CAPA &Effective InvestigationsKen PetersonMasterControl LTD

QualityManagement

System

Quality EventManagement

TrainingManagement

SupplierManagement

AuditManagement

Quality EventManagement

DocumentManagement

CAPA PerformanceS

olutionsS

olutions

ProcessProcess

ExpertiseExpertise

OpenCAPA

CAPA Outcomes

Your CAPA Process should:– Be closed loop– Identify and resolve problems– Improve all department outputs– Reduce downtime, scrap, rework, etc.– Eliminate complaints & other quality events feeders– Comply with ISO standards– Make sound business sense

CAPA Closed Loop

• Identify• Prioritize (FDA’s 3 Loops in one)• Assign/Acknowledge• Investigate• Correct• Implement• Verify/Check• Close

1-7

Quality EventsIt all starts with INPUTS..• Customer Complaints• Nonconformity reports• Management Review• (SPC) Data• Quality Issues• Audit Findings• OOS• Deviations • _________________ • _________________

1-8a

CAPA Required

Cause Unknown Cause Known

Issue Review Launch

OOS

Complaint Audit NC

Deviation

Data Gathering

Risk Assessment and

Recommended Course of Action

Containment / Correction

Escalation to CAPA From Issue Review

Issue Review Disposition

CAPA Not Required

Issue Closure – Track and Trend

Root Cause Description

Investigation

Corrective and/or Preventive

Action

Effectiveness Check(s)

Management Approval

QA Disposition

Implement Actions

Verification

Quality Event Management (QEM)

Complaint Closure –

Track and Trend

Issue Review Launch

OOS

Complt. Audit NC

Deviation

Risk Assessment and

Recommended Course

of Action

Containment /

Correction

Escalation to CAPA From

Issue Review

Issue Review Disposition

CAPA Not Required

Issue Closure – Track and

Trend

Root Cause Description

Investigation

Corrective and/or

Preventive Action

Effectiveness Checks)

Management Approval

QA Disposition

Implement Actions

Verification

CAPA Closure – Track

and Trend

What Action Should I Take?

Correction Corrective Action

Preventive Action

Key Term… Existing Reoccurrence Occurrence

The Focus of… Immediate situationEliminating the Root Cause(s)

What could happen

Is Defined as…eliminating an existing nonconformity or undesirable situation.

elimination of the causes of an existing nonconformity undesirable situation in order to prevent reoccurrence.

Identify and eliminate the causes of potentialnonconformance's from occurring.

Suggested tools for…

• 5 Why’s• Brainstorming

• Root Cause Analysis

• Process Mapping

• Failure Mode Effect Analysis (FMEA)

• Fault Tree Analysis (FTA)

6

Solutions

How Does Your Company Respond To…

• Correction?

• Corrective action?

• Preventive action?

• What about “no action”?

6

CAPA & Issue Review

• Define the origin of concerns (quality event).

• Outline the specifics of the quality event.

• Determine the Risk (impact and frequency) of quality event.

• Determine the next level of action required (disposition).

What Quality Events do you see?

Issue Review: Bulls-Eye

WhatWhereWhenWeightWho

2-6a

Decide on Path Forward

How severe (impact) is the problem?How often (frequent) is the problem?

GATEWA

Y

2-11

Determine the Risk

Guidelines:• Assess each issue for impact and

frequency.• Be specific in your assessment.• Score each issue for impact and

frequency.• Determine what issues feed into CAPA.• Register into CAPA system.

Risk Gateway Score

Descriptor Definition

Continually Occurring continually

Frequently Occurs several times in the life of the product

Occasionally Occurs once in a while

Rarely Unlikely to occur again

Frequency

Risk Gateway Score

Descriptor Definition

Critical The problem resulted in serious injury or death to the patient and or operator

Important The problem resulted in non-serious injury to the patient and or operator that required medical intervention

Minor The problem resulted in non-serious injury to the patient and or operator that does not require medical intervention

Negligible There is no risk of injury to the patient and or operator

Impact

F x I =Gateway Score

Impact (Severity) ScaleNegligible Minor Important Critical

1 3 5 10

Continually 5 5 15 25 50

Frequently 3 3 9 15 30

Occasionally 2 2 6 10 20

Rarely 1 1 3 5 10

Acceptable (1 to 3)

Undesirable (5 to 10)

Unacceptable (15 to 50)

Fre

qu

ency

Sca

le

24

Recommendation Cont.

