Annex - 2 - FSMS Checklist

ANNEX 2 to GI-31.
211 - 09/2014
1. Scope
2. Normative References
Terms and definitions

REQUIREMENTS
ISO 22000 requirements
4. Food Safety Management S
4.1.General requirements
4.2. Documentation requirements
4.2.1 General
4.2.2 Control of documents
4.2.3 Control of records
4.2.4 Nestl QMS
4.2.5 Regulatory requirements, documentation and

labeling
5. Management Responsib
5.1 Management commitment
5.2 Food safety policy
5.3 Food safety management system planning
5.4 Responsibility and authority
5.5 Food safety team leader
5.6 Communication
5.6.1 External communication
5.6.2 Internal Communication
5.6.2 Internal Communication
5.6.3 Management of change
5.7 Emergency preparedness and response
5.8 Management Review
5.8.1 General
5.8.2 Review input
5.8.3 Review output
6. Resource managemen
6.1. Provision of resources
6.2. Human resources
6.2.1 General
6.2.2. Competence, awareness and training
6.3. Infrastructure
6.4. Work environment
7. Planning and realization of saf
7.1. General
7.1.1 New product development
7.2. Prerequisite programmes
7.2.1.Establishment of PRPs
7.2.1.Establishment of PRPs
7.2.2. Scope of PRPs
7.2.3. Input for PRP selection
7.2.4 Construction and layout of buildings
7.2.4 Construction and layout of buildings
7.2.5 Layout of premises and workspace
7.2.6 Utilities air, water, energy
7.2.6 Utilities air, water, energy
7.2.7 Waste disposal
7.2.8 Equipment and maintenance
7.2.8 Equipment and maintenance
7.2.9 Management of purchased materials
7.2.10 Measures for prevention of cross contamination
7.2.10.1 Pathogen monitoring
7.2.10.2 Allergen control
7.2.10.2 Allergen control
7.2.11 Cleaning
7.2.12 Pest control
7.2.12 Pest control
7.2.13 Personal hygiene and employee facilities
7.2.14 Rework
7.2.15 Product recall procedures
7.2.15 Product recall procedures
7.2.16 Warehousing
7.2.17 Product information / consumer awareness
7.2.18 Food defence, bio vigilance and bio terrorism
7.3 Preliminary steps to enable hazard analysis
7.3.1 General
7.3.2 Food safety team
7.3.3 Product characteristics
7.3.3.1 Raw material, ingredients and product contact

material
7.3.3.2 Characteristics of end products
7.3.3.2 Characteristics of end products
7.3.4 Intended use
7.3.5 Flow diagram, process steps and control measures
7.3.5.1 Flow diagram
7.3.5.2 Description of process steps and control measures
7.4 Hazard Analysis

7.4.1 General
7.4.2 Hazard identification and determination of

acceptable levels
7.4.3 Hazard assessment
7.4.4 Selection and assessment of control measures
7.5 Establishing the operation prerequisite program

(PRPs)
7.6 Establish the HACCP plan
7.6.1 HACCP plan
7.6.2 Identification of CCPs and (OPRPs)

7.6.3 Determination of critical limits for critical control
points
7.6.4 System for the monitoring of CCPs and OPRPs
7.6.4 System for the monitoring of CCPs and OPRPs
7.6.5 Action when monitoring result exceed critical limits
7.7 Updating of preliminary information and document

specifying the OPRPs and HACCP plan
7.8 Verification
7.9 Traceability system
7.10 Control of nonconformity
7.10.1 Correction
7.10.2 Corrective action
7.10.3 Handling of potential unsafe products
7.10.3.1 General
7.10.3.2 Evaluation for release
7.10.3.2 Evaluation for release
7.10.3.3 Disposition of nonconformity products
7.10.4 Withdrawals
8. Validation, verification and improvement of food
8.1 General
8.2 Validation of control measure combination
8.2.1 Validation of thermal processing
8.3 Control of monitoring and measuring
8.3.1 Internal control Plan
8.4 Food safety management system verification
8.4.1 Internal audit
8.4.2 Evaluation of individual verification result
8.4.3 Analysis of result of verification activities
8.4.3 Analysis of result of verification activities
8.5 Improvement
8.5.1 Continuous improvement
8.5.2 Updating the FSMS
a) This checklist covers detailed requirements of the Nestl Food Safety Management System (FSMS) and includes
b) The Nestl FSMS applies to all food and pet food sold under any of the Groups brand names. It also applies to n
c) It is to be used by all Markets, Globally Managed Businesses, factories and R&D units. According to the actual p
d) External Business Partners e.g. contract manufacturers must either apply this FSMS or their own, providing the
- ISO 22000:2005 - Food safety management systems - Requirements for any organization in the food chain
- ISO 22002-1:2009 - Prerequisite programmes on food safety - Part 1: Food manufacturing
- ISO 22002-4:2013 - Prerequisite programmes on food safety - Part 4: Food packaging manufacturing
DETAILED REQUIREMENTS
4. Food Safety Management System

Check if the facility has the general requirements in place :
a) Established, documented and implemented effective FSMS programs. A procedure to update the FSMS
when necessary in accordance with the requirements of the normative references and NGMP.
b) Defined scope of the FSMS specifying the products or product categories and processes covered.
c) To ensure that food safety hazards that may reasonably be expected to occur in products are identified,
evaluated and controlled in such a manner that they do not, directly or indirectly, harm the consumer.
d) To communicate appropriate information throughout the relevant parts of the value chain regarding food
safety issues related to products.
e) To communicate, within the facility, the necessary information concerning development, implementation and
updates of the FSMS to ensure the required food safety.
f) Toperiodically evaluate and update, when necessary, the FSMS programs and associated documentation to
ensure that they reflect the facilitys activities and incorporates the most recent information on relevant hazards.
The FSMS documentation shall cover all safety and regulatory requirements of the countries where the
product is sold and include :
a) Statements on the Nestl Food Safety policy and related objectives.
b) Procedures and records required by Nestl and any additional specific ones from ISO 22000 e.g. those
specifying how PRP(s) activities are managed (7.2.3); those dealing with the assessment and disposition of
potentially unsafe products (7.10.3).
c) Documents needed by the facility to ensure the effective implementation and updating of FSMS.
d) Documents that define all safety and regulatory requirements of the selling countries.
e) Inter-market product briefs for all exported products. These briefs have to be signed both by the receiving
and producing markets and include safety and regulatory requirements of the countries where the product is
sold.
A document control procedure is established and implemented in each facility to ensure that:
a) Documents are reviewed and updated as necessary and approved before issue
b) Only current versions of documents are in use
c) Relevant documents are readily identifiable and available at points of use
d) All relevant status information, including main changes, are covered
e) Distribution and disposal of documents are controlled
A record control procedure is set up and implemented to ensure that records are:
a) Properly identified and maintained stored, protected, retrieved, retained and disposed of to provide
evidence of compliance to all food safety requirements and implementation of FSMS.
b) Readily available for data analysis and auditing.
a) The Nestl Quality Monitoring Scheme (NQMS) must include all control activities related to food safety,
regulatory compliance and quality.
b) The NQMS covers all areas from raw and packaging material reception, production processes, labelling, to
food handling, storage and transportation conditions and change of ownership.
c) The NQMS defines all safety and regulatory parameters which must be monitored to demonstrate
compliance taking into account the HACCP study, Nestl specifications and regulatory requirements of the
selling market.
d) NQMS requirements must be readily accessible to all personnel performing quality checks at or near their
workstation.
e) The QMS is reviewed, at least annually, even if there is no change, and is updated when necessary; (see
also 8.5.2 on updating FSMS).
Records of all regulatory requirement must be documented and must be reflected on all appropriate
labeling. The following points are critical regarding labeling:
a) Declarations on labels must be in accordance with the legislation of the selling country, as well as with
internal specifications.
b) Measures must be in place to ensure that halal or kosher requirements of the manufacturing or selling
market are correct taking into consideration the process from raw materials to finished products, including
potential cross-contacts.
c) Labeling information must be correct, complete, and legible and be established according to the procedures
outlined in the relevant policies and standards.
d) Ingredients must be correctly listed and named.
e) Instructions for preparation and storage conditions must be valid.
f) Expiry date, shelf-life information must be correctly addressed.
g) Ingredients and precautionary labeling for major allergens must be appropriate.
h) The text must be readable, with type, size, color, contrast and placement of the text in line with regulatory
requirements and Nestl's internal legibility policy.
i) In case of multi-lingual labelling, information must be consistent for all the languages, in particular with
respect to allergens and quantitative ingredient declarations.
j) Where relevant, the intended use of product, e.g. age of consumer, preparation instructions must be correctly
addressed.
k) Health claims must comply with Nestl requirements as in Policies and regulatory requirements, and be
documented, validated, documented.
5. Management Responsibility
The management is committed in ensuring FSMS is applied and also that:
a) The Food Safety policy is supported by the groups business objectives.
b) The Food Safety policy has been communicated at all levels of the organization.
c) The management team members ensure that personnel understands and implements measures according
to their respective responsibilities within FSMS.
d) Management Reviews are conducted.
a) The Nestl Quality Policy includes the Nestl Food Safety Policy, which covers food safety, regulatory and
customer requirements.
b) In the case the Nestl Policy is translated and/or adapted into a local one, it must be aligned with the Nestl
Policy and be approved by the Market/Region management.
Food Safety management planning requires that:
a) There are food safety/regulatory compliance-related factory objectives. Objectives are specific, measurable,
achievable, relevant and time-framed (SMART).
b) The food safety objectives are known, understood and applied consistently.
c) The principles of the FSMS are maintained when changes are implemented.
a) The management team members are aware of Nestl FSMS requirements and their impact on food safety.
b) The members of the management team take leadership initiatives for the development and implementation
of the Nestl FSMS requirements. When they observe or are informed about problems with the FSMS system,
actions are immediately initiated, recorded and reported to the Food Safety Team Leader.
c) All personnel is aware of their responsibility to immediately report food safety related issues to their
supervisors or to the Food Safety Team Leader or facility Manager.
d) All details on responsibilities are documented.
a) A Food Safety team leader has been nominated for the facility.
b) The Food Safety team leader must have knowledge and hands-on experience on hygiene management and
on the application of the HACCP principles.
c) The Food Safety team leader's responsibilities and authority are clearly defined: they include coordinating
and leading the food safety team, ensuring training on food safety is effective and that Nestl FSMS is
understood, implemented, maintained.
d) The Food Safety Manager reports to the facility and/or Market Quality Manager on the effectiveness of the
FSMS
a) Authorized persons responsible for communicating externally, e.g. with regulatory authorities, suppliers,
customers, other external organizations, on any information concerning food safety have been defined and are
known by all relevant personnel.
b) There is a procedure in place to inform the Food Safety Team Leader on external communication.
a) The members of the local management team receive updates on food safety and quality by means of, for
example, Business Reviewss and Management Review of Quality,
b) All relevant technical instructions issued by Nestec are received by the facility
c) The food safety-related information issued by Nestec is communicated to the appropriate people in the
facility.
d) Quality Briefs issued by CO-QM are received by the facility and used for prevention
e) The food safety team must be informed on changes potentially affecting food safety so that timely action can
be taken.
a) When changes occur such as in the line, recipe, vendor, raw material, new hazards, new country for export,
there is a formal procedure for reporting, assessing, decision-making, communicating and implementing the
necessary actions.
b) Assessment of changes includes the possibilities for product contamination or deterioration during transport
and distribution, and its misuse by the consumer.
c) Every change must be evaluated for its possible impact on food safety and regulatory compliance using
appropriate tools such as HACCP for food safety hazards.
d) The Food Safety team leader is informed of changes in a timely manner.

