Procedures and Personnel

Where computerized systems are not utilized for the execution of the chemical synthesis, the chemical operator, following detailed batch records is responsible for the operation of the equipment. The batch records must provide for sufficient detail to insure that the worker can safely and properly perform the desired actions. In certain larger process trains, more than one operator will work simultaneously on the same batch. Provided that their activities are closely integrated, there is little problem with this type of approach. The personnel must be trained in their jobs and records of the training must be retained by the firm. 

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It seems almost perfect. Established methods, established acceptance criteria, established procedures and personnel qualification schemes. Almost perfect. Because the reason of this presentation is, to show that things could be improved. 

Flare elevation and spacing must be such that permissible radiant heat densities for persoimel at grade are not exceeded under conditions of maximum heat release. The appropriate calculation procedures and personnel exposure criteria are described later. In some special cases, flare elevation and spacing may be governed by radiant heat exposure of certain vulnerable items of equipment, rather than personnel. 

Quality control examinations shall include the requirements of the construction organization s Quality System Program for materials, products, components, workmanship, quality documents, procedures and personnel qualifications, construction, and subcontract services. 

In many companies, the scale-up process may include or overlap with the validation process. In any case, demonstration of the process in the production environment at full scale, using the materials, equipment, procedures, and personnel established in production, is required. Often, multidisciplinary teams are arranged to manage the scale-up, and the overall roles and responsibilities for those involved with the product may change. Typically, extensive documentation, including protocols and reports, is involved, as... 

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)... 

Manufacturing site, facilities, operating procedures, and personnel for sterile manufacturing plants. See Guidance for Industry for the Submission Documentation for Sterilization Process Validation in Applications for Human and Veterinary Drug Products. 

For foreign facilities, manufacturing site facilities, operating procedures, and personnel information must be included in this section. This information can also be available as a type I DMF therefore, a letter from the DMF holder to the FDA that authorizes the use of applicable data in conjunction with the review of the sponsor s application is sufficient for this section. 

The Canadian Oil and Gas Operations Act. (R.S., 1985, c. 0-7) The National Energy Board and Chief Safety Officer shall review installations, equipment, operating procedures, and personnel before authorizing any oil or gas production activity. 

The results of QC sample analyses are evaluated with statistical tests (see Section 10.5) and presented in tandem with the sample batch results to which they correspond. Good QC results give confidence that the laboratory procedures and personnel operated satisfactorily for that batch. Bad QC results show the need for investigation and remeasurement. The QA officer keeps track of the laboratory s QC efforts, and the results are filed as specified by the QAP. 

Input requirements for MORT analysis, like those for any other detailed, comprehensive analysis, are extensive. Detailed information about the hardware and facilities, environment, procedures, and personnel directly involved is required for full evaluation of the specific control factors, and additional information about the management system is required to evaluate the policies, procedures, implementation plans, risk assessment program, and other upstream factors. Normally, a combination of interviews, physical inspections, and reviews of many procedures and project documents is required. The MORT chart and/or mini-MORT chart can serve as a planning and organizational tool for the collection of evidence and other relevant information. 

The project evaluation tree (PET) can be used to evaluate and analyze common operating and maintenance procedures and personnel, as well as common acquisition, construction, installation, testing, and manufacturing processes (see Chapter 16). 

System analysis (safety analysis) The formal analysis of a system and the interrelationships among its various parts (including plant and hardware, policies and procedures, and personnel) to determine the real and potential hazards within the system, and suggest ways to reduce and control those hazards. 

An examination, observation, measurement, or test undertaken to assess structures, systems, and components and materials, as well as operational activities, technical processes, organizational processes, procedures, and personnel competence. See also Safety Inspection. 

Determining possible causal factors is facilitated by listing major categories Equipment Tools Environment Procedure and Personnel. 

Operating procedures and personnel training in loading and discharging material. The procedures and training should emphasize minimizing exposure to hazardous material. 

Flight test safety covers those safety aspects involved with flight-testing of an aircraft. It includes the aircraft, special subsystems, test equipment, procedures, and personnel involved in the flight tests. Range safety is a major component of flight test safety. 

This technique is a system safety analysis-based process to semi-quantitatively analyse, measure and evaluate planned or actual loss outcomes resulting from the action of equipment, procedures and personnel during emergencies or accidents. 

Launch System (LS) - The Launch System consists of the hardware, software, facilities, procedures, and personnel used to conduct launch operations. The Launch System includes the launch vehicle(s), transfer vehicle(s), launch site facilities, and launch services. 

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