Mondelēz international Supplier quality expectations (SQE

Valentyna Kasyanova

UA based suppliers

Bob Petré

Packaging suppliers

Helena Straniec

Fruits & Raisins

Fats & Oils

Emulsifier and greasing

agents

Gum based products

and Gelatine

Milena Seyller

Chocolate

AlicjaAlchimowicz

Cocoa materials

Antonina Perovska

Flavours Food Additives

SaltChemicals (APIs)

YeastsColours

Glycerine

MarcoBosi

Egg

Flour & Cereals

Sugars & Starches

Polyols & High Intense

Sweeteners

SusanaCunquero

Cheese

Vegetables

Herb, Spices, &

Seasonings

Fish & Meat

Bakery

Hayati Kasci

TR based suppliers

Olesya Rachevskaya

RU/BY based suppliers

Larisa Pirogova

RU/BY based suppliers

SouhilaGhidouche-Porcher

Dairy

Bakery

Joanna Czaczkowska

Nuts

Seeds

Inclusions

Iga Ganczarczyk

SQPerformance

Anna Mikheeva

Cross-Category Quality Coordinator

• Introduce the 2020 MDLZ Supplier qualityexpectations manual to MEU suppliers

• Highlight the changes from the previous version

• Raise implications for suppliers & Traders

• You are in a broadcast and are anonymous to other participants

• You cannot speak but can ask questions in the Q&A box

• We will answer questions during the broadcast, If your question is not answeredduring the session, please contact us via email and we will respond to you after thesession

• You will receive the training material via email after the session

• The training presentation and the recording will be published under the Mondelēzinternational supplier portal

Supplier Quality Expectations (SQE) Manual

Processing expectations Manual

Supplier HACCP Manual

The documents are accessible in the MDLZ Supplier portal :

https://www.mondelezinternational.com/procurement.aspxFor Processing expectations not all documents are in the portal. If so, contact with your Procurement contact.

All MONDELEZ documents are confidential

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Supplier Quality Expectations Manual

1. Why a new SQE Revision/Updates?

2. What is the process?

3. What are the changes Vs. previous revision?


1. Why a new SQE Revision/Update?

➢ Current SQE revision issued in 2013

➢ Challenge the current content Vs. Internal MDLZ quality policies

➢ Incorporate learnings from specific supplier management situations

➢ Simplify, reduce where possible for certain areas

➢ Focus on other areas

2. What is the process followed ?

➢ Cross functional team review across the globe (SME, SQ, Auditing)

SQE Section Allocation

Global SQ

✓ Selection of appropriate subject matter experts (SME)

SME Section Review

Section SME

✓ Expert review against current SQE and QP changes

SQE Core Team Review

Supplier Quality, Audit, Food Safety

✓ Review of SME work and incorporate supplier learning

Approval

E2E Q leader

Dir. SC Quality

✓ Alignment on changes and feedback

Test & Learn

Selected suppliers

✓Webinar for selected suppliers for feedback on main changes

Publish

Global Audit

✓ Implementation period

✓New version in MSI in Dec 20‘

✓Reminders in March 21‘

✓ Audit (July 2021)


3. What are the main changes Vs. previous revision?

➢ 2 new sections added :

• Quality & Food Safety Culture

• Food fraud

➢ Focus areas :

• Trader management

• Allergens

• Maintenance

• CAPA and QN management

• Hold & Release

• Control of Non-conforming Product

What is changing?

CHAPTER PAGE

1 INTRODUCTION 31.1 For brokers, Distributors, Traders 32 CONFIDENTIALITY 33 MONDELĒZ INTERNATIONAL AUDIT REQUIREMENTS 43.1 Quality Performance Verification Programs 43.2 GFSI Certification 43.3 Mondelēz Global Food Safety Assessments 43.4 Audit requirements for packaging material suppliers 43.5 Audit requirements for chemical material suppliers 44 QUALITY SYSTEM CONTROLS 55 MANAGEMENT RESPONSIBILITY 55.1 Notifying Mondelēz Global of significant events 55.2 Regulatory Inspections and Contacts 55.3 Food Safety & Quality Culture 66 RESOURCE MANAGEMENT 66.1 Good Manufacturing Practices (GMP) 66.2 Personnel Training 66.3 Employee Illness and Communicable Disease 76.4 Utilities Management 76.5 Equipment Maintenance Controls 86.6 Sanitary Design: Plant Structure & Equipment Design 96.7 Sanitation Programs 96.8 Pest Management 106.9 Hygienic Zoning Programs 116.10 Pathogen Environmental Monitoring 126.11 Food Defense 136.12 Food Fraud 14

