October 2022
EHEDG White Paper on GFSI Hygienic Design Scopes JI & JII
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.
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
** Chairman
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
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 foodsafety 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.
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
HACCP 1.6 Hygienic design process
The hygienic design and suitability of buildings and equipment shall be evaluated throughout their life cycle from the design concept, through construction, purchasing and during use, until the end of their intended life.
FSM 9.1.2 Documentation requirements
A procedure shall be established, implemented, and maintained for the management and control of documented information required to demonstrate the effective operation and control of processes and the Hygienic Design Management System.
GMP 7.2 Training
Procedures shall be established, implemented and maintained to ensure all employees and contractors involved in building and equipment evaluation, 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
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
JI Hygienic Design of Food Buildings and Processing Equipment (for building constructors and equipment manufacturers)
JII Hygienic Design of Food Buildings and Processing Equipment (for building and equipment users)
K Production of (Bio) chemicals and bio-cultures used as food ingredients or processing aids in food production
Table with the GFSI Benchmarking Requirements for scope JI and JII
Section 1: Hazard and Risk Management Systems Requirements
Scope Reference Element
JI JII HACCP 1.5
JI JII HACCP 1.6
Hygienic design process
Hygienic design process
The standard shall require that
A competent multidisciplinary team shall assess the hygienic design and risk assessment of new buildings/equipment.
The hygienic design and suitability of buildings and equipment shall be evaluated throughout their life cycle from the design concept, through construction, purchasing and during use, until the end of their intended life.
JI JII HACCP 1.7 Risk assessment
JI HACCP 1.8 Risk assessment
JI HACCP 1.9.1 Intended use
JI HACCP 1.9.2 Intended use
JI JII HACCP 1.10 Hygienic design principles
JI HACCP 1.11 Hygienic design principles
JI HACCP 1.12 Hygienic design principles
JI HACCP 1.13 Hygienic design principles
JI HACCP 1.14
Hygienic design principles
JI JII HACCP 1.15
Hygienic design principles
JI HACCP 1.16
Hygienic design principles
JI HACCP 1.17 Hygienic design principles
A documented hygienic design risk assessment for food safety hazards on new and existing buildings/equipment shall be 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 other hazards arise, or at a minimum frequency defined by applicable laws and regulations.
The intended use of the building/equipment shall be specified.
The intended use of the building/equipment shall be described, as a specification for the intended purchase of new buildings and equipment.
Appropriate building/equipment hygienic design principles shall be adopted based on the designated risk assessment, appropriate to their intended use and taking into consideration a user specification.
Buildings and equipment shall be of a cleanable design, to meet all cleaning objectives.
Buildings and equipment shall be designed and constructed to avoid favourable growth conditions (for microorganisms, pests and their harbourage), appropriate to their intended use.
Buildings and equipment shall be designed to prevent contamination appropriate to their intended use.
Wherever relevant, recognised hygienic design standards/guidance shall be consulted for the design and construction of buildings and equipment, appropriate for their intended use.
Appropriate hygienic design principles shall be adopted for the installation of new equipment and construction of buildings at sites handling food.
Hygienic design principles shall be adopted to ensure the maintenance of the hygienic performance of the buildings/equipment, appropriate for their intended use.
Appropriate measures (with frequencies) shall be specified, undertaken accordingly and documented to mitigate any remaining food safety risks identified in the hygienic design risk assessment following building/equipment construction, purchase and installation.
Source: GFSI Benchmarking Requirements:2020
Section 2: Hygienic Design Management Systems Requirements
Scope Reference Element
JI FSM 1.2
JI FSM 2.2
Management responsibility
Management commitment and food safety culture
JI FSM 3.2 Management review
JI FSM 4.4 Legislation
JI FSM 5.2
JI FSM 6.2
Hygienic Design Management System
Hygienic Design Policy
JI FSM 9.1.2
JI FSM 9.2.4
JI FSM 10.1
JI FSM 10.2
Documentation requirements
Documentation requirements
Specified requirements/ Specifications
Specified requirements/ Specifications
JI FSM 11 Procedures
JI FSM 12.2
JI FSM 13.1.3
Resource management
Purchasing and supplier performance
The standard shall require that
A clear organisational structure identifying the job functions and responsibilities of at least those employees whose activities affect Hygienic Design shall be established, implemented and maintained.
