Cláusula

Reunión de
apertura
Reunión de
cierre
Descripción
de las
instalaciones
Recomendaci
ones del
auditor

2.1
2.1.1
2.1.1.1
2.1.1.2

2.1.1.3

2.1.1.4

2.1.1.5
2.1.1.6

2.1.1.7

2.1.1.8

2.1.2
2.1.2.1

2.1.2.2

2.1.3
2.1.3.1

2.1.3.2
2.1.3.3

2.2
2.2.1
2.2.1.1

2.2.1.2

2.2.2
2.2.2.1

2.2.3
2.2.3.1

2.2.3.2

2.2.3.3

2.3
2.3.1
2.3.1.1

2.3.2
2.3.2.1

2.3.2.2
2.3.2.3

2.3.2.4

2.3.2.5
2.3.2.6

2.3.2.7

2.3.3
2.3.3.1

2.3.3.2

2.3.3.3

2.3.4
2.3.4.1

2.3.4.2

2.3.4.3

2.4
2.4.1
2.4.1.1

2.4.1.2
2.4.1.3

2.4.2
2.4.2.1

2.4.2.2

2.4.3
2.4.3.1

2.4.3.2

2.4.3.3

2.4.3.4
2.4.3.5

2.4.3.6

2.4.3.7

2.4.3.8

2.4.3.9

2.4.3.10
2.4.3.11

2.4.3.12

2.4.3.13

2.4.4
2.4.4.1

2.4.4.2

2.4.5
2.4.5.1
2.4.6
2.4.6.1

2.4.6.2
2.5
2.5.1
2.5.1.1

2.5.2
2.5.2.1

2.5.2.2

2.5.3
2.5.3.1
2.5.3.2

2.5.4
2.5.4.1

2.5.4.2

2.5.4.3

2.5.4.4

2.6
2.6.1
2.6.1.1

2.6.1.2

2.6.2
2.6.2.1

2.6.3
2.6.3.1
2.6.3.2

2.6.3.3

2.6.3.4

2.6.4
2.6.4.1

2.6.4.2

2.7
2.7.1
2.7.1.1

2.7.1.2

2.7.1.3

2.7.1.4

2.7.2
2.7.2.1

2.7.2.2

2.7.2.3
2.7.2.4

2.8
2.8.1
2.8.1.1

2.8.1.2

2.8.1.3

2.9
2.9.1
2.9.1.1

2.9.1.2

2.9.2
2.9.2.1

2.9.2.2

2.9.2.3
People Present at the Opening Meeting (Please list names and roles in the following
format Name: Role separated by comas)
People Present at the Closing Meeting (Please list names and roles in the following
format Name: Role separated by comas)
Auditor Description of Facility (Please provide facility description include # of employees,
size, production schedule, general layout, and any additional pertinent details

Auditor Recommendation

SQF System Elements for Food Manufacturing

Management Commitment
Management Responsibility (Mandatory)
Senior site management shall prepare and implement a policy statement that outlines at
a minimum the commitment of all site management to:
i. Supply safe food;
ii. Establish and maintain a food safety culture within the site;
iii. Establish and continually improve the site’s food safety management system; and
iv. Comply with customer and regulatory requirements to supply safe food.

The policy statement shall be:

v. Signed by the senior site manager and displayed in prominent positions; and
vi. Effectively communicated to all site personnel in language(s) understood by all site
personnel.
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. Staff are informed and held accountable for their food safety and regulatory
responsibilities;
v. Staff are positively encouraged and required to notify management of actual or
potential food safety issues; and
vi. Staff are empowered to act to resolve food safety issues within their scope of work.

The reporting structure shall identify and describe site personnel with specific
responsibilities for tasks within the food safety management system and identify backup
for 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.

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.

The primary and substitute SQF practitioner shall:

i. Be employed by the site;
ii. Hold a position of responsibility in relation to the management of the site’s SQF
System;
iii. Have completed a HACCP training course;
iv. Be competent to implement and maintain HACCP-based food safety plans; and
v. Have an understanding of the SQF Food Safety Code: Storage and Distribution and
the requirements to implement and maintain an SQF System relevant to the site’s scope
of certification.
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.

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.
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.

Management Review (Mandatory)

The SQF system shall be reviewed by senior site management at least annually and
include:
i. Changes to food safety management system documentation (policies, procedures,
specifications, food safety plan);
ii. Food safety culture performance;
iii. Food safety objectives and performance measures;
iv. Corrective and preventative actions, and trends in findings from internal and external
audits, customer complaints, and verification and validation activities;
v. Hazard and risk management system; and
vi. Follow-up action items from previous management review.

Records of all management reviews and updates shall be maintained.

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.

Complaint Management (Mandatory)

The methods and responsibility for handling, investigating, and resolving food safety
complaints from commercial customers, consumers, and authorities, arising from
products stored or handled on-site shall be documented and implemented.

Adverse trends of customer complaint data shall be investigated and analyzed and the
root cause established by personnel knowledgeable about the incidents.
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.
Document Control and Records
Food Safety Management System (Mandatory)
The methods and procedures the site uses to meet the requirements of the SQF Food
Safety Code: Storage and Distribution shall be maintained in electronic and/or hard copy
documentation. It will be made available to relevant staff and include:
i. A summary of the organization’s food safety policies and the methods it will apply to
meet the requirements of this standard;
ii. The food safety policy statement and organization chart;
iii. The processes and products included in the scope of certification;
iv. Food safety regulations that apply to the site and to the country of sale (if known);
v. Raw material, ingredient, packaging, and finished product specifications;
vi. Food safety procedures, pre-requisite programs, food safety plans;
vii. Process controls that impact product safety; and
viii. Other documentation necessary to support the development and the
implementation, maintenance, and control of the SQF System.

Food safety plans, Good Storage and Distribution 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 Storage and Distribution Practices, and other
aspects of the SQF System shall be validated or justified prior to their implementation.
The reasons for the changes shall be documented.

Document Control (Mandatory)

The methods and responsibility for maintaining document control and ensuring staff
have access to current requirements and instructions shall be documented and
implemented.

Current SQF System documents and amendments to documents shall be maintained.

Records (Mandatory)
The methods, frequency, and responsibility for verifying, maintaining, and retaining
records shall be documented and implemented.

All records shall be legible and confirmed by those undertaking monitoring activities that
demonstrate inspections, analyses, and other essential activities have been completed.

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.

Specifications and Supplier Approval

Product for Storage and Distribution
Product handling and storage requirements for all products received, stored, and
intended for distribution, shall be documented, current, approved by the site and their
customer (if applicable), accessible to relevant staff, and include temperature
requirements, storage conditions, packaging requirements, and handling and
transportation conditions.

Supplier Approval and Incoming Supplies

The methods and responsibility for developing and approving product descriptions shall
be documented. Product descriptions for all incoming supplies used by the site but not
intended for distribution, including, but not limited to hazardous chemicals, ice, food
packaging materials, or janitorial supplies that are used on-site and impact on product
safety shall be documented and kept current.

All incoming supplies shall comply with the relevant legislation.

Incoming supplies shall be verified to ensure product safety is not compromised and the
material is fit for its intended purpose. Verification of incoming materials shall include a
review of the product description to determine conformance.

Incoming goods that may have an impact on product safety shall be supplied by an
approved supplier. The responsibility for selecting, evaluating, approving, and monitoring
an approved supplier shall be documented and implemented.

Incoming goods received in emergency situations shall be acceptable provided they are
inspected or analyzed before use and the supplier has been evaluated.
Incoming goods and packaging received from other sites under the same corporate
ownership shall be subject to the same product requirements and approved supplier
requirements as all other material providers.
Specifications, product requirements, and incoming supplies shall be reviewed annually
or as changes occur.
Contract Service Providers
Description of services for contract service providers that have an impact on product
safety shall be documented, current, include a full description of the service to be
provided, and the relevant food safety training requirements of all contract personnel
prior to conducting work.

Contracted services that have an impact on product safety shall be reviewed against the
description. The methods and responsibilities for contracted services review shall be
documented and validated as needed or at a minimum of annually.

A record of all contract service descriptions that have an impact on product safety shall
be maintained.
Contract Third-Party Storage or Distributor
The methods and responsibility for ensuring all agreements relating to food safety and
customer product requirements and its realization and delivery are specified and agreed
shall be documented and implemented.
The site shall:
i. Ensure changes to contractual agreements are approved by both parties and
communicated to relevant personnel;
ii. Verify compliance with the SQF Code and that all customer requirements are being
met at all times.

Records of all contract reviews and changes to contractual agreements and their
approvals shall be maintained.
Food Safety System
Food Legislation (Mandatory)
The site shall ensure that food stored and delivered to customers is handled in a manner
that complies with the relevant legislation in the country of its production and
destination.
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.
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].
Good Storage and Distribution Practices (Mandatory)
The site shall ensure the Good Storage and Distribution Practices described in Module 12
of this Food Safety Code are applied or exempted according to a written risk analysis
outlining the justification for exemption or evidence of the effectiveness of alternative
control measures to ensure that food safety is not compromised.

The Good Storage and Distribution Practices applicable to the scope of certification that
outline how food safety is controlled and assured shall be documented and implemented.

Food Safety Plan (Mandatory)

A hazard and risk management system shall be developed and take into consideration
relevant legislation in all countries of operation. The system shall be risk based,
systematic and comprehensive, and based on HACCP or preventive controls. The food
safety plan shall be effectively implemented, maintained, and outline the means by
which 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 food safety plan may be required to cover all products included in the scope of
certification.

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, storage
and distribution, and facility /maintenance knowledge of the relevant 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.

The scope of each food safety plan shall be developed and documented including the
start and endpoint of the processes under consideration and all relevant inputs and
outputs.
Product requirements shall be developed and documented for all products (or groups of
products) included in the scope of the food safety plans. This shall reference the product
descriptions (refer to 2.3.2.1) plus any additional information relevant to product safety,
such as temperature for storage, how the product is packaged, allergen requirements,
raw or cooked, etc.
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
material, packaging, service inputs (e.g., water, steam, gases as appropriate), scheduled
process delays, and all process outputs including waste, rework, and recoup. Each flow
diagram shall be confirmed by the food safety team during all stages and hours of
operation.

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 food products
received and stored.

The food safety team shall conduct a hazard analysis for every identified hazard, to
identify which hazards are significant. The methodology for determining hazard
significance shall be documented and used consistently to assess all potential hazards.

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.

Based on the results of the hazard analysis (refer to 2.4.3.7), 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 (e.g., a preventive control {PC} or critical
control point {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.

For each identified step requiring control (e.g. PC or CCP) the food safety team shall
document the limits that separate safe from unsafe product. The food safety team shall
validate the critical limits to ensure the designated 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 2.5.1.1).
The food safety team shall develop and document procedures to monitor identified steps
requiring control (e.g. PC or CCP) to ensure they remain within the established limits
(refer to 2.4.3.12). Monitoring procedures shall identify the personnel assigned to
conduct testing, the sampling and test methods, and the testing frequency.

