CQV

ELEMENTS DEFINITIONS SUCCESS CRITERIA LANDING ZONES GENERAL ROLES & RESPONSIBILITIES

PHASED CQV LEADERSHIP ALIGNMENT

CQV
ELEMENTS DEFINITIONS SUCCESS CRITERIA LANDING ZONES GENERAL ROLES & RESPONSIBILITIES

PHASED CQV LEADERSHIP ALIGNMENT

CQV ELEMENTS & GLIDE PATH

Key Elements
Equipmentmeets product, process, and operational criteria. The seamless and Peopleproficient and qualified to effective transfer sustain technical and operational of process knowledge and capability criteria. from Project Teams to Operations Materialsquality and availability to achieve and sustain assured. Project Success Functional SystemsLanding Zone Criteria and Support Function Plans in place and effective.

CQV
ELEMENTS DEFINITIONS SUCCESS CRITERIA LANDING ZONES GENERAL ROLES & RESPONSIBILITIES

PHASED CQV LEADERSHIP ALIGNMENT

Toddy Quality Project-CQV

CQV Project Phases
Preparation Preparation Develop the CQV Plan and begin implementation. Commissioning Demonstrate that the equipment and process conform to design specifications, QA, safety, and environmental requirements. Qualification Demonstrate that manufacturing resources can proficiently operate the process at design specifications and manage functional systems. Verification Ensure that manufacturing resources, equipment, materials, and functional systems can be sustained at targeted
performance levels.

Purpose

Key Activities

CQV Success Criteria Landing Zone Plans Staffing Training Production Scheduling Operational Systems Facilities Maintenance/Demoliti on Environmental Safety

Equipment Installation Support Function &

Success Criteria Achieved Ongoing Effectiveness of Support Function and Landing Zone Plans Lessons Learned

Static, Dynamic Checks Safety Conformance Complete Operational Training Technical Checkout Commissioning

Landing Zone Plans In Place & Active Complete Operational Qualification

Final Project Report Manufacturing Acceptance of Equipment Release Project Team and Process

CQV
ELEMENTS DEFINITIONS SUCCESS CRITERIA LANDING ZONES GENERAL ROLES & RESPONSIBILITIES

PHASED CQV LEADERSHIP ALIGNMENT

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 SOPs identified, tested, effective Punch list items identified, complete QA protocols identified, tested, validated

CQV
ELEMENTS DEFINITIONS SUCCESS CRITERIA LANDING ZONES GENERAL ROLES & RESPONSIBILITIES

PHASED CQV LEADERSHIP ALIGNMENT

Key Preparation Activities

Establish Landing Zone Plans
Staffing Training Production Scheduling Operational Systems Facilities Maintenance Environmental Safety

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, raw material changes, etc. Operational Systems Plans to achieve operational performance targets including daily results tracking and monitoring systems, goal setting, process control requirements, operating SOPs, etc.

Landing Zone Plans

Operational Systems Plans to achieve operational performance targets including daily results tracking and monitoring systems, goal setting, process control requirements, operating SOPs, etc. Facilities Plans for site preparation, utilities (air, water, power, etc.), material handling requirements, etc. Maintenance Plans to ensure site preparation, receipt of spare parts, required documentation, and initial and preventive maintenance requirements are complete.

Landing Zone Plans

Environmental Plans to identify and manage plant environmental issues including required waste handling, recycling, and Emergency Response plans Safety Plans to satisfy personnel safety requirements in accordance with Toddy standards, train required personnel, etc.

CQV Criteria - Support Function Plans

Date:______ Preparation Phase Criteria Resp Quality Assurance Develop QA Plan for Commissioning, Qualification, Verification Develop product validation runs schedule (what,how much,when) Quality specs issued Identify any training for new test method 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 Complete P&ID's, functional description, process definition Develop listing of operating parameters to be measured for Commissioning Verify equipment specifications are met before Commissioning Verify correct operation of CIP skid and circuits Provide recommended Spare Parts 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 Define technology HMI & Valves Establish Training Docs Electrical installation review I/O checks Negotiate vendor requirements for CQV support Date:______ Commissioning Phase Criteria Resp Validate CIP for line/tank cleanability Riboflavin testing of tanks? Date:______ Qualification Phase Criteria Resp Provide final approval to release batch by QC, QA, R&D Complete any additional lab technician/operator training Date:______ Verification Phase Criteria Resp Ongoing (4 wks) evaluation of performnce

Validate all product meets specs Verification of Line Flushes (Documentation)

Engineering

Verify System Functionality Complete piping and equipment labeling Complete program validation

Installation/ Construction Mgt.

