Good and Bad Practices in Risk Analysis
Dev Raheja, MS, CSP(Certified Safety Professional) has been a Quality Management, System Reliability Engineering and System Safety consultant for over 25 years, His range of consulting and training encompasses automotive industry, defense systems, transportation systems, electric power systems, the high tech industry, aerospace, nuclear, medical systems, and consumer products. He has conducted training in several countries including Sweden, Australia, Japan, the UK, Belgium, Finland, Turkey, Germany, Poland, Singapore, Brazil, South Africa, and Canada. He has done training and consulting work with NASA, U.S. Army, U.S. Navy, U.S. Air Force, GM, Ford, Boeing, Eaton, Nissan Aerospace, Litton, General Dynamics, ITT, BAE Systems, Lockheed-Martin, Harley-Davidson, and United Technologies.
Prior to consulting, Dev Raheja worked at General Electric (Manager of Manufacturing), Cooper Industries (Chief Engineer), and at Booz-Allen & Hamilton (Senior Consultant). He is the author of several books including Assurance Technologies Principles and Practices (Second Edition, Wiley 2006), Zen and the Art of Breakthrough Quality Management, and Design for Reliability (Wiley, 2012). He has taught several courses for the American Society for Quality and was their representative judge on the selection of the first National Malcolm Baldridge Award. He has received Scientific Achievement Award and the Educator-of the-Year Award from the International System Safety Society.
He has conducted training courses at several universities including the University of Maryland and at Florida Tech University. He is a member of the SAE G48 Committee and the Fellow of the American Society for Quality.
Selecting the most appropriate risk treatment option involves balancing the costs and efforts of implementation against the benefits derived, with regard to legal, regulatory, and other requirements such as social responsibility and the protection of the natural environment. A number of treatment options can be considered and applied either individually or in combination. Risk treatment itself can introduce new risks. A significant risk can be the failure or ineffectiveness of the risk treatment measures. Therefore the monitoring needs to be an integral part of the risk treatment plan to give assurance that the measures remain effective.
ISO 31000: the generic risk treatment standard at a business level, suggests selecting one or more of the following options for managing risks, and implementing those options. Risk treatment options are not necessarily mutually exclusive. The options can include combinations of the following:
- Sharing the risk with another party or parties (including suppliers and insurers)
- Avoiding the risk by deciding not to start or continue with the activity that gives rise to the risk of removing the risk source
- Changing the likelihood
- Changing the consequences (impact)
- Retaining the risk by informed decision
- Taking the risk in order to pursue an opportunity
- How FMEAs are usually misused?
- How to get the most value from risk analysis
- The correct way to conduct a risk analysis
- How to get users involved in the risk analysis
- How to integrate risk analysis in the risk analysis process
- Eliminating design defects to reduce risks of recall
- Eliminating manufacturing defects to reduce the risk of recall
- Eliminating maintenance mistakes using risk analysis
- New heuristics for getting fast results
Course Level - All levels including senior management
Who Should Attend
- All Technical managers
- Design and research staff
- Technical staff
- QA staff
- Manufacturing staff
- Product safety staff
- Maintenance staff
- Marketing staff
Why Should You Attend
The risk analyses are usually incomplete and too late even after so much attention paid to them. By this time you only have the high-risk design. The purpose of risk analysis is to discover new safety, reliability, maintenance, and quality-related risks, and therefore add more new requirements. Before any analysis is done, management should establish the range of risks that are acceptable, unacceptable, which risks require further investigation, and those that require the management review. Management should also make sure the definitions of risk and its components (the hazard, the hazardous situation) are clearly defined in the engineering standards and understood by the entire chain of command. This understanding is critical for clear communications.
Risk must include a combined impact of the severity of harm and the probability of harm. Therefore we need acceptance criteria for each combination of the severity and the probability of harm. This is done by developing a hazard assessment matrix, also called risk assessment matrix. It shows what combinations are acceptable based on the ISO 14971. This webinar covers the main tools for risk analysis is the Preliminary Hazard Analysis. We will go deeper into this most important analysis, and how to use them using innovative thinking.
- Using ineffective tools touted as best practices in the industry is not cool!
- Using proactive risk analysis tools using the right way at the right time is wisdom with a high return on investment