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 an
identified step requiring control (e.g. PC or CCP). The procedures shall also prescribe
actions to correct the process step to prevent recurrence of the safety failure.

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.

Non-conforming Product and Equipment

The responsibility and methods outlining how non-conforming product, raw materials,
ingredients, work-in-progress, packaging, or equipment detected during receipt, storage,
handling, or delivery and including food found to be damaged and/or returned from
customers is handled shall be documented and implemented. The methods applied shall
ensure:
i. Non-conforming product is quarantined, identified, handled, and / or disposed of in a
manner that minimizes the risk of inadvertent use, improper use or delivery, or risk to
the integrity of the product;
ii. Non-conforming equipment is effectively identified, repaired, or disposed of in a
manner that minimizes the risk of inadvertent use, improper use, or risk to the integrity
of finished product; and
iii. All relevant staff are aware of the organization’s quarantine and release
requirements applicable to equipment or product placed under quarantine status.

Quarantine records and records of the handling, corrective action, or disposal of

nonconforming product or equipment shall be maintained.
Product Recoup
The responsibility and methods outlining how product is recouped shall be documented
and implemented. The methods applied shall ensure:
i. Recouping operations are conducted by trained personnel; and
ii. Recouped product is traceable.
Product Release (Mandatory)
The responsibility and methods for releasing products shall be documented and
implemented. The methods applied shall ensure the product is released by authorized
personnel.
Records of all product release shall be maintained.
SQF System Verification
Validation and Effectiveness (Mandatory)
The methods, responsibility, and criteria for ensuring the effectiveness of all applicable
elements of the SQF Program shall be documented, implemented, and effective. The
methods applied shall ensure that:
i. Good Storage and Distribution Practices are confirmed to ensure they achieve the
required result;
ii. Critical food safety limits are reviewed annually and re-validated or justified by
regulatory standards when changes occur; and
iii. Changes to the processes or procedures are assessed to ensure controls are still
effective.

Records of all validation activities shall be maintained.

Verification Activities (Mandatory)

The methods, responsibility, and criteria for verifying monitoring of Good Storage and
Distribution Practices, critical control points, and other food safety controls shall be
documented and implemented. The methods applied shall ensure that personnel with
responsibility for verifying monitoring activities authorize each verified record.

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.

Corrective and Preventative Action (Mandatory)

The responsibility and methods outlining how corrective and preventative actions are
determined, implemented, and verified, including identification of the root cause and
resolution of non-compliance of critical food safety limits and deviations from food safety
requirements, shall be documented and implemented.

Deviations from food safety requirements may include customer complaints,

nonconformances raised at internal or external audits and inspections, non-conforming
product and equipment, or withdrawals and recalls, as appropriate.
Records of all investigation, root cause analyses and resolution of non-conformities, their
corrections, and implementation of preventative actions shall be maintained.

Internal Audits and Inspections (Mandatory)

The methods and responsibility for scheduling and conducting internal audits to verify
the effectiveness of the SQF System shall be documented and implemented. Internal
audits shall be conducted in full and at least annually. The methods applied shall ensure:
i. All applicable requirements of the SQF Food Safety Code: Storage and Distribution are
audited as per the SQF audit checklist or similar tool;
ii. Objective evidence is recorded to verify compliance and/or non-compliance;
iii. Corrective and preventative actions of deficiencies identified during the internal
audits are undertaken; and
iv. Audit results are communicated to relevant management personnel and staff
responsible for implementing and verifying corrective and preventative actions.

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.
Regular inspections of the site and equipment shall be planned and carried out to verify
Good Storage and Distribution Practices and facilities and equipment maintenance are
compliant with the SQF Food Safety Code: Storage and Distribution. The site shall:
i. Take corrections or corrective and preventative action; and
ii. Maintain records of inspections and any corrective action taken.

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.

Product Traceability Recall and Crisis Management

Product Identification (Mandatory)
The methods and responsibility for identifying products during all stages of storage shall
be documented and implemented. The product identification system shall be
implemented to ensure:
i. Proper stock rotation; and
ii. Accurate location of product.

Records of product receipt and use and product dispatch and destination shall be
maintained.
Product Trace (Mandatory)
The responsibility and methods used to trace product shall be documented and
implemented to ensure:
i. Traceability of food products to the customer (one step forward);
ii. Traceability of product to the supplier or manufacturing supplier with date of receipt
(one step back);
iii. Traceability is maintained where product is recouped; and
iv. The effectiveness of the product trace system is reviewed at least annually as part of
the product recall and withdrawal review (refer to 2.6.3.2).

Product Withdrawal and Recall (Mandatory)

The responsibility and methods used to withdraw or recall products shall be documented
and implemented. The procedure shall:
i. Identify those responsible for initiating, managing, and investigating a product
withdrawal or recall;
ii. Describe the management procedures to be implemented including sources of legal,
regulatory and expert advice, and essential traceability information;
iii. Outline a communication plan to inform employees, customers, consumers,
authorities, and other essential bodies in a timely manner appropriate about the nature
of the incident;
iv. Ensure that SQFI, the certification body, and the appropriate regulatory authority are
listed as essential organizations and notified in instances of a food safety incident of a
public nature or product recall for any reason.
The product withdrawal and recall system shall be reviewed, tested, and verified as
effective at least annually. Testing shall include incoming materials (one back), inhouse
identification and isolation/quarantine, and where the product is shipped to (one
forward).

Records shall be maintained of withdrawal and recall tests, root cause investigations into
actual withdrawals and recalls, and applied corrective and preventative actions.
SQFI and the certification body shall be notified in writing within twenty-four (24) hours
upon identification of a food safety event that has been initiated by the site requires
public notification. SQFI shall be notified at [email protected].

Crisis Management Planning

A crisis management plan based on the understanding of known potential dangers (e.g.,
flood, drought, fire, tsunami, or other severe weather event, warfare or civil unrest,
computer outage, pandemic, loss of electricity or refrigeration, ammonia leak, labor
strike) that can impact the site’s ability to deliver safe food, shall be documented by
senior management outlining the methods and responsibility the site shall implement to
cope with such a business crisis. The crisis management plan shall include at a
minimum:
i. A senior manager responsible for decision making, oversight, and initiating actions
arising from a crisis management incident;
ii. The nomination and training of a crisis management team;
iii. The controls implemented to ensure a response does not compromise product safety;
iv. The measures to isolate and identify product affected by a response to a crisis;
v. The measures taken to verify the acceptability of food product prior to release;
vi. The preparation and maintenance of a current crisis alert contact list, including
supply chain customers;
vii. Sources of legal and expert advice; and
viii. The responsibility for internal communications and communicating with
authorities, external organizations, and media.

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.
Food Defense and Food Fraud
Food Defense Plan (Mandatory)
A food defense threat assessment shall be conducted to identify potential threats that
can be caused by a deliberate act of sabotage or terrorist-like incident.

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 the food defense
plan;
iii. The methods implemented to ensure only authorized personnel have access to
equipment and vehicles and storage areas through designated access points;
iv. The methods implemented to protect sensitive operational points from intentional
adulteration;
v. The measures taken to ensure the secure receipt and storage of products, packaging,
equipment, and hazardous chemicals to protect them from deliberate act of sabotage or
terrorist-like incidents;
vi. The measures implemented to ensure products, packaging (including labels), work-in
progress, and process inputs are held under secure storage and transportation
conditions; and
vii. The methods implemented to record and control access to the premises by
employees, contractors, and visitors.

Instruction shall be provided to all relevant staff on the effective implementation of the
food defense plan (refer to 2.9.2.1).
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.

Food Fraud (Mandatory)

The methods, responsibility, and criteria for identifying the site’s vulnerability to food
fraud including susceptibility to product substitution, mislabeling, dilution, or
counterfeiting shall be documented, implemented, and maintained.

A food fraud mitigation plan shall be developed and implemented that specifies the
methods by which the identified food fraud vulnerabilities shall be controlled.
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.
Records of reviews of the food fraud vulnerability assessment and mitigation plan shall
be maintained.
Allergen Management
Allergen Management (Mandatory)
The responsibility and methods used to control allergens and to prevent sources of
allergens from contaminating product shall be documented and implemented. The
allergen management controls shall be based on a risk assessment and include the
identification, labeling, and handling of allergen-containing product, including product
recoup, to prevent inadvertent cross contact.

Recouped product containing food allergens (refer to 2.4.5) shall be repackaged under
conditions that ensure product safety and integrity is maintained. Recouped product
containing allergens shall be clearly identified and traceable.

Sites that do not handle allergenic materials or store allergenic products shall document,
implement, and maintain an allergen management program that addresses, at a
minimum, the mitigation of introduced or unintended allergens from suppliers, contract
manufacturers, site personnel, and/or visitor activities.

Training
Training Requirements
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 product legality and safety shall be defined and documented
(refer to 2.1.1.6).

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.
Training Program (Mandatory)
A training program shall be documented and implemented that, at a minimum, outlines
the necessary competencies for specific duties and the training methods to be applied
for personnel carrying out tasks associated with:
i. Developing and maintaining food safety plans to meet regulatory requirements and
the SQF Code;
ii. Monitoring and corrective action procedures for all staff engaged in monitoring critical
control points (CCPs);
iii. Personal hygiene for all staff involved in handling of food products and food contact
surfaces;
iv. Good Storage and Distribution Practices and work instructions for all staff engaged in
food handling, food storage and transport, and associated equipment;
v. Allergen management, food defense, and food fraud for all relevant staff; and
vi. Tasks identified as critical to meeting effective implementation and maintenance of
the SQF Code.

The training program shall include provision for identifying and implementing the
refresher training needs of the organization.

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
languages understood by staff.

