Safety, reliability, and quality assurance

Intervention in any activity to avoid an unnecessary safety risk Recommend a Safety, Reliability, and Quality Assurance plan for each project Chair Engineering Risk Review Panels at each Space Operations Center... 

Following the successful completion of the orbital flight test phase of the Shuttle program, the system was declared to be operational. Subsequently, several safety, reliabihty, and quality assurance organizations found themselves with reduced and/or reorganized functional capabilities.. . . The apparent reason for such actions was a perception that less safety, reliability, and quality assurance activity would be required during routine Shuttle operations. This reasoning was faulty. 

When operating at elevated levels of risk, the only question is which of many potential events will trigger the loss. Before the Columbia accident, NASA manned space operations was experiencing a slew of problems in the orbiters. Ihe head of the NASA Manned Space Program at the time misinterpreted the fact that they were finding and fixing problems and wrote a report that concluded risk had been reduced by more than a factor of five [74]. The same unrealistic perception of risk led to another report in 1995 recommending that NASA restructure and reduce overall safety, reliability, and quality assurance elements [105]. 

The safety, reliability, and quality assurance (SR QA) efforts with NASA are complex and organized in such a way that extracting a pure system safety program from the overall SR QA effort is difficult. 

National Aeronautics and Space Administration, (undated). Safety, Reliability, and Quality Assurance Phase I 11 Training Manual. Houston Office of SR QA, Johnson Space Center. 

Reductions in the safety, reliability and quality assurance work force at Marshall and NASA Headquarters have seriously limited capability in those vital functions. 

Safety and Mission Assurance (SSMA), 47, 51, 92, 274, 344, 345 Safety, Reliability and Quality Assurance (SRaQA), Office of, 46, 47, 48, 275-6 see also Safety and Mission Assurance safety-reporting channels, 327-8 Safety Reporting System, 327 safety working groups, 277 schedule pressures... 

Cuts in the safety, reliability, and quality assurance staffs were justified because the shuttle was now operational and no longer an experimental vehicle. Human flight into space was considered routine. 

The Internal NASA Safety System consisted of the Safety, Reliability and Quality Assurance Program (SR QA), and the Space Shuttle Crew Safety Panel (SSCSP). An external panel was added by Congress the Aerospace Safety Advisory Panel (ASAP) ... 

Some hospital administrators have learned that with the in-house availability of such talent and expertise, the hospital is in a far better position to make more effective use of its technological resources (Bronzino, 1992). By providing health professionals with needed assurance of safety, reliability, and efficiency in using new and innovative equipment, clinical engineers can readily identify poor-quality and ineffective equipment, thereby resulting in faster, more appropriate utilization of new medical equipment. Typical pursuits of clinical engineers, therefore, include ... 

Safety community That group of individuals who provide staff support to the line organization in support of the safety effort. It includes occupational and industrial safety, system safety, industrial hygiene, health, occupational medicine, environmental safety, fire protection, reliability, maintainability, and quality assurance personnel. 

The safety organizational structures and protocol vary widely with the NASA community. At headquarters level, the System Safety Branch is part of the Safety Division. The Safety Division manager reports to the Associate Administrator for Safety, Reliability, Maintainability, and Quality Assurance. 

When a computerized I C system is part of a backfit or an upgrade, its function in ensuring the safety of the nuclear power plant should be considered. The safety classification of the I C system should be established according to the criteria given in Section 2. Requirements for system reliability, qualification and quality assurance and other requirements will be defined in accordance with the safety classification. 

The final element which regulations address is quality. Safety and fitness for purpose, as discussed above, are two of the characteristics that you would associate with a quality product. However, these characteristics alone would not describe a quality product. For any product or service to be considered quality you would also expect it to be reliable and consistent. Additionally in the context of medical products, quality means a requirement to demonstrate conformance to agreed specifications or applicable standards for content, purity and stability. Many organisations, from manufacturers to service providers, voluntarily apply quality assurance systems in order to more effectively meet their customers needs on a consistent basis. However,... 

Different groups of customers may introduce different requirements due to different levels of awareness of quality assurance and laboratoiy reliability issues. Competent authorities with a responsibility for the implementation of the legislation e.g. health, safety, envirorunental issues, organizations involved in procurements, the industry and individuals may have different requirements. 

The safety of the medication system is the primary concern of every hospital pharmacist. Recently published reports of the incidence, causes, and cost of injury resulting from medication errors have led many hospitals to critically evaluate their quality assurance systems (Bates et al., 1996, 1997 Classen et al., 1997 Kohn, Corrigan, and Donaldson, 1999 Leape et al., 1991, 1995 Poon et al., 2006 Stelfox, et al., 2006). Written incident reports were once the standard for gathering information about medication misadventures. This method is now believed to lack sufficient completeness and reliability for identifying weaknesses in a medication system (Classen et al., 1991 Cullen et al., 1995 Leape, 1994, 2002 Leape et al., 1995). 

Controls. Process consistency is a function of equipment and process repeatability. Design and manufacturing quality is also very important. All systems should be supplied with a control strategy that allows automatic cycling. Automatic operation improves consistency, safety and reliability, and reduces the labor content, assuring efficient and cost effective operation. 

Instead of an isolated and formal checklist activity, validation of analytical procedures should be regarded as part of an integrated quality assurance concept to guarantee the accuracy and reliability of the analytical results and therefore quality, safety, and efficacy of pharmaceuticals. 

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