QFS-MA-DIR-005

QFS DIRECTIVE VERSION N° 1.0

FOOD SAFETY IN MANUFACTURING DATE: 10 APRIL 2024
(SUPERSEDES ALL PREVIOUS VERSIONS) PAGE 1/16

Publication
April 10, 2024
Date
Application
April 19, 2023 [1 year after Publication in 2022]
Date

Objectives This Directive defines the general requirements and accountabilities to ensure the safety of
food and beverage products manufactured by Danone, by supporting the establishment
and/or revision of Manufacturing sites’ Food Safety Management System (FSMS) in
consistency with:
− ISO22000 standard and FSSC22000 scheme;
− Applicable Danone Food Safety standards as reminded in the chapters of this Directive;
− Applicable Food Safety regulations.
As an integrated part of Danone’s FSMS, this Directive outlines all Danone FS requirements
applicable at Manufacturing site level and states how interfaces with other steps of the
value chain must be managed.

Scope
Activities and − Finished products intended to be placed on the market under a Danone brand (e.g.,
products commercial production), whatever the Product Target Category (PTC);
covered
− Semi-finished products intended to be delivered to another food producer;
− Products under development manufactured in the frame of industrial tests, whether the
output of the test can be placed on the market or not.

Sites covered − DANONE Manufacturing Sites, which include:

- DANONE factories;
- Pilot plants in the specific situation where they manufacture commercial products.;
− Manufacturing sites of Joint-Ventures controlled by Danone (i.e., in which Danone
holds more than 50% of the share capital).

Out of the − Finished products produced by third-party manufacturers (3PM) and Licensees (covered
scope of this by the FS Directive 3PM Management and case-by-case contractual agreement);
Directive
− Finished products produced by a Joint-Venture not controlled by Danone (covered by
case-by-case contractual and specification agreements with the JV partner);

− Finished products produced by a JV not placed on the market under a Danone brand;
− Samples/products intended for internal or external trials and produced in the frame of
Design activities, including Fast prototyping for controlled consumer groups (covered by
the FS in Design Directive and associated Procedures);
− Non-commercial products manufactured for clinical trials;
− Medical devices.

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Accountabilities

FS@D is accountable for:

− Issuing, updating, and maintaining this Directive and the associated FS standards, and verifying compliance with
them;
− Defining the minimum FS requirements applicable to each PTC;
− Developing the FS trainings and making them available as part of the FS Learning Offer;
− Fostering the development of a FS Culture through active contribution to the Icare program;
− Planning, organizing, and providing the FSI audits and reports;
− Selecting, approving, and managing the contractual relationship with FSSC22000 certification bodies.
− Providing FS expertise and support to QFS in case of incidents or crises.

The Managing Board of each Manufacturing Site is accountable for:

− Allocating adequate resources and ensuring effective implementation of this Directive’s requirements at
Manufacturing site level.

QFS is accountable for:

− Implementing and improving the Food Safety Management System at Manufacturing Site level
− Implementing FS standards applying the risk-based approach;
− Ensuring that all the requirements related to Food Safety in Manufacturing are applied by all functions involved
in the in-house manufacturing of products (QFS, Operations, Engineering, etc.);
− Developing and applying process to follow up on action plans for compliance and continuous improvement;
− Managing product non-conformities and implementing adequate corrections and corrective actions under a
continuous improvement mindset;
− Driving the Culture of Quality and Food Safety through the right mindset, behaviors, and accountability for
excellence in Food Safety execution;
− Identifying and developing the right technical skills across the team (knowledge in Food Safety, FSMS, PRP,
HACCP, FSHCP, FS Regulation);
− Assuring FS Regulatory Compliance;
− Representing the Company and the Manufacturing Site in front of Local/National FS authorities.

Operations (Manufacturing, Engineering, Maintenance, etc.) are accountable for:

− Application of all FS requirements relevant to their activities according to the site’s FSMS.

Local Regulatory affairs/Food Law and/or the FS Regulatory Referent is accountable for:
− Identification of food safety regulations applicable to the manufactured products, considering all sales
countries. When local regulation differs from Danone requirements, the more stringent of the two
requirements apply.

