Quality assurance specifications

The detection systems first must be calibrated for counting efficiency to permit conversion of the sample count rate to the disintegration rate. These systems are monitored periodically for their stability and performance by measuring the count rates of reliable radionuclide sources and the radiation background. Records are maintained for each instrument to comply with quality assurance specifications. Graphs of count rates recorded at frequent intervals for periods of months or years provide a visual record of detector and background stability and indicate deviations from the norm. 

In a series of test runs, 15 rolls of wrap are made under carefully controlled conditions and the tear resistance of each roll is measured. The results are used as the basis of a quality assurance specification (see Problem 2.19). If X for a subsequently produced roll fails more than two standard deviations away from the test period average, the process is declared out of specification and production is suspended for routine maintenance. 

Quality control/quality assurance Specification of raw materials Stability testing... 

Quality Assurance Specific Impairments and Related Technologies Future Developments References Further Information... 

In its review procedures, NRC has shown particular interest in the criticality, cooling, and seismic analysis in addition to the design and quality assurance specifications and codes. 

Composes written or drawn instructions and quality assurance specifications overall or in detail for individual tasks. 

That set of modules includes alongside the traditional procedures related to product control, quality assurance procedures for conformity assessment. The intervention of a third party in these procedures comprises an initial audit of the manufacturer s quality system which must include both the specific technological aspects of the products concerned and the methodology of the quality assurance procedures. Furthermore the manufacturers are subject to periodic audits to ensure that the systems are maintained. Finally, on the occasion of unexpected visits, the notified body can carry out tests on the products. 

With a prescriptive approach to quality assessment, duplicate samples, blanks, standards, and spike recoveries are measured following a specific protocol. The result for each analysis is then compared with a single predetermined limit. If this limit is exceeded, an appropriate corrective action is taken. Prescriptive approaches to quality assurance are common for programs and laboratories subject to federal regulation. For example, the Food and Drug Administration (FDA) specifies quality assurance practices that must be followed by laboratories analyzing products regulated by the FDA. 

The components of a quality assurance program are designed to serve the two functions just mentioned—control and assessment. Quality control operations are defined by operational procedures, specifications, calibration procedures, and standards and contain the following components ... 

Quality Assurance Handbook for Air Pollutant Measurement Systems/ Vol. Ill, "Stationary Source Specific Methods," EPA-600/4-77-027b. U.S. Environmental Protection Agency, Research Triangle Park, NC, 1977. 

It is often deemed that quality assurance serves prevention and quality control detection, but a control installed to detect failure before it occurs serves prevention, such as reducing the tolerance band to well within the specification limits. So quality control can prevent failure. Assurance is the result of an examination whereas control produces the result. Quality assurance does not change the product, quality control does. 

The standard requires the supplier to evaluate and select subcontractors on the basis of their ability to meet subcontract requirements, including the quality system and any specific quality assurance requirements. 

The quality plan would be a logical place for such controls to be defined but clause 4.2.3 does not specifically refer to subcontractor controls. Any intention that they be defined in the quality plan is hidden in 4.2.3.1(b) where it requires you to give timely consideration to the identification and acquisition of any controls etc. Some companies produce a Quality Assurance Requirement Specification to supplement ISO 9001 and also produce a Subcontractor Surveillance Plan. In most other cases the controls may be defined on the reverse side of the purchase order as standard conditions coded and selected for individual purchases. 

This feasibility study shows that determination of pellet wt by fast neutron oxygen activation analysis can be used for quality assurance inspection of M34 primers. Either direct oxygen analysis, where a comparison standard (such as lucite) is used, or a ratio method, utilizing the Cu in the cup-anvil combination as an internal standard, can be applied. In general, the uniformity of production primers is quite satisfactory, as is usually the case where production procedures are standardized. It seems likely that the light pellet is one which has been improperly manufd and will probably be well below specifications in pellet wt. Production experience with such primers indicates that only one in 3x10s primers is expected to show low pellet wt therefore, one would not expect to find a reject in a small sampling. Nevertheless, detection and rejection of this one bad unit is critical for the prevention of weapon malfunctions and possible injuries to personnel... 

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,... 

All formulas are to be written out by hand with the specific numbers in the right places on a sheet provided for the purpose, and the calculations are to be done by calculator. Caution Write the numbers exactly as printed, do not round any digits, or the quality assurance unit (a sort of corporate vice squad) will not approve the report out of fear that someone could have cheated. A validated program can be used. While an Excel spreadsheet as such needs no validation, a simple cell-formula calls for extensive tests and documentation and proof that the sheet is password protected against fraudulent manipulation. On top of that, the analyst s supervisor is required to confirm the calculation and sign off on... 

Specification Limits) allows (vertical) dashed lines to be added to illustrate the Accept/Reject decision points that the Quality Assurance Department uses in product release. 

---