Root Cause Investigation for CAPA

Weaver Consulting
Solving Local Problems Globally
About Weaver Consulting
• Focus on root cause analysis since 2003

• Thousands of alumni from hundreds of companies across dozens

of industries worldwide

• Proud partner of the FDA, RAPS, ASQ, PDA, the U of Penn, and
other quality/regulatory focused institutions

Rob Weaver

Weaver Consulting
Objectives
• Overview of the investigation methodology

• Questions

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Investigation Scenario

22
Upper Control
20 Limit (UCL)

18
Performance
16
Lower Control
Limit (LCL)
14

12 Change
(Special cause of variation)
10

Time
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Common Investigation Mistakes To Avoid
• Inconsistent approach to investigations

• Focusing on possible causes too early in the

investigation

• Neglect to identify and address systemic (contributing)

root causes

• Lacking documentation

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Critical Terms

Correction

Corrective action

Preventive action

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Correction
• Action taken to eliminate a detected nonconformity

• Containment to stabilize problem

• Examples
o Scrap
o Repairs or modifications
o Recalls

• Investigation has not been conducted

• Nonconformities continue
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Corrective Action
• Action taken to eliminate the cause of a detected
nonconformity

• Requires investigation and identification of root cause

• Action taken to stop or minimize recurrence

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Preventive Action
• Action taken to eliminate the cause of a potential
nonconformity

• Often impractical to prevent all possible nonconformities

• Some, perhaps most can be prevented

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Root Cause Investigation for CAPA Roadmap © 2022 Weaver Consulting

1. Define the Performance Problem 2. Collect Data

Multi-Vari Chart
Is/Is Not Diagram Is/Is Not Diagram Data Collection Plan
Is Is Not Data Data Analysis
What Timeline of Events Is Is Not

Measure
Needed Location Tools
Event Event Event Discovery
Define

Where What
When Date/Time Date/Time Date/Time Date/Time Analysis of Mean
Where
How Much When
How Much
Process Flow Chart Team Charter
Step 1 Step 2 Step 3 Problem Statement
→ → Heat Map Capability Study Control Chart Cheeksheet
Key inputs Key inputs Key inputs Acceptance Criteria
xxxxxxxxxxxxx
↓ Cost Savings Goals
xxxxxxxxx
Step 6 Step 5 Step 4 Team Members
← ← xxxxx
Key inputs Key inputs Key inputs Executive Sponsor

3. Identify Possible Causes Cause & Effect Diagram 4. Test Possible Causes
Is/Is Not Diagram Test Sheet
Is/Is Not Diagram Differences & Changes
Is Is Not Differences Changes Facts Support Verification of
Is Is Not Explanation Assumptions
What Cause? Assumptions
Analyze

Where Risk Analysis What

When Where
How Much When
How Much
Is/Is Not Diagram Contradiction Maxtrix
Brainstorming Is Is Not Cause 1 Cause 2 Cause 3 Cause 4
Timeline of Changes What
Change Change Change Discovery Where
Date/Time Date/Time Date/Time Date/Time When
How Much

5. Identify Technical & Systemic Root 6. Determine Corrective & Preventive 7. Verify Corrective &
Causes Actions Preventive Actions
Component Swap Response Surface Corrective & Preventive Action Plan Trend Analysis
Improve

