Critical Item Program

Operating devices may become miscalibrated after a while (e.g., the temperature accuracy of a gas chromatography [GC] column oven or the wavelength accuracy of a UV/visible detector s optical unit). This can have an impact on the performance of an instrument. Therefore, a calibration program should be in place to recalibrate critical items of an instrument. 

The second process, the Unrestricted Operations Maintenance Requirements Card (URO MRC) program, involves periodic inspections and tests of critical items to ensure they have not degraded to an unacceptable level due to use, age, or environment. In fact, URO MRC did not originate with SUBSAFE, but was developed to extend the operating cycle of USS Queenflsh by one year in 1969. It now provides the technical basis for continued unrestricted operation of submarines to test depth. 

Describe the six critical items required in the Hazard Communication program. 

A written hazard communication program is a blueprint which describes how a company will achieve the goals set by the Hazard Communication standard. The program must address six critical items ... 

List four critical items the HAZCOM program must address. 

Minor adjustments to maintenance program fornon-critical items... 

In the design of modem aircraft, ease of maintenance is a critical item. Manufacturers elicit feedback from operators on maintenance issues as part of the design process. As discussed earlier, ROM is fundamental to maintenance programs in modern aircraft operations. Importantly, ROM principles are already invoked at the design stage. 

A scheduled maintenance program that focuses on the high criticality items is set up. This program can be condition-based. 

A maintenance and inspection program should also be developed for other critical equipment, especially pressure containing items. 

Properly trained custodial and maintenance workers are critical to a successful A M program. The following items are highlighted training requirements ... 

The focus then shifts to a discussion of transdermal process validation. This particular discussion will share a method for completing this critical step. Although the method for completing validation for transdermals is important, there are two other items that must not be forgotten validation documentation and the establishment of a solid change control program. Later sections of this chapter will discuss each area in adequate detail. As the chapter draws to a... 

Flame Treatment. In this the surfaces are flamed, usually by application of a gas burner for a brief period. Factors such as the temperature of the flame (the ratio of gas to air in the fuel), distance of flame from the surface, and speeds of travel of flame and objects, all are critical—and small variations in any of these factors can lead to unsatisfactory results (that is, under-treatment, or overtreatment). Because of this, standardization and consistent results are best achieved through programmed control with robots. Even so it is difficult to treat more complex shapes satisfactorily, and normally such items would be primed after flame treatment—that is, two methods of promoting adhesion vould be used in combination. 

The purpose of this program is to establish safe separation distances relative to explosive end-items and in-process materials, as well as critical and safe depths of bulk explosives on conveyors, hoppers, tubes, or other transfer lines. 

In an attempt to assure universal availability of medical equipment, pharmaceuticals, and vaccines, the Strategic National Stockpile (SNS, formerly the National Pharmaceutical Stockpile) is a federally funded program that maintains a reserve of these items. In the event of disaster, the SNS may be activated to meet critical supply needs, particularly for those items that are rapidly consumed in the early management of patients during... 

Excipients are pharmaceutical ingredients that are used in product formulations. Each serves a specific purpose (i.e, binder, disintegrant, or pH adjustment) for the proper performance of the dosage form. Most of the excipients used in product formulations are compendial items [United States Pharmacopeia (USP), European Pharmacopeia (EP), etc.], and therefore, they are widely used and understood and there is usually no requirement to perform stability tests for them. Many are also used in the food industry. In addition, since the excipient s function in the product is not directly linked to efficacy, its need for tight stability control is less critical. For these two reasons, it is seldom necessary to organize a formal stability program or database for excipients. 

Final documentation for a validated manufacturing facility is critical to the success of the project. Documentation and certiflcation of the work is the responsibility of the construction management team. The format and items required for certiflcation should be included in both the design documents and the validation plan. Almost all documentation provided by vendors is available in electronic format. The computer design programs used to provide this documentation should be established in the early stages of the project and validation plan. The construction manager insures that the subcontractors and suppliers comply with these requirements. Weld documentation and instrument calibration are two of the most common certifications required of the contractors. 

In summary, the proposed Bayesian approach appears very promising in supporting the RIPBR practice for digital I C QA programs. However, there is still more work yet to be done before this technique can be fully utilized for example, issues of uncertainty, sensitivity and importance, criticality measures, etc. all are necessary information items to be submitted in a formal RIPB application. In the future, we will conduct a more comprehensive investigation to consider more QA related factors and to develop methods to address the sensitivity and imcertainty issues. 

The critical path for this project was the headframe erection time after the demolition of the service headframe. This required extensive planning to schedule as much work to be completed prior to service headframe demolition. The plan to design for and execute this work was known as the early works program. Though designing main headframe to be modular was the primary element of the early works program, there were several other items that qualified ... 

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