DANONE QFS Document 2024/do not copy/copyright DANONE©

This document must be implemented in accordance with all applicable local laws
Electronic Version from Authorized Document Library Prevails

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Links to all related documents including QFS Acronyms and Definitions

are provided in the Document Control section at the end of this document.

CONTENT
OBJECTIVES......................................................................................................................................................1
SCOPE..............................................................................................................................................................1
ACCOUNTABILITIES ..........................................................................................................................................2
FOOD SAFETY GOVERNANCE IN MANUFACTURING SITES ........................................................................4
SENIOR MANAGEMENT FOOD SAFETY COMMITTMENT ............................................................................................. 4
FOOD SAFETY MANAGEMENT SYSTEM DESCRIPTION ACCORDING TO THE PROCESS APROACH........................................... 4
FOOD SAFETY RESOURCES AND RESPONSIBILITIES .................................................................................................... 5
FOOD SAFETY TRAINING AND COMPETENCIES ......................................................................................................... 6
FOOD SAFETY CULTURE AND INTERNAL COMMUNICATION ........................................................................................ 7
IMPLEMENTATION OF THE FOOD SAFETY MANAGEMENT SYSTEM ..........................................................7
FOOD SAFETY PREREQUISITES DESIGN AND IMPLEMENTATION ................................................................................... 7
HACCP METHOD AND FSHCP DESIGN AND IMPLEMENTATION ................................................................................. 8
RELEASE OF FINISHED AND SEMI-FINISHED PRODUCTS .............................................................................................. 8
CHANGE MANAGEMENT ...................................................................................................................................... 9
DOCUMENTED INFORMATION CONTROL............................................................................................................... 10
VERIFICATION AND CONTINUOUS IMPROVEMENT OF THE FSMS ........................................................... 11
VERIFICATION OF THE FSMS .............................................................................................................................. 11
MANAGEMENT OF NON-CONFORMITIES, INCIDENTS AND CRISES ............................................................................. 11
FSMS REVIEW AND UPDATE .............................................................................................................................. 12
PERFORMANCE EVALUATION WITHIN DANONE OVERALL FSMS................................................................................ 13
DOCUMENT CONTROL.................................................................................................................................... 14

The following verbal forms are used in this Directive:

- “must” indicates a mandatory requirement;
- “should” indicates a recommendation;
- “may” indicates permission;
- “can” or “could” indicates a possibility or capability.

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Food Safety Governance in Manufacturing Sites

Senior Management Food Safety Committment

The Manufacturing site director is accountable for formalizing its commitment to Food Safety in a Policy established
at site level, consistent with the Danone Quality & Food Safety Commitments and Food Safety Policy.
The site’s FS Policy must consider the overall context in which the manufacturing site operates, in consistency with
ISO 22000 principles. This context must be formally analyzed based on risks and opportunities, using tools such as
a SWOT analysis. The tool Strategic Planner ISO 22000 can be used to carry out such analysis.
The site’s Food Safety Policy must be:
− formally endorsed by the whole Manufacturing Site Managing Board (or any other terminology used locally
e.g., Plant Lead Team, Site Manufacturing Board, CODU, etc.);
− actively shared with all internal teams and with concerned external contractors;
− supported by clear and relevant objectives, which must be known by all employees, and measured with
appropriate KPIs;
− revised and updated at an appropriate frequency, in consistency with Management Review cycle (see 3.3).

Associated documents:
− Danone Quality & Food Safety Commitments
− Danone Food Safety Policy
− Strategic Planner ISO 22000 FSD-SY-REF-006 (optional)

Food Safety Management System description according to the process aproach

Food Safety is one of the risk domains a Manufacturing site needs to control, together with Occupational Health
& Safety (“Wise” program), Environmental impacts (“Nature”), Security stakes including Food Defense (see 2.1),
and overall Quality performance.
For each of these risk domains, effective control implies:
− Sound Prerequisite programs,
− Risk-based approach,
− Continuous improvement in a Plan-Do-Check-Act (PDCA) loop at all levels.
Each manufacturing site should establish an Integrated Management System covering all those aspects.

Applied to the management of Food Safety these principles are illustrated in figure 1 hereafter.

