CONTROL SYSTEMS DESIGN SPECIFICATION

CONTROL SYSTEMS DESIGN SPECIFICATION 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

REVISION HISTORY Revision Date Completed by Comments 1.00 28-Feb-17 M Thorne Initial document 2

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 3

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. 4

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 CSDS Control System Design Specification EDS Electrical Design Specification HDS Hardware Design Specification SDS Software Design Specification PLC SDS Software Design Specification HMI SDS Software Design Supervisory SAS Systems Architecture Specification AIS Automated Inspection System Specification HMI AIS Automated Inspection System Specification Engine AIS Automated Inspection System Specification PLC AIS Automated Inspection System Specification Architecture OEES Overall Equipment Effectiveness Specification PMSS Performance Monitoring System Specification Comments Header document for controls standards Standards for the electrical construction and design of control systems Standards and guidance for the selection of hardware components and their interconnections Standards for structure and content of PLC code and Coopervision standard issue code blocks Standards for the look and feel of the HMI navigation structure and standard project files Standards for the supervisory system including batch handling and database/cvm interaction Standards for the construction of system architecture at all levels from the bus system topology for the machine up to the IT infrastructure Standards for the look and feel of the user interface navigation structure for AIS Standards for the design and integration of AIS systems to the main engine Standards for structure and content of the PLC-AIS interface Standards for the construction of system architecture of the AIS system including the IT infrastructure Standards for structure and content of the OEE system and Coopervision standard issue code blocks Standards for structure and content of the PMS system and Coopervision standard issue code blocks 5

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 6

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. 7

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. 8

10 APPENDICES 10.1 Appendix A -Regional Standards Description Supplier Guide for Validation of Automated Systems in Pharmaceutical Manufacture Section 2 Legal Requirements UK GAMP IPSE s guide Current Version For CE Marking :- 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 9

Contactors and motor-starters. Electromechanical contactors and motorstarters 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 10

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.. 11

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 : No. Documents Vers./ date YES NO N/A 1 Schematic and full electrical wiring diagrams 2 General arrangement drawing 3 Panel layout drawing 12

No. Documents Vers./ date YES NO N/A 4 Part list 5 SDS (software design specification) 6 Full I/O listing 7 Risk assessment detailing required performance levels and category 8 Functional safety specification 9 Sistema report Drawing and Electrical Design Checklist No. Question YES NO N/A 10 Are the drawing components drawn, named and numbered as required on ESRS? 11 Do the drawings use a cross-reference system? 12 Do the components chosen comply with ESRS requirements? 13 Are the panels designed according to ESRS? 14 15 Do the drawings include a terminal and multicore detail? Do the drawings include an overview of Guards & E-Stop? 16 Do the drawings include an overview of Panels? 13

No. Question YES NO N/A 17 Do the drawings include an overview of RFID? 18 19 20 Do the drawings include all bus structures with detailed addresses and nodes? Do the drawings include robot and other machines interfaces? Do the drawings include all inputs/outputs diagrams? 21 Is the safety circuit dual channel? 22 Does the safety circuit comply with ESRS specifications? 23 Add any additional requirements. Comments: 14

Attached documentation: Appendix Item Attached by Pages 1 2 Issues to be reviewed (add a table for each non-conforming point in the checklist). Point: Issue: Summary of the issue: Requirement: Reviewed and accepted By: Date: Comments: 15

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 No. Documents Vers./ Date YES NO N/A 1 As-built Schematic and full electrical wiring diagrams 2 As-built General arrangement drawing 16

No. Documents Vers./ Date YES NO N/A 3 As-built Panel layout drawing. 4 As-built Part list 5 Inverters/Controllers configuration/settings 6 Fully annotated PLC software listing and ladder logic (with cross-references and symbolic table) 7 Draft Operating Instructions 8 Maintenance Manual 17

Electrical Build Checklist No. Question YES NO N/A 10 11 Is the machine built using the components from the part list? Are the components, wires and multicores named and numbered as in the drawings? 12 Are the panels built according to ESRS? 13 14 15 16 17 18 19 20 21 22 Do the panels match with as-built panel layout drawings? Do the Guards & E-Stop locations match with the as-built overview? Do the Panels & RFID locations match with the as-built overview? Do all nodes and addresses detailed as-built on the drawings? Do the bus structures matches with the as-built drawings? (including nodes and addresses) Are the robot and other machines interfaces wiring as detailed in the drawings? Do all inputs/outputs detailed in the drawings match with the machine and with the software? Does the safety circuit wired according to the drawings? A 10% Wiring Inspection has been completed successfully? Is the Inverters/Controllers configuration/settings documentation clear and complete? 23 Add any additional requirements 18

Comments: Attached documentation: Appendix Item Attached by Pages 1 2 Issues to be reviewed (add a table for each non-conforming point in the checklist). Point: Issue: Summary of the issue: Requirement: Reviewed and accepted By: Date: Comments: 19

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 noconformances 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: 20

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. 21

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. 22

Date: When the issue has been amended. Comments: Any observations once amendment has been completed. 23

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-guidancedocuments/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] 24