Control
Root Corrective Risk Control Acceptance
Causes Actions Mitigation Plan Criteria
3 Legged 5 Why Technical
Systemic
Detection
Screening Experiment Robust Tolerance Mistake Proofing Variation Reduction Risk Mitigation Capability Study Control Chart
Eliminate
Facilicate
Mitigate
Flag
Summary © 2022 Weaver Consulting
Define
Analyze
1. Define the Performance Problem
3. Identify Possible Causes
• Establish problem statement (1st two “What Is” questions below) to help investigators
• Leverage the Differences & Changes template (included in the Is/Is Not Diagram) by
maintain focus if other issues are discovered during the investigation.
Asking “What is different about the Is fact compared to the corresponding Is Not
• Develop flow diagram with key inputs of process(es) being investigated to enhance the
fact?” For each difference identified, also ask “Has anything changed?”
investigators’ understanding of the work being investigated.
• Develop a timeline of changes, review risk analysis, and brainstorm.
• Begin developing a problem description with an Is/Is Not Diagram to consider the problem
• Create master list of possible causes from the above mentioned techniques.
wholistically, break it down into smaller sections that are easier to work with, and start to
establish the general scope of the investigation.
4. Test Possible Causes
• Leverage the Test Sheet template (included in the Is/Is Not Diagram). Ask “If X is the
Is Is Not
cause, how does it explain each set of Is and Is Not facts?”
What specific o bject has the defect? What similar o bjects co uld have the defect but don't?
• Record any facts that do not perfectly support each possible cause.
What is the specific defect? What o ther defects co uld be seen but aren't? • Record any realistic assumptions to explain how the facts could still support the
possible cause, or document that a set of facts has eliminated the possible cause.
What

What are the defect characteristics? What co uld the characteristics be but aren't?

What pro duct lo ts have the defect? What pro duct lo ts co uld have the defect but don’ t?
5. Identify Technical & Systemic Root Causes
A re any part lo ts asso ciated with the defect? What part lo ts co uld be asso ciated but aren't?
• Collect data to verify assumptions made in Step 4. If an assumption is proven false
What patterns are in the "What" answers? and no new realistic assumptions can be made to support the facts, document on
Where co uld the defective o bject be o bserved geo graphically the Test Sheet template and eliminate the possible cause.
Where is the defective o bject o bserved geo graphically?
but isn't? • Conduct experiments on the remaining probable causes to identify the technical
root cause.
Where

Where is the defect o n the o bject? Where co uld the defect be o n the o bject but isn't?
• Leverage the 3 Legged 5 Why template to document the technical root cause, and
Where is the defect 1st seen in the pro cess? Where co uld the defect 1st be seen in the pro cess but isn't?
identify potential systemic root causes. Ask “Why did this problem occur?” “Why
Where else is the defect? Where else co uld the defect be but isn't? wasn’t this problem detected earlier?”
What patterns are in the "Where" answers?

When was the defective o bject 1st seen (date & time)? When co uld the defective o bject 1st been seen but wasn't? Improve
6. Determine Corrective & Preventive Actions
When since the 1st time has the defective o bject been seen When since the 1st time co uld the defective o bject have been
• Apply mistake proofing (poka-yoke) techniques for root causes stemming from
When

(date/time)? seen but wasn't?

human error.
What is the trend (stable, wo rse, better)? What co uld the trend be but isn't?
• Apply optimization & variation reduction (OVR) techniques for root causes stemming
What patterns are in the "When" answers? from excessive and/or improper targeting of variation.
Ho w many o bjects have the defect? Ho w many o bjects co uld have the defect but don't? • Consider and mitigate risks associated with corrective/preventive actions by
How Much

Ho w big o r small is the defect? Ho w big o r small co uld the defect be but isn't?
leveraging a risk analysis (FMEA, Fault Tree, etc.), design verification and/or process
validation.
Ho w many defects are o n the o bject? Ho w many defects co uld be o n o bject but aren't?
• Establish a control plan to monitor performance and prevent or minimize
What patterns are in the "Ho w M uch" answers? recurrence.
Measure
2. Collect Data Control
• Continue developing the problem description by using the Data Collection Plan template 7. Verify Corrective & Preventive Actions
(included in the Is/Is Not Diagram) to verify the initial Is/Is Not answers, and to better • Document that the corrective/preventive actions have been implemented.
characterize the problem by asking additional, more specific questions relevant to the • Measure effectiveness of the corrective/preventive actions & control plan.
patterns and red questions in effort to narrow the investigation scope. • If performance gap continues to exist, first look to improve current
corrective/preventive actions. If still unsuccessful, continue to follow the
methodology to investigate and identify/address additional technical root causes.
• Update risk analysis to reflect knowledge gained in the investigation, and share with
Weaver Consulting organization, key suppliers, etc.
Solving Local Problems Globally +1 (612) 720-7918 info@[Link] [Link]
Define the Performance Problem
1. State the problem
2. Describe the problem
3. Describe the process(es) under investigation
4. Timeline of events
5. Team charter

