FSA® Food Safety
Management Systems Audit
No non - conformances noted at the time of the audit.
of:
Brainwave Projects 88 CC t/a Küpel Water
conducted on:
Wednesday, June 23, 2021
By:
Heinrich Boshoff
© Intertek Services
PO Box 12445, Aston Manor, 1630, South Africa
Private and Confidential
© 2021 Intertek Services is the copyright owner of all material contained herein.
No unauthorized use, reproductions or distributions in part of as a whole are permitted.
v5.4.1 : Date Issued: 2021-03-05
© 2020 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Brainwave Projects 88 CC t/a Küpel Water
Auditee:
FSA® Certification number:
Office Use Only
Farm Goedgedacht
Location of site:
FOOD SAFETY MANAGEMENT SYSTEM AUDIT
Version 5.4.1
Date issued: March 2021 Admin review.
Vredefort
Free State.
AUDITEE INFORMATION
AUDIT INFORMATION
Authorized representative:
Pieter Rademan
Audit Date:
E - Mail Address :
admin@kupel.co.za
Audit Type :
FSA
Contact Number :
056 931 0686
Auditor Name :
Heinrich Boshoff
SCOPE Statement
23 June 2021
Bottling and distribution of natural still water.
(to appear on certificate)
Processes observed during
audit
Receiving, filtering, bottling, storage and
dispatch
Main Food Sector:
CIV - Processing of ambient stable products
Sub-category (Process):
C4-02 - Ambient stable beverages (Soft drinks
including flavoured water, isotonics,
concentrates, squashes, cordials, minerals,
table waters, ice, herbal, drinks, food drinks).
Products contained in scope:
Bottled still water
Scope exclusions:
Audit Hours On Site:
No exclusions allowed
8 hours
No additional comments recorded by auditor
Auditor Notes:
To establish the auditee's level of commitment to develop, implement, maintain and continuously improve an effective food safety
management system based on the requirements of the relevant GFSI Benchmarking Document and GFSI Global Markets Program, regulatory
and customer requirements.
Audit objective:
Terms of Reference:
Management System Components (ISO 22000, BRC, IFS, SANS 10330)
Prerequisite programmes on food safety (ISO 22002 - 1, CAC/RCP 01, BRC, IFS, SANS 10049, CFA Guidelines)
HACCP (ISO 22000, Codex HACCP, BRC, IFS, SANS 10330)
The auditee did not dispute any of the non-conformances in this report when given the opportunity to do so during the closing meeting.
AUDIT RESULTS
This summary report must be considered in conjunction with the full report.
Documentation and Implementation of Audit Criteria
Nature and Number of Non - Conformances Noted
(<85% is Area of Concern)
No of Criteria
Section
Implementation
Documentation
Total
N/A
Minor NC's
Major NC's
Critical NC's
Management System
95.7%
97.8%
70
3
5
0
0
Prerequisite Programs
95.3%
100.0%
81
7
6
0
0
HACCP Implementation
96.7%
100.0%
17
6
1
0
0
High Risk
-
0
15
0
0
0
168
31
12
0
0
Total :
PRP / Process Performance Indicators
Overall Score Per Section
(<85% is Area of Concern)
Section
Documentation
Implementation
Overall
HACCP
HIGH RISK
-
94.7%
94.7%
Management
System
PRP's / GMP's
Facility and Equipment
96.8%
97.7%
98.3%
-
Training
100.0%
100.0%
100.0%
Staff Control
100.0%
100.0%
100.0%
Services Control
100.0%
94.7%
97.4%
Contamination Control
100.0%
83.3%
91.7%
Allergen Control
100.0%
100.0%
100.0%
Final Score
Audit Outcome
97.6%
PASS
Stock Control
100.0%
100.0%
100.0%
Process Control
100.0%
100.0%
100.0%
Next Audit due before:
03 June 2022
Testing and Verification
100.0%
100.0%
100.0%
Type of Audit:
Full annual audit
Food Fraud and -Defense
100.0%
100.0%
100.0%
Certificate (if applicable) valid to:
23 June 2022
This audit report is CONFIDENTIAL and is to be used only for purposes expressly allowed and agreed to by the audit client. The audit report reflects our findings at the time of the audit and is based on a sampling exercise,
considering the facilities, operations, practices and systems viewed on site during the audit. It therefore does not follow that no non-conformances exist where none have been noted. The information emanating from Intertek
Services is given after the exercise of all reasonable care and skill in its compilation, preparation and issue. No liability for the display, use, and application of this report is accepted by Intertek Services and Intertek Services
does not guarantee the quality and safety of any goods produced on the premises.
© 2020 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
FSA® Certificate Qualification and Grading Interpretation
Fail
Audit Outcome
Pass
Marginal Pass
Aduit Frequency
Annual audit
Clearance audit within 6 month
Clearance audit within 3 months
Any one(1) of the below
Full re-audit within 3 months
A combination of any two(2) below
5 to 8 Major NC's
Critical
Final score <80%
> 8 Major NC's
> 8 Major NC's
< 75 % for High risk
< 75 % for
High risk
< 75 % for Testing and verification
< 75 % for Testing and verification
< 75 % for Contamination control
< 75 % for Contamination control
<75% HACCP
<75% HACCP
Criteria
< 80 %
PRP / Process Performance Indicators (<85% is Area of Concern) - This is indicated in a red block, and attention should be given to these areas.
Additional Information
1) Any single Critical Non-conformance will result in an automatic FAIL. The audit may not be terminated and the auditor has to complete the full audit.
2) In a clearance audit, the audit will focus on all the non-conformances noted during the initial audit. The clearance audit will also include a facilities inspection. If the non-conformances have been cleared to
the satisfaction of the auditor the grade will be adjusted to a PASS and the certificate will be issued. Please note that auditors may make additional findings if noted during the clearance audit.
3) The audit frequency is always 12 months (for PASS grades or successful clearance audits resulting in the issue of a certificate) and the next audit date will be calculated from the date of the issue of the
certificate.
Classification of Non - conformances
Type
Score
Critical NC
0 for audit
Description
A critical element that causes a direct food safety risk is missing, has not been documented or implemented and compliance to the criteria could
not be proven.
A critical (serious and dangerous) failure impacting directly on food safety or non -compliance to legislative or regulatory requirements.
Only a small part of a requirements has been implemented but the missing elements can potentially pose a direct risk to the safety of the product
produced.
