Food Manufacturing Checklist Edition 9
Food Manufacturing Checklist Edition 9
Food Manufacturing Checklist Edition 9
Clause Item Primary Response Evidence Supplier Onsite Correction/ Corrective Action
Opening Meeting People Present at the Opening Meeting (Please list names and roles in the following format Name: Role
separated by comas)
Closing Meeting People Present at the Closing Meeting (Please list names and roles in the following format Name: Role separated
by comas)
Facility Description Auditor Description of Facility (Please provide facility description include # of employees, size, production
schedule, general layout, and any additional pertinent details
2.1.1.2 Senior site management shall lead and support a food safety culture within the site that ensures at a minimum:
i. The establishment, documentation, and communication to all relevant staff of food safety objectives and
performance measures;
ii. Adequate resources are available to meet food safety objectives;
iii. Food safety practices and all applicable requirements of the SQF System are adopted and maintained;
iv. Employees are informed and held accountable for their food safety and regulatory responsibilities;
v. Employees are positively encouraged and required to notify management about actual or potential food safety
issues; and
vi. Employees are empowered to act to resolve food safety issues within their scope of work.
2.1.1.3 The reporting structure shall identify and describe site personnel with specific responsibilities for tasks within the
food safety management system and identify a backup for the absence of key personnel.
Job descriptions for the key personnel shall be documented.
Site management shall ensure departments and operations are appropriately staffed and organizationally aligned
to meet food safety objectives.
2.1.1.4 Senior site management shall designate a primary and substitute SQF practitioner for each site with responsibility
and authority to:
i. Oversee the development, implementation, review, and maintenance of the SQF System;
ii. Take appropriate action to ensure the integrity of the SQF System; and
iii. Communicate to relevant personnel all information essential to ensure the effective implementation and
maintenance of the SQF System.
2.1.1.6 Senior site management shall ensure the training needs of the site are resourced, implemented, and meet the
requirements outlined in system elements 2.9 and that site personnel meet the required competencies to carry out
those functions affecting the legality and safety of food products.
2.1.1.7 Senior site management shall ensure the integrity and continued operation of the food safety system in the event
of organizational or personnel changes within the company or associated facilities.
2.1.1.8 Senior site management shall designate defined blackout periods that prevent unannounced re-certification audits
from occurring out of season or when the site is not operating for legitimate business reasons. The list of blackout
dates and their justification shall be submitted to the certification body a minimum of one (1) month before the
sixty (60) day re-certification window for the agreed-upon unannounced audit.
2.1.2.2 The SQF practitioner(s) shall update senior site management on at least a monthly basis on matters impacting the
implementation and maintenance of the SQF System.
The updates and management responses shall be documented.
2.1.3.2 Adverse trends of customer complaint data shall be investigated and analyzed and the root cause established by
personnel knowledgeable about the incidents.
2.1.3.3 Corrective and preventative action shall be implemented based on the seriousness of the incident and the root
cause analysis as outlined in 2.5.3. Records of customer complaints, their investigation, and resolution shall be
maintained.
2.2.1.2 Food safety plans, Good Manufacturing Practices, and all relevant aspects of the SQF System shall be reviewed,
updated, and communicated as needed when any changes implemented have an impact on the site's ability to
deliver safe food.
All changes to food safety plans, Good Manufacturing Practices, and other aspects of the SQF System shall be
validated or justified prior to their implementation. The reasons for the change shall be documented.
2.2.3.3 Records shall be readily accessible, retrievable, and securely stored to prevent unauthorized access, loss, damage,
and deterioration. Retention periods shall be in accordance with customer, legal, and regulatory requirements, at
minimum the product shelf-life or established by the site if no shelf-life exists.
2.3.1.2 New product formulations, manufacturing processes, and the fulfillment of product requirements shall be
established, validated, and verified by site trials and product testing as required to ensure product safety.
Product formulations shall be developed by authorized persons to ensure that they meet the intended use. Where
necessary, shelf life trials shall be conducted to validate and verify a new product’s:
i. Pre-consumer handling and storage requirements, including the establishment of “use by,” “best before dates,”
or equivalent terminology;
ii. Microbiological criteria, where applicable; and
iii. Consumer preparation, where applicable, and storage and handling requirements.
2.3.1.3 A food safety plan shall be validated and verified by the site food safety team for each new product and its
associated process through conversion to commercial production and distribution or where a change to
ingredients, process, or packaging occurs that may impact food safety.
2.3.1.4 Product formulations and manufacturing processes for products included in the scope of certification shall be
reviewed when there are changes in materials, ingredients, or equipment.
2.3.1.5 The process flows for all new and existing manufacturing processes shall be designed to ensure that product is
manufactured according to approved product formulations and to prevent cross-contamination.
2.3.1.6 Records of product design, formulations, label compliance, process flows, shelf life trials, and approvals for all
new and existing products shall be maintained.
2.3.2 Specifications (Raw Material, Packaging, Finished Product and Services)
2.3.2.1 The methods and responsibility for developing, managing, and approving raw material, finished product, and
packaging specifications shall be documented.
2.3.2.2 Specifications for all raw materials and packaging, including, but not limited to, ingredients, additives, hazardous
chemicals, processing aids, and packaging that impact finished product safety shall be documented and kept
current.
2.3.2.3 All raw materials, packaging, and ingredients, including those received from other sites under the same corporate
ownership, shall comply with specifications and with the relevant legislation in the country of manufacture and
country(ies) of destination if known.
2.3.2.4 Raw materials, packaging, and ingredients shall be validated to ensure product safety is not compromised and the
material is fit for its intended purpose.
2.3.2.5 Site management shall require approved raw materials suppliers to notify the site of changes in product
composition that could have an impact on product formulation (e.g., protein content, moisture, amino acid
profiles, contaminant levels, allergens, and/or other parameters that may vary by crop or by season).
2.3.2.6 Verification of packaging shall include a certification of all packaging that comes into direct contact with food
meets either regulatory acceptance or approval criteria. Documentation shall either be in the form of a declaration
of continued guarantee of compliance, a certificate of conformance, or a certificate from the applicable regulatory
agency.
In the absence of a certificate of conformance, certificate of analysis, or letter of guarantee, analyses to confirm
the absence of potential chemical migration from the packaging to the food contents shall be conducted and
records maintained.
2.3.2.7 Finished product labels shall be accurate, comply with the relevant legislation, and be approved by qualified
company personnel.
2.3.2.8 Description of services for contract service providers that have an impact on product safety shall be documented,
current, include a full description of the services to be provided, and detail relevant training requirements of all
contract personnel.
2.3.2.9 Finished product specifications shall be documented, current, approved by the site and its customer, accessible to
relevant staff, and shall include, where applicable:
i. Microbiological, chemical, and physical limits;
ii. Composition to meet label claims;
iii. Labeling and packaging requirements; and
iv. Storage conditions.
2.3.2.10 Specifications for raw materials and packaging, chemicals, processing aids, contract services, and finished
products shall be reviewed as changes occur that impact product safety. Records of reviews shall be maintained.
A list of all the above specifications shall be maintained and kept current.
