HACCP Analysis

OVERVIEW & GUIDE FOR THE HACCP WORKSHEETS
Worksheet No Worksheet Name
WS 1 Management Sheet
WS 2 Product Description
WS 3 Flow Diagram
WS 4 Hazard Identification and Description
Control Measure Selection and

WS 5
Categorization
HACCP Plan including OPRP's &

WS 6
CCP's
WS 7 Verification Plan
WS 8 List of Supporting Documents
WS 9 Validation of Control measure
WS 10 Modification and Follow up
WS 11 Meeting Activity Log

E HACCP WORKSHEETS
Description
Registration and approval of the study
Product and process description, including

raw material and end product
characteristics
Simplified process flow diagram with OPRP

and CCP location
Each potential hazard is listed and

significance is determined by severity of
health effect and likelihood of appearance
Using the decision tree, the control

measures are categorized to CCP, OPRP or
Modification
List and overview of all identified CCPs and

OPRPs with control measures, limits,
corrective actions and responsibilities
Overview of verification activities that show

that the CCPs and OPRPs have been
implemented properly
Recording and filing of supporting

information
Evidence that the control measure can

achieve the targeted limits
Document the changes related to HACCP
Recording meetings, attendance and

decisions made by the team
MANAGEMENT SHEET
Complete the first section (below) at the start of the HACCP study
HACCP Study N°: Version N°: HACCP Study Scope
2 1 Factory
HACCP study details Tick as appropriate Plant/line
New HACCP study Brand
Scheduled review √ Product Name
Unscheduled review Product Code
Study started Apr'17 QMS Reference
Description of scope of study, e.g. module (start and end point) or products included
1. This study covers the Receipt, Storage and Packing of Malt based bulk powder received from Primary Manufacturing sites (Nabha, JIL &
Rajahmundry)
2. Scope of this HACCP study covers the packing of Bulk powder in Polypropylene jars
3. The study covers the hazards originated from the raw material/ packing material used, suction, powder transfer system, filling, packing
process & transportation, and includes the processing of Bulk rework.
Scheduled or unscheduled review: Main changes and reasons

This is a Scheduled review. The Whole study was revamped in alignment with GSK, ISO & Codex requirements.
Main Changes are
- Hazard Assessment
- Categorization of Control measures
- Validation and Verification of OPRP/ CCP
HACCP Team Members
Name Responsibility / Role / Expertise
HACCP Team Leader/ Documentation & Assisiting in the HACCP
C Shankar
Study
HACCP Team member/ Documentation & Assisting in the HACCP
V Babynath
study
G Balakrishnan HACCP Team memer/ Flow Diagram Verification/ Packing Expert
HACCP Team member/ Flow Diagram Verification/ Inputs on

M.Pachaippan
Hygienic Engineering & Engineering support
TS.Ravikumar HACCP Team member/ Warehouse Operations
Raja HACCP Team member/ HR Induction & Training
Authorisation for new HACCP study or update to new version

General Manager M.R.Pragatheeswaran
Complete the section below after completion of the HACCP study
HACCP study review HACCP study issue date
Next scheduled review Date: Study issued
Authorisation of finished study
HACCP Team Leader C Shankar
QA Manager D Balamurugan
Factory Manager Janardhan
General Manager M.R.Pragatheeswaran
t of the HACCP study
Avalon Cosmetics (P) Limited

Jar line
Horlicks/ Boost & Its Variants
Std Horlicks 200g, Std Horlicks 500g, Std

Horlicks 1kg, Boost 200g & 500g and
Chocolate Horlicks 200g
ACPL/
s included
eived from Primary Manufacturing sites (Nabha, JIL &
s
sed, suction, powder transfer system, filling, packing
SO & Codex requirements.
Department / Company
QA/ Avalon Cosmetics Pvt Limited
QA/ Avalon Cosmetics Pvt Limited
Production/ Avalon Cosmetics Pvt Limited
Engineering/ Avalon Cosmetics Pvt

Limited
Stores/ Avalon Cosmetics Pvt Limited
HR/ Avalon Cosmetics Pvt Limited
Date:
of the HACCP study
Date:
Date:
Date:
Date:
Date:
PRODUCT DESCRIPTIONS
Characteristics of End Product
Name (product(s), product group(s), line)
Type (e.g. raw, cooked, ready-to-eat)
Key physical and chemical characteristics (e.g.

water activity, pH, ..)
Key processing steps (e.g. drying, heat

treatments, freezing)
Other (services…)
Incoming Materials
All Raw materials / Ingredients
High risk ingredient(s) (e.g. microbial risks,

foreign body source)
Packaging materials in contact with food
Rework (Wet/ Dry)
Other (e.g preservatives, processing aids,

sevices)
Specifications and Regulatory requirements (food safety-related)

Product specifications
Product-specific regulatory requirements

Filling and Packing
Packaging description (e.g. size)
Packaging system (e.g. modified atmosphere)
Claims and Label Information
Instruction for use by consumers (incl. use or

storage after opening)
Statements for safe use (e.g. special instr. for

safe handling)
Other
Distribution / Storage
Distribution instructions (e.g. ambient, chilled,
frozen)
Storage instructions (e.g. ambient, chilled,
frozen)
Shelf life conditions
Other
Use by Consumers
Intended use
Target group of users and special consumer

considerations (e.g. infants, elderly)
Reasonably expected mishandling and misuse

PRODUCT DESCRIPTIONS
Std Horlicks, Chocolate Horlicks and Boost
Horlicks: Ready to drink after mixing with hot/ cold milk or water
Boost: Ready to drink after mixing with cold milk
Std Horlicks:
Appearance - Light Creamish Brown
Bulk density - 0.83 to 0.96 g/cc & pH - 6.60 to 7.10 g/cc
Chocolate Horlicks:
Appearance - Chocolate Brown
Bulk density - 0.83 to 0.96 g/cc & pH - 6.60 to 7.10 g/cc
Boost:
Appearance - Light Brown granular powder with evenly distributed orange & yellow granules
Bottle Fill capacity - 510 to 580 & pH - 6.7 + 0.2
Powder Transfer, Metal seperation, Filling and Induction Sealing.
NA
Std Horlicks & Chocolate Horlicks:

Wheat flour, Malted Barley,Dark Malt – 1,Malt Extract, Finamul 2705,MilkSNF,Skimmed Milk
Powder, Whey powder / Whey Powder), Wheat gluten, Fine Crystalline Sugar, Vitamin Pre-mix ,
Vitamin C, Isolated Soy protein, Calcium carbonate, Magnesium Oxide, Magnesium chloride, Ferric
pyrophosphate,Potassium iodate, Zinc Sulphate, Potassium bicarbonate,Sodium bicarbonate,
Sodium chloride, New Oily Vitamin premix, Copper Sulphate, Selenium dioxide.
Cocoa powder, Caramel & Chocolate Flavour are additional ingredients in Chocolate Horlicks
Boost:
Malt Extract, Boost Intermediate powder, Milk fat, Milk SNF, Isolated Soya protein, Wheat Gluten,
Sugar Caramel, Cocoa powder, Calcium Carbonate, Ferric Pyrophosphate, Potassium bicarbonate,
Sodium Chloride, Cocoa Flavor, Vanilla Flavor, Ascorbic acid, Oil Vitamin premix, Dry Vitamin
premix, Magnesium chloride, Potassium iodate, Zinc Sulphate, Copper Sulphate & Glucose.
Std Horlicks , Chocolate Horlicks and Boost Bulk material
Packed in Polypropylene Randon Copolymer food grade jars sleeved with Transparent heat
shrinkable PVC Sleeves and capped with polypropylene food grade cap.
Dry rework
NA
equirements (food safety-related)

Refer GSK Finished Product Specifications
As per FSSAI requirements

Std Horlicks 200g, 500g and 1kg in PP Jars
Chocolate Horlicks 200g in PP jars and
Boost 200g & 500g in PP jars
Packed in Controlled Condition (HVAC - Max 55% RH & 15mm/ Hg of VP)
Horlicks: Take 200ml of hor or cold milk/ water

Stir quickly to mix well and add a little sugar if required
Boost: Stir 2-3 teaspoons (20g) of Boost to a cup of hot/ cold milk
Add Sugar to taste
Horlicks:Do not use if inner seal beneath cap is missing or broken.

