General Standard Requirements For Manufacturing Facilities

Global Quality and Food Safety
STANDARD
REQUIREMENTS FOR MANUFACTURING
FACILITIES
FIRST EDITION
ISSUE DATE: 11/12/16

SUPERSEDES: NEW
REVIEWED: N/A Page 1 of 59
CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

This standard set of requirements is intended for those manufacturing facilities producing finished
products for or on behalf of Kellogg and has been assessed to be able to produce at the General
Manufacturing Standards.
The requirements set out in this document shall be met in full. The manufacturing facility will be
audited against these requirements and will be initially approved or disapproved.


SUPERSEDES: NEW

Contents
1. Facility Leadership and Management Commitment

1.1. Regulatory Requirements
1.2. Facility Leadership of Quality and Food Safety Objectives
1.3. Continuous Improvement of Quality and Food Safety
1.4. Organizational Structure and Quality/Food Safety Authority
1.5. Recall Plan
2. Food Safety Plan

2.1. Food Safety/HACCP Team Competency
2.2. Prerequisite Program Effectiveness
2.3. Hazard Analysis and Risk Assessment
2.4. Critical Control Points (CCPs)/Critical Limits
2.5. Monitoring System
2.6. Corrective Action Plan
2.7. Verification Programs
2.8. Documentation
2.9. Review and Validation of Plan
2.10. Food Safety Plan/HACCP Reassessment
3. Quality and Food Safety Management System

3.1. Quality and Food Safety Change Management Process
3.2. Implementation of Quality and Food Safety Policies and Procedures
3.3. Quality and Food Safety Management System Verification - Internal Audit
4. Quality and Food Safety Standards/Programs

4.1. Documentation Control, Record Completion, Maintenance and Retention
4.2. Supplier Management
4.3. Facility Building and Grounds
4.4. Equipment Layout and Hygienic Design Standards
4.5. Utilities and Waste Management
4.6. Housekeeping and Sanitation
4.7. Pest Control
4.8. Facility Security
4.9. Storage and Transportation
4.10. Allergen Management
4.11. Good Manufacturing Practices

SUPERSEDES: NEW

4.12. Product Protection
4.13. Maintenance Programs
4.14. Training
4.15. Regulatory Inspections
4.16. Complaints Management
4.17. Traceability
4.18. Incident Management
4.19. Corrective Action and Preventive Action Programs
5. Product Control
5.1. Product Labeling
5.2. Assured Product Status
5.3. Product Packaging
5.4. Product Hold and Release
5.5. Product Inspection and Laboratory Testing
5.6. Environmental Monitoring Program
5.7. Response to Food Safety Events/Incidents
6. Process Control
6.1. Control of Operations
6.2. Calibration of Measuring and Monitoring Equipment
6.3. Product Image Standards
7. Notification Requirements
8. Exemptions for Facilities Contract Packing Kellogg Fully Sealed Products Only

SUPERSEDES: NEW

1. Facility Leadership and Management Commitment
Statement of Intent
The facility’s senior leadership team shall be able to demonstrate they are committed to the
implementation of the requirements of the quality and food safety policies and to processes
and programs, which facilitate the continual improvement of quality and food safety
management.
1.1. Regulatory Requirements
Regulatory Requirements
The facility shall understand and be fully compliant with the standards of the region where the
food is produced and the target market(s)’ regulatory requirements.
The facility senior management shall provide the human and financial resources required to
produce food safely and in compliance with the requirements of this standard.

Elements:
 The facility’s senior management shall have a system in place to ensure that the site is
kept informed of and reviews relevant food safety legislation applicable to the
production site and as applicable in the country where the product is intended for sale.
 The facility’s senior leadership team shall commit to meet the local and target market(s)’
regulatory requirements.
 A notification contact tree shall be established and documented as followed for a
regulatory inspection, including contacting the designated Kellogg Company
representative.
1.2. Facility Leadership of Quality and Food Safety Objectives

SUPERSEDES: NEW

Leadership Goals
Facility leadership goals shall ensure that clear objectives are defined to maintain and improve
quality and food safety programs. The objectives and goals shall be documented and include
targets or clear measures of success, be clearly communicated to all relevant staff, and be
monitored.

Elements:
 Senior management shall set objectives concerning food safety and quality, which help
to achieve the overall compliance of the food safety and quality policies.
 The objectives shall be communicated to the relevant staff, so that they understand
what is required from them.
1.3. Continuous Improvement of Quality and Food Safety
Quality and Food Safety Communication

A communication process exists to ensure all relevant quality and food safety policies are
communicated effectively and are accessible throughout the facility.
Elements:
 There shall be a process established to ensure that all employees are made aware of all
relevant quality and food safety policies and procedures pertinent to their specific role.
 The process shall ensure that any changes are effectively communicated.
 The process shall record the acceptance/understanding of the communication.

SUPERSEDES: NEW

Leadership Review
The facility senior leadership team shall meet to review the performance of the facility’s
quality and food safety programs. The leadership review shall include at a minimum:
- Action plans and completion timeframes.

- Internal audit results.
- External audit results.
- Complaints.
- HACCP management review.
Any actions/decisions agreed shall be implemented within the agreed timeframes.
The facility shall have a demonstrated meeting schedule which enables food safety, regulatory,
and quality issues to be escalated to the senior leadership team and a process is in place to
ensure that immediate issues requiring resolution are identified
Elements:
 The facility’s senior leadership team is considered to be the managers that have the
authority to make decisions on food safety/quality objectives and provision of the
appropriate resources. This usually includes the facility manager/director and
managers that are responsible for operations, engineering, procurement, human
resources, quality, and food safety.
 The leadership review meeting purpose is to take a systematic overview of the facility’s
food safety and quality systems. The meeting should consider:
o What has been achieved?

o Progress against objectives.
o Identification of targets and areas of improvement to be made.
 The specific agenda items need to be covered at a minimum as demonstrated through

the meeting minutes.
 An expected outcome of the meeting is a review of performance against the objectives
and establishment of actions or appropriate escalation.

SUPERSEDES: NEW

 The outcome of the review meeting shall be communicated to relevant staff to ensure
implementation. This could be through employee briefings and notice boards, as
examples.
 Where timings are given to actions, there shall be a system in place to ensure that they
are followed up on and completed within the timeframe. The system shall be able to
demonstrate that the action has been effective.
 The objective of the management meetings is to enable escalation of issues to the senior
leadership team. Frequency needs to be based on the facility’s management systems in
place.
Quality and Food Safety Corrective Action/Preventative Action (CAPA) Effectiveness

The facility leadership shall ensure that the root causes of identified non-conformances have
been effectively addressed to prevent recurrence.
Elements:
 A formal process shall be established to identify root cause, mitigate immediate risks to
food safety, and determine permanent corrective actions.
 Non-conformities identified shall have been fully and effectively rectified and these will
be checked during the audit.

Continuous Improvement
The facility shall have a system in place that tracks and trends quality and food safety data.
Corrective actions shall be established to address unfavorable trending.
1.4. Organizational Structure and Quality/Food Safety Authority
Quality and Food Safety Organization

The facility shall establish a clear management structure of the facility. The responsibilities for
the management of activities, which ensure food safety, regulatory, and quality are allocated
and understood by the managers responsible.

SUPERSEDES: NEW

Elements:
 The objective is to ensure that the staff has a clear understanding of who has
responsibility for all aspects of the quality and food safety management system and
that the responsible person has the knowledge and ability to fulfill the requirements.
 An organizational chart shall indicate reporting lines for all managers within the
facility. Associated documentation shall clearly indicate the responsibilities of each
relevant member of the staff with responsibility for the management of food safety,
regulatory, or quality.
Quality and Food Safety Supervision

The facility’s senior leadership shall ensure that all employees are aware of their
responsibilities.
All employees, contractors, and visitors shall be made aware of the expectations for reporting
and/or taking the appropriate action in the event of a quality or food safety incident. (See
Section 5.7 for a definition.)
Elements:
 All employees including temporary employees and contractors shall be aware of their
roles and responsibilities with regard to quality and food safety. They shall be able to
communicate the reporting and escalation procedures, including notification to Kellogg.
 Persons that have a specific food safety responsibility within their role (e.g., CCP
monitoring or prerequisite program) shall be able to demonstrate an understanding of
what is expected of them and be able to access the relevant procedure(s).
1.5. Recall Plan
The facility management shall develop and maintain a written plan for management of a
recall. The plan shall ensure that Kellogg Company is notified when impact to Kellogg is
identified.

