cqv landing zones
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CQV
ELEMENTSDEFINITIONSSUCCESS CRITERIA
LANDING ZONES
GENERAL ROLES & RESPONSIBILITIES
PHASED CQV LEADERSHIP ALIGNMENT
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CQV
ELEMENTSDEFINITIONSSUCCESS CRITERIA
LANDING ZONES
GENERAL ROLES & RESPONSIBILITIES
PHASED CQV LEADERSHIP ALIGNMENT
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CQV ELEMENTS & GLIDE PATH
“The seamless and
effective transfer
of process knowledge and capability
from Project Teams to Operations
to achieve and sustain
Project Success
Criteria
Key Elements
Equipment…meets product, process,and operational criteria.
People…proficient and qualified tosustain technical and operational
criteria.
Materials…quality and availabilityassured.
Functional Systems…Landing Zone
and Support Function Plans in place
and effective.
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CQV
ELEMENTSDEFINITIONSSUCCESS CRITERIA
LANDING ZONES
GENERAL ROLES & RESPONSIBILITIES
PHASED CQV LEADERSHIP ALIGNMENT
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Equipment Installation
Static, Dynamic Checks
Safety Conformance
Complete Operational
Training
Technical Checkout
Commissioning
Support Function &
Landing Zone Plans In
Place & Active
Complete Operational
Qualification
Manufacturing
Acceptance of Equipment
and Process
Success Criteria Achieved
Ongoing Effectiveness of
Support Function and
Landing Zone Plans
Lessons Learned
Final Project Report
Release Project Team
Key Activities
CQV Success Criteria
Landing Zone Plans
StaffingTraining
Production Scheduling
Operational Systems
Facilities
Maintenance/Demoliti
on
Environmental
Safety
CQV Project Phases
Purpose
Develop the CQV Plan
and begin
implementation.
Demonstrate that the
equipment and process
conform to designspecifications, QA,
safety, and
environmental
requirements.
Demonstrate that
manufacturing
resources canproficiently operate
the process at design
specifications and
manage functional
systems.
Ensure that
manufacturing
resources, equipment,materials, and
functional systems can
be sustained at targeted
performance levels.
Toddy Quality Project-CQV
5
Preparation Commissioning Qualification
Preparation Verification
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CQV
ELEMENTSDEFINITIONSSUCCESS CRITERIA
LANDING ZONES
GENERAL ROLES & RESPONSIBILITIES
PHASED CQV LEADERSHIP ALIGNMENT
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CQV Success Criteria - Examples
Machine performance requirements (FAT, Technical Checkout)
Training plan defined, operators trained, Qualification achieved
Spare parts identified, received, verified
Documentation received, verified
Safety procedures modified, implemented
Control Screens complete, system operational, operators trained
Operational SOP’s identified, tested, effective
Punch list items identified, complete
QA protocols identified, tested, validated
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CQV
ELEMENTSDEFINITIONSSUCCESS CRITERIA
LANDING ZONES
GENERAL ROLES & RESPONSIBILITIES
PHASED CQV LEADERSHIP ALIGNMENT
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Key Preparation Activities
• Establish Landing Zone Plans• Staffing
• Training
• Production Scheduling
• Operational Systems
• Facilities
• Maintenance
• Environmental
• Safety
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Landing Zone Plans• Staffing
– Plans completed for operational crewing schedules,manning requirements, etc.
• Training
– Operators, mechanics, electricians and support
resources trained and qualified.• Production Scheduling
– Plans for operating schedules, volume forecasts, rawmaterial changes, etc.
• Operational Systems – Plans to achieve operational performance targets
including daily results tracking and monitoringsystems, goal setting, process control requirements,operating SOP’s, etc.
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Landing Zone Plans
• Operational Systems – Plans to achieve operational performance targets
including daily results tracking and monitoringsystems, goal setting, process control requirements,operating SOP’s, etc.
• Facilities – Plans for site preparation, utilities (air, water, power,
etc.), material handling requirements, etc.
