Addendum ISO 23412: Indirect temperature-controlled refrigerated delivery services

FSSC 22000 ADDENDUMHAVI tms GLOBAL QUALITY AND SAFETYREQUIREMENTS

Version 3 | February 2024

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HAVI tms Global Quality and Safety Requirements Addendum

COPYRIGHT
Copyright © 2024, Foundation FSSC
All rights reserved. No part of this publication may be reproduced and/or published in any form,by means of printed matters, photocopy, microfilm, recording or any other method or technology,
without written approval by the Foundation FSSC.
Foundation FSSC
P.O. Box 2047
4200 BA Gorinchem, The Netherlands
Phone +31 183 645028
Website: www.fssc.com
Email: questions@fssc.com

TRANSLATIONS
Please note that in case of translations of this Addendum, the English version is the valid andbinding version.

REVISION HISTORY
Date Published

Issue

ChangesNovember 2022

1

First publication

April 2023

2

Updated Section 5.12 (Disposal of customer branded materials)
due to HAVI tms GQSR version update from V1.14 to V1.15

February 2024

3

Updated in line with Version 6 of the FSSC 22000 Scheme,
including but not limited to:
•
•
•

•

Version 3 | February 2024

Replaced HAVI with HAVI tms
Minor updates made to Section 3, 3.3, 3.9 and 4.1
Updated Section 5 and Annex A:o Removed clause 3.5, 3.5.2, 4.3; ando Updated clause 4.1, 4.2.1, 5.3.1
Added COID into Annex A

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CONTENTS
1

Purpose ...........................................................................................................................................3

2

Scope................................................................................................................................................3

3

Requirements for the Certification Process .............................................................................4

4

Requirements for Certification Bodies......................................................................................6

5

Specific Audit Requirements .......................................................................................................7

6

Definitions ................................................................................................................................... 14

7

References ................................................................................................................................... 14

Annex A: Addendum Report Template .......................................................................................... 15

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1. PURPOSE
This document describes the additional requirements for organizations certified to FSSC 22000 tomeet those specified in HAVI tms Global Quality and Safety Requirements (GQSR), as well as theprocess for Certification Bodies to follow when conducting audits to this Addendum. The HAVI tms
GQSR Addendum can only be delivered when combined with an FSSC 22000 audit against Category
I - Production of food packaging and packaging materials. It is necessary for the supplier to fully meetthe requirements of both FSSC 22000 and the specific requirements within this document.

2. SCOPE
This addendum is a mandatory document for all HAVI tms supplier partners who need to meetthe requirements of HAVI tms Global Quality and Safety Requirements.
This addendum is applicable to:
1. Suppliers manufacturing or supplying packaging and packaging materials to HAVI tms andwithin the scope of FSSC 22000.
2. Production of materials to be used further in manufacturing packaging materials.
3. Where additional processing to stored packaging materials takes place (coating,repacking).
4. Disposable plastic or paper plates and cups, aluminum foil, cling film, disposable cutlery
when sold together with the food product.
Scope exclusion – there is no exclusion allowed to HAVI tms products/processes from the scopeof certification.
In terms of exclusion of specific HAVI tms requirements, risk mitigation and justification of lack ofapplicability of particular requirements need to be documented and submitted to HAVI tms forapproval by the organization. This approval needs to be referenced in the audit report. The
organization must obtain documented evidence of the approval from HAVI tms to exclude HAVI
tms-specific requirement(s), for the requirement to be indicated as not applicable in the
Addendum report. If the evidence of the exclusion is not available, then the organization shall be
audited on the requirement, and if the organization does not meet the requirement, a nonconformity shall be raised.
The additional requirements as specified in this document are based on a GAP analysis between
FSSC 22000 and the HAVI tms Global Quality and Safety Requirements (GQSR). Meeting theadditional requirements in this Addendum, in addition to the FSSC 22000 requirements, results incompliance with HAVI tms GQSR. This Addendum must be read in conjunction with the full HAVI
tms Global Quality and Safety Requirements document in order to fully understand the context of
the Addendum.
This document also sets out the auditing and certification process requirements for FSSC 22000
licensed Certification Bodies (CBs) wanting to audit to this Addendum.

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Note: In relation to the content of this addendum, the term “Supplier Partner” and the term
“Organization” are interchangeable. Both refer to the HAVI tms supplier who is being audited.

3. REQUIREMENTS FOR THE CERTIFICATION PROCESSThis section sets out the requirements for the certification process and applies to bothorganizations and FSSC 22000 licensed CBs as relevant.
The CB shall have procedures for including the Addendum in the FSSC 22000 audit process andapply the Addendum under the same principles as FSSC 22000.
This addendum may only be delivered by certification bodies that are licensed with the Foundation
to deliver FSSC 22000 audits; no additional license with the Foundation is needed. HAVI tms
supplier partners must notify their certification body that they need to undertake this Addendum
audit going forward.
This Addendum may only be carried out together with an FSSC 22000 packaging audit with acorresponding scope and may not be delivered as a stand-alone addendum. The Supplier Partnermust notify the certification body in advance that they want to undertake this addendum, so that
additional audit duration may be determined prior to the commencement of the audit.
The scope of certification must include all HAVI tms products and production facilities. The
Supplier Partner and certification body must agree to the scope of certification prior to the audit.

