Laboratory quality documentation

The primary purposes for which reference materials are employed are encompassed within the laboratory Quality Assurance Procedures. Quality assurance comprises a number of management responsibilities which focus on how the laboratory is organized, how it deals with situations, how it interacts with users, together with analytical responsibilities re internal quality control and external quality assessment (Sargent 1995 Burnett 1996). Ideally each component follows a documented protocol and written records of all activities are maintained. 

In the previous chapters of this book, we have looked at many aspects of quality in laboratories. Some of the relevant Standards have been mentioned and their similarities and differences outlined. This chapter aims to give more detail on the components of the Standards and show how a quality management system can be achieved in the laboratory. The documentation required and the processes necessary to demonstrate that the management system operates to the requirements of International Standards will be explained. It is important to be clear that the overall management system of a laboratory or organization will cover all of their operations this includes quality, administration and technical systems. 

ISO, IUPAC and AOAC INTERNATIONAL have co-operated to produce agreed protocols on the Design, Conduct and Interpretation of Collaborative Studies 14 and on the Proficiency Testing of [Chemical] Analytical Laboratories .11 The Working Group that produced these protocols has prepared a further protocol on the internal quality control of data produced in analytical laboratories. The document was finalised in 1994 and published in 1995 as the Harmonised Guidelines For Internal Quality Control In Analytical Chemistry Laboratories .12 The use of the procedures outlined in the Protocol should aid compliance with the accreditation requirements specified above. 

The laboratory shall document its policies, systems, prograrrwnes, procedures and insb-uctions to the extent necessary to assure the quality of the test and/or calibration results. 

The laboratory quality control program has several components documentation of standard operating procedures for all analytical methods, periodic determination of method detection levels for the analytes, preparation of standard calibration curves and daily check of calibration standards, analysis of reagent blank, instrument performance check, determination of precision and accuracy of analysis, and preparation of control charts. Determination of precision and accuracy of analysis and method detection limits are described under separate subheadings in the following sections. The other components of the quality control plan are briefly discussed below. 

Standard operating Written, authorized and controlled quality document that procedure (SOP) details instructions for the conduct of laboratory activities ... 

Quality assurance is a set of operating principles that enable laboratories to produce defensible data of known accuracy and precision. These operating principles that form laboratory quality system are documented in the Laboratory QA Manual, in a set of laboratory SOPs, and in various laboratory records. 

After the authentication, the Secretariat s Office of the Internal Oversight (OIO) then certifies this data. The OPCW Laboratory has a quality system, which has been accredited by the Dutch Accreditation Council (RvA). The accreditation covers the quality system as well as the specific activity of the OCAD process and other processes. The OPCW Laboratory has in place quality documents (standard operating procedures (SOPs) and work instruction) for the OCAD process. 

In addition to the mass spectral aspects of these assays, which are outlined below, there may also be extensive requirements to be met by the analyst with respect to compliance with good laboratory practice, which governs the operations of analytical laboratories and includes sampling regimes, assay validation procedures (e.g., limits of detection, limits of quantification, accuracy, reproducibility, and ruggedness), and laboratory accreditation (e.g., staff training, laboratory equipment, documentation, quality assurance, and quality control).142-145... 

Aitio, A. Laboratory quality control, European Cooperation on the Health Aspects of the Control of Chemicals - Interim document No. 4, WHO, Copenhagen, 1981. 

Where available, reference materials need to be used for calibration or quality control. The National Institute of Standards and Technology (NIST) and many commercial sources supply such materials. Many high performing technology laboratories are capable of preparing their own reference materials using the same approach used by NIST in certifying their Standard Reference Materials (SRM). The calibration reference materials (RM) should be traceable to national standards, and the traceability must be preserved in the laboratory s documentation system. 

The standard requires laboratories to document their policies, systems, programs, procedures, and instructions to the extent necessary to meet the requirements of customers while ensuring the quality and traceability of measurements, meaning that the laboratory determines the degree of detail found in its documentation. The laboratory must also be able to demonstrate objective evidence that the degree of detail presented in its quality system documentation is generating the desired and required outcome. Documentation must be available in a repeatable form and will normally be in either written or electronic form. 

