EHEDG White Paper on GFSI Hygienic Design Scopes JI & JII

October 2022
European Hygienic Engineering and Design Group

EHEDG Headquarters
Karspeldreef 8
1101 CJ Amsterdam
The Netherlands
E-Mail: office@ehedg.org
Web: www.ehedg.org

THE ENGLISH VERSION OF THIS EHEDG DOCUMENT IS THE OFFICIAL VERSION. THE RESPONSIBILITY
FOR THE PREPARATION, DEVELOPMENT AND ISSUANCE OF SUCH WHITE PAPERS LIES WITH EHEDG.
DUE TO THE TECHNICAL AND GENERAL NATURE OF THE WHITE PAPERS, EHEDG MAY NOT ASSUME
ANY LIABILITY RESULTING FROM THE INTERPRETATION, APPLICATION OR USE OF SUCH WHITE
PAPERS. THIS WHITE PAPER WAS DEVELOPED IN CO-OPERATION WITH 3-A SANITARY STANDARDS.

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Content
Introduction ............................................................................................................................................... 5
Objective and Scope .................................................................................................................................. 6
GFSI Benchmarking Requirements explained ............................................................................................ 7
Table with the GFSI Benchmarking Requirements for scope JI and JII ...................................................... 9
Section 1: Hazard and Risk Management Systems Requirements .......................................................... 13
Section 2: Hygienic Design Management Systems Requirements........................................................... 27
Section 3: Good Industry Sector Practice Requirements ......................................................................... 46
Abbreviations, definitions and terms ...................................................................................................... 55
References ............................................................................................................................................... 58

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 EHEDG White Paper on GFSI Hygienic Design Scopes JI & JII

First Edition – October 2022

©EHEDG

Working Group*
Stefan Akesson Tetra Pak, Sweden
Ellen Brinkman FrieslandCampina, The Netherlands
Olivier Couraud GSF, France
Dirk Nikoleiski Commercial Food Sanitation LLC, Germany
Peter Overbosch The Netherlands
Gerdien Raap Raap Interim, The Netherlands
Olivier Rondouin DOCEOR – DIGITALIAA, France
Katie Satterthwaite Marks & Spencer, United Kingdom
Patrick Wouters** Cargill BV, The Netherlands

* Report prepared by the Working Group “GFSI Hygienic Design Scopes JI & JII” of the European
Hygienic Engineering & Design Group (EHEDG)
** Chairman

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EHEDG White Paper on GFSI Hygienic Design Scopes JI & JII
Introduction
The hygienic design of food-processing buildings and equipment has a major effect on global food
safety across many sectors from farm to fork. Poor hygienic design has led to many major food safety
issues caused by cross-contamination of food products as a result of biological, chemical and physical
hazards. Well thought-out and implemented hygienic design supports food safety and product quality
and contributes to the effectiveness of food-safety management programmes.

In 2020 the Global Food Safety Initiative (GFSI) published a high-level set of hygienic design
benchmarking requirements with the objective of enhancing food safety from farm to fork. These
Hygienic Design of Food Buildings and Processing Equipment requirements were published as scope JI
(for building constructors and equipment manufacturers) and scope JII (for building and equipment
users).

Certification Programme Owners (CPOs) will include the benchmarking requirements of scopes JI and
JII in their standards for GFSI-recognised certification of the hygienic design, fabrication, installation,
maintenance and cleanability of facilities and equipment. Compliance with these standards will benefit
supply chain stakeholders and consumers by contributing to consistent food safety and quality across
the global food supply chain.

3-A Sanitary Standards Inc. (3-A SSI) and the European Hygienic Engineering and Design Group
(EHEDG) have a long history of developing criteria for the hygienic design of buildings and equipment
in the form of standards and guidelines. These are essential tools for equipment manufacturers,
building constructors and food manufacturers to meet food safety and quality objectives and for
government agencies and regulatory authorities to achieve public health objectives.

Together, 3-A SSI and EHEDG welcome this GFSI initiative. With this white paper, the EHEDG
organisation would like to provide support to its stakeholders in the farm-to-fork chain, in interpreting
and applying the requirements of scopes JI and JII.

This white paper is not a standard, it presents the EHEDG views on the GFSI benchmarking
requirements and advice and recommendations on how these can be fulfilled. In accordance with the
definitions provided by ISO 9001, the term “should” is used to express a recommendation by EHEDG,
whereas the
term “shall” is only used in quotations of the GFSI benchmarking requirements.

ISO 9001 definitions:

- “shall” indicates requirements
- “should” indicates a recommendation
- “may” indicates permission
- “can” indicates a possibility or a capability
- Information marked as “NOTE” is for guidance in understanding or clarifying the associated
requirement

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Objective and Scope
Anticipating the inclusion of the GFSI hygienic design benchmarking requirements by Certification
Programme Owners, EHEDG has compiled this white paper to give guidance to companies that are
interested in applying the requirements of GFSI scope JI or JII. Ultimately it will be the CPO standards,
based on GFSI scope JI or JII requirements, against which companies can be certified.

- JI: For food building constructors and processing equipment manufacturers, including, according
to the GFSI, the following product services and activities:
- Manufacturers of equipment, including any components necessary to link them together, and
their utilities and utensils necessary for their operation, for farms, food production facilities,
food retail and wholesale operations, and packaging dedicated to food;
- Architects, Engineers and Designers of food handling facilities, including farm, food
manufacturing, storage and retail buildings;
- The builders of the above facilities.
- JII: For food building and processing equipment users, including, according to the GFSI, the
following product services and activities
- Specifying, purchasing, design and construction of buildings or refurbishments by farmers,
food manufacturers, wholesalers and retailers, and packaging manufacturers for their own
use;
- specifying, purchasing, design and construction of equipment, including any components
necessary to link them together, and their utilities and utensils necessary for their operation,
and facilities by farmers, food manufacturers, wholesalers and retailers, and packaging
manufacturers for their own use.

The structure of this white paper follows the structure of the GFSI benchmarking requirement
documents JI and JII. For each requirement, interpretations, guidance and references (recognised
standards and EHEDG guidelines) are given.
- JI: For building constructors and equipment manufacturers, covers the requirements for the
establishment of a Hygienic Design Management System including hygienic design, hazard and risk
management and good industry practice requirements.
- JII, for building and equipment users, can be seen as hygienic design requirements additional to
the scope of recognition that the building and equipment users will already comply to. It is about
integrating hygienic design into existing Food Safety Management Systems.

The method of executing food safety management may differ between the users of JI and JII:
Food manufacturers are typically familiar with HACCP or HACCP-based concepts as part of their Food
Safety Management System (reference ISO 22000:2021) of which hygienic design is a prerequisite
programme, whereas equipment manufacturers are typically familiar with hygiene risk assessments
based on EN 1672-2:2020, ISO 14159:2008, or other recognised standards. It is important for food-
safety management that expectations and interpretations of needs, capabilities and intended use are
clear during development, realisation or handover of food buildings and equipment.

In the GFSI benchmarking requirements food is used as an umbrella term and refers to the object of
each of the items contained within the scope, i.e. food, feed, packaging as applicable. See also
abbreviations, definitions and terms.
When we use the term food manufacturer, we imply the users of food manufacturing buildings and
the users of processing equipment at any point in the chain from farm to fork.
For the suppliers of these food buildings and processing equipment, GFSI uses building constructors
and equipment manufacturers.

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GFSI Benchmarking Requirements explained
The Global Food Safety Initiative (GFSI), initiated by the Consumer Goods Forum, is an industry-driven
initiative to harmonise food safety audit requirements, worldwide. GFSI publishes Benchmarking
Requirements that are translated into standards by recognised Certification Programme Owners (e.g.
BRCGS, FSSC 22000, IFS or SQF). Operators in the food chain certify against one of these standards; a
GFSI recognised certificate is considered a “license to operate” in the worldwide food industry.

The GFSI has published multiple scopes of recognition A to K (see table with overview of the multiple
GFSI Scopes) that together cover the food supply chain from farm to fork. The most recent publication,
version 2020, includes two new scopes of recognition, JI and JII, which each concern Hygienic Design
of Food Buildings and Processing Equipment:
- JI: For building constructors and equipment manufacturers
- JII: For building and equipment users
JI is a full standalone scope of recognition and consequently has a larger number of requirements than
JII, which contains the additional hygienic design requirements for the scope of recognition the JII
users already comply with.

The GFSI has the same document structure for all farm-to-fork benchmarking requirements, scopes A
to K, including JI and JII. All scopes of recognition are divided into three Sections:
- Section 1: Hazard and Risk Management Systems Requirements (HACCP)
- Section 2: Food Safety (or Hygienic Design) Management Systems Requirements (FSM)
- Section 3: Good Industry (Sector) Practice Requirements (GMP)

The Sections have several sub sections, called Elements, these contain one or more benchmarking
requirements that have a certain commonality (e.g. Documentation requirements). All benchmarking
requirements (The standard shall require that) have a unique Reference (e.g. HACCP 1.6).

Reference Element The standard shall require that

The hygienic design and suitability of buildings and equipment shall be
Hygienic design
HACCP 1.6 evaluated throughout their life cycle from the design concept, through
process
construction, purchasing and during use, until the end of their intended life.
A procedure shall be established, implemented, and maintained for the
Documentation management and control of documented information required to
FSM 9.1.2
requirements demonstrate the effective operation and control of processes and the
Hygienic Design Management System.
Procedures shall be established, implemented and maintained to ensure all
employees and contractors involved in building and equipment evaluation,
GMP 7.2 Training specification, purchase, maintenance and hygienic design shall be trained in
hygienic design principles appropriate to their tasks and to the hygienic
design requirements of the building or equipment for its intended use.
Source: GFSI Benchmarking Requirements:2020

This document addresses the benchmarking requirements of scopes JI and JII in the order that the
GFSI has given to these requirements; some are shared by JI as well as JII, some are scope specific.
(see Table with the GFSI Benchmarking Requirements scope JI/JII).
Each benchmarking requirement has:
- A table that indicates to which scope it is applicable and the requirement text as it is given by GFSI.
- Guidelines with EHEDG interpretation and explanation. If there are links between requirements,
this is indicated by a reference (e.g. (HACCP 1.6)) to a document where more details or guidance
can be found.
- References to relevant standards and guidelines

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 Overview of the multiple GFSI scopes of recognition
AI Farming of Animals for Meat/ Milk / Eggs / Honey

AII Farming of Fish and Seafood

BI Farming of Plants (other than grains and pulses)

BII Farming of Grains and Pulses

BIII Pre-process handling of plant products

C0 Animal primary conversion

CI Processing of perishable animal products

CII Processing of perishable plant products

CIII Processing of perishable animal and plant products (mixed products)

CIV Processing of ambient stable animal and plant products (mixed products)

D Production of feed

E Catering

FI Retail / Wholesale

FII Food Broker / Agent

H Provision of Food Safety Services

G Provision of Storage and Distribution Services

I Production of Food Packaging

Hygienic Design of Food Buildings and Processing Equipment
JI
(for building constructors and equipment manufacturers)
Hygienic Design of Food Buildings and Processing Equipment
JII
(for building and equipment users)
Production of (Bio) chemicals and bio-cultures used as food ingredients or
K
processing aids in food production

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 Table with the GFSI Benchmarking Requirements for scope JI and JII
Section 1: Hazard and Risk Management Systems Requirements
Scope Reference Element The standard shall require that
Hygienic design A competent multidisciplinary team shall assess the hygienic
JI JII HACCP 1.5
process design and risk assessment of new buildings/equipment.
The hygienic design and suitability of buildings and equipment
Hygienic design shall be evaluated throughout their life cycle from the design
JI JII HACCP 1.6
process concept, through construction, purchasing and during use, until
the end of their intended life.
A documented hygienic design risk assessment for food safety
hazards on new and existing buildings/equipment shall be
JI JII HACCP 1.7 Risk assessment established, implemented and maintained. It shall include as a
minimum the following considerations: intended use, food safety
hazard identification, evaluation.
The hygienic design risk assessment shall be reviewed when any
change to the building/equipment/product/process is made or
JI HACCP 1.8 Risk assessment
other hazards arise, or at a minimum frequency defined by
applicable laws and regulations.
HACCP
JI Intended use The intended use of the building/equipment shall be specified.
1.9.1
The intended use of the building/equipment shall be described, as
HACCP
JI Intended use a specification for the intended purchase of new buildings and
1.9.2
equipment.
Appropriate building/equipment hygienic design principles shall be
Hygienic design adopted based on the designated risk assessment, appropriate to
JI JII HACCP 1.10
principles their intended use and taking into consideration a user
specification.
Hygienic design Buildings and equipment shall be of a cleanable design, to meet all
JI HACCP 1.11
principles cleaning objectives.
Buildings and equipment shall be designed and constructed to
Hygienic design
JI HACCP 1.12 avoid favourable growth conditions (for microorganisms, pests and
principles
their harbourage), appropriate to their intended use.
Hygienic design Buildings and equipment shall be designed to prevent
JI HACCP 1.13
principles contamination appropriate to their intended use.
Wherever relevant, recognised hygienic design
Hygienic design standards/guidance shall be consulted for the design and
JI HACCP 1.14
principles construction of buildings and equipment, appropriate for their
intended use.
Appropriate hygienic design principles shall be adopted for the
Hygienic design
JI JII HACCP 1.15 installation of new equipment and construction of buildings at
principles
sites handling food.
Hygienic design principles shall be adopted to ensure the
Hygienic design
JI HACCP 1.16 maintenance of the hygienic performance of the
principles
buildings/equipment, appropriate for their intended use.
Appropriate measures (with frequencies) shall be specified,
undertaken accordingly and documented to mitigate any
Hygienic design
JI HACCP 1.17 remaining food safety risks identified in the hygienic design risk
principles
assessment following building/equipment construction, purchase
and installation.
Source: GFSI Benchmarking Requirements:2020

