Training Program on Training Program on CORRECTIVE ACTION CORRECTIVE ACTION AND AND PREVENTIVE ACTION PREVENTIVE ACTION
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
• 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 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
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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
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
THE CAPA LANGUAGE: LEXICON (Cont.)
Containment:Containment:•Action taken to arrest the Action taken to arrest the effects of nonconformanceeffects of nonconformance
THE CAPA LANGUAGE: LEXICON (Cont.)
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
THE CAPA LANGUAGE: LEXICON (Cont.)
A Correction:A Correction:•Action taken to rework, or Action taken to rework, or repair product to meet repair product to meet specificationsspecifications
THE CAPA LANGUAGE: LEXICON (Cont.)
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
THE CAPA LANGUAGE: LEXICON (Cont.)
Corrective loop:Corrective loop:•Information fed into the Information fed into the CAPA system about CAPA system about nonconformitiesnonconformities
THE CAPA LANGUAGE: LEXICON (Cont.)
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
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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
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
THE CAPA LIFE CYCLETHE CAPA LIFE CYCLE
1.DISCOVERY
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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
THE CAPA LIFE CYCLETHE CAPA LIFE CYCLE
2.CONTAINMENT
1.DISCOVERY
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3.Impact assessment data
•Implications
•Cost
THE CAPA LIFE CYCLETHE CAPA LIFE CYCLE
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
5.MONITOR FOR EFFECTIVENESS
3.INVESTIGATION
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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
5.MONITOR FOR EFFECTIVENESS
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.MONITOR FOR EFFECTIVENESS
5.ASSESSMENT
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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
5.MONITOR FOR EFFECTIVENESS
7.CLOSURE