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
Company Confidential
BAS Lifecycle Overview using GaMP
ƒ
GaMP Model
ƒ
System Impact Assessment
– Direct Impact Systems
– Indirect Impact Systems
ƒ
Good Engineering Practice
ƒ
Commissioning
ƒ
Qualification Practices
– Installation and Operational Qualification
ƒ
Documentation Requirements
ƒ
Ongoing Operation
Company Confidential
Good Automated Manufacturing Practice (GaMP)
As a regulated site supplier, what guidance do we have in
delivering a validated and compliant system?
Planning
Design &
Development
Installation
FAT
Required?
YES
Factory
Acceptance
Testing
Company Confidential
NO
Commissioning
& Qualification
Ongoing
Operation
Good Automated Manufacturing
Practice (GaMP)
GaMP provides a method to relate
development activities to validation
activities on automated systems using a
life cycle approach
Good Automated Manufacturing Practice (GaMP)
ƒ
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
ƒ
GaMP benefits FDA regulated companies by:
– Improving the understanding & interpretation of regulations
– Providing established guidelines for
suppliers of automated systems
– Clarifying the division of responsibility
between user and supplier
– Reducing the cost and time taken to
achieve compliant systems
ƒ
A GaMP Industry Board establishes
GaMP principles and recommendations
Company Confidential
Project Lifecycle (GaMP)
Planning
Design &
Development
Installation
FAT
Required?
YES
Factory
Acceptance
Testing
Company Confidential
NO
Commissioning
& Qualification
Ongoing
Operation
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
Engineering Submittal
Hardware
Software
Software
Design &
Development
Phase
Customer Approval of
Functional and Design
Factory
Acceptance Test
(FAT) Phase
Company Confidential
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:
ƒValidation Strategy
ƒValidation Deliverables
ƒAcceptance Criteria
ƒChange Control Management
ƒStandard Operating Procedures
ƒTraining
ƒDocumentation Management
ƒMaintaining a Validated State
Company Confidential
Master Validation Plan
ƒ
BAS needs to be addressed
– Monitor & Alarm only
– Direct Impact only
…If you want tomatoes,
don’t plant turnips!
Company Confidential
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
Engineering Submittal
Hardware
Software
Software
Design &
Development
Phase
Customer Approval of
Functional and Design
Factory
Acceptance Test
(FAT) Phase
Company Confidential
User Requirements
ƒ
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
ƒ
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
ƒ
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
Company Confidential
BAS User Requirement Spec
ƒ
Do you want
– to follow GaMP
• traceability matrix
• functional specs
• testing
– calibratable sensors
– commissioning documents
– remote notification
• horn/bell
• paging
Company Confidential
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
Engineering Submittal
Hardware
Software
Software
Design &
Development
Phase
Customer Approval of
Functional Design
Factory
Acceptance Test
(FAT) Phase
Company Confidential
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).
Company Confidential
Relationship Between Systems and Components
Components
Critical
Direct
Impact
Systems
Indirect/
No Impact
Company Confidential
8
Non-Critical
Good
Engineering
Practices +
Qualification
Practices
Good
Engineering
Practices +
Commissioning
System Level Assessment
ƒ System: An organization of engineering components
which have defined operational function (e.g., piping,
instrumentation, equipment, facilities, computer hardware,
computer software, etc.)
ƒ System Boundary: A limit drawn around a system to
logically define what is and is not included in the system.
Company Confidential
System Level Assessment
ƒ Direct Impact System: An engineering system that is
expected to have a direct impact on product quality.
ƒ 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.
ƒ No Impact System: An engineering system that is not
expected to have an impact on product quality.
Company Confidential
System Level Assessment
ƒ 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.
ƒ 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
Company Confidential
Component Level Assessment
ƒ 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.
ƒ 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.
Company Confidential
Relationship Between Systems and Components
Components
Critical
Direct
Impact
Systems
Indirect/
No Impact
Company Confidential
8
Non-Critical
Good
Engineering
Practices +
Qualification
Practices
Good
Engineering
Practices +
Commissioning
BAS Draw Boundaries
– HVAC
– BAS only
• AHU controls
• zone controls
• monitor & alarm
– Design system accordingly
• Separation by panels
• Separate GMP from non GMP
Company Confidential
Where are YOUR Boundaries
Sample P&ID of HVAC and BAS Equipment
Company Confidential
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
Engineering Submittal
Hardware
Software
Software
Design &
Development
Phase
Customer Approval of
Functional and Design
Factory
Acceptance Test
(FAT) Phase
Company Confidential
Quality System Program and Implementation Plan
ƒ The Quality System Program and Implementation Plan is
a contractual document between the Client and BAS
supplier.