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Section 2: Hygienic Design Management Systems Requirements
Scope Reference Element The standard shall require that
A clear organisational structure identifying the job functions and
Management
JI FSM 1.2 responsibilities of at least those employees whose activities affect
responsibility
Hygienic Design shall be established, implemented and maintained.
Management
Evidence of the senior management’s commitment to establish,
commitment
JI FSM 2.2 implement, maintain and continuously improve the Hygienic Design
and food safety
Management System shall be provided.
culture
The organisation’s senior management shall review the verification
Management
JI FSM 3.2 of the Hygienic Design System at planned intervals, to ensure their
review
continuing suitability, adequacy and effectiveness.
Procedures shall be established, implemented and maintained to
ensure that buildings and equipment are legally compliant in the
JI FSM 4.4 Legislation
hygienic design requirements in the country of known
implementation/sale.
Hygienic Design
A Hygienic Design Management System shall be established,
JI FSM 5.2 Management
implemented, maintained and continuously improved.
System
A clear, concise and documented Hygienic Design policy statement
Hygienic Design shall be in place, as well as measurable objectives specifying the
JI FSM 6.2
Policy organisation’s commitments to meet the food safety needs of its
products.
A procedure shall be established, implemented, and maintained for
Documentation the management and control of documented information required
JI FSM 9.1.2
requirements to demonstrate the effective operation and control of processes
and the Hygienic Design Management System.
All the above-mentioned documented information shall be securely
stored for the time period required to meet customer and legal
Documentation
JI FSM 9.2.4 requirements, or for a period exceeding the lifetime of buildings/
requirements
equipment if customer or legal requirements are not available. It
shall be effectively controlled and readily accessible when needed.
Specified requirements or specifications shall be established,
Specified
implemented and maintained for all inputs to the process, including
JI FSM 10.1 requirements/
services that are purchased or provided and have an effect on food
Specifications
safety.
Specified
A review process of the specified requirements or specifications
JI FSM 10.2 requirements/
shall be in place.
Specifications
Procedures and instructions shall be established, implemented and
JI FSM 11 Procedures maintained for all processes and operations having an effect on
food safety.
The resources needed to establish, implement, maintain, review
Resource
JI FSM 12.2 and improve the Hygienic design Management System shall be
management
identified and assigned.
A purchasing procedure shall be established, implemented and
Purchasing and maintained to ensure that all inputs to the process including
JI FSM 13.1.3 supplier externally purchased materials and services which have an effect on
performance food safety, conform to specified requirements as well as
regulatory requirements.
Source: GFSI Benchmarking Requirements:2020

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Section 2: Hygienic Design Management Systems Requirements
Scope Reference Element The standard shall require that
Purchasing and A procedure shall be established, implemented and maintained to
JII FSM 13.1.4 supplier ensure that the newly purchased building/equipment meets the
performance hygienic design specification.
A procedure for the evaluation, approval and continued monitoring
of suppliers which have an effect on food safety shall be
Purchasing and established, implemented and maintained. The procedure shall
JI FSM 13.2.4 supplier address procurement in emergency situations to ensure buildings/
performance equipment still confirms to the documented specified requirements
or specification, and the supplier has been evaluated. The results of
evaluations, investigations and follow-up actions shall be recorded.
Purchasing and Outsourced processes or service that affect food safety shall be
JI FSM 13.3.2 supplier identified and controlled. Such controls shall be documented in the
performance Hygienic Design Management System.
Procedures shall be established, implemented and maintained to
ensure the ability to trace or follow a material or article critical to
JI FSM 14.1.5 Traceability
food safety through all stages of purchase, construction and
distribution (minimum one step forward and one step backward).
Where external testing of construction materials, buildings or
equipment is required, it shall be carried out by an accredited
JI FSM 19.4 Testing
testing facility or one that follows relevant international testing
guidelines.
Where in-house testing is carried out, calibration of equipment that
JI FSM 19.5 Testing is critical to food safety shall be carried out against national
standards or other accurate means.
An internal audit procedure shall be established, implemented and
JI FSM 20.2 Internal audit maintained; it shall cover all elements of the Hygienic Design
Management System.
A procedure for the management of complaints and complaint data
Complaint shall be established, implemented and maintained to ensure that
JI FSM 21
handling complaints are assessed and corrective actions implemented, when
necessary.
An incident management procedure, including product recall,
Serious incident withdrawal, and retrofit shall be established, implemented and
JI FSM 22.4
management maintained. The recall procedure shall be regularly tested for
effectiveness.
Commissioning or building/equipment release procedures shall be
JI FSM 23.2 Product release
established, implemented and maintained.
Hygienic design construction specifications shall be verified for
JI FSM 23.3 Product release buildings and equipment prior to dispatch or hand-over to the
customer.
A procedure shall be established, implemented and maintained to
Control of non- ensure that any non-conformity impacting food safety and any non-
JI FSM 24.1
conformity conforming products are clearly identified and controlled to
prevent unintended use or delivery.
A procedure shall be established, implemented and maintained for
Corrective
JI FSM 25 the determination and implementation of corrective actions in the
actions
event of any significant nonconformity relating to food safety.

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Section 2: Hygienic Design Management Systems Requirements
Scope Reference Element The standard shall require that
Change control shall be undertaken and documented to evaluate
Change
JII FSM 26 the impacts of any changes/ modifications on equipment/building
management
hygienic design.
Source: GFSI Benchmarking Requirements:2020

Section 3: Good Industry (Sector) Practice Requirements

Scope Reference Element The standard shall require that
The building in which equipment is manufactured shall be designed,
JI GMP 3.2 Equipment constructed and maintained to minimise any contamination of the
manufactured equipment which may affect food safety.
Product
Suitable employee, contractor and visitor access requirements shall
contamination
JI GMP 4.8 be in place such that food safety is not compromised if construction
risk and
is undertaken at a site in which food is being handled.
segregation
Product
Procedures shall be in place to prevent the cross-contamination of
contamination
JI GMP 4.9 food from hazards created by construction activities if construction
risk and
is undertaken at a site in which food is being handled.
segregation
Prior to building commissioning or equipment dispatch, buildings /
Product
equipment shall be cleaned by the manufacturer / constructor
contamination
JI GMP 4.10 using appropriate methods that will remove all food safety hazards
risk and
associated with the construction process. Cleaning should be
segregation
recorded and verified.
Product
Following purchase (and installation), all buildings and equipment
contamination
JII GMP 4.11 shall be cleaned/commissioned by the user before they are used for
risk and
the processing of food. Cleaning should be recorded and verified.
segregation
Procedures shall be established, implemented and maintained to
ensure all employees and contractors involved in building and
equipment evaluation, specification, purchase, maintenance and
JII GMP 7.2 Training
hygienic design shall be trained in hygienic design principles
appropriate to their tasks and to the hygienic design requirements
of the building or equipment for its intended use.
Procedure shall be established, implemented and maintained to
ensure all employees and contractors involved in building
JI GMP 7.3 Training construction and equipment installation, undertaken at a site
handling food shall be trained in food safety principles appropriate
to their task.
A procedure shall be established, implemented and maintained to
JI GMP 13 Pest control prevent, monitor and control or eliminate the risk of pest
infestation at the site.
Manufactured equipment shall be stored and transported to the
JI GMP 15.2 Transport final customer in a manner that prevents contamination of the
equipment which may affect food safety.
Source: GFSI Benchmarking Requirements:2020

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Section 1: Hazard and Risk Management Systems Requirements
Scope Reference Element The standard shall require that
A competent multidisciplinary team shall assess the
JI
HACCP 1.5 Hygienic design process hygienic design and risk assessment of new
JII
buildings/equipment.

Guidelines
A multidisciplinary team, responsible for HD and HDRA should be competent in:
- Food safety and quality including microbiology and allergen expertise
- Hygienic design requirements and principles for equipment and facilities (HACCP 1.10-1.17 )
- Hygienic engineering/maintenance
- Product and process requirements and conditions
- Operational and functional considerations that could affect hygienic design (e.g. cleaning
method, operating conditions, possible future applications, etc.)
- Interpretation of technical engineering drawings and PI&D
- Legal requirements and industry standards
- Hazard analysis and risk assessment methods (HACCP 1.7)
- Cleaning & disinfection (sanitation)

Hygienic design training courses can be based on recognised training programmes such as those of
EHEDG or 3-A SSI. These courses should incorporate the content of recognised standards and
guidelines, such as EN 1672-2 (2020), and those of the EHEDG, 3-A SSI.

In this benchmarking requirement, the multidisciplinary team is specifically mentioned in relation to

HD and HDRA of new buildings/equipment. However, additional, broader tasks of such a competent
multidisciplinary team can also include:
- Evaluating the hygienic design and suitability of buildings and/or equipment throughout their life
cycle (HACCP 1.6)
- Taking responsibility for the hygienic design risk assessment of new and existing
buildings/equipment (HACCP 1.7)
- Making recommendations to management regarding the need for upgrading/re-design, or
mitigation measures, if HD criteria cannot be met in their entirely (for example: changes in
periodic cleaning programmes)
- Taking the initiative in engaging end users, (sub)suppliers and subject matter experts
- Acting as a partner for management in the HD management reviews (FSM 1.2 & 3.2)
- Establishing the internal HD criteria and principles (e.g. purchasing specifications)

References
- EHEDG Guideline Doc 58, Hygienic design risk management
- ISO 22000:2018, 7.2 Competence

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Scope Reference Element The standard shall require that
The hygienic design and suitability of buildings
and equipment shall be evaluated throughout
JI
HACCP 1.6 Hygienic design process their life cycle from the design concept, through
JII
construction, purchasing and during use, until the
end of their intended life.

Guidelines
The GFSI has introduced the hygienic design process concept. It involves the management of
equipment, buildings and utilities, throughout their lifecycle from the perspective of hygienic
performance and suitability. The requirements are indicated in various benchmarking clauses:

Hygienic design
- Specification and design for the intended use (JI: HACCP 1.9.1 or JII: HACCP 1.9.2).
- Hygienic design risk assessment (HACCP 1.7-1.8)
- Hygienic design principles to mitigate food safety risks (HACCP 1.10-1.17, GMP 3.2)
Hygienic Build & Integration
- Hygienic construction and installation (HACCP 1.14 & 1.15)
- The use of procedures and training to prevent contamination (GMP 4.8- 4.11; 7.2-7.3; 15.2)
Hygienic operational use
- Residual risk mitigation by cleaning, maintenance, etc. (HACCP 1.17)
- The use of procedures and training to prevent contamination (GMP 7.2)
- HDRA and change control on legacy buildings/equipment (FSM 26)

To confirm that hygienic entities (building/equipment) will meet all specified hygienic design
criteria, their suitability shall be evaluated at various stages throughout the design- and
commercialisation-phases and when in use. The V-model (described in EHEDG Doc 34) focuses on
qualification activities from the start and during the life cycle of a project to enhance the probability
that the building or process line is fit for purpose and meets user expectations.

For bespoke or assigned entities this should happen in close partnership between building
constructors / equipment manufacturers and users (i.e. the food manufacturer); with a joint
acknowledgment of criteria laid out in a user requirements specification. Compliance, design
changes, and workarounds to overcome deviations from design criteria should be documented and
records should be kept at the manufacturing site where the hygienic entity is in use.

Unassigned entities, typically equipment modules or units that are integrated into lines, should be
risk assessed by the supplier according to the intended range of products and processes to confirm
suitability in principle for a certain application (e.g. for dry foodstuffs). Compliance with hygienic
design criteria and the suitability for cleaning can be confirmed by certification according to EHEDG-
procedures carried out by authorised certification bodies. The supplier should also evaluate hygienic
design based on EN ISO 14159 and/or EN 1672-2. In any case, users of unassigned entities should
review the unassigned entities to check their suitability for the intended use.

Specifications and (expected) outcomes of the qualification process can be used during the
purchasing process to draw up concrete agreements between supplier and customer.

Depending on the phase within the lifecycle evaluation, activities related to hygienic design will
vary:

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Design phase
Concepts or feasibility studies usually result in the creation of user or stakeholder requirements.
These requirements should be laid down in one or more documents that shall be reviewed. In the
absence of a user requirements specification (unassigned entities) designers may have to use other
sources to determine user needs, such as focus-groups, consultants, customer-surveys, customer-
partnerships, co-development with customers, etc.

Based on an approved requirements specification, functional and design specifications should be

developed (for less complex entities this may be one single step) to translate requirements into
detailed design solutions. In an iterative process, which is typically referred to as design
qualification, design solutions should be reviewed before agreeing on a “design freeze” and
fabrication of an entity. A hygienic design risk assessment (HDRA) should be performed as part of
the design qualification process. Based on the outcome of this HDRA, the specifications for
purchasing can also be established. These specifications can stipulate the specifics regarding
hygienic design.

Installation and commissioning phase

During installation it should be checked that the correct hygiene-entity has been received and has
been installed according to the approved design specification.

For prefabricated (assigned) entities, a factory-acceptance test (FAT) should be performed by the
user at the supplier’s site prior to shipment.

After installation and before use at the user's premises, it should be verified that all functional
(operational) parameters, limits and tolerances detailed in the user requirements specification can
be met to achieve the required hygienic performance. A site-acceptance test (SAT) should be done
after the equipment/building components are installed at the user’s site and typically includes the
functional testing.

Operational Use
To confirm that new hygienic entities consistently perform according to criteria laid out in user
requirement specifications, including food safety, quality, and cleanability aspects, documentary
evidence should be provided by validation (hygiene-related process qualification).
Cleaning validation activities, which may have been initiated and planned prior to hygienic entities
being built, should be completed as part of the process qualification taking into consideration
anticipated maximum run-lengths.

Legacy entities, which have not previously been evaluated in respect of their hygiene-related
performance, should undergo hygienic design risk assessments and a retrospective cleaning
validation based on historical data.

An ongoing and suitable planning should be established for periodically verifying the hygienic
performance of all hygienic entities during their lifetime, their operational use and maintenance.
This may include internal audits carried out by users to evaluate for example cleaning execution,
compliance with hygienic equipment and infrastructure design requirements, and maintenance
practices.

References
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- EHEDG Guideline Doc 45:2021 Cleaning Validation in the Food Industry - General Principles, Part
1

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- EHEDG Guideline Doc 58 Hygienic design risk management
- EN 1672-2:2020 Food processing machinery - Basic concepts - Part 2: Hygiene and cleanability
requirements
- ISO 14159:2008 Safety of machinery - Hygiene requirements for the design of machinery

Scope Reference Element The standard shall require that

A documented hygienic design risk assessment for
food safety hazards on new and existing
JI buildings/equipment shall be established,
HACCP 1.7 Risk assessment
JII implemented and maintained. It shall include as a
minimum the following considerations: intended
use, food safety hazard identification, evaluation.

Guideline
A hygienic design risk assessment is specific to an application (e.g. product, process, procedures,
location) and can be seen as complementary to other existing risk assessments (e.g. HACCP,
EN1672-2:2020 or ISO 14159:2008.)

EHEDG has established a hygienic design risk management guideline (including HDRA and HD risk
mitigation) that can be used for new and existing food buildings and process lines. It contains
several checklists, including the considerations required for scopes JI & JII.; intended use, food
safety hazard identification and evaluation

Intended use (HACCP 1.9.1 & 1.9.2; HACCP 1.10)

- Intended use is determined by the product and process requirements, operating modes,
cleaning processes, end users, etc.
Food safety hazard identification (HACCP 1.11; 1.12 & 1.13)
- Food safety hazards (biological, chemical, physical) and the contamination mechanisms (ingress,
accumulation, growth) that need to be considered and controlled during operational use.
Evaluation (HACCP 1.14; 1.15; 1.16 & 1.17)
- Risk evaluation considers the severity or impact of the food safety hazard and the likelihood or
probability that the food safety hazard occurs.