• Maintenance
– Plans to ensure site preparation, receipt of spareparts, required documentation, and initial andpreventive maintenance requirements are complete.
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Landing Zone Plans
• Environmental
– Plans to identify and manage plant environmentalissues including required waste handling, recycling,and Emergency Response plans
• Safety
– Plans to satisfy personnel safety requirements inaccordance with Toddy standards, train requiredpersonnel, etc.
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Criteria Resp Criteria Resp Criteria Resp Criteria Resp
Develop QA Plan for
Commissioning, Qualification,
Verification
Validate CIP for line/tank
cleanability
Provide final approval to release
batch by QC, QA, R&D
Ongoing (4 wks) evaluation of
performnce
Develop product validation runs
schedule (what,how
much,when)
Ribofla vi n te sti ng of ta nks? Compl ete any addi tiona l la b
technician/operator training
Quality specs issued Validate all product meets specs
Identify any training for new test
method
Verification of Line Flushes
(Documentation)
Process specifications
CCP's
Product formulas delivered to
Eng
All LAMP criteria defined and in
place
Product specifications delivered
to Eng and Mfg
Complete system qualifications
criteria
Verify System Functionality
Complete P&ID's, functional
description, process definition
Complete piping and equipment
labeling
Develop listing of operating
parameters to be me asured for
Commissioning
Complete program validation
Verify equipment specifications
are met before Commissioning
Verify correct operation of CIP
skid and circuits
Provide recommended Spare
Parts list
Complete punch list
Verify Vendor Documentation
Define Remaining Construction
Schedule
Complete Mechanical &
Electrical installation
Complete passivation
Hydrostatic checks
Define Criteria for Software
Development
FAT criteria. Complete FAT
V eri fy S oftw are HMI & P LC Compl ete con tro ls, autom ati on
hands-on training
Ongoing interface betwe en
operations and vendors
Define technology HMI & Valves Veri fy standards fol lowed
Esta blish Training Docs Conduct training for PLC,
Operator, Maintenance
Electrica l insta ll ation review Ver ify controller interaction
I/O checks Verify Valve sequencing
Equipment Vendor Negotiate vendor requirements
for CQV support
Commissioning Vendor Support
provided
Qualification Vendor support
provided
On-Call Vendor support
Quality Assurance
Engineering
Installation/
Construction Mgt.
IM/Controls/
Automation
Preparation Phase Commissioning Phase Qualification Phase Verification Phase
CQV Criteria - Support Function PlansDate:______ Date:______ Date:______ Date:______
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Criteria Resp Criteria Resp Criteria Resp Criteria Resp
Define training goals,
objectives, strategy
Develop operator on-the-job
training criteria
Update training materials
based on Commissioning
learnings
Complete any follow-up
training, documentation and
proceduresDevelop training
framework/template
Create job safety documents
for all new
equipment/processes
Schedule follow-up training
after startup
Identify capability gap.
Develop plan to address
gaps
Operators, mechanics,
electricians, instrument
techs, automation team fully
trained and qualified
Update SOP's/MI's based on
Qualifications learnings
Training Materials complete Train employees on proper
use of any personal
protective equipment
Changes to new
SOP's/Doc's/MI's
Identify who will be trained -
get alignment from various
groups
Complete 5S documentation
and installation
Identify additional
resource(s) required for
development of training
manuals
Identify operator training
required to support the
Maitnenance PM plan
Establish training timeline Develop operating SOP's
Receive vendor training
manuals/information.