Boost: Do not use if the seal under cap is broken or tampered with.
NA
Ambient conditions
Store in a Clean & Dry place away from Sunlight
Best before 12 months from date of packing
NA
For All Age group
Childrens
NA
HACCP STUDY - Jar Line
Flow Diagram
Shape Code M1 - Bulk material

(Horlicks/ Boost/ M2 - PP Jars M4 - Sleeves
M = Materials M3 - Cartons
Chocolate Horlicks)
L = Logistics (Transport, Storage)
P = Process
P8 - Unloading of PP P19 - Unloading of
P1 - Unloading of
Jars in Cartons Sleeves
Bulk drums
Material -"M"
P2 - Wet Cloth
mopping of drums L11 - Storage of L16 - Storage of
with IPA solution PP jar/ Cartons Sleeves
Process step
"P"
NOT NOT
OK OK
L1 - Storage of
Drums in RM QA Inspection QA Inspection
L12 - Jar L17 - Sleeve
Condition warehouse
Movement to Movement to
rejection area rejection area
OK OK
L2 - Movement of
Drums to Day
P9 - Removal of P20 - Sleeves
Storage area
Outer Cartons Overprinting
Transport "L"
P3 - Wet Cloth NOT
mopping of drums L13 - Bottle OK
with IPA solution Feeding through
Conveyor Sleeve Code inspection
Storage "L" P21 - Sleeve offline
coding
L3 - Drum
M6 - Bulk rework Movement to P10 - Air Blowing & OK
Suction room Suction Unit
Connector in P22 - Sleeve code L18 - Sleeve
same Flow D inspection Movement to
Production area
NOT P11 - Pre-heating
L4 - Bulk Drum OK
Movement to Bulk powder inspection
rejection area (Infestation & FM etc)
Document or P12 - Empty Jar

Note inspection
Rejected drum are OK
scrapped in alignment
with Manufacturing site
L5 - Bulk powder
OPRP 's Suction P13 - Sleeving
OPRP 2
CCP's
P14 - Sleeve taping
L6 - Powder
Transfer System
P15 - Sleeving
P4 - Vibro Sieving through Shrink tunnel
OPRP 1 10*10 - Horlicks I, II & III
6*6 - Boost
P16 - Sleeved Jar

Inspection
P5 - Metal Seperator
P16 - Sleeved Jar
Inspection
OPRP 3 P5 - Metal Seperator
NOT
OK
Sleeved Jar Quality

P17 - Sleeve cutting
P6 - Powder & Segregation of jars
MS passed powder
inspection with magnet
OK
OK P18 - UV treatment of
L14 - Torn sleeves
Metal seperator rejected moved to scrap Jars
powder after magnet area
inspection are scrapped L7 - Day hopper
L15 - Jar Infeed

Conveyor
L8 - Y Chute
pipeline
L9 - Screw Feeder
L10 - Filling
Machine Hopper
L10 - Screw Feeder
NOT OK
OPRP 2 P7 - Linear Filling
NOT OK
P23 - Checkweigher
NOT
OK
L19 - Weight
Filled Jar weight correction
OK
M5 - Caps P24 - Filled jar rim &

body cleaning by Air
knives
P28 - Unloading of
Caps
CCP 1 P25 - Metal Detector
L20 - Storage of NOT

Caps OK
Metal Detector passed jar

L20 - Storage of NOT
Caps OK
P26 - MD rejected jars P27- Powder
Metal Detector passed jar collected from Metal detector rejected
inspection with magnet powder after magnet
NOT conveyor
inspection are scrapped
OK L21 - Cap
QA Inspection Movement to
rejection area
OK
P29 - Jar Lip Cleaning

OK
P30 - Manual Capping

& Tightening
P31 - Jar Body

Cleaning with Brush
P32 - Cap Tightening
CCP 2A P33 - Empty Wad

Sensor
NOT
OK
P34 - Check the wad
Jar pass through Sensor & Repass
OK
P35 - Induction
CCP 2B Sealing
P37 - Opening of P38 - Retrieval of

NOT
Burnt jars in powder & scrapped
OK
Controlled condition
P36 - Segregation of
Seal Integrity condition Burnt & Unsealed/
Micro leaker jars
P39 - Openingof
Unsealed/ Micro P40 - Retrieval of M6 - Bulk rework
OK leaker jars in powder
Controlled condition
P41 - Caton Filling &
Weighing
P42 - Caton Coding

& Taping
P43 - Carton Stacking

P43 - Carton Stacking
P44 - Online QA
Insection
P45 - FG Storage
P46- Batch Release by

QA & Dispatch
HAZARD IDENTIFICATION
Location of potential hazard Hazard Description
Indicate the step (e.g. raw material, logistics

Describe clearly and specifically the hazards that are "reasonably expected" to occur at each step: Class
or process) at which the hazard may be
Microbiological, P = Physical, C = Chemical, A = Allergens, ), origin, source & acceptable level etc.
introduced.
Origin or source of the hazard

M #, L# or (e.g. where and how it can be
Step (description) Hazard Class
P# introduced into the product or
its environment)
Bulk material - Horlicks &

M1 Foreign Body - Metal piece P Raw material
Chocolate Horlicks
Bulk material - Horlicks & Foreign Body - Plastic/ Paint

M1 P Raw material
Chocolate Horlicks piece

M1 Foreign Body - Hair P Raw material
Chocolate Horlicks
Heavy metals (Lead, Cadmium,

M1 Tin, Chromium, Arsenic, Methyl C Raw material
Chocolate Horlicks
Mercury)
Bulk material - Horlicks & Residual pesticides &

M1 C Raw material
Chocolate Horlicks Hydrogen Phosphide

M1 Aflatoxin (M1, B1, B2, G1 & G2) C Raw material
Chocolate Horlicks
Antibiotic (Tetracycline,
Bulk material - Horlicks & Oxytetracycline, Chlor
M1 C Raw material
Chocolate Horlicks tetracycline, Streptomycin &
Sulfonamide etc)
NOT'S (Ochratoxin, Agaric

M1 Acid, Hydrocyanic acid, C Raw material
Chocolate Horlicks
Hypercine, Saffrole)
B.Ceresus,Yeast
M1 Mould,Coliforms, M Raw material
Chocolate Horlicks
PCT,Salmonella
Shigella, S.aureus,V.Cholera,
M1 V.Para heamolyticus,Feacal M Raw material
Chocolate Horlicks
Streptococci

