Operational Requirements
Requirements Revision: 15-Apr-2021
This document outlines the minimum obligations for manufacturing operations and distribution
facilities to ensure adherence to The Coca-Cola Company’s Quality, Food Safety, and
Regulatory Compliance Policy. The operating unit (OU) may define additional requirements
based on the risk assessment. For contract manufacturers and acquired facilities, the OU has
the responsibility to establish the timeline for full compliance to operational requirements.
Manufacturing operations include bottling partners, contract manufacturers, and Commercial
Product Supply (CPS) facilities that produce products from the Coca-Cola portfolio. Distribution
includes both company-owned and third-party warehouse facilities and transportation.
1 Comply with company and OU requirements unless local legal requirements are stricter.
1.1 Maintain records to demonstrate compliance with company, OU, and local legal
requirements.
1.2 Ensure all outsourced services performed by third-party providers are performed in
accordance with Company, OU or local regulatory requirements.
2 Comply with Human Rights and Supplier Guiding Principles (WR-RQ-150).
2.1 Ensure that bottling partner-approved suppliers comply with Human Rights and
Supplier Guiding Principles (WR-RQ-150).
3 Establish, implement, and maintain a procedure to determine, assess, and address risks
that have impacted or have the potential to make a significant impact on operations.
4 Maintain and report technical data based on Corporate QSE and OU-defined criteria.
Standard Certification
5 Company and franchise bottling partner manufacturing facilities must implement, obtain and
maintain certification to the following International standards:
• ISO 9001
• FSSC 22000
• ISO 14001
• ISO 45001 (OHSAS 18001)/NOSA
Note: FSSC 22000-Q certification is accepted as a valid alternative to achieve ISO
9001 and FSSC 22000 certification as a combined certificate.
5.1 Facilities must always demonstrate the effective implementation of each standard.
5.2 Obtain certification from an accredited third-party certification body.
5.3 Newly built facilities must have a HACCP plan and implement management systems
before the start-up of operations, until required certifications are obtained.
6 Contract manufacturing facilities must be certified to the following standards after one year
of operation:
6.1 Certification from an accredited certification body that meets the following:
• Food Safety Management System (FSMS) certification against an approved GFSI
scheme, and
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Operational Requirements
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• Quality Management System (QMS) certification against ISO9001.
Note: The additional QMS certification is not required if QMS is included in the
GFSI Food Safety management system certification through one of the
following schemes:
• BRC
• IFS
• SQF3, or
• FSSC22000-Q.
Security, Asset Protection, and Product Integrity
7 Comply with the company Information Protection Policy found in the Workplace & Security
section on KO Connect.
8 Establish a security plan to ensure the integrity of the information, personnel, incoming
goods, assets, and products.
9 Perform a risk assessment to determine the needs to protect ingredients, personnel,
incoming goods, intermediate materials, finished products and assets.
10 Implement a process to control and record access to the facility.
11 Protect the integrity of ingredients, intermediate materials, and finished products during
processing when personnel are absent.
12 Establish procedures to prevent and respond to security breaches.
13 Perform a risk assessment for the following sensitive areas to determine any additional
security needs beyond facility access:
• Water treatment • Hazardous chemical storage
• Beverage gas manufacturing area • Wells and boreholes
• Liquid and powder filling • Processing/production, mixing and
blending tanks
• Laboratories
• Label storage
• Ingredient storage
• Retention sample storage
14 Maintain a list of restricted areas and define who has access.
15 Establish procedures to manage the access of contractors and visitors to the facility.
Change Management
16 Develop and implement a change management procedure.
16.1 Ensure that the program addresses, at a minimum, internal and external system
changes:
• Internal: changes in suppliers, ingredients, packaging, equipment, processes,
cleaning and sanitation.
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Operational Requirements
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• External: changes in regulations that impact food safety, shelf-life, workplace
safety, environment, sustainability performance, product composition, labeling,
and/or claims.
16.2 Perform a validation and obtain OU approval for modifications.
16.3 Control nonconforming materials and process deviations.
16.3.1 Follow OU-defined requirements for decision-making rights and communication
needs for nonconforming materials/ingredients.
