HACCP and GMP Self Assessment Checklist
HACCP and GMP Self Assessment Checklist
HACCP and GMP Self Assessment Checklist
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
1.3.2 A programme to measure and improve HACCP will support the food safety culture Develop and implement a policy or
food safety culture shall be established and of an organization. However, HACCP on programme to build a positive food safety
maintained. its own does not guarantee a strong food culture by demonstrating commitment
safety culture. to providing safe and suitable food and
encouraging appropriate food safety
practices.
1.4 Roles, responsibilities and authorities
1.4.1 Roles, responsibilities and authorities with Identify the resources required to maintain Identify and assign the roles and
an impact on food safety shall be clearly and implement the HACCP plan. responsibilities to those authorized to impact
communicated in the organization. food safety.
1.4.2 Position descriptions or equivalent, All positions shall have good knowledge Document position descriptions including
should be available for all positions that of the product and processes within their roles and responsibilities for those authorized
have a responsibility for food safety and organization. to impact food safety.
maintenance of the HACCP system.
1.5 Controls for documented information
1.5.1 A system to manage documented These are requirements for having Implement a system for managing all
information (electronic and hardcopy) shall documented information of the food documentation related to the maintenance
be implemented to ensure the currency safety system (i.e. hardcopy and digital of the HACCP food safety system in the
of documentation in use and provide a documents and records). following areas:
system for records to be retained and
readily retrieved. Documentation and record • Control and issue
keeping should be appropriate to the nature • Communication on updates
and size of the organization and sufficient to • Removing obsolete documents
verify that the HACCP controls are in place • Control of customer-facing materials
and being maintained. This may include, but
is not limited to:
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
1.6.2 The organization shall have access to, and The organization needs to have access The organization and its HACCP team shall
control of, external documents or references to external resource documents and show evidence of how they are using external
required to maintain the HACCP system. references to support ongoing. resources to keep the HACCP food safety
This may include but is not limited to food system up to date on an ongoing basis.
safety statutory and regulatory requirements,
codes of practice, guidelines and standards
appropriate to the country in which the food
products are manufactured and sold.
BSI HACCP & GMP Self-assessment checklist 5
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
2.1 HACCP system
2.1.1 The organization shall develop, document Develop and implement HACCP-based Ensure the HACCP-based food safety system
and implement a HACCP system based on food safety system based on Codex is documented.
the Codex Alimentarius General Principles of Principles as outlined in the application
Food Hygiene. section of the Codex Guideline.
2.2 The HACCP team
2.2.1 The organization shall identify and document Assemble members of the HACCP team. Document the members of the HACCP team
the members of the HACCP team. and their responsibilities.
2.2.2 The HACCP team shall comprise those Sufficient expertise is required within the It is preferable to have the HACCP
within the organization who have the skills HACCP team to understand and apply team represented by several functional
and knowledge to develop and maintain the HACCP preliminary steps, principles and departments of the organization.
HACCP plan. It is preferable to have a multi- methodology.
functional HACCP team.
2.2.3 Where a consultant has been engaged by The consultant needs to be appropriately A copy of the consultant’s qualifications shall
the organization to assist in the development trained. be kept on record.
and ongoing maintenance of the HACCP
system, the organization shall ensure
that the consultant holds appropriate
qualifications.
2.2.4 The organization shall demonstrate they are The responsibilities shall be reflected Document the members of the HACCP team
responsible for the day-to-day management in the job descriptions for those who and their responsibilities for the day-to-day
of the HACCP system. manage the HACCP system. management of the HACCP system.
2.3 Scope and purpose of the HACCP plan
2.3.1 The scope of the HACCP plan shall be Define the scope of the HACCP plan Document the scope of the HACCP plan
defined and documented to define the start including: within the HACCP system.
and end point of the process(es) under
consideration and the products covered in i) Start and end point of the processes
the HACCP system.
ii) Products covered
BSI HACCP & GMP Self-assessment checklist 6
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
2.3.2 The purpose of the HACCP system shall Apply the awareness of specific hazards Define the purpose of the HACCP plan.
include the intent that all food safety hazards for raw materials, production or preparation
will be identified and controlled. Food safety process, and environment in which the
hazards may include but are not limited food is handled.
to: biological, chemical, physical (foreign
matter), allergen and radiological hazards
as appropriate to the products in the scope
of the HACCP plan.
2.4 Product description and intended use
2.4.1 A product description shall be developed A product description needs to be Document a product description, intended
and documented for all products included developed for each product. use and identify consumers for each product
within the scope of the HACCP system. category.
2.4.2 ‘Like’ products that are processed in ‘Like’ products may exist under one Determine if any “like” products can be
similar ways may be grouped together HACCP study or HACCP family. grouped under one HACCP family or
in one product description. Products HACCP study. Include “like” products when
that are processed using different food developing product descriptions.
safety controls, processing techniques or
packaging methods shall have a separate
product description.
BSI HACCP & GMP Self-assessment checklist 7
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
2.4.3 A product description for each product or These are the minimum requirements Document a product description, intended
group of products shall detail the following (but not limited to) to develop product use and identify consumers for each product
information: description, intended use and identify or product category.
consumers.
• Composition (e.g. formulation/ingredients)
• Physical and chemical characteristics (e.g.
final product aW, pH, addition of
preservatives)
• Production methods and technologies
(e.g. heat treatment, high pressure
processing (HPP), freezing, drying,
brining, etc.)
• Primary and secondary packaging (e.g.
type of packaging used, durability,
functional effect on food safety such as
extension of shelf life etc.)
• Storage, handling and distribution methods
(e.g. refrigerated/ambient transport
requirements)
• Shelf life (including best-before or use-by
date coding)
• Intended use of the product(s)
Labelling requirements including any
claims as per local legislation in the
country of sale
• Allergens as per local legislation in the
country of sale
• Sensitive consumers
Some or all of this information may be
contained within finished product
specifications
BSI HACCP & GMP Self-assessment checklist 8
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
2.6.3 Identification and assessment of hazards Types of hazards shall not be grouped Consider all individual hazards for the product
are not to be grouped (e.g. foreign matter together because the control measure will and process and determine the cause of
which shall be separated into wood need to be specific to that individual type each hazard to identify the appropriate
splinters, packaging materials, hair, etc.). of hazard. control measure for each.
The identification of potential hazards should
also take into consideration hazards reported
in food recalls and outbreaks of foodborne
illness as appropriate to the product,
process and global supply chains.
2.6.4 The HACCP team shall evaluate the hazards The significance of potential hazards The HACCP team shall show evidence
to identify the hazards that are essential to will be dependent on the severity or that they have applied the HACCP food
prevent, eliminate or reduce to acceptable consequence of the hazard if it occurs safety risk assessment methodology to
levels for the production of safe food (i.e. and the likelihood of the hazard occurring. the products and processes to facilitate
identify significant hazards). Severity/consequence is normally fixed, safe food production and meet compliance
however the likelihood of the hazard requirements of food safety standards.
occurring will change depending on the
effectiveness of the control measures for
each hazard.