M1 Bacteria Count( SPC) M Raw material
Chocolate Horlicks

M1 Thermophiles(Thermophilic) M Raw material
Chocolate Horlicks

M1 Wheat flour containing Gluten A Raw material
Chocolate Horlicks

M1 Soya Protein Isolate A Raw material
Chocolate Horlicks

M1 Milk Solids A Raw material
Chocolate Horlicks
M1 Bulk material - Boost Foreign Body - Metal piece P Raw material
Foreign Body - Plastic/ Paint

M1 Bulk material - Boost P Raw material
piece

M1 Foreign Body - Hair P Raw material
Chocolate Horlicks
Heavy metals (Lead, Cadmium,

M1 Bulk material - Boost Tin, Chromium, Arsenic, Methyl C Raw material
Mercury)
Residual pesticides &

M1 Bulk material - Boost C Raw material
Hydrogen Phosphide
M1 Bulk material - Boost Aflatoxin (M1, B1, B2, G1 & G2) C Raw material
Antibiotic (Tetracycline,
Oxytetracycline, Chlor
M1 Bulk material - Boost C Raw material
tetracycline, Streptomycin &
Sulfonamide etc)
NOT'S (Ochratoxin, Agaric

M1 Bulk material - Boost Acid, Hydrocyanic acid, C Raw material
Hypercine, Saffrole)
B.Ceresus,Yeast
M1 Bulk material - Boost Mould,Coliforms, M Raw material
PCT,Salmonella
Shigella, S.aureus,V.Cholera,
M1 Bulk material - Boost V.Para heamolyticus,Feacal M Raw material
Streptococci
M1 Bulk material - Boost Bacteria Count( SPC) M Raw material
M1 Bulk material - Boost Thermophiles(Thermophilic) M Raw material
M1 Bulk material - Boost Wheat flour containing Gluten A Raw material
M1 Bulk material - Boost Soya Protein Isolate A Raw material
M1 Bulk material - Boost Milk Solids A Raw material
Foreign matter (Dust, Dirt, Hair

M2 PP Jars P Packing material
& Plastic piece)
M2 PP Jars Oil/ Wax C Packing material
Batcterial, Coliform, Yeast &

M2 PP Jars M Packing material
Mould
M3 Carton Foreign matter (Dust & Dirt) P Packing material
Foreign matter (Dust, Dirt &

M4 Sleeve P Packing material
Hair)
M4 Sleeve Oil/ Wax C Packing material
Foreign matter (Plastic piece,

M5 Caps P Packing material
Hair, dirt & dust etc.)
Transportation (Damaged
P1 Unloading of Bulk drum Dust & Foreign matter P
drum)
Transportation & Unloading
P1 Unloading of Bulk drum Infestation P
Envionment
P1 Unloading of Bulk drum Microbiological contamination M Transportation & Handling
Wet Cloth mopping of

P2 Dust & Foreign matter P Improper Cleaning
drums with IPA solution

P2 Microbiological contamination M Improper Cleaning
Storage of drums in
L1 Dust & Foreign matter P Storage area environment
Warehouse
Storage of drums in
L1 Infestation P Storage area environment
Warehouse
Movement of drum to day Drum damage during

L2 Foreign matter P
storage area handling
Movement of drum to day Personnel

L2 Microbiological contamination M
storage area Mix up of rejected drum

P3 Dust & Foreign matter P Improper Cleaning

P3 Microbiological contamination M Improper Cleaning
Drum movement to suction

L3 Foreign matter P Drum damage
room
L4 Bulk powder inspection Metal piece P Raw material

Foreign matte (Plastic/ paint
L4 Bulk powder inspection P Raw material
peel off)
Raw material/ Process

L4 Bulk powder inspection Infestation P
Environment
L4 Bulk powder inspection Microbiological contamination M Raw material
Foreign matter (Hair,

L5 Bulk powder suction mechanical tools, polyliner P Personnel & Facility
pieces)
Mixing of Bulk powder

ALC failure & Untrained
L5 Bulk powder suction (Chemical & Nutrient C
manpower
composition change)
Suction room environment

L5 Bulk powder suction Microbiological contamination M (RH variation/ HVAC
issues)
PTS Section
L6 Powder Transfer system Microbiological contamination M (RH variation/ HVAC
issues)
Vibro Sieve
Foreign matter (Metal & Other Damaged Sieve
P4 Horlicks - 10*10 P
FM from Bulk) Bulk material
Boost - 6*6
Vibro Sieve Improper Cleaning

Microbiological contamination
P4 Horlicks - 10*10 M RH variation (HVAC
(Bacteria, Yeast & Mould)
Boost - 6*6 issues)
P5 Metal Seperator Metal P Bulk/ Process line

Improper Cleaning
P5 Metal Seperator M RH variation (HVAC
(Bacteria, Yeast & Mould)
issues)
Powder inspection with

P6 Metal P Metal rejected powder
magnet
Improper Cleaning of
P6 Microbiological contamination M magnet & Storage of
magnet
rejected powder
Microbiological contamination Improper Cleaning & RH

L7 Day Hopper M
(Bacteria, Yeast & Mould) variation

L8 Y Chute Pipeline M
Metal to Metal contact

L9 Screw feeder Metal piece P
screw feeder

L9 Screw feeder M
Metal (Nut, Bolt & Other moving

Loose nut & bolts
L10 Filling Machine hopper parts) P
Damaged Gaket
Gasket

L10 Filling Machine hopper M
Metal to Metal contact

L10 Screw feeder Metal piece P
screw feeder
Metal (Nut, Bolt & Other moving
P7 Rotary Filling P Loose nut & bolt
parts)
Improper Cleaning & RH

P7 Rotary Filling Microbiological contamination M
variation
Unloading of PP Jars in
P8 Dust/ Dirt P Transit
Cartons
Unloading of PP Jars in
P8 Microbiological contamination M Transportation & Handling
Cartons
L11 Storage of PP Jars/ Cartons Dust/ Dirt/ Plastic piece P Storge & Handling
Jar movement to rejection

L12 Dust/ Dirt/ Plastic piece P Mix up of rejected jars
area
P9 Removal of Outer Cartons Carton piece/ dust P Storge & Handling
Bottle feeding through Improper cleaning of

L13 Dust/ dirt P
conveyor conveyor
Improper functioning of Air

P10 Air Blowing & Suction unit Foreign matter, Dust & Dirt P
Blowing/ Suction unit
P10 Air Blowing & Suction unit Microbiological contamination M Environment/ Equipment
Inadequate Cleaning &

P11 Pre-heating Foreign matter & Dust P Maintenance of Pre-
heating tunnel
P12 Empty jar inspection Dust/ Dirt/ Plastic piece P Improper inspection
P19 Unloading of Sleeves Dust/ Dirt P Transit
L16 Storage of Sleeves Dust/ Dirt/ Thermocol P Storge & Handling
Sleeve movement to
L17 Dust/ Dirt P Mix up of rejected sleeves
rejection area
P20 Sleeve Overprinting Solvent/ Ink smell C Ink Supplier
Sleeve movement to
L18 Foreign matter (Dust) P Storge & Handling
Production area
Personnel & Sleeving

P13 Sleeving Foreign matter P
Environment

P13 Sleeving Microbiological contamination M
Environment

P14 Sleeve taping Microbiological contamination M
Environment
Inadequate maintenace &

