This case study will detail a real nonconformance investigation using the Root Cause Analysis (RCA). The Quality Assurance of a pharmaceutical company has detected a failure during the test audit after a manufactured lot inspection. The investigation concluded that the failure was due to a defective component; which later led the supplier to authorize the return of their product, and to initiate substantial process corrective actions.

1. Root Cause Analysis
A Case Study
Eliminate the Nonconformities

2. Contact Information
TAREK ELNEIL: TELNEIL@MSN.COM
TEL: 805-732-1739
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3. Main Points
• What is Root Cause Analysis?
• Continuous Improvement components and
relationships
• Cause and Effect Principles
• Investigation requirements and methodology
• Real Case Study
• Questions and Answers
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4. What is Root Cause Analysis (RCA)?
• Root Cause is the fundamental breakdown or failure
of a process which, when resolved, prevents a
recurrence of the nonconformance
• Root Cause Analysis is a systematic approach to
investigate, identify and eliminate the true root
causes of the process failure
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5. How to Use RCA
– Investigate an incident or series of incidents
– Attempt to understand the underlying causes of
the incident(s)
– Generate effective corrective actions to prevent
and mitigate incident(s)
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6. Continuous Improvement
Establishing adequate processes for measurement, analysis and
improvement within the QMS as related to corrective and/or
preventative actions.
• Preventive Action • Corrective Action
– Proactive – Reactive
– Cost of Quality : Preventive – Cost of Quality: Failures
and Appraisal cost (Internal and ExternalFailure )
– Quality Systems: Audit – Quality Systems:
(Supplier, Internal), Nonconformance
Validation Investigation, CAPA
– Tools: Improvement Projects – Tools:, Root Cause Analysis
(Lean/Six Sigma, ….), FMEA
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7. QMS Improvement Relationships
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8. Six Sigma vs. RCA
Function Six Sigma RCA
Use •Proactive : Reduce process •Reactive: Identify, reduce or
variation eliminate root causes
Phases •Define •Problem Statement
•Measure •Risk Assessment
•Analyze •Analyze
•Improve •Corrective Action
•Control •Effectiveness
Definition Is/ Is not, Time Line, Input Output, What, When, Where, Significance
Tools Pareto Chart , Flowchart
Analysis Fishbone Diagram, Contradiction 5 “Whys”
Tools Matrix, FMEA,
5 “Why”s
Solution Selection Matrix, Force Field Eliminate root cause conditions
Selection Analysis, Brainstorming
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9. Approaches to Treat Nonconformance
Any organization has two choices to treat their nonconformance. They can
choose between treating the symptom, or eliminating the root causes.
Approach Treating Symptom Eliminating Root Causes
Cause Errors are often a result of worker Errors are the result of defects in
carelessness the system. People are only part of
the process
Corrective Actions train and motivate workers to be need to find out why this is
more careful happening, and implement mistake
proofs so it won’t happen again
Justification don’t have the time or resources to failure to eliminate the root causes
really get to the bottom of this will results in the reappears of the
problem problem but in different forms
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10. RCA Methodology
Uses facts to narrow the search to
identify and eliminate the root cause
Present
Why?
CAUSES
Evidence!
Why? CAUSES
Evidence!
Why?
CAUSES
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11. Process Root Causes
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12. Components of Good Investigation
• Organization Leadership and Culture
– Proactive Analysis (Preventative Action)
– Reactive Analysis (Corrective Action)
• Dashboard Metrics (Historical Data)
• Investigator
– Knowledgeable
– Curious
• Actual Sample of the Nonconformance
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13. Root Cause Analysis
CAUSE AND EFFECT PRINCIPALS
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14. 1. Causes and Effects Are the Same Thing.
