MFFL

Preventive Control (Spp) Documentation Doc No.

Effective no:
Form G - COA Verification
Review Date:

Line Number and Product Countline, Moro Plain

Each lot of sensitive ingredients will be pre-tested and found to contain no detectable target pathogens of concern
Preventive Control Identification (Salmonella) prior to use. Pre testing can include supplier test results in the form of a certificate of analysis (COA).
Result shall be generated by a External laboratory that has been approved by MDLZ or by MDLZ Internal Labs.

Indicate CCP or Spp CCP- COA

Sensitive Ingredients Addition to process post lethal step.

1 SMP
2 Coca mass
3 Hyfoama
4 SMP
Process Step
5 Whey Premediate
5 Full Cream Milk powder
6 Egg Albumin
7 SF11HU Cocoa
8 Alkalize coca powder
Hazzard Biological: Vegetative Pathogen- Salmonella

Each lot of sensitive ingredients must have a supplier COA certifying ingredients negative for Salmonella 10*25 grams
Critical Limit(s) for CCP Control or MDLZ generated test result the indicate material are negative for Salmonella 10*25 grams
measures/Limits for OPRP
Note: Target pathogens(s) and the sample size to be tested are defined in the respective ingredients specification. Any
deviation must be approved by a MDLZ Corporate.

Monitoring Activity & Frequency

1. Responsibility WHO Plant Microbiologist/Quality executive

1. Receipt and verification of result on COA from Mondelez approved laboratory, or Mondelez internal lab generated
test results for each lot received.
2. Verification that product remains on Category III hold until test results from Mondelez approved laboratory is
2. Activity WHAT
received
3. Verify that testing was performed at the required sampling size and approved method as per Mondelez meridian
specification

3.Location Where Quality/Micro Lab

4.Frequency When Each lot of sensitive ingredients delivery.
 1. If with each lot of sensitive ingredient, the external lab report is received, the batch # mentioned in the external lab
report is verified with the batch numbers received with the accompanying CoA by QAO.
2. On confirmation of the same, the external lab reports are shared with the Microbiologist for approval and release.
3. In case the test method or results is not from a Mondelez approved lab or the sample size /method is not as per the
specification, then the samples are drawn for External Laboratory / Mondelez Lab testing and released based on the
results, material should be kept on cat III hold until results are available.
Note :The internal laboratory should use approved method based on meridian or as per the Mondelez global
5.Method How
microbiology manual
4. The same is performed for quarterly CoA verification and first 10 deliveries for new suppliers.
6. If the COA does not accompany the delivery & the material cannot be kept on hold, it can be issued for Production
provided the finished goods is kept on Category III hold & only released on receipt of COA of the butter and post FG
clearance.
7.Incase of RM/PM come from Mondelez HUB plant the material will be accepted on receiving the COA from
Mondelez HUB Lab.

1. If the COA or test results are not received for each lot, that lot of sensitive ingredient will remain on Category III
hold until COA (stating material negative for pathogens) is received.

2. Hold/release documentation is required.

3. If the COA result is positive for target pathogen-Salmonella , reject that lot of material upon receipt, isolate the lot
& placed it in Category I Hold until it is dispose and notify MFFL Quality and Corporate Quality of Mondelez.

4.If Mondelez generated test result is positive for target pathogen-Salmonella ,isolate the lot & placed it in Category I
Corrective Action Hold until it is disposed and notify the MFFL Quality and Corporate Quality of Mondelez.

5. Hold/Release documentation is required.

6. Corrective action must be documented

Corrective action: Microbiologist and Quality Manager shall be overall responsible for appropriate corrective actions
as per HACCP plan.
+E93
Disposition of Product: MFFL QA Manager shall be responsible for the disposition of products, in consultation with
Corporate Quality of Mondelez

1. COA Records or Mondelez generated Test Records/MFFL generated Test Records- Quality Lab
Record & Location 2. Incident Report - Quality Lab
3. Hold and release Record - Quality Lab
Verification testing for first 10 consecutive lot in case of sensitive ingredient new to Mdlz International, new suppliers,
existing suppliers producing in new plant or new line.
Sensitive ingredient verification every quarter for supplier who provides approved external lab test results.
Minimum Preventive Control
Verification Activities
Physical verification of pathogen test result of each lot for Mondelez approved external lab , received for sensitive
ingredient added with no or post kill process step- Microbiologist
Annually compliance verification of all existing products produced on the site as part of HACCP Verification process

