Cleaner training

By coincidence the day before the Editor suggested this article I was approached by the Director of the Cleaning Industry National Training Organisation seeking advice for their proposed cleanroom training scheme.

I spend my business life immersed in training for contamination control, cleanrooms and GMP, but these two recent projects made me pause to think about what is really important when discussing training for cleanrooms. The answer is that the need for a formally constituted training process is generic – regardless of industry and special circumstances. The unique component is that the cleanroom training plan must be cleanroom specific. Training is not rocket science but it is a process and as with every process has inputs, actions and outcomes. Understanding all three can make training one of the key mechanisms for corporate performance improvement. The training process is a cycle that starts with the corporate training policy to detail management expectations. This is followed by an audit of need, then audit of (existing) training inventory followed by the training plan by which policy is executed. The cycle is completed by regular training reviews, possibly by a third party, to evaluate performance and the assessment of the Return on the Training Investment (ROTI), and, of course, to provide feedback to make changes (see Fig. 1).

Continuity It is no accident that those who excel at any sport, the most respected military forces and other top flight achievers reach that state by continuous and taxing coaching or training. Good management and good training are indivisible; you can't have one without the other. Any organisation that clings to the notion that training can be turned on or off, can be left to junior managers or, worse, believes that it has no impact on company performance is being mismanaged. As with quality systems, it is essential that ownership (or accountability) of the training process is vested at the highest level of executive management and responsible for achieving the ROTI. A training policy should be published to include such matters as corporate and individual training objectives, individual accountability, the resources to be applied and, of paramount importance in GMP regulated healthcare manufacturing, how training documentation will be handled. The approach must be systematic and starts with an audit of training needs. This identifies the subjects for training needed to ensure effective coverage of every policy, skill and regulatory requirement for all departments at every level of employment – yes, every level of employment. This should be matched to an inventory audit to compare existing training with what the 'need audit' reveals. The major component is the training plan. It provides the detail for all input to the training process; for the specification, design, development and implementation – the actions – of all training (see Fig. 2). The training plan identifies trainer resource, whether professional trainers, external consultants, supervisors or peer trainers. It details methods to be used, whether internal or external, classroom, on-the-job (OTJ) training, practical and computer-based training (CBT) – or all of the above. It is the source and control document for planning and implementing training to new and existing employees. If your company is regulated, say, by the FDA, then training and its documentation is a critical element in your GMP compliance programme. And of course, there is no point in undertaking a training programme without assessing its impact. This means that people should be assessed for their understanding of and/or competence in the subject of each training session. The accumulated competence of all employees determines the effectiveness of training and how it affects company performance overall. Stripped to the essentials, training consists of content and delivery. In the past, an organisation of any size would employ a training manager whose department would create and carry out the training. In addition, OTJ training would be undertaken by people who worked next to you or who had special knowledge of certain items of equipment. Delivery would be by classroom presentation and work demonstration.

Quality The quality of training varies dramatically but even in pharmaceutical manufacturing, as regulated an industry as any, there is more than anecdotal information to confirm that much training depends merely on a supervisor handing the trainee an SOP (standard operating procedure), then asking if he or she has read it before signing a piece of paper to say that that person is trained and competent to undertake the task. In today's economic environment, senior management often view training as a non-productive cost that can be cut to the bare minimum – or further. In addition, the computer, in stand-alone or network format, has provided the background for vendors to create training software, which they hope will generate a CBT golden sunrise. In reality, training software performs two discrete functions. Firstly, as databases to provide a detailed history of the company's and each individual's training plans and records. There are several proprietary packages on the market. Some are very good, others seem to have missed the mark so far. The second use for training software is in holding and presenting training content, often featuring interactive operation and performance recording capabilities. This is a fruitful method to deliver appropriate and effective training. It is our experience that a surprising number of companies do not have the capacity widely to adopt CBT. In practice, training content and delivery methods should almost certainly be a mix of media that suit the particular subject. Just to put a middle-aged operator with 20 years' service in front of a keyboard and VDU, and expect them to emerge from the experience fully trained is rather optimistic. Alternatively, a young chemist or micro-biologist will be comfortable using a CBT interactive skills-development package. In the final analysis, CBT or e-learning is of necessity theoretical and there is no substitute to doing the real thing.