3.1 CONTRACT AND APPLICATION PROCESSThe organization shall inform the CB that they wish to include the Addendum as part of their FSSC
22000 audit, prior to the start of the audit. The CB determines how much notice is required fromthe organization to request a HAVI tms Addendum to be delivered with the FSSC 22000 audit. The
CBs application system shall allow for this information to be captured, including the scope, andthe contract with the organization shall be updated to include the Addendum.

3.2 AUDIT DURATIONThe CB shall determine the additional audit duration needed to assess the Addendum
requirements based on the size and complexity of the organization.
The minimum audit duration shall not be less than 0.5 man-days (4 hours) in all cases and does
not include planning, reporting, or travel activities and only relates to effective time spent auditing
the Addendum.

3.3 ALLOCATION OF THE AUDIT TEAM
The audit to the Addendum shall be conducted by an FSSC 22000 qualified auditor for category I,
in accordance with the Scheme, Part 4, Section 3.5, and additionally, the auditor shall meet therequirements as defined under section 4 below.

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3.4 AUDIT PROCESSThe Addendum audit is always a full audit covering all the requirements listed in Part 5 of thisdocument and is to be assessed as an integrated part of the FSSC 22000 audit.
The audit program and audit plan shall clearly reference and include the Addendum requirements.
The combined audit shall be conducted annually as part of the FSSC 22000 audit. The first audit to
the Addendum can take place at any full FSSC 22000 audit during the cycle (initial, surveillance, or
recertification).
The audit delivery method (on-site, ICT Audit approach or full remote) shall be aligned to that of
the FSSC 22000 audit and follow the same requirements.

3.5 UNANNOUNCED AUDITS
Where the FSSC 22000 audit is conducted as an unannounced audit, the Addendum shall also beassessed as unannounced.

3.6 AUDIT REPORTThe CB shall provide a written report for each audit to the Addendum. The report may becustomized by the CB but shall include sufficient objective evidence to confirm that all therequirements in the Addendum have been assessed, including a summary of the nonconformities
raised (where relevant) and meeting the requirements of Annex A of this document. It shall bereferenced in the “Audit Details” section of the FSSC 22000 audit report that the HAVI tms GQSR
Addendum was combined with the FSSC 22000 audit.
It is the responsibility of the organization to supply a copy of the full FSSC 22000 audit report anda copy of the HAVI tms Addendum Annex A report to their HAVI tms representative. The CB andFoundation FSSC do not supply this to HAVI tms directly.

3.7 NONCONFORMITY MANAGEMENT
The same criteria as defined in the FSSC 22000 Scheme applies to any nonconformities identified
against the specific requirements of the HAVI tms Addendum, including grading, timelines, andfollow-up actions. With the exception that:•

For minor and major nonconformities if the timelines are not met, then conformance to
the Addendum will not be recommended.

•

For critical nonconformities then conformance to the Addendum will not berecommended, as suspension does not apply to the Addendum.

The organization shall immediately notify their HAVI tms Representative, at the end of the audit, if
any critical non-conformity is raised during their FSSC 22000 audit.
For nonconformities that also relate to a requirement of the Scheme, it shall also be raised andmanaged in accordance with the Scheme requirements for nonconformity management, Part 3,
Section 6.2.
Where a systemic failure to meet the customer requirements of this Addendum is identified, anonconformity shall also be raised against the relevant clause of ISO 22000 within the FSSC 22000
certification audit.

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3.8 CERTIFICATION DECISION PROCESSThe CB shall conduct a technical review and undertake a certification decision for all audits against
the Addendum, in conjunction with the review of the FSSC 22000 audit, to agree with the audit
report content and outcome, NCs (objective evidence and grading), and effectiveness ofcorrections and corrective action plans. A positive certification decision for the FSSC 22000 audit
is a prerequisite for achieving conformance to this Addendum.
It remains the responsibility of the CB to ensure a proper and robust audit and certification
process.

3.9 ASSURANCE PLATFORM DATA AND DOCUMENTATIONThe Addendum report shall be uploaded to the Assurance Platform, together with the FSSC 22000
related audit within 2 months of the last day of the audit. In addition, the CB shall indicate in the
Assurance Platform, under the Addendum section of the relevant audit, that this Addendum wasincluded as part of the FSSC 22000 audit. The same requirements relating to Data Quality, as set
out in FSSC 22000, apply.

4. REQUIREMENTS FOR CERTIFICATION BODIES
4.1 COMPETENCEThe CB shall follow the same requirements described in Annex C of ISO 22003-1:2022 for defining
the competencies required to conduct the audit and certification activities.
In addition, Technical Reviewers and Certification Decision Makers, are required to undertake thesame specific training as the auditors as per 4.1.1 below.
Records of training shall be maintained by the CB.

4.1.1 AUDITOR REQUIREMENTS
Only FSSC 22000 auditors with the relevant category I approval may conduct audits to the
Addendum. The auditor shall receive training on the following, by the CB, prior to conducting any
audits:••FSSC 22000: HAVI tms GQSR Addendum, and
HAVI tms Global Quality & Safety Requirements document

Records of the training shall be maintained and uploaded in the Auditor database, under the
maintenance tab, prior to commencing with Addendum audits.
The CB may define additional competency requirements in line with their procedures or
accreditation requirements.
A specific witness audit to the Addendum is not required for approval to audit against the
Addendum. Where an auditor does have approval to audit to the Addendum, it would be preferred
if the CB can assign a 3-yearly witness audit which includes the Addendum, however, it is notmandatory.