SUPERSEDES: NEW

Elements:
 Facility management shall be trained in crisis management at least annually and shall
administer notification and recall as appropriate.
 Facility Management shall notify Kellogg Company of any food safety crisis or recall
involving Kellogg food or ingredients provided to Kellogg.
 Notification to Kellogg shall occur prior to initiating action against the product and/or
public/regulatory communication.
 Follow requirements for notification in Section 7 of this document including
communication with the Kellogg Quality Representative.
2. Food Safety Plan
Statement of Intent
The facility shall have a fully implemented and effective food safety plan based on Codex
principles and shall cover every product and process in the facility.
2.1. Food Safety/HACCP Team Competency
The HACCP Plan shall be developed and managed by a multi-disciplinary food safety team.

Elements:
 The HACCP/Food Safety Plan shall be established and maintained by the facility team
with the relevant skills and experience with records of training.
 Team members and their relevant skills and experience shall be available.
 The team leader shall have in-depth food safety knowledge and be able to demonstrate
competency and experience.
 Basic HACCP concept training shall be communicated to new employees and annual
refresher training shall be provided.
 The HACCP plan shall be integrated into the quality and food safety management
system within the facility.

SUPERSEDES: NEW

2.2. Prerequisite Program Effectiveness
Effective operational and environmental controls (prerequisite programs) shall be in place to

produce safe and legal food.
The control measures and monitoring procedures for the prerequisite programs shall be
clearly documented and shall be included within the development and reviews of the HACCP
program.
Elements:
 Each prerequisite program shall have a work process or system to ensure the relevant
activity/procedures are in place and are demonstrated as effective through verification.
 The prerequisite programs shall be monitored to ensure that the program provides the
level of control required.
2.3. Hazard Analysis and Risk Assessment
Product Description
Product profile description or production description shall be incorporated as part of the
HACCP plan.
Elements:
 Intended Use
o The intended use of the product shall be defined, detailing the end user and
suitability for vulnerable groups of the population.
 Process Flow Diagram
o The process flow diagrams shall be signed and dated.

SUPERSEDES: NEW

o The HACCP team shall review and verify the accuracy of the flow diagrams by on
site verification and challenge at least annually. Records of verification of flow
diagrams shall be maintained.
 Ingredient Hazard Analysis
o The HACCP team shall conduct a hazard analysis for all ingredients, additives,
food contact packaging, and processing aids. All potential hazards will be
assessed for significance of risk.
o All relevant information needed to conduct the hazard analysis shall be collected,
maintained, documented, and updated.
 Process Hazard Analysis
o A hazard analysis related to the product, process, and facility shall be conducted
to identify the potential hazards which need to be prevented, eliminated, or
reduced to acceptable levels.
o All relevant information needed to conduct the hazard analysis shall be collected,
maintained, documented, and updated.
 Control Measures
o The HACCP team shall consider the control measures necessary to prevent or
eliminate a food safety hazard or reduce it to an acceptable limit.
2.4. Critical Control Points (CCPs)/Critical Limits
Critical Control Point (CCP) Identification

The critical limits regarding food safety shall include appropriate control procedures,
monitoring procedures, and documentation.
Monitoring shall be documented and standardized to ensure that the product is produced
within the required specification.
Process microbial lethality shall be reviewed with the Kellogg Quality representative to ensure
product meets the required standards for Kellogg foods.

SUPERSEDES: NEW

The facility shall immediately notify the Kellogg representative, if there is a failure in a critical
control point (CCP) (e.g., equipment or processes does not meet the critical limits).
The facility shall demonstrate the ability to manufacture microbiologically safe food in a
manner that meets regulatory standards for the food category.
The facility shall evaluate their process lethality against their internal standards and notify the
Kellogg representative when changes are identified.
For each CCP that has been identified, the appropriate critical limits shall be defined and
validated in order to identify clearly if the process is in or out of control.
Elements:
 For each hazard that requires control, identify the controls that need to be managed as
critical control points (CCPs).
 For each CCP, critical limits shall be established that define necessary food safety
parameters for the processing step. Critical limits shall be:
o Measurable.
o Documented.
o Supported by science.
 The control measures for each CCP shall be validated. Documented evidence shall show
that the control measures selected and critical limits identified are capable of
consistently controlling the hazard to the specified acceptable level.
 Any proposed addition or change in the CCPs to a HACCP plan for Kellogg production
shall be communicated to the assigned Kellogg representative (or Regional
representative) prior to the HACCP team approval.
 All justification shall be documented and retained within the HACCP plan.

SUPERSEDES: NEW

2.5. Monitoring System
Monitoring System
Documented procedures for monitoring shall be developed for all identified controls within the
food safety/HACCP plan.
For each CCP, monitoring procedures shall be established.
Any CCPs shall be effectively implemented.

Elements:
 The monitoring system shall be able to detect loss of control and wherever possible
provide information in time for corrective action to be taken.
 Records associated with the monitoring of each control shall include the date, time, and
result of measurement and shall be signed by the person responsible for the monitoring
and verified, when appropriate by an authorized person.
 Any electronic records shall have evidence that records have been checked and verified.
2.6. Corrective Action Plan
Corrective Action Plan

Pre-determined corrective actions shall be established for each CCP in the event critical limits
are exceeded.

Elements:
 Documentation shall be available to show appropriate actions were taken in the event of
a CCP failure, including holding all affected product and rework, which will be
communicated to the Kellogg Quality representative.
 Any proposed addition or change in the CCPs to a HACCP plan for Kellogg production
shall be communicated to the assigned Kellogg Quality representative prior to the
HACCP team approval.

SUPERSEDES: NEW

2.7. Verification Programs
Verification Programs
Verification procedures shall be established for each CCP.
The operation of the CCP shall be verified to confirm that it is effective.
Elements:
 Verification shall be established to confirm the control and monitoring of CCPs,

including appropriate corrective actions have been applied according to plan. Examples
of verification activities include:
o Internal audits.
o Review and trending of CCP records.
o Review of incidents.

 Documented verification shall be in place.
2.8. Documentation
Documentation
Documentation and record keeping shall be sufficient to enable the site to verify that the
HACCP controls, including controls managed by prerequisite programs are in place and
maintained.
2.9. Review and Validation of Plan
Validation
All critical control points (CCPs) shall be validated as part of the facility’s monitoring system.

SUPERSEDES: NEW

Elements:
 All critical limits shall be validated and revalidation shall occur at the defined frequency
or any time there are changes to the product or process.
 Validation shall be based on scientific evidence, industry standard, or other recognized
standards.
2.10. Food Safety Plan/HACCP Reassessment
Review
The HACCP plan and prerequisite programs shall be reviewed at least annually and prior to
any changes which may affect the food safety of the product.

Elements:
 The facility’s food safety plan/all HACCP plans shall be reviewed/reassessed at a

minimum of once per year.
 Reassessment of critical limits shall occur at least annually. The reassessment may
identify need for completing a revalidation, if changes to the CCPs or critical limits are
required.
 Where lethality is required as a CCP, annual reassessment of the processing controls
(e.g., bed depth, processing time in the kill step, temperature of kill step, etc.), processing
equipment, and process flow shall take place to determine if any changes have occurred.
Should the parameters have changed, lethality determination shall be conducted and
the results provided to the Kellogg representative.
o The assessment shall take place for lethality any time a change to process
controls, process equipment, or process flow occur.
o The Kellogg representative shall be notified, if decreased levels of inactivation are
measured.
 Changes that may affect product safety shall be evaluated in the context of the HACCP
plan before they are introduced and the HACCP plan amended accordingly.

SUPERSEDES: NEW

3. Quality and Food Safety Management System
Statement of Intent
The facility shall ensure that they have processes and procedures in place to meet the
requirements. The processes and procedures shall be documented to enable consistent
application, facilitate training, and support due diligence.
3.1. Quality and Food Safety Change Management Process
Quality and Food Safety Policy Changes

The facility shall have a documented process for the communication, training, implementation,
and verification of any changes to quality and food safety documents.
3.2. Implementation of Quality and Food Safety Policies and Procedures
Quality and Food Safety Manual

The facility shall have documented procedures, and practices, collated in a printed or
electronic quality/food safety manual.
The quality and food safety manual shall be fully implemented and be readily available to all
relevant staff.
3.3. Quality and Food Safety Management System Verification - Internal Audit
Statement of Intent
The facility shall verify effective application of the quality and food safety plan.

