The following slides are not contractual in nature and
are for information purposes only as of June 2015.
2015, Lockheed Martin Corporation. All Rights Reserved.
Corrective Action
Root Cause Analysis and Corrective
Action
2015, Lockheed Martin Corporation. All Rights Reserved.
Overview Webinar 6: Root Cause Analysis
and Corrective Action
What is Root Cause Analysis (RCA)?
Why is RCA important?
When is RCA required?
Overview of the Corrective Action Process
Root Cause Analysis Tools:
The 5-Whys
Ishikawa Cause & Effect (Fishbone) Diagrams
Cause Mapping
Failure Modes & Effects Analysis
Design of Experiments
3
What is Root Cause Analysis (RCA)?
Root Cause Analysis (RCA): The process of identifying all
the causes (root causes and contributing causes) that have
or may have generated an undesirable condition, situation,
nonconformity, or failure.
IAQG Root Cause Analysis and Problem Solving
April 2014.
Root Cause Analysis (RCA)
CAUSE = ROOT
(not obvious)
Cause
PROBLEM =
Weed
(obvious)
Cause
Why Root Cause Analysis (RCA)?
Helps prevent problems from repeating or occurring.
Focus on Continuous Improvement throughout the
Enterprise.
Drives Breakthrough Performance.
Focus on improving processes that actually effect
organization performance metrics.
When is RCA required?
Undesirable condition, defect, or failure is detected
Safety
Product strength, performance, reliability
High impact on Operations
Repetitive Problems
Customer Request
Significant Quality Management System (QMS) issues
IAQG Root Cause Analysis and Problem Solving,
April 2014
7
The Corrective Action (CA) Process
Identify Problem
Objective: Identify the cause(s) of problems and
initiate actions to prevent recurrence.
Extent of corrective actions shall be
proportional to the effects of the related
problems.
Corrective action is applicable to the
enterprise and not limited to the
manufacturing environment.
Problems may originate and/or be identified
within a product, process, and/or capability in
any business area, function, or program.
Define Problem
Investigate Problem
Analyze Problem and Identify Cause(s)
Generate and Implement Solutions
Verify Results and Document
Monitor and Meausure
8
The Corrective Action Process
Identify Problem
Increased focus on Problem Definition
Requirement for Evidence-Based Causes
Requirement to always look for Multiple
Causes
A Corrective Action end state that includes
Verified successful mistake proofed
solutions
Goal of 0% Chance of Recurrence
Define Problem
Investigate Problem
Analyze Problem and Identify Cause(s)
Generate and Implement Solutions
Verify Results and Document
Monitor and Meausure
9
Overview of the Corrective Action Process
Step 1: Identify the Problem
Step 2: Define the Problem
Step 3: Investigate the Problem (Complete Containment
Actions)
Step 4: Analyze the Problem & Identify Root Cause (s)
Step 5: Generate, Select and Implement Solutions (CA)
Step 6: Verify the Results and Document
Step 7: Monitor and Measure Corrective Actions
10
Corrective Action Process Flow:
Inputs:
Nonconforming
Products or Services
Noncompliant
Processes or
Capabilities
Audit Findings
Customer Complaints
Management
Directives
Program Monitoring or
Review
Identify Problem
Define Problem
Investigate Problem
Analyze Problem and Identify Cause(s)
Generate and Implement Solutions
Verify Results and Document
Monitor and Meausure
Outputs:
Implemented/Verified
CA Plan
Improved
Capabilities/Products
Costs Reduced
Schedule Improved
Quality Improved
Customer Satisfaction
Record of Corrective
Action and Verification
11
Corrective Action Process
7 tools to determine root cause:
The 5 Why's
Cause & Effect Diagram (Fishbone)
Cause Mapping
FMEA: Failure Modes & Effects Analysis
Fault Tree Analysis
DOE: Design Of Experiments
Statistical Process Control
Perform a Cause/Failure Analysis to determine the cause(s) of the problem.
The appropriate root cause analysis tool will be used.
The RCA tools are utilized and retained/attached as objective evidence to
support root cause validation.
