Supplier Quality and Food Safety Forum

Process Guidelines - Dairy

November 2013

Agenda Topics

• Introduction 5 min

• Key Processing Expectations for Dairy Suppliers 45 min

1. Pasteurization

2. Spray Dryers

3. Zoning requirements

4. Pathogen Environmental Monitoring

• Issues encountered at Dairy Suppliers 10 min

• Questions 30 min

Introduction

A Global Snacks Powerhouse with $36 Billion in Revenue (2)

(1) Biscuits includes salty/other snacks

(2) Based on 2011 reported net revenues; includes accounting calendar changes and 53rd Week.

Biscuits(1)

30%

Chocolate

27%

Gum &

Candy

16%

Beverages

17%

Cheese

&

Grocery

10%

Latin

America

MEA

Asia

Pacific

Europe

37%

North

America

19%

Developing

Markets

44%

CEE

• Nearly 75% of revenues in fast-growing snacks categories

Approximately $36 billion in revenue

Global snacks powerhouse

Operations in more than 80 countries

No. 1 in Biscuits, Chocolate, Candy and Powdered Beverages

No. 2 in Gum and Coffee

Approximately 100,000 employees

Donated more than one billion servings of food since 1997

Material Categories and Audit Matrix

Tier Ingredient Categories

(List is not all inclusive - refer to the Raw Material Tier Assignment list for details)

Qualification

Process

(new)

Accepted Audits &

Certifications

(ongoing)

Target

Freq.

(years)

1 RTE Meats, Cheeses, RTE Raw Fruits/Vegetables MDLZ Audit MDLZ Audit 1.5

2

RTE Nuts/Seeds/Coconut, Retorted & Aseptic Products (Low Acid

Canned Foods), Cocoa/Chocolate/Confectionary, Treated

Herbs/Spices/Seasoning; Tea & Tea Products; Egg & Egg Products;

Dairy Products & Substitutes; Yeast; Enzymes

MDLZ Audit

1Certifications or 3rd

Party SQE + Supplier

Food Safety

Assessment (frequency

determined by Food Safety

Group)

2

Fruit & Fruit Products, Vegetable & Vegetable Products, Flavoring

Ingredients (material assigned to tier 2 or 4 - refer to the Raw Material

Tier Assignment list for details)

4

4Grain & Grain Products, Emulsifiers; Prepared

Sauces/Spreads/Condiments, Coffee &Coffee Products, Bread &

Bakery Products; Sugars & Sweeteners; Starter Media/Culture; Fats

& Oils; Food Additives; 3Raw Meat & Raw Meat Products, Food

Chemicals Hydrocolloids & Gums, Wafers; Untreated

Herbs/Spices/Seasoning;

3rd Party SQE

or

1Certifications

3rd Party SQE or

1Certifications 3

5

Raw Milk & Cream, Nationally Branded Confections; Green Coffee

Beans; Compressed Gases; Raw Grains; Raw Nuts/Seeds/Coconut;

Raw earthen materials (e.g., unprocessed materials mined from the

earth); Alcoholic Substances (Spirits, Liquors)

Audits may be required as result of a

risk assessment by BU or Plant using

the material

NA

• Ready to Eat cheese : is classified as tier 1: Mondelēz International audit as a qualification process and re-audit every 18 months as a re-approval process

• Other dairy materials (dairy powders, butter, AMF) : are classified as tier 2: first approval is based on a Mondelēz International audit, then can be re-approved based on a GFSI certification every 2 years + Supplier Food Safety Assessment visit.

