Management quality

The Quality Management department is expected to carry out regular target-performance comparisons of specifications and requirements, document the evaluations, and provide management with information on the results. For all possible discrepancies from the desired state, for example, complaints, results out of specification (OOS), changes, deviations, and audit results (internal and external audits), the appendant information are collected centrally and processed by means of the Corrective And Preventive Action (CAPA) system. These monitoring and control functions are performed by the staff of quality management. 

It is very likely that during the inspection historical events of the above-mentioned topics will be surveyed and it is expected that the involved persons have evaluated the processes with scientific expertise and appropriate risk assessments. A controlled, informed, and trained handling of these critical issues is mandatory. Compliance with set review-cycles for specification-documents will be checked randomly and should be considered in the preparation phase of the inspection. 

Eventually, it should be paid attention to documentation in paper and electronic form, according to 21 CFR Part 11. Often a combination of paper and electronic records (hybrid solution) is used in companies and it has to be decided case by case which type of document is stored in which system. For important electronic systems, it has to be determined, for example, which data format is used, how the data retrieval over the retention period can be ensured (data format, data rehabil-ity, data integrity), and how the document has been authenticated. 

The different departments should verify the applicable parts of the registration dossiers and related documents and records for accuracy, completeness, and consistency. This ensures that there will be no surprises during the FDA inspection, which could lead to agitation and discussions. 

Case 5 Box Practical Tips on the Subject Quality Management 

The enterprise shall document and apply quality-management procedures for the development of products and life cycle processes consistent with established quality practices (see IKKK/EIA 12207.0-19% [B2]). 

Regardless of the standard on which it is based, some of the essential requirements for establishing a laboratory quality system are as follows  

The quality system demonstrates in an objective and transparent manner that the results produced are reliable, representative, and reproducible, thereby fulfilling the agreed criteria. The science used, including the selection of appropriate analytical procedures, is another very important 

Whilst a quality system does not provide a scientific justification for the type of tests conducted, it does encompass procedures to document the analytical methods used, to demonstrate that they are valid and under control, and to ensure that the laboratory personnel using the test method are adequately trained and skilled to perform the analyses. 

Some important aspects of quality management are outlined below. More detail is available in documents such as the ISO/IEC 17025 2005 standard. 

Companies in the process industries have typically implemented a wide range of quality management programs in recent years. In many cases, there is a strong overlap between quality management, OIM, and PSM. A brief discussion of some of the quality techniques that are used in the process industries is provided below. 

Statistical process control (SPC) involves using statistical techniques to measure and analyze and control the variation in processes. SPC will not improve the quality of a poorly designed facility, but it can be used not only to maintain the consistency of how the product is made but also to improve equipment reliability. 

May quality programs are organized using the ISO 9000 system. It provides management with an infrastructure on which to build a workable, manageable quality system based on the following points. 

A company that implements ISO 9000 does four things  

It trains everybody to follow the standards that have been set. 

Data quality initiatives can help to ensure the accuracy of clinical/biomedical engineering data. The data needed to establish basic, accurate, maintainable automated records for medical equipment management include nomenclature, manufacturer, nameplate model, serial number. 

Nowadays, safeguarding and improving specified quality has to be planned systematically and put into practice in all of a company s relevant areas. The above mentioned quality management system serves that purpose. 

This philosophy contrasts completely with past definitions of quality. These only concerned themselves with meeting the product characteristics, that were being individually checked at the end of the production process. 

The ISO 9000, (or the QS-9000 and also the VDA6.1, which have specifically been designed for the automotive industry), represent international standards. They contain guidelines for the structure and essential contents of a quality management system. 

Customers-and the automotive industry in particular-demand certification of a quality management system from their supplier, which is based on one of the earlier mentioned standards. The reason is, that the supplier s own assessment can be dispensed with, as far as possible, because certification is carried out by an independent organization. Granting of a certificate is subject to regular checks (audits). 

The basic idea behind quality assiuance nowadays is the prevention or elimination of faulty products, by the precise open- and closed-loop controlling of production nms, instead of sorting-out rejects as a separate operation. 

Core processes that are unique to the laboratory have to be identified and documented preferably using flowcharts (Fig. 1). This stepwise approach allows characterization of each single step, for example, in sample analysis in laboratories (shipment of samples, pre-analytical processing, analysis and post-analytical processing, reporting of results), determination of responsibilities, and documentation of analysis-specific SOP s. All documents are summarized in identical copies of the Quality Handbook that serve as important source of information for the laboratory staff (Fig. 1). 

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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) ... 