Reference the HACCP Model

Name
If CCP or sPP Model does not sPP 01- CoA
exist, cite scientific basis for
Critical Limit, Control Measures
or Limits.
 MFFL
Preventive Control (Spp) Documentation Doc No.
Effective no:
Form G - Caramel cooking
Review Date:
Caramel cooking vessel in caramel making process- CM-17
Line Number and Product
Moroplain

Preventive Control
Caramel cooking temperature >113
Identification

Indicate CCP or Spp sPP

Process Step Cooking E-milk premix in caramel cooling pan , Step CM.17 in HACCP

Biological Hazard:
Hazzard
Vegetative pathogens: Salmonella spp. are the target organisms associated with incoming sensitive raw materials.

Product is heated at a temperature not less than 113 °C.

Critical Limit(s) for CCP Control
measures/Limits for OPRP
Critical limit: Temperature >/=105 °C.

Monitoring Activity &

Frequency
1. Responsibility WHO Cooking Operator

The established caramel making tank temperature profiles at the plant is >/= 113°C to form a sealable product.
After the temperature reaches >113C on the display unit, then the steam valve will be cut-off.
The temperature is manually recorded from the temperature display unit (this is from temperature probe inside the
cooker).
2. Activity WHAT
The divert valve is manually opened and then manually check the temperature of the caramel coming out through a
calibrated thermometer and ensure it is greater than 113C .
If ok, then discharge valve will be opened.
Then record the both temperature from cooker display and also from manual thermometer at exit.

3.Location Where Caramel Cooking Area

4.Frequency When Every batch : after reaching 113C

1. Syrup transfer from portable tank to caramel cooker.

2. Maintain set-point of cooker caramel above >113°C in Caramel making Cooker.
3. Cooking of caramel by steam.
5.Method How
4. Recording and documenting cooked caramel temperature every batch. First reading is from cooker temperature
screen which shows temperature of inside the cooker and second from reading is from the discharge using external
calibrated thermometer
 CONDITION 1
1. During line start up, till the temperature of the product does not reach >113°C, the material is continuously stirred
inside the cooker till the temperature is achieved.
2. Valve will open only after both probes reads > 113°C
3. If the temperature does not reach >113C in spite of reheating, the line will not start and the material will be drained.
Cooker will be cleaned and sanitized.
4. Identify and correct Root cause and then restart the line.

CONDITION 2
Corrective Action 1. During operation, if the temperature of the product falls below 105°C, keep the material on cooker till 15 mts max to
identify the root cause.
If problem is resolved within 15 mins. then reheat the material. In case issue is not resolved within 15 mts, then entire
batch inside the cooker will be drained off inside white colour drums.
2. Inform Quality and Production executive for initiating root cause analysis and establishing corrective action.
3. Line is stopped and entire loop is cleaned and sanitized
4. Bypassed material will be scrapped

Condition 3
If internal probe of caramel cooker fails, then external thermometer will be used for verification in case there is product
inside the cooker.
After preparation of the batch, the caramel cooking will be stopped till the rectification of internal probe
1 Time and Temperature Record :- Production office
2. Corrective Action Record :- Production office
Record & Location 3. Verification Record :- Production office
4. Calibration Records of Temp Probes - Maintenance office
5. Designated Location of Each Record -Utility Room & Production office

1. Designated shift Production Operator will document and signs processing records every shift.
2. SPP record shall be reviewed & verified by Production Executive/Quality assurance officer on shift basis
2. Temperature probe used to monitor critical control parameters shall be calibrated at a frequency of minimum every
Minimum Preventive Control 6 months. Control action as per Mondelez EMQR 7.6-01 Calibration R03.
Verification Activities 3. During verification if the verifier identify that the corrective action was not taken in case of deviation . Implicated
Material/Finished goods should be kept on Cat 1 Hold .In case the hold cannot be performed the same needs to be
informed to QA Manager for further actions.

