Laboratory Accreditation in a Lipid Analysis Context
Abstract: Laboratory accreditation is accepted as an important goal to achieve, but the difficulty is in the detail. The author describes the strategies taken by his laboratory to attain ISO 9001 accreditation, and in particular how this related to service and research activities.
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.
The Scottish Crop Research Institute (SCRI) is a large-ish Institute, financed mainly by government, with 450 staff (permanent and short-term) covering a wide range of 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.
My colleagues and I 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.
ISO 9001 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 9001 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 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. Second, they are invaluable as a training guide to new staff or visiting scientists and students. Third, 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 increased substantially, as we were 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 has not proved difficult.
Quality Plan Essentials
Regardless of whether formal accreditation is being sought, every laboratory should have a quality plan that contains a set of rules that govern the day-to-day workings of the laboratory and with which all staff should be familiar. The following is based on the system at SCRI (with thanks to Dr. Tom Shepherd). The rules may appear straightforward and self-evident, but it is surprising how often some are transgressed, especially in a research as opposed to a routine analysis environment.
- Staff. All staff must be properly trained and qualified for the tasks they undertake. They must have defined responsibilities.
- Resources. Adequate staff, funding and equipment should be allocated to meet the objectives of the work.
- Planning. A documented framework for a project should exist, defining objectives, resources required, methodology, staff responsibilities, time scales, etc.
- Work practices. These should be fit-for-purpose and up-to-date, and have a documented framework. Appropriate work records should be maintained at all times. All formal Health and Safety requirements should be met, and good standards of laboratory tidiness and hygiene maintained. The correct radiological safety precautions must be observed.
- Facilities. The general environment should be suitable for the work. A responsible person should be designated for each piece of equipment to ensure that it is maintained and operated properly, and that staff is trained in its use. Written instructions in use and maintenance should be available. All equipment should be in good working order, and unserviceable equipment should be so labelled until repairs are effected. Chronological log books should be kept for all major pieces of equipment (balances, HPLC, GC, etc.), giving details of identity of samples analysed, methods used, user, file numbers, etc., and of any repairs effected.
- Sample/material handling. All samples should be clearly identified and labelled, and should be stored correctly in appropriate containers under proper conditions (e.g. refrigerator, freezer). A record of samples received and processed may be required.
- Quality control/performance checks. Equipment performance should be checked at regular intervals with appropriate standards or calibration materials, and limits of acceptable performance should be defined. Records of such checks should be kept. Appropriate quality control measures should be taken during the conduct of work, e.g. adequate replication, sample blanks, standards, and format and documentation of software.
- Standard operating procedures (SOPs). All laboratory procedures and methodologies in regular use must be documented using a standardized format. This should first list the purpose, scope, responsibilities, principles, and any hazards with suitable safety precautions. The detailed procedure should then be described, giving details of equipment and materials required, list of actions, details of result/process outputs and quality control measures. Any changes should only be made by an appropriate senior scientist and must be recorded and approved.
- Research/work records. The primary record of all work activities should be a hardbound laboratory notebook. This must contain details of all work carried out and should refer to any other relevant (secondary) records, such as computer files from chromatography instrumentation. Written records should be clear and legible and any changes must be made correctly and initialled. The records should be sufficiently complete for another qualified person to repeat the work. Electronic records should contain the date of creation and sufficient basic information for identification. Security of records must be maintained in proper storage facilities. All electronic records should be backed up regularly and duplicate copies should be archived (together with hard copies where appropriate).
- Traceability. All records generated during the conduct of work should be sufficiently well cross-referenced that they can quickly be identified, located and accessed. The concept of traceability should also apply to samples processed during the conduct of work. Some form of master record should be kept.
- Monitoring. If the above requirements are met, activities should be of an acceptable standard. If supervision standards are good, individuals should be able to monitor their own conformance with requirements. However, independent and objective monitoring of conformance is beneficial and is a requirement of formal accreditation.
This article is based on one first published by William W. Christie, Gary Dobson and Tom Shepherd in Lipid Technology, 11, 118-119 (1999), and has been updated substantially (by kind permission of P.J. Barnes & Associates (The Oily Press Ltd)).