ƒ Defines actions, deliverables, responsibilities, and
procedures satisfying the user quality and validation
requirements.
Company Confidential
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
Engineering Submittal
Hardware
Software
Software
Design &
Development
Phase
Customer Approval of
Functional and Design
Factory
Acceptance Test
(FAT) Phase
Company Confidential
Functional Requirements Specification
ƒ
The Functional Requirements Specification (FRS) describes the
detailed functions of the facility, equipment, and system (i.e.,
what the system will do).
ƒ
The Functional Specification is normally written by the Supplier
and then reviewed and approved by the Customer.
ƒ
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).
Company Confidential
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
Engineering Submittal
Hardware
Software
Software
Design &
Development
Phase
Customer Approval of
Functional and Design
Factory
Acceptance Test
(FAT) Phase
Company Confidential
Design Specification
ƒ
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).
ƒ
It is recommended that the Design Specification is illustrated by
the use of diagrams wherever possible.
ƒ
The Design Specification is normally written by the Supplier
and then reviewed and approved by the Customer.
ƒ
In most cases the DS may be included in the FS
Company Confidential
Planning and Design/Development Phases
Master Validation Plan
(MVP)
Planning
Phase
User Requirement
Specification (URS)
Quality System Program
and Implementation Plan
Impact
Assessment
Functional Specification
Hardware
Engineering Submittal
Linked to
Installation
Qualification (IQ)
Linked to
Operational
Qualification (OQ)
Linked to
Performance
Qualification (PQ)
Company Confidential
Hardware
Software
Software
Design &
Development
Phase
Customer Approval of
Functional and Design
Factory
Acceptance Test
(FAT) Phase
Project Lifecycle (GaMP)
Planning
Design &
Development
Installation
FAT
Required?
YES
Factory
Acceptance
Testing
Company Confidential
NO
Commissioning
& Qualification
Ongoing
Operation
Project Lifecycle (GaMP)
Planning
Design &
Development
Installation
FAT
Required?
YES
Factory
Acceptance
Testing
Company Confidential
NO
Commissioning
& Qualification
Ongoing
Operation
FAT and Installation Phases
NO
Factory
Acceptance
Test (FAT)
Required?
Factory Acceptance
Test (FAT) Phase
YES
BUILD SYSTEM
Factory Acceptance Test
(FAT)
BUILD SYSTEM
Installation at Job Site
Installation Phase
Develop
IQ/OQ/PQ Tests
Develop
Commissioning Plan
Commissioning& Qualification Phase
Company Confidential
FAT and Installation Phases
NO
Factory
Acceptance
Test (FAT)
Required?
Factory Acceptance
Test (FAT) Phase
YES
BUILD SYSTEM
Factory Acceptance Test
(FAT)
BUILD SYSTEM
Installation at Job Site
Installation Phase
Develop
IQ/OQ/PQ Tests
Develop
Commissioning Plan
Commissioning& Qualification Phase
Company Confidential
Factory Acceptance Test (FAT)
ƒ
A FAT is recommended when the project deadline is critical
and construction schedule does not allow enough time for
commissioning and validation after installation.
ƒ
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.
ƒ
Other tests used during the FAT and SAT may be used to support
the validation effort.
ƒ
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).
Company Confidential
Project Lifecycle (GaMP)
Planning
Design &
Development
Installation
FAT
Required?