CHAPTER PAGE

7 PLANNING AND REALIZATION OF SAFE PRODUCTS 147.1 Specification Compliance and Contract Review 147.2 Incoming Materials: Supply Chain Quality Management 157.3 Incoming Materials: Inspection and Testing 157.4 HACCP 15

7.5 Allergen Management 167.6 Extraneous Matter 167.7 Net Content & Packaging (for ingredients delivered to MDLZ) 177.8 Label Control 177.9 Traceability 187.10 Warehousing and Transportation 187.11 Calibration of Measurement and Monitoring Equipment 208 MEASUREMENT, ANALYSIS AND IMPROVEMENT 218.1 Internal Audit 218.2 Testing Controls: Laboratory Requirements 218.3 Rework Control 218.4 Hold and Release & control of non-conforming products 218.5 Corrective and preventive actions 229 PACKAGING REQUIREMENTS 229.1 Introduction 229.2 Transfer of constituents from a food contact material to food 239.3 Environmental impact of packaging 249.4 Other requirements 249.5 Reference list of regulations and methods 24

APPENDIX 25Tables, Definitions, Revision Log 26

Major: Requirements have been changed and will require supplier procedure change and/or potential capital investmentMinor: Wording has changed, been simplified or further reiteration has been givenNew: New section in 2020 version

CHAPTER PAGE


CHAPTER PAGE


7.5 Allergen Management 167.6 Extraneous Matter 167.7 Net Content & Packaging (for ingredients delivered to MDLZ) 177.8 Label Control 177.9 Traceability 187.10 Warehousing and Transportation 187.11 Calibration of Measurement and Monitoring Equipment 208 MEASUREMENT, ANALYSIS AND IMPROVEMENT 218.1 Internal Audit 218.2 Testing Controls: Laboratory Requirements 218.3 Rework Control 218.4 Hold and Release & control of non-conforming products 218.5 Corrective and preventive actions 229 PACKAGING REQUIREMENTS 229.1 Introduction 229.2 Transfer of constituents from a food contact material to food 239.3 Environmental impact of packaging 249.4 Other requirements

9.5 Reference list of regulations and methods 24APPENDIX 25Tables, Definitions, Revision Log 26

New: New section in 2020 version

• No dedicated section to Foodsafety & Quality culture

• Suppliers not measured/assessedon their culture program

• The Supplier shall have a program toimprove food safety & quality culture

• The supplier should be able todemonstrate the program efficiency

• Efficiency can be measured through engagement survey or KPI’s such complaints, recognition program,etc..

• No dedicated section to FoodFraud

• The Supplier shall have a system in place tominimize the risk of procuring potentiallyadulterated raw materials

• The supplier should ensure all productsdescriptions and claims are legal, accurate andverified

• Vulnerability assessment shall be completedand documented on all raw materials toevaluate the potential risk of economicallymotivated adulteration, fraud or substitution

• Based on the vulnerability assessment results,the supplier shall have a control plan tomanage the identified risks.

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CHAPTER PAGE


7.5 Allergen Management 167.6 Extraneous Matter 167.7 Net Content & Packaging (for ingredients delivered to MDLZ) 177.8 Label Control 177.9 Traceability 187.10 Warehousing and Transportation 187.11 Calibration of Measurement and Monitoring Equipment 208 MEASUREMENT, ANALYSIS AND IMPROVEMENT 218.1 Internal Audit 218.2 Testing Controls: Laboratory Requirements 218.3 Rework Control 218.4 Hold and Release & control of non-conforming products 218.5 Corrective and preventive actions 229 PACKAGING REQUIREMENTS 229.1 Introduction 229.2 Transfer of constituents from a food contact material to food 239.3 Environmental impact of packaging 249.5 Reference list of regulations and methods 24

APPENDIX 25Tables, Definitions, Revision Log 26

Major: Requirements have been changed and will require supplier procedure change and/or potential capital investment

• Requirements defined in the SQE,however traders are not oftencompliant

• Highlights the point on traders/brokersresponsibility for making sure themanufacturer is compliant to SQE and isaware of the material specification

• Traders MUST ensure SAR is signed

• Trader shall have a procedure for approvingstorage facilities and warehouses (WH)

• Trader is responsible for storage facilitiesand WH compliance to GWP

• Basic requirements; a writtenpreventive and correctivemaintenance program shall be inplace

• There should be a process to assessequipment's criticality to food safety. Toolslike FMEA (failure mode effect analysis) canbe used.

