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.
The ISO 9000 family is a set of five quality management systems (QMS) standards by the International Organization for Standardization (ISO) that help organizations ensure they meet customer and other stakeholder needs within statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of QMS, including the seven quality management principles that underlie the family of standards. ISO 9001 deals with the requirements that organizations wishing to meet the standard must fulfill. ISO 9002 is a model for quality assurance in production and installation. ISO 9003 for quality assurance in final inspection and test. ISO 9004 gives guidance on achieving sustained organizational success.
In software engineering, software configuration management is the task of tracking and controlling changes in the software, part of the larger cross-disciplinary field of configuration management. SCM practices include revision control and the establishment of baselines. If something goes wrong, SCM can determine the "what, when, why and who" of the change. If a configuration is working well, SCM can determine how to replicate it across many hosts.
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).
A checklist is a type of job aid used in repetitive tasks to reduce failure by compensating for potential limits of human memory and attention. Checklists are used both to ensure that safety-critical system preparations are carried out completely and in the correct order, and in less critical applications to ensure that no step is left out of a procedure. they help to ensure consistency and completeness in carrying out a task. A basic example is the "to do list". A more advanced checklist would be a schedule, which lays out tasks to be done according to time of day or other factors, or a pre-flight checklist for an airliner, which should ensure a safe take-off.
Business process modeling (BPM), mainly used in business process management; software development or systems engineering, is the action of capturing and representing processes of an enterprise, so that the current business processes may be analyzed, applied securely and consistently, improved, and automated. BPM is typically orchestrated by business analysts, leveraging their expertise in modeling practices. Subject matter experts, equipped with specialized knowledge of the processes being modeled, often collaborate within these teams. Alternatively, process models can be directly derived from digital traces within IT systems, such as event logs, utilizing process mining tools.
GxP is a general abbreviation for the "good practice" quality guidelines and regulations. The "x" stands for the various fields, including the pharmaceutical and food industries, for example good agricultural practice, or GAP.
Good clinical practice (GCP) is an international quality standard, which governments can then transpose into regulations for clinical trials involving human subjects. GCP follows the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), and enforces tight guidelines on ethical aspects of clinical research.
IEC 61508 is an international standard published by the International Electrotechnical Commission (IEC) 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.
ISO 22000 is a food safety management system by the International Organization for Standardization (ISO) which is outcome focused, providing requirements for any organization in the food industry with objective to help to improve overall performance in food safety. These standards are intended to ensure safety in the global food supply chain. The standards involve the overall guidelines for food safety management and also focuses on traceability in the feed and food chain.
ISO 13485Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices. The latest version of this standard supersedes earlier documents such as EN 46001 and EN 46002 (1996), the previously published ISO 13485, and ISO 13488.
In natural and social science research, a protocol is most commonly a predefined procedural method in the design and implementation of an experiment. Protocols are written whenever it is desirable to standardize a laboratory method to ensure successful replication of results by others in the same laboratory or by other laboratories. Additionally, and by extension, protocols have the advantage of facilitating the assessment of experimental results through peer review. In addition to detailed procedures, equipment, and instruments, protocols will also contain study objectives, reasoning for experimental design, reasoning for chosen sample sizes, safety precautions, and how results were calculated and reported, including statistical analysis and any rules for predefining and documenting excluded data to avoid bias.
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.
ISO/TC 176 is Technical Committee 176 of the International Organization for Standardization (ISO), responsible for Quality management and quality assurance - the ISO 9000 family of standards.
In order to comply with government regulatory requirements pertinent to clinical trials, every organization involved in clinical trials must maintain and store certain documents, images and content related to the clinical trial. Depending on the regulatory jurisdiction, this information may be stored in the trial master file or TMF, which today takes the form of an electronic trial master file (eTMF). The International Conference on Harmonization (ICH) published a consolidated guidance for industry on Good Clinical Practice in 1996 with the objective of providing a unified standard for the European Union, Japan, and the United States of America to facilitate mutual acceptance of clinical data by the regulatory authorities in those jurisdictions. This guidance document established the requirement across all ICH regions to establish trial master files containing essential documents that individually and collectively permit evaluation of the conduct of a trial and the quality of the data produced.[2] In some jurisdictions, for example the USA, there is no specific requirement for a trial master file. However, if the regulatory authority requires ICH GCP to be followed, then there is consequently a requirement to create and maintain a trial master file.[2]
A procedure is a document that instructs workers on executing one or more activities of a business process. It describes the sequence of steps, and specifies for each step what needs to be done, often including when the procedure should be executed and by whom.
Guidances for statistics in regulatory affairs refers to specific documents or guidelines that provide instructions, recommendations, and standards pertaining to the application of statistical methodologies and practices within the regulatory framework of industries such as pharmaceuticals and medical devices. These guidances serve as a reference for statisticians, researchers, and professionals involved in designing, conducting, analyzing, and reporting studies and trials in compliance with regulatory requirements. These documents embody the prevailing perspectives of regulatory agencies on specific subjects. It is worth noting that in the United States, the term "Guidances" is used, while in Europe, the term "Guidelines" is employed.
Standardisation Testing and Quality Certification (STQC) Directorate, established in 1980, is an authoritative body offering quality assurance services to IT and Electronics domains.
References
- ↑ “Standard operating procedure.” Merriam-Webster.com Dictionary, Merriam-Webster, https://www.merriam-webster.com/dictionary/standard%20operating%20procedure. Accessed 15 Jun. 2023.
- ↑ Nolen, Jeannette L. "standard operating procedure". Encyclopedia Britannica. Retrieved 15 June 2023.
- ↑ In Pursuit of Progress: Narratives of Development on a Philippine Island. University of Hawaii Press. 31 January 2017. ISBN 9780824858902.
- ↑ "Anticorruptiondigest.com". anticorruptiondigest.com.
- ↑ "McMurdo Station Medical Standard Operating Procedures as of 2006/06" (PDF). Archived from the original (PDF) on 2016-03-04.
- ↑ "Guidance on the Documentation Requirements of ISO 9001:2008". Archived from the original on 2011-10-15.
- ↑ Taylor, Geoffrey A. (2012). "Readability of OHS documents - A comparison of surface characteristics of OHS text between some languages". Safety Science . 50 (7): 1627–1635. doi:10.1016/j.ssci.2012.01.016.
