Accred Qual Assur 3 : 197–202 Q Springer-Verlag 1998
PRACTITIONER’S REPORT
Reports and notes on experiences with quality assurance, validation and accreditation
P. Bode K. Heydorn R.W. Innes R. Wood R. Zeisler
Received: 5 June 1997 Accepted: 7 December 1997 P. Bode (Y) IRI, Delft University of Technology, Mekelweg 15, 2629JB Delft, The Netherlands Tel.: c31–15–278 3530; Fax: c31–15–278 3906; e-mail:
[email protected] K. Heydorn Risø National Laboratory, Isotope Division, Roskilde, Denmark R.W. Innes ANSTO, Lucas Heights Research Laboratories, Lucas Heights, Australia R. Wood MAFF, Food Science Laboratory, Norfolk, United Kingdom
Basic steps towards a self-sustainable quality system and laboratory accreditation
Abstract Laboratory managers are facing the task of altering the attitudes of themselves and their employees in order to implement a quality lifestyle, which is the prerequisite for successful implementation of a quality system complying with appropriate international standards. The alterations require a painstaking and constructive approach. Not all laboratories have the resources to secure the assistance of quality consultants. For those laboratory managers who have to find their way towards quality management on their own,
some recommendations are given for a path towards a self-sustaining quality system. Several practical aspects of the basic steps in this path, which starts with assessing the current status of the laboratory and is followed by awareness building, are discussed. The recommendations are derived from the experience of the authors in their own laboratories. Key words Pathway 7 Quality system 7 Implementation 7 Self-sustainable 7 accreditation
R. Zeisler 1 IAEA, Seibersdorf Laboratories, Seibersdorf, Austria 1
Present address: NIST, Nuclear Methods Group, Gaithersburg, USA
Introduction It is now internationally recognised that, for a laboratory to produce consistently reliable data, it must implement an appropriate programme of quality assurance measures following the requirements prescribed in the internationally recognised standards derived from the ISO-Guide 25. Formal accreditation of the quality system may then be considered. Laboratory managers frequently face the difficult task of altering the organisation and the management
of their laboratory in order to be able to introduce these new requirements. Alterations to traditions of many years standing have to be made, such that employees have to carry out more checks and are themselves checked more frequently than they have been used to. The need to give objective evidence of quality often demonstrates the difficulty of providing quantifiable criteria. Laboratory managers at research and university laboratories face additional difficulties such as objections stemming from alleged reduction in academic freedom, and they may not be able to use external
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consultants because of lack of finances. These considerations mean that these managers will not only have to head the operation, but will also have to design the operation using their common sense and information from seminars, articles and books. The International Atomic Energy Agency (IAEA) organised in 1995 an expert workshop which, amongst other objectives, served to provide guidance on actions to aid the development and implementation of measures to assess and to improve the quality of laboratories that provide data in Agency projects and programmes. One of the specific tasks of this expert workshop was to specify actions (“milestones”) needed to implement the recommendations for improvement of the laboratories, as a plan “how to proceed from here to there”. This pathway, and the underlying objectives, are not only applicable to laboratories employing nuclear analytical techniques (as might be assumed given the instigator of this work, the IAEA), but may also serve as an aid to the analytical (research) laboratory community as a whole. The more general suggestions from the results of this workshop are therefore presented in this paper. Many of these suggestions come from the experience of the authors during the implementation of the quality systems at their own laboratories.
