Production assurance is a way to ensure a productive capacity meets its intended end-results such as customer requirements, [1] planned production levels, [2] safety, reliability, risk and direct economic cost. The term is used in industries as far reaching as livestock production, [3] oil and gas [4] and information technology. Production assurance is broadly related to productivity and quality management since organizational and human factors must be considered, as well as technical aspects. [5] ISO 20815:2008 introduces production assurance as a concept composed of twelve processes where "seven are defined as core production-assurance processes".
Productive capacity is the maximum possible output of an economy. According to the United Nations Conference on Trade and Development (UNCTAD), no agreed-upon definition of maximum output exists. UNCTAD itself proposes: "the productive resources, entrepreneurial capabilities and production linkages which together determine the capacity of a country to produce goods and services." The term may also be applied to individual resources or assets; for instance the productive capacity of an area of farmland.
Information technology (IT) is the use of computers to store, retrieve, transmit, and manipulate data, or information, often in the context of a business or other enterprise. IT is considered to be a subset of information and communications technology (ICT). An information technology system is generally an information system, a communications system or, more specifically speaking, a computer system – including all hardware, software and peripheral equipment – operated by a limited group of users.
Productivity describes various measures of the efficiency of production. A productivity measure is expressed as the ratio of output to inputs used in a production process, i.e. output per unit of input. Productivity is a crucial factor in production performance of firms and nations. Increasing national productivity can raise living standards because more real income improves people's ability to purchase goods and services, enjoy leisure, improve housing and education and contribute to social and environmental programs. Productivity growth can also help businesses to be more profitable. There are many different definitions of productivity and the choice among them depends on the purpose of the productivity measurement and/or data availability.
Production assurance normally exists in the context of an enterprise or between producers and oversight bodies, such as regulators.
A quality management system (QMS) is a collection of business processes focused on consistently meeting customer requirements and enhancing their satisfaction. It is aligned with an organization's purpose and strategic direction (ISO9001:2015). It is expressed as the organizational goals and aspirations, policies, processes, documented information and resources needed to implement and maintain it. Early quality management systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continual improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality is increasingly tied to these factors. Of QMS regimes, the ISO 9000 family of standards is probably the most widely implemented worldwide – the ISO 19011 audit regime applies to both, and deals with quality and sustainability and their integration.
Risk management is the identification, evaluation, and prioritization of risks followed by coordinated and economical application of resources to minimize, monitor, and control the probability or impact of unfortunate events or to maximize the realization of opportunities.
Safety engineering is an engineering discipline which assures that engineered systems provide acceptable levels of safety. It is strongly related to industrial engineering/systems engineering, and the subset system safety engineering. Safety engineering assures that a life-critical system behaves as needed, even when components fail.
The ISO 9000 family of quality management systems (QMS) standards is designed to help organisations ensure that they meet the needs of customers and other stakeholders while meeting statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of quality management systems, including the seven quality management principles upon which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill.
A management system is a set of policies, processes and procedures used by an organization to ensure that it can fulfill the tasks required to achieve its objectives. These objectives cover many aspects of the organization's operations. For instance, an environmental management system enables organizations to improve their environmental performance and an occupational health and safety management system (OHSMS) enables an organization to control its occupational health and safety risks, etc.
Quality assurance (QA) is a way of preventing mistakes and defects in manufactured products and avoiding problems when delivering products or services to customers; which ISO 9000 defines as "part of quality management focused on providing confidence that quality requirements will be fulfilled". This defect prevention in quality assurance differs subtly from defect detection and rejection in quality control, and has been referred to as a shift left as it focuses on quality earlier in the process i.e. to the left of a linear process diagram reading left to right.
Quality Assurance International (QAI) is a U.S.-based international organic certification company that is authorized by the United States Department of Agriculture (USDA) as "a USDA-accredited certifying agent that operates globally to certify organic operations to National Organic Program standards." It is a for-profit corporation, established in 1989, and headquartered in San Diego, California. It is one of the world's largest certifiers, operating in the United States, Canada, Latin America, European Union, and Japan. It is owned by public health and environmental organization NSF International.
