L-01Topic L-01Fundamental
Governance & CultureLeadership ownership
Can senior management show active ownership of product safety, legality, authenticity and quality objectives?
Evidence to look for- Signed policy
- Objectives and measures
- Leadership meeting records
L-02Topic L-02Fundamental
Governance & CultureFood safety culture plan
Is there a documented, site-specific food safety and quality culture plan with activities, owners, measures and review dates?
Evidence to look for- Culture plan
- Communication records
- Effectiveness review
L-03Topic L-03Fundamental
Governance & CultureManagement review
Does management review system performance, audit trends, complaints, incidents, resources and improvement actions at planned intervals?
Evidence to look for- Management review agenda
- Minutes
- Action tracker
L-04Topic L-04Fundamental
Governance & CultureResources and escalation
Are competent people, time, facilities and escalation routes available to maintain the food safety and quality system?
Evidence to look for- Resource plan
- Escalation matrix
- Budget or staffing decisions
L-05Topic L-05
Governance & CultureResponsibilities
Are responsibilities, deputies and reporting lines clear for activities that can affect product safety, legality, authenticity or quality?
Evidence to look for- Organisation chart
- Role descriptions
- Deputy arrangements
L-06Topic L-06
Governance & CultureIssue reporting
Do personnel know how to report risks or non-conforming conditions promptly to an authorised manager?
Evidence to look for- Induction material
- Reporting route
- Interview evidence
H-01Topic H-01Fundamental
Hazard & Control PlanningHACCP team competence
Is the food safety plan developed and maintained by a multidisciplinary team with an identified, competent leader?
Evidence to look for- Team list
- Competence records
- Terms of reference
H-02Topic H-02Fundamental
Hazard & Control PlanningPrerequisite programmes
Are prerequisite programmes defined, controlled and considered when hazards and control measures are assessed?
Evidence to look for- PRP register
- Monitoring records
- Verification results
H-03Topic H-03Fundamental
Hazard & Control PlanningProduct description
Does the study describe materials, formulation, processing, packaging, storage, shelf life and relevant safety characteristics?
Evidence to look for- Product description
- Specifications
- Shelf-life basis
H-04Topic H-04Fundamental
Hazard & Control PlanningIntended use
Are intended use, foreseeable misuse and vulnerable consumer groups identified where relevant?
Evidence to look for- Intended-use statement
- Consumer group assessment
- Preparation instructions
H-05Topic H-05Fundamental
Hazard & Control PlanningProcess flow
Is there an accurate flow diagram covering inputs, rework, delays, outsourced steps and waste routes?
Evidence to look for- Controlled flow diagram
- Process description
- Change history
H-06Topic H-06Fundamental
Hazard & Control PlanningOn-site verification
Has the HACCP team verified each process flow on site and after significant change?
Evidence to look for- Signed verification record
- Walk-through notes
- Change review
H-07Topic H-07Fundamental
Hazard & Control PlanningHazard analysis
Are biological, chemical, physical, radiological, allergen, fraud and malicious-contamination hazards considered at each relevant step?
Evidence to look for- Hazard analysis
- Risk method
- Scientific references
H-08Topic H-08Fundamental
Hazard & Control PlanningCCP determination
Is the method for deciding critical control points consistent, documented and technically defensible?
Evidence to look for- CCP decision method
- Decision records
- Rationale
H-09Topic H-09Fundamental
Hazard & Control PlanningValidated limits
Are measurable critical limits established and validated for every critical control point?
Evidence to look for- Critical-limit table
- Validation study
- Reference data
H-10Topic H-10Fundamental
Hazard & Control PlanningCCP monitoring
Does CCP monitoring define method, frequency, responsibility, records and immediate response to loss of control?
Evidence to look for- Monitoring procedure
- Completed records
- Competence records
H-11Topic H-11Fundamental
Hazard & Control PlanningDeviation action
Are product disposition, process correction, investigation and authorisation defined for each CCP deviation?
Evidence to look for- Corrective-action plan
- Deviation records
- Product disposition approval
H-12Topic H-12Fundamental
Hazard & Control PlanningValidation and verification
Are control measures validated before use and is the complete plan verified and reviewed at least annually and after relevant change?
Evidence to look for- Validation file
- Annual review
- Verification schedule
H-13Topic H-13Fundamental
Hazard & Control PlanningHACCP records
Are HACCP documents controlled and records legible, complete, authorised and retained for an appropriate period?
Evidence to look for- Document index
- Record samples
- Retention schedule
Q-01Topic Q-01
Assurance SystemSystem manual
Does the food safety and quality manual describe the system, scope, responsibilities and links to supporting procedures?
Evidence to look for- Controlled manual
- Scope statement
- Procedure map
Q-02Topic Q-02
Assurance SystemDocument control
Can the site ensure that only current, approved documents are available where work is performed?
