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User Requirement Specification FOR [NAME HERE] Your Logo
Protocol Approval
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Production Engineering R&D Regulatory Affairs Quality Assurance
Executionl Approval Production Engineering R&D Regulatory Affairs Quality Assurance
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Revision History No 1
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CONTENTS
Page No.
Management Topics 1.0 2.0 3.0 4.0 5.0 6.0 7.0
Introduction………………………………………………………………4 Identification of organisation‟s goals and objectives………… 4 Expected benefits…………..………………………………………… 4 Budget and resources …………………………………………….. 4 Time, security, procedural and maintenance constraints…… 4 Existing infrastructure, policies and practices………………… 4 Contract and Services agreement …………………………….. 4
Operations Topics 8.0 9.0 10.0 11.0 12.0
Intended equipment usage……………………………………… Environmental constraints ……………………………………… Profile of users ………………………………………………….. Modes of operation……………………………………………… Desired functionalities ………………………………………….
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Equipment Topics 13.0 14.0 15.0 16.0 17.0 18.0 19.0 20.0
Production and quality performance………………………….. Components assembly and construction …………………… Operators and external systems interface …………………. Alarms, events, messages and reports……………………... Training, maintenance and qualification documentation….. System backup and restore………………………………….. General Requirements…………………………………… Validation………………………………………………………
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BS EN 953:1998 Safety of Machinery – Guards. BS EN 954: Part 1:1997 Safety of Machinery – Control systems BS EN 1037:1996 Safety of Machinery – Prevention of unexpected start-up. BS EN 1088:1996 Safety of Machinery – Interlocking devices associated with guards. The machine guards shall be designed to enclose all danger points or areas of the machine where there is a risk of injury. Where access is required to a danger area of the machine and a fixed guard is impractical, then an interlocking guard shall be provided. The guard shall be interlocked with the machinery controls, such that: The part(s) of the machinery causing danger cannot be set in motion until the guard is closed, and, Access to the danger point or area is denied while danger exists. The control switch for the guard interlock shall be either A captive key switch, or A limit switch installed in the „positive‟ mode, to ensure against the deliberate scotching of the switch. Magnetic switches may also be used for interlocking duties. 19.5 Delivery All machinery shall be insured and delivered to the Company‟s site XXXX Details of delivery date, overall size and weight of the equipment or packing case(s) shall be given at least 48 hours prior to the date of delivery. All equipment shall be packaged in such a manner that is stable & secure during its transport & off-loading. Lifting instructions shall be clearly defined on the outer packaging of each item. Off-loading of the equipment from transport to a position agreed with Your company, will be undertaken by the supplier.
19.6 Drawings and Instruction Manuals Within eight weeks of placing the contract, the supplier shall supply two copies of fully dimensioned drawings of the machines. One copy hard copy of the drawings shall be supplied together with a second electronic version via email or CD ROM in either “DXF” or “DWG” format. The supplier shall provide three copies of the operating and maintenance instructions for the equipment including an electronic copy on CD ROM The operating and maintenance instructions shall be supplied no later than the date of delivery of the equipment. Included with the operating and maintenance instructions shall be electrical drawings covering all electrical equipment and contents that form part of the machine.
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