Project Programming and
Commissioning as a Risk
Mitigation and Threat
Analysis Tool
Presented by
Michael L. Weiss, Ph.D ABD,
HCCP
PURPOSE OF
COMMISSIONING
Is to confirm through a
systematic process which is
documented and verifiable that
all building systems both hard
and soft will work in compliance
with Owners Performance
Phases of
Commissioning
Post
Occupancy
Phase
Construction
Phase
Acceptance
Phase
Facility
Program
Pre-design
Phase
Design
Phase
Pre-911 Commissioning
• Mechanical
• Electrical
• Plumbing
Changing based on Real World
Conditions
9/11 changed the way we
program, design, build
COMPLIANCE AND
CERTIFICATION
•
NIH/NIAID/ July 2004
•
CFR 42/PART 73/Patriot Act – April 19, 2005
•
CDC Biosafety in Microbiological and Biomedical
Laboratories – 5
THEdition
•
NIJ/ASCLD Forensics Laboratories Handbook
•
American Pathologists Checklist of Accreditation
•
USDA 242.1 ARS Facilities Design Standards –
Chapter 9
•
NIH
Guidelines
for Research Involving Recombinant
DNA Molecules
•
NSF 49
•
NFPA 30, 45, 55, 70, 101
•
OSHA
•
Building Codes
•
ANSI
•
ASHRAE
DISASTER RECOVERY
•
Uncertainty regarding
the effectiveness of
decontamination
methods
•
No national clean-up
standards or consensus
•
Unknown
vulnerabilities and
contamination patterns
•
Lack of large scale
tests and demos of
decon operations
Lab
Procedure
Secondary
Containment
Room/Other
Primary
Containment
Room/Equipment
Operations
Maintenance
Equipment
Procedure
Facilities
Operations
MATCHING FACILITIES
AND PROTOCOL
Containment Requirements Facility Requirements Systems Maintenance Access Equipment Maintenance AccessCommissioning
Process
Ascertain Owner’sProject Requirements Develop Cx Plan Pre-functional Checklist
Execute Checklist Approve Startup Report
Conduct Functional Performance Tests Approval Final Cx Report Correct Deficiencies Make Corrections Deficiencies? Compliance YES YES NO NO
How would (could) you respond ?
QuickTime™ and a
YUV420 codec decompressor
are needed to see this picture.
PLANNING FOR RESPONSE
Threats
•
Terrorism
•
Biological
•
Chemical
•
Radiation
•
Explosive
•
Naturally Occurring
Pandemics
•
Emerging Infectious
Diseases
•
Environmental Disasters
•
Climate Change
•
Natural Disasters
•Real, evolving, continuous
worldwide threat
•Effective plan incorporated into
OPR
•Provide solid foundation for
preventing and reacting to
terrorist/emergency incidents
•Predictable, planned and concise
Risk Analysis and Management in Projects
Risk to
Health and
Safety
Risk to
Environment
Risk to
Activity
COST
Risk to Health and Safety of
People and Protection of Animal
Colonies
Risk to Environment Including Harm and
Damage to Flora and Fauna Due to
Breech of Containment
Risk to Activity Including Damage to
Systems, Equipment, Loss of Research
and Contractual/Construction Delays and
Penalties
The Biggest Challenge of a Project of this Magnitude is
the Execution and Delivery Within Budget
Project Level
Risks
• Areas of Risk: Health and
safety, environment and
activity
• Directly affect project
budgets
• Risks constantly change
throughout the life of a
project
Elements of a Threat
Analysis
• Identifies system
vulnerabilities
• Maps system assets
• Assesses threat risk
Threat analysis is most effective when used in
the design intent phase and continues as an
ongoing process throughout the project’s life
Risk Threat
Analysis Report
Assessment of potential risk areas
includes:
• Operational processes
• Supply and delivery chains
• Communications protocols
• Emergency procedures
General Security Risk
Assessment
Identify Assets Specify Loss Events Frequency of Events Impact of Events Options to Mitigate Feasibility of Options Cost/Benefit Analysis DecisionReassessment
Risk Management
Program
• Offers security and continuity
planning
• Provides practical risk management
• Optimizes emergency response
• Ensures operational continuity
• Lowers risk and liability
The purpose of implementing a risk
mitigation plan is to accurately
identify countermeasures and their
relationship to project and
facility vulnerabilities
Threat
Risk
Non standardized quality assurance programs
contribute to duplication of resources, widespread
fragmentation and project confusion. Combined, these
factors are driving up the cost of our projects and the
operational cost on a yearly basis.