12
Occurrence
< Likelihood of the Event Recurring >
Severity/Impact Based RCA Approach
High
Future failures with this and
similar processes are inevitable
Level 3 RCA
Level 4 RCA
Highest Risk Items
Most RCA Efforts
100% at Level 5 RCA
Level 2 RCA
Level 3 RCA
Level 4 RCA
Lowest Risk Items
Level 1 RCA
Level 2 RCA
Level 3 RCA
Low
Medium
High
Minor disruption to process
Output may have to be sorted and
a portion reworked
Fit and finish does not conform
Noticeable to some customers
Minor disruption to process
Portion may have to be scrapped
Operable but without all
conveniences
Fit and finish does not conform
Concerned customer
DCMA Level II CAR
Medium
Likely to find future failures with
this and similar processes
Low
May find future isolated failures
Instructions:
1. Use the description of Low,
Medium, High to assess issues
Severity and Likelihood of
Recurrence
2. Based on the issues Severity and
Likelihood of Recurrence, map to
the corresponding Level of RCA
3. Using the color of the RCA Level
as a guide, assess the
requirements for that RCA tool
Severity
< Significance of Impact >
Major disruption to process
100% may have to be scrapped
Inoperable, loss of primary
function
Dissatisfied customer
DCMA Level III CAR
What RCA Tool Should I Use?
RCA
Level
Impact
RCA Requirements
Recommended
RCA Lead
High-High
Apollo RCA using
RealityCharting Tool
Experienced and
Certified Apollo RCA
Facilitator
High-Medium
Medium-High
RCA using Think
Reliability Tool
Apollo RCA using
RealityCharting Tool
Experienced and
Certified Apollo or Think
Reliability RCA
Facilitator
FMEA - Failure Modes
Effects Analysis
High-Low
Medium-Medium Apollo Methodology
Apollo RealityCharting
Low-High
Think Reliability
FMEA Trained
Employee
Apollo or Think
Reliability RCA Trained
Facilitator or
5 Whys
Fishbone Diagram
FMEA - Failure Modes
Effects Analysis
Trained Employee
Green Belt / Black Belt
5 Whys
Fishbone Diagram
All Trained Employees
Low-Medium
Medium-Low
Low-Low
Typical
Analysis
Span*
Output Templates
2 6 Weeks
1. Summary including Problem Statement
2. RCA Findings and Conclusions
3. RCA Corrective Action Solutions and
Measurement Strategy
4. Illustration of Apollo RCA Template
OR
1.
Illustration of Apollo
RCA Template
1 4 Weeks
1. Summary including Problem Statement
2. RCA Findings and Conclusions
3. RCA Corrective Action Solutions and
Measurement Strategy
4. Applicable Illustration of RCA Template
OR
1.
Applicable Illustration
of RCA Template
1.
2.
1 day 3 weeks 3.
4.
Summary including Problem Statement
RCA Findings and Conclusions
RCA Corrective Action Solutions and
Measurement Strategy
Applicable Illustration of RCA Template
1 day 2 weeks
1.
2.
Summary including Problem Statement
Applicable Illustration of RCA Template
1 8 hours
1.
2.
Summary including Problem Statement
Applicable Illustration of RCA Template
OR
1.
Applicable Illustration
of RCA Template
* Analysis Span Time for completion of an effective RCA is dependent upon:
1) Scope of problem; 2) Quality of preparation; and 3) Resources allocated to RCA and problem resolution
Selecting a RCA Leader
Basic
Advanced
Problem Complexity
Data type and availability
Type analyses required
Individual or team based
approach RCA
Severity of issue/impact to
business
Internal/external
engagement
15
Root Cause Analysis Tools
The 5-Whys
Cause & Effect (Fishbone/Ishikawa Diagrams)
Cause Mapping
Failure Modes & Effects Analysis
Design of Experiments
16
The 5 Whys
What is a 5 Why?
A question based technique used to explore cause-and-effect relationships
Determine root cause of a problem
Ask Why? As many times as needed!
Advantages
Why?
Easy to use and teach
Identifies more than one cause
Useful for minor problems
Used to generate causes for use in other RCA methods
Why?
Why?
Why?
Why?
