EMMP

EMMP MANUAL Doc Name -
DG/CQG/QFS/FSSC/002
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EMMP MANUAL
IN COMPLIANCE WITH IS0 22000:2018
GUIDANCE DOCUMENT: ENVIRONMENTAL
MONITORING (Additional requirement-October 2022)
ADDRESS:
HO
Maruthi Infotech Center No 11/1, 12/1 Tower B, 1st Floor,
Amarjyothi Layout, Intermediate Ring Road, Domlur,
Bengaluru Karnataka - 560071
EMMP MANUAL INDEX
Created By Verified By Approved By

Lab Technologist FSTL/CFSTL Director QA
DG/CQG/QFS/FSSC/002
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Sr.No DOCUMENT Page No.

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1 PURPOSE
2 INTRODUCTION
3 RISK ASSESSMENT & ZONING - Links
4 SAMPLING PLAN
5 AIR MONITORING SOP
6 SWAB ANALYSIS SOP - TPC
- YEAST & MOULD
- S.AUREUS
- ENTEROBACTERIACEAE
- E.COLI
- SALMONELLA
- LISTERIA
7 WATER & ICE TESTING SOP
8 SPECIFICATION
9 TRIGGER LIMIT IDENTIFICATION
10 CORRECTIVE ACTION FOR FAILURE - AIR
11 - SWAB
- WATER
12 VALIDATION SOP
13 RECORD KEEPING & TREND ANALYSIS
14 MEDIA CODES
*ESCALATED CLEANING
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S.NO MASTER COPY ISSUE

NUMBE
R
1 PC-FSTL & CFSTL 01
DISTRIBUTION LIST OF CONTROLLED COPY
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DEPARTMENT NUMBE
R
1 MANAGEMENT HEAD 02
2 LAB TECHNOLOGISTS 03
3 PRODUCTION MANAGER 04
4 MAINTENANCE MANAGER 05
5 HOUSEKEEPING HEAD 06
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As Per FSSC Additional Requiement 2.5.7

PURPOSE: Implementation of environmental microbiological monitoring in food safety
management systems.

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INTRODUCTION: An environmental monitoring program oversees the effectiveness of the overall

hygienic practices in facilities and provides the necessary information to prevent possible
microbial contamination
of food products. It also identifies potential risks in open product areas that can lead to the
production of non-conforming products, customer or consumer complaints, or even an incident.
Environment Monitoring Program Includes:

 Air Monitoring
 Swab Analysis
 Water Ice Testing
Swab Zoning
Zone 1: Direct Food Contact Surface
Zone 2: Non Food Contact Surface
Zone 3: Remote Non Food Contact Surface that are within Processing Range which could
potentially contaminate Zone 1 o Zone 2.
Zone 4: Remote Non Food Contact Surface outside of Processing Range
Air Zoning
High Risk: Processing Area where Ready to Eat products are processed
Medium Risk: Processing Area where Ready to Cook & Fresh Cut products are processed
Low Risk: Areas outside Processing Area
Water& Ice (As per IS 10500 (2012))

E.coli: Absent
Coliform: Absent
Risk Analysis for Zone Classification:
Bangalore Environment RA :
Mumbai Environment RA :

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NCR Environment RA :
Hyderabad Environment RA :
Sampling Plan:
Program Risk Zone Frequency Sampling Point Parameters