Risk & Secured
Perimeter
Cost & Secured Perimeter
Cost
Time
Complexity
Space
Project
Consequences
SECURITY & THREAT MATRIX
2. PARKING CCTV ROADWAY/PEDESTRIAN LIGHTING ROAMING SECURITY 3. VISITOR CENTERNON-PIGGY BACK DOORS CARD READING DEVICES CCTV @ ALL LOBBIES SECURITY COMMAND CENTER ‘A’
4. BUILDING ENVELOPE / ADMIN.
CARD READING DEVICES HALLWAY CAMERAS
BLAST/PENETRATION RESISTANCE CCTV AT ALL DOORWAYS
SITE LIGHTING WITHIN FENCED AREAS
5. DATA CENTER / CONTROL CENTER
BIOMETRIC READING DEVICES CCTV OF ALL OCCUPIED SPACE
BLAST/PENETRATION PROOF SECURITY COMMAND CENTER ‘B’
1. SITE PERIMETER
PERIMETER DETECTION (CCTV, MOTION DETECTION)
GUARDHOUSES – VEHICULAR IDENTIFICATION SYS. CONTROL GATES
LANDSCAPING - BERMING - GRADING LIMITED SITE LINES
LOW RISK ZONE
HIGH RISK ZONE
MODERATE RISK ZONE
Select Agents Biocontainment ADMINISTRATION PARKING EMPLOYEE BUILDING ENTRY SERVICE PACKAGE INSPECTION EMPLOYEE & VISITOR CENTER ENTRY / EXIT SERVICE & DELIVERY SCREENING ENTRY / EXIT SECURITY FENCE PERIMETER DETECTION PERIMETER DETECTION SECURITY FENCE
1
2
4
5
POWER PLANT3
LA N DS C AP IN G & G R AD IN G DISPATCHER PARKINGRisk Management RAMP
Identify Deliverables
Risk Mitigation Plan
Risk Management
Action Item Task
Plan, organize & launch RAMP Establish Baseline
Plan & initiate risk review Identify Tasks
Evaluate Risks Devise Measures Assess Residual Risks
Plan Responses Communicate
Implement Strategy & Plans Control Risks
Assess Outturn Review RAMP Process
Activity A: Identify deliverables
1. Plan, organize and launch the RAMP process
2. Establish baseline
Activity B: Risk Mitigation Plan
1. Plan and initiate risk review
2. Identify risks
3. Evaluate risks
4. Devise measures for mitigating risks
5. Assess residual risks and decide whether to
continue
6. Plan responses to residual risks
7. Communicate mitigation strategy and response
plan
Activity C: Risk Management
1. Implement strategy and plans
2. Control risks
Activity D: Action item task
1. Assess investment outturn
2. Review RAMP process
Activity A: Identify deliverables
1. Plan, organize and launch the RAMP process 2. Establish baseline
Activity B: Risk Mitigation Plan 1. Plan and initiate risk review
2. Identify risks 3. Evaluate risks
4. Devise measures for mitigating risks 5. Assess residual risks and decide
whether to continue
6. Plan responses to residual risks 7. Communicate mitigation strategy and
response plan
Activity C: Risk Management 1. Implement strategy and plans
2. Control risks
Activity D: Action item task 1. Assess investment outturn
2. Review RAMP process
•Coordinate Team Members
•Confirm Source of Risk
•Plan Strategy
•Prepare a Brief
•Establish a Baseline
•Document Risk Diary
Activity A: Identify deliverables 1. Plan, organize and launch the RAMP
process
2. Establish baseline
Activity B: Risk Mitigation Plan 1. Plan and initiate risk review
2. Identify risks 3. Evaluate risks
4. Devise measures for mitigating risks 5. Assess residual risks and decide whether to
continue
6. Plan responses to residual risks
7. Communicate mitigation strategy and response plan
Activity C: Risk Management 1. Implement strategy and plans
2. Control risks
Activity D: Action item task 1. Assess investment outturn
2. Review RAMP process
RAMP Process
•Identify Sources of Risk
•Identify Causes
•Group Like Risks and Cause
•Establish relationships
•Classify Level of Risk
Low
Medium
Activity A: Identify deliverables 1. Plan, organize and launch the RAMP
process
2. Establish baseline
Activity B: Risk Mitigation Plan 1. Plan and initiate risk review
2. Identify risks 3. Evaluate risks
4. Devise measures for mitigating risks 5. Assess residual risks and decide
whether to continue