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The CB shall include the HAVI tms Addendum as a specific element in the 3-yearly auditor
performance review during requalification of the FSSC 22000 auditor.

5. SPECIFIC AUDIT REQUIREMENTS
This section of the document sets out the specific requirements for organizations in addition to
those defined in FSSC 22000 packaging. This includes requirements that have not been specificallydefined in ISO 22000 or ISO/TS 22002-4, are partially addressed or have been addressed in a moregeneral way. The organization shall comply with the FSSC 22000 requirements as well as these
additional requirements to demonstrate compliance to the Addendum.
RelatedGQSR Clause

HAVI tms Addendum Requirement

1

General

1.1

Scope

1.1.2

Supplier Partners shall acknowledge that they have received, reviewed, andunderstood the contents of the HAVI tms Global Quality and Safety
Requirements document as set forth and agree to abide by the requirements
by annually signing a statement of agreement.

2

Management Commitment

2.5

Management Review
The Supplier Partner’s management shall implement a plan to meet the needsof the customer. The plan shall be reviewed for effectiveness and relevancy.
Periodic reviews shall be scheduled and led by management at least once per
year.

3

Hazard and Risk Management

3.2

Food Safety (HACCP)

3.2.2

The organization shall formally review the plan (HACCP Plan and Flow Chart)
at least annually.

3.2.3

A copy of the plan shall be forwarded to HAVI tms.

3.4

Food Packaging Defense Plan

3.4.3

A formal annual audit of the food packaging defense plan shall be conducted
to review the plan’s effectiveness. The plan shall be revised and updated asneeded or as changes dictate. All changes and results shall be documented.

3.9

Chemical Control

3.9.5

Identification of all chemicals with Safety Data Sheets (SDS) that are readily
available to all employees. SDS sheets shall be maintained on-file for all
chemicals in the appropriate language. SDS is the same as a MSDS (Material
safety data sheet).

3.10

Regulatory and Legislative Compliance
HAVI tms shall be notified of all visits and findings resulting from audits bygovernmental agencies.

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RelatedGQSR Clause

HAVI tms Addendum Requirement

3.11

Material Compliance3.11.4The organization shall issue to HAVI tms CoC and CoA in keeping with HAVI
tms and market regulatory and legislative requirements upon request - CoC
and CoA - Where applicable, by country.
Note: This requirement is for those suppliers that are required to provide a CoC or
CoA to the government of the country they are supplying, such as, but not limited
to Japan and Korea. If this is not applicable to the country of sale, then pleaseindicate not applicable.

3.11.5

CoC shall be issued at least every two years or more frequently as
requested/required by HAVI tms or the market.

3.11.6

CoC shall be issued in English and the official local government language
where the packaging item shall be used.

3.11.10The organization shall provide full product transparency to the CAS number
for all packaging products, as HAVI tms requires and specifies.

4

Quality Management

4.1

General• Provide and maintain the map of the production process quality
flowchart and quality matrix documents required by HAVI tms.

4.2

Documentation

4.2.1 a - e

The organizations quality system shall include at a minimum:
a. Documented quality manual,b. Written work instructions, procedures, and protocols that drive
planning, manufacturing, and control of their respective processes,
including documented process maps and control plans, andc. Records associated with the quality systems, manuals, and products
produced.

4.2.2

The organization shall establish, document, implement, train against, andmaintain a quality manual that includes: The scope of the quality systems, The
documented procedures established for the quality system, or reference tothem, and a description of the interaction between the processes of the foodsafety, compliance, and quality system. The organization can define what its
QMS Manual is.

4.2.4 dDocuments, records, and data which are part of the quality management
system shall be retained for a minimum of 3-years or as specified by HAVI tms
and/or regulatory and legislative requirements.

4.2.4 eAll records shall be retrievable within 24 hours.

4.3.5 a - c

Quality Improvement Plan
The organization shall develop, implement, and provide a quality
improvement plan to proactively identify potential and real quality
improvement opportunities to drive the efficiency and effectiveness of thequality system. This plan shall be reviewed at least annually for effectiveness.
The organization shall review this plan with HAVI tms.

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RelatedGQSR Clause

HAVI tms Addendum Requirement

4.3.6 a - b

Probationary Improvement Plan
An improvement plan may be required in order to improve unsatisfactory
performance as determined by HAVI tms. The organization shall develop,
implement, monitor, and report results of their probationary improvement
plan upon request by HAVI tms. Failure to do so may result in loss of business,
up to and including termination of the contract. The Probationary
Improvement Plan must be approved by HAVI tms.

5

Product and Process Control

5.2

Specifications
The organization shall collaborate with HAVI tms on the latest
specification/revision for the packaging items the organization has been
awarded to supply through the GSM System. The questionnaire contains thecritical-to-quality characteristics of the product. The supplier agrees to
produce to specification by signing off the acknowledgment of compliance foreach specification. The approval process, including the agreed-upon
qualification process, shall be completed before the organization is approved
to supply the corresponding packaging item into the HAVI tms system unlessauthorization is provided in writing by HAVI tms.
Note: The GSM (Global Specification Management) is an Oracle-based specification
management system employed by HAVI tms for controlling and managing
specifications. A copy of the specification for each item manufactured by theorganization must be available from the GSM system. The excel spreadsheet is thedraft specification to outline the criteria of the specification before this informationis entered into a GSM specification.

