The Significance of Quality Management Systems with special reference to Good Manufacturing Practices

SESSION 3 . Microbiological hazards and control measures

Abstract

As with hygiene and food safety, the issue of quality has been rapidly growing in prominence and importance in recent years and the optimum approach to these two areas is remarkably similar.

Providing quality assured products to the consumer has traditionally relied on quality control of finished products, i.e. a set of procedures to test and analyze the product to ensure it conforms to the required specification.

The microbiological safety of dairy products is not a single term but a complex and integrated system, a “philosophy” combining the rules of growth and death of micro-organisms with the properties of the product, the mastering of highly developed technologies and the application of this know-how by properly trained and motivated personnel.

GMPs comprise procedures, processes, controls and precautions that ensure safe, wholesome food. GMPs also facilitate the production of foods of uniform quality. Although this is an important consideration, maintenance of product safety remains the most important objective.

Focus on prevention of defects through effective design and hazard elimination has led to the development of preventative Quality Assurance (QA) systems, in particular HACCP, to identify places where pathogenic organisms can survive/enter/ proliferate in the food and to manage these as the key control strategy, rather than rely on end product testing.

Management must implement a system of Hygiene Management Review whereby Management minutes all the non-conformances and non-compliance’s, initiate and/or takes note of the corrective actions and monitors the results.

HACCP is a food safety management system, which concentrates prevention strategies on known hazards and the risks of them occurring at specific points in the food chain. HACCP works in conjunction with pre-requisite practices (PRPs). This is an umbrella term used to describe all those activities, other than specific HACCP plans, which affect food safety.

Introduction

As with hygiene and food safety, the issue of quality has been rapidly
growing in prominence and importance in recent years and the optimum approach to these two areas is remarkably similar.

Providing quality assured products to the consumer has traditionally relied on quality control of finished products, i.e. a set of procedures to test and analyse the product to ensure it conforms to the required specification. The drawbacks of this approach are well known and include the following:

• In spite of control procedures, incidents of food poisoning still occur;
• Extensive quality control programs result in a relatively high cost of sampling and analysing;
• Microbial organisms may not be evenly distributed and may be concentrated in a very small proportion of a batch of food. This makes traditional quality control testing schedules, based on statistical sampling, even less effective;
• The cost of rejected goods will be higher if control is based solely on finished product testing (IDF Bulletin, 1994).

The implementing of Quality Systems (QS) is becoming an international
necessity more than just to having in place standards for improving efficiency and accuracy. There is an increasing need for veterinary testing laboratories to comply with International Standards to improve accountability that can be accepted by third parties.

Definitions of Quality and quality related issues

1. Quality is defined as the totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs.
2. Quality control (QC) concerns the operational means to fulfill the quality requirements. 
3. Quality Assurance (QA) aims at providing confidence in this fulfillment, both within the organization and externally to customers.
4. Quality management (QM) includes QC and QA, as well as the additional concepts of quality policy, quality planning and quality improvement. QM operates through the quality system.
5. Total quality management (TQM) brings to these concepts a long-term global management strategy and the participation of all members of the organization for the benefit of the organization itself, its members, customers and society as a whole.

Why quality?

Quality matters because:

[What about producing a good product?]

1. you want to be respected
2. you want to have job satisfaction
3. you want to enjoy work and be proud to work for you organization
4. you want to eliminate the negative chain reaction caused by mistakes and injuries
5. you want to have confidence in the results.

Quality matters to the external customers because they want:

1. to be respected and do not want any hassles
2. a product and service that is value for money
3. a product and service that is reliable and meets their requirements
4. a product and service that is available on time
5. a product and service that improves their quality of life (UNISA, 2001)

Is quality a condition or a process?

Quality should refer to both since we have quality enablers and quality results. Quality therefore refers to inputs, processes and outputs. We need quality inputs and quality processes to obtain quality outputs. Quality is not dependent on inputs alone - it is obtained by multiple variables and also expressed by in terms of multiple dimensions. These dimensions originate from people needs and internal and external customer specifications.

Normally a process will consist of a variety of resource inputs that may vary. These variables may cause variation in the process that will lead to some inconsistencies or defect.

The continuous improvement of the Quality Management System is illustrated in Figure 1 (SABS ISO 9001).

What influence quality?

The attitudes of personnel are among the most important indicators to consider in measuring an organisation’s performance. It is often said that it is better to work with “poorly” qualified personnel with positive attitudes than the other way round. Attitudes are a vital force behind culture. Culture is a collective organisational attitude of how things are done. It consists of many things such as a strong and clear value system for quality, commitment and communicating quality. If a strong total quality value system can be established, then people’s attitudes towards quality could result in spontaneous participation to obtain and sustain quality through teamwork and other quality improvement techniques. The climate of an organisation is the current level of satisfaction that employees may have with the culture. Climate can vary over a short period of time while culture is highly resistant to change (UNISA, 2001).

Quality and leadership

 Leadership is a crucial factor in the successful implementation of a Quality Management System (QMS). Firstly it shows that the top management provides a vision of where the organisation wants to be and what factors will play key roles in realizing its vision. The vision is the picture of the desired future state and the mission will encapsulate what factors will be needed to reach this state. After being informed of the organisation’s mission, customers, suppliers and employees should have no doubt as to what the organisation stands for and how it will conduct business. After the mission has been defined, management should live the mission. They should be totally committed to it and by their example should shows employees what needs to be done.

