Tuesday, 28 April 2015

EU GMP Vol 4 Part 1 Chapter 2


"2.10 The manufacturer should provide training for all the personnel whose duties take them into production and storage areas or into control laboratories (including the technical, maintenance and cleaning personnel), and for other personnel whose activities could affect the quality of the product."

Training is generally considered a Human Resource Department function. That could be as it should be from the organization's point of view but it is more relevant to the department concerned with an employee within its folds. 

So, what is training?

Training and development describes the formal, ongoing efforts of organizations to improve the performance and self-fulfillment of their employees through a variety of methods and programs.

The key words are "formal" and "ongoing". While most organizations achieve the objective of "formal" because auditors insist on checking training records, the ongoing training is an issue. 

Let us explore the circumstances that guide the training policies and philosophies:

In-house training is the most popular. While this will be the most relevant training module as it deals with the subject matter with reference to context, it has some in-built short-comings.

a. Availability of a skillful trainer is a difficulty with most organizations. 
b. Availability of time for the trainer and the trainees since both belong to the same set-up and have their job descriptions crystallized, the job priorities pulls them away from training and justice is not done to training.
c. Existence of power pulls due to superior and subordinate hierarchy.
d. Focus shift as familiar background and urgency of matters will tend to drag the discussions out of context and the focus would shift from the topic in hand to the topic burning on the floor.
e. Interference of inter-departmental rivalry and depends on presence of dominant personalities or numbers
f. The age old syndrome of what is in-house is not good enough. The grass is always greener across the borders.

External Training is perhaps better received because of lack of familiarity with the trainer and a new outlook towards the subject as the perspective of the external trainer will be refreshingly different from that of those within the organization. But external training can be fraught with the following dangers:

a. There is a possibility of a mismatch between what the trainer wants to teach and what the organization and its individuals want to learn if the initial groundwork is slipshod.
b. The external trainer's knowledge and experience may be questionable
c. The context of the trainer might not be relevant to the trainees. For example a trainer from a formulations background would use that context which may not be wholly understood by the trainees from API background
d. There is a communication gap or failure of communication between the trainer and the trainees due to unfamiliarity.
e. The trainer may not be allowed access to the trainees' facilities in tune with company policy. This makes the job of the external trainer that much difficult as he is not in a position to tailor the training to the context of the trainees.
f. Cost of the external trainer may be an unbudgeted issue and hence always easy to axe the training itself.

In both cases, internal or external, the unstinted support and commitment of the top management is absolutely essential. It is very easy to convert a training program to a farce. Mere classroom training is 50% of the job done. On-the-job training, whether done by the internal trainer or the external trainer, is an absolute must. Real knowledge comes from actual practice. Theoretical knowledge is cramming of information and it tends to evaporate rather quickly. Things done physically or practically tend to stick and the finer nuances of the job can best be demonstrated in practical training.

"2.11 Besides the basic training on the theory and practice of the quality management system and Good Manufacturing Practice, newly recruited personnel should receive training appropriate to the duties assigned to them. Continuing training should also be given, and its practical effectiveness should be periodically assessed. Training programmes should be available, approved by either the head of Production or the head of Quality Control, as appropriate. Training records should be kept."

Newly recruited persons, especially those coming directly from Universities with no industrial experience come with a baggage. A human being is not a machine to be switched on and off. Whoever the person is in his personal life, it is the same person who walks in to work. For example, an undisciplined individual person at home will be more difficult to discipline and made to fall in line with the organizational needs than a disciplined person in his personal life. Moreover, University life is vastly different. There is glamour, bravado, show-off opportunities and a little bit of anit-establishment atmosphere, which is considered 'cool'. All these are detrimental in the industry and take quite some time to erase. 

The induction program and the probationary period are crucial times for a new entrant and it is here that many companies are found wanting. Attaching a fresh recruit to an experienced guy is not the best form of training and induction. Especially if this combination is not monitored.

Refresher training programs are generally not done and whenever undertaken, there is a feeling of "so what's new?" in the whole approach. Here the skill lies in designing the program and the power and skill of the facilitator or speaker plays a vital role. Most companies miss out on this front. I suspect that the major reason is that such training programs are conceptualized mostly to fulfil regulatory needs more than knowledge or skill needs.

There is more to training considerations than what has appeared here. This is just a brain teaser for people to sink their teeth into and mull over. There is a huge gap in what the regulatory guidelines say and what is the actual need in the industry. Lot of what is required is unsaid in the guidelines as it is impossible to cover all practical aspects in guidelines. It is for the industry captains to wake up and give training the due importance. 

The results of lack of training are there for all to see!

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