The output of the HDRA will be a categorised list of hazards and risks. Hygienic design principles are
used to eliminate or mitigate these hazards and risks. (HACCP 1.10-1.17).

See HACCP 1.8; FSM 2.2 & FSM 3.2 for maintaining the documented HDRA

The equipment manufacturers have the responsibility of informing users of food safety risks that
could not be eliminated by hygienic design and also of providing the user of the equipment with an
instruction handbook covering information needed for hygienically safe operation within the limits
of use of the respective equipment. This includes but is not limited to:
- Instructions regarding limitations and operational use
- Instructions regarding technical measures (e.g. control or inspection devices)
- Instructions regarding disassembling for inspection, cleaning and maintenance
- Instructions for cleaning

References
- Codex Alimentarius CXC 1-1969: 2020 (+ HACCP annex)
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities

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- EHEDG Guideline Doc 58, Hygienic design risk management
- EN 1672-2:2020 Food processing machinery. Basic concepts. Hygiene and cleanability
requirements
- ISO 14159:2008 Safety of machinery – Hygiene requirements for the design of machinery

Scope Reference Element The standard shall require that

The hygienic design risk assessment shall be
reviewed when any change to the building/
JII HACCP 1.8 Risk assessment equipment/product/ process is made or other
hazards arise, or at a minimum frequency defined
by applicable laws and regulations.

Guideline
This requirement to review the HDRA at a minimum frequency or upon any change to the building,
equipment, product or process is applicable for the users of food buildings and processing lines (JII).
Additionally, users are required to implement change management (FSM 26).

This indicates that after the agreed hand over from supplier to customer, the user is responsible for
the hygienic operational use of the building, equipment, product or process. In addition to
performing a HDRA prior to any change, the user of a food building or processing equipment should
incorporate a generic HDRA into its periodic review of the food safety management system.

An HDRA assesses any changes in conditions that result in the building or equipment no longer
being fit for its originally intended purpose. Such changes may include:
- Wear/failures/breakdowns (other than wear and tear corrected by routine maintenance)
- Sources or origin of the same raw materials/new raw materials
- Product portfolio
- Intended use of products
- Use of building/equipment
- Process parameters
- Cleaning chemicals or methods
- Legislation, industry standards, customer requirements

An HDRA may also be required as a response to:

- Customer complaints
- Repeated failures in cleaning programmes
- Increasing levels of pathogens or other (newly identified) hazards in the processing
environment
- Food safety incidents
- Building constructors or equipment suppliers signalling generic issues with similar
buildings/equipment

References
- EHEDG Guideline Doc 58, Hygienic design risk management

Scope Reference Element The standard shall require that

HACCP The intended use of the building/equipment shall
JI Intended use
1.9.1 be specified.

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Guideline
The supplier/manufacturer is expected to specify the intended use and to provide concrete
information regarding the operating window for their building/equipment.
In case of assigned entities, the manufacturer can take the customer’s user requirement
specification as a basis and determine the limitations in conjunction with the customer.
The intended use of the building or equipment can be determined by:
Product:
- Range of product, raw materials and recipes
- Variation in local or international properties/requirements for raw materials or product
- Product characteristics (e.g. solid/liquid, viscosity, particles/fibres, etc.)
- Vulnerability/sensitivity of the product to identified hazards
- Intended shelf life and under what conditions (from long-term ambient stable raw materials to
ready-to-eat products that are perishable if not cooled)
Process:
- Process step (e.g. heating, drying, baking, cutting, mixing, etc.)
- Parameters (e.g. temperature, pH, time, etc.)
- Performance-requirements (speed, capacity, range of products, turnaround times, maintenance
intervals, up-times, maximum cleaning frequency, etc.)
- The susceptibility of the process to identified hazards
Operating modes:
- Processing, cleaning, maintenance, etc.)
- Automatically or manually operated
- Open or closed
- Wet or dry
Cleaning:
- Cleaning method and frequency
- Wet or dry cleaning
- Type and concentration of detergents and disinfectants to be used
Value chain:
- The position of the operation in the farm-to-fork value chain
- The relevant stage of production and processing in the food chain (e.g. raw, semi-finished,
finished, ready-to-eat) and industry sector (e.g. meat industry, low moisture food, etc.)
- The next customer (from to-be-processed by subsequent professional company to ready-to-eat
by the end customer)
Vulnerability of end users:
- How vulnerable are the intended users: animals, healthy people, vulnerable babies or elderly or
sick
Building or machine users:
- Anticipated foreseeable users’ level of competence, experience or ability (e.g. operators,
cleaning personnel, maintenance personnel)
Life cycle:
- Lifetime of components
- Recommended maintenance and cleaning intervals
Environment:
- The kind of environment the building/equipment will operate in or be located in.
- The conditions the building/equipment is exposed to (e.g. weather conditions, maximum
temperatures, humidity levels, indoors, outdoors, tolerance to dust and humidity, chemicals
and cleaning agents)
- Space required for movement, operation, cleaning or maintenance of machines
Laws and regulations:
- Applicable laws/regulations and standards to be considered (e.g. local or international; where

EHEDG White Paper on GFSI Hygienic Design Scopes JI & JII ©EHEDG Page 18 of 59
 the entity is made or where the entity will be used)
Additional requirements:
- Quality of utilities (water, steam, air and ventilation)
- Reasonably foreseeable misuse, failure or malfunction
Additional considerations for buildings:
- Plant layout/zoning (e.g. basic, medium or high hygiene zone)
- Expected flows (personnel, raw material, product, packaging residues, etc.)

Note: Changes in any of the above should trigger a re-evaluation of intended use and HDRA.

References
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- EHEDG Guideline Doc 58, Hygienic design risk management
- EN 1672-2:2020 Food processing machinery. Basic concepts. Hygiene and cleanability
requirements
- ISO 14159:2008 Safety of machinery – Hygiene requirements for the design of machinery

Scope Reference Element The standard shall require that

The intended use of the building/equipment shall
HACCP
JII Intended use be described, as a specification for the intended
1.9.2
purchase of new buildings and equipment.

Guideline
A user should describe the intended use in a user requirement specification (URS), and for what type
of product, process etc. the building or equipment should be appropriate. Intended use
specifications for HD purposes should include the elements mentioned under HACCP 1.9.1, but in
this case the information should be provided by the end-user.

For HD purposes, a URS typically includes:

- Hazards identified for consumers of the food products manufactured in the building or by the
equipment following the HACCP analysis.
- Mandatory design requirements (legal, corporate, or any other applicable recognised standards
and guidelines, provided these have been properly qualified/validated).
- Performance criteria for the cleaning objectives.
- List of relevant, previously qualified, hygienic entities/modules.
The URS may include aspects other than just an HD (e.g. criteria for operational performance,
safety, electrical and automation systems, sustainability, etc.).

References
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- EHEDG Guideline Doc 58, Hygienic design risk management

Scope Reference Element The standard shall require that

Appropriate building/equipment hygienic design
principles shall be adopted based on the
JI HACCP Hygienic design
designated risk assessment, appropriate to their
JII 1.10 principles
intended use and taking into consideration a user
specification.

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Guideline
The hygienic design principles are the basic design aspects and methods used to eliminate, reduce
or mitigate biological, chemical and physical food safety hazards, as well as negative influences on
product quality.

The hygienic design of equipment and buildings has the following objectives:
- To ensure a cleanable design and meet all cleaning objectives to prevent an accumulation of
undesirable materials (HACCP 1.11)
- To prevent growth of undesirable microorganisms or pests (HACCP 1.12)
- To prevent contamination due to the ingress of undesirable materials or hazards (HACCP 1.13)

EHEDG recognises and promotes the following hygienic design principles to meet the above
hygiene objectives:
- Segregation
- Cleanability
- Accessibility
- Drainability
- Material compatibility
- Surface and Geometry

More details regarding the hygienic design principles and explanations can be found in EHEDG
guidelines (see references).

The HD principles need to be adopted based on the intended use and user requirement
specification (HACCP 1.9.1 & 1.9.2) and associated risk assessment (HACCP 1.7 & 1.8) .

The EHEDG guideline Hygienic design risk management provides guidance for hygienic design risk
assessment and hygiene risk mitigation (elimination or reduction). It explains with several checklists
and tables how hygienic design principles can be used in relation to:
- Identifying food safety hazards by assessing (the design of) the food building or process
equipment against the hygienic design principles, e.g. is this vessel drainable, is this building
construction or piece of equipment assessable for cleaning, inspection or maintenance?
- Identifying hygienic design solutions that should be applied for the food building or process
equipment to eliminate or mitigate identified food safety hazards.
- Identifying technical control measures and operational procedures that are needed to mitigate
the remaining food safety risks that cannot be eliminated by hygienic design, e.g. inserted
sensors, cleaning and disinfection, or preventive maintenance.

References
- EHEDG Guideline Doc 8:2018 Hygienic design principles
- EHEDG Guideline Doc 32:2005 Materials of construction for equipment in contact with food
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- EHEDG Guideline Doc 44:2014 Hygienic Design Principles for Food Factories
- EHEDG Guideline Doc 58, Hygienic design risk management
- EN 1672-2:2020 Food processing machinery - Basic concepts - Part 2: Hygiene and cleanability
requirements
- GMA/CBA, Grocery Manufacturers Association, now Consumer Brands Association
- ISO 14159:2008 Safety of machinery – Hygiene requirements for the design of machinery
- NAMI:2021 North American Meat Institute, Food Safety Equipment Design Principles, checklist
and glossary
- Regulation EU 1935/2004 on materials and articles intended to come into contact with food

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Scope Reference Element The standard shall require that
HACCP Hygienic design Buildings and equipment shall be of a cleanable
JI
1.11 principles design, to meet all cleaning objectives.

Guideline
Hygienic design principles are applied to enable effective and efficient cleaning, disinfection and
sterilisation regimes, and to minimise cross-contamination risks. Improperly or insufficiently cleaned
equipment or buildings can become a food hazard contamination risk.

For a food manufacturing facility, the application of validated cleaning and disinfection regimes
belongs to the prerequisite programmes (PRP) required in a robust HACCP system based on ISO
22000.

The purpose of cleaning is to remove contaminants from direct and indirect food contact surfaces.
Contaminants may be physical, chemical or microbiological, they include, for example, soils,
lubricants, grease, blood, chemical and food residues, food allergens, and microorganisms. Once a
surface has been successfully cleaned, an additional disinfection step may be required for residual
microorganisms. Insufficiently cleaned surfaces cannot be effectively disinfected.

The cleaning objectives depend on the intended use (HACCP 1.9.1 & 1.9.2). These can be translated
into cleanliness acceptance criteria to be achieved for the building/equipment in relation to the end
product specifications. In case of unassigned entities, this applies to the assumed end product.
For example, a cleanable design implies that a building or equipment has:
- Accessible surfaces for CIP or COP, and, where necessary, access may involve disassembly.
- Construction materials suitable for the intended cleaning method, e.g. wet vs. dry cleaning or
for the prevention of corrosion caused by cleaning chemicals.
- Smooth surfaces and geometries for easy soil or fouling removal.
- Junctions between walls and floor rounded and sealed for ease of cleaning.
- Adequate sloping of floor and flat surfaces to prevent any standing water.

Note: an easily cleanable design is also more economic and sustainable. Equipment and factories
that are difficult to clean will require harsher cleaning procedures involving the use of more
corrosive chemicals, more water and energy, longer down times or more frequent cleaning. The
consequences are higher direct and indirect costs, reduced availability for production, reduced
lifetime of the equipment, and more waste and effluents, as well as increased safety risks to
personnel.

EHEDG has published several guidelines on cleaning methods and cleaning validation (see
references). EHEDG tested and certified equipment is evaluated for its cleanability (see EHEDG.org).

References
- EHEDG Guideline Doc 8:2018 Hygienic design principles
- EHEDG Guideline Doc 45:2021 Cleaning Validation in the Food Industry - General Principles, Part
1
- EHEDG Guideline Doc 50:2019 Hygienic Design requirements for CIP Installations
- EHEDG Guideline Doc 52:2021 Basic principles of Cleaning and Disinfection in Food
Manufacturing

EHEDG White Paper on GFSI Hygienic Design Scopes JI & JII ©EHEDG Page 21 of 59
Scope Reference Element The standard shall require that
Buildings and equipment shall be designed and
Hygienic design constructed to avoid favourable growth conditions
JI HACCP 1.12
principles (for microorganisms, pests and their harbourage),
appropriate to their intended use.

Guideline
Favourable growth conditions for microorganisms and pests typically involve soil and water.
Preventing such conditions depends on applying one or more of the following hygienic design
principles:
- Draining and preferably self-draining design to allow products and/or cleaning and disinfection
fluids to be discharged from building/equipment structures and surfaces.
- Surfaces and geometries*:
- No dead areas, niches or crevices, or ingress opportunities
- Smooth surfaces
- Accessibility to areas identified as critical during the risk assessment for inspection, cleaning,
sampling, and maintenance (with or without disassembly).

These principles apply to both equipment and buildings. EHEDG has established a guideline with
hygienic design principles for food factories

* Acceptance levels for surface finishing or crevices, craters etc. are defined in guidelines and
standards, such as those of EHEDG, 3-A SSI.

References
- EHEDG Guideline Doc 8:2018 Hygienic design principles
- EHEDG Guideline Doc 9:1993 Welding stainless steel to meet hygienic requirements
- EHEDG Guideline Doc 10:2007 Hygienic design of closed equipment for the processing of liquid
food
- EHEDG Guideline Doc 13:2004 Hygienic design of equipment for open processing
- EHEDG Guideline Doc 22:2014 General hygienic design criteria for the safe processing of dry
particulate materials
- EHEDG Guideline Doc 28:2018 Safe and Hygienic Treatment, Storage and Distribution of Water
in Food and Beverage Factories
- EHEDG Guideline Doc 35:2006 Hygienic welding of stainless steel tubing in the food processing
Industry
- EHEDG Guideline Doc 44:2014 Hygienic Design Principles for Food Factories
- EHEDG Guideline Doc 54:2020 Testing of Hygienic Weld Joints
- EN 1672-2:2020 Food processing machinery. Basic concepts. Hygiene and cleanability
requirements
- ISO 14159:2008 Safety of machinery – hygiene requirements for the design of machinery
- ISO 14644-4:2001 - Cleanrooms and associated controlled environments - Part 4: Design,
construction and start-up

EHEDG White Paper on GFSI Hygienic Design Scopes JI & JII ©EHEDG Page 22 of 59
Scope Reference Element The standard shall require that
Buildings and equipment shall be designed to
Hygienic design
JI HACCP 1.13 prevent contamination appropriate to their
principles
intended use.

