Sense and nonsense of quality assurance in an R&D environment

Quality has always been one of the key issues in laboratories in general and formal quality assurance (QA) in testing laboratories has gained popularity over the last decade. However, the implementation QA in research and development (R&;D) laboratories is still the domain of a few pioneers. We can even ask whether a QA system in research makes sense at all and if such a system really provides any added value? Difficulties with respect to the implementation of such a system are mainly associated with the nature of the research process itself. However, it is obvious that QA offers clear advantages in R&;D, if some critical success factors have been taken into account. An important issue is the selection of a good QA standard for R&;D. This is certainly not an easy task, since there are no specific standards. Fortunately, some useful international guides have been published recently.     

The human factor in quality management

 "Quality management is not just a strategy. It must be a new style of working, even a new style of thinking. A dedication to quality and excellence is more than good business. It is a way of life, giving something back to society, offering your best to others" (George Bush 1991). From this statement it becomes immediately clear that the human factor plays an eminent role in quality management. Therefore, some important relevant aspects of quality management are highlighted which are not so frequently discussed elsewhere. Various definitions and statements on quality lead to the fact that quality depends essentially on people. Some thoughts are developed on the Japanese quality culture which contributed essential impulses to the evolution of certain quality installations such as quality circles. The Japanese also developed a philosophy of quality, Kaizen, which is significantly different from Western industrial quality concepts. Kaizen works well in a slow growth economy, contrary to Western innovation which is more suited to the fast growth economy of the past. Some ideas on the quality control of top management as well as on the quality control of ourselves are expressed and it is shown how this is related to ethical principles. Every human society is as successful as: its intrinsic degree of honesty and righteousness, its degree of prevention of corruption and nepotism, and its readiness to work hard for personal advancement and for the sake of the community. Leadership, political or economic, is a special cultural effort – or at least it should be. But the striving for quality must be everybody's business in a company. It is the old 'pride of workmanship' which is greatly lost in today's industrial structures, and which is so absolutely important to again find satisfaction and contentment in our work. It is shown that the human factor in quality management, apart from all the necessary formal and institutional regulations, is of major importance, but very often neglected, especially in the present situation of over-rationalization. It is shown that dynamic equilibria do not only regulate chemical and biological systems but also operate in our psychic world. Unfortunately, there is a tendency to unhealthy extremes in the latter, e.g. to workaholics or neo-capitalism. Installations of total quality management such as systems, procedural and product audits are important facets of modern quality assurance. They are again closely related to human behaviour, as well as the procedure of company and laboratory accreditation. Finally the "Codex Hammurabi" shows that product liability was a clearly regulated issue in ancient Babylon, 2200 BC. This may be indicative of the fact that many new trends propagated by management gurus usually stem from a very old part of the wisdom of mankind but they are newly decorated and formed to modern slogans. Received: 11 May 1999 / Accepted: 24 September 1999     

The Italian way: Accreditation and continuous quality improvement in clinical laboratories

 The transition from quality assurance of the analytical phase to the quality management of total testing in clinical laboratories is still at an early stage. But it has begun. Accreditation through voluntary, educational and professional schemes, like the Clinical Pathology Accreditation scheme, is a useful tool for following defined standards of practice and having these independently confirmed on the basis of a peer review. Approved clinical laboratories can obtain a hallmark of performance and offer reassurance to users of their services. However, accreditation does not guarantee an error-free service; it is not the final step, but an important stage in the improvement process. Quality is a journey and continuous quality improvement is the paradigm for better addressing our efforts to satisfy customers' expectations for the desired health outcomes related to a high-quality laboratory service.     

