A Failure Modes, Effects and Criticality Assessment (FMECA) is a requirement for some applications and should also be considered for novel technology, complex devices or safety critical applications. Although some FMECA columns can be populated by the technology developer, best practice recommends workshop input/review to capture relevant technology and user expertise as part of understanding the risk and appropriate mitigation - including facilitation by an experienced FMECA practitioner.
Provides an at-a-glance overview of the risks identified on the sheet which highlights the total number of risks and identifies the number of risks at each criticality and risk mitigation level. The dashboard will dynamically update as the sheet content is changed.
This is where risks are identified, described, and evaluated. Each row represents one failure mode. The current status of each risk will be reflected in the dashboard.
The risk matrix for the FMECA sheet is located on a separate sheet, to allow for easier navigation between the two rather than scrolling up and down the same page. The generic 5 x 5 risk matrix provides an assessment of risk. This includes 5 columns which define the consequence severity levels. Generic example business, user, and technology consequences are provided for the example severity levels (negligible, noticeable, significant, major, and catastrophic). These example definitions may be modified to align with the device / equipment application and any required industry regulations / codes / standards.
The risk matrix includes 5 rows which define the likelihood of the risk occurring. Two generic example likelihood scales are provided, one based on the number of uses and the other on time periods. These definitions should be modified as required to align with the device / equipment application and any required industry regulations / codes / standards. It is important that time / use scales appropriately reflect the user application; definitions for a device used several times a day may need to be different to those for a device used once a month / year, or for a disposable device which is only used once.
The risk criticality matrix includes 5 default risk criticality levels (very low, low, medium, high, very high) with the risk criticality level for a specific risk likelihood and consequence severity combination determined from the corresponding cell colour on the risk matrix (i.e. red cells correspond to very high criticality).
There are a series of steps involved in the process of identifying and evaluating risks:
The 'Requirements' worksheet identifies the functions and requirements for the device / equipment. For each component, list the relevant requirement / performance targets and the associated failure mode(s). For each failure mode, identify the failure mechanisms (the underlying physical / chemical process leading to the failure event) and the underlying causes initiating this. These could include design or manufacturing errors (e.g. incorrect material specification), damage during transit or incorrect use, storage, testing or maintenance by users, etc. Each row is automatically given a unique reference number for traceability.
The risk matrix likelihood and severity values are used to evaluate each risk. The 'Risk Criticality' will be automatically populated from these values, based on the corresponding risk matrix cell. Note any assumptions made in assessing the level of risk.
Identify what can be done to mitigate and control the risk - this is particularly important for high / very high criticality risks. Examples include use of alternative materials / parts, manufacturing quality control checks, improved product labelling, instructions, and user training. The mitigated risk criticality column is used to understand the effectiveness of the mitigation action; consider the extent to which the mitigation action has reduced risk likelihood or the consequence severity, and from this, identify the mitigated risk criticality using the dropdown list. It is unusual for both the likelihood and the consequence severity to be reduced.
Each mitigation action should be assigned an owner, who has responsibility for ensuring the action is implemented, and a target completion date. The status column reflects the current status of the action.
There are various interactive and dynamic features on this worksheet:
