Quality Assurance procedure

Quality assurance (QA) is a generic term for all activities required to maintain quality in analytical results. These include laboratory management structures and sample documentation procedures, as well as the more practical sample preparation and analysis requirements (as described above). The ISO (International Organization for Standardization) develops standards across a wide range of areas, from screw threads to banking cards. The majority of ISO standards are specific to certain areas they are documented agreements containing technical specifications or precise criteria to be used 

ISO has two important functions in analytical chemistry. The first is to publish descriptions of accepted methods. These are effectively industry standard methods for particular protocols. The second is in laboratory accreditation. For a laboratory to be ISO accredited, compliance with international QA standards must be confirmed by an initial assessment and subsequently from repeated audits by an independent assessor. Since ISO has no legal or regulatory powers, the standards are voluntary. It is unlikely, however, that a forensic analysis which did not conform to an ISO standard would be upheld in court, for example. Most commercial laboratories need to be accredited to remain competitive and to deal with regulatory authorities. Most university labs are not accredited, mainly due to the time and costs involved, and also to the nonroutine nature of much university research. However, university accreditation may become a requirement in the near future, especially for publicly funded research in the UK. The details of laboratory accreditation are discussed by Christie et al. (1999) and Dobb (2004). 

An outline laboratory QA procedure would need to include the following. In addition to the use of freshly made synthetic calibration standards, in-house standards, internationally recognized reference materials, and method blanks, as described above, it should include  

The financial cost of accreditation is undoubtedly substantial. It has been estimated that the additional cost of being a fully accredited laboratory might add around 30% to the cost of an analysis. Some laboratories state that they work to ISO standards, but without submitting themselves for accreditation, thus avoiding the substantial cost of the external assessment procedure necessary for obtaining certification. It is self-evident that a laboratory which adheres to ISO standards (whether certificated or not) ought to routinely 

Although chemical analysis of archaeological materials for purposes of identification and provenance is now well established, there are still many challenges ahead for the inorganic chemist in archaeology. The field of lead 

---

That set of modules includes alongside the traditional procedures related to product control, quality assurance procedures for conformity assessment. The intervention of a third party in these procedures comprises an initial audit of the manufacturer s quality system which must include both the specific technological aspects of the products concerned and the methodology of the quality assurance procedures. Furthermore the manufacturers are subject to periodic audits to ensure that the systems are maintained. Finally, on the occasion of unexpected visits, the notified body can carry out tests on the products. 

The use of these techniques is an important element of industrial policy since they contribute to the creation of a business friendly regulatory environment allowing the combination of measures taken for internal organisational reasons and obligations of certification without lowering the level of safety to be achieved. Wlienever possible a choice between product control and quality assurance procedures is offered to manufacturers. 

Quality-assurance procedures have to be established for the checking of both input and results checks of energy balances, plausibility tests, and comparison with steady-state calculations and with results from similar cases. These checks are demanding and time consuming and thus prone to be omitted but are mandatory for reliable simulations. 

Clearly It Is not possible to separate the required quality assurance procedures for soil monitoring from the objectives of the study. Examples of objectives are ... 

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. 

Suitable quality control and quality assurance procedures should be in place and the analytical system must be in a state of statistical control. 

In many cases, there is difficulty in preserving residues in samples after collection and prior to pesticide analysis which coincides with a rapid further degradation and mineralization of the pesticide residues under most environmental conditions. Storage stability studies and studies on the reactivity of sample collection equipment in addition to field quality assurance procedures can help address some of these questions. Concerns are accentuated for compounds that have short half-lives in the environment but still have high acute toxicity. 

These statistical methods give a comprehensive description of the whole separation and therefore can also be used as tools to investigate separation properties for quality assurance procedures. 

Organizations making analytical measurements should have well defined Quality Control and Quality Assurance procedures. 

Safety is important in any chemical laboratory but is not normally considered a formal part of quality assurance procedures, unless the lack of safety also imperils the quality of the work. The relevance of safety is based on it being part of good operating practice within a laboratory and this in turn needs to be optimized in order to produce good quality results. Many of the chemicals used, and some of the samples encountered in a laboratory, are dangerous and certain rules should be followed to ensure that they can be handled safely. Most countries have a list of substances which have to be controlled carefully and the maximum level to which workers can be exposed. 