Training records shall be maintained and include:

i. Participant name;
ii. Skills description;
iii. Description of the training provided;
iv. Date training completed;
v. Trainer or training provider; and
vi. Verification that the trainee is competent to complete the required tasks.
 Lista de Verificación del
Artículo
Personas presentes en la reunión de apertura (enumere los nombres y funciones con el
siguiente formato: nombre, función separado por comas)
Personas presentes en la reunión de cierre (enumere los nombres y funciones con el
siguiente formato: nombre, función separado por comas)
Descripción de las instalaciones por parte del auditor (proporcione una descripción de las
instalaciones que incluya el número de empleados, el tamaño, el cronograma de
producción, el diseño general y cualquier detalle pertinente adicional)
Recomendaciones del Auditor

Elementos del Sistema SQF para la fabricación de alimentos

Compromiso de la gerencia
Responsabilidad de la gerencia (obligatorio)
La gerencia general de la planta deberá preparar e implementar una declaración de
políticas que describa, como mínimo, el compromiso de la gerencia de la planta para:
i. Suministrar alimentos seguros
ii.Establecer y mantener una cultura de Inocuidad alimentaria dentro de la planta.
iii. Establecer y mejorar continuamente el Sistema de gestión de la inocuidad de
alimentos de la planta.
iv. Cumplir con los requisitos regulatorios y de los clientes para suministrar alimentos
inocuos.
La Declaración de políticas deberá:
v. Firmarse por la gerencia general de la planta y exhibirse en ubicaciones visibles; y
vi. Comunicarse eficazmente al personal de la planta en idiomas que todo el personal
comprenda.
La gerencia general de la planta dirigirá y apoyará una cultura de inocuidad de los
alimentos dentro de la planta que garantice, como mínimo:
i. El establecimiento, la documentación y la comunicación a todo el personal pertinente
de los objetivos de inocuidad alimentaria y las medidas para lograrlo.
ii. Recursos adecuados disponibles para cumplir con los objetivos de inocuidad de
alimentos.
iii. Se adopten y mantengan prácticas de inocuidad de alimentos y de todos los
requisitos aplicables del Sistema SQF.
iv. Que los empleados estén informados y estén comprometidos con sus
responsabilidades de inocuidad alimentaria y normativas.
v. Se aliente positivamente al personal y se le exija que notifique a la gerencia sobre los
problemas de inocuidad alimentaria reales o potenciales; y
vi. Que el personal esté facultado para actuar para resolver problemas de inocuidad
alimentaria dentro de su alcance de trabajo.

La estructura organizacional deberá identificar y describir al personal de la planta con

responsabilidades específicas para las tareas dentro del Sistema de gestión de la
inocuidad de alimentos e identificar el personal de respaldo cuando el personal clave se
ausente.
Deberán documentarse las descripciones de trabajo del personal clave.
La gerencia de la planta deberá asegurarse que los departamentos y las operaciones
cuenten con el personal adecuado y estén alineados organizacionalmente para cumplir
con los objetivos de inocuidad de los alimentos.

La gerencia general de la planta deberá designar, para cada planta, un encargado del
Sistema SQF primario y sustituto con responsabilidades y autoridad para lo siguiente:
i. Supervisar el desarrollo, la implementación, la revisión y el mantenimiento del Sistema
SQF.
ii. Tomar las medidas adecuadas para garantizar la integridad del Sistema SQF.
iii. Comunicar al personal correspondiente toda la información esencial para asegurar la
implementación y el mantenimiento eficaces del Sistema SQF.

El encargado principal y sustituto del sistema SQF deberá:

i. Ser un empleado de tiempo completo de la planta.
ii. Tener un cargo de responsabilidad en la gestión del Sistema SQF de la planta.
iii. Haber realizado un curso de capacitación en APPCC.
iv. Ser competente para implementar y mantener los planes de inocuidad de alimentos
basados en APPCC.
v. Debe comprender el Código SQF sobre inocuidad de los alimentos: Almacenamiento y
Distribución, y los requisitos para implementar y mantener el Sistema SQF aplicables al
alcance de la certificación de la planta.
La gerencia general de la planta deberá asegurar que se satisfagan las necesidades de
capacitación de la planta, además que se implementen y cumplan los requisitos
descritos en los elementos del sistema 2.9, y que el personal de la planta cuente con las
competencias requeridas para llevar a cabo las funciones que afecten la legalidad e
inocuidad de los productos alimenticios.

La gerencia general de la planta debe garantizar la integridad y la operación del sistema

de inocuidad alimentaria en caso de cambios organizativos o de personal dentro de la
compañía o instalaciones asociadas.
La gerencia general de la finca deberá designar períodos de restricción definidos que
eviten que se realicen auditorías de recertificación no anunciadas fuera de la temporada,
o cuando la planta no está en operación por motivos legítimamente comerciales. La lista
de fechas de restricción y su justificación se enviarán al organismo de certificación, como
mínimo, un (1) mes antes de los sesenta (60) días de la ventana de recertificación para
realizar la auditoría no anunciada acordada.

Revisión por la gerencia (obligatorio)

El Sistema SQF será revisado por la gerencia general de la planta al menos una vez al
año e incluirá:
i. Cambios en la documentación del Sistema de gestión de inocuidad alimentaria
(políticas, procedimientos, especificaciones, plan de inocuidad alimentaria)
ii. Desempeño de la cultura de inocuidad alimentaria
iii. Objetivos de inocuidad alimentaria y medidas de cumplimiento.
iv. Medidas correctivas y preventivas y tendencias en los hallazgos de auditorías internas
y externas, quejas del cliente y actividades de verificación y validación.
v. Sistema de gestión de riesgos y peligros y
vi. Medidas de seguimiento pendientes de las revisiones de la gerencia anteriores.
Se deberán conservar registros de todas las revisiones y actualizaciones realizadas por
la gerencia.

Los encargados del Sistema SQF deberán poner a la gerencia general de la planta al
corriente, por lo menos una vez por mes, de los asuntos que afecten la implementación y
el mantenimiento del Sistema SQF. Se deberán documentar las actualizaciones y
respuestas de la gerencia.

Gestión de quejas (obligatorio)

Deberán documentarse e implementarse los métodos y las responsabilidades para
manejar, investigar y resolver las quejas de inocuidad alimentaria de clientes y
autoridades, que provengan de productos fabricados o manipulados en la planta o
cofabricados.

Las tendencias adversas de los datos de quejas de clientes deberán ser investigadas y
analizadas, y la causa raíz establecida, por el personal que tenga conocimiento sobre los
incidentes.
Las medidas correctivas y preventivas se deberán implementar según la gravedad del
incidente y el análisis de la causa raíz tal como se describe en el elemento 2.5.3.
Deberán mantenerse registros de quejas del cliente y sus investigaciones y soluciones.
Control de documentos y registros
Sistema de gestión de la inocuidad de alimentos (obligatorio)
Los métodos y procedimientos que utiliza la planta para cumplir con los requisitos del
Código SQF sobre inocuidad de los alimentos: Almacenamiento y Distribución se
mantendrá en documentación electrónica y/o impresa. Se pondrán a disposición del
personal relevante e incluirán:
i. Un resumen de las políticas de inocuidad de alimentos de la organización y de los
métodos que esta aplicará para cumplir con los requisitos de este estándar.
ii. La declaración de la política de inocuidad alimentaria y el organigrama.
iii. Los procesos y productos incluidos en el alcance de la certificación.
iv. Regulaciones de inocuidad de alimentos que se aplican a la planta de fabricación y al
país de venta, si se conocen.
v. Especificaciones de materias primas, ingredientes, empaques y productos terminados.
vi. Procedimientos de inocuidad alimentaria, programas de requisitos previos y planes de
inocuidad alimentaria.
vii. Controles de procesos que afectan la inocuidad del producto.
viii. Otra documentación necesaria para apoyar el desarrollo, la implementación, el
mantenimiento y el control del Sistema SQF.

Los planes de inocuidad de alimentos, las Buenas prácticas de almacenamiento y

distribución y todos los aspectos pertinentes del Sistema SQF se deberán revisar,
actualizar y comunicar según se requiera, cuando cualquier cambio implementado afecte
la capacidad de la planta para suministrar alimentos inocuos.
Se deberán validar y justificar todos los cambios en los planes de inocuidad de
alimentos, Buenas prácticas de al,macenamiento y distribución y otros aspectos del
Sistema SQF antes de su implementación. Deberán documentarse los motivos del
cambio.

Control de documentos (obligatorio)

Se deberán documentar e implementar los métodos y la responsabilidad para mantener
el control de documentos y asegurar que el personal tenga acceso a requisitos e
instrucciones actualizados.
Se mantendrán los documentos actuales del Sistema SQF y las enmiendas a los
documentos.

Registros (obligatorio)
Se deberán documentar e implementar los métodos, la frecuencia y las
responsabilidades para llevar a cabo las actividades de verificación, mantenimiento y
conservación de registros.
Todos los registros deberán ser legibles y estar confirmados por aquellas personas que
realizan actividades de monitoreo que demuestran que las inspecciones, los análisis y
otras actividades esenciales se han completado.
Los registros deberán ser fácilmente accesibles, recuperables y almacenados de manera
segura para evitar el acceso no autorizado, la pérdida, el daño y el deterioro. Los
períodos de retención deben cumplir con los requisitos legales, regulatorios y del cliente;
y, como mínimo, la vida útil del producto o establecerlos por la planta si no existe vida
útil.

Especificaciones y aprobación del proveedor

Producto para almacenamiento y distribución
Los requisitos de almacenamiento y manejo de producto para todos los productos
recibidos, almacenados y destinados a la distribución, deberán ser documentados,
actualizados, aprobados por la planta y su cliente (si aplica), accesibles para el personal
pertinente e incluir requisitos de temperatura, condiciones de almacenamiento,
requisitos de empaque, y condiciones de manejo y transportación.

Aprobación de proveedor y suministros entrantes

Deberán documentarse los métodos y responsabilidades para el desarrollo y aprobación
de descripciones de productos. Deberán documentarse y mantenerse actualizadas las
descripciones de producto de todos los suministros entrantes usados por la planta pero
no destinados a distribuirse, incluyendo, pero no limitándose a, químicos peligrosos,
hielo, materiales de empaque de alimentos, o suministros sanitarios que son usados
dentro de la planta e impactan en la inocuidad alimentaria.

Todos los suministros entrantes deben cumplir con la legislación relevante.

Se deberán verificar los suministros entrantes para asegurar que la inocuidad del
producto no está comprometida y que el material se ajuste a su propósito. La
verificación de los materiales entrantes debe incluir una revisión de la descripción del
producto para determinar la conformidad.

Las mercancías entrantes que pudieran tener impacto en la inocuidad del producto
deberán ser suministrados por un proveedor aprobado. Deberá documentarse e
implementarse la responsabilidad de selección, evaluación, aprobación y control de un
proveedor aprobado.

Las mercancías entrantes recibidas en situaciones de emergencia serán aceptables

siempre que sean inspeccionadas o analizadas antes de su uso y el proveedor haya sido
evaluado.
Los bienes entrantes y empaques recibidos de otras plantas del mismo propietario
corporativo deberán estar sujetas a los mismos requisitos de producto y de proveedor
aprobado que todos los demás proveedores de materiales.
Las especificaciones, requisitos de producto y suministros entrantes deberán revisarse
anualmente o cada que ocurra un cambio.
Proveedores de servicio por contrato
La descripción de los servicios para proveedores de servicio por contrato, que impacten
la inocuidad del producto deberán ser documentadas y estar actualizadas, y deberán
incluir una descripción completa del servicio que se prestará; y deberán detallar los
requisitos de capacitación pertinentes para el personal contratado.

Los servicios contratados que pudieran impactar en la inocuidad del producto deberán
compararse con la descripción. Los métodos y responsabilidades para la revisión de
servicios contratados deberán documentarse y validarse conforme sea necesario o como
mínimo anualmente.