Supplier Food Safety Assessments

New tier 2 suppliers are audited by Mondelēz International but GFSI certification or 3rd Party audits are accepted for periodic audits

Suppliers in tier 2 are providing microbiologically sensitive material (may contain pathogens) for Mondelēz International products

Food Safety Assessment of Tier 2 existing suppliers to verify if their Food Safety programs continue to meet Mondelēz International requirements

Suppliers must manage their food safety programs to prevent / minimize food safety contamination; the Food Safety Assessments ensure that they continue to do so

Background (Why important)

Key take a way – Supplier safety assessments are done for Tier 2 existing suppliers

Key Processing Expectations for Dairy Suppliers

1. Pasteurization

1. Definition of milk pasteurization

2. Basic of pasteurization process

3. Pasteurization records

4. Verification activities

5. Managing systems with softwares

1.1. Definition of milk pasteurization: The terms "pasteurization", "pasteurized" and similar terms shall mean the process of heating every particle of milk or milk product, in properly designed and operated equipment, to a minimum specified temperature for a minimum pre-defined time.

Product Time/Temperature

Combination*

Z value (°C) Min effective temperature (°C)

Reference

Milk (Batch process) 63°C, 30mins 6.3 63 Mondelēz model CCP2 (Pasteurisation Batch dairy expectations)

Milk (Continuous process)

Various:

72°C, 15.0 seconds

6.3 72

(temperature may be driven by equipment limitations such as the length of the holding tube)

Mondelēz model CCP1 (Pasteurisation HTST/HHST )

If the fat content of the milk product is 10%, or if it contains added sweeteners, the specified temperature shall be increased by 3°C (5°F).

Z

TT

R

R

FF

10

T = temperature

F = the time required at actual applied temperature T

FR = the time required at given TR (i.e. the time/temp. stated in Model CCP)

Z

TT

R

R

FF

10

1.2. Basic pasteurization process:

P

P

TI Mix

T

R

Manometer

1. Balance tank

7. Diversion valve

To process

Flow meter

Manometer

2. Pump

3.a) plate heat exchanger

4. a)hold tube

5. Temperature indicator

6. Temperature recorder

8. Intermediate cooler 9. cooling

1. Balance tank/ Feed silo

Risks: • Control of Holding Time & Temperature (staphylococcus aureus).

• Extraneous matter (metal/metal contact) or chemical contamination from cooling fluid (e.g. glycol in jacketed tank)/ check tank design

• Siphon untreated product back along divert valve pipe

• Raw product overflow during operation (e.g. during divert)

• Equipment damage/product burning due to feed failure from tank

2. Flow controller/ pump

Risks: • Needs to be maximum calculated flow has not been exceeded

• If there is no flow meter, flow verified regularly (min 6months)

• Risk of extraneous matter/ lubricants needs to be assessed

Centrifugal pump Positive displacement pump

Screw/ mono pump

3.a) Plate heat exchangers

Risks: • Micro leaks in plates/gasket leaks- when using for heat regeneration product to product Must maintain positive pressure differential on treated product side - min 0.1bar, recommend 0.3bar, even in start-up/shut down or divert- continuous monitoring

• Maintenance: Integrity testing of plates frequency • Fouling of plates, increasing limiting factor to heat transfer efficiency • Pressure drops (due to changing viscosity of product) • Water used as the heat regeneration medium (temperature control

and water quality checks)

3.b) Tube heat exchangers

Risks: • Water used as the heat regeneration medium (good to have some control of the temperature to ensure that any contamination from leaks would not increase signifficantly)

• Tube in shell need to ensure that flow is consistent in all the tubes

3.c) Scrapped surface heat exchangers

Risks: • Maintenance and extraneous matter risks

4.a) Hold tube

Risks: • Inadequate length of holding tube or use of wrong tube if multiple tubes available for different products

• Large difference in speed between largest and smallest product particles

• Length calculation not done correctly max flow rate not used/ inadequate characterization of product flow (turbulent vs. laminar: ‘Reynolds no.’)/ theoretical calculation not documented in HACCP documentation

• Divert valve distance from hold tube must be sufficient to react to drop in temperature

4.a) Hold tube (cont.)

