LABORATORY ACCREDITATION IN A LIPID ANALYSIS CONTEXT
William W. Christie, Gary Dobson and Tom Shepherd
Scottish Crop Research Institute (SCRI), Invergowrie, Dundee (DD2 5DA), Scotland
Abstract: Laboratory accreditation is accepted as an important goal to achieve, but the difficulty is in the detail. The authors describe the strategies taken by their Institute to attain ISO 9000 accreditation and in particular how this related to service and research activities. This article was first published in Lipid Technology, 11, 118-119 (1999), and it is reproduced here with the permission of the Oily Press Ltd.
No scientist will ever argue with the principles of laboratory accreditation and quality control, and few will admit that their procedures fall short of the ideal. It would be like criticizing the principle of motherhood. Most commercial laboratories have had to seek laboratory accreditation to remain competitive, as have most dealing with regulatory authorities. However, many research laboratories with a more academic outlook apparently do not see this as something they need to deal with urgently. No one doubts that formal laboratory accreditation is an ideal to which they should strive - the devil is in the detail. Concerns quickly surface regarding bureaucracy and costs.
SCRI is a largish Institute, financed mainly by government, with 450 staff (permanent and short-term) covering a wide range of mainly biological disciplines. We knew quality procedures were needed, but it is difficult to imbue everyone with the same enthusiasm. As analytical chemists, we were deemed to have a special interest and aptitude in this area, and we were given responsibility for putting a quality system in place.
Laboratory Notebooks
We evolved a two-pronged strategy. For the Institute as a whole, we were aided by changes in the patent law to conform to US practice, which made it necessary to have stricter controls on recording of experimental data. We designed new laboratory notebooks, use of which was mandatory. They are the property of SCRI and are numbered individually and must be signed for by the scientist. Eventually they are archived. Each comes with full instructions as to how data should be recorded, and colleagues and line managers should check them regularly. We also issue every scientist with a 'Quality System - Code of Practice', an eight-page document that sets out the principles of quality control in the laboratory (now incorporated into the lab notebooks). This sets out the responsibilities of individuals not only for the quality of the work, but also for health and safety, and for training. However, the most important section deals with work practices and how data should be recorded, first in the primary record the laboratory notebook, but also via secondary records such as computer output. All records must be stored in secure places, they must be backed up if appropriate and eventually archived formally. For the conduct of experimental work, written laboratory protocols (Standard Operating Procedures or SOPs) setting out the detailed practical steps to be carried out, together with any precautions necessary, are strongly recommended. In addition, the code gives recommendations on the use and maintenance of equipment, on performance checks and on monitoring performance. At present, we don't check on compliance with the system, but this will undoubtedly follow.
ISO 9000 Laboratory Accreditation
The second part of the strategy was to put in place formal laboratory accreditation in selected laboratories, and we were guinea pigs of course. The first step was to decide which accreditation scheme to go for. NAMAS was one possibility for us, but would not be suitable for SCRI as a whole. GLP is intended mainly for those doing work for regulatory authorities, and might be suitable in some areas. ISO 9000 seemed most appropriate for all of SCRI. In addition to two 'high tech' laboratory facilities (mass spectrometry and stable isotopes analysis), we obtained accreditation for our commercial arm, Mylnefield Research Services Lipid Analysis Unit, and this has now been achieved for our lipid research work.
Excessive bureaucracy is rightly feared when accreditation is considered, and it must be recognized that our Quality Assurance Officer had to put in a tremendous amount of background work to ensure that much of the general purchasing, training and other administrative procedures of SCRI were properly documented. This is necessary whether one laboratory or a hundred is seeking accreditation, but much of it only has to be done once. However, we have been concerned that the scientist at the bench would not be loaded down with unnecessary paperwork, formalities or costs, especially if we hope to extend the system throughout SCRI.
An essential feature is that we must be able to demonstrate a documented trail of data from accession of a sample, which must have a unique identifier (name or number), through the required analytical procedures to a final report, first to our colleagues and then to scientific auditors. We must check this ourselves via an internal audit system.
Standard Operating Procedures or SOPs
Arguably the most important single exercise has been the creation of the formal experimental protocols or SOPs. First, we decided on the leanest format that satisfied the ISO standard. Many of the methods we used were already documented in one way or another, so it did not prove too onerous to transcribe and update them to the new format. Where they did not exist, the exercise of preparing them was useful in that it made us think carefully about every aspect of our work. Typically, each SOP starts with an introduction describing its purpose followed by sections detailing hazards and responsibilities. The detailed procedure follows, with concluding sections on recording data, equipment maintenance and so forth.
The benefits of having these SOPs have proved considerable. First and foremost, it ensures that each method is carried out in the same way every time whoever is doing it. Secondly, they are invaluable as a training guide to new staff or visiting scientists and students. Thirdly, they are instantly accessible - there is no need to search through old notebooks or scientific papers. They are not set in stone, but can be modified or extended as experience dictates. However, by having a defined procedure for making changes, we make sure that every copy is altered simultaneously. Checks are in place to make sure there is no possibility of
unauthorized changes being made by inexperienced staff. Ad hoc alterations can also be made to a protocol to suit a novel type of sample, for example, provided such changes are noted in the scientist's laboratory notebook. Formality does not mean rigidity. Of course in a research environment, it may be necessary to develop novel methodology or to use published procedures for which no formal SOP exists, and again the scientist's laboratory notebook provides a suitable record.
The second useful exercise has been to have logbooks for all appropriate equipment, which in our case is mainly for high-performance liquid chromatography, gas chromatography and mass spectrometry. Here, data on the sample number, type of analysis and the file name and directory for the computerized data output are recorded. Data files are backed-up regularly and eventually are archived onto compact disk. When this information is used in conjunction with the laboratory notebook, a scientific audit should be straightforward.
Of course, much else requires to be done to meet the ISO standard, including instrumental checks and putting analytical controls with suitable replicates in place. All of these are essential to good experimental science in any situation, and making them a fixed part of our routine simply ensures that they are not skimped.
Although it is a different matter to obtain accreditation for a service facility as opposed to a research activity (ISO9002 versus ISO9001), they have much in common. The main difference is that with the latter, we have to provide more documentation on the planning of projects or series of experiments. This does not seem to be proving too onerous.
The benefits of having laboratory accreditation to our commercial analysis unit have been considerable. Our turnover has nearly trebled in three years, as we are able to undertake work for a wider range of customers. Increasingly, granting bodies such as government departments are asking what quality system is in place when they award research contracts. We expect that formal accreditation will assist our research effort, and a culture of quality in the laboratory is certainly beneficial. Extending our formal system to other areas of work at SCRI should not be difficult. We have now started to bring our procedures into line with Good Laboratory Practice (GLP), so watch this space for further information.
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Updated: 7/4/2008 |
Scottish Crop Research Institute (and MRS Lipid Analysis Unit), Invergowrie, Dundee (DD2 5DA), Scotland
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