Quality system assessments - meaning

Next is a questionnaire which only covers the specific requirements of the standard. This breaks down the requirements into their individual components where it is likely that the solutions for each part will be different. It can be used as a basic checklist for verifying that the quality system you have designed addresses all the requirements, or as a means of creating policy or of assessing conformity. 

The computerized systems, both hardware and software, that form part of the GLP study should comply with the requirements of the principles of GLP. This relates to the development, validation, operation and maintenance of the system. Validation means that tests have been carried out to demonstrate that the system is fit for its intended purpose. Like any other validation, this will be the use of objective evidence to confirm that the pre-set requirements for the system have been met. There will be a number of different types of computer system, ranging from personal computers and programmable analytical instruments to a laboratory information management system (LIMS). The extent of validation depends on the impact the system has on product quality, safety and record integrity. A risk-based approach can be used to assess the extent of validation required, focusing effort on critical areas. A computerized analytical system in a QC laboratory requires full validation (equipment qualification) with clear boundaries set on its range of operation because this has a high... 

The purpose of validation is to demonstrate the capability of the water treatment and air handling system to continuously supply the required quantity of water and air with the specified quality attributes. Documented means to provide documented evidence. Validation provides the system owner with the means of assessing when a water treatment and/or air handling system is operating outside established control parameter limits and provides a means for bringing the system back into a state of control. It results in written operating and maintenance procedures for personnel to follow, which in turn helps ensure consistent system performance. 

These more specific criteria for data quality are important, but represent only one aspect of the more multidimensional problem of ensuring data quality in exposure assessment. For example, they are not designed to deal with the implications of further use of the data in an exposure assessment or other kinds of assessments. Judgements about the quality of data often depend on the utility of the data for their intended purpose and may change when the same data are used for other purposes. Furthermore, statistical methods can be useful in describing the extent and sources of variability in data, but may not capture major limitations and uncertainties in a data set or the methods used to generate data (see text box for the distinctions between variability and uncertainty). They often assume that other steps in the exposure assessment process are known or can be flawlessly specified. Such characteristics mean that standard data quality systems or statistical methods cannot be relied on as the sole bases for assessing data quality in exposure assessments as it has been more broadly defined in this document. 

It is part of the early decision-making process to assess which parts of the LIMS are to be subject to full validation and which are to be covered by good IT or engineering testing practice. The function of LIMS within the company computing architecture may mean that it is utilized for both product quality related and non-product-quality-related activities. The validation determination for LIMS ensures that the validation effort is focused toward those system elements with direct GxP impact. The justification for validating only certain parts of LIMS must be based on an assessment of the GxP criticality of the data in the LIMS database, the use of the data and the sources of the data. In the ideal world LIMS would be dedicated to GxP activities. However, the economics of the system may mean that it is not practical to separate GxP and non-GxP activities into separate systems. 

A clause in the measurement and monitoring section provides a means for self- assessment of an organization s quality system. The actual methodology along with appropriate questions to be answered are included in an annex to the standard. 

Accreditation of a laboratory means the official assessment and certification of its quality system as meeting the requirements of such a standard. 

A validation report or the therapeutic assessment of a pharmacy stock preparation exists and needs to be accessed and up to date as soon as related activities are performed. Providing availability and readability has to be an element of the quality system. It would mean for instance that a file system has to be developed whether physically or digitally. In case of digital storage care has to be taken that the documents remain accessible when programs are updated. 

In specifying the criteria against which the products or the quality system of an organisation are evaluated and how they should be assessed, a certification body has to establish working documents. The working documents are part of a certification scheme that reflects the content and functioning of the certification. Inherent to certification is a structure that should enable the participation of all relevant parties concerned to approve a certification scheme. Representation on an Advisory Board and or in an impartial committee of experts forms the means to take into account the views of the significant interested parties. 

