Information & Training. | Risk Management.Risk management can be defined as …. “the systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk”. Risk management training needs to provide an understanding of why an organization needs to implement a risk management process, how to approach in terms of implementing a risk analysis, risk evaluation, risk reduction and ongoing risk monitoring processes.
Why perform Risk Management?♦ It is expected by the various international regulatory agencies, e.g. U.S. FDA, European Notified Bodies to show compliance with the European Product Directives (Medical Device, Low Voltage, CE safety regulations), etc., etc…
♦ Customers expect designers and manufacturers to have considered the risks associated with their products and have eliminated or minimised risks to an acceptable level compared to the potential benefits.
♦ It is good business practice to understand potential risks and to minimize.
How to approach Risk Management:1 – Questions to be asked.
What are the potential risks, which are the most harmful, which are the risk most likely to occur?
2 – Actions to be taken.
Determine the root causes associated with the risks? Identify the potential actions to address, implement the actions and verify that the actions are effective. If effective, proceed to monitor the process, if ineffective, identify further potential actions to address, also if ineffective, revisit the root causes. Then monitor and update the risk plan.
Effort versus Risk:The greater the potential risk, the greater the effort in eliminating or reducing the risk. In approaching Risk Management, we must keep in mind the effort expended versus the potential risk.
More complete and formal Risk Management begins with an understanding of the meaning behind key terminology:
Risk is a “Combination of the probability of occurrence of harm and the severity of that harm”.
– Probability – how often the harm may occur.
– Harm – physical injury, damage to the health of people, damage to property or the environment, or the financial health of the business.
– Severity – measure of the possible consequences of a hazard. A hazard is a potential source of harm.
Risk Assessment:… is an overall process comprising a Risk Analysis and a Risk Evaluation. Risk Analysis is the systematic use of available information to identify hazards and to estimate risk. Risk Evaluation is the process of comparing the estimated risk against given risk criteria to determine the acceptability of the risk.
Risk Control:… a process in which decisions are made and measures implemented by which risks are reduced to, or maintained within, specified levels.
Risk Management Training:… is applicable at all stages of product and process design and development and includes all supporting processes and systems. Risk Management should be performed as required throughout the product and process life cycle.
When performing risk management, you need to consider the following types of questions.
What types of risk(s) are involved with the new design or the proposed product or process change? Is there a risk to the product quality, to regulatory compliance, are there technology, safety, environmental or business risks?
If you are implementing a change as part of a risk management process you need to consider if there are potential failure modes associated with the change?
Are there potential …. physical, chemical, biological, data failure modes, …. which pose potential risks?
What are the likely causes of the failure modes? Are they…human, method, material, machine, environmental, measurement?
Information & Training.
- Risk Identification. Risk Evaluation. Risk Mitigation. Risk Control. Risk Planning.
- How to Assess Risk.
- Developing a Risk Management Process.
- Risk Management in a Project.
- Risk in Product and Process Design.
- Supply Chain Risk Management.
- Developing Risk Management Strategies.
- Creating a Risk Management Plan. … … Etc. Etc….
- Requirements. Standards. Current best practices.
- Information & Training presentation >>>
ISO – International Organization for Standardisation – Risk Management Standard ISO 31000