2.6.5 Hazards that are reasonably likely to occur Types of hazards shall be specific to the Determine a control measure which is specific
in the absence of control and reasonably control measure. to the cause of the hazard.
likely to cause illness or injury if present shall
be identified and controlled by measures
designed to prevent or eliminate these
hazards or reduce them to an acceptable
level.
2.6.6 Where the organization has included quality The HACCP team needs to identify Where the organization has identified quality
hazards in the HACCP plan, these are to potential food safety hazards hazards to be included, assess these
be identified in the risk assessment. These (allergen, regulatory, quality, chemical, separately to the safety hazards.
hazards shall be considered separately to microbiological and other).
the food safety hazards.
BSI HACCP & GMP Self-assessment checklist 10
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
2.6.7 When determining significant hazards, the The HACCP team needs to apply risk Determine significance of potential hazards
HACCP team shall consider the following as assessment methodology to assign levels using a severity and likelihood methodology
applicable to the product and process: of severity and likelihood of occurrence which is documented in the form of a hazard
and identify the control measures analysis.
• Hazards known to be associated with the that reduce the likelihood of a hazard
type of food, ingredients used in the occurring.
product and process steps
• Likelihood of occurrence of hazards,
taking into consideration pre-requisite
programmes, in the absence of additional
control
• Likelihood and severity of adverse health
effects associated with the hazards in the
food in the absence of control
• Identified acceptable levels of the hazards
in the food (e.g. permissible additives and
maximum residue limits defined by
regulations in the country of sale)
• The food-handling environment and
equipment used to produce the food
product
• The likelihood of survival and/or growth of
pathogenic micro-organisms
• The potential for the presence of toxins
(e.g. mycotoxins), chemicals (e.g.
pesticides, drug residues) or foreign
matter (e.g. glass, metal, soft plastic)
• The intended use and/or probability of the
product being mishandled by potential
consumers that may cause the food to
become unsafe
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
2.6.8 For all hazards determined to be significant, Identify control measures for all hazards Document a relevant control measure to be
there shall be at least one control measure and determine critical control points applied for each CCP.
designed to prevent or eliminate the hazard, (CCPs) for significant hazards.
or reduce the hazard to an acceptable
level. Control measures may reference the
application of a pre-requisite programme
to reduce, prevent or eliminate a significant
hazard (e.g. cleaning of equipment to
prevent cross contact of food allergens from
one food to another food that does not
contain that allergen). In other instances, the
control measures shall be applied within the
process at critical control points (CCPs).
2.7 Critical control points
2.7.1 The HACCP team shall determine the critical The HACCP team shall determine CCPs CCPs need to be relevant to the control
control points for hazards identified in the which have specific food safety control measure that is controlling the type of hazard.
hazard analysis as significant hazards. CCPs measures which are appropriate to the
shall be established at steps where control process and product.
is essential to safe food production and
where a deviation could result in potentially
unsafe food. There may be more than one
CCP in a process at which control is applied
to address the same hazard. If no control
measures exist at any step for an identified
significant hazard, then the product or pro-
cess should be modified.
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
2.10.4 The organization shall also ensure that All personnel in food safety and HACCP Train the personnel who are undertaking the
personnel who conduct monitoring checks who are undertaking monitoring checks CCP monitoring checks and document the
are trained in the correct method and that must have appropriate training. training record.
training for CCP monitoring activities is
assessed and documented.
2.10.5 Records of CCP monitoring shall be Records of CCP monitoring will be used for Keep a record of monitoring and corrective
maintained to demonstrate a history of HACCP reviews, food safety management actions to prove that the HACCP plan was
compliance to critical limits. reviews and audits. followed.
2.10.6 All CCP records shall be signed or initialled CCP records need to be signed or initialled Ensure the person who does the monitoring
by the person performing the monitoring by the trained personnel conducting the are signs or initials each CCP record.
and shall report the results and timing of the monitoring.
monitoring activity.
2.11 CCP corrective actions
2.11.1 Specific written corrective actions shall be Predetermined corrective actions Check every CCP has both product and
developed for each CCP in the event that for product and process need to be process actions to be taken if critical limits are
critical limits are not achieved to prevent identified to ensure non-conforming not met.
the release of potentially unsafe food. or unsafe product is not sold and the
Actions shall be taken to segregate the food production process is corrected or
affected product and assess the safety of modified to prevent production of unsafe
the food product to ensure the appropriate food.
disposition.
2.11.2 The procedures shall state what action is A process action of ‘contact supervisor’ Document corrective action procedures
to be taken regarding the affected product, (for example) may not be adequate as which are appropriate and relevant to
who is responsible and what action is to be the supervisor will need to know what deviations that have occurred to fix the
taken regarding the process. actions to take. This may be documented immediate deviation and prevent from
in the HACCP plan or in a cross-referenced recurrence.
corrective action document to ensure
consistency of actions taken.
2.11.3 A root cause analysis should be conducted The procedures need to state what action CCP data needs to be collected and reported,
to identify and correct the cause(s) of the is to be taken regarding the affected including: monitoring records, corrective
deviation to prevent recurrence. product, the process for root cause actions taken when monitoring indicates
analysis and what will be done to prevent critical limits haven’t been met and verification
recurrence. of monitoring records.
BSI HACCP & GMP Self-assessment checklist 15
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
2.12.2.2 Verification shall include a comprehensive The HACCP system is expected to improve The review of the HACCP system should
review of the HACCP system annually or over time with continued experience in confirm:
when changes occur, to confirm the efficacy application of HACCP and the inclusion
of all elements of the HACCP system. The of new information. Periodic verification • The appropriate significant hazards have
review of the HACCP system shall confirm helps improve the plan by highlighting been identified
the following: weaknesses and ineffective control • Control measures and critical limits are
measures. adequate to control the hazards
• Appropriate significant hazards have been • Monitoring and verification activities are
identified occurring in accordance with the plan and
• Control measures and critical limits are are capable of identifying deviation
adequate to control the hazards • Corrective actions are appropriate for
• Monitoring and verification activities occur deviations that have occurred
as planned and are capable of identifying
deviations
• Corrective actions are appropriate for
deviations that have occurred
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
2.12.2.6 The organization shall undertake verification These verification activities challenge and Review the effectiveness of the HACCP plan
activities to confirm that GMP procedures confirm that the critical limits are relevant through verification activities to confirm the
have been effectively implemented and and that the corresponding monitoring and HACCP plan has worked.
that monitoring is occurring as planned, corrective action activities remain suitable.
and appropriate corrective actions are taken
when requirements are not met. Examples of
verification activities may include but are not
limited to the following:
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
2.12.3.4 Corrective action shall be taken when results When tests results are reviewed and Evidence of the corrective action taken shall
indicate that limits have been exceeded. deemed to have exceeded specification be documented.
Appropriate actions shall be taken to identify limits, appropriate corrective action shall
and isolate the product as per clause 3.8 be followed.
Control of Non-Conforming Product.
2.12.4.5 Records of test results and corrective Maintain records of test results and Evidence of the results and corrective
actions shall be kept. corrective actions for the life of the action(s) taken shall be documented.
product manufactured.