Guideline
Preventing contamination is primarily concerned with the HD requirements for preventing the
ingress of food hazards. In this context, this means the prevention of unwanted materials (solids,
liquids, chemicals, pests, microorganisms, allergens etc.) entering into places or contaminating
materials that should be kept free of them for:
- food safety
- quality
- authenticity/integrity
- religious (Halal, Kosher)
- legal or other pertinent reasons.

For example, ingress may refer to:

- pests or dust entering a building or, within a building, a zone of higher hygienic level
- unwanted materials finding their way through inadequately closed/protective equipment (e.g.
leaking joints)
- materials from inside processing equipment contaminating food (lubricants, processing fluids,
shavings, broken pieces, loose parts).

Other hygienic design objectives for preventing contamination are described in:
- (HACCP 1.11) Be of a cleanable design, in order to meet all cleaning objectives to prevent
accumulation of undesirable materials
- (HACCP 1.12) Avoid growth of undesirable microorganisms or pests

References
- EHEDG Guideline Doc 8:2018 Hygienic design principles
- EHEDG Guideline Doc 23:2018 Use of H1 and HT1 Registered Lubricants Part 1 and Production
of H1 & HT1 Food Grade Registered Lubricants, Part 2
- EHEDG Guideline Doc 32:2005 Materials of construction for equipment in contact with food
- EHEDG Guideline Doc 44:2014 Hygienic Design Principles for Food Factories

Scope Reference Element The standard shall require that

Wherever relevant, recognised hygienic design
Hygienic design standards/guidance shall be consulted for the
JI HACCP 1.14
principles design and construction of buildings and
equipment, appropriate for their intended use.

Guideline
Recognised standards and guidelines are available in many countries and regions and may reflect
regulatory requirements (FSM 4.4), (e.g. relevant USDA requirements in the United States of
America, or Directive 2006/42/EC on machinery in the European Economic Area).

Reputable and authoritative national or international design standards and guidelines, are available
from organisations such as EHEDG, 3-A SSI, NAMI or CBA. These documents can be used as a basis
for developing tailored in-house standards and specifications.
EHEDG White Paper on GFSI Hygienic Design Scopes JI & JII ©EHEDG Page 23 of 59
References
- ASME-BPE 2022 American Society of Mechanical Engineers, Bioprocessing Equipment
- Directive 2006/42/EC The Machinery Directive
- EHEDG Guideline Doc 8:2018 Hygienic design principles
- EHEDG Guideline Doc 44:2014 Hygienic Design Principles for Food Factories
- EN 1672-2:2020 Food processing machinery. Basic concepts. Hygiene and cleanability
requirements
- ISO 14159:2008 Safety of machinery – hygiene requirements for the design of machinery
- NAMI:2021 North American Meat Institute; Food safety Equipment Design Principles, checklist
and glossary

Scope Reference Element The standard shall require that

Appropriate hygienic design principles shall be
JI Hygienic design adopted for the installation of new equipment
HACCP 1.15
JII principles and construction of buildings at sites handling
food.

Guideline
During construction and installation, the HD principles (HACCP 1.10) should be taken into account
and compliance with these HD principles should be verified.

For example:
Drainability
- Floors to be sloped towards the drains
- Valves to be placed in the correct position to allow full drainability
Accessibility
- Floor drains not placed under equipment
- Sufficient clearance underneath, around and above equipment
Cleanability
- Sensors to be placed to allow full cleanability (considering the flow direction)
- Junctions and joints not properly sealed
- Cables not to be bundled
Geometry and surfaces
- Staircases not to be placed over manholes
- Hygienic welding
Materials of construction
- Correctly specified gaskets to be used

Successful use of hygienic design principles during the act of building, construction, installation and
commissioning/qualification requires a HD-trained and competent project management team and
HD-trained and competent employees (GMP 7.2 and 7.3)

References
- EHEDG Guideline Doc 8:2018 Hygienic design principles
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- EHEDG Guideline Doc 44:2014 Hygienic Design Principles for Food Factories
- EHEDG Guideline Doc 45:2021 Cleaning Validation in the Food Industry - General Principles, Part
1
- EHEDG Guideline Doc 58, Hygienic design risk management
EHEDG White Paper on GFSI Hygienic Design Scopes JI & JII ©EHEDG Page 24 of 59
- EN 1672-2:2020 Food processing machinery - Basic concepts - Part 2: Hygiene and cleanability
requirements
- ISO 14159:2008 Safety of machinery – hygiene requirements for the design of machinery

Scope Reference Element The standard shall require that

Hygienic design principles shall be adopted to
Hygienic design ensure the maintenance of the hygienic
JII HACCP 1.16
principles performance of the buildings/equipment,
appropriate for their intended use.

Guideline
The HD requirements and principles are applicable throughout the life cycle of buildings or
equipment. Buildings, hygiene-zones and equipment must be designed and built to protect against
contamination with unwanted materials, to be maintained throughout their life cycle.

The application of HD principles (HACCP 1.10) in itself facilitates the maintenance of original
specified hygienic performance of the building/equipment during operational use.

For example “accessibility” facilitates inspection, cleaning and maintenance.

References
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities

Scope Reference Element The standard shall require that

Appropriate measures (with frequencies) shall be
specified, undertaken accordingly and
Hygienic design documented to mitigate any remaining food
JII HACCP 1.17
principles safety risks identified in the hygienic design risk
assessment following building/ equipment
construction, purchase and installation.

Guideline
Mitigation of remaining food safety risks due to inadequate HD includes, but is not limited to:
- Cleaning and disinfection
- Preventive maintenance / replacement of components
- Inspection programmes
- Condition monitoring
- Procedures regarding the flow of people or materials throughout the plant

The user is responsible for:

- Implementing procedures that record and follow-up on, e.g. cleaning frequencies, level of
cleanliness etc.
- Requesting that the supplier provides information, concerning the equipment or building, on
compatibility of cleaning chemicals (including temperature, concentration and exposure time),
replacement of spare parts and maintenance instructions.
The user of a food building or processing equipment can incorporate these mitigation procedures in
the food safety management system.

Note: elimination of food safety risks by HD may initially seem expensive, however, addressing

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these food safety risks with mitigation measures may result in:
- Higher operational costs
- Reduced availability for production
- Reduced lifetime of the equipment
- Higher environmental impact of cleaning operations
- Increased risk of human error and associated costs of incidents or recalls.
Therefore, determination of the total cost of ownership (TCO) and decision-making based on the
TCO is recommended.

References
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- EHEDG Guideline Doc 44:2014 Hygienic Design Principles for Food Factories
- EHEDG Guideline Doc 45:2021 Cleaning Validation in the Food Industry - General Principles, Part
1

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Section 2: Hygienic Design Management Systems Requirements
Note on FSM benchmark requirements for scope JI and JII:
Hygienic design supports operational excellence, sustainability and economic performance, and is an
integral element of any food safety management system (FSMS).
JI– aimed at equipment Manufacturers – a significant number of equipment suppliers have evolved
design and fabrication processes that fulfil the needs of their food manufacturing customers.
However, the base assumption should be that there is no FSMS in place (since these organisations do
not manufacture food). Therefore, the JI requirements for a hygienic design management system
(HDMS) should be newly created, but they can subsequently be integrated into existing quality
management systems.
JII – aimed at food manufacturers – the HDMS is best integrated within the existing FSMS. For
companies interested in JII, in most cases this would mean integration into an existing GFSI-recognised
certification standard. Otherwise, integration into an ISO 22000 based management system would be
appropriate.

Scope Reference Element The standard shall require that

A clear organisational structure identifying the
job functions and responsibilities of at least those
Management
JI FSM 1.2 employees whose activities affect Hygienic
responsibility
Design shall be established, implemented and
maintained.

Guideline
Setting up the organisational structure related to hygienic design will involve defining and allocating
specific responsibilities and authorities related to HD, including:
- An HD team (leadership and members) (HACCP 1.5)
- An HDMS, including procedures, documentation, reporting and reviewing structure around HD
(FSM 5.2)
- The responsibility for ensuring relevant training is provided, and verification of competence
(FSM 7.2 & 7.3) for identified functions

The organisational structure should be maintained, updated, and continually improved by senior
management, including the work processes, procedures and interactions needed.

The organisational structure should include employees with activities affecting hygienic design.
(e.g. personnel responsible for the purchase of materials and/or components, mechanical
engineers, electricians, welders, workshop employees, architects, installation employees)

References
- ISO 22000:2018, 5.3 Organizational roles, responsibilities and authorities

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Scope Reference Element The standard shall require that
Evidence of the senior management’s
Management
commitment to establish, implement, maintain
JI FSM 2.2 commitment
and continuously improve the Hygienic Design
and food safety culture
Management System shall be provided.

Guideline
Commitment to HD is an aspect of company culture, and needs to be expressed and reinforced as
such. The integration of the HDMS requirements into the organisation’s business processes is
demonstrated through:
- Policy statement (FSM 6.2)
- HDMS (FSM 5.2)
- Commitment to conform to applicable regulatory and statutory HD requirements
- Commitment to mutually agreed customer HD requirements

Evidence is generated through the management system, including:

- Regular management reviews, their agendas, minutes and action points (FSM 3.2)
- Records of
- Performance indicators (FSM 9.1.2 & 9.2.4; FSM 13.1.3,13.2.4 & 13.3.2)
- Non-conformities (FSM 22.4)
- Customer complaints (FSM 21)
- Internal and external audit reports (FSM 20.2)

References
- GFSI:2018 A Culture of Food Safety - A Position Paper from the Global Food Safety Initiative
(GFSI) V1.0
- ISO 9001:2015, 9.3 Management review
- ISO 22000:2018, 5 Leadership

Scope Reference Element The standard shall require that

The organisation’s senior management shall
review the verification of the Hygienic Design
JI FSM 3.2 Management review
System at planned intervals, to ensure their
continuing suitability, adequacy and effectiveness.

Guideline
Establishing an effective hygienic design management system is crucial for meeting the
requirements of the standard. Part of this system is a regular review, in order to ensure that the
system remains effective and relevant.

The management review includes a scheduled specific review, involving assessments, a defined
agenda and minutes including agreed actions.
The frequency of these assessments typically reflects the organisation, its activities, size and the
complexity of its operations (at least once a year).

The management review may follow the requirements as laid out in ISO22000:2018, 9.3
(Management review) (in this case related to HD and food safety) which includes:
- Previous management review documents, action plans and timeframes
- Results of internal, second-party and third-party audits

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- Any customer performance indicators, complaints and feedback
- Effectiveness of the hazard and risk management system
- Impact of any applicable legislative and certification scheme changes
- Any incidents, corrective actions, out-of-specification results and non-conforming materials
- Resource requirements
- Any objectives that have not been met, so that the underlying reasons can be understood. This
information shall be used when setting future objectives and to facilitate continual
improvement

The management review is the responsibility of senior management.

Senior management is assumed to have the authority to make decisions on HD objectives and/or
the provision of adequate human and financial resources. The management team would usually
include the site manager and those managers responsible for HD-related aspects (production,
technical operations, purchasing, engineering, cleaning etc.)

References
- ISO 9001:2015, 9.3 Management review

Scope Reference Element The standard shall require that

Procedures shall be established, implemented and
maintained to ensure that buildings and
JI FSM 4.4 Legislation equipment are legally compliant in the hygienic
design requirements in the country of known
implementation / sale.

Guideline
This will require the ability to demonstrate an ongoing awareness and understanding of relevant
legislation relating to their buildings and equipment in the country, state or territory where they are
manufactured (as a minimum) and, where known, the country, state or territory where the
buildings and equipment are used. Furthermore, a process is required to ensure that the
information is translated into action as necessary.

Activities for remaining up to date may include:

- Membership of a trade association and receipt of its newsletters
- Subscription to a service provider supplying legal updates related to HD, cleaning, hazards, etc.
- Organised help from local legal offices
- Regular reviews of identified websites covering legislation and standards legislation
- Certification of food building or equipment parts/units to acknowledged standards such as 3-A
standards

Note:
The prevention of migration of harmful substances should be considered in any part of the farm-to-
fork supply chain. A risk assessment should be performed and documented for all the applications
in the supply chain to provide an overview of what has been considered and how these risks have
been mitigated. Typical of the implementation of this in legislation is the Declaration of Compliance
(EU legislation), which indicates that the item complies with EU legislation for food contact
materials.

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References
Examples of relevant legislation include:
- For Europe: EC Regulation 852/2004; EC Regulation 1935/2004; EC Regulation 2023/2006; EC
Regulation 10/2011, EC Directive 2006/42
- For the USA: FDA CFR21; 3A; NSF/ANSI and also state-specific regulation (for example ban on
bisphenol-A in California)
- For China: GB 4806 series
- For Japan: MHLW (Ministry of Health, Labour and Welfare) specifications

Scope Reference Element The standard shall require that

A Hygienic Design Management System shall
Hygienic Design
JI FSM 5.2 be established, implemented, maintained and
Management System
continuously improved.

Guideline
As a minimum, an HDMS consists of:
- A definition and communication of the organisation’s understanding of and commitment to the
application of HD. This is covered under FSM 6.2 (Hygienic design policy).
- The allocation of resources and responsibilities, as covered under FSM 1.2 (Management
responsibility) and FSM 12.2 (Resource management)
- Procedures and specifications, as covered under FSM 9.1.2 & 9.2.4 (Documentation
requirements), FSM 10.1 & 10.2 (Specified requirements/specifications) and FSM 11
(Procedures). This would include the integration of HDMS requirements into the organisation’s
overall quality management and business systems. See also ISO 22000:2018, 5.1.b.
- Release procedures as covered under FSM 23.2 & 23.3 (product release) and FSM 14.1.5
(Traceability)
- Performance evaluation, follow-up and continual improvement, covered under FSM 3.2
(Management review); FSM 13.1.3, 13.1.4, 13.2.4, 13.3.2 (Purchasing and supplier
performance); FSM 20.2 (Internal audit); FSM 20.2 (Complaint handling); FSM 24.1 (Control of
non-conformities); FSM 25 (Corrective actions) FSM 26 (Change management; not required for
JI, but advisable in order to capture information on intended use, risks identified through HDRA,
records of HD to mitigate hazards and risks)

References
- ISO 22000:2018, 5.1.b Ensuring the integration of the FSMS requirements into the
organization’s business processes

Scope Reference Element The standard shall require that

A clear, concise and documented Hygienic Design
policy statement shall be in place, as well as
JI FSM 6.2 Hygienic Design Policy measurable objectives specifying the
organisation’s commitments to meet the food
safety needs of its products.