Major NC
0 / 10
An uncontrolled breakdown of a Critical Control Point, process control or PRP that may cause a significant food safety risk to the public or
whereby product may require an immediate recall. Falsification of records relating to food safety controls.
Nonconformities affecting the capability of the management system to achieve intended results.
Almost full compliance with the requirements but a small deviations where found. None of the missing elements will directly impact on the safety of
the product produced.
Minor NC
5 / 10
A non-conformance/s that produces a deficiency in the system that may carry a food safety risk and is likely to result or may lead to a systems
element breakdown if not addressed.
A nonconformity that does not affect the capability of the management system to achieve the intended results.
FSA® Audit workshops are held regularly across South Africa. Please visit www.intertek.com to view our training calendar for upcoming workshop dates.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
GREEN TEXT denotes Documentation Requirements, RED TEXT denotes Implementation Requirements.
Indicates the requirement for documented policies and/or procedures detailing how the element will be controlled.
Indicates the requirement for documented supporting records to indicate that the element is controlled.
These sections are required for the Global Markets Capacity Building Program. (B - Clauses: Basic, I - Clauses: Intermediate)
GFSI
Indicates the GFSI (Version 7) Guidance Document Clause Numbers
Ref.
Requirements
Outcome
Comments / Nonconformities
1. FOOD SAFETY MANAGEMENT SYSTEM REQUIREMENTS
1.1 Food Safety Management System - Manual and Procedures
1.1.1 Management System Manual and Scope
The organization shall establish and document in a food safety manual or
other documented system an effective food safety management system which
shall be implemented, maintained and updated when necessary.
GFSI
ISO
22000
The food safety and quality manual shall be fully documented (printed or
electronic), understandable (language of use - staff), legible, and the manual
or relevant components shall be readily available to relevant staff.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
The organization shall define the scope (range of activities, processes and
products) of the food safety management system. The scope shall specify
the products or product categories, processes (and their interaction) and
production sites that are addressed by the food safety management
system.
1.1.2 Procedures
Are detailed procedures developed for all processes and operations that affect
food safety?
I.A 10.1
All processes and instructions used to manufacture, test, store and ship the
product must be documented in paper or electronic format, and be available.
Note: This is a generic requirement - Are adequate procedures / work
instructions relating to manufacturing documented and in place to
ensure the production of safe food?
1.1.3 Procedures - Implementation
Are procedures clearly communicated to staff?
All procedures and work instructions shall be clearly legible, unambiguous, in
appropriate languages and sufficiently detailed to enable their correct
application by appropriate staff.
I.A 10.2
This shall include the use of photographs, diagrams or other pictorial
instructions where written communication alone is not sufficient.
Note: This is a generic requirement - Are procedures / work instructions
suitable and detailed enough to ensure the production of safe food?
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
1.1.4 Records of Compliance
B.A 7.1
Are records available to support the compliance of the business with the food
safety system which includes all regulatory and customer food safety
requirements that apply?
Note: This is a generic requirement linked to 1.1.2 / 3 - Are adequate
records in place to prove the production of safe food?
1.2 Specifications (Raw Material, Process and Final Product)
1.2.1 Specifications - General
Are specifications available for all product inputs (raw materials, ingredients,
additives, packaging materials, rework) and finished products?
Food Safety Related acceptance criteria specified (could include Certificate of
Analysis (CoA) and Technical data sheet available for processing aids).
Specifications shall be signed off by all relevant parties, if applicable.
B.A 1.1
Specifications shall be reviewed and review dates shall be recorded.
Conform
No non - conformances noted at the time of
the audit.
Minor NC
Final product specification for bottled water
RC04.010 did not reference R455-2010
bottled water regulations amendment in terms
of the maximum levels for metal in the water.
(R454-2008 was referenced.)
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Specifications shall include key data and defined limits for relevant attributes
of the product which may affect the quality or safety of the final products (e.g.
chemical, physical, microbiological and allergenic standards).
Final product specifications shall assist in the safe usage of the product.
1.2.2 Specifications - Compliance
B.A 1.2 Are the available specifications compliant with relevant safety, legislative and
customer requirements?
1.2.3 Specifications - Status and Changes
Are specifications up to date and unambiguous?
Are specifications available to relevant staff (e.g. receiving and quality control
staff) and stored in a location where relevant staff can easily access it?
Are changes to specifications clearly communicated internally and externally?
Changes shall be communicated internally to all relevant staff (emails, posting
B.A 1.4
signs or verbally at meetings) and recorded.
Changes to any specification (formulation, packaging size, process, labelling
etc.) must be recorded, documented and authorized.
1.2.4 Specifications - Control
B.A 1.6
Is there a designated person responsible for controlling specifications?
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
1.3 Product Release
1.3.1 Procedure for Product Release / Quality Control
Is there a documented product release procedure in place to ensure that the
final product meets specifications (prior to release)? Could form part of
processing records.
Procedures/ works instructions with clearly defined test parameters (pass / fail
criteria) and responsibilities and frequencies. Only authorized persons shall
B.A 1.5
release final product.
Portion/ mass/ volume control.
Labelling checks.
Documented procedures for concessions.
1.3.2 Product Release / Quality Control Records
Records to provide proof of compliance to specifications and procedures.
Records indicating what tests have been done (clear parameters) to release
product (visual, laboratory, sensory, chemical) shall be in place (CoA) and
shall have been filled in at the time of manufacture / testing.
B.A 1.5
Do records indicate that tests effectively ensure that the final product meets
the specification?
Records of concessions.
Handling of non - conformances and corrective action.
Data analysed (trend analysis) and communicated to top management.
1.4 Traceability
1.4.1 Traceability - Documented Procedures
Is a documented traceability system in place for every product that meets
regulatory and customer requirements?
The system shall enable the identification of product batches and their
relation to batches of raw materials, primary and consumer unit packaging
materials, processing and distribution records.
B.A 2.1
One step forward and one step back as a minimum.
Where rework is performed, traceability shall be maintained.
Staff members responsible for traceability shall be competent as they shall
have undergone sufficient and required training.
1.4.2 Traceability - Effectiveness
Is the traceability system, including work in progress, post-treatment and
rework, fully operational and effective?
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
1.4.3 Traceability - Annual System Testing
Is the traceability system tested at least annually and are records
available?