Cleanrooms Training for working in a cleanroom differs in that the stakes are higher, so each person who enters a cleanroom must have a fundamental understanding of why and how it functions in addition to their occupational skills. This basic knowledge should be augmented by more detail for those who work full-time in the environment, in accordance with their responsibilities. The problem with working in a cleanroom is that, by definition, when entering, it is difficult to understand what makes it so special – everything looks so clean (see Fig. 3). Obviously the all-enveloping clothing protocol is out of the ordinary and initially may feel restricting but it is difficult to see why walking at a normal pace or working quickly increases the probability of causing (airborne) contamination (see Figs. 4 and 5). The cost of operating cleanrooms is much higher than for conventional environments and the return on the training investment is critical – not just nice to have. Dependent on the activity and the level of each employee, the cleanroom training plan should include the following modules: • Basic Contamination Control The contaminants – particles, micro- organisms, chemicals, ESD Contamination dissemination mechanisms Cleanrooms and clean air standards and effects etc. • Personal hygiene How humans contaminate and control methods Cleanroom clothing, construction and gowning procedures etc. • Cleanroom behaviour Movement and turbulence Eating, drinking, chewing, smoking and medication • Cross contamination etc Cleaning cleanrooms Which surfactants and disinfectants do what Cleaning materials Cleaning techniques Verification of cleaning effectiveness etc. • Operational tasks and procedures under clean conditions Production requirements • Environmental qualification and monitoring Quality department personnel • Cleanroom Engineering & Maintenance Appropriate in-house engineering and vendor staff The minimum physical training should be undertaken in the cleanroom itself. Certainly, all theoretical material should be handled in a normal training environment. Basic training in the cleanroom can lead to contamination and must be closely supervised. Submicron size particles, microorganisms and their impact are difficult to explain. This was driven home when, a few years ago, I was training a large number of people at every level of management and operation who did not speak English. More to the point, with their eastern European background and even using colour slides, they had difficulty in accepting the standard of contamination control we took for granted. We knew we had a problem when the first session with senior managers, through an interpreter, ended on a sceptical note after five hours rather than the allocated 90 minutes. Creating a video package for each problem area, which luckily worked, solved the problem (see Fig. 6). People who work in cleanrooms tend to be of a reasonable educational standard and the use of multi-media CBT is realistic. However, apart from the limited library of available material, cleanroom training has to be traditional, done in cleanroom clothing to ensure the theory works in practice. Training is pointless unless you evaluate its effectiveness. If training is given in a policy, principle or regulatory guideline, then the trainee's knowledge should be tested and qualified to a predetermined standard. In addition to teaching specifics, one of the great strengths of training is that it develops intangible benefits such as motivation, team spirit and personal commitment. Hopefully, the days are long gone when senior managers think of their staff as gormless beings, able only to be shown how to do one particular task. Our experience is that most adults appreciate being trained and when it is done well, the company has a noticeable air of purpose and achievement (see Fig. 6). Training can be one of the great contributors to corporate wellbeing. Training for cleanrooms requires additional thought and practice. When assessing whether training is worthwhile, think 'value added'. It works like this; your product has a specification calling for a number of components or ingredients. If one of those is delivered faulty or contaminated, then it costs you money to take corrective action. If you don't find the problem, the materials go on to the next procedure and if they are compounded wrongly or damaged, then all previous costs – 'value added' – are incremental to the cost of the raw material when assessing the wasted – lost – cost. If there are multiple procedures to the complete process, and a mistake or contamination occurs at any of them, then the cost of the raw material plus the accumulated labour and overhead cost of each preceding procedure creates a substantial – unnecessary – loss of money. If the final product is found to be out of specification or contaminated then every single task in the company has been wasted – at substantial loss. If the shipment is lost or damaged during transit to the customer, the cost is even greater. Training is the critical element of the quality system that can minimise these value added losses and more than justify the training investment.