Leaky
Injury Valve
Primary Effect Cause
Caused By Caused By
Cause Caused By Effect
Effect Cause Wet
Fall Surface
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15. 2. Causes and Effects are Part of an Infinite
Continuum of Causes
Primary Effect
Injury
Caused By
Fall
Caused By
Wet Leaky Seal Failure
Caused By
Surface Caused By Valve
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16. 3. Each Effect has at Least Two Causes
Action
Cause
Effect
Condition
Cause
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17. 4. effect & causes exists at the same point in
time and space
Action Cause
Condition Cause
Effect
Space
Oxygen
Past -10 0 10 Future
Present
Time
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18. Problem Investigation
Y
LCL UCL
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19. The Product Components
Needle
Liner /Septum
Roll Grove
Aluminum shell
Cartridge
Aluminum Cap Drug
Plunger
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20. Sterile Environment
Barrier
Feeding
Filing
Sealing Needle
Assembly
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21. The problem
• On 10/6 the MQ light test audit rejected a segment of
12,422 units for a bad seal during the second light test
audit in the CPM line.
• What: Light Test Audit
• When: 10/6
• Where: CPM line
• Significance: 12,422 units
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22. Understanding the Problem
• Why did this lot fail the light test audit?
Action
Inspectors failed to
identify and remove
bad seal
Condition
Caused By Light test depends on
Failed Light test Audit human visual
inspection
Condition
Primary Effect
Cartridges inspected
on moving conveyor
belt
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23. Personnel
High volume of Bad Seals
Inspectors failed to Caused By Bad Seals are difficult to detect
identify and remove visually
Bad Seal
Visual inspection is inefficient
(80%- 85% accuracy)
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24. Equipment
Spinning wheel didn’t engage
with the cap edge properly
High volume of Caused By
Bad Seals
Aluminum Caps were not
crimped properly into the
Cartridge necks
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25. Equipment
Aluminum Caps were
not properly seated
during the crimping
process
Spinning wheel didn’t Caused By
engage with the cap edge
properly
Not enough crimping
Low pressure during
pressure on the cap and
the cap crimping
cartridge
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26. Process
Cap lining was misaligned
inside the aluminum cap
Aluminum Caps were
not properly seated Caused By
during the crimping
process
Crimping pressure could
not be increased (limited
by process spec)
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27. Process
Lining resisted the
crimping pressure
Not enough crimping Caused By
pressure on the cap and
cartridge
Not enough space for the
lining to move inside the
shell
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28. Component
Shell geometrical
shape and lining
were nonconforming
Lining resisted the Caused By
crimping pressure
The lining inside the cap
occupied more space
than expected
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29. Supplier
Nonconforming caps were
used in manufacturing
Shell geometrical shape Caused By
and lining were
nonconforming
Liner thickness spec has
35% variance between USL
and LSL
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30. Quality Systems
QA Receiving
accepted
nonconforming Caps
Nonconforming caps Caused By
were used in
manufacturing
Supplier produced
nonconforming product
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31. Not all reject criteria
are listed on the Lot
Inspection Form
QA accepted Caused By
nonconforming
caps
QA Receiving couldn’t
measure some of the
cap’s critical dimensions
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32. Supplier CAPA Investigation
Equipment modified
without approvals
(Change control
violations)
Supplier produced Caused By
Nonconforming die shape
nonconforming
(Equipment Setup)
product
Dull blades were used
(Preventive Maintenance)
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33. Corrective Actions
• Recommended
– Evaluate the feasibility for using an automatic visual system to
identify and remove the non-conformed units
– Reduce the MQ Audit segment size
– Review the component specifications which are critical to
manufacturing
– A vendor qualifications program should be evaluated
• Implemented
– Management was satisfied with the Supplier corrective actions,
and decided no more corrective actions are required
– No effectiveness check is needed because there is no corrective
action
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34. Previous Failure Investigation
Corrective Actions
• A CAD (Communication Awareness Discussion)
session was conducted with all CPM line
personnel for failing to identify a possible unit
closure defect.
• Personnel were reminded of the need to pay
more attention to detail!
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35. Questions?
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