INTRODUCTION TO QUALITY ASSURANCE Basic Quality Terminology No more definitions...please! Page 1
Quality is the degree to which a specific product conforms to a design or specification H.L. Gilmore Product Conformance Cost Quality Progress 1974 Quality is the totality of features and characteristics of a product or service that bears on its ability to satisfy stated or implied needs Johnson and Winchell Productivity and Quality ASQC 1989 Quality is Fitness for Use Juran Quality Control Handbook 1974 Page 2
Quality is defined by the customer; customers want products and services that through their lives, meet customers needs and expectations at a cost that represents value Ford s definition 1991 Even though quality cannot be defined, you know what it is! R.M. Pirsig Zen and the Art of Motorcycle Maintenance 1974 Quality is an Outcome not a Method Deming METHOD QUALITY Page 3
QUALITY A formal definition of Quality is to be found in ISO 8402 (1994) Totality of characteristics of an entity that bear on its ability to satisfy stated and implied needs. The achievement of satisfactory quality involves all stages of the quality loop as a whole. The contributions to quality of these various stages are sometimes identified separately for emphasis, for example, quality due to definition of needs, quality due to product design, quality due to conformance, quality due to product support throughout its lifetime. In some references, quality is referred to as fitness for use or fitness for purpose or customer satisfaction or conformance to the requirements. These represent only certain facets of quality, as defined above QUALITY ASSURANCE Where market considerations and competitiveness point to the importance of quality this implies the necessity of evaluating it. This may be done by the use of Quality Assurance, defined in ISO 8402 as All the planned and systematic activities implemented within the quality system, and demonstrated as needed, to provide adequate confidence that an entity will fulfill requirements for quality. Page 4
QUALITY CONTROL One of the techniques of Quality Assurance is Quality Control ie. Operational techniques and activities that are used to fulfill the requirementfor quality. Quality control involves operational techniques and activities aimed both at monitoring a process and at eliminating causes of unsatisfactory performance at all stages of the quality loop in order to result in economic effectiveness. QUALITY IMPROVEMENT Actions taken throughout the organisation to increase the effectiveness and efficiency of activities and processes in order to provide added benefits to both the organization and its customers QUALITY MANAGEMENT Quality Management involves: All activities of the overall management function that determine the quality policy, objectives and responsibilities, and implement them by means such as quality planning, quality control, quality assurance and quality improvement within the quality system. Page 5
Quality Assurance Quality Management Quality Improvement Quality Control THE ASSURANCE OF QUALITY In order to assure quality, it is necessary to ensure that all the requirements for the total presentation are known. In other words the customer's requirements must be sufficiently detailed to be fully understood by the supplier so that there are no areas of doubt as to the service requirements Page 6
Quality assurance requires the total integration and control of all elements within a particular area of operation so that none is subservient to the other. These elements cover such aspects as administration, finance, sales, marketing, design, procurement, manufacture, installation, commissioning and even decommissioning. Quality Assurance is a management function which cannot be delegated. A properly constituted quality assurance department can produce a plan of action and a scheme to be followed but its implementation is a management responsibility. THE CUSTOMER - SUPPLIER RELATIONSHIP The background to quality assurance is the customer - supplier relationship. The ultimate purpose of any quality assurance scheme is to ensure complete satisfaction to the customer with the goods or services provided by the supplier Page 7
Although this customer - supplier relationship may be regarded, at least partly, as external to the suppliers activities, much of the same philosophy applies internally within a supplier's work-place, at each stage of the company's operations from receipt of the order to final delivery. The customer may be regarded as the next stage in the process and so a quality assurance scheme applies throughout the complex of activities The Customer is the next stage in the process Page 8
Often in the past, the quality level of an item was defined more by the experience of a supplier then any specific requirements of the customer. The customer stated his need in broad terms and the supplier manufactured an item which he considered filled that need. It was only when the item was complete that it was determined whether or not the item suited the customers requirements. In today's highly demanding environment of quality, together with the concern by customers and the cost constraints within a company, the emphasis must now be pro-active rather than reactive. The question "have we got it right" (quality control/ inspection) must give way to "are we doing it right" (quality assurance). THE SYSTEMATIC APPROACH The results of old inspection practices leave much to be desired. The philosophy now is to insist on objective or real evidence of quality rather than make an assumption by inspection, or accept a guarantee by a contractor or supplier, that the required quality does exist. Page 9
The real evidence of quality must be seen to exist, not only in the completed item but in all activities which are involved in completing that item: design, procurement, manufacture and installation. By controlling all those functions in a systematic manner one can be reasonably assured that each activity is right before the next activity commences. Quality, as discussed so far relates to all the activities concerned with the actual design, procurement, manufacture and installation of an item. These activities in themselves, if they are under control will give the customer the item in a "fit for purpose" condition and within budget and on schedule. There are many other functions outside these areas which indirectly affect the efficiency of achieving fitness for purpose. These include such functions as: market research, sales, finance, administration and maintenance, and should all be included in the total quality assurance programme. Thus we would not only achieve fitness for purpose but it would be achieved in the most efficient and cost-effective manner. Page 10
Design Procurement Manufacture Delivery or Installation Sales & Marketing, Administration, Accounts, Public Relations, Personnel, Training ORGANISATION FOR QUALITY To be effective, the quality system requires an organisation that clearly defines who does what and how responsibility and authority are delegated. This requirement can be considered under three main headings: (i) Structure (ii) Responsibilities (iii)role and Position of the Quality Assurance Function Structure Each Employee needs to know where they are in the organisation. The company organisation structure should be established and documented to clearly define: the lines of reporting and communication functional responsibilities and decision making responsibilities position of the quality assurance function overall organisation Page 11