16.4 Provide training following any changes, or as needed.
16.5 Ensure the procedure includes any OU-defined protocols.
Regulatory Agencies
17 Ensure a process is in place to address situations when a regulatory agency arrives on site.
18 Ensure the information shared with any external agency complies with the company’s
applicable policies.
19 Consult with the OU to prepare an Ingredient Risk Management Program, to be shared with
regulatory agencies, that demonstrates that ingredients used to produce finished product
comply with
• regulatory limits of usage and
• maximum allowable limits for identified potential food safety risks.
Production
20 Validate and obtain OU authorization for production lines, new processes, equipment and
technology, to ensure they demonstrate the capability to achieve company specifications.
20.1 Conduct risk/readiness assessment prior to line validation.
20.2 Obtain OU approval of the readiness assessment.
20.3 Obtain OU approval of the validation(s) prior to the release of product.
21 Use company/OU-approved service suppliers.
22 Manufacturing facilities must use the following to manufacture company products:
• Company/OU-approved Master Mixing Instructions (MMI),
• Company/OU-approved primary packages and closures from authorized suppliers or
self-manufacturing facilities that meet company specifications.
22.1 Use company-approved tamper-evident closures, including unique identification or
designs provided by the OU.
22.2 Use proprietary packages for company products only.
22.3 Company/OU-approved ingredients from authorized suppliers that meet company
specifications:
22.3.1 Obtain OU approval for onsite treatment of nutritive sweetener.
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Operational Requirements
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22.3.2 Validate and obtain OU authorization for the water treatment system.
22.3.3 Ensure quality and safety when carbon dioxide is delivered or produced onsite.
22.4 Auxiliary materials and processing aids must comply with local regulations.
22.4.1 When local regulations are not available, follow the industry standards.
22.4.2 Activated carbon materials must be virgin (regenerated carbon is not
permitted).
22.5 Company/OU-approved dispensing equipment.
23 Design and implement an OU-defined sensory program.
24 Design, implement, and maintain a calibration program for control and measurement
devices for all equipment.
25 All personnel performing microbiology testing must complete the Basic level of the
Microbiology Academy at Coca Cola University, or an equivalent, validated program at the
bottling partner’s learning management system (LMS).
25.1 New personnel must complete training within one month of service.
Good Manufacturing Practices
26 Follow and ensure the effective implementation of PD ISO/TS 22002-1, Prerequisite
Programs on Food Safety.
27 Implement OU traceability and product-coding requirements.
27.1 If a line is not capable of applying legible codes to packages, stop the line and do not
proceed with production.
28 Conduct mock traceability exercises using the OU-defined frequency and protocol.
29 Clear the line prior to performing maintenance activities. Eliminate food safety risks prior to
resuming production following maintenance activities and line interruptions.
Environmental Protection and Occupational Safety
30 Follow an OU-defined approval process to ensure compliance with locally applicable
environmental protection regulations, as well as company requirements, for the following:
• Source Vulnerability Assessment (SVA)/Source Water Protection Plan (SWPP)
• Wastewater treatment system
• Combining sanitary and process wastewater
• Post-use of wastewater sludge
• Post-use of wastewater
• Shipment of hazardous materials offered directly to passenger aircrafts when there are
no viable alternatives
31 Develop and implement occupational safety and environmental protection programs to
prevent and address fatalities and serious injuries/incidents.
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32 Develop and implement a program to address contractor and visitor management, as well
as regulatory visits.
33 Develop and implement a behavior-based safety (BBS) program, as well as an ergonomic
injury prevention program.
34 Provide EOSH performance metrics as required by TCCC.
35 Follow an OU-provided purchasing plan for phasing in the use of natural refrigerants or
ultra-low Global Warming Potential (GWP) refrigerants.
Sample Retention
36 Implement OU requirements for the collection and maintenance of ingredient and finished
product retention samples.
Handling, Control, and Destruction of Trademarked Materials and
Nonconforming Products
37 Implement OU requirements for the destruction and disposal of nonconforming products,
intermediate materials, and/or obsolete trademarked materials, as well as company waste
management requirements.
38 Notify the OU and obtain approval for the transfer of
• Concentrate and beverage base.
• Finished products to another country.
38.1 Ensure adequate handling, storage and security of concentrate and finished products
between manufacturing facilities, including any OU-specific conditions.
