Specific Aspects of

Food Safety Auditing

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 Contents
• Review auditing principles and practices
• Specific aspects of food safety auditing
• Notes and guidance on how compliance may
look
• Discussion
• Auditing Assignment

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QUICK REVIEW

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 What is an audit?
The systematic, independent and documented
process for obtaining...
• Audit evidence
• And evaluating it objectively to determine the
extent to which the audit criteria are fulfilled

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 Essential

Standard

Auditing

Competent
Auditor

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 Standard
• Legal Regulations, Directives and Legal
Instruments
• GFSI e.g. BRC, SQF, ISO 22000, IFS
• National Standards
• Voluntary Standards e.g. Quality Assurance
Schemes
• Trade Standards
• Internal Standards

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 Competent Auditor
• Trained
• Qualified
• Experienced
• Knowledgeable
• Personal skills and attributes
• Protocol

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GUIDANCE ON
FOOD SAFETY AUDITING

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 Objectives
• What are the objectives of food safety
auditing?
• General compliance or non-compliance
• Specific to determine if a food operation is
capable of producing safe food products
• Based on evidence audit or inspection
evidence
• What might this evidence look like?

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 Things to consider
• Risk based approach
• What product(s) are being produced?
• What quantities are being produced?
• What hazards are typically associated with the product, industry,
business?
• Who might consume the product?
• Are there any recent out-breaks or alerts reported?
• Management capabilities
• Structural hygiene standards
• Operational hygiene standards
• Criteria: Regulatory / COP / Voluntary
• Size of premises / complexity of operation

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 Risk Assessment

Adverse
Frequency Risk
Impact

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 How is risk assessment applied in food safety auditing?

• Preparation
• Research
• Experience
• Knowledge of the product and process
• Education
• Networks
• Supports
• Using the standard(s), technical specifications and guidance notes that
are available and refer to them and depend upon them

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Trust but verify guiding principle
of the food safety auditor
Trust but verify
Trust the information provided by the auditee
Assume it represents the true picture and position of the
company
But seek objective evidence to support this
Establish this principle early on in the audit
Auditee will quickly understand how the audit will be
conducted and will therefore be more accurate in the
information provided

This will be the initiation of the verification process

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GUIDANCE ON HACCP

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 HACCP - General
• HACCP studies based on the actual process and product
• Generic studies should be challenged
• The number and structure of HACCP studies should be logical and be
capable of covering the main hazards
• E.g. One HACCP study covering 60 products made on 6 production lines
with 40 recipes
• was the HACCP system developed
• external expertise used and who has ownership now
• you had any problems with the HACCP system recently
• Good questions to ask at the beginning of the audit

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 HACCP - Team
• List or register of team members

• Should clearly state the Team Leader

• Names, roles, positions

• Cross functional technical, production, engineering

• Evidence of competency HACCP training certificates

• Team Leader: C.V. or detailed account of experience

• Team Leader: External HACCP course certificate and also scope of training, what
exactly was the training?

• Team Leader: Demonstrate knowledge via questions...

• External Expertise: C.V. for external specialist on file? Are they on the approved
suppliers list?

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 HACCP Scope / Data / Flow
• Take a look at the HACCP Study

• Is it documented and clear?

• Check that the scope has been defined

• Product Data Sheet: All the relevant information documented e.g. Composition, shelf-
life, storage conditions

• Product Data Sheet: Intended use (ready-to-eat) and abuse covered, population
groups and sub-groups consistent with the scope

• Flow Diagrams: check they are clear, cover all steps, recycling loops, external facilities,
key info etc.

• High Risk / High Care: Flow diagrams indicate physical barriers?

• Verified? By production maybe signed off by staff?

• ?

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 HACCP Hazards / Control Measures

• Hazard Identification
etc. and should be relevant
to the operation
• Physical, chemical and microbiological
• Hazard Analysis ask for documented records of the analysis
and supporting documentation e.g. Reference sources
• Control Measures are they specific e.g. Pest Control, Glass
Audits etc.
• Look at grouping of HACCP studies make sure they cover all
hazards e.g. Company makes two products that are similar but
one has a difference recipe e.g. Use of chemical preservative,
different pH, different portion size, different cooking
temperature

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 HACCP
• Table or work sheet showing application of CODEX i.e. Decision tree for each process
step
• Look for notes explaining / justifying decisions taken

• Why is this point a CCP or NOT a CCP?