Reference the HACCP Model

Name
If CCP or sPP Model does not Caramel Cooking (Heat Processing Internal Product Temperature)
exist, cite scientific basis for
Critical Limit, Control Measures
or Limits.
 MFFL
Preventive Control (Spp) Documentation Doc No.
Effective no:
Form G - Allergen Labelling
Review Date:

Line Number and Product Countline and Moroplain

Preventive Control Identification Product Allergen(Global ,Regional) and Labelling declaration

Indicate CCP or Spp sPP- Labelling

Visual check of
1. Correct packaging material receipt at incoming goods receipt and appropriate linkage to local plant identification
system (according EMQR Traceability) for each lot .
Process step
2. A proper label application to ensure correct allergen declaration; Upon use of the packaging material- the material
number (lot number or equivalent) to be documented in a way that enables traceability (EMQR).

Hazard Improper label leading to undeclared or incorrectly declared allergen(s)

Critical Limit(s) for CCP Control 1) Each lot of packaging material allergen labelling should be in alignment with E2 of site approved HACCP plan
measures/Limits for OPRP 2) Correct allergen information on the label for product being produced

Monitoring Activity & Frequency

1) Receiving of new art work Epson hard copy / soft copy (during NPD,artwork change ,packaging material change) :
Mondelez team (PCM, Procurement)
1. Responsibility WHO 2) Checking against current E1 / E2 and approvals : Mondelez Team R&D, Regulatory.
3) Checking of each lot of primary packaging material against approved artwork : RM PM Executive
4) Material Receipt Note (MRN) & Stock Transfer Note (STN) : Production shift executive

1) Checking new artwork Epson Hard / soft copy against current E1 / E2 and approvals
2. Activity WHAT 2) Checking of each lot of primary packaging material against approved artwork
3) Filling product and laminate details in MRN & STN documents

1. Approval of artworks on email - Mondelēz team laptop (emails)

3.Location Where 2. Verification of artwork with approved artwork - Mitchelle's Quality Lab
3) MRN & STN : Production office/RMPM Store

1. Verification of new artwork - With each change of primary packaging material

4.Frequency When 2. Verification of laminates against approved artwork : each lot
3 . MRN & STN : for every shift (when laminate is issue form store)

1) Visual check of the Allergen declaration with the standard artwork during receipt and documentation of the same
5.Method How 2) Visual check of each lot of laminate against approved artwork
3) Visual check of correct laminate usage through MRN and STN
 Condition 1 : If the allergen labelling on the epson proof issued by central artwork management is found to be having
mismatch with current approved E2
1) The artwork epson print should be signed off as disapproved by the hub plant, R&D & Regulatory Inform the
Central artwork management team and the Category quality manager on the mismatch in labelling. Sr.Specialist
Supply chain Quality will do further action.

Condition 2 : During verification of each lot of Laminate, if it is found that the allergen labelling is incorrect
1) If during checks of the material against the standard approved artwork shows discrepancy- block the material on
Cat II according to EMQR Hold and Release Notify Quality Manager & EM Quality Manager / Sr.Specialist Supply chain
Quality for doing further action.

Condition 3 : During verification of MRN, if it is found that the wrong laminate is issued:
1) If during checks of the material against the MRN discrepancy is observed, Production executive shall return the
wrongly issued laminate back to Warehouse and reissue new one with documentation of the same.

Corrective Action

Condition 4 : During verification of STN, if it is found that the wrong laminate is used for the run
1) If deviation is noticed in the laminate used during STN, Production executive shall inform Quality Assurance Officer
& Quality manager
2) Place all affected material of the entire run on Cat II Hold and conduct investigation to check all FG produced
3) If investigation reveals affected product is confirmed to have incorrect laminate used, place product on Category I
hold and inform site EM Quality manager/Sr.specialist SC Quality for further actions.
4) Stop line till clearance of wrong laminate from packing machine and restart the line with correct laminate. Site will
continue with investigation of the incident.
5) Initiate a traceability to find from when the wrong laminate was used for manufacturing of the product.
6) Physical verification of all the suspected implicated lots and hold and release should be initiated for the confirmed
lot.
7) In case the finished good is send to external warehouses.Immidiate information should be provided for holding the
material at warehouse.
8)Hold/Release documentation is required. Corrective action must be documented. Hold /Release record shall be
filled with corrective action plan.
9)Mitchelle's Quality Team along with collaboration of Mdlz Quality team will submit the investigation report to mdlz
procurement, PPL, ISC & further actions (disposition) or necessary escalation will be proceed
Note :- If any known change in allergen labelling , shall be documented through change control format
All Hold and Release of packing material is done by Quality Assurance Officer