• The assessment should drive preventivemaintenance program and frequency

• If changes are made to the plan (Task missedor rescheduled) which could affect foodsafety, appropriate risk assessmentconsidering risk to product and approval isrequired

• Maintenance hand-back process (sanitation,inspection & clearance) required aftercompletion of line intervention

• The supplier shall have a suppliermanagement program in place

• The Supplier shall haveappropriate incoming materialschecks

• For microbiologically sensitive materials forwhich a MDLZ supplier is reliant on theirsupplier’s kill step, the MDLZ supplier shallbe able to demonstrate they have checkedtheir supplier’s kill step has been validated

• The kill step should be compliant with therelevant MDLZ Processing Expectations

• The kill step validation shall be available toMDLZ on request

• The supplier shall have an allergenmanagement program that shallbe integrated into HACCP plan

• Generic allergen managementprinciples

• Focus on carry-over: suppliers must take stepsto minimize carry-over

• Whole or partial pieces of materials fromprevious run are not deemed as carry-over andare not acceptable

• Carry over levels shall be defined andestablished

• A validated and documented change-overprocedure shall be in place

• Specific requirements on what a change-overshould include (i.e. ID of each piece ofequipment, cleaning protocol, acceptable visiblestandards, sign off)

• Tankers should be clean and forpurpose

• Made of stainless steel finish orother suitable food grade material

• Cleaning certificate requirementsdefined

• Cleaning certificates should beavailable and checked before eachloading

• The supplier shall have a procedure in place for theapproval of hauliers and bulk tanker providers

• There should be a process to ensure the tanker companyis using approved cleaning facilities

• Tanker companies should comply to EFTCO requirementsor other national associations where they are present

• The supplier shall have a documented cleaning matrixconsidering parameters such as product compatibility,compositions, allergens..etc.

• Cleaning shall include coupling, detachable parts and airlines

• Cleaning certificates should detail specifically the partscleaned

• Cleaning validation, verification, and monitoringprotocols shall be in place

• Two separate sections with similarcontent

• Additional section dedicated toproduct retrieval (section 8.6)detailing product retrieval processand procedures

• Hold and release categories aredefined

• The two sections are combined and duplicationremoved

• The hold categories are for guidance and notmandatory

• The site can define the inventory checksfrequency

• The system must be effective, but the supplierhas more flexibility on how to do it

• Part previously dedicated to product retrieval isincorporated in this section

• General CAPA requirementsdetailing what should beincorporated into a CAPA system

• If it is identified through MDLZ site assessment(audit, technical visit) that non-conformancesfrom previous site assessments have not beenactioned, the supplier site approval status maybe affected

• Formalized process shall be in place for rootcause identification and appropriate CAPAimplementation for quality notifications raisedby MDLZ against supplier site(s), out of specMMP results and incidents that led to MDLZearly warning or special situation

• QNs have timelines for actions, includingacknowledgment from supplier, preliminaryinvestigation and completion of RCA & CAPA

Priority level DefinitionAcknowledgement

from supplier

Preliminary

Investigation result

(potential cause + size

of the issue) +

immediate correction

RCA + CAPA (plan

agreed with MDLZ)

1

An issue that poses a potential product safety

issue (Microbiological, chemical or physical

contaminants, allergens), regulatory impact, or

any significant quality issue leading to

business interruption.

1-2 business days

Max 4 days (business days)

From initial communication –

QN may follow

Target 10 business days, max

30 days unless otherwise

agreed with MDLZ

2

Material non-conformity to specification or

requirements with impact on process and

product (functional/ organoleptic parameters,

packaging integrity, etc.) without food safety

risk.