SUPERSEDES: NEW

Internal Audit
The HACCP program and associated prerequisite programs shall be covered by the facility’s
scheduled internal audits.
Appropriately trained and competent personnel shall conduct facility internal audits.
Facility audit results shall be reported to the personnel responsible for the activity audited.
Corrective actions and timescales for their implementation shall be agreed and completion of
the actions verified.
Elements:
 The scope of internal audits shall ensure all aspects of the quality and food safety
system, including the HACCP program, prerequisite programs, policies, and hygiene
practices are assessed.
 The facility shall establish and maintain a schedule of internal audits.
 Facility internal auditors shall be independent of the process or system being audited.
Internal Inspections
There shall be a program of documented inspections to ensure the factory environment and
processing equipment is maintained in a suitable condition for food production.
Elements:
 These inspections shall include:
o Sanitation inspections to assess housekeeping and cleaning performance.

o Equipment and infrastructure inspections to identify risks to the product from
the building or equipment.
o Frequency of these inspections shall be based on risk, but will be no less than once
per month in open product areas.
4. Quality and Food Safety Standards/Programs

SUPERSEDES: NEW

4.1. Documentation Control, Record Completion, Maintenance and Retention
Document Control
The facility shall have an effective document control system to ensure that only the correct
versions of documents (including forms) are available and in use.
The facility shall have a procedure to manage documents.
Controlled documents shall ensure confidentiality by being housed and organized in a secure
environment and maintained as trade secret or confidential as required in the region.
Documents shall be reviewed for accuracy and relevance to the quality and food safety
management system at least annually.
Elements:
 All documents in use need to be properly authorized and shall be the correct version.
o System for the management and replacement of existing documents when they
are updated.
 Any requests for Kellogg information from non-Kellogg entities shall be approved in
writing from Kellogg Legal prior to distributing the information.
Record Completion
All records shall be legible, signed, and dated by those undertaking monitoring activities that
demonstrate that the activities have been verified as completed. Initials are acceptable
provided that a master sheet is provided to identify an initial to a signature.
Elements:

SUPERSEDES: NEW

 Records shall be maintained in an appropriate way to ensure they demonstrate control
of systems and operation.
 Records shall be appropriately authorized. This may include initials/signature of the
operator or supervisor verifying the records.
 Any alteration to records needs to be justified and authorized.
 Records shall be created in a manner that they accurately transmit the intended
information (i.e., they can be read by others).
Record Retention
Records shall be retained for a time period of a maximum of 2 years in compliance with
document retention schedules and in accordance with regional/regulatory requirements. Any
variation to record retention periods shall be approved by Kellogg Quality and Legal.
4.2. Supplier Management
Raw Material, Packaging and Services Approval Program

The facility shall have a documented procedure for the acceptance of their suppliers, raw
materials, packaging, and services.
COAs for incoming raw materials shall be reviewed and approved against the specification for
the material. Out of standard (OOS) materials shall be prevented from entry into the system,
communicated, and appropriate holds deployed.
Elements:
 The facility shall maintain an up-to-date list of approved suppliers based on the
outcome of the supplier approval process.
 A defined material approval process shall be in place and documented including:
o The facility shall meet all regional regulatory (i.e., FSMA for US markets) and
destination market for ingredient and supplier manufacturing facility approval.
o Prerequisite programs including, but not limited to:

SUPERSEDES: NEW

 Physical hazard protection.
 Hygienic zoning.
 Sanitation.
 Good manufacturing practices.
 Pathogen environmental monitoring.
 Chemical control.
 Allergen control.
 Pest control.
 The supplier or contract manufacturer shall have a risk based assessment to drive the
frequency of a confirmation audit for their suppliers. The risk shall be assessed against
the material provider’s adherence to Quality and Food Safety requirements, regulatory
history, and the inherent material risk.
 Contracted services shall have clearly defined service expectations and ensure potential
food safety risks with the service has been addressed, including as appropriate: pest
control, laundry services, contracted cleaning, off-site storage, lab testing, catering,
equipment service and maintenance, transportation, and distribution.
 Contracts or formal agreements shall exist with the suppliers of services.
 An ongoing procedure for the approval and monitoring of suppliers and services shall
be followed to ensure that these suppliers are capable of providing the services/goods to
the required standard. Records shall be maintained to demonstrate approval status.
 Raw material and packaging acceptance shall include a documented procedure, which
requires monitoring and nonconformances recorded. The procedure shall document the
action to be taken if any material is found to be nonconforming.
 Bulk transport of ingredients shall have appropriate seals, be accompanied by a wash ticket,
and handled to maintain dietary status (e.g., kosher, organic, non-GMO, halal, etc.), where
applicable. Vehicles used for the transport of food ingredients shall not be used for the
transportation of non-food grade material.
Specifications
The facility shall ensure that they have access to specifications for raw materials including
packaging, finished products, and any product or service that could affect the integrity of the
finished product.
Manufacturing instructions and process specifications shall comply with recipes and quality
criteria.

SUPERSEDES: NEW

Elements:

Raw Material and Packaging Specifications
 Specifications for all materials shall be available. They shall include the defined limits
for all critical parameters relating to quality, food safety, and regulatory of the product.
 Source materials shall be appropriate to supply Kellogg Company with image/specified
materials.
Finished Product Specifications

 Specifications shall be in place detailing finished products.
4.3. Facility Building and Grounds
External Standards
The production facility shall be designed to reduce the risk of contamination or pest activity
and facilitate the production of safe finished product.
The external areas shall be maintained in good order.
Elements:
 Yards and grounds shall not have areas where solid or liquid wastes cannot be
effectively removed.
 Equipment stored outside shall be maintained off the ground and inspected on a
predetermined schedule to eliminate pest harborages.
Facility Infrastructure
The fabrication of the facility, building, and associated facilities shall be suitable for the
intended purpose.

SUPERSEDES: NEW

Walls
Walls shall be constructed, finished and maintained to prevent the accumulation of dirt,
minimize condensation, minimize mold growth, and facilitate cleaning.
Floors
Floors shall be suitably hard wearing to meet the demands of the process and withstand
cleaning materials and methods. They shall be impervious and maintained in good repair.
Overheads
Ceilings and overheads shall be constructed, finished, and maintained to prevent the risk of
product contamination.
Ceilings
Where suspended ceilings or roof voids are present, adequate access to the void shall be
provided to facilitate inspection.
Drains
Drains shall be sited, designed, and maintained to minimize risk of product contamination and
not compromise product safety.
Lighting
Suitable and sufficient lighting shall be provided for the correct operation of processes,
inspection of product, and cleaning.

SUPERSEDES: NEW

Ventilation
Adequate ventilation and extraction shall be provided in product storage and processing
environments to prevent condensation, excessive dust, and product contamination.
Doors
Doors shall be maintained in good condition. External doors and dock levelers shall be close
fitting and/or adequately proofed. External doors to open product areas shall not be opened
during production other than in emergencies.
Hand Wash Facilities

A hand wash basin shall be provided adjacent to all access points and in accessible locations
throughout the facility, including those required transition areas.
Back Flow Devices

Back flow devices shall be in place in the facility, where appropriate.
Employee Amenities
Amenity and support facilities (e.g., break stations, storage, etc.) shall be maintained and
operated in such a way to prevent contamination or adulteration of food.
4.4. Equipment Layout and Hygienic Design Standards
Statement of Intent
The factory layout, flow of processes, and movement of personnel shall be sufficient to prevent
the risk of product contamination and to comply with relevant regulatory requirements.

SUPERSEDES: NEW

Equipment Layout
The facility shall have a plan of the site which designates areas where product is at different
levels of risk.
If it is necessary to allow access through production areas, then designated walkways shall be
provided that ensure there is adequate segregation from materials.
Where sensitive areas (e.g., Ready to Eat (RTE) area or areas where post-process contamination
may occur) are part of the facility, there shall be separation between these areas and other
areas of the facility. Control measures, such as walls, partitions, air handlers, air curtains,
distance, neutral air balance or positive pressure, shall be in place to protect RTE areas against
potential contamination from pulling in air from raw areas.
Where high risk (e.g., freezers/cooling spirals) is part of the facility, there shall be adequate
physical separation between these areas and other areas of the facility.
Refurbishment or construction requires temporary structures to be designed and located to

avoid harborage and ensure the safety and quality of products based on a risk assessment.
Airflow shall be sufficient to protect against potential contaminate transfer from raw to RTE.
Equipment Hygienic Design

All food processing equipment shall be suitable for the intended purpose and shall be used to
minimize the risk of contamination of product.
All equipment shall be constructed of appropriate materials. The design and placement of
equipment shall ensure it can be effectively cleaned and maintained.
The facility HACCP team shall complete a hygienic and sanitary design risk assessment for any
new, used, or refurbished equipment that is brought into the facility.
Equipment that is in direct contact with food shall be suitable for food contact and meet
regulatory requirements, where applicable.