Processes with hold tube, kill effect is achieved on hold tube only! Data necessary to calculate the length of the holding tube: Q: flow rate of pasteurization in liters / hour HT: holding time in seconds (legal or CCP) L: length of the holding tube in dm corresponding to Q and HT D: inner diameter of the holding tube in dm V: volume of product in liters corresponding to Q and HT η: efficiency factor L = hold tube length Q= Maximum Flow Rate t= time required A = cross sectional Area of the Tube

L = Q x t / A

4.a) Hold tube (cont.)

η: efficiency factor, if no flow considerations are done then laminar flow should be used! Note: The correlation flow rate/holding time for the fastest particle must be documented and filed with the HACCP plan

Laminar flow (worst case scenario) : Velocities are maximum at center of tube. Maximum speed is 2X the average speed. Gives wide distribution of residence time. We divided the calculated holding time by 2 when we considerer a laminar flow Turbulent flow: Irregular flow. Increases heat & mass transfer efficiency and flatter velocity gradient profile. We divided the calculated holding time by 1.2 when we considerer a laminar flow

Streamline Flow Re= <2100

Turbulent Flow Re= >4000 Re= ρxQxD/ μ

ρ- density Q- max flow D- diameter μ- viscosity

4.b) Without hold tube/ Tank

Risks: • Tank continuous temperature probe not in cold spot

• Inlet piping not disconnected after batch pumpin is complete

• Splashes of raw milk above surface level and on underside of cover could contain pathogens.

• Milk foams when heated: Surface of foam may not reach critical temperature.

• Half-batches: Difficult to maintain uniform hig temperature, particularly if lid is not insulated.

• The batch pasteurizer air space above the milk and milk products shall be at a temperature not less than 3 °C (5 °F ) higher than the minimum required temperature of pasteurization during the holding period

Thermometers

-

5.a) Temperature indicator

5.b) Temperature recorder

Risks: • Accuracy needs to be checked minimum every 6months

• Reaction time of the sensor • Location of the sensor (should be in product

and not in the heating medium) • Location at the beginning of the hold tube • Accuracy verification activities not at the

right frequency or not at the relevant temperatures

• Location of the sensor in comparison with the recorder sensor could lead to discrepancies

• Accuracy needs to be checked minimum every 6months

• When wrongly adjusted, could lead to under processed product not being diverted (according to PMO must be adjusted to read -0.5C of the temperature given by the indicator sensor)

• Accuracy verification activities not at the right frequency or not at the relevant temperature range

• Location of the sensor in comparison with the indicator sensor could lead to discrepancies

• Fails to activate diversion valve

7. Flow diversion/ divert valve

Risks: MUST BE AUTOMATIC

• Must be temperature and flow operated

• If after the hold tube and before cooling, distance must be sufficient to allow acivation of the valve before under processed product reaches it

• If after the cooling any deviation must lead to CIP

• Position must be cotinuously monitored and recorded

• Maintenance of the seals of valves are crucial to avoid cross contamination risk by the under processed product

• Fail safe valves are preffered means that if valve fails flow is diverted

• Cut in/ cut out testing done to verify functionality (PMO daily) must be done on temperature and flow and not other properties on product

7. Flow diversion/ divert valve

To Production Product In

Reject/Recycle

Fail safe design valves: when valve fails flow would be rejected/ diverted

8. Intermediate cooler

Risks: • Micro leaks in plates/gasket leaks- when using for heat regeneration product to product Must maintain positive pressure differential on treated product side - min 0.1bar, recommend 0.3bar, even in start-up/shut down or divert- continuous monitoring

• Maintenance: Integrity testing of plates frequency • Water used as the heat regeneration medium (temperature control

and water quality checks)

9. Cooling

Risks: • Chemicals used can be a source of chemical contamination of the product

• Cold water used must be in water testing program

• Cooling section maintenance

1.3. Pasteurization records/ record keeping:

• Must be held for a minimum period of SL +2years • Must be reviewed and signed at least daily by someone other than the operator

