Leading failure modes and effects analysis (FMEA) activities
Overview
This standard covers the competences required for leading failure modes and effects analysis (FMEA) activities. It involves leading the principles and processes of FMEA and agreeing the key features of FMEA **required for the activity under investigation. The activities will include concepts, designs, systems, products, processes and machines.
You will be required to agree the key features of FMEA, check the recording of the information gathered in an appropriate format, and consider and approve valid judgements about the activity, using FMEA principles. This will include approving risk priority numbers (RPNs), agreeing high RPNs and agreeing actions to improve them. Once actions have been completed, you will need to lead the reassessment of the activity and review the re-score of severity, occurrence and detection.
Your responsibilities will require you to comply with organisational policy and procedures for the activities undertaken, and to report any problems with the activities that you cannot solve, or that are outside your responsibility, to the relevant authority. You will need to ensure that all the necessary documentation is completed accurately and legibly. You will be expected to take full responsibility for your own actions within the activity, and for the quality and accuracy of the work that you produce.
Your underpinning knowledge will provide a good understanding of FMEA, and will provide an informed approach to the techniques and procedures used. You will need to understand the principles and application of FMEA, in adequate depth to provide a sound basis for carrying out the activities to the required criteria.
Applying and advising on safe working practices will be a key issue throughout.
Performance criteria
You must be able to:
- work safely at all times, complying with health and safety and other relevant regulations, directives and guidelines
- agree the key features of failure modes and effects analysis required for the activity under investigation
- lead the production of a failure modes and effects analysis
- approve the recording of the information gathered in an appropriate format
- consider and approve valid judgements about the risk evaluation procedure of the activity using failure modes and effects analysis principles
- approve the risk priority numbers (RPNs) calculations, agree high RPNs and agree actions to improve them
- implement and monitor the progress of FMEA activities
- lead the reassessment of a failure modes and effects analysis once actions have been completed, and review the re-score of severity, occurrence and detection
Knowledge and Understanding
You need to know and understand:
- how to work safely at all times, complying with health and safety and other relevant regulations, directives and guidelines
- lead the production of a total cost model and supply chain map for the product or process, which shows how cost are related to function
- how to plan the resources and time needed to carry out the agreed activity
- the main features and benefits of carrying out a failure modes and effects analysis
- who should be part of a team that constructs and updates a failure modes and effects analysis
- system FMEA, concept FMEA, design FMEA and process FMEA - what they are, and where you should use them
- the meaning of failure mode, failure effect and failure cause
- the rating scale used in failure modes and effects analysis projects, to include the severity rating scale, the occurrence rating scale and the detection rating scale
- how to calculate a risk priority number (RPN)
- how to use the risk priority numbers
- how to apply a structured approach to risk reduction
- when to start a failure modes and effects analysis
- when to update a failure modes and effects analysis
- the roles and responsibilities of individuals within a failure modes and effects analysis team
- the extent of your own authority within the project, and to whom you should report in the event of problems that you cannot resolve
Scope/range
Scope Performance
1. Lead the activities within your area of responsibility to include all of the following:
- set out and communicate the purpose of the improvement activities
- involve the team in planning how the improvement activity will be achieved
- ensure each team member has individual objectives and understands how these objectives contribute to the overall improvement objective
- provide advice and support the team to achieve both team and individual improvement objectives
- motivate the team to present their own improvement ideas
- encourage the team and/or individuals to take the lead where appropriate
- agree the implementation of the improvement ideas
- negotiate any physical and/or financial resources required to implement the improvement activity (where appropriate)
- monitor the progress of improvement activities
- deal with any organisational problems identified during the improvement activity
2. Lead the carrying out of a failure modes and effects analysis on two of the following:
- concept
- product
- design
- process
- system
- machine
3. Agree, for the activities analysed above, all of the following:
- the potential failure modes
- the potential effects from failure modes
- the potential causes of failure modes
4. Check rating tables for all of the following:
- occurrence
- severity
- detection
5. Approve the score for all of the following:
- the likely occurrence of a potential failure modes
- the severity of the potential failure modes
- the likelihood of detection of the potential failure modes