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Verification and validation  

2011-05-15 20:16:07|  分类: 默认分类 |  标签: |举报 |字号 订阅

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Verification and validation is the process of checking that a product, service, or system meets specifications and that it fulfills its intended purpose. These are critical components of a quality management system such as ISO 9000.

Verification is a Quality control process that is used to evaluate whether or not a product, service, or system complies with regulations, specifications, or conditions imposed at the start of a development phase. Verification can be in development, scale-up, or production. This is often an internal process.

Validation is a Quality assurance process of establishing evidence that provides a high degree of assurance that a product, service, or system accomplishes its intended requirements. This often involves acceptance of fitness for purpose with end users and other product stakeholders.

 

It is sometimes said that validation can be expressed by the query "Are you building the right thing?"[1] and verification by "Are you building it right?"[2] "Building the right thing" refers back to the user's needs, while "building it right" checks that the specifications are correctly implemented by the system. In some contexts, it is required to have written requirements for both as well as formal procedures or protocols for determining compliance.

 

Verification of machinery and equipment usually consists of

Design Qualification - DQ [3],

Installation Qualification - IQ [4],

Operational Qualification - OQ [5] and

Performance Qualification - PQ [6].

DQ is usually a vendor's job. However, DQ can also be performed by the user, by confirming through review and testing that the equipment meets the written acquisition specification.

If the relevant document or manuals of machinery/equipment are provided by vendors, the later 3Q needs to be thoroughly performed by the users who work in an industrial regulatory environment.

Otherwise, the process of IQ, OQ and PQ is the task of validation. The typical example of such a case could be the loss or absence of vendor's documentation for legacy equipment or do-it-yourself (DIY) assemblies (i.e., cars, computers etc.) and, therefore, users should endeavour to acquire DQ document beforehand.

Each template of DQ, IQ, OQ and PQ usually can be found on the internet respectively, whereas the DIY qualifications of machinery/equipment can be assisted either by the vendor's training course materials and tutorials, or by the published guidance books, such as step-by-step series if the acquisition of machinery/equipment is not bundled with on- site qualification services.

This kind of the DIY approach is also applicable to the qualifications of software, computer operating systems and a manufacturing process. The most important and critical task as the last step of the activity is to generating and archiving machinery/equipment qualification reports for auditing purposes, if regulatory compliances are mandatory.

 

 

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Quality assurance, or QA for short, is the systematic monitoring and evaluation of the various aspects of a project, service or facility to maximize the probability that minimum standards of quality are being attained by the production process.

QA cannot absolutely guarantee the production of quality products.

Two principles included in

QA are: "Fit for purpose" - the product should be suitable for the intended purpose; and

"Right first time" - mistakes should be eliminated.

QA includes regulation of the quality of raw materials, assemblies, products and components, services related to production, and management, production and inspection processes.

Quality is determined by the product users, clients or customers, not by society in general. It is not the same as 'expensive' or 'high quality'. Low priced products can be considered as having high quality if the product users determine them as such.

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Quality control is a process by which entities review the quality of all factors involved in production. This approach places an emphasis on three aspects:[citation needed]


Elements such as controls, job management, defined and well managed processes,[1][2] performance and integrity criteria, and identification of records
Competence, such as knowledge, skills, experience, and qualifications
Soft elements, such as personnel integrity, confidence, organizational culture, motivation, team spirit, and quality relationships.

The quality of the outputs is at risk if any of these three aspects is deficient in any way.

Quality control emphasizes testing of products to uncover defects, and reporting to management who make the decision to allow or deny the release, whereas quality assurance attempts to improve and stabilize production, and associated processes, to avoid, or at least minimize, issues that led to the defects in the first place.[citation needed] For contract work, particularly work awarded by government agencies, quality control issues are among the top reasons for not renewing a contract.[

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