human factors as substitutes for operator error in FMEA and Root Cause Analysis

1. Technical Risk Methodology
Cameco Fuel Systems Proposal

2. Methodology
• Technical Risk Assessment and
subsequent counter measures or
containment is not about FMEA or FTA.
• Risk Mitigation Methodology proposed by
QAI Inc. utilizes several levels of analysis
and increasing levels of detail as risk is
determined to exist.

3. Methodology
• Technical Risk Assessment and
subsequent counter measures or
containment is not about FMEA or FTA.
• Risk Mitigation Methodology proposed by
QAI Inc. utilizes several levels of analysis
and increasing levels of detail as risk is
determined to exist.

4. Process Risk Factors
• When working with various causes of
Failure Modes in a process or assembly,
there are several categories to consider.
– Methods
– Machines
– Materials
– Measurement
– Mother Earth (Engineering Noise Factors)
– Man

5. Causal Considerations
• The primary items are typically part of :
– Aristotle’s Theory of Causality
– Ishakawa’s Cause and Effects Diagram
(Fishbone)
• Most are self explanatory.
• Mother Earth and Man require additional
explanation.

6. Noise Factors
• Mother Earth refers to the Noise factors which
when present can affect proper function.
• A Parameter or P Diagram is a common
Input/output tool used to capture the noises.
• There are five noises which are investigated.
– Environment
– Process/Design Interfaces
– Degradation
– Customer/Processor/User/Duty Cycles
– Unit to Unit or Batch to Batch variation

7. P-Diagram
Noise
Factors
Product or Process
Input Outputs
Response
Control Error
Factors States

8. FMEA Working Model
Per AIAG FMEA
Handbook, pg 3
What Severity 9 & 10 What can be done?
How bad
are the • Design Changes
is it?
Effect(s)?
• Process Changes
What are the
Functions, Severity < 9 and 9/10 inclusive • Special Controls
Features, or
Requirements? • Changes to
Pot. Standards,
What How often
are the does it KPCs Procedures, or
Guides
Cause(s)? happen?
What can go wrong?
• No Function
• Partial/Over
Function/Degraded How can
Over Time the cause
be All items
• Intermittent prevented requiring
Function and test
detected? How good
• Unintended planning
is this
Function method at
detecting
it?

9. The Completed Characteristics
Matrix
Characteristics
Ranked in Order of
Importance
Process Operations
from Process Flow
Potential Significant
and Critical
Characteristics
from DFMEA
High / Medium Interactions
become Causes / Failure
Modes in PFMEA
Prioritized Ranking
of Process Steps
Relative to Risk

10. Level III Process
Operations
QFD Level IV
QFD
Level III Process
Characteristics High Priority Process Parameters /
Matrix Operations Variables
Level IV
Characteristics
Matrix
KPC’s
Failure Causes on
Process related Modes on PFMEA
KPC’s Key Control
from all DFMEA’s
PFMEA Characteristics
Process FMEA
Inputs
•Failure Data •Process Flow
Control Plan
•Process •Line Layout
Capability •MFMEA
KCC Development

11. Selective on Processes
• Perform FMEA as required
– New processes or technology
– Process or design changes affecting KPC’s &
KCC’s
– Poor performance in the past
• Focus only on exceptions to the Legacy of
“what we know we know”
– Drives mistake proofing
– Process capability and variation control
– Kaizen and Lean events

12. Example of Significant / Critical
Threshold
10
CRITICAL CHARACTERISTICS
S 9 Safety / Regulatory
E 8
SIGNIFICANT
V 7
CHARACTERISTICS
E 6
Customer Dissatisfaction
R 5
I 4 ANNOYANCE
T 3 ZONE
Y 2 ALL OTHER CHARACTERISTICS
Appropriate actions /
1 controls already in place
1 2 3 4 5 6 7 8 9 10
OCCURRENCE

13. Actions
• Derived from focused effort and are timely
• Can be based on Kaizen and area
improvement activities
• Actions should be tracked outside of the
FMEA for efficiency
– Concerns database at York
• Actions drive control activities when
mistake proofing cannot be deployed

14. FMEA Control Plan
PFMEA
Recommended
Actions
KPC’s &
KCCs Current
Controls
Pre - Launch
Control
Plan

15. Legacy Matrix Example
Detective
controls
related to
the Failure
Mode
Issues
Occurrence color-coded
values from by risk
PFMEA
Worst Preventive
severity controls
values from related to
PFMEA the process
parameters
/ causes

16. Fault Tree Analysis
• FTA Example: Spindle Failure
Bearing
Motor Inadequate
Failure
Failure PM
1
Improperly
Incorrect Supplier
Scheduled
Recommendations
2

17. Human Factors
Operator Dependant Operations

18. Human Factors
• Man or Manpower is often thought of as
operator error.
• Operator Error is possible but not
actionable therefore the study of Operator
impacts on process and product is
required.
• Human Factor analysis and design is the
technical approach used to quantify the
human impact on product or process.

