C ONTROL S YSTEMS
D ESIGN
S PECIFICATION
Version : 1.00
This document aims to identify clearly and precisely what
CooperVision seeks to achieve with this project/system. It
defines the function of the system and how system must behave
when presented with specific inputs and conditions.
Matthew Thorne
28-Feb-17
28-Feb-17
REVISION HISTORY
Revision Date Completed by Comments
1.00 28-Feb-17 M Thorne Initial document
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1 Contents
1 Contents .......................................................................................................................... 3
2 Introduction ...................................................................................................................... 4
3 Purpose and Background ................................................................................................. 4
4 Scope ................................................................................................................................. 4
5 Responsibility ................................................................................................................... 4
6 Documentation Strategy .................................................................................................. 4
7 Related Documentation ................................................................................................... 5
8 Project Lifecycle................................................................................................................ 6
8.1 Lifecycle Phases ....................................................................................................... 6
8.2 Validation Phases..................................................................................................... 7
8.2.1 Installation Qualification (IQ) ......................................................................... 7
8.2.2 Operation Qualification (OQ) .......................................................................... 7
8.2.3 Software Operation Qualification (SOQ) ........................................................ 7
8.2.4 Performance Qualification (PQ) ...................................................................... 7
9 Documentation Requirements ......................................................................................... 7
9.1 User Requirements Specification (URS) ................................................................. 7
9.2 Design Review .......................................................................................................... 8
9.3 Build .......................................................................................................................... 8
9.4 Facility Acceptance Test (FAT) ............................................................................... 8
9.5 Installation ............................................................................................................... 8
9.6 Site Acceptance Test (SAT) ..................................................................................... 8
10 Appendices .................................................................................................................... 9
10.1 Appendix A -Regional Standards ............................................................................ 9
10.2 Appendix B - Statement of Compliance ................................................................ 11
10.3 Form A .................................................................................................................... 12
10.4 Form B .................................................................................................................... 16
10.5 Guidance for completing Form A & B ................................................................... 20
11 Table of Figures .......................................................................................................... 24
12 References ................................................................................................................... 24
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CONTROL SYSTEMS DESIGN
SPECIFICATION
Version : 1.00
2 INTRODUCTION
This document and the documents referenced here comprise Coopervision’s control
system standards. The standards described here are the basis of all control systems to be
specified by Coopervision. The User Requirements Specification document which is also
issued for new control systems captures, in significantly more detail, than the Project
Proposal the scope, business objectives and requirements of the system. The User
Requirements Specification can be seen as a specialisation of these underlying standards.
The vendor must comply with all the relevant standards and legislation in force at the
commencement of the contract as well as the purchasing terms and conditions laid out in
“Supply of Systems (Term) Agreement”.
3 PURPOSE AND BACKGROUND
The purpose of this document is to define the required Electrical and Controls Standard
for Machines and Equipment to be supplied, installed or modified at Coopervision.
Modified equipment will only comply as far as is reasonably practicable with the
exception that all safety topics described in these documents are mandatory.
4 SCOPE
This standard relates to electrical/electronic control panels and equipment supplied
separately or with production/service machinery and plant.
5 RESPONSIBILITY
It is the responsibility of all Coopervision employees and those representing Coopervision
who select, purchase or modify machinery and equipment to ensure that the design and
delivery complies with the standards referenced here. This standard MUST be issued to
suppliers with the User Requirement Specification (URS).
The statement of compliance in the appendices must be completed by the vendor.
6 DOCUMENTATION STRATEGY
Coopervision controls standards are documented as separate documents to modularise
the various aspects of the control system. This document, CSDS (Control System Design
Specification) forms the header document from which all other documents are referenced.
The overall structure of the complete documentation strategy is described in figure 6-1.
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Figure 6-1 : Documentation Strategy
Depending on the scope of the project it may not be necessary to study all of the
documents listed. You will be guided by the Coopervision project team as to which
documents are relevant within the scope of work. Indeed some documentation may be
intended for use internally only.
7 RELATED DOCUMENTATION
Follows is a list of all documents comprising the Coopervision controls systems
standards. The latest versions of each of these can be downloaded from
http://coopervision.co.uk/esrs.
