4.2 Analysis of Design Potential Failures and Effects
Activity Purpose:
Identify potential design failure modes, their associated causes and their effects.
Implement effective and adequate countermeasures to minimize the probability of failure occurring.
Notes:
Significant system faults shall be analyzed using a top down approach from a single potential failure mode to identify all possible causes (Fault Tree Analysis)
The supplier must consider historical concerns, recurrence prevention, and customer satisfaction targets on assemblies and sub-assemblies / components when deciding the scope of this activity
Phase
1
2
3
4
5
Activity Content
-Complete a Design Potential Failure and Effects Analysis including a Fault Tree Analysis
-Implement a risk priority number (R.P.N.) reduction activity.
-Implement countermeasures prior to tooling release and record on related documents, such as Drawing / CAD data etc.
-Initiate 'Analysis of Process Potential Failure and Effects' for simultaneous engineering activities
-Review and update the DFMEA / Product FMEA and the FTA whenever the design is changed or modified.
Output Document
-Design Potential FMEA
-Product FMEA
-Fault Tree Analysis