Evidence to look for- Document-control procedure
- Master list
- Change approvals
Q-03Topic Q-03
Assurance SystemRecord integrity
Are records completed at the time of activity, protected from unauthorised change and retained for the defined period?
Evidence to look for- Record procedure
- Completed samples
- Access controls
Q-04Topic Q-04Fundamental
Assurance SystemRisk-based internal audit
Does the audit programme cover the complete system and production environment at a frequency based on risk and previous performance?
Evidence to look for- Audit schedule
- Risk rationale
- Audit reports
Q-05Topic Q-05Fundamental
Assurance SystemAuditor independence
Are internal auditors competent and sufficiently independent from the activity they assess?
Evidence to look for- Auditor matrix
- Training records
- Audit allocation
Q-06Topic Q-06Fundamental
Assurance SystemRaw-material supplier approval
Is supplier approval based on a documented risk assessment and supported by appropriate certification, audit or questionnaire evidence?
Evidence to look for- Supplier risk assessment
- Approval evidence
- Approved supplier list
Q-07Topic Q-07Fundamental
Assurance SystemSupplier monitoring
Are supplier performance, changes, incidents and approval status reviewed at a defined risk-based frequency?
Evidence to look for- Supplier scorecard
- Review records
- Escalation actions
Q-08Topic Q-08
Assurance SystemSpecifications
Are current specifications agreed and available for materials, packaging, finished products and relevant services?
Evidence to look for- Specification register
- Approved specifications
- Review dates
Q-09Topic Q-09Fundamental
Assurance SystemRoot cause and prevention
Do significant or recurring issues receive documented root-cause analysis, corrective action, preventive action and effectiveness review?
Evidence to look for- CAPA procedure
- Root-cause records
- Effectiveness checks
Q-10Topic Q-10Fundamental
Assurance SystemTraceability system
Can the site trace materials, packaging, processing records, rework and distribution in both directions within the defined test target?
Evidence to look for- Traceability procedure
- Test report
- Mass-balance result
Q-11Topic Q-11
Assurance SystemComplaint learning
Are complaints investigated, trended and used to drive proportionate corrective and preventive action?
Evidence to look for- Complaint log
- Trend analysis
- Actions
Q-12Topic Q-12
Assurance SystemIncident and recall readiness
Are incident, withdrawal and recall arrangements current, tested and connected to regulators, customers and other relevant external contacts?
Evidence to look for- Incident plan
- Recall test
- Contact list
S-01Topic S-01
Facility & HygieneExternal environment and security
Are external contamination risks, site boundaries, access and security controls assessed and maintained?
Evidence to look for- Site risk assessment
- Inspection records
- Access controls
S-02Topic S-02
Facility & HygieneFood defence
Is there a current threat assessment and a proportionate plan to prevent deliberate contamination?
Evidence to look for- Threat assessment
- Food-defence plan
- Review record
S-03Topic S-03Fundamental
Facility & HygieneFlow and segregation
Do layout, people, materials, waste and product flows prevent cross-contamination and unintended mixing?
Evidence to look for- Site plan
- Flow map
- Zoning controls
S-04Topic S-04
Facility & HygieneBuilding fabric
Are floors, walls, ceilings, drains, doors and overhead structures suitable, intact and cleanable?
Evidence to look for- Fabric inspections
- Repair log
- Hygiene verification
S-05Topic S-05
Facility & HygieneUtilities
Are water, ice, air, steam and gases risk assessed, specified, monitored and suitable for their intended contact?
Evidence to look for- Utility risk assessment
- Test results
- System diagram
S-06Topic S-06
Facility & HygieneEquipment hygienic design
Is equipment suitable for its purpose, accessible for cleaning and controlled through purchase, installation and commissioning?
Evidence to look for- Equipment specification
- Commissioning record
- Hygienic-design review
S-07Topic S-07
Facility & HygieneMaintenance controls
Does planned and reactive maintenance protect product and include release checks after work is completed?
Evidence to look for- Maintenance plan
- Work orders
- Post-maintenance release
S-08Topic S-08
Facility & HygieneContamination control
Are chemicals, glass, brittle materials, wood, metal and other physical-contamination risks controlled and verified?
Evidence to look for- Contamination procedures
- Registers
- Incident checks
S-09Topic S-09
Facility & HygieneForeign-body systems
Are detection or removal systems selected by risk, challenged at defined frequencies and supported by failure procedures?
Evidence to look for- Risk assessment
- Challenge records
- Failure investigation
S-10Topic S-10Fundamental
Facility & HygieneCleaning programme
Are cleaning methods, frequencies, responsibilities and acceptance criteria validated or otherwise technically justified?
