Root Cause Analysis A Case Study
Eliminate the Nonconformities
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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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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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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Continuous Improvement
Establishing adequate processes for measurement, analysis and improvement within the QMS as related to corrective and/or preventative actions.• Preventive Action
– Proactive – Cost of Quality : Preventive
and Appraisal cost– Quality Systems: Audit
(Supplier, Internal), Validation
– Tools: Improvement Projects (Lean/Six Sigma, ….), FMEA
• Corrective Action – Reactive– Cost of Quality: Failures
(Internal and ExternalFailure )– Quality Systems:
Nonconformance Investigation, CAPA
– Tools:, Root Cause Analysis
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QMS Improvement Relationships
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Six Sigma vs. RCAFunction Six Sigma RCA
Use •Proactive : Reduce process variation
•Reactive: Identify, reduce or eliminate root causes
Phases •Define•Measure •Analyze•Improve•Control
•Problem Statement•Risk Assessment •Analyze•Corrective Action•Effectiveness
Definition Tools
Is/ Is not, Time Line, Input Output, Pareto Chart , Flowchart
What, When, Where, Significance
Analysis Tools
Fishbone Diagram, Contradiction Matrix, FMEA, 5 “Why”s
5 “Whys”
Solution Selection
Selection Matrix, Force Field Analysis, Brainstorming
Eliminate root cause conditions
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Approaches to Treat NonconformanceAny 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 carelessness
Errors are the result of defects in the system. People are only part of the process
Corrective Actions train and motivate workers to be more careful
need to find out why this is happening, and implement mistake proofs so it won’t happen again
Justification don’t have the time or resources to really get to the bottom of this problem
failure to eliminate the root causes will results in the reappears of the problem but in different forms
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Uses facts to narrow the search to identify and eliminate the root cause
Present
RCA Methodology
Evidence!
Evidence!
CAUSES
CAUSES
CAUSES
Past
Why?
Why?
Why?
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Process Root Causes
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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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CAUSE AND EFFECT PRINCIPALS Root Cause Analysis
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1. Causes and Effects Are the Same Thing.
Injury
FallWet
Surface
Leaky Valve
Caused By
Caused By
Caused By
Primary Effect
Cause
Effect Cause
Effect
Cause
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2. Causes and Effects are Part of an Infinite Continuum of Causes
Injury
Fall
Wet Surface
Leaky Valve
Caused By
Caused By
Caused ByCaused By
Primary Effect
Seal Failure
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3. Each Effect has at Least Two Causes
Effect
ActionCause
ConditionCause
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4. effect & causes exists at the same point in time and space
Oxygen
Action Cause
Condition Cause
Effect
Time
Spa
ce
Past -10 0 10 FuturePresent
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Problem Investigation
Y
LCL UCL
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The Product Components
Cartridge
Liner /Septum
Aluminum shell
Needle
Roll Grove
Plunger
DrugAluminum Cap
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Sterile Environment Barrier
Feeding
Filing
Sealing Needle Assembly
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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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Understanding the Problem
• Why did this lot fail the light test audit?
Failed Light test AuditCaused By
Inspectors failed to identify and remove
bad seal
Light test depends on human visual
inspection
Cartridges inspected on moving conveyor
belt
Primary Effect
Action
Condition
Condition
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Personnel
Inspectors failed to identify and remove Bad Seal
Caused By
Visual inspection is inefficient (80%- 85% accuracy)
High volume of Bad Seals
Bad Seals are difficult to detect visually
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Equipment
High volume of Bad Seals
Caused By
Aluminum Caps were not crimped properly into the Cartridge necks
Spinning wheel didn’t engage with the cap edge properly
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Equipment
Aluminum Caps were not properly seated during the crimping process
Low pressure during the cap crimping
Caused BySpinning wheel didn’t engage with the cap edge properly
Not enough crimping pressure on the cap and cartridge
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Process
Caused By
Crimping pressure could not be increased (limited by process spec)
Aluminum Caps were not properly seated during the crimping process
Cap lining was misaligned inside the aluminum cap
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Process
Caused By
Not enough space for the lining to move inside the shell
Not enough crimping pressure on the cap and cartridge
Lining resisted the crimping pressure
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Component
Caused ByLining resisted the crimping pressure
The lining inside the capoccupied more space than expected
Shell geometrical shape and lining were nonconforming
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Supplier
Caused By
Liner thickness spec has 35% variance between USL and LSL
Shell geometrical shape and lining were nonconforming
Nonconforming caps were used in manufacturing
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Quality Systems
Caused By
Supplier produced nonconforming product
Nonconforming caps were used in manufacturing
QA Receiving accepted nonconforming Caps
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QA accepted nonconforming caps
QA Receiving couldn’t measure some of the cap’s critical dimensions
Caused By
Not all reject criteria are listed on the Lot Inspection Form
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Supplier produced nonconforming product
Caused ByNonconforming die shape (Equipment Setup)
Equipment modified without approvals (Change control violations)
Dull blades were used (Preventive Maintenance)
Supplier CAPA Investigation
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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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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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Questions?
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