Deberá mantenerse un registro de todas las descripciones de los servicios contratados

que pudieran tener un impacto en la inocuidad del producto.
Contrato de Almacenamiento o Distribución de Terceros
Se deberán especificar, documentar, acordar e implementar métodos y
responsabilidades para asegurar que se especifiquen los acuerdos relacionados con la
inocuidad alimentaria, los requisitos del producto del cliente, la elaboración y la entrega.
La planta deberá:
i. Asegurar que los cambios a los acuerdos contractuales sean aprobados por ambas
partes y comunicados al personal correspondiente.
ii. Verificar el cumplimiento del Código SQF y que todos los requisitos del cliente se
cumplen en todo momento.

Deberán mantenerse registros de auditorías, contratos y cambios a los acuerdos

contractuales y su aprobación.
Sistema de inocuidad alimentaria
Legislación alimentaria (obligatorio)
La planta deberá asegurar que los alimentos almacenados y entregados al cliente sean
manejados de manera que cumplan con la legislación correspondiente en el país de su
producción y de destino
Deberán documentarse e implementarse los métodos y las responsabilidades para
asegurar que la planta se mantenga informada sobre los cambios en la legislación
pertinente, los desarrollos científicos y técnicos, los problemas emergentes de inocuidad
alimentaria y los Códigos de práctica de la industria pertinentes.
El SQFI y el organismo de certificación deberán ser notificados, por escrito, en un plazo
de veinticuatro (24) horas en caso de una advertencia regulatoria o evento. Se deberá
enviar la notificación al SQFI por correo electrónico a [email protected]
Buenas prácticas de almacenamiento y distribución (obligatorio)
La planta deberá asegurar que las Buenas prácticas de almacenamiento y distribución
pertinentes descritas en el módulo 12 del presente Código sobre inocuidad alimentaria,
se apliquen o se excluyan de acuerdo con un análisis de riesgos escrito, que describa la
justificación de la exención o proporcione evidencia de la efectividad de las medidas de
control alternativas, para garantizar que no se comprometa la inocuidad alimentaria.

Se deberán documentar e implementar las Buenas prácticas de almacenamiento y

distribución aplicables al alcance de la certificación que describan cómo se controla y se
asegura la inocuidad alimentaria.
Plan de inocuidad de alimentos (obligatorio)
Se deberá elaborar un sistema de gestión de riesgos y peligros, tomando en
consideración la legislación pertinente en todos los países de operación. El sistema
deberá ser basado en riesgos, sistemático y comprensdible, y basado en APPCC o
controles preventivos. Deberá implementarse y mantenerse, de manera efectiva, un plan
de inocuidad de alimentos que describa los medios por los que la planta controla y
asegura la inocuidad alimentaria de los productos o grupos de productos incluidos en el
alcance de la certificación SQF y sus procesos asociados. Es posible que se requiera más
de un plan de inocuidad de alimentos APPCC para cubrir todos los productos incluidos en
el alcance de la certificación.

El plan o los planes de inocuidad de alimentos deberán ser desarrollados y mantenidos

por un equipo multidisciplinario que incluya al encargado del Sistema SQF y al personal
de la planta con conocimiento técnico, de almacenamiento y distribución, y conocimiento
de mantenimiento / instalaciones de los productos y los procesos relacionados
correspondientes. Cuando no se disponga de la experiencia pertinente en la planta, se
debe buscar asesoría de otras fuentes para ayudar al equipo de inocuidad de alimentos.

El alcance del plan de inocuidad de alimentos se deberá desarrollar y documentar,

incluyendo el inicio y final del proceso en consideración, y todas las entradas y salidas
relevantes.
Se deberán desarrollar y documentar las descripciones del producto para todos los
productos (o grupos de productos) incluidos en el alcance de los planes de inocuidad de
alimentos. Las descripciones deberán mencionar las especificaciones del producto
terminado (consulte 2.3.2.1) además de toda información adicional relacionada con la
inocuidad del producto, como la temperatura de almacenamiento, cómo se empaqueta
el producto, requisitos de alérgenos, crudo o cocido, etc.
El equipo de inocuidad alimentaria deberá desarrollar y documentar un diagrama de flujo
que cubra el alcance de cada plan de inocuidad de alimentos. El diagrama de flujo
deberá incluir cada paso en el proceso, todas las materias primas, empaque e insumos
de servicios (por ejemplo, agua, vapor, gases según corresponda), retrasos en los
procesos programados y todos los productos resultados del proceso, incluyendo
desperdicios y recuperación. Cada diagrama de flujo deberá ser confirmado por el equipo
de inocuidad de alimentos para cubrir cada etapa y hora de operación.

El equipo de inocuidad de alimentos deberá identificar y documentar todos los peligros

para la inocuidad de los alimentos que puedan existir razonablemente en cada paso de
los procesos, incluyendo productos alimenticios recibidos y almacenados.

El equipo de inocuidad de alimentos deberá realizar un análisis de riesgos de cada uno

de los peligros identificados, para determinar cuáles son los más significativos. La
metodología empleada para determinar la importancia de un peligro deberá ser
documentada y utilizada de manera sistemática para evaluar todos los peligros
potenciales.

El equipo de inocuidad de alimentos deberá determinar y documentar las medidas de

control que se deben aplicar a todos los peligros significativos. Es posible que se requiera
más de una medida de control para controlar un peligro identificado, y que se pueda
controlar más de un peligro significativo mediante una medida de control específica.

Con base en los resultados del análisis de riesgos (consulte el elemento 2.4.3.7), el
equipo de inocuidad de alimentos deberá identificar los pasos en el proceso donde se
debe aplicar una medida de control para eliminar un peligro significativo o reducirlo a un
nivel aceptable (es decir, punto crítico de control {PCC} o control preventivo). En las
instancias en las que se ha identificado un peligro significativo en un paso del proceso y
no existe una medida de control, el equipo de inocuidad de alimentos deberá modificar
el proceso para incluir una medida de control adecuada.

Para cada paso identificado que requiere control (PCC o CP), el equipo de inocuidad de
alimentos deberá identificar y documentar los límites que separan un producto inocuo de
un producto no inocuo (límites críticos). El equipo de inocuidad de alimentos deberá
validar todos los límites críticos para asegurar el nivel de control de los peligros para la
inocuidad de los alimentos identificados, y para asegurar que todos los límites críticos y
las medidas de control proporcionen de manera eficaz, individualmente o en
combinación, el nivel de control requerido (consulte el elemento 2.5.1.1).
El equipo de inocuidad de alimentos deberá desarrollar y documentar los procedimientos
para monitorear los pasos que requieren control (PCC o CP) y asegurar que permanezcan
dentro de los límites establecidos (consulte el elemento 2.4.3.12). Los procedimientos de
monitoreo deberán identificar al personal asignado para llevar a cabo el monitoreo, el
muestreo, los métodos de prueba y la frecuencia de las pruebas.

El equipo de inocuidad de alimentos deberá desarrollar y documentar los procedimientos

de separación que identifiquen la disposición de los productos afectados cuando el
monitoreo indique una pérdida de control en un paso identificado que requiere control
(PCC o CP). Los procedimientos también deberán recomendar medidas para corregir el
paso del proceso y evitar la reincidencia de una falla en la inocuidad.

Deberán implementarse en su totalidad los planes de inocuidad de alimentos

documentados y aprobados. El equipo de inocuidad de alimentos deberá monitorear la
implementación eficaz y deberá realizar una revisión completa de los planes
documentados e implementados, al menos una vez al año, o cuando se produzcan
cambios en el proceso, equipo, insumos u otros cambios, que puedan afectar la
inocuidad de los alimentos.

Materiales y productos no conformes

Deberán documentarse e implementarse las responsabilidades y los métodos que
describen cómo manipular los productos, las materias primas, los ingredientes, el trabajo
en curso, el empaque que no reúnen los requisitos necesarios detectados durante la
recepción, el almacenamiento, el procesamiento, la manipulación o la entrega. Los
métodos aplicados deberán asegurar que:
i. Que el producto que no reúna los requisitos necesarios sea puesto en cuarentena,
identificado, manipulado y eliminado de un modo que reduzca el riesgo de uso
inadvertido o inadecuado, o el riesgo para la integridad del producto terminado.
ii. Que el equipo que no reúna los requisitos necesarios sea puesto en cuarentena,
identificado, manipulado y eliminado de un modo que reduzca el riesgo de uso
inadvertido o inadecuado, o el riesgo para la integridad del producto terminado.
iii. Que todo el personal pertinente tenga conocimiento de la condición de cuarentena de
la organización y de los requisitos de despacho que aplican al producto puesto en
cuarentena.

Deben mantenerse registros de cuarentena y registros de la manipulación, acción

correctiva o desecho del producto o equipo no conforme.
Recuperación de productos
Se deberá documentar e implementar las responsabilidades y los métodos que describen
cómo se recupera el producto. Los métodos aplicados deberán asegurar lo siguiente:
i. Que las operaciones de recuperación sean supervisadas por el personal calificado.
ii. Que el producto recuperado sea rastreable (trazabilidad)
Despacho de productos (obligatorio)
Se deberán documentar e implementar las responsabilidades y los métodos para liberar
y despachar productos. Los métodos aplicados garantizarán que el producto sea
despachado por personal autorizado.
Se deberán mantener registros de todos los despachos de producto.
Verificación del Sistema SQF
Validación y efectividad (obligatorio)
Se deberán documentar e implementar los métodos, las responsabilidades y los criterios
para asegurar la efectividad de todos los elementos correspondientes del Programa SQF.
Los métodos aplicados deberán validar:
i. Que las Buenas prácticas de almacenamiento y distribución se ratifiquen para asegurar
que logren el resultado requerido.
ii. Que los límites críticos de inocuidad de los alimentos se revisan anualmente y se
revalidan o justifican según los estándares regulatorios cuando se producen cambios.
iii. Que los cambios en los procesos o procedimientos se evalúen para asegurar que los
controles sigan siendo efectivos.
Deberán mantenerse registros de todas las actividades de validación.

Actividades de verificación (obligatorio)

Deberán documentarse e implementarse los métodos, las responsabilidades y los
criterios para verificar el monitoreo de las Buenas prácticas de almacenamiento y
distribución, puntos críticos de control y otros controles de inocuidad de los alimentos.
Los métodos aplicados deberán asegurar que el personal con responsabilidad para
verificar las actividades de monitoreo autorice cada registro verificado.

Deberá prepararse e implementarse un cronograma de verificación que describa las

actividades de verificación, su frecuencia de cumplimiento y la persona responsable de
cada actividad.
Deberán mantenerse registros de verificación de actividades.