• Critical Limits: Challenge if required?

• Are they clearly stated - tolerances?

• Are they measureable?

• Are they validated , who, show me

• Monitoring measures are they capable of doing the job?

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 HACCP Corrective Actions / Verification / Review

• Are corrective actions clearly defined?

• may not be sufficient

• Evidence of clearly defined corrective actions: production. Hold product from

last in-
samples to external laboratory for pathogen testing. If positive reject and conduct
investigation. If negative, release

• me the records for recent CCP corrective

• Verification - Evidence of internal audits, review of customer complaints, micro test
reports, external specialist review.

• HACCP Review:
• was your last HACCP review
• me your latest HACCP Review

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GUIDANCE ON
QUALITY MANAGEMENT SYSTEMS

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 Food Safety Management (FSM) - General

• Compliance will be based on the totality of the audit

evidence
• Quality Policy Statement: Signed copy, posted, signed by
staff members after training
• Legal: Registration Certificate from Regulatory Body on file
• )
• Quality Manual: Is it available? Check the contents page for
the scope

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 FSM - Team
• Structure organisational chart in place

• Where does the key food safety person appear in the structure?

• Responsibility & Accountability Signed off job descriptions for Key Persons

• Job descriptions for all employees

example? Are they signed off?

• Legal Updates: who is responsible? How does it work?

• Quality Objectives: Check these are documented and are current.
• complaints by 10% in
• HACCP system by end September
• high care room Capex Target June

• Management Review Minutes, signed, dated, actions etc.

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 FSM Customer Focus
• Product specifications in place, up-to-date,
signed off
• Customer surveys and questionnaires
• 000

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 FSM Management Review
• Is the process formal?
• Procedure in place
• Set frequency
• Include senior managers
• Agenda pre-defined
• Are notes taken i.e. Minutes
• What are the key inputs e.g. Customer complaints
• me what actions were decided to deal with complaints
• Look for evidence that actions from previous meetings were reviewed

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 FSM Resource Provision
• Technical skills on site evidence might
include qualified food technologist
• If not, is there evidence of an external
specialist employed as required. Evidence
documented, including name, company,
details of qualification

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 FSM Supplier / Raw Material Control
• Seek evidence of an effective control procedure
• Approved Suppliers List (ASL)
• Is there a risk assessment in place? Show me...
• Supplier history
• Number of ingredients used / number of products
• History of the supplier ... Records
• How are suppliers categorised and rated? High / Low Risk?
• What checks are conducted ... If any? Retention of samples?
• Are audits conducted.... Reports?
• Non-conformance reports
• Signed off specifications (One or both parties?)
• Stock rotation FIFO or FIFU?
• Contract facilities and how are they controlled?

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 FSM Document Control
• Ask for Document Control procedure
• Is there a master list of approved documents with current
revision?
• Are responsibilities defined?
• Look at some documents and check if there is evidence of
control
• Check if the CCP procedures are available at the CCP location
and other important operations e.g. Weight control, recipes and
mixing instructions
• Ask about retention time relate back to shelf life in HACCP
documents
• instructions

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 FSM Record Control
• Ask to see the Record Control procedure
• Is there a master list of approved records with current revision?
• Are records available and stored correctly?
• Things to look for....
• Records are complete
• Clearly filled in
• Authentic
• Signed-off
• Indicate corrective actions / out of control conditions
• Contain the specification and tolerances of any checks / testing

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 FSM Corrective Action
• Procedure in place
• Does the procedure define when and at what level corrective
actions are required e.g. Risk
• Who is responsible?
• Where are actions recorded?
• Minor or non-critical recorded on check form e.g. Adjustment to
filler
• Major and Critical dedicated form?
• Are they reviewed?
• Check they are an input into Management Review process

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 FSM Traceability 1
• Traceability of product from a finished item back to...
• Process conditions
• Raw materials (Batch of ingredients, packaging, in-process)
• Suppliers
• All quantities should be checked reconciliations and mass balance
• The time taken should be looked at in a crises situation it should not
take 2-3 days
• Review records of companies own internal traceability audit
• Frequency: minimum of 6 months

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 FSM Traceability 2
• In the warehouse select a product (base on risk, what is available, quantity, brand,
scope)
• Note the product, brand, batch number, durability information, D.O.M etc.