39 Utilize ingredients, concentrate and beverage bases within their shelf lives.
39.1 When needed, submit shelf life extension (SLE) requests for ingredients, concentrate
and beverage bases to the OU within at least 6 weeks (45 days) of the item’s
expiration date. Follow the OU decision on the SLE request.
40 When concentrate, beverage base, juice, or other materials received from CPS are
damaged or past shelf life at the manufacturing facility, contact CPS and the OU for a
decision.
41 Notify the OU or CPS where applicable, and follow their protocols in the following situations:
• Nonconforming materials are used or suspected of being used in production of
products.
• Concentrate or beverage base is suspected of not conforming to company
specifications.
• Nonconforming products have been distributed to the market.
Distribution and Marketplace
42 Store, ship and display products and packages in a manner that protects quality and food
safety.
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43 Implement a process to remove products and packages that do not meet quality, food
safety, or regulatory requirements.
44 Implement an OU-approved program to monitor age and rotation of company products
during distribution and in the marketplace.
45 Implement a program to ensure immediate consumption equipment (ICE) is safe, clean,
displays a good appearance, meet company specifications, and offers products and
packages that meet quality, environmental, and food safety requirements.
45.1 Use only company/OU-approved dispensing equipment.
45.2 Implement a risk-based dispensed beverage quality monitoring program for water, ice,
and finished products as directed by the OU.
Environmental Protection and Occupational Safety
46 Implement environmental protection and occupational/fleet safety programs to prevent and
address fatalities and serious injuries/incidents in distribution locations, during
transportation, as well as in the marketplace.
46.1 Ensure that environmental protection and occupational/fleet safety programs are in
place when these activities are contracted to third-party organizations.
46.2 Ensure that distribution locations address contractor and visitor management, as well
as regulatory visits.
47 Provide environmental and occupational safety and health (EOSH) performance metrics as
required by TCCC.
Incident Management
48 Implement an OU-defined Incident Management and Crisis Resolutions (IMCR) program
that includes
• Procedures to record, track, analyze and report incidents.
o Refer to the IMCR Reporting Guidelines for guidance.
• IMCR-trained primary and secondary points of contact representing bottling partner
Technical and Supply Chain.
• A training program.
• A list of OU and Analytical Service Laboratory-authorized third-party laboratories to
include, at a minimum, analytical testing, microbiological identification, enumeration
and toxicological analysis.
• The definitions of incident classifications and reporting requirements.
o Refer to the IMCR Reporting Guidelines for guidance.
• Defined requirements for product recall, product withdrawal, and on-site serious
incident and fatality incidents.
• The reporting process from bottling partners to the OU.
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Operational Requirements
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• Defined requirements and the process for root cause analyses and corrective actions
for incidents within the scope of Technical & Supply Chain.
Consumer Engagement
49 Develop and implement a process for monitoring, analyzing data, and responding to
consumer complaints and inquiries.
49.1 Inform the OU and follow their instructions when contacted by third parties,
consumers, regulatory agencies and media.
Customer Management
50 Do not authorize customer audits of manufacturing facilities and/or distribution centers
without specific review and approval from the OU.
50.1 Notify the OU if a customer requests an audit.
50.2 Do not provide information (e.g. audit, findings, corrective action plans) to the
customer without OU and legal approval.
51 Follow the OU-defined protocol to manage customer complaints, including product recovery
actions initiated by IMCR.
McDonald’s Corporation
52 Implement an OU-approved program to meet the McDonald’s Corporation’s Global
Supplier’s Quality Management System (SQMS) and Distribution Quality Management
Process (DQMP) expectations.
52.1 Manufacturing facilities (branded and non-branded TCCC products) supplying to the
McDonald’s Supply Chain are exempted from unannounced SQMS audits by the
McDonald’s Corporation.
52.2 Ensure facilities are ISO 9001 and FSSC 22000 certified by a certification body that is
accepted by the McDonald’s Corporation.
53 Ensure Coca-Cola system-managed third-party warehouse and distribution centers meet the
requirements of the McDonald’s Distribution Quality Management Process (DQMP) or are
certified to a recognized GFSI scheme and to ISO 9001.
54 Demonstrate the ability to trace and recover/recall all products within three hours of
request/non-compliance.
