Quality Assurance

Quality Assurance Reference : Quality assurance – the route to efficiency and competitiveness 3rd edition by Lionel Stebbing

Definition 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, as we have seen, decommissioning. Quality assurance department can produce a plan for action and a system to be followed but its implementation is a management responsibility. Quality assurance is a philosophy of total integration of the business to achieve the required result.

Definition (cont’) It is important, in the first place, to understand what quality assurance is not : It is not quality control or inspection. It is not super-checking activity. It is not responsible for engineering decisions. It is not a massive paper generator. It is not a major cost area. It is not a panacea for all ills.

What is quality assurance ?? It is cost-effective. It is an aid to productivity. It is means of getting it right first time every time. It is good management sense, and, most importantly; It is the responsibility of everyone.

The background to quality assurance The ultimate purpose of any quality system is to ensure complete satisfaction by the customer with the goods or services provided by the supplier. Sometimes defects were not discovered until manufacture was at an advanced stage, often leading to costly repair work and sometimes involving scrapping, with the inevitable schedule days. In today’s highly demanding environment of quality, together with the concern by customers and the costs restraints within a company, the emphasis must now be proactive rather than reactive. The question “have we got it right ? ” (quality control/inspection) must give way to “are we doing it right ?” (quality assurance)

Objective evidence of quality Objective evidence of quality is that which confirms that all activities within each of the functions of a service or manufacturing process 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 & job instructions. Procedures detail the purpose and scope of an activity and also identify how, when, where, and by whom the activity is to be carried out. Emanating from such will be documents which will detail the results of these activities. Job instructions direct personnel in carrying out a specific task. Job instructions do not necessarily produce documentation and, in such instances, can be audited only by watching the person involved carry out the task. Procedures and job instructions, together with the methods for ensuring they work, make up a quality system.

The need for audit Once procedures are established, how can it be ensured that the procedures are being implemented and are effective ? What takes the place of inspection in the old system of operation ? The answer is a compliance audit. An audit is undertaken to indicate whether a procedure or job instruction is working satisfactorily.

Principles, philosophies, standards and procedures In the main, quality system standards are issued to cover three parts, levels, or categories, of application, as follow : Level 1 covering design, manufacture, and installation. Level 2 covering manufacture and installation. Level 3 covering final inspection and/or test. There are two types of quality assurance standards : industry-related standards and general standards

Principles, philosophies, standards and procedures (cont’) Industry-related standards are those developed by purchasing bodies to enable suppliers to meet the quality requirements of a particular industry. General standards are those issued by national bodies to give guidance to industry in general on quality system development. They are normally for guidance purposes only but are becoming increasingly prevalent as a contract requirement. Quality plan a document setting out the specific quality practices, resources, and sequence of activities relevant to a particular product, service, contract, or project. (based on ISO 8402).

Setting up and developing the appropriate quality system Satisfying customer requirements and improving overall business efficiency are generally considered to be the two main reasons for implementing a quality system. There are however, a number of other objectives which could be considered, such as : To increase customer confidence To enhance the company’s corporate image To improve employee participation and morale. To achieve registration as a quality-assured company.

Establishing the appropriate quality system The objective of the working party is to establish the appropriate quality system applicable to the organization concerned. Before this can be done, experience has shown that it is usually necessary for certain actions to be taken, such as : To define responsibilities and lines of communication within each department or discipline. To establish interdepartmental interfaces. To verify and agree the activities and functions that are to be procedurally controlled. To communicate to all employees the reason for, and the benefits to be obtained from, the implementation of a quality management system.

CORSET It is used when identifying whether or not an activity should be controlled one should question, in the event that the activity should go wrong, what would be the : COst of putting it right ?? Resources required to put it right ?? Safety implications should it go wrong ?? Environmental impacts should it go wrong ?? Time involved in putting it right ??

In summary, the essence of a quality system is simply : Say what you do. Do what you say. Record that you have done it. Audit for effective implementation. Feedback and improve.

Quality Cost Generally, quality costs can be allocated to three distinct costing centers, as follow : Prevention costs Appraisal (or inspection) costs Failure/rectification costs

Prevetion costs These are incurred to reduce the costs associated with the failure, rectification and appraisal of the manufacturing or service process and would normally be related to : The activities of planning and implementing the quality system, developing the quality system documentation, checking and approving such documentation and distributing or communicating the information contained within the documentation. The activity involving the verification of the entire quality system, i.e. internal audit. The subsequent management review of the entire system. The assessment and verification of suppliers organizations. The costs associated with training and education, which will include the development, implementation, operation and maintenance of inhouse and external training programmes. The costs related to developing and implementing quality improvement programmes, such as quality circles, performance measurement, problem solving, statistical process control, and others.

Appraisal costs These are the costs incurred in verifying the conformance of the product or process to requirements and would normally include : Verifying that purchased items are in conformance with requirements. Checking and verifying the manufacturing or service activity throughout the process and then, finally, confirming the quality of the completed work-for example, analysing and reporting of verification results, which are conducted after confirming that the activity has been satisfactorily accomplished. The costs associated with the storage of records as required to confirm the quality of the items or service.

Failure/rectification costs These are the costs associated with “getting it wrong” and, subsequently “putting it right”. Internally, these can include such things as scrap, corrective action, re-verification and down-time.

The role of the quality assurance department • • • •

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Verifying, by audit, that the quality system requirements are being followed throughout the organization and that effective procedures and job instructions are being implemented by all departments or disciplines. Verifying that those responsible for controlling and checking an activity have done so in a systematic manner and that there is objective evidence available to confirm such; Ensuring that all procedural non-conformances are resolved. Ensuring that fundamental working methods are established and that fully approved procedures are developed to cover them and that all departments and personnel are aware of, and have access to, current versions of these procedures. Verifying that all procedures are regularly reviewed and updated as necessary. Determining and reporting the principal causes of quality losses and nonconformances; Determining, with senior management, where improvements are required and, where necessary, recommending the corrective action.