Preliminary Hazard Checklists (PHCs) are used to identify hazards that exist for a specific HCF location as part of the isotope processing activities (e.g., hot cell laboratory, quality control laboratory, etc.) or radioactive material storage location, A PHC is a location-based form of assessment that is, the facility is first subdivided into several distinctly separate locations or entities, then process-related hazards specific to each facility segment are identified. PHCs document energy sources and hazardous materials, potential accident initiators, and preventive or mitigative systems or practices present in each facility location. 

When CRMs are not available, trace element standards or uncertified control materials may be purchased with manufacturer certificates stating purity. However, it is the responsibility of the laboratory to document that the quality of such standards is satisfactory [39,40]. Eventually a conventional true value may be established by a reference laboratory, and whenever possible a validated definitive method should be used [5]. Using uncertified quality control samples the uncertainty of the reference value should be considered and expressed as the 0.95 confidence interval of (Xy, i.e., XY t( - l)o.9750-YVn. A practical criterion is that t(n - l)o.975ffY should be less than a defined fraction of ixy, e.g., 5%. 

The way rejected materials and products should be removed safely has to be described in a procedure. In addition a procedure on the permissibility of reprocessing (when an intermediate or bulk product does not meet the requirements) has to be in place. Reprocessing should be minimised and performed only in close collaboration with the quality control laboratory and documented carefully. Reprocessing of previously delivered and returned products must be excluded. 

You should be aware that accreditation can be revoked. All accredited laboratories will be re-assessed on a regular, probably yearly, basis, at which time adherence to agreed procedures will be examined and non-compbances reported for correction within a short time scale. These on-going costs should be budgeted for. Serious non-compbance with the agreed quality documentation conld result in removal of accreditation. 

Due to overregulation and contradictory effects such as unacceptable results from accredited laboratories, quality assurance in analytical chemistry is constantly under discussion and exposed to criticism. Certainly quality assurance (QA) will not improve analytical work and its quality, which is at present very high in routine analysis as well as in research and development. " Documenting all important processes, however, will make results trackable and possibilities for improvements (errors, quality, costs etc.) will be made visible. Therewith QA leads to better transparency and thus improves comparability. Proving properties of the applied analytical procedure like bias, uncertainty, reproducibility etc., which is often viewed as a key objective of QA, is actually the bread-and-butter work in analytical chemistry and should be self-evident for every reliable analyst. 

Quality control encompasses all activities used to bring a system into statistical control. The most important facet of quality control is written documentation, including statements of good laboratory practices, good measurement practices, standard operating procedures, and protocols for a specific purpose. 

However, the significance of results from such analyses depends on the quality of the input data. For example, laboratory recipes often do not meticulously document solvent and auxiliary input masses. In many cases, water inputs and waste management are not determined before the pilot stage is reached. Estimates similar to those applied in LCA may be used in order to complete a preliminary mass balance. While such estimations cause considerable uncertainty, it seems more appropriate to evaluate alternatives based on preliminary information, that is, experience-based assumptions concerning the production of substrate or catalyst, than to simply ignore potentially important contributions to the mass balance. 

Apart from innovative work, RMs are essential during exerdses such as the introduction to a laboratory of a method from elsewhere or the transfer of an established method onto new instrumentation. Even where the conditions for the analysis have been standardized by the manufacturer of a reagent kit, some validation work should still be undertaken so as to have documented data for quality assurance purposes, e.g. accreditation, as a basis for IQC, for later reference when problems which may be related to equipment, reagents or staff etc. need to be investigated. 

Fraser has extensively discussed this relationship between laboratory work and clinical needs (Fraser and Hyltoft Peterson 1993) and has recently addressed the role of documented analytical quality as derived from measurements of RMs (Fraser and Hyltoft Peterson 1999). Among the concepts proposed by Fraser and his colleagues, it is suggested that analytical imprecision should be <0.50 CVi and bias should be <0.25 (CVi + where CVj is the within-subject biological variation (i.e. changes from day to... 

There is an abundance of references defining and describing the role played by QA, Quality Control (QC) and Total Quality Management (TQM) in a modem commercial analytical laboratory. The role played by reference materials (RMs) and certified reference materials (CRMs) in the pursuit of analytical measurement accuracy is also well documented. 

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