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
File Name: SAPRAA Date: 21 November 2008
Presentation to:
CONFIGURATION MANAGEMENT
SOUTH AFRICAN PHARMACEUTICAL REGULATORY AFFAIRS
ASSOCIATION
Carol Cotty
1
Configuration Management
Problem and Background
Time Line
Why Re-engineer CM?
The Goal
The How
2
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
4
Understood to be ...
CONFIGURATION MANAGEMENT
=
Configuration Management is not …
5
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
6
TIME LINE
WHY ?
7
8
REQUIREMENTS DRIVEN
Corrective Action …
WHAT IS OUR EXPERIENCE?
9
• 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 ?
10
ELIMINATES CORRECTIVE ACTION (CONT.)
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
• Requirements driven
• Creates one common set of operating standards
• Eliminates corrective action
• Accommodates change
• Promotes cost reductions
• Restores accountability, responsibility, authority and most strategically …
17
CONCLUSION
REPUTATION
18
AUTHORIZE AND CONTROL WORK