5.2.2

Specifications shall contain technical and performance requirements for thefollowing areas, at a minimum: Raw materials, Environmental information,
Finished goods performance characteristics, Shipping container, Unit load,
Graphics, and Engineered part drawing of the product.

5.3

Product Traceability

5.3.1

The organization shall be able to provide complete traceability of product,both forward and backward, within 3 hours of receiving item and lot code
information during business hours and within 5 hours during off and holiday
hours.

5.3.6

The organization shall test the traceability upstream and downstream (trace
forward and trace backwards) through a timed and documented mock recall
exercise at least once per year, to be successfully completed within 3 hours or
less.

5.3.7

The organization shall objectively demonstrate the capability to implement a
recovery scenario outside of regular office hours.

5.4.1 - 4

Manufacturing Data Collection/Submission
The organization shall have a system in place to monitor and control
compliance of properties for the product(s) they are responsible for
manufacturing and demonstrate the ability to control their processes.

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RelatedGQSR Clause

HAVI tms Addendum Requirement
The organization shall have the capability to collect and report manufacturing
data on performance criteria. Manufacturing data shall be reported to HAVI
tms QA at a frequency and in a format agreed upon with HAVI tms. Forprocesses with high variability and/or as required by HAVI tms:
• Suppliers shall demonstrate statistical methods for maintaining
control• Where required by HAVI tms, CTQ properties with Cpk values shall begreater than 1.33
• Product attributes shall meet product functionality requirements
Note: For those suppliers that have SPC or electronic data collection capability,
CTQ characteristics should be electronically documented for variable attributes.

5.7

Notification of Formula, Material, Facility, or Process Change

5.7.1 - 2

HAVI tms shall be notified in writing of all product-related changes prior to thechanges taking effect. This includes, but is not limited to changes in: Formula,
Process, Tooling, Equipment and Facility. Written notification of proposedchanges to HAVI tms shall be provided as follows to give HAVI tms adequate
time to assess and determine approvals and qualification requirements:• 30-days: Changes in process or raw materials, new inserts• 60-days: Changes in existing tooling, equipment relocation to anotherqualified facility• 90-days: new facility, new tooling, new equipment
Note: Tooling is generally classified as “forming” tools to form plastic lids or plastic
or paper cups. Printing plates or die changes are not classified as tools that need
to be notified via change management.

5.8

Product & Line Qualification Process
HAVI tms utilizes the “Commissioning, Qualification and Verification” (CQV)
process to establish the process capability of a tool. The CQV process provides
a total quality approach so that packaging produced at the start of production
will fall within acceptable tolerances for all critical variable dimensions,
attributes, and functional requirements.
The CQV process is defined as:• Commissioning – The commissioning phase aims to ensure that lead/cavity
production tooling can produce the packaging in agreement with component
specifications and part drawing(s). Packaging will be examined on a cavity-tocavity basis.
• Qualification – The qualification phase aims to understand process capability
once variation identified in the commissioning phase has been eliminated.
Demonstrates over time that, using a larger sample base, packaging
established during the commissioning stage could be maintained. This also
defines how the tooling will perform in production.
• Verification – The verification phase aims to ensure that production toolinghas long–term capability. This is to understand how components fromproduction are impacted by changes in raw material (lot-to-lot), shift(operators), and production facility environment (seasonal & within the plant).

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RelatedGQSR Clause

HAVI tms Addendum Requirement
The qualification of Extreme and High-Risk products, such as hot and cold
beverage packaging, may require the completion and submission of a
Production Part Approval Process (PPAP). A PPAP is used to anticipate andprevent problems, reduce costs, shorten product development time, andachieve safe and reliable products and processes.

5.8.1

The organization shall provide all relevant information necessary to
successfully complete the qualification process.

5.8.1.a

The organization shall ensure that all materials used in the production of
packaging products are compliant and meets all regulatory, legislative, and
HAVI tms requirements. Objective evidence shall be provided.
Note: Organizations will have different KPIs and metrics that are specific to thefacility.

5.8.1.b

The organization shall verify that the packaging produced meets all foodsafety requirements, validating that the processes can consistently produce
products to satisfy HAVI tms expectations. Objective evidence shall be
provided.

5.8.2

The product shall not be introduced into the HAVI tms system without
approval from HAVI tms Quality Assurance.

5.9

Shipping Containers, Print Specifications and Other Tertiary Packaging
Requirements

5.9.1 – 2Graphics, artwork, printing, and labels shall be in accordance with HAVI tms
guidelines and approved by HAVI tms prior to the start of production. Used
corrugated material shall be approved for its intended purpose.
Load Containment Specifications (Stretch wraps and others):•••

All unit loads shall be stretch wrapped, the material of which is to becompatible with polyethylene as scrap.
Supplier Partners shall not use PVC.
Corrugated cartons shall be secured by glue or tape.

5.10

Control of Nonconforming Product5.10.1

The nonconforming product shall not be used without written authorizationfrom HAVI tms Quality Assurance. Disposition by HAVI tms is provided inwriting or via e-mail.

5.11

Product Holds and Recoveries

5.11.4The organization shall not send replacement products to the market or
distribution centers without HAVI tms authorization. Any rework or
replacement product is not released and remains on hold until HAVI tms
provides approval/disposition.

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RelatedGQSR Clause

HAVI tms Addendum Requirement

5.12

Disposal of Customer Branded Materials
Supplier Partners shall establish, document, implement, train against, andmaintain procedures that require the clear identification, containment andhandling of customer branded bulk materials that have been designated aswaste. This excludes routinely generated production line waste such as
samples discarded after testing or inspection.