2.12.4 Shelf-life testing
2.12.4.1 New and re-developed products with a shelf Establish a procedure for shelf-life Document records of processing, production
life of less than two (2) years, shall have a determination and ongoing shelf-life and distribution retained for the purpose of
schedule of shelf-life testing documented testing parameters to meet the desired shelf-life validation and testing.
and implemented. The shelf-life testing shelf life for the product’s label.
schedule shall include the type of testing to
be undertaken and shall be carried out after
the expiry date of the product (i.e. not on the
date of expiry). Considerations for shelf-life
testing may include, but are not limited to
the following:
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
3.2 Cleaning
3.2.1 The organization shall develop, document, To maintain an effective cleaning Implement a full cleaning programme which
implement and maintain a cleaning programme to remove soil, food residue, covers the cleaning requirements including
programme to remove food residues which dirt, grease or other objectional matter but not limited to - all processing areas,
may be a source of contamination, including (such as allergens). equipment, amenities, staff facilities.
allergens. Cleaning may be carried out
using wet or dry cleaning methods, (e.g.
heat, scrubbing, turbulent flow, vacuum)
and chemical methods using solutions of
detergents, alkalis or acids. Cleaning meth-
ods and materials shall be appropriate to the
food type and the surface to be cleaned.
3.2.2 The programme shall identify the following The cleaning programmes are required Specific requirements are detailed for
(where appropriate): to ensure a suitable food storage and cleaning, sanitation and/or disinfection
processing environment. methods and procedures including the
• Areas within and outside the building that monitoring of effectiveness.
require cleaning
• Equipment that requires cleaning
(including cleaning equipment and waste)
• Between batch cleaning
• Method of cleaning and, where required,
sanitation (disinfection)
• Frequency of cleaning
• Chemicals used, if applicable (all cleaning
chemicals shall be approved for use within
a food production facility)
• Chemical concentrations, contact time
and temperature
• Persons responsible for cleaning
• Records of the monitoring of cleaning
• Appropriate training for cleaning personnel
BSI HACCP & GMP Self-assessment checklist 24
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
3.2.3 The cleaning programme shall state how The documented cleaning programme The cleaning procedures shall detail:
monitoring of cleaning is undertaken, the fre- shall include detail specific to each item or
quency of monitoring and corrective action requirement for cleaning. • how monitoring of cleaning is undertaken
to be taken if monitoring reveals that the • the frequency of monitoring
cleaning is not effective. • corrective action to be taken if monitoring
reveals that the cleaning is not effective.
Guidance note: Micro-organisms may become
tolerant to sanitizing (disinfecting) agents over
time. A periodic review with the organization’s
chemical supplier(s) should be completed to
ensure the sanitizer(s) (disinfectant(s)) used are
effective to ensure inactivation of different types
of micro-organisms (e.g. bacteria and fungi).
3.2.4 The condition of cleaning utensils and The condition of cleaning utensils and Implement regular inspections as part of GMP
equipment shall be assessed regularly to equipment need to be inspected regularly audits or checks prior to commencement of
ensure any worn equipment or utensils do to eliminate any potential for physical cleaning or at the finish of cleaning.
not pose a risk of cross contamination to the contamination to the process and product.
production process.
3.2.5 Environmental monitoring (e.g. protein and Cleaning should be in line with food Document procedures for the environmental
allergen test swabs or microbiological testing hygiene practice and the environmental monitoring programme. Records of sampling
for indicator organisms) to validate the control limits set out by the organization locations, methodology, corrective actions
effectiveness of the cleaning programme for its processes. and retests of sampling locations shall be
should be undertaken commensurate maintained.
with product and process risk. Records of
sampling locations, methodology, corrective
actions and retests of sampling locations
shall be maintained.
3.2.6 Where required, clean in place (CIP) systems Implement procedures for the use of CIP Document procedures for each CIP system or
shall have procedures documented and systems. machine.
implemented to ensure there are no residual
cleaning chemicals in products.
3.2.7 Validation of the CIP system shall be The CIP system method needs to be Validation data needs to be recorded for the
completed to ensure that the system is validated to determine the process CIP system at a regular defined frequency
capable of removing soiling and preventing capability for effectiveness of cleaning. which is determined based on product and
contamination of food products. The risk.
frequency of validation should be based on
product and process risk.
BSI HACCP & GMP Self-assessment checklist 25
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
3.2.8 Housekeeping and cleaning standards Check your cleaning programme is Collate records of cleaning and
shall be maintained in all areas to prevent documented to cover all of the areas housekeeping.
environmental contamination. required for cleaning and housekeeping.
3.3 Approved supplier programme
3.3.1 An approved supplier programme shall be Develop and document a programme Check your approved supplier programme
documented and implemented for products for the use of approved suppliers for is documented to cover all of the criteria
and services (ingredients, packaging, supplying inputs and services to the indicated.
chemicals, outsourced processes and organization.
third-party contractors) that may affect
the food safety or quality of the finished
product.
3.3.2 The approved supplier programme should Suppliers need to be assessed to ensure Collate records of supplier assessments,
include criteria for: they are capable of supplying inputs for information on supplier certification and any
the production of safe, quality products. service contracts ready for review at your
• Selecting and approving suppliers and audit.
service providers
• Emergency suppliers/providers
• Removing suppliers/providers
• Records of approval may include evidence
of regulatory compliance, certificates of
food safety certification, supplier
questionnaires and other formal
agreements
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BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
3.3.3 The method of monitoring incoming Receival records are required to Collate receival records for all incoming
products and services shall be documented provide the receival checks of suppliers inspections of raw materials and inputs.
and implemented and records maintained. completed to confirm acceptance by
Methods of monitoring may include but are the organization, including the criteria of
not limited to: acceptance.
3.4 Specifications
3.4.1 Documented specifications shall be available Microbiological, chemical or physical Maintain a register of all specifications for raw
for all raw materials (including packaging) specifications supported by monitoring materials, packaging and finished products
and finished products to ensure compliance procedures, analytical methods and (including WIP where required).
with relevant food safety and legislative action limits, (where appropriate) shall
requirements for food products handled by be made available by suppliers and/or
the site. internal specifications developed by the
organization.
BSI HACCP & GMP Self-assessment checklist 27
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
3.5 Labelling
3.5.1 The organization shall ensure there is a Labels on food products need to meet the Document a procedure for the checking and
process for the preparation and review of legal requirements for the country of sale. approval of labels.
labels which includes:
3.5.2 Records of labelling reviews shall be Conduct label reviews for all products Keep records of all label reviews.
maintained. (and new products in development) on a
defined regular basis.
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BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
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BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
3.6.2 Employees and contractors shall be trained All personnel accessing the site need to Maintain evidence of documented training
in the allergen management programme. be trained in the allergen management records for all employees and contractors.
programme. This includes contractors
(such a maintenance, cleaners, etc).
3.6.3 Compliance to the site allergen management The organization will need to assess all Have all steps from sourcing, to storage,
programme shall be maintained in all areas of steps in their process to maintain the ingredient preparation and production
operation. management of allergens. assessed to determine suitable controls for
the allergen management programme.
3.7 Packaging
3.7.1 All packaging shall be fit-for-purpose Packaging materials used in the Obtain specifications for packaging materials
taking into consideration the product manufacture / processing of food to demonstrate they are fit for purpose.
characteristics and handling in the supply products need to be fit for purpose and
chain. food grade.