Limitations
Linear thinking ignores additional causes
Not appropriate for formal investigations
Perpetuates the myth of single root cause
Does not provide guidance for solutions
Supporting Tools
5 Why Template - this is a text only approach
17
5 Whys Template
Instructions: Start with your focused problem and then ask WHY five times.
Focused Problem Statement:
Problem: High reject rate of parts used by downstream aircraft assembly process
Why
There is bare material exposed
Why
The primer paint coating does not cover the whole part
Why
The priming process does not ensure full coverage
Why
Solution: Create a standard
work method that defines
the exact sequence and
tools for priming the parts.
This will significantly
improve the process yield.
The priming process is never done the same way twice
Why
The priming process has always relied on word-of-mouth
training and has no standard process defined
18
A New Look at 5 Why Templates
THE SINGLE CAUSE TEMPLATE
PROBLEM STATEMENT: ___________________________________________________
WHY?
WHY?
WHY?
WHY?
This example is a typical format for narrow problem statements where one cause-path exists. For
problem statements with multiple causes, use the template below.
MULTIPLE CAUSES TEMPLATE
PROBLEM STATEMENT: _______________________________________________________
WHY?
WHY?
WHY?
WHY?
__% of Pareto
__% of Pareto
19
Proposed Operating Instruction for alternate 5
Why Template
20
Ishikawa Cause & Effect Diagram (Fishbone)
What is A Cause and Effect Diagram?
A
tool used to illustrate the relationship between an effect and
the causes that influence the effect
When to Use It?
Identify causes of a problem (Effect)
Can be used to prevent future problems
CAUSES
HAND
WAVE
METHODS
EFFECT
PEOPLE
ENVIRONMENT
ABSENTEEISM
SOLDER
TRAINING
INSERTION
ESD
DEBRIS
P. C. Board
Yield Too Low
INCORRECT
GAGE
AUTO TEST
SHORTAGE
WRONG PARTS
VENDOR
MEASUREMENTS
MACHINES
MATERIALS
PURCHASING
21
Ishikawa Cause & Effect Diagram (Fishbone)
Advantages
Encourages brainstorming
Can be used when time is very limited
Helps organize many potential causes
Limitations
Categories may cause investigations to stop at "categorical causes
Creates the illusion of equal weight among causes
No guidance for prioritizing causes or developing solutions
Usually stops at 1 or 2 levels of causes (stops too soon)
CAUSES
HAND
WAVE
METHODS
EFFECT
PEOPLE
ENVIRONMENT
ABSENTEEISM
SOLDER
TRAINING
INSERTION
ESD
DEBRIS
P. C. Board
Yield Too Low
INCORRECT
GAGE
AUTO TEST
SHORTAGE
WRONG PARTS
VENDOR
MEASUREMENTS
MACHINES
MATERIALS
PURCHASING
22
Ishikawa Cause & Effect Diagram (Fishbone)
every Effect there are likely to be several Major Causes
For
Major Causes include: People, Measurements, Machines, Methods,
Materials, Environment
Any major category that helps people think creatively can be used
CAUSES
HAND
WAVE
METHODS
EFFECT
PEOPLE
ENVIRONMENT
ABSENTEEISM
SOLDER
TRAINING
INSERTION
ESD
DEBRIS
P. C. Board
Yield Too Low
INCORRECT
GAGE
AUTO TEST
SHORTAGE
WRONG PARTS
VENDOR
MEASUREMENTS
MACHINES
MATERIALS
PURCHASING
23
Ishikawa Cause & Effect Diagram (Fishbone)
Methods = work instructions, procedures, test methods
Material = components and raw materials
Measurements = standards, calibration, gages, data collection
People = training and staffing
Machines = tools, equipment, fixtures
Environment = temperature, humidity, lighting, noise
Goal is to discover all possible Causes related to the Effect!
CAUSES
HAND
WAVE
METHODS
EFFECT
PEOPLE
ENVIRONMENT
ABSENTEEISM
SOLDER
TRAINING
INSERTION
ESD
DEBRIS
P. C. Board
Yield Too Low
INCORRECT
GAGE
AUTO TEST
SHORTAGE
WRONG PARTS
VENDOR
MEASUREMENTS
MACHINES
MATERIALS
PURCHASING
24
Ishikawa Cause & Effect Diagram (Fishbone)
How to Construct a Cause & Effect Diagram:
Brainstorm include Subject Matter Experts (SME)
Add the problem to the EFFECT box.