SUPERSEDES: NEW

4.5. Utilities and Waste Management
Utilities
Water used as an ingredient in the manufacture, preparation, or for cleaning of equipment
shall be potable.
Air, steam, and other gases used directly in contact with or as an ingredient in products shall
be monitored to ensure this does not represent a contamination risk. Compressed air used
directly in contact with product or product contact surfaces shall be filtered.
Waste Management
Waste disposal shall be managed in accordance with legal requirements and to prevent
accumulation, risk of contamination and the attraction of pests.
Food products intended to be supplied for animal feed shall be segregated from waste and
managed in accordance with the relevant regulatory requirements.
External waste collection containers and rooms housing waste facilities shall be managed to
minimize risk.
4.6. Housekeeping and Sanitation
Statement of Intent
Housekeeping and sanitation programs shall be in place, which ensures appropriate standards
of hygiene are maintained at all times and that the risk of product contamination is minimized.

SUPERSEDES: NEW

Housekeeping and Sanitation

Documented sanitation standard operating procedures (SSOPs) shall be in place and
maintained for the building, infrastructure, and all equipment within the facility.
Facility deep cleaning (such as overheads and other infrastructure) shall be based on risk
assessment and the frequency documented on the master sanitation schedule (MSS).
The facility cleaning frequency shall be compliant with the maximum Kellogg established run
length or applicable regulatory standards.
Wet and dry cleaning activities shall be segregated to protect areas from cross contamination
to production. Following any wet cleaning activities, the area shall be returned to dry
conditions before start of production.
Equipment that is cleaned or cleaned with dry steam shall be followed by a

sanitizer/disinfectant step.
Food spillages are addressed immediately to prevent potential contamination of food contact
surfaces or equipment.
Cleaning Verification
Monthly sanitation audits shall be completed and results trended with corrective actions
associated with the MSS based on audit trends.
Limits of acceptable and unacceptable cleaning performance shall be defined, based on the
potential hazards (e.g., microbiological, allergens, foreign material, etc.).
The cleanliness of equipment shall be inspected before the equipment is released back to
production.
Analytical results from verification shall be recorded and used to identify trends in cleaning
performance and trigger improvements, where required.

SUPERSEDES: NEW

Cleaning Equipment
Cleaning equipment shall be:
- Fit for purpose.
- Suitably identified for intended use (e.g., color coded or labeled).
- Cleaned and stored in a hygienic manner to prevent contamination.
Clean in place (CIP) systems shall be monitored and documented to ensure their effective
operation.
Vacuums for cleaning shall have the appropriate filtration.
Drain Cleaning
A drain cleaning program shall be in place and based on risk assessment. Drains in wet areas
shall be cleaned and sanitized at a minimum of weekly.
4.7. Pest Control
Pest Control Program

The entire facility shall have a documented and effective pest control program in place to
minimize the risk of infestation.
There shall be the necessary resources available to respond to any issues to prevent risk to
products.

SUPERSEDES: NEW

Pest Control Management

The facility shall either contract the services of a qualified pest control vendor or have
certification for the regular inspection and treatment of the site to deter and eradicate
infestation. The frequency of inspection shall be determined by risk assessment and shall be
documented. Where the services of a pest control contractor are employed, the service
contract shall be clearly defined and reflect the activities of the site.
Pest Control Procedures

Bait stations shall be robust, of tamper-resistance construction, secure in place, and
appropriately located to prevent contamination risk to product.
In the event of infestation or evidence of pest activity, immediate action shall be taken to
eliminate the hazard. Any potentially affected products shall be subject to the food safety
incidents procedure.
Records of pest control inspections, pest-proofing, hygiene recommendations, and actions

taken shall be maintained. It shall be the responsibility of the company to ensure all of the
relevant recommendations made by their contractor or in-house expert are carried out in a
timely manner.
An in-depth, documented pest control survey shall be undertaken at a frequency based on risk,
but typically quarterly, by a pest control expert to review the pest control measures in place.
The timing of the survey shall be such as to allow access to equipment for inspection where risk
of stored product insect infestation exists.
Annual review of the program is required to evaluate the effectiveness of the pest control
program.

SUPERSEDES: NEW

Pest Control Analysis

Results of pest control inspections shall be assessed and analyzed for trends on a regular
basis, but at a minimum of:
- In the event of an infestation.
- Annually.
The analysis shall be used as a basis for improving the pest control procedures.
4.8. Facility Security
Facility Security
The facility security systems shall ensure that products are protected from theft or malicious
contamination while under control of the facility.
The facility shall complete a documented assessment of the security arrangements and
potential risks to the product from any attempt to contaminate or damage product.
Sensitive or restricted areas shall be defined.
Identified security arrangements shall be implemented and reviewed at least annually.
Authorized Access
Measures shall be in place to ensure only authorized personnel have access to production and
storage areas.
Access to the site by employees, contractors, and visitors shall be controlled.
A visitor reporting system shall be in place.
All staff shall be trained in facility security and encouraged to report unidentified visitors.

SUPERSEDES: NEW

Unapproved personnel or unapproved photography and/or use of recording devices including
camera phones are strictly prohibited. Only facility management may authorize exceptions.
Access to computer process control systems, critical data systems, laboratories, and chemical
storage areas shall be limited to those with approved clearance.
All windows, roof openings, airflow units, water supply, electrical access points, unloading
equipment, and trailer bodies shall be secured.
The facility shall be protected through fencing, gates, or an appropriate deterrent for entry. A
system shall be in place to control vehicle access to the facility.
4.9. Storage and Transportation
Storage
All facilities used for the storage of ingredients, work-in-process (WIP), and finished products
shall be suitable for its purpose.
Documented procedures to maintain product safety and quality during storage shall be
developed.
Where temperature control is required, the storage area shall be capable of maintaining
product temperature within specification and operated/documented to ensure specified
temperatures are maintained.
Receipt documents and/or product identification shall facilitate correct stock rotation (first in,
first out (FIFO)).
Transportation
Procedures shall be in place to maintain product safety and quality during loading and
transportation.

SUPERSEDES: NEW

Traceability shall be maintained during transportation. There shall be a clear record of
dispatch and receipt of goods.
All vehicles shall be inspected prior to loading with the inspection documented.
Where temperature control is required during transit, the transportation shall be capable of
maintaining product temperature within the specification. There shall be a system to verify
and record the temperature at predetermined frequencies.
Maintenance systems and documented cleaning procedures shall be maintained for all
vehicles and equipment used for loading/unloading (e.g., silo connection hoses, etc.).
4.10. Allergen Management
Statement of Intent
The facility shall have developed a system for the management of allergenic materials, which
minimizes the risk of allergen contamination of products and meets regulatory requirements
for labeling.
For facilities manufacturing food bearing an allergen or gluten free claim, the allergen
management system shall include any conditions required to ensure food with these claims
are compliant with regulatory and Kellogg requirements.
Labeling
All products shall have appropriate allergen labeling that meets the defined Kellogg and
regulatory requirements for the target market(s).

Elements:
 Documented procedure to evaluate finished product labels including allergen

information upon receipt.