Medidas correctivas y preventivas (obligatorio)

Deberán documentarse e implementarse las responsabilidades y métodos que describan
cómo se determinarán, implementarán y verificarán las medidas correctivas y
preventivas, incluida la identificación de la causa raíz y la resolución del incumplimiento
de los límites críticos de inocuidad de los alimentos, y las desviaciones de los requisitos
de inocuidad de alimentos.
Las desviaciones de los requisitos de inocuidad de alimentos pueden incluir quejas del
cliente, no-conformidades planteadas en auditorías e inspecciones internas o externas,
productos y equipos no conformes, retiros y retiradas del mercado, según corresponda.
Se deberán mantener registros de todas las investigaciones, los análisis de causa raíz y
las resoluciones de no-conformidades, incluidas las correcciones y la implementación de
medidas preventivas.
Inspecciones y auditorías internas (obligatorio)
Se deberán documentar e implementar los métodos y las responsabilidades para
programar y realizar auditorías internas para verificar la efectividad del Sistema SQF. Se
deberán realizar auditorías internas completas y al menos una vez por año. Los métodos
aplicados deberán asegurar que:
i. Todos los requisitos del Código SQF sobre inocuidad de los alimentos: almacenamiento
y distribución, se auditen según la lista de verificación de auditoría SQF o una
herramienta similar.
ii. Se registre evidencia objetiva para verificar el cumplimiento y/o incumplimiento.
iii. Se tomen medidas correctivas y preventivas de las deficiencias identificadas durante
las auditorías internas.
iv. Se comuniquen los resultados de las auditorías al personal administrativo pertinente y
al personal responsable por la implementación y verificación de las medidas correctivas.

El personal que realice las auditorías internas deberá estar capacitado y ser competente
en procedimientos de auditoría interna. Si es posible, el personal que realice las
auditorías internas no deberá trabajar en el área auditada.
Se deberán planificar y llevar a cabo inspecciones periódicas de la planta y equipos para
verificar que las Buenas prácticas de almacenamiento y distribución y el mantenimiento
del edificio y de los equipos cumplan con el Código SQF sobre inocuidad de los
alimentos: Fabricación de alimentos. La planta deberá:
i. Deberá realizar correcciones o medidas correctivas y preventivas.
ii. Mantener registros de las inspecciones y de cualquier medida correctiva adoptada.

Se deberán mantener registros de inspecciones y auditorías internas, y de cualquier

medida correctiva y preventiva adoptada como resultado de las auditorías internas
según 2.5.3.
Los cambios implementados a partir de auditorías internas que tengan un impacto en la
capacidad de la planta para entregar alimentos inocuos requerirán una revisión de los
aspectos aplicables del Sistema SQF.

Trazabilidad del producto y gestión de crisis

Identificación del producto (obligatorio)
Deberán documentarse e implementarse los métodos y las responsabilidades para
identificar productos durante todas las etapas dealmacenamiento. Se deberá
implementar el sistema de identificación del producto para garantizar lo siguiente:
i. Rotación de inventario apropiada
ii. Ubicación precisa del producto.

Se deberán mantener registros de la recepción y uso del producto y envío y destino del
producto.
Seguimiento del producto (obligatorio)
Deberán documentarse e implementarse las responsabilidades y los métodos utilizados
para hacer un seguimiento (trazabilidad) al producto, para asegurar que se cumpla con
lo siguiente:
i. La trazabilidad de los productos alimentarios hacia el cliente (un paso hacia adelante);

ii. La trazabilidad del producto hacia el proveedor o proveedor de manufactura con fecha
de recepción (un paso hacia atrás);
iii. Que se mantenga la capacidad de seguimiento (trazabilidad) siempre que el producto
sea recuperado
iv. La efectividad del sistema de seguimiento del producto debe revisarse al menos una
vez al año, como parte de la revisión del retiro y devolución de productos (consulte el
elemento 2.6.3.2).

Retiro de productos (obligatorio)

Deberán documentarse e implementarse las responsabilidades y los métodos de retiro
de productos. El procedimiento deberá cumplir con lo siguiente:
i. Identificar a los responsables de iniciar, gestionar e investigar el retiro de un producto.
ii. Describir los procedimientos de gestión que se deben implementar, incluidas las
fuentes de asesoría legal, regulatoria y de expertos, y la información de seguimiento
fundamental.
iii. Describir un plan de comunicación para informar al personal de la planta, a clientes,
consumidores, autoridades y otros organismos esenciales de manera oportuna y
adecuada la naturaleza del incidente.
iv. Garantizar que el SQFI, el organismo de certificación y la autoridad reguladora
correspondiente figuren como organizaciones importantes y deberán ser informados en
casos de un incidente de inocuidad alimentaria de naturaleza pública, o una retirada de
producto por cualquier motivo.
El sistema de retiro y devolución de productos deberá revisarse, probarse y verificarse
como efectivo, al menos, una vez al año. Las pruebas deben incluir materiales entrantes
(rastreabilidad mínima de un paso atrás), identificación interna y aislamiento/cuarentena
y hacia dónde es enviado el producto (trazabilidad mínima de un paso adelante).

Deberán mantenerse registros de las pruebas de retiro, investigaciones de causa raíz de

retiros reales, y medidas correctivas y preventivas aplicadas.
El SQFI y el organismo de certificación serán notificados, por escrito, en un plazo de
veinticuatro (24) horas desde la identificación de cualquier caso de inocuidad alimentaria
que requiera notificación pública. Se deberá notificar a SQFI mediante correo electrónico,
a [email protected].

Planes de gestión de crisis

Un plan de gestión de crisis basado en la comprensión de posibles peligros conocidos
(por ejemplo, inundación, sequía, incendio, tsunami u otras circunstancias climáticas
graves, guerras o conflictos sociales, interrupción informática, pandemia, corte de
electricidad o refrigeración, fuga de amoníaco, huelga de mano de obra) que puedan
afectar la capacidad de la planta para suministrar alimentos inocuos deberá ser
documentado por la gerencia general y deberá describir los métodos y la responsabilidad
que la planta deba implementar para enfrentar una crisis comercial. El plan de gestión
de crisis deberá incluir como mínimo:
i. Un gerente general responsable para la toma de decisiones, la supervisión y el inicio
de medidas que surjan de un incidente de gestión de crisis.
ii. La designación y la capacitación de un equipo de gestión de crisis.
iii. Los controles implementados para asegurar que una respuesta a la crisis no
comprometa la inocuidad del producto.
iv. Las medidas para aislar e identificar un producto afectado por una respuesta a la
crisis.
v. Las medidas adoptadas para verificar la idoneidad de los alimentos antes de su
despacho.
vi. La preparación y el mantenimiento de una lista actualizada de contactos de alerta en
caso de crisis, incluyendo los clientes de cadena de suministro.
vii. Fuentes de asesoría legal y de expertos.
viii. La responsabilidad por la comunicación interna y la comunicación con las
autoridades, organizaciones externas y los medios.

Se deberá revisar, probar y verificar el plan de gestión de crisis al menos una vez al año
con espacios y medidas correctivas pertinentes documentadas. Se deberán mantener
registros de las revisiones del plan de gestión de crisis.
Defensa alimentaria y fraude alimentario
Plan de defensa alimentaria (obligatorio)
Se realizará una evaluación de amenazas de defensa alimentaria para identificar
posibles amenazas que pueden ser causadas por un acto deliberado de sabotaje o un
incidente terrorista.
Deberá documentarse, implementarse y mantenerse un plan de defensa alimentaria
basado en la evaluación de amenazas (consulte 2.7.1.1). El plan de defensa alimentaria
cumplirá con los requisitos legislativos según corresponda e incluirá, como mínimo:
i. Los métodos, la responsabilidad y los criterios para prevenir la adulteración de los
alimentos causada por un acto deliberado de sabotaje o un incidente terrorista.
ii. El nombre de la persona de la gerencia general de la planta responsable de la defensa
alimentaria.
iii. Los métodos implementados para asegurar que solo el personal autorizado tenga
acceso a los vehículos y equipo y a las áreas de almacenamiento a través de puntos de
acceso designados.
iv. Los métodos implementados para proteger los puntos sensibles de procesamiento de
la adulteración intencional.
v. Las medidas tomadas para asegurar la recepción y el almacenamiento seguro
productos, empaques, equipos y productos químicos peligrosos para protegerlos de
actos deliberados de sabotaje e incidentes similares al terrorismo.
vi. Las medidas implementadas para asegurar que los productos, empaque (incluyendo
etiquetas), trabajos en curso e insumos del proceso se mantengan en condiciones
seguras de transporte y almacenamiento.
vii. Los métodos implementados para registrar y controlar el acceso a las instalaciones
por parte de los empleados, contratistas y visitantes.

Deberán proporcionarse instrucciones a todo el personal pertinente sobre la

implementación efectiva del plan de defensa alimentaria (consulte 2.9.2.1).
La evaluación de amenazas de defensa alimentaria y el plan de prevención deben
revisarse y probarse al menos una vez al año o cuando cambie el nivel de amenaza,
según se define en la evaluación de amenazas. Se deberá mantener un registro de las
revisiones y las pruebas del plan de defensa alimentaria.

Fraude alimentario (obligatorio)

Deberán documentarse, implementarse y mantenerse los métodos, la responsabilidad y
los criterios para identificar la vulnerabilidad de la planta al fraude alimentario, incluida
la susceptibilidad a la sustitución de producto, el etiquetado incorrecto, la dilución o la
falsificación.

Se deberá elaborar y aplicar un plan de mitigación de fraude alimentario que especifique

los métodos mediante los cuales se deberán controlar las vulnerabilidades.
Se deberá revisar y verificar la evaluación de vulnerabilidad de fraude alimentario y el
plan de mitigación al menos una vez al año con oportunidades de mejora y medidas
correctivas documentadas. Se deberán mantener registros de las revisiones.
Se deberán mantener registros de las revisiones de la evaluación de vulnerabilidad de
fraude alimentario y del plan de mitigación.
Gestión de alérgenos
Gestión de alérgenos (obligatorio)
Se deberán documentar e implementar la responsabilidad y los métodos que se utilizan
para controlar los alérgenos y para evitar que fuentes de alérgenos contaminen el
producto. Los controles de gestión de alérgenos deberán basarse en una evaluación de
riesgo e incluir identificación, etiquetado y manejo del producto que contiene alérgenos,
incluyendo producto recuperado, para prevenir contacto cruzado inadvertido.

Los productos recuperados que contienen alérgenos alimentarios (consulte 2.4.5)

deberán reempaquetarse bajo condiciones que aseguren que se mantenga la inocuidad
e integridad del producto. Los productos recuperados que contienen alérgenos deberán
ser claramente identificados y rastreables.

Las plantas que no manipulen materiales alergénicos ni produzcan productos alergénicos

deberán documentar, implementar y mantener un programa de gestión de alérgenos
para abordar, como mínimo, la mitigación del ingreso de alérgenos imprevisto mediante
las actividades del proveedor, fabricante por contrato, personal de la planta y visitantes.

