AUDIT PROGRAM STATUS Status of Audits Auditor Activities Audit Program Looking Ahead
API Certification Programs June 2008 – June 2009 Audits 1684 Total Audits
API Certification Programs 2009 Audits to Date 805 Total Audits
API Certification Programs Monogram Audits June 2008-June 2009Year-to-Date Monogram Total Renewals Initials23082 Re-Audits8340 Other4319
June 2008-June 2009Year-to-Date Dual Total Periodic-Annual/Initial/Transfer Renew-Annual/Initial/Transfers14271 Initial-Initial/Annual/Transfer11861 Re-audits2514 Other10 API Certification Programs Dual Audits
Licensing Audits Re-Audits
Auditor Activities Auditor Qualification So Far 95 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 Program Audit Assignments Testing automated, electronic audit documentation Focusing resources on getting more audits out to auditors Audit Program Tools Enhanced auditor website – ready for testing Real-time audit report evaluations – positive feedback Product Questions 5CT questions added - should see on audits 5L, 44 th 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 Status 2009 – Looking Ahead
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-package 2.Enhanced auditor website – download-upload documents 3.Bulk audit assignments Geographic regions 6-months prior to due dates 4.Eliminate redundancies – enter assignment information once AUDITOR QUALIFICATION October 2009 – more fully qualified End of Q – 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