5.12.2

5.12.35.12.45.12.55.12.65.12.7

No customer branded waste material shall be shipped outside of the countryof origin prior to pre-processing as outlined in 5.12.5 to 5.12.8.
• 5.12.2.1. Supplier Partners shall receive written verification that thebranded material was pre-processed within 48 hours following preprocessing.
• 5.12.2.2. The written verification shall reference the notification
outlined in 5.12.3, including the weight and or volume of the material
disposed of. This record shall be retained for a minimum of 3 years.
A process shall be in place to formally notify the 3rd party waste management
organization through documentation that branded waste materials arecontained in a waste shipment. Objective evidence of this notification,
including photographs prior to pre-processing, as well as the weight and orvolume of the branded waste included in the shipment, shall be retained for aminimum of 3 years.
Note: Obsolete printing plates, dies, etc., are also classified as branded wastematerials.
Supplier Partners shall receive written certificates of destruction within 48
hours following the destruction of customer branded waste materials, where
3rd party waste management organizations are utilized.
• 5.12.4.1. Certificates of destruction shall include photographs before
and after pre-processing.
• 5.12.4.2. The certificates of destruction shall reference the notification
outlined in 5.12.3, including the weight of the material disposed of.
• 5.12.4.3. This record shall be retained for a minimum of 3 years.
Branded wastepaper materials, including work-in-process materials, shall at aminimum be hogged or shredded to safeguard against unintended use prior
to final disposition to safeguard against unintended use and must beprocessed at the first, primary waste handler. Note: Rolls of printed material
can be over printed in place of hogging or shredding before sending the final
waste handler, all branded names, trademarks, and images must be 100%
obscured throughout the entire roll.
Branded waste plastic materials, including work-in-process materials, shall at
a minimum be ground or chipped prior to final disposition to safeguard
against unintended use and must be processed at the first, primary waste
handler.
Branded waste metal materials, including work-in-process materials, shall at aminimum be cut, or ground prior to final disposition to safeguard against
unintended use and must be processed at the first, primary waste handler.

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RelatedGQSR Clause

HAVI tms Addendum Requirement

5.12.8Branded waste wooden or other materials made of heavy gauge fibrous
substrates, including work-in-process materials, shall at a minimum be cut orchipped prior to final disposition to safeguard against unintended use andmust be processed at the first, primary waste handler.
Supplier Partners may, at their discretion, dispose of branded waste materials
by means of waste-to-energy and thereby avoid hogging/shredding/chipping
costs. Certificates of destruction shall be issued in accordance with 5.12.4.
Supplier Partners shall annually perform an unannounced audit of their 3rdparty waste management organization to verify compliance.
• 5.12.10.1. Supplier Partners shall audit the physical movement fromloading through final disposition and ensure all elements of thissection are adhered to for 3rd party waste management partners.

5.12.95.12.10

7.2

Competence, Awareness, and Training

7.2.8

The training program shall be reviewed for effectiveness at least annually andafter changes in customer expectations, food safety, compliance, and quality
policies and/or procedures.

7.3

Medical screening / Hygiene

7.3.5

The organization shall require the use of hairnets and beard nets in the
manufacturing environment where primary or secondary packaging is being
produced.

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6. DEFINITIONS
The definitions in the HAVI tms GQSR document apply to the relevant terminology in Part 5 of thisdocument, including but not limited to the following, extracted from the HAVI tms GQSR
document:
•
•
•
•

•
•
•
•
•
•
•
•

•
•

Restricted Substances List – A list of substances prohibited for use in packaging or raw
materials used in producing packaging for HAVI tms.
Customer – The customer is HAVI tms, who is responsible for understanding andcommunicating the expectations of its customers to the Supplier Partners.
CTQ (Critical-to-Quality) – Specification properties identified as critical for ensuringconsistent quality during manufacturing.
CoC (Certificate of Compliance) – Document certifying that the product provided iscompliant with the regulatory, legislative and HAVI tms requirements for the markets it will
be used in.
SPC (Statistical Process Control) – Methodology for measuring and controlling quality
during the manufacturing process through the use of statistics.
Cpk (Process Capability Index) – Statistical measurement of the capability of process.
COA (Certificate of Analysis) – Document certifying that the product provided meetsspecification.
GSM (Global Specification Management) – Oracle based specification management
system employed by HAVI tms for controlling and managing specifications.
Quality – Those product features that meet the needs of the customer. It is the degree towhich a set of inherent characteristics fulfills the customer’s requirements.
Quality Flowchart – Flowchart describing each step of the manufacturing process and thetest procedures associated with it.
Quality Matrix – Matrix describing actions around each manufacturing process step.
Quality Management System – A management system that directs and controls anorganization with regard to food safety, quality and compliance, including theestablishment of quality policies and objectives, planning, control and continuous
improvement. A management system approach encourages an organization to analyze
customer requirements, define the processes that contribute to the achievement of a
product that is acceptable to the customer, and keep these processes under control.
Re-usable – An item which is specifically designed to be used more than once.
HSS – Hygiene, Safety and Sanitation (HSS) includes single-use and reusable face coverings,
sanitizing chemicals and gloves.

The definitions in FSSC 22000 Appendix 1 apply to the remainder of the document unlessotherwise specified.

