QSIT Corrective & Preventive Actions. QSIT Workshops

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1 QSIT Corrective & Preventive Actions QSIT Workshops

2 Corrective & Preventive Actions (CAPA) Importance Assessment Data

3 Management Design Controls Production & Process Controls Material Controls Corrective & Preventive Actions Records, Documents, & Change Controls Controls Equipment & Facility Controls

4 Top Ten FDA 483 Items Records (20%) CAPA (50%) PAPC (30%) Non-QSIT Inspections

5 Top Ten FDA 483 Items PAPC (20%) Records (10%) CAPA (30%) Mgmt (40%) QSIT Inspections

6 QSIT Progression 1. Management Controls 2. Design Controls 3. Corrective and Preventive Actions 4. Production and Process Controls 5. Management Controls

7 How Will CAPA be Inspected? QSIT Guide Purpose and Importance Objectives Flow charts Narratives Sampling Plans FOOD AND DRUG ADMINISTRATION GUIDE TO INSPECTIONS OF QUALITY SYSTEMS August 1999

8 Assessment Top Down - Defined and Documented 1. CAPA system procedures Address the requirements of the regulation Management provides definition and interpretation of words or terms

9 Terms and Definitions

10 Corrective Action Action taken to eliminate the causes of an existing non-conformity, defect or other undesirable situation in order to prevent recurrence. [ISO 8402]

11 Correction vs. Corrective Action Correction refers to repair, rework, or adjustment and relates to the disposition of an existing nonconformity Corrective action relates to the elimination of the causes of nonconformity [ISO 8402]

12 Examples Correction: Devices returned because of out-of-box failures are repaired and put back into inventory Corrective action: Defective components damaged by ESD during assembly caused out-of-box failures. ESD controls instituted; operators are trained in ESD controls

13 Preventive Action Action taken to eliminate the cause of a potential non-conformity, defect, or other undesirable situation in order to prevent occurrence [ISO 8402]

14 Example SPC charts indicate process is drifting toward upper limit for diameter of injection molded part. Investigation determines cause of drift is wear to mold. Replace mold, and verify/validate that process yields parts meeting specs.

15 CAPA [21CFR ] Includes Actions Needed To: Correct ( correction ) nonconforming product and other quality problems Prevent recurrence ( corrective action ) of nonconforming product and other quality problems Eliminate the cause of potential ( preventive action ) nonconforming product and other quality problems

16 Assessment Top Down - Implemented 2. ID existing problems (Corrective Actions) Quality data sources are identified Data from sources are analyzed 3. ID potential problems (Preventive Actions) Quality data sources are identified Data from sources are analyzed

17 Assessment Top Down - Implemented 4. Data challenge Complete Accurate Timely

18 Assessment Top Down - Implemented 5. Statistical and non-statistical techniques Detect recurring quality problems Results of analyses» compared across different data sources» identify and develop extent of problems

19 Assessment Top Down - Implemented 6. Failure Investigation Procedures followed Commensurate with significance and risk of nonconformity Depth to root cause, where possible Control to prevent distribution of nonconforming product

20 Assessment Top Down - Implemented 7. Appropriate action taken 8. Actions Were effective Were verified or validated Do not adversely affect the finished device

21 Assessment Top Down - Implemented 9. Actions Implemented Documented 10. Information dissemination Individuals directly responsible for» assuring product quality» prevention of quality problems more...

22 Assessment Top Down - Implemented Management Review!

23 Remember? CAPA Audits Management Review

24 Info disseminated QSIT Study Findings Firms with Observations Procedures ID existing problems Data challenge Analysis techniques Failure Investigation Actions taken Actions effective Actions inplemented (Population 42 Firms) QSIT Objectives

25 Data Sources Internal Feedback External Feedback

26 Internal Data Sources Inspection/Test Data In-Process Final Scrap/Yield Data Process Control Data

27 Internal Data Sources Incoming Components By Part Number By Supplier Equipment Data Calibration Maintenance Internal Audits more...

28 Internal Data Sources Device History Records Training Records Change Control Records Rework Nonconfoming Material Reports more...

29 External Data Sources Complaints Customers Employees MedWatch Field Service Reports Journal Articles FDA more...

30 External Data Sources Field Service Reports Legal Claims Product Warranty more...

31 Approach to Data Analysis Rank areas from major to minor Select items with major impact to business Product related Process related Proceed to items with less impact Assure that eventually all areas are addressed

32 Statistical Techniques Statistical methodologies Pareto charts Run charts Control charts

33 Reminder! 21CFR Part 11 - Electronic Records; Electronic Signatures

34 At the Conclusion of the Inspection... Evaluate whether management with executive responsibility ensures that an adequate and effective quality system has been established and maintained.

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