Management processes, documenting

Process definition and design criteria Process and equipment design Company memory (management information) Documentation of risk management decisions Protective systems Normal and upset conditions Chemical and occupational health hazards... 

Systems governing legally required processes are, of course, more likely to be formal and documented. If you find a one-to-one correspondence, this may suggest that your company tends toward an informal approach to management systems, documenting them only as they apply to mandatory processes. If you find formal documentation of a number of systems that support discretionary activities, this may indicate that your compands style requires more structure. 

Woodlawn is concentrating on its process documentation system, while Kingston continues to work on process hazard assessment. Winston and Highgate continue to work on Management of Change. 

Process documentation and knowledge Documentation of hazards, equipment design, risk management decision, etc. applies... 

Each PSM system can then be examined to determine what system modifications (if any) are needed to address the new issues. For example, the process hazard assessment system might be modified to include participation by industrial hygienists to identify potential sources of exposure. Some process safety management systems (e.g., process documentation) may require no modification to support a wider scope. 

Process documentation and knowledge As defined by CCPS guidelines, this element includes collection and retention of information important to industrial hygiene management... 

GLP compliance for electronic records does not differ from GLP compliance for paper records. The increased access and distribution of records and documents enabled by electronic systems provide compliance challenges. There are many new questions to answer for example, what is the difference between electronic approvals and electronic signatures The solutions to these challenges lie in ensuring that system validation and management processes are in place, such as SOPs or procedures... 

Process Knowledge and Documentation—The main features here are process definition and design criteria, process and equipment design, company memory (management information), documentation of risk management decisions, protective systems, normal and upset con-dtions, and chemical and occupational health hazards. 

Document Chemical Reactivity Risks and Management Decisions Process Knowledge and Documentation Process Risk Management Process Safety Information Process Hazard Analysis Operating Procedures Operational Control... 

The management system for process definition documentation should ensure that the contents of the process documentation package are accurate and complete. A suitable review and quality assurance program should be implemented for the process documentation. This may involve a hierarchical review process, and/or using external experts in a review capacity. 

Decision making, process risk management decisions, documentation, 105-106 Decision point, chemical reactivity tests, 90 Decommissioning, chemical reactivity hazard management, 25 Decomposition pressure test, chemical reactivity tests, 88... 

Procedural controls, process controls, 98-99 Process controls, 96-100 active controls, 98 inherently safer approach, 97 mitigation techniques, 99 passive controls, 97-98 procedural controls, 98-99 safe operating limits, 99-100 Process definition, documentation, 102-104 Process design, documentation, 105 Process hazard analysis (PHA) risk assessment, 92-93 screening methods, 63 Process risk management decisions, documentation, 105-106... 

The California Air Resources Board has prepared risk assessments for a number of toxic airborne compounds and mixtures, designated as toxic air contaminants, TACs (Table 16.15). For example, risk assessments for individual compounds such as benzene, benzo[a]pyrene (see Chapter 10), formaldehyde, and vinyl chloride have been carried out, in addition to complex mixtures such as diesel exhaust (California Air Resources Board, 1997a) and environmental tobacco smoke (California Environmental Protection Agency, 1997). These risk assessment documents form the basis for controls imposed as part of the risk management process (e.g., see Seiber, 1996). 

These processes are managed by the organization in accordance with the requirements of these international standards. The quality management system documentation is reviewed, updated, and maintained both in hardware and software form. 

Multiple change management processes may exist within a company— documentation, equipment, CRS, andproject-or system-specific processes. 

The chances of passing a PAI are greatly enhanced if the relevant development is carried out in conformance with well-defined quality principles and some applicable cGMPs. These quality principles should cover such topic as batch disposition, stability, process validation, training, deviations, management notification, documentation change, and history of development. These principles have been described in detail in Chapter 2 and by Hynes [3],... 

Quality assurance refers to activities that demonstrate that a certain quality standard is being met. This includes the management process that implements and documents effective QC. Quality control refers to procedures that lead to statistical control of the different steps in the measurement process. So QC includes specific activities such as analyzing replicates, ensuring adequate extraction efficiency, and contamination control. 

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