Complete punch list

IM/Controls/ Automation

Verify Software HMI & PLC

Complete controls, automation hands-on training

Ongoing interface between operations and vendors

Verify standards followed Conduct training for PLC, Operator, Maintenance Verify controller interaction Verify Valve sequencing Commissioning Vendor Support provided

Equipment Vendor

Qualification Vendor support provided

On-Call Vendor support

CQV Template - Training Landing Zone Plans

Preparation Phase Criteria Training Define training goals, objectives, strategy Develop training framework/template Identify capability gap. Develop plan to address gaps Training Materials complete Resp Commissioning Phase Criteria Resp Develop operator on-the-job training criteria Create job safety documents for all new equipment/processes Operators, mechanics, electricians, instrument techs, automation team fully trained and qualified Train employees on proper use of any personal protective equipment Complete 5S documentation and installation Identify operator training required to support the Maitnenance PM plan Develop operating SOP's Initiate training to all groups Operations, Electricans, Mechanics, Automation, SOP's Qualification Phase Criteria Update training materials based on Commissioning learnings Schedule follow-up training after startup Update SOP's/MI's based on Qualifications learnings Resp Verification Phase Criteria Complete any follow-up training, documentation and procedures Resp

Changes to new SOP's/Doc's/MI's

Identify who will be trained get alignment from various groups Identify additional resource(s) required for development of training manuals Establish training timeline Receive vendor training manuals/information. Transmit to overall document writer Determine current capabilities of individuals within each group

CQV Template - Landing Zone Plans

Preparation Phase Criteria Staffing Develop staffing schedule for CQV support Define startup production volumes, inventory Staffing requirements complete Funding requirements complete Resp Commissioning Phase Criteria Resp Receive product testing schedule for Commissioning Identify Changeover and CIP requirements Provide product testing schedule for Commissioning Schedule production testing Production reports/formats complete Make updates to documentation Qualification Phase Criteria All training completedOperators Qualified Resp Verification Phase Criteria Resp

Production Scheduling

Operational Systems

Develop Production Report Formats Develop listing of SOP's to be created SOP for recipe update Determine changes created in current operational systems by the project Vendor technical documentation complete Finalize spare parts

Facilities Maintenance

All spare parts are on-site. All training documents ready and training schedule set PM requirements and Maint. procedures in place

Adjust Spare Parts and PM requirements All mechanics trained and qualified As-built drawings complete

Technical documentation complete PM and Spare Parts system support requirements

Identify PM requirements

Determine training needs Environmental ID all new equipment and Safety/Process create list of safety Safety requirements Identify 5S requirements Identify changes required for existing safety manuals Complete Design Safety Review Safety Review Complete Complete Pre-Startup Safety Review

Receive Eng. defined operating parameters Complete all safety punch lsit items

Audit installation for completeness

CQV
ELEMENTS DEFINITIONS SUCCESS CRITERIA LANDING ZONES GENERAL ROLES & RESPONSIBILITIES

PHASED CQV LEADERSHIP ALIGNMENT

CQV General Roles and Responsibilities

Although all entities have the same objective to reach the Project Success Criteria, roles will change during phases of the startup process as defined below: Construction Manager Renato Palmeira - has the ultimate responsibility that the objective of completing the installation is met

Engineering Startup Manager Rodrigo Staibani - Will organize and conduct the daily meetings through Commissioning and have responsibility for technical aspects of the mechanical, electrical, and process systems after installation. Qualification Manager - ??????? - Will have responsibility for the qualification process and be the operational interface between Operations and Engineering.

Draft- Production Managements CQV Responsibilities

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

Draft- Maintenance CQV Responsibilities

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 all vendor required documentation Work with vendors to facilitate information transfer compatibility

CQV
ELEMENTS DEFINITIONS SUCCESS CRITERIA LANDING ZONES GENERAL ROLES & RESPONSIBILITIES

PHASED CQV LEADERSHIP ALIGNMENT

Phased CQV Leadership Alignment

Commissioning - During this phase the Engineering Startup Manager will control the startup process, conduct the daily meetings, and schedule tasks for best use of resources Qualification - During this phase the Operations controls the operation process and run the daily meetings as needed, with support from Engineering, Edelstahl,. Training - Training will be occurring during the Commissioning phase. It will be the responsibility of the Training Leader to coordinate with the Engineering Startup manager or the Construction manager to ensure that the training needs are met.