Transmit to overall
document writer
Initiate training to all groups
Operations, Electricans,
Mechanics, Automation,
SOP's
Determine current
capabilities of individuals
within each group
Training
CQV Template - Training Landing Zone PlansPreparation Phase Commissioning Phase Qualification Phase Verification Phase
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Criteria Resp Criteria Resp Criteria Resp Criteria Resp
Staffing Develop staffing schedule
for CQV support
Receive product testing
schedule forCommissioning
All training completed-
Operators Qualified
Define startup production
volumes, inventory
Identify Changeover and
CIP requirements
Staffing requirements
complete
Provide product testing
schedule for
Commissioning
Funding requirements
complete
Schedule production
testing
Production reports/formats
complete
Develop Production Report
Formats
Make updates to
documentation
Develop listing of SOP's to
be createdSOP for recipe update
Determine changes created
in current operational
systems by the project
Vendor technical
documentation complete
All spare parts are on-site. Adjust Spare Parts and PM
requirements
Technical documentation
complete
Finalize spare parts All training documents
ready and training
schedule set
All mechanics trained and
qualified
PM and Spare Parts system
support requirements
Identi fy PM requirements PM requirements and
Maint. procedures in place
As-built drawings complete
Determine training needs Receive Eng. defined
operating parameters
ID all new equipment and
create list of safety
requirements
Complete Pre-Startup
Safety Review
Complete all safety punch
lsit items
Identify 5S requirements
Identify changes required
for existing safety manuals
Audit installa tion for
completeness
Complete Design Safety
Review
Safety Review Complete
Environmental
Safety/Process
Safety
Production
Scheduling
Operational
Systems
Facilities
Maintenance
CQV Template - Landing Zone PlansPreparation Phase Commissioning Phase Qualification Phase Verification Phase
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CQV
ELEMENTSDEFINITIONSSUCCESS CRITERIA
LANDING ZONES
GENERAL ROLES & RESPONSIBILITIES
PHASED CQV LEADERSHIP ALIGNMENT
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CQV General Roles and Responsibilities
Although all entities have the same objective to reach the ProjectSuccess Criteria, roles will change during phases of the startupprocess as defined below:
Construction Manager – Renato Palmeira - has the ultimateresponsibility that the objective of completing the installation is met
Engineering Startup Manager – Rodrigo Staibani - Will organizeand conduct the daily meetings through Commissioning and haveresponsibility for technical aspects of the mechanical, electrical,and process systems after installation.
Qualification Manager - ??????? - Will have responsibility for thequalification process and be the operational interface betweenOperations and Engineering.
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Draft- Production Management’s CQV “R”esponsibilities
• interacts as plant single point contact during CQV
• Is responsible for the acquisition and delivery of necessary materials for trials• Communicates CQV activities, status, and schedule to other operational
groups• Provides inputs to all checklists and work lists• Conducts construction complete inspection with Engineering team• Signs off on all CQV completion documents• Participates in development of detailed performance criteria and test protocol• Coordinate plant schedule and participation in Commissioning, Qualification,
and Verification activities• Provides staffing and management of performer work force during trials and
through operational qualification activities• Responsible for supporting testing, data collection and reporting during trials• Responsible for development of all SOPs and operational data collection
requirements
• Documents and certifies performer competency• Communicates training progress to Operations Management
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Draft- Maintenance CQV “R”esponsibilities
• Active participation and support during CQV implementation• Communicates CQV activities, status, and schedule to other
operational groups• Sign off on Step completion documents• Provides inputs to all checklists and work lists• Assist and support in the development of Commissioning,
Qualification, and verification work plan and activity matrix• Participate and contribute to development of detailed performance
criteria and test protocol• Communicates training progress to CQV leader• Responsible for transition of all project information to operating plant
systems for maintenance
• Supports Construction manager in delivery and adequacy of allvendor required documentation• Work with vendors to facilitate information transfer compatibility
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CQV
ELEMENTSDEFINITIONSSUCCESS CRITERIA
LANDING ZONES
GENERAL ROLES & RESPONSIBILITIESPHASED CQV LEADERSHIP ALIGNMENT
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Phased CQV Leadership Alignment
• Commissioning - During this phase the EngineeringStartup Manager will control the startup process, conductthe daily meetings, and schedule tasks for best use ofresources
• Qualification - During this phase the Operationscontrols the operation process and run the dailymeetings as needed, with support from Engineering,Edelstahl,….
• Training - Training will be occurring during theCommissioning phase. It will be the responsibility of the
Training Leader to coordinate with the EngineeringStartup manager or the Construction manager to ensurethat the training needs are met.