Mapping Your Success Top Non-Conformities Requiring a CAPA Process

Transcription

1 Mapping Your Success Top Non-Conformities Requiring a CAPA Process

2 Agenda FDA Statistics for 2012 BSI Statistics for 2012 EQMS industry benchmark data About CAPA Traits of Software Solution for CAPA 2

3 Quality System (QS) Subsystems P&PC CAPA MGMT DES DOC Production & Process Controls Corrective & Preventative Actions Management controls Design Controls Document Controls 3

4 Observations Data QS Subsystem Observations Percentage CAPA % P&PC % DES % MGMT % DOC % Total: 4243 Source of data - FDA s Turbo Establishment Inspection Reporting (EIR) Database Time frame 1/1/2012 to 12/31/ FDA Form 483 observations cited for 21 CFR 820 (Quality System regulation*) deficiencies 4

5 Most Frequent QS 483 Observations 2011 Citations Observations 2012 Citations Observations 21 CFR (a) [CAPA] CFR (a) [CAPA] CFR (a) [Complaint Files] CFR (a) [Complaint Files] CFR [Quality Audit] CFR [Quality Audit] CFR (a) [Process Validation] 21 CFR (g) [Design Controls] CFR (a) [Nonconforming Product] CFR (g) [Design Controls] CFR (b) [CAPA] CFR [Device History Record] 21 CFR (a) [Process Validation] 21 CFR (a) [Nonconforming Product] 21 CFR (b) [Personal] CFR (b) [CAPA] CFR (c) [Mgmt. Responsibility] 21 CFR [Purchasing Control] CFR (b) [Personal] CFR (c) [Mgmt. Responsibility] 21 CFR [Document Control] CFR [Document Control]

6 2012 CAPA Observations Observation Count Percentage 21 CFR (a) [CAPA] % 21 CFR (a) [Complaint] % 21 CFR (a) [Nonconforming Product] % 21 CFR (b) [CAPA] % 21 CFR (c) [Complaint Files] 93 7% 21 CFR (b)(2) [Nonconforming Product] 50 3% 21 CFR (b) [Complaint Files] 33 3% 21 CFR (e) [Complaint Files] 33 3% 21 CFR (b)(1) [Nonconforming Product] 24 1% 21 CFR (d) [Complaint Files] 22 1% 21 CFR (a)(3) [Complaint Files] 2 <1% 21 CFR (f) [Complaint Files] 2 <1% 21 CFR (a)(5) [CAPA] 1 <1% % 6

7 Warning Letters with QS Citations Year # WL s Country 2012 # WL s USA China Germany Italy UK Denmark Japan Taiwan Canada 2 Source of data - FDA s Warning letters Time frame 1/1/2012 to 12/31/ Warning Letters with 21 CFR 820 (Quality System Regulation*) deficiencies * 7

8 2012 Warning Letters QS Subsystem Total Citations % (1085 Total Citations) CAPA % P&PC % DES % DOC % MGMT % QS Subsystem # WL w/ Cite % (164 Total WLs) CAPA % P & PC % DES 91 55% DOC 78 48% MGMT 70 43% Source of data - FDA s Warning letters Time frame 1/1/2012 to 12/31/

9 CAPA Subsystem Warning Letter Cites Citations Number of WL Cites 21 CFR CFR CFR CFR Total 342 Source of data - FDA s Warning letters Time frame 1/1/2012 to 12/31/ Warning Letters with 21 CFR 820 (Quality System Regulation*) deficiencies * 9

10 Americas - ISO13485 NCRs Section 8 Measurement, Analysis & Improvement 27% 2012 Section 4 Quality Management System 22% Section 5 Management Responsibility 7% Section 7 Product Realization 34% Section 6 Resource Management 10% * Based on over 2,400 non conformities identified on ISO audits performed by BSI in Americas between 1-Jan-2012 to 31- Dec

11 Americas ISO NCRs: Section 8 Section 8 Section % Section % Section 8.2, 8.3, % * Based on over 2,400 non conformities identified on ISO audits performed by BSI in Americas between 1-Jan-2012 to 31- Dec /09/

12 Sample Top NCRs Issued by BSI CAPAs overdue or ineffective in root cause, correction and corrective actions No validations in place for equipment or processes, such as sealing, sterilization Complaints not fully investigated or reported to regulatory authorities Design controls incomplete A number of incorrect records related to document control, training, or calibration 12

13 Top Financial/Operational/Quality Management Objectives Source of data LNS Research 13

14 Why CAPA? Prevention Costs: $1 Detection Costs: $10 Correction Costs: $100 Regulatory Requirements FDA EPA Customer Satisfaction Good Business Practice Source: Rule; Total Quality Management, Joel E.Ross 14

15 How do companies manage their processes today & the challenges Cost Reporting 15

16 16

17 CAPA Process` Characterize Investigate Analyze Action Plan Implementation Follow Up 17

18 Closing The Loop Root cause Secondary situations Prevention Side effects Monitoring 18

19 What Will Auditors Be Looking For? Promptness Records Action CAPA Side effects Training Communication 19

20 8 Traits of Effective Corrective Action System #1 Work flow types for multiple types of CA #2 -- Integrating adverse events into CA process #3 -- Not everything needs to be a CA #4 -- Filtering 20

21 8 Traits of Effective Corrective Action System, Continued #5 -- Action Plans #6 -- Measuring effectiveness #7 -- Linking CA to change management #8 -- Traceability and reporting 21

22 Questions? 22