Sample audit checklist

Company name: Luscious Bites

Date of audit: 18 October 2006

Auditor: Rita Heywood

Key:
IMP = Improvement
Crit = Critical
Maj = Major
Min = Minor

Area Complian CAR reference / Observations

t?

Crit IMP

Maj

Min

1.0 Pre-audit

1.1 At start or before the audit, establish if there have

been any changes to the existing scope, including:
 the food safety plan
 personnel/shift patterns
 product types/variety extensions
 new equipment/changes to processes
 new raw material sources
 changed packaging.
If yes, note these details and then set up audit
trails to review that these changes have been
effectively implemented into the existing HACCP
system when reviewing documents.
Add these questions and audit trails into Section
23 of this checklist.
2.0 Food safety responsibilities and

Food Safety Auditing Toolbox 1

Sample audit checklist
 resources

2.1 Is there at least one person identified as

accountable and responsible for development,
implementation and ongoing maintenance of the
food safety systems? (In Victoria this is the food
safety supervisor.)
Provide the name of that person:

2.2 Verify that:

 the HACCP system (the food safety
plan) is developed, reviewed and
managed by a multi-disciplinary team
 key personnel identified as HACCP
team members have adequate HACCP
training and appropriate experience.
Records sighted.
2.3 If the company does not have the appropriate
expertise and has used external expertise to
develop and review the HACCP system, it must:
 show the credentials of the external
consultant
 re-confirm that day-to-day management
remains the responsibility of the
company.
3.0 Food safety policy

3.1 Food safety policy requires that:

 the company’s product safety policy is
defined
 the policy shall refer to the company’s
intentions to:
- meet its obligations to produce safe
and legal products
- to comply with food safety regulations
- meet its obligations to customers.
 the company’s product safety policy is
clearly communicated to employees and
implemented.
3.2 Does the company have a quality policy or
mission statement?
3.3 Is there a documented quality system in place?
Does it include HACCP documentation?
3.4 Is the quality system accredited and, if so, by
whom?
3.5 Do the hazard audit tables reflect the risks
associated with the product?

2 Food Safety Auditing Toolbox

Sample audit checklist
3.6 Does the company have a documented customer
complaints handling procedure?
3.7 Does the company have a documented recall
procedure?

4.0 HACCP methodology and documentation

4.1 Has the food safety plan been based on the Codex
Alimentarius HACCP principles and is reference
made to relevant legislation, codes of practice or
guidelines?
Does the food safety plan identify, monitor and
manage physical, chemical or microbiological
risks in products and processes?
(Victorian companies: does the company use an
approved food safety plan template?)
4.2 Does the food safety plan describe what
processes are covered within the context of the
paddock to plate through chain process?
4.3 Has a food safety plan been written to include all
products and processes?
Total number of food safety plans within audit
scope:
Date of the food safety plan(s):
4.4 Does the food safety plan include an appropriate
flow diagram of the process?
4.5 Check that the company has used HACCP
principles to:
 conduct a hazard analysis
 determine the Critical control points
(CCPs) by use of the Codex decision
tree when determining CCPs
 establish critical limits
 establish a system to monitor control of
the CCPs. Is the established frequency
for monitoring each CCP sufficient to
control the hazard?
 establish the corrective action to be
taken when monitoring indicates that a
particular CCP is not under control
 establish procedures of validation and
verification to confirm that the HACCP
system is working effectively, including
auditing of the HACCP system
 establish documentation concerning all
procedures and records appropriate to

Food Safety Auditing Toolbox 3

Sample audit checklist
 these principles and their application
 establish the records required to show
ongoing conformance to CCP
requirements. Also, check that there are
records to show that effective corrective
action occurred when there has been a
non-conformance to these CCP
requirements.
4.6 The HACCP study shall be based on an
assessment of risk. In conducting the hazard
analysis, wherever possible, the following shall
be included:
 the likely occurrence of hazards
(physical, microbiological and chemical)
and the severity of their adverse health
effects
 the qualitative and/or quantitative
evaluation of the presence of hazards
 the survival and multiplication of micro-
organisms of concern.
4.7 Check that the company has included in its
documentation some reference to its prerequisite
programs which are there to support the HACCP
system, eg Good manufacturing practice (GMP),
Quality assurance, Allergen control, etc. (See also
later sections in checklist.)
5.0 Product information/specifications