19. Human Factors
Operator Error
Level 1 Cause
Why? Level 2 Causes
Why?
Level 3 Causes Level…n Cause
Why?
When operator dependant operations
are the main cause of a Failure
Mode: Operator Error must be
translated to an
Operator Error is not an actionable state.
acceptable response!
3. The Level 2 Cause must be
selected.
4. If Risk (Severity or/and
Occurrence) is unacceptable
therefore level 3…n is required.

20. Human Factors
Level 1
Operator Error
1.0 Work Station Layout
Level 2
2.0 Ergonomics
3.0 Documentation and Training
4.0 Assist/tool Design
5.0 Attention/Concentration
Level 3
See following pages for Level 3 Causes
1.1….n
Level …n (multiple why) to root cause level
1.1.1…n

21. Human Factors
• Man or Manpower is often thought of as
operator error.
• Operator Error is possible but not
actionable therefore the study of Operator
impacts on process and product is
required.
• Human Factor analysis and design is the
technical approach used to quantify the
human impact on product or process.

22. Example of Significant / Critical
Threshold
10
CRITICAL CHARACTERISTICS
S 9 Safety / Regulatory
E 8
SIGNIFICANT
V 7
CHARACTERISTICS
E 6
Customer Dissatisfaction
R 5
I 4 ANNOYANCE
T 3 ZONE
Y 2 ALL OTHER CHARACTERISTICS
Appropriate actions /
1 controls already in place
1 2 3 4 5 6 7 8 9 10
OCCURRENCE

23. Human Factors
Operator Error
Level 1 Cause
Why? Level 2 Causes
Why?
Level 3 Causes Level…n Cause
Why?
When operator dependant operations
are the main cause of a Failure
Mode: Operator Error must be
translated to an
Operator Error is not an actionable state.
acceptable response!
3. The Level 2 Cause must be
selected.
4. If Risk (Severity or/and
Occurrence) is unacceptable
therefore level 3…n is required.

24. Human Factors
Level 1
Operator Error
1.0 Work Station Layout Level 2
2.0 Ergonomics
3.0 Documentation and Training
4.0 Assist/tool Design
5.0 Cognitive/Attention/Concentration
Level 3
See following pages for Level 3 Causes
1.1….n
Level …n (multiple why) to root cause level
1.1.1…n

25. Level 2 Causes Work Station
Design
• Level 3 Causes
– Bench/Table Height
– Organization of work tools (5S)
• # of tools and placement
– Component Positions
• Quantity
• Similarity
– Extended Reach (occasional)
– Lighting
– Comfort Features
• foot rests/seat position
• Standing work bench position

26. Level 2 Causes Ergonomics
• Level 3 causes
• Height and Reach
– Work type
• Weight
– Lifting
• Motion
– #of steps
– Degrees of freedom
• Work station interface
– Blind operation
• Posture
• Insertion force
• Static insertions
– Plastic deformation of end source
• Tool
– vibration
– Tool design

27. Level 2 Causes Documentation and
Training
• Level 3 Causes
• Illustrations on Process Documentation
• “A4” One page
• No Documentation
• Validation of Work Practice
– Testing
– Demonstration
– Frequency of validation
• Training definition
• Complexity of documentation
• Labeling
• Legibility of work instructions
– # of pages
– Understandability (5 second rule)
– Fonts size and type

28. Level 2 Causes Assists and Tool
Design
• Level 3 Causes
• Error proofing features
• Tool calibration
– Pallet compliance
• Correct tool
• Life of tool
• Fixture control
• Clamp pressure
• Cycle completion/interruption
• Locator/proximity life
• Measurement instrument

29. Level 2 Causes
Cognitive/Perception
• Level 3 Causes
• Audible Noise
• Environment
– Temperature
– Humidity
• Sensitivity to Interruption
• Repetition
– Motion
• Trance/Zone Inducement
– Sound Quality
– Harmonics
– Vibration/cyclical noise