7. REFERENCESHAVI tms GLOBAL QUALITY & SAFETY REQUIREMENTS Version 1.15

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ANNEX A: ADDENDUM REPORT TEMPLATEThe Addendum only addresses areas not specifically covered or not covered to the same extent
as in FSSC 22000. The Report Addendum should always be read in conjunction with the FSSC 22000
Audit Report. The same general principles as set out in Annex 2 of the FSSC 22000 Scheme also
apply to the completion of the Addendum report.

AUDIT DETAILS
Registered legal nameName of organization to be certified.

Location/Address

Full address (or other unique identification of site locationi.e., GPS, GLN etc. where a postal address is not available).

COID
Contact person

Name and function – if different to the FSSC 22000 audit

General description ofactivities
Scope of certification

Specific to the Addendum, but in line with the FSSC 22000 scope

FSSC 22000 reportreference

Record the date and type of FSSC audit delivered in order for the
Addendum report to be linked to the FSSC 22000 report.

Addendum Audit
duration

Time spent auditing the Addendum in hours

AUDIT TEAM
Name

Function

Audit delivery

Date(s)Time

Auditor nameIncludes lead auditor,
auditor, translators, TE,
witnessor, trainees,
observers

i.e., remote/onsite

DD/MM/YYYY

08h00-17h00

SUMMARY OF AUDIT FINDINGS# Critical nonconformities# Major nonconformities# Minor nonconformities

ADDENDUM AUDIT RECOMMENDATION
Recommended
Not recommended

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NON-CONFORMITIES#

1

Nonconformity
Grading(Minor, Major,
Critical)Requirement

For example:
Minor

For example:

Reference(std., clause)

HAVI tms
GQSR
§5.2

NC
statement(incl
objective
evidence)
Provide aclear
statement of
the deviationfrom therequirement.

Root Cause
Analysis

Corrective ActionPlan(determine
why it arose)(action to prevent
repeat; person
responsible; duedate for completion)

Completed byclientCompleted by client

Providedetailed
objective
evidence.
2
3
4

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Correction(to addresstheimmediateissue)
Completedby clientObjective
Evidence
Reviewed

Acceptanceof correction
and CAP(relating to thecorrection)(auditor anddate)

Indicate
evidence
reviewed for thecorrection i.e.,
document nameand number

Auditor nameand date ofacceptance ofRoot cause
analysis, CAP,
correction,and objective
evidenceHAVI tms Global Quality and Safety Requirements Addendum

HAVI TMS GQSR ADDENDUM CHECKLISTHAVI tms GQSR V1.15
ClauseConform

Requirement

Yes

No

N/A

Grade
Minor/
Major/
Critical

1

General

1.1

Scope

1.1.2

Supplier Partners shall acknowledge that they have received, reviewed, andunderstood the contents of the HAVI tms Global Quality and Safety Requirements
document as set forth and agree to abide by the requirements by annually signinga statement of agreement.

Summary on General:
Scope:
2

Management Commitment

2.5

Management Review
The Supplier Partner’s management shall implement a plan to meet the needs ofthe customer. The plan shall be reviewed for effectiveness and relevancy. Periodic
reviews shall be scheduled and led by management at least once per year.

Summary on Management Commitment:
Management Review:

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If No – detail NC
If N/A – provide
justification

NC #HAVI tms Global Quality and Safety Requirements Addendum

HAVI tms GQSR V1.15
ClauseConform

Requirement

Yes

No

N/A

Grade
Minor/
Major/
Critical

3

Hazard and Risk Management

3.2

Food Safety (HACCP)

3.2.2

The organization shall formally review the plan (HACCP Plan and Flow Chart) atleast annually.

3.2.3

A copy of the plan shall be forwarded to HAVI tms.

3.4

Food Packaging Defense Plan

3.4.3

A formal annual audit of the food packaging defense plan shall be conducted toreview the plan’s effectiveness. The plan shall be revised and updated as neededor as changes dictate. All changes and results shall be documented.

3.9

Chemical Control

3.9.5

Identification of all chemicals with Safety Data Sheets (SDS) that are readily
available to all employees. SDS sheets shall be maintained on-file for all
chemicals in the appropriate language. SDS is the same as a MSDS (Material
safety data sheet).

3.10

Regulatory and Legislative Compliance
HAVI tms shall be notified of all visits and findings resulting from audits bygovernmental agencies.

3.11

Material Compliance3.11.4The organization shall issue to HAVI tms CoC and CoA in keeping with HAVI tms
and market regulatory and legislative requirements upon request - CoC and CoA- Where applicable, by country.
Note: This requirement is for those suppliers that are required to provide a CoC or
CoA to the government of the country they are supplying, such as, but not limited to

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NC #HAVI tms Global Quality and Safety Requirements Addendum

Japan and Korea. If this is not applicable to the country of sale, then please indicate
not applicable.
3.11.5

CoC shall be issued at least every two years or more frequently as
requested/required by HAVI tms or the market.

3.11.6

CoC shall be issued in English and the official local government language where
the packaging item shall be used.

3.11.10The organization shall provide full product transparency to the CAS number for
all packaging products, as HAVI tms requires and specifies.

Summary on Hazard and Risk Management:
Food Safety (HACCP):
Food Packaging Defense Plan:
Chemical Control:
Regulatory and Legislative Compliance:
Material Compliance:
4

Quality Management

4.1

General•Provide and maintain the map of the production process quality
flowchart and quality matrix documents required by HAVI tms.

