Equipment Qualification

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EQUIPMENT QUALIFICATION

MISS SYEDA RIMA ISHAQ

Atco Laboratories Limited

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EQUIPMENT QUALIFICATIONS

Frequency:

Whenever it is planned to purchase/Install a new plant/machinery/equipment.

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EQUIPMENT QUALIFICATIONS

There are four phases of Equipment Qualification

1. Design Qualification(DQ)

2. Installation Qualification(IQ)

3. Operation Qualification(OQ)

4. Performance Qualification(PQ)

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DESIGN QUALIFICATION

It is the first phase of Equipment Qualification for the approval of Purchasing an equipment and selection of the vendor.

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DESIGN QUALIFICATION

1. Concerned department shall establish the user requirement/specification.

2. Quotations will be collected from different manufacturer/supplier.

3. Vendor selection will be done.4. Concerned department will be

responsible for gathering all technical information in a file.

5. 5.Copy of Indent/requisition shall be attached.

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CHECK LIST FOR DQ

Required specification/user requirementApproval from Concerned departments,Production,QC ,QA and Higher authorities.Comaparision data of quotations from different manufacturers/suppliers.Vendor selection CriteriaName of selected manufacturer/supplier and its quotation copy.

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CHECK LIST FOR DQ

Correspondence related to technical discussion between company and manufacturer/supplier.

Copy of approved requisition

Copy of technical data regarding the equipment.

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INSTALLATION QUALIFICATION

Installation Qualification consists of Instrument calibration/inspection to verify that equipment is ok and installation meets the design requirement.

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Concerned department will collect the copy of purchase order and Material receiving note.

The installation area equipment and its requirement will be reviewed by the concerned department to verify that it is in accordance with the specifications

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The physical condition of equipment at the time of receiving will be checked

Following documents will be collected from supplier

1.Service and operators manual

2.Recommended spare parts list

3.Calibration certificates of monitoring and measuring devices

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Installation drawing shall be made

Concerned department/Engg. Department will review the spare parts list.

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CHECK LIST OF IQ

Copy of purchase order and material receiving note.

Installation area and equipment review report

Physical condition of the unit at the time of receiving

Documents collected from the supplier:

Services and Operational Mannual

Recommended Spare parts list

Calibration Certificates

Installation Drawing

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Installation Area & Equipment Review Report

Utilities and building services:

-Compressed air

-Electricity

-Electrical Back up system

-Plumbing and drains

Lighting

Steam

Vacuum

Ventilation air filtration

Pest Control

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Installation Area & Equipment Review Report

Equipment Features:

Model No.

Serial No

Capacity /speed

Location

Name of constrction material of product contact surface

Utilization

Filters

Lubricants

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OPERATION QUALIFICATION

It consists of tests and inspections to verify that the equipment,system alerts and controls are operating reliably

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Concerned Department will make all the standard Operating Procedures related to operations such as Operation,Sanitation,preventive maintenance etc.

Log book for Preventive maintenance programme , cleaning and utilization shall be made.

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All the operations will be checked and verified.

A list shall be made of all the critical operating parameters which have significant impact on the equipment’s ability, and their testing methods.

Sampling and testing schedule and acceptance criteria shall be agreed.

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Concerned department shall make a list of all the instruments and their calibration record utilized to conduct test functions prescribed in the protocol.

A summary report shall be made with conclusion and the concerned department will issue acceptance report of equipment.

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CHECK LIST OF OQ

1. SOPs and Log books2. Check list of Operations to be checked3. List the critical Operating Parameters and

its testing method4. Sampling and testing schedule and

acceptance criteria5. List of the instrument to be used for

testing and their calibration6.Testing results and summary report7.Acceptance report of Equipment Qualification

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Performance Qualification

This qualification will allow the project to move close to final close out and transfer the entire project to the operating department

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Performance Qualification

A performance qualification protocol will describe the detailed sample locations frequencies and acceptance criteria over an appropriate time period

Action and alert limit shall be mentioned.

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CHECK LIST OF PQ

Validation Protocol

Alert and action limit

Testing results and summary report

Any recommendations and suggestions

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