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ISO and quality management

Ten key changes in AIAG & VDA FMEA

2019-11-17 08:28:52 | Lượt xem: 3749 | ISO and quality management

ITVC Global summarises ten changes introduced by the harmonised AIAG & VDA FMEA approach to help organisations plan implementation.

Original image: AIAG & VDA FMEA implementation 1
Illustration of quality management and process improvement.

1. A seven-step approach to FMEA

FMEA development uses the following seven steps:

  • Step 1 | Planning and preparation
  • Step 2 | Structure analysis
  • Step 3 | Function analysis
  • Step 4 | Failure analysis
  • Step 5 | Risk analysis
  • Step 6 | Optimisation
  • Step 7 | Results documentation

These steps are organised into three phases:

  • Steps 1-3 form the system-analysis phase of a PFMEA study.
  • Steps 4-6 cover failure analysis and risk mitigation.
  • The third phase is risk communication through Step 7, results documentation.

2. Define the scope

State clearly what is included in, and excluded from, the FMEA.

3. Supplemental FMEA-MSR

MSR: Monitoring and System Response

Supplemental FMEA for Monitoring and System Response (FMEA-MSR) addresses monitoring and response that help maintain a safe or regulatory-compliant state during customer operation, including relevant environmental requirements.

4. Structure analysis

The approach expands on a brief description of the process step by analysing the process item, process step and process work elements. This makes the structure and boundaries of the operation clearer.

5. Function analysis

Functions are considered at three levels, helping the team identify failure modes and effects more clearly.

  • Function of the process item: the function of the system, subsystem, part element or process.
  • Function of the process step and the associated product characteristic; quantitative values are used where appropriate.
  • Function of the process work element and the associated process characteristic.

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6. Revised Severity, Occurrence and Detection tables

  • Severity considers effects at the organisation's own plant, the receiving plant and the end user, where relevant.
  • Occurrence criteria consider the likelihood of a potential cause, process experience and prevention controls.
  • Detection criteria are more explicit, helping the team assess the ability of controls to detect the cause or failure mode.

7. Action Priority replaces RPN-based prioritisation

How does the risk-analysis step change?

In Step 5, Action Priority (AP) replaces RPN-based action prioritisation. AP tables combine Severity, Occurrence and Detection ratings to indicate a high, medium or low priority for action. AP prioritises action to address risks that could prevent functions from being fulfilled; it is not simply another numerical ranking of risk. Unlike ranking all items from the highest RPN downwards, the tables assign action priority to each combination independently of how many other items the FMEA contains.

8. Separate prevention and detection actions

In Step 6, the former recommended-action field is separated into prevention actions and detection actions.

9. Assign responsibility

Step 6 identifies who is responsible for implementing the prevention and detection actions for potential failures.

10. Document the PFMEA results

Document the results for internal or external communication. The records may include:

  • An executive summary
  • The FMEA scope
  • S/O/D rating table
  • Action Priorities
  • Analysis results and conclusions

AIAG & VDA FMEA introductory resource

The full AIAG & VDA FMEA Handbook is not reproduced here. The following introductory document provides further information about the changes. AIAG-and-VDA-FMEA-Handbook-Apr-4-2019-1

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