6. Plan responses to residual risks 7. Communicate mitigation strategy and
response plan
Activity C: Risk Management 1. Implement strategy and plans
2. Control risks
Activity D: Action item task 1. Assess investment outturn
2. Review RAMP process
RAMP Process
•Develop Risk Mitigation Strategy
•Develop Risk Response Plan
Contain the Risk
Establish Contingency Plan
Establish Contingency Budget
Establish Contingency Schedule
Plan for Potential Impact
Activity A: Identify deliverables 1. Plan, organize and launch the RAMP
process
2. Establish baseline
Activity B: Risk Mitigation Plan 1. Plan and initiate risk review
2. Identify risks 3. Evaluate risks
4. Devise measures for mitigating risks 5. Assess residual risks and decide
whether to continue
6. Plan responses to residual risks 7. Communicate mitigation strategy and
response plan
Activity C: Risk Management 1. Implement strategy and plans
2. Control risks
Activity D: Action item task 1. Assess investment outturn
2. Review RAMP process
RAMP Process
•Implement Risk Response Plan
•Implement Revised Schedule
•Implement Revised Budget
•Set Review Milestones
Activity A: Identify deliverables
1. Plan, organize and launch the RAMP process 2. Establish baseline
Activity B: Risk Mitigation Plan 1. Plan and initiate risk review
2. Identify risks 3. Evaluate risks
4. Devise measures for mitigating risks 5. Assess residual risks and decide
whether to continue
6. Plan responses to residual risks 7. Communicate mitigation strategy and
response plan
Activity C: Risk Management 1. Implement strategy and plans
2. Control risks
Activity D: Action item task 1. Assess investment outturn
2. Review RAMP process
RAMP Process for Containment
Pressurization Verification
Architectural
Owner Representative
MEP Engineering
General Contractor
Appropriate Subs
Commissioning
Confirm and Document Pressure Decay
Test Criteria
Activity A: Identify deliverables 1. Plan, organize and launch the RAMP
process
2. Establish baseline
Activity B: Risk Mitigation Plan 1. Plan and initiate risk review
2. Identify risks 3. Evaluate risks
4. Devise measures for mitigating risks 5. Assess residual risks and decide whether to
continue
6. Plan responses to residual risks
7. Communicate mitigation strategy and response plan
Activity C: Risk Management 1. Implement strategy and plans
2. Control risks
Activity D: Action item task 1. Assess investment outturn
2. Review RAMP process
Design Detail
Electrical Conduit Installation
Autoclave Bio-seal Installation
Embed Detail
Construction Detail
Wire Stripping and Conduit Seal
Mounting Frame and Gasket
Integrity
Embed Installation
Group Like Risks
Mock-up Time
Revised Detailing
Construction Scheduling
Cost
Activity A: Identify deliverables 1. Plan, organize and launch the RAMP
process
2. Establish baseline
Activity B: Risk Mitigation Plan 1. Plan and initiate risk review
2. Identify risks 3. Evaluate risks
4. Devise measures for mitigating risks 5. Assess residual risks and decide
whether to continue
6. Plan responses to residual risks 7. Communicate mitigation strategy and
response plan
Activity C: Risk Management 1. Implement strategy and plans
2. Control risks
Activity D: Action item task 1. Assess investment outturn
2. Review RAMP process
•Establish Communication Protocol
and Coordination Approval
•
Benchmark Primary & Alternative Design
Solutions
•
Develop & Test including Mock-up
•
Assess Schedule Impact
•
Establish Contingency Budget
Activity A: Identify deliverables 1. Plan, organize and launch the RAMP
process
2. Establish baseline
Activity B: Risk Mitigation Plan 1. Plan and initiate risk review
2. Identify risks 3. Evaluate risks
