ISPE Central Canada Chapter BAS Lifecycle Overview using GaMP

1
ISPE Central Canada Chapter BAS Lifecycle
Overview using GaMP

• January 24, 2006 Toronto
• January 25, 2006 Montreal
• Irene Miess Sr Manager Regulated Industries
• Siemens Building Technologies

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BAS Lifecycle Overview using GaMP

• GaMP Model
• System Impact Assessment
• Direct Impact Systems
• Indirect Impact Systems
• Good Engineering Practice
• Commissioning
• Qualification Practices
• Installation and Operational Qualification
• Documentation Requirements
• Ongoing Operation

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Good Automated Manufacturing Practice (GaMP)
As a regulated site supplier, what guidance do we
have in delivering a validated and compliant
system?
Good Automated Manufacturing Practice (GaMP)
GaMP provides a method to relate development
activities to validation activities on automated
systems using a life cycle approach
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Good Automated Manufacturing Practice (GaMP)

• GaMP was created due to
• the increased use and complexity of automated
  systems in FDA regulated manufacturing areas
• the less mature interpretation of regulations in
  automated applications than in more conventional,
  non-automated areas

• A GaMP Industry Board establishes GaMP principles
  and recommendations

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Project Lifecycle (GaMP)
Planning
Design Development
Ongoing Operation
Installation
Commissioning Qualification
FAT Required?
NO
YES
Factory Acceptance Testing
6
Planning and Design/Development Phases
Master Validation Plan (MVP)
Planning Phase
User Requirement Specification (URS)
Impact Assessment
Quality System Program and Implementation Plan
Functional Specification
Hardware
Software
Engineering Submittal
Design Development Phase
Hardware
Software
Customer Approval of Functional and Design
Factory Acceptance Test (FAT) Phase
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Master Validation Plan
The Validation Master Plan (VMP) is the key
document in the overall validation process, and
is critical to the success of the project. It is
an important project document and a living
document that must be maintained throughout the
project life cycle. The validation master plan
typically defines

• Validation Strategy
• Validation Deliverables
• Acceptance Criteria
• Change Control Management
• Standard Operating Procedures
• Training
• Documentation Management
• Maintaining a Validated State

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Master Validation Plan

• BAS needs to be addressed
• Monitor Alarm only
• Direct Impact only
• If you want tomatoes, dont plant turnips!

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Planning and Design/Development Phases
Master Validation Plan (MVP)
Planning Phase
User Requirement Specification (URS)
Impact Assessment
Quality System Program and Implementation Plan
Functional Specification
Hardware
Software
Engineering Submittal
Design Development Phase
Hardware
Software
Customer Approval of Functional and Design
Factory Acceptance Test (FAT) Phase
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User Requirements

• The User Requirement Specification (URS)
  specifies the requirements of the user for
  individual aspects of the facility, equipment,
  and systems in terms of function, throughput,
  operability, and applicable standards
• Defines what the user wants the system to do.
  What functions will be carried out, the data on
  which the system will operate, and the operating
  environment. Non-functional requirements, such as
  constraints (that is, time) and what deliverables
  will be provided by the system (that is,
  Training, Testing, Tools), are also documented
• The User Requirement Specification (URS) and
  Performance Testing are linked. The URS provides
  the performance benchmark criteria upon which the
  performance qualification (PQ) is based

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BAS User Requirement Spec

• Do you want
• to follow GaMP
• traceability matrix
• functional specs
• testing
• calibratable sensors
• commissioning documents
• remote notification
• horn/bell
• paging

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Planning and Design/Development Phases
Master Validation Plan (MVP)
Planning Phase
User Requirement Specification (URS)
Impact Assessment
Quality System Program and Implementation Plan
Functional Specification
Hardware
Software
Engineering Submittal
Design Development Phase
Hardware
Software
Customer Approval of Functional Design
Factory Acceptance Test (FAT) Phase
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Impact Assessment

• A process which allows a complex situation of
  interdependent engineering systems and components
  to be reviewed, understood and systematically
  evaluated for their effect on product quality
  (Commissioning vs. Qualification).

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Relationship Between Systems and Components
Components
Critical
Non-Critical
Direct Impact
Good Engineering Practices Qualification
Practices
Systems
?
Indirect/ No Impact
Good Engineering Practices Commissioning
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System Level Assessment

• System An organization of engineering
  components which have defined operational
  function (e.g., piping, instrumentation,
  equipment, facilities, computer hardware,
  computer software, etc.)
• System Boundary A limit drawn around a system
  to logically define what is and is not included
  in the system.