Capacitación
Requisitos de capacitación
Deberán definirse y documentarse las responsabilidades para establecer e implementar
las necesidades de capacitación del personal de la organización para asegurar que
tengan las competencias necesarias para llevar a cabo aquellas funciones que afecten la
legalidad y la inocuidad de los productos, (consulte el elemento 2.1.1.6).

Se deberá ofrecer capacitación adecuada al personal que lleve a cabo tareas

importantes para la implementación efectiva del Sistema SQF y para el mantenimiento
de la inocuidad alimentaria y de los requisitos regulatorios.
Programa de capacitación (obligatorio)
Deberá documentarse e implementarse un programa de capacitación que, como mínimo,
describa las competencias necesarias para tareas específicas y los métodos de
capacitación que se aplicarán al personal que lleva a cabo tareas asociadas con:
i. El desarrollo y mantenimiento de planes de inocuidad alimentaria para alcanzar
requisitos regulatorios y el Código SQF.
ii. Procedimientos de monitoreo y medidas correctivas para todo el personal involucrado
en el monitoreo de puntos críticos de control (PCC).
iii. Higiene personal para todo el personal involucrado en la manipulación de productos
alimenticios y superficies en contacto con alimentos.
iv. Buenas prácticas de almacenamiento y distribución e instrucciones de trabajo para
todo el personal involucrado en la manipulación de alimentos, el almacenamiento de
alimentos y transporte, y el equipo asociado.
v. Gestión de alérgenos, defensa alimentaria y fraude alimentario para todo el personal
pertinente.
viii. Tareas identificadas como críticas para cumplir con la implementación y el
mantenimiento efectivos del Código SQF.
El programa de capacitación deberá incluir una previsión para identificar e implementar
las necesidades de capacitación de la organización.

Los materiales de capacitación, el desarrollo de la capacitación y los procedimientos

sobre todas las tareas críticas para cumplir con el cumplimiento normativo y el
mantenimiento de la inocuidad de los alimentos se proporcionarán en idiomas que el
personal comprenda.

Los registros de capacitación se mantendrán e incluirán:

i. Nombre del participante.
ii. Descripción de destrezas.
iii. Descripción de la capacitación brindada.
iv. Fecha de terminación de la capacitación.
v. Capacitador o proveedor de capacitación y
vi. Verificación que el aprendiz es competente para completar las tareas requeridas.
del Almacenamiento y Distr
Primary Response
Distribución, Edición 9
Evidence
Supplier Onsite Correction/ Corrective Action
Need to identify a back-up practioner.
 Clause
12.1
12.1.1
12.1.1.1

12.1.2

12.1.2.1

12.1.2.2

12.1.2.3

12.1.2.4

12.1.2.5

12.1.2.6

12.1.2.7

12.1.3
12.1.3.1
12.1.3.2

12.1.3.3

12.1.4
12.1.4.1

12.1.4.2

12.1.5
12.1.5.1
12.1.5.2

12.1.6
12.1.6.1

12.1.6.2

12.1.6.3

12.1.6.4

12.1.6.5

12.1.6.6

12.1.7
12.1.7.1

12.1.7.2

12.1.7.3

12.2
12.2.1
12.2.1.1

12.2.1.2

12.2.1.3

12.2.1.4

12.2.1.5

12.2.1.6

12.2.1.7

12.2.1.8

12.2.2
12.2.2.1

12.2.2.2

12.2.2.3

12.2.3
12.2.3.1

12.2.3.2

12.2.3.3

12.2.3.4

12.2.3.5

12.2.4
12.2.4.1
12.2.4.2

12.2.4.3

12.2.4.4

12.2.4.5
12.2.4.6
12.2.5
12.2.5.1

12.2.5.2
12.2.5.3

12.2.5.4
12.2.5.5

12.2.5.6

12.2.5.7
12.2.5.8

12.3
12.3.1
12.3.1.1

12.3.1.2

12.3.1.3

12.3.2
12.3.2.1

12.3.2.2
12.3.2.3

12.3.2.4

12.3.2.5
12.3.3

12.3.3.1

12.3.3.2

12.3.3.3

12.3.3.4

12.3.4
12.3.4.1

12.3.4.2

12.3.4.3

12.3.4.4

12.3.4.5

12.3.4.6
12.3.5
12.3.5.1

12.3.5.2

12.3.5.3

12.3.5.4

12.3.5.5

12.3.5.6

12.3.5.7

12.3.5.8

12.4
12.4.1
12.4.1.1
12.4.1.2

12.5
12.5.1
12.5.1.1

12.5.1.2

12.5.1.3

12.5.1.4

12.5.1.5

12.5.1.6

12.5.2
12.5.2.1

12.5.2.2
12.5.2.3

12.5.3
12.5.3.1

12.5.3.2

12.6
12.6.1
12.6.1.1

12.6.1.2
12.6.1.3

12.6.1.4

12.6.1.5

12.6.1.6

12.6.1.7

12.6.2
12.6.2.1

12.6.2.2

12.6.2.3

12.6.2.4

12.6.2.5

12.6.3
12.6.3.1

12.6.4
12.6.4.1

12.6.4.2

12.6.4.3

12.6.4.4

12.6.4.5

12.6.5
12.6.5.1

12.6.5.2
12.6.5.3

12.6.5.4

12.6.5.5

12.6.5.6

12.7
12.7.1
12.7.1.1

12.7.2
12.7.2.1

12.7.2.2

12.7.2.3

12.7.2.4

12.7.2.5

12.7.2.6

12.7.2.1

12.7.2.2
12.7.2.3

12.7.2.4

12.7.2.5

12.7.2.6

12.7.2.7

12.7.2.8

12.7.2.9

12.7.2.10

12.7.3
12.7.3.1

12.7.3.2

12.8
12.8.1
12.8.1.1

12.8.1.2

12.8.1.3

12.8.1.4
12.8.1.5

12.8.1.6

12.8.1.7
 Storage and Distrib
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 on product safety and implement
controls for any identified risks. The assessment shall be reviewed in response
to any changes in the local 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, is impervious to liquid, and easily cleaned.
When drains are present in the warehouse, floors shall be sloped at gradients
suitable to allow for the effective removal of all overflow or wastewater under
normal working conditions.

Drains shall be constructed and located so they can be easily cleaned and do
not present a hazard. Drains if located in storage and handling areas, shall be
kept clean.
Waste trap system shall be located away from any food handling or storage
area or entrance to the premises.
Walls, partitions, ceilings, and doors shall be of durable construction. Internal
surfaces shall have an even and regular surface and be impervious with a
light-colored finish and shall be kept clean (refer to 12.2.5).

Wall-to-wall and wall-to-floor junctions shall be designed to be easily cleaned

and sealed to prevent the accumulation of food debris.

Doors shall be of solid construction. Windows shall be made of shatterproof

glass or similar material, or otherwise protected.
Drop ceilings (where applicable) shall be constructed to enable monitoring for
pest activity, facilitate cleaning, and provide access to utilities.
In warehouses where food products are recouped or exposed, the product
contact surfaces shall be constructed of materials that will not contribute a
food safety risk
Lightings and Light Fittings
Lighting in warehouses where food product is recouped or exposed shall be of
appropriate intensity to enable the staff to carry out their tasks efficiently and
effectively.
Light fittings in areas where food product is recouped or exposed shall be
shatterproof, manufactured with a shatterproof covering or fitted with
protective covers, and recessed into or fitted flush with the ceiling.
Where fixtures cannot be recessed, structures must be protected from
accidental breakage, manufactured from cleanable materials, and addressed
in the cleaning and sanitation program.
Light fittings in other areas of the warehouse where product is covered or
otherwise protected shall be designed to prevent breakage and product
contamination.
Dust, Insect, and Pest Proofing
All external windows, ventilation openings, doors, and other openings shall be
effectively sealed when closed and proofed against dust, insects, birds, and
other pests.