YES
Factory
Acceptance
Testing
Company Confidential
NO
Commissioning
& Qualification
Ongoing
Operation
Commissioning/Qualification Phase & Ongoing Ops
Start-up & Commissioning
Site Acceptance Test (SAT)
DIRECT IMPACT
SYSTEMS
INDIRECT & NO
IMPACT SYSTEMS
Installation
Qualification (IQ)
Trending to verify
operational changes
Commissioning &
Qualification Phase
Operational
Qualification (OQ)
Performance
Qualification (PQ)
Change Control
Standard Operations (SOPs)
Maintenance Operations
Company Confidential
Document Control
Training
Business Continuity
Ongoing
Operations
Impact Assessment
GEP Only
Parking Facilities
No Impact
Office Terminal Devices
Office HVAC Systems
Chilled Water Systems
Indirect Impact?
cGMP HVAC Systems
Building Management System
GEP and
Qualification
Company Confidential
cGMP Terminal Devices
Direct Impact
Commissioning Plan
IMPACT ASSESSMENT
GEP
DOCUMENTATION
COMMISSIONING
GEP / QUALIFICATION
IQ / OQ
Parking Facility
Vendor Standard
X
Office Terminal HVAC
Equipment
Vendor Standard
X
Office Central HVAC
Equipment
Vendor Standard
X
Chilled / Hot Water
Systems
Vendor Standard
X
Building Automation
System
Vendor Standard
X
Enhanced Documentation
/ FAT?
X
cGMP Central HVAC
Critical Systems
X
Enhanced Documentation
X
cGMP Terminal HVAC
Critical Systems
X
Enhanced Documentation
X
Other Validated Ancillary
Systems
X
Enhanced Documentation
X
Company Confidential
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.
Company Confidential
Commissioning
Concepts:
ƒ Requires close cooperation of a multi-disciplined team
ƒ Builds on concepts and activities such as Impact Assessment
and Good Engineering Practices
ƒ Execution typically occurs after the installation of equipment,
piping and instrumentation is complete and operational
ƒ Systems, equipment and instrumentation need to be physically
complete and operational
Company Confidential
Commissioning Plan
ƒ
Agree on the Commissioning Plan early in the project
ƒ
Plan should identify systems to be commissioned, activities and
sequences, deliverables, personnel and organizations involved
and their roles/responsibilities
ƒ
Provide list of facilities, utilities and equipment to be commissioned
ƒ
Approvers should include Design, Construction and the End-User
representatives; include Validation and QA for direct impact
systems
ƒ
Commissioning should be integrated with qualification activities for
direct impact systems
ƒ
Commissioning may be the final activity prior to use/operation by
the end-user
ƒ
Plan for either phased or one-time turnover
Company Confidential
Commissioning Process
ƒ
Levels of commissioning for building automation systems:
– Standard Commissioning
– Enhanced Commissioning
ƒ
The level of commissioning is defined in the VMP and Quality
Plan.
ƒ
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.
Company Confidential
Commissioning/Qualification Phase & Ongoing Ops
Start-up & Commissioning
Site Acceptance Test (SAT)
DIRECT IMPACT
SYSTEMS
INDIRECT & NO
IMPACT SYSTEMS
Installation
Qualification (IQ)
Trending to verify
operational changes
Commissioning &
Qualification Phase
Operational
Qualification (OQ)
Performance
Qualification (PQ)
Change Control
Standard Operations (SOPs)
Maintenance Operations
Company Confidential
Document Control
Training
Business Continuity
Ongoing
Operations
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
Company Confidential
Site Acceptance Test
ƒ
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.
ƒ
The SAT normally constitutes a repeat of the FAT (or portions of the
FAT) in the user’s environment plus those test made possible with all
process, field instrumentation, interfaces, and service connections
established.
ƒ
The SAT may be combined with equipment and plant
commissioning, and this will provide a basis for the IQ and OQ.
ƒ
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.