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Figure 1: Structure of a Food Safety Management System (FSMS)

In application of the process approach, a process map must be available, in which interested parties and main
interfaces are legible. The Strategic Planner ISO 22000 can be used to identify the processes and interested parties
(e.g., customers, consumers, authorities, competitors, suppliers, and Danone functions such as R&I, Operations,
global QFS, BUCM, FS@D, C&P, etc.) which are relevant for the site.
Each process description must include as a minimum:
− Process ownership;
− Clear responsibilities (e.g., in connection with job descriptions, RACI, etc.);
− Inputs and outputs of the process.

In particular, the key FS activities must be described with related responsibilities defined in consistency with the
manufacturing site process map. These activities include at least:

− Capturing and analyzing new or evolving information from all relevant interested parties with a potential
impact on the Manufacturing site FSMS, so that applicable Food Safety requirements are duly identified, e.g.:
o Regulatory requirements applicable in country of production and all selling countries;
o Danone FS standards applicable to the PTCs produced on the site (transversal and PTC-specific);
o Additional requirements from customers or other external professional standards owners;
− Implementing a sound and efficient FSMS covering all activities within Manufacturing sites’ scope, which must
be fully compliant at all times with applicable requirements identified above;
− Supporting Food Safety competencies (see 1.4);
− Verifying Food Safety is under control (see 3.1);
− Updating and improving the overall FSMS (see 3.3 & 3.4).

Associated Documents:
− Strategic Planner ISO 22000 FSD-SY-REF-006 (optional)
− Recording Document for Cross-Reference ISO 22000, FSSC22000 and Danone standards
− Danone FS standards applicable to the PTCs produced on the site

Food Safety Resources and Responsibilities

The Manufacturing Site Director must appoint a manager with adequate skills and competencies to be responsible
for Food Safety in the Manufacturing Site (hereafter referred to as “Manager in charge of FS”).

The Manager in charge of FS must involve representatives from all processes identified in the process map (see
1.2) from design to implementation of the FSMS, both for Pre-requisite Programs (PRPs, see 2.1) and the Food
Safety Hazard Control Plan (FSHCP, see 2.2).

Responsibilities for FSMS design, effective PRP and FSHCP application and monitoring must be formally appointed
in the manufacturing site documentation (job descriptions, SOPs, instructions, RACIs, etc.) in consistency with the
process approach (see 1.2) and the FSMS design.

Human resources (amount, experience, and competencies) allocated to FS must be consistent with the size of the
manufacturing site and the complexity and/or sensitivity of its products, processes, and target consumers.

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Food Safety Training and Competencies

A Human Resources development process (see 1.2) must ensure continuous adequacy of individual competencies
and FS control needs at all levels of Manufacturing site organization. This adequacy must be regularly measured
and adjusted, using internal or external training when needed, and training refreshers at appropriate frequencies.

The manager in charge of FS must demonstrate both the technical skills (knowledge in Food Safety, FSMS, PRP,
HACCP, FSHCP, etc.) and the soft skills (cross-functional leadership, communication, etc.) necessary to carry out
his/her mission.

Each individual operating under Manufacturing site’s responsibility - starting with Managing board members and
including all personnel (both internal and external) - must undergo an effective training and/or induction in Food
Safety. The content must be adapted in content and duration to the trainees’ effective contribution to the FSMS,
and must at least contain information related to:
− Understanding of the FS Policy;
− Basic food safety principles i.e., relevant hazards (allergens managed and prohibited on site, main
microbiological, chemical, physical, and nutritional hazards significant at site level), hygiene practices, etc.;
− FS Management principles, based on PRPs, HACCP methodology, and FSHCP;
− PRP and control measures (CCPs/oPRPs) and standards relevant to the trainees’ activities (when applicable).

More specific training requirements for personnel involved in activities with a direct impact on Food Safety may
be detailed in other documents (for instance, see FS Hazard Control Plan Procedure); such requirements must be
taken into account when designing FS training/induction plans.

Records must be kept of:

− the training date and content;
− the attendance list and results of the evaluation of participants’ knowledge at the end of the training.

To achieve these objectives:

− Trainings on major FS topics are developed by FS@D department. They constitute the FS Learning Offer,
available to all Danoners through the Campus X learning platform;
− Ad-hoc trainings can be developed and deployed at local level by the CBU and/or the Manufacturing site;
− External training providers can be engaged, provided they are managed as requested in the Pre-Requisite
Programs General Procedure.