Document Comments
CSDS Control System
Header document for controls standards
Design Specification
EDS Electrical Design Standards for the electrical construction and design of
Specification control systems
HDS Hardware Design Standards and guidance for the selection of hardware
Specification components and their interconnections
SDS Software Design Standards for structure and content of PLC code and
Specification PLC Coopervision standard issue code blocks
SDS Software Design Standards for the look and feel of the HMI navigation
Specification HMI structure and standard project files
SDS Software Design Standards for the supervisory system including batch
Supervisory handling and database/cvm interaction
Standards for the construction of system architecture at
SAS Systems Architecture
all levels from the bus system topology for the machine up
Specification
to the IT infrastructure
AIS Automated Inspection Standards for the look and feel of the user interface
System Specification HMI navigation structure for AIS
AIS Automated Inspection
Standards for the design and integration of AIS systems to
System Specification
the main engine
Engine
AIS Automated Inspection Standards for structure and content of the PLC-AIS
System Specification PLC interface
AIS Automated Inspection
Standards for the construction of system architecture of
System Specification
the AIS system including the IT infrastructure
Architecture
OEES Overall Equipment Standards for structure and content of the OEE system
Effectiveness Specification and Coopervision standard issue code blocks
PMSS Performance
Standards for structure and content of the PMS system
Monitoring System
and Coopervision standard issue code blocks
Specification
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8 PROJECT LIFECYCLE
Coopervision’s approach to introducing new modules and machines follows the Good
Automated Manufacturing Practice guidelines (GAMP).i
Good automated manufacturing practice (GAMP) is both a technical subcommittee of the
International Society for Pharmaceutical Engineering (ISPE) and a set of guidelines for
manufacturers and users of automated systems in the pharmaceutical industry. More
specifically, the ISPE's guide The Good Automated Manufacturing Practice (GAMP)
Guide for Validation of Automated Systems in Pharmaceutical Manufacture describes a
set of principles and procedures that help ensure that pharmaceutical products have the
required quality. One of the core principles of GAMP is that quality cannot be tested into
a batch of product but must be built into each stage of the manufacturing process. As a
result, GAMP covers all aspects of production; from the raw materials, facility and
equipment to the training and hygiene of staff. Standard operating procedures (SOPs) are
essential for processes that can affect the quality of the finished product. The lifecycle is
described in figure 8-1.
Figure 8-1 : GAMP Lifecycle
8.1 Lifecycle Phases
The project lifecycle typically comprises the following key elements as shown in figure 8-
2..
Figure 8-2 : Project Lifecycle
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At each stage various documentation and testing is required. This is described in the next
section. When Site Acceptance Testing (SAT) has been completed then validation can
begin.
8.2 Validation Phases
Validation normally follows the following phases. The tests contained within each
qualification document are written specifically for the machine to be validated. These are
not standard documents and changed based on the requirements of the system.
Figure 8-3 : Validation Phases
8.2.1 Installation Qualification (IQ)
The Installation Validation execution (IQ)ii verifies that the equipment, and its ancillary
systems or sub-systems have been installed in accordance with installation validation
drawings and or specifications. It further details a list of all the cGMP requirements that
are applicable to this particular installation qualification. These requirements must all
be satisfied before the IQ can be completed and the qualification process is allowed to
progress to the execution of the Operational Qualification (OQ).
8.2.2 Operation Qualification (OQ)
The Operation Validation execution (OQ)iii verifies that the equipment and its ancillary
systems or sub-systems have been installed in accordance with performance criteria
agreed with the vendor. The purpose is to ensure that all aspects of the system comply
with the original design. Each of the equipment’s functions is checked to ensure they
conform to the manufacturers specifications.
8.2.3 Software Operation Qualification (SOQ)
The software operation validation execution verifies that any system data exchange and
supervisory system controlled batch handling meet the criteria required in the
specification. The SOQ is often performed simultaneously with the OQ.
8.2.4 Performance Qualification (PQ)
The performance validation execution (PQ)iv verifies that the equipment and its ancillary
systems or sub systems function to meet agreed performance criteria on a consistent
basis. The purpose is to ensure that the criteria specified can be achieved on a reliable
basis over a period of time.
9 DOCUMENTATION REQUIREMENTS
At each phase of the project lifecycle from section 8.1 certain requirements are made for
the supply of documentation from both the vendor and from Coopervision.
9.1 User Requirements Specification (URS)
The user requirements specification (URS)v is issued to the vendor by Coopervision and
describes broadly the requirements of the system. This enables the next stage of the
process Design Review. The vendor should at this point review the relevant control
system standards as described here and submit a statement of compliance. The
statement of compliance is available in the appendix of this document.
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9.2 Design Review
During design review the vendor will develop a Functional Design Specification (FDS).
This captures in detail the approach used to implement the user requirements captured
in the URS. During this phase the vendor must also develop a Hardware Design
Specification (HDS). These specifications are specific to the project but must follow the
standards and guidance set out in the Coopervision overall controls standards. During
the design review process with Coopervision, a Coopervision representative will use Form
A to track progress of the deliverables. Form A can be found in the appendix of this
document.