MRN / STN : Production floor/RMPM store

Record & Location Artwork approval on emails - location emails

incoming verification quality PM Report - Mitchelle's lab
Hold and Release Records: Mitchell's Quality Lab

Corrective Action Records : Mitchell's Quality lab & Emails conversation

Annual HACCP verification of correct allergen labelling information versus E1 / E2 form for all existing products on
Minimum Preventive Control site: HACCP Coordinator
Verification Activities Annual verification of Line Allergen spec Report information is update (during process audit/ HACCP verification):
HACCP Team

Reference the HACCP Model

Name

If CCP or sPP Model does not CCP-Allergen Labelling

exist, cite scientific basis for
Critical Limit, Control Measures
or Limits.
 MFFL
Preventive Control (Spp) Documentation Doc No.

Effective no:
Form G - sPP Water
Review Date:

Countline and Moroplain

Line Number and Product

Preventive Control
ssP Water testing
Identification

Indicate CCP or Spp Process water testing sPP

Process Step Surface water treatment with chlorination and water monitoring

Biological Hazard -Salmonella ,E.coli

Hazzard

All the incoming treated water used in processing area direct and indirect water should be chlorinated & Incoming
water pH should be between 6.5 - 8.5 pH.

Sample
Test methodology Acceptance criteria
specification

25ml Visual turbidity Clear , <1NTU

Sample size Test methodology Acceptance criteria

Limits Free chlorine min 0.1ppm or max 5 ppm

25ml Chlorine strips

Biological parameters

Direct less than 500/ml,Indirect less than

APC/TVC 120ml As per approved NPEM manual
1000/ml

Coliform 120ml As per approved NPEM manual <1 per 100ml

Parameter/ Location Frequency Location

Incoming water pH Daily As per approved water testing plan

Turbidity by visual
Monitoring Activity & Daily
Turbidity meter (if any abnormality As per approved water testing plan
Frequency whenever abnormality arise
found in visual check)

Chlorine Daily As per approved water testing plan

Microbiological parameter As per approved NPEM manual As per approved NPEM manual
 The facility shall document corrective actions when out of standard results are reported. If results continue to exceed
specified criteria on consecutive sampling, an action plan must be developed and agreed with Corporate Microbiology
and sanitation, and shall include the following:
For Out of Specification of PH
Note: In case pH of incoming water is less than 6.5 & more than 8.5 contact MDLZ Site quality and microbiology for
further actions & stop the production
Note2:In case of out of specification impact on the water already used needs to be evaluated.
For out of standard of turbidity
1) inspect & Clean the filters
2) Check Cleanliness of storage tanks. (In case additional suspended solids)
For Out of Standard Free Chlorine Results:
1) Resample and retest for free chlorine at specified test locations. Verify that testing methodology is correct.
2) If free chlorine levels of <0.1 ppm or mg/l continue, or levels exceed 5 ppm, correct dosing at own source; i.e. check
Corrective Action Activity internal water chlorination system [level, retention time, indicator probes etc.].
3) Further Action plans (if chlorine levels cannot be corrected) for out of range chlorine must be agreed with Regional
Food safety and sanitation.
For Out of Standard microbiology results
1) Trace water lines to establish potential contamination sources (inlets, filters, dead ends, recent plumbing changes
etc.)
2) Check re-circulated water systems, change water if necessary, disinfect as applicable.
3) The implicated test locations shall be retested to verify the effectiveness of the corrective actions taken. Results
must be in-standard prior to returning to routine testing schedules.
4) If in the case the source of contamination is found to be from the incoming water. Escalate the same to supplier and
further action to be taken post discussion with Plant quality ,Corporate Sanitation and Microbiology.

Record & Location Water Inspection record- Microbiology lab

Microbiology Testing water as per approved site water testing plan.

