file name : sapraa
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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. - PowerPoint PPT PresentationTRANSCRIPT
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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
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- Incorrect items (numbering, naming, etc.)
- Delinquent time scales
- Incorrect/inadequate documentation
- Cumbersome processes
- Accountability, responsibilities, authorities
- Reputation?
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- Frustrated Workers?
- Frustrated Management?
- Frustrated Organization?
What about
THE PROBLEM
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• 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
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=
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
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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
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WHY ?
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REQUIREMENTS DRIVEN
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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
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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
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• 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