Evidence of the senior management’s commitment to establish, implement, maintain and continuously improve the Hygienic Design Management System shall be provided.
The organisation’s senior management shall review the verification of the Hygienic Design System at planned intervals, to ensure their continuing suitability, adequacy and effectiveness.
Procedures shall be established, implemented and maintained to ensure that buildings and equipment are legally compliant in the hygienic design requirements in the country of known implementation/sale.
A Hygienic Design Management System shall be established, implemented, maintained and continuously improved.
A clear, concise and documented Hygienic Design policy statement shall be in place, as well as measurable objectives specifying the organisation’s commitments to meet the food safety needs of its products.
A procedure shall be established, implemented, and maintained for the management and control of documented information required 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 requirements, or for a period exceeding the lifetime of buildings/ 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, implemented and maintained for all inputs to the process, including services that are purchased or provided and have an effect on food safety.
A review process of the specified requirements or specifications shall be in place.
Procedures and instructions shall be established, implemented and maintained for all processes and operations having an effect on food safety.
The resources needed to establish, implement, maintain, review and improve the Hygienic design Management System shall be identified and assigned
A purchasing procedure shall be established, implemented and maintained to ensure that all inputs to the process including externally purchased materials and services which have an effect on food safety, conform to specified requirements as well as regulatory requirements.
Source: GFSI Benchmarking Requirements:2020
Section 2: Hygienic Design Management Systems Requirements
Scope Reference Element
JII FSM 13.1.4
JI FSM 13.2.4
Purchasing and supplier performance
Purchasing and supplier performance
The standard shall require that
A procedure shall be established, implemented and maintained to ensure that the newly purchased building/equipment meets the hygienic design specification.
A procedure for the evaluation, approval and continued monitoring of suppliers which have an effect on food safety shall be established, 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.
JI FSM 13.3.2
Purchasing and supplier performance
JI FSM 14.1.5 Traceability
JI FSM 19.4 Testing
JI FSM 19.5 Testing
JI FSM 20.2 Internal audit
JI FSM 21 Complaint handling
JI FSM 22.4
JI FSM 23.2
JI FSM 23.3
JI FSM 24.1
JI FSM 25
Serious incident management
Product release
Product release
Control of nonconformity
Corrective actions
Outsourced processes or service that affect food safety shall be identified and controlled. Such controls shall be documented in the 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 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 testing facility or one that follows relevant international testing guidelines.
Where in-house testing is carried out, calibration of equipment that 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 maintained; it shall cover all elements of the Hygienic Design Management System.
A procedure for the management of complaints and complaint data shall be established, implemented and maintained to ensure that complaints are assessed and corrective actions implemented, when necessary.
An incident management procedure, including product recall, withdrawal, and retrofit shall be established, implemented and maintained. The recall procedure shall be regularly tested for effectiveness.
Commissioning or building/equipment release procedures shall be established, implemented and maintained.
Hygienic design construction specifications shall be verified for buildings and equipment prior to dispatch or hand-over to the customer.
A procedure shall be established, implemented and maintained to ensure that any non-conformity impacting food safety and any nonconforming products are clearly identified and controlled to prevent unintended use or delivery.
A procedure shall be established, implemented and maintained for the determination and implementation of corrective actions in the event of any significant nonconformity relating to food safety.
Section 2: Hygienic Design Management Systems Requirements
Scope Reference Element
JII FSM 26
Change management
The standard shall require that
Change control shall be undertaken and documented to evaluate the impacts of any changes/ modifications on equipment/building hygienic design.