9.3 Build
Using the documents developed by the vendor above (FDS, HDS) the machine can then
be built at the vendors site. During this time the vendor must develop a specific Software
Design Specification (SDS) to describe how the software is structured for the project.
9.4 Facility Acceptance Test (FAT)
When the machine is deemed to be ready at the vendor site a Facility Acceptance Test
will be carried out at the customer site by Coopervision. The purpose of this test is to
check that the functionality specified in the URS, FDS and the build as specified in the
HDS are all satisfactory. At this stage Form B will also be completed. Form B can be
found in the appendix of this document.
9.5 Installation
Once the FAT has been satisfied the machine can be integrated at Coopervision’s site.
During this time the vendor SDS for the machine must be finalised.
9.6 Site Acceptance Test (SAT)
When the machine is deemed to be ready at Coopervision’s site a Site Acceptance Test
will be carried out at the customer site by Coopervision. The purpose of this test is to
check that the functionality specified in the URS, FDS and the build as specified in the
HDS are all satisfactory. This test will be largely the same as the FAT test but may also
include elements that are not possible to test at the vendor site.
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10 APPENDICES
10.1 Appendix A -Regional Standards
Description UK
Supplier Guide for Validation of Automated GAMP – IPSE’s guide Current Version
Systems in Pharmaceutical Manufacture
Section 2 For CE Marking :-
Legal Requirements
The Machinery Directive
2006/42/EC
Low Voltage Directive 2006/95/EC
Directive 94/9/EC (ATEX)
Section 3.1.19 UK Style 13 Amp Socket.
Mains supply for programming units
Wiring regulations / Electrical code BS 7671
Code of practice for protective earthing of BS 7430
electrical installations
Safety of machinery - General principles for BS EN ISO 12100
design - Risk assessment
and risk reduction
Explosive Atmospheres BS EN 60079
Safety of machinery — Interlocking devices BS EN 1088 (ISO 14119)
associated with guards — Principles for
design and selection
Safety of Machinery - Safety Related Parts of BS EN ISO 13849 - Part 1
Control Systems – General Design Principles
Safety of Machinery - Safety Related Parts of BS EN ISO 13849 - Part 2
Control Systems – Validation
Safety of machinery - Emergency stop - BS EN ISO 13850
Principles for design
Safety of machinery - Electrical equipment of BS EN 60204-1
machines - Part 1
Safety of machinery - Positioning of BS EN ISO 13855
safeguards in respect of approach
speeds of parts of the human body
Safety of machinery - Interlocking devices BS EN 1088 (ISO 14119)
associated with guards -
Principles for design and selection
Low-voltage switchgear and controlgear . BS EN 60947-3
Switches, disconnectors, switch-disconnectors
and fuse-combination units
Control circuit BS EN 60947-5-5
devices and switching elements - Electrical
emergency stop
device with mechanical latching function
Low-voltage switchgear and controlgear. BS EN 60947-4-1
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Contactors and motor-starters.
Electromechanical contactors and motor-
starters
Preparation of documents used in BS EN 61082-1
electrotechnology
Graphical symbols for diagrams IEC 60617
Electromagnetic compatibility (EMC). BS EN 61000-6-3
Immunity for industrial environments
Electromagnetic compatibility (EMC). BS EN 61000-6-3
Emission standard for residential, commercial
and light-industrial environments
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10.2 Appendix B - Statement of Compliance
STATEMENT OF COMPLIANCE
This statement of compliance must be completed and returned with the
quotation.
Failure to return this statement with the quotation will be interpreted as
confirmation that equipment fully complies.
1. Are there any sections within this standard, which you feel, DO NOT apply to
you?
YES/NO
2. If the answer to 1. above is YES, please list the sections and explain your reasons.
3. Apart from any sections listed in 2 above, does your equipment FULLY comply
with this document?
YES/NO
4. If the answer to 3 above is NO, please list all exceptions and, where applicable,
list the alternatives offered with this statement. This includes the preferred parts
list from the HDS
Name: ……………………………………… Position: ……………………………….
For and on behalf of: ……………………………………………………………………….
Signature: ………………………………………Date:……………………………………
CVI acceptance of statement
Name…………………….. Signature…………………
Date………………………..
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10.3 Form A
MACHINE ELECTRICAL DESIGN REVIEW CHECKLIST
This document is to be used at the design stage of new machinery to ensure
electrical design and drawings comply with CooperVision requirements.
