corrective and preventive action (capa)

Training Program onTraining Program on

CORRECTIVE ACTION CORRECTIVE ACTION AND AND

PREVENTIVE ACTIONPREVENTIVE ACTION

THE QUALITY SYSTEM

1Has six subsystems held together by management controls

Quality System

1. It is interactive2. Monitored through Management review

MANAGEMENT CONTROLS

3To produce products and services that meet requirements of your internal and external customers

PURPOSE OF YOUR QUALITY SYSTEM

2

THE QUALITY SYSTEMTHE QUALITY SYSTEM

PROCESSF(X)

X1X2X3X4X5

INPUTS

Y

OUTPUT


• Each subsystem has a defined function• CAPA is one of the subsystems• The function of a CAPA system is to improve

product and processes in the Quality system• CAPA is a continuous improvement Quality

subsystem• CAPA is Facts and data driven: risk assessment

and impact assessment.

THE ROLE OF CAPA

WHAT IS THE ROLE OF CAPA IN THE QUALITY SYSTEM ?

THE ROLE OF CAPA IN THE QUALITY SYSTEM

CAPA defined:

• CAPA is an acronym for CCORRECTIVE AACTION and PPREVENTIVE AACTION

tPPreventive Action:•Action taken to prevent occurrence of a nonconformance.Action taken before the fact

PREVENTIVE LOOP: PA

CCorrective AAction:•Action taken to Prevent recurrence of a nonconformance.Action taken after the fact

CORRECTIVE LOOP: CA

21

THE ROLE OF CAPA IN THE QUALITY SYSTEM (Cont.)THE ROLE OF CAPA IN THE QUALITY SYSTEM (Cont.)

THE ROLE OF CAPA IN THE QUALITY SYSTEM (Cont.)THE ROLE OF CAPA IN THE QUALITY SYSTEM (Cont.)

CAPA SYSTEMCAPA SYSTEM

PREVENTIVE LOOP AND CORRECTIVE LOOPPREVENTIVE LOOP AND CORRECTIVE LOOP

THE ROLE OF CAPA IN THE QUALITY SYSTEMTHE ROLE OF CAPA IN THE QUALITY SYSTEM

The role of a CAPA system is to continuously improve continuously improve product and processes product and processes in the Quality systemin the Quality system•CAPA is a continuous Quality improvement subsystem•CAPA is Facts and data driven•CAPA decision making is based on risk assessment and impact assessment•Risk assessment is performed on three levels: End-user, compliance ,and business

THE ROLE OF CAPA IN THE QUALITY SYSTEMTHE ROLE OF CAPA IN THE QUALITY SYSTEM

The CAPA system receives information from two Quality management loops:•The internal feedback-loop: Quality data from within the organization•The external feedback-loop: Quality data from outside the organization

THE CAPA LANGUAGE

THE CAPA LANGUAGE

A nonconformance: A nonconformance: •Not meeting Not meeting specifications, or specifications, or requirementsrequirements

THE CAPA LANGUAGE: LEXICON (Cont.)

A deviation:A deviation:•Not following specified Not following specified instructionsinstructions


Containment:Containment:•Action taken to arrest the Action taken to arrest the effects of nonconformanceeffects of nonconformance


A variance:A variance:•A one time waver to A one time waver to perform a task through a perform a task through a planned deviationplanned deviation


A Correction:A Correction:•Action taken to rework, or Action taken to rework, or repair product to meet repair product to meet specificationsspecifications


Risk assessment:Risk assessment:•Action taken to estimate Action taken to estimate the likelihood and the likelihood and consequence of a potential consequence of a potential failure, and failure failure, and failure happening againhappening again

THE CAPA LANGUAGE: LEXICON (Cont.) THE CAPA LANGUAGE: LEXICON (Cont.)

Preventive loop:Preventive loop:•Information fed into the Information fed into the CAPA system about CAPA system about potential (future) potential (future) nonconformitiesnonconformities


Corrective loop:Corrective loop:•Information fed into the Information fed into the CAPA system about CAPA system about nonconformitiesnonconformities


Closed loop:Closed loop:•CAPA Information flow CAPA Information flow from initiation in the CAPA from initiation in the CAPA system to management system to management review and back to the review and back to the CAPA system for closureCAPA system for closure

CAPA SYSTEM REQUIREMENTS

Your own footer Your Logo

KNOW CAPA REQUIREMENTS: PHARMACEUTICALSKNOW CAPA REQUIREMENTS: PHARMACEUTICALS

ICHQ10 :

KNOW CAPA REQUIREMENTS: PHARMACEUTICALSKNOW CAPA REQUIREMENTS: PHARMACEUTICALS

ICHQ10 :1.You must have a CAPA system for product and process improvement2.Suppliers to your CAPA should be:•The complaint system•Process reject data•Nonconformities•Deviations•Audit findings•Regulatory inspections•Adverse trends from KPIs3.Your effort and level of investigation should be risk-based