3.7.2 Packaging shall be protected from Rooms needed for storage of packaging Maintain designated storage areas of
contamination when in storage. Packaging for the manufacture of food products shall packaging and monitor compliance during
should be stored in a designated area be separated or segregated from other GMP audits.
separate to food ingredients, finished storage areas.
products and non-food chemicals (including
cleaning materials, lubricants).
3.8 Control of non-conforming product
3.8.1 Controls for non-conforming product shall be Non-conforming product may be unsafe Confirm procedure details for the process for
developed, documented and implemented. to consume and should be segregated to segregation of non-conforming product.
As a minimum, non-conforming product shall prevent accidental use.
be segregated and identified to prevent
accidental release or use.
3.8.2 The procedures shall state what action is Pre-determined corrective actions Check every CCP has both a product and
to be taken regarding the affected product, for product and process need to be process action to be taken if critical limits are
who has responsibility for the action, identified to ensure non-conforming not met.
the need for root cause analysis and or unsafe product is not sold and the
what actions should be taken to prevent food production process is corrected or This may be documented in the HACCP plan
recurrence. modified to prevent production of unsafe or in a cross-referenced corrective action
food. document to ensure consistency of actions
taken
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
3.8.3 Records of non-conforming product for All non-conforming product records need Maintain all records relating to non-
raw materials and through all stages of the to include details of the non-conforming conforming materials and products.
process including rework shall be maintained issue and the product/material.
to ensure full traceability. Records may
include product hold, corrective actions and
disposal.
3.9 Traceability
3.9.1 The organization shall have a documented Suitable information is required for the next Document this procedure to identify how all
procedure that ensures, for all stages of person in the food chain to handle, store, inputs will be traced and recorded throughout
production from receival through to finished process, prepare and display the product production.
goods, products are clearly identified. This safely and correctly.
shall include (where applicable):
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
3.9.3 Records of traceability shall be Records are required to enable traceability Keep records of lot identification and
maintained. of products for a recall. traceability to facilitate potential product
recall and stock rotation. All food must have
information to identify the producer and the
lot and records of this information shall be
maintained.
3.10 Corrective action
3.10.1 The organization shall demonstrate that they The organization needs to identify the root Document all corrective action records.
are able to use information from identified cause, make necessary corrections and
failures in the HACCP system to identify the prevent re-occurrence for failures in the
root cause, make necessary corrections and HACCP system and food safety system.
prevent re-occurrence.
3.11 Recall
3.11.1 The organization shall have a documented An implemented recall programme Ensure the recall programme is documented
recall procedure in place that complies with is required to meet local legislation including records of all events or actions
the requirements of the local legislation in requirements in the country of sale. taken to remove from sale, distribution and
the country of sale. Recalls are conducted by food businesses consumption foods which may pose a safety
to ensure that potentially hazardous or risk to consumers.
unsafe foods are not consumed.
3.11.2 The annual review shall include a test of Food safety incidents and recalls provide Information on food safety incidents and near
the traceability process on at least an valuable information on the issues misses are also useful to review.
annual basis. This may be performed as a that need to be controlled to ensure
component of the mock recall and should production of safe food.
include a test of the forwards and backwards
traceability (this makes up part of the
product traceability exercise referred to in
clause 3.9 of this Criteria document).
3.11.3 Clear and accurate records of the recalls, Ensure records are maintained for food Ensure records are maintained for withdrawals
withdrawals and mock recalls shall be safety incidents, near misses, withdrawals and recalls.
maintained. and recalls.
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BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
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BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
3.12.2.2 Smokers waste shall be controlled to prevent External areas should be well maintained Inspect for cigarette butts in smoking areas
potential contamination of food products to prevent harbourage of litter such as being contained within receptacles and not
stored and handled by the facility. cigarette butts. loose on the ground where they could be
walked into food production areas.
3.12.3 Layout, product flow and segregation
3.12.3.1 The layout of premises and the flow of The layout of the premises and the flow Walk through production to assess the
operations, including the movement of of production must not compromise the process flow diagram and layout to identify
personnel, raw materials, utensils, packaging food safety of the end products and inputs any points of compromise.
rework and/or waste shall not compromise along the way.
the food safety of products.
3.12.3.2 Food handling areas that have different The intent of this requirement is to avoid Address the following:
levels of hygiene control (e.g. low-risk cross-contamination between people,
vs. high-risk area) shall have appropriate processes, equipment and products from • Are there segregated areas in your facility
segregation to minimize cross- different areas of risk. defined for different food processing
contamination. Segregation may include activities based on risk?
walls, partitions and/or allocation of areas • Walk through your premises to check the
within an open production area and adequacy of segregation
separation in time as appropriate to product • Are doors or plastic strip dividers intact and
and process risks. in place?
• Are designated storage areas provided for
high-care or high-risk food items?
• Is outer packaging (cartons) removed in
low-risk areas prior to transfer to high-care
or high-risk areas?
• Are there additional hygiene controls for
food handlers to move from low-risk to
high-care or high-risk areas?
• Is there a higher standard of housekeeping
and hygiene maintained in high-care and
high-risk areas?
3.12.4 Building fabric and equipment
3.12.4.1 The fabrication of the buildings shall be The condition of the building fabric, During construction of new areas, check
suitable for the intended purpose and its suitability for a food premise and its for the materials intended for use prior
constructed of durable materials that are able effectiveness of cleaning is a minimum to building. Ongoing checks for building
to be maintained, effectively cleaned and requirement. fabrication and its condition can be
where appropriate, sanitized (disinfected). monitored.
Building materials should be constructed of
non-toxic materials according to intended
use and normal operating conditions.
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3.12.4.2 Walls shall be impervious to moisture, Food handling and storage areas need Any wall surfaces that are damaged, have
maintained in good condition and easy to to be maintained in a clean condition holes, flaking paint or unclean surfaces
clean and maintain clean. to prevent contamination of food and should be repaired prior to your audit.
work areas. Flaking paint could fall onto
food handling work areas or equipment If this is not possible you will need an action
and be found in food as foreign matter. plan showing when the wall will be repaired
Cockroaches, rats and mice may be able and the controls in place until repairs are
to hide in wall cavities. completed, e.g. routine inspection for
pests, additional cleaning, relocation of food
handling activities etc.
3.12.4.3 Floors shall be impervious to moisture, Floor surfaces need to be easy to clean Address the following:
maintained in good condition and easy to so that the food handling environment
clean and maintain clean. Where required, can be maintained in a clean and sanitary • Repair any floors that are damaged (e.g.
floors shall be graded to drains to prevent condition. Damaged flooring may allow cracks in concrete or tiles) prior to your
pooling. water to seep under the floor surface audit
and further damage the flooring or create • If sections of the floor do not slope towards
stagnant water which may become a the drain, then additional controls will be
contamination risk that is ‘walked’ through needed to remove pooling water (e.g. mop
your facility by the movement of peole and and bucket)
equipment.