2.3.3.2 The site shall establish a method to determine the food safety risk level of contract manufactured product and
shall document the risk. The site shall ensure that:
i. Products and processes of co-manufacturers that are considered high-risk have undergone an audit by the site or
third-party agency to confirm compliance with the SQF Food Safety Code: Food Manufacturing and regulatory
and customer requirements;
ii. Products and processes of co-manufacturers that are considered low-risk meet the requirements of the SQF
Food Safety Code: Food Manufacturing, or other GFSI benchmarked certification programs, and regulatory and
customer requirements; and
iii. Changes to contractual agreements are approved by both parties and communicated to relevant personnel.
2.3.3.3 Contractual agreements with third party storage and distribution businesses shall include requirements relating to
customer product requirements and compliance with clause 2.3.3.2 of the SQF Food Safety Code: Food
Manufacturing. Contractual agreements shall be approved by both parties and communicated to relevant
personnel. The site shall verify compliance with the SQF Code and ensure that customer and regulatory
requirements are being met at all times.
2.3.3.4 Records of audits, contracts, and changes to contractual agreements and their approvals shall be maintained.
2.3.4.2 The approved supplier program shall be based on the past performance of a supplier and the risk level of the raw
materials, ingredients, processing aids, packaging, and services supplied, and shall contain at a minimum:
i. Agreed specifications (refer to 2.3.2);
ii. Reference to the level of risk applied to raw materials, ingredients, packaging, and services from the approved
supplier;
iii. A summary of the food safety controls implemented by the approved supplier;
iv. Methods for granting approved supplier status;
v. Methods and frequency of monitoring approved suppliers;
vi. Details of the certificates of conformance, if required; and
vii. Methods and frequency of reviewing approved supplier performance and status.
2.3.4.3 Verification of raw materials shall include certificates of conformance, certificates of analysis, or sampling, and
testing. The verification frequency shall be identified by the site.
2.3.4.4 The receipt of raw materials, ingredients, processing aids, and packaging from nonapproved suppliers shall be
acceptable only in an emergency situation and provided a receiving inspection or analysis is conducted and
recorded before use.
2.3.4.5 Raw materials, ingredients, and packaging received from other sites under the same corporate ownership shall be
subject to the same specification requirements (refer to 2.3.2), approved supplier requirements, and receiving
inspections as all other material providers.
2.3.4.6 Supplier audits shall be based on risk (as determined in 2.3.4.2) and shall be conducted by individuals
knowledgeable of applicable regulatory and food safety requirements and trained in auditing techniques.
2.4.1.2 The methods and responsibility for ensuring the site is kept informed of changes to relevant legislation, scientific
and technical developments, emerging food safety issues, and relevant industry codes of practice shall be
documented and implemented.
2.4.1.3 SQFI and the certification body shall be notified in writing within twenty-four (24) hours as a result of a
regulatory warning or event. Notification to SQFI shall be by email to [email protected].
2.4.2.2 The Good Manufacturing Practices applicable to the scope of certification outlining how food safety is controlled
and assured shall be documented and implemented.
2.4.3 Food Safety Plan (Mandatory)
2.4.3.1 A food safety plan shall be prepared in accordance with the twelve steps identified in the Codex Alimentarius
Commission HACCP guidelines. The food safety plan shall be effectively implemented and maintained and shall
outline how the site controls and assures food safety of the products or product groups included in the scope of
the SQF certification and their associated processes. More than one HACCP food safety plan may be required to
cover all products included in the scope of certification.
2.4.3.2 The food safety plan or plans shall be developed and maintained by a multidisciplinary team that includes the
SQF practitioner and those site personnel with technical, production, and engineering knowledge of the relevant
raw materials, packaging, processing aids, products, and associated processes. Where the relevant expertise is not
available on-site, advice may be obtained from other sources to assist the food safety team.
2.4.3.3 The scope of each food safety plan shall be developed and documented including the start and endpoints of the
processes under consideration and all relevant inputs and outputs.
2.4.3.4 Product descriptions shall be developed and documented for all products included in the scope of the food safety
plans. The descriptions shall reference the finished product specifications (refer to 2.3.2.9) plus any additional
information relevant to product safety, such as pH, water activity, composition, and/or storage conditions.
2.4.3.5 The intended use of each product shall be determined and documented by the food safety team. This shall include
target consumer groups, the potential for consumption by vulnerable groups of the population, requirements for
further processing if applicable, and potential alternative uses of the product.
2.4.3.6 The food safety team shall develop and document a flow diagram covering the scope of each food safety plan
The flow diagram shall include every step in the process, all raw materials, packaging, service inputs (e.g., water,
steam, gasses as applicable), scheduled process delays, and all process outputs including waste and rework. Each
flow diagram shall be confirmed by the food safety team to cover all stages and hours of operation.
2.4.3.7 The food safety team shall identify and document all food safety hazards that can reasonably be expected to
occur at each step in the processes, including raw materials and other inputs.
2.4.3.8 The food safety team shall conduct a hazard analysis for every identified hazard to determine which hazards are
significant, i.e., their elimination or reduction to an acceptable level is necessary to control food safety. The
methodology for determining hazard significance shall be documented and used consistently to assess all
potential hazards.
2.4.3.9 The food safety team shall determine and document the control measures that must be applied to all significant
hazards. More than one control measure may be required to control an identified hazard, and more than one
significant hazard may be controlled by a specific control measure.
2.4.3.10 Based on the results of the hazard analysis (refer to 2.4.3.8), the food safety team shall identify the steps in the
process where control must be applied to eliminate a significant hazard or reduce it to an acceptable level (i.e., a
critical control point or CCP). In instances where a significant hazard has been identified at a step in the process,
but no control measure exists, the food safety team shall modify the process to include an appropriate control
measure.
2.4.3.11 For each identified CCP, the food safety team shall identify and document the limits that separate safe from
unsafe product (critical limits). The food safety team shall validate all of the critical limits to ensure the level of
control of the identified food safety hazard(s) and that all critical limits and control measures individually or in
combination effectively provide the level of control required (refer to 2.5.2.1).
2.4.3.12 The food safety team shall develop and document procedures to monitor CCPs to ensure they remain within the
established limits (refer to 2.4.3.11). Monitoring procedures shall identify the personnel assigned to conduct
monitoring, the sampling and test methods, and the test frequency.
2.4.3.13 The food safety team shall develop and document deviation procedures that identify the disposition of affected
product when monitoring indicates a loss of control at a CCP. The procedures shall also prescribe actions to
correct the process step to prevent recurrence of the safety failure.
2.4.3.14 The documented and approved food safety plan(s) shall be implemented in full. The effective implementation
shall be monitored by the food safety team, and a full review of the documented and implemented plans shall be
conducted at least annually, or when changes to the process, equipment, inputs, or other changes affecting
product safety occur.
2.4.3.15 Procedures shall be in place to verify that critical control points are effectively monitored and appropriate
corrective actions are applied. Implemented food safety plans shall be verified as part of SQF System verification
(refer to 2.5).
2.4.3.16 Critical control point monitoring, corrective action, and verification records shall be maintained and appropriately
used.
2.4.3.17 Where food safety regulations in the country of production and destination (if known) prescribe a food safety
control methodology other than the Codex Alimentarius Commission HACCP guidelines, the food safety team
shall implement food safety plans that meet both Codex and food regulatory requirements.
The methods applied shall ensure that inspections and analyses are completed at regular intervals as required and
to agreed specifications and legal requirements.