3 business days20 business days – RCA and

CAPA

3

Non-conformity to specification or

requirements with no impact on food-safety,

process or product (quality of palletization,

missing non-critical parameter in certificate,

delivery conditions). Minor documentation

errors.

3 business days 30 business days – RCA and

CAPA

12 – Quality Notifications (QNs)

Note: in the case of big impact on MDLZ finished product or MDLZ production lines, a daily update on progress of investigation from the supplier may be required in order to minimize the risk of business disruption

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7.5 Allergen Management 167.6 Extraneous Matter 167.7 Net Content & Packaging (for ingredients delivered to MDLZ) 177.8 Label Control 177.9 Traceability 187.10 Warehousing and Transportation 187.11 Calibration of Measurement and Monitoring Equipment 208 MEASUREMENT, ANALYSIS AND IMPROVEMENT 218.1 Internal Audit 218.2 Testing Controls: Laboratory Requirements 218.3 Rework Control 218.4 Hold and Release & control of non-conforming products 218.5 Corrective and preventive actions 229 PACKAGING REQUIREMENTS 229.1 Introduction 229.2 Transfer of constituents from a food contact material to food 239.3 Environmental impact of packaging 249.4 Other requirements

9.5 Reference list of regulations and methods 24APPENDIX 25Tables, Definitions, Revision Log 26

Minor: Wording has changed, been simplified or further reiteration has been given

• GMP requirements defined

• Specific requirements coveringmaterial groups regardless of therisk (personnel practices, hair,hands, clothing & personalequipment

• Where a GMP is not deemed asnecessary, a documented riskassessment must be in place todemonstrate this (e.g. haircoverage in completely enclosedprocess such as oil or glucose)

• No requirement on managementof Cleaning Out of Place (C-O-P)

• CIP (cleaning in place) operatingrequirements such as validation,verification and monitoringunclear and often not followed bysuppliers

• Monitoring, verification and validation ofCOP systems and semi-automated partswashers shall be in place to demonstrateeffectiveness as appropriate to product andequipment

• CIP operating requirements added

• CIP validation, verification and monitoringshall be performed and documented

• Idle time: when prolonged equipmentdowntime can lead to microbiologicalgrowth, additional sampling at start up maybe required

• Pest management programcomponents described (visitsfrequency, documentations,pesticides usage…etc. )

• The program should include an escalationprocedure with action limits defined foreach target pest

• Effective CAPA and RCA plans should beimplemented whenever pest activitybreaches the action limits for any targetedpest species (applicable for sporadic andrecurring pest activity)

• The program must be effective.Effectiveness should be assessed as part ofinternal audit plan

• Ongoing pest activity is not acceptable

• A risk assessment to identify potentialsources of cross-contaminationbetween different areas is required

• Based on the outcome of the HygienicZoning assessment, the different areas(zones) of the production facility shallbe defined and classified

• Risk assessment shall be documented

• Wording changed: “zone” replacedwith “area “

• PEM “zones” cause someconfusion with the use of “zones”in zoning

• If swabs are taken from zone 1 “productcontact surfaces”, the product made must beplaced on hold until PEM results areobtained

• In case of positive result, root cause must beestablished and documented and MDLZ mustbe notified

• Sampling guidelines enriched (samplespooling, compositing…)

• Recommendations for PEM samplestransport conditions to minimize microbialgrowth added

• Reference to GKIT (Global Kraftingredient tool) as the documentfor the supplier to complete

• GKIT replaced with a MDLZ ingredientsSupplier Questionnaire (ISQ)

• Materials/ suppliers included in the MDLZCoA Verification program, and whichrequire monthly sampling, must be placedon hold until acceptable results have beenobtained

• MMP material must be placed on hold untilresults received

• Supplier contaminants testing program maybe used to supplement or replace MDLZMMP program (upon agreement from theprogram owner)

• Incoming materials inspection and testing

• There should be a program in place tomanage incoming ingredients andpackaging

• Documented verification of deliveryvehicle prior accepting the goods

• Bulk materials in trucks or railcars: domescreened, transfer through sanitary pipesor hoses. Air filtration in place to avoidforeign matters contamination.

