MICROBIOLOGICAL QUALITY AND SAFETY IN DAIRY INDUSTRY

Module 2. Food safety and quality management systems

Lesson 6
CONCEPTS OF QUALITY MANAGEMENT SYSTEM (QMS) – ISO 9000:2000

6.1 Introduction

The concept of ‘quality’ has existed for many years, though the meaning has changed and evolved over time. In the early twentieth century, quality management meant inspecting products to ensure that they met specifications. In the 1940s, during World War II, quality became more statistical in nature. Statistical sampling techniques were used to evaluate quality, and quality control charts were used to monitor the production process. In the 1960s, with the help of so-called ‘quality gurus’, the concept took on a broader meaning. Quality began to be viewed as something that encompassed the entire organization, not only the production process. Since all functions were responsible for product quality and all shared the costs of poor quality and finally quality was considered as a concept that affected the entire organization.

Today, successful companies understand that quality provides a competitive advantage. They put the customer first and define quality as meeting or exceeding customer expectations. Since the 1970s, competition based on quality has grown in importance and has generated tremendous interest, concern, and enthusiasm. Companies in every line of business are focusing on improving quality in order to be more competitive. In many industries quality excellence has become a standard for doing business. Companies that do not meet this standard simply will not survive. The term used for today’s new concept of quality is total quality management or TQM. One can see that the old concept is reactive, designed to correct quality problems after they occur. The new concept is proactive, designed to build quality into the product and process.

6.2 Basic Definition and Terminology

Quality: The quality of something can be determined by comparing a set of inherent characteristics with a set of requirements. If those inherent characteristics meet all requirements, high or excellent quality is achieved. If those characteristics do not meet all requirements, a low or poor level of quality is achieved. Quality is, therefore, a question of degree. As a result the central quality question is: how well does this set of inherent characteristics comply with this set of requirements? In short, the quality of something depends on a set of inherent characteristics and a set of requirements and how well the former complies with the latter. According to this definition quality is a relative concept. By linking quality to requirements, ISO 9000 argues that the quality of something cannot be established in a vacuum. Quality is always relative to a set of requirements. Thus, quality is the totality of features and characteristics of a product that bear on its ability to satisfy stated or implied needs/ or the operational techniques and activities that are used to satisfy quality requirements.
Quality characteristic: A quality characteristic is tied to a requirement and is an inherent feature or property of a product, process, or system. A requirement is a need, expectation, or obligation. It can be stated or implied by an organization, its customers, or other interested parties. An inherent feature or property exists in something or is a permanent characteristic of something.

Quality assurance (QA): Quality assurance is a set of activities intended to establish confidence that quality requirements will be met. QA is one part of quality management.

Quality control (QC): Quality control is a set of activities intended to ensure that quality requirements are actually being met. QC is one part of quality management.

Quality improvement: Quality improvement refers to anything that enhances an organization's ability to meet quality requirements. Quality improvement is one part of quality management.

Quality management: Quality management includes all the activities that organizations use to direct, control, and coordinate quality. These activities include formulating a quality policy and setting quality objectives. They also include quality planning, quality control, quality assurance and quality improvement.

Quality management system (QMS): QMS may be defined as ‘a set of coordinated activities to direct and control an organisation in order to continually improve the effectiveness and efficiency of its performance’. It comprises of collective policies, plans, practices and the supporting infrastructure by which an organization aims to reduce and eventually eliminate non-conformance to specifications, standards and customer expectations in the most cost effective and efficient manner.

Quality planning: Quality planning involves setting quality objectives and then specifying the operational processes and resources that will be needed to achieve those objectives. Quality planning is one part of quality management.

Quality plan: A quality plan is a document that is used to specify the procedures and resources that will be needed to carry out a project, perform a process, realize a product, or manage a contract. Quality plans also specify who will do what and when.

Quality policy: An organization’s quality policy defines top management’s commitment to quality. A quality policy statement should describe an organization’s general quality orientation and clarify its basic intentions. Quality policies should be used to generate quality objectives and should serve as a general framework for action. Quality policies can be based on the ISO 9000 Quality Management Principles and should be consistent with the organization’s other policies.

