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FMEA Measure Categories

The product and process FMEA generates as a major result of the risk minimization "Development-accompanying prevention and detection measures". Practice shows that it can be beneficial for the development process of the FMEA, the FMEA moderator and the experts involved to enter the creative process with defined "measure categories". These structures and standardize the necessary discussions clearly, without restricting the creative part of the work. These structures and standardize the necessary discussions clearly, without restricting the creative part of the work. The contents of the download are a well referred example without any claim to completeness. In terms of content, these must also be concretized in the context of the respective cause-fault relationship.

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

Categories
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.
Avoidance measures:

  1. 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).
  2. System/feature design based on benchmark study
  3. 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):

  1. Verification measures by: Design review to verify function X (perform code review).
  2. Detection by: Analytical procedures to confirm the design of the system/components (simulation model).
  3. 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).
  4. 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.
  5. 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.
  6. 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.
  7. Verification management by: Design validation measures according to the recognized rules of technology.
  8. Verification by: Market observation (Field follow activities are another, albeit very late, measure in certain industries with small series).

Measure categories Examples Process FMEA.
Avoidance measures:
Man:

  1. Process assurance by: Develop and implement documented specifications.
  2. Process assurance by: Qualification and use of demonstrably qualified employees.
  3. Process assurance by: Development and implementation of constructive safeguards (e.g. devices,..)

Machine:

  1. Process safeguarding by: process engineering investigations to determine the process parameters.
  2. Process safeguarding by: Machine/process capability studies to determine machine capability/process capability.
  3. Process validation by: Preventive and/or condition-based maintenance/maintenance.
  4. Process safeguarding by: Adoption of series-proven process designs from comparable and series-proven process designs.
  5. Process validation by: Process design on the basis of analytical methods for robust process design (e.g. mold flow analysis)
  6. Process validation by: Process design on the basis of internal and/or external specifications (standards, guidelines, supplier knowledge, machine manufacturers,..)
  7. Periodic requalification of the process
  8. Statistical process control

Material:

  1. Process assurance by: Technical specifications, quality assurance agreements, QM system of internal and external suppliers.
  2. Process assurance through: Incoming goods inspection
  3. Co-environment
  4. 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,..)

Discovery measures:

  1. Quality assurance by development and implementation of in-process inspections (workers, inspection personnel, camera inspection,..)
  2. Series-accompanying findings of causative conditions (wear,...
  3. Quality assurance by product audits
  4. ...