• Receipt and Shipping controls, Inspectionand Testing (Inbound and Outbound)

• In addition to previous requirements, thereshall be a system in place for recordingtraceability information such as batch or lotnumbers for incoming materials

• Additional requirements regarding theverification activities for Inbound/outboundvehicles (i.e. trucks or railcars)

• The supplier shall have a documentedprogram for extraneous mattercontrol

• For extraneous matter detection/ rejectiondevices (i.e. metal detectors, X-Rays..etc.)Probability of Detection (PoD) and False RejectRate (FRR) shall be included in the program

• Detection devices shall have annual calibration(minimum frequency)

• Verification with test piece: One pass acceptable• Where end point metal detectors are not

possible, a risk assessment is needed• Bulk materials shall have a filter/sieve on the

vehicle discharge line (where practically possible)

• Written internal audit program shall bein place with defined frequencies

• Employees may conduct audits, butshould only be assigned to areas inwhich they do not work

• Follow-up activities such as correctiveactions required

• Audit must be completed and closed upwithin an established time frame

• Site management shall review auditresults as part of regular meeting

• Trained competent employeesconducting audits shall have strongknowledge on the audit scope and thereshall be a process to monitor auditorcompetency

• Thorough root cause analysis in case ofrepeat findings

• Output and findings of internal auditsmust be brought to the site’s leadershipattention and used to drive food safetyculture

• The Supplier shall notify the MGreceiving location if a lot is splitbetween two or more MG locations

• For microbiological sensitive materials

steps must be taken to reasonably

practicably deliver material to MDLZ

containing only one batch/lot number and

shall not be a split lot i.e. the batch / lot

must not be delivered to more than one

MDLZ location. At a minimum each

individual pallet shall be made up of only

one batch/lot number.

• Where split lot delivery is unavoidable you

MUST inform the receiving site.

1 INTRODUCTION MG changed to MDLZ throughout the document

1.1For Brokers, Distributors and Traders

Section reworded to break out more clearly the requirements. Responsible for ensuring warehousing being used is fit for purpose and follows GWP

3.2 Global Food Safety Initiative (GFSI) Certification

Any discrepancy between MDLZ SQE audit and GFSI audit supplier could be invited to discuss with CPO

3.4 Audit Requirements for packaging material suppliers

Added additional guidelines to be in line with GFSI / ISO 9001 requirements

5.1 Notifying Mondelēz Global of significant events

Food Fraud added as a requirement, some other wording amendments

5.3 Food Safety & Quality Culture New section detailing the need for a program to improve site food safety and quality culture

6.1 GMP Risk assessment can be completed to adjust GMP requirements depending on product risk

6.3 Employee Illness and Communicable Disease

Pathogen and disease list updated

6.5Equipment Maintenance Controls

Specified maintenance plan should be based on equipment criticality to food safety. Maintenance hand-back procedure should be in place

6.7 Sanitation Programs Operating requirements listed for CIP in 6.7.2. Line idle time requirements have been added and requirements for COP

6.8 Pest Management The program must be effective

6.9 Hygienic Zoning A zoning assessment shall be completed AND documented

6.10Pathogen Environmental Monitoring

Sampling guidelines enriched and recommendations about PEM samples transport.Specified actions in case of positive result and in case swabbing from zone 1 “product contact surface”

6.12 Food Fraud New section added on food fraud requirements

7.1 Specification Compliance and Contract Review

Section 7.1 has been reworded. Timescale added for completion of SAR. Packaging added to the scope of MMP in 7.1.3

Major / Minor / New

7.2 Incoming Materials: Supply Quality Management

New requirements about validation of the process used to eliminate pathogenic organisms when this step is not performed on the supplier’s facility

7.3 Receipt and Shipping controls, Inspection and Testing (Inbound and Outbound)

Additional requirements added about verification activities and traceability

7.4 HACCP Food Safety Plan referenced in this section, validation section has been reworded with more specific detail

7.5Allergen Management

Carry-over levels should be established. Change-overs shall be clearly documented with procedures, visual standards, line acceptance, validation and verification of cleaning

7.6Extraneous Matters

More detail on false reject rates and probability of detection. Requirement to record abnormal findings on detection device. Rejection limits to be set and double pass of test piece not mandatory

7.9 Traceability Detail on split lots i.e. split lots not to be delivered to more than one MDLZ location unless unavoidable

