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File Name : SAPRAA

CONFIGURATION MANAGEMENT. Presentation to :. SOUTH AFRICAN PHARMACEUTICAL REGULATORY AFFAIRS ASSOCIATION Carol Cotty. Date : 21 November 2008. File Name : SAPRAA. SCOPE. Configuration Management Problem and Background Time Line Why Re-engineer CM? The Goal The How.

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File Name : SAPRAA

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  1. CONFIGURATION MANAGEMENT Presentation to: SOUTH AFRICAN PHARMACEUTICAL REGULATORY AFFAIRS ASSOCIATION Carol Cotty Date: 21 November 2008 File Name: SAPRAA

  2. SCOPE • Configuration Management • Problem and Background • Time Line • Why Re-engineer CM? • The Goal • The How

  3. Frustrated Workers? • Frustrated Management? • Frustrated Organization? What about THE PROBLEM • Incorrect items (numbering, naming, etc.) • Delinquent time scales • Incorrect/inadequate documentation • Cumbersome processes • Accountability, responsibilities, authorities • Reputation?

  4. CONFIGURATION MANAGEMENT Understood to be ... • A discipline ensuring that a product is what it was intended to be • Knowing what something is comprised of and managing changes to it • Maintaining consistency between the product and it’s documentation

  5. = Caution Configuration Managementis not… documentation management Documentation Management is … • Registration and indexing • Filing and storage • Control • Retrieval and distribution • Archiving

  6. TIME LINE 1960’s early US Defence Force documents 1960s late First USA Military Standards 480 series 1970s mid CM Process re-engineered (CMII) 1992 MIL-STD-973 - Released 1994 MIL-STD-973 - Cancelled 1995 ISO 10007 - Updated 2003 1998 ANSI/EIA 649 - Updated 2004 6

  7. WHY ?

  8. REQUIREMENTS DRIVEN 8

  9. ELIMINATES CORRECTIVE ACTION Corrective Action… • is nothing more than rework • performing tasks that we should not have to do • the unnecessary costs to do business i.e. Intervention WHAT IS OUR EXPERIENCE?

  10. 60% 40% - 60% resources spent on intervention 40% ELIMINATES CORRECTIVE ACTION (CONT.) Studies by the ICM and in SA indicate … HOW DID WE DO ?

  11. THE COAL OF CMII

  12. THE COAL OF CMII (CONT.)

  13. COMMON SET OF OPERATING STANDARDS

  14. COMMON OPERATING STANDARDS (CONT.)

  15. COMMON OPERATING STANDARDS (CONT.)

  16. CM – AS REINVENTED

  17. CONCLUSION • Requirements driven • Creates one common set of operating standards • Eliminates corrective action • Accommodates change • Promotes cost reductions • Restores accountability, responsibility, authority and most strategically … REPUTATION

  18. AUTHORIZE AND CONTROL WORK

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