What Frequency

Temperature hold tube/ cold spot tank Continuous (every sec)

Flow (if flowmeter available/ when pump not locked) Continuous (every sec)

Divert valve position Continuous (every sec)

For batch process: process time: heating/ hold/ cool Continuous

When using product to product regeneration (Pressure of products)

Continuous

When using water regeneration temperature of water (when pressure differential not available)

Frequency sufficient to demonstrate control

1.4a. Verification activities:

Temperature reading every 6 months: •Check temperature indicator for accuracy •Check temperature recorder for accuracy

Flow testing when flowmeter not used every 6 months:

•Salt test tests the flow of the fastest particle (uses salt and conductivity readings and water, need to understand to understand product characterisitics)

*New frequency of checks according to the new SQE reduced to once per year.

1.4b. Monitoring activities:

Daily Monitoring activities :

• Compare the recording and the indicating thermometer (difference not>0.5°C)

• Verify daily the pressure difference between the raw and the pasteurized side (when product to product regeneration)

• Check the functionality of the divert valve (position continuously monitored)

• Pasteurization records are signed/checked daily by operator and production supervisor or quality personnel.

1.5. Managing systems with softwares:

1. When the system is relying on a software to operate tasks critical to food safety of the product, it is critical to understand:

2. How is the program written?

3. Validation and verification activities and documentation

4. Ensure that program has the right controls in place: divert valve action that the program will actually trigger divert valve for temperature and flow

5. (when the divert valve is after cooling and software is written in order that automatic CIP is done before going to production, this functionality should be verified)

6. Limit the personnel able to make the changes to the software, control of changes to the software and ensure that a food safety knowledgeable person is informed of the changes

2. Spray Dryer

2. Spray Dryer

• This is NOT a kill step and can not replace product pasteurization.

• Although air in the chamber is blown at 150-250 °C, the milk itself is only 70 to 80 °C for a few seconds. Moreover the aw is too low for a sufficient killing effect.

• After the Spray dryer:

Fluidized beds: is the air filtered according to our requirements ?

Is air used to transport product? If so, is it filtered according to our requirements?

Is the packing area dry and clean? Is the air monitored if the product is exposed? Is pathogen environment monitoring in place?

Are there foreign body risks?

GMP

If gas is used in packaging (nitrogen/CO2 ), is it food grade?

3. Zoning

1. What is Zoning?

2. Zoning requirements

3. Different levels of Zoning

4. Zoning assessment

5. Zoning example

3.1. What Is Zoning?

• Identification and differentiation of the processing areas within the manufacturing facility where microbiological cross contamination by relevant spoilage or pathogenic organisms may occur during the receipt, storage, processing and packaging of products.

• This separation may include personnel, personnel and materials traffic, air handling, equipment, effluent, drains and waste systems, locker rooms, or other situations that could result in transfer of microorganisms.

• All facilities which manufacture or handle Mondelēz International Dairy products shall have a Zoning program.

3.2. Zoning Requirements

• A documented risk assessment shall be conducted to identify and differentiate processing areas within the facility where potential sources of pathogen and non-pathogen (spoilage) microbial contamination exist (e.g.: air, traffic, people, equipment and materials). Adequate controls shall be identified and implemented.

• The Zoning Assessment must be documented. Plant Checklist for Prevention of Microbial Cross Contamination and Hygienic Zoning Map (Form J) is required.

3.3. Production Zones are classified based on the risk of cross - contamination:

Non-manufacturing zone:

• Area where there is no product processed/packaged.

• May Includes areas such as utility rooms, offices, cafeteria, locker room, laboratory, etc.

Raw zone:

• Areas, such as raw meat/raw milk/raw agricultural receiving and storage.

• May also include refuse/recycling, restrooms (when in manufacturing area), roof access and emergency door exits to processing

• These zones may have dedicated employees and shall be physically separated from controlled zones or high control zones.