Pathway towards a self-sustainable quality system It is assumed that someone at the top of the organisation’s hierarchy, such as the chief executive officer or the director, appreciates the importance of introducing quality management at the laboratory and/or of pursuing quality system certification or accreditation. However, a quality system and its management will only be sustainable and successful if the quality culture is not only accepted by the employees (including staff) involved, but if there is also a determination that the quality “lifestyle” should typify the employees’ attitude to their work both technically and emotionally. Therefore, the first (and decisive) stage concerns building awareness. Building awareness Awareness is generated by 1. General information on the quality lifestyle. Articles and books are currently available which serve this purpose [1–10]. Some of them outline the external reasons for improving the overall performance of the organisation or laboratory, and indicate how quality management can serve this goal. 2. Motivation by requirements from outside the laboratory and competition. International organisations, governmental bodies or industry may prefer to con-
tract-out their research or routine analyses to accredited laboratories only to assure the international acceptance of the data. 3. Motivation from inside the laboratory. Perhaps the laboratory itself, the staff or the employees have already observed some essential shortcomings, technical or organisational, and have anticipated the needs and benefits of a quality lifestyle to eliminate such deficiencies. 4. Promotion of staff involvement. The quality lifestyle cannot be effectively created solely by management nor can the subordinates solely carry the burden of the quality efforts. A management style should be considered that fosters responsibility at every level of the organisation (laboratory), for example, by forming operational and management teams. When providing information on quality management it should be made clear that there is no condemnation of the existing performance and style of working of the laboratory, but that the requirements set by international society have changed. The laboratory may work well according to its own standards, but it simply does not comply with the international requirements. It is important for the awareness building to clearly identify the need for adoption of this new lifestyle ; as clarified above, is it because the government or the customers want it, or are there internal considerations? If there are any shortcomings or problems, they should be brought forward and discussed at all levels in the laboratory with the aim “what can be done about it” rather than “who’s to blame for it”. The difference between any shortcomings now identified and the prime objectives results from the way the laboratory has taught itself to operate. Checklists (e.g. in [3]) may be considered useful to assess the employees’ understanding of quality assurance principles. In this awareness-building stage, much is asked of the tact of the laboratory manager. Often at first some reluctance is encountered, and too much pressure to change the attitude to work will be experienced as a “top-down” instruction which, although perhaps initially effective, often results in more and more opposition: the quality lifestyle then is not whole heartedly adopted by the employees. Universally, one of the keys to success with the development of a quality system has been identified as its “bottom-up” character: it should become an accomplishment of all the employees themselves. Changing the attitude to work is a process that takes much longer than is usually anticipated, sometimes more than one year. But such a time investment pays back later when alteration and implementation starts. Additionally, the laboratory may start to compile, in categories, any presently identified deficiencies like repetition of work, miscommunications, malfunctioning equipment, improper calibrations etc. Such a compilation is of importance to mirror the performance of the
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Schematic Pathway towards a Self-Sustainable Quality System Pathway
Action points
References and input
From now on, all actions must be documented! Start
Scope: If a laboratory undertakes analysis, there is a need to be able to show objective evidence that the tests were I undertaken in a proper manner I undertaken by appropriate tools and environment I undertaken with validated methods
Awareness
Building awareness: Awareness of the scope among staff is generated by I general information on quality I motivation by requirements from outside the laboratory and competition I motivation from inside the laboratory I discussion of problems being experienced I discussion to establish what is felt to be the minimum requirements for the laboratory Z Awareness OK? Then proceed to next step
Awareness OK
Milestone 1
Laboratory status document
Current Status: collect information on current status of the laboratory system. This is best done by those who actually do the work. I Flowchart your procedures I Make a list of all procedures and actions for the current practices. I Include the laboratory’s mission statement I Be alert for completeness Z Check for completeness, have any deficiencies corrected so that procedures reflect agreed current procedure
Document completed
Milestone 2
Evaluation
Z Assessment of compliance of the identified current status with the requirements in (the standards derived from) the ISO Guide 25 Z Decide whether compliance is acceptable or not (if “yes”, go to stage 7, otherwise continue)
Plan
Prepare a plan for improvement: The purpose of the plan is to close the gap between the identified current status and the requirements. Actions to achieve this include: I Clarify responsibilities and authorities for the allocation of resources and setting the priority of work I Identify and allocate laboratory resources, personnel, equipment, work environment I Identify and request potential external assistance I Define the essential procedures to be improved and to what extent modification/harmonisation/documentation/assurance is required I Set time frame I Participate in proficiency testing in current status Z Obtain approval from management
Plan completed
Milestone 3
Implementation
Bring plan into action: All actions shall be documented: I Harmonise procedures when necessary, that is, get everyone working the same way I Pay attention to process situations of non-conformance I Establish the uncertainty budget I Ascertain statistical control and traceability I Participate systematically in proficiency testing and evaluate results as work proceeds Z Check improvements through quality indicators of results such as completeness, representativeness, comparability and traceability and internal audits. Z Obtain verification by second opinion
laboratory when quality practices have been introduced. Also the requirement for complete documentation of all actions within the laboratory, necessitates much concentrated effort, both technically and organisationally.