Associated Documents:
− FS Hazard Control Plan Procedure FSD-VC-PRO-004
− Food Safety Learning Offer, available in the General Secretary Channel on Campus X
− FS Procedure on Pre-requisite Programs FSD-VC-PRO-001 (Chapter 19)

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Food Safety Culture and Internal Communication

Local QFS is accountable for the development of the Food Safety Culture, drawing on content and animation
provided by global teams as part of the iCare program on Q&FS Culture and taking into account local cultural
environment. The iCare program provides the vision, tools, and events to raise awareness on FS.

Food Safety culture maturity must be regularly measured using adequate methods and means, and improvement
action plans must be implemented where appropriate. This evaluation can be combined with the evaluation of the
culture of Quality, for which a methodology is provided as part of the iCare program.

An efficient internal communication system must be implemented to ensure:

− Food Safety is brought to front where relevant throughout the manufacturing site;
− Anyone within Manufacturing site scope can freely raise any FS concern any time (whistleblower principle).

Implementation of the Food Safety Management System

Food Safety Prerequisites Design and Implementation

The following topics constitute the Food Safety Prerequisites, which must all be in place and effective in the
Manufacturing Site before building the FS Hazard Control Plan.

PRP As an essential basis of the FSMS (see Figure 1), PRPs provide the basic structural,
environmental, and operational conditions to produce safe food. The PRPs must be
implemented in the Manufacturing site according to the General Procedure Pre-Requisite
Programs, applicable to any Danone Manufacturing site whatever the PTC.

PTC-specific The Manufacturing site must also apply PTC-specific Good Manufacturing Practices (GMPs)
GMPs when they exist.
PTC-specific GMPs are established by FS@D to complement the PRPs, when needed due to
specific sensitivities of some products and/or consumers.

Traceability Manufacturing site’s traceability system and product withdrawal/recall procedures must
comply with the Traceability Procedure.

Food Fraud Manufacturing site’s Food Fraud vulnerability assessment and mitigation plan must comply
with the Food Fraud Mitigation Directive.

Food Defense Manufacturing site’s Food Defense plan must comply with the Food Defense Directive.

Associated Documents:
− FS Procedure on Pre-requisite Programs FSD-VC-PRO-001
− Traceability General Procedure FSD-VC-PRO-002
− Food Fraud Mitigation Directive FSD-VC-DIR-004
− Food Defense Procedure QFS-VC-PRO-002
− PTC-specific GMPs (when applicable)

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HACCP Method and FSHCP Design and Implementation

Each manufacturing site must apply the HACCP methodology in consistency with the FS Hazard Control Plan
Procedure, in order to implement effective FS Control measures (CCP/OPRP) which constitute the site’s Food Safety
Hazard Control Plan (FSHCP).
Allergens are considered as a specific type of hazards for the purpose of the hazard analysis. Risks related with the
deliberate introduction or unintended presence of allergens must be controlled in accordance with the Allergen
Risk Management Procedure.
Depending on the PTCs produced on site, any applicable PTC-specific Hazard Control requirement must be
considered during the hazard assessment and for the determination of the control measures. In particular, FS
Control Equipment (FSCE) are control measures defined per PTC.
Alternative control measures can be accepted if supported by robust rationale based on science and site studies.

Associated Documents:
− FS Hazard Control Plan Procedure FSD-VC-PRO-004
− Allergen Risk Management Procedure FSD-VC-PRO-003
− PTC-specific Hazard Control measures and FSCE
− Procedure Validation of Control Measures and Equipment

Release of Finished and Semi-finished Products

Release of finished and semi-finished products must be the outcome of a deliberate human decision made on the
basis of sound evidence that the products are safe. The release decision can only be made and executed by Danone
employees.

