Inventory of systems

Establish Site Validation Steering Committees to prepare an inventory of systems, set priorities, establish site validation master plans, approve validation procedures, assign resources, and monitor progress. 

Completion of retrospective validation across a number of computer systems, whether by remediation or replacement of individual systems, should be achieved within 2 to 3 years from the outset of the overall program of work. Status reports should be periodically prepared to demonstrate progress. It may be useful to extend the inventory of systems discussed in Chapter 3 to include a status flag indicating whether retrospective validation is outstanding or in progress. 

An inventory of systems and knowledge, of which one is GMP-critical, must be maintained and available for inspections. An MHRA preinspection checklist has this as one of its opening topics. The availability or otherwise of this information is a clear indicator of whether management is in control of its computer systems validation. The use of an inventory need not be limited to inspection readiness it could also be used for determining supplier audits and periodic reviews, etc. Many pharmaceutical and healthcare companies use a spreadsheet or database to maintain this data. Where a site s inventory is managed between a number of such applications (perhaps one per laboratory, one for process control systems, one for IT systems), care must be taken that duplicate entries are avoided and, equally, that some systems are missed and not listed anywhere. It should be borne in mind that where spreadsheets and databases are used to manage an inventory, it should be validated just like any other GxP computer application. 

Inventory of systems System/project overviews Validation plans/reports and reviews Presentation slides Internal briefing papers Document map Trained persoimel... 

A line item inventory of system hazards, with no evaluation of prohahility, severity, or risk. 

The total compartment inventory of Systems, Structures and Components (SSC) including cables has to be associated to POS in accordance with their safety functions to one of the following three classes (1 no safety relevance, 2 — basic event in the PSA plant model, 3 failure may contribute to an initiating event). 

The best way to deal with a hazard in a flowsheet is to remove it completely. The provision of safety systems to control the hazard is much less satisfactory. One of the principal approaches to making a process inherently safe is to limit the inventory of hazardous material, called intensification of hazardous material. The inventories we wish to avoid most of all are flashing flammable liquids or flashing toxic liquids. 

Once the process route has been chosen, it may be possible to synthesize flowsheets that do not require large inventories of materials in the process. The design of the reaction and separation system is particularly important in this respect, but heat transfer, storage, and pressure relief systems are also important. 

The overall inventory. In the preceding chapter, the optimization of reactor conversion was considered. As the conversion increased, the size (and cost) of the reactor increased, but that of separation, recycle, and heat exchanger network systems decreased. The same also tends to occur with the inventory of material in these systems. The inventory in the reactor increases with increasing conversion, but the inventory in the other systems decreases. Thus, in some processes, it is possible to optimize for minimum overall inventory. In the same way as reactor conversion can be varied to minimize the overall inventory, the recycle inert concentration also can be varied. 

Safety. A large inventory of radioactive fission products is present in any reactor fuel where the reactor has been operated for times on the order of months. In steady state, radioactive decay heat amounts to about 5% of fission heat, and continues after a reactor is shut down. If cooling is not provided, decay heat can melt fuel rods, causing release of the contents. Protection against a loss-of-coolant accident (LOCA), eg, a primary coolant pipe break, is required. Power reactors have an emergency core cooling system (ECCS) that comes into play upon initiation of a LOCA. 

The inventory of these plants can run into over 20,000 items, including over 100 complete rotor systems. The field of spare parts is changing rapidly and is much more complex than in the past. A group of plants have gotten together in a given region and formed Part Banks. ... 

The various steps of the inventory phase are shown in Fig. 15.2. The aim of the inventory phase is to comprehensively identify and quantify flows between the technical product system and the environment, i.e., emissions and resources. An example of an inventory of a product system is shown in Fig. 15.3 and Table 15.1. 

The principles outlined in the standard can be applied to any creative activity and while the standard primarily addresses the design of automotive products for onward sale to customers, the principles can be applied to internal systems such as an information technology system, an inventory control system, and even the quality system. 

The standard requires use of an inventory management system to optimize inventory turns over time and assure stock rotation. 

An inventory management system should be established - meaning set up on a permanent basis to meet defined inventory policies and objectives approved by executive management. It should be documented - meaning that there should be a description of the system, how it works, the assignment of responsibilities, the codification of best practice, procedures, and instructions. The system should be planned, organized, and controlled in order that it achieves its purpose. A person should therefore be appointed with responsibility for the inventory management system and the responsibilities of those who work the system should be defined and documented. Records should be created and maintained that show how order quantities have been calculated in order that the calculations can be verified and repeated if necessary with new data. The records should also provide adequate data for continual improvement initiatives to be effective. 

Fuel cannot be completely eliminated, though the inventory of combustible fuels can be kept to a minimum. Oil and gas will be present in any production facility, and either an oil spill or escaping gas can provide the fuel needed. Escaping gas can result from rupture, opening a closed system, or gas that is normally vented. The amount of fuel present can be minimized by preventing oil spills and gas leaks. 

Use this exercise to create a comprehensive, current inventory of the benefits that are unique to your PSM system. The next step is to describe these benefits in terms of the people you want on board. Think about each one in terms of the people whose support you need. These will probably fall into several categories, and it s important to distinguish them from one another, since, as in any sales situation, you must personalize benefits and make them relevant to the customer s interests. 

The Failure and Inventory Reporting System (FIRS) program was developed by the Geological Survey Division of the U.S. Department of the Interior for safety and pollution prevention devices on offshore structures that produce or process hydrocarbons. The program collected data on mechanical and some electromechanical systems on offshore oil platforms. About 8,000 failure events were documented. Access has been limited to internal materials management system use. No real-time access or periodic output products have been available. 

Only a small inventory of hydrogen cyanide will be present in tlie cyanide reactor. Tlierefore, catastrophic failure of tliis miit is not likely to result directly in the release of large quantities of hydrogen cyanide. However, such failure could result in damage to other portions of tlie system where larger quantities of the gas are present. 

The impact of Ice Storm 98 was unprecedented in Canadian electric power system history. The Ontario Hydro Report provides a chronology of the twenty-three major storms that have impacted the system since 1942. The report also provides a detailed inventory of the effects, consequences, and mitigation measures taken due to the ice storm. The estimated direct total cost to Ontario due to the ice storm is 472 inillioii (Canadian), which includes costs incurred by Ontario I lydro, local Ontario and federal governments, the Insurance Bureau of Canada and associated insurance companies, the Department of National Defence, and affected customers, incliidiiig... 

Some hospitals are using a bar code scanner in the administration of unit dose drugs. To use this system, a bar code is placed on the patient s hospital identification band when the patient is admitted to the hospital. The bar codes, along with bar codes on the drug unit dose packages, are used to identify the patient and to record and charge routine and PRN dm. The scanner also keeps an ongoing inventory of controlled substances, which eliminates the need for narcotic counts at the end of each shift. 

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