Operational risk management design

Function with Cross-Reference to Specification Document Subfunction GxP Relevant (Y/N) Short Justification Potential Impact Cause OP (Operation) iT (Design) impact Recognition (S—Source) (K—Knock-on Effect) Level of Risk Without Risk Management Risk Management Design Enhancement Test Thoroughness Operationai Measures (e.g., SOPs)... 

The structure of the paper is as follows section 2 contains a brief introduction to Bayesian Networks as well as the motivation for using BN models as a tool for operational risk management in financial institutions and section 3 describes our suggested model design process, along with advice on how to efficiently build large models. Section 4 documents a quality assurance... 

Thus, great strides forward with respect to all hazard-related endeavors that fit under the caption Operations Risk Management can be made in the design and redesign processes. 

Prevention through design concepts must be instituted as an element within an Operational Risk Management System. 

Proposing that Prevention through Design be a specifically defined element in an Operational Risk Management System is also influenced by ongoing transitions observed by this author in the methods to eliminate or reduce the occurrence of human error. 

This author admits to being a Deming disciple. He stressed again and again in Out of the Crisis that processes must be designed, or redesigned, to achieve superior quality if such performance is desired, and that superior quality cannot be attained otherwise. And the same principle applies to all aspects of operations risk management. 

Although the MORT system is an analytical procedure for inquiring into causes and contributing factors of accidents and incidents, it provides an extensive educational base for subjects that should be considered in the design process, both with respect to the physical aspects and, particularly, for the design of work methods and operational risk management systems. 

To minimize the potential for the occurrence of low-probability/high consequence incidents, the operations risk management system should include a distinctly identified activity designed for that purpose—if the inherent risks in an operation indicate that it is needed. 

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... 

Quality by Design The incorporation of functional relationships between inputs, parameters, and product quality (or efficiency), which inherently imply magnitude and directionality, enables the use of a process design space as a tool for multiobjective process optimization. Furthermore, the model-based representation of knowledge is compatible with concepts of risk management, enabling more flexible operation since the risk associated with extrapolation could be predicted. 

Safety considerations are an inseparable part of the development of a chemical process and the design and operation of a chemical plant. While risk management and safety features can be added on to a plant design or to an operating plant, safety is most reliably and robustly ensured by developing inherently safer processes. 

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