e) Personnel understands the importance of reporting a change and to whom to report it.
a) The Facility Manager, Food Safety Team Leader and othe rmembers of the management team are aware of
potential emergency situations (e.g. fire, flooding, bioterrorism and sabotage, energy failure, vehicle accidents
and contamination of the environment) which may impact on the safety of the products. If such a situation
occurs, the product and raw/packaging materials which might have been affected are immediately blocked and
evaluated according to the procedures on handling of non-complying products.
a) The Food Safety management system is reviewed at least annually by the management team.
b) A review of the achievement of the objectives with respect to the food safety policy and the overall
effectiveness of the FSMS must be carried out.
c) Gaps and opportunities identified during all internal and external assessments , visits, P-tests, etc. must be
turned into an action plan identifying the persons responsible and defining the time-frame. The progress must
be systematically tracked to determine if actions are completed in due time. Modifications of action plans must
be documented.
d) The review is important for Continuous improvement (see 8.5.1)
The following items have been taken as an input to the review process:
a) Outcome of previous reviews, audits or inspections (internal and external).
b) Analysis of results of verification activities.

c) Specific needs with regard to organizational matters, human resources, equipment and investment
d) Results of system-updating activities
e) FTR, incidents, recalls and withdrawals.
f) Communication and training needs.
g) Changing circumstances that can affect food safety
h) Consumer and customer complaints
The output from the management review includes decisions and actions related to :
a) Improved assurance of food safety
b) Improved effectiveness of the FSMS
c) Resource needs
d) Revised food safety objectives
6. Resource management
a) The facility shall provide adequate resources for the establishment, implementation, maintenance and
updating of the FSMS.
a) The food safety team and other personnel implementing food safety and regulatory activities, including
HACCP studies, must have appropriate knowledge and experience in line with their individual responsibilities.
a) The Management team must receive training on food safety, quality management, regulatory compliance and
evaluation of the implementation and effectiveness of the food safety management system, according to the
scope of their responsibility.
b) All facility personnel must have been trained on hygiene, GMP and food safety.
c) All non-Nestl personnel such as contractors must receive basic training on hygiene, GMP and food safety
d) Implementation and effectiveness of the training activities are evaluated and necessary actions taken.
e) Personnel training records are kept up-to-date.
a) The facility shall provide resources for the establishment and maintenance of the infrastructure needed to
implement requirements of Nestl FSMS
a) The working environment is adequate for employees to perform their task effectively (sufficient light to read
the measuring equipment, to see foreign materials, etc).
b) Equipment, tools and material must adequate for employees to perform their task efficiently.
c) Investments made in the previous year or the plan of the current year indicate that priority was given to food
safety related improvements and modifications.
7. Planning and realization of safe product

a) The facility shall plan and develop the processes needed for the realization of safe products.
b) The facility shall implement, operate and ensure the effectiveness of the planned processes and any
changes to them.
a) New processing lines must be validated. Validation, including design, installation, operational and
performance qualification, and its acceptance by a team must be a critical step during the scaling up of a new
process and during the transfer to a factory
b) Before a new or modified product is launched or before a new, modified or transferred line is started-up, it
must be ensured that HACCP and QMS are prepared and updated and that regulatory compliance of the
product is met, including packaging, ingredients, processing conditions and labeling information. Methods must
be available to demonstrate safety and regulatory compliance.
c) The data gathered from the first commercial runs of a new/modified product shall be reviewed in order to
verify that the product meets food safety and regulatory requirements.
d) Before new or existing products are exported, it must be ensured that the intended use of the product is
checked by the receiving market and regulatory requirements of receiving countries are met.
e) The impact of local conditions on the quality and safety of products in the selling market, including probable
unfavourable conditions during transportation and distribution such as temperature, shall be considered when
designing the product.
PRP(s) must be established, implemented and maintained to assist in controlling:

a) Likelihood of introducing food safety hazards to products via the processing environment
b) Microbiological, allergen, chemical and physical contamination of products including cross contamination
c) Food safety hazards associated with the products and their process environment
The PRPs shall be:
a) Appropriate to the facility needs with regard to food safety
b) Appropriate to the size and type of operation and the nature of the products being manufactured and
handled
c) Implemented across the entire production system either as programmes applicable in general or as
programmes applicable to a particular product or operational line
d) Approved by the food safety team
When selecting and/or establishing PRPs documents to be considered are:
a) Regulatory and consumer requirements
b) Information from industry guidelines
c) Mandatory elements from NGMP.
d) Specific product requirements for foods produced
e) Any additional requirements linked to local environment
General requirements:
a) Each facility must have an up-to-date Master Plan with site boundaries and access control.
b) Buildings shall be designed, constructed and maintained according to the nature of the processing
operations to be carried out, the food safety hazards associated with those operations and the potential
sources of contamination from the plant environment.
c) Buildings shall be of durable construction which represents no hazard to the product. For example, roofs
should be self-draining with no leaks.
d) Ensure compliance to NEMS checklist as per GI 14.001 and environmental requirements as per GI-14.020
e) Buildings used for the storage and distribution of Nestl products must provide the adequate infrastructure to
enable a high quality, cost effective logistics operation.
f) Painted surfaces should comply with the hygiene requirements of food production and storage.Eg Solvent
free, mineral based paints are preferred. Glossy/shiny paints are preferred to matt paints because of their
higher smoothness, which helps to prevent dust, water or residue from settling in and contaminating the
surface.
Substrate mostly cement plaster or concrete must be firm, dry, and free from dust and dirt.
Environment and Locations of establishments:

