Quality Assurance

12 Key excerpts on "Quality Assurance"

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  eBook - ePub

  Quality Management in Construction Projects

  • Abdul Razzak Rumane(Author)
  • 2017(Publication Date)
  • CRC Press

    (Publisher)

  During this period, quality became a means to safety. Unsafe military equipment was clearly unacceptable, and the armed forces inspected virtually every unit of product to ensure that it was safe for operation. This practice required huge inspection forces and caused problems in recruiting and retaining competent inspection personnel. To ease the problems without compromising product safety, the armed forces began to utilize sampling inspection to replace unit-by-unit inspection. With the aid of industry consultants, particularly the Bell Laboratories, they adapted sampling tables and published them in a military standard: Mil-Std-105. The tables were incorporated into the military contracts themselves. In addition to creating military standards, the armed forces helped their suppliers improve their quality by sponsoring training courses in Shewhart’s statistical quality control (SQC) techniques. While the training led to quality improvements in some organizations, most companies had little motivation to truly integrate the techniques. As long as government contracts paid the bills, organizations’ top priority remained meeting production deadlines. Most SQC programs were terminated once the government’s contracts came to an end.

  According to ISO 9000 (or BS 5750), Quality Assurance is “those planned and systematic actions necessary to provide adequate confidence that product or service will satisfy given requirements for quality.” ISO 8402-1994 defines Quality Assurance as “all the planned and systematic activities implemented within the quality system, and demonstrated as needed, to provide adequate confidence that an entity will fulfill requirements for quality.”

  The third era of quality management saw the development of quality systems and their application principally to the manufacturing sector. This was due to the impact of the following external environment upon the development take-up of quality systems at this time:

  • Growing, and more significantly, maturing populations
  • Intensifying competition

  These converging trends contributed greatly to the demand for more, cheaper, and better quality products and services. The result was the identification of Quality Assurance schemes as the only solution to meet this challenge.

  Harold Kerzner (2001) has defined Quality Assurance as the collective term for the formal activities and managerial processes that are planned and undertaken in an attempt to ensure that products and services are delivered at the required quality level. Quality Assurance also includes efforts external to these processes that provide information for improving the internal processes. It is the Quality Assurance function that attempts to ensure that the project scope, cost, and time function are fully integrated (p. 1098).

  According to Frank M. Gryna (2001):

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  Quality (Pharmaceutical Engineering Series)

  • Kathleen E. McCormick, Kate McCormick(Authors)
  • 2002(Publication Date)
  • Butterworth-Heinemann

    (Publisher)

  This structure must have the backing of the most senior management of the company to be sure that it will succeed. (This topic is covered in more detail in Chapter 6.) 2.3.2 Systematic actions Once the infrastructure is in place, it needs to be seen to be carrying out a set of systematic actions, which bring the quality policy to life. It is these actions that make up the function of QA. 2.4 Definition of Quality Assurance In the EU guidelines, QA is defined as ‘a wide-ranging concept which covers all matters which individually or collectively influence the quality of a product’. Inside an organization, Quality Assurance provides a management tool. In contractual situations, Quality Assurance provides confidence for the customer (whether that is a pharmacist, doctor or patient) in the quality of the drug being supplied. An important part of the systematic actions is the availability of a complete system of standard operating procedures. They describe all the actions that need to be taken in a standardized way. This means that everyone involved in pharmaceutical manufacturing has a book of procedures, which guides them in the way that they should do their job. It thus provides a standardized way of working. Hence, although there is a specific department within the company called QA, the achievement of Quality Assurance is not the duty of this single organizational unit alone, but is the responsibility of all staff members who can influence product quality in any way. One specific aspect of QA is encompassed in the term itself. It is the process that gives assurance that quality will be achieved. It is about putting things in place in advance so that everything goes according to plan and there are no problems with the quality of the final product.

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  Providing Quality to Customers

  • Institute of Leadership & Management(Author)
  • 2013(Publication Date)
  • Routledge

    (Publisher)

  The quality systems of an organization will determine how successful it is in achieving the required product and service quality. In the next session, we discuss total quality management. For the moment, let us focus on quality control and Quality Assurance, which, until fairly recently at least, have been the terms used for ‘the work that the quality department does’. These are the systems that are set up mainly to ensure conformance to specification.