Sleeving through Shrink Foreign matter (Dust, Wire
P15 P Cleaning
tunnel I, II & III pieces & Plastic piece)
Jar melting due to jamming
Personnel & Sleeve

P16 Sleeved jar inspection Microbiological contamination M
inspection Environment
Sleeve cutting &

P17 Foreign matter (torn sleeves) P Torn sleeves
segregation of jars
Sleeve cutting & Personnel & Sleeve cutting

P17 Microbiological contamination M
segregation of jars Environment
Torn sleeves movement to

L14 Foreign matter (torn sleeves) P Torn sleeves
rejected area
P18 UV treatment of Jars Glass piece P UV light

Improper functioning of UV
P18 UV treatment of Jars Microbiological contamination M
light
Personnel & Filling room

L15 Jar Infeed conveyor Microbiological contamination M
Environment
Improper handling of low

P23 Checkweigher Microbiological contamination M weight/ high weight jars by
personnel
Improper handling of low

P23 Checkweigher Foreign matter (hair) M weight/ high weight jars by
personnel
Filled jar rim & body

P24 Microbiological contamination M Compressed air
cleaning by air knives
P25 Metal detector Metal piece P Bulk/ Process line
Non- Compliance to MD
MD rejected jars collected
P26 Metal piece P rejection handling &
from the conveyors
Untrained personnel

P27 Metal P Metal rejected powder
magnet
Improper Cleaning of
P27 Microbiological contamination M magnet & Storage of
magnet
rejected powder
P29 Jar lip cleaning Foreign matter (Nut & Bolt) P Loose nut & bolts
P29 Jar lip cleaning Microbiological contamination M Inadequate cleaning
Manual Capping & Cap handling by personnel

P30 Fine dust & Plastic piece P
Tightening & Capping Environment
Manual Capping & Cap falling on floor & Cap
P30 Microbiological contamination M
Tightening handling
Jar Body cleaning with Inadequate Brush cleaning

P31 Dust & Loose bristles P
Brush & maintenance
Foreign matter (Damaged cap/ Mishandling of caps & jar

P32 Cap tightening P
jar piece) by personnel
No wad in cap &

P33 Empty wad sensor Foreign matter/ Pest P malfunctionin of wad
sensor
No wad in cap &

P33 Empty wad sensor M malfunctionin of wad
(Solidification)
sensor
Improper inspection &

P34 Check the wad & repass Foreign matter/ Pest P
capping by personnel
Microbiological contamination Improper inspection &

P34 Check the wad & repass M
(Solidification) capping by personnel
P35 Induction Sealing Foreign matter/ Pest P Improper Induction Sealing
Cross/ Loose caps/

defective cap application
P35 Induction Sealing Fumes/ Off smell C by workmen
Improper Induction Sealing
machine setting
P35 Induction Sealing M Improper Induction Sealing
(Solidification)
Segregation of Burnt & Improper segregation by

P36 Foreign matter - Burnt particles P
Unsealed/ Micro leaker jars personnel
Segregation of Burnt & Improper segregation by

P36 Burnt smell of powder C
Unsealed/ Micro leaker jars personnel
Opening of Unsealed/ micro

Improper handling of jars
P39 leaker jars in controlled Torn Induction seal pieces P
by trainned personnel
environment
Unhygienic tool usage &

P40 Retrieval of powder Microbiological contamination M
personnel
Opening of Burnt jar in Improper segregation by
P37 Foreign matter - Burnt particles P
controlled condition personnel
Opening of Burnt jar in Improper segregation by

P37 Burnt smell of powder C
controlled condition personnel
P38 Retrieval of powder & scrap - - -
Foreign matter (Hair, Stapler,

P41 Carton Filling P Cartons & Personnel
Carton dust)
P42 Carton Coding & tapping - - -
Carton damage due to

P43 Carton Stacking Foreign matter P Improper Stacking &
Untrainned personnel
Foreign matter/ Pest issues Improper Online inspection

P44 Online QA inspection P
due to ISM seal damage & Untrainned personnel
Foreign matter / Pest Improper Storage &

P45 FG Storage P
issues/Damage Untrainned personnel
IDENTIFICATION and DESCRIPTION
Hazard assessment
Q1: Based on the hazard description, likelihood of occurrence

" to occur at each step: Class (M =
and severity of health effects, does this hazard need to be
ource & acceptable level etc.
controlled, i.e. is it a significant hazard?
Severity of Significant hazard?

Acceptable level in end Likelihood of (Yes/No)
adverse
product occurrence For significant hazard, select
health effect
and categorize control
measure(s) on WS 5.
GSK Finished product

3 B Yes
spec
Absent 2 C No
Absent 2 C No
FSSAI spec 1 B No
FSSAI spec 1 B No
FSSAI spec 1 B No
FSSAI spec 1 B No

1 B No
spec

1 B No
spec
1 B No
spec

1 B No
spec

1 B No
spec
Codex 1 B No
Codex 1 B No
Codex 1 B No

3 B Yes
spec
Absent 2 C No
Absent 2 C No
FSSAI spec 1 B No
FSSAI spec 1 B No
FSSAI spec 1 B No
FSSAI spec 1 B No

1 B No
spec
1 B No
spec

1 B No
spec

1 B No
spec

1 B No
spec
Codex 1 B No
Codex 1 B No
Codex 1 B No
GSK AQL 1 C No
GSK AQL 2 C No
<1 cfu/swab 1 B No
Absent 1 C No
Absent 1 C No
GSK AQL 2 C No
GSK AQL 2 C No
Absent 2 C No
Absent 1 B No

1 B No
spec
Absent 2 C No

1 B No
spec
Absent 2 C No
Absent 1 B No
Absent 2 C No

1 B No
spec
Absent 1 B No

1 B No
spec
Absent 2 C No
Absent 3 B Yes
Absent 2 C No
Absent 1 B No

1 B No
spec
Absent 1 B No
No mix up of product 1 B No

2 B Yes
spec

2 B Yes
spec

2 B Yes
spec

1 B No
spec

3 B Yes
spec
1 B No
spec
NA - - -
NA - - -

1 B No
spec

1 B No
spec
Absent 1 B No

1 B No
spec
Absent 1 B No

1 B No
spec
Absent 1 B No
Absent 1 B No

2 B Yes
spec
GSK AQL 1 C No

1 D No
spec
Absent 1 C No
Absent 1 C No
Absent 2 C No
Absent 2 C No
Absent 1 B No

1 B No
spec
Absent 2 C No
Absent 2 C No
GSK AQL 2 D No
Absent 2 C No
GSK AQL 2 D No
Absent 1 E No
Absent 1 C No
Absent 2 C No

1 B No
spec

1 B No
spec
Absent 1 B No

1 C No
spec
Absent 1 C No

1 C No
spec
NA - - -
Absent 1 B No
1 B No
spec

1 B No
spec

1 B No
spec

2 C No
spec

1 B No
spec

5 B Yes
spec

1 B No
spec
NA
(Material will be - - -
scrapped)
NA
scrapped)
Absent 1 B No

1 B No
spec
Absent 1 B No
1 B No
spec
Absent 1 C No
Absent 1 B No
Absent 5 B Yes

5 B Yes
spec
Absent 1 B No

1 B No
spec
Absent 5 B Yes
Absent 5 B Yes

5 B Yes
spec
Absent 1 B No
Absent 1 B No
Absent 1 B No

1 B No
spec
NA
(Material will be 1 B No
scrapped)
NA
(Material will be 1 B No
scrapped)
NA
scrapped)
Absent 1 C No
- - - -
Absent 2 C No
Absent 1 B No
Absent 2 C No
Justification
Hazard assesment
Provide supporting data/references
For non significant hazards, document how it is managed

e.g: Through a specification or Checklist etc.
Bulk material received from Approved Manufacturing sites.