At least annually, simulated (mock) recalls are required to ensure that the
traceability program works and testing shall include:
I.A 2.5
a) Identification of item traced (i.e. ingredient or finished product).
b) Time for completion and percentage of product traced, according to both
regulatory or customer requirements.
c) Key learnings, gaps, system improvement opportunities.
d) Receipt and dispatch discrepancy and reconciliation.
e) All staff are to be trained in the procedures and improvements that are
identified and implemented.
f) Results to be summarized and reported as evidence of system verification.
Is the system updated as necessary and records maintained?
1.4.4 Traceability - Labelling
Are there clear labelling procedures that ensure continuous identification of
the product through all stages of production and delivery?
B.A 2.4
The product and containers through all production stages from beginning to
finished products shall be clearly identified.
All batch/lot numbers/date codes shall be recorded throughout the production
process for traceability purposes.
1.4.5 Traceability - Records
Are records enabling product identification available through all production
stages: stock / inventory, work in progress, post processing, rework?
B.A 2.3
Are records available from purchase through production and to immediate
destination for all raw materials and packaging materials (primary and final
product)?
1.5 Food Safety Incident Management (Actual Recall)
1.5.1 Incident Management - Procedures
Is a documented incident management system in place that addresses
incident reporting, responsibilities, communication, risk assessment, product
withdrawal and product recall?
Procedures must clearly define assignment of responsibility, the names and
contact numbers of the crisis management team, sources of legal advice,
methods of determining affected customers and an effective communication
plan internally and to consumers.
I.A 3.3
Conform
No non - conformances noted at the time of
the audit.
Must be realistic and appropriate to the product.
Procedures must clearly define handling, storage, testing and disposal of
recalled product (may link to control of non - conforming product).
Is the documented programme in line with regulatory requirements (CPA Notice 490 OF 2012)?
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
N /A
No actual incidents / recalls.
Minor NC
The National Consumer Commission (email
address and phone number) was not included
in the Recall communication plan as per
Consumer Product Safety Recall Guidelines
Notice 490-2012.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
1.5.2 Incident Management - Effective Recall
Can the business effectively withdraw and recall affected product?
B.A 3.1
Incident management training records shall be in place.
Note: Refer to Section 1.4.5 for recall requirements. This section refers to
the effectiveness of the recall only.
1.5.3 Incident Management - Records (actual incidents
Are records of incidents maintained?
Records shall illustrate the following:
a) All incidents have been reviewed
b) Method to determine the severity of incidents and consumer risk.
B.A 3.2 c) The severity and consumer risk(s) have been taken into consideration when
a final decision has been made i.e. release to retail, rework or destroy.
d) The corrective action was completed.
NOTE: n/a if no actual incidents - Refer 1.5.5
1.5.4 Incident Management - Communications Plan
I.A 3.4
Is an effective documented communication plan in place with a designated,
responsible person identified to provide information to customers, consumers
and regulatory authorities?
1.5.5 Incident Management - Review
Is the incident management system reviewed, tested and verified at least
once a year?
I.A 3.5
Note: This may be done as part of 1.4.5 Traceability - Annual System
Testing.
1.5.6 Incident Management - Corrective Action
I.A 3.6
Are all incidents recorded and assessed to establish their severity and
consumer risk?
Are detailed corrective actions in place for any recorded incidents?
1.6 Control of Non-conforming Product
1.6.1 Control of Non - Conforming Product - Procedure
Is a documented procedure in place to identify and manage all nonconforming raw materials, product inputs, semi finished and finished products,
processing equipment and packaging materials?
B.A 4.1
Procedures are required to ensure that substandard material or finished
product is labelled and controlled so that it does not contaminate other
products or get released for sale or consumption.
Conform
No non - conformances noted at the time of
the audit.
These procedures will include reporting, labelling, isolation, disposal and
corrective actions.
Responsibilities clearly defined.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
1.6.2 Control of Non - Conforming Product - Implementation
Is the program effectively implemented?
Is there evidence that non-conforming product is effectively
identified and segregated pending decisions on use or disposal?
B.A 4.2
Records of further use or safe destruction in place if relevant.
Is a designated, clearly marked non - conforming product storage area
available in the facility?
Is the programme managed by a competent person?
1.7 Corrective Action System
1.7.1 Corrective Action - Procedure
Is a documented corrective action procedure in place in event of a
nonconformity relating to food safety or failure of any component of the food
safety management system (must encompass complete system)?
B.A 5.1
Does the procedure address immediate corrections and methods to
investigate and analyse any nonconformity or complaint to prevent
reoccurrence?
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Is clear timelines indicated?
Does it address processes for root cause analysis?
1.7.2 Corrective Action - Implementation and Effectiveness
Are corrective actions (i.e. release, rework, quarantine, rejection/disposal)
identified and effectively implemented?
Are records in place for all non - conformances (may be electronic) with
corrective actions?
B.A 5.2
Are records signed off and is effectiveness by competent staff?
Is root cause and trend analysis done and are results reported to
management?
All findings from previous FSA audit must be addressed.
1.8 Management Responsibility, Commitment and Resource Provision
1.8.1 Documented Policy
Is a documented management responsibility and commitment policy in place
addressing senior management commitment to establish, implement, maintain
and improve the Food Safety Management System?
GFSI
ISO
22000
Is it practical and organization specific?
Conform
Appointment of management representative and food safety team.
No non - conformances noted at the time of
the audit.
Senior management must determine and provide the required resources
(including suitably qualified personnel) needed to implement, maintain and
improve the food safety management system.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
1.8.2 Resource Provision - Implementation
Is there clear evidence that management is committed to provide the
resources to implement and comply with their food safety program? (Evidence
of the senior management’s commitment to
establish, implement, maintain and continuous improvement).
B.A 6.1
Facility and equipment suitable and adequate training in place.
Finances for testing and verification.
Enough suitable staff provided for control of food safety.
1.8.3 Organizational Chart
Is an up to date organizational chart outlining the business structure available
(by name)?
I.A 6.2
Responsibilities and levels of authority for food safety and reporting lines must
be defined.
1.8.4 Job Descriptions
Are documented, clearly defined responsibilities and job functions regarding
food safety, product safety and legality available?
I.A 6.3
Evidence must be available that the responsibilities have been communicated
to all relevant staff.
1.9 Training
1.9.1 Documented Training Programme
Is a people training program relevant to the product requirements documented
and does it address:
I.A 9.3
• process and product specific training requirements
• training content, frequency and language of training
• qualifications of trainer
• evaluation methodology
• specific HACCP Training
1.9.2 Training Records
Are adequate training records available?