Therefore, each Manufacturing site must:

− Determine the appropriate Food Safety Release Requirements with associated Release Criteria, among the
verification activities carried out for each product or semi-finished product manufactured by the site in
accordance with the Verification Plan Procedure. The choice of these Release Requirements and associated
Criteria (including Finished Product testing or not) must be based on a documented risk analysis taking into
account the following:
o The minimum FS Release Requirements identified in the applicable PTC-specific Verification Plans,
o Applicable regulatory requirements in country of manufacturing and sales,
o The specific sensitivity of the target consumer,
o The specific sensitivity of the finished products,
o The site’s historical data and current trends (environmental management plan, non-conformities, etc.),
o Specific planned or unplanned events increasing temporarily the prevalence of hazards on the site.
− Set-up a documented process with formally appointed responsibilities, ensuring that release decision (either
manual or automatic) can be made only if the following cumulative conditions are met:
o Operational verification of monitoring results is carried out, and demonstrates full compliance with
the FSHCP in accordance with the FS Hazard Control Plan Procedure; and
o All other Food Safety Release Requirements comply with their corresponding Food Safety Release
Criteria; and
o No event or NC has occurred which may raise a doubt on above mentioned results reliability, and
o Any other applicable release criteria (e.g., quality or regulatory parameters) is met.
− Have in place a dedicated and secure tool or software to support and track the effective release of finished
and semi-finished products.

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Products must in any case remain under Danone ownership during the quarantine time, until the release decision
is made (whether they are physically still at the manufacturing site or shipped to a distribution center).
Potentially unsafe products must be managed in consistency with the site’s FSHCP and the Verification Plan
procedure.

Associated Documents:
− Verification Plan Procedure FSD-MA-PRO-002
− PTC specific Verification Plans
− FS Hazard Control Plan Procedure FSD-VC-PRO-004

Change Management
Potential impacts on the Manufacturing site FSMS must be formally identified, assessed, and tracked for any
change in the manufacturing site, such as:

− Launch of a new product or renovation of an existing product, which must be managed in accordance with FS
in Design standards;
− Use of new raw materials, ingredients, packs, which must be sourced according to FS in Sourcing standards;
− Technical projects such as modification of equipment, process, infrastructure, layout, building, etc.;
− Temporary activity, such as realization of an industrial trial or other tests needed to validate a new recipe,
process, equipment etc.;
− Measures implemented following a crisis or incident;
− Any other situation such as change in the organization (e.g., change in a key position impacting FS,
implementation of a new shift, etc.), the set-up of a subcontracted activity, etc.
Project managers must involve as early as possible a FS representative appointed by the local QFS manager. Her/his
role is to anticipate and assess the impacts on the manufacturing site’s FSMS, and when relevant to ensure the
connection with the risk analysis carried out as part of the Design or Sourcing steps.

The Manufacturing Site Managing Board must ensure that the GO/NO GO decision to implement any change is
made collectively and takes into account the outcome of the risk analysis.

When an impact to the FSMS is identified, all concerned FSMS documents (e.g., PRP rules, HACCP studies, FSHCP,
etc.) must be updated accordingly before the change occurs.

Operational rules given to staff at shopfloor level must be systematically updated when necessary. Changes must
be approved by duly appointed manager(s) in consistency with Manufacturing site organization (see 1.2).
Appropriate internal communication must accompany all changes in operational rules, supported by appropriate
training when relevant (see 1.5).

Associated Documents:
− Food Safety in Design Directive FSD-DE-DIR-001
− QFS in Sourcing Directive QFS-SO-DIR-001

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Documented Information Control

All documented information that is relevant for the FSMS must be appropriately controlled, including:

− All applicable Danone FS Standards (directives, procedures, reference documents, etc.);

− External reference documents supporting the FSMS (e.g., applicable regulations, external standards, customer
specifications, etc.);
− Manufacturing site’s procedures, instructions, SOPs or equivalent which detail how activities are to be
executed and related responsibilities;
− Documents supporting rules set in the FSMS (e.g., HACCP studies, validation protocols and reports, etc.);
− Applicable templates;
− Records that demonstrate activities have been executed as planned; these records may be digital (e.g.,
captured in SAP or dedicated software or files, etc.) or handwritten;
− Any other type of document relevant for the FSMS.

To this end, each site must have a documented procedure in place with clearly appointed responsibilities,
containing explicit rules which ensure, as a minimum, that:
− Only controlled, approved, and updated documents are available in operations, with no possible ambiguity
regarding applicable versions;
− Targeted recipients of any new or revised document are informed and/or trained in such a way that the new
requirements are consistently applied at the latest by the corresponding application date;
− Overlaps are avoided as far as possible in an integrated management system mindset (see 1.2);
− Records (whether electronic or handwritten) are filled, controlled, and retained in appropriate conditions to
ensure their reliability as key evidence;
− The documented information meets the minimum retention requirements set by applicable legislation,
Danone Traceability Procedure and FSSC 22000 scheme. At a minimum, this must be no less than six months
after the longest shelf life of the products manufactured by the site.

