USER REQUIREMENTS SPECIFICATION

Review and approval

This user requirements specification has been reviewed and approved by the following individuals. Our collective signatures
acknowledge that the document was reviewed, approved and ready for implementation to satisfy the requirements of
Packaging Equiment #123 and we individually agree with the contents of this specification.

The significance of each respective signature is shown below.

Written by:

Role Name Title Signature Date

Significance: The information is this specification was assembled from vendor proposes, R&D engineering and quality
associates and is accurate reflected with this specification.

Review and approved by:

Role Name Title Signature Date

Project Enginner
Plant Manger

Table of contents

1. Objective
2. Scope
2.1. Product in scope of this specification
2.2. Equipment in scope of this specification
3. Responsibilities
4. Background
5. References
6. Equipment representation
7. Process Description
8. Equipment design requirements
9. Computer system(s) requirements
10. Process Performance/CTQ Requirements
11. Documentation Requirements
12. Revision History

1. Objective
This URS establishes the basis from which all subsequent development and validation shall be measured and
documents. Its purpose is to assist un designing the system to meet user requirements. The scope of this
specification covers all aspects of the design, fabrication, and assembly of this requirement. The appendixes list in
this document define the general name standards for equipment build including general requirements for machine
construction, machine acceptance, ergonomics evaluation, electrical design, documentation requirements, safety
standards and hazard identification and risk assessment. Any discrepancies identified in this document shall be
noted, discussed and resolved prior to machine fabrication. The validation criteria and testing requirements will be
covered in the factory acceptance testing protocol.

2. Scope
The scope of this validation is to install and validate packaging equipment #123 to package products SR1234 thru
SR 1239
2.1. Product in scope of this specification:
Include o general description of the product with a listing of all product catalogue numbers affected by the
validation.

Product Description Finished Goods/Catalogue Numbers

Some device with feature A SR1234

2.2. Equipment in scope of this specification

 Equipment name and Equipment Identification Equipment Software Department and site
description
Packaging equipment Equipment identification PLC Program HMI Name dept city, state
Program Vision System
Program

3. Responsibilities
The following table defines the roles and responsibilities associated with this specification

Roles Responsibility
Author Prepares and submits this specification to include the equipment design
specifications, process and performance requirements, computer system
design specifications, and documentation requirements.
Engages the site functions in creation of this specification.
Ensures that the specification meets technical and procedure requirements.
Ensure the specification is established in accordance with the validation
plan.
Plan Quality Ensure that this specification is verification to include the equipment design
specifications, process, performance and CTQ requirements, computer
system design specifications and documentation requirements
Review and approve a charges associated with this specification
Operations/Engineering Ensure that this specification is verification to include the equipment design
specifications process, performance and CTQ requirements, computer
system design specifications and documentation requirements.
Review and approve a charges associated with this specification
Site Validation Leader Ensure that this specification is verification to include the equipment design
specifications process, performance and CTQ requirements, computer
system design specifications and documentation requirements

4. Background
Describe the background for this equipment or product

5. References

Document No. Revision Document Title

VP-XXX XX Process validation Plan
URS-XX XX User Requirements Specification

6. Equipment representation
Insert image or drowsing of the equipment if available

7. Process description
The process description is defined below
The packaging equipment receives product from conveyor A
The packaging equipment utilized bottom web material
Top web material is
The bottom web in indexed into the equipment
The bottom web is heated to temperature 150 degrees
Product pockets are formed in the bottom web
Product is placed in formed pocks by robot
Inspection Equipment: inspects product for proper placement
Top web is sealed to bottom web using pressure and heat
Reject able product is rejected at the reject station

8. Equipment design requirements

The equipment design requirements below include the major aspects of the equipment design. These
requirements will be reviewed at the design review and challenged during the factory acceptance testing (FAT)
prior to equipment shipment.
8.1. Production Environment

Req # Details
8.1.1 Equipment shall be designed for
1) Class environment
2) Humidify
3) Temperature
8.2. Utilities
 Req # Details
8.2.1 Electrical
1) Voltage
2) Phase
3) Cycle
4) Circuit Breaker Amperage
8.2.2 Air:
1) Verity Plant Supplied (psi)
8.2.3 Vacuum_
1) Plant Supplied:
2) Volume-CFM
8.2.4 Chiller Water:
1) Plant Supplied
8.3. Auxiliary Equipment Interface

Req # Details
8.3.1 Equipment shall be design to feed input product by use of a vibratory bowl.
1) Vibratory bowl shall feed syringes
2) Vibratory bowl shall be a dual construction
3) Vibratory bowl shall use a minimum of air jets
4) Vibratory bowl vibration shall be adjustable
8.3.2 Seal die cooling system:
List make/model of cooling system
8.4. Product output handing

Req # Details
8.4.1 Output product shall exit equipment by use of a conveyor
1) Conveyor design shall be
8.5. Equipment Design

Req # Details
Bottom Web Handing
1) Web material vs
8.5.1 2) Fell size
3) Registration requirements
4) Loading requirements
Top web handing
1) Include material
2) Roll
8.5.2.
3) Registration requirements
4) Loading requirements
5) Sloping requirements
Char overt
8.5.3.
1) Insert change over requirements
Pre-heat station
1) Include # of stations
8.5.4. 2) Temperature (Range)
3) Pressure (Range)
4) Duration (Range)
Forming station
1) Include drawings
2) form temperature
8.5.5
3) pressure
4) vacuum assist
5) Duration
Package sealing station
1) Include die size for mat
2) Seal with
8.5.6
3) Seal Pressure
4) Seal Temperature
5) Seal Duration
8.5.7 Se at die cooling requirements
Packing separation requirements
8.5.8
1) Include separation method
8.5.9 Splice detection requirements
Inspection system requirements
8.5.10 1) Reference the computer system requirements section for Inspection
requirements
8.5.11 Printing requirements
 1) Print method
2) Print information
8.5.12 Reject system securements
HMI Interface
8.5.13
1) Refer to the computer system requirements for HMI requirements