Sampling and testing shall be representative of the process batch and ensure that
process controls are maintained to meet specification and formulation.
2.4.4.2 Product analyses shall be conducted to nationally recognized methods or company requirements, or alternative
methods that are validated as equivalent to the nationally recognized methods.
Where internal laboratories are used to conduct input, environmental, or product analyses, sampling and testing
methods shall be in accordance with the applicable requirements of ISO/IEC 17025, including annual proficiency
testing for staff conducting analyses.
External laboratories shall be accredited to ISO/IEC 17025, or an equivalent international standard, and included
on the site’s contract service specifications list (refer to 2.3.2.11).
2.4.4.3 On-site laboratories conducting chemical and microbiological analyses that may pose a risk to product safety
shall be located separate from any food processing or handling activity and designed to limit access only to
authorized personnel.
Signage shall be displayed identifying the laboratory area as a restricted area,
accessible only by authorized personnel.
2.4.4.4 Provisions shall be made to isolate and contain all hazardous laboratory waste held on the premises and manage it
separately from food waste. Laboratory waste outlets shall at a minimum be downstream of drains that service
food processing and handling areas.
2.4.4.5 Retention samples, if required by customers or regulations, shall be stored according to the typical storage
conditions for the product and maintained for the stated shelflife of the product.
2.4.5.2 Quarantine records and records of the handling, corrective action, or disposal of nonconforming materials or
product shall be maintained.
2.4.6 Product Rework
2.4.6.1 The responsibility and methods outlining how ingredients, packaging, or products are reworked shall be
documented and implemented. The methods applied shall ensure:
i. Reworking operations are overseen by qualified personnel;
ii. Reworked product is clearly identified and traceable;
iii. Reworked product is processed in accordance with the site’s food safety plan;
iv. Each batch of reworked product is inspected or analyzed as required before release;
v. Inspections and analyses conform to the requirements outlined in element 2.4.4.1;
vi. Release of reworked product conforms to element 2.4.7; and
vii. Reworked product does not affect the safety or integrity of the finished product.
Records of all reworking operations shall be maintained.
2.4.7.3 In the event that the site uses positive release based on product pathogen or chemical testing, a procedure shall be
in place to ensure that product is not released until acceptable results have been received.
In the event that off-site or contract warehouses are used, these requirements shall be effectively communicated
and verified as being followed.
2.4.8.2 An environmental sampling and testing schedule shall be prepared. It shall at a minimum:
i. Detail the applicable pathogens or indicator organisms to test for in that industry;
ii. List the number of samples to be taken and the frequency of sampling;
iii. Outline the locations in which samples are to be taken and the rotation of locations as needed; and
iv. Describe the methods to handle elevated or undesirable results.
2.4.8.3 Environmental testing results shall be monitored, tracked, and trended, and preventative actions (refer to 2.5.3.1)
shall be implemented where unsatisfactory results or trends are observed.
2.5.2.2 A verification schedule outlining the verification activities, their frequency of completion, and the person
responsible for each activity shall be prepared and implemented.
Records of verification of activities shall be maintained.
2.5.3.2 Records of all investigation, root cause analysis, and resolution of non-conformities, their corrections, and the
implementation of preventative actions shall be maintained.
2.5.4.2 Staff conducting internal audits shall be trained and competent in internal audit procedures. Where practical, staff
conducting internal audits shall be independent of the function being audited.
2.5.4.3 Regular inspections of the site and equipment shall be planned and carried out to verify Good Manufacturing
Practices and facility and equipment maintenance are compliant to the SQF Food Safety Code: Food
Manufacturing. The site shall:
i. Take corrections or corrective and preventative action; and
ii. Maintain records of inspections and any corrective actions taken.
2.5.4.4 Records of internal audits and inspections and any corrective and preventative actions taken as a result of internal
audits shall be recorded as per 2.5.3.
Changes implemented from internal audits that have an impact on the site's ability to deliver safe food shall
require a review of applicable aspects of the SQF System (refer to 2.3.1.3).
2.6.1.2 Product start-up, product changeover, and packaging changeover (including label changes) procedures shall be
documented and implemented to ensure that the correct product is in the correct package and with the correct
label and that the changeover is inspected and approved by an authorized person.
Procedures shall be implemented to ensure that label use is reconciled and any inconsistencies investigated and
resolved.
Product changeover and label reconciliation records shall be maintained.
2.6.3.2 The product withdrawal and recall system shall be reviewed, tested, and verified as effective at least annually.
Testing shall include incoming materials (minimum traceability one step back) and finished product (minimum
traceability one step forward).
Testing shall be carried out on products from different shifts and for materials (including bulk materials) that are
used across a range of products and/or products that are shipped to a wide range of customers.
2.6.3.3 Records shall be maintained of withdrawal and recall tests, root cause investigations into actual withdrawals and
recalls, and corrective and preventative actions applied.
2.6.3.4 SQFI and the certification body shall be notified in writing within twenty-four (24) hours upon identification of a
food safety event that requires public notification. SQFI shall be notified at [email protected].
2.6.4.2 The crisis management plan shall be reviewed, tested, and verified at least annually with gaps and appropriate
corrective actions documented. Records of reviews of the crisis management plan shall be maintained.
2.7.1.2 A food defense plan shall be documented, implemented, and maintained based on the threat assessment (refer to
2.7.1.1). The food defense plan shall meet legislative requirements as applicable and shall include at a minimum:
i. The methods, responsibility, and criteria for preventing food adulteration caused by a deliberate act of sabotage
or terrorist-like incident;
ii. The name of the senior site management person responsible for food defense;
iii. The methods implemented to ensure only authorized personnel have access to production equipment and
vehicles, manufacturing, and storage areas through designated access points;
iv. The methods implemented to protect sensitive processing points from intentional adulteration;
v. The measures taken to ensure the secure receipt and storage of raw materials, ingredients, packaging,
equipment, and hazardous chemicals to protect them from deliberate acts of sabotage or terrorist-like incidents;
vi. The measures implemented to ensure raw materials, ingredients, packaging (including labels), work-in-
progress, process inputs, and finished products are held under secure storage and transportation conditions; and
vii. The methods implemented to record and control access to the premises by site personnel, contractors, and
visitors.
2.7.1.3 Instruction shall be provided to all relevant staff on the effective implementation of the food defense plan (refer
to 2.9.2.1).
2.7.1.4 The food defense threat assessment and prevention plan shall be reviewed and tested at least annually or when
the threat level, as defined in the threat assessment, changes. Records of reviews and tests of the food defense
plan shall be maintained.
2.7.2.2 A food fraud mitigation plan shall be developed and implemented that specifies the methods by which the
identified food fraud vulnerabilities shall be controlled, including identified food safety vulnerabilities of
ingredients and materials.
2.7.2.3 Instruction shall be provided to all relevant staff on the effective implementation of the food fraud mitigation plan
(refer to 2.9.2.1).
2.7.2.4 The food fraud vulnerability assessment and mitigation plan shall be reviewed and verified at least annually with
gaps and corrective actions documented. Records of reviews shall be maintained.
2.8.1.2 Instructions shall be provided to all relevant staff involved in the receipt or handling of raw materials, work-in-
progress, rework, or finished product on how to identify, handle, store, and segregate raw materials and products
containing allergens.
