Operations quality management

The wide acceptance of ISO 9001 and the confidence that specifiers and purchasers have in products and services provided by companies/organizations operating quality management systems according to ISO 9001 cannot be easily ignored. Laboratories have to meet the needs of their customers. Increase in awareness is still necessary. 

The organizations involved in the execution of the safety lifecycle shall have an operational quality management system complying with a quality standard, such as ISO/TS 16949, ISO 9001, or equivalent. 

The UK government enquiry into the Piper Alpha disaster in the North Sea in 1988 has had a significant impact on working practices and equipment and has helped to improve offshore safety around the world. One result has been the development of a Safety Management System (SMS) which is a method of integrating work practices, and is a form of quality management system. Major oil companies have each developed their own specific SMS, to suit local environments and modes of operation, but the SMS typically addresses the following areas (recommended by the Cullen Enquiry into the Piper Alpha disaster) ... 

Another often forgotten aspect of quality management is the behavior of people in an organization. Such behavior is formed by the core values to which that organization subscribes. The absence of core values that form a positive behavior may not have an immediate effect because individuals will operate according to their own personal values. When these conflict with the organization s values, an individual could resent being forced to comply and may eventually adopt the values of the majority or leave to find a more suitable company to work for. 

Primarily, the designated person is the system designer for the quality system. This person may not produce the policies and procedures but operate as a system designer. He/she lays down the requirements needed to implement the corporate quality policy and verifies that they are being achieved. It is also necessary to have someone who can liaise with customers on quality issues, who can coordinate the assessment and subsequent surveillance visits, who can keep abreast of the state of the art in quality management. The person should be an adviser to the top management who can measure the overall performance of the company with respect to quality. 

PSM buiids on what is in piace, and seeks to integrate safety issues into ongoing business operations"as opposed to imposing an eiaborate exter-nai structure. The goais of PSM are process-oriented, not procedure-driven, and reflect the Total Quality Management principle of continuous improvement. 

The major benefits that arise from the application of human factors principles to process operations are improved safety and reduced down time. In addition, the elimination of error has substantial potential benefits for both quality and productivity. There is now a considerable interest in applying quality management approaches in the CPI. Many of the major quality experts em-... 

As discussed earlier in this chapter, the main requirements to ensure an appropriate safety culture are similar to those which are advocated in quality management systems. These include active participation by the workforce in error and safety management initiatives, a blame-free culture which fosters the free flow of information, and an explicit policy which ensures that safety considerations will always be primary. In addition both operations and management staff need feedback which indicates that participation in error reduction programs has a real impact on the way in which the plant is operated and systems are designed. 

In Quality Management there are generally two groups identified stakeholders, and customers and suppliers. Stakeholders are those who have an interest in and benefit from the safe operation of your facilities. Stakeholders can include ... 

In quality management terms, the customer is the next person in an activity or management process, including, of course, the traditional customer who receives the final product. Each person is supplied with information, equipment, product or raw material which must be worked on and then passed to the next customer for further refinement. Thus an activity or management process consists of a series of suppliers and customers. For PSM and ESH integration, customers include people such as ESH staff, operating staff and individuals to be trained. 

Teams such as quality improvement teams (QIT), may be used for implementation of all Quality Management projects. These teams are usually established for specific improvement projects and consist of staff involved in the management processes under review. For this project, PSM and ESH specialists, operations, maintenance, and engineering representatives would be members of the team. 

A common concern expressed by managers is that PSM and ESH are costs to their operations that adds little or nothing to customer satisfaction. The use of quality management approaches should ensure that the new systems will be more efficient and so costs will actually fall. It may also be possible to demonstrate that facilities with excellent PSM and ESH records have good performance in other areas. You should look for such examples within your own organization. 

Control systems will play a key role in future distributed plants ]139,145]. As a rule of thumb, plants will be smaller and simpler, but the control systems will be much more advanced, of a standard not known today. Plant personnel for operation and managing will ultimately no longer be required, except for start-up, shutdown, and services. This is a shift from a regulatory to a servo role, supported by a sophisticated sequence control. Control is needed for safety issues, operability, and product quality control. Sensors have a central role to provide the information needed for control and modeling and simulation is needed for process models. 

The analyst provides scientific evidence on which important decisions are made. The work of an analyst is devalued if it is merely considered to be making measurements and reporting results. There has to be some added value. This is provided when it can be demonstrated that the results produced have been obtained in an organization that operates a quality management system. It is because of the importance of the work that the quality has to be assured. This means that all of the necessary actions have been taken to make sure that any factor which has an influence on the final result has been considered, understood and reported in a permanent record - that the appropriate measurements have been made and these have been carried out correctly using a validated method. 

In the previous chapters of this book, we have looked at many aspects of quality in laboratories. Some of the relevant Standards have been mentioned and their similarities and differences outlined. This chapter aims to give more detail on the components of the Standards and show how a quality management system can be achieved in the laboratory. The documentation required and the processes necessary to demonstrate that the management system operates to the requirements of International Standards will be explained. It is important to be clear that the overall management system of a laboratory or organization will cover all of their operations this includes quality, administration and technical systems. 

Quality Audit is the only option available to them. It is therefore vital that, to ensure standards of quality are maintained, a laboratory must operate its own internal audits to test its quality management system. If the internal system of audits is not operating adequately, external assessment visits are liable to be traumatic experiences, awaited with trepidation and producing unexpected and embarrassing nonconformities in several areas of operation. 

Responsibility for maintaining, operating and improving the laboratory s quality management system lies with every member of the laboratory s staff. A... 

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