Basics of Quality Assurance

In analytical chemistry, the product is not spaghetti sauce, but, rather, raw data, treated data, and results. Raw data are individual measurements, such as peak areas from a chromatogram or volumes from a buret. Treated data are concentrations or amounts found by applying a calibration procedure to the raw data. Results are what we ultimately report, such as the mean, standard deviation, and confidence interval, after applying statistics to treated data. 

If you manufacture a drug whose therapeutic dose is just a little less than the lethal dose, you should be more careful than if you make spaghetti sauce. The kind of data that you collect and the way in which you collect them depend on how you plan to use those data. An important goal of quality assurance is making sure that results meet 

Quotation from Ed Urbansky, U.S. Environmental Protection Agency, Cincinnati, OH. Section 5-1 is adapted from a description written by Ed Urbansky. 

Treated data concentrations derived from raw data by use of calibration method 

Results quantities reported after statistical analysis of treated data 

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Definitions of quality assurance and statistics Part 11 - Basic definitions of quality assurance Part 18 - Definitions regarding certification of results of quality tests/quality test certificates 8/95 7/87... 

These questions are at the core of the basic principles of quality assurance. 

Integration of Quality Assurance concepts into the laboratory is the key to GLP compliance and is usually accomplished in three phrases under the guidance of the QAU. In the Management Phase the basic plan is formulated based on policies decided upon by management. In the second phase the QAU prepares the laboratory for the final implementation phase. General rules for integration are given as are levels of acceptance that may be expected from laboratory personnel. 

Quite obviously, the quality of analytical results strongly depends on the representativeness of the sample examined, the appropriateness of the pretreatment procedures applied for the quantitative conversion of analytes into detectable forms, and the btness for purpose of the laboratory setting. Because of the low concentration and the numerous interferences which affect the various detection systems, measurements methods must be thoroughly validated. Even if values obtained by several laboratories for PGEs concentrations in environmental and biological samples were compliant with the basic requirements of quality assurance (QA) and internal quality control (QC), striking differences have been... 

The Technical Services function of AOCS establishes, revises, and annually updates AOCS Methods, the Official Methods and Recommenced Practices of the American Oil Chemists Society22 for fats, oils, and soap technology Spanish AOCS Methods, a Spanish translation of the more commonly used AOCS Methods and Physical and Chemical Characteristics of Oils, Fats and Waxes. Leaders of the methods development committees coordinate closely with AOAC International (formerly the Association of Official Analytical Chemists). AOCS Methods are recognized as Official Methods in US FDA activities and when litigation becomes necessary in industry trade. Additionally, the Technical Services function operates a Laboratory Proficiency Program (formerly the Smalley Check Sample Program) and oversees distribution and statistical analysis of 30 different series of basic laboratory quality assur-ance/quality control test samples. Certification as AOCS Approved Chemists, or as AOCS... 

The number of CRMs available on the market is, and probably always will be, smaller than the actual need of the scientific community at large. This does not mean, however, that the analyst in pursuit of quality assurance can take any CRM that is at that moment on a shelf in the laboratory. Five general criteria can be formulated to characterize basic features of a CRM [15, 35] that is fit for a given type of analysis ... 

The concept of quality control should be discussed in general comparison with that of the concept of quality assurance. The basic concept of quality assurance is that quality should be assured comprehensively and wholly from the beginning to the end of a fixed volume of successive procedures. It assures that whole data acquired by using the fixed volume come to have a signification result to meet intended objectives. On the other hand, quality control is related only to definite and practical control of respective procedures, and is limited to only some portions of those procedures. Its main objective being maintenance of quality of results within a specific limit. 

Validation is an essential part of good manufacturing practices (GMP). It is, therefore, an element of the quality assurance programme associated with a particular product or process. The basic principles of quality assurance have as their goal the production of products that are fit for their intended use. These principles are as follows ... 

The basic concept of Quality Assurance, Good Manufacturing Practice and Quality Control are inter-related. They are described here in order to emphasise their relationships and their fundamental importance to the production and control of medicinal products. 

The aspects of quality assurance which deal with production and quality control are dealt with in the guidelines provided for this purpose under the term GMP (Good Manufacturing Practice). Production is the department in charge of the manufacture and packaging of products according to the effective basic documents. This includes the series of operations from the collection of the necessary starting materials to the delivery of the end product as well as control of the conditions under which these activities take place. 

AFNOR NFX50-111, Quality Assurance Systems for the Use of Companies DIN 55-355, Basic Elements of Quality Assurance Systems... 

As a part of today s quality management, multiple methods of measurement and statistics are used to detect, analyze, and eliminate potential or existing faults as a task of quality assurance towards an internal or external customer. A basic precondition for a comprehensive quality assurance approach is to gain and involve internal and external customer requirements and to assess products and processes by these requirements and indicate problems. To plan and accomplish these assessments are the main objectives of quality assurance. Due to the high complexity of today s products and processes, inspection planning and adequate capability of the measurement equipment represent two of its key elements. 

Table IV. 1 Basic elements of quality assurance programmes that...

TABLE IV. 1. BASIC ELEMENTS OF QUALITY ASSURANCE PROGRAMMES THAT SHOULD BE CONSIDERED AND ADDRESSED IN THE SAFE TRANSPORT OF RADIOACTIVE MATERIAL... 

The interpretation of quality assurance is, according to ISO 9000, all those planned and systematic actions necessary to provide adequate confidence that the product or service will satisfy given requirements for quality . Basic elements of quality assurance are quality policy and activities of quality assurance programs, e.g., calibration, collaborative studies, good measurement practice (GMP), standard operating procedure (SOP), staff training, and instrument maintenance and inspection (audit). 

A method of quality assurance is required to solve the basic problems that still remain. In order to obtain comparable analytical results it is first necessary to solve the physiologically determined analytical problems. 

The basic concept of quality assurance for flexible circuits is the same as that for rigid boards, in the sense that any critical defect must be eliminated before shipping. This includes failures due to opens and shorts dimensional degradation of pad arrays, serious defects on conductors, substrates, coverlay, and so on. These defects need to be inspected for each circuit, whether it is flexible or rigid. Technically, however, there are several differences in quality assmance for flexible circuits because of their additional functions, such as dynamic flexing capability. 

The properties of the glass ceramics and their varieties are also reported on. Additionally, methods of quality assurance are mentioned, which are necessary to grant the mechanical, thermal, and chemical properties and the demanded final shapes of the products. The considerable effort in the analysis of bulk material and surface analysis, which must be applied in basic research and development to study the appropriate parameters for nucleation and crystal growth, could not be covered by the present book. The reader is referred to the two volumes on analysis and surface analysis to appear in this series. 

American Society of Quality, 2011. Basic Concepts—Quality Assurance and Quality Control. (http //asq.org/learn-about-quality/quality-assurance-quality-control/overview/overview. html). May 10. 

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