Qualifications & ValidationsQuality Assurance

FAT OF INSPECTION CONVEYOR

FACTORY ACCEPTANCE TEST  OF INSPECTION CONVEYOR

Contents

  • Objective
  • Scope
  • Responsibility
  • Verification of Technical Specification
  • Verification of Material of Construction
  • Verification of Instruments
  • Verification of Operation
  • Verification of  InterLock
  • Machine Trail Sheet
  • Suggestions/  Modifications
  • FAT Closed Out

OBJECTIVE:

To verify that the machine at the Manufacturer’s site is ready as per the Design Qualifications and in line with all the Technical Specifications laid down in the User Requirement Specification.

SCOPE:

The scope of this document is limited to the Factory Acceptance Test of Inspection Conveyor

RESPONSIBILITIES:

Manufacturer:

The manufacturer is responsible for the preparation of the FAT protocol, unless and until, it is specified by the Customer for its indigenous protocol.

The manufacturer shall assist the customer in performing the Factory Acceptance Test at the manufacturer’s factory, until and unless, it is specified by the customer to conduct the PROXY-FAT.

Customer:

  • The Customer shall conduct the Factory Acceptance Test at the manufacturer’s factory.
  • In case the customer wants the manufacturer to conduct the PROXY-FAT, a written communication, as an ANNEXURE, shall be attached along with this protocol.
  • Execution team for the FAT conducting consist of _________
  • FAT BY THE CUSTOMER
  • PROXY-FAT BY THE MANUFACTURER

VERIFICATION OF TECHNICAL SPECIFICATION:

Sr. NoParameterSpecifications
1.MODELPVBI-120
2.MAIN MOTORMAKE : BONFIGLIOLI

0.25HP/0.18KW/1.01A/230V/1360RPM/3PHASE

SRNO.210380522292

3.MAIN GEAR BOXMAKE : BONFIGLIOLI

MODEL : VF44 F120 P63 B5B3

SRNO.09 B03202500180

RATIO : 20:01

4.MAIN A.C DRIVEMAKE : ALLEN BRADLEY

MODEL : 22F-A2P5N103

0.5HP/2.5A/230V

SRNO.FA2P5NOW21030279

5.MAIN SWITCHMAKE : SCHNEIDER
6.MACHINE DIMENSION1520mm L x 850mm W x 1550mm H

VERIFICATION OF MATERIAL OF CONSTRUCTION:

ComponentMOC
Machine frame structureSS Sq. Pipe frame
ConveyorSS 304
SprocketNylon

VERIFICATION OF INSTRUMENT:

Sr. No.ComponentSpecification
1.      PotentiometerMake:  POT KNOB

VERIFICATION OF OPERATION:

Method of SimulationFunction
Main Power ON/OFF switchTo supply power to the unit with Green indication ‘ON’.
PotentiometerFor the speed variation

VERIFICATION OF INTERLOCKS (IF ANY):

Sr. No.Interlock FeatureMethod of testingAcceptance Criteria

N.A.

MACHINE TRIAL SHEET:

RUN TEST
Sr. No.Check Points
1.           Machine trail in empty run
2.           Abnormal Sound

SUGGESTIONS / MODIFICATIONS:

COMMENTS FROM THE CUSTOMER /MANUFACTURER’S ACCEPTANCE

FAT CLOSE OUT:

  • The Factory Acceptance Test for Turn Table stands completed.
  • All the parameters have been checked and found in line with the requirement
  • The machine is cleared, by the undersigned authority.

ABHA

Abha is the Author  of pharmaceutical guidance, she is a pharmaceutical professional having more than 22 years of rich experience in pharmaceutical field. During her career, she works in the quality assurance department with multinational companies i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd. During his experience, she faces many regulatorily audits i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda, Kenya, Tanzania, Zimbabwe. She is currently leading a regulatory pharmaceutical company as a Head Quality. You can join him by Email, Facebook, Google+, Twitter, and YouTube