Whether it’s called risk based thinking, risk assessment or risk management, management system requirements for organizations of all types are now calling for more rigorous consideration of risks and their effective control. While there are many different ways to do such an analysis, failure mode and effects analysis (FMEA) is perhaps the more comprehensive in its coverage.
A process FMEA allows an organization to apply a structured approach to analyzing a process to determine the potential risks, their effects and their likelihood, as well as the adequacy of existing or proposed controls to prevent and detect such failures. It allows probabilistic determination of which aspects of the process may need to be modified in order to fall within the organization’s risk appetite.
This two day workshop provides participants with an understanding of the methodology for performing a process FMEA, as well as how to create guidelines to be used during and afterwards. Participants will participate in both discussions and practice to expose them to various options that can be used.
Learning Objectives:
Upon completing this course participants should:
- Understand the relationship between the process FMEA and a design FMEA (if available)
- Know how to develop tables for Severity, Occurrence and Detection appropriate to their organizational context
- Be able to determine the appropriate scope (e.g., range of customers/stakeholders) to include in the analysis
- Know how to respond to various combinations of risk ranking
- Understand how to simplify the analysis when possible, as well as aggregate the findings
Who Will Benefit:
This course is designed for those who are involved in managing, control and improvement of organizational processes. This includes personnel such as:
- Quality managers and engineers
- Manufacturing/process engineers
- Design engineers
- Production managers/supervisors
- Process owners
- Registration Process: 8:30 AM – 9:00 AM
- Purpose and benefits of the pFMEA
- Risk assessment versus risk management
- ISO 31000 steps
- Basic components of the analysis
- Header information
- Process steps and requirements
- Risks and potential impact
- Probability given controls
- Overall risk and responses
- Guidelines for FMEAs
- Aerospace
- Automotive
- Electronics
- Where pFMEA fits into the quality management system
- Process design phase
- Training and process control
- Root cause analysis and corrective action
- Levels of FMEAs
- Relationship of dFMEA and pFMEA
- Details of a pFMEA
- Practice
- Developing ranking tables
- Consideration of process scope
- Consideration of risk appetite
- Practice
- Analyzing outcomes and deciding actions
- Hazards of the RPN
- Iterative approaches
- Aggregation of risks
- Practice
- Alternatives to level of analysis, modular/generic FMEAs
- Common errors in pFMEAs
- Auditing/evaluating a pFMEA
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