7-Step Roadmap: Critical Activities

Protect the
Define the customer-
reported problem
(failure) in terms related to
the product and its use.
customer,
Determine all both internal and external,
possible causes for by quickly minimizing
the reported problem/ the effect of product
failure mode. problem/failure mode.
Select and verify Quantify the long
an effective Plan and implement term effectiveness
Determine the permanent solution the permanent of the permanent solution
assignable cause(s) that will eliminate the solution, fail-safe and prevent recurrence
of the product problem. cause and the problem. where possible. of the problem.

STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 STEP 6 STEP 7

Identify the Problem Identify and Rank Take Short-Term Determine Failure Select and Verify Implement Permanent Monitor and Prevent
Possible Causes Action Cause(s) the Solution Solution Recurrence

Determine the Fully understand Assess the severity Systematically Select the best Implement the Define how
symptoms, the failure with of the effect of the conduct tests solution that permanent the long-term
conditions, and respect to the 3 problem on the to demonstrate will address the solution into the effectiveness of the
circumstances Realities (Real customer(s) and a correlation failure cause(s) design or process permanent solution
of the problem Parts, Real take appropriate, between the and permanently documentation. will be quantified
(failure). Place, in the Real immediate action. possible causes(s) eliminate the and verify that
Situation). and the observed product/failure Plan, control, and the permanent
Define the system, Determine product problem/ mode. document the solution meets
subsystem, or Utilize a cross containment failure mode. introduction of the the effectiveness
component that functional team strategies, Verify through permanent solution criteria.
failed. of experts to quarantine Replicate the analysis, into production or
systematically methods, product problem/ simulation, and/ the next prototype Ensure that
Understand the derive all possible and inventory failure mode (be or testing, that build. the underlying,
loss of function causes of the assessments. able to turn the the selected systemic,
and the failure problem. failure mode on permanent solution Ensure all affected process issue
mode. Ensure that short- and off). is effective and areas (design, that allowed the
Document a term actions will does not cause manufacturing, product problem
Document a prioritized list of not create other additional product supplier, to occur has been
problems, are
concise and possible causes problems. purchasing, etc.) addressed.
documented, and
quantifiable of the product remain effective approve or are
problem statement. problem/failure until a permanent informed of the
mode. solution is permanent solution
implemented. and timing.
7-Step Roadmap: Key Tools
STEP 1 STEP 2 STEP 3 STEP 4 STEP 5 STEP 6 STEP 7
Identify the Problem Identify and Rank Take Short-Term Determine Failure Select and Verify Implement Permanent Monitor and Prevent
Possible Causes Action Cause(s) the Solution Solution Recurrence

3 Realities Fault Tree Analysis Product Safety Fault Tree Analysis Critical Parameter Control Plans Root Cause
Hazard Analysis Flowdown Analysis
Failed Parts Form Review FMEAs Capability Analysis Failsafing
Local Campaign Process Mapping Update FMEAs
Field Investigation Root Cause Processes t-Tests RACI Diagram
Form Analysis Capability Analysis Capability Analysis
Local Quality Alerts ANOVA Engineering Job
Review FMEAs Critical Parameter t-Tests Request Statistical Process
Flowdown Correlation and Control (SPC)
Regression ANOVA Local Campaign Charts
Process Mapping Analysis Processes
Correlation and
Statistical Process Regression Local Inspection
Control (SPC) Analysis Processes
Charts
Statistical Process Local Build
Design of Control (SPC) Standards
Experiments Charts
Local Quality Alerts
Comparative Design of
Analysis Experiments

Comparative
Analysis

Preferred Tools for FIRG & RPS