a) Consideration shall be given to potential sources of contamination from the local environment. Food
production should not be carried out in areas where potentially harmful substances could enter the product.
b) The site boundaries shall be clearly identified. Appropriate barriers at boundaries must be in place and
maintained to prevent entry of potential vectors of contamination
c) Access to the site shall be controlled.
d) The site shall be maintained in good order. Vegetation shall be tended or removed,
e) Roads, yards and parking areas shall be drained to prevent standing water and shall be maintained.
f) Waste collection and effluent treatment must not be sources of contamination to the plant
g) All reservoirs of potential contamination outside buildings must be minimized to reduce risks of ingress into
process areas.
h) Regular monitoring of potential sources of contamination and vectors must be made and documented
considering historical, existing and changing local environment with actions taken according to deviations.
k) The effectiveness of measures taken to protect against potential contaminants shall be periodically
reviewed.
a) Internal layouts shall be designed, constructed and maintained to facilitate good hygiene and manufacturing
practices. The movement patterns of materials, products and people, and the layout of equipment, shall be
designed to protect against potential contamination sources.
b) All facilities must have an up-to-date zoning plan in line with the master plan.
c) The zoning plan must be known by all factory personnel, each of whom understands which relevant routines
apply to their activities.
d) Adequate barriers with correct routines must be established to prevent ingress and spread between zones of
potential contaminants with e.g. dust, infiltrations and pests.
e) Halls,corridors, warehouses,gangways,offices,pallet stacks, platforms must be kept clean,
organized,arranged and tidy.
f) Maintenance and monitoring of consistent operation of barriers must be ensured and documented.
g) Visitors and 3rd parties must respect routines at barriers, with no exceptions to facility rules being permitted.
Internal design, layout and traffic patterns:

a) The building shall provide adequate space, with a logical flow of materials, products and personnel, and
physical separation of raw/unprocees from processed areas.
b) Risk and security analysis
c) Openings intended for transfer of materials shall be designed to minimize entry of foreign matter and pests.
Internal building structures and fittings:
a) Building elements must be used to separate process areas from the outside in accordance with zoning
definitions.
b) Design must be simple, avoiding ledges and recesses.
c) Surfaces must be accessible, cleanable and maintained.
d) Elements of building, especially roofs and joints, must not be the source of infiltrations into process and
storage areas.
e) Construction materials must be used that are long-lasting, resistant to climatic conditions and safe for
personnel(occupational exposure controls,hygiene measures,respiratory protection,hand-eye & skin protection,
environmental exposure controls, slip resisitance).
f) Walls and floorsof processing area shall be washable or cleanable, as appropriate for the process or
identified hazards. Materials shall be resistant to the cleaning procedures applied. Wall floor junctions and
corners shall be designed to facilitate cleaning. It is recommended that wall floor junctions are rounded in
processing areas.
g) The conditions of grounds must be inspected on a regular basis and results should be documented.An
action plan for improvement must be in place
h) Floors shall be designed to avoid standing water. In wet process areas floors shall be sealed and drained.
i) Ceilings and overhead fixtures shall be designed to minimize build up of dirt and condensation.
j) External opening windows, roof vents or fan, where present, shall be insect screened.
k) External opening doors shall be closed or screened when not in use.
l) The warehouse layout which is to store Nestl products (Finished goods, but also Raw and Pack material as
well as other assets of Nestl) must meet high standards of hygiene, safety, environmental protection and
operational efficiency.
Drains and drainage:
a) Drains shall be designed, constructed and located so that the risk of contamination of materials or products
is avoided.
b) Drains shall have a capacity sufficient to remove expected flow loads.
c) Drains shall not pass over processing lines or leak over exposed lines on lower floors.
d) Drainage direction shall not flow from a contaminated area to a clean area.
e) Drainage systems must be chosen according to the type of cleaning and hygiene level of the zone; for dry
cleaned areas, there should be either no drains or dry drains. Any wet drains shall be trapped and covered.
Location of equipment:
a) Equipment shall be designed and located so as to facilitate good hygiene practices and monitoring.
b) Equipment shall be located to permit access for operation, cleaning and maintenance.
Laboratory facilities:
a) In-line and on-line test facilities shall be controlled to minimize risk of product contamination.
b) Specifically the main microbiology laboratory shall be designed, located and operated so as to prevent
contamination of people, plant and products. It must not open directly to a production area.
Temporary/mobile premises and vending machines:
a) Temporary structures shall be designed, located and constructed to avoid pest harbourage and potential
contamination of products.
b) Additional hazards associated with vending machines shall be assessed and controlled, not forgetting the
drink dispensers for personnel.
Storage of food, packaging materials, ingredients and non food chemicals (see warehousing 7.2.16)
a) The provision and distribution routes for utilities to and around processing and storage areas shall be
designed to minimize the risk of product contamination.
b) Industrial services must not become sources of contamination by direct or indirect contact with product.
c) Monitoring and regular maintenance of all industrial services - filters, water and steam must be carried out
with responsibilities for such activities clearly defined.
d) Establish and apply PRPs and HACCP for the whole water distribution system associated with the facility.All
types of water, including recycled or re-used are included in HACCP studies for each product or in a separate
specific HACCP study for water. All identified CCPs, OPRPs and CPs are included in the QMS/GLOBE
inspection plans along with, where appropriate, critical or action limits, monitoring procedures, verification and
actions/corrective actions in case of deviations.
Water supply
a) A water map must be availale with enough detail as to represent the major water process units, including the
closed-loop water systems. All water consumers must be represented, and all wastewater generators must be
represented
b) The supply of potable water shall be sufficient to meet the needs of the production processes including
cleaning. Potable water should conform to the World Health Organizations Guidelines for drinking-water
quality.
c) As for all raw materials used in processes, water must be traceable with regards to origin and time of
tapping.Traceability can be achieved by linking origin of the water, time of use and related analytical data.
d) Systems for storage and distribution shall be designed to meet specified water quality requirements. It is
recommended that water that can come into contact with the product should flow through pipes that can be
disinfected.
e) Individual water specifications and monitoring must reflect the specific quality requirements of each
product/process step. Water used as a product ingredient, including as ice or steam (including culinary steam),
or in contact with products or product surfaces, shall meet specified quality and microbiological requirements
relevant to the product.
f) Where there is temperature control of the water and a risk of indirect product contact e.g. jacketed vessels,
tempering systems, heat exchangers shall meet specified quality and microbiological requirements relevant to
the application.
g) Where water supplies are chlorinated, checks shall ensure that the residual chlorine level at the point of use
remains within limits given in relevant specifications.
h) Non potable water shall have a separate supply system that is labelled, not be connected to the potable
water system and is prevented from reflux into the potable system.
i) Appropriate sampling plans with defined sampling points are established. Required analytical results are
available and trended.
j) Cow water or recycled water (where used) must comply with requirements
Culinary steam
a) Culinary steam must not be a source of toxic chemicals and other contaminants.
b) Boiler chemicals, if used, shall be exclusively either:

1) Approved food additives which meet relevant or
2) Additives which have been approved by the relevant regulatory authority as safe for use in water intended for
human consumption.
c) Boiler chemicals shall be stored in a separate, secure (locked or otherwise access controlled) area when not
in immediate use
d) Release procedures should meet the requirements of the relevant HACCP study
Air quality and ventilation:
a) The facility shall establish requirements for filtration, humidity (RH%) and quality of air used as an ingredient
or for direct product contact. Where temperature and/or humidity are deemed critical, a control system shall be
put in place and monitored at the air handling unit (AHU).
b) Ventilation or extraction shall be provided to remove excess or unwanted steam, dust and odours, and to
facilitate drying after wet cleaning.
c) Room air supply quality shall be controlled using appropriate AHUs to minimize risk of contamination with
dust and micro-organisms and of excessive humidity. It is mandatory to source 2 and 3-Star AHUs from Nestec
qualified suppliers.
d) Filters supplying air in direct contact with product and with the potential to introduce pathogens must be
regularly monitored and replaced when necessary
e) Programs for air quality monitoring e.g. using AHU gauges and other parameters shall be established in
areas and within equipment where products which support growth or allow survival are exposed.
f) Ventilation systems shall be designed and constructed in such a way that air does not flow from
contaminated or raw areas into clean areas. Specified air pressure differentials shall be maintained. Systems
shall be accessible for cleaning, filter changing and maintenance.
g) Exterior air intake ports shall be examined periodically for physical integrity and any new local source of
potential airborne contaminants.
Compressed air and other gases:
a) Compressed air, carbon dioxide, nitrogen and other gas systems used in manufacturing and/or filling shall
be constructed and maintained so as to prevent contamination. Based on the results of the HACCP study, the
compressed air standard is defined for each compressed air user. This standard indicates the minimum
requirements to avoid product contamination by compressed air.
b) Gases intended for direct or incidental product contact (including those used for transporting, blowing or
drying materials, products or equipment) shall be from a source approved for food contact use, filtered to
remove dust, oil and water.
c) Where oil is used for compressors and there is potential for the air to come into contact with the product, the
oil used shall be food grade. Use of oil free compressors is recommended.
d) Requirements for filtration, humidity (RH%) and microbiology shall be specified. Filtration of the air should be
as close to the point of use as is practicable.
Lighting:
a) The lighting provided (natural or artificial) shall allow personnel to operate in a hygienic manner. The intensity
of the lighting should be appropriate to the nature of the operation.
b) Light fixtures shall be protected to ensure that materials, product or equipment are not contaminated in the
case of breakages.
a) Systems shall be in place to ensure that waste materials are identified, collected, removed and disposed of
in a manner which prevents contamination of products or production areas.
b) Containers for waste and inedible or hazardous substances shall be clearly identified for their intended
purpose; located in a designated area; constructed of impervious material which can be readily cleaned; closed
when not in immediate use; sealed/closed well where the waste may pose a risk to the product.
Waste management and removal:

a) Provision shall be made for the segregation, storage and removal of waste. Accumulation of waste shall not
be allowed in food handling or storage areas. Removal frequencies shall be managed to avoid accumulations,
with a minimum daily removal.
b) Labelled materials, products or printed packaging designated as waste shall be disfigured or destroyed to
ensure that trademarks cannot be reused. Removal and destruction shall be carried out, under company's
supervision, by approved disposal contractors who can destroy the materials in a safe, legally acceptable and
environmentally compatible manner. The facility shall retain records of destruction.
Product contact surfaces:
a) Shall be designed and constructed to facilitate cleaning, disinfection and maintenance. Contact surfaces
shall not affect, or be affected by, the intended product or cleaning system.
b) Shall be constructed of durable materials able to resist repeated cleaning, being also impermeable and rust
or corrosion free.
c) Must be designed for the type of product.
d) Must have been designed and installed according to HACCP, thereby ensuring that safe food can be
produced
e) Must be able to produce consistent product having been assessed for process capability.
Hygienic design:
Equipment shall be able to meet established principles of hygienic design, including:
a) Smooth, accessible, cleanable surfaces, self draining in wet process areas;
b) Use of materials compatible with intended products and cleaning or flushing agents;
c) Framework not penetrated by holes or nuts and bolts.
d) Where required, access for sampling and monitoring
e) Ease to maintain as appropriate for the process.
f) Absence of hollow bodies where there are risks of product contact.
g) Design and installation to avoid production of foreign material from metal-to-metal contact, e.g. star valves,
augers, screw feeds.
h) Associated piping that is cleanable, drainable, and with no dead ends.
i) Design to minimize contact between the operators hands and the products and moving parts; also for
personnels safety.
j) use preventive foreign bodies check lists
k) Ensure a risk assessment (HACCP) is carried out, when product is exposed, to anticipate the appearance
and reduce sources of Foreign Bodies
Temperature control and monitoring equipment:
a) Equipment used for thermal processes shall be able to meet the temperature gradient and holding
conditions given in relevant product specifications.
b) Equipment shall have adequate and hygienically designed sensors for the monitoring and control of the
temperature.
Cleaning plant, utensils and equipment (see 7.2.11)
Preventive and corrective maintenance:
a) TPM is used as the Nestl methodology to implement the Nestl Maintenance Strategy, under the NCE
umbrella.
b) Maintenance must not lead to product contamination. LOTO practices must be respected taking into
consideration that it must not represent a foreign body risk. Therefore, particularly after major maintenance,
areas and/or lines must be released for production by a team (QA, Production and Engineering) and this action
must be documented. The procedure for releasing maintained equipment back to production shall include
validated clean up, where specified in process cleaning procedures, and pre-use inspection are performed. The
equipment must comply with the established NGMP visual standard.
c) A preventive maintenance programme shall be in place. The preventive maintenance programme shall
include all devices used to monitor and/or control food safety hazards. Examples of such control devices can
include screens & filters (including air filters), magnets, metal detectors , X-ray detectors, food radar etc.
d) In all cases where glass containers (bottles, jars) are used for packaging products, the implementation of
glass breakage procedures, as described in GI-31.715 is mandatory. It must be covered through PRPs, OPRPs
and/or CCPs and verified.
e) Corrective maintenance shall be carried out in such a way that production on adjoining lines or equipment is
not at risk of contamination.
f) Maintenance requests which impact product safety shall be given priority.
g) Maintenance of equipment in High Hygiene Areas must follow the directives mentioned in the MI-08.719
h) Temporary fixes shall not put product safety at risk. A request for replacement by a permanent repair shall be
included in the maintenance schedule.
i) Materials for maintenance, especially those with potential direct product contact, e.g. lubricants, must come
from approved suppliers applying GMP and traceability; part of supplier specification. Lubricants and heat
transfer fluids shall be food grade where there is a risk of direct or indirect contact with the product.
j) Local area PRP requirements shall apply to maintenance areas and maintenance activities in process areas.
Maintenance personnel shall be trained in the potetntial hazards associated with their activities. A responsible
person must supervise maintenance after production hours.
k) Products and equipment must be protected during maintenance, especially from extraneous matter and
fumes.
l) Replacements parts must be controlled to ensure that they will not be the source of contamination.
m) Damaged and worn out utensils and tools must be removed so they do not become sources of foreign
bodies
n) Use the product category foreign body tool kits in assessing the risks associated to the areas of operation in
order to prevent and control the risks at the source.To serve as a trouble shooting guide for foreign body issues
and as a training tool for new operators
o) Operators/mechanics should receive training on the key elements related to hygienic design and foreign
body prevention for each specific equipment or installation. Personnel and any 3rd parties/visitors must have
an understanding of relevant aspects that lead to generation of foreign bodies. Training on relevant aspects
related on reducing Foreign Bodies by design, operate , maintain with the use also of problem solving
techniques at all levels is critical.
a) Purchasing of materials which impact food safety shall be controlled to ensure that the suppliers used have
the capability to meet the specified requirements. The conformance of incoming materials(including auxiliary or
promotional items) to specified purchase requirements and written specifications shall be verified and release
system is implemented.
b) All suppliers must comply with the appropriate aspects of NGMP and FSMS (Food / Packaging Safety and
Quality) and.with the responsible sourcing assessment process.
c) No expired materials (raw and packaging materials, rework and semi-finished goods) are allowed to be
used.
Selection and management of suppliers:
a) There shall be a defined process for the selection, approval and monitoring of suppliers as per GI-31.104.
The process used shall be justified by hazard assessment, including the potential risk to the final product. This
includes assessment of the suppliers ability to meet quality and food safety expectations, requirements and
specifications
b) Has the vendor risk classification resulting in an approval procedure for each vendor site? Approval has to
be based on:
- High quality risk vendors: vendor audits by Nestl staff (minimally on food safety components important for
Nestl).
- Low quality risk vendors: acceptance of certification schemes or analytics.
c) Monitoring of the performance of the supplier to assure continued approval status shall be documented.
d) Suppliers must ensure traceability.
Incoming material requirements (raw/ingredients/packaging):
a) Transport conditions of materials must not result in their contamination or damage.
b) Delivery vehicles shall be checked prior to, and during, unloading to verify that the quality and safety of the
material has been maintained during transit e.g. seals are intact, free from infestation, temperature records
exist,
c) Materials shall be inspected, tested or covered by certificate of analysis to verify conformance to specified
requirements prior to acceptance or use. The method of verification shall be documented and scope will be
based on the hazard presented by the material and the risk assessment of the specific suppliers. Moreover the
Minimum Remaining Shelf Life requirement (MRSL) must be respected
d) All incoming material must have written specifications icluding the shipping material associated with finished
goods including returnable packaging material,auxiliary items,material to come in contact with food. For the
allergenic material ASL specifications must be defined.
e) Materials which do not conform to relevant specifications shall be handled under a documented procedure
which ensures they are prevented from unintended use.
f) Access points to bulk material receiving lines shall be identified, capped and locked. Discharge into such
systems shall take place only after approval and verification of the material to be received.
g) Rejected lots must be handled correctly and disposed of as necessary.
a) Quality Programs shall be in place to prevent, control and detect physical, chemical, allergen and
microbiological contamination.
b) Status of prevention of cross contamination is part of pathogen monitoring programme (see specific section
below 7.2.10.1)
Microbiological cross contamination:
a) Areas where potential for microbiological cross contamination exists shall be identified and a zoning plan
implemented.
b) A hazard assessment shall be carried out to determine potential contamination sources, susceptibility of the
product and control measures suitable for these areas and should cover for example separation of raw from
finished products; structural segregation with physical barriers; access controls with requirements to change
into required work wear; circulation of people, materials, equipment and tools; use of dedicated tools; air
pressure differentials.
Allergen management (see specific section below 7.2.10.2)

Physical contamination:
a) Foreign body occurrence in raw materials and in the process, must be monitored ,trended in control charts
and foreign body identification performed.
b) Each factory must have a library or logbook of foreign bodies originating from the factory and its raw
materials.
c) Where glass and/or breakable material is used, periodic inspection requirements and defined procedures in
case of breakage shall be put in place. Glass and hard plastic components in equipment should be avoided
where possible or replaced where necessary by elements made of shatterproof material. The implementation
of the GI-31.715 is mandatory
d) Glass breakage records shall be maintained.