Add the Major Cause categories
Place the potential causes in the Major Cause category.
For each Cause ask, Why does it happen?
List the responses as branches off the Major cause.
CAUSES
HAND
WAVE
METHODS
EFFECT
PEOPLE
ENVIRONMENT
ABSENTEEISM
SOLDER
TRAINING
INSERTION
ESD
DEBRIS
P. C. Board
Yield Too Low
INCORRECT
GAGE
AUTO TEST
SHORTAGE
WRONG PARTS
VENDOR
MEASUREMENTS
MACHINES
MATERIALS
PURCHASING
25
Ishikawa Cause & Effect Diagram (Fishbone)
How to Interpret?
Look for causes that appear frequently.
Reach a team consensus.
Determine the relative frequencies of the different causes.
CAUSES
HAND
WAVE
METHODS
EFFECT
PEOPLE
ENVIRONMENT
ABSENTEEISM
SOLDER
TRAINING
INSERTION
ESD
DEBRIS
P. C. Board
Yield Too Low
INCORRECT
GAGE
AUTO TEST
SHORTAGE
WRONG PARTS
VENDOR
MEASUREMENTS
MACHINES
MATERIALS
PURCHASING
26
Example of Cause & Effect Diagram
Materials
Machines
Measurement
Gas Gauge Broken
Starter Broken
Lost the Keys
Battery Dead
Out of Gas
Engine Overheated
Battery Cables Corroded
Car Will Not Start
Not Pressing Accelerator
Lack of Training
Too Cold
Using Wrong Key
Locked Out of Car
No Preventive Maintenance
Forgot Code to Start Car
Methods
People
Environment
27
Example C&E Diagram - Canopy Leakage
28
What is a Cause Map?
A visual explanation of why an incident occurred
Connects single cause-and-effect relationships to a system
of causes
A Cause Map can be basic or very detailed
29
Cause Mapping for Root Cause
Step 1: Problem Statement
Identify/Outline the Problem (What, When, Where, Goal)
The Outline explains why time is spent on an issue
Step 2: Analysis
Identify/Breakdown the Causes
This step is where the Cause Map is built
Step 3: Solutions
Identify Possibilities
Select the most appropriate Solution
Implement specific Corrective Action
Verify/Validate Effectiveness
Document with Objective Evidence
30
Cause Mapping - How to read a Cause Map
State the Problem
Ask Why Questions - "Why did this effect happen?"
Record Response = Cause (or causes)
31
Cause Map Example
Pushing cart
Standard procedure for
picking up/delivering
items to work area
Evidence:
Safety Goals
Impacted
Possible
Solutions:
Melissa
Injured Right
shoulder
Heavy load on
cart
There is not
current load
limit
Standard load
limit can not
be defined
Evidence:
Cart was not
rolling right
Possible
Solutions:
Wheel was
jammed
Possible
Solutions:
Twig/stick
stuck in wheel
Carts are also
used outside
Evidence:
32
Cause Mapping
When to Use It:
Use to develop an effective solutions to prevent recurrence of undesired effects
Use when you want to fully understand causes of success
Use to reveal the entire system of causes
Use it when you need to dive deeper into a problem
Advantages:
Reveals the entire system of causes and effects
Focuses on cause-effect relationships
Emphasizes effective solutions to prevent recurrence
Mitigates the hazards of using categories or checklists alone to drive analysis
Focuses attention on events and conditions rather than people
Limitations:
Does not prioritize causes or solutions
Has a learning curve for facilitators and team members
Lengthier process than other tools
Does not lend itself to proactive problem solving
33
Failure Mode & Effects Analysis (FMEA)
What is FMEA?
A systematic method for identifying, analyzing, prioritizing, and documenting
potential failure modes and their effects on a system, product, or process and the
possible causes of failure.
Where Is FMEA Used?
Used extensively in safety oriented and aerospace businesses.