• Adaptive/No Action. Live with this issue and still operate within daily objectives:

• Interim/Correction. Actions that alleviates the effects of the issue and buys time before a corrective action is implemented.

• Corrective. Actions that eliminates the issue permanently.

• Preventive. Anticipates potential problems and eliminates the most likely causes of the problem so they are much less likely to occur:

Acceptable (1 to 3) Undesirable (5 to 10) Unacceptable (15 to 50)

CAPA Required

Cause Unknown Cause Known

Issue Review Launch

OOS

Complaint Audit NC

Deviation

Data Gathering

Risk Assessment and

Recommended Course of Action

Containment / Correction

Escalation to CAPA From Issue Review

Issue Review Disposition

CAPA Not Required

Issue Closure – Track and Trend

Root Cause Description

Investigation

Corrective and/or Preventive

Action

Effectiveness Check(s)

Management Approval

QA Disposition

Implement Actions

Verification

Quality Event Management (QEM)

Complaint Closure –

Track and Trend

Issue Review Launch

OOS

Complt. Audit NC

Deviation

Risk Assessment and

Recommended Course

of Action

Containment /

Correction

Escalation to CAPA From

Issue Review

Issue Review Disposition

CAPA Not Required

Issue Closure – Track and

Trend

Root Cause Description

Investigation

Corrective and/or

Preventive Action

Effectiveness Checks)

Management Approval

QA Disposition

Implement Actions

Verification

CAPA Closure – Track

and Trend

Use Cause Analysis to Investigate when:

-Cause is unknown.

-You need to know the cause.

3 Approaches to Problem Solving

3-4a

“Lights Out” Activity Comparing ResponsesResponse Pros (+) Cons (-)

Trial & Error � instant gratification

� can reduce damages

� might find solution on first try

� reactive

� may add to variability in problem

� risky

Expert / Experiential

� expand participation

� more proactive

� use experience

� educated guesswork vs. facts

� risk of “group think,” challenge of consensus

� when consultant leaves so does expertise

Comparative � fact-based

� objective

� very proactive

� works with experience/expertise

� requires facts

� may take time at first

� people may resist

5 Steps to Cause Analysis Define the Problem—ask yourself…

What is wrong with what?

3-7

Investigate

What exactly has gone wrong?Where…When…Who…Weight.

Compare

What similar object orcircumstance can I compare this

to?

Comparisons Clues

What is unique about theproblem versus the

comparison?

Clues Cause

What causes are suggested by the clues?

Likely Cause Test Likely Causes

• Destructively test against each set of observed and comparative facts.

• Resist testing selectively against just some of the facts.

• If you have time constraints, eliminate writing the reasons you have destroyed a likely cause.

Testing Effectively Testing

9 People die last night in hospitals on our IV Solution

RC Investigations Summary

CAPA Required

Cause Unknown Cause Known

Issue Review Launch

OOS

Complaint Audit NC

Deviation

Data Gathering

Risk Assessment and

Recommended Course of Action

Containment / Correction

Escalation to CAPA From Issue Review

Issue Review Disposition

CAPA Not Required

Issue Closure – Track and Trend

Root Cause Description

Investigation

Corrective and/or Preventive

Action

Effectiveness Check(s)

Management Approval

QA Disposition

Implement Actions

Verification

Quality Event Management (QEM)

Complaint Closure –

Track and Trend

Issue Review Launch

OOS

Complt. Audit NC

Deviation

Risk Assessment and

Recommended Course

of Action

Containment /

Correction

Escalation to CAPA From

Issue Review

Issue Review Disposition

CAPA Not Required

Issue Closure – Track and

Trend

Root Cause Description

Investigation

Corrective and/or

Preventive Action

Effectiveness Checks)

Management Approval

QA Disposition

Implement Actions

Verification

CAPA Closure – Track

and Trend

QualityManagement

System

Quality EventManagement

TrainingManagement

SupplierManagement

AuditManagement

Quality EventManagement

DocumentManagement

Presented ByKen PetersonMasterControl LTD