Need for quality management in research and development

 There is growing interest in setting up a general concept for quality management and quality control in research and development, which in this case means, for example, research in the fields of medicine and social sciences. This article is a strong plea for a quality management system in all fields of research and development and will probably initiate broad discussion on this delicate topic. Received: 28 June 1998 · Accepted: 13 July 1998     

External quality assurance programmes in medical laboratories

 Medical laboratories have a long tradition of external quality assessment. Starting from pure quality control of laboratory performances, most schemes have evolved to a powerful tool for improving quality of clinical outcome of results. External quality assurance in medical laboratories not only includes laboratory performance evaluation, but also evaluation of method performance, post-marked vigilance, training and help. In the future, the quality of programmes must further be improved by accreditation of schemes and by using electronic data interchange. Received: 9 December 2000 Accepted: 14 December 2000     

QASKI – the quality assurance system of the National Institute of Chemistry

 The quality assurance system (QASKI) developed and implemented in the National Institute of Chemistry is presented. It tries to eliminate the incompatibilies between the present methods of quality assurance used in research and development institutes such as good laboratory practice and accreditation. Since 1991, QASKI has been used for internal accreditation of laboratories located in the institute, regardless of the fact that some of them deal with routine analyses and others with research and development. Every laboratory that wishes to ensure the credibility of its research or routine work enters QASKI and at the same time chooses an external method of approval. All interested laboratories, study directors, principal investigators, internal auditing staff, heads of documentation, quality assurance unit staff, the Director of the institute and the Quality Management Board participate in the internal system.     

Anti-HIV quality assurance programs in Australia and the southeast Asian and Western Pacific regions

Anti-HIV testing is the most regulated area of laboratory medicine in Australia. These regulations have placed the National Sero-logy Reference Laboratory, Australia (NRL) in a unique position to implement a comprehensive quality assurance (QA) program for HIV testing. The elements of our QA program include pre-market evaluation of assays, external quality assessment schemes (EQAS), quality control, specificity monitoring, consultations, and training workshops. The results of the NRL EQAS for Australian laboratories were compared with those of a program developed by the NRL for reference laboratories in the Southeast Asian and Western Pacific (SEAWP) regions. For laboratories authorized to use tests for HIV in Australia, participation in the entire QA program is mandatory, whereas the SEAWP EQAS program is voluntary. While the overall percentage of discrepant results for these programs are similar, the percentage of false negatives, variation in laboratory results, and choice of assay differ. These differences have decreased with time with improvements in assays and laboratory testing practices. The educational component of both EQAS, which comprises workshops, laboratory questionnaires, consultancies, and newsletters, has had a critical impact on the testing practices of laboratories. Received: 30 October 2000 Accepted: 9 December 2000     

The role of Nordtest in testing and quality assurance

 This article describes on the idea behind Nordtest, the results of its activities and how Nordtest has influenced testing and quality assurance. By financing projects in the field of technical testing Nordtest has been able to utilise the best available Nordic knowledge and resources to respond to Nordic needs and has gained acceptance in all Nordic countries. During Nordtest's 25 years of operation its projects have resulted in over 500 test methods and over 350 technical reports that are widely used both within and outside the Nordic countries. Examples of some project results are given. Important issues in testing and quality assurance are expressed in Nordtest position papers. Nordtest's active participation in the European and global co-operation in testing and quality assurance is also described.     

Key requirements for introducing quality assurance in measurement laboratories

 The implementation of a quality assurance system is fraught with difficulties. However, these difficulties may be overcome if the laboratory uses suitable means to facilitate the process. It is necessary to mobilise the intelligence and energy of all members of the laboratory. In order to command adherence, the project must be shared, and this necessitates a major effort by all concerned. Communication is a major factor in obtaining the support of all parties. Six important steps must be distinguished: – Defining quality policy – Creating awareness, information, training – Creating a quality structure – Establishing a deadline for obtaining accreditation – Progressive implementation – Experimentation and validation. Even if the task of obtaining and maintaining accreditation remains difficult, it clearly promotes a minimum level of organisation and stepwise progress in quality assurance. The laboratory must keep improving its quality system, using European Standard EN 45001 as an effective management model. Received: 9 April 1997 · Accepted: 11 September 1997     

The new ISO 17025 – basic idea

 This paper offers a concise overview of the recent draft of ISO 17025, which is expected to replace EN 45001 in 1999. Reference is made to the general area of related ISO standards for management systems. The main changes compared with EN 45001 are discussed for testing laboratories.     