e) Based on hazard assessment, measures shall be put in place to prevent, control or detect potential
contamination and include for example adequate covers over equipment or containers for exposed materials or
products; use of screens, magnets, sieves or filters;
f) Detection/ rejection devices such as metal detectors or X-ray shall be installed where appropriate.
h) Rejected products must be investigated before releasing the product
a) Pathogen and hygiene monitoring programs are in place
b) Raw material, environmental, line and finished product pathogen and hygiene monitoring programs are in
place for the relevant product groups and they are part of the factory QMS.
c) Relevant factors such as zoning, type of cleaning,risk of contamination of products, historical results,
regulatory requirements, HACCP studies,instructions like respective MIs,etc. have been considered in the
design of the program and the establishment of the hygiene control levels.
d) Documentation of the pathogen and hygiene monitoring program contains a routine and investigative
sampling plan, types of pathogens, hygienic indicators analysed and analysis method.
e) Monitoring is conducted at the prescribed frequency as shown on the monitoring program of the product
category.
f) Corrections / Corrective actions are promptly taken when the results of pathogen and hygiene monitoring
indicate a deviation from set limits. Root cause(s) are thoroughly investigated and promptly resolved.
g) Data collected through hygiene and pathogen monitoring activities are carefully examined and analysed for
trends.
a) Allergens present in the product, either by design or by potential manufacturing cross contact, shall be
declared (see more details below on labelling of allergens). Exception are petfoods.
b) Allergens which are present in ingredients (by nature) have been properly identified and addressed in the
HACCP study. Allergens which are potentially present due to cross contact, both at the suppliers or at a Nestl
facility, have been properly identified and addressed in the HACCP study.
c) Products shall be protected from unintended allergen cross contact: a) by cleaning and line change-over
practices and/or product sequencing. Manufacturing cross contact may arise from for example traces of
product from the previous production run which cannot be adequately cleaned from the product line due to
technical limitations; when contact is likely to occur, in the normal manufacturing process, with products or
ingredients that are produced on separate lines, or in the same or adjacent processing areas. b) by transport or
storage. An Allergen Matrix with all raw materials must be established for all products run on each shared line
d) Rework containing allergen(s) shall be used only in products which contain the same allergen(s) by design;
or through a process which is demonstrated to remove or destroy the allergenic material. Rework allergen
matrix exists
e) Allergen awareness and management must be covered in quality training programs for the production and
QA personnel.
f) A Major Allergen Declaration (MAD) is available for raw materials as well as semi-finished products supplied
by external vendors to the factory and is appropriate.
g) Adequate allergen information for materials from internal vendors must be available as either a MAD or the
equivalent information stored in SAP.
Labelling of allergens:
a) The declaration shall be on the label for consumer products, and on the label or the accompanying
documentation for products intended for further processing. A procedure is in place to ensure that all major
allergens and/or allergens required under local regulations are declared on the label
b) When potential cross-contacts are identified labelling shall include precautionary labelling This procedure
also includes inter-market supply, changes in the layout of artwork and ingredient changes.
c) The factory shall be involved in the label development and approval procedure ensuring that allergen
labelling information is correct on new lots of incoming packaging material and that correct packaging material
with the appropriate allergen information is used with special attention during product changeover at the same
line.
a) Cleaning programmes shall be established during the line commissioning already to ensure that the food
processing equipment and environment are maintained in a hygienic condition.
b) Cleaning must be considered as a process step, preparing the line for products.
c) Risks of process line contamination must be reduced by appropriate cleaning of the environment.
d) Cleaning procedures for process lines must be validated with all information documented in the form of a
protocol.
e) Cleaning programmes shall be monitored at frequencies specified to ensure their continuing suitability and
effectiveness
f) All cleaning must be supervised, under the responsibility of production
g) Third parties must not be used for cleaning of product contact surfaces.
h) Safety of personnel during cleaning must be part of the cleaning plan.
Cleaning plant, utensils and equipment
a) Must be easy to clean as appropriate for the process.
b) Wet and dry cleaning programmes shall be documented to ensure that all plant, utensils and equipment are
cleaned at defined frequencies. The programmes shall specify what is to be cleaned, responsibilities, the
method of cleaning (e.g. CIP/COP), and the use of dedicated cleaning tools, removal or disassembly
requirements and methods for verifying the effectiveness of the cleaning.
c) Cleanability of equipment and any other product contact surfaces must be validated and verified. Visual
standards must be established.
Cleaning agents and tools:
a) Facilities and equipment shall be maintained in a condition which facilitates wet or dry cleaning
b) Cleaning agents and chemicals shall be clearly identified, of suitable quality for ti purpose (e.g. food contact
surfaces), stored separately and used only in accordance with the manufacturers instructions.
c) Tools and equipment shall be of hygienic design (photos used are useful) and maintained in a condition
which does not present a potential source of extraneous matter.
d) Suppliers of cleaning products must be able to provide data with supporting analytical data ensuring the
absence of unacceptable potential contaminants.
Wet Cleaning programmes:
a) Cleaning programmes for equipment or other product contact surfaces shall be validated to ensure that all
parts equipment are cleaned to a defined schedule, including the cleaning of cleaning equipment.
b) Cleaning programmes shall specify at a minimum areas, items of equipment and utensils to be cleaned;
responsibility for the tasks specified; cleaning method and frequency; monitoring and verification arrangements;
post-clean inspections; pre start-up inspections.
c) Results must be documented with action being taken in case of unacceptable results.
d) Cleaning must precede disinfection.(for dry cleaning disinfection only applies exceptionally)
e) Cleaning must be effective and efficient, especially for and after the heat process step.
f) Chemicals must not contaminate products.
Cleaning in place (CIP) systems:
a) CIP systems shall be separated from active product lines.
b) Parameters for CIP systems shall be defined and monitored (including type, concentration, contact time and
temperature of any chemicals used
These points will be part of the Quality Monitoring Scheme (QMS) and will have associated specifications.
c) 6T's of CIP must be respected and validated.