2.8.1.3 Provisions shall be made to clearly identify and segregate foods that contain allergens. Segregation procedures
shall be implemented and continually monitored.
2.8.1.4 Where allergenic material may be intentionally or unintentionally present cleaning and sanitation of product
contact surfaces between line changeovers shall be effective, appropriate to the risk and legal requirements, and
sufficient to remove all potential target allergens from product contact surfaces, including aerosols as appropriate,
to prevent cross-contact.
Separate handling and production equipment shall be provided, where satisfactory line hygiene and clean-up or
segregation are not possible.
2.8.1.5 Based on risk assessment, procedures for validation and verification of the effectiveness of the cleaning and
sanitation of areas and equipment in which allergens are used shall be documented and effectively implemented.
2.8.1.6 Where allergenic material may be present, product changeover procedures shall be documented and implemented
to eliminate the risk of cross-contact.
2.8.1.7 The product identification system (refer to 2.6.1.1) shall make provision for clear identification and labeling, in
accordance with the regulatory requirements of those products produced on production lines and equipment on
which foods containing allergens are manufactured.
2.8.1.8 The product trace system (refer to 2.6.2) shall take into consideration the conditions under which allergen-
containing foods are manufactured and ensure full traceback of all ingredients and processing aids used.
2.8.1.9 The site shall document and implement methods to control the accuracy of finished product labels (or consumer
information where applicable) and assure work-in progress and finished product are true to label with regard to
allergens. Measures may include label approvals at receipt, label reconciliations during production, destruction of
obsolete labels, verification of labels on finished product as appropriate, and product change over procedures.
2.8.1.10 Re-working of product (refer to 2.4.6) containing food allergens shall be conducted under conditions that ensure
product safety and integrity are maintained. Re-worked product containing allergens shall be clearly identified
and traceable.
2.8.1.11 Sites that do not handle allergenic materials or produce allergenic products shall document, implement and
maintain an allergen management program addressing at a minimum the mitigation of introduced or unintended
allergens through supplier, contract manufacturer, site personnel, and visitor activities.
2.9 Training
2.9.1 Training Requirements
2.9.1.1 The responsibility for establishing and implementing the training needs of the organization’s personnel to ensure
they have the required competencies to carry out those functions affecting products, legality, and safety shall be
defined and documented (refer to 2.1.1.6).
2.9.1.2 Appropriate training shall be provided for personnel carrying out the tasks essential to the effective
implementation of the SQF System and the maintenance of food safety and regulatory requirements.
2.9.2.2 Training materials, the delivery of training, and procedures on all tasks critical to meeting regulatory compliance
and the maintenance of food safety shall be provided in language(s) understood by staff.
11.1.2
11.1.2.1
11.1.2.2
11.1.2.3
11.1.2.4
11.1.2.5
11.1.2.6
11.1.2.7
11.1.2.8
11.1.2.9
11.1.3
11.1.3.1
11.1.3.2
11.1.3.3
11.1.4
11.1.4.1
11.1.5
11.1.5.1
11.1.5.2
11.1.5.3
11.1.6
11.1.6.1
11.1.6.2
11.1.6.3
11.1.6.4
11.1.7
11.1.7.1
11.1.7.2
11.1.7.3
11.1.7.4
11.1.7.5
11.1.7.6
11.1.7.7
11.1.7.8
11.1.7.9
11.1.8
11.1.8.1
11.1.8.2
11.1.8.3
11.2
11.2.1
11.2.1.1
11.2.1.2
11.2.1.3
11.2.1.4
11.2.1.5
11.2.1.6
11.2.1.7
11.2.1.8
11.2.2
11.2.2.1
11.2.2.2
11.2.2.3
11.2.3
11.2.3.1
11.2.3.2
11.2.3.3
11.2.3.4
11.2.3.5
11.2.3.6
11.2.4
11.2.4.1
11.2.4.2
11.2.4.3
11.2.4.4
11.2.4.5
11.2.4.6
11.2.5
11.2.5.1
11.2.5.2
11.2.5.3
11.2.5.4
11.2.5.5
11.2.5.6
11.2.5.7
11.2.5.8
11.2.5.9
11.3
11.3.1
11.3.1.1
11.3.1.2
11.3.1.3
11.3.2
11.3.2.1
11.3.2.2
11.3.2.3
11.3.2.4
11.3.2.5
11.3.2.6
11.3.3
11.3.3.1
11.3.3.2
11.3.3.3
11.3.3.4
11.3.3.5
11.3.3.6
11.3.3.7
11.3.3.8
11.3.4
11.3.4.1
11.3.4.2
11.3.4.3
11.3.4.4
11.3.5
11.3.5.1
11.3.5.2
11.3.5.3
11.3.5.4
11.3.5.5
11.3.5.6
11.3.5.7
11.3.5.8
11.3.5.9
11.3.5.10
11.4
11.4.1
11.4.1.1
11.4.1.2
11.4.1.3
11.4.1.4
11.5
11.5.1
11.5.1.1
11.5.1.2
11.5.1.3
11.5.1.4
11.5.1.5
11.5.1.6
11.5.2
11.5.2.1
11.5.2.2
11.5.2.3
11.5.3
11.5.3.1
11.5.3.2
11.5.3.3
11.5.4
11.5.4.1
11.5.4.2
11.5.4.3
11.5.5
11.5.5.1
11.5.5.2
11.6
11.6.1
11.6.1.1
11.6.1.2
11.6.1.3
11.6.1.4
11.6.1.5
11.6.1.6
11.6.2
11.6.2.1
11.6.2.2
11.6.2.3
11.6.2.4
11.6.3
11.6.3.1
11.6.3.2
11.6.4
11.6.4.1
11.6.4.2
11.6.4.3
11.6.4.4
11.6.4.5
11.6.4.6
11.6.4.7
11.6.5
11.6.5.1
11.6.5.2
11.6.5.3
11.6.5.4
11.6.5.5
11.6.5.6
11.6.5.7
11.6.5.8
11.7
11.7.1
11.7.1.1
11.7.1.2
11.7.1.3
11.7.1.4
11.7.1.5
11.7.2
11.7.2.1
11.7.2.2
11.7.2.3
11.7.3
11.7.3.1
11.7.3.2
11.7.3.3
11.7.3.4
11.7.3.5
11.7.3.6
11.7.3.7
11.7.3.8
11.7.3.9
11.7.4
11.7.4.1
11.7.4.2
11.7.4.3
11.7.4.4
11.7.4.5
11.8
11.8.1.1
11.8.1.2
11.8.1.3
11.8.1.4
11.8.1.5
11.8.1.6
11.8.1.7
11.8.1.8
11.8.1.9
11.8.1.10
Food Manufacturing Ed
Item
Site Location and Premises
Premises Location and Approval
The site shall assess local activities and the site environment to identify any risks that may have an adverse impact
and implement controls for any identified risks. The assessment shall be reviewed in response to any changes in th
environment or activities.
The construction and ongoing operation of the premises on the site shall be approved by the relevant authority.
Building Materials
Floors shall be constructed of smooth, dense, impact-resistant material that can be effectively graded, drained, imp
and easily cleaned. Floors shall be sloped to floor drains at gradients suitable to allow the effective removal of all
wastewater under normal working conditions.