Why FMEA?
Reduce development cost by early risk identification
Documented evaluation of risk
Minimize product failures
Track process improvements
Develop efficient test plans
34
Failure Modes and Effects Analysis (FMEA)
When to Use FMEA:
Identify and eliminate known or potential failures or errors from a product or a
process
Engineering mitigate risk in product design
Manufacturing reduce and eliminate product defects
Transactional reduce and eliminate process errors
Use when identification of the root cause may be complex
Advantages
Provides quantitative rankings with defined scale for prioritizing based on severity,
occurrence, and detection of current controls
Analyzes potential causes
Can be used proactively (risk management)
Can be used to assess current mitigation plans
Provides a structure for developing and prioritizing solutions
Limitations
Does not delineate causal relationships
Does not require supporting causes with evidence
Addresses specific failure modes individually without taking a systems view
35
Failure Mode & Effects Analysis (FMEA)
Types of FMEAs
Process: Used to analyze processes and identify
potential failure modes
Design/Product: Used to analyze products and identify
potential failure modes early in the development cycle
Defect: Used to analyze and prioritize defects to
prevent recurrences in products and processes
36
Failure Mode & Effects Analysis (FMEA) Tool
Form Team
Brainstorm potential
failures that may
cause the product
or process to fail to
meet its intent
List product
or process
Process
Assign a severity
score to each
failure mode based
on severity of
impact
List the consequences
of each failure mode
Failure Mode Failure Effect
Assign an
occurrence score to
each failure mode
based on frequency
of occurrence
Identify causes
of failure mode
Sev Cause Occ
Assign a
detection score to
each failure mode
based on ability to
detect failure mode
Identify controls that
detect failure mode
Controls
Det
RPN
RPN (Risk Priority Number) = SEV * OCC * DET
This serves as the level of priority that should be assigned to each failure mode
37
Design of Experiments (DOE)
Why Use DOE?
Can be used to help improve the capability of a process by identifying
the process and product variables that effect the mean and the variance of
the quality characteristics of a product.
Can be used as a powerful tool to achieve manufacturing cost savings by
minimizing process variation, reducing rework and reducing scrap
Use DOE when more than one input factor is suspected of influencing an
output.
38
Design of Experiments (DOE)
When Can I Use DOE?
When you want to find the input settings that optimize the output
of a process
When you want a mathematical model relating the outputs and / or
variance of a process to the inputs
When you want to identify the most important input factors that
influence the mean output or the variance of the output
When you want to determine the cause of a product failure
39
Design of Experiments (DOE)
Where Can I Use DOE?
Any process with measurable quantitative or qualitative
inputs and quantitative outputs is a potential application for DOE
In engineering design, to find component values and tolerances that
optimize the response
In production, to optimize the yield of a machine or assembly
process
In testing, to ensure the fullest coverage of possible inputs with a
minimum number of tests
DOE Applications Are Limited Only By The Imagination
40
Summary
Root Cause Analysis is not easy!
Be diligent in the pursuit of Root Cause
Address the Cause not the Symptom
The RCA Tools presented today will help ensure:
Thorough Investigations
Identification of Root Cause
Effective Corrective Actions
Root Cause + Effective Corrective Action =
Problem Elimination!
41
Summary
Root Cause Analysis is the process of applying the cause and
effect principle to solve problems. A root cause analysis program
should be a systems approach to finding effective solutions to
prevent problems from occurring or recurring.
RCA Tools provide a means to conduct systematic analysis of a
problem to identify cause and effect relationships and identify
appropriate solutions to eliminate nonconformances
Corrective Action: Action(s) taken to eliminate the cause of
nonconformances in order to prevent recurrence
Root Cause Analysis helps ensure:
Continuous improvement
Efficient use of resources
Focus on actions that are most impactful
Root Cause + Effective Corrective Action =
Problem Elimination!
42
Root Cause Analysis References
IAQG Root Cause Analysis and Problem Solving
(aligned with IAQG 9136 draft) [Link]/scmh
The Memory Jogger 2 Tools for Continuous Improvement
and Effective Planning
The Lean Six Sigma Pocket Tool Book
Think Reliability [Link]
43