SUPERSEDES: NEW

 Documented monitoring records showing verification of correct allergen information on
finished product labels upon receipt.
 Documented operational procedures defining a process to ensure accurate allergen
labeling on finished foods.
Allergen Management – Ingredients and Finished Products

An assessment of all raw materials shall be conducted to identify the presence of allergens and
gluten and evaluate risk for allergen and gluten cross contact throughout the supply chain of
the material.
The facility shall identify and list allergen containing materials handled on site. This shall
include raw materials, processing aids, intermediate, finished products, and any new product
development ingredients or products.
Elements:
 Documentation showing allergens identified in each raw material, processing aid,

intermediate, and finished product present and/or manufactured within the entire
manufacturing facility.
 Documented procedure and assessment identifying the allergen and gluten risk
throughout the ingredient supply chain.
 Documented ingredient receiving and ingredient handling procedures designed to
mitigate unidentified allergens from entering the facility and prevent cross contact due
to ingredient handling.
 Documented monitoring records showing verification of correct allergen labels on
ingredients.
Allergen Management – Operational Controls

A documented risk assessment shall be carried out to identify potential routes of allergen cross
contact in the facility. The facility shall identify controls and establish documented operational
procedures designed to manage allergens and mitigate risk for cross contact.
Elements:

SUPERSEDES: NEW

 Documented hazard analysis identifying allergens and their entry points in each
process.
 Documented evaluations of potential allergen cross contact on shared and adjacent
equipment within the facility.
 Documented identification of operational controls to mitigate the allergen cross contact
risk in the facility.
 Facility demonstration of adequate allergen controls during operation, sanitation, or
downtime activities including, but not limited to: ingredient handling, adequate cross
over protection, dust and other debris accumulation, and proper housekeeping.
 Documented procedures to incorporate allergen changeover into facility scheduling.
 Documented sanitation changeover matrix defining any specific allergen changeover
requirements.
 Documented procedure for investigation of allergen related consumer contacts.
 Documented process for periodic allergen management prerequisite program review.
 For facilities manufacturing foods with allergen and gluten free claims, identification of
any specific controls and inclusion into other allergen operational practices.
Allergen Management – Sanitation

The facility shall have sanitation controls in place to manage allergens in the facility and
mitigate risk for cross contact. Effectiveness of the allergen sanitation program shall be shown
through verification and validation procedures.
Facilities manufacturing products with an allergen or gluten free claim shall also identify and
incorporate allergen and gluten free standards into the sanitation assessment and procedures.
Elements:
 Documented sanitation standard operating procedures (SSOPs) for equipment that

handles allergen containing foods and any specific sanitation activities that are
designed to mitigate allergen cross contact.
 Documented sanitation records from a sanitation activity conducted around an allergen
changeover, including SSOP completion, visual inspection records, and corrective action
records.
 Documented risk assessment to determine allergen sanitation verification and
validation program of the facility and/or line. Assessment shall state allergens present,

SUPERSEDES: NEW

which allergens are target for the sanitation validation, justification for the target
allergen, and frequency of validation.
 History of verification and validation results showing SSOP effectiveness and corrective
actions to nonconformance results.
 Documented verification and validation plan for products bearing an allergen or gluten
free claim, designed in cooperation with the Kellogg Quality representative.
 Documented corrective action process for nonconforming results, including notification
of nonconformance to the identified Kellogg Quality representative.
Allergen Training
A documented annual allergen training program shall be in place for all employees. At a
minimum, training shall include general food allergen awareness and specific allergen
management standard elements.
The facility shall develop and document annual job specific training for employees handling or
dealing with allergens including, but not limited to: sanitation, maintenance, warehouse, and
operations.
Facilities manufacturing products with allergen and gluten free claims shall include allergen
and gluten free standards into the identified training requirements.
4.11. Good Manufacturing Practices
Personnel Hygiene Standards

The facility shall have documented good manufacturing practices (GMP)/personnel hygiene
standards that are consistently applied by all personnel including visitors, temporary staff,
and contractors.
The requirements for personnel hygiene shall be documented and communicated to all
personnel.
Hand washing shall be performed on entry into the production area of the facility and at a
frequency that is appropriate to the risk of product contamination.

SUPERSEDES: NEW

Personnel protective clothing shall be worn as intended:

- No external pockets above waist height.
- Hair nets to enclose all scalp and ears.
- Beard nets/snoods to be worn to cover beards/moustaches.
- Ear protection to be attached and/or metal detectable.
All cuts and grazes on exposed skin shall be covered by an appropriately colored bandage
(preferably blue) and containing a metal detectable strip.
If the HACCP risk assessment determines that gloves are required, only approved types of
gloves may be used for handling products or product contact surfaces.
Personal items (e.g., clothing, bags, medicines, etc.) shall not to be taken into the production
area of the facility.
Food and drink shall only be consumed in designated areas.
Smoking shall only be permitted in designated areas with appropriate waste disposal.
The facility shall have a procedure which enables the notification by employees, temporary
visitors, and contractors of any infection, disease, or condition with which they may have been
in contact with or suffering from. Infectious individuals shall not be allowed to work in
manufacturing areas.
The facility shall also have documented policies and procedures in place to protect employees
and product zones in the event of possible bloodborne pathogen contamination.
Latex gloves or other latex products shall not be permitted.
Employee Hygiene Facilities and Practices

Toilets/Restrooms shall be adequately segregated and not open directly into production,
packing, and storage areas.


SUPERSEDES: NEW

Where a facility has a raw GMP area, personnel shall enter via a specifically designated
changing facility with arrangements to ensure that protective clothing will not be
contaminated before re-entry into the non-high risk area.

Elements:
 High risk changing facilities shall incorporate the following requirements:
o Clear instructions for the order of changing into dedicated protective clothes.
o Dedicated footwear/foot coverings.
o Protective clothing to be visually distinctive (i.e., different color).
o Hand washing and/or foot sanitation incorporated into the procedure for entry
into the production areas:
 Before entering a food production area.

 Upon returning to their work area.
 After each visit to the toilet facility.
 After hands are used for unsanitary purposes.
 Any other time hands become soiled.
4.12. Product Protection
Product Protection
The facility shall ensure raw material handling, preparation, processing, packing, and storage
areas have the appropriate controls and procedures in place to control the risk of physical
contamination of the product.

SUPERSEDES: NEW

Chemical Control
Procedures shall be in place to manage the use, storage, and handling of nonfood chemicals to
prevent chemical contamination:
- An approved list of chemicals for purchase.
- Safety Data Sheets (SDS)/Specifications.
- Suitability for use/food grade.
- Avoidance of strongly scented products.
- Labeling and identification of chemicals and containers.
- Segregated and secure storage with restricted access.
- Used by trained personnel only.
Where strongly scented or taint-forming materials have to be used, for instance for building
work, procedures shall be in place to prevent the risk of contamination of products.
Metal Control
A procedure shall be in place to monitor, reduce, and/or avoid the risk of metal contamination.
Wood Control
The use of wood within the production and storage areas where possible shall be eliminated
(e.g., hand tools, pencils, clipboards, brooms, pallets, etc.). Documented monitoring shall be in
place, where elimination is not possible.
Glass Control
Glass in production and storage areas shall be replaced with suitable alternatives. If this is not
possible, glass items shall be suitably protected.
All glass, brittle plastic, and ceramic material in production and storage areas shall be listed
on a register.

SUPERSEDES: NEW

A procedure shall be in place for the management of breakages.
Foreign Material Detection and Removal Programs

The type, location and sensitivity of the detection and/or removal method shall be identified as
part of the HACCP plan. The location of the equipment or any other factors influencing the
sensitivity of the equipment shall be validated.
Detection and separation equipment shall be readily accessible for cleaning and inspection.
Calibration shall be conducted at a frequency recommended by the manufacturer, regulatory

requirements, or annually, whichever is most frequent.
The verification check of the metal detector shall occur at a frequency that permits the facility
to identify, hold, and prevent the release of any affected materials should the equipment fail.
Where foreign material is detected or removed by the equipment, the source of any unexpected
material shall be investigated in a timely manner. The investigation shall determine the ability
to continue production and disposition of affected product. Action levels for repeat rejects
shall be established and followed.
Documented justification based on a risk assessment shall be established, if metal detection or

X-ray is not in place.
All CCP metal detection devices for consumer packages shall be capable of detecting:
- Ferrous 1.5 mm.
- Non-ferrous 1.5 mm.
- Stainless steel 2.0 mm.
- Bulk or WIP - 2.0 mm ferrous, non-ferrous, and stainless steel.
- For ferrous only equipment (used for metalized packaged products), the maximum limit is 3.2
mm.
Programs shall be in place for all ingredients and packaging materials to ensure Kellogg
finished products are capable of meeting this standard.
Procedures shall be in place for the inspection, cleaning, and calibration checks.