Guideline
The hygienic design policy expresses the commitments of the company relating to HD. It forms the
basis of the entire HDMS including the annual review and is used for internal and external
communication.
ISO 22000:2018, 5.2 (Policy) covers the requirements for establishing and communicating a food

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safety policy, but can also be used as well as a blueprint for a hygienic design policy and its
communication within the organisation.

References
- ISO 22000:2018, 5.2 Policy

Scope Reference Element The standard shall require that

A procedure shall be established, implemented,
and maintained for the management and control
Documentation of documented information required to
JI FSM 9.1.2
requirements demonstrate the effective operation and control
of processes and the Hygienic Design
Management System.

Guideline
Documentation typically includes all risk-assessments, reasoning, experimental evidence,
qualifications, verifications, procedures, recordings, technical information and dispositions
(“unassigned”, “assigned”, “quarantined”, “decommissioned”) relevant to HD. The documentation
procedure defines the types of documents, document management (responsibilities, accessibility,
version control, record keeping, electronic or paper, document retention), and is a subject of the
management review (FSM 3.2).

References to external documents (e.g. EHEDG guidelines or relevant legislation (FSM 4.4)) are to be
kept up to date (i.e. checked periodically for updates).

Additional guidance on documentation may be found in ISO 22000:2018, 7.5 (Documented

information)

References
- ISO 22000:2018, 7.5 Documented information

Scope Reference Element The standard shall require that

All the above-mentioned documented
information shall be securely stored for the time
period required to meet customer and legal
Documentation requirements, or for a period exceeding the
JI FSM 9.2.4
requirements lifetime of buildings/equipment if customer or
legal requirements are not available.
It shall be effectively controlled and readily
accessible when needed.

Guideline
Document retention may vary depending on local legislation or customer contracts and recognises
the need to maintain concurrent records establishing the traceability and concurrency of relevant
production conditions and systems/equipment/software used for any item, at least for its expected
lifetime.

Apart from individual contract requirements, a company’s document retention policy provides
guidelines for the review, secure storage, and periodic destruction of unneeded records.
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This requirement is implicitly covered under FSM 9.1.2.

For additional guidance, see ISO 22000:2018, 7.5.3 (Control of documented information)

References
- ISO 22000:2018, 7.5.3 Control of documented information

Scope Reference Element The standard shall require that

Specified requirements or specifications shall be
established, implemented and maintained for all
Specified requirements
JI FSM 10.1 inputs to the process, including services that are
/ Specifications
purchased or provided and have an effect on food
safety.

Guideline
Proper specification (adequate and accurate, including defined limits) of all inputs (e.g. materials,
components, water, cleaning chemicals,) is essential for the ongoing integrity and proper
functioning of the hygienic status of the manufacturing environment.

This also applies to contractors, suppliers and services where applicable conditions, restrictions,
materials and methods to be used need to be clear to both the customer and its suppliers.

In order to establish and maintain the right hygienic conditions, it is important to formulate specific
requirements or specifications for spare parts (e.g. seals or gaskets), functional substances (e.g.
lubricants or signal fluids), utilities (e.g. water, steam, cleaning agents) and the tools used for
maintenance and ensure all this information is clearly understood by the customer.

For international trade, it will be necessary to investigate local legislation on food contact materials.
E.g. a simple statement that the materials comply with EU regulations or FDA requirements may be
insufficient for international trade.

References
- EN 1672-2:2020 Food processing machinery - Basic concepts - Part 2: Hygiene and cleanability
requirements
- FDA CFR-title 21 (Code of Federal Regulations title 21 Food & Drugs Administration)
- Regulation EC 852/2004 On the hygiene of foodstuffs
- Regulation EC 1935/2004 On materials and articles intended to come into contact with food

Scope Reference Element The standard shall require that

Specified requirements A review process of the specified requirements or
JI FSM 10.2
/ Specifications specifications shall be in place.

Guideline
The aim of such a review process is to determine if the specified requirements or specifications still
fulfil internal and market expectations regarding hygienic performance as well as regulatory
requirements.

This review process should be carried out:

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- As part of the management review (at an appropriate predetermined interval)
- Whenever there are relevant changes in legislations
- To address feedback from the market
- To assess the applicability of specified requirements or specifications after changes in e.g.:
- Buildings
- Equipment
- Process or design
- Product composition or characteristics
- Construction and installation techniques

Any changes to existing specifications should be agreed, documented and communicated to the
customer and appropriate (internal) functions.

References
- EN 1672-2:2020 Food processing machinery - Basic concepts - Part 2: Hygiene and cleanability
requirements
- ISO 14159:2008 Safety Of Machinery - Hygiene Requirements For The Design Of Machinery
- ISO 22000:2018 Food safety management systems - Requirements for any organization in the
food chain

Scope Reference Element The standard shall require that

Procedures and instructions shall be established,
JI FSM 11 Procedures implemented and maintained for all processes
and operations having an effect on food safety.

Guideline
A well-controlled, systematic and documented management system forms the basis for the controls
necessary for the production (from design to handover to the customer) of buildings/equipment
that ensure safe food products and comply with customer specifications.

This will require policies, procedures and work instructions to be established, communicated, and
readily available - including in other relevant languages where appropriate. Moreover, training must
be provided on these policies, procedures and instructions.
Where the site/office is part of a company governed by a head office, the allocation of
responsibilities between the site/office and the corporate functions will be documented.

Recommended documentation should include:

- Any limitations for use/exclusions
- Working instructions, standard operational procedures, control instructions
- Certification of the training of employees
- HDRA (HACCP 1.7)
- Qualification, validation and verification activities and functional testing protocols
- Documents recording the management of corrective actions
- Description of planned monitoring and verification activities (what, who, when)
- Record forms
- Supporting documents (e.g. generic guides, scientific evidence)

References
- ISO 9001:2015, 7.5 Documented information

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Scope Reference Element The standard shall require that
The resources needed to establish, implement,
maintain, review and improve the Hygienic Design
JI FSM 12.2 Resource management
Management System shall be identified and
assigned.

Guideline
See also FSM 1.2 & 2.2.
The identified and assigned people should be appropriately competent and qualified, and enabled
(time, facilities, services) to establish, implement, maintain, review and improve the HDMS.

Relevant requirements may be derived from ISO 22000:2018, 5.1.c (ensuring that the necessary
resources are available), 5.3 (Organisational roles, responsibilities and authorities) and especially
7.1 (Resources), 7.2 (Competence) and 7.3 (Awareness).

References
- ISO 22000:2018 Food safety management systems - Requirements for any organization in the
food chain

Scope Reference Element The standard shall require that

A purchasing procedure shall be established,
implemented and maintained to ensure that all
Purchasing and
inputs to the process including externally
JI FSM 13.1.3 supplier
purchased materials and services which have an
performance
effect on food safety, conform to specified
requirements as well as regulatory requirements.

Guideline
A purchasing procedure provides a systematic approach for recording all the necessary
requirements and actions to ensure that purchased materials, components, units and services do
not jeopardise hygienic design or increase food safety risks of food buildings or equipment
manufactured for customers. It should contain:

Purchase conditions that include requirements to meet agreed specifications, references to

guidelines or standards such as EHEDG guidelines or 3-A standards, ISO standards, regulatory
requirements (local as well as country of destination) as well as applicable certificates (e.g. a
Declaration of Compliance for Europe (FSM 10.1))

Request for material specification:

- Composition of all building and non-food contact equipment materials that may form a food
safety hazard due to wear or deterioration
- Composition of all materials (including anti-corrosion properties/impurities) in contact with the
product, such as metal alloys, composites, ceramics, plastics and elastomers
- Conditions of use, taking into account the process conditions and the product characteristics

Traceability system for those materials in contact with the food or its ingredients, as referred to in
FSM 14.1.5.

A set of HD requirements based on the hygienic design process (HACCP 1.6) and risk assessment
(HACCP 1.7)

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A purchasing procedure needs to ensure all risk-based hygienic design requirements are
established, qualified and validated during the relevant stages of a project for establishing a new
building or process line. This approach is well described in EHEDG Guideline Doc 34 Integrating
hygienic entities. Critical to this whole process is that it starts with developing and defining an
adequate risk-based specification that comprehensively covers relevant hygienic design
requirements. During the next stages of the project/activity it should then be ensured that these
specifications are indeed correctly executed including during construction, installation, required
checks and qualifications.
For this it is expected that hygienic design and risk assessment form an integral part of the required
project management and purchasing procedures.
Examples of what should be included in an HDRA for various purchased services:
- Painting and flooring subcontractors (e.g. type of paint, materials used)
- Welders (e.g. type of welding materials, qualification of the welders)
- Pipe fitters (e.g. type of materials used, finishes)
- Sheet metal fabricators (e.g. type of finishing technology to manage smoothness)
- Insulation-installers (e.g. materials used, corrosion-prevention, pest-proofing, hermetic
systems, robustness)
- Electrical contractors (e.g. cleanable equipment/installations, assurance of supply to CCPs and
critical systems)
- Automation contractors (e.g. functional description, feedback signals)
- Civil engineering contractors (e.g. materials used or construction layout)

References
- CFR 21 Code of Federal Regulations - Title 21 - Food and Drugs, FDA
- Council of Europe:2013 Metals and alloys used in food contact materials and articles, A practical
guide for manufacturers and regulators
- Directive EC 42/2006 The machinery directive
- EHEDG Guideline Doc 32:2005 Materials of Construction for Equipment in Contact with Food
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- EN 1672-2:2020 Food processing machinery - Basic concepts - Part 2: Hygiene and cleanability
requirements
- ISO 14159:2008 Safety of machinery - Hygiene requirements for the design of machinery
- Regulation EC 1935/2004 on materials and articles intended to come into contact with food
- Regulation EC 2023/2006 on good manufacturing practice for materials and articles to come
into contact with food

Scope Reference Element The standard shall require that

A procedure shall be established, implemented
Purchasing and supplier and maintained to ensure that the newly
JII FSM 13.1.4
performance purchased building/ equipment meets the
hygienic design specification.

Guideline
A purchasing procedure provides a systematic approach for recording all the necessary
requirements and actions for ensuring that purchased food buildings or equipment do not
jeopardise food safety.
It contains:

Purchase conditions that include requirements to meet agreed specifications, references to

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guidelines or standards such as EHEDG guidelines or 3-A standards, ISO standards, regulatory
requirements (local as well as country of destination) as well as applicable certificates (e.g. a
Declaration of Compliance for Europe (FSM 10.1))

Request for material specification:

- Composition of all building and non-food contact equipment materials that may form a food
safety hazard due to wear or deterioration
- Composition of all materials (including anti-corrosion properties or impurities) in contact with
the product such as metal alloys, composites, ceramics, plastics or elastomers
- Conditions of use taking into account the process conditions and the product characteristics

Traceability system for those materials in contact with the food or its ingredients, as mentioned in
FSM 14.1.5

A set of HD requirements for monitoring the hygienic design process (HACCP 1.6) and risk
assessment (HACCP 1.7)

A purchasing procedure needs to ensure all risk-based hygienic design requirements are
established, qualified and validated during the relevant stages of a project for establishing a new
building or process line. This approach is well described in EHEDG Guideline Doc 34 Integrating
hygienic entities. Critical to this whole process is that it starts with developing and defining an
adequate risk-based specification that comprehensively covers relevant hygienic design
requirements. During the next stages of the project/activity it should then be ensured that these
specifications are indeed correctly executed including during construction, installation, required
checks and qualifications.

For this it is expected that hygienic design and risk assessment are an integral part of the required
project management and purchasing procedures .
Examples of what should be included in an HDRA for various purchased services:
- Painting and flooring subcontracts (e.g. type of paint, materials used)
- Welders (e.g. type of welding materials, qualification of the welders)
- Pipe fitters (e.g. type of materials used, finishes)
- Sheet metal fabricators (e.g. type of finishing technology to manage smoothness)
- Insulation-installers (e.g. materials used, corrosion-prevention, pest-proofing, hermetic
systems, robustness)
- Electrical contractors (e.g. cleanable equipment/installations, assurance of supply to CCPs and
critical systems)
- Automation contractors (e.g. functional description, feedback signals)
- Civil engineering contractors (e.g. materials used or construction layout)

References
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- ISO 9001:2015, 8.2 Requirements for products and services
- Regulation EC 1935/2004 on materials and articles intended to come into contact with food
- Regulation EC 2023/2006: on good manufacturing practice for materials and articles intended to
come into contact with food

Scope Reference Element The standard shall require that

A procedure for the evaluation, approval and
Purchasing and supplier
JI FSM 13.2.4 continued monitoring of suppliers which have an
performance
effect on food safety shall be established,

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 implemented and maintained.
The procedure shall address procurement in
emergency situations to ensure buildings/
equipment still confirms to the documented
specified requirements or specification, and the
supplier has been evaluated.
The results of evaluations, investigations and
follow-up actions shall be recorded.

Guideline
Building constructors or equipment manufacturers need to understand the performance and
qualification of all suppliers and subcontractors that are used in the production or construction
process. This is not only relevant for materials but also for personnel and the activities they carry
out during fabrication and installation, during new-build activities and during emergency repairs.

Evidence has to be provided in the form of qualifications, documents, pictures, videos or test results
of all checks that have been performed to ensure the correct execution of critical activities needed
to manage hygienic design. For example, the sign-off and revision history of P&ID’s, 3D diagrams,
constructability workshops and attendance records; verification of hygienic welding (both manual
and automatic), verification of food contact surface treatment activities and methodologies,
lubrication management etc.

For addressing procurement in emergency situations, we refer to ISO 22000:2018, 8.4 Emergency
preparedness and response.

References
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- EHEDG Guideline Doc 58, Hygienic design risk management
- ISO 22000:2018, 8.4 Emergency preparedness and response

Scope Reference Element The standard shall require that

Outsourced processes or service that affect food
Purchasing and supplier safety shall be identified and controlled. Such
JI FSM 13.3.2
performance controls shall be documented in the Hygienic
Design Management System.

Guideline
All outsourced processes or services that affect food safety should be listed. Examples are services
regarding lubrication, water and steam quality, hardware and software for automation control
systems. Examples of subcontractors are epoxy floor fabricators and all subcontractors who for
example supply the floor surface, provide drainage and sewage management, lighting, noise
reduction, pest control, waste management, as well as the distribution companies responsible for
shipping equipment to a site.
To achieve control over their suppliers, building constructors and equipment manufacturers can
require that their suppliers and subcontractors, meet the (applicable) requirements stated in the JI
scope. An approved supplier system can be used to facilitate and manage this.