9. Computer system(s) Requirements

The computer system(s) requirements below include all aspect of the computer system(s) including the user
requirements specifications(URS), System Requirements Specifications (SRS), Functional Specifications (FS) and
the System Design Specifications (SDS). These requirements will be challenged during the Factory Acceptance
Testing (FAT) prior to equipment shipment and installation and also challenges during the installation
qualification(IQ). This equipment does not utilize electronic records. This equipment does not utilize electronic
signature.
9.1. Computer Hardware

Req # Details
9.1.1 PLC
1) PLC controls
2) PLC memory be scored according to scale of project
3) PLC shall have a minimum of … spare memory capability
HMI
9.1.2 1) HMI shall be
9.1.3 Motion Control System
9.1.4 Vision Systems
9.1.5 Ethernet
9.1.6 Writing Requirements
9.1.7 Electrical Cabinets
9.2. Computer System Functions/Cycle Control

Req # Details
9.2.1 Mode of operation
9.2.2 Equipment operation
9.2.3 Excessive waste
9.2.4 Motion control homing sequence
9.2.5 The PLC shall have master control of all motion drives
9.3. Inpecction Systems

Req # Details
9.3.1 Inspection
9.3.2 Inspection system operation
9.3.3 Challenge parts
9.4. HMI Requirements

Req # Details
9.4.1 Operator pushbuttons-pushbuttons shall be provided for:
1) Start and cycle stop
2) Emergency stop and reset
9.4.2 HMI Display of Error Messages/Error Logs:
1) HMI shall property display all error messages
2) HMI shall display an error history log
9.4.3 HMI Production Display
9.4.4 HMI Data Display
9.4.5 HMI Data Entry
9.4.6 HMI Function
9.4.7 HMI Screens
9.4.8 HMI Security Login/Logout
9.5. Reject Systems

Req # Details
9.5.1 List reject system controls
9.5.2 Reject Verification
9.5.3 Product Tracking
9.6. PLC Programming

Req # Details
9.6.1 Programming standards
9.6.2 PLC Subroutines
 9.6.3 Non-functioning code
9.6.4 Code Review
9.7. Security

Req # Details
9.7.1 The vendor shall maintain backup copies of the machine control software for a
period of 10 years
9.7.2 Plant engineering shall maintain current backup copies of the machine control-
software
9.7.3 PLC programs full be version controlled by the software developer
9.7.4 The system shall provide a minimum of 3 levels of HMI logins.

10. Process Performance/CTQ Requirements

The process performance and critical to Quality(CTQ) requirements will be challenged during the factory
Acceptance Testing(FAT) prior to equipment shipment and installation and also challenged during the operational
qualification(OQ) and/or Performance Qualification (PQ)
10.1.Performance Requirements

Req # Details
10.1.1 Production Rate
10.1.2 Overall Equipment Efficiency
10.1.3 Equipment steps
10.1.4 Changeover
10.1.5 Waste
10.2.Critical to quality Requirements

Req # Details
10.2.1 CTQ Characteristics
10.2.2 Quality
1) Equipment shall be designed to handle product without creating acts,
souths, or damage to the product that exceed our critical to quality
(CTQ) characteristics.

11. Documentation Requirements

These documentation requirements (if applicable) will be challenged during the factory acceptance testing(FAT)
prior to equipment shipment and installation and also challenged during the Installation Qualification (IQ).
11.1.Equipment Documentation

Req # Details
11.1.1 Vendor shall provide equipment operation manual
11.1.2 Vendor shall provide required maintenance schedule and procedure
11.1.3 Vendor shall provide recommended spare parts
11.2.Computer System Documentation

Req # Details
11.2.1 Schematics
1) Electrical schematics shall be provided in a reproducible format
11.2.2 Software/Firmware documentation
1) All software of the system shall be provide to name
11.2.3 System parameters:
2) All parameters of all motion control system shall be documented
3) A description of all vision system tools and parameters shall be
provided
11.2.4 Commercial Components
1) Listing of all commercial components
2) All commercial components out sheets
11.2.5 Vendor Testing/Validation Documentation (if applicable)
Vendor shall provide in a reproducible format, all testing/validation documents
performed by the vendor.
11.2.6 Inspection system documentation shall include the following:
1) Inspection System user’s manual
2) Documentation describing all vision tools used in this application
including parameters of these tools.
3) Documentation describing the vision system set-up, lens settings
lighting requirements
4) Instructions for product changeover/ recipe management
11.2.7 Motion Control documentation shall include the following:
1) Motion Control user’s manual
 2) Documentation describing the communications between the PLC and
motion control system
11.2.8 Software License
1) Vendor shall re-license inspection system software, if applicable, to
name
2) Vendor shall provide all inspection system software including
development system software, if applicable
3) Vendor shall provide all motion control software including development
system software. If applicable.

12. Revision History

Revision Control Log

Rev. # Date Change Description Responsible
01 Initial Submission