54.1 Conduct mock recoveries twice a year.
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Operational Requirements
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Revision History
Revision Date Summary of Change
15-Apr-2021 Added sub-requirements to requirement 20 to align with BP-RQ-430.
Added requirement to include language for product recall, product
withdrawal and on-site serious incidents and fatalities in IMCR program to
req. 48 to align with OU-SR-010 changes.
11-Feb-2021 Added requirement to complete Basic level of the Microbiology Academy
for all microbiology practitioners.
30-Oct-2020 Added new requirement 38 and 38.1 to outline the shelf-life extension
request process of concentrate and beverage bases for bottling partners.
Updated language to requirement 48.2 to remove “certifications” and
added language to include corrective action plans and legal approval.
30-Sep-2020 Updated Incident Management requirements to align with changes made
to OU-SR-010. Also added a note regarding an alternative way to satisfy
the FSSC22000 Q certification.
31-Mar-2020 Defined which requirements apply to acquired facilities to align with
contract manufacturers in the scope of the document.
30-Aug-2019 Added requirement for certification requirements in section 6 for contract
manufacturers in document scope.
28-Jun-2019 Added requirement 1.1 to address record keeping. Added requirement #4
to support data reporting needs to OU. Added shelf life caveat to
requirement 16.1. Added shelf life, workplace safety, environment, and
sustainability as part of change management requirements to 16.1.
Added req. 16.3.1 to stress importance of aligning with OU defined
requests for nonconforming materials. Included OU defined protocols as
part of change management procedure in 16.4. Added new processes,
equipment and technology as part of requirement 20. Included closures
as part of requirement in 22.2 and removed word “primary” to include all
closures in requirement. Inserted language to use packages for intended
use as requirement 22.3. Added conditions for tamper evident closures to
22.2.1. Added 22.6 to requirement use of approved dispensing
equipment. Added requirement 23 to include sensory program
implementation at the bottling partner. Added requirement for calibration
program to #24. Added requirements 29-34 to enforce focus on safety
and environment. Added intermediate materials as part of req. 36. Added
requirement 37.1 to cover handling, storage, and security of concentrates
and finished products. Added Distribution to title along with Marketplace.
Added location specifics to req 42 for monitoring rotation and age. Req
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43.1 was added to ensure dispensing equipment in the marketplace is
OU approved. Req. 43.2 provides requirement for quality monitoring
program. Added requirements 44-45 to include safety and environment
requirements at distribution and in marketplace. Added requirement 48.1
to direct bottling partners to inform OU if contacted by third party
organizations. Added req. 50 to define how to manage customer specific
opportunities.
31-Jan-2019 Changed wording in requirement #2 to reflect updated title of the
document. Added requirement 2.1 to reflect bottling partners
responsibility for HR and SGP compliance. Added Customer
Requirements and McDonald’s Corporation requirement sections to
ensure OU and OR manuals are aligned and that bottling partners
understand what is required of them regarding customers. McDonald’s
requirements were agreed upon during the annual meeting between
TCCC and McDonald’s in 2018.
27-Aug-2018 Added NOSA as an alternative to ISO 45001 because it is recognized as
an equivalent.
12-Apr-2018 Added caveats to implement, obtain, and maintain certifications to
requirement 4. Also added requirements 4.1 and 4.2 to identify effective
implementation is required at all times and certifications are to be
obtained from an accredited third party.
01-Feb-2018 Added requirement 22 to ensure effective GMP practices. Revised
requirement 24 for easier readability.
08-Jan-2018 Published as a result of the 2017 Technical Governance review and
optimization of the Coca-Cola operational requirements. Evaluated and
reformatted the content against the lean governance model, focusing on
risk-based and fit-for-purpose requirements. Ensured language is more
Merged from the following published requirement revisions that
were in effect as of 2017: Management System, Calibration and
Maintenance of Equipment, Security, Asset Protection and Product
Integrity, Incident Management and Crisis Resolution, Control and
Destruction of Trademarked Materials and Nonconforming Products,
Risk Management, Corrective Action, Records and Retention, Customer
and Consumer Response, Roles and Responsibilities, Traceability and
Coding, Equipment and Technology Validation, Process Change
Validation, Auxiliary Materials and Processing Aids.
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