References

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Scope Reference Element The standard shall require that
Procedures shall be established, implemented and
maintained to ensure the ability to trace or follow
a material or article critical to food safety through
JI FSM 14.1.5 Traceability
all stages of purchase, construction and
distribution (minimum one step forward and one
step backward).

Guideline
The scope of this traceability clause includes those materials and articles that through their function
or material characteristics are critical to food safety.

From a building constructor's/equipment manufacturer’s perspective:

- The step forward refers to the onward supply of the entity, e.g. to:
- A distributor
- An engineering company
- A food manufacturer
- Another building constructor or equipment manufacturer
- The step backward refers to materials and components used for fabrication of the entity, e.g.:
- Materials such as elastomers or stainless steel that come into contact with food
- A valve, a fan or a sensor
- Materials used in flooring, walls and ceiling systems
- Lubricants

All incoming materials and articles used for fabrication of a hygienic entity (i.e., any item for
integration into a hygienic system, for example: part, module, operating unit, etc.) should be
supplied with clearly legible information from the supplier, which is printed directly on materials or
articles, or securely reported on labels, bar codes, or in another form of accompanying
documentation (including electronic data transmission). Any labelling should not potentially
compromise the hygienic performance of the entity.

Traceability is a requirement of many quality management systems, such as ISO 9001:2015 and ISO
22000:2018, and EC regulation 1935/2004. These quality management systems require the
preparation and maintenance of documented procedures addressing identification and lot/batch
assignment of products from the manufacturer, the purchase and storage of materials through the
production process, and shipment to the customer. The documentation of all procedures should be
available either in hard copy or electronic format.

References
- ISO 9001:2015 Identification and traceability
- ISO 22000:2018, 8.3 Traceability system
- Regulation EC 1935/2004 on materials and articles intended to come into contact with food

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Scope Reference Element The standard shall require that
Where external testing of construction materials,
buildings or equipment is required, it shall be
JI FSM 19.4 Testing carried out by an accredited testing facility or one
that follows relevant international testing
guidelines.

Guideline
Accredited testing facilities should follow international testing guidelines and hold accreditation
according to ISO/IEC 17025. Accredited testing laboratories should demonstrate that they operate
competently and are familiar with recognised testing standards and guidelines.

It is expected that a test facility carries out testing in a transparent and systematic way and will be
able to provide a list of their:
- Accredited tests
- Procedures and methods
- Calibrations including references to national standards (this can be ISO, DIN etc.)

The testing of construction materials, buildings or equipment may be required as per local
legislation or by a customer. Legislation varies from country to country, and likewise testing
standards or guidelines.

Typical tests are tests of/on:

- Food contact material (typically migration tests)
- Filters
- Leak tightness
- Cleanability
- Potable water systems
- Air treatment systems

EHEDG offers several classes of certified equipment for the benefit of equipment suppliers and food
manufacturers. Certification is carried out by Authorised Evaluation Officers (AEOs) and associated
testing by EHEDG Authorised Testing Laboratories (ATLs).

References
- ISO 9001:2015, 7.1.5.2 Measurement traceability
- ISO/IEC 17025:2017 General requirements for the competence of testing and calibration
laboratories
- Regulation EC 2023/2006 on good manufacturing practice for materials and articles intended to
come into contact with food
- www.ehedg.org “Certification & testing”

Scope Reference Element The standard shall require that

Where in-house testing is carried out, calibration
of equipment that is critical to food safety shall be
JI FSM 19.5 Testing
carried out against national standards or other
accurate means.

Guideline
Whether through external or in-house testing, it is expected that a supplier will carry out all testing
in a transparent and systematic way and comply with local legislation or customer requirements

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(FSM 19.5)

- Equipment used for testing parameters that are critical to food safety may include
thermometers, pH meters etc. Criticality is determined by the intended use. Calibration
procedures and records should be made available for all equipment that has been identified as
critical to food safety and quality. For example:
- A list with each piece of equipment with an identification code
- Location of the equipment
- Calibration protocol (method), including calibration frequencies
- Responsibilities
- Dates of last calibration
- Calibration-records (values, deviations and any corrective actions).

Use of an accredited third-party calibration service is recommended.

Examples of other parameters critical to food safety can be welding quality; surface roughness;
filter integrity; leak tightness or cleanability.

References
- ISO 9001/2015: 7.1.5.2 Measurement traceability
- ISO/IEC 17025:2017 General requirements for the competence of testing and calibration
laboratories

Scope Reference Element The standard shall require that

An internal audit procedure shall be established,
implemented and maintained; it shall cover all
JI FSM 20.2 Internal audit
elements of the Hygienic Design Management
System.

Guideline
The manufacturer has a documented internal audit programme which captures all hygienic design
topics and processes (as listed in the JI scope) that are to be reviewed. The programme covers the
following points:

- The internal audit procedure sets out the method, frequency, scope and predetermined criteria
by which all key controls are audited
- A document review to ensure the requirements of all applicable standards are being met.
- A review of the practical implementation of the HDMS to verify the correct implementation of
the procedures through observation and by challenging operator understanding.
- The findings from the audit are recorded to demonstrate evidence of a (non-) conformity.
- In case of non-conformities, the severity of the finding is established, and corrective actions and
timescales are agreed with the responsible person.
- The close-out of the actions is tracked by the site and escalated to senior management in the
event of overdue actions.
- Frequencies of the internal audit can be adjusted in response to audit outcomes or changes.

The company identifies those who will be responsible for conducting internal audits (FSM 1.2).
Competent internal auditors have:
- Good auditing skills and communication
- Knowledge of (food safety) hazard and risk management.

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- Technical knowledge of the process as required.
Independent internal auditors are:
- Independent of the function/process that is the subject of the audit
- Able to raise findings
- Able to communicate findings to senior management and ensure these are addressed.

References
- ISO 9001:2015, 9.2 Internal audit
- ISO 22000:2018, 9.2 internal audit

Scope Reference Element The standard shall require that

A procedure for the management of complaints
and complaint data shall be established,
JI FSM 21 Complaint handling implemented and maintained to ensure that
complaints are assessed and corrective actions
implemented when necessary.

Guideline
The manufacturer has a complaint management procedure in place that outlines how complaints
are handled and over what timeframe. The procedure ensures all complaints are consistently
recorded, investigated and responded to in a timely manner. Comprehensive recording allows for
easy data analysis, identifying complaint trends and reporting of the number of complaints (per
topic).

Manufacturers should consider including ‘defects’ identified by their own team during the
production process as internal complaints to give a fuller picture of the potential complaint levels
and to feed into continuous improvement plans.

Complaints are investigated in detail by a multi-disciplinary team including representatives from

Production and Engineering in order to identify the root cause of the issue and at which point in the
process it is likely to have occurred. The investigation and corrective actions will be clearly
documented. It is good practice to report the number of complaints during regular senior
management meetings as a key performance indicator.

References
- BRCGS:2008 Global Standard Best Practice Guideline Complaint Handling
- FSIS:2020 Food Safety and Inspection Service (FSI) USDA; Guideline for Industry Response to
Customer Complaints
- ISO 9001:2015 8.2.1.Customer satisfaction

Scope Reference Element The standard shall require that

An incident management procedure, including
product recall, withdrawal, and retrofit shall be
Serious incident
JI FSM 22.4 established, implemented and maintained. The
management
recall procedure shall be regularly tested for
effectiveness.

Guideline
The manufacturer has an incident management procedure involving the production or use of the

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supplied building/equipment that defines the range of incidents that the company could experience
and clearly sets out roles and responsibilities for those who would be involved. Often the procedure
includes decision trees or key questions to help consistently differentiate between major incidents
and routine incidents, recalls, withdrawals or retrofits.

An important part of incident management is communication; hence the procedure will define the
exact method for contacting customers and other relevant bodies. The incident management
procedure is required to be mock-tested on a regular basis (e.g. 6-monthly, annually) to ensure it is
effective and to ensure all contacts have been kept up to date.

References
- BRCGS:2019 Global Standard for Packaging Materials Interpretation Guideline
- ISO 22000:2018 8.4 Emergency preparedness and response

Scope Reference Element The standard shall require that

Commissioning or building/equipment release
JI FSM 23.2 Product release procedures shall be established, implemented and
maintained.

Guideline
The release or handover procedures should include a defined way of working to ensure that any
out-of-specification instance related to hygienic design is assessed.
Release procedures include procedures to:
- Ensure that only buildings/equipment conforming to predefined hygienic design construction
requirements (including critical specifications or action criteria) are built, processed and
released. Ensure that potentially unhygienic buildings/equipment are not released.
- Specify corrections and corrective actions to be taken when critical specifications or action
criteria are not met.
- Ensure the cause of a non-conformity is identified. In the event of non-conformities, the
building/equipment potentially affected will be identified and controlled with in respect of its
eventual use and release.
- Ensure blocking (holding) is in place that is justified by risk assessment.
- Ensure written procedures are in place that cover release and blocking, including
responsibilities for blocking and decision-making for release, rejection or modification. Also
included is the organisation of follow-up actions where appropriate.
- Ensure that contamination of the food product to be produced in the building or with the
equipment is prevented (FSM 23.3; GMP 4.8-4.10)

If release is automated in or supported by Enterprise Resource Planning (ERP) systems, there must
be a system in place to ensure that the correct authorisations, (internal) notifications and
specifications, including test methods are implemented. This is to ensure that non-conformities are
taken into account in the automated release step.

The way of working in respect of release and blocking should be periodically reviewed for its
effectiveness. Examples of input data are incidents related to incorrect release and (absence of)
issues such as complaints or market returns.

References
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities

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- ISO 9001:2015 8.6 Release of products and services
- ISO 22000:2018 Food safety management systems - Requirements for any organization in the
food chain

Scope Reference Element The standard shall require that

Hygienic design construction specifications shall be verified for
FSM Product
JI buildings and equipment prior to dispatch or hand-over to the
23.3 release
customer.

Guideline
The supplier should provide documented evidence that, prior to dispatch or handover, buildings
and equipment perform according to predefined hygienic design construction specifications. It
should be verified that the correct building/equipment has been built, manufactured and installed
according to specifications. Formal handover will include confirmation of the actual capability in
comparison with the initial specifications.

Checklists may be useful, with their content selected using a risk-based approach. Checklists may
include topics related to layouts, electrical systems & instrumentation, certificates, operations
(including instructions and training), calibration, engineering, equipment, manufacturing,
information technology, qualification & validation documentation, etc.

EHEDG Document No 34 (Integrating hygienic entities) describes how to verify compliance to

hygienic design specifications related to, e.g., food safety and quality, cleanability, maintenance,
instructions and procedures.

References
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- ISO 22000:2018 Food safety management systems - Requirements for any organization in the
food chain

Scope Reference Element The standard shall require that

A procedure shall be established, implemented
and maintained to ensure that any non-
Control of non-
JI FSM 24.1 conformity impacting food safety and any non-
conformity
conforming products are clearly identified and
controlled to prevent unintended use or delivery.

Guideline
A procedure with the aim of preventing the delivery of or use by the customer of any non-
conforming products that would impact food safety may include:
- Prerequisite procedures that identify and detect non-conformities
- A risk assessment identifying risks that may impact food safety
- Product acceptance criteria
- Audit and testing schemes to detect products that do not conform to these acceptance criteria
- A track and trace system linking specific batches of used material to specific batches of products
and to customers to which these product batches are delivered
- Registration of identified non-conformities
- Clear labelling and secure segregation of non-conforming products, such that they cannot be
used inadvertently. Increasingly, this is electronically managed

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- Commitment of the senior management to ensure a workplace environment that ensures that
non-conformities are escalated to the right management level.
- Commitment of senior management to deal with the consequences of non-conformities
including:
- Informing customers in time
- Executing corrective actions (FSM 25)

References
- ISO 9001:2015 Quality management systems – Requirements
- ISO 22000:2018 Food safety management systems - Requirements for any organization in the
food chain

Scope Reference Element The standard shall require that

A procedure shall be established, implemented
and maintained for the determination and
JI FSM 25 Corrective actions implementation of corrective actions in the event
of any significant non-conformity relating to food
safety.

Guideline
The key message of this benchmarking requirement is that non-conformities and the consequential
actions are filed and addressed in a systematic way. Use of a Corrective Actions and Preventive
Actions (CAPA) procedure is recommended.

The input to a CAPA procedure can be:

- A non-conformity that may impact food safety
- A deviation in the process that could result in a non-conformity impacting food safety
- A complaint
- An observation during an audit or by any other person

The CAPA procedure consists of:

- Reviewing non-conformities
- Implementation of an immediate corrective action if applicable
- A root cause analysis
- Including an evaluation linking potential non-conformities to similar root causes
- An action plan to eliminate or mitigate the root cause in order to prevent the non-conformity
from occurring again
- Including an independent evaluation of the effectiveness of the actions taken
- Involvement of senior management and the ability to escalate the non-conformity if issues are
not addressed or overdue

References
- ISO 22000:2018 Food safety management systems - Requirements for any organization in the
food chain

Scope Reference Element The standard shall require that

Change control shall be undertaken and
JII FSM 26 Change management documented to evaluate the impacts of any
changes/ modifications on equipment/building

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 hygienic design.

Guideline
The objective of change control is to handle changes in such a manner that the impact on food
safety by a change is foreseen and not missed and that the correct mitigation actions are executed.

Change control consists of:

- Hygienic design risk assessment (HACCP 1.7)
- Hygienic risk mitigation based on hygienic design principles (HACCP 1.10 & HACCP1.11-1.17)
- Systematic and accessible documentation of changes including their owner, due date, status (in
progress or completed)

The scope of change control management covers any change that impacts the 3 HD Requirements
and/or the 6 HD principles (see HACCP 1.10)

It is applicable for any situation in the value chain such as development, production, construction,
maintenance, engineering, capacity increase or new products.
Furthermore, it is applicable for all entities such as changes in equipment, warehousing, software,
raw materials, packaging materials, cleaning chemicals, processing aids or change of supplier.

It is advisable that all personnel are made aware of what constitutes a change that requires HDRA,
that is, should be notified of the requirement for HDRA prior to the intended change.

References
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- EHEDG Guideline Doc 58, Hygienic design risk management
- ISO 22000:2018 Food safety management systems - Requirements for any organization in the
food chain

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Section 3: Good Industry Sector Practice Requirements
Scope Reference Element The standard shall require that
The building in which equipment is manufactured
shall be designed, constructed and maintained to
JI GMP 3.2 Equipment
minimise any contamination of the manufactured
equipment which may affect food safety.

Guideline
The building in which equipment is manufactured has an important role to play in terms of
preventing the equipment from becoming a contamination risk when introduced to and being put
into use at the food manufacturing site of the customer.