Minimum SPP Verification
Annual water testing as per WHO standards

Activity Frequency Responsibility

Testing water from all water

points inside production as per As per approved NPEM manual Microbiologist - MFFL
approved site water testing plan.
Minimum Preventive Control
Verification Activities External water testing in case of
As per water testing result Quality Manager - MFFL
high turbidity by visual inspection

NPEM results verification from lab Upon receipt of each report Microbiologist - MFFL

Reference the HACCP Model

Name

If CCP or sPP Model does not 1)Mondelez International EMQR 6.3-01-01

exist, cite scientific basis for 2) Incoming water risk assessment
Critical Limit, Control Measures
or Limits.
 MFFL
Preventive Control (Spp) Documentation Doc No.
Effective no:
Form G - sPP Allergen Quality Clean
Review Date:

Line Number and Product Moro Line - Caramel layer chocolate coated product

Preventive Control
Minimizing Allergen Carry-Over in Cross-Contact Labelled Product (CCL)
Identification

Indicate CCP or Spp sPP

All stages in the process flow associated with the manufacture of finished product requiring a cross-contact label for
Process Step allergen(s)
Change Over cleaning of Morro line after Jubilee with inclusions

Chemical
Hazzard
Allergen carry-over above established indicative levels due to an ineffective quality clean

Correct application of the approved quality change over process resulting in allergen Carry-Over below established
Critical Limit(s) for CCP Control indicative levels for products labelled with CCL
measures/Limits for OPRP
No visible product residue on the surface of the processing/packaging equipment.

Monitoring Activity &

Frequency
1. Responsibility WHO Production Operator to clean & Production supervisor, PE, QAO for Verification

• Application of the agreed change over program

2. Activity WHAT • Visual inspection of equipment
• Review product sequencing or volume of flushing records

3.Location Where • All lines, associated equipment and food contact surfaces associated with the changeover of Countline

4.Frequency When Every changeover from Jubilee inclusion (almond or peanut) to Moro Plain

As per validated quality clean protocol defined by Sanitation procedure, shall include :
5.Method How • Visible inspection
• Quantity of flushing material / product sequencing

Condition 01:
If during the inspection allergen containing product residue is visible or if the review indicates non-compliance with
the Equipment Cleaning Process, re-clean the equipment surfaces to remove the residue prior to running the non-
allergen (or different allergen) containing product.
Condition 02:
• If records review indicate that potentially allergen containing visible product residue was not removed or the
Corrective Action
equipment clean was not completed prior to start-up with non allergen containing product or a product with a
different allergen profile, place all of the affected product (packed, unpacked, associated rework) on Category 1 hold
and notify EM Quality Manager to determine way forward for disposition.
Condition 03:
• If during tear down inspection indicates that potentially allergen containing visible product residue was not
removed notify EM Quality Manager to determine next steps.

1. Weekly sanitation checklist

2. Shift Pre-Start up
Record & Location
3. Pre-Operational cleaning checklist
4. Cleaning procedure of Changeover

Minimum Preventive Control

Review of records within 7 working days
Verification Activities

Reference the HACCP Model

Name
If CCP or sPP Model does not CCP equipment cleaning for Allergen Removal
exist, cite scientific basis for
Critical Limit, Control Measures
or Limits.
 MFFL
Preventive Control (Spp) Documentation Doc No.
Effective no:
Form G - Metal Detection
Review Date:

Line Number and Product Countline and Moroplain

Preventive Control
Metal detection prior to primary packaging
Identification

Indicate CCP or Spp Metal Detector CCP

Process Step Passing the enrobed bars through online metal detector after cooling tunnel and before packing at step number(BF-16)

Physical (metal) of the size, hardness and shape to pose a health hazard in finished product
Hazzard 1. Metal Detector -Metal,
(defined by the HACCP std) ->reference HACCP std. Chapter 1, topic 7.3

All product must pass through an Operating Metal detector set at its design detection limit for the product being run and capable of detecting & rejecting the below standard test
pieces:

Fe-1.0 mm Dia
Critical Limit(s) for CCP Control Non Fe- 1.5mm Dia
measures/Limits for OPRP SS- 2.0mm Dia

1 or more confirmed metal positive pieces in 4 hrs confirmed by dissolution method post repassing through an off line metal detector of equivalent or greater sensitivity

Monitoring Activity & Frequency

1. Passing of Metal cards & verificaton at every 4 hours - Line operator

2. Bin Clearance :- Quality Assurance Officer
1. Responsibility WHO Line Operator 3. Repassing through MD : Quality Assurance Officer
4. Dissolution :- Quality Officer
(Note: Site will use online MD as Offline MD, by stopping/slowing the production.)