Vibro sieve (10*10), Metal seperator and Metal detector is in place
Only approved bulk material used for suction
Bulk powder inspection is in place before suction

Bulk drum inspection for foreign matter & Vibro sieve (10*10) is in place

Routines at entry & Process area entry procedure is in place
Bulk powder monitored for heavy metal minimum yearly twice by

Manufacturing sites
It is also monitored at Site level after packing through External lab and
trends are OK.
Bulk powder monitored for Residual Pesticide & Hydrogen Phosphide

minimum yearly twice by Manufacturing sites
trends are OK.
Bulk powder monitored for Aflatoxin minimum yearly twice by

Manufacturing sites
trends are OK.
Bulk powder monitored for Antibiotic minimum yearly twice by

Manufacturing sites
trends are OK.
Bulk powder monitored for NOT's minimum yearly twice by Manufacturing

sites
trends are OK.
Weekly complete microbiological parameters monitoring of Finished

product through External lab is in place
Past trends are ok
Past trends are ok

Past trends are ok
Past trends are ok
As wheat flour in Bulk material which is the source of the gluten

Wheat gluten is declared in the label
Soya protein isolate (Allergen) is an ingredient in Bulk material, which is

declared in label
Milk Solids is an ingredient (Allergen) in Bulk material, which is declared

in label

Bulk powder inspection is in place before suction

Bulk drum inspection for foreign matter & Vibro sieve (10*10) is in place

Routines at entry & Process area entry procedure is in place
Bulk powder monitored for heavy metal minimum yearly twice by

Manufacturing sites
trends are OK.
Bulk powder monitored for Residual Pesticide & Hydrogen Phosphide

minimum yearly twice by Manufacturing sites
trends are OK.
Bulk powder monitored for Aflatoxin minimum yearly twice by

Manufacturing sites
trends are OK.
Bulk powder monitored for Antibiotic minimum yearly twice by

Manufacturing sites
trends are OK.
Bulk powder monitored for NOT's minimum yearly twice by Manufacturing

sites
trends are OK.
Past trends are ok

Past trends are ok

Past trends are ok

Past trends are ok
As wheat flour in Bulk material which is the source of the gluten

Wheat gluten is declared in the label
Soya protein isolate (Allergen) is an ingredient in Bulk material, which is

declared in label
Milk Solids is an ingredient (Allergen) in Bulk material, which is declared

in label
Jar PM inspection basis GSK AQL

Air Blowing/ Suction unit & Empty Jar inspection through magnifying glass
is in place

is in place
UV treatment of Jars in place

Micro monitoring of Jars after UV treatment done on weekly basis - Trend
is ok
Routines at Entry - Hand washing/ Hand sanitization in place for
contractual handling jars
Carton PM inspection basis AQL

Material received from Approved vendor and unloaded as per Truck
inspection checklist
Sleeve PM inspection basis AQL

Sleeve PM inspection basis AQL

Material received from Approved vendor and Sleeve inspection is done
during mounting and after coding
Cap PM inspection basis AQL

Cap inspection through magnifying glass is in place before issuing to
packing
All the Bulk drums are unloaded as per Truck inspection checklist
Bulk drums received in closed containers/ containers covered with
tarpaulin sheets
Pallet stacker is in place for unloading of bulk drums
Bulk drums received in closed containers/ containers covered with
tarpaulin sheets
Bulk material received from Approved manufacturing site
Bulk material received from Approved manufacturing site
Bulk drums cleaned with IPA solution after unloading
Trained manpower deployed for Bulk drum cleaning with IPA

Bulk drum is cleaned again with IPA solution before issuing to Suction
Bulk drum inspection is in place at Suction room
Trained manpower deployed for Bulk drum cleaning with IPA

Bulk drum is cleaned again with IPA solution before issuing to Suction
RM warehouse unloading bay is fully protected with fine mesh for
preventing the entry of dust
House keeping checklist is in placing for ensuring the hygiene condition in
RM warehouse.
Air Curtains and PVC strips are in place
RM warehouse unloading bay is fully protected with fine mesh for

preventing the entry of pests and dust
Air Curtains and PVC strips are in place
Incoming inspection of bulk drums for damage.
All the drums are received in closed condition with tamper evidence seal.
Follow Stacking norms & maintain FIFO, Adequate labeling w r t to
identification & clearance status in place in use
House keeping checklist is in placing for ensuring the hygiene condition in
RM warehouse.
Pest Control programme is in place for the entire site.
Drum movement done by trained manpower in trolley

Bulk drum inspection is in placebefore suction
Trained man power deployed & Only full approved Bulk drums issued for
Suction
Dedicated Rejected drum storage area is in place with lock & key
arrangement
Trained man power deployed for Drum cleaning with IPA solution
Bulk drum inspection is in place before Suction
Trained man power deployed for Drum cleaning with IPA solution
Bulk drums are cleaned twice with IPA before transferring to Suction room
Drum movement done by trained manpower in trolley

Bulk drum inspection is in placebefore suction

Bulk powder inspected for foreign matter before suction by trained
manpower
Bulk powder received from Approved manufacturing site
Vibro sieve (10*10 & 6*6) is in place
Bulk powder inspected for foreign matter before suction by trained

manpower
Bulk powder received from Approved manufacturing site
Vibro sieve (10*10 & 6*6) is in place
Integrated Pest Management is in place
Fully approved Bulk material taken for Suction

Past trends are ok
Routines at entry (Cap, Mask, Gloves & Apron) & Jewellery policy is in
place for persons entering the process area
Trained man power deployed for suction
Bulk powder inspected before suction for any foreign matter
Color Coding of Bulk drums is in place for Drum identification

Trained man power deployed and ALC will be verified by QC Executive
before any change overs
Suction room is maintained in controlled environment of temperature &

RH.
Monitoring of Relative humidity & Vapour pressure on hourly basis is in
place - OPRP
Monthly Air monitoring regime is in place - Trends are ok
Suction room is maintained in controlled environment of temperature &

RH.
place - OPRP
Monthly Air monitoring regime is in place - Trends are ok
Sieve integrity checked at the frequency of twice/ shift

Regular sieve integrity checking while at receipt, wet, dry cleaning & as &
when changed and
Trained personnel, Regular monitoring, Maintenance schedule as per
frequency, Area Line Clearance
PTS room is maintained in controlled environment of temperature & RH.

place - OPRP
Cleaning effectiveness checked by taking swab samples from Vibro sieve
after deep wet cleaning.
Challenge test for metal seperator is in place for every 4 hours with the
standard test piece
There is a subsequent metal detector is in place to avoid the metal
contamination
Trained QC Executives deployed for metal seperator & metal detector
monitoring
PTS room is maintained in controlled environment of temperature & RH.
place - OPRP
Cleaning effectiveness checked by taking swab samples from metal
seperator after deep wet cleaning.
Metal rejected powder discarded as waste
Magnet are sanitized with IPA solution before inspection of rejected

powder
Metal rejected powder discarded as waste
PTS/ Filling room is maintained in controlled environment of temperature