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Describe Problem
Causes Is Not Causes

What
How much

Where
Is Not Is Is Not

When

Causes Causes
Is Not Weaver Consulting
Is/Is Not Diagram
Is/Is Not Diagram
Problem Statement:

Verified ✓

Verified ✓
Is Is Not
What specific object has the defect? What similar objects could have the defect but don't?

What is the specific defect? What other defects could be seen but aren't?
What

What are the defect characteristics? What could the characteristics be but aren't?

What product lots have the defect? What product lots could have the defect but don’t?

Are any part lots associated with the defect? What part lots could be associated with the defect but aren't?

Where is the defective object observed geographically? Where could the defective object be observed geographically but isn't?

Where is the defect on the object? Where could the defect be on the object but isn't?
Where

Where is the defect 1st seen in the process? Where could the defect 1st be seen in the process but isn't?

Where else is the defect? Where else could the defect be but isn't?

When was the defective object 1st seen (date & time)? When could the defective object 1st been seen but wasn't?
When

When since the 1st time has the defective object been seen When since the 1st time could the defective object have been seen but
(date/time)? wasn't?

What is the trend (stable, worse, better)? What could the trend be but isn't?

How many objects have the defect? How many objects could have the defect but don't?
How Much

How big or small is the defect? How big or small could the defect be but isn't?

How many defects are on the object? How many defects could be on object but aren't?
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Define the Performance Problem
1. State the problem
2. Describe the problem
3. Describe the process(es) under investigation
4. Timeline of events
5. Team charter

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Describe the Process(es) Under Investigation
Process flow diagram with key inputs

Product development Laboratory

Manufacturing Customer usage
Sterilization Disposal
Release Repair/service
Distribution
Input 1
Input 2
Input 3

Step 3
Start Step 1 Step 2 Step 5 End
Input 1
Input 1
Input 2
Input 1
Input 2 Step 4 Input 2
Input 3 Input 3
Input 3

Input 1
Input 2
Input 3

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Define the Performance Problem
1. State the problem
2. Describe the problem
3. Describe the process(es) under investigation
4. Timeline of events
5. Team charter

Weaver Consulting
Root Cause Investigation for CAPA Roadmap © 2022 Weaver Consulting

1. Define the Performance Problem 2. Collect Data

Multi-Vari Chart
Is/Is Not Diagram Is/Is Not Diagram Data Collection Plan
Is Is Not Data Data Analysis
What Timeline of Events Is Is Not

Measure
Needed Location Tools
Event Event Event Discovery
Define

Where What
When Date/Time Date/Time Date/Time Date/Time Analysis of Mean
Where
How Much When
How Much
Process Flow Chart Team Charter
Step 1 Step 2 Step 3 Problem Statement
→ → Heat Map Capability Study Control Chart Cheeksheet
Key inputs Key inputs Key inputs Acceptance Criteria
xxxxxxxxxxxxx
↓ Cost Savings Goals
xxxxxxxxx
Step 6 Step 5 Step 4 Team Members
← ← xxxxx
Key inputs Key inputs Key inputs Executive Sponsor

3. Identify Possible Causes Cause & Effect Diagram 4. Test Possible Causes
Is/Is Not Diagram Test Sheet
Is/Is Not Diagram Differences & Changes
Is Is Not Differences Changes Facts Support Verification of
Is Is Not Explanation Assumptions
What Cause? Assumptions
Analyze