4. Devise measures for mitigating risks 5. Assess residual risks and decide
whether to continue
6. Plan responses to residual risks 7. Communicate mitigation strategy and
response plan
Activity C: Risk Management 1. Implement strategy and plans
2. Control risks
Activity D: Action item task 1. Assess investment outturn
2. Review RAMP process
•Implement Design Solution
•Assign Critical Path Schedule
•Document Lessons Learned
Program Similarity
Ascertain Owner’s Project Requirements Develop Cx Plan Pre-functional Checklist Execute ChecklistApprove Startup Report
Conduct Functional Performance Tests Approval Final Cx Report Deficiencies? Compliance YES YES NO NO
HARD SYSTEMS
Commissioning
Identify DeliverablesRisk Mitigation Plan
Risk Management
Action Item Task
Plan, organize & launch RAMP
Establish Baseline
Plan & initiate risk review Identify Tasks Evaluate Risks Devise Measures Assess Residual Risks
Plan Responses Communicate
Implement Strategy & Plans Control Risks
Assess Outturn Review RAMP Process
SOFT SYSTEMS
R/T/M
Develop OPR Develop Cx Plan Pre-functional Checklist Execute ChecklistApprove Startup Report
Conduct Functional Performance Tests Approval Final Cx Report Deficiencies? Compliance YES YES NO NO
Plan & initiate risk review Identify Tasks Evaluate Risks Devise Measures Assess Residual Risks
Plan Responses Communicate
Assess Outturn Review RAMP Process
Early Adoptors
Successful projects:
• Centers for Disease
Control and
Prevention
• US Department of
Energy National
Laboratory Program
• Regional Biological
Defense Program
• NJPHEAL
New Jersey Public
Health,
Environmental and
Agriculture
Laboratory
Case Study
•
Location:
West Trenton, NJ
•
Gross SF:
200,000
•
Net SF: 116,000
•
Efficiency
58%
•
Construction Budget:
$118,900,000
•
Current Cost Estimate:
$121,300,000
•
Phase:
Construction Documents
•
Completion Date:
Q1 2010
•
Mid Point Construction:
Q1 2009
Risk Scoring –
Comparison
Complex Flexible 100 90 Biology Biomedical 80 Computer Science Geology Civil Eng BSL-2Clean Room Psychology 70 Ballroom BioChemistry Chemistry Clean Room Aerospace 60 B/C cGMP Industrial BSL-3 Elec Eng Mechanical Large Animal No Contain Small Animal No Contain Physics 50 BSL-3E Imaging BSL-3 Clean Room
Small Animal Chem Eng 40 Contain BSL-3Ag Material Nano Large Animal Containment BSL-4 30 20 10 0 Inflexible Simple 0 20 30 40 50 60 70 80 90 100 Grea ter Flex ibil ity Less Com plex ity
Shared 3% Office 17% Amenities 2% BSL-2 34% Environmental Chemistry 20% Animal Facilities 2% BSL-3 6% Waste 1% Support 15%
General Conditions 12% Contingency 3% Escalation 7% Photo Voltaics 2% Finishes 4%
Doors & Windows 4% Specialties 1% Conveying 1% Plumbing 4% Fire Protection 1%
Equipment & Casework 9% HVAC 17% Electrical 10% Pre Screening Building >1%
Thermal & Moisture 5%
Wood & Plastic 1% Metals 7% Masonry 1% Concrete 3% Site Work 6% Earth Work 1%
Cost by Category
Where the Big Money is…
•
Mechanical Systems
•
Electrical
•
Structural
•
Security
•
Decontamination
•
Equipment
•
Casework
Where the Pocket Change
is…
•Architectural
•Lighting
•Finishes
•Doors and Hardware
45-60% of Total
Cost
HVAC
•
Temperature
• Humidity
• Pressure
• Directional
Airflow
• Exhaust
• Filtration
•Decontamination
Plumbing
• Effluent Treatment
• Water Supply
• DI/RO Water
• Fire Protection
• Lab Gases
•Breathing Air
Electrical
• Lighting
• Power
– Emergency • Fuel – UPS• Security Systems
• Telecommunications
Architectural/
Structural
• Blast Protection
• Security
• Progressive
Collapse
• Force Protection
• Protocol
• Durability
• Life Safety
Cost Containment
Level 1
Full
Redundancy
HVAC•
Temperature Control•
Humidity Control•
Pressure Control•
Maintain Directional Airflow•
Maintain Exhaust•
Maintain Filtration•