Source: GFSI Benchmarking Requirements:2020
Section 3: Good Industry (Sector) Practice Requirements
Scope Reference Element
JI GMP 3.2
JI GMP 4.8
JI GMP 4.9
Equipment
Product contamination risk and segregation
Product contamination risk and segregation
JI GMP 4.10
JII GMP 4.11
Product contamination risk and segregation
Product contamination risk and segregation
JII GMP 7.2 Training
JI GMP 7.3 Training
JI GMP 13 Pest control
JI GMP 15.2 Transport
The standard shall require that
The building in which equipment is manufactured shall be designed, constructed and maintained to minimise any contamination of the manufactured equipment which may affect food safety.
Suitable employee, contractor and visitor access requirements shall be in place such that food safety is not compromised if construction is undertaken at a site in which food is being handled.
Procedures shall be in place to prevent the cross-contamination of food from hazards created by construction activities if construction is undertaken at a site in which food is being handled.
Prior to building commissioning or equipment dispatch, buildings / equipment shall be cleaned by the manufacturer / constructor using appropriate methods that will remove all food safety hazards associated with the construction process. Cleaning should be recorded and verified.
Following purchase (and installation), all buildings and equipment shall be cleaned/commissioned by the user before they are used for the processing of food. Cleaning should be recorded and verified.
Procedures shall be established, implemented and maintained to ensure all employees and contractors involved in building and equipment evaluation, 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.
Procedure shall be established, implemented and maintained to ensure all employees and contractors involved in building 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 prevent, monitor and control or eliminate the risk of pest infestation at the site.
Manufactured equipment shall be stored and transported to the final customer in a manner that prevents contamination of the equipment which may affect food safety.
Source: GFSI Benchmarking Requirements:2020
Section 1: Hazard and Risk Management Systems Requirements
Scope Reference Element The standard shall require that
JI
JII HACCP 1.5 Hygienic design process
Guidelines
A competent multidisciplinary team shall assess the hygienic design and risk assessment of new buildings/equipment.
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
Scope Reference Element The standard shall require that
JI
JII HACCP 1.6 Hygienic design process
Guidelines
The hygienic design and suitability of buildings and equipment shall be evaluated throughout their life cycle from the design concept, through construction, purchasing and during use, until the end of their intended life.
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 EHEDGprocedures 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:
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, customerpartnerships, 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 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
JI
JII
Element The standard shall require that
HACCP 1.7 Risk assessment
Guideline
A documented hygienic design risk assessment for food safety hazards on new and existing buildings/equipment shall be established, implemented and maintained. It shall include as a minimum the following considerations: intended use, food safety hazard identification, evaluation.
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
- 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
The standard shall require that JII HACCP 1.8 Risk assessment
The hygienic design risk assessment shall be reviewed when any change to the building/ 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
The standard shall require that
The intended use of the building/equipment shall be specified.
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
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
JII HACCP 1.9.2 Intended use
Guideline
The standard shall require that
The intended use of the building/equipment shall be described, as a specification for the intended purchase of new buildings and equipment.
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
JI JII HACCP 1.10 Hygienic design principles
The standard shall require that
Appropriate building/equipment hygienic design principles shall be adopted based on the designated risk assessment, appropriate to their intended use and taking into consideration a user specification.
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
Scope Reference Element
JI HACCP 1.11 Hygienic design principles
Guideline
The standard shall require that
Buildings and equipment shall be of a cleanable design, to meet all cleaning objectives.
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
Scope Reference Element The standard shall require that
JI HACCP 1.12 Hygienic design principles
Guideline
Buildings and equipment shall be designed and constructed to avoid favourable growth conditions (for microorganisms, pests and their harbourage), appropriate to their intended use.
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
Scope Reference Element The standard shall require that
JI HACCP 1.13
Guideline
Hygienic design principles
Buildings and equipment shall be designed to prevent contamination appropriate to their intended use.