SUPERSEDES: NEW

There shall be procedures for the operation and testing of the metal detector or X-ray,
including:
- A test that both the detection and rejection mechanism is working.
-Checks that test the memory/reset function.
Where in-line detectors are used, the test piece shall be placed in the product flow, where
possible.
Filters, Sieves, and Screens

Filters, screens and sieves shall be of a specified mesh size or gauge and designed to provide
the maximum practical protection for the product.
The type location and size of filters, sieves and screens shall be fully documented in a register.
Procedures shall be in place for the inspection, cleaning and integrity checks. Records shall be
maintained.
All filters, sieves, and screens shall be included in the preventive maintenance schedule with
integrity and performance checked based on risk assessment.
Magnets
The type, location, and pull strength of magnets shall be fully documented in a register.
Procedures shall be in place for the inspection, cleaning, strength testing, and integrity checks.
Records shall be maintained.

SUPERSEDES: NEW

4.13. Maintenance Programs
Maintenance Programs
The maintenance and condition of facility equipment shall be documented.
All maintenance requirements shall be defined when commissioning new equipment.
Maintenance Activities
Temporary repairs shall be controlled to ensure the safety of the product.
To ensure product safety, a risk assessment shall be completed prior to any food stream
maintenance activities to detail the requirements.
Maintenance work shall be followed by a documented cleaning and sanitation procedure with
a documented record of the area being cleared to resume production.
Maintenance Materials
Food grade materials shall be used for equipment and facility maintenance that pose a risk to
food or food contact surfaces.
4.14. Training
Statement of Intent
All personnel that perform work that affects product safety, legality, and/or quality shall be
competent.

SUPERSEDES: NEW

Training Requirements
All personnel, including temporary staff and contracted personnel shall be appropriately
trained prior to commencing work and adequately supervised throughout the work period.
Where personnel are engaged in activities relating to critical control points, relevant training
and competency assessment shall be in place.
The facility shall put in place documented programs covering the training needs of relevant
personnel.
Competency Management
The facility shall routinely review the competencies of its staff. Corrective actions shall be
taken for nonconformance to the competency assessments.

Elements:
 The facility shall ensure that all staff, including temporary staff, agency staff, and
contractors receives training to a level commensurate with their responsibility and the
type of work they carry out. The following shall be included:
o Induction training covering company policies and a basic introduction to HACCP.

o Training in all areas that impact food safety such as cleaning, inspections,
escalations, etc.
 Operators involved in activities identified as critical control points (CCPs) within the
HACCP plan shall be specifically trained in the detailed procedure including:
o How to carry out the task.

o When the task is to be completed.
o Records to be maintained.
o Action to be taken in the event of a deviation.
 A competency assessment shall take place on completion of the training and at

predetermined frequencies. The assessment needs to confirm that the procedure is
followed correctly and test knowledge of corrective actions and escalation procedures.
 Evidence of all training needs to be retained.

SUPERSEDES: NEW

 Training records for temporary or agency staff shall also be retained.
4.15. Regulatory Inspections
Regulatory Inspections
A notification list shall be established and documented as followed for a regulatory inspection.
The facility shall have a procedure in place which details the escalation to the Kellogg Quality
representative of any regulatory inspections.
The facility shall have a documented procedure, which details the actions to be taken in the
event of a regulatory inspection.
All appropriate facility personnel shall be trained on the key elements of the procedure.
4.16. Complaints Management
Complaints Management
Consumer/Customer complaints shall be handled effectively and information used to reduce
recurring complaint levels.
All complaints shall be recorded, investigated and the results of the investigation and root
cause of the issue recorded, where sufficient information is provided.
Actions appropriate to the seriousness and frequency of the problems identified shall be
carried out promptly and effectively by appropriately trained staff.
Complaint data shall be analyzed for significant trends, used to implement ongoing
improvements to product safety and quality, and to avoid recurrence.
Facility specific complaint performance targets shall be established and reviewed on a regular
basis and actions against these targets put in place to effect improvement.

SUPERSEDES: NEW

The facility shall have a procedure in place to ensure that all complaints are reviewed and
corrective actions communicated to the Kellogg Company representative.
4.17. Traceability
Statement of Intent
The facility shall be able to trace all raw material product lots including packaging from their
supplier through all stages of processing and distribution.
Records
Identification and records of materials (e.g., packaging, processing aids, WIP, part used
materials, nonconforming materials, and finished products) shall be adequate to ensure
traceability.
Where rework or any reworking operation is performed, traceability shall be adequate to

ensure traceability.
Work-in-Process (WIP)/Rework
Where rework or any reworking operation is performed, traceability shall be maintained.
Mock Recall
A formal mock recall procedure shall be in place and include procedures on how to conduct an
effective recall.
The recall process shall be tested annually.
Full traceability shall be proven as achievable. The mock recall shall be completed within 4
hours.

SUPERSEDES: NEW

The mock recall shall be capable of being executed at any time regardless of specific Quality
roles being available.
Traceability Exercise
A traceability challenge shall be conducted a minimum of twice per year. The challenge shall
incorporate a bulk item, a unit ingredient, and primary packaging.
Traceability shall be demonstrated to the first level of distribution beyond control of the plant.
Elements:
 The facility shall be able to demonstrate they are able to effectively meet the
requirements of the product withdrawal and recall procedures. The facility shall be able
to demonstrate they can meet the procedure at any time.
 The product withdrawal and recall procedures shall be tested at least annually, in a way
that ensures their effective operation. The results of the test shall be used to review the
procedure and implement improvements as necessary.
 The product withdrawal and recall procedure shall include provisions for waste, rework,
and WIP.
Product Disposition Records

Records of disposition of ingredients and finished food (i.e., damaged or destroyed) shall be kept
to maintain traceability of finished goods.

SUPERSEDES: NEW

4.18. Incident Management
Incident Management
The facility shall have and execute documented procedures to report to Kellogg Company and
effectively manage incidents and potential emergency situations that impact food safety,
legality, or quality. This shall include the consideration of contingency plans. Incidents may
include:
- Disruption to key services such as water, energy, and transport.
- Events such as fire, flood, or natural disaster.
- Fraudulent or economic adulteration.

Elements:
 A documented facility incident management procedure is required which details the

escalation to the Incident Management Team (IMT) and Corporate Incident
Management Team (CIMT) as necessary.
4.19. Corrective Action and Preventive Action Programs
Statement of Intent
The facility shall have a documented procedure that analyzes any food safety incidents and
applies appropriate corrective action.
Corrective Action Preventive Action (CAPA) Effectiveness

The facility shall have a documented procedure for investigating and applying corrective
action for nonconformances.

Elements:

 The facility shall have a documented procedure for applying corrective action against
all nonconformances of the food safety or quality systems.
 Documentation of CAPA shall be maintained to demonstrate effective investigation and
implementation of corrective actions to nonconformances.
SUPERSEDES: NEW

 The facility shall notify the Kellogg representative of the nonconformance, investigation
findings, and corrective actions taken, including product disposition prior to applying
the corrective action.
5. Product Control
5.1. Product Labeling
Product Labeling
Product labeling shall comply with the appropriate legal requirements and contain
information to enable the safe handling, display, storage, and preparation of the product
within the food supply chain or by the customer.
5.2. Assured Product Status
Assured Product Status

Procedures shall be in place to ensure that all product descriptions and claims are legal,
accurate, and verified.

Elements:
 The site shall maintain the necessary certification status in order to make a claim (e.g.,
organic, Halal, Kosher, etc.).
5.3. Product Packaging
Product Packaging
Product packaging shall be appropriate for the intended use and shall be stored under
conditions to prevent contamination and minimize deterioration.

SUPERSEDES: NEW

5.4. Product Hold and Release
Hold and Release Procedures

The facility shall ensure that any out of specification material and finished product is
effectively managed to prevent release.
The facility shall have documented procedures for the management and hold of
nonconforming products.

Elements:
 Documented within the procedure:
o Requirement for staff to identify and report potentially nonconforming product.

o Clear identification (i.e., direct labeling) of nonconforming product.
o Holds shall be designated by Level I (food safety) and Level II (quality).
o Secure storage to prevent accidental release.
o Defined responsibilities for decision making on the use or disposal of products
appropriate to the issue (e.g., destruction, rework, downgrading, etc.).
o Records of the decision for disposition.
o Records of destruction where product is destroyed for food safety reasons.
 A master listing of all product holds should be maintained and available.
5.5. Product Inspection and Laboratory Testing
Product Inspection and Laboratory Testing

The facility shall undertake or subcontract inspection and analyses which are critical to
confirm product safety, legality, and quality using appropriate procedures, facilities and
standards.