5.1 Does the food safety plan reference a complete

raw materials list?
Does each food safety plan clearly describe the
final product and its intended use?
This can often be in the form of appropriate
specifications:
 raw materials (including ingredients and
packaging)
 finished products
 intermediate/semi-processed products
(where appropriate)
 recipes/formulations/batch sheets (where
appropriate).
5.2 Are specifications regularly reviewed to ensure
adequacy?
5.3 Are characteristics of the product adequately
defined? Consider:
 product description
 raw materials and additives used

4 Food Safety Auditing Toolbox

Sample audit checklist
  description of traceability from raw
materials to delivery
 general product characteristics
 specific food safety characteristics
(composition, chemical, microbiological
and physical characteristics)
 specific requirements (relevant
legislation, customer demands)
 storage conditions
 packaging
 shelf life – evidence to support claim.
5.4 Are characteristics for use adequately defined?
Consider:
 target groups that the product(s) are
intended for sale to (eg immunodeficient
populations, babies, preschoolers,
pregnant women, patients, elderly
people, diabetics, etc)
 information on the label, including
directions for use
 special legislation
 whether Critical control points (CCPs)
concerning the methods of storage and
use have been checked
 known improper use.
6.0 Process information

6.1 Flow diagrams

Are these periodically validated to ensure they
include:
 transfer and/or delay steps
 immediate storage steps
 subcontracted processes (on or off site)
 rework loops
 reprocessing/recycling loops?
6.2 Layouts of the production process
Check these are documented to ensure
consideration to:
 regulatory layout requirements
 the possibility of cross-contamination
 air currents in high-care areas
 pest control plans.
6.3 Critical control points (CCPs)

Food Safety Auditing Toolbox 5

Sample audit checklist
 For each process step defined as a CCP check that
the documents define:
 responsibility for the monitoring of this
CCP
 critical limit and what is its pass/fail
criteria
 frequency of the monitoring check
 corrective action if outside critical limit
 what will constitute the record of the
CCP check
 responsibility, frequency and record of
the verification check of the CCP record.
6.4 Corrective actions
Is there a documented procedure for recording
food safety incidents and is it used to ensure
appropriate correct action? Also, where
applicable, does the procedure make provision for
investigation and follow up to identify root
causes to prevent likely recurrence?
Is there a customer complaint system that
responds to and investigates the causes of non-
conformance to prevent recurrence? Is feedback
provided to the customer?
Does it trigger any withdrawal or recall
procedures that may be necessary?
6.5 Non-conforming product
Is identification and disposition of non-
conforming product undertaken in accordance
with documented procedures and under the
directive of an authorised person, eg release,
hold, rework and/or dump?
7.0 Verification

7.1 Check that a verification schedule exists,

describing the range of verification activities.
Check also that the schedule describes the
activity, responsibility, frequency and records.
It should include some or all of the following:
 verification of cleaning and sanitation
 verification of CCP record compliance
 verification of GMP policy compliance
 verification of equipment accuracy.
7.2 Is there sufficient evidence of the implementation
of the verification schedule?
7.3 Is there evidence of internal audits conducted by

6 Food Safety Auditing Toolbox

Sample audit checklist
 personnel independent of the area being audited?
7.4 Is there evidence of management review
processes to show periodic verification and
analysis of at least:
 CCP records
 product non-conformities
 customer and consumer complaints.
Where deviations from any of the above
requirements have occurred, review that
corrective actions have been taken in a timely
manner and closed off appropriately.
7.5 There is a system for ensuring verification of the
applicable regulations and/or food laws to ensure
compliance to these obligations.
8.0 Validation

8.1 The company has data to substantiate the claims

related to food safety and/or regulatory
compliance, eg:
 shelf life studies have been conducted to
verify the product is safe according to its
use-by date as claimed on the packaging
 special product claims, eg fat free,
gluten free, nutritional information
panel, etc
 special allergen statements (eg nut free)
 preparation or storage instructions to
customers for safe handling of the
product, eg heating instructions,
statements like ‘consume within four
days of opening’.
9.0 Traceability system

9.1 Does the traceability system enable identification

of product lots and their batches of raw materials
through to production and the distribution
records?
9.2 Are traceability records maintained for a defined
and sufficient period of time (two years)?
9.3 Is there a documented product withdrawal/recall
procedure?
9.4 Is the system periodically tested by a mock recall
at frequencies proscribed by customers or a
company policy (generally one to two times a
year)?
9.5 Set up a traceability exercise during the audit to
verify its effectiveness. Time how long it takes.