Evidence of specialized or advanced training in place where required.
I.A 9.5
Note: This may include High Risk, Candling, Seam Inspections, Meat
Inspection etc.
Note: For HACCP training findings refer to Section 1.11.6
For Pest Control training findings refer to Section 2.9.7
For Cleaning Chemical training findings refer Section 2.10.6
1.9.3 New Staff / Induction
B.A 9. 1
Have all new people been effectively trained?
1.9.4 Refresher Training Programme
I.A 9.6
Is a refresher training program documented specifying who must receive this
training and the frequency of the training?
Note: May be included in general training procedure
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
1.9.5 Refresher Training Implementation
B.A 9.2
Have all relevant people received (annual or defined) refresher training?
Are records in place ?
1.9.6 HACCP Training
Is a HACCP training program in place?
HACCP team members shall receive specific training in HACCP principles
and implementation.
I.A 9.4
The team leader must have acquired an advanced HACCP training certificate.
The production people in charge of the monitoring of CCP’s shall
have received specific training therein.
1.10 Documentation Requirements (Control of Documents and Records)
1.10.1 Documented Procedures
Is a written Document Control procedure in place and effectively implemented
that define the controls needed to:
I.A 7.1
a) Approve documents for adequacy prior to issue,
b) Review and update and re-approve documents as necessary,
c) Ensure that changes and revisions of documents are identified,
d) Ensure that relevant documents versions are available at points of use,
e) Ensure that documents remain legible and readily identifiable,
f) Ensure that relevant documents of external origin are identified and their
distribution controlled to prevent the unintended use of obsolete documents
and also to ensure that they are identified as such.
g) Controls needed for the identification, storage, protection, retrieval,
retention time and disposition of records
Minor NC
As per Document control policy PP 01, all
documents should be issued with document
numbers, but not all were issued, i.e.
Calibration of Scales and Trend analysis.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Are latest and correct versions in use?
1.10.2 Record Retention
Has the business set timescales for record retention which comply with
regulatory or customer requirements ?
B.A 7.2
Records shall be retained (and securely stored) for a time period required to
meet customer requirements / or duration of shelf-life, the strictest (longest)
time period required is applicable.
Minimum of 1 year is required for food safety audit purposes.
1.10.3 HACCP Record Keeping Procedures
I.C 3.10
Are procedures for record keeping relating to HACCP documentation
established?
Note: May be included in general documentation procedure.
1.10.4 HACCP Records
I.C 3.11
Are procedures for record keeping relating to HACCP documentation
effectively implemented?
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
1.11 Complaints Handling
1.11.1 Documented Procedures
Is a documented program for the handling of customer complaints in place?
Formal recording system which is integrated with corrective action system.
I.A 11.1
Complaints assessed by appointed competent staff (not call centres).
1.11.2 Records
Are records of all customer and consumer complaints in place?
Clear identification of non - conformance and corrective action.
I.A 11.2
Communication with complainant in place.
Records of investigation done.
Root Cause and Trend analysis done and presented to senior management.
1.12 Verification - Final product analysis, Inputs, Product Assessment and Improvement of PRP's
1.12.1 Documented Procedures
Is a risk based procedure in place to ensure that raw materials, ingredients
and final product are analysed for issues that are identified as being critical
to food safety and legal requirements as well as customer specifications?
I.A 12.1
Do procedures ensure that all specified requirements are met, including legal
and customer specifications throughout the whole shelf life?
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Are the tests relevant and do they compliment the HACCP plan and its
associated prerequisite programs to ensure you are meeting food safety, legal
requirements and customer specifications?
1.12.2 Methods of Analysis
Are test methods that are relevant for food safety used to provide valid results
(e.g. by procedures set forth in ISO 17025 and/or industry recognized
methods)?
I.A 12.2
When performed internally, the testing activities shall be compared on a
regular basis with an accredited laboratory (testing activities /
methodologies).
1.12.3 Verification of Inputs - Raw Materials
I.A 12.1
Are raw materials testing in place (including Certificates of Analysis review,
import documentation, relevant certificates)?
Tested for microbiological and chemical contaminants (regulatory).
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
1.12.4 Final Product Testing
Is finished product testing in place for all product categories?
Full spectrum of testing identified - (microbiological and chemical).
I.A 12.1
Full range of product categories tested at least annually or as per customer
requirements with supporting records indicating compliance to both internal
and customer testing requirements.
Any label claims - records of testing must be available.
1.12.5 Verification of Hygiene
SANS
10049
Surface swabs done monthly (preferred) or as per hazard analysis or
customer requirements.
TMA (< 100 / cm2 as per R638) but suitable consideration given to
pathogens. Done as per SANS 5763.
Surface swabs to be taken directly after cleaning and disinfecting.
Drains / chiller drip trays tested for Listeria if identified as potential hazard.
Records showing proof of compliance. (SANS 10049 Annex A)
1.12.6 Verification of Personal Hygiene
SANS
10049
Hand swabs done monthly (preferred) or as per hazard analysis or customer
requirements.
Tested for E. coli , and S. aureus as minimum.
Taken directly after hand washing.
Records showing proof of compliance.
1.12.7 Verification of Inputs - Water
SANS
10049
Monthly analysis of water / ice / steam if it is an ingredient or in direct food
contact, bi- annual if not. According to SANS 241:2015
Tested for TMA, Coliforms, Faecal coliforms, E.coli
Annual chemical analysis.
Check of all water points in facility.
Testing of Ice if in direct food contact.
Records showing proof of compliance.
1.12.8 Verification of Inputs - Air and Gasses
SANS
10049
Air analysis (compressed air, high risk areas, filtered air, air used in
processing, hand dryers).
Tested for Yeast & Moulds (TMA optional - depending on risk)
Records showing proof of compliance
1.12.9 Retention Samples
SANS
10049
Only valid if retention samples kept - customer requirements
Scope of retention samples kept must be representative of product range.
In line with customer requirements. Assessment at end of shelf life
(organoleptic, microbiological, chemical, physical).
Records and trend analysis.
1.12.10 Shelf life Assessment
SANS
10049
Documented program in place addressing scientific determination and
validation of shelf - life. Quality or Food Safety related?