The documents supporting the manufacturing site’s FSMS must be made available upon request to relevant internal
functions, authorized external inspectors and auditors, and regulatory authorities for consultation.

Associated Document:
− Traceability General Procedure FSD-VC-PRO-002

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Verification and Continuous Improvement of the FSMS

Verification of the FSMS

Verification activities must be formally planned in order to confirm the effectivity and the efficiency of the FSMS.
As a minimum:
− PRP verification must be implemented based on inspections, audits, trends, and analytical plan reviews as per
the PRP Procedure.
− Verification plans must be established and implemented at operational level as per the Verification plan
Procedure, taking into account the minimum applicable PTC-specific Verification Plans.
− Internal audits of the site FSMS, as required by ISO 22000, must be performed regularly (ideally on a yearly
basis) under the following conditions:
o They must cover all activities involved in the design, implementation, monitoring, and verification of
the PRPs and FSHCP;
o They must be carried out by competent auditors, who can be internal or external. The auditor(s)
training and qualification process must be defined, documented, and recorded;
o The internal audit planning and audit outcomes must be recorded;
o The FSI audit provided by FS@D may be considered as replacing the internal audit on the years when
it happens for the site (in full or in part, upon decision of the Manufacturing site) (see also 3.4).

Verification activities outputs must fuel continuous improvement and be consolidated as key inputs to FSMS
reviews (see 3.3).

Associated Procedures:
− FS Procedure on Pre-requisite Programs FSD-VC-PRO-001
− Verification Plan Procedure FSD-MA-PRO-002
− PTC-specific Verification Plans

Management of Non-Conformities, Incidents and Crises

A Food Safety related non-conformity (NC) is any deviation to specifications, standards or procedures which is
assessed as triggering a confirmed FS risk, or for which a FS risk cannot be excluded.

A documented process must define how FS related NCs are formally tracked and corrected, covering all sources of
NCs related to the manufacturing site activities, such as:
− NCs detected during manufacturing site activities (deviation in CCP/OPRP, verification activities, etc.)
− Customer/consumer complaints assigned to the site,
− NCs identified in internal audits (see 3.1) and external audits (e.g., FSI, FS investigation, FSSC 22000, customers’
audits, official controls from authorities), etc.
When the local team has a suspicion of FS risk without being able to conclude, the corresponding FS PTC point of
contact must be informed by QFS according to the process in place locally. The FS PTC assesses the situation and
consults the DFSC for scientific risk assessment (if necessary), to identify if the NC is indeed a FS related NC (as
defined above), or if the FS risk can be excluded.

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Corrections must be implemented for all FS related NCs, based on the criticality of the NC and its FS impact. The
following information must be documented, as a minimum:
− Determination of the consequences of the failure with regards to food safety;
− Determination of the immediate likely cause(s) of failure;
− Identification of the affected products and handling, in accordance with applicable specific procedures (FS
Hazard Control Plan Procedure, Verification Plan procedure, etc.);
− Actions implemented to set process back to normal and eliminate immediate likely cause(s);
− Communication to relevant Danone stakeholders (e.g., CBU Q&FS, other factories, R&I, Operations, etc.).

The need for corrective action(s) must then be assessed based on the impact (i.e., severity of FS risk for consumers
/ customers, economic consequences, regulatory non-compliance, etc.) and recurrence of the NC.

When implementing corrective actions, the following information must be documented, as a minimum:
− Root cause analysis to determine the causes of the NC, using problem solving methods/tools when necessary.
− Determination of similar NC that could potentially occur elsewhere.
− Actions implemented to eliminate the causes of NC based on outputs of the root-cause analysis.
− Responsibilities and deadlines for implementing the actions.
− Review of corrective actions effectiveness.
− Any changes made to the FSMS if necessary (e.g., HACCP update, FSHCP re-validation, PRP upgrades, etc.).
− Communication to relevant Danone stakeholders (e.g., CBU Q&FS, other factories, R&I, Operations, etc.).
If a non-conformity is likely to evolve into an incident or crisis, it must be handled in full consistency with the
Danone Crisis Management Policy, including escalation to global QFS and FS@D when required.

