Rca Case Study R6

Root Cause Analysis A Case Study

Eliminate the Nonconformities

TAREK ELNEIL: [email protected]: 805-732-1739

Contact Information

May 2011 2Tarek Elneil

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


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


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)


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


QMS Improvement Relationships


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


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


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?


Process Root Causes


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


CAUSE AND EFFECT PRINCIPALS Root Cause Analysis


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


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


3. Each Effect has at Least Two Causes

Effect

ActionCause

ConditionCause


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


Problem Investigation

Y

LCL UCL


The Product Components

Cartridge

Liner /Septum

Aluminum shell

Needle

Roll Grove

Plunger

DrugAluminum Cap


Sterile Environment Barrier

Feeding

Filing

Sealing Needle Assembly


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


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


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


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


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


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


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


Component

Caused ByLining resisted the crimping pressure

The lining inside the capoccupied more space than expected

Shell geometrical shape and lining were nonconforming


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


Quality Systems

Caused By

Supplier produced nonconforming product

Nonconforming caps were used in manufacturing

QA Receiving accepted nonconforming Caps


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


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


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


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!


Questions?


Rca Case Study R6

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