3.12.4.4 Where required for wet cleaning operations, The coving needs to be smooth between Check all walls and floors and ensure coving
coving between the floor and wall should be floor and wall so that there are no gaps is in place.
used to facilitate cleaning. for water to pool and remain stagnant for
bacteria to thrive.
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3.12.4.5 Drains shall be in maintained in good Drains must be installed in the required Address the following:
condition and easy to clean and maintain locations to remove liquids from cleaning,
clean. Drain grates and basket traps should food preparation processes and spills from • Are all drains are fitted with covers to
be removable to allow for ease of cleaning. the food handling area. prevent large items flushing down the drain
causing blockage?
• Are drain covers and removable basket
traps included on a cleaning schedule to
ensure they are regularly cleaned and
disinfected to prevent the growth of
bacteria (which may be transferred from the
floor to work surfaces through unhygienic
practices)?
3.12.4.6 In facilities where there is segregation An assessment of the suitability of water Assess and document this requirement
between areas of different hygiene controls used where it may pose a hazard, for annually as part of internal audit requirements.
(e.g. low and high-risk areas), wastewater example, for crop irrigation or rinsing
shall not drain from low-risk to high-risk activities.
areas.
3.12.4.7 Ceilings (including false ceilings) shall be Inspect for the structural condition and Ensure ongoing inspection and maintenance
smooth, impervious to moisture, easy to ongoing physical condition of ceilings and of ceiling structures in GMP audits.
clean and maintain clean and not allow for their surfaces.
the entry of pest or dust ingress.
3.12.4.8 Windows located in production areas with Windows in working areas shall have Ensure ongoing inspection and maintenance
open and exposed products shall be kept sealed structure or screens for pest of window structures in GMP audits.
closed or have adequate pest proofing or proofing.
screens.
3.12.4.9 Doors into production areas shall be close- Doors leading into working areas shall be Ensure ongoing inspection in GMP audits and
fitting to prevent pest and dust ingress. close-fitting to prevent ingress of pests maintenance of doors leading into production
and dust. areas
3.12.4.10 Doors (including rapid roller doors) shall be Rapid roller doors shall be kept closed at In GMP audits, ensure ongoing inspection
kept closed at all times when not in use. all times when not in use. Doors operating and maintenance of air locks and rapid roller
Doors that operate as an airlock should within airlocks should not allow for the doors within production areas.
not allow for both doors to be open at the opening of both doors at same time to
same time as this would compromise airlock maintain the integrity, effectiveness and
controls intended to minimize contamination. performance of the airlock.
3.12.4.11 Light fittings shall be protected to ensure Lighting fixtures in working areas shall have In GMP audits, ensure ongoing inspection
food is not contaminated by breakage. The a protection covering to prevent potential and maintenance of light fittings.
replacement of light fittings above open contamination of materials and products
product areas should be scheduled to occur with falling materials or potential dispersion
when production is not in process. of fragments (upon breakage).
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3.12.4.12 Glass windows shall be protected to prevent In case of breakage, glass windows shall In GMP audits, ensure ongoing inspection
glass contamination in the event of a be protected so that the glass breakage and maintenance of glass windows.
breakage. does not contaminate the working areas of
production.
3.12.4.13 Equipment used for thermal processes or Equipment shall have a system to maintain Purchase the correct equipment for the
to chill/freeze food should be designed to appropriate conditions (freezing or purpose of use.
achieve the process requirements to ensure refrigeration condition) for products.
food safety and suitability. Where necessary,
equipment should also be designed to allow
for temperature monitoring.
3.12.4.14 Equipment used in food processes must All equipment used shall be maintained Check condition of equipment with
be industry standard and maintained in a in a suitable condition to assure reasonable frequency.
suitable condition. contamination control.
3.12.5 Employee amenities
3.12.5.1 Employee amenities shall be suitably located Employee amenities need to be suitably Walk through your premise and inspect the
and include as required, designated areas located within the facility and have employee amenities and ensure GMP policies
for employees to keep personal belongings, adequate functional areas. are being adhered to.
changerooms, toilets, hand-washing and
drying facilities as well as areas for eating,
drinking and smoking. These facilities shall
not be used for other purposes such as
storage of food or items that contact food.
3.12.5.2 Hand-washing stations shall be located in Easy access hand wash basins are Walk through your premises to check hand
appropriate locations throughout the site, required to encourage all food handlers to wash basins in food production areas are
made of suitable materials and in good regularly wash their hands. located close to the entrance of production
condition and have a supply of warm, in areas segregated for high-care or high-risk
running, potable water, with liquid soap and a processes.
suitable method of drying hands.
3.12.5.3 Hand-washing facilities shall be of an Hands-free taps are preferred as they Identify hand wash basins that are not
appropriate hygienic design and should have reduce the risk of bacteria transfer from ‘hands-free’ and determine priorities for
hands-free taps; where this is not possible unclean hands to hands that have been future upgrade to hands-free taps; prioritize
appropriate measures are required to cleaned. upgrades for wash basins located in areas
minimize contamination from taps should be segregated for high-care or high-risk food
in place. handling activities.
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3.12.5.4 Where personal protective clothing and Protective clothing may include uniforms, Ensure arrangements are in place to provide
footwear is required for employees, aprons, coats etc. The purpose of this is extra laundered or disposable PPE to
contractors and visitors, there shall be to prevent contamination from personal contractors and/or visitors in multiple sizes.
suitable provisions provided (e.g. this may clothing.
require multiple sizes of protective clothing
and footwear to be maintained).
3.12.5.5 Lunchrooms shall have adequate Staff lunches should be appropriately Walk through your staff lunchroom to check
refrigeration space for personnel to store stored to prevent staff from becoming ill perishable foods are correctly stored and out-
perishable food items and be of suitable and prevent contamination within staff of-date food is discarded.
size for the number of personnel using the facilities.
lunchroom at the same time.
3.13 Receival and storage
3.13.1 Procedures for the safe and suitable Establish and implement procedures Document procedures for receival and
storage of products shall be implemented. for safe and suitable storage practices storage and walk through your process
These procedures shall include reference which should encompass requirements from receival and storage of raw ingredients
to allergen management, cleaning, stock/ to control allergen management, stock through all stages of production. Look for
inventory control, segregation of non- rotation, cleaning, minimal stock damage opportunities to minimize the potential for
conforming product and handling to and cross contamination and the cross contamination:
minimize stock damage and cross handling of non-conforming product for
contamination. segregation. • Storage areas including cool rooms, freezer
rooms and refrigerators should be well
organized and uncluttered
• Shared work areas should have sufficient
space to allow for segregation of raw and
cooked products
• Shared equipment and utensils for different
products will need thorough cleaning and
disinfection (sanitizing) between use, e.g.
food processors and blenders
• People movement throughout the food
preparation area should be organized so
that microbiological or allergen risks are not
transferred from one area to another
3.13.2 Facilities for the storage of ingredients, Adequate facilities need to be available Inspect and maintain areas of storage facility.
packaging, work in progress and finished onsite for storage of all inputs. These
product shall be fit for purpose, clean facilities shall be clean, fit for purpose
and large enough for use at peak times of and suitably large for capacity (for busy
production. production periods of the year).
