Corrective and Preventive action (CAPA)
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The document outlines a training program focused on Corrective and Preventive Action (CAPA) within a quality system framework. It details the roles, functions, and requirements of CAPA, emphasizing its importance in continuous improvement and risk assessment related to product and process quality. Additionally, it discusses the lifecycle of CAPA, including discovery, containment, investigation, implementation, and closure phases.
Corrective and Preventive action (CAPA)
- 1. Training Program onTraining Program on CORRECTIVE ACTIONCORRECTIVE ACTION ANDAND PREVENTIVE ACTIONPREVENTIVE ACTION
- 2. THE QUALITY SYSTEM 11 Has six subsystems held together by management controls Quality System 1. It is interactive 2. Monitored through Management review MANAGEMENT CONTROLS 3 To produce products and services that meet requirements of your internal and external customers PURPOSE OF YOUR QUALITY SYSTEM 2
- 3. THE QUALITY SYSTEMTHE QUALITY SYSTEM
- 4. 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.
- 5. THE QUALITY SYSTEMTHE QUALITY SYSTEM
- 6. THE ROLE OF CAPA WHAT IS THE ROLE OF CAPA IN THE QUALITY SYSTEM ?
- 7. THE ROLE OF CAPA IN THE QUALITY SYSTEM CAPA defined: • CAPA is an acronym for CCORRECTIVE AACTION and PPREVENTIVE AACTION
- 8. 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 211 THE ROLE OF CAPA IN THE QUALITY SYSTEM (Cont.)THE ROLE OF CAPA IN THE QUALITY SYSTEM (Cont.)
- 9. 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
- 10. 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 productcontinuously improve product and processesand 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
- 11. 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
- 13. THE CAPA LANGUAGE A nonconformance:A nonconformance: •Not meetingNot meeting specifications, orspecifications, or requirementsrequirements
- 14. THECAPA LANGUAGE: LEXICON (Cont.) A deviation:A deviation: •Not following specifiedNot following specified instructionsinstructions
- 15. THE CAPA LANGUAGE: LEXICON (Cont.) Containment:Containment: •Action taken to arrest theAction taken to arrest the effects of nonconformanceeffects of nonconformance
- 16. THE CAPA LANGUAGE: LEXICON (Cont.) A variance:A variance: •A one time waver toA one time waver to perform a task through aperform a task through a planned deviationplanned deviation
- 17. THE CAPA LANGUAGE: LEXICON (Cont.) A Correction:A Correction: •Action taken to rework, orAction taken to rework, or repair product to meetrepair product to meet specificationsspecifications
- 18. THE CAPA LANGUAGE: LEXICON (Cont.) Risk assessment:Risk assessment: •Action taken to estimateAction taken to estimate the likelihood andthe likelihood and consequence of a potentialconsequence of a potential failure, and failurefailure, and failure happening againhappening again
- 19. THE CAPA LANGUAGE: LEXICON (Cont.)THE CAPA LANGUAGE: LEXICON (Cont.) Preventive loop:Preventive loop: •Information fed into theInformation fed into the CAPA system aboutCAPA system about potential (future)potential (future) nonconformitiesnonconformities
- 20. THE CAPA LANGUAGE: LEXICON (Cont.) Corrective loop:Corrective loop: •Information fed into theInformation fed into the CAPA system aboutCAPA system about nonconformitiesnonconformities
- 21. THE CAPA LANGUAGE: LEXICON (Cont.) Closed loop:Closed loop: •CAPA Information flowCAPA Information flow from initiation in the CAPAfrom initiation in the CAPA system to managementsystem to management review and back to thereview and back to the CAPA system for closureCAPA system for closure