Where Risk Analysis What

When Where
How Much When
How Much
Is/Is Not Diagram Contradiction Maxtrix
Brainstorming Is Is Not Cause 1 Cause 2 Cause 3 Cause 4
Timeline of Changes What
Change Change Change Discovery Where
Date/Time Date/Time Date/Time Date/Time When
How Much

5. Identify Technical & Systemic Root 6. Determine Corrective & Preventive 7. Verify Corrective &
Causes Actions Preventive Actions
Component Swap Response Surface Corrective & Preventive Action Plan Trend Analysis
Improve

Control
Root Corrective Risk Control Acceptance
Causes Actions Mitigation Plan Criteria
3 Legged 5 Why Technical
Systemic
Detection
Screening Experiment Robust Tolerance Mistake Proofing Variation Reduction Risk Mitigation Capability Study Control Chart
Eliminate
Facilicate
Mitigate
Flag
Data Needed

Verified ✓

Verified ✓
• Verify initial opinion based Is Is Not
What object has the defect? What similar objects could
Is/Is Not answers to have the defect but don’t?

establish investigation What is the specific defect? What other defects could be
seen but aren’t?

What
scope
What are the defect What could the characteristics
characteristics? be but aren’t?

What
• Determine additional
data needed to narrow How Much

Where
Is
investigation scope

When
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 Data Collection Plan
Is/Is Not Diagram Data Collection Plan
Problem Statement:

Verified ✓

Verified ✓
Is Is Not Data Needed Data Location Analysis Tool
What specific object has the defect? What similar objects could have the
defect but don't?

What is the specific defect? What other defects could be seen but
aren't?

What are the defect characteristics? What could the characteristics be but
What

aren't?

What product lots have the defect? What product lots could have the defect
but don’t?

Are any part lots associated with the What part lots could be associated with
defect? the defect but aren't?

Where is the defective object observed Where could the defective object be
geographically? observed geographically but isn't?

Where is the defect on the object? Where could the defect be on the object
but isn't?
Where

Where is the defect 1st seen in the Where could the defect 1st be seen in the
process? process but isn't?

Where else is the defect? Where else could the defect be but isn't?

Output: factually based Is/Is Not diagram Weaver Consulting

Root Cause Investigation for CAPA Roadmap © 2022 Weaver Consulting

1. Define the Performance Problem 2. Collect Data

Multi-Vari Chart
Is/Is Not Diagram Is/Is Not Diagram Data Collection Plan
Is Is Not Data Data Analysis
What Timeline of Events Is Is Not

Measure
Needed Location Tools
Event Event Event Discovery
Define

Where What
When Date/Time Date/Time Date/Time Date/Time Analysis of Mean
Where
How Much When
How Much
Process Flow Chart Team Charter
Step 1 Step 2 Step 3 Problem Statement
→ → Heat Map Capability Study Control Chart Cheeksheet
Key inputs Key inputs Key inputs Acceptance Criteria
xxxxxxxxxxxxx
↓ Cost Savings Goals
xxxxxxxxx
Step 6 Step 5 Step 4 Team Members
← ← xxxxx
Key inputs Key inputs Key inputs Executive Sponsor

3. Identify Possible Causes Cause & Effect Diagram 4. Test Possible Causes
Is/Is Not Diagram Test Sheet
Is/Is Not Diagram Differences & Changes
Is Is Not Differences Changes Facts Support Verification of
Is Is Not Explanation Assumptions
What Cause? Assumptions
Analyze

Where Risk Analysis What

When Where
How Much When
How Much
Is/Is Not Diagram Contradiction Maxtrix
Brainstorming Is Is Not Cause 1 Cause 2 Cause 3 Cause 4
Timeline of Changes What
Change Change Change Discovery Where
Date/Time Date/Time Date/Time Date/Time When
How Much

5. Identify Technical & Systemic Root 6. Determine Corrective & Preventive 7. Verify Corrective &
Causes Actions Preventive Actions
Component Swap Response Surface Corrective & Preventive Action Plan Trend Analysis
Improve