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3.13.3 Ingredients, raw materials, work in progress, Raw materials and other materials shall be Inspect and maintain areas of storage facility.
finished product and packaging shall be stored in spaces or areas separate from
stored in such a manner that they do not that for storage of products.
pose a food safety (or quality) risk to the
product.
3.13.4 Climate controlled (temperature and If storage conditions are specified, Implement monitoring procedures and
humidity) storage areas shall be monitored raw materials and other materials shall document records to control temperature and
with records of monitoring activities be stored at refrigerating or freezing humidity.
maintained. temperatures appropriate for such
specified storage conditions.
3.13.5 Deliveries and receivals that are unloaded Stock that’s unloaded externally needs Inspect external areas where stock may be
in external areas shall be protected from to be relocated as soon as possible received or unloaded or despatched regularly.
environmental damage and contamination to a covered and protected area to
(e.g. rain and dust) with products moved minimize contamination from the external
to covered and protected areas as soon as environment.
practicable.
3.13.6 A process for stock rotation shall be in place Raw materials and other materials used Implement and maintain stock principles and
and based on First in/First out (FiFo) or in the manufacture/processing of food inspect regularly for rotation of stock.
First expiry/First out (FeFo) principle for raw products shall be used according to the
materials and finished products. principle of “first-in, first-out”.
3.13.7 Where offsite storage facilities under the Include offsite storage requirements as Check if offsite storage is used and include
direct control of the organization are used, part of the approved supplier programme these service providers in the approved
these shall be included in the HACCP system for any contracted storage warehouse. supplier programme.
and monitored for compliance to GMP
requirements.
3.13.8 Where storage of raw materials or finished Include storage requirements as part of Check if third-party storage is used and
products is contracted to a third-party the approved supplier programme for any include these service providers in the
service provider they shall be included in the contracted storage warehouse. approved supplier programme.
approved supplier programme.
3.14 Dispatch and transport
3.14.1 The transport vehicle(s) required to transport Food should be adequately protected Implement controls on the transport of food
temperature controlled foods shall be able to during transport to prevent contamination to protect food from contamination including
maintain appropriate temperatures. and have suitable conditions maintained allergen cross contact during distribution.
during transportation to ensure the safety
and suitability of the food.
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3.14.2 The methods for securing transport for Controls for the security of the load shall Implement ways of securing transport loads
the transportation of products (including be considered from the perspective and monitor and record the traceability of all
the transport of interim products that are of food security, food fraud and food secured loads.
transported to a third party for part of the defence.
process) shall be documented and records
of checks maintained.
3.14.3 Procedures shall be documented and Specific requirements are detailed for Implement procedures for the monitoring of
implemented for the breakdown of transport design and construction of transport and loads and product during breakdown.
vehicles used to transport food products bulk containers as well as their use and
requiring temperature, humidity, atmosphere maintenance.
and other conditions necessary to protect
food from microbial growth and deterioration.
3.14.4 Contingencies for loading and dispatching Specific requirements are detailed for Implement contingency procedures for
product in adverse weather shall be the management of loads during adverse loading and dispatch in adverse weather
documented and implemented as required. weather conditions to protect products. conditions.
3.15 Control of water, ice, air and other gases
3.15.1 An adequate supply of potable water shall be Control of water quality to minimize the Water used in food-handling facilities shall be
available to ensure the safety and suitability presence of potential water borne hazards suitable for human consumption from a mains
of the products supplied. Potable water shall (e.g. biological, chemical, physical). source of potable supply.
be used for post-harvest wash treatments,
hand-washing, cleaning, ingredient, making
and drinking water.
3.15.2 Water recirculated for reuse and recovered Re-use of water, in whatever form, shall be Recirculated water and water recovered from
water (e.g. water recovered from food controlled and monitored for its safety and the processing of food may be permitted for
production operations, evaporation and/or quality so that it is fit for purpose and use. use, provided its use does not constitute
filtration) shall be treated where necessary a risk to the safety and suitability of food.
to ensure the safety and suitability of food is This needs to be validated with ongoing
not compromised. monitoring and verification.
3.15.3 Water, ice and steam shall be fit for the An assessment of the suitability of water, Implement an assessment of the inputs and
intended purpose. This may require a risk- ice and steam used as inputs where it may their purpose for use so the HACCP team can
based testing programme to be documented pose a hazard, for example, crop irrigation, determine a risk-based testing programme for
and implemented. rinsing activities, etc. the inputs.
3.15.4 Where a risk-based water testing programme If implementing a risk-based testing A verification programme for the testing of
is required, the programme shall include the programme for the inputs of water, ice and inputs (water, ice, steam) and its methods
frequency of testing, test method, limits and steam, identify frequency of testing, test shall be in place.
action to be taken for results that are outside method, limits and action to be taken for
of limits. results that are outside of limits.
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3.15.5 Air, steam and other gases used directly Contaminated air and gases can be a Ensure compressed air used in direct contact
in contact with food product shall be source of contamination. with food is filtered to prevent contamination.
suitable and not present a contamination
risk. Confirm suitability of gases used for any direct
food contact (e.g. MAP packing).
3.16 Control of foreign materials
3.16.1 Controls for foreign materials in food Manufacture/processing of food products Procedures for the control of foreign materials
handling areas (e.g. glass, metal, hard and shall be controlled in a manner of avoiding shall be documented, with appropriate
soft plastics, wood splinters, jewellery) contamination with potential foreign records of compliance, to procedures
shall include suitable prevention strategies materials (both intrinsic and extrinsic). retained.
including preventative maintenance and
regular inspection of equipment. Procedures
for the control of foreign materials shall be
documented, with appropriate records of
compliance to procedures retained.
3.16.2 Personnel responsible for monitoring Ensure personnel are competent Identify these personnel in a training matrix
equipment related to control of foreign according to their responsibilities. and ensure training records are documented.
material shall be trained in the use of the
equipment, monitoring methods and
corrective actions.
3.16.3 Controls for metal items including, but Document policy for the control of metal Implement a procedure for the control of
not limited to, knives, needles, wires, items. metal items permitted for use.
staples and knife sharpening equipment
shall be implemented to manage the
potential contamination risk from these
items.
3.16.4 Where possible, glass and brittle materials Implemented policy should intend to Examine and inspect all areas, surfaces
shall be excluded from food handling areas exclude glass and brittle materials. and equipment containing glass and brittle
or protected against breakage. materials with intent to eliminate, replace or
monitor for permitted use.
3.16.5 There shall be a documented and Document policy for the control of glass, Implement procedure for the control of glass,
implemented policy on the use of glass, brittle plastics, ceramics and similar brittle plastics, ceramics and similar materials.
brittle plastics, ceramics and similar materials materials.
in food handling areas.
3.16.6 Where the final product is packed into glass Document policy for the control of glass Implement procedure for the control of glass
packaging there shall be appropriate controls breakages. breakages and how to effectively remove
and documented procedures in place for broken glass so that the food remains suitable
line cleaning following breakages. for use.
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3.16.7 A policy for the use and control of soft Document policy for the control of soft Examine and inspect all areas, surfaces
plastic items shall be documented and plastics and outline the permitted use and and equipment containing glass and brittle
implemented. controls. materials with intent to eliminate, replace or
monitor for permitted use.