- 23. Your own footer Your Logo KNOW CAPA REQUIREMENTS: PHARMACEUTICALSKNOW CAPA REQUIREMENTS: PHARMACEUTICALS ICHQ10 :
- 24. KNOW CAPA REQUIREMENTS: PHARMACEUTICALSKNOW CAPA REQUIREMENTS: PHARMACEUTICALS ICHQ10 : 1.You must have a CAPA system for product and process improvement 2.Suppliers to your CAPA should be: •The complaint system •Process reject data •Nonconformities •Deviations •Audit findings •Regulatory inspections •Adverse trends from KPIs 3.Your effort and level of investigation should be risk-based
- 25. CAPA REQUIREMENTSCAPA REQUIREMENTS ICHQ10ICHQ10 The 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
- 26. 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
- 27. CAPA LIFE CYCLECAPA LIFE CYCLE THE SEVEN PHASES
- 28. THECAPA LIFECYCLE CAPA is definitive: •It has a beginning and it has an end •CAPA workflows in six phases •Each phase accomplishes a task
- 29. THE CAPA LIFE CYCLE
- 30. Quality issues are discovered through the following discovery vehicles: Internal loop: Primary inputs for this loop includes 1.Internal audit findings 2.Batch record review and batch release 3.Trend analysis / Annual product review 4.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 records 8.Equipment maintenance records 9.Facilities environment control records 10.Management review feedback 11.Risk analysis data THE CAPA LIFE CYCLETHE CAPA LIFE CYCLE 2.CONTAINMENT 1.DISCOVERY
- 31. Quality issues are discovered through the following discovery vehicles: External loop: 1.Customer complaint 2.Customer returns 3.Customer audit findings 4.Regulatory audit findings : FDA 483s, warning letters, ISO audit findings 5.Product recall 6.Supplier (Vendor) audits THE CAPA LIFE CYCLETHE CAPA LIFE CYCLE 1.DISCOVERY
- 32. Your own footer Your Logo 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
- 33. Your own footer Your Logo 3.Impact assessment data •Implications •Cost THE CAPA LIFE CYCLETHE CAPA LIFE CYCLE 2.CONTAINMENT DISCOVERY
- 34. RISK ASSESSMENT FIVE EVALUATION LEVELS: 1.LIKELYHOOD1.LIKELYHOOD •Almost certain •Likely •Moderate •Unlikely •Rare 2. CONSEQUENCES •Catastrophic •Major •Moderate •Minor •Insignificant TWO RISK FACTORS
- 35. ASSESSMENT KEYASSESSMENT KEY RISK ASSESSMENT 1.EXTREME1.EXTREME CA: NOWCA: NOW ContainmentContainment required !required ! 4.LOW TRENDABLE EVENT: MONITOR
- 36. 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
- 37. Containment may involve the following: 1.Stopping production 2.Recalls 3.Stop ship 4.Quarantine 5. 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
- 38. 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
- 39. Your own footer Your Logo C 1.CHOOSE BEST SOLUTION: Through validation , or verification 2.DEFINE THE CRITERIA FOR SUCCESS 3.DEVELOP IMPLEMENTATION PLAN 4. DEFINE WHAT DATA TO COLLECT AND WHEN TO COLLECT IT This is an example text. Go ahead and replace it with your own text. tThis is an example text. Go ahead and replace it with your own text. This is an example text. Go ahead and replace it with your own text. 6.CLOSURE 5.MONITOR FOR EFFECTIVENESS 4.IMPLEMENTATION
- 40. 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 SUCCESS 4.COMPARE AND DRAFT REPORT 6.CLOSURE 5.MONITOR FOR EFFECTIVENESS 5.ASSESSMENT
- 41. Your own footer Your Logo 1.DEFINE ELEMENTS OF THE CAPA FILE1.DEFINE ELEMENTS OF THE CAPA FILE 22.AUDITED CAPA FILE ACCURACY2.AUDITED CAPA FILE ACCURACY 3.3.FILE THE CONTENT3.FILE THE CONTENT 6.CLOSURE 5.MONITOR FOR EFFECTIVENESS 7.CLOSURE
- 42. 1.A DEFINED CRITERIA FOR ESCALATION 2.22.DEFINED COMPOSITION OF THE CAPA REVIEW BOARD 3.DEFINED FREQUENCY 6.CLOSU RE 5.MONIT OR FOR EFFECTI VENESS ESCALATI ON