Air High Risk Weekly During Processing TPC & Yeast and Mould
Monitorin Medium Monthly During Processing TPC & Yeast and Mould
g Risk
Low Risk Quarterly During Processing TPC & Yeast and Mould
Swab Zone 1 Weekly 4 hours Post Sanitization TPC, Yeast & Mould, E.coli,
Analysis (RTE Zone) Coliform, S.aureus, Salmonella &
Listeria spp
Zone 1 Fortnightly 4 hours Post Sanitization TPC, Yeast & Mould, E.coli,
(Remainin Coliform, S.aureus, Salmonella &
g) Listeria spp
Zone 2 Monthly 4 hours Post Sanitization TPC, Yeast & Mould, E.coli,
Coliform, S.aureus, Salmonella &
Listeria spp
Zone 3 Bimonthly 4 hours Post Sanitization Salmonella, Listeria spp & E.coli
Zone 4 Quarterly 4 hours Post Sanitization Salmonella, Listeria spp & E.coli
Hand 3 Post Hand washing and TPC, Coliform & S.aureus
samples sanitization
/section in
month
Water & All Areas Monthly During Processing E.coli & Coliform
Ice Once
Air Monitoring SOP
Method Name: Sedimentation (Settle Plate Method)

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Media : St. Plate Count Agar petriplate

St. Rose Bengal Chloramphenicol Agar petriplate or Chloramphenicol Yeast Glucose Agar
Sampling Procedure :
1. Take solidified sterile agar plates 1 PCA & 1 RBA to testing area in sample box.
2. Label area name and date on petri plate.
3. Place the plates at least 1 meter above the floor and approximately 1 meter from the walls or
any other major obstacles.
4. Open lid of the plate carefully and allow direct exposure for 15mins. Particles and
microorganisms will settle onto surfaces.
5. Post 15 mins place back the lid and Incubate PCA at 37°C for 48 hrs and RBA at 25°C for 5-8
days.
Result Interpretation:
1. Viable particles will grow, Enumerate colonies and record counts in cfu/15min exposure
2. Compare with specs and trigger limit.
3. Follow Sampling plan and maintain trend analysis (Pg No: )
4. In case of failure, Proceed with Corrective action mentioned (Pg No: )
Swab Analysis SOP
Method Name: Surface Swabbing

Material Required: St. Cotton Swab

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St. 5X5 cm stencil Optional

Media : 10ml St 0.85% Nacl tube
Equipment required : Vortex
Sampling Procedure : Surfaces

1. Wet sterile cotton swab in st peptone water tube by dipping.
2. Drain excess peptone water by pushing swab on inside of tube.
3. Swab 5 x 5 cm of surface using st square template using slow and firm wipe motions in interior
direction ensuring palm distance from surface.
4. Rotate the swab against the direction of the overall wiping movement. Then stroke the area in
the same direction three times, turning the swab slightly between strokes.
5. Finally roll the swab once over the wiped area, but in the opposite direction from that in which
the original strokes were made. This will serve to pick up whatever may be adhering to the
surface.
4. Place the swab immediately in tube and plug it properly.
5. Label the tube with surface name and date
6. Vortex the tube thoroughly, Use this solution for further analysis
Sampling Procedure : Hand

1. Wet sterile cotton swab in st peptone water tube by dipping.
2. Drain excess peptone water by pushing swab on inside of tube.
3. Swab from the worker’s hand shall be drawn from different parts of hand and
4. Aseptically transported immediately in tube and plug it properly.
5. Label the tube with name of worker and date
6. Vortex the tube thoroughly, Use this solution for further analysis
A) Enumeration of Total Plate count

Media : St. Molten Plate Count Agar

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St. 0.85% Nacl

Testing Procedure :
1. Create dilution using serial dilution method using 9 ml st 0.85% Nacl – 10
2. Take 1000 µL from desired dilution in sterile empty petriplate.
3. Perform pour plate using molten st Plate Count Agar
4. Allow to set. Incubate plates in inverted position at 37°C for 48 hrs
1. Enumerate all colonies
2. Apply formula : No. Of colonies x Volume of sterile Nacl x Dilution Factor
Area of swabbing surface (lxb) cm²
3. Compare with spec and trigger limit
B) Enumeration of Yeast & Mould

