Capa The Challenge And Solution
- 1. Prepared by: Dr/Anthony Gamal (CMQ/OE certified professional) For Contact: Antonygamal@yahoo.com
- 4. Corrective & Preventive actions Facility & Design Equipmen control t controls Quality Management System Productio n& Material Process controls controls Records & document s Change control
- 5. Corrective & Preventive actions Facility & Design Equipmen control t controls CAPA system Productio n& Material Process controls controls Records & document s Change control
- 7. Symptoms: Losing balance , Hypertension , paralysis and finally death. Overloading system with inputs without first organizing them will result in : 1-wasting time and effort in so many tasks without considerable outcomes. 2-Losing directions inside the CAPA maze. 3-Tension between departments and Silo thinking. 4-Paralysis of all activities waiting for the system to restart. 5-CAPA system terminated prematurely and abandoned .
- 8. Where to start ? When to start ? How to start ? How to organize effort?
- 11. 1-First collect data about the inputs for the CAPA system. 2-Rate inputs using a risk based prioritization system. 3-Focus on the Vital few and monitor the useful many until being addressed. 4-Set actions based upon relative weight. 5-Allocate resources based upon the risk based approach. 6-Investigate root cause . 7-Apply corrective actions. 8-Assess the effectiveness of corrective actions. 9-Assess the impact and in case of presence of high impacts set preventive actions. 10- 10-Assess effectiveness of preventive actions. 11- 11-Track and trend. 12- 12-Set control points. 13- 13-Document all steps at the quality management system.
- 12. Input CAPA system Evaluate (Issue review) Flow Chart Yes NO Correct (Take action) Effectiveness Corrective checks action High Preventive Impact action Low Track/Trend Fail Pass Implement Changes Document
- 13. CAPA input Deviation Origin Document Review Worksheet assessment Worksheet OOT Product Non-conformity OOS External Audit finding NCR Internal Audit finding Define origin Incident Complaint Others:……………………… management review Report No.: …………………………………...…………………………………………………………… Collect Data Data collection ………………………………………………………………………………………………… What …………………………………………………………………………………………………… Where ……...…………………………………………………………………………………………… .…………………………………………………………………………………………… …………………………………………………………………………………………………… When ……...…………………………………………………………………………………………… .…………………………………………………………………………………………… …………………………………………………………………………………………………… Who ……...…………………………………………………………………………………………… .…………………………………………………………………………………………… …………………………………………………………………………………………………… Weight ……...…………………………………………………………………………………………… .…………………………………………………………………………………………… Define risk priority Risk assessment Matrix ( Gateway ) 1. Put circle around the figure that Acceptable Unacceptable Impact(Severity)Scale Negligible describe the corresponding Severity and Critical Major Minor Occurrence of the problem. High risk 2. Define the reproducible number for the two values. Revised problem statement ١ ٣ ٥ ١٠ The encountered Deviation ٥ ٥ ١٥ ٢٥ ٥٠ Occurrence risk assessment rating is: Continually ……………………………… Frequently ٣ ٣ ٩ ١٥ ٣٠ Occasionally ٢ ٢ ٦ ١٠ ٢٠ ١ ١ ٣ ٥ ١٠ Revised problem statement The encountered deviation is described as Rare ………………………………………………………………………………………………………………………………… ………………………………………………………………………………………………………………………………… …………………… Action Recommendations Recommendation Initiate CAPA request Add to NCR and start Investigation Track and trend archive for knowledge management Prepared By: ……………………………… approved By: ………………………………
- 14. 1. Select the figure that Acceptable Impact(Severity)Scale describe the corresponding Severity and Occurrence of Unacceptable the problem. Negligible Critical Minor Major High risk 2. Define the reproducible number for the two values. 1 3 5 10 5 5 15 25 50 Continually Occurrence 3 3 9 15 30 Frequently 2 2 6 10 20 Occasionally 1 1 3 5 10 Rare
- 15. Response Adv. Consequences Trial & Error 1-Instantanious. 1-Reactive. 2-Can reduce damage. 2-May add to variability in 3-Might find solution on problem. first trial. 3-Very risky. Expert 1-Expand participation. 1-depend upon educated /experiential 2-More Proactive. guesswork 3-Depend on rather than facts. experience 2-Risk of “Group think”. 3-When experienced personnel leaves so does tacit knowledge. Comparative 1-Fact-based. 1-Requires facts. (Investigative) 2-Objective. 2-May take time at first. . 3-Very proactive 3-People always resist. 4-work efficiently with experience/Expertise
- 16. Actions Levels
- 17. 1-Arrange actions into categories. 2-Set action categories in order using their due dates. 3-Test actions for effectiveness. 4-follow up proper implementation. 5-Close CAPA.
- 18. CAPA inputs CAPA Filtration system Investigation Root cause A
- 19. A Define Action Functional departments Define responsibility Quality Assurance Define Due dates Apply Actions Effectiveness check Closing CAPA
- 20. Dr/Anthony Gamal