CAPA REQUIREMENTSCAPA REQUIREMENTS

ICHQ10ICHQ10The decision as to whether to open a CAPA or not after reviewing data from data sources is based on:•Risk assessment•Impact assessment•Trend analysis

CAPA SYSTEM REQUIREMENTSCAPA SYSTEM REQUIREMENTS

The two Quality feedback loops feed two CAPA loops with information:•The reactive loop: After the fact (CAR)•The pro-active loop: Before the fact (PAR)CARs are initiated based on a nonconformance.PARs are initiated based on risk and adverse trends

CAPA LIFE CYCLECAPA LIFE CYCLE

THE SEVEN PHASES

THE CAPA LIFE CYCLE

CAPA is definitive:

•It has a beginning and it has an end•CAPA workflows in six phases•Each phase accomplishes a task

THE CAPA LIFE CYCLE

1.DISCOVERY

2.CONTAINMENT

3. INVESTIGATION

4.IMPLEMENTATION

5.ASSESSMENT

ESCALATION

6.CLOSURE

END

START

Quality issues are discovered through the following discovery vehicles:

Internal loop: Primary inputs for this loop includes

1.Internal audit findings2.Batch record review and batch release3.Trend analysis / Annual product review4.Process control indices (Yield, CCP etc)5.Cost to quality (Re-processing, Re-working etc)6.Quality control Test reports (OOS, Lab Deviations)7.Calibration records8.Equipment maintenance records9.Facilities environment control records 10.Management review feedback11.Risk analysis data

THE CAPA LIFE CYCLETHE CAPA LIFE CYCLE

2.CONTAINMENT

1.DISCOVERY

Quality issues are discovered through the following discovery vehicles:

External loop:

1.Customer complaint2.Customer returns3.Customer audit findings4.Regulatory audit findings : FDA 483s, warning letters, ISO audit findings5.Product recall6.Supplier (Vendor) audits


1.DISCOVERY


The decision on whether to open a CAPA ,or

not is based on:

1.The risk assosiated with the finding:

•Regulatory risk

•Business risk

•Risk to the end user of your product

2.An adverse trend exists


2.CONTAINMENT

1.DISCOVERY


3.Impact assessment data

•Implications

•Cost


2.CONTAINMENT

DISCOVERY

RISK ASSESSMENT

FIVE EVALUATION LEVELS: 1.LIKELYHOOD1.LIKELYHOOD•Almost certain •Likely•Moderate•Unlikely•Rare2. CONSEQUENCES•Catastrophic•Major•Moderate•Minor•Insignificant

TWO RISK FACTORS

ASSESSMENT KEYASSESSMENT KEY

RISK ASSESSMENT

1.EXTREME1.EXTREMECA: NOWCA: NOW

Containment Containment required !required !

4.LOWTRENDABLE EVENT:

MONITOR

Containment reffers to arresting the implications or impact of the problem,or potential problem so it doesn’t spread

The question that drive this phase are

1.What is the problem or potential problem?2.Is it important?3.What should we do to correct it while we look for long term solution?4.Does it affect our mission?5.What is the risk inolved?6.What is its effect on product, process and quality management system?

6.CLOSURE

5.MONITOR FOR EFFECTIVENESS

2.CONTAINMENT

Containment may involve the following:

1.Stopping production 2.Recalls3.Stop ship4.Quarantine5. Reprocess / Re-work

The level or degree of containment taken should be appropriate to the risk possed by the problem,or potential problem.

6.CLOSURE

2.CONTAINMENT

Quality system problems and potential

problems are classified in three categories:

1.Product: Specification related

2.Process

3.System• During investigation the right tool for the right job

should be be used

• The analysis to find the underlying cause of the problem: Root Cause analysis should be performed

6.CLOSURE


3.INVESTIGATION


C1.CHOOSE BEST SOLUTION: Through validation , or verification2.DEFINE THE CRITERIA FOR SUCCESS

3.DEVELOP IMPLEMENTATION PLAN4. DEFINE WHAT DATA TO COLLECT AND WHEN TO COLLECT IT

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6.CLOSURE


4.IMPLEMENTATION

1.CHOOSE STATISTICAL TOOLS FOR DATA MANIPULATION

2.DECIDE HOW YOU WANT TO PRESENT YOU’RE YOUR DATA TO EFFECTIVENESS

3.REVIEW YOUR MEASURE OF SUCCESS4.COMPARE AND DRAFT REPORT

6.CLOSURE


5.ASSESSMENT


1.DEFINE ELEMENTS OF THE CAPA FILE 1.DEFINE ELEMENTS OF THE CAPA FILE

22.AUDITED CAPA FILE ACCURACY2.AUDITED CAPA FILE ACCURACY

3.3.FILE THE CONTENT3.FILE THE CONTENT6.CLOSURE


7.CLOSURE

1.A DEFINED CRITERIA FOR ESCALATION

2.22.DEFINED COMPOSITION OF THECAPA REVIEW BOARD

3.DEFINED FREQUENCY6.CLOSURE


ESCALATION

corrective and preventive action (capa)

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