& RH.
place - OPRP
Cleaning effectiveness checked by taking swab samples from day hopper
after deep wet cleaning.
Filling room is maintained in controlled environment of temperature & RH.

place - OPRP
Cleaning effectiveness checked by taking swab samples from metal
seperator after deep wet cleaning.
Area Line Clearance is in place post cleaning and product changeovers

for checking screw feeder condition
Metal detector is in place to avoid metal contamination risk

place - OPRP
Cleaning effectiveness checked by taking swab samples after deep wet
cleaning.

for nut/ bolt/ gasket inspection

place - OPRP
Cleaning effectiveness checked by taking swab samples after deep wet
cleaning.

for checking screw feeder condition
for checking the nut/ bolt

place - OPRP
Cleaning effectiveness checked by taking swab samples from filling
machine cleaning after deep wet cleaning.
Truck inspection checklist is in place

is in place
Truck inspection checklist is in place

UV treatment of Jars in place
Micro monitoring of Jars after UV treatment done on weekly basis - Trend
is ok
Cleaning regime is in place at PM warehouse, which will be verified basis

House keeping checklist
Rejected jars are stored in dedicated crates

Trained man power deployed for Jar operation
Jar defects Visual display is in place
Trained man power deployed for jar feeding

is in place
Cleaning regime is in place for Conveyors and it is verified during Area

line clearance
Challenge test is in place for Air Blowing/ Suction Unit
All jars are passed through UV tunnel for elimintation of micro

contamination
Air is passed through 5 micron filter clother before Suction and Blowing
operation
Air monitoring is in place for Suction and Blowing unit
Cleaning regime is in place for Pre heating tunnel

It is verified during Shift handovers, Area Line Clearance and during GMP
audits.
Trained man power deployed for Empty jar inspection

Inspection persons are replaced for every 4 hours
Magnifying glass is in place for easy identification of defective jars
Truck Inspection checklist is in place
Sleeves are received in closed boxes from Approved vendor
Sleeves are checked for its condition before mounting in Sleeve cutting/
coding machine
Sleeves are stored in controlled condition after opening it from the box
Sleeves are checked for its condition before mounting in Sleeve cutting/
coding machine
All the rejected sleeves are stored in the dedicated box

Area line clearance is in place for Offline coding of rejectd sleeves
Ink is being procured from the Approved vendor

Sleeves are inspected for Coding legibility before issuing it to production
All the Sleeves are stored in closed SS boxes and then transferred to
production area
Routines at entry - Hand washing & sanitization is in places for all

personnel inside the process area
Jewellery policy and adminstrative controls are in place
UV treatment is in place for Sleeved jars


Cleaning regime is in place for Shrink tunnel

Tunnels are operating within the validated ranges and trained man power
deployed for Jar feeding to avoid jamming issues
Maintenance schedule is in place for Shrink tunnels

Sleeve cutting & segregation of jar is done in dedicated place by trained

contractual
All the torn sleeves are discarded as waste
Jars are again re-passed through Air Blowing/ Suction and Magnifying
glass inspection

All the torn sleeves are discarded as waste
Regular inspection of UV light is in place

Inspection of UV light condition at regular frequency is in place
Replacement of UV light tube as per schedule (9000 glowing hours) and
glowing hours is monitored for every shift
Adequate training personnel for monitoring as per frequency
Jars before and after UV treatment are sent for micro analysis at the
frequency of weekly once.


PPE Gloves is in place for all the persons inside Jar filling area
Trained man power deployed in Jar line
Routines at entry - Cap, Mask & Coat is in place

Trained man power
10 micron, 5 micron and 2 micron filter is in place at Compressed air inlet

line
Compressed air micro monitoring is done at the frequency of yearly once.
Challenge test of Metal detector at the frequency of hourly once with

standard test piece
Trained QC Executive carry out the Challenge test
Preventive maintenance of Metal detector is in place
All QC/ Production Executives are trained on Metal detetcor handling

procedure
Metal detector rejected jars are stored in the dedicated box
Trained QC Executive handles & repass the MD rejected jars
Metal detector rejected powder discarded as waste
Magnet are sanitized with IPA solution before inspection of rejected

powder
Metal detector rejected powder discarded as waste
Nut & Bolt checklist is in place on shift basis

All the Nuts/ Bolts are fixed & can be removed by mechanic tool only
Jar lip cleaner is cleaned & sanitized at regular freqency
Caps are issued to Packing after inspection through magnifying glass

Cleaning regime is in place in Jar filling area, which is verifed basis
House keeping checklist
Trained personnel deployed for Capping
Training is in place
PPE Gloves is in place for all the persons inside Jar filling area
Brush condition is inspeced on daily basis
Cleaning is in place for brush at defined frequency
Jar is passing through the Brush after capping.
Trained man power is in place
Challenge test for “No wad rejection Mechanism” at the frequency of

every 30 mins

every 30 mins
Trained personnel
Trained personnel

every 30 mins
Visual inspection of Seal integrity by QC Inspector and QC Executive -
20% Online inspection
Preventive maintenace of Induction Sealer
Adequate & Trainned personnel for Induction Seal Inspection

ISM setting parameters are checked at the frequency of hourly once.

every 30 mins
Visual inspection of Seal integrity by QC Inspector and QC Executive -
20% Online inspection
Preventive maintenace of Induction Sealer
ISM setting parameters are checked at the frequency of hourly once.
Trainned personnel deployed for rework activity
Clean Sanitized tool used for opening of jars

Bulk powder from Burnt jar discarded as waste

Bulk powder from Burnt jar discarded as waste
Powder retrieved discarded as scrap
Carton procured from approved vendor & Inspection is in place post

receipt
Traineed personnel
20% Online inspection is in place
Trainned personnel deployed for stacking activity
Trainned personnel deployed for Online QC inspection

Final Random check at FG warehouse is in place before release
FG is stored in plastic pallets with proper stacking pattern

Final Random check at FG warehouse is in place before release
CONTROL MEASURE SEL
Step and Hazard
Transfer hazards considered as significant in the hazard assessment in WS 4 to this

worksheet (WS 5).
M#,L# or
Step Hazard
P#
Bulk Material - Horlicks, Chocolate

M1 Foreign Body - Metal
Horlicks & Boost
L4 Bulk Powder Inpsection Foreign Body - Metal
Vibro Sieve (Horlicks - 10*10 & Boost -

P4 Foreign matter
6*6)
L5, L6 & Bulk Powder Suction, Powder Transfer

P7 System & Rotary Filling
P5 Metal Seperator Foreign Body - Metal
P25 Metal Detector Foreign Body - Metal
Foreign matter/ Pest &

P33 Empty Wad Sensor Microbiological contamination
(Solidification)

P35 Induction Sealing Microbiological contamination
(Solidification)
CONTROL MEASURE SELECTION and CATEGORIZATION
Control Measures Categorization of control measures in OPRPs and CCPs.
Select and describe a control measure or combination of control

measures capable of preventing, eliminating or reducing the Q1: Based on the likelihood of occurrence and the severity of adverse health effe
hazard to an acceptable level. YES: This is a significant hazard. Go to Q2. NO: This is not a significant hazard.
Q2: Will subsequent steps alone or in combination guarantee the remova