  4.1   Quality control

  Quality control (QC) is concerned with the operational techniques and activities that are used to fulfil requirements for quality.

  Typically, quality control specialists will be involved in:

      inspection and testing of materials, parts, assemblies and final products, to see whether they conform to defined standards and specifications;

      using charts and basic statistics to check results and feed back data;

      maintaining and validating test equipment;

      sampling services to see whether they meet desired quality levels.

  4.2   Quality Assurance

  Quality control is part of Quality Assurance (QA).

  Quality Assurance is defined in ISO 9000:2000 as:

  ‘part of quality management focused on providing confidence that quality requirements will be fulfilled’.

  Quality Assurance is intended to implement and manage a quality system. It may be involved in:

      producing and maintaining a quality manual, which defines the organization’s quality system;

      ensuring conformance to the quality system;

      supplier approval;

      analysing statistical quality data;

      (perhaps) analysing quality costs;

     quality planning.

  It has long been realized that simply checking the quality of products is not enough. The Quality Assurance system must take control of all stages of product manufacture, because:

  effective quality must be based on prevention, not detection.

  However, the idea of QA as a separate function within an organization is also now recognized as being outdated. Quality Assurance must exist, but the whole organization must be involved in promoting and improving quality. This philosophy is embodied in a system called total quality management (TQM)

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  Total Quality Management for Engineers

  • M Zairi(Author)
  • 1991(Publication Date)
  • Woodhead Publishing

    (Publisher)

  The purpose and goal of a quality managementsystem are to ensure and oltain the desired and specified quality of products and services.” ’Quality assumnce is a struciured approach to business managementand control, which embraces the ability to consistently provide productsand services to specification, programmeand cost? 59 Total Qualii Management for engineen f Products and Services ttd Quality strategy Quality systems W improvemenk 4.3 Quality systems in a dynamic context. WHY ARE Quality Assurance SYSTEMS NEEDED? Figure 4.3 illustrates the point on the relevance of Quality Assurance systems accurately. A vehicle without an engine is useless since the controls for the destination cannot function without it and the wheels are unable to turn. Similarly, a quality policy is meaningless if it is not accompanied by a quality system which in turns needs to rely on continuous improvement for the realisation of set objectives. This is perhaps the major justification for having quality systems. There are however a host of other reasons including the following: If Zero Defects, Zero Risk, Zero Breakdown and Zero Defections are the goal, then quality systems are the means by which compliance to customer requirements and the achievement of customer satisfaction can be obtained by linking the internal part of the chain to the external part; Modern competitiveness relies more and more on a TQM driving force to achieve a mix that the customer desires. It is therefore by NECESSITY that quality systems are implemented; Quality management is its CONTROL. To control quality companywide, there has to be an implemented quality system; Quality systems are necessary for auditing and measurement purposes; More and more customers are demanding that their suppliers have quality systems implemented.

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  Educational Administration

  • Judith Chapman, Colin Evers(Authors)
  • 2020(Publication Date)
  • Routledge

    (Publisher)

  17 Quality Assurance and Quality Management in Education Systems Peter Cuttance

  The literature on quality over the past forty years can be viewed as having developed three key areas relating to different aspects of assuring and managing quality. The first area describes approaches to quality control. Quality control refers to a system for comparing output with defined standards. The second area describes approaches to Quality Assurance. Quality Assurance can be viewed as addressing the same objectives as quality control but doing so in a preventative rather than after-the-fact way. It goes beyond the comparison of output with defined standards, seeking to prevent defects from arising in the first place. Thus, it extends the focus from outcomes or outputs to the processes that produced them. The third area directly addresses strategies for ensuring that not only are preventative practices established but also that the whole of general management practice is orientated towards the management of quality. This is manifest in the literature by reference to such approaches as ‘total quality management’.

  Quality control

  Quality control refers to a system for comparing output with defined standards:

  . . . the activities and techniques employed to achieve and maintain the quality of a product or service. It involves a monitoring activity, but also concerns finding and eliminating causes of quality problems so that the requirements of the client are continually met. (Oakland 1989: 10)

  In education systems, large-scale student testing can be viewed as one manifestation of quality control. The purpose of such testing is to certify some students as meeting a predefined quality standard, often defined by norms, and to ‘reject’ other students as having not met those standards. This non-certification of some students leaving the education system is evidence that not all outcomes of the system meet the predefined quality standard. Another example is students being held back to repeat a grade.