Decontamination ELECTRICAL•
Emergency Lighting•
Emergency Power•
Maintain Security Systems•
No Loss of Telecommunications PLUMBING•
Effluent Treatment•
Water Supply•
DI/RO Water•
Fire Protection•
Lab Gases•
Breathing AirLevel 2
Partial
Redundancy
HVAC• Limited Temperature Control • Limited Humidity Control • Maintain Pressure
• Maintain Directional Airflow • Limited Exhaust
• Maintain Filtration • Limited Decontamination
ELECTRICAL
• Emergency Lighting • Selected Emergency Power • Maintain Security Systems • No Loss of Telecommunications
PLUMBING
• Limited Effluent Treatment • Water Supply • DI/RO Water • Fire Protection • Lab Gases
Level 3
No Requirement
HVAC • No Temperature Control • No Humidity Control • Limited Pressure Control • No Directional Airflow • Limited Exhaust• Limited Filtration • No Decontamination
ELECTRICAL
• Emergency Lighting (Life Safety)
• Limited Emergency Power • Maintain Security Systems • No Loss of Telecommunications PLUMBING • No Effluent Treatment • Water Supply • No DI/RO Water • Fire Protection
Operational Levels
•
Level 1
•
N+1- 24/7/365 Operation•
< 1 min downtime•
Full Temp/Hum/Pressure•
Emergency Power•
Life Safety/Lighting•
Security•
Level 2
•
N - 24/7/365 Operation•
< 5 min downtime•
Full Pressure Control•
Limited Temp/Humidity•
Selected Emergency Power•
Life Safety/Lighting•
Security•
Level 3
•
N - 24/7/365 Operation•
< 1 day downtime•
No Pressure Control•
No Temp/Humidity•
Selected Emergency Power•
Life Safety/Lighting Operational StatusSpace Type NSF Subtotal 1 2 3
DEPARTMENT OF HEALTH & SENIOR SERVICES I. DHSS
BACTERIOLOGY ADMIN
Clerical Office OFFICE 128 128 Directors Office OFFICE 400 400 Lead Supervisor Office OFFICE 100 100 Program Manager Office OFFICE 150 150 Records Room OFFICE 100 100 Staff Office OFFICE 448 448
1,326 0 0 1326
CLINICAL SERVICES
Clinical Services - BSC Prep Room BSL2 200 200 Clinical Services - Cold Room BSL2 150 150
Clinical Services - Hematology BSL2 300 300 Clinical Services - Microscopy BSL2 150 150 Clinical Services - Oral Fluids BSL2 600 600 Clinical Services - Sample Transfer Area BSL2 50 50 Clinical Services - Urine Testing BSL2 600 600 Special Immunology - BSC Room BSL2 125 125 Special Immunology - Equipment Room BSL2 100 100 Special Immunology - Microscopy BSL2 75 75 Special Immunology Lab BSL2 300 300
Customer Service Unit (non-lab) OFFICE 150 150 Lead Supervisor Office OFFICE 200 200 Program Manager Office OFFICE 150 150 Records Storage- COC OFFICE 150 150 Staff Office OFFICE 384 384
3,684 150 2500 1034
ENTERIC FOOD BORNE
Enteric Lab BSL2 450 450 Equipment Room BSL2 200 200
Food Lab BSL2 450 450 Microscopy BSL2 100 100 Parasitology Lab BSL2 100 100
Specimen Holding (COC) BSL2 100 100
Enteric/Food Office OFFICE 300 300 Enteric/Food Tech OFFICE 50 50 Animal Holding BSL3 BSL3 300 300 2,050 600 1100 350
Evaluat
e
Assig
n
PROGRAM GOALS - REDUNDANCY
Lower = Less
Cost
•
Operational
Levels
•
Level 1
•
Most
Expensive
•
Level 2
•
Mean Level
Status
•
Level 3
•
Least
Expensive
Operational Status NSF NSF 1 2 3 PUBLIC HEALTH I. CLINICAL 23,887 13,825 5,382 II. NEWBORN SCREENING7,609 3,475 1,984 III. BSL3 9,617 342 450 IV. ACCESSIONING 7,950 2,200 3,850 V. ENVIRONMENTAL CHEMISTRY 25,702 12,450 5,752 VI. SHARED RESOURCES
8,668 600 6,068 VII. ADMINISTRATIVE SERVICES
11,010 1,450 9,460 VIII. OPERATIONS 16,834 850 15,884 111,277 27,255 35,192 48,830 AGRICULTURE I. ANIMAL SCIENCE 12,420 910 7,030 4,480 II. PLANT SCIENCE
5,850 - 3,650 2,200
Total AGRICULTURE 18,270 910 10,680 6,680 SUMMARY
Total NET SQUARE FEET 129,547 28,165 45,872 55,510
Building Efficiency 57% 22% 35% 43%
Total GROSS SQUARE FEET 227,275
4,680 2,150 8,825 1,900 7,500 2,000 100 100