Company Confidential
Commissioning/Qualification Phase & Ongoing Ops
Start-up & Commissioning
Site Acceptance Test (SAT)
DIRECT IMPACT
SYSTEMS
INDIRECT & NO
IMPACT SYSTEMS
Installation
Qualification (IQ)
Trending to verify
operational changes
Commissioning &
Qualification Phase
Operational
Qualification (OQ)
Performance
Qualification (PQ)
Change Control
Standard Operations (SOPs)
Maintenance Operations
Company Confidential
Document Control
Training
Business Continuity
Ongoing
Operations
BAS Installation Qualification – Table of Contents
Documentation Verification
SOP Verification
Hardware and Software Verification
Field Panel
ƒHardware and Firmware Verification
ƒUtility Verification
Application Code Version Verification
Company Confidential
Installation Qualification – Table of Contents
Database Configuration Verification
ƒ Trend Configuration Verification
ƒ Trend Collection Schedule Verification
ƒ Alarm Configuration Verification
ƒ Point Configuration Verification
Alarm Management Configuration Verification
Remote Notification Configuration Verification
Alarm Paging Notification Verification
Point List Verification
Company Confidential
Installation Qualification – Table of Contents
Archive Database Configuration Verification
ƒ Data Base Verification
ƒ Data Server Configuration Verification
ƒ Archive Schedule Verification
ƒ Data Purge Configuration Verification
ƒ Summary Point Configuration Verification
Uninterruptible Power Supply Installation Verification
Field Device Calibration Verification
Field Equipment Installation Verification
Company Confidential
Commissioning/Qualification Phase & Ongoing Ops
Start-up & Commissioning
Site Acceptance Test (SAT)
DIRECT IMPACT
SYSTEMS
INDIRECT & NO
IMPACT SYSTEMS
Installation
Qualification (IQ)
Trending to verify
operational changes
Commissioning &
Qualification Phase
Operational
Qualification (OQ)
Performance
Qualification (PQ)
Change Control
Standard Operations (SOPs)
Maintenance Operations
Company Confidential
Document Control
Training
Business Continuity
Ongoing
Operations
Operational Qualification – Table of Contents
System Security Qualification Test Cases
ƒUser Account Security
ƒAccess Groups
Audit Trail Qualification Test Cases
ƒAudit Trail Verification
ƒLong 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
Company Confidential
Operational Qualification – Table of Contents
Uninterrupted Power Supply
Custom Code Testing
Scheduled Functions Qualification Test Cases
ƒTrend Collection Report Verification
ƒData Server Verification
ƒArchive Schedule Verification
System Alarms Qualification Test Cases
Standard Alarm Notification Test
Enhanced Alarms Notification Test
Company Confidential
Operational Qualification – Table of Contents
Remote Notification Qualification Test Cases
ƒ Building Level Network Event
ƒ Escalation Test
Alarm Management Qualification Test Cases
ƒ Alarm Management Operational Test Case
ƒ Alarm Management Archival Test Case
Data Integrity Qualification Test Cases
Transmitter Failure Test
72 Hour Trend Analysis
Company Confidential
Commissioning/Qualification Phase & Ongoing Ops
Linked to User
Requirements Spec
Start-up & Commissioning
Linked to Functional
Requirements Spec
Linked to Design
Spec
Site Acceptance Test (SAT)
DIRECT IMPACT
SYSTEMS
INDIRECT & NO
IMPACT SYSTEMS
Installation
Qualification (IQ)
Trending to verify
operational changes
Commissioning &
Qualification Phase
Operational
Qualification (OQ)
Performance
Qualification (PQ)
Change Control
Standard Operations (SOPs)
Maintenance Operations
Company Confidential
Document Control
Training
Business Continuity
Ongoing
Operations
Standard Operating Procedures (SOPs)
ƒ System Operation
ƒ Change Control/ Upgrade Procedures
ƒ Hardware Maintenance Procedures
ƒ Software Maintenance Procedures
ƒ Electronic Records/Data Management Procedures
ƒ Incident Management Procedures
ƒ System Security Procedures
ƒ Training Procedures
ƒ Disaster Recovery Procedures
ƒ Source Code Handling
Company Confidential
The V-Model:
A Basic Framework for Specification, Design and Testing
User Requirements
Specification
PQ Test Plan
Functional
Specification
OQ Test Plan
Design Specification
IQ Test Plan
System Build
Company Confidential
Performance
Qualification
Operational
Qualification
Installation
Qualification
IQ/OQ
Pre-Approved Protocol
Installation
Direct Impact
Systems
Critical Devices
Calibration
Operation
Performance
<
<
<
Change
Control
Indirect/
No Impact
Systems
Non-Critical
Devices
Point to Point
Start Up
Trending
Forms with Signatures & Dates
Related
Specifications
Design
Specification
Company Confidential
Functional
Specification
User Requirement
Specification
Questions??
If you want
tomatoes
…
Don’t plant turnips!
Company Confidential
Company Confidential
Siemens Building Technologies
ƒ Irene Miess
847-941-5840
irene.miess@siemens.com
ƒ Dave Barrett
905-799-9937
david.barrett@siemens.com
Company Confidential