3.16.8 Soft plastic items shall be of an appropriate Be able to minimize potential damage of During procurement, ensure the type of soft
gauge to prevent tears and rips and used for soft plastic items. plastic items are suitable.
the intended purpose.
3.16.9 Where possible, the soft plastic item shall be Be able to easily identify contrast in colour For ease of identification in case of
a contrasting colour to the product. in case of physical contamination. contamination, all soft plastics shall be a
different colour to that of product(s).
3.16.10 A wood policy outlining the control of wood Document policy for the control of Implement control of wood policy.
within the processing environment shall be wood and outline the permitted use and
documented and implemented. Wood shall controls.
be excluded from the processing areas
unless the wood is part of the processing
equipment.
3.16.11 Where wooden pallets cannot be excluded Only wooden pallets which are dry, in Inspect incoming condition of wooden pallets
from the processing area, adequate controls good condition and free from damage in the permitted area. Ensure pallets of bad
shall be in place to ensure that the pallets are permitted for use in certain areas of condition are removed from point of use and
are dry, in good condition and free from production. do not re-enter production for use.
damage.
3.17.2 A list of chemicals stored and used on the Implement a system for all approved Develop and regularly update a register of
site and the intended use for each chemical chemicals and their intended purpose of approved chemicals.
should be documented. use.
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3.17.3 Evidence shall be available to demonstrate Cleaning agents, disinfectants and other Keep a register of safety data sheets (SDS or
that the chemicals are suitable for use in chemicals used in working area(s) shall MSDS) for chemicals that are used or stored
a food premise and appropriate for the be handled and used for their intended on site. For chemical handling safety, also
intended use by the organization. purpose. keep copies of MSDS at point of use.
3.17.4 Chemicals (e.g. cleaning materials, non- Cleaning agents, disinfectants and other Walk through your facility to confirm that
food grade lubricants, chemical residues chemicals used in working area(s) shall be all chemicals, (e.g. cleaning chemicals,
from pesticides and veterinary drugs such stored and controlled in a place separate pest control chemicals) stored in bulk and/
as antibiotics) shall not present any direct from those for handling of food products. or decanted for ease of use are labelled
contamination risks to the process and/or and securely stored when not in use. Any
product. chemicals that have not been approved for
use should be discarded.
3.17.5 All personnel and contractors who handle Ensure personnel are competent and Maintain documented evidence of records
chemicals on the site shall have appropriate trained appropriately to their chemical and content of training.
training. handling responsibilities.
3.18 Maintenance
3.18.1 The organization shall have in place a Equipment needs to be maintained to A preventive maintenance programme shall
documented preventative maintenance prevent equipment wear and tear from be documented and implemented according
programme covering the premises, creating the potential for foreign matter to procedure.
equipment, services and external areas. contamination.
Maintenance activities shall not pose a food
safety risk to the products.
3.18.2 The preventative maintenance schedule A preventive maintenance schedule A preventive maintenance schedule shall be
shall be implemented. shall identify all necessary inputs documented and implemented according to
(e.g. machinery, equipment) which plan.
require regular scheduled maintenance
requirements.
3.18.3 Temporary repairs shall be controlled Temporary repairs may use sticky tape, Check adequacy of controls for temporary
to ensure the food safety and legality string or rope which may present a foreign repairs and be mindful that best practice is
of the product. Temporary repairs shall matter or microbiological hazard. that temporary repairs are dated and reported
be permanently repaired as soon as for permanent repair as a priority.
practicable.
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3.18.4 Maintenance employees and contractors Maintenance activities can be a source Check adequacy of controls for maintenance
shall take measures to ensure all tools are of microbiological, chemical and foreign works to prevent contamination of food and
suitable for food production areas and matter contamination. food handling areas.
that measures are in place to ensure tools
and maintenance debris is removed when Confirm instructions and supervision of
maintenance activities are completed. This contractors.
is critical for intrusive maintenance activities
Where maintenance is to be carried out,
where maintenance tools and debris will not
ensure all food products are removed from
be visible to production employees following
the area of maintenance activity.
maintenance activities.
3.18.5 Food products, ingredients and packaging Maintenance activities can be a source Check adequacy of controls for maintenance
shall be removed from the immediate area of microbiological, chemical and foreign works to prevent contamination of food and
where there is a risk of contamination while matter contamination, therefore protect food handling areas.
maintenance is to be carried out. or remove food products, ingredients and
packaging in the immediate area. Confirm instructions and supervision of
contractors and service providers.
3.18.6 The area/equipment undergoing Maintenance activities can be a source Where areas/equipment are subject to
maintenance should be checked to ensure of microbiological, chemical and foreign maintenance, check that all materials have
the area and equipment has been cleaned matter contamination. been removed and that area/equipment
and sanitized, tools and materials used or has been cleaned and sanitized before
any swarf or shavings have been removed reassembling the equipment correctly to
and that equipment has been reassembled return to use.
correctly.
3.18.7 Maintenance workshops shall be maintained Maintenance workshops are considered Maintenance workshops, like all other facilities
in a clean condition and pest-proofed. part of the site’s premise and facility under of the site’s premise, need to be maintained
its GMP policy. in clean and pest-proof condition.
3.18.8 A record shall be kept of planned A history of equipment inspections Collate equipment inspection, service and
maintenance and breakdown planned maintenance and breakdowns repair records. Equipment service reports will
maintenance. demonstrates precautions are taken to need to be provided for all equipment.
prevent contamination from equipment
issues.
3.18.9 Equipment used in direct contact with food Equipment and utensils used in the Include inspection of condition of equipment
products shall be constructed of suitable manufacture/processing of food in internal audits or GMP audits, etc.
food grade materials and capable of being products, shall be fit for use (food grade),
cleaned and maintained clean. maintained and controlled in a sanitary
manner.
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3.18.10 Equipment inspections to ensure continued Such equipment shall be in good repair Include inspection of the condition of
food safety suitability (e.g. inspection and order so as not to shed fragments of equipment in internal audits or GMP audits,
of sieves, screens and filters) shall be contamination. etc.
completed.
3.18.11 Steel wool and wire brushes, where required, Steel wool and wire brushes and such Include inspection of condition of equipment
shall be maintained in good condition like equipment shall be in good repair in internal audits or GMP audits, etc.
to minimize the risk of foreign matter and order so as not to shed fragments of
contamination. contamination.
3.19 Calibration
3.19.1 The organization shall have in place a Calibration of monitoring equipment is Machinery, analytical equipment, measuring
documented procedure to ensure that all required to confirm accuracy of the results. and testing apparatus shall be periodically
equipment used to inspect, measure or test calibrated.
the product is reading accurately so that the
results are valid.
3.19.2 Personnel conducting calibrations and Personnel conducting internal calibrations Ensure that the training plan or matrix
reviewing calibration records shall be need to be appropriately trained on the includes the training of personnel conducting
appropriately trained. methods of calibration. calibrations and maintain training records.
