Quality assurance processing

The SST was empowered by plant management and had members from every discipline involved in the shipping and handling of monomers at the plant shipping, pumping, production, quality assurance, process chemistry, chemical engineering, and safety/risk analysis. Consequently, it was not difficult to obtain cooperation when requests were made of various entities. 

Government agencies such as the U.S. Environmental Protection Agency set requirements for quality assurance for their own labs and for certification of other labs. Published standard methods specify precision, accuracy, numbers of blanks, replicates, and calibration checks. To monitor drinking water, regulations state how often and how many samples are to be taken. Documentation is necessary to demonstrate that all requirements have been met. Table 5-1 summarizes the quality assurance process. 

This FDA Orphan-Drug Review checklist has been designed in consultation with FDA reviewers, industry consultants, and regulatory professionals to serve as a summary tool indicating the evaluative criteria used by the Office of Orphan-Drug Development to critique and assess applications received. It can be used internally as a part of the Quality Assurance process, as a guideline for regulatory development of an application, and/or as a self-assessment tool to predict likely FDA response to an application. 

PAT is an automated quality-assurance process originally developed in the petrochemical industries. It is defined by three general principles continuous, cybernetic, and potentially remote monitoring of processes. 

But that sense of control can be regained and the result made rational and predictable through a careful Quality Assurance process that checks the submission against FDA established criteria and through the use of an internal, self-regulating review process that applies the checklist criteria used by the FDA to the submission development process. 

Quality assurance processes that will be implemented to ensure that all data management procedures are compliant with regulatory governance. 

All forms, reports, lists etc referred to during the quality assurance process. 

Although the GLP and quality assurance processes and principles are critical for the maintenance of a toxicology study system that is valid and credible, it is unusual for findings in the unaudited draft toxicologic report of the completed studies to change during the production of the final, quality-assured individual study reports in ways important to determining whether use in humans is safe. 

Define quality assurance processes to be built into the audit process. 

Quality assurance process according to ASME/ ANSI B31.8S, section 12. 

Of course, if a firm is ISO 9000 acaedited, this already speaks volumes about its commitment to quality, although the limitations of ISO 9001 to software development need to be clearly understood. These shortcomings have given rise to ISO 9000-3 (TickIT), to which over 1,000 firms have now been accredited however, this is a drop in the ocean when viewed against the industry as a whole. The consistent pattern of commercial success enjoyed by TicklT-accredited software houses is no coincidence and should be used by the auditor as a powerful endorsement of the benefits of a quality-assured process in securing the future prosperity of a firm involved in any way with software development. 

Process Flaw The internal LMA quality assurance processes did not detect the error in the role rate filter constant software file. 

Process engineering Electrical engineering Instrument engineering Maintenance/mechanical engineering Quality assurance Process safety/risk management... 

SAV Quality Assurance (processes comply with plans and standards, conformity review)... 

Because more than one hundred universities worldwide have adopted the CDIO approach, it is becoming important to estabUsh processes that assure internal and external stakeholders that engineering programs are adhering to the CDIO Standards. The standards provide a vehicle for realizing the CDIO vision to transform the culture of engineering education. Five key program evaluation questions can be used to enhance quality assurance processes ... 

After these steps, the power is transferred to storage drums for transfer to pelletization. At each step in the process, careful attention is paid to the physical, chemical, and nuclear properties of the powder. The quality assurance process ensures that the final material will provide for safe operation of the reactor in which the fuel is used. 

Most organisations imdertake a technical audit (or check) of their designs. Sometimes these are formalised through their Quality Assurance process and sometimes they involve less formal procedures. They are used to ensure that the design complies with national or local standards and to minimise mistakes within the design. They may include elements of road safety but do not set out to check the final safety performance of a scheme. The audits may be carried out by a senior member within the design team or by an independent person from another design team. 

Quality Assurance Process by which a video game is tested for software defects and other issues to achieve maximum quality before product launch... 

Section 7 Software configuration management process. Section 8 Software quality assurance process. Section 9 Certification liaison process. Section 10 Overview of aircraft and engine certification and Section 11 Software life cycle data... 

On-line sources of data from routinely updated databases are excellent in the sense that one always has the most up-to-data information - much more reassuring than the book and CD-ROMS we have been used to. There is, however, a down-side to that. Quality-assurance processes may require the data source for a particular measurement to be specified within the written method. How would the QA manager feel about taking data from a continuously changing source that does not have an audit trail We have a duty to use the most reliable source of data, but we could end up in a situation where, at the... 

Functional test is a quality assurance process based on black-box approach that aims to provide a proof of implementation correctness regarding to the specifications of the software under test. The test is performed feeding the software under test with well-known values and examining the output produced. 

Quality Assurance Process followed during the Production of the Generic Pre-... 

Quality Control and Quality Assurance Process This PP element is likely to be needed if your organization does not provide a quality control/quality assurance (QC/QA) procedure. QC/QA is discussed in Chapter 7. 

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