Quality assurance - meaning

Quality Assurance means all those actions that provide confidence that quality is achieved. 

It might be argued by those whose measurements are only used in a semi-quantitative fashion that a QA system is not necessary in their case. Not true. Quality assurance means that, whatever the degree of quality of the result on an absolute scale, the expected quality can be relied upon. (A trite comparison might be the warranty on a used car that gives confidence that the car is fit for its purpose as a used car but does not imply that it will give the performance of a brand new one.)... 

Over the last 20 years, an effort has been made to reform the quality assurance system. In the past, primary importance was given to the control of the quality of the final product and of services at the interfaces during the construction process. Current quality assurance focuses more on process control during production. In this respect, quality assurance means quality management of processes and is directed as much toward the internal organization of each participant and to the interfaces between them. The purpose of this change is the reduction of faUure cost due to deficiencies in the project. 

As a first step in the direction outlined here some manufacturers and BAM last year discussed the problems and the possible procedures of such a system of quality assurance. As a result of this meeting round robin tests for the harmonization of the measurements of film system parameters and a possible procedure of surveillance of the quality of film systems were proposed. Closely related to these the BAM offers to perform the classification of film systems. But as during the production of films variations of the properties of the different batches cannot be avoided, the results of measurements of films of a single batch will be restricted to this charge, while only the measurements and mean of several batches of a film type will give representative values of its properties. This fact is taken into account already in section 4 of the standard EN 584-1 which can be interpreted as a kind of continuous surveillance. In accordance with this standard a film system caimot be certified on the base of measurements of a single emulsion only. 

Control charts were originally developed in the 1920s as a quality assurance tool for the control of manufactured products.Two types of control charts are commonly used in quality assurance a property control chart in which results for single measurements, or the means for several replicate measurements, are plotted sequentially and a precision control chart in which ranges or standard deviations are plotted sequentially. In either case, the control chart consists of a line representing the mean value for the measured property or the precision, and two or more boundary lines whose positions are determined by the precision of the measurement process. The position of the data points about the boundary lines determines whether the system is in statistical control. 

Although I have defined terms such as quality control and quality assurance in this chapter, what is important is not the definition but the deeds which it imbues. Whether we call the set of principles I have listed under the heading Quality assurance, Quality Assurance, Quality Improvement or Quality Control makes no difference since it does not change the set of principles. We often seem to invent a term then decide what it means rather than invent or discover a set of principles and think of a suitable name which conveys exactly what we intend without confusing people. Instead of saying Quality control is. .. or TQM is. .. to which there will be many propositions, we should be asking What should we call this group of principles so that we can communicate with each other more efficiently As Shakespeare once said That which we call a rose/By any other name would smell as sweet. ... 

Although written reports are the inspecting authority s end product they by no means comprise the whole of the professional service that is supplied or is available on request. The authority s quality assurance objective is likely to be on the lines of client satisfaction allied to compliance with contractual obligations . Although reports are almost certainly monitored, they are a poor indicator of the quality of the examination, and the authority s quality control will rely less on report... 

The final element which regulations address is quality. Safety and fitness for purpose, as discussed above, are two of the characteristics that you would associate with a quality product. However, these characteristics alone would not describe a quality product. For any product or service to be considered quality you would also expect it to be reliable and consistent. Additionally in the context of medical products, quality means a requirement to demonstrate conformance to agreed specifications or applicable standards for content, purity and stability. Many organisations, from manufacturers to service providers, voluntarily apply quality assurance systems in order to more effectively meet their customers needs on a consistent basis. However,... 

Good manufacturing practice (GMP) comprises that part of quality assurance which is aimed at ensuring that a product is consistently manufactured to a quality appropriate to its intended use. GMP requires that (i) the manufacturing process is fully defined before it is commenced and (ii) the necessary facilities are provided. In practice, this means that personnel must be adequately trained, suitable premises and equipment employed, correct materials used, approved procedures adopted, suitable storage and transport facilities available and appropriate records made. 

