Big Chemical Encyclopedia

Chemical substances, components, reactions, process design ...

Articles Figures Tables About

Quality system characteristics

These are the characteristics which need to be specified and their achievement controlled, assured, improved, managed, and demonstrated. These are the characteristics which form the subject matter of the specified requirements referred to in ISO 9000. When the value of these characteristics is quantified or qualified they are termed quality requirements or requirements for quality. ISO 8402 1994 defines requirements for quality as an expression of the needs or their translation into a set of quantitatively or qualitatively stated requirements for the characteristics of an entity to enable its realization and examination. While rather verbose, this definition removes the confusion over quality requirements and technical requirements. (An additional definition is provided in Appendix A.) Technical requirements for a product or service are quality requirements. The requirements of ISO 9000 are quality system requirements. [Pg.25]

Quality systems need to possess certain characteristics for them to be fit for their purpose. ISQ/TS 16949 specifies functional requirements for quality systems rather than performance requirements. It specifies what a quality system must do but not how well it must do it. The performance required will however depend on the environment in which the system will be used. Some of these performance characteristics will be as follows ... [Pg.42]

The quantitative measure of these characteristics may be difficult if not impractical, but nevertheless they provide a means of judging the effectiveness of the system once it is installed. The effectiveness of quality systems is also addressed in Part 2 Chapter 1. [Pg.43]

ISO/TS 16949 is not a set of requirements for producing documentation (as many perceive ISO 9000 to be). It contains requirements that address the key characteristics of a quality system which if not met will put product quality (and consequently customer satisfaction) at risk. [Pg.43]

Subcontractor/supplier performance will be evident from audit reports, surveillance visit reports, and receipt inspections carried out by you or the third party if one has been employed. You need to examine these documents for evidence that the subcontractor s quality system is controlling the quality of the products and services supplied. You can determine the effectiveness of these controls by periodic review of the subcontractor s performance what some firms call vendor rating . By collecting data on the performance of subcontractors/suppliers over a long period you can measure their effectiveness and rate them on a scale from excellent to poor. In such cases you should measure at least three characteristics quality, delivery, and service. Quality would be measured by the ratio of defective conforming products received delivery would be measured by the number of days early or late and service would be measured by the responsiveness to actions requested by you on scale of excellent to poor. The output of these reviews should be in the form of updates to the list of assessed subcontractors/suppliers. [Pg.323]

If a quality record was intended to be any document generated or used by the quality system, the definition would surely have indicated this. If we decompose the definition further, requirements for quality are defined in ISO 8402 as the expression of the needs or their translation into a set of quantitatively stated requirements for the characteristics of an entity to enable its realization and examination. Clearly, such a requirement would be a contract, product specification, design requirement, etc. This implies that any product verification records are quality records, but it rules out any recorded information as being a quality record. [Pg.495]

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. [Pg.147]

All the concepts and examples presented in this chapter refer to natural phenomena in the hydrosphere, and are basic for understanding the dynamics, quality, and characteristics of aqueous systems. They are also relevant for understanding what may happen to these natural systems that could alter, deviate, or intensify the natural processes when other types of substances or conditions are introduced by anthropogenic activities and pollution processes. These issues are further discussed in Chapter 8, where we will consider the impact of these activities on the surrounding systems and the resulting chemical processes. [Pg.132]

For inhalation treatment of respiratory diseases, a pharmaceutical DNase I aerosol is on the market. Pulmozyme is a sterile solution for respiratory use at a concentration of 1000 Genentech Units/mL [22]. It contains 1 mg/mL rhDNase, sodium chloride as a tonicity modifier, calcium chloride as a stabilizer, and water for injection. Since deamidation is rapid at high pH and aggregation occurs at low pH, a nearly neutral solution (pH 6.3) is required. It is administered by means of a compressed air-driven nebulizer. Each 2.5-mL single-unit ampule will deliver 2.5 mg of rhDNase to the nebulizer chamber. The efficacy of DNase inhalation therapy largely depends on the aerosol quality and characteristics, which determine the respirable fraction. Significant differences were found between the different aerosol drug-delivery systems [68,81]. [Pg.297]

Qause 8.3 is on control of nonconformity. This is a requirement to identify rmd control product that is in nonconformance and to take appropriate action to see that such product does not reach the customer. The next subclause requires data dealing with the quality system to be collected and analyzed. These data include customer satisfaction and dissatisfaction, conformance to requirements, characteristics of processes and products, emd suppliers. [Pg.1971]

The quality characteristics of medicinal products and quaUty objectives of a preparing pharmacy or manufacturer are generally and sometimes in detail covered by European and national legislation and guidelines. A quality system for medicinal products will therefore have to connect with the appropriate legislation and professional guidelines that are meant to support their quality. [Pg.775]

The choice of the right suppliers for raw materials is critical because validation of a bioresorbable polymer includes the characteristics of all the suppliers involved in the production process, ie, their quality systems and certifications. An unreliable supplier represents a possible source of issues when producing a device under regulatory approval. For example, a supplier could fail obliging the company to begin a validation process for the new supplier, the quality of the raw material could be erratic, or the supply of a determined material could be discontinued [20]. Moreover, in the past years the number of suppliers of bioresorbable materials did not increase as expected,... [Pg.135]

The definition of system is quite varied, but a common element is that it focuses on the whole entity, for example A system is a construct or collection of different elements that together produce results not obtainable by the elements alone. The elements, or parts, can include people, hardware, software, facihties, poHcies, and documents that is, all things required to produce systems-level results. The results include system-level qualities, properties, characteristics, functions, behavior and performance. The value added by the system as a whole, beyond that contributed independently by the parts, is primarily created by the relationship among the parts that is, how they are interconnected. Using this definition, one can identify a variety of systems within the clinical setting. For example, an MRI device is... [Pg.3]

Secondly, they analyzed five areas of the OH S management system, in particularly OHSAS 18001 2007, by the application of earlier chosen quality information criteria. The first area concerned information about the OH S policy. In particularly, it encompassed strategic assumptions for the OH S management system, characteristics of... [Pg.30]

FEDERAL GRADES OF FORK. Grades of barrow and gilt carcasses are based on quality-indicating characteristics of the lean and expected yields of the four lean cuts (ham, loin, picnic shoulder, and Boston butt). Quality and yield are combined in one set of grades and are not kept separate, in contrast to the system us with beef and lamb. [Pg.869]


See other pages where Quality system characteristics is mentioned: [Pg.43]    [Pg.175]    [Pg.392]    [Pg.552]    [Pg.7]    [Pg.123]    [Pg.99]    [Pg.182]    [Pg.492]    [Pg.492]    [Pg.212]    [Pg.7]    [Pg.41]    [Pg.18]    [Pg.29]    [Pg.130]    [Pg.411]    [Pg.214]    [Pg.431]    [Pg.7]    [Pg.898]    [Pg.29]    [Pg.218]    [Pg.227]    [Pg.235]    [Pg.198]    [Pg.449]    [Pg.327]    [Pg.803]    [Pg.173]    [Pg.288]    [Pg.1]    [Pg.174]   
See also in sourсe #XX -- [ Pg.42 ]




SEARCH



© 2024 chempedia.info