• Go back to the office...request all relevant records...it will take time to gather these so
ideally one member of staff will do this while you proceed with the audit with the key
manager

• Production records for batch number...clear link to batch number

• Batch make up / recipe sheets. (Quantity / Mass Balance)

• Material incoming and check records (Quantity / Mass Balance)

• Audit record for supplier(s)

• Raw material specifications

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 FSM Traceability 3
• Approved Suppliers List
• Final product specification
• Final product checks and quantities produced
• Order and delivery records linked to batch number
• Supplier and customer contact details
• Supplier audits and questionnaires
• Take detailed notes
• Farm and grower records should be included where relevant

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 FSM Incidents / Product Recall
• Procedure
• Risk assessment classification of incidents etc.
• Look at contact register regulatory bodies,
customers, media
• Communication plan is defined
• Team named with responsibilities
• Mock recall program check reports

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 FSM Customer Complaints
• Procedure
• Review records
• Look at the type of complaints, nature, frequency
• This may be conducted early in the audit to provide audit leads
• Are complaints classified according to risk
• Are actions defined for these review
• Is there a complaints log in place clear referencing?
• Report generated for management
• Trending and analysis (Pareto)

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GUIDANCE ON PREREQUISITE

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 Pest Control 1
• Ask how and who manages pest control
• manual
• In particular, focus on the specification / scope of the service provided
• Rodents, flying insects, crawling insects, birds etc.
• -baiting,
reporting
• Look at site map and check all points of monitoring
• Review field biologists latest report and check follow-up
• Examine procedure for follow-up inspections after bait take
• Focus on dead-zones and poorly accessible places
• credentials

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 Pest Control 2
• Check bait points on walk around location, security,
type, I.D.
• location, function, ask for records of
bulb changes and specification
• Is there a risk assessment on the measures
employed?
• Door and premises proofing
• Review inspection reports, action reporting
• Analysis reports trending

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 - Maintenance
• Preventive schedule based on risk assessment of equipment
• Schedule for premises
• Records should be reviewed
• Control procedures for how maintenance is conducted
• Seek physical evidence during walk around
• Typical examples are flaking paint, damage to walls & floors, drainage,
tape engineering, tool control, chemicals, lubricant, missing machine
panels
• Personnel
• Control for cleaning and release of equipment into production

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 - Calibration
• Calibration plan
• Note 1 or 2 inspection equipment items serial number,
calibration dates etc.
• Check internal calibration checks
• Temperature probes: Internal checks and external
calibrations
• Traceability to national standards calibration certificates
• CCP equipment calibration check frequency should be
reviewed during audit

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 - Cleaning Program
• Check there is a program in place and it is adequate
• Focus on contract cleaners if applicable control
• Cleaning procedures and training of staff
• Verification of cleaning program
• Chemical verification
• Risk assessment as basis of program and procedures
• Safety data sheets and COSHH
• Appropriateness of chemicals employed
• Cleaning-in-place (CIP)
• Records

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 - Transport
• Check all suppliers are on the ASL
• Check Code of Practice / Contract is in place and signed
off
• In-house fleet maintenance and cleaning programs
• Look for records of checks conducted on delivery vehicle
(in-coming and out-going)
• Temperature control: Incoming temperature checks, data
logging, specifications for same
• Procedure for loading and unloading
• Security and over-night delivery
• Breakdown procedures

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 Medical Screening
• New employee records
• Return to work
• Visitors and contractors
• Illness reporting procedure evidence that
staff are aware of it signed off

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 - Equipment
• Specification on file for equipment in use
• Suitable for food applications i.e. Food grade
• Capable of being cleaned

