Mapping Your Success Top Non-Conformities Requiring a CAPA Process
Agenda FDA Statistics for 2012 BSI Statistics for 2012 EQMS industry benchmark data About CAPA Traits of Software Solution for CAPA 2
Quality System (QS) Subsystems P&PC CAPA MGMT DES DOC Production & Process Controls Corrective & Preventative Actions Management controls Design Controls Document Controls 3
2012 483 Observations Data QS Subsystem Observations Percentage CAPA 1258 30% P&PC 1303 30% DES 630 15% MGMT 583 14% DOC 469 11% Total: 4243 Source of data - FDA s Turbo Establishment Inspection Reporting (EIR) Database Time frame 1/1/2012 to 12/31/2012 4243 FDA Form 483 observations cited for 21 CFR 820 (Quality System regulation*) deficiencies http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820&showfr=1 4
Most Frequent QS 483 Observations 2011 Citations Observations 2012 Citations Observations 21 CFR 820.100(a) [CAPA] 367 21 CFR 820.100(a) [CAPA] 378 21 CFR 820.198(a) [Complaint Files] 301 21 CFR 820.198(a) [Complaint Files] 349 21 CFR 820.22 [Quality Audit] 207 21 CFR 820.22 [Quality Audit] 234 21 CFR 820.75(a) [Process Validation] 21 CFR 820.30(g) [Design Controls] 154 21 CFR 820.90(a) [Nonconforming Product] 173 21 CFR 820.30(g) [Design Controls] 214 147 21 CFR 820.100(b) [CAPA] 127 21 CFR 820.184 [Device History Record] 21 CFR 820.75(a) [Process Validation] 21 CFR 820.90(a) [Nonconforming Product] 21 CFR 820.25(b) [Personal] 117 21 CFR 820.100(b) [CAPA] 126 21 CFR 820.20(c) [Mgmt. Responsibility] 21 CFR 820.50 [Purchasing Control] 105 190 166 145 112 21 CFR 820.25(b) [Personal] 119 21 CFR 820.20(c) [Mgmt. Responsibility] 21 CFR 820.40 [Document Control] 101 21 CFR 820.40 [Document Control] 101 109 5
2012 CAPA Observations Observation Count Percentage 21 CFR 820.100(a) [CAPA] 378 30% 21 CFR 820.198(a) [Complaint] 349 28% 21 CFR 820.90(a) [Nonconforming Product] 145 12% 21 CFR 820.100(b) [CAPA] 126 10% 21 CFR 820.198(c) [Complaint Files] 93 7% 21 CFR 820.90(b)(2) [Nonconforming Product] 50 3% 21 CFR 820.198(b) [Complaint Files] 33 3% 21 CFR 820.198(e) [Complaint Files] 33 3% 21 CFR 820.90(b)(1) [Nonconforming Product] 24 1% 21 CFR 820.198(d) [Complaint Files] 22 1% 21 CFR 820.198(a)(3) [Complaint Files] 2 <1% 21 CFR 820.198(f) [Complaint Files] 2 <1% 21 CFR 820.100(a)(5) [CAPA] 1 <1% 1258 100% 6
Warning Letters with QS Citations Year # WL s Country 2012 # WL s 2012 164 USA 98 2011 122 China 20 2010 89 Germany 9 2009 77 Italy 6 2008 98 UK 6 2007 74 Denmark 3 2006 79 Japan 3 2005 97 Taiwan 3 2004 113 Canada 2 Source of data - FDA s Warning letters Time frame 1/1/2012 to 12/31/2012 164 Warning Letters with 21 CFR 820 (Quality System Regulation*) deficiencies * http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820&showfr=1 7
2012 Warning Letters QS Subsystem Total Citations % (1085 Total Citations) CAPA 342 32% P&PC 331 30% DES 174 16% DOC 131 12% MGMT 107 10% QS Subsystem # WL w/ Cite % (164 Total WLs) CAPA 143 87% P & PC 134 82% DES 91 55% DOC 78 48% MGMT 70 43% Source of data - FDA s Warning letters Time frame 1/1/2012 to 12/31/2012 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820&showfr=1 8
CAPA Subsystem Warning Letter Cites Citations Number of WL Cites 21 CFR 820.198 154 21 CFR 820.100 130 21 CFR 820.90 54 21 CFR 820.86 4 Total 342 Source of data - FDA s Warning letters Time frame 1/1/2012 to 12/31/2012 164 Warning Letters with 21 CFR 820 (Quality System Regulation*) deficiencies * http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=820&showfr=1 9
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 13485 audits performed by BSI in Americas between 1-Jan-2012 to 31- Dec-2012 10
Americas ISO 13485 NCRs: Section 8 Section 8 Section 8.5 36% Section 8.1 45% Section 8.2, 8.3, 8.4 19% * Based on over 2,400 non conformities identified on ISO 13485 audits performed by BSI in Americas between 1-Jan-2012 to 31- Dec-2012 24/09/2013 11
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
Top Financial/Operational/Quality Management Objectives Source of data LNS Research 13
Why CAPA? Prevention Costs: $1 Detection Costs: $10 Correction Costs: $100 Regulatory Requirements FDA EPA Customer Satisfaction Good Business Practice Source: 1-10-100 Rule; Total Quality Management, Joel E.Ross 14
How do companies manage their processes today & the challenges Cost Reporting 15
16
CAPA Process` Characterize Investigate Analyze Action Plan Implementation Follow Up 17
Closing The Loop Root cause Secondary situations Prevention Side effects Monitoring 18
What Will Auditors Be Looking For? Promptness Records Action CAPA Side effects Training Communication 19
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
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
Questions? 22