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System Level Assessment

• Direct Impact System An engineering system that
  is expected to have a direct impact on product
  quality.
• Indirect Impact System An engineering system
  that is not expected to have a direct impact on
  product quality, but is linked to a direct impact
  system.
• No Impact System An engineering system that is
  not expected to have an impact on product quality.

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System Level Assessment

• System Impact Assessment The process of
  evaluating the impact of the operating,
  controlling, alarming and failure conditions of a
  system on the quality of a product.
• The quality of the product can be impacted by a
  system or systems which meets any of the
  following criteria
• In contact with the product
• Used as an excipient
• Controls the process or
• Provides information relative to product
  acceptance or rejection

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Component Level Assessment

• Critical Component A component within a system
  where the operation, contact, data, control,
  alarm or failure will have a direct impact on the
  quality of the product.
• Non-Critical Component A component within a
  system where the operation, contact, data
  control, alarm or failure will have an indirect
  or no impact on the quality of the product.

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Relationship Between Systems and Components
Components
Critical
Non-Critical
Direct Impact
Good Engineering Practices Qualification
Practices
Systems
?
Indirect/ No Impact
Good Engineering Practices Commissioning
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BAS Draw Boundaries

• HVAC
• BAS only
• AHU controls
• zone controls
• monitor alarm
• Design system accordingly
• Separation by panels
• Separate GMP from non GMP

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Where are YOUR Boundaries
Sample PID of HVAC and BAS Equipment
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Planning and Design/Development Phases
Master Validation Plan (MVP)
Planning Phase
User Requirement Specification (URS)
Impact Assessment
Quality System Program and Implementation Plan
Functional Specification
Hardware
Software
Engineering Submittal
Design Development Phase
Hardware
Software
Customer Approval of Functional and Design
Factory Acceptance Test (FAT) Phase
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Quality System Program and Implementation Plan

• The Quality System Program and Implementation
  Plan is a contractual document between the Client
  and BAS supplier.
• Defines actions, deliverables, responsibilities,
  and procedures satisfying the user quality and
  validation requirements.

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Planning and Design/Development Phases
Master Validation Plan (MVP)
Planning Phase
User Requirement Specification (URS)
Impact Assessment
Quality System Program and Implementation Plan
Functional Specification
Hardware
Software
Engineering Submittal
Design Development Phase
Hardware
Software
Customer Approval of Functional and Design
Factory Acceptance Test (FAT) Phase
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Functional Requirements Specification

• The Functional Requirements Specification (FRS)
  describes the detailed functions of the facility,
  equipment, and system (i.e., what the system will
  do).
• The Functional Specification is normally written
  by the Supplier and then reviewed and approved
  by the Customer.
• The FRS is used to develop the Acceptance Test
  Specification that outlines those items to be
  tested as part of the Factory Acceptance Test
  (FAT) and/or Site Assessment Test (SAT).

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Planning and Design/Development Phases
Master Validation Plan (MVP)
Planning Phase
User Requirement Specification (URS)
Impact Assessment
Quality System Program and Implementation Plan
Functional Specification
Hardware
Software
Engineering Submittal
Design Development Phase
Hardware
Software
Customer Approval of Functional and Design
Factory Acceptance Test (FAT) Phase
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Design Specification

• The Design Specification (DS) document developed
  by Supplier describes how to build the facility,
  equipment, and system (that is, how to design or
  construct the system).
• It is recommended that the Design Specification
  is illustrated by the use of diagrams wherever
  possible.
• The Design Specification is normally written by
  the Supplier and then reviewed and approved by
  the Customer.
• In most cases the DS may be included in the FS

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Planning and Design/Development Phases
Master Validation Plan (MVP)
Planning Phase
User Requirement Specification (URS)
Impact Assessment
Quality System Program and Implementation Plan
Functional Specification
Hardware
Software
Engineering Submittal
Design Development Phase
Hardware
Software
Customer Approval of Functional and Design
Factory Acceptance Test (FAT) Phase
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Project Lifecycle (GaMP)
Planning
Design Development
Ongoing Operation
Installation
Commissioning Qualification
FAT Required?
NO
YES
Factory Acceptance Testing
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Project Lifecycle (GaMP)
Planning
Design Development
Ongoing Operation
Installation
Commissioning Qualification
FAT Required?
NO
YES
Factory Acceptance Testing
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FAT and Installation Phases
Factory Acceptance Test (FAT) Required?
NO
Factory Acceptance Test (FAT) Phase
YES
BUILD SYSTEM
Factory Acceptance Test (FAT)
BUILD SYSTEM
Installation at Job Site
Develop IQ/OQ/PQ Tests
Installation Phase
Develop Commissioning Plan
Commissioning Qualification Phase
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FAT and Installation Phases
Factory Acceptance Test (FAT) Required?
NO
Factory Acceptance Test (FAT) Phase
YES
BUILD SYSTEM
Factory Acceptance Test (FAT)
BUILD SYSTEM
Installation at Job Site
Develop IQ/OQ/PQ Tests
Installation Phase
Develop Commissioning Plan
Commissioning Qualification Phase
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Factory Acceptance Test (FAT)