Dry cleaning programmes
a) For most dry processes, no attempt must be made to wet clean unless justified to prevent crosscontamination by e.g. allergens, non-Kosher or non-Halal residues if there are not dedicated lines.
b) The environment of a dry cleaned process must not be wet cleaned.
c) Dry cleaning must be done with dedicated vacuum cleaners and/or well-designed, durable brushes.
Controlled wet cleaning of environment:
a) A critical option that must be adopted where limiting use of water helps prevent build-up of contamination.
General requirements: consult the GI-31.122
a) Hygiene, cleaning, incoming materials inspection and monitoring procedures shall be implemented to avoid
creating an environment conducive to pest activity.
b) All products spills must be cleaned immediately, as this is an important preventive measure against pests
c) All efforts must be made to prevent products from being contaminated by pests or their excrements.
d) Pest prevention is the responsibility of the supplier, factory, storage facility or other food-handling
establishment, even though an outside pest control service may be used.
Pest management & control programmes:
a) The establishment shall have a nominated person to manage pest control activities and deal with appointed
expert contractors.
b) Pest management programmes shall be documented and shall identify target pests, and address plans,
methods, schedules, control procedures and, where necessary, training requirements.
c) Programmes shall include a list of chemicals which are approved for use in specified areas of the
establishment.
Preventing access:
a) Buildings shall be maintained in good repair. Holes, drains and other potential pest access points shall be
sealed.
b) External doors, windows or ventilation openings shall be designed to minimize the potential for entry of
pests.
Harbourage and infestations:
a) Storage practices shall be designed to minimize the availability of food and water to pests. Material found to
be infested shall be handled in such a way as to prevent contamination of other materials, products or the
establishment. Potential pest harbourage shall be removed.
b) Where outside space is used for storage, stored items shall be protected from weather or pest damage
Monitoring and detection:
a) Pest monitoring programmes shall include the placing of detectors and traps in key locations to identify pest
activity. A map of detectors and traps shall be maintained.
b) Detectors and traps shall be designed and located so as to prevent potential contamination of materials,
products or facilities.
Eradication:
a) Eradication measures shall be put in place immediately after evidence of infestation is reported.
b) Pesticide use and application shall be restricted to trained operatives and shall be controlled to avoid
product safety hazards.
c) Records of pesticide use shall be maintained to show the type, quantity and concentrations used; where,
when and how applied, and the target pest.
a) Requirements for personal hygiene and behaviours proportional to the hazard posed to the process area or
product shall be established and documented. All personnel, visitors and contractors shall be required to
comply with the documented requirements.
b) Standards of personal hygiene are a must for all people working with food products and must be in line with
the image that Nestl portrays to our clients and consumers.
Personnel hygiene facilities and toilets:
a) Personnel hygiene facilities shall be available to ensure that the degree of personal hygiene required by the
organization can be maintained.
b) The facilities shall be located close to the points where hygiene requirements apply and shall be clearly
designated. Employee hygiene facilities must not open directly onto production, packing or storage areas;
c) The need for regular hand washing must be constantly emphasized.
d) Gloves do not replace hand washing and in food processing, where food is not intimately handled, wearing
gloves does not provide significant extra food protection. Use of latex gloves must be avoided
e) Facilities shall provide adequate numbers, locations and means of washing and drying hands. This includes
wash basins with a supply of hot and cold or temperature controlled water and soap. The sinks designated for
hand washing shall be separate from sinks for food use and equipment cleaning stations. Taps at hand wash
stations should not be hand operated.
f) An adequate number of toilets of appropriate hygienic design (*or in compliance with the local sanitary
regulations) shall be provided, each with hand washing and drying
g) Changing facilities shall be sited to enable food handling personnel to move to the production area in such a
way that risk to the cleanliness of their work wear is minimized.
Staff canteens and designated eating areas: consult GI-31.717
a) Staff canteens and designated areas for food storage and consumption shall be situated so that the
potential for cross contamination of production areas is minimized.
b) Staff canteens shall be managed to ensure hygienic storage of ingredients and preparation, storage and
serving of prepared foods. Storage conditions and storage, cooking and holding temperatures, and time
limitations, shall be specified.
c) Employees own food shall be stored and consumed in designated areas only.
Work wear and protective clothing:
a) Management must provide essential clothing and footwear for personnel. Personnel who work in, or enter
into, areas where exposed products and/or materials are handled shall wear work clothing that is fit for
purpose, clean and in good condition.
b) Clothing worn for food protection or hygiene purposes shall not be used for any other purpose. Such clothing
and footwear should not be exposed to contamination outside the facility environment.
c) Work wear shall not have buttons. Work wear shall not have outside pockets above waist level. Zips or press
stud fastenings are acceptable.
d) Work wear shall be laundered to standards and at intervals suitable for the intended use of the garments.
e) Work wear shall provide adequate coverage to ensure that hair, perspiration, etc. cannot contaminate the
product. Hair, beards and moustaches shall be protected (i.e. completely enclosed) by restraints in processing
areas. Long sleeves must be worn in case of activities where exposed product can be contaminated
f) Where gloves are used for product contact, they shall be clean and in good condition.
g) Shoes for use in processing areas shall be adequate for safety of the person, fully enclosed and made from
non absorbent materials.
Health status:
a) Employees shall undergo a medical examination prior to employment in food contact operations including
site catering, unless documented in official publications and/or hazard or medical assessment indicate
otherwise. Additional medicals shall be carried out at intervals defined by the organization, subject to legal
restrictions in the country of operation.
Illness and injuries:
a) Where stated by law, employees shall be required to report the following conditions to management for
possible exclusion from food handling areas: jaundice, diarrhoea, vomiting, fever, sore throat with fever, visibly
infected skin lesions and discharges from the ear, eye or nose.
b) People known or suspected to be infected with, or carrying, a disease or illness transmissible through food
shall be prevented from handling food or food contact materials.
c) In food handling areas, personnel with wounds or burns shall be required to cover them with specified
dressings.
Personal cleanliness:
a) Personnel in food production areas shall be required to wash hands before starting any food handling
activities, immediately after using the toilet or blowing the nose and immediately after handling any potentially
contaminated material. Washing of hands also applies as a rule to all visitors to production areas.
b) Personnel shall be required to refrain from sneezing or coughing over materials or products. Spitting
(expectorating) shall be prohibited.
c) Fingernails shall be kept clean and trimmed.
Personal behaviour:
A documented policy shall describe the behaviours required of personnel in processing, packing and
storage areas. The policy shall at a minimum cover:
a) Permissibility of smoking, eating, chewing in designated areas only;
b) Control measures to minimize hazards presented by permitted jewellery, including specific types of jewellery
which may be worn by the personnel in processing and storage areas, taking into account religious, ethnic,
medical and cultural imperatives.
c) Permissibility of personal items, such as smoking materials and medicines, in designated areas only;
d) Prohibition of the use of nail polish, false nails and false eyelashes and of piercing at body exposed areas
like: head, face and hands.
e) Prohibition of carrying of writing implements behind the ears;
f) Maintenance of personal lockers so that they are kept free from rubbish and soiled clothing;
g) Prohibition of storage of product contact tools and equipment in personal lockers.
h) Any lost item such as tools, glasses, dressings of wounds and sampling tools shall be reported to
supervision immediately.
a) Rework shall be stored, handled and used in such a way that product safety, quality, traceability and
regulatory compliance are maintained.
b) Rework must be handled correctly as would any ingredient and used only after appropriate release.
c) Market returns (products having left areas managed by Nestl) must not be used as rework. Such products
must be destroyed according to the same procedures used for disposal of unsafe products
Storage, identification and traceability:
a) Stored rework shall be protected from exposure to microbiological, chemical or extraneous matter
contamination.
b) Segregation requirements for rework (e.g. allergen) shall be documented and met.
c) Rework shall be clearly identified and/or labelled to allow traceability. Traceability records for rework shall be
maintained.
Rework usage:
a) Where rework is incorporated into a product as an in-process step, the acceptable quantity, type and
conditions of rework use shall be specified. The process step and method of addition, including any necessary
pre-processing stages, shall be defined.
b) Where rework activities involve removing a product from filled or wrapped packages, controls shall be put in
place to ensure the removal and segregation of packaging materials and to avoid contamination of the product
with extraneous matter.
c) The rework classification or the reason for rework designation shall be recorded (e.g. product name,
production date, shift, line of origin, shelf life).
a) Systems shall be in place to ensure that products failing to meet required food safety standards can be
identified, located and removed from all necessary points of the supply chain.
Product recall requirements:
a) A list of key contacts in the event of a recall shall be maintained.
b) Where products are withdrawn due to immediate health hazards, the safety of other products produced
under the same conditions shall be evaluated. The need for public warnings shall be considered.
a) Maintenance of product quality must be ensured in the supply chain after production, during storage and
distribution.
b) Incoming materials and products shall be stored in clean, dry, well ventilated spaces protected from dust,
condensation, fumes, odours or other sources of contamination.
c) If returned for exceptional reasons, defective stock and market returns must be stored in a separate and
secure area, preferably in another building
d) Any exceptions for bulk or agricultural crop materials shall be documented in QMS/FSMS
Warehousing requirements for Storage of food, packaging materials, ingredients and non food
chemicals
a) Facilities used to store ingredients, packaging and products shall provide protection from dust,
condensation, drains, waste and other sources of contamination.
b) Effective control of warehousing temperature, humidity and other environmental conditions shall be provided
where required by product or storage specifications.
c) Storage areas shall be designed or arranged to allow segregation of raw materials, work in progress and
finished products. A separate area or other means of segregating materials identified as non-conforming shall
be provided.
d) All materials and products shall be stored off the floor and with sufficient space between the material and the
walls to allow inspection and pest control activities to be carried out. It is recommended that where products
are stacked, consideration is given to measures necessary to protect the lower layers.
e) Waste materials and chemicals (cleaning products, lubricants, and pesticides) shall be stored separately. A
separate, secure storage area shall be provided for cleaning materials, chemicals and other hazardous
substances.
f) First expiry First Out (FEFO) is observed and expired products are not used in production.
g) Gasoline, diesel or butane gas powered fork lift trucks shall not be used in food ingredient or product storage
areas.
Vehicles, conveyances and containers:
a) Vehicles, conveyances and containers shall be maintained in a state of repair, cleanliness and condition
consistent with requirements given in relevant specifications.
b) Vehicles, conveyances and containers shall provide protection against damage or contamination of the
product. Control of temperature and humidity shall be applied and recorded where required by the organization.
c) Where the same vehicles, conveyances and containers are used for food and non food products, certified
cleaning shall be carried out between loads.
d) Bulk containers shall be dedicated to food use only. Where required by the facility, bulk containers shall be
dedicated to a specified material.
Product information:
a) Reliable Information shall be presented to consumers in such a way as to enable them to understand
healthier diets and make informed choices. Final approved label text has to be embedded into the product
brief. Information may be provided by labelling or other means, such as company websites and
advertisements, and may include storage, preparation and serving instructions applicable to the product.
b) Online recognition systems are mandatory for factories producing NN, NHSc/HCN products to confirm that
all delivered labels and packaging are identical in all respects to the reference artwork.
Labelling of products (see 7.4.2)
General requirements
a) Each establishment shall assess the hazard to products posed by potential acts of sabotage, vandalism or
terrorism and shall put in place proportional protective measures.
b) The maintenance of an effective traceability system for food materials is required by many legislations and
regulations.Upstream and downstream traceability must be documented.Vendor upstream traceability must be
verified during vendor audits.
Access controls
a) Potentially sensitive areas within the establishment shall be identified, mapped and subjected to access
control. Where feasible, access should be physically restricted by use of locks, electronic card key or
alternative systems.
b) Security guarding services must be performed by outsourced security staff (unless exceptional local
circumstances indicate in-house staff should be employed, in such cases, in-house employees must receive
external, professional training).
c) Building security , fencing,vehicle and pedestrian access control must follow the security requirements
d) In accordance with local regulations, pre-employment screening procedures should be performed, before
appointing a new employee or contracted staff.
e) Conduct a program of periodic security seminars for all employees involved in cargo handling and
documentation processing.
f) security precautions and guidelines are integral part of the SOPs established and used by markets and
businesses to manage Carriers relationships
g) Vehicle/containers seals should be of a design that prevents re-use, requiring them to be irrevocably broken
in order to gain access to the protected merchandise.
h) Documentation must be detailed and accurate, as specified by the laws and regulations of the exporting as
well as the importing country.
i) Shipping documents must correctly reflect all necessary cargo details
j) provide a secure working environment to Nestl staff and to mitigate security risks for operations, the risk
assessment of Supply Chain must be conducted under the guidance of the market Nestl Group Security.
Based on risk assessment, the proper security Standard Operating Procedures (SOPs) for all cargo handling
facilities and transport operations along the Supply Chain must be established and implemented
a) All relevant information needed to conduct the hazard analysis shall be collected, maintained, updated and
documented.
b) A list of regulations that the products/processes/practices must meet have been established and kept up-todate.
c) There is a system to identify any new or changed legislation. When information is received on new or
changed legislation, they are immediately taken into consideration.
a) Responsibilities for the coordination and execution of the HACCP study must be clearly defined.
b) Appropriate experts, e.g. the microbiologist, chemical/allergen experts or engineers have been included in
the HACCP team or have been consulted when they are not available on the factory site.
c) Their names and expertise are specified in the HACCP documentation.
a) Specifications must be available for all raw materials used as ingredients, packaging materials, promotional
items, cleaning chemicals, materials used in the process, industrial services.
b) Where appropriate for HACCP, raw material and primary packaging material specifications should include
biological, chemical and physical characteristics, composition including additives and processing aids, origin,
method of production, packaging, storage conditions, shelf life, how to prepare before usage.
a) The following documents shall be available: release criteria for raw materials, processing parameters and
specifications, specifications for intermediate and finished products, recipes and manufacturing instructions,
including thermal processing specifications (where relevant).
b) Finished product specifications include the following information as appropriate: name, composition,
biological, chemical and physical characteristics, intended shelf life, expiry date and storage conditions,
packaging, labeling related to food safety and/or instructions for handling, preparation and usage, age of
consumer where appropriate, method(s) of distribution.
The product is thoroughly described with assessed risk in the HACCP study with the following
information:
a) Product, its ingredients, packaging, shelf-life, labeling and any associated promotional items
b) Target consumers and intended use & "possible misuse"
a) An accurate flow diagram, which covers all steps including raw materials, process/storage activities and
transport, is available. The flow diagram indicates any outsourced processes and subcontracted work if they
exist. It shall also include inter factory transfer
b) All raw materials/ingredients including, rework, auxiliary systems (e.g. air, steam and water in direct contact
with the product) and packaging materials are listed.
a) The flow diagram indicates existing control measures, process parameters or procedures that may influence
food safety and the CCPs
b) The flow diagram has been verified by the HACCP team on the site and is updated when changes occur
c) Regulatory and customer requirements which may impact the choice of control measures and severity of the
control measures are described when they exist.
A HACCP study is available for all the products/lines.
a) Includes physical, chemical (including packaging contaminants), microbiological and nutritional hazards e.g.
essential vitamins and allergens and is based on data collected, experience, external information, pHACCP
studies, databases on food safety hazards, early warning systems.
b) Addresses each hazard specifically, e.g. Salmonella, C. botulinum, lead, dioxin, glass, peanuts
c) Existing control measures / PRPs for each hazard are mentioned specifically, e.g. cleaning, heat treatment,
sieving and changing of filters.
d) For each hazard identified, the acceptable level of the hazard in the end product is determined whenever
possible. This level takes into account the regulatory and customer food safety requirements.
a) For each potential hazard identified, a hazard assessment is conducted to determine whether its elimination
or reduction to acceptable levels is essential to the production of a safe food i.e. hazard is significant and its
control is needed to enable the defined acceptable levels to be met.
b) The likelihood of occurrence and the possible severity of adverse health effects are evaluated to decide if a
potential hazard is significant or not using technical information e.g. monitoring data for occurrence of a
chemical, audit reports of supplier, Major Allergen Declaration (MAD) and epidemiological information on the
occurrence of a pathogen
c) Rationale and results of the hazard assessment shall be recorded.
a) A control measure or a combination of control measures must be selected for each significant hazard which
needs to be controlled.
b) If control measures are already in place, the effectiveness of the current control measures is reviewed
against the significant hazard. If the current control measures are not effective, new, modified or additional
control measures must be defined.
c) If there are no control measures in place, a control measure or a combination of control measures must be
selected and validated.
d) The control measures are categorized so as to be managed through OPRP(s) or by the HACCP plan
(CCPs).
a) The operational PRPs must be documented in the QMS, stating the food safety hazards, control measure(s),
monitoring procedures, corrections to be taken when they are not under control, responsibilities and records of
monitoring.
For each CCP and OPRP:

a) Have the CCPs and OPRPs from the model HACCP been compared with the ones of the factory HACCP or
pHACCP? Have differences been addressed (corrected, differences justified and feedback provided to relevant
PTC or R&D Centers
b) Control parameters and critical limits (CCP) or action limits (OPRP) must be identified, validated, monitored
and verified.
c) Corrective actions to be taken in case of deviations at CCPs and OPRPs are clearly defined
d) Responsibilities for carrying out of each step the HACCP plan are noted in the QMS, which is available at
appropriate work stations
a) Each CCP and OPRP must be associated with the relevant control measure
a) Control parameters and critical limits have been identified and validated, as appropriate.
a) A monitoring procedure e.g. monitoring method, monitoring frequency, sampling, sampling location,
analytical method, calibration and necessary corrections must be identified and validated, as appropriate.
b) Monitoring of control parameters of the CCPs and OPRPsare part of the release criteria.
c) Monitoring records of CCPs and OPRPS, including corrections, are systematically reviewed to verify that
above requirements are implemented and to identify additional corrective actions for repeated deviations.
a) Planned corrective actions must be taken when critical limits are exceeded.
b) These actions must ensure that the CCP is brought back under control and that recurrence is prevented.
c) After rejection, procedures must be applied to make certain that these potentially unsafe products are not
released. Documents must exist confirming unsafe products were not released.
a) Following the establishment of operational PRP(s) and the HACCP plan, the information must at a minimum
be updated annually including product characteristics, intended use, flow diagrams, process steps and current
control measures. However within the year, updates must be initiated by any changes to such product and
process details.
b) Updates can also be initiated due to a change in risk factors e.g. suppliers, climatic conditions for
mycotoxins, a change in the regulatory requirements
c) Such updating must be done in the QMS so it is in line with the modified HACCP study.
a) Verification procedures are in place to ensure that PRPs, control measures for operational PRP(s) and
elements within the HACCP plan) are adequately implemented. A documented program is available with the
verification methods, frequency and the person(s) responsible for the activity.
b) Results of verifications at CCPs and OPRPs are part of the release procedure.
Verification activities include reviewing monitoring records, deviations, effectiveness of corrective
actions and taking follow-up actions, covering:
a) Handling of rejected product
b) Calibration results for the equipment used in monitoring of CCPs and operational PRP(s)
c) Visual inspecting operations to observe if control measures are under control
d) Analytical testing
e) Auditing monitoring procedures
f) Analyzing samples of environment
g) Process or end products
h) Reviewing consumer or customer complaints

A traceability exercise must be conducted regularly, at least once a year, and corrective actions taken
when needed. Traceability must be in place for all products and includes:
a) Links to upstream traceability and internal tracking in the factory till finished product is ready for shipment.
b) Links to downstream traceability until change of ownership.
c) Rework.
d) Recording data in accordance with regulatory and customer requirements e.g. from a key account customer
a) There is a documented procedure in place to specify when, by whom and how the actions are identified and
taken when non-compliance is encountered. The actions include; reviewing non-compliances (including
customer complaints), reviewing trends of monitoring results, evaluating the need for corrective actions,
determining, implementing and recording the actions taken and evaluating the effectiveness of the corrective
actions.
a) Corrective actions are recorded.