Must address frequency (customer requirements), methods and interpretation
of results. Industry standards are not enough unless documented proof can
be provided.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
1.12.11 Shelf life Assessment
SANS
10049
Scientific evaluation and verification during the product development phase.
Verification testing at regular intervals.
Records.
1.13 Control of Measuring and Monitoring Devices
1.13.1 Device Control
Have the organization identified the measurement of parameters critical to
ensure food safety and have suitable measuring and monitoring devices for
this measurement been identified?
I.A 8.2
Are measuring and monitoring devices critical to food safety identified,
calibrated and effectively controlled?
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Is calibration traceable to recognized standards?
1.13.2 Device Reliability
B.A 8.1
Are measuring and monitoring devices critical to food safety and regulatory
requirements reliable and fit for their intended purpose?
Is the reliability of equipment verified at regular intervals?
1.13.3 Corrective Action
I.A 8.3
Are actions taken and recorded when measuring and monitoring devices are
found to be outside of specified limits?
1.14 Purchasing
1.14.1 Documented Procedure
Are documented purchasing requirements established for products and/or
services used.
I.A 13.1
Do purchased products and services meet current specifications and
contractual agreements?
Are purchasing requirements based on the impact of products or services on
food safety?
1.14.2 Records
I.A 13.1
Is a list of approved suppliers maintained?
Are all suppliers used listed?
1.15 Supplier Approval and Performance Monitoring
1.15.1 Documented Supplier Approval Program
Is a documented supplier approval program in place
I.A 14.1;
SANS
10049
Shall clearly address approval process (criteria for approval).
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Handling of exemptions.
1.15.2 Supplier Approval Records
Is the programme effectively implemented?
I.A 14.1;
SANS
10049
Are records of supplier approval in place?
All suppliers on the approved suppliers list meet requirements.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Minor NC
A supplier questionnaire was not received
from the filter supplier.
1.15.3 Documented Supplier Monitoring Program
I.A 14.2;
SANS
10049
Is a documented supplier monitoring program in place?
1.15.4 Supplier Monitoring Records
I.A 14.2;
SANS
10049
Suppliers’ food safety assessments shall be scheduled and/or monitored by
the company as defined.
Records of the supplier evaluations shall be maintained.
Records shall include corrective actions when required.
1.16 Food Safety and Compliance Policy
1.16.1 Documented Policy
Is a company specific, documented food safety policy in place that address
food safety and legality specifically.
Terms of reference (may be separate) must specify (by name) the relevant
acts, regulations, compulsory specifications and standards used.
SANS
10049;
SANS
10330
ISO
22000
Must Identify PRP standards used (e.g. SANS 10049, ISO 22002-1), must
Identify / Specify HACCP standard used (e.g. Codex, ISO 22000).
Conform
No non - conformances noted at the time of
the audit.
Minor NC
Some of the legislation referenced to were
outdated and repealed regulations, such as
R500 and R545 (Heavy metals in food stuffs),
R918 and R962.
Conform
No non - conformances noted at the time of
the audit.
Must Identify customer requirements and for export - legislation of country of
destination.
Top management shall ensure that the food safety policy is supported by
clear, measurable food safety objectives.
1.16.2 Policy Implementation
Food safety policy dated and signed by top management.
SANS
10049;
SANS
10330
ISO
22000
Copies of all terms of reference (documents) available (may be electronic).
Documented proof of the communication of the food safety policy throughout
the organization in place (signed copies, induction training or notice boards).
Are food safety objectives monitored and reviewed annually to determine
performance?
1.17 Internal Audit
1.17.1 Documented Programme
Documented program in place for internal audit.
SANS
10049;
SANS
10330
Scope clearly defined (must encompass whole FSMS, PRP program and
HACCP and as a minimum cover the criteria of the FSA audit) and a preplanned schedule must be in place.
Description of methodology and responsibility must be in place.
Independence (impartiality) and competence of auditors defined.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
1.17.2 Records
Suitable template in use.
Records of last internal audit.
SANS
10049;
SANS
10330
Non - conformances carried over to the corrective action system, actioned,
verified and cleared.
Internal auditors independent and suitably qualified (evidence of competence).
1.18 Management Review
1.18.1 Documented Program
Documented program in place for management review.
Top management shall review the organization's food safety management
system at planned intervals to ensure its continuing suitability, adequacy and
effectiveness.
SANS
10049;
SANS
10330
ISO
22000
Must address frequency (pre - planned minimum annually).
The input to management review shall include, but is not limited to,
information on:
a) follow-up actions from previous management reviews,
b) analysis of results of verification activities
c) changing circumstances that can affect food safety
d) emergency situations, accidents and withdrawals
e) reviewing results of system-updating activities,
f) review of communication activities, including customer feed-back
g) results of external audits or inspections.
1.18.2 Records
SANS
10049;
SANS
10330
ISO
22000
Detailed minutes (records) and attendance registers of reviews available.
Opportunity for improvement noted.
1.19 Control over Outsourced Processes
1.19.1 Documented Program
Documented program for control of outsourced processes.
SANS
10049;
SANS
10330
Procedures used to approve contractors (clear parameters for approval).
Food safety management system requirements needed by contractor.
N /A
Procedures for review.
1.19.2 Records
SANS
10049;
SANS
10330
Clear contracts in place.
Verification and inspection records of suppliers.
N /A
Records of inspection of product against agreed specifications.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
1.20 Labelling
1.20.1 Label Compliance
Labelling complies with R 146, Guidelines to R. 146 and any product specific
labelling regulations (e.g. Juices).
Name and description as per regulation (DAFF).
Reg
146;
SANS
10049;
SANS
10330
Contact details, net contents, applicable storage instructions, batch numbers
and sell by / best by dates (D-M-Y).
Claims on labels validated by testing.
Allergens clearly identified.
Labelling in line with specifications.
Labels may not be removable.
1.21 Communication
1.21.1 Documented Program
SANS
10049;
ISO
22000
SANS
10049;
ISO
22000
Documented program in place for internal and external communication
addressing communication of information relating to the food safety
management system to suppliers, customers and internal staff.
Procedures must address communication of changes to products, systems,
PRP programs, legislative changes and complaints.
1.21.2 Records
Proof of communication - memos, meeting agendas, notice boards, green
areas, correspondence.
1.22 Regulatory Compliance
1.22.1 Compliance Records
Reg
638
Consider all legal requirements.
