Food Safety Prerequisites Program

Title: product changeover w rzw /ts

ssue Date: 01/09/20L7

SOP FOR PRODUCT CHANGEOVER

Objective: To lay down a procedure for the product Change Over during
iVfunufacturing.

Scope: This SOP is applicable for the product change over during
manufacturing of Product in the formulation of ABS FOODS LTD.

Rgsponsibility

Production Operator/ Technician shall be responsible for operation of the

machine.
Production/QA Officer/ Executive shall be responsible for the implementation
of the,SOP.
Accountability: Production and QA Head shall be accountable for compliance
o[,SOP.

P4ocedure

Before starting the product change over first go through the SOP of cleaning
and maintenance of equipment and line clearance.
Perform the cleaning as per SOP.
Switch "OFF" the utilities supply of equipment during cleaning, dismantling
and assembling of machine parts.
Product change over shall be done by trained production Operator and
s'upervisor.
Uge the hand gloves & nose masks while performing the changeover.
Ensure the absence of residue/material of previous batch executed.
Ensure the availability of tools required for dismantling and assembling of
equipment change parts.
Prpcedure for dismantling and cleanitrg of equipment change parts.
Ensure that tools required for dismantling of equipment chartge parts are
avpilable.
Clean the outer and inner surface of the equipment with lint free dry duster
fotlowed by wet duster.
Dismantle the equipment change parts with the help of appropriate tools.

REVIEWED BY APPROVED BY

Food Safety Team Leader Managing Director

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Doc. Tifle: product changeover {3t4? lxry

Issue Date: 01109/2017 R.ev. No.: 00 Rev. Date: ---

Plpce the dismantled machine parts on pallets and wipe with dry duster.
Keep the dismantled machine parts in polybag.
Transfer the equipment change parts to washingateaby using trolley.
Clean the equipment change parts in manufacturing.
After completion of cleaning perform the swab testing (if applicable).
Before transfer of change parts to respective area, ensure that area has been
clganed as per area cleaning SOP.
Transfer the equipment change parts to respective area for assembling if
required.
Transfer the Equipment change parts to change parts storage room if not
required to perform the production activities.
Prpcedure for Area and Equipment Cleaning
Folloy the respective SOP for area cleaning
EnsurB that there is no residueAylaterial of previous product lying on the floor.
Ensurp that there is no dust particles on the floor, walls, panel and ceiling.
Folloy the Respective equipment cleaning SOP for the equipment cleaning.
Ensure that there is no residue/l\4aterial of previous product lying on the surface
of eqqipment.
Ensure that equipment has been cleaned as per respective equipment cleaning
SOP.
After"completion of the cleaning process, record the cleaning time of the
equipment in "Equipment Operation, Cleaning & Maintenance Log Book"

Pfocedure for Swab Analysis

After completion of the cleaning, production/officer executive shall inform the
QA fqr swab collection.
QA officer/Executive shall collect the swab sample of equipment and send to
QC fqr testing.
QC personnel shall perform the analysis as per standard testing procedure and
prepa[e a swab analysis report.
QA personnel shall collect the swab analysis report from the QC and hand over
to prq$uction department.
If resglt of the swab analysis is passed, start the assembling of machine parts.
If resglt of the swab analysis is failed, re-clean the equipment'change parts.
Procedure for Assembling of equipment change parts

t REVIEWED BY APPROVED BY
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Food Safety Team Leader fuM" Managing Director .J'----
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Food Safety Prerequisites Program

Doc. Title: product changeover YW?11*3

lssue Date: 0L/09/20L7 Rev. No.r 00 Rev. Date: ---

Ensurp that result of swab analysis has been passed

Ensure the sterilizationreport of change parts used in aseptic area.
Ensure the availability of required tools for assembling of equipment machine
parts.
Start {re assembling of equipment change parts as per sequence.
Tightgn the nut and bolts properly.
WipeShe outer surface of the equipment with dry duster.
Take a line clearance for area and equipment for batch processing as per SOP.

Precautions: Product Change over includes:

Dismantling of equipment change parts
Cl,eaning of Equipment and equipment change parts
C[eaning of area adjacent to equipment
Agsembling of machine change parts
Swab analysis
Lipe Clearance

REVIEWED BY APPROVED BY

Food Safety Team Leader Managing Director :,4,_-