All non-conformances should be reviewed and approved before FAT commences.
Supplier:
Machine:
Revision: Date:
Reviewer:
Acceptance:
Signature Print Name Date
CooperVision
Control Engineer
Manufacturer
Documents received :
Vers
No
Documents ./ YES NO N/A
.
date
1 Schematic and full electrical wiring diagrams
2 General arrangement drawing
3 Panel layout drawing
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Vers
No
Documents ./ YES NO N/A
.
date
4 Part list
5 SDS (software design specification)
6 Full I/O listing
Risk assessment detailing required
7
performance levels and category
8 Functional safety specification
9 Sistema report
Drawing and Electrical Design Checklist
No. Question YES NO N/A
Are the drawing components drawn, named and
10
numbered as required on ESRS?
11 Do the drawings use a cross-reference system?
Do the components chosen comply with ESRS
12
requirements?
13 Are the panels designed according to ESRS?
Do the drawings include a terminal and multicore
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detail?
Do the drawings include an overview of Guards &
15
E-Stop?
16 Do the drawings include an overview of Panels?
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No. Question YES NO N/A
17 Do the drawings include an overview of RFID?
Do the drawings include all bus structures with
18
detailed addresses and nodes?
Do the drawings include robot and other machines
19
interfaces?
Do the drawings include all inputs/outputs
20
diagrams?
21 Is the safety circuit dual channel?
Does the safety circuit comply with ESRS
22
specifications?
23 Add any additional requirements.
Comments:
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Attached documentation:
Appendix Item Attached by Pages
Issues to be reviewed (add a table for each non-conforming point in the checklist).
Point:
Issue:
Summary of the
issue:
Requirement:
Reviewed and
Date:
accepted By:
Comments:
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10.4 Form B
MACHINE ELECTRICAL DESIGN REVIEW CHECKLIST
This document is to be used at the FAT stage of new machinery to ensure
machine electrical installation is built as designed and all documentation is
update to “as built” stage.
All non-conformances that are not sorted out at this stage must be reviewed and
approved before SAT is validated.
Supplier:
Machine:
Revision: Date:
Reviewer:
ACCEPTANCE:
Signature Print Name Date
CooperVision
Control Engineer
Manufacturer
Documents received
Vers./
No. Documents YES NO N/A
Date
As-built Schematic and full electrical
1
wiring diagrams
2 As-built General arrangement drawing
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Vers./
No. Documents YES NO N/A
Date
3 As-built Panel layout drawing.
4 As-built Part list
5 Inverters/Controllers configuration/settings
Fully annotated PLC software listing and
6 ladder logic (with cross-references and
symbolic table)
7 Draft Operating Instructions
8 Maintenance Manual
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Electrical Build Checklist
No. Question YES NO N/A
Is the machine built using the components from
10
the part list?
Are the components, wires and multicores named
11
and numbered as in the drawings?
12 Are the panels built according to ESRS?
Do the panels match with as-built panel layout
13
drawings?
Do the Guards & E-Stop locations match with the
14
as-built overview?
Do the Panels & RFID locations match with the
15
as-built overview?
Do all nodes and addresses detailed as-built on
16
the drawings?
Do the bus structures matches with the as-built
17
drawings? (including nodes and addresses)
Are the robot and other machines interfaces
18
wiring as detailed in the drawings?
Do all inputs/outputs detailed in the drawings
19
match with the machine and with the software?
Does the safety circuit wired according to the
20
drawings?
A 10% Wiring Inspection has been completed
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successfully?
Is the Inverters/Controllers configuration/settings
22
documentation clear and complete?
23 Add any additional requirements
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Comments:
Attached documentation:
Appendix Item Attached by Pages
Issues to be reviewed (add a table for each non-conforming point in the checklist).
Point:
Issue:
Summary of the
issue:
Requirement:
Reviewed and
Date:
accepted By:
Comments:
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10.5 Guidance for completing Form A & B
1 Completing Form A:
This form is available as a separate file to be completed.
This form should be a live document and updated as many times as a new set of
documents is received from the supplier. The final revision must not have any no-
conformances on it and must be accepted and signed for both parts CooperVision
and the manufacturer representatives before the FAT commences.
Supplier: machine manufacturer name.
Machine: Machine type.
Revision: Revision number of the form. (Every time new review is performed, it
will be necessary to update the form and this revision will be incremented by 1:
Revision 1…99.
Date: Date that the review is performed.
Reviewer: The controls engineer who is filling out the form.