Media : St. Rose Bengal Chloramphenicol Agar / Chloramphenicol Yeast Glucose Agar
St. 0.85% Nacl
Testing Procedure :
1. Create dilution using serial dilution method using 9 ml st 0.85% Nacl – 10
2. Take 1000 µL from desired dilution in sterile empty petriplate.
3. Perform pour plate using molten st Rose Bengal Agar/Chloramphenicol Yeast Glucose Agar
4. Allow to set. Incubate plates in inverted position at 25°C for 5- 8 days
C) Detection of S.aureus
Media : St. Baird Parker Agar

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Testing Procedure :
1. Take 100 µL from undiluted tube
2. Perform Spread plate using sterile solidified Baird Parker Agar Medium having egg yolk emulsion
using sterile spreader.
3. Incubate plates in Inverted position at 37°C for 48 hrs.
4. Positive Observation: Black colonies with white margin surrounded by halo zone.
1. Absent/Present in cfu/cm
2. In case of failure, Proceed with Corrective action mentioned (Pg No: )
D) Detection of Enterobacteriaceae
Media : St. Violet Red Bile Glucose Agar
Testing Procedure :
1. Take 1000 µL from undiluted tube in sterile empty petriplate.
2. Perform pour plate using molten st Violet Red Bile Glucose Agar
3. Allow to set. Incubate plates in inverted position at 37°C for 24 hrs
E) Detection of E.coli

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F) Detection of Salmonella
G) Detection of Listeria
Water Testing SOP
Method Name: Membrane Filtration

Apparatus:-
1. Membrane filtration assembly units
2. Autoclave
3. Laminar Air Flow cabinet
4. Incubators

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5. Membrane Filter Paper Nylon pore size 0.45µm

6. Sterile measuring flask - 100ml
Glassware:-
1.Sterile petriplates
2.Sterile reagent screw cap bottle
Membrane filtration
Apparatus
Media & Chemicals:-
1. Sterile Distilled water
2. HiChrome Chromogenic Coliform Agar
Miscellaneous:-
1. Aluminium foil
2. Forceps
3. Spirit
Procedure:-
A) Assembly of Filtration unit
1) Wrap each part of filtration unit and other miscellaneous requirements with
aluminum paper
2) Autoclave to sterilize at 121°C at 15psi for 30mins
3) Clean working surface of LAF with spirit and sterilize by UV light
4) Take sterilized Filtration unit parts to LAF cabinet for set up
5) Assemble collection flask (Bottom) & Filter base (Middle). Connect Vacuum pump
(Do not switch on)
6) Place sterile filter paper on filter base with sterile forcep
7) Place top funnel part (Upper) on top of membrane filter by adjusting it properly

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8) Fix the parts using sterile locker clip or clamp provided with apparatus
9) All this steps should be done aseptically inside LAF cabinet
10) Set up is complete for sample analysis
B) Water sampling
1) Use sterile screw cap bottle for water collection of atleast 1 litre capacity
2) Clean the tip of tap/faucet using spirit
3) Run the water for 1min
4) Rinse the bottle twice with sample water
5) Fill the bottle as full as possible. Half filled bottled leaves room for oxygen which can
promote degradation of sample water
6) Screw cap it tightly
7) The sample should be tested as promptly as possible after collection.
8) If there is a delay in the examination of the sample, it should be stored at a
temperature between 0 and 10°C not more than 4hrs.
Ice sampling
1) A minimum of 1 Kg. of ice used for processing shall be collected aseptically in a
sterile stainless steel container or St. Screw cap bottle and transported to the
laboratory.
2) If there is considerable delay from the time from drawal of samples and actual
analysis the samples shall be kept in cool condition.
3) Ice to be allowed to melt before proceeding for analysis
C) Sample processing-Filtration
1) Mix the sample by inverting its container several times.
2) Pour desired volume of sample into the filter funnel aseptically. Lid the Top to avoid air
entry from top.
3) Whenever high microbial load suspected, dilutions to be done using sterile distilled
water.
4) Turn on vacuum pump to draw the sample through the filter; once all sample is filtered
out through membrane filter, disconnect the vacuum.
5) Dismantle the filtration apparatus and remove the membrane filter using the sterile

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forceps, taking care to touch only the edge of the filter.

