| • |
Specifications |
| • |
Installation Drawings |
| • |
Materials of Construction |
| • |
Installing Contractor |
| • |
Assessments |
| • |
Installation Procedures & Protocol |
| • |
cGMP Compliance Program |
| • |
Work Scope & Task
Definitions |
| • |
Visual Acceptance Standards |
| • |
> Materials Weld
Library |
| • |
> Materials
Acceptance |
| • |
Testing Procedures &
Methodology |
| • |
Testing Criteria/Acceptance |
|
| • |
Strategic Planning & Execution |
| |
| > |
High Return QA/QC Activities |
| > |
Risk Assessment |
| > |
Execution Best Practices |
|
| • |
Manpower & Equipment
Utilization |
| • |
Schedule & Contingency
Planning |
| • |
Budget & Cost Control |
| • |
Safety Execution &
Performance |
|
| • |
Supplier
Material & Component Assessments |
| |
| > |
Supplier Audits |
| > |
Source Inspections |
| > |
Pedestal Inspections |
|
| • |
On-site
Material & Component Receiving Assessments |
| |
| > |
Prefab Inspection & Verification |
| > |
Cleanroom Certification |
| > |
Welder Qualification |
| > |
Welding/Systems Qualification |
| > |
Remediation Oversight |
|
| • |
Field Installation Inspection |
| |
| > |
Welding/Systems Qualification |
| > |
Borescope Inspection |
| > |
Slope Verification |
| > |
Critical Systems Validation |
| > |
NDE |
| > |
Remediation Oversight |
|
| • |
Installation Value Assessments |
|
| • |
UHP Installation Procedures & Protocol |
| |
| > |
Installation Contractor Personnel |
| > |
Owner Personnel |
| > |
Sustaining Operations Personnel |
|
| • |
cGMP Compliance Program |
| |
| > |
Installation Contractor Personnel |
| > |
Owner Personnel |
| > |
Sustaining Operations Personnel |
|
|
| • |
Acceptance Testing |
| |
| > |
Installed Process Gas & Chemical
Systems |
| |
• Pressure
Decay
• Helium Leak
• Trace Gases
• Particles
• THC Analysis |
| > |
Installed
Process Water Systems |
| |
• TOC
Analysis
• Resistivity
• Particles |
| > |
Non-Process
Systems |
|
| • |
Certification Testing |
| |
| > |
Low ppb/ppt Certification of Process Bulk Gases |
| > |
Gas Chromatography |
| > |
RGD, FID, DID Analysis |
| > |
APIMS |
|
| • |
Lab Analysis Interpretation |
| • |
Testing Value Assessments |
| • |
Troubleshooting Failed Systems |
|
| • |
Material Control |
| |
| > |
Source Inspections |
| > |
Material Receiving/Handling
Logs |
|
| • |
Welder Qualification Reports |
| • |
Cleanroom & Operations
Certification |
| • |
Weld Procedure Qualification
Reports & Logs |
| • |
Inspection Reports & Logs |
| • |
Testing Reports & Logs |
| • |
Verification Logs & Reports |
| • |
ISO Drawings & Weld Map
Packages |
| • |
cGMP Documentation, Logs, Reports |
| • |
Cleaning/Passivation Documentation |
| • |
Turnover Package |
| • |
Electronic Information Collection, Analysis, and Dissemination |
|