1.1 Documents received:
1. The reviewer will tick “Yes” when each document is received. If a
new version of any existing document is received, the version/date
will need to be updated.
2. If any of those documents are not received, tick “NO” in the form.
3. If for any reason, a document is not necessary for a machine, tick
“N/A”
4. Once the form is completed and ready to be signed, it shouldn’t
have any “NO” box ticked.
1.2 Drawing and Electrical Design Checklist:
5. The reviewer must reply to all questions on this section.
6. If any answer is not positive, a new table must be created and
filled, in the “Issues to be reviewed” section.
7. Add to the checklist any additional design point that could improve
the machine or the maintenance of it in the future.
8. Once the form is complete and ready to be signed, it shouldn’t have
any “NO” box ticked.
1.3 Comments:
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Add any relevant comment that explains your ticks. N/A checks can
be justified here.
1.4 Attached documentation:
Include any relevant document. E.g. documents justifying design
decisions not conforming to the specifications.
1.5 Issues to be reviewed:
Add a table for each non-conforming point of the Drawing and
Electrical Design Checklist. If more than one points share the same
issue, they could be written down using the same table.
• Point: Point/s in question.
• Issue: Title of the issue.
• Summary of the issue: Describe the issue.
• Requirement: Describe the actions that have to be taken for
sorting out this issue.
• Reviewed and accepted by: Print the reviewer name that
has reviewed and accepted the amendment of the issue.
• Date: When the issue has been amended.
• Comments: Any observations once the amendment has been
completed.
2 Completing Form B:
This form is available as a separate file to be completed.
This form should be a live document and updated as many times as a new review
is performed. The final version must not have any no-conformances on it and
must be accepted and signed from both parts CooperVision and the manufacturer
representatives before the SAT is completed.
Supplier: machine manufacturer name.
Machine: Machine type.
Revision: Revision number of the form. (Every time new review is performed, it
will be necessary to update the form and this revision will be incremented by 1:
Revision 1…99.
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Date: Date that the review is performed.
Reviewer: The controls engineer who is filling out the form.
2.1 Documents received:
1. The reviewer will tick “Yes” when the document is received. If a
new version of any existing document is received, the version/date
will need to be updated.
2. If any of those documents are not received, tick “NO” in the form.
3. If for any reason, a document is not necessary for a machine, tick
“N/A”
4. Once the form is completed and ready to be signed, it shouldn’t
have any “NO” box ticked.
2.2 Assessment Checklist:
5. The reviewer must reply to all questions on this section.
6. If any answer is not positive, a new table must be created and
filled, in the “Issues to be reviewed” section.
7. Add to the checklist any additional design point that could improve
the machine or the maintenance of it in the future.
8. Once the form is complete and ready to be signed, it shouldn’t have
any “NO” box ticked.
2.3 Comments:
Add any relevant comment that explains your ticks. N/A checks can
be justified here.
2.4 Attached documentation:
Include any relevant document. E.g. documents justifying change
decisions not conforming to the specifications.
2.5 Issues to be reviewed:
Add a table for each non-conforming point in the Electrical Build
Checklist. If more than one points share the same issue, they could
be written down using the same table.
• Point: Point/s in question.
• Issue: Title of the issue.
• Summary of the issue: Describe the issue.
• Requirement: Describe the actions that have to be taken for
sorting out this issue.
• Reviewed and accepted by: Print the reviewer name that
has reviewed and accepted the amendment of the issue.
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• Date: When the issue has been amended.
• Comments: Any observations once amendment has been
completed.
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11 TABLE OF FIGURES
Figure 6-1 : Documentation Strategy ..................................................................................... 5
Figure 8-1 : GAMP Lifecycle.................................................................................................... 6
Figure 8-2 : Project Lifecycle ................................................................................................... 6
Figure 8-3 : Validation Phases ................................................................................................ 7
12 REFERENCES
i GAMP [Accessed on 28-Feb-2017 - http://www.ispe.org/publications-guidance-
documents/series]
ii Installation Qualification [Accessed on 28-Feb-2017 -
https://www.ispe.org/glossary?term=Installation+Qualification+(IQ)]
iii Operation Qualification [Accessed on 28-Feb-2017 -
https://www.ispe.org/glossary?term=Operation+Qualification]
iv Performance Qualification [Accessed on 28-Feb-2017 -
https://www.ispe.org/glossary?term=Performance+Qualification+%28PQ%29]
v User Requirements Specification [Accessed on 28-Feb-2017 -
http://www.springer.com/cda/content/document/cda_downloaddocument/9780854049691-
c7.pdf?SGWID=0-0-45-148241-p49644019]
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