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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.

Objectives

 

  • Structuring of the development of measures
  • Content input for measure development
  • Optimized consistency of measure development

That’s how it works!

 

  • 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.

File for download

Typical measures for Process-FMEA

  • Preventive measures

  • Detection measures

  • Man:

    1. Process Protection through: Developing and implementing documented specifications
    2. Process Protection through: Qualification and use of qualified employees
    3. Process Protection through: development to implement constructive safeguards (e.g. devices...)

    Machine:

    1. Process Protection through: process engineering investigations for the determination of the process parameters
    2. Process Protection through: machine / process capability tests for the determination of the machine capability / process capability
    3. Process Protection through: preventive and / or condition-dependent maintenance / servicing
    4. Process Protection through: Take-over of series-proven process designs from comparable and series-tested process designs
    5. Process Protection through: Process design based on analytical methods for the robust design of the process (e.g. Mold Flow Analysis)
    6. Process Protection through: Process design based on internal and / or external specifications (standards, guidelines, supplier knowledge, machine manufacturers, etc.)
    7. Periodic requalification of the process 
    8. Statistical process regulation

    Material:

    1. Process Protection through: Technical specifications, quality assurance agreements, QM system of internal and external suppliers
    2. Process Protection through: Incoming goods inspection
    3. Other
    4. Process Protection through: Identification and control of interfering physical and chemical interactions from the environment (e.g. air humidity, vibrations, particle loading of the air...)

    1. Quality assurance through the development and implementation of series-accompanying tests (workers, test personnel, camera testing, etc.)
    2. Series accompanying appraisal of causative states (Abrasion ...
    3. Quality assurance through product audits