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 Employee Facilities 1
• Check appropriate facilities are in place for staff
• Canteens and rest areas
• Toilets
• Locker rooms
• Separation of facilities based on the risk of the activities
• Laundering facilities and services
• Personal item facilities
• Inspect the flow of staff facilities leading to ingress into production
• Recourse to external
• Segregation of protective clothing and personal
• Segregation of toilet facilities

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 Employee Facilities 2
• Observe work practices jewellery, movement, protective
clothing, hand-washing etc.
• Check WHB units temperature, time, operation, facilities
• Food storage facilities for staff
• Hair protection and glove control
• Colour coding for high risk operations
• Swabbing results for overalls high risk
• Hand sanitizers identification
• Control of external laundry providers
• Logical of donning procedure

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 - Waste
• Look for accumulation of waste
• Covers on external storage containers
• Housekeeping in waste areas
• Containers for waste are specified for the
purpose
• Movement of waste high risk to low risk
• Clear identification of specific waste types
• Identification of sewage flow and risk

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 Personal Hygiene
• Hand Washing procedure in place and posted
• Hand swabbing results records
• Hand sanitizers
• Personal Hygiene check rules are in place and
signed off by staff
• Plaster Control metal detectable, colour use of
gloves, accounting
• Jewellery policy check and observe

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 Process / Product Control
• Spend time looking at process control records
• Challenge what is done - where claims are important
• Seek deviations in the process and follow through to conclusion
• Positive release aspects
• Temperature control requirements
• Cooking multipoint validation
• pH / acidification validation against target pathogen
• Temperature controlled storage validation, hot spots
• Packaging controls MAP etc.
• Allergen control measures
• Free-from controls if applicable
• Foreign body control measures

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 Glass / Hard Plastics
• Determine if there is a register
• Review audit reports
• Review actions and controls
• the breakage
• procedure is glass breakage occurs during
filling or

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 - Wood
• Look for evidence of poor storage practices
and condition of wooden pallets
• What is the policy on wood and wooden
pallets
• Are there exclusion areas?
• Look for the wooden handled brushes etc. in
production areas

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 Metal / Other
• On-line metal detection units
• Start-up checks last off checks etc.
• Sensitivity
• Alarm
• Reject
• Ask operator to demonstrate the various checks
• Knife and utensil control
• Staples
• Sieves
• Plastic packaging
• Cardboard
• Dirt / Debris / etc.

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 - Testing
• Testing plans, schedules
• Review testing methods
• Are procedures in place
• External laboratory: ILAB accreditation and scope
of accreditation on file and available
• Review laboratory reports reviewed by
competent staff member and signed off, actions
are recorded

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 Water and Services
• Risk assessment
• Source controls
• Legionella
• Potability look at test results
• Do not forget Ice and Steam
• Water treatment and storage risk
assessment

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 Labelling / Coding / Weight / Volume

• Labels and printed coded material retention

• Checked and signed-off
• Code generation system
• Verification of bar-codes and other coded data
• Durability data Best before / Use by end etc.
• Weight / volume checks legal requirements, sampling
plans for average weight, min weight, multi-packs
• Automation check procedures, packs, TNE, T1, T2

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 - Training
• Training Plan review
• Select a number of staff members e.g. CCP monitors
• Review training records and note details in your report
• Certificates
• Signed records
• Induction training program
• Formal training
• Follow-up on training
• Training scope

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 External Factory Standards

• Established during walk-around

• Check site security perimeter fence,
controlled access to site and factory
• External Proofing
• Site conditions redundant machinery, hard
margins, external storage, planted areas

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 Premises Design
• Check for proper and logical flow based on risk
• Interfaces between high and low risk stages of operation
• Interlocking doors, hatches, door closing
• Floor drainage
• Walkways
• Windows
• Doors
• Lighting
• Ventilation / Extraction
• Air filtration and system
• Temperature control rooms

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WHAT IS SAFEFOOD 360º?

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 Safefood 360º
• Safefood 360º is a food safety management
software that brings all aspects of food safety
management into one intuitive product
• It is widely used by food manufacturers
around the world as a more effective and
efficient alternative for paper based systems

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