Quality assurance traceability

See also Dioxins. Electrophoresis Proteins. Ethanol. Flow Injection Analysis Instrumentation. Geochemistry Inorganic. Quality Assurance Traceability. Voltammetry Inorganic Compounds. X-Ray Absorption and Diffraction X-Ray Diffraction - Powder. 

Assembling this material is a large data management task to assure the availability and traceability of all needed information with the output of one task fitting the input of another. This requires that quality assurance has been adhered to throughout the PSA project. 

A second reason for using reference materials in clinical chemistry is to ensure values obtained are traceable to those in a recognized, authoritative reference material (Johnson et al. 1996). As a result, the assignment of values of secondary and tertiary reference materials, calibrants, controls, and proficiency samples shordd be performed as precisely as possible (Johnson et al. 1996). Surprisingly there is still debate on this topic, and on the need for clinical chemistry to incorporate the principals of analytical quality assurance (Dybkaer et al. 1999). 

Although there are many similar definitions for traceability, the essence of trace-ability is an unbroken pathway to the definition of the accepted units used to express the measurement result and a measurement process in which quality assurance is an integral component. 

Point 1 would need special attention to assure the quality and traceability for the calibration standard. 

Where practical, the calibration standards used for production and quality assurance measurement equipment shall be traceable to the national standards of the National Bureau of Standards, Department of Commerce. If national standards are not practical for the parameter being measured, an independent reproducible standard shall be used. If no applicable standard exists, an in-house standard shall be developed and used. 

This update on analytical quahty issues a common understanding on the topics of method validation, traceabihty, and MU of measurements. The interrelationships between method validation and traceability and MU of results have been elucidated. Throughout the landscape of guidelines and standards, the most relevant information was selected, compiled, and summarized. Different approaches are discussed for establishing traceability and assessing MU of analytical methods in general. The importance of both concepts and the link with method validation and analytical quality assurance are highlighted. 

There are some existing texts that cover the material in this book, but I have tried to take a holistic view of quality assurance at a level that interested and competent laboratory scientists might learn from. I am continually surprised that methods to achieve quality, whether they consist of calculating a measurement uncertainty, documenting metrological traceability, or the proper use of a certified reference material, are still the subject of intense academic debate. As such, this book runs the risk of being quickly out of date. To avoid this, I have flagged areas that are in a state of flux, and I believe the principles behind the material presented in this book will stand the test of time. 

The software design specification is written by the system supplier and must identify how the supplier intends to provide system software under a software quality assurance plan. The design specification must describe the subsystem software that will make up the computer system software and subsystem interfaces to implement the aims set out in the FDS. Each subsystem should be traceable back to statements in the FDS. 

Traceability concepts are just some of the many means to foster quality assurance as a drive for analytical reliability. They are heavily centred on the measurement part of the overall analytical process. Their application is hampered by the adoption of a number of strict rules so that truly traceable CRMs relying on primary methods are only available in exceptional circumstances. 

Keywords Chemical metrology Traceability Proficiency evaluation Accuracy of chemical analysis Quality assurance in chemistry... 

In this example, internal consistency, over time, can suffice to assure production, with minimal analytical cost, of acceptable alloy. Indeed, portions of previous batches which have yielded high-quality materials and products can serve as measurement standards without the need for traceability to SI or national standards. Measurement traceability to a higher laboratory may be useful in attaining certain objectives, such as inter-plant comparisons and reaching agreement between producer and buyer laboratories, but, it is not essential to immediate quality assurance for production in a single plant. 

This paper has described new approaches to providing quality assurance within the operation of proficiency evaluation programs. The approaches are used in a new NIST program to monitor providers of proficiency testing in an environmental field. A part of that monitoring is conducted by means of indirect proficiency evaluation of the providers. The new program demonstrates that both direct and indirect proficiency evaluation can provide traceability links, in chemical metrology, to measurements carried out at NIST. 

Keywords Traceability Laboratory medicine Biological variation Analytical bias Quality assurance Standardization Reference measurement system Joint Committee on Traceability for Laboratory Medicine... 

It is shown that an Si-traceable result does not necessarily coincide with the median or average of a number of participants results, thus demonstrating that a set of systematic errors from a set of laboratories is not necessarily normally distributed. It is also shown that the use of certified reference materials (CRMs) does not automatically lead to correct results and the same is true when different systems for quality assurance are applied. 

An integrated approach to disseminating traceability is described as it has crystallized from more than 15 years of practice with IMEP. It shows how Si-traceable values are disseminated for the benefit of the end-users, consistent with the title and objective of this CCQM workshop. It contains the essential elements needed standardization, quality assurance, accreditation, metrology and education (SQAME). The key tasks of metrological and other reference measurement institutes as well as accreditation bodies in the dissemination and use of metrological traceability naturally follow from these 15 years of experience. 

Keywords Traceability Gas standards Calibration Quality assurance Proficiency testing International comparisons... 

The function of reference materials to establish traceability and means of quality assurance is emphasized. 

This anthology contains 56 outstanding papers on the topic Traceability, published in the Journal Accreditation and Quality Assurance since its inception, but mostly in the period 2000 2003. They re ect the latest understanding of the concept measurement traceability -or lack thereof- and possibly some rationale(s) for the answer to the question why it is important to integrate the concept of measurement trace-ability into the standard measurement procedures of every analytical laboratory. 

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