Transcript International Certification Perceived Benefits

Where does Failure Mode and Effects
Analysis (FMEA) come from?
Developed by the Aerospace industry
in the1960s
Spread to the Automotive industry
Now used extensively
across all industry sectors
Root Cause Analysis: Documenting, implementing and closing nonconformances
Different Types of FMEA
Design
An analytical technique used primarily by Design
Responsible Engineer/Team as a means to assure
potential failure modes, causes and effects have been
addressed for design related characteristics
Process
An analytical technique used primarily by a Manufacturing
Engineer/Team as a means to assure potential failure
modes, causes and effects have been
addressed for process related
characteristics
Root Cause Analysis: Documenting, implementing and closing nonconformances
Process FMEA
A structured approach to:
•Identifying the way in which a process can fail to meet
critical customer requirements
•Estimating the risk of specific causes with regard to these
failures
•Evaluating the current control plan for preventing these
failures from occurring
•Prioritizing the actions that should
be taken to improve the process
Root Cause Analysis: Documenting, implementing and closing nonconformances
Our Focus is on Process FMEA
Concept:
To identify ways the product or process can fail and
then plan to prevent those failures, utilizing mistake
proofing tools
and techniques.
Refer to sample sheet 2 – FMEA template
Root Cause Analysis: Documenting, implementing and closing nonconformances
Why we use FMEA?
Prevention rather than cure.
Increase probability of DETECTION
Identify biggest contributor to failures and eliminate
them
Reduce probability of failure occurring
Build quality into the product
& process
.
Root Cause Analysis: Documenting, implementing and closing nonconformances
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When to use FMEA?
FMEA is most beneficial as a “before theevent” action
Design FMEA should be done during initial
design of product
Process FMEA should be done during
design of manufacturing process
Root Cause Analysis: Documenting, implementing and closing nonconformances
Potential Applications for PFMEA
Outsourcing / Resourcing of product
Develop Suppliers to achieve Quality
Renaissance / Scorecard Targets
Major Process / Equipment / Technology
Changes
Cost Reductions
New Product / Design Analysis
.
Root Cause Analysis: Documenting, implementing and closing nonconformances
Guide to Process FMEA?
.
Step 5
Step 4
Step 3
Step 2
Identify causes of failure
Determine severity
rankings
Identify potential effects
of failure
Brainstorm all potential
failure modes
Step 1
Root Cause Analysis: Documenting, implementing and closing nonconformances
Scope the project
Guide to Process FMEA?
.
Prioritize actions
Step 10
Step 9
Calculate Risk Priority
Rankings
Step 8
Determine Detection rankings
Step 7
Define current control
methods
Step 6
Determine occurrence ranking
Root Cause Analysis: Documenting, implementing and closing nonconformances
Step 1 - Scope Process
•Formulate cross functional team
•Understand customer/process requirements
•Define start and end of process
•All team members walk and observe the
process
•Get the ‘process worker’ to explain the
operation/process under review.
•Make notes/observations.
Root Cause Analysis: Documenting, implementing and closing nonconformances
Definition of a failure mode
The way in which a specific process
input fails - if not detected and either
corrected or removed, will cause an
effect to occur.
Root Cause Analysis: Documenting, implementing and closing nonconformances
Step 2 –
Brainstorm all potential failure modes
•Utilize process flow chart - break down each
step
•Use knowledge of previous and existing
parts/processes
•Review all quality information -complaints,
scrap, rework, turn backs, etc.
•Talk to internal and external
customers.
Refer to handout
Root Cause Analysis: Documenting, implementing and closing nonconformances
Definition -Effects of failure
Effect - impact on customer requirements.
Generally focused on impact on external
customer, but can also include downstream
processes.
Does not fit/Cannot load or fasten
Intermittent operation/Unscheduled
Downtime
Poor performance of product
Lost sales
Root Cause Analysis: Documenting, implementing and closing nonconformances
Step 3 –
Identify potential effects of failures
For each failure mode, identify the effect(s) on
the current or next process or customer
downstream in the manufacturing/assembly
process.
Describe the effects of the failure in terms of
what the customer might notice
or experience
Root Cause Analysis: Documenting, implementing and closing nonconformances
Step 4 –
Determine severity ranking
Refer to handout
Root Cause Analysis: Documenting, implementing and closing nonconformances
Definition - Causes
Sources of process variation that causes the
failure mode to occur.
E.g.
 Part not in fixture properly
 Incorrect tool
Inaccurate Gauge
Inaccurate quote/invoicing
Root Cause Analysis: Documenting, implementing and closing nonconformances
Step 5 –
Identify all potential causes off failure
How the failure could occur, described in
terms of something that can be corrected or
controlled
• Experiments may have to be conducted to
determine causes - use Technical Problem
Solving
• There could be more than one cause for
each failure
Root Cause Analysis: Documenting, implementing and closing nonconformances
Step 6 –
Determine occurrence ranking
Refer to handout
Root Cause Analysis: Documenting, implementing and closing nonconformances
Definition –Current Controls
Systematic methods/devices in place to
prevent or detect failure modes or causes
(before causing effects)
Prevention consists of mistake proofing,
Automated control and set up verifications
Controls consists of audits, inspection,
training, etc.
Root Cause Analysis: Documenting, implementing and closing nonconformances
Step 8 -Determine detection ranking
Refer to handout
Root Cause Analysis: Documenting, implementing and closing nonconformances
Step 9 -Calculate the Risk Priority Number
RPN = Risk Priority Number
Multiply severity, occurrence and detection
rankings together
Root Cause Analysis: Documenting, implementing and closing nonconformances
Step 10 - Prioritize corrective actions
Tackle highest RPN’s first
• How can we reduce the occurrence?
• How can we improve the detection?
• Use process improvement skills
• Where possible apply mistake proofing
techniques.
Root Cause Analysis: Documenting, implementing and closing nonconformances
Step 10 - Prioritize corrective actions
Standardization across all products or
processes
Introduce any change in a controlled
manner.
Note :- Mistake proofing process will result in
either lower occurrence or detection rankings
Root Cause Analysis: Documenting, implementing and closing nonconformances
Reassess rankings when action completed
FMEA must be a live document
 Review regularly
 Reassess rankings whenever changes
made to product and/or process
 Add any new defects or potential
problems when found
Root Cause Analysis: Documenting, implementing and closing nonconformances