In this context, the HD requirements and principles (HACCP 1.10) will apply to:
- The requirement for the relevant building elements to be non-toxic and of durable construction
to prevent contamination originating from:
- External sources: e.g. rain, dirt, pests, potential flooding, pollution
- Internal sources: e.g. chemicals, glass from broken lights or windows, particles shed from
ceilings
- The manufacturing process: sufficient separation/zoning to prevent metal splinters,
corrosion, etc.
- Access to buildings/areas to be controlled for safety, food-defence purposes etc.
- The flows of people, materials and vehicles on site, including access controls (safety, tampering)
- The relevant building elements and areas to ensure adequate drainage, cleaning and
maintenance.
- The taking into account of the purposes and typical needs and challenges of the various areas:
- Storage (hazardous and non-hazardous materials separated, cleanable, no ingress of pests,
moisture and condensation-control, prevention of physical damage)
- Production
- Personal hygiene, toilet and changing facilities
- Offices
- Canteen (food safety)
- Waste disposal (promotion of sustainable disposal)

References
- CFR21 Code of Federal Regulations - Title 21 - Food and Drugs, FDA §117 Subpart B, Current
Good Manufacturing Practice
- Codex Alimentarius CXC 1-1969:2020 GENERAL PRINCIPLES OF FOOD HYGIENE
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- EHEDG Guideline Doc 44:2014 Hygienic Design Principles for Food Factories
- ISO 22000:2018 Food safety management systems — Requirements for any organization in the
food chain
- Regulation EC 852/2004 On the hygiene of foodstuffs (appendix)

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Scope Reference Element The standard shall require that
Suitable employee, contractor and visitor access
requirements shall be in place such that food
Product contamination
JI GMP 4.8 safety is not compromised if construction is
risk and segregation
undertaken at a site in which food is being
handled.

Guideline
Food manufacturers are responsible for suitable employee, contractor and visitor access
requirements in their own plant. An equipment manufacturer or building constructor incorporates
these requirements into the project plan and determines with the customer if requirements need to
be adjusted to ensure food safety during the project.

It is important to control the movement of people around a site during construction, both from a
food safety, and a health and safety perspective. Temporary access for contractors and visitors, and
any changes to entrance routes for employees are considered as part of the project plan to ensure
areas can be temporarily cordoned off while still meeting all necessary requirements. For example,
ensuring adequate changing and handwashing facilities are available, and maintaining legal
compliance regarding emergency exits.

Building work naturally generates considerable amounts of dust and debris, therefore, sites will
ensure that any areas of construction are fully segregated from the rest of the factory to prevent
contamination. This will include not only physical containment of the building work but also
controlling the risk posed by personnel. It is common for sites to apply the same site entrance
procedures to contractors as are used for visitors in order to confirm their identification, health
status and to communicate site rules. This typically includes:
- Identification – confirmation that the individual works for an approved contractor and is
expected on site;
- Fitness to work – declaration that the person is free from any symptoms of food poisoning and
infectious diseases;
- Jewellery policy – outline of what jewellery is permitted while working on site;
- Allergens – notification of what allergens are on site and any prohibited items e.g. nuts;
- Personal hygiene policy – what personal protective equipment must be worn in different areas
of the site and when to wash hands etc.

Where approved workers have been issued access passes, access is restricted to necessary areas
only and passes are only issued once the contractors have successfully completed all necessary
induction training. Site senior management is responsible for the management of contractors while
they are on site.

In addition to these checks, it is good practice to minimise the overlap between contractor and
employee/visitor pedestrian routes wherever possible. Ideally, the access routes into contractor
areas are separate from those of employees or visitors and should lead directly outside to help
contain the dust and debris caused by construction.

Sites can support compliance with control procedures such as visual signs, regular briefings,
behavioural observations or (where permitted by law) video surveillance.

References

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- ISO/TS 22002-1:2009 Prerequisite programmes on food safety — Part 1: Food manufacturing

Scope Reference Element The standard shall require that

Procedures shall be in place to prevent the cross-
contamination of food from hazards created by
Product contamination
JI GMP 4.9 construction activities if construction is
risk and segregation
undertaken at a site in which food is being
handled.

Guideline
Food manufacturers are responsible for procedures for preventing cross-contamination in their own
plant. An equipment manufacturer or building constructor incorporates these procedures into the
project plan and determines with the customer if procedures need to be adjusted to mitigate
contamination risks during the project.

If construction is undertaken at a site in which food is being handled:

- Follow the hygienic design principles established as described in HACCP 1.15
- Employees are to be made aware of relevant hygienic practices and food safety risks before
commencing work in the area.
- Construction activities are to be evaluated considering and addressing their potential impact on
identified cross-contamination risks: chemicals (e.g. cleaning agents, paint, surface treatment),
microbiological hazards (e.g. food pathogens or spoilage organisms), physical hazards (e.g.
wood, paint flakes, rust, tools & equipment, glass) or allergens (e.g. from engineering tools).
Checklists may include HVAC system, drains and traffic patterns.
- Appropriate control measures to eliminate the cross-contamination hazards or mitigate the risk
may include:
- Training in advance of construction activities (GMP 7.2 & 7.3)
- Cleaning of equipment and tools to remove all potential food safety hazards associated with
the construction process, both before and after construction activities
- Segregation of construction and production areas where required (heavy plastic sheeting or
temporary walls, air flow and ventilation)
- Wrap or cover equipment to prevent introduction of food safety hazards
- Apply specified traffic patterns and equipment segregation for people, materials and
equipment, use dedicated tools, consider use of a designated single entrance for
construction employees
- Implementation of hygiene precautions by construction employees, e.g. adhering to
clothing, shoe and other personal hygiene measures as required in the food production
area (hygiene zone)
- Temporary structures to be designed and constructed to avoid pest harbourage and
potential product contamination
- Once work is complete, ensure all tools and accessories are collected and that none are
missing
- Report any deviations or unusual working methods and structures
- Assess whether the building work impacts the food manufacturers pest control practices.
(E.g. do bait boxes have to be removed or have new entrances been made into production
areas that could allow pest access.)

References
- Codex Alimentarius, CAC/RCP 75-2015:2016 CODE OF HYGIENIC PRACTICE FOR LOW-MOISTURE
FOODS, Adopted in 2015. Revision 2016

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- EHEDG Guideline Doc 8:2018 Hygienic design principles
- EHEDG Guideline Doc 44:2014 Hygienic Design Principles for Food Factories
- EHEDG Guideline Doc 47:2016 Guidelines on Air Handling Systems in the Food Industry - Air
Quality Control for Building Ventilation
- FDA, 2017. Control of Listeria monocytogenes in Ready-To-Eat Foods: Guidance for Industry
(Draft Guidance).
- ISO/TS 22002-1:2009 – 10.1 General requirements. Programmes shall be in place to prevent,
control and detect contamination.
- US Dairy Innovation Center:2019 Controlling Pathogens in Dairy Processing Environments.
Guidance for the US Dairy Industry

Scope Reference Element The Standard shall require that

Prior to building commissioning or equipment
dispatch, buildings / equipment shall be cleaned
Product contamination by the manufacturer / constructor using
JI GMP 4.10
risk and segregation appropriate methods that will remove all food
safety hazards associated with the construction
process. Cleaning should be recorded and verified.

Guideline
To avoid contamination, equipment manufacturers have to ensure that equipment is clean and
correctly protected during transport (GMP 15.2), installation and commissioning (GMP 4.9).

During and after installation/building, appropriate prevention and cleaning procedures need to be
agreed between the manufacturer/constructor and the customer (food manufacturer). These may
involve:
- Excluding and removing construction-related contaminants (metal-working fluids, dirt, dust,
cement, metal particles, dust or splinters, disposables, personal items, tools, loose parts,
clothing, etc.).
- Excluding and removing metal particles produced by mechanical treatment (grinding, welding,
etc.)
- Passivation of stainless steel surfaces where appropriate

Here, the purpose is not to control other hazards such as microorganisms, these will be controlled
by the user of the food buildings/equipment by the performance of a systematic, verified and
recorded cleaning process prior to actual food production (GMP 4.11)

Just like commissioning, cleaning as a final preparation step for the start of production should be
considered as an integral part of the project plan. The order of commissioning and cleaning is
important and needs to be aligned between suppliers and customer. (E.g. preventing the turning on
of an HVAC system before construction debris has been removed from the ducts). It is
recommended that an HDRA be carried out for the specific build and integration project situation in
cooperation between supplier and customer.

- EHEDG guidelines dealing with cleaning and disinfection for general or specific equipment
should be considered; specifically EHEDG Guideline Doc 45 Cleaning Validation in the Food
Industry - General Principles, Part 1 explains the process.

Note that metal-working fluids cannot normally be removed by standard food-industry cleaning
agents and must be removed by the supplier prior to dispatch/handover.

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References
- EHEDG Guideline Doc 18:2014 Chemical Treatments of Stainless Steel Surfaces
- EHEDG Guideline Doc 45:2021 Cleaning Validation in the Food Industry - General Principles, Part
1
- EHEDG Guideline Doc 47:2016 Guidelines on Air Handling Systems in the Food Industry - Air
Quality Control for Building Ventilation
- EHEDG Guideline Doc 52:2021 Basic Principles of Cleaning and Disinfection in Food
Manufacturing

Scope Reference Element The standard shall require that

Following purchase (and installation), all buildings
and equipment shall be cleaned/ commissioned
Product contamination
JII GMP 4.11 by the user before they are used for the
risk and segregation
processing of food. Cleaning should be recorded
and verified.

Guideline
Installation of new equipment and opening of new buildings will require specific inspection and
cleaning to ensure that they meet food safety requirements because contaminants remaining after
construction, installation and commissioning can differ from those expected during food production
(e.g. bacteria, dirt, dust, cement, metal dust or shavings). In principle, no such contaminants should
be present and the purchase/supply-contract should require this.

Just like commissioning, cleaning as a final preparation step for the start of production should be
considered as an integral part of the project plan. For repetitive small build projects this may be
embodied in a general procedure based on an HDRA for hygienic building and integration. For
unique or large projects, a separate HDRA based on the specific situation is recommended. The
order of commissioning and cleaning is important and needs to be aligned between suppliers and
customer and sequenced accordingly. (E.g. preventing the turning on of an HVAC system before
construction debris has been removed from the ducts, or preventing the introduction of water into
piping systems before any metal or concrete debris has been removed). Food building and
equipment users should verify the efficiency of the cleaning performed before starting any food
production.
EHEDG guidelines dealing with cleaning and disinfection, for general or specific equipment should
be considered (see references).
–
References
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities.
- EHEDG Guideline Doc 45:2021 Cleaning Validation in the Food Industry - General Principles, Part
1
- EHEDG Guideline Doc 47:2016 Guidelines on Air Handling Systems in the Food Industry - Air
Quality Control for Building Ventilation
- EHEDG Guideline Doc 52:2021 Basic Principles of Cleaning and Disinfection in Food
Manufacturing

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Scope Reference Element The standard shall require that
Procedures shall be established, implemented
and maintained to ensure all employees and
contractors involved in building and equipment
JI evaluation, specification, purchase, maintenance
GMP 7.2 Training
JII and hygienic design shall be trained in hygienic
design principles appropriate to their tasks and to
the hygienic design requirements of the building
or equipment for its intended use.

Guideline
The learning objectives of basic hygienic design training include the following elements:
- How/which food safety hazards can be managed by hygienic design
- HD requirements and principles (HACCP 1.10) and their impact on food safety and how they
apply during the life cycle of equipment, processes or buildings (design, construction,
installation, qualification and operation).
- The basic principles of a hygienic design risk assessment and the factors impacting this risk
assessment.

Note: These are the basics – specific projects may require additional training in hygienic design

The learning objectives to be considered depend on the job/role. These could include:
- Ability to recognise non-hygienic design principles/practices in a plant being operated for its
intended use
- Ability to identify hygienic design requirements on technical drawings of equipment
- Ability to evaluate piping & instrumentation diagrams (P&ID) in respect of hygienic design and
impact on food safety
- Ability to evaluate drawings of buildings, processes or equipment in respect of their hygienic
design and impact on food safety, for example configuration of flows of people, materials and
air in a building design such that the risk of cross-contamination is minimised
- Ability to recognise how utilities and their connections to processes and systems can influence
food safety.
- Ability to recognise how construction and installation procedures can affect hygienic design and
ultimately food safety and quality
- Ability to recognise how automation and control can influence hygienic design
- Understanding of how to select the right construction materials and ensure they are suitable for
the intended use
- Ability to recognise how, alongside hygienic design aspects, maintenance procedures and
practices can influence hygienic design in operations
- Ability to define effective cleaning and disinfection procedures based on the hygienic design of
buildings and equipment
- Ability to choose effective cleaning and disinfection agents for the equipment and its intended
use (products/ process), including efficiency validations of those chemicals
- Understanding of how to qualify, validate, verify and monitor equipment, processes and
buildings to ensure they suitable for the intended use.

Note: Personnel should not only be trained as appropriate for their role, but should also be
qualified. A competency-matrix can facilitate the identification and allocation of individuals
according to their level of competence.

Note: Several basic and advanced hygienic design courses, as well as authorised trainers can be
found on the EHEDG website
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References
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- EHEDG Guideline Doc 58, Hygienic design risk management

Scope Reference Element The standard shall require that

Procedure shall be established, implemented and
maintained to ensure all employees and
contractors involved in building construction and
JI GMP 7.3 Training
equipment installation, undertaken at a site
handling food shall be trained in food safety
principles appropriate to their task.

Guideline
Prior to commencing work, all personnel at a food handling site, including temporary personnel and
(sub)contractors, shall be trained in a manner appropriate for their duties and then subsequently
adequately supervised throughout the working period.

The provided training procedure to prevent food safety hazards is based on-site specific food safety
policies, programmes, and procedures including:
- Identification of training needs
- Identification of individuals to be trained and qualified
- Training subjects/materials, including:
- Good manufacturing practices (GMP’s) for performing work on a food handling site
- Storage and handling procedures for construction materials and tools
- Selection and use of food contact materials, spare parts, lubricants etc.
- Management of tools (cleanliness, no lost pieces)
- Specific procedures regarding intrusive maintenance activities
- Permit to work system, lock-out and tag-out
- Specific procedures regarding completion of work and handover on completion

The procedure addresses two scopes:

- General GMP and food safety training independent of where the building construction or
equipment installation takes place
- A procedure that is part of the project plan and covers implementing GMP procedures and
training specifically required by the customer or by the build situation

General GMP and food safety training procedure

All employees receive general training about food safety issues and the main food safety hazards
(biological, physical and chemical). During this training, the link between the control of
contamination by food safety hazards, good engineering practices and good manufacturing
practices is to be clearly explained.

