Risk management defined

Process risk management Define process information needs Develop PHA procedure flow Document PHA procedures Define staff training needs Develop follow-up tracking process... 

Developed under tlie Clean Air Acts (CAA s) Section 112(r), tlie Risk Management Program (RMP) rule is designed to reduce tlie risk of accidental releases of acutely toxic, flanunable and explosive substances. USEPA finalized its list of regulated substances (138 chemicals) and defined tlireshold quantities for these chemicals. 

Not surprisingly, there is no agreed definition of the risk management process. The associated issues and interactions can be very complex, and much effort continues to go into defining how they can be characterised. It is however possible to sketch the overall process into a coherent architecture, based on the principles of ... 

Article 3(37) of REACH defines exposure scenarios as the set of conditions, including operational conditions and risk management measures, that describe how the substance is manufactured or used during its life-cycle and how the manufacturer or importer controls, or recommends downstream users to control, exposures of humans and the environment [...] . 

The EPA Risk Management Plan (RMP) defines a worst-case scenario as the catastrophic release of the entire process inventory in a 10-min period (assumed to be a continuous release). The dispersion calculations must be completed assuming F stability and 1.5 m/s wind speed. As part of the RMP rule, each facility must determine the downwind distance to a toxic endpoint. These results must be reported to the EPA and to the surrounding community. 

In larger organizations, there often are risk management committees or departments. Usually there are well-defined protocols for how to address and report a crisis in such organizations. The protocol often specifies contacting a risk management official, whose role it is to assess the risk to the organization and... 

To this end the following guideline describes a general approach toward risk management for a laboratory instrument and then applies it to the performance of the operational qualification of a CE instrument. Tests then need to be devised in order to determine the suitability of the instrument for its intended use and to fulfill those user requirements that have been defined by the operator. 

It is widely understood within the industry that risk is defined as the combination of the probability of harm and the severity of that harm. Within the pharmaceutical industry whenever risk is considered the equipment or product being assessed must be viewed in the context of the protection of the patient. From our perspective, analytical instruments may impact on the validity of data that determines the safety and efficacy of drug products, or on the quality of the drug product. They may also impact on the identity or potency of the drug product and therefore it is important to ensure that risk management is performed throughout the complete life cycle of the instrument. 

Figure 7.1 is adapted from the red book (actual title Risk Assessment in the Federal Government Managing the Process ). The committee offered this figure as a depiction of the broad framework under which the three major activities necessary to protect public health from the hazardous properties of environmental chemicals (very broadly defined) - research, risk assessment, and risk management -should be organized. The committee further emphasized that the three involve quite discrete sets of analytical undertakings, and serve different purposes, so that efforts should be made to reduce the chance of inappropriate influence of one upon another. Thus, for example, risk... 

Medication errors have been defined in many ways, depending on research methodologies, incident reporting systems, risk management, or total quality improvement systems. USP uses the broad definition of medication error from the NCC MERP ... 

Risk is defined as a measure of human injury, economic loss, or environmental damage in terms of both the likelihood and severity of the consequences. It is important to recognize that risk is an estimate. It can not be exactly measured or, if calculated, is not an accurate number. There will be a level of uncertainty with any risk estimate and management should understand that risk estimates have some uncertainty. 

SRA provides an open forum for all those who are interested in risk analysis. Risk analysis is broadly defined to include risk assessment, risk characterization, risk communication, risk management, and policy relating to risk. ... 

The assessment endpoint should be not only measurable (at least potentially) but also modelable. Defining a modelable endpoint is likely to require close discussion between an assessor (who knows what they can model) and a risk manager (who knows what they want to protect). Sometimes the assessment endpoint is only indirectly related to the management goal, for example, if the assessment endpoint is a risk to individuals, but the aim is to protect population sustainability. In such cases, qualitative inference will be required to interpret the assessment result. This inference will need to be done jointly by the risk assessor and risk manager. It is likely to involve substantial uncertainty, which will have to be taken into account qualitatively when producing a narrative description of the assessment outcome. This step should be identified as part of the conceptual model. 

If the assessment is to be probabilistic, the risk assessor and risk manager should consider together how this influences the definition of the assessment endpoint. Suter (1998) suggests 5 questions for the risk assessor to ask the risk manager to help define the assessment endpoint ... 

Should any assessment endpoints be expressed as probabilities Suter (1998) points out that it can be confusing to use the term probability in defining assessment endpoints because it is unclear whether it relates to variability or uncertainty, so it will be helpful to distinguish these in the discussion with the risk manager. 

Bnrmaster DE, Thompson KM. 1995. Backcalculating cleanup targets in probabilistic risk assessments when the acceptability of cancer risk is defined under different risk management policies. Hnman Ecol Risk Assess 1 101-120. 

Three consensus guidelines define the core of the ICH s involvement in harmonization of pharmaceutical quality systems—Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality Systems (in addition, each of the guidance documents cites critical areas of overlap with Q6A Specifications Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products Chemical Substances). 

Guidances recommend an integration of software life-cycle management and risk management activities. Software validation and verification activities must be conducted throughout the software life cycle [12,14]. Software verification and validation are terms frequently confused. Software verification is defined as the process that provides objective evidence that the design outputs of a particular phase of the software development life cycle meet all of the specified requirements for that phase... 

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