Food Safety Auditing Toolbox 7

Sample audit checklist
9.6 Does the company have an approved supplier
program?
Prerequisite programs (PRPs)
Support programs are established, implemented and maintained across the entire production system and are to a level as
deemed appropriate by the HACCP team. PRPs are to assist in controlling:
 the likelihood of food safety hazards occurring
 contamination of products including cross-contamination
 maintaining food safety in product and process environment
They include but are not limited to the following:
10 Supply chain management

10.1 Has the food safety plan identified which

purchased and/or incoming materials could be a
source of a significant food safety hazard?
Note: incoming materials requirements include:
ingredients, raw materials, processing aids,
seedlings, food contact packaging, secondary
packaging materials, agricultural chemicals,
cleaning chemicals, ice, water, etc.
10.2 Does the raw material risk assessment drive the
incoming inspection and test plan?
10.3 Are all goods received and inspected as
prescribed by the inspection and test quality plan?
10.4 Is there a system for handling supplier related
non-conformances? Do records show evidence of
corrective actions when incidents occur?
10.5 Do procedures exist for approval and removal of
suppliers from the approved supplier system?
Does it also include approval of emergency
alternative suppliers?
11 Allergen management

11.1 Allergen identification and control includes:

 a current list of allergens present in all
raw materials and finished product
 policy to prevent cross-contamination of
non-allergenic product, including:
scheduling, rework, production runs,
separate processes, etc
 records kept for allergen use, type,
product labelling.
11.2 What preventative measures are in place to
provide allergen control between different
product runs?
11.3 Are any of the following products produced,

8 Food Safety Auditing Toolbox

Sample audit checklist
 packaged or stored on the premises?
Products containing gluten, eg wheat starch, rye,
barley or triticale?
Egg products, nuts and nut products, sesame
products, milk and milk products, soybean
products?
11.4 Is testing carried out to detect residual allergens?
11.5 Are dust collection units installed?
Is there regular pneumatic back flushing of these
units?
12 Design of production facilities

12.1 Are there adequate standards maintained to

safeguard the product? Consider, as needed:
 product flow (eg for raw and cooked
foods)
 building interior (eg lighting, floors,
employee facilities)
 building exterior (eg location, waste
management)
 utilities (eg water, air).
13 Employee hygiene policy

13.1 Are there hygiene and security policies and

procedures?
Does the company communicate the hygiene
requirements to all employees, visitors and
contractors?
Check that records are maintained for details of
visitor’s entry and departure into process area, as
appropriate.
13.2 Are the following prohibited in processing areas?
 watches
 jewellery, including earrings, bracelets
and rings
 nail polish and false fingernails
 smoking
 eating and drinking.
Are personal items stored outside the process
areas? If not, is this justified on the basis of risk?
13.3 Check there are processes to manage staff:
 washing hands policy, including the use
of sanitiser and/or gloves
 if they have an infectious disease as

Food Safety Auditing Toolbox 9

Sample audit checklist
 prescribed by FSANZ FSS 3.2.2.
13.4 Are hand washing facilities located in toilets, Operator observed returning from
amenities rooms and cleaning areas? a break, entering production area
and handling ready-to-eat product
In areas where employees handle food? without washing hands.
Supplied with warm running water?
Antibacterial soap, paper towel and bin supplied?
13.5 Are good hygiene practices observed to be
followed by employees?
Are hair covers provided and worn in processing
and packaging areas?
13.6 Are employee uniforms supplied? Are employee
uniforms laundered in house? Is consideration
given to temperature of laundering water?
If employees supply their own clothing, is it clean
and adequate for the tasks performed?
13.7 Are adequate, clean uniforms provided (ie no top
pockets, no buttons, uniforms not worn off site)?
Are uniforms cleaned or laundered by an external
laundry service?
13.8 Are hands washed?
13.9 Are gloves provided for operators and is there a
procedure for the use and changing of the item?
13.10 Are there injury procedures for protection of
employee wounds?
13.11 Is personnel movement restricted from raw to
processed food areas, where applicable?
14 Factory hygiene policy: walk through

14.1 Exclusion of physical contaminant hazards in

high-risk food processing areas.
Where they cannot be excluded, are there
adequate control measures documented and
implemented for:
14.2  glass

14.3  metal

14.4  bone

14.5  wood

14.6  rubber

14.7  plastics (soft)

14.8  plastics (hard)

14.9  other (eg insects)