[1–10] Seminars and Workshop
[11–13, 21–23]
[14–15] [17–20] [16]
The milestone of this awareness-building stage has been reached when the employees themselves start taking initiatives to alter their (attitude to) work, irrespective of whether these changes apply directly to the execution of the analysis or to supporting activities.
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Schematic Pathway towards a Self-Sustainable Quality System (continued) Pathway
Action points
Quality-plan implemented
Milestone 4
Assessment
Assessment of the current system against international requirements. I Compile quality manual I Have system assessed independently Z Is the laboratory operating according to this self-supporting system?
Selfsupporting quality system
References and input
[16]
Milestone 5
Z Is there a need for a more formal quality system? Z Obtain approval from management Go on your own way for accreditation I Contact national accreditation body Z Certificate of accreditation Fully accredited laboratory
Milestone 6
Assessment of current status A compendium may be collected as a reflection of the laboratory’s mission, including all actual (analytical and organisational) activities and interactions, formats for administration, data evaluation and reporting, safety procedures etc. It appears to be useful to flowchart the processes in the laboratory. When this is carried out by the employees involved in the processes, a more clear understanding of all steps evolves, and shortcomings or awkward situations are spotted at this early stage. Flowcharting often results in the identification of small unit operations and faster awareness of the procedures and written documents required. Evaluation Upon completion, the compendium is to be compared to the requirements as laid down in the standards derived from the ISO-Guide 25 [11–13]. Prepare a plan for improvement The purpose of this plan is to close the gap between the identified current status and the requirements of the standards derived from the ISO-Guide 25. Characteristic of this plan will be the attention to the preparation of written documents describing the procedures and actions in the laboratory, and a distribution of the work. It must be established and made clear to everyone which person is going to make the plan and which person will be in charge of bringing the plan into action.
This may be the same person, capable of becoming the laboratory’s future quality manager. It may be considered a good idea to appoint one of the technicians as a quality manager rather than the laboratory head, in order to facilitate the acceptance of his authority by the other employees and to emphasise their involvement. Depending on the size of the laboratory, it may be a full-time or part-time job. Next, the resources needed should be identified. How much time will be allotted to the persons involved? At this stage, 20% is a normal time investment. It has also to be established if there is a need for help from the outside, e.g. from the national accreditation body. Do the employees need to attend additional seminars or workshops, and is expert assistance required, for instance on any typical aspects related to the analytical technique(s)? The plan should also include a list of procedures to be changed. What has to be improved it should be decided upon and defined, e.g. harmonisation activities, quantification acceptance criteria within procedures, corrective and preventive actions upon non-conformance situations, and better assessment of the contribution to the uncertainty budget evaluation [14]. At this stage, under the current status, participation in a proficiency testing scheme or other type of laboratory intercomparison is recommended. The results of this are not needed immediately: they are used later on to assess the effects of improvement. The plan concludes with a realistic time frame for the operation and an estimate of the financial resources required. Typically, for a laboratory with up to ten employees and one technique it may take 1–1.5 years. The plan needs approval from the director of the organisa-
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tion, marking the quality improvement a ’corporate’ activity rather than the activity of an (isolated) laboratory. Bring plan into action The quality manager has the important task of guiding harmonisation wherever this is necessary. But since the persons involved need to have consensus on their new way of working, they really should develop the new procedures themselves. The quality manager or the laboratory manager should in the final stage inspect the drafts, remove the jargon, check if all actions written down are in a logical order, and check for quantified acceptance criteria at the completion of an action. The new “standard operating procedures” have also to be understandable by new personnel or visitors. In the documents, attention has to be paid to situations of non-conformance to avoid the quality system being perceived as bureaucratic. However, flexibility and operability have always to be balanced against the effect of non-conformance on the final quality. Procedures are also required to ascertain statistical control and traceability. Compliance with other international reference documents and guidelines, e.g., for uncertainty evaluation, internal quality control and use of control charts, are a necessity [14, 15]. During the implementation of the new procedures, compliance with them and effects of other improvements made should be assessed via, e.g., internal auditing [16] and non-conformance registrations. The importance of the support by the director, but more importantly the commitment of the head of the laboratory himself to the new lifestyle should not be underestimated. If the director reduces quality management at the first opportunity to the status of a ’niceto-have’ by changing priorities, or if the laboratory manager decreases his commitment because he is “too busy”, it will be difficult to convince the employees to change their attitude to work.