Online MD functionality Verification

MD Functionality verification with standard test strips Fe-1.5mm, Non
Fe-2.0 mm and SS-2.5 mm ensuring 100% detection & rejection of two Diverted Product Evaluation :
passes of each of the test strips.
Functionality verification in running line shall be done with product
All diverted product shall be evaluated to confirm cause of rejection by re-passing through the metal detector
2. Activity WHAT flow. During start-up only with strips and between production with
and cause of rejection to be evaluated by dissolution of chocolate in quality lab by QA Officer as per current
strips with product and end of the production and post repair or major
SOP "HACCP / 04 / 098"
maintenance the functionality verification will be done with the
product.
(Note: In case their is no product, MD verification at start-up will be
done without the product and repeated as soon as products are
available, same shall be documented.)

Forming line Metal Detector (MD) Repassing: MD

3.Location Where 1. MD Name - TR-MD-650 1. MD Name : TR-MD-650
2. MD Name - TR-MD-650 Dissolution : As per SOP "HACCP / 04 / 098" in quality lab

Rejection bin is cleared every 4 hour (+/- 20mins) and repassed through MD (with in 1 hour from time of
At start of production
collection)

Offline MD verification (Online MD used as Offline)

Every 4 hrs through production (+/- 20 min)
Every 4hrs (+20mins.)
4.Frequency When

In case of line shut before the next MD verification, the MD will be verified with the last products of the
At end of the production
production run. the reject material should be verified in offline

After major repair or maintenance The MD will be verified

1. Clean and sanitize test strips with IPA

2. Take test strips (1.5mm, Non Fe-2.0 mm and SS-2.4 mm)
3. Pass the test strips through approx. centre of MD with product for
metal detector verification at start and end of the production and Rejected material checking
during any repair or maintenance activity. 1. Empty the online MD trolley within 4 hrs. (+/- 20mins). Place it in the dedicated container
3. Post start up, verification shall be done every 4 hrs ± 20 min. Each 2. Ensure that the online metal detector bin is empty and free of any material.
test strip shall be passed along with the product flow through approx. 3. Re-pass the units through MD twice in different orientation as far as possible. Even if one of the re-passes
centre of the MD. come as positive, the bar is rejected.
5.Method How
4. Ensure 100% detection and rejection (dump into the rejection bin) 4. Make sure the bars are not one on top of each other.
of each test piece. 5. Record the relevant data, check the rejection tray for metal positive bars, take suspected bars to analytical
5. Repeat the same for all the 3 test strips twice for all verifications. lab for dissolution.
6. Record the relevant data in MD verification record. 6. After dissolution document the confirmed number of metal positive bars & piece/s found in Offline MD
(Note: In case their is no product MD verification at start-up will be verification record "HACCP / 04 / 099"
done without the product and repeated as soon as products are 7. Maintain the record of the metal positives(write number of rejected metal positive on record)
available) 8. Cleared material will be sent for rework
 Line operator should inform the Production Shift Executive in case of any deviation for further actions as per the conditions below. Production Shift Executive along
with the Quality control officer is overall responsible for corrective actions.

Condition 1) -Failure during start up functionality verification

If the metal detector fails during start up verification and verification after repair or maintenance activity - line shall not start until the functioning of metal detector
has been restored and verification is successful., i.e. metal detector verification start up performed by using naked units which is cleared previously by metal detector

Condition 2)-Failure during 4 hr functionality verification

If the Metal Detector fails during verification at every 4 hour, the line shall be stopped. All products since the last successful verification shall be placed for category II
hold. The Metal Detector shall be repaired & confirmed by test strips before the line can start.

Condition 3) -Failure during end of production functionality verification

If the metal detector fails during end of production verification or if production does not continue to the next shift - All product since the last successful verification of
the particular MD shall be put on category II hold. Restore/repair the metal detector to functioning order and verify before restarting.

Condition 4) Confirmed metal detection greater than 1 in 4 hrs.

Corrective Action If number of confirmed metal detected bars (after Repassing & dissolution) from the rejection bin is 1 or more in 4 hrs, the line shall be stopped and place all product
as well as rework manufactured under category II hold from last successful check.

Initiate an investigation to identify the root cause to determine disposition of the product and implement corrective action accordingly before restarting the line.

Investigation concludes contamination in held product

In the investigation, if the product is determined to be contaminated with metal then the held product shall be placed on Category I hold.

