UNIT-1 QUALITY CONCEPT Evolution of Quality control

The historical evolution of Total Quality Management has taken place in four stages. They can be categorized as follows: 1. quality inspection 2. quality control 3. quality assurance 4. Total Quality Management Quality has been evident in human activities for as long as we can remember. However the first stage of this development can be seen in the 1910s when the Ford Motor Companys T Model car rolled off the production line.The company started to employ teams of inspectors to compare or test the product with the project standard. This was applied at all stages covering the production process and delivery, etc. The purpose of the inspection was that the poor quality product found by the inspectors would be separated from the acceptable quality product and then would be scrapped, reworked or sold as lower quality. With further industrial advancement came the second stage of TQM development and quality was controlled through supervised skills, written specification, measurement and standardization. During the Second World War, manufacturing systems became complex and the quality began to be verified by inspections rather than the workers themselves. Statistical quality control by inspectionthe post-production effort to separate the good product from the bad productwas then developed. The development of control charts and accepting sampling methods by Shewhart and Dodge-Roming during the period 19241931 helped this era to prosper further from the previous inspection era. At this stage Shewhart introduced the idea that quality control can help to distinguish and separate two types of process variation; firstly the variation resulting from random causes and secondly the variation resulting from assignable or special causes. He also suggested that a process can be made to function predictably by separating the variation due to special causes. Further, he designed a control chart for monitoring such process variation in order to decide when to interact with the process. The main processes which help products and services to meet customers needs are inspection and quality control which require greater process control and lower evidence of non-conformance. Quality control has been with us for thousands of years, but it was not until about 200 years ago, at the beginning of the Industrial Revolution, that we began to drift away from the craftsman method of assuring quality. The craftsman's method of controlling quality was a very personal one. He made sure that whatever he produced was, to his way of hinking, acceptable for commerce. It met his standards. When the industrial revolution began, other influences arose that determined the quality of a product, the market, or the end user. In the beginning of this period, factories were small and located in the"industrial" cities. It was dif- ficult to move commerce across the landscape, so industries served local communities. This provided for small lot sizes and screening (100% inspection) as a method to control quality. During the 1920s and into the 1940s the pace of manufac- turing changed from small production lots to larger and larger production runs. Included with this increase in production were advances in engineering, which led to more complex design and assemblies. It was during this period that lot-by-lot inspection gained wide acceptance by man- agement. During the 1940s and 1950s, lot-by-lot inspection

was the only way quality control personnel (i.e., inspectors) could keep up with production because screening slowed the process too much. However, it was not long before everyone realized that lot- by-lot inspection, although fast, had serious shortcomings, not the least of which was the possibility of accepting a lot containing nonconforming parts simply because the sample taken was free of these parts. Thus, the customer or end user would receive a percentage of parts that were either useless, or worse yet, dangerous. During the 1960s and 1970s, the shortcomings of both screening (time consuming and ineffective) and lotby-lot inspection (not fully acceptable to the customer) encouraged management to develop what came to be known as in- process inspection. In-process inspection was usually accom- plished by an inspector who patrolled the manufacturing floor checking on equipment, materials, methods, people, and output. In-process inspection was also sometimes carried out by the machine operator responsible for a particular phase of the manufacturing process. For example, a machine operator may measure a few pieces every hour during the production run to make sure the parts are within engineering specifications, or a plater may check the coating thickness on a fastener on one or two pieces every tenth barrel or rack to assure conformance. In-process inspection coupled with lot-by-lot inspection was much more acceptable from the consumers' point of view because they were assured of a better chance of receiving a product to their requirements. But it still had its short comings: There was no way of knowing what went on between visits by the inspector. Lot-by-lot inspection still permitted nonconforming partsto be shipped, even with zero as the acceptance number for rejects. When nonconforming parts were discovered, it caused production delays that were unplanned. The costs of scrap and rework for the manufacturer were very high. The system bred mistrust between inspector and machine operator. Quality Control Quality Control is that part of Good Manufacturing Practice which is concerned withsampling, specifications and testing, and with the organisation, documentation and releaseprocedures which ensure that the necessary and relevant tests are actually carried out andthat materials are not released for use, nor products released for sale or supply, until theirquality has been judged to be satisfactory. The basic requirements of Quality Control are that: i. adequate facilities, trained personnel and approved procedures are available forsampling, inspecting and testing starting materials, packaging materials, intermediate, bulk, and finished products, and where appropriate for monitoringenvironmental conditions for GMP purposes; ii. samples of starting materials, packaging materials, intermediate products, bulk products and finished products are taken by personnel and by methods approved by Quality Control; iii. test methods are validated; iv. records are made, manually and/or by recording instruments, which demonstratethat all the required sampling, inspecting and testing procedures were actuallycarried out. Any deviations are fully recorded and investigated; v. the finished products contain active ingredients complying with the qualitative andquantitative composition of the Marketing Authorisation, are of the purity required, and are enclosed within their proper containers and correctly labelled; vi. records are made of the results of inspection and that testing of materials,intermediate, bulk, and finished products is formally assessed against specification.Product assessment includes a review and evaluation of relevant productiondocumentation and an assessment of deviations from specified procedures;

vii. no batch of product is released for sale or supply prior to certification by a Qualified Person that it is in accordance with the requirements of the MarketingAuthorisation; viii. sufficient reference samples of starting materials and products are retained to permit future examination of the product if necessary and that the product is retained in itsfinal pack unless exceptionally large packs are produced.