Where floor drainage is not available, plumbed options to handle overflow or wastewater shall be in place.
Drains shall be constructed and located so they can be easily cleaned and not present a hazard.
Waste trap system shall be located away from any food handling areas or entrances to the premises.
Walls, partitions, ceilings, and doors shall be of durable construction. Internal surfaces shall have an even and regu
impervious with a light-colored finish and shall be kept clean (refer to 11.2.5).
Wall-to-wall and wall-to-floor junctions shall be designed to be easily cleaned and sealed to prevent the accumula
Ducting, conduit, and pipes that convey ingredients, products, or services, such as steam or water, shall be designe
to prevent the contamination of food, ingredients, and food contact surfaces and allow ease of cleaning.
A risk analysis shall be conducted to ensure food contamination risks are mitigated.
Pipes carrying sanitary waste or wastewater that are located directly over product lines or storage areas shall be de
constructed to prevent the contamination of food, materials, ingredients, and food contact surfaces and shall allow
A risk analysis shall be conducted to ensure food contamination risks are mitigated.
Doors, hatches, and windows and their frames in food processing, handling, or storage areas shall be of a material
that meets the same functional requirements as for internal walls and partitions. Doors and hatches shall be of soli
windows shall be made of shatterproof glass or similar material.
Product shall be processed and handled in areas that are fitted with a ceiling or other acceptable structure that is co
maintained to prevent the contamination of products. Drop ceilings, where present, shall be constructed to enable
activity, facilitate cleaning, and provide access to utilities.
Stairs, catwalks, and platforms in food processing and handling areas shall be designed and constructed so they do
product-contamination risk and with no open grates directly above exposed food product surfaces. They shall be k
11.2.5).
Lightings and Light Fittings
Lighting in food processing and handling areas and at inspection stations shall be of appropriate intensity to enabl
out their tasks efficiently and effectively and shall comply with local light-intensity regulations or industry standar
Light fixtures in processing areas, inspection stations, ingredient and packaging storage areas, and all areas where
exposed shall be shatterproof, manufactured with a shatterproof covering or fitted with protective covers, and rece
flush with the ceiling.
Where fixtures cannot be recessed, structures must be protected from accidental breakage, manufactured from clea
and addressed in the cleaning and sanitation program.
Light fixtures in the warehouse or other areas where product is covered or otherwise protected shall be designed to
and product contamination.
External doors, including overhead dock doors in food handling areas used for product, pedestrian, or truck access
and maintained to prevent pest ingress by at least one or a combination of the following methods:
i. A self-closing device;
ii. An effective air curtain;
iii. A pest-proof screen;
iv. A pest-proof annex; and
v. Adequate sealing around trucks in docking areas.
Electric insect control devices, pheromone, or other traps and baits shall be located and operated so they do not pr
contamination risk to the product, packaging, containers, or processing equipment. Poison rodenticide bait shall no
ingredients or product storage areas or processing areas where ingredients, packaging, and products are handled, p
exposed.
Ventilation
Adequate ventilation shall be provided in enclosed processing and food handling areas.
Where appropriate, positive air-pressure systems shall be installed to prevent airborne contamination.
All ventilation equipment and devices in product storage and handling areas shall be adequately cleaned as per 11
unsanitary conditions.
Extractor fans and canopies shall be provided in areas where open cooking operations are carried out or a large am
generated. Capture velocities shall be sufficient to prevent condensation build-up and to evacuate all heat, fumes,
to the exterior via an exhaust hood positioned over the cooker(s).
Fans and exhaust vents shall be insect-proofed and located so they do not pose a contamination risk and shall be k
Equipment and Utensils
Specifications for equipment and utensils and procedures for purchasing equipment shall be documented and impl
Equipment and utensils shall be designed, constructed, installed, operated, and maintained to meet any applicable
requirements and to not pose a contamination threat to products.
Equipment storage rooms shall be designed and constructed to allow for the hygienic and efficient storage of equi
containers. Where possible, food contact equipment shall be segregated from non-food contact equipment.
Product contact surfaces and those surfaces not in direct contact with food in food handling areas, raw material sto
storage, and cold storage areas shall be constructed of materials that will not contribute to a food safety risk.
Benches, tables, conveyors, mixers, mincers, graders, and other mechanical processing equipment shall be hygien
located for appropriate cleaning. Equipment surfaces shall be smooth, impervious, and free from cracks or crevice
Product containers, tubs, and bins used for edible and inedible material shall be constructed of materials that are n
impervious, and readily cleaned as per 11.2.5.1. Bins used for inedible material shall be clearly identified.
All equipment and utensils shall be cleaned after use (refer to 11.2.5.1) or at a set and validated frequency to contr
and be stored in a clean and serviceable condition to prevent microbiological or cross-contact allergen contaminat
Vehicles used in food contact, handling, or processing zones or cold storage rooms shall be designed and operated
present a food safety hazard.
Non-conforming equipment shall be identified, tagged, and/or segregated for repair or disposal in a manner that m
inadvertent use, improper use, or risk to the integrity of finished product. Records of the handling, corrective actio
disposal of non-conforming equipment shall be maintained.
Grounds and Roadways
A suitable external environment shall be established, and the effectiveness of the measures shall be monitored and
reviewed. The premises, its surrounding areas, storage facilities, machinery, and equipment shall be kept free of w
accumulated debris, and vegetation shall be controlled so as not to attract pests and vermin or present a food safety
sanitary operation of the site.
Paths, roadways, and loading and unloading areas shall be maintained so as not to present a hazard to the food saf
the premises. They shall be adequately drained to prevent the pooling of water. Drains shall be separate from the s
and regularly cleared of debris.
Routine maintenance of plant and equipment in any food processing, handling, or storage areas shall be performed
maintenance control schedule and recorded.
The maintenance schedule shall be prepared to include buildings, equipment, and other areas of the premises critic
maintenance of product safety.
Failures of plant and equipment in any food processing, handling, or storage areas shall be documented and review
repair(s) incorporated into the maintenance control schedule.
Site supervisors shall be notified when maintenance or repairs are to be undertaken in any processing, handling, o
The maintenance supervisor and the site supervisor shall be informed if any repairs or maintenance activities pose
product safety (e.g., pieces of electrical wire, damaged light fittings, and loose overhead fittings). When possible,
be conducted outside operating times.
Temporary repairs, where required, shall not pose a food safety risk and shall be included in routine inspections (r
the cleaning program. There shall be a plan in place to address the completion of temporary repairs to ensure they
not become permanent solutions.
Food contact equipment and equipment located over food contact equipment shall be lubricated with food-grade lu
shall be controlled to minimize the contamination of the product.
Paint used in a food handling or processing area shall be suitable for use, in good condition, and not be used on an
surfaces.
Maintenance Staff and Contractors
Maintenance staff and contractors shall comply with the site’s personnel and process hygiene requirements (refer
All maintenance and other engineering contractors required to work on-site shall be trained in the site's food safety
procedures or shall be escorted at all times until their work is completed.
Maintenance staff and contractors shall remove all tools and debris from any maintenance activity once it has been
inform the area supervisor and maintenance supervisor, so appropriate hygiene and sanitation can be conducted an
inspection completed prior to the restarting of site operations.