7.10 Warehousing and Transportation New sub section on bulk tanker management and cleaning requirements

8.1 Internal Audit Output of internal audits shall be brought to the attention on site leadership

8.3 Rework Rework control requirements have been split out

8.4 Hold and Release & Control of Non-Conforming Product

Whole section has been restructured and combined with Control of Non-conforming product. The hold categories are for guide and not mandatory. The Product Retrieval section has been removed and incorporated into this section

8.5Corrective and Preventive Actions

Requirements laid out for supplier quality notifications, definitions are referenced Table 12. Root cause analysis added as a requirement

9.1 Packaging requirements Whole section has been restructured and addition of new sections.(Only for Packaging suppliers)

APPENDIX TABLES Updated

Table 1 Packaging Material Audit Matrix

Table 8 PEM Reference Sampling Plans

Table 11 List of Packaging regulations, Codes of Practices and Standards

Table 12 QN CAPA timelines expectation guidelines

Major / Minor / New

https://www.mondelezinternational.com/procurement.aspx

Will other regions be organizing this Webinar too? Yes.AMEA: 2 session already done.NALA: some session will come in near future

In which way do you notify supplier about QN? Notification to supplier is done via email generallyHow is timeline of communication monitored? Through our system - SAPWill the acknoledgement be done via email or how is it done? It should be done via email, as a response to the assigned QN, Users who raises

QN from plant sent it to suppliers through email Who is the recipient for Acknowledgement in case of QN ? The recipient shall be the Mondelez International contact that has raised the QN.Is there a definition of sensitive ingredient? Please see SQE (page 30, Table 14). You have a table of sensitive ingredients.Are you planning to continue to use the same 3rd party auditing company to perform the site audits?

Currently no change in our audit program .

Where can I find copy of GWP ? https://www.mondelezinternational.com/Procurement Do we need a GMO procedure even if we don't have a GM material for Mondelez

If your organization has GFSI certification GMO procedure is expected by them too, so ideally yes expected to have a policy which describes what process they have in place to ensure they do not have GMO

Are the H&R classification is affected by the QN levels? We as Mondelez has hold and release procedure based on Priority classification. We Expect form All suppliers that they should have also H&R procedure in place based on risk and severity .

Could you please confirm what the end point filtration for compressed air should be? Is it still the 1.3.1 for MDLZ ?

It depends on the use, please refer to section 6.4.2

Do we need to inform Mondelez when we have a positive PEM sample?

YES, same is very clearly mentioned in SQE , in Supplier portal one addendum there are an attached which give more clarity on same.

When we receive QN from MDLZ do we know what type of priority level is this?

YES this is indicated in QN report which you received from MDLZ

Will you update the HACCP manual soon? HACCP plan mentioned in Portal is for guidance & updated one .

What is the timeline expected if investment is necessary We will recommend 1st do gap analysis vs new MDLZ SQE, which section or requirements your Organization Can't meet and why . Based on gap you can define timeline upfront in your site gap assessment program and same can be talked with MDLZ SQ representative along with Procurement representative for final alignment . MDLZ auditor will Audit based on SQE and any non compliance, he /she will evaluate what gap and timelines you have defined internally or agreed with MDLZ, if any.

Is the intention to relaunch MetricStream questionnaires now that the suppliers have had this training/webinar session?

No, there is no plan through MSI now . Rational for same are below :1) We have done series of session in all regions on SQE changes 2) SQE is live on Supplier portal from Jan onwards 3) Generic email was sent to all supplier about update 4) 2 reminder was alos give though MSI already . So all these actions are enough to prove that supplier know about new SQE .

SQE 2020 supersedes 2013; what about SQE 2017? There was no offical version of 2017 launched on Supplier portal , most recent version was 2013 only & after that we launced in 2020 .( Most updated)

8.1 what is an acceptable process to monitor auditor competency?

8.1 ( Auditing) , so there should be process and procedure to certified auditor , regular calibration on there skills verification

Will the presentation be sent to the participants? Yes , it will be sent to all participants Is there attendance list for Webinar ? List of participants will not be shared with anyone; MDLZ only keep # of

participants.What are the differences between the SQE and the BRC requirements ?

SQE will have additional very specific expectation mentioned based on opportunity and risk which we have observed

Documents

Mondelēz international Supplier quality expectations (SQE