Quality objectives: A quality objective is a quality oriented goal. A quality objective is something aim for or tries to achieve. Quality objectives are generally based on or derived from organization’s quality policy and must be consistent with it. These are usually formulated at all relevant levels within the organization and for all relevant functions.

Continual improvement: Continual improvement is a set of activities that an organisation periodically carries out in order to enhance its ability to meet requirements. Continual improvements can be achieved by carrying out audits (and using audit findings and conclusions), performing management reviews, analysing data, setting objectives and implementing corrective and preventive actions.

Customer: A customer is anyone who receives products or services from a supplier organisation. Customer can be people or organisation and can be either external or internal to the supplier organisation. For example, a factory may supply products or services to another factory (customer) within the same organisation. According to ISO 9000, examples of customers include clients, customers, end-users, purchasers, retailers and beneficiaries.

Customer satisfaction: It is a perception. It is also a question of degree. It can vary from high satisfaction to low satisfaction. If customers believe that their requirements have been met, they experience high satisfaction. If they believe that their requirements have not been met, they experience low satisfaction. Since satisfaction is a perception, customers may not be satisfied even though all the contractual requirements have been met. Just because one hasn’t received any complaints doesn’t mean that customers are satisfied. There are many ways to monitor and measure customer satisfaction. One can use customer satisfaction and opinion survey, can collect product quality data (post delivery), track warranty claims, examine dealer reports, study customer compliments and criticisms and analyse lost business opportunities.

Management: The term management refers to all the activities that are used to coordinate, direct and control an organisation. In this context the term management does not refer to people. It refers to activities. ISO 9000 uses the term Top Management to refer to people.

Management system: A management system is a set of inter-related or interacting elements that organisations use to implement policy and achieve objectives. There are many types of management systems. Some of these include quality management, emergency management, food safety management, occupational health and safety management, information security management systems and business continuity management systems.

Nonconforming product: When one or more characteristics of a product fall to meet specified requirements, it is referred to as a nonconformity product. When a product deviates from specified product requirements, it fails to confirm. Nonconformity products must be identified and controlled to prevent uninterrupted delivery.

Nonconformity: It refers to failure to comply with requirements. A requirement is a need, expectation, or obligation. It can be stated or implied by an organisation, its customers, or others interested parties.

Procedure: A procedure is a way of carrying out a process or activity. According to ISO 9000, procedures may or may not be documented. However, in most cases, ISO 9001 expects documentation of procedures. Documented procedures can be very general or very detailed, or anywhere in between. While a general procedure could take the form of a simple flow diagram, a detailed procedure could be a one page form or it could be several pages of text. A detailed procedure defines and controls the work that should be done, and explains how it should be done, who should do it and under what circumstances. In addition, it explains what authority and what responsibility has been allocated, which inputs should be used and what outputs should be generated.

Process: A process is a set of activities that are interrelated or that interact with one another. Processes use resources to transform inputs into outputs. Processes are interconnected because the output from one process becomes the input for another process. In effect, processes are “glued” together by means of such input output relationships. Organizational processes should be planned and carried out under controlled conditions. An effective process is one that realizes planned activities and achieves planned results.

Process approach: The process approach is a management strategy. When managers use a process approach, it means that they manage the processes that make up their organization, the interaction between these processes and the inputs and outputs that tie these processes together.

6.3 QMS Concept

6.3.1 Process-based quality management system (QMS)

A quality management system is a set or network of many of interrelated or interacting and interconnected processes (elements) that organizations use to direct and control how quality policies are implemented and quality objectives are achieved. A process-based quality management system uses a process approach to manage and control how its quality policy is implemented and how its quality objectives are achieved. A process-based QMS is a network of interrelated and interconnected processes. Each process uses resources to transform inputs into outputs. Since the output of one process becomes the input of another process, processes interact and are interrelated by means of such input-output relationships. These process interactions create a single integrated process-based QMS. The concept of a “process-based quality management system” is briefly mentioned in the introduction to ISO 9001 (Fig. 6.1). However, ISO 9000 does not formally define this important term. Since the output of one process becomes the input of another process, processes interact and are interrelated by means of such input-output relationships. These process interactions create a single process-based QMS. Top management is called to establish a customer oriented organization:

• By defining the systems and processes that can be managed and improved in effectiveness and efficiency,
• Acquiring and using process data and information on a continuing basis,
• Directing progress towards continual improvement and
• Using suitable methods to evaluate process improvement.