Evidence to look for- Cleaning schedules
- Validation or rationale
- Verification trends
S-11Topic S-11
Facility & HygienePest management
Does the pest-management system use competent support, current site plans, trend review and timely corrective action?
Evidence to look for- Pest plan
- Visit reports
- Trend and action records
S-12Topic S-12
Facility & HygieneStorage and transport
Are storage, loading, dispatch and transport conditions controlled to protect identity, safety, legality and quality?
Evidence to look for- Storage procedure
- Vehicle checks
- Temperature records
P-01Topic P-01
Product & Material ControlsProduct development
Does product development assess hazards, legal requirements, claims, shelf life and the capability of the process before launch?
Evidence to look for- Development procedure
- Launch approval
- Shelf-life evidence
P-02Topic P-02
Product & Material ControlsLabel legality and approval
Are labels reviewed against the destination market, product specification, allergens, claims and preparation instructions before use?
Evidence to look for- Label approval
- Legal review
- Master artwork
P-03Topic P-03Fundamental
Product & Material ControlsAllergen risk assessment
Are allergen presence, cross-contact routes, changeover, rework and label declarations controlled through a current risk assessment?
Evidence to look for- Allergen matrix
- Risk assessment
- Validation or verification
P-04Topic P-04
Product & Material ControlsAuthenticity and claims
Are vulnerability, chain-of-custody and claim-substantiation risks reviewed and controlled for materials and finished products?
Evidence to look for- Vulnerability assessment
- Claim evidence
- Chain-of-custody records
P-05Topic P-05
Product & Material ControlsPackaging suitability
Is packaging appropriate for contact, process, storage and distribution conditions, with specifications and supplier evidence?
Evidence to look for- Packaging specification
- Compliance declaration
- Suitability trial
P-06Topic P-06
Product & Material ControlsTesting programme
Is inspection and laboratory testing risk based, performed by competent providers and reviewed against defined limits?
Evidence to look for- Sampling plan
- Laboratory scope
- Trend review
P-07Topic P-07
Product & Material ControlsProduct release
Can only authorised, conforming product be released, including when release is based on pending or external results?
Evidence to look for- Release procedure
- Release records
- System permissions
C-01Topic C-01Fundamental
Process & Release ControlsProcess specifications
Are key process parameters, recipes, equipment settings and acceptance criteria defined and available to operators?
Evidence to look for- Process specification
- Recipe control
- Operator instructions
C-02Topic C-02Fundamental
Process & Release ControlsOperational monitoring
Are important process controls monitored, deviations recorded and product status controlled until disposition?
Evidence to look for- Production records
- Deviation log
- Hold and release evidence
C-03Topic C-03Fundamental
Process & Release ControlsLabel and pack checks
Do start-up, changeover and in-process checks prevent use of incorrect labels, coding or packaging?
Evidence to look for- Line-clearance record
- Pack checks
- Reconciliation
C-04Topic C-04
Process & Release ControlsQuantity control
Are legal and customer quantity requirements monitored with defined methods, frequency and response limits?
Evidence to look for- Weight-control plan
- Check records
- Trend review
C-05Topic C-05
Process & Release ControlsCalibration
Are measuring and monitoring devices identified, calibrated or verified, protected and assessed when found out of tolerance?
Evidence to look for- Calibration register
- Certificates
- Out-of-tolerance assessment
T-01Topic T-01Fundamental
People & CompetenceTraining and competence
Are people competent before unsupervised work and periodically reassessed for tasks that affect product safety, legality or quality?
Evidence to look for- Training matrix
- Competence assessments
- Refresher plan
T-02Topic T-02Fundamental
People & CompetenceAgency and temporary staff
Do temporary, agency and contractor personnel receive role-specific instruction and suitable supervision?
Evidence to look for- Induction records
- Agency agreement
- Supervision plan
T-03Topic T-03
People & CompetencePersonal hygiene
Are personal-hygiene rules based on risk, communicated, monitored and applied consistently to staff and visitors?
Evidence to look for- Hygiene rules
- Inspection records
- Visitor controls
T-04Topic T-04
People & CompetenceMedical screening
Are health screening and illness-reporting arrangements defined, confidentially managed and linked to return-to-work decisions?
Evidence to look for- Health questionnaire
- Illness procedure
- Return-to-work record
T-05Topic T-05
People & CompetenceProtective clothing
Are protective clothing rules, laundering, storage, issue and replacement suitable for the production risk?
Evidence to look for- Clothing procedure
- Laundry controls
- Issue records
PS-01Topic PS-01
People & CompetenceProtective footwear condition
Are protective footwear selection, issue, storage, cleaning, inspection and replacement managed according to production risk?
Evidence to look for- Footwear procedure
- Issue or inspection record
- Cleaning controls