Controlling the quality of testing

 This article mainly focuses on the testing of products, materials, etc., but the general principles are applicable in a broader perspective. Quality of testing should be judged based on fitness for purpose. This judgement includes both objective and subjective elements. The possibility to make decisions and other professional judgements based on test results alone is discussed and compared with the decisions and judgements being made through the certification and inspection process. Quality, including the uncertainty of the test results, depends on many factors, and in order to make necessary improvements in the testing procedures based on the customers' needs, the right issues should be addressed. The question arises as to whether, in laboratories' quality systems and in the accreditation and certification process, attention is really paid to those factors that are crucial to obtaining reliable results.     

Detection of genetically modified organisms in food: critical points for quality assurance

 The detection of genetically modified organisms (GMOs) by the polymerase chain reaction (PCR) is a complex multiparameter problem. Therefore, a number of critical issues in respect to quality control need to be considered. For practical purposes, the PCR process itself can be divided into three subprocesses: template isolation and reaction setup (pre-PCR), PCR reaction and detection of amplification products, and data evaluation (post-PCR). Crucial factors for the pre-PCR process are the following: homogeneity of the sample to be analysed, performance of template isolation and purification in terms of yield and purity, standardized process for the estimation of concentrations of genomic DNA and all reagents used in the reaction. For the PCR itself, crucial factors to be controlled are: setup of reactions, batch to batch variations of reagents, temperature-time programs used for the PCR amplification, and the performance of different types of hardware (e.g. different brands of thermocyclers). The crucial factor for the post-PCR process is the detection of the amplification products of the PCR. The tremendous sensitivity of PCR methods requires a careful and consequent separation of the three processes in terms of hardware, laboratory space and sample handling. The avoidance of contamination is one of the most critical factors. The goal of quality assurance measures must be to ensure appropriate results at maximum sensitivity. The complexity of any PCR system used for the detection of GMOs leads to the requirement of a careful validation process for any laboratory using such methods. For qualitative analyses crucial validation parameters are: specificity, selectivity, repeatability, intermediate precision, reproducibility, limit of detection and robustness. Received: 5 October 1998 / Accepted: 22 February 1999     

Quality assurance in clinical chemistry laboratories in the UK

 Since the mid-1960s quality assurance in clinical chemistry has progressed from a need to define and improve precision and accuracy in analytical test procedures to an all-embracing process of assuring that the whole process of pre-analytical, analytical and post-analytical phases of handling patient samples is managed effectively and efficiently. Automated and computer-controlled equipment has reduced many of the analytical errors, in particular in imprecision, that were present in manual analysis. New management techniques have been developed to control the quality and appropriateness of results. Developments in internal quality control and external quality assessment procedures have enabled laboratories to continually improve the quality of assays. Laboratory accreditation and external quality assessment scheme accreditation have ensured that peer review and peer pressure have been applied to both laboratory and external quality assessment scheme performance. As the NHS reviews its priorities and places more emphasis on primary care provider demands, hospital laboratories will of necessity assist with near patient testing outside the laboratory. This will provide new challenges to the quality of the service provided. Received: 2 July 1998 · Accepted: 1 August 1998     

Quality assurance in analytical measurement

 The peculiarities of analytical measurement require to check characteristics of the error (its components) of the obtained analysis results to assure the quality of the measurements. This article deals with the various quality assurance procedures and algorithms which are used to check the quality indices, i.e. the accuracy, reproducibility, certainty and repeatability of analytical measurements: These procedures include: laboratory rapid control; Intra-laboratory statistical control (statistical selection control by alternative attribute, statistical selection control by quantity method of periodic check of the analysis procedure for conformity to the specified requirements) and external control (inter-laboratory control checks, inter-laboratory comparison tests, and intra-laboratory control algorithms carried out by the appropriate supervisory body.) in the separately taken laboratory. The respective algorithms, control plans and control requirements, specified according to the different control aims and assurance tasks, enable the quality and certianty of analytical information obtained in laboratories in Russia to be assured. Received: 9 November 1998 / Accepted: 24 November 1998     

Quality in clinical laboratory measurements

 Clinical chemistry deals with measurements and observations using samples from patients in order to supply clinicians with information to support their decisions in diagnosis and treatment. The discipline utilizes advanced chemical and biochemical methods and also sophisticated instrumentation which allows a high throughput. Clinical chemistry has a long tradition of quality assessment and improvement. The major tools have been proficiency testing or external quality assessment and internal quality control. Nowadays, total quality management has become widely recognized, and accreditation according to international, regional or national schemes has contributed to the design of quality systems and improvement of the reliability of results from clinical laboratories.     