Customer/project specific GMP procedure

It is recommended that the food building/equipment supplier and user (customer) perform a pre-
qualification with respect to GMP requirements regarding hygiene and food safety.
The user has to understand the type of risks that could occur during the construction or
maintenance activities that the supplier has to execute. The user also has to explain the procedures
and practices that the supplier has to follow to ensure the risks are appropriately mitigated.

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Suppliers that hire subcontractors have to ensure that all training requirements mentioned are also
followed by the subcontractors, if necessary, with assistance from the user.

References
- EN 1672-2:2020 Food processing machinery - Basic concepts - Part 2: Hygiene and cleanability
requirements
- ISO 14159:2008 Safety Of Machinery - Hygiene Requirements For The Design Of Machinery
- ISO 22000:2018 Food safety management systems - Requirements for any organization in the
food chain

Scope Reference Element The standard shall require that

A procedure shall be established, implemented

JI GMP 13 Pest control and maintained to prevent, monitor and control
or eliminate the risk of pest infestation at the site.

Guideline
The building where equipment is manufactured has an important role to play in terms of preventing
the equipment from becoming a contamination hazard when introduced to and being put into use
at the food manufacturing site of the customer.

Integrated pest management (IPM) should be pursued as an ecological protection approach that
combines various management strategies and practices to exclude pests while minimising the use of
pesticides. Buildings and their openings should be pest-tight and internal traps should be for
monitoring, not control. Granular baits are not acceptable and no poisons should be used inside
controlled areas.

It is generally advisable to use a qualified and certified contracted pest control company for pest
monitoring and elimination. Also, the contractor will be able to give recommendations to the
serviced plant on preventative measures. Maintaining the site and facilities in good condition will
always remain the facilities’ responsibility. The primary focus when inspecting monitoring devices
and evidence of pest infestation will be on habitat areas that provide food, water and shelter for
pests, such as food storage rooms/canteens, waste areas, restrooms, perimeter building walls.

When selecting a contractor, the following criteria should be considered:

- Evidence that the contractor can deliver services to the required level.
- Valid license and qualification can be demonstrated through regional certification schemes.
- Each employee providing pest management service at the plant can provide evidence of his/her
qualification.
- Key performance indicators (KPIs) of the service level agreement should be part of a contract.

References
- BRCGS:2008 Global Standard, Best Practice Guideline Pest Control
- EN 16636:2015 Pest management services - Requirements and competences

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Scope Reference Element The standard shall require that
Manufactured equipment shall be stored and
transported to the final customer in a manner that
JI GMP 15.2 Transport
prevents contamination of the equipment which
may affect food safety.

Guideline
Hygienic storage and transportation plays a role in preventing equipment becoming a
contamination hazard at the food manufacturing site of the customer.
For appropriate storage and transport conditions, the 6 HD principles (see HACCP 1.10) need to be
considered by members of the design team including the logistics expert:
- Segregation: the isolation of the equipment during transport and storage from external
influences such as airborne contamination (smoke, exhaust fumes, dust etc.) and contact
contamination (direct contact with floors, walls etc.).
- Cleanability and actual cleanliness and sanitary condition of storage locations and transport
vehicles, enabling logistical operations in an environment where the outer packaging of the
equipment can be expected to remain free from contamination that must not be introduced in
a food manufacturing site – even in low-risk zones.
- Accessibility in this context is a facilitating factor for the cleanability of storage
locations/vehicles, as are surfaces and geometries.
- Drainability of storage locations/vehicles will enable effective wet cleaning and/or restoration
of clean and sanitary conditions after flooding (high water, rains).
- Materials used in construction must be durable and protect against contamination through
deterioration (rust, flaking, cracking etc.) and act as effective barriers against external
influences (physical, chemical, other environmental influences).

Furthermore, the appropriate packaging for the equipment during transport/storage needs to be
considered from the perspective of protection of:
- the equipment (physical, chemical, other environmental influences),
- the transport/storage environment and
- the environment in the food manufacturing sites where the equipment will be unpacked.

References
BRCGS:2020 Global Standard for Storage and Distribution

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Abbreviations, definitions and terms
As stated in the GFSI Benchmarking Requirements: food is used as an umbrella term and refers to e.g.
food, feed, packaging as applicable. When we use the term food manufacturer, we imply the users of
food manufacturing buildings and the users processing equipment from farm to fork.
For the suppliers of these food buildings and processing equipment, GFSI uses building constructors
and equipment manufacturers.

See also:
- GFSI benchmarking requirements (version 2020) Part IV : Glossary of terms
- EHEDG Glossary version 2020/8.G04

A class of entities, from a pump to an installed skid, to a software -

routine or process-line, which is designated for manufacturing
Assigned or bespoke entities
specific product(s), by specified processes, in specific
systems/locations or for a specific user.
In this context: buildings, machines, process lines or equipment,
including any components, utilities and utensils necessary for their
Building/equipment operation, for farms, food production facilities, food retail and
wholesale operations, and packaging dedicated to food (i.e. food,
beverages, food ingredients, feed)
Clean in Place (see EHEDG Glossary)
CIP / COP
Clean out of Place (see EHEDG Glossary)
CPO Certification Programme Owner (see website GFSI)
Machines and equipment (including their parts and components
necessary to link them together , and services and utensils
necessary for their operation), feed and food transport systems to
Equipment
bring ingredients/packaging to them, together with food storage
Food equipment
and display units to allow the processing and retail of food, feed and
packaging materials in the GFSI scopes of recognition. (GFSI Glossary
of Terms)
A structured safety-tool based on risk-assessment and management
FMEA
of the consequences of failure of any entities, within a process. The
Failure-Mode and Effects
method is specified in: IEC 60812:2018 Failure modes and effects
Analysis
analysis (FMEA and FMECA)
Biological, chemical or physical agent in food with the potential to
Food Safety Hazard
cause adverse health effect. (CAC/RCP 1-1969; ISO 22000)
Assurance that food will not cause an adverse health effect for the
Food Safety consumer when it is prepared and/or consumed in accordance with
its intended use (CAC/RCP 1-1969; ISO/IEC 22000)
FSM Food Safety Management
FSMS Set of interrelated elements to establish policy and objectives and
Food Safety Management to achieve those objectives, used to direct and control an
System organisation with regard to food safety (ISO/IEC 22000)
Single or multiple products, whether processed, semi-processed or
Feed raw, which is intended to be fed to food producing animals.
(ISO/EC 22000; CAC / GL81-2013)
Substance (ingredient), whether processed, semi-processed or raw,
which is intended for consumption, and includes drink, chewing
Food gum and any substance which has been used in the manufacture,
preparation or treatment of “food”, but does not include cosmetics
or tobacco or substances (ingredients) used only as drugs. (ISO/EC
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 22000; CAC / GL81-2013)
Umbrella term for any product in the GFSI scope, i.e. packaging,
feed , etc. (see website GFSI)
Food building A building in which food is manufactured
GMP Good Manufacturing Practices (see EHEDG Glossary)
Greenfield engineering or construction is the process of developing
Greenfield a new building or structure on a completely vacant site.
Brownfield Brownfield projects are on sites or in factories where there already
has been development or where activities are still in place.
Hazard Analysis and Critical Control Points
HACCP
(See EHEDG glossary/Codex Alimentarius)
Harbourage means any place where microorganisms, insects,
Harbourage
rodents, vermin, or other pests can live, nest, or seek shelter.
HD Hygienic design (see EHEDG Glossary)
GFSI introduces the Hygienic Design Process concept. It involves the
management of equipment, buildings and utilities, throughout their
Hygienic Design Process
lifecycle from the perspective of hygienic performance and
suitability.
Hygienic design risk assessment is a risk assessment focussed on of
HDRA
hygiene risks caused by poor hygienic design of food buildings or
Hygienic Design Risk
equipment. Note: for EHEDG purposes, 'risk' is synonymous to
Assessment
probability or likelihood and can include risks to quality.
Hygienic Design Risk
Hygienic design risk management consists of an HDRA as well as
Management
hygiene risk mitigation by hygienic design.
HDMS GFSI has introduced the Hygienic Design Management System for
Hygienic Design food building/equipment suppliers as the equivalent of the FSMS for
Management System food building/equipment users
Designs and practices that avoid unacceptable levels of
microbiological, physical or chemical contamination, which would
Hygiene
otherwise compromise safety-,quality and/or sustainability
requirements.
An area with fixed boundaries, which has restrictions on the access
and egress of material, personnel and/or equipment, in which a
Hygiene zone
defined level of hygiene and care is maintained and in which the
costs of building, equipment, utilities, and procedures are
minimised, as appropriate for the designated hygiene-standard
Any scheduled or unscheduled maintenance activity that is carried
Intrusive maintenance
out on direct or indirect product contact surfaces.
In this context it denotes existing items: legacy equipment or
Legacy
buildings are already in use by a company.
A non-fulfilment of a requirement, which is a need or expectation,
Non-conformity
that is stated, generally applied or obligatory (ISO 22000:2018)
PRP Basic conditions and activities that are necessary within the
Pre Requisite Programmes organisation and throughout the food chain to maintain food safety
(ISO22000 2018)
P&ID Piping & Instrumentation Diagram
A class of entities, such as a pump, sensor, cleaning-formulation,
seal, cutter or a door-module, that is designed/manufactured
Unassigned entities prospectively for a range of hygienic or aseptic uses. That is, those
for which the assigned product, process and location are not yet
known.

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 Explained in EHEDG Doc 34, V2 August 2020: Integrating hygienic
entities.
An overview of the recommended integration plan is given in the
form of a V-diagram, which shows a numbered sequence of phases.
V-model
Design phases are on the left leg of the V and implementation
phases on the right leg. It also shows how each of the
implementation phases (right) should be validated against its
corresponding design phase (left).

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References
3-A SSI 3-A Sanitary Standards, Inc
ASME-BPE 2022 American Society of Mechanical Engineers, Bioprocessing
Equipment
BRCGS:2008 Global Standard, Best Practice Guideline Complaint Handling
BRCGS:2008 Global Standard, Best Practice Guideline Pest Control
BRCGS:2019 Global Standard for Packaging Materials Interpretation Guideline
BRCGS:2020 Global Standard for Storage and Distribution
CFR 21 Code of Federal Regulations - Title 21 - Food and Drugs, FDA
Codex Alimentarius, CAC/RCP CODE OF HYGIENIC PRACTICE FOR LOW-MOISTURE FOODS
75-2015:2016 Adopted 2015, revision 2016
Codex Alimentarius GENERAL PRINCIPLES OF FOOD HYGIENE
CXC 1-1969:2020 Including HACCP annex
Metals and alloys used in food contact materials and articles, A
Council of Europe:2013
practical guide for manufacturers and regulators
Directive 2006/42/EC The Machinery Directive
EHEDG:2020 Glossary v. 2020/08. G04
EHEDG Guideline Doc 8:2018 Hygienic design principles
EHEDG Guideline Doc 9:1993 Welding stainless steel to meet hygienic requirements
EHEDG Guideline Doc 10:2007 Hygienic design of closed equipment for the processing of liquid
food
EHEDG Guideline Doc 13:2004 Hygienic design of equipment for open processing
EHEDG Guideline Doc 18:2014 Chemical Treatment of Stainless Steel Surfaces
EHEDG Guideline Doc 22:2014 General hygienic design criteria for the safe processing of dry
particulate materials
EHEDG Guideline Doc 23:2018 Use of H1 and HT1 registered lubricants Part 1 and Production of
H1 & HT1 Food Grade Registered Lubricants, Part 2
EHEDG Guideline Doc 28:2018 Safe and Hygienic Treatment, Storage and Distribution of Water
in Food and Beverage Factories
EHEDG Guideline Doc 32:2005 Materials of construction for equipment in contact with food
EHEDG Guideline Doc 34:2020 Integrating hygienic entities
EHEDG Guideline Doc 35:2006 Hygienic welding of stainless steel tubing in the food processing
industry
EHEDG Guideline Doc 44:2014 Hygienic Design Principles for Food Factories
EHEDG Guideline Doc 45:2021 Cleaning Validation in the Food Industry - General Principles, Part
1
EHEDG Guideline Doc 47:2016 Guidelines on Air Handling Systems in the Food Industry - Air
Quality Control for Building Ventilation
EHEDG Guideline Doc 50:2019 Hygienic Design requirements for CIP Installations
EHEDG Guideline Doc 52:2021 Basic Principles of Cleaning and Disinfection in Food
Manufacturing
EHEDG Guideline Doc 54:2020 Testing of Hygienic Weld Joints
EHEDG Guideline Doc 58
Hygienic design risk management
Publication planned in 2023
Food processing machinery - Basic concepts - Part 2: Hygiene and
EN 1672-2:2020
cleanability requirements
EN 16636:2015 Pest management services - Requirements and competences
FDA:2017 US Food & Drug Administration. Control of Listeria
monocytogenes in Ready-To-Eat Foods: Guidance for Industry
(Draft Guidance).

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FSIS:2020 Food Safety and Inspection Service (FSI) USDA; Guideline for
Industry Response to Customer Complaints
GB 4806 National Food Safety Standard of China
GFSI:2018 A Culture of Food Safety - A Position Paper from the Global
Food Safety Initiative (GFSI) V1.0
GFSI:2020 Benchmarking requirements. PART III Requirements for the
content of standards. JI Hygienic Design of Food Buildings and
Processing Equipment (for building constructors and equipment
manufacturers)
GFSI:2020 Benchmarking requirements. PART III Requirements for the
content of standards. JII Hygienic Design of Food Buildings and
Processing Equipment (for building and equipment users)
ISO 9000:2015 Quality management systems – Fundamentals and vocabulary
ISO 9001:2015 Quality management systems – Requirements
ISO 14159:2008 Safety Of Machinery - Hygiene Requirements For The Design Of
Machinery
ISO 14644-4:2001 Cleanrooms and associated controlled environments - Part 4:
Design, construction and start-up
ISO 22000:2018 Food safety management systems - Requirements for any
organization in the food chain
General requirements for the competence of testing and
ISO/IEC 17025:2017
calibration laboratories
Prerequisite programmes on food safety — Part 1: Food
ISO/TS 22002-1:2009
manufacturing
North American Meat Institute; Food safety Equipment Design
NAMI:2021
Principles, checklist and glossary
Regulation EC 10/2011 Plastic materials and articles intended to come into contact with
food
Regulation EC 852/2004 On the hygiene of foodstuffs
On materials and articles intended to come into contact with
Regulation EC 1935/2004
food
Regulation EC 2023/2006 On good manufacturing practice for materials and articles
intended to come into contact with food
US Dairy Innovation Controlling Pathogens in Dairy Processing Environments.
Center:2019 Guidance for the US Dairy Industry

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