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  Quality Improvement Techniques in Construction

  Principles and Methods

  • Steven Mccabe(Author)
  • 2014(Publication Date)
  • Routledge

    (Publisher)

  CHAPTER 5 THE USE OF Quality Assurance

  OBJECTIVES

  ■ Describe what QA really means.

  ■ Appreciate that ISO 9000 is the international standard for quality management.

  ■ Explain the requirements of ISO 9000.

  ■ Give a practical example of each clause in ISO 9000.

   

  5.1 CONTEXT

  Much has been written in recent years about the introduction of QA using quality systems such as ISO 9000 (formerly BS 5750). The result has been debate, usually conducted on the basis of either defence or condemnation of QA.

  This chapter describes what QA is intended to do, and what it can do, if implemented and managed in a way that seeks to support the efforts of those who use it. However, using QA as a ‘weapon’ to ensure that employees ‘do what they are told’ is likely to result in it being resented. It will also require someone to ‘police’ the system.

  5.2 WHAT IS ISO 9000?

  Chapter 2 dealt with definitions of quality management. It assumed that all organisations aim to provide their customers with the ‘best’. In practice this does not always happen. There may be good reasons, and customers are normally free to choose whether or not they accept them. If there are no good reasons and if alternative suppliers exist, then it will not be surprising if customers look elsewhere.

  Any organisation will therefore be well advised to do all it can to ensure it satisfies its customers. Quality Assurance is something that can assist in achieving this. BS EN ISO 8402 Quality management and Quality Assurance — vocabulary defines it as ‘all the planned and systematic activities implemented within the quality system, and demonstrated as needed, to provide confidence that an entity will fulfil requirements for quality’ (1995:25).

  The choice of activities is entirely up to the organisation. If the organisation is small, or its processes extremely simple, its QA may be on accepted practice, i.e. do what has always been done. Usually by word of mouth, this was the way that skilled workers traditionally learned their trade.

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  The Quality Improvement Field Guide

  Achieving and Maintaining Value in Your Organization

  • Matthew A. Barsalou(Author)
  • 2017(Publication Date)
  • Productivity Press

    (Publisher)

  11 Chapter 2 Quality Management Quality management (QM) is the “coordinated activities to direct and control an organization with regard to quality” (ISO 9000:2005 2005). A functioning quality management system is companywide and process oriented. There are international standards available to provide guidance on implementing a quality management system. Quality management is sometimes referred to as total quality management. Quality management includes documents that define the operations of processes that can have an effect on product qual-ity. An important element of quality management is continuous improvement. This is partially important in the modern, competitive environment where industry leaders can be pushed aside by innovative new companies. The quality management function directs and coordinates the quality actions within an organization. Quality management controls the Quality Assurance and quality control functions to achieve product or service quality. Quality management is supported by Quality Assurance and quality control as illustrated by the Venn diagram in Figure 2.1. Quality Assurance (QA) is the “part of quality management focused on providing confidence that quality requirements will be fulfilled” (ISO 9000:2005 2005). Quality Assurance uses methods such as process audits. Other methods include the use of failure modes and effects analysis (FMEA), control plans, and measurement system analysis (MSA). Quality Assurance is used to provide confidence that quality related requirements are being met. Quality control (QC) is the “part of quality management focused on ful-filling quality requirements” (ISO 9000:2000 2000). Controlling for quality includes inspecting the product, whether during production in an in-process 12 ◾ The Quality Improvement Field Guide inspection or as a final inspection as well as the use of statistical process control (SPC), performance testing, and product audits.

