EQUIPMENT QUALIFICATION

MISS SYEDA RIMA ISHAQ Atco Laboratories Limited

EQUIPMENT QUALIFICATIONS
Frequency: Whenever it is planned to purchase/Install a new plant/machinery/equipment.

EQUIPMENT QUALIFICATIONS
There are four phases of Equipment Qualification Design Qualification(DQ) Installation Qualification(IQ) Operation Qualification(OQ) Performance Qualification(PQ)

1. 2. 3. 4.

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

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 requirement Approval from Concerned departments,Production,QC ,QA and Higher authorities. Comaparision data of quotations from different manufacturers/suppliers. Vendor selection Criteria Name of selected manufacturer/supplier and its quotation copy.

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.

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

INSTALLATION QUALIFICATION
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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INSTALLATION QUALIFICATION
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 QUALIFICATION
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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OPERATION QUALIFICATION
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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OPERATION QUALIFICATION
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 equipments ability, and their testing methods. Sampling and testing schedule and acceptance criteria shall be agreed.
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OPERATION QUALIFICATION
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 books 2. Check list of Operations to be checked 3. List the critical Operating Parameters and its testing method 4. Sampling and testing schedule and acceptance criteria 5. List of the instrument to be used for testing and their calibration 6.Testing results and summary report 7.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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