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
JI HACCP 1.14
Guideline
Element The standard shall require that
Hygienic design principles
Wherever relevant, recognised hygienic design standards/guidance shall be consulted for the design and construction of buildings and equipment, appropriate for their intended use.
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.
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
JI
Element The standard shall require that
JII HACCP 1.15 Hygienic design principles
Guideline
Appropriate hygienic design principles shall be adopted for the installation of new equipment and construction of buildings at sites handling food.
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
- 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
JII HACCP 1.16
Guideline
Hygienic design principles
Hygienic design principles shall be adopted to ensure the maintenance of the hygienic performance of the buildings/equipment, appropriate for their intended use.
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
JII HACCP 1.17
Hygienic design principles
Appropriate measures (with frequencies) shall be specified, undertaken accordingly and documented to mitigate any remaining food 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
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
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
JI FSM 1.2 Management responsibility
A clear organisational structure identifying the job functions and responsibilities of at least those employees whose activities affect Hygienic 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
Scope Reference Element
JI FSM 2.2 Management commitment and food safety culture
Guideline
The standard shall require that
Evidence of the senior management’s commitment to establish, implement, maintain and continuously improve the Hygienic Design Management System shall be provided.
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
JI FSM 3.2 Management review
Guideline
The standard shall require that
The organisation’s senior management shall review the verification of the Hygienic Design System at planned intervals, to ensure their continuing suitability, adequacy and effectiveness.
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
- 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
JI FSM 4.4 Legislation
Procedures shall be established, implemented and maintained to ensure that buildings and 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-tofork 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.
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
JI FSM 5.2 Hygienic Design Management System A Hygienic Design Management System shall be established, implemented, maintained and 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
JI FSM 6.2 Hygienic Design Policy
A clear, concise and documented Hygienic Design policy statement shall be in place, as well as 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
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
JI FSM 9.1.2
Documentation requirements
The standard shall require that
A procedure shall be established, implemented, and maintained for the management and control of documented information required to 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
JI FSM 9.2.4
Documentation requirements
All the above-mentioned documented information shall be securely stored for the time period required to meet customer and legal requirements, or for a period exceeding the 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.
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
JI FSM 10.1
Specified requirements / Specifications
Specified requirements or specifications shall be established, implemented and maintained for all inputs to the process, including services that are 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
JI FSM 10.2
Guideline
Specified requirements / Specifications A review process of the specified requirements or specifications shall be in place.
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:
- 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
JI FSM 11 Procedures
Guideline
Procedures and instructions shall be established, implemented and maintained for all processes and operations having an effect on food safety.
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
Scope Reference Element
JI FSM 12.2 Resource management
Guideline
See also FSM 1.2 & 2.2.
The standard shall require that
The resources needed to establish, implement, maintain, review and improve the Hygienic Design Management System shall be identified and assigned.
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
JI FSM 13.1.3
Purchasing and supplier performance
Guideline
The standard shall require that
A purchasing procedure shall be established, implemented and maintained to ensure that all inputs to the process including externally purchased materials and services which have an effect on food safety, conform to specified requirements as well as regulatory requirements.
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)
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
A procedure shall be established, implemented and maintained to ensure that the newly purchased building/ equipment meets the
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
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
JI FSM 13.2.4
Purchasing and supplier performance
The standard shall require that
A procedure for the evaluation, approval and continued monitoring of suppliers which have an effect on food safety shall be established,
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
JI FSM 13.3.2
Guideline
Purchasing and supplier performance
The standard shall require that
Outsourced processes or service that affect food safety shall be identified and controlled. Such controls shall be documented in the Hygienic Design Management System.
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
Scope Reference Element The standard shall require that
JI FSM 14.1.5 Traceability
Procedures shall be established, implemented and maintained to ensure the ability to trace or follow a material or article critical to food safety through 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
Scope Reference Element
JI FSM 19.4 Testing
The standard shall require that
Where external testing of construction materials, buildings or equipment is required, it shall be 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
JI FSM 19.5 Testing
Guideline
The standard shall require that
Where in-house testing is carried out, calibration of equipment that is critical to food safety shall be carried out against national standards or other accurate means.