Calibration
The methods and responsibility for calibration and re-calibration of measuring, testing, and inspection equipment
activities outlined in prerequisite programs, food safety plans, and other process controls, or to demonstrate compl
customer specifications, shall be documented and implemented. Software used for such activities shall be validate
Equipment shall be calibrated against national or international reference standards and methods or to an accuracy
use. In cases where standards are not available, the site shall provide evidence to support the calibration reference
Calibration shall be performed according to regulatory requirements and/or to the equipment manufacturers’ recom
Procedures shall be documented and implemented to address the resolution of potentially affected products when
or inspection equipment is found to be out of calibration.
Calibrated measuring, testing, and inspection equipment shall be protected from damage and unauthorized adjustm
A directory of measuring, testing, and inspection equipment that require calibration and records of the calibration
maintained.
Pest Prevention
A documented pest prevention program shall be effectively implemented. It shall:
i. Describe the methods and responsibility for the development, implementation, and maintenance of the pest prev
ii. Record pest sightings and trend the frequency of pest activity to target pesticide applications;
iii. Outline the methods used to prevent pest problems;
iv. Outline the pest elimination methods and the appropriate documentation for each inspection;
v. Outline the frequency with which pest status is to be checked;
vi. Include the identification, location, number, and type of applied pest control/monitoring devices on a site map;
vii. List the chemicals used. The chemicals are required to be approved by the relevant authority and their Safety D
made available;
viii. Outline the methods used to make staff aware of the bait control program and the measures to take when they
with a bait station;
ix. Outline the requirements for staff awareness and training in the use of pest and vermin control chemicals and b
x. Measure the effectiveness of the program to verify the elimination of applicable pests and to identify trends.
Pest activity risks shall be analyzed and recorded. Inspections for pest activity shall be conducted on a regular bas
personnel and the appropriate action taken if pests are present. Identified pest activity shall not present a risk of co
products, raw materials, or packaging.
Records of all pest control inspections and applications shall be maintained.
Food products, raw materials, or packaging that are found to be contaminated by pest activity shall be effectively d
source of pest infestation shall be investigated and resolved. Records shall be kept of the disposal, investigation, a
Pesticides shall be clearly labeled and stored per 11.6.4 if kept on-site.
The methods and responsibility for the effective cleaning of the food handling and processing equipment and envi
storage areas shall be documented and implemented. Consideration shall be given to:
i. What is to be cleaned;
ii. How it is to be cleaned;
iii. When it is to be cleaned;
iv. Who is responsible for the cleaning;
v. Validation of the cleaning procedures for food contact surfaces (including CIP);
vi. Methods used to confirm the correct concentrations of detergents and sanitizers; and
vii. The responsibility and methods used to verify the effectiveness of the cleaning and sanitation program.
Detergents and sanitizers shall be suitable for use in a food manufacturing environment, labeled according to regu
requirements, and purchased in accordance with applicable legislation. The organization shall ensure:
i. The site maintains a list of chemicals approved for use;
ii. An inventory of all purchased and used chemicals is maintained;
iii. Detergents and sanitizers are stored as outlined in element 11.6.4;
iv. Safety Data Sheets (SDS) are provided for all detergents and sanitizers purchased; and
v. Only trained staff handle sanitizers and detergents.
Detergents and sanitizers that have been mixed for use shall be correctly mixed according to the manufacturers’ in
in containers that are suitable for use, and clearly identified. Mix concentrations shall be verified and records main
Cleaning-in-place (CIP) systems, where used, shall not pose a chemical contamination risk to raw materials, ingre
CIP parameters critical to assuring effective cleaning shall be defined, monitored, and recorded (e.g., chemical and
used, contact time, and temperature). CIP equipment, including spray balls, shall be maintained, and any modifica
equipment shall be validated. Personnel engaged in CIP activities shall be effectively trained.
Cleaning equipment, tools, racks, and other items used in support of the cleaning and sanitizing program shall be c
stored, and maintained in a manner that prevents contamination of processing areas, product handling equipment,
well as the tools themselves.
Suitably equipped areas shall be designated for cleaning product containers, knives, cutting boards, and other uten
The areas for these cleaning operations shall be controlled so they do not interfere with manufacturing operations,
equipment, or product. Racks and containers for storing cleaned utensils shall be provided as required.
Pre-operational inspections shall be conducted following cleaning and sanitation operations to ensure food process
contact surfaces, equipment, staff amenities, sanitary facilities, and other essential areas are clean before the start
of production. Pre-operational inspections shall be conducted by qualified personnel.
Staff amenities, sanitary facilities, and other essential areas shall be inspected by qualified personnel at a defined f
the areas are clean.
The responsibility and methods used to verify the effectiveness of the cleaning procedures shall be documented an
verification schedule shall be prepared.
A record of pre-operational hygiene inspections, cleaning and sanitation activities, and verification activities shall
Personnel with exposed cuts, sores, or lesions shall not engage in handling or processing exposed products or hand
contact) packaging or touching food contact surfaces. Minor cuts or abrasions on exposed parts of the body shall b
colored, metal-detectable bandage or an alternative suitable waterproof and colored dressing.
Handwashing
All personnel shall have clean hands, and hands shall be washed by all staff, contractors, and visitors:
i. On entering food handling or processing areas;
ii. After each visit to a toilet;
iii. After using a handkerchief;
iv. After smoking, eating, or drinking; and
v. After handling wash down hoses, cleaning materials, dropped product, or contaminated material.
Handwashing stations shall be provided adjacent to all personnel access points and in accessible locations through
and processing areas as required.
Handwashing stations shall be constructed of stainless steel or similar non-corrosive material and at a minimum su
i. A potable water supply at an appropriate temperature;
ii. Liquid soap contained within a fixed dispenser;
iii. Paper towels in a hands-free cleanable dispenser; and
iv. A means of containing used paper towels.
Signage in appropriate languages instructing people to wash their hands before entering the food processing areas
in a prominent position in break rooms, at break room exits, toilet rooms, and in outside eating areas, as applicable
When gloves are used, personnel shall maintain the handwashing practices outlined above.
Clothing and Personal Effects
The site shall undertake a risk analysis to ensure that the clothing and hair policy protects materials, food, and foo
from unintentional microbiological or physical contamination.
Clothing worn by staff engaged in handling food shall be maintained, stored, laundered, and worn so it does not p
contamination risk to products.
Clothing, including shoes, shall be clean at the start of each shift and maintained in a serviceable condition.
Excessively soiled uniforms shall be changed or replaced when they present a product contamination risk.
Disposable gloves and aprons shall be changed after each break, upon re-entry into the processing area, and when
Non-disposable aprons and gloves shall be cleaned and sanitized as required and when not in use stored on racks p
processing area or in designated sealed containers in personnel lockers. They should not be placed or stored on pa
ingredients, product, or equipment.
Protective clothing shall be manufactured from material that will not pose a food safety threat and is easily cleaned
All protective clothing shall be cleaned after use, or at a frequency to control contamination, and stored in a clean
condition to prevent microbiological or cross-contact allergen contamination.
Racks shall be provided for the temporary storage of protective clothing when staff leave the processing area and
nearby or adjacent to the personnel access doorways and handwashing facilities.
Jewelry and other loose objects shall not be worn or taken into a food handling or processing operation or into any
exposed. Wearing plain bands with no stones, prescribed medical alert bracelets, or jewelry accepted for religious
can be permitted, provided these items are properly covered and do not pose a food safety risk.