• A FAT is recommended when the project deadline is
  critical and construction schedule does not allow
  enough time for commissioning and validation
  after installation.
• Combining the commissioning findings with the FAT
  as part of the validation process helps avoid
  collecting data twice, making better use of time
  and project resources.
• Other tests used during the FAT and SAT may be
  used to support the validation effort.
• The request for the FAT occurs during the
  planning stage of a project and usually is
  included in the Validation Master Plan and the
  Request for Quote (RFQ).

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Project Lifecycle (GaMP)
Planning
Design Development
Ongoing Operation
Installation
Commissioning Qualification
FAT Required?
NO
YES
Factory Acceptance Testing
35
Commissioning/Qualification Phase Ongoing Ops
Start-up Commissioning
Site Acceptance Test (SAT)
Commissioning Qualification Phase
INDIRECT NO IMPACT SYSTEMS
DIRECT IMPACT SYSTEMS
Installation Qualification (IQ)
Trending to verify operational changes
Operational Qualification (OQ)
Performance Qualification (PQ)
Document Control
Change Control
Ongoing Operations
Training
Standard Operations (SOPs)
Business Continuity
Maintenance Operations
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Impact Assessment
GEP Only
No Impact
Parking Facilities
Office Terminal Devices
Office HVAC Systems
Chilled Water Systems
Indirect Impact?
cGMP HVAC Systems
Building Management System
cGMP Terminal Devices
Direct Impact
GEP and Qualification
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Commissioning Plan
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Commissioning
A well planned, documented and managed
engineering approach to the start-up and turnover
of facilities, systems and equipment to the
end-user that results in a safe and functional
environment that meets established design
requirements and stakeholders expectations.
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Commissioning

• Concepts
• Requires close cooperation of a multi-disciplined
  team
• Builds on concepts and activities such as Impact
  Assessment and Good Engineering Practices
• Execution typically occurs after the installation
  of equipment, piping and instrumentation is
  complete and operational
• Systems, equipment and instrumentation need to be
  physically complete and operational

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Commissioning Plan

• Agree on the Commissioning Plan early in the
  project
• Plan should identify systems to be commissioned,
  activities and sequences, deliverables, personnel
  and organizations involved and their
  roles/responsibilities
• Provide list of facilities, utilities and
  equipment to be commissioned
• Approvers should include Design, Construction and
  the End-User representatives include Validation
  and QA for direct impact systems
• Commissioning should be integrated with
  qualification activities for direct impact
  systems
• Commissioning may be the final activity prior to
  use/operation by the end-user
• Plan for either phased or one-time turnover

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Commissioning Process

• Levels of commissioning for building automation
  systems
• Standard Commissioning
• Enhanced Commissioning
• The level of commissioning is defined in the VMP
  and Quality Plan.
• Direct Impact systems require enhanced
  documentation, which may involve additional
  tests, documentation, QA change control, and QA
  review/approval. Enhance documentation should
  complement (not repeat) the documentation that is
  created through GEP.

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Commissioning/Qualification Phase Ongoing Ops
Start-up Commissioning
Site Acceptance Test (SAT)
Commissioning Qualification Phase
INDIRECT NO IMPACT SYSTEMS
DIRECT IMPACT SYSTEMS
Installation Qualification (IQ)
Trending to verify operational changes
Operational Qualification (OQ)
Performance Qualification (PQ)
Document Control
Change Control
Ongoing Operations
Training
Standard Operations (SOPs)
Business Continuity
Maintenance Operations
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Site Acceptance Test

• Tests that are completed On-site with installed
  equipment to prove the correct operation of the
  software, hardware, and instrumentation as
  defined by the URS

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Site Acceptance Test

• The Site Acceptance Test (SAT) is performed to
  determine that the system and any associated
  equipment has not been damaged and functions
  correctly in its operating environment.
• The SAT normally constitutes a repeat of the FAT
  (or portions of the FAT) in the users
  environment plus those test made possible with
  all process, field instrumentation, interfaces,
  and service connections established.
• The SAT may be combined with equipment and plant
  commissioning, and this will provide a basis for
  the IQ and OQ.
• The incorporation of SAT into qualification
  testing is acceptable where the level of detail
  and documentation of the tests meet the
  requirement of user company policies and
  procedures, and are acceptable to user company QA.