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
(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
JI FSM 20.2
Internal audit
The standard shall require that
An internal audit procedure shall be established, implemented and maintained; it shall cover all 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.
- 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
JI FSM 21 Complaint handling
A procedure for the management of complaints and complaint data shall be established, 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
JI FSM 22.4
Element The standard shall require that
Serious incident management
Guideline
An incident management procedure, including product recall, withdrawal, and retrofit shall be established, implemented and maintained. The recall procedure shall be regularly tested for effectiveness.
The manufacturer has an incident management procedure involving the production or use of the
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
JI FSM 23.2
Guideline
The standard shall require that
Product release Commissioning or building/equipment release procedures shall be established, implemented and maintained.
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
- 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
JI FSM 23.3
Guideline
Product release
Hygienic design construction specifications shall be verified for buildings and equipment prior to dispatch or hand-over to the customer.
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
JI FSM 24.1
Control of nonconformity
Guideline
The standard shall require that
A procedure shall be established, implemented and maintained to ensure that any nonconformity impacting food safety and any nonconforming products are clearly identified and controlled to prevent unintended use or delivery.
A procedure with the aim of preventing the delivery of or use by the customer of any nonconforming 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
- 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
JI FSM 25
Corrective actions
A procedure shall be established, implemented and maintained for the determination and 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
JII FSM 26 Change management
The standard shall require that
Change control shall be undertaken and documented to evaluate the impacts of any changes/ modifications on equipment/building
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
Section 3: Good Industry Sector Practice Requirements
Scope Reference Element
JI GMP 3.2 Equipment
Guideline
The standard shall require that
The building in which equipment is manufactured shall be designed, constructed and maintained to minimise any contamination of the manufactured equipment which may affect food safety.
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)
Scope Reference Element The standard shall require that
JI GMP 4.8 Product contamination risk and segregation
Guideline
Suitable employee, contractor and visitor access requirements shall be in place such that food safety is not compromised if construction is undertaken at a site in which food is being handled.
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
- ISO/TS 22002-1:2009 Prerequisite programmes on food safety Part 1: Food manufacturing
Scope Reference Element
JI GMP 4.9
Product contamination risk and segregation
The standard shall require that
Procedures shall be in place to prevent the crosscontamination of food from hazards created by construction activities if construction is 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
- 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
JI GMP 4.10
Product contamination risk and segregation
Prior to building commissioning or equipment dispatch, buildings / equipment shall be cleaned by the manufacturer / constructor using 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.
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
JII GMP 4.11
Product contamination risk and segregation
The standard shall require that
Following purchase (and installation), all buildings and equipment shall be cleaned/ commissioned by the user before they are used for the 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
Scope Reference Element
JI
JII GMP 7.2 Training
The standard shall require that
Procedures shall be established, implemented and maintained to ensure all employees and contractors involved in building and equipment evaluation, 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.
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
References
- EHEDG Guideline Doc 34:2020 Integrating hygienic entities
- EHEDG Guideline Doc 58, Hygienic design risk management
Scope Reference Element
JI GMP 7.3
Training
The standard shall require that
Procedure shall be established, implemented and maintained to ensure all employees and contractors involved in building construction and 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 prequalification 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.
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
JI GMP 13 Pest control
The standard shall require that
A procedure shall be established, implemented 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
Scope Reference Element
JI GMP 15.2 Transport
Guideline
The standard shall require that
Manufactured equipment shall be stored and transported to the final customer in a manner that prevents contamination of the equipment which may affect food safety.