The disposition of Category I hold products shall be determined by the Plant QA Manager, Factory Manager and Mondelez Quality Manager based on the outcome of
the root cause analysis and type of metal contamination in product .

If investigation reveals that the held product contamination is unlikely, retain the product on category 2 hold, based on internal assessment of the Quality team, the
product can be released by Mondelez team. In case of uncertainty, notify Mondelez Quality Manager and Regional FS for product disposition.

# Hold /Release record shall be filled, corrective action plan and product disposition shall be documented.

Note 1. In case during verification the ejection of the test strips is found to be in outside the bin for MD, then operator needs to inform shift production Executive and
Quality control officer for further actions.

Note 2 : In case during verification metal found in rejection bin rather than the product then inform Shift Production Executive and Quality control officer . All the
product shall be released and the root cause analysis should be performed to evaluate the cause of occurrence and same needs to be informed to Asst. Manager of
Quality or Plant Quality Manager.

# Hold /Release record shall be filled, corrective action plan and product disposition shall be documented.

Metal detector verification records - Production office

Hold/Release Records - MFFL quality lab
Record & Location Corrective Action Records - MFFL quality lab
Verification Records - MFFL quality lab

Online MD record verification

Minimum Preventive Control Shift wise - Shift Production executive or Line Operator
Verification Activities
During verification if the verifier identifies that the corrective action was not taken in case of deviation . material should be kept on hold as per the corrective actions mentioned
above . In case the hold cannot be performed the same needs to be informed to Quality control officer and Manager for further actions.

Reference the HACCP Model

Name

If CCP or sPP Model does not CCP-Metal Detector

exist, cite scientific basis for
Critical Limit, Control Measures
or Limits.
 MFFL
Preventive Control (CCP/Spp) Documentation
Form G
NOTE: A separate FORM G is required for EACH CCP
Purpose:
To define food safety, monitoring and corrective action requirements that are consistent with the CCP models (HAC
prerequisite models (HACCP section 4)

NOTE: A separate FORM G is required for EACH preventive Control (CCP/OPRP)

E milk holding tank is EM-13 as Haccp form B

Line Number and Product Countline, Moroplain

Preventive Control
Identification Holding time and temperature in order to prevent more than 10 multiplication of s

Indicate CCP or Spp E-milk Holding-OPRP

Process Step Emilk holding tank is EM-13 as Haccp form B
Hazzard Biological (Staphylococcus aureus enterotoxin)

Critical Limit(s) for CCP Control Each batch of E-milk holding in holding tank.
measures/Limits for OPRP Critical limit: Temperature >/=55 °C.
Monitoring Activity &
Frequency
1. Responsibility WHO Processing room operator

2. Activity WHAT

The E-milk holding temperature profiles at is >/= 55°C. Temperature monitoring is p

temperature after every hour by Caliberated thermometer.
3.Location Where E-Milk Processing Room
4.Frequency When Every hour

1. Temperature of product in the Emilk holding tank shall be monitored and recore
5.Method How checking by thermometer to ensure that the temperature is maintained ≥ 55°C . M
temperature every hour by verifying the temp profile. During the verificatoin the t
acceptable check.

2. Operator shall review the time and temperature readings and verifies CCP comp
 Condition 1:
If the temperature of Emilk falls below 55 deg C ( however greater than 51 deg c)
Reheat the batch to acheive the temperature above 55deg C by ensuring jacketed
maintenance Executive immediatelty.

Condition 2:.
If the batch is not reheated to maintain above 55 deg C
If the batch in the respective tanks fails in the process of reheating(as per condition
batch.
If the temperature of batch is above 51°C the batch can be used for production. Sto
batch and initiate root cause analysis.
The equipment such as holding tanks and lines shall be cleaned and sanitized.
Implement the corrective action accordingly. Restore / repair the process to functio
preparing the next batch.

Condition 3 :
If the batch temperature falls below 51 deg C during above condition
If the temperature is not >/= 51°C continuously and if the temp.of the batch is bet
batch shall be used within 3 hours.
Equipment such as holding tanks and lines shall be cleaned and sanitized before ta
Corrective Action investegation to identify the root cause of failure. Implement the corrective action
process to functioning order & verify before preparing the next batch.