Fig. 6.1 Process module of the standard ISO 9000:2000

6.3.2 Interpretation of basic quality concepts and processes

Two significant attributes, among others which mark management processes at the beginning of the third millennium are: constant changes and the process approach to management. Changes, constant improvement and process approach are attributes of the Total Quality Management (TQM) concept and the characteristic of the new edition of the ISO 9000:2000 standard. The definition of the TQM and the process approach definition points that TQM is a concept or a philosophy for management operations where as quality is a function of management. It is a way of how to manage processes in order to achieve success and has become a movement and an approach, a religion of how to live. TQM concept is in literature and it is widely and thoroughly considered as the unity of several approaches such as:

1. Approaches that act on the removal of the burden created by the traditional way of work,
2. Approaches that allow science method usage in working process,
3. Approaches that allow equal distribution of work functions,
4. Approaches that provide the engineering of the process,
5. Approaches that allow transparency of the organization and
6. Group of approaches to TQM that enable competing ability.

ISO 9000:2000 standard defines process as the "system of activities that uses resources to transform inputs into outputs". This definition has a strong point in two major rules (1) inputs of one process are mainly outputs of another and (2) processes are managed in order to create new values that correspond to requirements and expectations of customers. So, cybernetic approach to management is at use today, an approach that establishes connection between inputs and outputs, during which process outputs must be verified according to input requirements in order to satisfy customer requirements and requirements of other interested sides. Also, process inputs must be defined and recorded in order to provide a base for demand formulation that is to be used for output validation and verification. Input requirements that are crucial for product or process must be identified in order to assign proper responsibilities and resources (ISO 9000:2000). Production process represents a flow that begins with external requirements of buyers and ends with the product that is used by buyers. Buyer makes judgment about realization or non-realization of his requirements. ISO 9000:2000 standards recommend that:

1. Desired results can be more efficiently achieved if proper resources and activities are managed as processes and
2. System approach to management: identification, understanding and system management of related processes to achieve goal that are set. Thus QMS make the organization efficient.

6.3.3 Process network - network architecture

Considering the definition that the process is "a system of activities..." then, every process can be structured as the unity of activities or chain of activities, and any activity can be structured as the chain of elementary tasks. For both definitions, for activities and tasks, the second part of the definition is the same "....that uses resources in order to transform inputs into outputs". ISO 9000:2000 standards explain the consistency of such structure as follows: "any activity that transforms inputs into outputs can be considered as the process". In order for its efficient functioning the organization should identify and manage inter related process.

6.3.4 The benefits of a QMS

A fully documented QMS will ensure that two important requirements as follow:

1. Customers’ requirements: confidence in the ability of the organisation to deliver the desired product and service consistently meeting their needs and expectations.
2. The organisation’s requirements: both internally and externally and at an optimum cost with efficient use of the available resources – materials, human, technology and information.

These requirements can be met truly only if objective evidence is provided, in the form of information and data, to support the system activities from the ultimate supplier to the ultimate customer. A QMS enables an organisation to achieve the goals and objectives set out in its policy and strategy. It provides consistency and satisfaction in terms of methods, materials, equipment, etc., and interacts with all activities of the organisation, beginning with the identification of customer requirements and ending with their satisfaction, at every transaction interface. Management systems are needed in all areas of activity whether large or small businesses, manufacturing, service or public sector. A good QMS will ensure the following in organisation:

i) Set direction and meet customers’ expectations
ii) Improve process control
iii) Reduce wastage
iv) Lower costs
v) Increase market share
vi) Facilitate training
vii) Involve staff
viii) Raise morale

The Quality Management System has been developed to comply with regulatory, industry and customer quality requirements imposed by customers or regulatory agencies for items and services. The QMS describes commitments to the quality assurance requirements of ISO 9001; ISO 9000-3. It defines the basic requirements applicable to customer contracts and is a commitment to the customers. It serves as a directive for all functions in establishing necessary policies and procedures that comply with the requirements of ISO 9001:2000 and ISO 9000-3:1997. Employees' involvement is most vital for effective quality management system. If we enforce quality management system following benefits of strategic quality planning could be availed by dairy industry: