FMEA Measure Categories
1. Purpose (Why?)
- Structuring of the development of measures
- Content input for measure development
- Optimized consistency of measure development
2. Procedure (How?)
- Develop the FMEA according to the VDA procedure model
- Develop prevention and detection measures for each cause-failure combination
- Define action categories for the analysis object together with the experts involved
- Use for that the available checklist as the base and start point
- Make sure that the measures describe exactly what is to be done. Copying the categories of measures is usually not sufficient.
- For example, you can use remark functions in accordance with the software tool you are using
The development accompanying Product and Process FMEA is a major contributor to risk minimization. Practice shows that it can be advantageous to define categories.
Note:In no case, the measure should be documented as a comment (e.g. prototype test). At least always one verb, as well as responsibilities and appointments, is part of a measure.
Measure categories Examples Design FMEA.
- System/feature design based on the adoption of a production-proven solution from a comparable system/component and use case (here, the FMEA should mention some of the systems/components from which the solution is adopted in order to concretize the risk assessment).
- System/feature design based on benchmark study
- System/feature design based on analytical verification methods for robust design (e.g. FEM strength verification)System/feature design on the basis of iterative proceduresSystem/feature design on the basis of applicable "normative" specifications (e.g. internal design guidelines, external specifications (suppliers, standards, etc.)).
Discovery measures (verification measures):
- Verification measures by: Design review to verify function X (perform code review).
- Detection by: Analytical procedures to confirm the design of the system/components (simulation model).
- Evidence management by: Hardware verification on component test bench (Verify the functions according to the functional analysis for diverse and relevant maturity levels of the type models such as A-model, B-model, prototypes, series parts. In addition, the following strategies can be applied: a. Limit sample build-up, b. Overload tests, c. Endurance tests with finding strategies (possibly pre- and post-test measures).
- Verification by: Assembly tests for various maturity levels of the prototypes such as A-sample, B-sample, prototypes, series parts to verify the functions according to the functional analysis.
- Verification by: Prototype tests to verify the functions for various maturity levels of the type such as A-sample, B-sample, prototypes, series parts to verify the functions according to the functional analysis.
- Verification by: Field test for verification of specific functions for various maturity levels of the type such as A-sample, B-sample, prototypes, series parts for verification of the functions according to the functional analysis.
- Verification management by: Design validation measures according to the recognized rules of technology.
- Verification by: Market observation (Field follow activities are another, albeit very late, measure in certain industries with small series).
Measure categories Examples Process FMEA.
- Process assurance by: Develop and implement documented specifications.
- Process assurance by: Qualification and use of demonstrably qualified employees.
- Process assurance by: Development and implementation of constructive safeguards (e.g. devices,..)
- Process safeguarding by: process engineering investigations to determine the process parameters.
- Process safeguarding by: Machine/process capability studies to determine machine capability/process capability.
- Process validation by: Preventive and/or condition-based maintenance/maintenance.
- Process safeguarding by: Adoption of series-proven process designs from comparable and series-proven process designs.
- Process validation by: Process design on the basis of analytical methods for robust process design (e.g. mold flow analysis)
- Process validation by: Process design on the basis of internal and/or external specifications (standards, guidelines, supplier knowledge, machine manufacturers,..)
- Periodic requalification of the process
- Statistical process control
- Process assurance by: Technical specifications, quality assurance agreements, QM system of internal and external suppliers.
- Process assurance through: Incoming goods inspection
- Process assurance through: Identification and control of interacting physical and chemical interactions from the environment (e.g. air humidity, vibrations, particle loading of the air,..)
- Quality assurance by development and implementation of in-process inspections (workers, inspection personnel, camera inspection,..)
- Series-accompanying findings of causative conditions (wear,...
- Quality assurance by product audits