Control
Root Corrective Risk Control Acceptance
Causes Actions Mitigation Plan Criteria
3 Legged 5 Why Technical
Systemic
Detection
Screening Experiment Robust Tolerance Mistake Proofing Variation Reduction Risk Mitigation Capability Study Control Chart
Eliminate
Facilicate
Mitigate
Flag
Identify Possible Causes
FMEA

6/1 6/2 6/3 6/4

Time of Changes

Risk Analysis

Difference Changes

People Material Machine

Brainstorming

Environment Method Measurement

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Identify Possible Causes
Is/Is Not Diagram Differences & Changes
Problem Statement:

Verified ✓

Verified ✓
Is Is Not Differences Changes
What specific object has the defect? What similar objects could have the
defect but don't?

What is the specific defect? What other defects could be seen but
aren't?

What are the defect characteristics? What could the characteristics be but
What

aren't?

What product lots have the defect? What product lots could have the
defect but don’t?

Are any part lots associated with the What part lots could be associated
defect? with the defect but aren't?

Where is the defective object Where could the defective object be

observed geographically? observed geographically but isn't?

Where is the defect on the object? Where could the defect be on the
object but isn't?
Where

Where is the defect 1st seen in the Where could the defect 1st be seen in
process? the process but isn't?

Where else is the defect? Where else could the defect be but
isn't?

Weaver Consulting
Root Cause Investigation for CAPA Roadmap © 2022 Weaver Consulting

1. Define the Performance Problem 2. Collect Data

Multi-Vari Chart
Is/Is Not Diagram Is/Is Not Diagram Data Collection Plan
Is Is Not Data Data Analysis
What Timeline of Events Is Is Not

Measure
Needed Location Tools
Event Event Event Discovery
Define

Where What
When Date/Time Date/Time Date/Time Date/Time Analysis of Mean
Where
How Much When
How Much
Process Flow Chart Team Charter
Step 1 Step 2 Step 3 Problem Statement
→ → Heat Map Capability Study Control Chart Cheeksheet
Key inputs Key inputs Key inputs Acceptance Criteria
xxxxxxxxxxxxx
↓ Cost Savings Goals
xxxxxxxxx
Step 6 Step 5 Step 4 Team Members
← ← xxxxx
Key inputs Key inputs Key inputs Executive Sponsor

3. Identify Possible Causes Cause & Effect Diagram 4. Test Possible Causes
Is/Is Not Diagram Test Sheet
Is/Is Not Diagram Differences & Changes
Is Is Not Differences Changes Facts Support Verification of
Is Is Not Explanation Assumptions
What Cause? Assumptions
Analyze

Where Risk Analysis What

When Where
How Much When
How Much
Is/Is Not Diagram Contradiction Maxtrix
Brainstorming Is Is Not Cause 1 Cause 2 Cause 3 Cause 4
Timeline of Changes What
Change Change Change Discovery Where
Date/Time Date/Time Date/Time Date/Time When
How Much

5. Identify Technical & Systemic Root 6. Determine Corrective & Preventive 7. Verify Corrective &
Causes Actions Preventive Actions
Component Swap Response Surface Corrective & Preventive Action Plan Trend Analysis
Improve

Control
Root Corrective Risk Control Acceptance
Causes Actions Mitigation Plan Criteria
3 Legged 5 Why Technical
Systemic
Detection
Screening Experiment Robust Tolerance Mistake Proofing Variation Reduction Risk Mitigation Capability Study Control Chart
Eliminate
Facilicate
Mitigate
Flag
 Test Possible Causes
If x the cause, how does it explain each set of Is and Is Not facts
Is/Is Not Diagram Test Sheet
Problem Statement: Possible Cause:
Facts

Verified ✓

Verified ✓
Support
Is Is Not Cause? Explanation Assumptions
Yes/No
What specific object has the defect? What similar objects could have the defect
but don't?

