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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.
Conformance testing — an element of conformity assessment, and also known as compliance testing, or type testing — is testing or other activities that determine whether a process, product, or service complies with the requirements of a specification, technical standard, contract, or regulation. Testing is often either logical testing or physical testing. The test procedures may involve other criteria from mathematical testing or chemical testing. Beyond simple conformance, other requirements for efficiency, interoperability, or compliance may apply. Conformance testing may be undertaken by the producer of the product or service being assessed, by a user, or by an accredited independent organization, which can sometimes be the author of the standard being used. When testing is accompanied by certification, the products or services may then be advertised as being certified in compliance with the referred technical standard. Manufacturers and suppliers of products and services rely on such certification including listing on the certification body's website, to assure quality to the end user and that competing suppliers are on the same level.
LAN eXtensions for Instrumentation (LXI) is a standard developed by the LXI Consortium, a consortium that maintains the LXI specification and promotes the LXI Standard. The LXI standard defines the communication protocols for instrumentation and data acquisition systems using Ethernet. Ethernet is a ubiquitous communication standard providing a versatile interface, the LXI standard describes how to use the Ethernet standards for test and measurement applications in a way that promotes simple interoperability between instruments. The LXI Consortium ensures LXI compliant instrumentation developed by various vendors works together with no communication or setup issues. The LXI Consortium ensures that the LXI standard complements other test and measurement control systems, such as GPIB and PXI systems.
Current good manufacturing practices (cGMP) are those conforming to the guidelines recommended by relevant agencies. Those agencies control the authorization and licensing of the manufacture and sale of food and beverages, cosmetics, pharmaceutical products, dietary supplements, and medical devices. These guidelines provide minimum requirements that a manufacturer must meet to assure that their products are consistently high in quality, from batch to batch, for their intended use. The rules that govern each industry may differ significantly; however, the main purpose of GMP is always to prevent harm from occurring to the end user. Additional tenets include ensuring the end product is free from contamination, that it is consistent in its manufacture, that its manufacture has been well documented, that personnel are well trained, and that the product has been checked for quality more than just at the end phase. GMP is typically ensured through the effective use of a quality management system (QMS).
In software project management, software testing, and software engineering, verification and validation (V&V) is the process of checking that a software 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?"
The V-model is a graphical representation of a systems development lifecycle. It is used to produce rigorous development lifecycle models and project management models. The V-model falls into three broad categories, the German V-Modell, a general testing model, and the US government standard.
Software assurance (SwA) is a critical process in software development that ensures the reliability, safety, and security of software products. It involves a variety of activities, including requirements analysis, design reviews, code inspections, testing, and formal verification. One crucial component of software assurance is secure coding practices, which follow industry-accepted standards and best practices, such as those outlined by the Software Engineering Institute (SEI) in their CERT Secure Coding Standards (SCS).
Similarly, the activity of qualifying systems and equipment is divided into a number of subsections including the following:
Production Part Approval Process (PPAP) is used in the automotive supply chain for establishing confidence in suppliers and their production processes. Actual measurements are taken from the parts produced and are used to complete the various test sheets of PPAP.
"All customer engineering design record and specification requirements are properly understood by the supplier and that the process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rate." Version 4, 1 March 2006
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. "Integration verification and validation" can be abbreviated as "IV&V".
Digital Prototyping gives conceptual design, engineering, manufacturing, and sales and marketing departments the ability to virtually explore a complete product before it's built. Industrial designers, manufacturers, and engineers use Digital Prototyping to design, iterate, optimize, validate, and visualize their products digitally throughout the product development process. Innovative digital prototypes can be created via CAutoD through intelligent and near-optimal iterations, meeting multiple design objectives, identifying multiple figures of merit, and reducing development gearing and time-to-market. Marketers also use Digital Prototyping to create photorealistic renderings and animations of products prior to manufacturing. Companies often adopt Digital Prototyping with the goal of improving communication between product development stakeholders, getting products to market faster, and facilitating product innovation.
The MIL-PRF-38534 specification establishes the general performance requirements for hybrid microcircuits, multi-chip modules (MCM) and, similar devices and the verification and validation requirements for ensuring that these devices meet the applicable performance requirements. Verification is accomplished through the use of one of two quality programs. The main body of this specification describes the performance requirements and the requirements for obtaining a Qualified Manufacturers List (QML) listing. The appendices of this specification are intended for guidance to aid a manufacturer in developing their verification program. Detail requirements, specific characteristics, and other provisions that are sensitive to the particular intended use should be specified in the applicable device acquisition specification.
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.
In the United States military integrated acquisition lifecycle the Technical section has multiple acquisition "Technical Reviews". Technical reviews and audits assist the acquisition and the number and types are tailored to the acquisition. Overall guidance flows from the Defense Acquisition Guidebook chapter 4, with local details further defined by the review organizations. Typical topics examined include adequacy of program/contract metrics, proper staffing, risks, budget, and schedule.
A First Article Inspection (FAI) is a design verification process for verifying that a new or modified production process produces conforming parts that meet the manufacturing specification detailed in technical or engineering drawings. Typically, a supplier performs the FAI and the purchaser reviews the report. The FAI process usually consists of fully testing and inspecting either the first part produced by the new process or a sample from the first batch of parts. First article inspection is typically a purchase order requirement of the purchaser for the supplier to complete. If the manufacturer doesn't have the in-house capability or if the purchaser requests, the first article inspection may be conducted by an approved subcontract supplier such as a dimensional inspection/metrology laboratory.
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.
References
- ↑ "Product news". Practical Failure Analysis. 2 (4): 23–25. 2002-08-01. doi:10.1007/BF02715446. ISSN 1864-1245. S2CID 195269651.
- ↑ Wang, Der-Wai; Hsu, Yen (2022). "A Study of Cross-Cultural Communication in the NPD: Applying Piaget's Theory to Multidisciplinary Communication in the Three Validation Stages". In Rau, Pei-Luen Patrick (ed.). Cross-Cultural Design. Applications in Business, Communication, Health, Well-being, and Inclusiveness. Lecture Notes in Computer Science. Vol. 13313. Cham: Springer International Publishing. pp. 188–201. doi:10.1007/978-3-031-06050-2_14. ISBN 978-3-031-06050-2.
- ↑ Dong, Jin Song; Woodcock, Jim (2003-11-06). Formal Methods and Software Engineering: 5th International Conference on Formal Engineering Methods, ICFEM 2003, Singapore, November 5-7, 2003, Proceedings. Springer. ISBN 978-3-540-39893-6.