4.2

Documentation

4.2.1 a - e

The organizations quality system shall include at a minimum:
a. Documented quality manual,

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b. Written work instructions, procedures, and protocols that drive
planning, manufacturing, and control of their respective processes,
including documented process maps and control plans, andc. Records associated with the quality systems, manuals, and products
produced.
4.2.2

The organization shall establish, document, implement, train against, andmaintain a quality manual that includes: The scope of the quality systems, The
documented procedures established for the quality system, or reference tothem, and a description of the interaction between the processes of the foodsafety, compliance, and quality system. The organization can define what its
QMS Manual is.

4.2.4 dDocuments, records, and data which are part of the quality management
system shall be retained for a minimum of 3-years or as specified by HAVI tms
and/or regulatory and legislative requirements.

4.2.4 eAll records shall be retrievable within 24 hours.

4.3.5 a - c

Quality Improvement Plan
The organization shall develop, implement, and provide a quality improvement
plan to proactively identify potential and real quality improvement
opportunities to drive the efficiency and effectiveness of the quality system.
This plan shall be reviewed at least annually for effectiveness. The organization
shall review this plan with HAVI tms.

4.3.6 a - b

Probationary Improvement Plan
An improvement plan may be required in order to improve unsatisfactory
performance as determined by HAVI tms. The organization shall develop,
implement, monitor, and report results of their probationary improvement
plan upon request by HAVI tms. Failure to do so may result in loss of business,
up to and including termination of the contract. The Probationary
Improvement Plan must be approved by HAVI tms.

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Summary on Quality Management:
General:Documentation:
Quality Improvement Plan:
Probationary Improvement Plan:

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HAVI tms GQSR V1.15
ClauseConform

Requirement

Yes

No

N/A

Grade
Minor/
Major/
Critical5

Product and Process Control

5.2

Specifications
The organization shall collaborate with HAVI tms on the latest
specification/revision for the packaging items the organization has been
awarded to supply through the GSM System. The questionnaire contains thecritical-to-quality characteristics of the product. The supplier agrees to produce
to specification by signing off the acknowledgment of compliance for eachspecification. The approval process, including the agreed-upon qualification
process, shall be completed before the organization is approved to supply thecorresponding packaging item into the HAVI tms system unless authorization isprovided in writing by HAVI tms.
Note: The GSM (Global Specification Management) is an Oracle-based specification
management system employed by HAVI tms for controlling and managing
specifications. A copy of the specification for each item manufactured by theorganization must be available from the GSM system. The excel spreadsheet is thedraft specification to outline the criteria of the specification before this informationis entered into a GSM specification.

5.2.2

Specifications shall contain technical and performance requirements for thefollowing areas, at a minimum: Raw materials, Environmental information,
Finished goods performance characteristics, Shipping container, Unit load,
Graphics, and Engineered part drawing of the product.

5.3

Product Traceability

5.3.1

The organization shall be able to provide complete traceability of product, bothforward and backward, within 3 hours of receiving item and lot code
information during business hours and within 5 hours during off and holiday
hours.

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NC #HAVI tms Global Quality and Safety Requirements Addendum

5.3.6

The organization shall test the traceability upstream and downstream (trace
forward and trace backward) through a timed and documented mock recall
exercise at least once per year, to be successfully completed within 3 hours or
less.

5.3.7

The organization shall objectively demonstrate the capability to implement a
recovery scenario outside of regular office hours.

5.4.1 - 4

Manufacturing Data Collection/Submission
The organization shall have a system in place to monitor and control
compliance of properties for the product(s) they are responsible for
manufacturing and demonstrate the ability to control their processes.
The organization shall have the capability to collect and report manufacturing
data on performance criteria. Manufacturing data shall be reported to HAVI tms
QA at a frequency and in a format agreed upon with HAVI tms. For processes
with high variability and/or as required by HAVI tms:
• Suppliers shall demonstrate statistical methods for maintaining control• Where required by HAVI tms, CTQ properties with Cpk values shall begreater than 1.33
• Product attributes shall meet product functionality requirements
Note: For those suppliers that have SPC or electronic data collection capability, CTQ
characteristics should be electronically documented for variable attributes.

5.7

Notification of Formula, Material, Facility, or Process Change

5.7.1 - 2

HAVI tms shall be notified in writing of all product-related changes prior to thechanges taking effect. This includes, but is not limited to changes in: Formula,
Process, Tooling, Equipment and Facility. Written notification of proposedchanges to HAVI tms shall be provided as follows to give HAVI tms adequate time
to assess and determine approvals and qualification requirements:• 30-days: Changes in process or raw materials, new inserts• 60-days: Changes in existing tooling, equipment relocation to anotherqualified facility• 90-days: new facility, new tooling, new equipment

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HAVI tms Global Quality and Safety Requirements Addendum

Note: Tooling is generally classified as “forming” tools to form plastic lids or plastic or
paper cups. Printing plates or die changes are not classified as tools that need to be
notified via change management.
5.8

Product & Line Qualification Process (Refer to section 5 above for further details on 5.8)

5.8.1

The organization shall provide all relevant information necessary to successfullycomplete the qualification process.

5.8.1.a

The organization shall ensure that all materials used in the production of
packaging products are compliant and meets all regulatory, legislative, and
HAVI tms requirements. Objective evidence shall be provided.
Note: Organizations will have different KPIs and metrics, which are specific to thefacility.

5.8.1.b

The organization shall verify that the packaging produced meets all food safety
requirements, validating that the processes can consistently produce products
to satisfy HAVI tms expectations. Objective evidence shall be provided.