What is the specific defect? What other defects could be seen but aren't?

What are the defect characteristics? What could the characteristics be but aren't?
What

What product lots have the defect? What product lots could have the defect but
don’t?

Are any part lots associated with the defect? What part lots could be associated with the
defect but aren't?

Where is the defective object observed Where could the defective object be observed
geographically? geographically but isn't?

Where is the defect on the object? Where could the defect be on the object but
isn't?
Where

Where is the defect 1st seen in the process? Where could the defect 1st be seen in the
process but isn't?

Where else is the defect? Where else could the defect be but isn't?

Weaver Consulting
Root Cause Investigation for CAPA Roadmap © 2022 Weaver Consulting

1. Define the Performance Problem 2. Collect Data

Multi-Vari Chart
Is/Is Not Diagram Is/Is Not Diagram Data Collection Plan
Is Is Not Data Data Analysis
What Timeline of Events Is Is Not

Measure
Needed Location Tools
Event Event Event Discovery
Define

Where What
When Date/Time Date/Time Date/Time Date/Time Analysis of Mean
Where
How Much When
How Much
Process Flow Chart Team Charter
Step 1 Step 2 Step 3 Problem Statement
→ → Heat Map Capability Study Control Chart Cheeksheet
Key inputs Key inputs Key inputs Acceptance Criteria
xxxxxxxxxxxxx
↓ Cost Savings Goals
xxxxxxxxx
Step 6 Step 5 Step 4 Team Members
← ← xxxxx
Key inputs Key inputs Key inputs Executive Sponsor

3. Identify Possible Causes Cause & Effect Diagram 4. Test Possible Causes
Is/Is Not Diagram Test Sheet
Is/Is Not Diagram Differences & Changes
Is Is Not Differences Changes Facts Support Verification of
Is Is Not Explanation Assumptions
What Cause? Assumptions
Analyze

Where Risk Analysis What

When Where
How Much When
How Much
Is/Is Not Diagram Contradiction Maxtrix
Brainstorming Is Is Not Cause 1 Cause 2 Cause 3 Cause 4
Timeline of Changes What
Change Change Change Discovery Where
Date/Time Date/Time Date/Time Date/Time When
How Much

5. Identify Technical & Systemic Root 6. Determine Corrective & Preventive 7. Verify Corrective &
Causes Actions Preventive Actions
Component Swap Response Surface Corrective & Preventive Action Plan Trend Analysis
Improve

Control
Root Corrective Risk Control Acceptance
Causes Actions Mitigation Plan Criteria
3 Legged 5 Why Technical
Systemic
Detection
Screening Experiment Robust Tolerance Mistake Proofing Variation Reduction Risk Mitigation Capability Study Control Chart
Eliminate
Facilicate
Mitigate
Flag
Identify Technical & Systemic Root Causes

Step 3 Step 4 Step 5

Possible Test Verify
causes assumptions

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 Test Possible Causes
If x the cause, how does it explain each set of Is and Is Not facts
Is/Is Not Diagram Test Sheet
Problem Statement: Possible Cause:
Facts

Verified ✓

Verified ✓
Support
Is Is Not Cause? Explanation Assumptions
Yes/No
What specific object has the defect? What similar objects could have the defect
but don't?

What is the specific defect? What other defects could be seen but aren't?

What are the defect characteristics? What could the characteristics be but aren't?
What

What product lots have the defect? What product lots could have the defect but
don’t?

Are any part lots associated with the defect? What part lots could be associated with the
defect but aren't?

Where is the defective object observed Where could the defective object be observed
geographically? geographically but isn't?

Where is the defect on the object? Where could the defect be on the object but
isn't?
Where

Where is the defect 1st seen in the process? Where could the defect 1st be seen in the
process but isn't?

Where else is the defect? Where else could the defect be but isn't?