D) Detection
E.coli & Coliform :-
1) Transfer the sample processed filter paper on to sterile solidified HiChrome
Chromogenic Coliform Agar Medium, without inverting filter paper keeping filter side
facing upward, make sure no air is trapped between media and filter paper.
2) Cover the plates with lid and label with sample name. Incubate plates at 36°C for 21-
24hrs
Positive Observation:
E.coli : Dark blue to violet colonies
Coliforms: Pale pink to pink and blue to violet colonies
1. Absent/Present in cfu/100ml
2. In case of failure, Proceed with Corrective action mentioned

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Specification
Program Risk Zone Parameters Specification Trigger Limit (80% of spec)
Air High Risk Total Plate <50 cfu/15mins exposure <40 cfu/15mins exposure
Monitoring Count <10 cfu/15mins exposure <8 cfu/15mins exposure
Yeast and Mould
Medium Total Plate <100 cfu/15mins exposure <80 cfu/15mins exposure
Risk Count <20 cfu/15mins exposure <16 cfu/15mins exposure
Yeast and Mould
Low Risk Total Plate <300 cfu/15mins exposure <240 cfu/15mins exposure
Count <50 cfu/15mins exposure <40 cfu/15mins exposure
Yeast and Mould
Swab Zone 1 Total Plate <10000 cfu/25 cm2 <8000 cfu/25 cm2
Analysis Count <100 cfu/25 cm2 <80 cfu/25 cm2
Yeast & Mould <10 cfu/25 cm2 <8 cfu/25 cm2
E.coli <10 cfu/25 cm2 <8 cfu/25 cm2
Coliform Absent/25 cm2 Present/25 cm2
S.aureus Absent/25 cm2 Present/25 cm2
Salmonella Absent/25 cm2 Present/25 cm2
Listeria spp
Zone 2 Total Plate <100000 cfu/25 cm2 <80000 cfu/25 cm2
Count <500 cfu/25 cm2 <400 cfu/25 cm2
Yeast & Mould <50 cfu/25 cm2 <40 cfu/25 cm2
E.coli <50 cfu/25 cm2 <40 cfu/25 cm2
S.aureus Absent/25 cm2 Present/25 cm2
Salmonella Absent/25 cm2 Present/25 cm2
Listeria spp
Zone 3 Salmonella Absent/25 cm2 Present/25 cm2
Listeria spp Absent/25 cm2 Present/25 cm2
E.coli Absent/25 cm2 Present/25 cm2
Zone 4 Salmonella Absent/25 cm2 Present/25 cm2
Listeria spp Absent/25 cm2 Present/25 cm2
E.coli Absent/25 cm2 Present/25 cm2
Hand Total Plate <50 cfu/25 cm2 <40 cfu/25 cm2
Count Absent/25 cm2 Present/25 cm2