ternational requirements. A quality system has a chance to become self-sustaining when there is a systematic approach to non-conformance, when internal audits are held, and when a management review is organised and improvement schedules have been set up. All documents should be compiled into a quality manual. Upon completion, an external expert may be invited to assess the new status. Such an expert may be e.g. a quality management consultant. A new milestone is reached when the laboratory operates according to this documented and self-sustaining quality assurance system and to international requirements. Final step for accreditation The institution needs to decide for itself whether accreditation is needed, what the scope of accreditation should be, and if the costs and resources needed to achieve accreditation are justifiable. Again, this is a decision to be taken by the director of the organisation.
Final remarks The number of acronyms and quality assurance approaches is growing, and workshop fliers, books, journals and consultancy brochures can be overwhelming to the point of confusion. There is no doubt that all information on quality requirements, aspects of traceability and statistical techniques is indispensable for effective and efficient development and implementation of a quality system. But often the prime questions a laboratory manager has to respond to are “how do I do it in practice?” and, specifically, how to pass the awarenessbuilding stage. Unfortunately, for this aspect there is no panacea, and even general recommendations have to be interpreted with great care because each laboratory has its own traditions and ways in which people interact with each other and can be addressed. This all determined by the nation’s culture(s). Therefore, the pathway and individual steps identified in this paper should be seen and used with this in mind.
Assessment of the current system When the plan has been completed, the laboratory has the basis of a quality system in compliance with the in-
References 1. Dux JP (1986) Handbook of quality assurance for the analytical chemistry laboratory. Van Nostrand Reinhold Company, New York
2. Garner WY, Barge MS, Ussary JP (eds) (1992) Good laboratory practice – standards, applications for field and laboratory studies, American Chemical Society
3. Taylor JR (1987) In: Quality assurance of chemical measurements. Lewis, Chelsea, MI, USA
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4. Garfield FM (1991) Quality assurance principles for analytical laboratories. AOAC International, Arlington, VA, USA 5. Parkany M (ed) (1996) Quality assurance and TQM for analytical laboratories. Royal Society of Chemistry, Cambridge, UK 6. Günzler H (ed) (1996) Accreditation and quality assurance in analytical chemistry. Springer Verlag, Berlin Heidelberg New York 7. Bode P (1995) Analyst 120 : 1527– 1533 8. Bode P (1997) J. Radioanal Nucl Chem 215 : 51–58 9. Nadkarni RA (1991) Anal Chem 63 : 675A-682A 10. Nadkarni RA (1993) Anal Chem 65 : 387A-395A
11. WELAC Guidance Document No WGD 2 (1993) Accreditation for chemical laboratories 12. CITAC Guide 1 (December 1995) International Guide to quality in analytical chemistry: an aid to accreditation 13. ISO/IEC Guide 25: 1990 (E) General requirements for the competence of calibration and testing laboratories (in course of revision) 14. Guide to the expression of uncertainty in measurements, 1st edn, (1993) ISO, Geneva (ISBN 92-67-10188-9) 15. Thompson M, Wood R (eds) (1997) Harmonised guidelines for internal quality control in analytical chemistry laboratories. Pure Appl Chem 67 : 649–666 16. WELAC Guidance Document WGD 1 (1993) Internal quality audits and reviews 17. Mullins E (1994) Analyst 119 : 369– 375 18. Heydorn K (1991) Microchim Acta (Wien) III : 1–10.
19. Heydorn K (1993) Anal Chim Acta 283 : 494–499. 20. ISO 9002: 1994 (E) Quality systems – Model for quality assurance in production, installation and servicing 21. ISO 9004.1: 1994 (E) Quality management and quality system elements – guidelines 22. International vocabulary of basic and general terms in metrology, 2nd edn (1993) ISO, Geneva (ISBN 92–67–01075–1) 23. ISO 8402 (1994) Quality vocabulary
