File Name: SAPRAA Date: 21 November 2008

Presentation to:

CONFIGURATION MANAGEMENT

SOUTH AFRICAN PHARMACEUTICAL REGULATORY AFFAIRS

ASSOCIATION

Carol Cotty

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Configuration Management

Problem and Background

Time Line

Why Re-engineer CM?

The Goal

The How

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SCOPE

- Incorrect items (numbering, naming, etc.)

- Delinquent time scales

- Incorrect/inadequate documentation

- Cumbersome processes

- Accountability, responsibilities, authorities

- Reputation?

3

- Frustrated Workers?

- Frustrated Management?

- Frustrated Organization?

What about

THE PROBLEM

• 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

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Understood to be ...

CONFIGURATION MANAGEMENT

=

Configuration Management is not …

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Caution

• Registration and indexing • Filing and storage• Control• Retrieval and distribution• Archiving

Documentation Management is …

documentation management

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

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TIME LINE

WHY ?

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8

REQUIREMENTS DRIVEN

Corrective Action …

WHAT IS OUR EXPERIENCE?

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• is nothing more than rework

• performing tasks that we should not have to do

• the unnecessary costs to do business

i.e. Intervention

ELIMINATES CORRECTIVE ACTION

Studies by the ICM and in SA indicate …

60%

40%

40% - 60% resources spent on intervention

HOW DID WE DO ?

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ELIMINATES CORRECTIVE ACTION (CONT.)

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THE COAL OF CMII

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THE COAL OF CMII (CONT.)

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COMMON SET OF OPERATING STANDARDS

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COMMON OPERATING STANDARDS (CONT.)

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COMMON OPERATING STANDARDS (CONT.)

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CM – AS REINVENTED

• Requirements driven

• Creates one common set of operating standards

• Eliminates corrective action

• Accommodates change

• Promotes cost reductions

• Restores accountability, responsibility, authority and most strategically …

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CONCLUSION

REPUTATION

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AUTHORIZE AND CONTROL WORK