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S.aureus
Water & All Areas E.coli Absent/100ml Present/100ml
Ice once month Coliform Absent/100ml Present/100ml
Corrective Action For Failure
In case of hygiene indicators failure of any environmental sample, the matter shall be immediately
reported to the QAM/FSTL and EMMP Team and escalated cleaning to be initiated. In case of
pathogen detection restrict traffic flow from that area & the recall procedures shall be initiated by
the establishment, product processed in that time frame to be destroyed. RCA should be done by
EMMP Team to identify source of contamination and immediate Corrective Action to be
implemented to prevent cross-contamination and spreading of the microorganism.
All possibilities of Cross contamination like recent maintenance activities, Construction work in
and around production area, roof leak, drain backup, flooding, equipment repair and installation
plant trials and visitors visit to be considered while doing RCA.
Air Monitoring Failure: After taking appropriate corrective action like Fumigation and escalated
deep cleaning, Next 7 consecutive days retesting in in- house lab shall be carried out to monitor
CAPA effectiveness. One can also verify the effectiveness of the corrective actions by sending
sample to External Lab.
Swab Analysis Failure: After taking appropriate corrective action like Foaming and escalated deep
cleaning, Next 7 consecutive days retesting in in- house lab shall be carried out to monitor CAPA
effectiveness. One can also verify the effectiveness of the corrective actions by sending sample to
External Lab.
Hand Swab Failure: After taking appropriate corrective action like Training, Next 5 consecutive
days retesting in in- house lab shall be carried out to monitor CAPA effectiveness. One can also
verify the effectiveness of the corrective actions by sending sample to External Lab.
Water/Ice testing Failure: After taking the corrective action, Next 7 consecutive days retesting in
in- house lab shall be carried out to monitor CAPA effectiveness. One can also verify the
effectiveness of the corrective actions by sending sample to External Lab.

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Cleaning and sanitation procedures & frequency to be reevaluated and modified in case of repeated
failure (Major deficiencies)
Validation SOP

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Record Keeping & Trend Analysis

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Media Codes
Sr. Media/Reagent Hi-Media Product

No Code
1 Rose Bengal Chloramphenicol Agar M640
2 Plate Count Agar M091A
3 Sodium Chloride MB023
4 Sterile Cotton Swab PW003
5 Baird Parker Agar Medium MU043
6 Egg Yolk Tellurite Emulsion (50ml / 100 ml per vial) FD045L
7 L Spreader
PALL Membrane Filter Paper Nylon 6, 6 0.45µm NX047100

diameter: 47MM
HiChrome Chromogenic Coliform Agar M1991I


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EMMP MANUAL Doc Name -

EMMP MANUAL INDEX

Created By Verified By Approved By

Sr.No DOCUMENT Page No.

Created By Verified By Approved By

DISTRIBUTION LIST OF MASTER COPY

Created By Verified By Approved By

S.NO MASTER COPY ISSUE

1 PC-FSTL & CFSTL 01

DISTRIBUTION LIST OF CONTROLLED COPY

S.NO DISTRUBUTION TO THE COPY

Sl. No Type of change Reason for change Date

As Per FSSC Additional Requiement 2.5.7

Created By Verified By Approved By

INTRODUCTION: An environmental monitoring program oversees the effectiveness of the overall

Environment Monitoring Program Includes:

Water& Ice (As per IS 10500 (2012))

Created By Verified By Approved By

Program Risk Zone Frequency Sampling Point Parameters

Air Monitoring SOP

Method Name: Sedimentation (Settle Plate Method)

Created By Verified By Approved By

Media : St. Plate Count Agar petriplate

Swab Analysis SOP

Method Name: Surface Swabbing

Created By Verified By Approved By

St. 5X5 cm stencil Optional

Equipment required : Vortex

Sampling Procedure : Surfaces

Sampling Procedure : Hand

A) Enumeration of Total Plate count

Created By Verified By Approved By

St. 0.85% Nacl

B) Enumeration of Yeast & Mould

Created By Verified By Approved By

Created By Verified By Approved By

Water Testing SOP

Method Name: Membrane Filtration

Created By Verified By Approved By

5. Membrane Filter Paper Nylon pore size 0.45µm

Created By Verified By Approved By

Created By Verified By Approved By

forceps, taking care to touch only the edge of the filter.

Created By Verified By Approved By

Created By Verified By Approved By

Coliform Absent/25 cm2 Present/25 cm2

Created By Verified By Approved By

Created By Verified By Approved By

Record Keeping & Trend Analysis

Created By Verified By Approved By

Sr. Media/Reagent Hi-Media Product

PALL Membrane Filter Paper Nylon 6, 6 0.45µm NX047100

Created By Verified By Approved By

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