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Commissioning/Qualification Phase Ongoing Ops
Start-up Commissioning
Site Acceptance Test (SAT)
Commissioning Qualification Phase
INDIRECT NO IMPACT SYSTEMS
DIRECT IMPACT SYSTEMS
Installation Qualification (IQ)
Trending to verify operational changes
Operational Qualification (OQ)
Performance Qualification (PQ)
Document Control
Change Control
Ongoing Operations
Training
Standard Operations (SOPs)
Business Continuity
Maintenance Operations
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BAS Installation Qualification Table of Contents

• Documentation Verification
• SOP Verification
• Hardware and Software Verification
• Field Panel
• Hardware and Firmware Verification
• Utility Verification
• Application Code Version Verification

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Installation Qualification Table of Contents

• Database Configuration Verification
• Trend Configuration Verification
• Trend Collection Schedule Verification
• Alarm Configuration Verification
• Point Configuration Verification
• Alarm Management Configuration Verification
• Remote Notification Configuration Verification
• Alarm Paging Notification Verification
• Point List Verification

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Installation Qualification Table of Contents

• Archive Database Configuration Verification
• Data Base Verification
• Data Server Configuration Verification
• Archive Schedule Verification
• Data Purge Configuration Verification
• Summary Point Configuration Verification
• Uninterruptible Power Supply Installation
  Verification
• Field Device Calibration Verification
• Field Equipment Installation Verification

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Commissioning/Qualification Phase Ongoing Ops
Start-up Commissioning
Site Acceptance Test (SAT)
Commissioning Qualification Phase
INDIRECT NO IMPACT SYSTEMS
DIRECT IMPACT SYSTEMS
Installation Qualification (IQ)
Trending to verify operational changes
Operational Qualification (OQ)
Performance Qualification (PQ)
Document Control
Change Control
Ongoing Operations
Training
Standard Operations (SOPs)
Business Continuity
Maintenance Operations
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Operational Qualification Table of Contents

• System Security Qualification Test Cases
• User Account Security
• Access Groups
• Audit Trail Qualification Test Cases
• Audit Trail Verification
• Long Term Storage of Audit Trails
• Field Panel Qualification Test Cases
• Field Panel Loss of Communication
• Field Panel Battery Check
• Field Panel Power Failure Alarming and Recovery
• Electric Field Instrument (EFI) Interference

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Operational Qualification Table of Contents

• Uninterrupted Power Supply
• Custom Code Testing
• Scheduled Functions Qualification Test Cases
• Trend Collection Report Verification
• Data Server Verification
• Archive Schedule Verification
• System Alarms Qualification Test Cases
• Standard Alarm Notification Test
• Enhanced Alarms Notification Test

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Operational Qualification Table of Contents

• Remote Notification Qualification Test Cases
• Building Level Network Event
• Escalation Test
• Alarm Management Qualification Test Cases
• Alarm Management Operational Test Case
• Alarm Management Archival Test Case
• Data Integrity Qualification Test Cases
• Transmitter Failure Test
• 72 Hour Trend Analysis

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Commissioning/Qualification Phase Ongoing Ops
Start-up Commissioning
Site Acceptance Test (SAT)
Commissioning Qualification Phase
INDIRECT NO IMPACT SYSTEMS
DIRECT IMPACT SYSTEMS
Installation Qualification (IQ)
Trending to verify operational changes
Operational Qualification (OQ)
Performance Qualification (PQ)
Document Control
Change Control
Ongoing Operations
Training
Standard Operations (SOPs)
Business Continuity
Maintenance Operations
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Standard Operating Procedures (SOPs)

• System Operation
• Change Control/ Upgrade Procedures
• Hardware Maintenance Procedures
• Software Maintenance Procedures
• Electronic Records/Data Management Procedures
• Incident Management Procedures
• System Security Procedures
• Training Procedures
• Disaster Recovery Procedures
• Source Code Handling

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The V-ModelA Basic Framework for Specification,
Design and Testing
User Requirements Specification
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IQ/OQ
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Questions??

• If you want tomatoes
• Dont plant turnips!

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(No Transcript)
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Siemens Building Technologies

• Irene Miess
• 847-941-5840
• irene.miess_at_siemens.com
• Dave Barrett
• 905-799-9937
• david.barrett_at_siemens.com