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Identify Technical & Systemic Root Causes

Step 3 Step 4 Step 5 Step 5

Possible Test Verify Experiment
causes assumptions

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Key Points
When, through experiments, the problem can be
controlled, moved, manipulated, etc…a technical root
cause has been identified

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Identify Systemic Root Cause(s)
Asking “why” may uncover
systemic root causes that
could allow similar issues to
continue to occur
• Why did the technical root cause
occur?
• Why wasn’t the technical root
cause detected earlier?
Systemic
Technical root cause Detection
root cause root cause

3L5WHY
(3 Legged 5 Why’s)

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3 Legged 5 Why Analysis
Technical Root Cause
Systemtic Root Cause(s) - Use this path to investigate the system failures.
Why did the technical root cause listed above occur?

Why?

Why?

Why?

Why?

Why?

Detection Root Cause(s) - Use this path to investigate why the problem was not detected.

Why wasn't the technical root cause listed above detected earlier?

Why?

Why?

Why?

Why?

Why?

Weaver Consulting
Root Cause Investigation for CAPA Roadmap © 2022 Weaver Consulting

1. Define the Performance Problem 2. Collect Data

Multi-Vari Chart
Is/Is Not Diagram Is/Is Not Diagram Data Collection Plan
Is Is Not Data Data Analysis
What Timeline of Events Is Is Not

Measure
Needed Location Tools
Event Event Event Discovery
Define

Where What
When Date/Time Date/Time Date/Time Date/Time Analysis of Mean
Where
How Much When
How Much
Process Flow Chart Team Charter
Step 1 Step 2 Step 3 Problem Statement
→ → Heat Map Capability Study Control Chart Cheeksheet
Key inputs Key inputs Key inputs Acceptance Criteria
xxxxxxxxxxxxx
↓ Cost Savings Goals
xxxxxxxxx
Step 6 Step 5 Step 4 Team Members
← ← xxxxx
Key inputs Key inputs Key inputs Executive Sponsor

3. Identify Possible Causes Cause & Effect Diagram 4. Test Possible Causes
Is/Is Not Diagram Test Sheet
Is/Is Not Diagram Differences & Changes
Is Is Not Differences Changes Facts Support Verification of
Is Is Not Explanation Assumptions
What Cause? Assumptions
Analyze

Where Risk Analysis What

When Where
How Much When
How Much
Is/Is Not Diagram Contradiction Maxtrix
Brainstorming Is Is Not Cause 1 Cause 2 Cause 3 Cause 4
Timeline of Changes What
Change Change Change Discovery Where
Date/Time Date/Time Date/Time Date/Time When
How Much

5. Identify Technical & Systemic Root 6. Determine Corrective & Preventive 7. Verify Corrective &
Causes Actions Preventive Actions
Component Swap Response Surface Corrective & Preventive Action Plan Trend Analysis
Improve

Control
Root Corrective Risk Control Acceptance
Causes Actions Mitigation Plan Criteria
3 Legged 5 Why Technical
Systemic
Detection
Screening Experiment Robust Tolerance Mistake Proofing Variation Reduction Risk Mitigation Capability Study Control Chart
Eliminate
Facilicate
Mitigate
Flag
Corrective/Preventive Actions

Human error Too much variation

Mistake proofing Optimization & variation

(poka-yoke) reduction (OVR)

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 Corrective & Preventive Actions
Root Corrective Risk Control Acceptance Actual
Causes Actions Mitigation Plan Criteria Measures

Technical

Systemic

Detection

Weaver Consulting
Root Cause Investigation for CAPA Roadmap © 2022 Weaver Consulting

1. Define the Performance Problem 2. Collect Data

Multi-Vari Chart
Is/Is Not Diagram Is/Is Not Diagram Data Collection Plan
Is Is Not Data Data Analysis
What Timeline of Events Is Is Not