There must be systems in place to monitor the study while it is in progress and to check that all systems are working in accordance with GLP requirements, to record any problems identified and to ensure that remedial action is taken. The person responsible for these quality assurance procedures must be independent of the study being audited. In large organizations, there may be a separate Quality Assurance unit but this will not be practical in smaller organizations. 

Issues of quality extend far beyond organizational arrangements. The analyst and the employer must both accept the equally important aspect of quality in professional skills and competences. Analysts need more help in order to learn about good laboratory practice and to work competently and professionally on a day-to-day basis within the framework of the VAM principles. This book offers analysts a new learning route to achieving these aims, and employers a convenient way to introduce quality assurance procedures. 

Conventional pharmaceutical quality assurance procedures should be applied to gene therapy products as well as appropriate infectivity tests for self-replicating, living vectors. 

Bidigare, R.R., and C.C. Trees. 2000. HPLC phytoplankton pigments Sampling, laboratory methods, and quality assurance procedures. Pp. 154-161 in Ocean Optics Protocols for Satellite Ocean Color Sensor Validation, Revision 2, J. Mueller and G. Fargion, eds., NASA Technical Memorandum 2000-209966. 

A laboratory may apply quality assurance procedures according to ISO/IEC 17025 to all (or part) of its operations... 

This is the sixth statement. Organizations making analytical measurements should have well defined quality control and quality assurance procedures. These procedures are explained in detail throughout this book. 

Sample extraction and hydrolysis details e.g., solvent extraction after freeze drying, with optimized acid or enzymatic hydrolysis Preparation of flavonoid standards and use of internal standards Chromatographic separation and detection method used, ideally RP-HPLC with UV or fluorescent detection Outline of quality assurance procedures employed... 

Quality in the Analytical Chemistry Laboratory, Pritchard, E. (Ed.), Wiley, Chichester, 1995. A concise practical guide to quality assurance procedures, this open learning text is ideal for beginners. 

While the provision of suitably validated analytical methods is a necessary requirement for ensuring compliance with MRLs, the method alone is not sufficient to ensure creditable analytical measurements. In addition to selecting suitable methods, the analyst must demonstrate that the method is operating under statistical control in the laboratory and is performed to meet performance specifications as required by the analytical problem. This means that all methods should be applied in an environment with appropriate quality assurance procedures and performance evaluation checks. 

Inspection instructions Work instructions Operation sheets Test procedures Operational procedures Quality assurance procedures Formulations Common practices... 

The molar absorptivity (e) of a known molecule is constant under identical conditions of solvent, concentration and path length, and can be used to quantify the amount of a particular pharmaceutical in a tablet. Such assays form the basis of many quality assurance procedures in the pharmaceutical industry, and have been extensively used by the British Pharmacopoeia (B.P.). More recently, however, high-performance liquid chromatography (HPLC) has replaced UV analysis in many B.P. assays, as most industrial analyses routinely use HPLC. 

This chapter describes the simpler cleanup approach of base extraction for XAD resin extracts. Quality assurance procedures statistically define the benefits of this analytical approach for broad spectrum capillary GC. The extraction procedure was optimized by studying UV absorbance of the base extractant. 

Sets of instructions that detail the procedures designed to reduce errors occurring during analytical procedures and ensure accurate quantitations are found in the quality assurance (QA) and quality control (QC) manuals. Quality assurance procedures are used by the laboratory to detect and correct problems in analytical processes. As newer methods and instrumentation are added to the laboratory, older procedures must be modified or changed completely. Quality control procedures are used to maintain a measurement system (i.e., a gas chromatograph) in a statistically satisfactory state to ensure the production of accurate and reliable data. 

Standard operating procedures (SOPs) are required for all routine activities that are critical to the successful outcome of the study including quality assurance procedures and inspections. Most of the SOPs for the field activities are written by the field scientists with guidance from the Quality Assurance Section. For the field activities, it is required that at each site there be SOPs for such things as how field plots are established and the plot boundaries marked, the maintenance of sample freezers, how to calibrate and maintain chemical balances and chemical application equipment, and how to obtain test chemicals. If an SOP for a critical item of equipment is not available, the study would be considered to be not in compliance with the principles of the GLP guidelines. The distribution of SOPs is carefully controlled so that when an SOP is changed, all outdated copies can be exchanged for the new version. 

---