Note:Discard the batch in case temperature further falls below 34 C during 3 hours
analysis

The equipment such as holding tanks and lines shall be cleaned and sanitized befo
an investegation to identify the root cause of failure. Implement the corrective acti
the process to functioning order & verify before preparing the next batch.

In case any other observation or deviation are noticed, MFFL Quality Manager nd M

Condition 4 :
In case the line is not continuous for 3 hours
Case 1 If there is no batch making or transfer and possibility of line hold is > 3 hrs th
and sanitized and same need to be documented.

Case 2 In case Emilk making tank is idle >3 hrs but there is continuous transfer of b
Premix making then entire system need to be clean prior to making and transfer of

Case 3 At the end of the production when Emilk batch making is stopped then line

Case 4 In case the material can not be completed, all the remaining material (which
transfer in Emilk making and Emilk holding tank shall be discarded . Fresh batch wil
sanitization of Emilk holding tanks, Emilk making tanks and lines from Emilk making
holding to premix
 Case 3 At the end of the production when Emilk batch making is stopped then line

Case 4 In case the material can not be completed, all the remaining material (which
transfer in Emilk making and Emilk holding tank shall be discarded . Fresh batch wil
sanitization of Emilk holding tanks, Emilk making tanks and lines from Emilk making
holding to premix

1. Holding Time and Temperature Record

2. Corrective Action Record
Record & Location
3. Verification Record
4. Designated location for Each Record -Utlitly Room & Production office

1. Designated shift Production Operator will document and sign processing records
Minimum Preventive Control 2. OPRP record shall be reviewed & verified by Production Executive on every shift
Verification Activities 2. Temperature probe used to monitor critical control parameters shall be calibrate
every 6 months. in case the calibration of the probe found to be out of specificatio
shall be done as per Calibration EMQR 7.6-01 Calibration R03.
3. During verification if the verifier identify that the corrective action was not take
Material/Finished goods should be kept on Cat 1 Hold .In case the hold cannot be
informed to QAO and QAM for further actions.
4.Site Production Manager is responsible for disposition of E-milk shall be documen
Reference the HACCP Model
Name
If CCP or sPP Model does not OPRP Milk holding
exist, cite scientific basis for
Critical Limit, Control Measures
or Limits.
 doc no:
Effective no:
Review Date:

stent with the CCP models (HACCP section 13) and specific

more than 10 multiplication of s. aureus.

°C. Temperature monitoring is performed by manually verifying

ometer.

k shall be monitored and recoreded continous through manually

rature is maintained ≥ 55°C . Manually monitor the
file. During the verificatoin the temp should be verified from last

readings and verifies CCP compliance

however greater than 51 deg c)
e 55deg C by ensuring jacketed temp. above 80 deg c. Conatct

eg C
ess of reheating(as per condition1), check the temperature of

can be used for production. Stop the line before taking the next

ll be cleaned and sanitized.

re / repair the process to functioning order & verify before

g above condition
d if the temp.of the batch is between >37C to 51°C, then the

cleaned and sanitized before taking the next batch. Initiate an

mplement the corrective action accordingly. Restore / repair the
ring the next batch.

falls below 34 C during 3 hours hold. Initiate the root cause

ll be cleaned and sanitized before taking the next batch. Initiate

e. Implement the corrective action accordingly. Restore /Repair
eparing the next batch.

ed, MFFL Quality Manager nd Microbiologist take action.

ossibility of line hold is > 3 hrs the Line shall be flushed, cleaned

here is continuous transfer of batch from Emilk holding tank to

prior to making and transfer of next batch.

tch making is stopped then line shall be cleaned and sanitised.

ll the remaining material (which exceeds > 3hrs ) after the batch
ll be discarded . Fresh batch will be taken after cleaning and
nks and lines from Emilk making to Emilk holding and Emilk
tch making is stopped then line shall be cleaned and sanitised.

ll the remaining material (which exceeds > 3hrs ) after the batch
ll be discarded . Fresh batch will be taken after cleaning and
nks and lines from Emilk making to Emilk holding and Emilk

m & Production office

ent and sign processing records every hour.

duction Executive on every shift basis
rol parameters shall be calibrated at a frequency of minimum
e found to be out of specification the evaluation of the product
ation R03.
e corrective action was not taken in case of deviation, implicated
old .In case the hold cannot be performed the same needs to be

ition of E-milk shall be documented