Certificate
of acceptability (R638) or relevant regulatory /
statutory registration certificates (Abattoir / Milk Shed) in place.
(In
the name of the person in charge, correct address and valid).
V registrations for pet food.
Eggand meat grading, Meat Safety Act compliance
Conform
No non - conformances noted at the time of
the audit.
2. Pre-Requisite Programs (R 638; SANS 10049)
2.1 Facility - Location and Environment
2.1.1 Plant Location and Positioning
Location, positioning and size of plant suitable.
B.B 2.1
No hazards from neighbours or surrounds - potential environmental,
physical, microbiological or chemical contamination risk.
Conform
No non - conformances noted at the time of
the audit.
Separate facility accessible from a separate entrance.
No domestic dwellings or no direct access from domestic dwellings.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.1.2 Condition of the Facility Environment
Condition of local environment / grounds within site of facility:
Perimeter suitably fenced and no animals within perimeter.
Roadways and areas that service the facility paved.
Unused buildings in good repair, not posing pest or other hazard.
Premises well drained - no pooling water.
Open areas paved, covered with lawn or protected to prevent dust.
Outside construction of buildings (walls, roofs, gutters) in good condition and
B.B 2.6
maintained.
No bird or pest activity or potential nesting sites.
Sewage and effluent lines, drains and gutters suitably covered, free flowing,
no smells and in good condition - not posing a hazard.
2.1.3 Site inspections
A programme of site inspections / checks shall be established,
to ensure the site environment
maintained in a suitable
condition to ensure food safety.
are
2.2 Facility Design, Construction, Fabrication, Layout and Product Flow
2.2.1 Roofs and Ceilings
Food handling and storage areas - weatherproof, non - absorbent, well
maintained, tight fitting with walls, min. 2.4 m above floor, 300 mm above
equipment, dust proof, corrosion resistant, light coloured, impermeable and
easily cleaned.
B.B 2.1
Minor NC
Openings observed in the bottle storage room
where roof and walls met.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Clean with no condensation, mould growth, flaking paint, rust, dirt.
Openings smooth and sealed.
Clean.
2.2.2 Walls, Overheads and Doors
Food handling and storage areas - Walls: Weatherproof, impermeable to
water, smooth, corrosion resistant, light coloured, washable and impact
resistant.
Clean with no condensation, mould, flaking paint, rust, dirt, holes or cracks.
Protected from moving equipment.
B.B 2.1
Overhead and Wall Mounted Structures: clean (on top), good condition.
No risk for contamination or dirt accumulation.
Entry and exit points into facility sealed.
Not flush against walls unless properly sealed.
Doors tight fitting, fitted with self closing devices and where required strip
curtains / air curtains. No exposed wood.
All doors controlled and kept closed.
Joints with other walls, floors and ceilings coved and sealed.
2.2.3 Windows and Skylights
B.B 2.1
Food handling and storage areas: Non - opening or pest proofed if used for
ventilation and clean.
Glass protected against breakage (on inside).
Window sills sloped.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.2.4 Floors
B.B 2.1
Food handling and storage areas - clean, impermeable to water, smooth,
corrosion resistant, washable, chemical resistant, free from cracks, holes or
open joints.
Safe to walk on (no slippery).
No mould growth, flaking paint, rust, dirt.
Suitably sloped to drains.
Manholes double sealed.
Clean as you go in place.
2.2.5 Drainage
B.B 2.1
Food handling and storage areas - channels open with easily removed
covers, designed to cope with flow.
Traps for waste fitted with strainers. Rodent proof.
No installations in channels to impede flow.
No blocked drains.
Duckboards suitable construction (no wood).
No smells and clean.
2.2.6 Ventilation
B.B 2.1
Food handling and storage areas - Adequate ventilation.
Air quality acceptable.
Suitable removal of steam, heat, smoke, fumes.
Intakes and outlets suitable position to prevent contamination.
Air filtered if required.
Fans and filters clean and easily cleanable.
Entry and exit points into facility sealed.
Flow from high to low risk.
No noxious odours, dust or contaminating aerosols.
2.2.7 Hand Washing Facilities in Production Facilities
B.B 7.3
Available at entrance.
Adequate number for staff compliment, warm (40-50oC) potable water.
Taps not hand or elbow operated unless no perceived hazard supported by
hazard analysis.
Food safe (see section 2.10) hand soap and alcohol based sanitizer.
Signage posted.
Hand drying facilities - paper only if inside production areas and waste
receptacles provided (non hand operated).
No utensil washing.
Drainage not directly to floor.
2.2.8 Lighting / illumination
B.B 2.3
Food handling and storage areas - Adequate to perform duties with natural
colour.
Glass components protected from breakage.
Easily cleaned and clean.
Protected from moisture.
General areas (R638) - 200 lux.
2.2.9 Separation of Processes and Facilities
B.B 4.1
Receiving, storage, preparation, processing, packaging and final product
storage areas clearly separated and well defined. This includes dedicated and
separate high risk areas.
Suitable in size and capacity to enable safe operations.
Separation may also be in time and not space (detailed procedures must be in
place).
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Minor NC
Evidence of smoking observed in the men's
toilet.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.3 Facilities - Staff
2.3.1 Change rooms and Lockers
Acceptable number of change rooms / cloakrooms / showers suitably situated
and separated.
Clean, ventilated, well maintained and hygienic.
Change rooms directly linked to production area but with doors or foyer (staff
not exposed to environment when in protective gear).
No preparation of meals and not used as living quarters.
B.B 7.1
Adequate separate storage/lockers for personal clothing, protective clothing
and food / food containers.
No glass risks (mirrors, crockery, bottles).
Clean, well maintained and hygienic.
Protective clothing not in contact with personal wear or food.
No protective gear in personal lockers.
Lockers clean on top.
Locker inspections done with supporting records.
2.3.2 Toilets
B.B 7.2
Separate toilet facilities.
No direct access between toilets and production areas unless foyer and self
closing devices are in place.
Clean, well maintained and hygienic with suitable air flow.
Amply supply of toilet paper.
Clear signage to support hand washing.
No smoking.
2.3.3 Hand Washing Facilities in Cloak Rooms / Toilets
Adequate hand wash and drying facilities separate from those in the
production facility, warm (40-50oC) potable water.
B.B 7.3 Food safe certified (see section 2.10) hand soap and alcohol based sanitizer.
Signage posted.
Hand drying facilities - paper or air driers and waste receptacles.