However this is not sufficient to give the customer confidence that a satisfactory quality of NDT will be provided. It is necessary to have a system of quality management and to confirm the effectiveness of its functioning. 

The specific character of NDT related to the quality assessment of safety critical products and objects requires constant analysis and continuous improvement of processes and their interconnection. Sometimes interaction of processes is very complicated (Figure 3) therefore the processes have to be systematized and simplified when possible to realize total quality management in NDT. 

Quality management in NDT is a fairly new trend and can be approached by two different conceptual routes (Figure 4). 

The second approach - creation of systems for non-destructive testing quality assurance in compliance with ISO standards 9000 series - considers the quality system as an assembly of organisational strueture, procedures, processes and resources necessary for overall quality management at the laboratory. This approach requires methodieal development. 

ISO 9000-1 Quality management and quality assurance standards - Part 1 Guidelines for selection and use ... 

M. Jenkins, ASTM Standard. News, 50 (July 1993) ISO 9000, International Standardsfor Quality Management, 5th ed., ISO, Geneva, Switzerland, 1994. 

Total Quality Management. Total quahty management (TQM) is the term which encompasses all of the continuous improvement activities with the goal of world class quahty. This corporate culture sets up the conditions for a climate favorable to companywide improvement. 

W. W. Eckenfelder, Jr., Principles of Water Quality Managements CBI Publishing, Boston, Mass., 1980. 

Pinal Air Quality Management Plan, 1982 rev.. South Coast Air QuaUty Management District and Southern California Association of Governments,... 

QUALITY MANAGEMENT IN THE INDUSTRIAL ANALYTICAL LABORATORY - DO WE GET OUR MONEY S WORTH ... 

Wageningen University and Research Centre Product design and Quality management group, PO Box 8129, 6700EV Wageningen, The Netherlands. E-mail kasper.hettinga wur.nl... 

Some approaches to quality management suggest that companies reduce the total number of suppliers for a service or material to just a few high quality entities. This allows the companies to symbi-otically develop relationships. Both parties can benefit greatly by using a system designed to rank preferred tollers. However, do not let the motivation to reduce the number of suppliers inhibit the critical review of potential tollers capable of performing the toll successfully. 

Is any processes quality management system certified under the requirements of an ISO 9000 or ISO 14000 standard If yes, skip question number 5. ... 

Similar as to quality, management should demonstrate indeed more than arm s length support for safety and safety improvement leading to the highest possible safety standards. Involved leadership and constancy of purpose is critical. 

ISO 14000 / ISO 9000 Standards published by the International Organization for Standardization. ISO 14000 standards are for companies establishing an environmental management system. ISO 9000 standards are for companies establishing a quality management system. 

ISO 9000 - Quality Management and Quality Assurance Standard. Guidelines for selection of Standards in the series and use of the same for the managemetit of quality systems. ISO 9001 - Model for Quality Assurance in Design or Development. Production. Installation and Servicing. 

ISO 9004 - Quality Management and Quality System Elements - Guidelines. 

Quality Management stresses participation by all involved in the work system, and their commitment to follow the systems meticulously and consistently. 

A recent survey of companies in the automotive and aerospace industry found that many companies are unaware of the benefits that can be gained from the utilization of quality tools and techniques. The adoption of BS EN ISO 9000 (1994) and Total Quality Management (TQM) strategies might be expected to increase the utilization of methods. However, the extent to which companies utilize methods is more strongly related to annual turnover than employee count, therefore the use of tools and techniques is dominated by large companies (Araujo et al., 1996). 

TQM involves all the organizations, all the functions, the external suppliers, the external customers and involves the quality policy. Similarly, TQM cannot be achieved without good Quality Management Systems (QMS) which bring together all functions relevant to the product, providing policies, procedures and documentation. The elements of a quality organization consist of these three mutually dependent items (Field and Swift, 1996) ... 

BS EN ISO 9000 1994 Quality Management and Quality A.ssurance Standards. London BSI. 

Kehoe, D. F. 1996 The Fundamentals of Quality Management. London Chapman Hall. 

Labovitz, G. H. 1988 Tough Questions Senior Managers Should he A.sking about Quality, The ODI Quality Management Series, Vol. 1. 

Radovilsky, Z. D., Gotcher, J. W. and Slattsveen, S. 1996 Implementing Total Quality Management statistical analysis of survey results. International Journal of Quality and Reliability Management, 13(1), 10-23. 

Schonberger, R. 1992 Total Quality Management Cuts a Broad Swathe - through manufacturing and beyond. Organisational Dynamics, Spring, 16-27. 

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