This overall NC management process must be considered as a key driver of Continuous improvement at
manufacturing site level.

Associated Procedures:
− FS Hazard Control Plan Procedure FSD-VC-PRO-004
− Verification Plan Procedure FSD-MA-PRO-002
− Danone Crisis Management Policy (restricted access, available to Crisis Managers (BUCMs))

FSMS Review and Update

A regular operational review and update of the FSMS and its components, i.e., PRP, HACCP studies and FSHCP must
be performed, ideally on a yearly basis. This operational review must take into account change management
outputs (see 2.4), outputs of the analysis of verification results (see 3.1), and continuous improvement outputs (see
3.2).
A FS management review must also be performed regularly (recommended frequency annually) with the
Manufacturing site managing board, taking into account the following inputs:
− The status of actions from previous management reviews;
− Changes in external and internal issues that are relevant to the FSMS, including Danone food safety standards,
Regulatory and customer requirements, changes in organization and resources;
− Changes in food safety-related organizational risks and opportunities (see 1.1);
− Information on the performance and the effectiveness of the FSMS, including trends in:
o monitoring, measurement, and analysis results;
o results of internal and third-party audits;

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o nonconformities and corrective actions;

− Any incident, crisis, or withdrawal/recall that occurred;
− Relevant information obtained through external and internal communication, including requests and
Complaints from interested parties;
− Opportunities for continual improvement.

The outputs of these reviews must be documented, and include at least:

− Decisions related to continuous improvement opportunities;
− Any need for changes to the site FSMS, including organization and resources, objectives, and specifications of
the FSMS, FSHCP and verification plans.
The Manufacturing site director must fully endorse conclusions of the FS Management review which help for
investment prioritization, project prioritization, resource allocations, etc.

Performance Evaluation within Danone overall FSMS

In order to regularly measure and confirm the overall Danone FSMS consistency and robustness, Danone
Manufacturing sites must undergo two complementary audit processes, as part of the overall Danone FSMS
verification activities:
− Each manufacturing site must obtain and maintain FSSC22000 certification for the scope of activities that falls
under the site responsibility. Only certification bodies approved by FS@D and mentioned in the List of approved
FSSC22000 certification bodies can be used for certification audits.

− Each manufacturing site is audited in accordance with the General procedure on FS Internal Audit for Danone
Manufacturing Sites, which implies regular audits performed by qualified auditors, at a frequency determined
by FS@D on a risk-based approach. The FS Index (FSI) is calculated for each site as a result of the FSI audit,
indicating the site FS performance.
Each Manufacturing site must conduct regular self-assessments against the One Manufacturing Audit Grid in order
to proactively identify improvement areas feeding the local Management Review (see 3.3).
Indeed, the results of the latest self-assessments are considered by the FS auditors during the FSI audit, and the
comparison between the audit outcomes and the self-assessment outcomes provides valuable insights on the level
of maturity of the site as regards the management of Food Safety.

Associated Documents:
− List of Approved FSSC 22000 Certification Bodies & Points of Contact FSD-MV-REF-002
− General Procedure FS Internal Audit for Danone Manufacturing Sites FSD-MV-PRO-003
− FSI RBA Audit Grid FSD-MV-TEM-004

Mandatory Application Confidential & privileged DANONE Internal Use

 QFS-MA-DIR-005
QFS DIRECTIVE VERSION N° 1.0
FOOD SAFETY IN MANUFACTURING DATE: 10 APRIL 2024
(SUPERSEDES ALL PREVIOUS VERSIONS) PAGE 14/16

Document Control

Food Safety Management System Leader Alexandra Ruel

Written by
EDPi Food Safety Operations Standard Manager Noël Sorrel
SN Food Safety Auditor Alexandra Colmant
Food Safety Certification Manager Christophe Boulais
Written with
Waters Food Safety Standards Manager Romain Cyr
the support of
External consultancy expert in Risk-Based
EXARIS
Management Systems for the food industry
EDPi Quality in Operations Director Catherine Pinchon-Baratier
SN Quality Compliance Manager, Milks Europe Damien Dalton
FS Waters, Bev. & Breakthrough Innovation Director Joana Domingues
DNA Director, Quality Operations in Corporate Quality Mark Deroin
Reviewed by
Waters Quality Operations Director Milena Hristova
Engineering G & E Director Nicolas Le Goff
DNA Director Quality Operations Travis Stanton
Food Safety Management System Technician Vera Chapelet