2.3.4 Canteen / Rest / Smoking Areas
B.B 7.4
Separate facilities provided.
Storage for food provided.
Waste control in place.
Clean, well maintained and hygienic.
No direct access to production facility or toilets.
Signage prohibiting protective clothing.
Catering areas - no contamination risk.
Clearly demarcated smoking area provided.
Smoking area controlled and clean.
No risk of contamination.
No evidence of smoking in non - designated areas.
2.4 Equipment
2.4.1 Position and Condition of Equipment
B.B 2.5
Situated to allow access for cleaning and maintenance (away from walls).
Drain directly to sewage system.
Equipment easily cleaned, clean and in good condition (no damage, rust,
flaking paint, temporary repairs).
Gearboxes with oil drip trays.
Grease nipples clean.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.4.2 Equipment (including Utensils) Construction
Equipment constructed of suitable material for intended purpose.
Designed to minimize food safety risks.
Surfaces in contact with food - smooth, light coloured, resistant to
corrosion, non - absorbent, no open joints or crevices, open ends sealed and
not painted. Easily cleaned, clean and in good condition (no damage, rust,
flaking paint, cracks, temporary repairs).
B.B 2.4
Utensils -Suitable material of construction (no wood) - must be industrial and
food safe. Good condition and clean, suitable storage when in use and after
production. No damage, rust, flaking paint, temporary repairs, tape, loose
bristles, wooden handles.
Forklifts and moving equipment in good condition.
Forklifts electric (inside facility) and not diesel.
2.4.3 Food Containers
B.B 2.4
Very clear differentiation between food and non food containers.
Suitable material of construction - must be industrial and food safe.
Good condition and clean.
Clearly Identified.
Not stored on floor - Dummy Crate System.
2.5 Staff - Personnel Hygiene, Protective Clothing and Medical Screening
2.5.1 Documented Program
Documented Personnel Hygiene, Protective Clothing and Medical.
Code of conduct / procedure in place and based on risk.
B.B 1.1
Behaviour - Acceptable and unacceptable behaviour, jewellery, wearing of
make-up and perfume and personal items.
Protective clothing - appropriateness, dedicated (low risk, high risk, clean
and dirty areas, laboratory), cleanliness, suitability of design to prevent
contamination, frequency and control of issue and return, cleaning and
laundering, control of footwear (separate footwear for use in the factory).
Control of disposables.
Facility entry and exit procedures - hand washing, boot washing,
dressing / undressing.
Medical - Screening prior to employment and further annual examination,
control of illness and return to work. Procedures in case of medical incidents
(blood spillage). Plaster and glove control.
Control of visitors and contractors addressed.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.5.2 Inspections
B.B 1.1
Checklist must be in place to determine compliance to the code of conduct /
procedure.
Minimum daily recorded checks at the start of shifts.
Control of visitors implemented.
2.5.3 Legal Compliance
B.B 1.2
Are personal hygiene requirements compliant with legal requirements, if
applicable?
2.5.4 Code of Conduct
B.B 1.5
Signed by all employees including management and acknowledged by
visitors.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.5.5 Observed Behaviour - Personal Hygiene
B.B 1.5
Adherence to code and observation of unacceptable behaviour (eating,
drinking, smoking, nail varnish, spitting, perfume, jewellery, long nails).
Signage prohibiting unacceptable behaviour in place.
Adherence to hand washing procedures.
2.5.6 Observed Behaviour - Protective Clothing
Adherence to protective clothing requirements (Clothing covers all personal
clothing, No buttons or pockets, Clothing not worn outside production areas,
Suitable change frequency, Control of dirty clothing and laundry practices).
B.B 1.6
Control of disposable protective gear.
Service level agreement with contracted laundry (SANS 10146)
2.5.7 Infectious Disease Control
B.B 1.3
Are communication procedures in place for people, contractors and visitors
addressing actions to be taken in the case of an infectious disease?
2.5.8 Medical Conditions (SANS 10049)
A documented procedure shall be established for the proactive identification,
monitoring, communication and management of controls required for the
administration of health conditions.
A qualified person responsible to decide if individuals with a suspect illness
may enter food areas and how these individuals are controlled?
B.B 1.4
Records in place and compliant for food handlers.
Records of visual screening for visible signs of illness.
Auditor to take random sample and check records against staff members.
Plasters clearly identifiable.
Suitable first aid equipment available and accessible.
Records of issue and return of plasters.
2.6 Services - Control of Utilities
2.6.1 Documented Program
Documented program must address the specification, use, management and
control of water, steam, ice, air and other gasses.
B.B 6.1
Relevant to plant - not generic.
Must be documented even if water is only used for cleaning.
Plan of water reticulation system in place.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.6.2 Water, Steam and Ice
All water used in direct contact with food must be potable.
Clear identification of potable vs. non potable.
Taps used for addition of water as ingredient fitted with vacuum breakers.
Hoses off floor. Holding tanks suitable and sealed.
Steam food safe. No steam leaks and condensation.
B.B 6.2
Holding tanks / bunkers for ice suitable and sealed.
Ice must be made from potable water.
Water Treatment
Chemicals used in treatment must be food safe.
Detailed records of filter changes and chemical dosage.
Records of verification of chemical dosage.
Control and management, if not from municipal source, suitable.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
2.6.3 Air and Other Gasses
Air lines clearly indicated, filters in place, no contamination sources.
Air used as an ingredient or used for direct food contact - filtered, correct
temperature and humidity (records).
Compressors correct type for food contact air.
GFSI
Direct food contact gasses food grade, filtered, records of use and application,
traceability (COA's).
Suitably stored.
Gasses (e.g., cooking gas) not potential pollutant source (gas leaks).
MAP gasses - records of use and verification.
2.7 Services - Maintenance
2.7.1 Documented Program
I.B 10.1
A documented program must be in place and must address all aspects of
maintenance including preventative maintenance.
Program to include management of outsourced services (boilers, filtration
plants, equipment, retorts, compressors and waste water treatment) if
applicable.
Maintenance plan in place.
Relevant to plant - not generic.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.7.2 Effective Maintenance Implementation
I.B 10.2
Schedules and Records
Planned program in place - includes equipment, buildings, vehicles and
facilities.
Lubrication schedules.
Records completed as per schedule.
Documented records of maintenance work done - job card system.
If outsourced: Contract signed, food safety criteria addressed.