Elements:

SUPERSEDES: NEW

Product Inspection
 There shall be a scheduled program of testing covering products and the processing
environment, which may include microbiological, chemical, physical, and organoleptic
testing according to risk. The methods, frequency, and specified limits shall be
documented.
Laboratory Testing
 Where routine testing laboratories are present on a manufacturing site, they shall be
located, designed, and operated to eliminate potential risks to the manufacturing
environment and product safety. Controls shall be implemented, documented, and
include consideration of:
o Design and operation of drainage and ventilation systems.

o Access and security of the facility.
o Movement of laboratory personnel.
o Protective clothing arrangements.
o Processes for obtaining product samples.
o Disposal of laboratory waste.
 Note: No pathogen tests are to be completed at onsite laboratories for Kellogg food or
food contact swabs for production of Kellogg food, without prior authorization.
 Analyses which are critical to product safety or legality shall be performed at external/
3rd party laboratories specifically approved by Kellogg that have ISO 17025 or regional
equivalent accreditation with a scope that includes the required assays. The following
sample types are included:
o Finished food or Zone 1 product contact surface swabs tested for pathogens such
as Salmonella and Listeria monocytogenes.
o Finished food tested for allergens.
 For the below sample types, laboratories require ISO 17025 accreditation with the
appropriate assay scope, but do not require specific Kellogg approval:
o Equipment/environmental swabs tested for allergens.

o Zone 2 to Zone 4 environmental monitoring program swabs tested for pathogens.
5.6. Environmental Monitoring Program

SUPERSEDES: NEW

Environmental Monitoring
The facility shall demonstrate that the environment is maintained to ensure no pathogenic
cross contamination.
A documented program shall be established to monitor the microbiological conditions of the

environment to meet the standards of the region where the food is produced and the target
market(s) regulatory requirements.
Facilities shall collect environmental monitoring samples at quantities, locations, and

frequencies agreed upon with the Kellogg regional lead or designee. Food contact surfaces
and food shall be tested at the direction of Kellogg. Increasing or decreasing risk shall trigger
changes in the established monitoring program.
All unfavorable results shall be immediately reported to the Kellogg representative.
Root cause investigation shall be initiated by the facility team and communicated to the
Kellogg representative who will agree upon required corrective action.
Facilities shall identify target pathogens for the facility and analyze risk. At a minimum,
Listeria and Salmonella shall be considered.
Facilities shall establish monitoring frequencies of zones based on the risk level of target
pathogens and regulatory expectations.
Facilities shall maintain a documented, risk-based environmental monitoring program (pEMP)

for the target pathogens of concern.
Results shall be trended.
Notify the Kellogg representative for any changes made to the environmental monitoring
program.
Elements:

SUPERSEDES: NEW

 A preliminary/baseline risk assessment (at a minimum) shall consider all areas within
the facility and be completed for target pathogens of concern which currently include:
Listeria and Salmonella.
 For each pathogen of interest, the documented program includes the following
elements:
o Target organism(s) identified.

o Risk assessment completed for the target organism(s) and the initial/baseline
sampling plan established from the risk assessment.
o Where monitoring is deemed necessary for a target organism, a master plan
shall be developed from the baseline and historical results.
o A schedule for testing the sample sites within the master plan:
 Routine environmental (Zones 2 to 4) samples.

 Routine line validation (Zone 1 and food) testing, when applicable.
o Maintenance of sample results in a manner that provides ability to trend

analysis.
 The facility shall have a program to identify risk and establish appropriate testing and
sites for all zones for a new line start or restart of an existing line and installation of
new or used equipment. The program shall be agreed upon by your Kellogg
representative.
 The facility escalates or de-escalates monitoring frequency in response to results.
 Investigatory sampling from non-product contact surfaces (Zones 2 to 4) shall be
selected such that no implication to food or product contact surfaces occurs.
 With written Kellogg approval, investigational sampling from Zone 1 may be conducted.
Affected food shall be held pending acceptable results.
 Root cause of unfavorable results shall be investigated by the facility team and include
investigatory swab samples being collected as appropriate to the findings.
 Tracking and trending shall document the results of routine testing and any
investigatory swabs.
 New sample sites shall be brought into the program at a regular frequency.
 Any Zone 1 site(s) that has/have returned unfavorable in past testing and have not been
permanently corrected shall be included on the line validation sampling plan for that
line.
 The Kellogg representative will approve which pathogen test(s) shall be performed for
environmental monitoring.

SUPERSEDES: NEW

5.7. Response to Food Safety Events/Incidents
Documented procedures and standards shall be established to return facility conditions to a

state suitable for the manufacture of food.
Planned events shall have a documented plan of action to account for risks to the environment
due to the activity. The risk assessment shall establish a monitoring plan to show the affected
area has been brought back to conditions suitable to produce food.
The Kellogg representative shall approve the plan of action for planned activities.
Unplanned incidents shall follow a pre-approved and documented plan of action for crisis
response to contain incidents and prevent further loss of suitable conditions.
The Kellogg representative shall approve the plan of action for crisis response and will provide
support when unplanned incidents occur.
Planned events or unplanned incidents that occur in food contact areas (Zone 1) or impact
food shall be reported to the Kellogg Company representative.
Remediation of unplanned incidents or planned events shall follow a standardized decision

process flow created by the facility, but approved by Kellogg.
Unfavorable microbiological results (from post clean) swabs shall follow a corrective action
plan and be reported to the Kellogg representative.
Planned events or unplanned incidents that occur in food contact areas (Zone 1) or impact
food shall be reported to Kellogg Company Representative as per the crisis management
communication expectations.
Remediation of unplanned incidents or planned events shall follow a standardized decision

process flow created by the facility but approved by Kellogg
Unfavorable microbiological results from post clean swabs shall follow a corrective action plan
and be reported to the Kellogg representative.

SUPERSEDES: NEW

Elements:
 For planned events:
o The facility team shall use a plan of action to protect the facility from
contamination of biological, chemical, and physical hazards due to event activity.
o Sanitation Standard Operating Procedures (SSOPs) shall be documented to
communicate controls.
o A crisis management plan shall be prepared to respond to breaches of biological,
chemical, or physical controls during planned activities.
o The planned event plan of action shall include documentation of a pathogen
sampling plan for target pathogens, if deemed necessary by the Kellogg
representative.
 For unplanned incidents:
o Incidents shall be documented and reported.
 All unfavorable results shall be reported to the Kellogg Quality representative.

 If a planned event or unplanned incident impact food contact surfaces, the equipment
and surrounding environment shall be brought back to conditions suitable to produce
food prior to startup of manufacturing.
 Adjustments to facility practices and/or programs, as a result of a food safety event or
incident, shall be communicated to the Kellogg representative.
6. Process Control
6.1. Control of Operations
Statement of Intent
The facility shall operate to documented procedures and/or work instructions that ensure the
production of consistent safe, quality product that meets the standards of the region where the
food is produced and the target market(s)’ regulatory requirements and in full compliance with
the facility’s food safety/HACCP plan.

SUPERSEDES: NEW

Operating Conditions
Documented process specifications and work instructions shall be available for all processes in
the production of products.
Documented preoperational checks of the production and packing line shall be carried out
prior to commencing production and following the changes in product type.
Elements:
 The documents shall be sufficient to ensure that all key process parameters are
specified and controlled, thereby ensuring that the product consistently meets safety,
quality, and regulatory requirements. At a minimum, these shall include:
o Recipes, including identification of any allergens.

o Mixing instructions, speed, and time.
o Equipment process settings.
o Cooking times and temperatures.
o Cooling times and temperatures.
o Labeling instructions.
o Coding and shelf life marking.
o Any additional critical control points identified in the HACCP plan.
Product Qualification
Any changes to the operating conditions shall initiate a product requalification. The facility
shall notify the Kellogg representative for further direction.
Labeling and Pack Control

Documented procedures shall be in place to ensure that products are correctly packaged,
labeled, and date coded. These shall include checks at the start of the run, following packaging
changes, and when changing batches of packaging materials.

