CONFIGURATION MANAGEMENT
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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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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


  • 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?


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


=

Caution

Configuration Managementis not…

documentation management

Documentation Management is …

  • Registration and indexing

  • Filing and storage

  • Control

  • Retrieval and distribution

  • Archiving


TIME LINE

1960’s earlyUS Defence Force documents

1960s lateFirst USA Military Standards 480 series

1970s midCM Process re-engineered (CMII)

1992MIL-STD-973- Released

1994MIL-STD-973- Cancelled

1995ISO 10007 - Updated 2003

1998ANSI/EIA 649 - Updated 2004

6


WHY ?


REQUIREMENTS DRIVEN

8


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?


60%

40% - 60% resources spent on intervention

40%

ELIMINATES CORRECTIVE ACTION (CONT.)

Studies by the ICM and in SA indicate …

HOW DID WE DO ?


THE COAL OF CMII


THE COAL OF CMII (CONT.)


COMMON SET OF OPERATING STANDARDS


COMMON OPERATING STANDARDS (CONT.)


COMMON OPERATING STANDARDS (CONT.)


CM – AS REINVENTED


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


AUTHORIZE AND CONTROL WORK


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