On the one hand, statistical quality control is an important tool for quality assurance within analytical chemistry itself (monitoring of test methods), and on the other for quality control of processes and products by means of analytical methods. 

Other industrial applications of 2DLC are known and have been used for applications from quality assurance to synthesis research. These applications will drive 2DLC into new areas as many of the applications used in industry cannot easily be obtained by other means. The analysis of polymers and other industrially useful molecules will be aided by further developments in 2DLC column and instrumental methodologies. 

Briefly, the quality management system is a combination of quality management, quality control and quality assurance. Quality assurance and quality control are components of the laboratory s quality management system. There is often confusion over the meaning of quality control and quality assurance and regrettably they are often used interchangeably. This is possibly because some quality control and quality assurance actions are interrelated. The definition of the terms can be found in the International Organization for Standardization (ISO) Standard, ISO 9000 2005 [2],... 

It is essential that all data generated and any other records or samples (if possible) are retained so that they are available for inspection at a later date. This means that there must be a secure and properly controlled archive, with an archivist to maintain it. The archive will contain a copy of the Study Plan, quality assurance reports, records of staff including their curriculum vitae (CV) and training records. Access to the archive has to be strictly controlled, and any additions to or withdrawals from the archive must be logged (see also electronic records in Section 9.2.1.8). Such removal or additions can only be undertaken by stated personnel. 

In the analysis of solid samples (e.g., LA-ICP-MS, SEM), synthetic standards cannot easily be prepared to the required concentrations, and accurate calibration of such techniques is often challenging. In some cases (e.g., SEM) pure element or single mineral standards are used, ideally with an appropriate standard for each element to be quantified. (It is possible in SEM, within limits, to use fewer standards than the number of elements to be determined, with the calibration for other elements being predicted from the response of the nearest element.) More often, however, multielement primary standards are used as the means of calibrating the instrument, e.g., for LA-ICP-MS of glasses, volcanics, and ceramics, two glass standards, NIST 610 and 612 (Pearce et al. 1996), are often used. It is always advisable to use more than one multielement standard in order to cover as wide a range of concentrations as possible, and to use at least one additional independent reference material as an unknown, for quality assurance purposes (see below). 

The most important aspect of the job of the chemical analyst is to assure that the data and results that are reported are of the maximum possible quality. This means that the analyst must be able to recognize when the test instrument is breaking down and when a human error is suspected. The analyst must be as confident as he or she can be that the readout from an instrument does in fact indicate a true readout as much as is humanly possible. The analyst must be familiar with error analysis schemes that have been developed and be able to use them to the point where confidence and quality is assured. 

In a quality assurance programme, the control with a mean value of 10.5 mg and a standard deviation of 0.1 mg was analysed with a batch of test samples and gave a result of 10.0 mg. Which of the following actions should be taken ... 

Predefined trees are a convenient means of identifying root causes. Providing all of the causal factors have been determined, use of a comprehensive predefined tree should ensure that most, if not all, root causes are identified. Several quality assurance tests should help identify any remaining root causes. 

Quality assurance unit means any person or organizational element, except the study director, designated by testing facility management to perform the duties relating to quality assurance of nonclinical laboratory studies. 

In order to implement the quality policy in the daily work, quality management systems are installed, covering quality planning, quality control, quality assurance and quality improvement. To ensure that the quality assurance system is in place and effective, external standards are used, for example the DIN EN ISO 9000 ff. standard system, commonly shortened to ISO 9000 (DIN is an acronym for Deutsches InstitutfiXr Normung, meaning German Industry Standard ). 

The PAT guidance facilitates introduction of new measurement and control tools in conjunction with well-established statistical methods such as design of experiments and statistical process control. It, therefore, can provide more effective means for product and process design and control, alternate efficient approaches for quality assurance, and a means for moving away from the corrective action to a continuous improvement paradigm. 

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