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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. 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 are 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.
Software testing is the act of checking whether software satisfies expectations.
Hazard analysis and critical control points, or HACCP, is a systematic preventive approach to food safety from biological, chemical, and physical hazards in production processes that can cause the finished product to be unsafe and designs measures to reduce these risks to a safe level. In this manner, HACCP attempts to avoid hazards rather than attempting to inspect finished products for the effects of those hazards. The HACCP system can be used at all stages of a food chain, from food production and preparation processes including packaging, distribution, etc. The Food and Drug Administration (FDA) and the United States Department of Agriculture (USDA) require mandatory HACCP programs for juice and meat as an effective approach to food safety and protecting public health. Meat HACCP systems are regulated by the USDA, while seafood and juice are regulated by the FDA. All other food companies in the United States that are required to register with the FDA under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, as well as firms outside the US that export food to the US, are transitioning to mandatory hazard analysis and risk-based preventive controls (HARPC) plans.
In science and engineering, root cause analysis (RCA) is a method of problem solving used for identifying the root causes of faults or problems. It is widely used in IT operations, manufacturing, telecommunications, industrial process control, accident analysis (e.g., in aviation, rail transport, or nuclear plants), medical diagnosis, the healthcare industry (e.g., for epidemiology), etc. Root cause analysis is a form of inductive inference (first create a theory, or root, based on empirical evidence, or causes) and deductive inference (test the theory, i.e., the underlying causal mechanisms, with empirical data).
Engineering tolerance is the permissible limit or limits of variation in:
- a physical dimension;
- a measured value or physical property of a material, manufactured object, system, or service;
- other measured values ;
- in engineering and safety, a physical distance or space (tolerance), as in a truck (lorry), train or boat under a bridge as well as a train in a tunnel ;
- in mechanical engineering, the space between a bolt and a nut or a hole, etc.
In software project management, software testing, and software engineering, verification and validation is the process of checking that a software engineer system meets specifications and requirements so that it fulfills its intended purpose. It may also be referred to as software quality control. It is normally the responsibility of software testers as part of the software development lifecycle. In simple terms, software verification is: "Assuming we should build X, does our software achieve its goals without any bugs or gaps?" On the other hand, software validation is: "Was X what we should have built? Does X meet the high-level requirements?"
Failure mode and effects analysis is the process of reviewing as many components, assemblies, and subsystems as possible to identify potential failure modes in a system and their causes and effects. For each component, the failure modes and their resulting effects on the rest of the system are recorded in a specific FMEA worksheet. There are numerous variations of such worksheets. An FMEA can be a qualitative analysis, but may be put on a quantitative basis when mathematical failure rate models are combined with a statistical failure mode ratio database. It was one of the first highly structured, systematic techniques for failure analysis. It was developed by reliability engineers in the late 1950s to study problems that might arise from malfunctions of military systems. An FMEA is often the first step of a system reliability study.
A medical device is any device intended to be used for medical purposes. Significant potential for hazards are inherent when using a device for medical purposes and thus medical devices must be proved safe and effective with reasonable assurance before regulating governments allow marketing of the device in their country. As a general rule, as the associated risk of the device increases the amount of testing required to establish safety and efficacy also increases. Further, as associated risk increases the potential benefit to the patient must also increase.
Reliability engineering is a sub-discipline of systems engineering that emphasizes the ability of equipment to function without failure. Reliability is defined as the probability that a product, system, or service will perform its intended function adequately for a specified period of time, OR will operate in a defined environment without failure. Reliability is closely related to availability, which is typically described as the ability of a component or system to function at a specified moment or interval of time.
Advanced product quality planning (APQP) is a framework of procedures and techniques used to develop products in industry, particularly in the automotive industry. It differs from Six Sigma in that the goal of Six Sigma is to reduce variation but has similarities to Design for Six Sigma (DFSS).
The process of establishing documentary evidence demonstrating that a procedure, process, or activity carried out in testing and then production maintains the desired level of compliance at all stages. In the pharmaceutical industry, it is very important that in addition to final testing and compliance of products, it is also assured that the process will consistently produce the expected results. The desired results are established in terms of specifications for outcome of the process. Qualification of systems and equipment is therefore a part of the process of validation. Validation is a requirement of food, drug and pharmaceutical regulating agencies such as the US FDA and their good manufacturing practices guidelines. Since a wide variety of procedures, processes, and activities need to be validated, the field of validation is divided into a number of subsections including the following:
A particle counter is used for monitoring and diagnosing particle contamination within specific clean media, including air, water and chemicals. Particle counters are used in a variety of applications in support of clean manufacturing practices, industries include: electronic components and assemblies, pharmaceutical drug products and medical devices, and industrial technologies such as oil and gas.
A design history file is a compilation of documentation that describes the design history of a finished medical device. The design history file, or DHF, is part of regulation introduced in 1990 when the U.S. Congress passed the Safe Medical Devices Act, which established new standards for medical devices that can cause or contribute to the death, serious illness, or injury of a patient. Prior to this legislation, U.S. Food and Drug Administration (FDA) auditors were limited to examining the production and quality control records of the device.
Verification and validation are independent procedures that are used together for checking that a product, service, or system meets requirements and specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000. The words "verification" and "validation" are sometimes preceded with "independent", indicating that the verification and validation is to be performed by a disinterested third party. "Independent verification and validation" can be abbreviated as "IV&V".
Design controls designates the application of a formal methodology to the conduct of product development activities. It is often mandatory to implement such practice when designing and developing products within regulated industries.
Quality by design (QbD) is a concept first outlined by quality expert Joseph M. Juran in publications, most notably Juran on Quality by Design. Designing for quality and innovation is one of the three universal processes of the Juran Trilogy, in which Juran describes what is required to achieve breakthroughs in new products, services, and processes. Juran believed that quality could be planned, and that most quality crises and problems relate to the way in which quality was planned.
ISO 26262, titled "Road vehicles – Functional safety", is an international standard for functional safety of electrical and/or electronic systems that are installed in serial production road vehicles, defined by the International Organization for Standardization (ISO) in 2011, and revised in 2018.
Process validation is the analysis of data gathered throughout the design and manufacturing of a product in order to confirm that the process can reliably output products of a determined standard. Regulatory authorities like EMA and FDA have published guidelines relating to process validation. The purpose of process validation is to ensure varied inputs lead to consistent and high quality outputs. Process validation is an ongoing process that must be frequently adapted as manufacturing feedback is gathered. End-to-end validation of production processes is essential in determining product quality because quality cannot always be determined by finished-product inspection. Process validation can be broken down into 3 steps: process design, process qualification, and continued process verification.
Continued process verification (CPV) is the collection and analysis of end-to-end production components and processes data to ensure product outputs are within predetermined quality limits. In 2011 the Food and Drug Administration published a report outlining best practices regarding business process validation in the pharmaceutical industry. Continued process verification is outlined in this report as the third stage in Process Validation.
Process performance qualification protocol is a component of process validation: process qualification. This step is vital in maintaining ongoing production quality by recording and having available for review essential conditions, controls, testing, and expected manufacturing outcome of a production process. The Food and Drug Administration recommends the following criteria be included in a PPQ protocol:
References
- ↑ "Design Space Verification". Atris Information Systems. Retrieved 17 December 2014.
- ↑ "Questions and Answers on Design Space Verification" (PDF). European Medicines Agency. Retrieved 17 December 2014.
- ↑ "Design Space Considerations" (PDF). FDA. Retrieved 17 December 2014.