Related Research Articles
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 examining the artifacts and the behavior of the software under test by validation and verification. Software testing can also provide an objective, independent view of the software to allow the business to appreciate and understand the risks of software implementation. Test techniques include, but not necessarily limited to:
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?"
On commercial products, the letters CE mean that the manufacturer or importer affirms the good's conformity with European health, safety, and environmental protection standards. It is not a quality indicator or a certification mark. The CE marking is required for goods sold in the European Economic Area (EEA), but is also found on products sold elsewhere that have been manufactured to EEA standards.
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.
An electronic lab notebook is a computer program designed to replace paper laboratory notebooks. Lab notebooks in general are used by scientists, engineers, and technicians to document research, experiments, and procedures performed in a laboratory. A lab notebook is often maintained to be a legal document and may be used in a court of law as evidence. Similar to an inventor's notebook, the lab notebook is also often referred to in patent prosecution and intellectual property litigation.
An Engineering Verification Test (EVT) is performed on first engineering prototypes, to ensure that the basic unit performs to design goals and specifications. Verification ensures that designs meets requirements and specification while Validation ensures that created entity meets the user needs and objectives. Thus, verification means you are doing it right, while validation means you are doing the right things.
Validation is 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:
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
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is an International Organization for Standardization (ISO) standard published for the first time in 1996; it represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. This standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
In software development, the V-model represents a development process that may be considered an extension of the waterfall model, and is an example of the more general V-model. Instead of moving down in a linear way, the process steps are bent upwards after the coding phase, to form the typical V shape. The V-Model demonstrates the relationships between each phase of the development life cycle and its associated phase of testing. The horizontal and vertical axes represent time or project completeness (left-to-right) and level of abstraction, respectively.
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".
A specification often refers to a set of documented requirements to be satisfied by a material, design, product, or service. A specification is often a type of technical standard.
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 and design history file and a formal method of providing a reported measurement for each manufactured feature of a part or assembly. Typically the supplier performs the FAI and the purchaser reviews or approves the report. Another method is for both the supplier and purchaser perform the First Article on the ordered product. The evaluation report consists of assuring all the properties and features are compliant to its specifications, for example a drawing. Despite the name, the inspected article may not necessarily be the 'first' produced, but an item or random sample of parts from the first lot. First article inspection is typically called for in a purchase order contract between the producer and buyer of a manufactured article.
In the software development process, a reference implementation is a program that implements all requirements from a corresponding specification. The reference implementation often accompanies a technical standard, and demonstrates what should be considered the "correct" behavior of any other implementation of it.
Single-use medical device reprocessing is the disinfection, cleaning, remanufacturing, testing, packaging and labeling, and sterilization among other steps, of a used,, medical device to be put in service again. All reprocessed medical devices originally labeled for single use in the United States are subject to U.S. Food and Drug Administration (FDA) manufacturing requirements and must meet strict cleaning, functionality, and sterility specifications prior to use. Although first regulated in the U.S., the reprocessing of medical devices, particularly those that are labeled “Single Use Device” (SUDs), is a global practice with countries in Europe, Asia, Africa, and North America actively engaged in reprocessing. Currently, approximately 2% of all SUDs on the U.S. market are eligible for reprocessing by a qualified commercial vendor. Reprocessing industry estimates indicate the amount of revenue saved by hospitals that use reprocessed devices to be $471 million in 2018. Over 8,800 hospitals and surgical centers use reprocessed devices, in the U.S., Canada, Israel, Europe and Japan, according to the Association of Medical Device Reprocessors.
A Device Master Record (DMR) is a compilation of all the instructions, drawings and other records that must be used to produce a product. The term is used in Quality Management Systems that cover product design and production.
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
- 1 2 Harnack, Gordon (1999). Mastering and Managing the FDA Maze: Medical Device Overview. American Society for Quality. ISBN 9780873894555 . Retrieved January 13, 2017.[ page needed ]
- ↑ FDA Staff (October 7, 1966). "Part 820—Quality System Regulation, Subpart C—Design Controls, § 820.30 Design Controls". Federal Register. 61 (195): 52657. ISBN 9781932074109 . Retrieved January 13, 2017. Also available in hardcopy, as FDAnews (2003). Device Inspections Guide (Document compendium). Washington, DC: Washington Business Information. p. 52657. ISBN 1932074104.