Quality management ensures that an organization, product or service is consistent. It has four main components: quality planning, quality assurance, quality control and quality improvement. Quality management is focused not only on product and service quality, but also on the means to achieve it. Quality management, therefore, uses quality assurance and control of processes as well as products to achieve more consistent quality. What a customer wants and is willing to pay for it determines quality. It is written or unwritten commitment to a known or unknown consumer in the market. Thus, quality can be defined as fitness for intended use or, in other words, how well the product performs its intended function
Software quality assurance (SQA) consists of a means of monitoring the software engineering processes and methods used to ensure quality. The methods by which this is accomplished are many and varied, and may include ensuring conformance to one or more standards, such as ISO 9000 or a model such as CMMI. It is a set of methods that try to ensure the quality of all projects in the software process. This includes standards and procedures that administrators may use to review and audit software products and activities to verify that the software meets standards. According to ISO/IEC 15504 v.2.5 (SPICE), it is a supporting process that has to provide the independent assurance in which all the work products, activities and processes comply with the predefined plans and ISO 15504.
IEC 61508 is an international standard published by the International Electrotechnical Commission consisting of methods on how to apply, design, deploy and maintain automatic protection systems called safety-related systems. It is titled Functional Safety of Electrical/Electronic/Programmable Electronic Safety-related Systems.
AS9100 is a widely adopted and standardized quality management system for the aerospace industry. It was released in October, 1999, by the Society of Automotive Engineers and the European Association of Aerospace Industries.
ISO 22000 is a standard developed by the International Organization for Standardization dealing with food safety. It is a general derivative of ISO 9000.
Software quality management (SQM) is a management process that aims to develop and manage the quality of software in such a way so as the best ensure the product meets the quality standards expected by the customer while also meeting any necessary regulatory and developer requirements, if any. Software quality managers require software to be tested before it is released to the market, and they do this using a cyclical process-based quality assessment in order to reveal and fix bugs before release. Their job is not only to ensure their software is in good shape for the consumer but also to encourage a culture of quality throughout the enterprise.
CSA CAN3-Z299 is a series of quality assurance standards developed by the Canadian Standards Association in the 1970s. It is an alternative to the ISO 9000 series of standards. The stated objectives of the Z299 series of standards are:
Clinical quality management systems (CQMS) are systems used in the life sciences sector designed to manage quality management best practices throughout clinical research and clinical study management. A CQMS system is designed to manage all of the documents, activities, tasks, processes, quality events, relationships, audits and training that must be administered and controlled throughout the life of a clinical trial. The premise of a CQMS is to bring together the activities led by two sectors of clinical research, Clinical Quality and Clinical Operations, to facilitate cross-functional activities to improve efficiencies and transparency and to encourage the use of risk mitigation and risk management practices at the clinical study level.
ISO 26262, titled "Road vehicles – Functional safety", is an international standard for functional safety of electrical and/or electronic systems in production automobiles defined by the International Organization for Standardization (ISO) in 2011.
The international standard IEC 62304 – medical device software – software life cycle processes is a standard which specifies life cycle requirements for the development of medical software and software within medical devices. It is harmonized by the European Union (EU) and the United States (US), and therefore can be used as a benchmark to comply with regulatory requirements from both these markets.
DNV GL is an international accredited registrar and classification society headquartered in Høvik, Norway. The company currently has about 14,500 employees and 350 offices operating in more than 100 countries, and provides services for several industries including maritime, renewable energy, oil & gas, electrification, food & beverage and healthcare. It was created in 2013 as a result of a merger between two leading organizations in the field - Det Norske Veritas (Norway) and Germanischer Lloyd (Germany).
The Offshore and Onshore Reliability Data (OREDA) project was established in 1981 in cooperation with the Norwegian Petroleum Directorate. It is "one of the main reliability data sources for the oil and gas industry" and considered "a unique data source on failure rates, failure mode distribution and repair times for equipment used in the offshore industr[y]. OREDA's original objective was the collection of petroleum industry safety equipment reliability data. The current organization, as a cooperating group of several petroleum and natural gas companies, was established in 1983, and at the same time the scope of OREDA was extended to cover reliability data from a wide range of equipment used in oil and gas exploration and production (E&P). OREDA primarily covers offshore, subsea and topside equipment, but does also include some onshore E&P, and some downstream equipment as well.
ISO 20815 is the International Organisation for Standardisation (ISO) standard for production assurance and reliability management in the petroleum, petrochemical and natural gas industries.