It s not my job! I Don t Know Nobody told me! I m new here We don t know what he does If she leaves nobody will know... What does the client want from us? Structure Each Employee needs to know where they are in the organisation. The company organisation structure should be established and documented to clearly define: the lines of reporting and communication functional responsibilities and decision making responsibilities position of the quality assurance function overall organisation Responsibilities It is necessary to delegate responsibility to suitably qualified and experienced personnel. It is equally important to define the limits of authority and responsibility, for each individual, and identify roles and positions regarding the quality function for both individuals and departments. Page 12
Role and Position of the Quality Assurance Function The quality assurance function is responsible for ensuring that the quality system is established, implemented and remains effective Demonstrability Demonstrability in the ISO sense is is an open demonstration between staff members themselves, between vendor and main manufacturer, and between manufacturer and customer. It is an attitude, a way of life. It opens up the shop-floor, exposing section to section, staff members to staff members, it brings the vendor in through the back door in ship to stock, ship to production, or just in time, and the customer in through the front door Demonstrability and Accreditation Demonstratability begins at the top with the decision to adopt a policy on quality. ISO 9000 makes this very easy as all management now needs to do is to go for ISO 9000 and all that decision entails, from assigning responsibilities for installing the system to applying to the national accreditation agency for certification and registration. Page 13
Traceability This expression appears throughout ISO 9000. It means that at all stages, from arrival of a component from the supplier, through production, to packaging and shipping, it is necessary to assign responsibility for relevant tasks which affect the quality of the product. There can be no question of not knowing who did what Real or Objective Evidence of Quality This is the evidence which confirms that all activities within each of the functions of design, procurement, manufacture and in the case of large projects, site construction and commissioning, have been carried out in accordance with established working methods. These methods are identified in documents, which are known as procedures. PROCEDURES Page 14
Procedures Procedures will detail the purpose and scope of an activity and will also identify how, when, where and by whom the activity is to be carried out. Emanating from such activities will be documents which will detail the results of activities or tests. It is these procedures, together with the documentation, which give the objective evidence of quality. The Need for Procedures To implement a quality assurance programme and to assess and report shortcomings within the programme, the Quality Assurance Department must have bases upon which to work. These bases are the written procedures already mentioned. These procedures should detail what is required or is to be controlled; who is responsible for ensuring the requirement met, or the control carried out; and how, when, where and possibly why it is controlled. Hierarchy of Documentation Policy Quality Manual System Process Procedures Work Practices Work Instructions Page 15
The Four Tiers of Documentation Quality Manual Tier 1 Procedures Tier 2 Job Instructions Tier 3 Forms & Records Tier 4 As well as taking account of quality and safety requirements, it is also important that procedures indicate how interface problems between departments or disciplines can be avoided. The procedures, which involve an interface between departments or disciplines must, therefore, have the approval of all groups directly concerned. Procedures Having established procedures to cover all activities and functions of a company, it has to be ensured that all these procedures are being properly adhered to... Page 16
AUDITS Quality Auditing The quality audit is a management tool used to evaluate confirm or verify activities related to quality. A properly conducted audit is a positive and constructive process. It helps prevent problems in the organisation of activities liable to create future problems. Problems generally arise through the inefficiency of the activity concerned. The internal and external assessment of a quality system lies at the very heart of maintaining an effective ISO 9000 system. The Need for Audit An audit is undertaken to indicate whether a procedure, or system is working satisfactorily. It readily highlights non-conformities and should lead to action being taken to correct them and prevent their recurrence. The requirements of quality assurance audits are determined by management and, as such, management responsibilities should be integrated into the quality assurance programme. Page 17
STANDARDS AND STANDARDIZATION " The process of formulating and applying rules for an orderly approach to a specific activity for the benefit and with the co-operation of all concerned and in particular for the promotion of optimum overall economy taking due account of functional conditions and safety requirements." Standards and standardization promote consistent quality and economic production. They provide for quality of goods and services by defining those features and characteristics that govern their ability to satisfy a given need. Standard specifications for materials, components and processes form the backbone of any programme of quality assurance. Standards for sampling, gauging and measurement lay down the methods of test and calibration which are the basic tools for assessing quality. Principles of Standardization 1.Standardization is essentially an act of simplification. 2.Standardization is a social as well as an economic activity and should be promoted by the mutual cooperation of all concerned. 3.The publication of a standard is of little value unless it can be implemented. 4.The action to be taken in establishing standards is essentially on of selection followed by fixing. Page 18
Principles of Standardization 5.Standards should be reviewed at regular intervals and revised as necessary. 6.When performance or other characteristics of a product are specified the specification must include a description of techniques and tests to be applied in order to determine whether or not a given article complies with the specification. 7.The necessity for legal enforcement of national standards should deliberately be considered. Aims of Standardisation Simplification of the growing variety of products and procedures in human life Standards as a means of communication Overall economy Safety, health and the protection of life Protection of consumer and community interests Elimination of trade barriers SUMMARY QA Requires the total integration and control of all elements QA should be based on prevention not detection Requires: Feedback to control and improve quality A systematic approach to provide real and objective evidence of quality Page 19
SUMMARY This is provided by documentation, audits and the use of standards Organisation is essential Structure and responsibilities should be clearly defined (who does what etc) Quality should be open and demonstrated Page 20