Impact Analysis Done: Only targeted impact analysis of requirements about finished product release
Rationale for not performing a full impact analysis: considering that the Directive provides a common
FSSC22000-based framework to Manufacturing activities within Danone, most of its requirements are already
known, and either applied or under implementation at Manufacturing sites’ level

VP, QFS in Operations & Risks Anticipations Ana Paula Fonseca

FS Product Categories Specific Population Director Angelika Tritscher
FS Product Categories Specific Population Director Farai Maphosa
Validated by
VP, Quality & Food Safety SNu Gerben Steggink
FSMS and Transversal Programs Director Isabelle Subirade
Senior Audit Director Stéphanie Gamot
Approved by Chief Food Safety Officer Monique Pellegrino

Mandatory Application Confidential & privileged DANONE Internal Use

 QFS-MA-DIR-005
QFS DIRECTIVE VERSION N° 1.0
FOOD SAFETY IN MANUFACTURING DATE: 10 APRIL 2024
(SUPERSEDES ALL PREVIOUS VERSIONS) PAGE 15/16

Danone Quality & Food Safety Commitments

Danone Food Safety Policy
FSD-SY-REF-006 Strategic Planner_ISO 22000
Recording document for cross-reference ISO 22000 FSSC22000 and Danone standards
FSD-DE-DIR-001 FS in Design Directive
FSD-MA-PRO-002 Verification Plan Procedure
QFS-S0-DIR-001 QFS in Sourcing Directive
FSD-VC-PRO-001 FS Procedure on Pre-requisite Programs
FSD-VC-PRO-002 Traceability General Procedure
FSD-VC-DIR-004 Food Fraud Mitigation Directive
QFS-VC-PRO-004 Food Defense Procedure
FSD-VC-PRO-004 Hazard Control Procedure
Related FSD-VC-PRO-003 Allergen Risk Management Procedure
Danone
QFS-MV-PRO-001 FS Internal Audit for Danone Manufacturing Sites
documents &
trainings FSD-MV-PRO-005 Qualification and Calibration of FS Internal Manufacturing Auditors
QFS-MV-SPT-002 List of Approved FSSC 22000 Certification Bodies & Points of Contact
FSD-MV-TEM-004 FSI RBA Audit Grid
QFS-VC-SPE-003-XC Finished Product Quality & Food Safety Criteria Milk & Dairy, Plant based,
and Waters & Beverages
QFS-MA-PRO-002 Control Measures and equipment validation*

PTC-specific GMPs**
PTC-specific Verification Plans**
PTC-specific Hazard Control measures and FSCE**

Food Safety Learning Offer

Danone Crisis Management Policy

*Under development and/or revision at the time of this Directive’s publication
** In each PTC-specific library

Related ISO 22000: 2018 Food safety management systems — Requirements for any organization in the
External food chain
documents FSSC 22000 Scheme Version 5.1 | November 2020

Mandatory Application Confidential & privileged DANONE Internal Use

 QFS-MA-DIR-005
QFS DIRECTIVE VERSION N° 1.0
FOOD SAFETY IN MANUFACTURING DATE: 10 APRIL 2024
(SUPERSEDES ALL PREVIOUS VERSIONS) PAGE 16/16

Change Control
Date &
Reason for change and description
Version №
19 April 2022 Document creation
V 1.1 Editorial update: integration of the publication/ application date after the electronic workflow.
20 January 2023
Editorial update: link & code change of the Traceability procedure
V 1.2
Editorial update:
. logo and code change (FSD-MA-DIR-001)
. link & code change of:
. QFS in Sourcing Directive
10 April 2024
. Food Defense Procedure
V 1.0
. FS Internal Audit for Danone Manufacturing Sites
. List of Approved FSSC 22000 Certification Bodies & Point of Contact
. New standard published: Finished Products Quality & Food Safety Criteria Milk & Dairy, Plant-
Based and Waters & Beverages

Mandatory Application Confidential & privileged DANONE Internal Use