3.3. Production Zones are classified based on the risk of cross - contamination:

Controlled zone:

• Product of low to medium microbiological sensitivity can be exposed to the environment and the operators.

• The controlled zone may also serve as transition from non-manufacturing zone or high risk zone to high control zone.

High hygiene zone

• Product of high microbiological sensitivity can be exposed to the environment and/or the operators.

• Additional GMP practices, such as captive footwear/clothing, may be required and more stringent equipment/building sanitary design requirements are followed.

• When product of very high sensitivity are exposed, additional production practices, such as preventing cardboard, wooden pallets, etc. from this area may be implemented

3.4. Zoning Assessment (1/2)

- Identification of potential cross-contamination between different processing environments and/or products

- Categorization of zones at the plant

- The following control mechanisms shall be taken into consideration:

• Usage of closed systems

• Structural separation of the respective area by design (raw/RTE, wet/dry environments)

• Utilites control (air, water)

• Control of traffic patterns of people, materials/supplies flow and equipment movements, internal transports

• Use of a vestibule as entrance and exit with personnel hygiene and changing measures

• Sanitation

3.4. Zoning Assessment (2/2)

• Personnel hygiene practices of employees

• Use of designated and/or coded tools and equipment

• Filtration of the room air to protect the food against pathogens and/or spoilage organisms

• Packaging material treatment (e.g. for clean cold filling or aseptic packaging)

• Separation of effluent and water waste drains coming from zones with potentially higher contamination risk

• Consider refuse /recycling, restrooms, roof access and emergency door exits to processing that maybe a risk

Zoning Example

4. Pathogen Environmental Monitoring

1. What is PEM?

2. Target Organisms

3. PEM Sampling and Sampling Areas

4. Findings and Corrective Actions

Pathogen Environmental Monitoring (PEM)

4.1 What is PEM?

It is a program to enable the detection of pathogens, harbourage areas, and organisms that indicate potential presence of pathogens in the processing environment. 4.2 Why do we need PEM?

• To be able to verify the effectiveness of controls for preventing cross-contamination (zoning), including Sanitation, GMPs, preventive maintenance, and plant traffic controls.

• Tool to provide information to improve environmental controls for prevention potential cross-contamination.

• Use data to correct problem areas before they pose a risk to product.

• Enable detection of pathogens, and/or organisms that indicate potential presence of pathogens.

4.3. PEM for Dairy suppliers- What pathogens and indicators are in scope of the program? • Salmonella sp.

• Listeria monocytogenes

• Indicator organisms (e.g. coliforms, enterobacteriaceae and Listeria spp.)

Meet the microbes

PEM for Wet and Dry Environments

Environment: Pathogens Limits Indicators Limits

1. Dry

Salmonella Negative n/a * Assessment of Environment e.g. wet

rooms for which Coliforms may additionally be recommended

n/a

Listeria genus Negative n/a n/a

2. Wet

Salmonella negative Coliforms/ Enterobactericeae

<20ufc/ 100cm2

Listeria genus negative Listeria genus negative

PEM - Where and when shall samples be taken? • Determine a site list for plant, ensure all critical swabbing locations have been

identified

• Swabs should be taken during production and at least 3-4 hours into a run

• PEM Sample size changes for large areas

• Composite – Take individual sponges for each site to form composite sample versus using same sponge

• Raw areas not included

• Focus on cross-contamination after the kill step

Definition of the PEM sampling areas

1. Direct product contact surface areas all surfaces that are exposed to the product during normal equipment operation. Conveyors, filling equip., pipes, inside storage vessels.

2. Indirect product contact surfaces areas

means all surfaces that touch product contact surfaces during normal equipment operation. Utensils/scrapers handles/tool handles, hands, etc.