3.19.3 Records shall be available for all calibrations, If such calibration is conducted by the Check records of calibration match the
calibration checks and any corrective action organization, calibration results shall be frequency of calibration indicated in your
taken when equipment is found to be out of recorded and maintained. If calibration calibration schedule.
calibration. is outsourced to external calibration
laboratories or service providers, Confirm records of calibration indicate that
calibration documents shall be obtained the equipment is operating within tolerance.
and retained.
Have a copy of your calibration schedule
ready for your audit.
3.20 Training
3.20.1 A food safety training programme shall be People handling food need to take Procedures and policies for food handler
implemented to ensure personnel handling measures to ensure that they are not a practices and hygiene shall be documented
food have the necessary knowledge and likely source of contamination. and monitored to prevent potential foodborne
skills. The training programme should communicable diseases.
consider the food safety knowledge required Control of food contact surfaces by
for the product and process risks including: cleaning to remove bacterial contaminants, Check training records are present to
including foodborne pathogens, and show food handlers have been trained to
• Type of food safety hazards known to be allergens. understand the personal hygiene policy and
associated with the food products handled procedures.
by site (e.g. growth of pathogenic or
spoilage micro-organisms, foreign matter
containments, allergens)
• The production and packing processes
used by the organization
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3.20.2 The training programme shall include, but is Training is fundamentally important to any Ensure adequate hygiene training, and/or
not limited to; environmental and personal food hygiene system and the competence instruction and supervision of all personnel
hygiene practices (GMP), preventative of personnel. involved in food-related activities contribute
controls for food safety (HACCP), allergen to ensuring the safety of food and its
controls, cleaning and prevention of food suitability for consumption is available and
contamination. documented. Specific requirements are
detailed for awareness and responsibilities
and refresher training.
3.20.3 Personnel in a role that directly or indirectly Staff responsible for an activity that Adequate competency requirements need to
impacts food safety shall be competent in is associated with a CCP or the be identified and met for personnel in a role
food safety at a level appropriate to the role implementation of a pre-requisite that directly or indirectly impacts food safety.
they perform. programme need to be competent in their Maintain records of competency achieved for
role. these personnel.
3.20.4 Any personnel responsible for an activity Staff who are responsible for an Maintain records of training achieved for
that is associated with a CCP, or responsible activity that is associated with a CCP or these personnel.
for the implementation of a pre-requisite responsible for the implementation of
programme, shall be competent in that a pre-requisite programme need to be
activity or programme. competent in that role.
3.20.5 Personnel moving into new roles shall Personnel moving into new roles need to Maintain records of training achieved for new
be appropriately trained in the new role. be trained. personnel or personnel who change roles.
3.20.6 Records of all training, qualifications and Demonstrate evidence of training, Maintain suitable training and training records
competence reviews undertaken by qualifications and competence reviews. maintained for all personnel.
personnel shall be maintained.
3.20.7 Refresher training shall be carried out at The organization shall establish and Personnel shall be periodically trained in
a suitable frequency commensurate with implement education and training plans their activities and training records shall be
the product risk and role of personnel; for personnel to perform their duties maintained.
regardless of their competency or length of effectively.
employment.
3.21 Waste management
3.21.1 Waste shall be removed from the processing Waste shall not be kept on site for longer Ensure that waste is removed and disposed
area at regular intervals and not allowed to periods of time to avoid accumulation of of at regularly scheduled intervals to minimize
accumulate. debris. accumulation, build up, odour and potential
physical contamination.
3.21.2 Waste receptacles shall be clearly identified There should be a point of differentiation Equipment used for containing waste shall be
and visually different from product, work in with the receptacles being used for waste separate from those for processing of food
progress or rework receptacles. so that there is no cross contamination. products.
BSI HACCP & GMP Self-assessment checklist 46
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
3.21.3 External waste bins shall have a lid which is Equipment used for containing wastes Ensure all waste receptacles have lids and
kept closed when not in use. shall have lid closure always in place. maintain close lids on all waste receptacles
to eliminate odours and contamination from
waste storage.
3.21.4 External waste bins (including recycling) shall External waste bins (including recycling) Maintain a regular schedule for the emptying
be emptied at an appropriate frequency with need to be emptied on a regular basis of of external waste bins and inspect area for
the area kept clean. appropriate frequency to keep the area cleanliness.
clean.
3.21.5 Equipment used in waste management shall Ensure that equipment being used for Include waste management equipment within
be included in the cleaning programme. waste management is also being cleaned. the cleaning schedule.
3.22 Pest management
3.22.1 The organization shall have a documented The pest management programme shall Check your pest management programme
pest management programme in place include rats, mice, cockroaches, flying is documented to cover all of the criteria
which includes a schedule for the application insects, ants, stored product pests indicated.
and frequency of treatments. and birds which can contaminate food,
packaging and your premises.
3.22.2 The programme shall cover all areas of the External areas should be well maintained Bird roosting areas are minimized to avoid bird
premise up to and including the boundary, to prevent harbourage of pests and droppings being walked into food production
maintenance areas and roof spaces (if ensure that litter, cigarette butts and debris areas.
appropriate). from external areas are not a source of
contamination. If the maintenance of these areas is
contracted to an external service provider,
communicate any issues that need to be
addressed to have them rectified or reported
for action.
3.22.3 The programme shall state how monitoring Implement and maintain a full pest control Check your pest management programme
is undertaken, the frequency of monitoring programme (whether internal or external) is documented to cover all of the criteria
and the corrective action to be taken if which is monitored, including appropriate indicated.
monitoring indicates the programme is not corrective action where required.
effective.
BSI HACCP & GMP Self-assessment checklist 47
BSI HACCP & GMP Certification Criteria Reason Compliance assessment tips Finding
(July 2021)
3.22.4 The programme shall also include: Implement and maintain a full pest control If pest inspection and servicing is contracted,
programme. check:
• Bait maps depicting the type and location
of treatments • The contract(s) cover all pests
• Bait stations shall be secured against • The bait station map is current and that a
movement and tampering copy of the contractor’s current valid pest
• Records of the chemicals used and the license has been provided
concentration • That records of all inspections and services
• Where required by local regulations, have been provided
current information for pest control • The treatments provided by the contracted
chemicals used or stored on site service are effective to prevent or treat
• If pest control chemicals are stored on pests
site, these shall be stored in a separate • All pest service records are available for
area away from food handling areas and review at your audit
chemicals used for production or • Pest sightings by staff have been reviewed
maintenance purposes and confirm the reporting process is used
• Where an external pest control contractor and that action is taken to address pest
is used, evidence of their competency to sightings
perform pest inspection and treatment
activities shall be maintained
• Where pest control activities are carried
out by internal personnel, these personnel
shall be suitably trained and records of
training retained
3.22.5 The facility must be maintained free of pest External areas should be well maintained Inspect and address the following:
infestation and/or pest harbourage. to prevent harbourage of pests and
ensure that litter, cigarette butts and debris • Gardens around the building must not be
from external areas are not a source of overgrown for potential harbourage.
contamination for pests. • Redundant building materials have been
removed for potential harbourage.
• Cigarette butts are contained within
receptacles and not loose on the ground
where they could be walked into food
production areas
BSI HACCP & GMP Self-assessment checklist 48
BSI/UK/1977/FOOD/0721/EN/JC/ PP204
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