10 Food Safety Auditing Toolbox

Sample audit checklist
14.10 Do customer complaint trends demonstrate that
the hazards listed above are under sufficient
control? If not, specify in what category it is not.
14.11 Is all packaging material that comes into contact
with food products is made of material that
doesn’t contaminate food? Packaging material
specifications stating packaging material is food
grade sighted.
14.12 During the packing process, is product protected
from damage, including contamination?
14.13 Are packaging materials stored in appropriate
conditions and clearly identified?
14.14 Is there in-line metal detection?
What checks are performed to ensure the detector
is working properly?
How often are checks performed?
14.15 Is there any scalping in the process?
14.16 Are checks carried out on weighing devices?
What is the frequency of the calibration?
14.17 What other processes are carried out during the
packing process?
14.18 Garbage is stored appropriately and bins are
provided?
14.19 Are there devices to reduce contaminant hazards?
 Has there been consideration to use of
magnets, sieves, screens, metal
detectors, X-ray machines and/or fine
filters?
 Where present, are devices positioned at
appropriate locations to ensure
maximum product protection?
 How often are checks carried out?
14.20 Dropped product policy
Are there controls to ensure that product that is
dropped on unsanitised or contaminated surface is
discarded to eliminate contamination to product?
14.21 Are incoming goods deliveries checked? If so, Operator shows good knowledge
what records are taken? of possible cross-contamination
linked to use of items such as
thermometers. Yet, he was
observed to be taking the
temperature of the liner, not the
product as specified by the food
safety plan.

14.22 Are raw materials stored so as to prevent

Food Safety Auditing Toolbox 11

Sample audit checklist
 contamination? Are food products arriving for
repacking stored under appropriate conditions
and clearly identified?
14.23 Is the incoming goods receipt area maintained in Door left open in receipt dock area.
a clean and hygienic manner? Plastic strips tied back while
unloading. Bird observed in
Are floors, walls and ceilings maintained in good building and droppings observed
condition? on crates in chiller.

14.24 Is there adequate ventilation to remove fumes?

14.25 Vents are not located directly near exposed
packaging?
14.26 Is there adequate lighting? (refer to AS1680 for
recommendations)
14.27 Are premises maintained in a clean and hygienic
manner?
14.28 Are floors in good condition and clean? Observed cracked floor tiles in
storage area

14.29 Are walls and ceilings sealed to prevent entry of

dirt, dust and pests? Are they maintained in a
clean condition?
14.30 Are pipes that pass through external openings
sealed to prevent the entry of pests?
14.31 Can fittings and fixtures be easily cleaned?
14.32 Are packaging lines designed so as to prevent Potential exists for product to
cross-contamination? become contaminated due to filth
and extraneous matter from
apparel (footwear) as people walk
over the line. This is a critical non-
conformance. In addition to audit
observation, the complaints log
indicates that product is being
contaminated. Hazards include
physical and microbiological.

14.33 Wood and glass, paper and plastic offcuts

minimised in manufacturing areas? No potential
to contaminate packaging?
14.34 Is there adequate product traceability, date coding
on inner and outer cartons?
14.35 Despatch area – is the final packed product stored
and transported under appropriate conditions?
14.36 Is this area hygienic?
14.37 What end product testing is carried out?
Microbiological?
Chemical?
15 Chemical control

12 Food Safety Auditing Toolbox

Sample audit checklist
15.1 Has the company conducted a food safety hazard
assessment of the chemicals used?
15.2 Are food-grade lubricants used on food contact
equipment?
15.3 Are non-food-grade chemicals stored and handled
so as to minimise potential contamination? (eg
paints, cleaners, detergents, diesel, battery fluids,
inkjet thinners, etc?)
16 Pest control

16.1 Is there a program to minimise the entry of Door left open in receipt dock area.
rodents, insects and birds in the manufacturing Plastic strips tied back while
and warehousing areas? unloading. Bird observed in
building.

16.2 Are there storage bait station maps identifying

their type and location?
16.3 Is one of the technicians a registered pest
controller? Is the contractor licensed for chemical
applications where needed? Records sighted.
16.4 Electronic pest devices to trap insects are located
correctly and do not scatter dead insects onto
food?
16.5 Are the pest control chemicals approved for use
in food plants? Are they stored correctly?
16.6 Are there points of possible ingress of pests, eg
are doors in the processing storage area closed or
are there holes in the walls? Is there no evidence
of infestation?
16.7 Is there regular removal of waste and rubbish to
prevent harbourage?
17 Cleaning and sanitation

17.1 Are cleaning and sanitation requirements Operator observed not to be

established, documented and implemented? This following basic hygienic work
should include: responsibility, task to be practices. Knife observed to fall on
performed, chemicals and equipment used. floor, possible cross-
contamination has occurred. Knife
was not re-sanitised prior to
recommencing chopping.

