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