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Approach to Good Manufacturing Practices
Since ages food is an area of commercial interest to mankind. Food Safety was discussed in various ways in various societies. In India, Good Manufacturing Practices were integral part of our cultural and social practices and were designed to take care of basic food safety requirements. Recall your childhood, when mother used to order "wash your hands before touching any food product", keep unwashed utensils far away from kitchen, keep your shoes out of kitchen, etc. etc. These methods are effective and even valid in modern science age. Traditionally, Indian Society is hygiene conscious. In recent years because of increased commercialisation and adoption of unhygienic habits for undue commercial gains and lack of resources available to the people in the food trade coupled with environmental pollution, food hygiene has become a major issue of concern in international trade.
Food safety has become a issue of great interest to everybody in food trade when the United States FSIS Pathogen Reduction/HACCP rule published in July 1996 combines the concepts of Hazard Analysis and Critical Control Point (HACCP) systems with the FSIS requirement for written Sanitation Standard Operating Procedures (SSOPs). However HACCP and SSOPs are only part of a total food safety system. Good Manufacturing Practices provide the foundation for SSOPs and HACCP. It is important to have a clear understanding of the relationship between the GMPs, SSOPs and HACCP plans for compliance of various food safety regulations.
GMPs' pre-requisite programmes comprise the basic, universal steps and procedures that control operating conditions within establishments and ensure favourable conditions for the production of safe food. These differ from HACCP systems which focus on the critical points in a manufacturing process that affects food safety. GMPs are the control factors that relate to the entire operation and are not process-specific. GMPs include programmes such as facilities/grounds, equipments/utensils, pest control, receiving and storage, process control, product recall and personnel training.
Prior to the development and implementation of HACCP plans, an establishment should first review existing programmes and verifies that all GMPs are in place and effective. Effective GMP programmes ensure that HACCP plans focus specifically on the critical control points (COPs) necessary for product safety. If any portion of the GMPs is not adequately controlled, there is possibility for a HACCP plan to be less effective in ensuring product safety.
This series of articles will provide you with some basic guidance to follow when writing and implementing GMP programmes. Before we go to details, please remember that food safety cannot be achieved in piecemeal approach. We will help you in understanding the fundamentals of food safety and to develop in-house quality system to meet your requirements. It in not difficult to implement these in your production facilities. What is needed is application of scientific knowledge with common sense approach and commitment from the top management. Quality is, however, not free, but it is the cheapest option to progress in business in the present day competitive environment.
Components of Good Manufacturing Practices (GMPs)
GMPs are like any policy programme any manufacturer has implemented. They require a written programme, an appropriate training programme and schedule, a maintenance schedule and most importantly management commitment.
Management commitment is the vital component of any programme the company implements. Management's role takes on many forms from providing funds, guidance, human resources, to following the rules themselves.
Once management has committed to the implementation of a programme other components will fall in place. Without this no amount of investment or external assistance will deliver results.
Written Programme and Records
Written Programme
The written programme will serve as the base for other components. A good written programme includes who, that, where, when, why and how of the programme. It should clearly explain the scope of the programme, responsible individuals, its importance, parameters, monitoring activities and records, corrective actions and records and verification activities. A multi-disciplinary team made up of individuals with technical and operational expertise should write the programme. In small units, entrepreneurs may take help of external well-qualified food industry professionals or can go for training themselves.
The written programme should be written at a level that is appropriate for the educational level of employees and in a language they understand. Furthermore, it should clearly set forth an effective communication system i.e. the record keeping system and the expectations of the record keeping system.
It is however an effort, which is required once, and later it will act as a basic guide and can be modified as and when required to upgrade the quality standards.
Records
A record keeping system creates the environment in which employees communicate with one another. Its proper design and implementation directly effects how information is shared and problems are solved. The record keeping system must be a proactive vehicle of communication, desigred primarily to be useful. Monitoring and corrective action records should be designed not only with the monitor in mind, but also the auditor.
Records should include a brief description of parameters being monitored corrective actions to be taken by the monitor, product code/code date, date, time, findings, monitors initials and any other appropriate information. Records should be reviewed, prior to being filed, for accuracy and to ensure that all the parameters of the programme were met and appropriate corrective actions taken. Monitors should be carefully chosen and appropriately trained. They should have good written communication skills, to make the records that ensures the proper compliance.
The following section, "Good Manufacturing Practices," will go into more detail for specific areas the written programme should consider.
Training Programme
Next to management commitment, an effective training programme and schedule are critical to the effectiveness of the GMP programmes. Without the proper training of all employees, the effectiveness of GMPs is jeopardised. Training of employees and of your own will help translate your dream into reality not only in terms of quality but also in terms of profits. Thus it is vital to develop human capital to face competition.
There should be stress on the importance of both employee participation and employee accountability. Literacy and language are two very important issues to be considered in developing the appropriate training programme for GMPs and other food safety programmes, because all persons involved in production processes may not be from the same place or may not be of the same educational evel. In addition, people learn visually and/or audibly, in other words, there are people who learn by reading or seeing, some learn by hearing and some learn by the combination of the both.
An effective training programme will incorporate different deliveries of information. Furthermore, an effective training programme is structured in such a way that the employees are told in advance what will be taught, and then they are trained and finally a review is done of what they have learnt. Once the programme has been developed, trainers must be selected and trained. Trainers should be chosen carefully and should be selected on the basis of his/her training skills and not by job description or position they hold in the company or department. It is a well acknowledged fact that a good player may not necessarily be a good coach always. Similarly In-house Managers, Supervisors and QA employees do not always make the best trainers.
Training schedule development should take into account turnover rate, and should have update or reminder sessions as well. All new employees, regardless of job, should go through an initial training session. Many times companies prefer on the job training to save time or money but on the job training (OJT) is not an effective way to train employees for GMP or food safety programmes. OJT hampers the learning process of new concepts and new benchmarking. In some situations it is conceivable to have "new employee" training on a daily basis.
All training activities should be documented including who received the training, the date and the type of training given. This will help in later date to identify the training needs of the employees for further up-gradation.
Scientific Inputs for Programme Maintenance
In today's world scientific and commercial information undergo change very fast. Like facilities and equipment, written programmes need to be maintained to ensure their effectiveness. A maintenance schedule for written programmes should be based on changes in your facility environment or new scientific developments. Employee turnover, new process introductions and facility layout changes are just a few issues that could trigger a review of the written programme.
In addition, any time you reassess food production and safety/programmes the GMPs should also be reassessed.
In the next article, we will discuss various dimensions of food safety and GMPs. Please send your commends to the editor, so that we can include issues which are important for your operation.
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