Measure
Needed Location Tools
Event Event Event Discovery
Define

Where What
When Date/Time Date/Time Date/Time Date/Time Analysis of Mean
Where
How Much When
How Much
Process Flow Chart Team Charter
Step 1 Step 2 Step 3 Problem Statement
→ → Heat Map Capability Study Control Chart Cheeksheet
Key inputs Key inputs Key inputs Acceptance Criteria
xxxxxxxxxxxxx
↓ Cost Savings Goals
xxxxxxxxx
Step 6 Step 5 Step 4 Team Members
← ← xxxxx
Key inputs Key inputs Key inputs Executive Sponsor

3. Identify Possible Causes Cause & Effect Diagram 4. Test Possible Causes
Is/Is Not Diagram Test Sheet
Is/Is Not Diagram Differences & Changes
Is Is Not Differences Changes Facts Support Verification of
Is Is Not Explanation Assumptions
What Cause? Assumptions
Analyze

Where Risk Analysis What

When Where
How Much When
How Much
Is/Is Not Diagram Contradiction Maxtrix
Brainstorming Is Is Not Cause 1 Cause 2 Cause 3 Cause 4
Timeline of Changes What
Change Change Change Discovery Where
Date/Time Date/Time Date/Time Date/Time When
How Much

5. Identify Technical & Systemic Root 6. Determine Corrective & Preventive 7. Verify Corrective &
Causes Actions Preventive Actions
Component Swap Response Surface Corrective & Preventive Action Plan Trend Analysis
Improve

Control
Root Corrective Risk Control Acceptance
Causes Actions Mitigation Plan Criteria
3 Legged 5 Why Technical
Systemic
Detection
Screening Experiment Robust Tolerance Mistake Proofing Variation Reduction Risk Mitigation Capability Study Control Chart
Eliminate
Facilicate
Mitigate
Flag
Verify Corrective & Preventive Actions
Evaluate Effectiveness

Performance

Change
Corrective Corrective
Action #1 Action #2

Time

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Root Cause Investigation for CAPA Roadmap © 2022 Weaver Consulting

1. Define the Performance Problem 2. Collect Data

Multi-Vari Chart
Is/Is Not Diagram Is/Is Not Diagram Data Collection Plan
Is Is Not Data Data Analysis
What Timeline of Events Is Is Not

Measure
Needed Location Tools
Event Event Event Discovery
Define

Where What
When Date/Time Date/Time Date/Time Date/Time Analysis of Mean
Where
How Much When
How Much
Process Flow Chart Team Charter
Step 1 Step 2 Step 3 Problem Statement
→ → Heat Map Capability Study Control Chart Cheeksheet
Key inputs Key inputs Key inputs Acceptance Criteria
xxxxxxxxxxxxx
↓ Cost Savings Goals
xxxxxxxxx
Step 6 Step 5 Step 4 Team Members
← ← xxxxx
Key inputs Key inputs Key inputs Executive Sponsor

3. Identify Possible Causes Cause & Effect Diagram 4. Test Possible Causes
Is/Is Not Diagram Test Sheet
Is/Is Not Diagram Differences & Changes
Is Is Not Differences Changes Facts Support Verification of
Is Is Not Explanation Assumptions
What Cause? Assumptions
Analyze

Where Risk Analysis What

When Where
How Much When
How Much
Is/Is Not Diagram Contradiction Maxtrix
Brainstorming Is Is Not Cause 1 Cause 2 Cause 3 Cause 4
Timeline of Changes What
Change Change Change Discovery Where
Date/Time Date/Time Date/Time Date/Time When
How Much

5. Identify Technical & Systemic Root 6. Determine Corrective & Preventive 7. Verify Corrective &
Causes Actions Preventive Actions
Component Swap Response Surface Corrective & Preventive Action Plan Trend Analysis
Improve

Control
Root Corrective Risk Control Acceptance
Causes Actions Mitigation Plan Criteria
3 Legged 5 Why Technical
Systemic
Detection
Screening Experiment Robust Tolerance Mistake Proofing Variation Reduction Risk Mitigation Capability Study Control Chart
Eliminate
Facilicate
Mitigate
Flag
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Weaver Consulting