbial testing procedures without a foundation in basic microbiology, or training on aseptic filling operation without basic knowledge of aseptic techniques, is nothing but pouring all your resources down the drain. Hence, to bridge this gap, the prevailing industry best practice is either to...
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