3. Non product contact areas adjacent to product areas

means all surfaces that, under normal operating procedures, do not contact the product or the product contact surfaces. Exterior of equipment, control panels/buttons, aprons, gloves, tables, etc.

4. Non product contact areas within the processing room

that are more remote from product contact surfaces. Floors, walls, drains, leg supports, wheeled items, forklifts, etc.

5. Areas remote from product contact surfaces outside the processing room Hallways, bathroom doors, cafeteria, coolers.

Example of a PEM plan for Dairy suppliers

Areas Sampling points Pathogens and Indicators Frequency at which points should be covered

1. Product contact surfaces e.g. conveyor belts, worktables, slicers

Indicators-indicators, to monitor conditions that could lead to Salmonella presence).

Weekly rotation so all points are covered once per month.

2. Indirect product contact surfaces areas adjacent to product

Includes but not limited to Handles of scrapers, dust samples collected from the floor e.g. vacuum samples

Listeria genus & Salmonella (or optional indicators to monitor conditions that could lead to Salmonella presence)

Sampling once per month

3. Non product contact areas adjacent to product

Includes but not limited to the exterior of equipment, framework, buttons, brush handles, gloves, handles of maintenance tools

Listeria genus & Salmonella (or optional indicators to monitor conditions that could lead to Salmonella presence)

Weekly rotation so all points are covered once per month.

4. Non product contact areas within the processing room remote from product contact surfaces

Hands of trucks, wheeled items, forklifts, walls, drains, floors.

Listeria genus & Salmonella (or optional indicators, to monitor conditions that could lead to Salmonella presence).

Weekly rotation so all drain, floor, wall points etc. are covered once per month.

5. Areas remote from product contact surfaces outside the processing room

e.g. hallways, elevators Listeria genus & Salmonella (or optional indicators, to monitor conditions that could lead to Salmonella presence).

Sampling once per month

4.4. What type of corrective actions have to be in place in the event of a positive pathogen finding?

• Investigate within 24 hours of reporting results and communicate finding to Mondelēz International

• Corrective action plans, including increased control procedures (e.g. sanitation) and verification requirements.

• A minimum of three consecutive negatives or in-standard results must be achieved prior to returning to the routine testing and sampling schedule.

• This must be completed within a 3-week time frame.

5. ISSUES ENCOUNTERED AT DAIRY SUPPLIERS

The purpose is to share some common

issues encountered at suppliers during food safety visits:

5.1. Pathogen Environmental Monitoring Issues

• Direct or Indirect product testing/ no hold and release procedure in place

• Do not contact Mondelēz International in the event of a positive PEM finding

• 3 negative sampling within 3 consecutive weeks not in the procedure as part of corrective actions

• Samples taken the same day every week and not rotated as required

• Relevant sampling points omitted from sampling plan Mobile equipment (e.g. forklifts, wheeled items, drains) is not included in PEM plan

• PEM procedure does not reflect that swabbing should be done 3-4 hours after production starts

• Not meeting with minimum laboratory requirements if testing on site for PEM especially testing pathogens.

• Reporting of results/ and action limits for indicators are not clearly defined or meet our specific target limits.

• Sampling frequencies are often inadequate

• Listeria spp not tested for in the environment

5.2. Zoning Issues

• Zoning map not always up to date, reflecting incorrect zoning assignment, or

new building areas not included. Risk assessment and zoning map missing.

• No separation between wet and dry environments (2 Dairy plants) e.g. between pasteurisers / spray dryers/evaporators

• Wet cleaning during dry production

5.3. Pasteurisation Issues

• Pasteurization issues

• Indicating thermometer not present

• CCP Thermometers located at start of the holding tube

• Pressure differences not monitored always

• Daily verification activities of pasteurization records not carried out.

• CIP not performed when divert was located at end of cooling section

• Divert not always checked daily as required.

• Production Flow exceeding the maximum as per documented in the theoretical calculation

• Theoretical calculation missing from the HACCP

Summary

52

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