YES: This step is a PRP or an OPRP. NO: Go to Q3.
Document the rationale for the selection, e.g. effectiveness of Q3: Are control measures or practices in place at this step and do
applied control measures alone or in combination against necessary? YES: Go to Q4. NO: Modify the process or the produ
identified hazard (refer to documents if possible)
Q4:Is it necessary to establish critical limits for the contro
YES: Go to Q5. NO: This hazard is managed by an OPR
Q5: Is it necessary to monitor the control measur
a loss of control?
YES: This hazard is managed by control measure
CCP / OPRP /
Description of control measures Q1 Q2 Q3 Q4 Q5
MOD
Bulk Powder Inspection Yes Yes
Bulk drum inspection for metal piece/ foreign matter Yes Yes
Monitoring of Sieve Intactness Yes No Yes Yes No OPRP
HVAC Monitoring
Monitoring of Relative Humidity, Vapour pressure and Dry Yes No Yes Yes No OPRP
Bulb temperature.
Metal Seperator installed after Vibratory sieve Yes Yes OPRP
Two Metal detectors are installed in 2 Jar filling line Yes No Yes Yes Yes CCP
Empty wad sensors are put in place to reject the Cap

Yes No Yes Yes Yes CCP
without Induction Sealing Wad
20% Online inspection of Jars for Induction Seal integrity Yes No Yes Yes Yes CCP
ATION
of control measures in OPRPs and CCPs. Answer questions Q1 to Q5 as necessary.
and the severity of adverse health effects, is this hazard significant ? (see hazard assessment table)
2. NO: This is not a significant hazard.
or in combination guarantee the removal of this significant hazard, or its reduction to an acceptable level?
RP. NO: Go to Q3.
or practices in place at this step and do they exclude, reduce or maintain this significant hazard as
4. NO: Modify the process or the product and go to Q1.
to establish critical limits for the control measure at this step?
O: This hazard is managed by an OPRP.
ecessary to monitor the control measure in such a way that action can be taken immediately when there is
ontrol?
hazard is managed by control measures at a CCP. NO: This hazard is managed by an OPRP.
Justification for decision
Metal Seperator & Metal Detector is in place for avoiding the metal risk
Metal Seperator & Metal Detector is in place for avoiding the metal risk
Vibratory sieve is checked on shift basis for Sieve intactness and it is free from any damages
Hourly monitoring of Relative Humidity, Vapour pressure and Dry Bulb temperature at
Suction, Powder Transfer section and Filling room is in place
Though, there is a subsequent control measure (Metal detector) is in place, this metal
seperator is categorized as OPRP, as it avoids the metal contamination in main product
stream and acts as the first line of defense for metal control.
Metal Seperator is monitored at the frequency of twice per shift with the standard test piece
of Fe - 1.6mm, Non Fe - 2.5mm & SS - 3.175mm
Challge test for metal detectors with Std test piece is in place
Fe - 1mm Non Fe - 1.5mm & SS - 1.5mm
Challenge test is in place for "No Wad Rejection Mechanism" on Houry basis
20% Packed jars are checked for Induction Seal Integrity by Quality Inspectors for avoiding
the Seal leakage and Micro leakage in jars
CCP N°
M #, L# or
OPRP N° Step Hazard description
P#
Vibro Sieve
OPRP 1 P4 (Horlicks - 10*10 & Foreign matter
Boost - 6*6)
Bulk Powder Suction,

Powder Transfer Microbiological
L5, L6 &
OPRP 2 System & Rotary contamination
P7
Filling -
HVAC Monitoring
OPRP 3 P5 Metal Seperator Foreign Body - Metal

CCP 1 P25 Metal Detector Foreign Body - Metal

Microbiological
CCP 2A P33 Empty Wad Sensor
contamination
(Solidification)

Microbiological
CCP 2B P35 Induction Sealing contamination
(Solidification)
HACCP PLAN INCLUDING OPRPs & CCP's
Monitoring
Critical Limits /
Targets
(or Limits if applicable) How Frequency
Sieve should be intact, free from any kind

Visual Once per shift
of damage and Sieve Size
. Dry/ Wet Bulb thermometer fixed

in the room is checked for Dry
Bulb & wet bulb temperature
Maximum RH%- 55% , Dry Bulb
.
temperature - 81°F , Vapour Pressure -
The reading is compared with Once per hour
Max 15 mm/Hg
chart to know the status of RH &
dry bulb temperature
.
Corresponding VP to be recorded
Critical Limit: Passing of Std test piece ( 1.6mm

Ferrous test piece - 1.6mm ferous, 2.5mmNon Ferrous and
Non Ferrous test piece - 2.5mm SS 3.175mm) through AMS as Every 4 hours
Stainless Steel 304 test piece - 3.175mm per Metal seperator Challenge
test procedure
Critical Limit: Passing of Std test piece (1mm
Ferrous test piece - 1mm ferous, 1.5mmNon Ferrous and
Non Ferrous test piece - 1.5mm SS 1.5mm) through Metal Once in a Hour
Stainless Steel 304 test piece - 1.5mm Detector as per Metal detector
Challenge test procedure
100% rejection of jar capped with “No Caps with no wad are passed Every 30
Wad” during challenge test through Empty wad sensor minutes
Sealing condition of 20% Packed 20% Packed

100% Sealing RFT for 20% Packed stock
stock are physically inspected Stock
NCLUDING OPRPs & CCP's
g
Corrections/
Corrective actions
Who Responsibilities
Correction:
1) Operation to be suspended immediately
2) Sieve to be replaced with good one.
3) All the packed product and powder in Day/ Machine hopper to be kept under
hold till last successful check.
4) Perform risk analysis and basis outcomes of the risk evaluation & in
agreement with Factory & GSK management release / exceptional release /
reject the product.
QA Executive
Responsibility:
Shift QA Executive / Shift Manager /Production & QA Manager
Corrective Actions:
1) Deviation to be raised & Investigation/ Root Cause Analysis to be done -
HACCP Team Leader
Correction:
1) Operation to be suspended immediately
2) Sieve to be replaced with good one if chocked
3) All the packed product and powder in PTS/ Day/ Machine hopper to be kept
under hold till last successful check.
reject the product.
5) Wait for RH to come under control & Process to be restarted after getting
QA Executive clearance for QA
Responsibility:
Corrective Actions:
HACCP Team Leader
Correction:
1) Operation to be suspended immediately and metal separator to be rectified
and rechallenged before commencement of the line operation.
2) Segregate the non confirming product & Quarantine entire stock till last
succesful check
QA Executive reject the product.
Responsibility:
Corrective Actions:
HACCP Team Leader
Correction:
1) Operation to be suspended immediately and metal detector to be rectified and
rechallenged before commencement of the line operation.
2)
Segregate the non confirming product & Quarantine entire stock till last
succesful check
QA Executive
reject the product.
Responsibility:
Corrective Actions:
HACCP Team Leader
Correction:
1) Operation to be suspended immediately and Empty Wad Sensor to be
rectified and rechallenged before commencement of the line operation.
2) Segregate the non confirming product & Quarantine entire stock till
last succesful check
QA Executive reject the product.
Responsibility:
Corrective Actions:
HACCP Team Leader
Correction & Corrective Action:

1) All the cartons packed till last successful check to be kept under hold
2) Induction Sealing machine to be rectified and rechallenged before
commencement of the line operation.
3) All cartons to be rechecked for Seal integrity
Responsibility - Shift QA Executive / Shift Manager /Production & QA Manager
4) The issue to be escalated to Engg and QA heads for the investigation and
QA Inspector/ QA
corrective actions.
Executive
5) If induction sealer is not working, packing to be stopped till it is repaired. After
repair initial 50 jars to be checked for seal integrity, if all are found to be sealed
then allow for packing. If any defect is observed stop the line till it is corrected.
Records Verification
Monthly OPRP
ACPL/SOP/PR/023/FM/002
Verification sheet
Monthly OPRP
Verification sheet
Monthly OPRP
Verification sheet
Monthly OPRP
Verification sheet
Monthly CCP
Verification sheet
Monthly CCP
Verification sheet
VERIFICATION PLAN
Purpose of the Verification activity
CCP N°
OPRP N°
OPRP 1
Vibro Sieve Monthly OPRP Verification
(Horlicks - 10*10 & Boost - 6*6)
OPRP 2
HVAC Monitoring of Bulk Powder
Monthly OPRP Verification
Suction, Powder Transfer System &
Rotary Filling
OPRP 3
Monthly OPRP Verification
Metal Seperator
CCP 1
Monthly CCP Verification
Metal Detector
CCP 2A - Empty Wad Sensor
Monthly CCP Verification

CCP 2B - 20% Induction Seal
inspec
VERIFICATION PLAN
Verification procedure & Record Frequency Responsible
(e.g. methods or procedures to use, observations to be (How often is the task to be (Who is responsible for
made or measurements to be taken, actions if there is a performed ?) the task ?)
deviation or follow-up)
Monthly FSMS team
Monthly FSMS team
Monthly FSMS team
Monthly FSMS team
Monthly FSMS team

LIST OF SUPPORTING DOCUMENTS
N° Document number Description: Title, Date of issue
NTS
Author / Company / Organisation
VALIDATION OF CONTROL ME
CCP N° Significant Hazard ?

OPRP N° (Why do you consider this as a significant
Hazardous agent hazard ?)
OPRP 1 Foreign Body like metal/plastic/ wood etc

Vibro Sieve Foreign matter above 10*10 & 6*6 mesh which can come
(Horlicks - 10*10 & Boost - 6*6) through supplier can become the source of
Potential significant Hazard.
Variation of HVAC Relative Humidity &

OPRP 2 Temperature will lead to Microbilological
HVAC Monitoring of Bulk Microbiological contamination in Finished product and
Powder Suction, Powder contamination Solidification issues
Transfer System & Rotary Filling
Metal contamination in Finished product will

OPRP 3
Foreign Body - Metal lead to Serious health issues to the end
Metal Seperator
consumer
Metal contamination in Finished product will

CCP 1
Foreign Body - Metal lead to Serious health issues to the end
Metal Detector
consumer
CCP 2A - Empty Wad Sensor

Foreign matter/ Pest & Jars with torn/ burnt indiction seal and
Microbiological induction seal missing will lead to
contamination microbiological contamination and FM
CCP 2B - 20% Induction Seal
(Solidification) issues.
inspec
TION OF CONTROL MEASURES
Control measure Validation Document

(Is the control measure effective
?)
Yes
(Vibro sieve rejection are
monitored on regular basis)
Yes
(HVAC RH, Temperature &
Vapour pressure are
monitored on hourly basis)
Yes
(Metal Seperator rejections
are monitored on shift basis)
Yes
(Metal Detector rejections
are monitored on shift basis)
Yes
(No Wad rejection
mechanism challenge test &
20% inspection for ISM
defects is in place)
Corrections
(Does the correction in case of deviation function
properly ?)
Yes
(Replace the Damaged Sieve and repass the hold
product)
Yes
(All the packed product and powder in PTS/ Day/
Machine hopper to be kept under hold till last
successful check.
Wait for RH to come under control & Process to be
restarted after getting clearance for QA)
Yes
(Metal separator to be rectified and rechallenged
before commencement of the line operation.
Segregate the
non confirming product & Quarantine entire stock till
last succesful check)
Yes
(Metal detector to be rectified and rechallenged
before commencement of the line operation.
Segregate the
non confirming product & Quarantine entire stock till
last succesful check
Yes
(All the cartons packed till last successful check to be
kept under hold
Induction Sealing machine/ Empty wad sensor to be
rectified and rechallenged before commencement of
the line operation)
MODIFICATION(s) AND FOLLOW-UP
Step Hazard Modification
descriptio Modifi- cation
Type
n N°
N° Description Recommended modification and confirmation Limit date
and H#
W-UP
Provisional Control Measure(s)
Immediate measures to be applied while

modifications are not yet implemented.
MEETING ACTIVITY LOG
Outcome
Date Partcipants Purpose Responsibility
(decisions/actions)
Performed

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OVERVIEW & GUIDE FOR THE HACCP WORKSHEETS

Worksheet No Worksheet Name

WS 4 Hazard Identification and Description

Control Measure Selection and

HACCP Plan including OPRP's &

WS 8 List of Supporting Documents

WS 9 Validation of Control measure

WS 10 Modification and Follow up

WS 11 Meeting Activity Log

Registration and approval of the study

Product and process description, including

Simplified process flow diagram with OPRP

Each potential hazard is listed and

Using the decision tree, the control

List and overview of all identified CCPs and

Overview of verification activities that show

Recording and filing of supporting

Evidence that the control measure can

Document the changes related to HACCP

Recording meetings, attendance and

New HACCP study Brand

Scheduled review √ Product Name

Unscheduled review Product Code

Study started Apr'17 QMS Reference

Scheduled or unscheduled review: Main changes and reasons

G Balakrishnan HACCP Team memer/ Flow Diagram Verification/ Packing Expert

HACCP Team member/ Flow Diagram Verification/ Inputs on

TS.Ravikumar HACCP Team member/ Warehouse Operations

Raja HACCP Team member/ HR Induction & Training

Authorisation for new HACCP study or update to new version

Avalon Cosmetics (P) Limited

Horlicks/ Boost & Its Variants

Std Horlicks 200g, Std Horlicks 500g, Std

eived from Primary Manufacturing sites (Nabha, JIL &

SO & Codex requirements.

QA/ Avalon Cosmetics Pvt Limited

QA/ Avalon Cosmetics Pvt Limited

Production/ Avalon Cosmetics Pvt Limited

Engineering/ Avalon Cosmetics Pvt

Stores/ Avalon Cosmetics Pvt Limited

HR/ Avalon Cosmetics Pvt Limited

Type (e.g. raw, cooked, ready-to-eat)

Key physical and chemical characteristics (e.g.

Key processing steps (e.g. drying, heat

All Raw materials / Ingredients

High risk ingredient(s) (e.g. microbial risks,

Packaging materials in contact with food

Rework (Wet/ Dry)

Other (e.g preservatives, processing aids,

Specifications and Regulatory requirements (food safety-related)

Product-specific regulatory requirements

Packaging description (e.g. size)

Packaging system (e.g. modified atmosphere)

Claims and Label Information

Instruction for use by consumers (incl. use or

Statements for safe use (e.g. special instr. for

Shelf life conditions

Target group of users and special consumer

Reasonably expected mishandling and misuse

Std Horlicks, Chocolate Horlicks and Boost

Powder Transfer, Metal seperation, Filling and Induction Sealing.

Std Horlicks & Chocolate Horlicks:

Std Horlicks , Chocolate Horlicks and Boost Bulk material