Implementation of a ”data filter” for the UK National Marine Monitoring Programme

The implementation of a strategy for the assessment of the validity of environmental monitoring data – a ”data filter”– is described. The approach was developed through the UK National Marine AQC Scheme for application to data collected during the UK National Marine Monitoring Programme. Data reported for the year 1999, by nine laboratories, for 74 determinand-matrix combinations were assessed on the basis of the completeness of their supporting quality assurance and quality control information. The approach to the establishment of criteria of acceptability for quality information is described. Received: 28 August 2001 Accepted: 29 November 2001     

Developing external quality assessment programmes for primary health: care level in resource limited countries

Laboratory services are an essential component of health care delivery in tropical countries and play a vital role in improving the accuracy of clinical diagnosis and the investigation of disease outbreaks. In developing countries, laboratories face numerous constraints to providing quality services, including poor selection of techniques, difficulties in equipment availability and maintenance, and shortages of supplies, staffing and supervision. Currently in the eastern African countries (Kenya, Tanzania and Uganda), internal quality control procedures are inconsistently carried out in most laboratories. National External Quality Assessment Schemes (EQAS) have been established in all countries addressing a limited number of tests, but are constrained by difficulties of sustainability and poor coverage. The Laboratory Programme of the African Medical and Research Foundation (AMREF) has been operating a simple EQAS for primary heath care laboratories since 1993. Tests addressed are those carried out in primary health care laboratories in eastern Africa. A total of 81 laboratories from 5 countries in the eastern African region have participated in the scheme since 1993 and 9 distributions were submitted since the start of the scheme. No laboratory participated in all distributions; 24 (30%) laboratories participated in 4 or more distributions. Of these, the hospital laboratories in Kenya and Tanzania showed improved average mean scores between the first two and subsequent distributions. The educational benefit of participation in the scheme is emphasised. There was an overall low rate of participation of laboratories (35%) once the scheme was expanded to include laboratories outside direct AMREF project activities. Contributing factors include shortages of staff and lack of time in busy rural laboratories, together with difficulties in communication; however, the voluntary nature and lack of appreciation of the benefits of participation may also play a role. To increase participation in the scheme and to address the quality of laboratory services throughout the region, AMREF is currently developing a Regional EQAS in collaboration with the Ministries of Health of Kenya, Tanzania and Uganda, in affiliation with the World Health Organisation (WHO). The approaches used to establish reference values for haemoglobin samples are discussed. The scheme has also been utilised to examine the performance of different techniques for haemoglobin estimation, demonstrating the inaccuracy of the visual comparator methods. Received: 13 April 2002 Accepted: 5 July 2002     

Internal user inquiries as a useful tool for adjustment of the quality system and for quality improvement

Who could be better than the staff themselves to point out inappropriate and ineffective elements in a quality system? A dialogue between the supplier and the customer for clarification of the customers' requirements and possible quality problems is often part of a quality management system. Of no less importance is a dialogue with the staff who "live" with the quality system in the everyday work environment, handling procedures, keeping records, and controlling documents, etc. For this reason a simple internal user inquiry was conducted. The anonymous inquiry form considered areas which effect daily work, and posed questions which, we had reasons to believe, could be tender points among staff. The result was a very positive feedback on the questions, and several advantages and disadvantages were brought forward. Our experience after 2 years with ISO 9001 certification is that internal inquiries are just as important as the dialogue with customers in maintaining an appropriate and effective quality system. Furthermore, such inquiries focus on the quality system and involve the staff in adjustments, tailoring the system and in quality improvements.