Secondly, management should be able to develop strategies that will guide the organisation towards the achievement of its mission. These strategies are the broad plans that members of the oganisation need to enable them to design operational plans that will actually make the strategies work.

The next requirement is an effective organizational structure of core functions. This should be designed to support the mission and strategies.

The last but vital function of leadership is to ensure that employees are empowered by making them co-responsible for the success of the company. There are a number of important issues related to people that leaders should attend to:

1. Effective and constant communication
2. Creating the right attitude and motivation for employees to serve their customers to the best of their abilities
3. Identifying and developing the abilities of employees so that they can contribute in the areas in which they are operational active
4. Helping them to understand the basics of sound management (UNISA, 2001).

What is a system?

It is an organized or complex whole; assemblage of things or parts interacting in a coordinated way. A system has three features:

1. Wholeness or holism. The whole is more that the sum of the parts. Parts of the system are affected by being in the system, which changes if parts are either removed or modified.
2. Purposefulness. The assemblage of things or parts does something.
3. Focus point of interest. The systems are conceived by people with their own particular points of interest or views.

Systems provide for structure, discipline and foundation and since quality has so many facets, interdependencies, variables and dimensions, it is internationally accepted that a QMS becomes business practice. To plan, control and improve quality without a well-documented system would not be
sufficient and will be too “loose”.

The systems approach:

1. requires a detailed examination of all the interactive relationships of the different subsystems
2. is viewed as a dynamic process in which the different activities and elements are integrated into a complete system
3. attempts to give optimal solution or strategy for solving a particular problem.

Why a system?

A documented system is the basis for improvement and consistency. When a system is not well documented, it is open to interpretation and you loose control.
The essence of the QMS philosophy is to:

• say what is done
• justify what is being done
• do what is said
• record what was done.

Quality Management Systems

1. Good Manufacturing Practices (GMP)
2. Hazard Analysis Critical Control Point (HACCP)
3. Certification (ISO 9000:2001, Euregap, etc)
4. Laboratory accreditation (ISO Standard 17025)
5. Good Hygienic practices (GHP)
6. Food Safety Management Systems (ISO/CD 22000),
   etc.

Good Manufacturing Practices (GMP)

GMPs comprise procedures, processes, controls and precautions that ensure safe, wholesome food. GMPs also facilitate the production of foods of uniform quality. Although this is an important consideration, maintenance of product safety remains the most important objective (IDF Bulletin, 1992).

The fundamentals of GMPs comprise of four practices:

• Exclusion of undesirable micro-organisms and extraneous material;
• Removal of undesirable micro-organisms or extraneous material;
• Inhibition of undesirable micro-organisms;
• Killing of undesirable micro-organisms.

GMP can be divided into seven elements:

• Personnel
• Plant and premises
• Sanitary operations
• Equipment and utensils
• Processes and controls
• Storage and distribution
• Recall procedure

Comprehensive GMPs require that all the elements be incorporated and integrated.

GMP applications

GMP systems can fulfill a variety of applications. First and foremost, of course, is “job one”, maintenance of product safety and quality. GMP systems can be used to train employees. There is no better knowledge to impart to employees than that which describes the practices and procedures with which they perform their jobs.

GMP elements can make important contributions to the design of facilities. Facilities designed with GMP principles and requirements in mind can be easier to maintain in GMP compliance than those which are not. Finally, GMP can make a positive contribution to regulatory oversight. A management team, which can demonstrate to regulatory authorities that they consistently operate in compliance with a well, conceived GMP system should experience a positive relationship.

SUMMARY

The implementation of a QMS required the involvement of top management, which gives the necessary perspective for understanding and anticipating the wide-ranging implications of the decision. They have the power to authorize the resource allocation and deployment for implementation. The decision made to implement a system has a significant impact on the long-term position of the organisation. The decision also has major multifunctional consequences and it required the involvement of more than one functional department. Each of these areas will be affected by the allocation or reallocation of responsibilities and resources.

It is also necessary to consider the factors in the organisation’s external environment. Organisations are open systems which impact, or are impacted upon by, external conditions that are largely beyond their control.

The food industry is dynamic. New food products are introduced to the marketplace, older products fade away. New technology may be specified which might require modification of GMPs. Thus, GMPs must evolve in concert with the development of new products and processes. GMPs have become essential to the production of safe products by the modern, complex, high volume food industry.

REFERENCES

Bulletin of the International Dairy Federation No 292. Recommendations for the hygienic manufacture of milk and milk based products. p. 1-2. (1994).

Bulletin of the International Dairy Federation No 276. Hygiene management in dairy plants. p. 6-9. (1992).

UNISA Centre for Business Management. Course in basics of TQM - Quality Management Systems and TQM implementation. Published by the Centre for Business Management, University of South Africa. First Edition. (2001).

Mortimore, S. and Wallace, C. HACCP a practical approach. Chapman & Hall, London, Glasgow, Weinheim, New York, Tokyo, Melbourne, Madras. p. 6. (1995).

SABS ISO 9001:2000. South African Standard. Code of practice: Quality management systems - Requirements. Published by the South African Bureau of Standards. p vi. 

IDF/FAO international symposium on dairy safety and hygiene Cape Town, March 2–5, 2004, South Africa