5.8.2

The product shall not be introduced into the HAVI tms system without approval
from HAVI tms Quality Assurance.

5.9

Shipping Containers, Print Specifications and Other Tertiary Packaging Requirements

5.9.1 – 2Graphics, artwork, printing, and labels shall be in accordance with HAVI tms
guidelines and approved by HAVI tms prior to the start of production. Used
corrugated material shall be approved for its intended purpose.
Load Containment Specifications (Stretch wraps and others):
•
•
•

5.10

All unit loads shall be stretch wrapped, the material of which is to becompatible with polyethylene as scrap.
Supplier Partners shall not use PVC.
Corrugated cartons shall be secured by glue or tape.

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5.10.1

The nonconforming product shall not be used without written authorizationfrom HAVI tms Quality Assurance. Disposition by HAVI tms is provided in writingor via e-mail.

5.11

Product Holds and Recoveries

5.11.4The organization shall not send replacement products to the market or
distribution centers without HAVI tms authorization. Any rework or
replacement product is not released and remains on hold until HAVI tms
provides approval/disposition.

5.12

Disposal of Customer Branded Materials
Supplier Partners shall establish, document, implement, train against, andmaintain procedures that require the clear identification, containment andhandling of customer branded bulk materials that have been designated aswaste. This excludes routinely generated production line waste such as samples
discarded after testing or inspection.

5.12.2

No customer branded waste material shall be shipped outside of the country oforigin prior to pre-processing as outlined in 5.12.5 to 5.12.8.
• 5.12.2.1. Supplier Partners shall receive written verification that thebranded material was pre-processed within 48 hours following preprocessing.
•
5.12.2.2. The written verification shall reference the notification outlined
in 5.12.3, including the weight and or volume of the material disposedof. This record shall be retained for a minimum of 3 years.

5.12.3

A process shall be in place to formally notify the 3rd party waste management
organization through documentation that branded waste materials arecontained in a waste shipment. Objective evidence of this notification, including
photographs prior to pre-processing, as well as the weight and or volume of thebranded waste included in the shipment, shall be retained for a minimum of 3
years.

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HAVI tms Global Quality and Safety Requirements Addendum

Note: Obsolete printing plates, dies, etc., are also classified as branded wastematerials.
5.12.4

Supplier Partners shall receive written certificates of destruction within 48
hours following the destruction of customer branded waste materials, where
3rd party waste management organizations are utilized.
• 5.12.4.1. Certificates of destruction shall include photographs before
and after pre-processing.
• 5.12.4.2. The certificates of destruction shall reference the notification
outlined in 5.12.3, including the weight of the material disposed of.
• 5.12.4.3. This record shall be retained for a minimum of 3 years.

5.12.5

Branded wastepaper materials, including work-in-process materials, shall at aminimum be hogged or shredded to safeguard against unintended use prior to
final disposition to safeguard against unintended use and must be processed at
the first, primary waste handler. Note: Rolls of printed material can be overprinted in place of hogging or shredding before sending the final waste handler,
all branded names, trademarks, and images must be 100% obscured
throughout the entire roll.

5.12.6

Branded waste plastic materials, including work-in-process materials, shall at aminimum be ground or chipped prior to final disposition to safeguard against
unintended use and must be processed at the first, primary waste handler.

5.12.7

Branded waste metal materials, including work-in-process materials, shall at aminimum be cut, or ground prior to final disposition to safeguard against
unintended use and must be processed at the first, primary waste handler.

5.12.8Branded waste wooden or other materials made of heavy gauge fibrous
substrates, including work-in-process materials, shall at a minimum be cut orchipped prior to final disposition to safeguard against unintended use andmust be processed at the first, primary waste handler.

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HAVI tms Global Quality and Safety Requirements Addendum

5.12.9Supplier Partners may, at their discretion, dispose of branded waste materials
by means of waste-to-energy and thereby avoid hogging/shredding/chipping
costs. Certificates of destruction shall be issued in accordance with 5.12.4.

5.12.10Supplier Partners shall annually perform an unannounced audit of their 3rdparty waste management organization to verify compliance.
•

5.12.10.1. Supplier Partners shall audit the physical movement fromloading through final disposition and ensure all elements of this section
are adhered to for 3rd party waste management partners.

Summary on Product and Process Control:
Specifications:
Product Traceability:
Manufacturing Data Collection/Submission:
Notification of Formula, Material, Facility, or Process Change:
Product & Line Qualification Process:
Shipping Containers, Print Specifications and Other Tertiary Packaging Requirements:
Load Containment Specifications (Stretch wraps and others):
Control of Nonconforming Product:
Product Holds and Recoveries:
Disposal of Customer Branded Materials:

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HAVI tms GQSR V1.15
ClauseConform

Requirement

Yes

No

N/A

Grade
Minor/
Major/
Critical

7

Personnel

7.2

Competence, Awareness, and Training

7.2.8

The training program shall be reviewed for effectiveness at least annually andafter changes in customer expectations, food safety, compliance, and quality
policies and/or procedures.

7.3

Medical screening / Hygiene

7.3.5

The organization shall require the use of hairnets and beard nets in the
manufacturing environment where primary or secondary packaging is being
produced.

Summary on Personnel:
Competence, Awareness, and Training:
Medical screening / Hygiene:

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If No – detail NC
If N/A – provide
justification

NC #