17.2 Are there records to prove compliance to the

cleaning and sanitation schedule?
17.3 Who is responsible for cleaning?
17.4 Are cleaning chemicals fit for purpose and stored
appropriately?
17.5 What types of chemicals are used?
- detergent
- sanitiser

Food Safety Auditing Toolbox 13

Sample audit checklist
 What is the name of the supplier?
17.6 Is cleaning equipment stored in an hygienic
manner?
Separate cleaning equipment used for amenities
area?
17.7 Are there Material safety data sheets (MSDS) for
all chemicals used on site?
17.8 Is there a system for verifying the effectiveness of
the sanitation program? Consider, where
appropriate:
 preoperational inspections
 environmental monitoring using rapid
methods and/or microbiological
swabbing
 allergen validation, if required.
Are records of results and corrective actions
maintained?
17.9 Is there evidence that corrective action occurs
when incomplete or inadequate sanitation has
been identified?
17.10 No evidence of dirt or debris in production areas?
17.11 Are walls, floors and ceilings clean?
18 Equipment maintenance and calibration

18.1 Do records show activities by maintenance

personnel have added to the customer complaints,
eg has foreign matter been found in product, etc?
18.2 Are food safety control points managed by
breakdown maintenance? Are hygiene controls
complied with when work occurs in high-risk
hygiene areas?
18.3 Are food safety control points managed by
preventative maintenance programs? If yes, have
these been done at the prescribed frequencies?
18.4 Are calibration procedures developed,
documented and implemented to ensure that all
parameters in the food safety plan read accurately
at the time of use?
Do they refer to:
 frequency of calibration
 criteria for degree of accuracy
 methods for calibration checks and
reference to recognised standards
 method of identifying equipment when it

14 Food Safety Auditing Toolbox

Sample audit checklist
 is found to be out of calibration
 when equipment is found to be out of
calibration, the progress for assessment
of impact on integrity
 records of all calibration checks, of
authorised calibration personnel and
corrective actions as required?
19 Training

19.1 Have procedures been developed, documented

and implemented to ensure activities, duties and
functions that have an effect on the food safety
plan are undertaken by a suitably trained person?
19.2 Are there suitable induction processes for
visitors, contractors and casuals?
Do records exist of these occurring?
19.3 How is training provided? In-house or third
party? Are records kept?
20 Transportation

20.1 Have procedures been developed and

implemented to ensure activities related to
storage and distribution of the food products are
undertaken to a defined standard?
20.2 Are any parts of the transportation loops
undertaken by outside contractors?
If yes, what controls exist to ensure standards are
defined, understood and periodically verified?
21 Document control

21.1 Check that procedures exist for document control

which ensure that systems are developed for:
 approval and issuing of new documents
 identifying general changes and changes
to the revision status of documents
 accessing documents at points of use
 identifying and controlling the
distribution of documents
 preventing the use of obsolete
documents.
22 Records

22.1 The company has a record filing system to ensure

easy retrieval of the obligatory records and data.
These are:
22.2  validation records to substantiate food
safety characteristics of the product,
including shelf life

Food Safety Auditing Toolbox 15

Sample audit checklist
22.3  detailed records by the HACCP teams
with respect to the risk assessments and
also the establishment of the Critical
control points (CCPs)
22.4  records of any subsequent HACCP
reviews or introduced changes to the
HACCP plans
22.5  expertise and training of employees
involved in the HACCP team and CCP
monitoring
22.6  CCP monitoring and reports (dated and
signed)
22.7  records of CCP deviations and corrective
actions
22.8  records of non-conformities and
corrective actions including customer
complaints, product withdrawals and
recalls
22.9  records of traceability for use from raw
material up to and including the delivery
of products
22.10  audit reports and verification reports

22.11  management reviews

22.12  process and product evaluations and

tests
23 Change control

23.1 Is there a system for identifying changed

conditions to trigger a new review of HACCP
systems, eg new final products, new ingredients,
changed suppliers and/or new equipment?
Are these changes assessed for their impact on
the food safety plan and its prerequisite
programs?

Table 1: Audit checklist

16 Food Safety Auditing Toolbox

Sample audit checklist