Académique Documents
Professionnel Documents
Culture Documents
Qualification Benchmarking
Educational Track #1
Agenda
Part 1
(8:30 10:00)
Panel Q&A
Wrap-up
(10:00 10:30)
My Background in Subject
Official trainer for ISPE Baseline
Commissioning and Qualification
Guide
Member of team that wrote ASTM
E2500
Terminology
Qualification practices
Focusing the effort
Roles and responsibilities
Managing changes during the project
Terminology
C&Q Baseline guide
Commissioning
Qualification
ASTM E2500
Verification
Qualification Practices
C&Q Baseline Guide
ASTM E2500
Not mentioned
Impact assessments
Direct impact systems and critical
components
V-model
ASTM E2500
ASTM E2500
Managing Change
C&Q Baseline Guide
ASTM E2500
Common Elements
Steve Connelly
Overview
Where Abbott Is Today
C&Q Approach
Commissioning & Qualification Activities
How We Manage Cost
Lessons Learned
Implementation:
Corporate policies support Science & Quality Risk
Management and includes Good Engineering Practice
(GEP) reference
Training ( RBA, GEP, ECM. Commissioning, Risk Assessments)
Tools and Templates
Discretion of the Validation Review Board (VRB)
*ASTM E2500-07: A Standard Guide for the Specification, Design, & Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and
Equipment
Science &
Quality Risk
Management
Qualification
Process
Flow
Commissioning
When supporting Qualification, Commissioning must
include or address:
Engineering Change Management (ECM)
After point commissioning data intended to support
Qualification
Testing
Methods described in sufficient detail for repeatability
Documentation confirms critical elements met criteria
Acceptance criteria documented prior to execution
Criteria based on User Requirements
Documentation of observed results
Qualification Equipment
User requirements
Qualification
Holistic Approach
Qualification Facilities
Qualification HVAC
Categorization
Qualification Utilities
ENGINEERING
FEP 1-3
User Requirements
Functional Specification (Draft)
Preliminary Design
Detailed Design
Construction
Loop Tuning
Equipment Installation/Alignment
COMMISSIONING
Risk Assessment
Failure Mode Effect Analysis
I/O checkout
Calibration
Functional Specification (Revisions)
Factory Acceptance Testing
Startup
Trouble Shooting
Sequence Testing
As-Builts (Non Qualified Systems)
QUALIFICATION (CERTIFICATION)
Validation Plan
Design Qualification
Equipment Installation Qualification
Equipment Operational Qualification
Computer Hardware Installation Qualification
Computer Software Installation Qualification
Controller Modification Qualification
HVAC Installation/Operational Qualification
Utility Installation Qualification
Process Qualification
Validated Drawings
Samples/Testing
Cleaning/Passivation
Inspections
Lessons Learned
Risk-Based C&Q is an iterative process (one
tiny
step at a time)
Application:
Site readiness tools - identifying opportunities for closing gaps
Lessons Learned
Listen, Speak, Deliver. Communication is key.
Quality may wonder:
What if engineering doesnt do its job?;ensure compliance
Engineering may wonder:
Quality = police & spell checkers; right the first tyme
Application:
Regular/frequent communication with VRB & project team
Lessons Learned
Sustainable Paradigm Shift
Sites: Implementation, accountability & ownership a must for
sustainability
Resources: People, time & money, site retaining technical
knowledge
Application:
Training & support implementation as applicable
Thank you!
Questions will be addressed during
the Panel Q&A session (after break)
C&Q Metrics
C&Q Metrics
Schedule Metrics
Cost Metrics
Discrepancy Metrics
FT duration/system: 42 days
IQ duration/system: 11 days
OQ duration/system: 17 days
Note: Metrics for new powder filling facility consisting of approx. 40 systems
20%
25%
10%
10%
5%
No C&Q prog
1998- 2001
5%
3% GOAL
Average:
Commissioning - Subcategory
FAT development
FAT execution
Receipt Verification development
Receipt Verification execution
Installation Verification development
Installation Verification execution
SAT development
SAT execution
Construction turnover packages
Qualification - Subcategory
IQ development
IQ execution
OQ development
OQ execution
PQ development
PQ execution
Administration - Subcategory
Training
Project management
C&Q resource travel
Administrative assistance
Audits
CSV support
(last 2 years)
GDP SOP
Change Management SOP
Transfer of Care, Custody and Control SOP
Discrepancy Management Best Practice
Vendor risk
Technology risk
Automation strategy
The resulting C&Q delivery strategy will hopefully be realized as another step
change in C&Q savings! Potential C&Q costs as low as 3% of TIC
Questions?
Q&A
Agenda
Basis of C&Q Practices
C&Q Program Management
Approach
C&Q Cost Management
Key Lessons
Agenda
Part 1
(8:30 10:00)
Panel Q&A
Wrap-up
(10:00 10:30)
Thank You!!