External personnel access doors shall be provided. They shall be effectively

insect-proofed and fitted with a self-closing device and proper seals to protect
against
Electric entry
insectof dust, birds,
control andpheromone,
devices, other pests.or other traps and baits shall be
located and operate so as not to present a contamination risk to the product,
packaging, containers, or processing equipment. Poison rodenticide bait shall
not be used inside ingredient of product storage areas where ingredients,
packaging, and product are handled, processed, or exposed.
Ventilation
Adequate ventilation shall be provided in enclosed storage and food handling
areas.
All ventilation equipment and devices in product storage and handling areas
shall be adequately cleaned as per 12.2.5 and effectively sealed against dust,
insects, and other pests as per 12.1.4.
Equipment and Utensils
Specifications for equipment and utensils and procedures for purchasing
equipment shall be documented and implemented.
Equipment and utensils shall be designed, constructed, installed, operated,
and maintained to meet any applicable regulatory requirements and not pose
a contamination threat to products.
Equipment storage rooms shall be designed and constructed to allow for the
hygienic and efficient storage of equipment and containers. Where possible,
food contact equipment shall be segregated from non-food contact
equipment.
All equipment and utensils shall be cleaned (refer to 12.2.5.1) at a frequency
to control contamination and stored in a clean and serviceable condition to
prevent microbiological or cross-contact allergen contamination.
Vehicles used in handling areas or in cold storage rooms shall be designed,
cleaned, and operated so as not to present a food safety hazard.
In addition to the above, locations handling exposed products and recouping
products on-site shall have:
i. Product contact equipment and utensils constructed of materials that are
non-toxic, smooth, impervious and readily cleaned as per 12.2.5;
ii. Clearly identified equipment and utensils that are used for inedible
material; and
iii. Clearly identified waste and overflow handling equipment and utensils.
The waste material is discharged hygienically and according to local
regulatory requirements.
Grounds and Roadways
The grounds and area surrounding the premises shall be maintained to
minimize dust and kept free of waste or accumulated debris so as not to
attract pests and vermin.
Paths, roadways, and loading and unloading areas shall be maintained so as
not to present a hazard to the food safety operation of the premises.
Surroundings shall be kept neat and tidy and shall not present a hazard to the
hygienic and sanitary operation of the premises or provide harborage for
pests.
Site Operation
Repairs and Maintenance
The methods and responsibility for the maintenance and repair of facility,
equipment, and buildings shall be documented, planned, and implemented in
a manner that minimizes the risk of product, packaging, or equipment
contamination.
The maintenance schedule shall be prepared to cover building, equipment,
and other areas of the premises critical to the maintenance of product safety.
Routine maintenance of plant and equipment in any food handling or storage
area shall be performed according to a maintenance control schedule and
recorded.
Failures of facility and equipment in any food storage and handling area shall
be documented, reviewed, and necessary repair incorporated into the
maintenance control schedule.
Site supervisors shall be notified when maintenance or repairs are to be
undertaken in any food handling or storage area.
The maintenance supervisor and the site supervisor shall be informed if any
repairs or maintenance pose a potential threat to product safety (e.g., pieces
of electrical wire, damaged light fittings, and loose overhead fittings). When
possible, maintenance is to be conducted outside operating times.
Temporary repairs, where required, shall not pose a food safety risk and shall
be included in the cleaning program. There shall be a plan in place to address
completion of temporary repairs to ensure they do not become permanent
solutions.
Equipment located over exposed product shall be lubricated with food grade
lubricants and their use controlled to minimize the contamination of the
product.
Paint used in a food handling or contact zone shall be suitable for use, in good
condition (i.e., no chips), and shall not be used on any product contact
surface.
Maintenance Staff and Contractors
Maintenance staff and contractors shall comply with the site’s personnel and
process hygiene requirements (refer to 12.3).
All maintenance staff and contractors required to work on-site shall be trained
in the site’s food safety and hygiene procedures or shall be escorted at all
times until their work is completed. Records of training shall be documented
and retrievable.
Maintenance staff and contractors shall remove all tools and debris from any
maintenance activity once it has been completed and inform the area
supervisor and maintenance supervisor so that appropriate hygiene and
sanitation can be completed and an inspection conducted prior to restarting
site operations. The inspections shall be documented.
Calibration
The methods and responsibility for calibration and re-calibration of measuring,
testing, and inspection equipment used for monitoring activities outlined in
prerequisite programs, food safety plans, and other process controls, or to
demonstrate compliance with customer specifications, shall be documented
and implemented. Software used for such activities shall be validated and
Equipment shall be calibrated against national or international reference
standards and methods or to an accuracy appropriate to its use. In cases
where standards are not available, the site shall provide evidence to support
the calibration reference method applied. A list of measuring, testing, and
inspection equipment requiring calibration shall be maintained.
Calibration shall be performed according to regulatory requirements and/or to
the equipment manufacturers’ recommended schedule.
Procedures shall be documented and implemented to address the disposition
of potentially affected products should measuring, testing, and inspection
equipment be found to be out of calibration state.
A directory of measuring, testing, and inspection equipment requiring
calibration and records of calibration tests shall be 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 prevention program;
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 on a site map the identification, location, number, and type of
applied pest control/ monitoring devices;
vii. List the chemicals used. They are required to be approved by the relevant
authority and their Safety Data Sheets (SDS) made available;
viii. Outline the methods used to make staff aware of the bait control
program and the measures required when they come into contact with a bait
station;
ix. Outline the requirements for staff awareness and training in the use of
pest and vermin control chemicals and baits; and
x. Measure the effectiveness of the program to verify the elimination of
applicable pests and identify trends.
Pest contractors and/or internal pest controllers shall:
i. Be licensed and approved by the local relevant authority;
ii. Use only trained and qualified operators who comply with regulatory
requirements;
iii. Use only approved chemicals;
iv. Provide a pest prevention plan (refer to 12.2.4.1), which includes a site
map indicating the location of bait stations traps and other applicable pest
control/monitoring devices;
v. Report to a responsible authorized person on entering the premises and
after the completion of inspections or treatments;
vi. Provide regular inspections for pest activity with appropriate action taken
if pests are present, and
vii. Provide a written report of their findings and the inspections and
treatments applied.
Pest activity risks shall be analyzed and recorded. Inspections for pest activity
shall be undertaken on a regular basis by trained site personnel and the
appropriate action taken if pests are present. Identified pest activity shall not
present a risk of contamination to food 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 disposed of and the source of pest
infestation investigated and resolved. Records shall be kept of the disposal,
investigation, and resolution.
Pesticides shall be clearly labeled and stored per 12.6.4 if kept on-site.
No animals shall be permitted on-site in food handling or storage areas.
Cleaning and Sanitation
The methods and responsibility for the effective cleaning of the food storage
and handling areas, staff amenities, and toilet facilities 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 cleaning;
v. Validation of cleaning procedures;
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 and storage and
handling environment, labeled according to regulatory 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 chemicals purchased and used is maintained;
iii. Detergents and sanitizers are stored as outlined in element 12.6.4;
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 manufacturers’ instructions, stored in containers that are
suitable for use, and clearly identified. Mix concentrations shall be verified
and records maintained.
Provision shall be made for the effective cleaning of equipment, utensils, and
protective clothing. tools, racks, and other items used in support of the
Cleaning equipment,
cleaning and sanitizing program shall be clearly identified, stored, and
maintained in a manner that prevents contamination of processing, product
handling equipment, and storage areas as well as the tools themselves.
Staff amenities, sanitary facilities, and other essential areas shall be
inspected by qualified personnel to ensure the areas are clean and at a
defined frequency.
Records of cleaning and sanitation activities, verification, and inspections
shall
Staff be maintained.
amenities, sanitary facilities, and other essential areas shall be
inspected by qualified personnel at a defined frequency to ensure the areas
are clean.
Personnel Hygiene and Welfare
Personnel Welfare
Personnel suffering from infectious diseases or who are carriers of any
infectious disease shall be restricted from working on the site or in the
transportation of food and shall not engage in food handling operations or be
permitted access to storage areas where the product is exposed or there is a
risk of contamination of food.
The site shall have measures in place to prevent contact of materials,
ingredients, food packaging, food, or food contact surfaces from any bodily
fluids from open wounds, coughing, sneezing, spitting, or any other means.

In the event of an injury that causes spillage of bodily fluid, a properly trained
staff member shall ensure that all affected areas, including handling and
storage areas, have been adequately cleaned and that all materials and
products have been quarantined and/or disposed of.
Personnel with exposed cuts, sores, or lesions shall not engage in handling
exposed products, recoup, repack or processing products, or handling primary
packaging or food contact surfaces. Minor cuts or abrasions on exposed parts
of the body shall be covered with a protective bandage or alternative suitable
dressing. A colored bandage or alternative suitable waterproof and colored
dressing is recommended for handling exposed products, recoup, or repack
processes.
Handwashing
All personnel shall have clean hands and hands shall be washed by all staff,
contractors, and visitors:
i. On entering food handling, storage, and processing areas;
ii. After each visit to a toilet;
iii. After using a handkerchief;
iv. After smoking, eating, or drinking; and
v. After sneezing or coughing.
Handwash stations shall be available and accessible as required.
Handwash stations shall be constructed of stainless steel or similar non-
corrosive material and at a minimum supplied with:
i. A potable water supply at an appropriate temperature;
ii. Liquid soap;
iii. Paper towels; and
iv. A means of containing used paper towels.

An effective hand dryer may be used in instances where there is no direct

hand contact of food or food contact surfaces.

Signage in appropriate languages instructing people to wash their hands shall

be provided in a prominent position.
When gloves are used, personnel shall maintain the handwashing practices
outlined
Clothingabove.
and Personal Effects

Clothing worn by staff engaged in handling food shall be maintained, stored,

laundered, and worn so as not to present a contamination risk to products.
Clothing, including shoes, shall be clean at the commencement of each shift
and maintained in a serviceable condition.
Protective clothing shall be manufactured from material that will not pose a
food safety threat and is easily cleaned.
Jewelry and other loose objects shall not be worn or taken into a food handling
or processing operation or any area where food is exposed. The wearing of
plain bands with no stones, prescribed medical alert bracelets, or jewelry
accepted for religious or cultural reasons can be permitted, provided it is
properly covered and does not pose a food safety risk.

All exceptions shall meet regulatory and customer requirements and shall be
subject to a risk assessment and evidence of ongoing risk management.
Visitors
All visitors shall be required to comply with all Good Storage and Distribution
Practices and hygiene standards required by the site, including those applying
to clothing and personal effects, hand-washing, and illness (refer to 12.3.1,
12.3.2 and 12.3.3).
All visitors, including management staff, shall wear suitable clothing and
footwear when entering any food storage and handling area.
Visitors exhibiting visible signs of illness shall be prevented from entering
areas in which food is handled or processed (refer to 12.3.1).
Visitors shall enter and exit food handling areas through the proper staff
entrance points and comply with all handwashing and personnel practice
requirements.
All visitors shall be trained in the site’s food safety and hygiene procedures
before entering any food processing or handling areas or shall be escorted at
all times in food handling and storage areas.
The site shall have a documented procedure for how driver access is
managed to minimize food safety risk and designated driver areas are
maintained to prevent food contamination or other food safety risks.
Staff Amenities (change rooms, toilets, break rooms)
Staff amenities shall have documented cleaning procedures, be supplied with
appropriate lighting and ventilation, and shall be made available for the use of
all persons engaged in the handling and processing of product.
Provision shall be made for staff to store their street clothing and personal
items separate from food contact zones and food storage areas.
Toilet rooms shall be:
i. Designed and constructed so that they are accessible to staff and separate
from any food handling operations;
ii. Accessed from the warehouse or food handling 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; and
v. Kept clean and tidy.