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
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
Assigned or bespoke entities
Building/equipment
CIP / COP
A class of entities, from a pump to an installed skid, to a softwareroutine or process-line, which is designated for manufacturing 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 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)
Clean out of Place (see EHEDG Glossary)
CPO Certification Programme Owner (see website GFSI)
Equipment
Food equipment
FMEA
Failure-Mode and Effects Analysis
Food Safety Hazard
Food Safety
FSM
FSMS
Food Safety Management System
Feed
Food
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 bring ingredients/packaging to them, together with food storage 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 of the consequences of failure of any entities, within a process. The method is specified in: IEC 60812:2018 Failure modes and effects analysis (FMEA and FMECA)
Biological, chemical or physical agent in food with the potential to cause adverse health effect. (CAC/RCP 1-1969; ISO 22000)
Assurance that food will not cause an adverse health effect for the consumer when it is prepared and/or consumed in accordance with its intended use (CAC/RCP 1-1969; ISO/IEC 22000)
Food Safety Management
Set of interrelated elements to establish policy and objectives and to achieve those objectives, used to direct and control an organisation with regard to food safety (ISO/IEC 22000)
Single or multiple products, whether processed, semi-processed or 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 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
22000; CAC / GL81-2013)
Umbrella term for any product in the GFSI scope, i.e. packaging, feed , etc. (see website GFSI)
Food building
GMP
Greenfield
Brownfield
HACCP
Harbourage
A building in which food is manufactured
Good Manufacturing Practices (see EHEDG Glossary)
Greenfield engineering or construction is the process of developing a new building or structure on a completely vacant site. 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
(See EHEDG glossary/Codex Alimentarius)
Harbourage means any place where microorganisms, insects, rodents, vermin, or other pests can live, nest, or seek shelter.
HD Hygienic design (see EHEDG Glossary)
Hygienic Design Process
HDRA
Hygienic Design Risk Assessment
Hygienic Design Risk Management
HDMS
Hygienic Design Management System
Hygiene
Hygiene zone
Intrusive maintenance
Legacy
Non-conformity
PRP
Pre Requisite Programmes
P&ID
Unassigned entities
GFSI introduces 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.
Hygienic design risk assessment is a risk assessment focussed on of hygiene risks caused by poor hygienic design of food buildings or equipment. Note: for EHEDG purposes, 'risk' is synonymous to probability or likelihood and can include risks to quality.
Hygienic design risk management consists of an HDRA as well as hygiene risk mitigation by hygienic design.
GFSI has introduced the Hygienic Design Management System for food building/equipment suppliers as the equivalent of the FSMS for food building/equipment users
Designs and practices that avoid unacceptable levels of microbiological, physical or chemical contamination, which would 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 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 out on direct or indirect product contact surfaces.
In this context it denotes existing items: legacy equipment or buildings are already in use by a company.
A non-fulfilment of a requirement, which is a need or expectation, that is stated, generally applied or obligatory (ISO 22000:2018)
Basic conditions and activities that are necessary within the organisation and throughout the food chain to maintain food safety (ISO22000 2018)
Piping & Instrumentation Diagram
A class of entities, such as a pump, sensor, cleaning-formulation, seal, cutter or a door-module, that is designed/manufactured prospectively for a range of hygienic or aseptic uses. That is, those for which the assigned product, process and location are not yet known.
Explained in EHEDG Doc 34, V2 August 2020: Integrating hygienic entities.
V-model
An overview of the recommended integration plan is given in the form of a V-diagram, which shows a numbered sequence of phases. 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).
