The 7 steps of FMEA according to the VDA/AIAG harmonization

Step 6 of the standardized FMEA method description:

Summary: Optimization

Optimization, which is the 6th step of the FMEA according to the standardized FMEA method description, builds on the results of the risk analysis. If unacceptably high risks have been identified as input variables for the optimization in the risk analysis, optimization is the next logical step in the FMEA. As in the risk analysis, there are two options for minimizing the risk:

Option 1: additional preventive actions
Option 2: and/or additional detection actions

These are formulated in the optimization of the . There is a new value for the likelihood of occurrence (O value) and a new value for the likelihood of detection (D value). Of course, the O value and D value must be changed in the optimization of the to achieve the objectives.

Important: Strictly speaking, optimization of the FMEA does not come to an end. As long as the product is in use and being produced (P-FMEA) or as long as there is design availability (D-FMEA), the 6th step in the standardized FMEA method description according to the handbook (AIAG & VDA) must be repeated at regular intervals.

The FMEA is therefore a living process. Findings that are arrived at in the lifecycle of the system or product – risks in particular – are entered in the optimization step of the FMEA.

At the same time, optimization of the FMEA is in turn the basis for the next step in the standardized FMEA method description: the final documentation and communication of the risk.

Detailed knowledge: Optimization in the FMEA method description

Purpose

In the optimization of the FMEA, actions to reduce risk are defined on the basis of the risk analysis and they are assessed. The main objectives of the 6th step in the standardized FMEA method description according to the FMEA handbook (AIAG & VDA) are:

Definition of further actions to reduce risk
Scheduling of and specification of responsibilities for the actions
Implementation of the actions including confirmation of their effectiveness and reconsideration of the risks
Coordination between suppliers, customers, FMEA team and management
Optimization of the starting point for improvement of the product requirements and process requirements

Optimization in the FMEA method description:

Continuous improvement and actions

With these actions, the optimization of the FMEA aims to minimize risk and increase customer satisfaction. In the 6th step of the standardized FMEA method description, the FMEA team reviews its results from the risk analysis and develops actions to minimize further the likelihood of occurrence of causes of failure. Actions can also be defined in the optimization of the FMEA, which improve the design without directly affecting the risk assessment.

The FMEA documents the progress. The original assessments of severity, occurrence and detection are not changed. In the optimization of the FMEA, additional actions are taken to reduce the risk further. The analysis thus becomes a fount of knowledge in which progress in the design decisions, improvements and process optimizations are stored.

The actions described in the optimization of the FMEA are designated as follows in the analysis, depending on their implementation status:

open – no actions have been defined
pending decision – actions have been defined, but no decision has yet been taken on them
pending implementation – actions have been agreed but not yet implemented
completed – measures have been implemented, their effectiveness verified, documented and then assessed
rejected – actions were initially agreed but it was then decided not to implement them

Overall, the FMEA is not concluded until the FMEA team has agreed to the residual risk or documented the completion of all actions.