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  Toward Quality Assurance and Excellence in Higher Education

  • Ahmed Odeh Al Jaber, Haifaa Omar Elayyan(Authors)
  • 2018(Publication Date)
  • River Publishers

    (Publisher)

  Getting recognized and accredited by higher education is a challenge for most of the universities. And this challenge can be resolved by understanding the concept which is by itself deceive. Theoretically, it refers to an accepted level of quality of everything the university does, or will do, as per the local, regional, and international benchmarks and standards. This indeed covers all programs 129 130 Quality Assurance for Universities from the Foundation Program to all study programs at all levels in addition to the other operations that make the college or university keep going. And practically, Quality Assurance is a stimulating field. It is a science in addition to being a field work not based on ink and paper but based on what is actually being done and employed in the university. It necessitates highly qualified and authentic people with academic specialization in Quality Assurance as field involvement. It is very disappointing to witness that a university assigns the Quality Assurance’s tasks and procedures to people who have no idea of how to plan for a university quality system. Quality absence inside the university leads for loosing accreditation opportunities and reputation later on. The expression of “Quality Assurance” is a generic term in higher educa-tion which lends itself to many interpretations; it is not possible to use one definition to compromise all conditions. But what we want here is how to adapt the quality transformation in the whole educational system and outline a university fitting framework of quality as excellence practice at each level sustaining the quality orientation in higher education system. Bogue and Saunders (1992, p. 20) perceived Quality Assurance process in universities as primarily based on coordinating the mission and achieving the goal within a framework of publicly accepted responsibility and integrity.

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  Software Design

  A Comprehensive Guide to Software Development Projects

  • Murali Chemuturi(Author)
  • 2018(Publication Date)
  • Chapman and Hall/CRC

    (Publisher)

  Quality of conformance : This refers to the seriousness with which we carry out quality-control activities during all the phases of product development/manufacture/construction. The infrastructure built for Quality Assurance in the organization, the support given by organizational management to QA activities, the diligence with which we carry out QA activities, what we do with the data generated during the QC activities, and the seriousness with which we carry out process improvement to ensure defect prevention form the basis for this activity. This is not an activity that is concurrent to the product development/manufacture/construction activities. This is a specialist activity that carries out Quality Assurance activities.

  While designers alone do not carry the onus of the quality of a product on their capable shoulders, the bulk of responsibility lies there. Therefore, it is imperative that QA activities be carried out diligently by the designers. If there are defects in design, they will percolate downward and get magnified in the downstream phases. While manufacturing defects get a bad name for the organization, design defects get the organization closed.

  Now, let us look at the techniques of QA and then see how to apply them to our design work.   Techniques of Quality Assurance

  Quality Assurance, or QA, is not just software testing, as understood by many in the software development industry. Quality Assurance has two dimensions. The first is to prevent defects, and the second is to trap defects before they are delivered to the customer. The second dimension is familiar to most and is often misunderstood to be Quality Assurance itself. The defect-prevention portion of Quality Assurance is achieved by implementing standards, guidelines, checklists, formats, and processes for carrying out work without defects in the organization. The second part of trapping defects and preventing them from being delivered to the customer is referred to as quality control, or QC. QC is achieved by using techniques such as inspection, verification, reviews, testing, and audits. While quality control is used at the execution level, the defect prevention portion of QA is achieved at the organizational level. Let us discuss these two parts here.

  Quality control activities are carried out while the work is being carried out in the organization. As soon as an activity is completed, the deliverables of that activity would be subjected to its applicable QC activity. Quality control is achieved by the following techniques:

  1. Inspections 2. Reviews 3. Audits 4. Validation Inspections

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  Drug Products for Clinical Trials

  • Donald Monkhouse, Charles F. Carney, Jim Clark, Peter Brun, Donald Monkhouse, Charles F. Carney, Jim Clark, Peter Brun(Authors)
  • 2005(Publication Date)
  • CRC Press

    (Publisher)

  Quality Assurance Systems for Global Companies 123 All customers cannot be satisfied in the identical way. Boundaries must be established in order to design each activity uniquely to achieve the desired result. Strategic planning for quality improvement, needs of a methodology that helps one to perceive, identify, and define which aspect of our operation should be improved, and then to develop and implement the specified improvements. Figure 3 summarizes the main aspects of Strategic Planning/ Quality. This concept is in accordance with the 14 processes that define a management system, which have been developed by Marvin Bower. Bower was for several decades the managing director of Mc Kinsey and Company. The processes are (i) setting objectives, (ii) planning strategy, (iii) establish-ing goals, (iv) developing a company philosophy, (v) establishing policies, Figure 3 Strategic planning and strategic quality concept. 124 Ferna´ndez and Lehmann (vi) planning the organization structure, (vii) providing personnel, (viii) establishing procedures, (ix) providing facilities, (x) providing capital, (xi) setting standards, (xii) establishing management programs and operational plans, (xiii) providing control information, and (xiv) activating people (1,19). Thinking the Quality Management System within the framework of Strategic planning principles assures a complete alignment to business goals, and an only one consistent message, which is a driver of a successful operation of any system. With respect to production and process controls, the regulations recognize the evolutionary character of the development process and emphasize the need for a Change Control system. Such a system will docu-ment the process improvements along the development pathway based on good scientific practices with the aim to support the final product registra-tion dossier. This understanding of the evolution of improvements is required for the total life of commercial products.

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  Implementing Quality in Laboratory Policies and Processes

  Using Templates, Project Management, and Six Sigma

  • Donnell R. Christian Jr., Stephanie Drilling(Authors)
  • 2009(Publication Date)
  • CRC Press

    (Publisher)

  The available technology may differ from laboratory to laboratory, but the underlying scientific principles remain constant. As with scientific principles, the basic principles of QA are applicable universally. They apply equally to forensic laboratories, water laboratories, and in-house quality control lab-oratories. These concepts are so universal, that the International Standards Organization (ISO) has established a standard that outlines the QA requirements for calibration and testing laboratories (17025). What Is Quality Assurance? We may have put the cart before the horse. We talked about how a universal principle equally applies to all laboratories. However, we neglected to define what this universal principle of QA is. Simply stated, Quality Assurance is: a documented system of protocols to assure the accuracy and reliability of analytical results. The definition of QA is simple and is divided into two parts: documenting protocols, and ensuring accuracy and reliability. To this end, there is a four-prong test used to evaluate the protocols of a QA program. These criteria are the following: Is there an official policy or procedure that addresses the issue or analytical • scheme? Is the protocol documented? • 14 Implementing Quality in Laboratory Policies and Processes Is the protocol followed? • Does the protocol meet the needs of the laboratory or its customers? • All four of these questions must be incorporated into the development and implemen-tation of a QA program. Having a policy or a procedure is one thing. Documenting the policy is another. Making sure everyone follows the policy as written is something else. Monitoring the relevance of a policy or analytical technique and how it affects the labora-tory’s end product is a different component. Documentation There is a legal adage that is applicable in the QA realm.

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  Quality Assurance in Higher Education: A Study of Developing Countries

  A Study of Developing Countries

  • David Lim(Author)
  • 2018(Publication Date)
  • Routledge

    (Publisher)

  2    Principles of Quality Assurance in Higher Education 2.1  Meaning of Quality in Higher Education

  The term ‘Quality Assurance’ refers to all the policies and processes directed to ensuring the maintenance and enhancement of quality. The concept of quality and the concern for assuring and enhancing it was developed in the business sector in the West, where commercial success depends on it. The need to maximise profit in a competitive environment requires that costs are reduced and sales increased. An important way to increase sales is to have a product or service that is in demand and of high quality at an affordable price.

  Over the same period, and in sharp contrast, quality was not of concern to the higher education sector. For a long time, higher education was seen as an essential public good for which abundant government funding was required and guaranteed. Universities were seen as symbols of social and economic responsibility, being established by acts of parliament to be guarantors of their own worth and credibility. They were also established by the elite classes for themselves, with little need to account for their action.

  However, things started to change in western societies in the late 1980s. Education, including higher education, no longer remained the preserve of the rich, and more students from more diverse backgrounds entered university. At the same time, funding for higher education became harder to obtain as public funds became scarcer, partly as the result of the ideological move to smaller government and the user-pays principle, and partly as the result of the greater demand for funds from other government departments.

  These developments led to more being asked of universities by students and funding authorities alike. Students asked universities to prove their worth by becoming more vocal in their demand for relevant and quality programs, and ultimately by voting with their feet. Funding authorities did it by requiring universities to justify the large public expenditure on them. Today, many years after it was accepted in the commercial world, there is general agreement on the need for accountability and value for money in the higher education sector and for establishing policies and processes to ensure the maintenance and enhancement of quality.

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