Sanitary drainage shall not be connected to any other drains within the
premises and shall be directed to a septic tank or a sewerage system.
Procedure shall be documented and implemented to properly manage sewage
back-ups to minimize the potential for contamination.
Handwash basins shall be provided immediately outside or inside the toilet
room and designed as outlined in 12.3.2.2.
Separate break room facilities shall be provided away from a food handling or
storage areas. Break rooms shall be kept clean and tidy and free from waste
materials and pests.
Where outside eating areas are provided, they shall be kept clean and free
from waste materials and maintained in a manner that minimizes the
potential for introduction of contamination including pests to the site.
Signage in languages understood by staff advising people to wash their hands
before entering the food storage areas shall be provided in a prominent
position in break rooms and break room exits.
Personnel Processing Practices
Staff Engaged in Food Storage and Repack/ Recoup Operations
All personnel shall comply with the following practices:
i. Personnel entry to food handling areas shall be through the personnel
access doors only;
ii. All doors are to be kept closed. Doors shall not be left open for extended
periods when access is required for waste removal or stock transfer;
iii. The wearing of false fingernails or fingernail polish is not permitted when
handling exposed food;
iv. Materials and products shall be kept in appropriate containers as required
and off the floor;
v. Waste shall be contained in the bins identified for this purpose and
removed from the operational area on a regular basis and not left to
accumulate;
vi. Staff shall not eat or taste any product in the food storage or handling
area;
vii. Smoking, chewing, eating, or spitting is not permitted in any food handling
or storage areas; and
All personnel engaged in storage, transport, and handling of packaged
products and materials shall ensure that products and materials are handled
and stored in such a way as to prevent damage or product contamination.
Water, Ice, and Air Supply
Water Supply
Adequate supplies of water drawn from a known clean source shall be
provided for use during holding, storage and cleaning of the premises and
equipment.
Contingency plans shall be in place for instances when the potable water
supply is deemed to be contaminated or otherwise inappropriate for use.
Supplies of hot and cold water shall be provided as required to enable the
effective cleaning of the premises and equipment.
The delivery of water within the premises shall ensure potable water is not
contaminated. Testing of the backflow system, where 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 back flow or back siphonage.
Where water is stored on-site, storage facilities shall be adequately designed,
constructed, and routinely cleaned to prevent contamination.
Water and Ice Quality
Microbiological analysis of the water and ice supply that comes into contact
with food or food contact surfaces shall be conducted to verify the cleanliness
of the supply, the monitoring activities, and the effectiveness of the treatment
measures implemented. Verification, at minimum, shall be made
annually.Water treatment equipment shall be monitored regularly to ensure it
Water and ice shall be analyzed using reference standards and methods.
Ice rooms and receptacles shall be constructed of materials as outlined in
elements 12.1.2 and designed to minimize contamination of the ice during
storage and distribution.
Air and Other Gases
Compressed air or other gases (e.g. nitrogen, carbon dioxide) that contact
food or food contact surfaces shall be clean and present no risk to food safety.
Compressed air systems and systems used to store or dispense other gases
used in food storage and distribution process shall be maintained and
regularly monitored for quality and applicable food safety hazards.
Receipt, Storage, and Transport
Receipt, Storage and Handling of Goods
The site shall implement an effective storage plan that allows for the safe,
hygienic storage of ice, food products (frozen, chilled, and ambient),
packaging, equipment, and chemicals.
Dry food products shall be received and stored in a way to prevent cross-
contamination with frozen and chilled products.
The responsibility and methods for ensuring effective stock rotation principles
are applied shall be documented and implemented.
Procedures shall be in place to ensure that all food products and recouped
products are utilized within their designated shelf life.
Where goods are held under temporary or overflow conditions that are not
designed for the safe storage of goods, a risk analysis shall be undertaken to
ensure there is no risk to the integrity of those goods, or contamination, or
adverse effects on food safety.
Records shall be available to verify alternate or temporary control measures
for storage of raw materials, ingredients, packaging, equipment, chemicals, or
finished products.
Racks provided for the storage of food products shall be constructed of
impervious materials and designed to enable cleaning of the floors and the
storage room. Storage areas shall be cleaned at a predetermined frequency.
Cold Storage, Freezing and Chilling of Foods
The site shall provide confirmation of the effective operational performance of
freezing, chilling, and cold storage facilities. Chillers, blast freezers, and cold
storage rooms shall be designed and constructed to allow for the hygienic and
efficient refrigeration of food and shall be easily accessible for inspection and
cleaning.
Sufficient refrigeration capacity shall be available to store chilled or frozen
food at the maximum anticipated throughput of product with allowance for
periodic cleaning of refrigerated areas.
Discharge from defrost and condensate lines shall be controlled and
discharged to the drainage system.
The site shall have a written procedure for monitoring temperatures of
storage rooms, including the frequency of checks, and corrective actions if the
temperature is out of specification. Cold and chilled storage rooms shall be
fitted with temperature monitoring equipment, located to monitor the
warmest part of the room, and be fitted with a temperature measurement
device that is easily readable and accessible. Records shall be kept of frozen,
cold, and chilled
Procedures shall storage room
be in place to temperatures.
identify the methods and responsibilities used
to ensure that processes applied to materials prior to distribution (e.g.
thawing, slacking, labeling) do not pose a risk to product safety or loss of
traceability.
Storage of Dry Goods
Dry goods shall be located away from wet areas to protect the product from
contamination and deterioration and to prevent packaging from becoming a
harborage for pests or vermin.
Storage of Hazardous Chemicals and Toxic Substances Used On-site
Hazardous chemicals, toxic substances, and pesticides that are for use on the
site with the potential for food contamination shall be:
i. Used only according to manufacturers’ instructions;
ii. Controlled to prevent contamination or a food safety hazard to raw
material, packaging, work-in-progress, finished product, or product contact
surfaces;
iii. Included in a current register of all hazardous chemicals and toxic
substances that are stored on-site;
iv. Supplemented with a current Safety Data Sheet (SDS) made available to
all staff;
v. Controlled to track usage and ensure return to the appropriate storage
areas after use;
vi. Be compliant with national and local legislation; and
vii. Used so that there is no cross-contamination between chemicals.
Hazardous chemicals and toxic substances shall be stored:
i. In an area with appropriate signage;
ii. Accessible only by personnel trained in the storage and use of chemicals;
iii. Separated from the distribution storage area so as not to present a hazard
to staff, product, packaging, or product handling equipment;
iv. In their original containers, or in clearly labeled secondary containers if
allowed by applicable legislation; and
v. Stored so that there is no cross-contamination between chemicals.

Personnel who handle hazardous chemicals and toxic substances, including

pesticides and cleaning chemicals:
i. Shall be fully trained in their purpose, storage, handling, and use;
ii. Be provided first aid equipment and personnel protective equipment; and
iii. Ensure compliance with the proper identification, storage, usage, disposal,
and clean-up requirements.

The site shall dispose of unused chemicals and empty containers in

accordance with regulatory requirements and ensure that:
i. Empty chemical containers are not reused;
ii. Empty containers are labeled, isolated, and securely stored while awaiting
collection; and
iii. Unused and obsolete chemicals are stored under secure conditions while
waiting authorized disposal by an approved vendor.
In the event of a hazardous spill, the site shall:
i. Have spillage clean-up instructions to ensure that the spill is properly
contained; and
ii. Be equipped with spillage kits and cleaning equipment.
Loading, Transport, and Staging Practices
The practices applied during loading, transport, and unloading of food
products and materials shall be documented, implemented, and designed to
maintain appropriate storage conditions and product integrity. Practices shall
protect against contamination from biological, chemical, and physical
hazards, and under conditions that prevent cross-contamination.
Sites shall have a procedure in place that is documented and implemented to
ensure trailers are inspected prior to receiving shipments or loading to ensure
that the trailer is in good repair, clean, secured and at the required
environmental condition and temperature.
Vehicles (e.g. trucks/vans/containers) used for transporting food shall be
inspected prior to loading to ensure they are clean, in good repair, suitable for
the purpose, and free from odors or other conditions that may impact
negatively on the product.
Receiving, staging, loading, and unloading practices shall be designed to
minimize unnecessary exposure of the product to conditions detrimental to
maintaining product integrity.
Where applicable, food transport vehicles’ refrigeration units shall maintain
the food at the required temperatures and the units’ temperature settings
shall be set, checked, and recorded before loading and product temperatures
monitored at regular intervals during loading as appropriate.

The refrigeration units shall be operational at all times and checks shall be
completed of the units’ operation, the door seals, and the storage
temperature at regular intervals during transit.
Upon arrival and prior to opening the doors, the food transport vehicles’
refrigeration unit storage temperature settings and operating temperature
shall be checked and recorded. Receiving shall be completed efficiently and
product temperatures shall be recorded at the commencement of unloading
and at regular intervals during unloading.
Separation of Functions
Process Flow
The process flow shall be designed to prevent cross-contamination and
organized so there is a continuous flow of product through the process. The
flow of personnel shall be managed such that the potential for contamination
is minimized.
Control of Foreign Matter Contamination
The responsibility and methods used to prevent foreign matter contamination
of the product shall be documented, implemented, and communicated to all
staff.
Inspections shall be performed to ensure plant and equipment remains in
good condition and potential contaminants have not been detached or
become damaged or deteriorated.
Containers, equipment, and other utensils made of glass, porcelain, ceramics,
laboratory glassware, or other like material (except where product is
contained in packaging made from these materials, or measurement
instruments with glass dial covers, or MIG thermometers required under
regulation) shall not be permitted in food processing/contact zones.
Where glass objects or similar material are required to be used by the site in
storage and handling areas, they shall be listed in a glass inventory including
details of their location.
Product that is in glass or similar material that is for distribution purposes
shall be stored and handled in a manner that prevents contamination.
Regular inspections of storage and handling zones shall be conducted (refer
to 2.5.4.3) to ensure they are free of glass or other like material and to
establish changes to the condition of the objects listed in the glass inventory.
The responsibility and methods used to prevent foreign matter contamination
of the product shall be documented, implemented, and communicated to all
staff.
Inspections shall be performed to ensure plant and equipment remains in
good condition and potential contaminants have not been detached or
become damaged or deteriorated.
Containers, equipment, and other utensils made of glass, porcelain, ceramics,
laboratory glassware, or other like material (except where product is
contained in packaging made from these materials, or measurement
instruments with glass dial covers, or MIG thermometers required under
regulation) shall not be permitted in food processing/contact zones.
Where glass objects or similar material are required to be used by the site in
storage and handling areas, they shall be listed in a glass inventory including
details of their location.
Product that is in glass or similar material that is for distribution purposes
shall be stored and handled in a manner that prevents contamination.
Regular inspections of storage and handling zones shall be conducted (refer
to 2.5.4.3) to ensure they are free of glass or other like material and to
establish changes to the condition of the objects listed in the glass inventory.
Glass instrument dial covers on equipment and MIG thermometers shall be
inspected at regular intervals.
Pallets used in food storage shall be made of a suitable material, dedicated
for that purpose, clean, maintained in good order, and their condition subject
to regular inspection.
Wooden pallets and other wooden utensils used in food handling areas shall
be dedicated for that purpose, clean, and 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 affixed so as not to present a hazard.
Managing Foreign Matter Contamination Incidents
In all cases of foreign matter contamination the affected food product shall be
isolated, inspected, reworked, or disposed of.
In circumstances where glass or similar material breakage occurs, the
affected area shall be isolated, cleaned, and thoroughly inspected (including
cleaning equipment and footwear) and cleared by a suitably responsible
person.

Waste Disposal
Waste Disposal
The responsibility and methods used to collect and handle dry, wet, and liquid
waste and store it prior to removal from the premises shall be documented
and implemented.
Waste shall be removed on a regular basis and not allowed to build up in food
handling or storage areas. Designated waste accumulation areas shall be
maintained in a clean and tidy condition until external waste collection is
undertaken.

Trolleys, vehicles, waste disposal equipment, collection bins, and storage

areas shall be maintained in a serviceable condition and cleaned and
sanitized regularly so as not to attract pests and other vermin.
Where applicable, a documented procedure shall be in place for the controlled
disposal of trademarked materials. Where a contracted disposal service is
used, the disposal process shall be reviewed regularly 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 or further processing. If denaturant is
used to identify inedible waste, it shall be demonstrated that it does not pose
a risk to animal health.
Reviews of the effectiveness of waste management will form part of regular
hygiene inspections and the results of these inspections shall be included in
the relevant hygiene reports (refer to 2.5.4.3).
A procedure shall be in place to ensure drainage wastewater is effectively
removed from the storage areas (refer to 12.1.2.2). If stored and/or treated on
the premises, it shall be stored in a separate storage facility and suitably
contained. Inspections of the drainage system and wastewater storage shall
be included in the regular site inspections (refer to 2.5.4.3).
Distribution Edition 9 Check
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Primary Response Evidence Supplier Onsite Correction