SUPERSEDES: NEW

Documented procedures shall include verification of any code information or other printing
carried out on the packaging.
Elements:
 Packaging for each production run shall be brought to the line following a documented
process.
 Documented monitoring carried out on the production line before production
commences shall ensure systems are correctly set and functioning. Monitoring shall
ensure that:
o Lines have been suitably cleaned.

o Lines have been cleared of any packaging from previous production runs.
o Lines are ready for production with processing parameters correctly set.
 Monitoring is also required following changes in product to ensure that all product and
packaging has been removed from the previous run.
 Specific documented packaging controls shall be in place to ensure the product does not
get packed into the incorrect packaging.
 Procedures shall also be in place to verify that adequate monitoring has been carried
out to minimize potential errors.
Label Verification
A documented system shall be in place to verify the accuracy of packaging for the product
being produced.
Quantity Control
The site shall operate a quantity control system, which conforms to legal requirements in the
country where the product is produced and sold.

Elements:

SUPERSEDES: NEW

 The frequency and methodology of quantity checks (e.g., weight, count, volume, etc.) shall
meet the requirements of appropriate legislation governing quantity verification and
records of checks shall be retained.
6.2. Calibration of Measuring and Monitoring Equipment
Calibration
The facility shall identify and control equipment used to monitor critical control points (CCPs)
and product safety.
The facility shall have a program in place to calibrate identified equipment.
Procedures shall be in place to record actions to be taken when the prescribed measuring and
monitoring devices are found not to be operating within the specified limits.
Where the safety or legality of products is based on equipment found to be inaccurate, action
shall be taken to ensure nonconforming product is not offered for sale.

Elements:
 The facility shall identify all equipment used to monitor critical control points (CCPs)
and control points (CPs). At a minimum, the facility shall:
o Maintain a list of equipment used to monitor CCPs or CPs and its location.
o Include this equipment in the preventive maintenance (PM) program.
o Keep record of calibration and the next due date.
o Prevent adjustment of this equipment by unauthorized staff.
o Protect this equipment from damage, deterioration, or misuse.
 The facility shall define the calibration frequency and methodology for which the
equipment shall be verified and shall include:
o A predetermined calibration frequency based on risk assessment or the

manufacturer’s recommendations.
o Trained staff to complete the calibration.
o The method to be used.

SUPERSEDES: NEW

 All reference equipment shall be calibrated and traceable to an appropriate regulatory

or industry standard.
 Documented procedures shall detail the action to be taken when equipment is found to
be outside of specified limits. Records shall be retained for the actions taken.
6.3. Product Image Standards
Defects
Operators shall evaluate product for defects on a routine basis and take product specific
actions to both food and packaging defects.
7. Notification Requirements
In the following situations, you shall notify your Kellogg Quality representative within 24
hours:
 Food safety incidents or a GMP breach of the facility including, but not limited to: roof
leaks, drain-backups, pest infestation, and foreign material incidents.
 Changes to raw materials, raw material sourcing and/or origin, process, equipment or
facility which might adversely affect our ingredient, packaging materials, or finished
product (e.g., changes in allergen status or seasonal variations in the raw material, etc.).
 Changes in emergency contact information for corporate offices or facilities.
 Nonconformance to Kellogg specifications.
 Identification of a critical food safety issue through an internal or third party audit or as
a result of regulatory audit, investigation, or other action.
 Failure of the Food Safety System or certifications such as HACCP, GFSI (i.e.,
recertification and/or suspension of the GFSI certificate), if these programs are required
by Kellogg Company.
You shall notify your Kellogg Quality representative prior to or concurrent with any
communication to regulatory authorities of the following:
 Recall of any ingredient, packaging material, or finished product supplied to Kellogg or

recall of any ingredient, packaging material, or finished product manufactured in a

SUPERSEDES: NEW

facility that also produces goods supplied to Kellogg. Reports of adverse events or food
safety reports to regulatory agencies, if there may be an impact to goods you supply to
Kellogg.
 Copies of any documents given to regulatory authorities concerning Kellogg products,
ingredients, or packaging materials shall also be provided to your Kellogg Quality
representative immediately.
 If a regulatory authority requests a copy of Kellogg proprietary information, the
supplier should contact Kellogg for instructions to ensure that required watermarks and
protective language is properly placed on the documents.
 If Kellogg product is sampled by a regulatory agency, product represented by that
sample shall be placed on hold and a duplicate sample shall be submitted immediately
to your Kellogg Quality representative.
Kellogg Written Approval Requirements:
 Any deviations from specified Critical Control Limits outlined in the food safety
management program shall be approved by your Kellogg Quality representative and
documented.
 Any new ingredient supplier or any changes to ingredient suppliers shall be approved by
the appropriate Kellogg Quality representative prior to use.
8. Exemptions for Facilities Contract Packing Kellogg Fully Sealed Products

Only
Definitions:
o Exposed Food: Food products that are without packaging or in which packaging
has been compromised to allow surface, air, or water contaminates to contact the
food material contained within. This may occur by processing or accidental
opening of closed packages or other environmental conditions that may cause
exposure.
o Fully Sealed Products: Food products that are protected from external air, water,
or physical contaminates by primary or secondary packaging barriers.
 Facilities co-packing fully sealed food, without any exposed food (see definitions above)
anywhere in the process are exempted from the following sections of both the General
Standard and Risk Based Ancillary Standards for Contract Manufacturing and Contract
Packing:
SUPERSEDES: NEW

o Section 4.2 – Supplier Management.

o Section 4.4 – Equipment Layout and Hygienic Design Standards.
o Section 4.5 – Utilities and Waste Management - exempt from only the following
sub-section:
 Utilities.
o Section 4.6 – Housekeeping and Sanitation - exempt from only the following sub-
sections:
 Cleaning Verification.
 Cleaning Equipment.
 Drain Cleaning.
o Section 4.10 – Allergen Management - exempt from only the following sub-
sections:
 Ingredient and Finished Products.

 Operational Controls.
 Allergen Sanitation.
o Section 4. 12 – Product Protection – exempt from only the following sub-sections:
 Wood Control.
 Foreign Material Detection and Removal Systems.
 Filters, Screens, and Sieves.
 Magnets.
o Section 5.5 – Product Inspection and Laboratory Testing - all exempt except for
sample submission to Kellogg and Packaging/Label/NLI verification requirements
in the Risk Based Ancillary Standard.
o Section 5.6 – Environmental Monitoring Program.
o Section 5.7 – Response to Food Safety Events/Incidents.

SUPERSEDES: NEW

General Standard Requirements For Manufacturing Facilities

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ISSUE DATE: 11/12/16

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

ISSUE DATE: 11/12/16

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

1. Facility Leadership and Management Commitment

2. Food Safety Plan

3. Quality and Food Safety Management System

4. Quality and Food Safety Standards/Programs

ISSUE DATE: 11/12/16

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

ISSUE DATE: 11/12/16

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

1.1. Regulatory Requirements

1.2. Facility Leadership of Quality and Food Safety Objectives

ISSUE DATE: 11/12/16

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

1.3. Continuous Improvement of Quality and Food Safety

Quality and Food Safety Communication

ISSUE DATE: 11/12/16

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

- Action plans and completion timeframes.

Any actions/decisions agreed shall be implemented within the agreed timeframes.

o What has been achieved?

 The specific agenda items need to be covered at a minimum as demonstrated through

ISSUE DATE: 11/12/16

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

Quality and Food Safety Corrective Action/Preventative Action (CAPA) Effectiveness

1.4. Organizational Structure and Quality/Food Safety Authority

Quality and Food Safety Organization

ISSUE DATE: 11/12/16

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

Quality and Food Safety Supervision

1.5. Recall Plan

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

2. Food Safety Plan

2.1. Food Safety/HACCP Team Competency

ISSUE DATE: 11/12/16

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

Effective operational and environmental controls (prerequisite programs) shall be in place to

2.3. Hazard Analysis and Risk Assessment

 Process Flow Diagram

o The process flow diagrams shall be signed and dated.

ISSUE DATE: 11/12/16

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

 Ingredient Hazard Analysis

 Process Hazard Analysis

2.4. Critical Control Points (CCPs)/Critical Limits

Critical Control Point (CCP) Identification

ISSUE DATE: 11/12/16

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

ISSUE DATE: 11/12/16

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

For each CCP, monitoring procedures shall be established.

Any CCPs shall be effectively implemented.

2.6. Corrective Action Plan

Corrective Action Plan

ISSUE DATE: 11/12/16

CONFIDENTIAL AND PROPRIETARY – © 2016 KELLOGG COMPANY

2.7. Verification Programs