All exceptions shall meet regulatory and customer requirements and shall be subject to a risk assessment and evid
risk management.
Visitors
All visitors shall be trained in the site's food safety and hygiene procedures before entering any food processing an
shall be escorted at all times in food processing, handling, and storage areas.
All visitors, including management staff, shall be required to remove jewelry and other loose objects in accordanc
Good Manufacturing Practices and 11.3.3.8. All visitors shall wear suitable clothing and footwear when entering a
and handling area.
Visitors exhibiting visible signs of illness shall be prevented from entering areas in which food is handled and pro
Visitors shall enter and exit food handling areas through the proper staff entrance points and comply with all hand
personnel practice requirements.
Staff Amenities (change rooms, toilets, break rooms)
Staff amenities shall have documented cleaning procedures, be supplied with appropriate lighting and ventilation,
available for use by all persons engaged in the handling and processing of product.
Change rooms shall be provided to enable staff and visitors to change into and out of protective clothing as require
shall be kept clean.
High-risk change areas shall be provided for staff engaged in the processing of high-risk foods or processing oper
clothing can be soiled.
Provision shall be made for staff to store their street clothing and personal items separate from clean uniforms, foo
food, and packaging storage areas.
Where required, a sufficient number of showers shall be provided for use by staff.
Toilet rooms shall be:
i. Designed and constructed so that they are accessible to staff and separate from any processing and food handling
ii. Accessed from the processing area via an airlock vented to the exterior or through an adjoining room;
iii. Sufficient in number for the maximum number of staff;
iv. Constructed so that they can be easily cleaned and maintained;
v. Located inside or nearby areas for storing protective clothing, outer garments, and other items while using the f
vi. Kept clean and tidy.
Tools/equipment used for cleaning toilet rooms shall not be used to clean processing areas.
Sanitary drainage shall not be connected to any other drains within the premises and shall be directed to a septic ta
system in accordance with regulations.
Handwashing basins shall be provided immediately outside or inside the toilet room and designed as outlined in 1
Separate break rooms shall be provided away from food contact/handling zones.
Break rooms shall be:
i. Ventilated and well lit;
ii. Provided with adequate tables and seating to cater for the maximum number of staff at one sitting;
iii. Equipped with a sink serviced with hot and cold potable water for washing utensils;
iv. Equipped with refrigeration and heating facilities, enabling staff to store or heat food and to prepare non-alcoho
required; and
v. Kept clean and free from waste materials and pests.
Where outside eating areas are provided, they should be kept clean and free from waste materials and maintained
minimizes the potential for the introduction of contamination, including pests to the site.
The delivery of water within the premises shall ensure potable water is not contaminated. Testing of the backflow
possible, shall be conducted at least annually and records shall be maintained.
The use of non-potable water shall be controlled such that:
i. There is no cross-contamination between potable and non-potable water lines;
ii. Non-potable water piping and outlets are clearly identified; and
iii. Hoses, taps, and other similar sources of possible contamination are designed to prevent backflow or back-siph
Where water is stored on-site, storage facilities shall be adequately designed, constructed, and routinely cleaned to
contamination.
Water Treatment
Water treatment methods, equipment, and materials, if required, shall be designed, installed, and operated to ensur
effective treatment.
Water treatment equipment shall be monitored regularly to ensure it remains serviceable.
Water used as an ingredient in processing or for cleaning and sanitizing equipment shall be tested and, if required,
potability (refer to 11.5.2.1).
Treated water shall be regularly monitored to ensure it meets the specified indicators.
Water treatment chemicals usage shall be monitored to ensure chemical residues are within acceptable limits. Rec
results shall be kept.
Water Quality
Water shall comply with local, national, or internationally recognized potable water microbiological and quality st
required when used for:
i. Washing, thawing, and treating food;
ii. Handwashing;
iii. Conveying food;
iv. An ingredient or food processing aid;
v. Cleaning food contact surfaces and equipment;
vi. The manufacture of ice; or
vii. The manufacture of steam that will come into contact with food or be used to heat water that will come into co
Microbiological analysis of the water and ice supply shall be conducted to verify the cleanliness of the supply, the
activities, and the effectiveness of the treatment measures implemented. Samples for analysis shall be taken at sou
water for the process or cleaning or from within the site. The frequency of analysis shall be risk-based and at a mi
Water and ice shall be analyzed using reference standards and methods.
Ice Supply
Ice provided for use during processing operations, as a processing aid, or an ingredient shall comply with 11.5.3.1
Ice that is purchased shall be from an approved supplier and included in the site's food safety risk assessment. Ice
containers that are appropriate for use, cleanable if reused, and tested as appropriate.
Ice rooms and receptacles shall be constructed of materials as outlined in element 11.1.2 and designed to minimize
the ice during storage, retrieval, and distribution.
Air and Other Gasses
Compressed air or other gases (e.g., nitrogen or carbon dioxide) that contact food or food contact surfaces shall be
no risk to food safety.
Compressed air systems and systems used to store or dispense other gases that come into contact with food or foo
shall be maintained and regularly monitored for quality and applicable food safety hazards. The frequency of anal
based and at a minimum annually.
Controls shall be in place to ensure all ingredients, raw materials, processing aids, and packaging are received and
prevent cross-contamination risks. Unprocessed raw materials shall be received and stored separately from proces
avoid cross-contamination risk.
The responsibility and methods for ensuring effective stock rotation principles shall be documented and implemen
Procedures shall be in place to ensure that all ingredients, materials, work- in-progress, rework, and finished produ
within their designated shelf-life.
Where raw materials, ingredients, packaging, equipment, and chemicals are held under temporary or overflow con
designed for the safe storage of goods, a risk analysis shall be undertaken to ensure there are no risks to the integri
no potential for contamination or adverse effect on food safety.
Records shall be available to verify the effectiveness of alternate or temporary control measures for the storage of
ingredients, packaging, equipment, chemicals, or finished products.
Cold Storage, Freezing and Chilling of Foods
The site shall provide confirmation of the effective operational performance of freezing, chilling, and cold storage
blast freezers, and cold storage rooms shall be designed and constructed to allow for the hygienic and efficient ref
and be easily accessible for inspection and cleaning.
Sufficient refrigeration capacity shall be available to chill, freeze, store chilled, or store frozen the maximum antic
of product with allowance for periodic cleaning of refrigerated areas.
The site shall have a written procedure for monitoring temperatures, including the frequency of checks, and correc
temperature is out of specification.
Freezing, chilling, and cold storage rooms shall be fitted with temperature monitoring equipment that is located to
warmest part of the room and be fitted with a temperature measurement device that is easily readable and accessib
kept of frozen, cold, and chilled storage room temperatures.
Discharge from defrost and condensate lines shall be controlled and discharged into the drainage system.
Racks provided for the storage of packaging shall be constructed of impervious materials and designed to enable c
inspection of the floors and behind the racks. Storage areas shall be cleaned at a pre-determined frequency.
Daily supplies of chemicals used for continuous sanitizing of water, as a processing aid, or for emergency cleaning
processing equipment and surfaces in food contact zones may be stored within or in close proximity to a processin
that access to the chemical storage facility is restricted to only authorized personnel.