The principal tool for performance-based quality assessment is the control chart. In a control chart the results from the analysis of quality assessment samples are plotted in the order in which they are collected, providing a continuous record of the statistical state of the analytical system. Quality assessment data collected over time can be summarized by a mean value and a standard deviation. The fundamental assumption behind the use of a control chart is that quality assessment data will show only random variations around the mean value when the analytical system is in statistical control. When an analytical system moves out of statistical control, the quality assessment data is influenced by additional sources of error, increasing the standard deviation or changing the mean value. 

The basis for assessment of river quality is valid data, but the question of data validity is secondary to the fundamental question What is the purpose of the river quality assessment activity What questions are being asked In short the means are determined by the ends. If, for example, the intent of an assessment program is to ascertain compliance with law, then a fixed interval "grab sampling program could be established at various river system sites selected on the basis of established guidelines which are consistent with the... 

In the first stage of the LCA analysis, it is necessary to define the objective and the scope of the paper before the actual start [35]. The study goal and scope definition determine the next procedure character and the circumstances in which the study outputs are valid [32]. [36] requires to establish a study goal and scope while the study scope means to determine the product system, the functional unit and system boundaries, to determine allocation rules, the assessment methodology, hypothesis and limits and data quality. 

It is difficult to define unequivocally the quality of fabric handle or softness/firmness differences, since this involves many factors. It is often linked with lubrication, especially as similar products are often used for softening and lubrication. Whilst experienced assessors can be quite remarkable in the extent to which they can grade and assess softeners simply by means of a highly developed tactile sense, more objective methods are clearly desirable for scientific investigations. Since many factors combine in producing an overall sense of softness, it is not surprising that objective determination of softness involves more than one parameter of measurement. The details of assessment are outside the scope of this chapter, but descriptions and discussions are available elsewhere [478-481]. Suffice it to say here that the Kawabata system has acquired considerable importance in quantifying various aspects of fabric handle. 

Although basic scientific research deals with variation and its sources, the results of research work are mainly described and compared in terms of mean values supplemented with information about whether specific factors have a significant impact or not. Most research studies focus on individual factors in isolation and there are limited data in the literature on the interaction of a number of factors, particularly in relation to on-farm production practice. Consequently, the meaningfulness of previous results is often limited and often does not allow general conclusions to be drawn. As the relevance of the various factors changes between different production systems it is even more difficult to assess the ranking position of each factor within each production system in relation to the variation of product and process quality traits. 

As mentioned previously, it is possible to include opinions and interpretations within the scope of accreditation. It should be realized that the opinions and interpretations themselves are not accredited. This accreditation is only given if the work is already accredited to ISO/IEC 17025 [1]. What is required by the Standard is evidence of the procedure used by the laboratory to authorize an individual to give an opinion or interpretation. This means there has to be a procedure within the management system of the laboratory that sets out the criteria upon which the quality of the person giving the opinion is assessed. This may be split into two parts, namely the criteria for assessing competence and the criteria for assessing experience. 

Soil quality and health play an important role in sustainable agriculture Soil quality assessment provides a basic means to evaluate the sustainability of agricultural and land management systems (Doran and Parkin 1994). Soils that are healthy have homeostatic properties, within broadly set limits (Coleman et al. 1998). The application of compost can results soil quality and health because of the organic matter content and humus-producing properties. 

The different instruments (Hunter, Gardner, Instrumental Colour Systems, etc.) process absorbance and reflectance data in slightly different ways, which means that the values obtained can differ slightly from one instrument manufacturer to another. Therefore, a product s defined colour has to be qualified with a statement indicating the instrument used. Notwithstanding this limitation, it is not uncommon to find a tristimulus colour meter in a manufacturer s quality assurance laboratory so that routine quantitative assessment of a product s colour can be made. This is particularly tine for tomato-based products, whose nature makes conventional spectrophotometric assessment meaningless. 

The taste sensor will be applicable for quality control in food industry and help automation of the production. The sense of taste is vague and largely depends on subjective factors of human feelings. If we compare the standard index measured by means of the taste sensor with the sensory evaluation, we will be able to assess taste objectively. Moreover, the mechanism of information processing of taste in the brain as well as the reception at taste cells will also be clarified by developing a taste sensor which has output similar to that of the biological gustatory system. 

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