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AUDIT PROGRAM STATUS
1. Status of Audits2. Auditor Activities3. Audit Program4. Looking Ahead
API Certification ProgramsJune 2008 – June 2009 Audits
Monogram; 930; 55%
Dual; 550; 33%
Registration; 133; 8%
Other; 71; 4%
1684 Total Audits
API Certification Programs2009 Audits to Date
Monogram; 445; 55%
Dual; 260; 32%
Registration; 70; 9%
Other; 30; 4%
805 Total Audits
API Certification ProgramsMonogram Audits
June 2008-June 2009
Year-to-Date
Monogram Total
930 445
Renewals 574 304
Initials 230 82
Re-Audits 83 40
Other 43 19
June 2008-June 2009 Year-to-Date
Dual Total 550 260
Periodic-Annual/Initial/Transfer 264 114
Renew-Annual/Initial/Transfers 142 71
Initial-Initial/Annual/Transfer 118 61
Re-audits 25 14
Other 1 0
API Certification ProgramsDual Audits
Licensing AuditsRe-Audits
Re-Audits0
20406080
100120140
20052006200720082009 (Projected)
Auditor ActivitiesAuditor Qualification - 2009 So Far95 total Monogram / QMS Auditors
2 auditors fully qualified – 1 China / 1 Middle East 10 in-process 16 new candidates for 2009 – Most in USA 25 EMS-TPCP-19B-1581 – 10 individual / 15 dual
Auditor Observations-Training 16 Total Auditors Observed At least 17 more to do Focused on China
• Use of Senior Auditors to observe / train• Senior Auditors in audit teams
8
Audit ProgramAudit Assignments
Testing automated, electronic audit documentationFocusing resources on getting more audits out to auditors
Audit Program ToolsEnhanced auditor website – ready for testingReal-time audit report evaluations – positive feedback
Product Questions 5CT questions added - should see on audits 5L, 44th Edition questions done – being added 6DSS expected by July 13 7-1 complete for August 1
Stage 1 Initial Audit Process 25 to date – only on ISO 9001 applications Still working out issues
Audit Program Status2009 – Looking Ahead
2004 2005 2006 2007 2008 20090
200
400
600
800
1000
1200
1400
1600
1800
2000 Total Audits
Monogram Audits
Dual Audits
Registration
2009 Looking Ahead
BETTER AUDITS Focus – get up-to-date on product questions
• Update 6D, 600, 4F, 11E & 7K• Develop 11B, 16A, 16C & 17D
Webinars & online testing• Stage 1 training – for August 1, 2009• Introductory & product spec training - end of 2009
Auditor observations Sharing lessons learned & expectations
• Need to get better at this
AUDITS ON-TIME – MORE AUDITS“LEAN” ASSIGNMENT PROCESS
1. Electronic audit documentation-package2. Enhanced auditor website – download-upload documents3. Bulk audit assignments
• Geographic regions• 6-months prior to due dates
4. Eliminate redundancies – enter assignment information once
AUDITOR QUALIFICATION• October 2009 – 10-12 more fully qualified• End of Q1 2010 – 15 more qualified (total up to 120)• October 2009 – Develop strategic plan
• Look ahead to 2010 & 2011• Where and how – Is our process effective?
2009 Looking Ahead