References
3-A SSI
3-A Sanitary Standards, Inc
ASME-BPE 2022 American Society of Mechanical Engineers, Bioprocessing Equipment
BRCGS:2008
BRCGS:2008
BRCGS:2019
BRCGS:2020
CFR 21
Codex Alimentarius, CAC/RCP 75-2015:2016
Codex Alimentarius
CXC 1-1969:2020
Council of Europe:2013
Global Standard, Best Practice Guideline Complaint Handling
Global Standard, Best Practice Guideline Pest Control
Global Standard for Packaging Materials Interpretation Guideline
Global Standard for Storage and Distribution
Code of Federal Regulations - Title 21 - Food and Drugs, FDA
CODE OF HYGIENIC PRACTICE FOR LOW-MOISTURE FOODS
Adopted 2015, revision 2016
GENERAL PRINCIPLES OF FOOD HYGIENE
Including HACCP annex
Metals and alloys used in food contact materials and articles, A practical guide for manufacturers and regulators
Directive 2006/42/EC The Machinery Directive
EHEDG:2020
EHEDG Guideline Doc 8:2018
EHEDG Guideline Doc 9:1993
EHEDG Guideline Doc 10:2007
EHEDG Guideline Doc 13:2004
EHEDG Guideline Doc 18:2014
EHEDG Guideline Doc 22:2014
EHEDG Guideline Doc 23:2018
EHEDG Guideline Doc 28:2018
EHEDG Guideline Doc 32:2005
EHEDG Guideline Doc 34:2020
EHEDG Guideline Doc 35:2006
EHEDG Guideline Doc 44:2014
EHEDG Guideline Doc 45:2021
Glossary v. 2020/08. G04
Hygienic design principles
Welding stainless steel to meet hygienic requirements
Hygienic design of closed equipment for the processing of liquid food
Hygienic design of equipment for open processing
Chemical Treatment of Stainless Steel Surfaces
General hygienic design criteria for the safe processing of dry particulate materials
Use of H1 and HT1 registered lubricants Part 1 and Production of H1 & HT1 Food Grade Registered Lubricants, Part 2
Safe and Hygienic Treatment, Storage and Distribution of Water in Food and Beverage Factories
Materials of construction for equipment in contact with food
Integrating hygienic entities
Hygienic welding of stainless steel tubing in the food processing industry
Hygienic Design Principles for Food Factories
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
EHEDG Guideline Doc 52:2021
Hygienic Design requirements for CIP Installations
Basic Principles of Cleaning and Disinfection in Food Manufacturing
EHEDG Guideline Doc 54:2020 Testing of Hygienic Weld Joints
EHEDG Guideline Doc 58
Publication planned in 2023
EN 1672-2:2020
EN 16636:2015
Hygienic design risk management
Food processing machinery - Basic concepts - Part 2: Hygiene and cleanability requirements
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).
FSIS:2020
GB 4806
GFSI:2018
GFSI:2020
GFSI:2020
ISO 9000:2015
ISO 9001:2015
ISO 14159:2008
ISO 14644-4:2001
ISO 22000:2018
ISO/IEC 17025:2017
ISO/TS 22002-1:2009
NAMI:2021
Regulation EC 10/2011
Regulation EC 852/2004
Regulation EC 1935/2004
Regulation EC 2023/2006
US Dairy Innovation
Center:2019
Food Safety and Inspection Service (FSI) USDA; Guideline for Industry Response to Customer Complaints
National Food Safety Standard of China
A Culture of Food Safety - A Position Paper from the Global Food Safety Initiative (GFSI) V1.0
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)
Benchmarking requirements. PART III Requirements for the content of standards. JII Hygienic Design of Food Buildings and Processing Equipment (for building and equipment users)
Quality management systems – Fundamentals and vocabulary
Quality management systems – Requirements
Safety Of Machinery - Hygiene Requirements For The Design Of Machinery
Cleanrooms and associated controlled environments - Part 4: Design, construction and start-up
Food safety management systems - Requirements for any organization in the food chain
General requirements for the competence of testing and calibration laboratories
Prerequisite programmes on food safety Part 1: Food manufacturing
North American Meat Institute; Food safety Equipment Design Principles, checklist and glossary
Plastic materials and articles intended to come into contact with food
On the hygiene of foodstuffs
On materials and articles intended to come into contact with food
On good manufacturing practice for materials and articles intended to come into contact with food
Controlling Pathogens in Dairy Processing Environments. Guidance for the US Dairy Industry