Personnel who handle hazardous chemicals and toxic substances, including pesticides and cleaning chemicals,:
i. Shall be fully trained in the purpose of the hazardous chemicals and toxic substances, their storage, handling, an
ii. Be provided first aid equipment and personnel protective equipment (PPE); and
iii. Ensure compliance with the proper identification, storage, usage, disposal, and clean-up requirements.
The site shall dispose of empty, obsolete, and unused chemicals, pesticides, toxic substances, and containers in acc
requirements and ensure that primary containers are:
i. Not reused;
ii. Segregated and securely stored prior to collection; and
iii. Disposed through an approved vendor.
Vehicles (e.g., trucks/vans/containers) used for transporting food within the site and from the site shall be inspecte
to ensure they are clean, in good repair, suitable for the purpose, and free from odors or other conditions that may
on the product.
Vehicles (e.g., trucks/vans/containers) shall be secured from tampering using seals or other agreed-upon and accep
systems.
Loading and unloading docks shall be designed to protect the product during loading and unloading. Loading prac
designed to minimize unnecessary exposure of the product to conditions detrimental to maintaining product and p
during loading and transport.
Refrigerated units shall maintain the product at the required temperature. The unit’s temperature settings shall be s
recorded before loading, and the product temperature shall be recorded at regular intervals during loading, as appl
The refrigeration unit shall be operational at all times and checks completed of the unit’s operation, the door seals
temperature at regular intervals during transit.
On arrival, prior to opening the doors, the food transport vehicle’s refrigeration unit’s storage temperature settings
temperature shall be checked and recorded. Unloading shall be completed efficiently, and product temperatures sh
the start of unloading and regular intervals during unloading.
Unloading practices shall be designed to minimize unnecessary exposure of the product to conditions detrimental
product and package integrity.
Separation of Functions
High-Risk Processes
The processing of high-risk food shall be conducted under controlled conditions, such that sensitive areas, in whic
food has undergone a “kill” step, a “food safety intervention” or is subject to post-process handling, are protected/
other processes, raw materials, or staff who handle raw materials, to ensure cross-contamination is minimized.
Ambient air in high-risk areas shall be tested at least annually to confirm that it does not pose a risk to food safety
Areas in which high-risk processes are conducted shall only be serviced by staff dedicated to that function.
Staff engaged in high-risk areas shall change into clean clothing and footwear or temporary protective outerwear w
risk areas. Staff access points shall be located, designed, and equipped to enable staff to change into the distinctive
clothing and practice a high standard of personal hygiene to prevent product contamination.
Product transfer points shall be located and designed, so they do not compromise high-risk segregation and minim
cross-contamination.
Thawing of Food
Thawing of food shall be undertaken in equipment and rooms appropriate for the purpose. Equipment for water th
continuous flow to ensure the water exchange rate and temperature do not contribute to product deterioration or co
overflow shall be directed into the floor drainage system and not onto the floor or shall be appropriately plumbed.
Air thawing facilities shall be designed to thaw food under controlled conditions at a rate and temperature that doe
product deterioration or contamination.
Provision is to be made for the containment and regular disposal of used cartons and packaging from thawed prod
no risk to the product.
Control of Foreign Matter Contamination
The responsibility and methods used to prevent foreign matter contamination of the product shall be documented,
communicated to all staff.
Inspections shall be performed (refer to 2.5.4.3) to ensure plant and equipment remain in good condition and equip
become detached or deteriorated and is free from potential contaminants.
Containers, equipment, and other utensils made of glass, porcelain, ceramics, laboratory glassware, or other simila
not be permitted in food processing /contact zones (except where the product is contained in packaging made from
measurement instruments with glass dial covers are used, or MIG thermometers are required under regulation).
Where glass objects or similar material are required in food handling/contact zones, they shall be listed in a glass i
including details of their location and condition.
Regular inspections of food handling/contact zones shall be conducted (refer to 2.5.4.3) to ensure they are free of
material and to establish changes to the condition of the objects listed in the glass inventory.
Glass instrument dial covers on processing equipment and MIG thermometers shall be inspected at the start of eac
they have not been damaged.
In circumstances where glass or similar material breakage occurs, the affected area shall be isolated, cleaned, thor
(including cleaning equipment and footwear), and cleared by a suitably responsible person prior to the start of ope
Wooden pallets and other wooden utensils used in food processing and handling areas shall be dedicated for that p
maintained in good order. Their condition shall be subject to regular inspection.
Loose metal objects on equipment, equipment covers, and overhead structures shall be removed or tightly fixed so
hazard.
Knives and cutting instruments used in processing and packaging operations shall be controlled, kept clean, and w
Snap-off blades shall not be used in manufacturing or storage areas.
Gaskets, rubber impellers, and other equipment made of materials that can wear or deteriorate over time shall be in
regular frequency (refer to 2.5.4.3).
Detection of Foreign Objects
The responsibility, methods, and frequency for monitoring, maintaining, calibrating, and using screens, sieves, filt
technologies to remove or detect foreign matter shall be documented and implemented.
Where detection and/or removal systems are used, the site shall establish limits for detection, based on a risk asses
product and its packaging, and identify the location(s) of the detector(s) in the process.
Metal detectors or other physical contaminant detection technologies shall be routinely monitored, validated, and v
operational effectiveness. The equipment shall be designed to isolate defective product and indicate when it is reje
Records shall be maintained of the inspection of foreign object detection devices, of any products rejected or remo
of corrective and preventative actions resulting from the inspections.
In all cases of foreign matter contamination, the affected batch or item shall be isolated, inspected, reworked, or di
Records shall be maintained of the disposition.
Waste Disposal
The responsibility and methods used to collect and handle dry, wet, and liquid waste and how to store it prior to re
premises shall be documented and implemented.
Waste shall be removed on a regular basis and not allowed to build up in food handling or processing areas. Desig
accumulation areas shall be maintained in a clean and tidy condition until external waste collection is undertaken.
Waste and overflow water from tubs, tanks, and other equipment shall be discharged directly to the floor drainage
alternative method that meets local regulatory requirements.
Trolleys, vehicle waste disposal equipment, collection bins, and storage areas shall be maintained in a serviceable
and sanitized regularly to prevent the attraction of pests and other vermin.
Adequate provision shall be made for the disposal of all solid processing waste, including trimmings, inedible mat
packaging.
Where applicable, a documented procedure shall be in place for the controlled disposal of trademarked materials w
high-risk for handling or other reasons. Where a contracted disposal service is used, the disposal process shall be r
to confirm compliance.
Inedible waste designated for animal feed shall be stored and handled so that it will not cause a risk to the animal o
processing. If denaturant is used to identify inedible waste, it shall be demonstrated that it does not pose a risk to a
Waste held on-site prior to disposal shall be stored in a separate storage facility that is suitably insect proofed and
does not present any hazards.
Adequate provision shall be made for the disposal of all liquid waste from processing and food handling areas. Liq
either be removed from the processing environment continuously or held in a designated storage area in lidded con
disposal where it does not present any hazards.
Reviews of the effectiveness of waste management shall form part of regular site inspections (refer to 2.5.4.3), and
these inspections shall be included in the relevant inspection reports.
ion 9 Checklist
Primary Response Evidence Supplier Onsite Correction