b) Incidents are thoroughly investigated (including root causes and responsibilities); necessary corrective
actions are taken.
c) Following an incident, learning lessons are discussed with relevant employees, corrective actions are
followed up and necessary measures are taken to prevent future similar incidents.
d) There is an incident report for each incident and it includes the root causes of the incident, corrective actions
and learning lessons.
a) All lots of product that may have been affected by a non-complying situation are held in "blocked" status until
they have been evaluated.
b) Non-complying products are properly evaluated. Each lot of affected product is released only if there is
evidence to show that the product is safe.
a) A documented release procedure with criteria is in place for finished products and raw materials.
b) Release criteria cover compliance with CCPs and OPRPs.
d) Responsibilities for release are defined and are independent of the production function
e) The procedure defines exceptional release, scope and authority. All exceptional release must adhere to this
procedure.
f) All release is well documented. If it is an exceptional release, this is noted next to the signature of the release
authority.
a) Written procedures are in place to identify, control and handle non-complying product.
b) The release status is indicated - visually and/or electronically - for each product lot.
c) Goods that are blocked and goods that are waiting for release are clearly identifiable to prevent nonauthorized dispatch. In case of electronic status control, additional physical status labeling is advised for
blocked products to avoid incidents.
d) If the lot of product is evaluated as "not acceptable for release", it is either reprocessed or further processed
to ensure that food safety hazard is eliminated or reduced to acceptable levels or destructed and/or disposed
as waste.
a) There is a procedure which defines responsibilities clearly in case of a recall: such as identification and
isolation of the incriminated lot with a safety margin, clearly marking the blocked products and moving them to
a separate area of the factory or warehouse, making available all processing records, daily production figures,
quality assurance records, raw and packaging material, examination and release data, traceability data,
processing downtime data and description of any problems.
b) The head office (TM or Corporate QM) must be immediately informed in case of a problem which may imply
a recall or withdrawal.
c) The recall system is tested at least annually to identify the areas for improvement.
rification and improvement of food safety management system

The food safety team shall plan and implement the processes needed to validate control measures and/or
control measure combinations and to verify and improve the FSMS.
a) The food safety team shall validate that the chosen control measures (alone or in combination) that are
capable of achieving the intended control of the food safety hazard to obtain products that meet defined
acceptable levels.
b) Any doubts arising from such validation studies shall result in modifications e.g. in process, raw materials
etc.
a) Is thermal processing (e.g. retorts, hot fill, double stage processing) included in the HACCP study and QMS
as a CCP? For factories having thermal processes (TP):
- Have TP been established / validated following recognized industry protocols?
- Is the re-qualification (temperature distribution study following recognized industry protocol) not older than 3
years?
- Has a TP specialist been nominated at factory level? Has a successor been identified?
- Has the TP specialist got in contact with a TP Expert (e.g. market / regional level) for validation and approval
of the thermal processes? If an external expert is used, has he been approved by the TP Community
Manager?
- Has a training program been developed and implemented for TP personnel?
- Are measurement equipment for temperature distribution and heat penetration studies available for the
manufacturing site?
b) Aseptic processes have been validated by thermal processing experts according to technical instructions.
c) For the other thermally-processed products, e.g. hot-filled products, heat treatment conforms to Nestl
technical instructions and internationally recognized standards.
d) Documentation for process validation is readily available.
e) Thermal process specifications exist for all thermally-processed products.
a) Accuracy of all test equipment and measuring instruments, used for the control of CCPs, release parameters
and monitoring activities for food safety and regulatory compliance, shall be suitable for their purpose, e.g. the
detection limit meets the requirements of regulatory authorities.
b) All such instruments whether in the laboratory or on the process floor, are controlled through an effective and
routine calibration/verification program. If an outside service is used for calibration, its competence in the
calibration has been carefully evaluated before approval.
c) The calibration/verification procedure contains at least the following elements:

- Frequency of calibration/verification
- Calibration against official standards with certified accuracy, either directly or via "in house" standards;
- Calibration of new equipment and instruments prior to use;
Immediate repair or replacement of inaccurate or damaged standards and instruments;
- Re-assessment of the affected product whenever the calibration/verification results are not accptable
d) Calibration/verification records are maintained.

e) Personnel who perform the calibration as well as those who perform tests using the equipment are trained
and competent in their duties.
Refer aslo to GI-31.113 and GI-31.215 and associated checklist
All analytical methods used in the control of monitoring and release parameters are covered by an
Internal Control Plan (ICP)
a) Participation in P tests for all monitoring parameters, release parameters and regulatory compliance
monitoring parameters.
b) Frequency of use of reference samples for the above analytical methods.
c) Control charting.
d) Frequency of checks of rapid methods against reference methods.
Refer to GI-31.113 and GI-31.215 and associated checklist
a) There is an internal audit procedure which is documented and implemented. Responsibilities and
requirements for planning and conducting audits, reporting the results and maintaining the records are defined
in the procedure.
b) Internal auditors (factory and/or market) are trained on Nestl FSMS requirements including the ISO 22000
standard.
c) Internal audits are scheduled taking into consideration e.g. the status of the processes and areas, the results
and needs for updating actions from the previous internal audits and the other audits, a specific and/or
recurrent problem, communications on incidents and cases, newly recognized food hazards from early
warnings etc.
d) When an audit is conducted, the manager responsible from the area being audited ensures that necessary
actions to eliminate non-conformities and their causes are taken without any delay.
e) Internal audit results are followed up, the actions taken as a result of audits are verified and reported to the
facility management and the market Quality Manager by the Food Safety Team Leader.
h) The Nestl FSMS self-assessment is verified by the Market Quality department with a quality assessment at
least once a year.
a) The food safety team shall systematically evaluate results of planned verification.
b) If verification does not demonstrate conformity action must be taken to review existing procedures,
communication channels, OPRPs, HACCP plan, PRPs and effectiveness of current training.
a) Data collected through verification activities are carefully examined and analyzed in terms of compliance and
trends. Verification activities confirm that hazard levels are within acceptable limits.
b) The results of verification activities, including internal and external audits are systematically analyzed by the
Food safety team in Food Safety Team meetings. The results of analyses are recorded and reported to the
facility management and market Quality Manager as an input for management review and for updating the
FSMS
a) The management team shall ensure the effectiveness of the FSMS which shall be continuously improved by
use of communication, management review, internal audits, evaluation of individual verification results, analysis
of results of verification activities, validation of the combinations of control measures and corrective actions.
The Food Safety Team evaluates the FSMS once a year and activities are based on:
a) Input from internal (information on changes) and external communication
b) Output from the analysis of results of verification of activities
c) Output from management review
d) Input from other information concerning the suitability, adequacy and effectiveness of the FSMS.
(FSMS) and includes references from ISO 22000:2005, ISO 22002-1:2009 and additional Nestl mandatory elements from the N
es. It also applies to non-branded products manufactured in factories under Nestl management.
ording to the actual processes within a unit/facility, there may be some requirements that are not totally applicable. Such exce
ir own, providing the latter is equivalent to that of Nestl.
RATING
YES
NO
N/A
22002-1:2009 and additional Nestl mandatory elements from the Nestl Good Manufacturing Practices (NGMP)
factories under Nestl management.
ay be some requirements that are not totally applicable. Such exceptions need to be documented with explanations.
EVIDENCE OF NON-CONFORMITY
ACTION
Deadline
(NGMP)
xplanations.
ACTION
Responsibility
CORRECTIVE ACTIONS

Annex - 2 - FSMS Checklist

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Annex - 2 - FSMS Checklist

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ANNEX 2 to GI-31.

Terms and definitions

4. Food Safety Management S

4.2. Documentation requirements

4.2.2 Control of documents

4.2.3 Control of records

4.2.4 Nestl QMS

4.2.5 Regulatory requirements, documentation and

5.1 Management commitment

5.2 Food safety policy

5.3 Food safety management system planning

5.4 Responsibility and authority

5.5 Food safety team leader

5.6.1 External communication

5.6.2 Internal Communication

5.6.2 Internal Communication

5.6.3 Management of change

5.7 Emergency preparedness and response

5.8 Management Review

5.8.2 Review input

5.8.3 Review output

6.2.2. Competence, awareness and training

6.4. Work environment

7. Planning and realization of saf

7.1.1 New product development

7.2. Prerequisite programmes

7.2.2. Scope of PRPs

7.2.3. Input for PRP selection

7.2.4 Construction and layout of buildings

7.2.4 Construction and layout of buildings

7.2.5 Layout of premises and workspace

7.2.6 Utilities air, water, energy

7.2.6 Utilities air, water, energy

7.2.7 Waste disposal

7.2.8 Equipment and maintenance

7.2.8 Equipment and maintenance

7.2.9 Management of purchased materials

7.2.10 Measures for prevention of cross contamination

7.2.10.1 Pathogen monitoring

7.2.10.2 Allergen control

7.2.10.2 Allergen control

7.2.12 Pest control

7.2.12 Pest control

7.2.13 Personal hygiene and employee facilities

7.2.15 Product recall procedures

7.2.15 Product recall procedures

7.2.17 Product information / consumer awareness

7.2.18 Food defence, bio vigilance and bio terrorism

7.3 Preliminary steps to enable hazard analysis

7.3.2 Food safety team

7.3.3 Product characteristics

7.3.3.1 Raw material, ingredients and product contact

7.3.3.2 Characteristics of end products

7.3.3.2 Characteristics of end products

7.3.4 Intended use

7.3.5 Flow diagram, process steps and control measures

7.3.5.1 Flow diagram

7.3.5.2 Description of process steps and control measures

7.4 Hazard Analysis

7.4.2 Hazard identification and determination of

7.4.3 Hazard assessment

7.4.4 Selection and assessment of control measures

7.5 Establishing the operation prerequisite program