Laboratory quality document control

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. 

As has already been mentioned in Chapter 2, ISO 9001, Management Systems - Requirements , is increasingly being adopted by laboratories to cover the aspects of their business that are not laboratory based. This is because this Standard is more about controlling the process and service enhancement rather than technical issues. It requires continuous improvement, demonstrating that quality is not a static process. The requirements for such matters as documentation, document control, purchasing and management responsibilities are much the... 

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 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 ... 

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... 

The standard operating procedure (SOP) manual contains the procedures validated by the laboratory it is a complete set of instructions for pre-analytical, analytical and post-analytical methodology and also procedures for quality assurance/control, chain-of-custody and security. Each step in the handling of the specimen should be evaluated, optimized where possible and documented in the SOP. Important steps in the analytical process include collection, transport and accessioning of the specimen, sample preparation, isolation and detection of the analytes, production of the report and disposal of the specimen. This chapter focuses on the quality assurance and control issues for analytical method development and validation as well as statistical representation of the data. 

Good laboratory—what it is, how to apply it, p. 125 e How to vahdate a method selectivity, hnearity, accuracy, precision, sensitivity, range, LOD, LOQ, ruggedness, p. 126 Quality assurance control charts, documenting, proficiency testing, p. 133 Electronic records, p. 135... 

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. 

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%. 

A method is distinctly different from a standard operating procedure (SOP). An SOP is the document that details the exact operating procedures that were derived from the method and are oflen laboratory specific. An SOP will define sample size/weight and preparation, diltient and dilution volumes, standard curve concentrations, flow rates, detector/data acquisition settings, etc. In essence, the SOP is the master document used in the quality assurance/control laboratory. 

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. 

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. 

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. 

Process validation is intended to show and document that the process described, when operating within the designated parameters, will produce product of the appropriate quality and demonstrate that the manufacturing process is under full control. Process validation should extend from laboratory-scale and preformulation studies (say to of production scale) to formulation to pilot-scale manufacture (say production scale) to full industrial-scale manufacture, with a clear, logical, and continuous path between these stages. The magnitude of scale-up at each stage should not normally exceed a factor of 10. 

Computerized System Requirements and Electronic Records Increasingly, computerized systems and electronic records are part of a laboratory s operations. However, records may be held in both paper and electronic format and the quality assurance required depends to some extent on the format of the definitive document. Because of space requirements involved with paper records and ease of retrieval of electronic records, the latter are gaining in popularity. The same requirements that we have for paper records, e.g. change control, readability and archiving, will still apply to electronic records. For this to be achieved, new procedures may have to be developed. 

All aspects of the laboratory s work which might affect the validity of the final result should be inspected. This will include, for example, documentation, equipment, calibrations, methods, materials, record keeping, sample recording, labelling, quality control checks and log of daily checks, among many others. Some aspects, however, are outside the scope of such an audit, such as safety and security matters, which usually have separate arrangements for auditing. 

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