Quality assurance defined

Statistical control The condition in which performance of a product or a service is deemed within bounds that have been set for quality assurance defined by upper and lower control limits. Statistical sample A finite set of measurements, drawn from a population of data, often from an infinite number of possible measurements. 

There should be specifications, approved at least by the person responsible for Quality Assurance, defining the nature and quality of each finished product... 

To operate the MPI or LPI equipment at stable and reprodncable inspection conditions modern units are equipped with a monitoring and control system called "Quality Assurance Package" (termed QAP). The QAP System is ba.sed on an industrial PC with a bus system and field sensors. It ensures that process parameters important for the reproducability of the MPI or LPI are controlled an held between defined limits by a central computer system. It can be adapted to any old system, as well as integrated into new systems. 

The "feedback loop in the analytical approach is maintained by a quality assurance program (Figure 15.1), whose objective is to control systematic and random sources of error.The underlying assumption of a quality assurance program is that results obtained when an analytical system is in statistical control are free of bias and are characterized by well-defined confidence intervals. When used properly, a quality assurance program identifies the practices necessary to bring a system into statistical control, allows us to determine if the system remains in statistical control, and suggests a course of corrective action when the system has fallen out of statistical control. 

Does the Quality Assurance Coordinator have clearly defined authority and responsibility and does he report directly to a senior manager ... 

The components of a quality assurance program are designed to serve the two functions just mentioned—control and assessment. Quality control operations are defined by operational procedures, specifications, calibration procedures, and standards and contain the following components ... 

Produce a plan that defines how an assurance of quality will be obtained, i.e. a quality assurance plan. 

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. ... 

The quality plan would be a logical place for such controls to be defined but clause 4.2.3 does not specifically refer to subcontractor controls. Any intention that they be defined in the quality plan is hidden in 4.2.3.1(b) where it requires you to give timely consideration to the identification and acquisition of any controls etc. Some companies produce a Quality Assurance Requirement Specification to supplement ISO 9001 and also produce a Subcontractor Surveillance Plan. In most other cases the controls may be defined on the reverse side of the purchase order as standard conditions coded and selected for individual purchases. 

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. 

Each contract laboratory used in the QPMBS and the organization that coordinated the field phase already had in place a well-defined GLP-compliant quality assurance program. In addition to these existing quality assurance programs, an independent QA specialist was engaged to ensure compliance of all the aspects of the smdy with GLP requirements. 

The design of an assay is, in large measure, prospective quality assurance. The factors that are likely to affect the results of the assay must be defined and controlled to the greatest extent possible. Once the general outlines of an assay have been established, key features should be examined, including optimization of sample preparation, sample stability, choice of standards, assay range, assay repeatability, optimization of separation, and optimization of detection. 

Most QI programs build upon an established quality assurance (QA) process. Quality assurance can be defined as a formal and systematic process in which problems in delivering health care are identified, solutions to the problems are developed and implemented, and follow-up monitoring then is carried out [30]. QA begins with problem identification. After possible sources of the problem are determined, solutions are developed and implemented. Then, the results of the intervention or solution are evaluated to determine whether or not the problem has been resolved. By incorporating a goal of continual improvement, a QA process can contribute to quality improvement activities. 

To be able to define what is meant by quality assurance and quality control. 

Organizations making analytical measurements should have well defined Quality Control and Quality Assurance procedures. 

The validation is therefore not complete until there is a detailed description of the method and records of the validation study. A responsible person needs to sign that the method meets the requirements, i.e. it is fit for purpose . The documentation facilitates the consistent application of the method, within its scope and defined performance parameters. This, in turn, helps ensure that when the method is applied in different laboratories or at different times, the measurand is the same and that the measurement results are comparable. Documentation is also required for quality assurance, regulatory and contractual purposes. 

The format of the final report from a study is closely defined and the Study Director is responsible for its production. The test item and name of the study must be clearly identified, along with the start and end date. It has to be accompanied by a statement from the Quality Assurance unit that the study and any critical aspects of the work have been conducted to the requirements of GLP principles. It will contain the names of all those involved with the study and their address this includes the Study Director, the Principal Investigator, and all the scientists... 

Doran JW, Parkin TB (1994) Defining and assessing soil quality. In Doran JW, Coleman DC, Bezdicek DF, Stewart BA (eds) Defining soil quality for a sustainable environment. SSSA Special Publiacation Number 35. Madison, WI Eastwood DJ (1952) The fungus flora of composts. Trans Br Mycol Soc 35 215-220 ECN (2006) Quality assurance system - user handbook. ECN/ORBIT e.V, Weimar ECN (2008) EU biowaste treatment. ECN/ORBIT e.V, Weimar... 

Quality assurance is defined by Donaobedian as all actions taken to establish, protect, promote, and improve the quality of health care (Donobedian 2003). He describes quality of care as an attribute of a system (structure), a set of organized activities (process), and an outcome that results from both. The definitions are described in Table 3.1. It should be noted that the efficacy of a drug (the ability for improvement under the most favourable circumstances) is included in the structure and that the effectiveness of a dmg (real improvement in the care) is included in the process. 

Part A describes the information that is to be provided by potential contractors at the time that the ROAME Bs are completed for submission to the Group. Provision of this information will permit any FSA Analytical Group and customers to make an informed assessment and comparison of the analytical quality of the results that will be obtained from the potential contractors bidding for the project. Previously potential contractors have not been given defined guidance on the analytical quality assurance information required of them and this has made comparison between potential contractors difficult. Part A is supplied to potential contractors at the same time as further information about the project is supplied. 

United States. GMP is defined by the FDA as a federal regulation setting minimum quality requirements that drug, biologies and device manufacturers must meet. It describes in general terms known and accepted quality assurance principles for producing these products. Its components are scientific understanding, documentation, analysis and measurements and personnel matters. Its intended result is total quality assurance and product control. ... 

Unlike quality assurance plans, which address primarily regulatory requirements involving comprehensive documentation, quality control programs are science based, the components of which may be defined statistically. The two most important components of quality control are (1) determination of the precision of analysis and (2) determination of the accuracy of measurement. 

An active program of surveillance of the quality of the immunostains produced must be defined. The primary elements of such a quality assurance (QA) program include procedures and policies for patient test management, quality control, proficiency testing, comparison of test results, relationship of clinical information to patient test results, personnel assessment, communications, complaint investigations, QA review with staff, and QA records. The documentation and review by the laboratory director of all QA procedures is imperative and cannot be overstressed. A brief explanation of each of the QA elements is as follows ... 

So PAC has indeed evolved to PAT, which encompasses not only process measurement, real-time quality assurance and control but process understanding to enable product quality by process design. The tools available to us for quality by design as defined by the FDA include ... 

The laboratoiy should have a documented Quality Assurance Programme, carried out by designated individual(s), to assure that the activities perfonned are in compliance with the principles of GLP. The QA personnel must conduct inspections to determine if all of the laboratory activities are conducted in accordance with the principals of GLP and defined SOPs. These personnel... 

This is the sixth statement. Organizations making analytical measurements should have well defined quality control and quality assurance procedures. These procedures are explained in detail throughout this book. 

In Section 3, quality assurance was defined as the laboratory operations employed to test a company s products, or an agency s samples, etc., to determine if they are within specification. This section discusses the specifics of these operations — what considerations are involved in the day-to-day work of a quality assurance technician or chemist. 

Define Quality Control, Quality Assurance, sample, analyte, validation study, accuracy, precision, bias, calibration, calibration curve, systematic error, determinate error, random error, indeterminate error, and outlier. 

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