Condition of Equipment
All equipment well maintained.
2.7.3 Post Maintenance Checks
Are effective hygiene procedures in place for maintenance activities?
I.B 10.3
Food safety checks (protective clothing check, tools in = tools out, post
maintenance cleaning not filled in by maintenance staff themselves).
2.7.4 Effective Post Maintenance Hygiene
No uncontrolled maintenance waste or tools
I.B 10.4
Temporary repairs clearly controlled, not in place for extended periods,
suitable and not posing a contamination risk.
Identified in corrective action system.
In case of construction - suitable protection of product, no risk posed, hygiene
and physical contamination risks.
2.7.5 Chemicals and Storage
I.B 10.5
Suitable storage for maintenance chemicals.
Separation of food vs. non food chemicals.
MSDS in place at point of storage.
Flammables in flammable store.
Post maintenance cleaning chemicals food safe.
Tools suitably stored if kept in production areas.
Tools clean and fit for purpose.
No uncontrolled tools in facility.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
2.8 Services - Waste Management
2.8.1 Documented Program
B.B 8.1
Documented program must address control and management of internal,
external waste and waste providers.
Relevant to plant - not generic.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.8.2 External waste management
B.B 8.1
Area suitable, clearly identified and enclosed.
No potential for pest infestation (no signs of activity and controls in place).
Containers covered. Hygienic and clean.
Removal at suitable frequency (no accumulation).
No food waste or product unless in dedicated controlled storage.
Records of safe disposal of food waste.
Waste rooms / skips closed and secured.
2.8.3 Internal Waste Management
B.B 8.2
Clear differentiation between food and non - food waste storage containers.
Containers with lids. Suitably lined.
Cleaned and disinfected daily.
No food in non - food containers.
Packaging not used for waste storage.
2.9 Services - Pest Prevention and Control
2.9.1 Documented Program
B.B 5.2
Documented program must address control and management of pests.
Must address internal and external control.
Relevant pests clearly identified.
Relevant to plant - not generic.
Conform
No non - conformances noted at the time of
the audit.
Minor NC
Opening were observed in clean room (where
bottles exit on the conveyor) where pests such
as cockroaches, flies and rodents can enter
filling and bottling room.
Minor NC
Pest Control provider’s Public Liability
certificate had expired in May 2021.
Conform
No non - conformances noted at the time of
the audit.
2.9.2 Pest Proofing / Infestation
B.B 5.1
Building pest proof.
No holes, gaps or other entrance areas for pests.
Consider doors, services entry and exit points, ceilings.
Any visible signs of pest infestation.
2.9.3 External Provider Documentation
B.B 5.4
Pest control provider file (hard copy with basic document set) in place.
Reputable contractor (registered with Dept. of Agriculture).
Copies of latest & current PCO registrations.
MSDS and datasheet of all pesticides used. Liability insurance.
Workmen's compensation certificates.
Up to date bait map available, Signed and dated by PCO.
2.9.4 Records of Control
B.B 5.4
External Service Provider
Detailed service records, detailed applications logs (pesticides). Minimum
biannual audits. Trend analysis.
Suitable inspections frequency - based on risk (min. monthly)
Internal Control
Internal inspection records, pest sightings logs.
Letter of appointment for internal pest control and prevention officer.
If handled internally staff must be suitably qualified (records).
Poisons suitably controlled (records).
Follow-up and Corrective Action
Follow-ups done in case of infestation problems.
Records of treatment or disposition of products.
Findings from pest control company carried over to corrective action system
and addressed.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.9.5 Pest Control Stations
Fixed, clean, tamper evident bait stations, suitably placed.
No loose bait, no loose seeds, powders or gels. Clean and dry.
No toxic bait inside facility. Records to indicate that live traps are inspected
regularly. No use of glue boards. No evidence of rodent activity.
Suitable fly killers correctly positioned - at entrances. No electrocution devices
in facility. Devices operational, clean and serviced, proof of lights replaced
B.B 5.3
annually. Fly screens where required.
Toxic monitoring stations not allowed in facility - glue boards / snap or live
traps only. No evidence of fly / insect activity
Are the controls appropriate in relation to the product, raw material and
facility?
2.9.6 Bird Control
B.B 5.3
Suitable bird control in place. No cats.
No evidence of bird infestation.
No evidence of bird droppings in facility.
2.9.7 Training
GFSI
Records of specific training in pest control.
2.10 Services - Facility Hygiene, Cleaning and Sanitation
2.10.1 Documented Cleaning Program
Detailed, documented master cleaning schedules (MCS) available for outside
areas, structural surfaces, equipment, utensils, vehicles, tankers.
Must address area to be cleaned, frequency of cleaning, chemical to use and
dilution, method of cleaning, equipment to use and colour thereof, responsible
person/s and verification.
B.B 3.1
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Documented procedures in place for CIP control (if relevant)
Must address process parameters, chemicals (type storage and control) and
dilutions, schematic plan, separation from product lines, control of valves.
2.10.2 Hygiene Inspections
B.B 3.1
Records of hygiene inspections in place.
Records clearly in line with MCS, carried out and recorded for all items at
least daily even if cleaning frequency differs.
Non - conformances carried over to corrective action system.
2.10.3 Cleaning Equipment (including CIP)
Suitable cleaning equipment - industrial, food safe and clearly identifiable.
Storage suitable - hung up, clean, dry and away from food.
Clear colour differentiation between colour of equipment used on food vs. non
food contact surfaces, between high and low risk areas, between inside and
outside, between toilets and rest of facility.
B.B 3.2
CIP system hygienically designed - no dead ends, effective draining, end caps
fitted to all open pipes. Spray balls in place in tanks.
Clear separation from product lines.
Records of verification of dilution and residue testing (rinse water) of CIP.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.10.4 Chemicals and Their Control
Correct food grade chemicals and sanitizers being used.
Documented proof that chemicals is food safe (SANS 1828 and 1853
certificates or any other suitable validated scientific evidence).
All disinfectants must be registered with the NRCS.
MSDS and Datasheets in place.
B.B 3.2
Suitable storage of food safe cleaning chemicals.
Separate, locked, control of issue.
Records of management and verification of chemical dilutions.
Sanitizers - testing of working solutions for active ingredient.
2.10.5 Clean as you go (General Plant Hygiene)
B.B 2.2
All areas and equipment kept clean, dry and hygienic at all times.
Clean as you go practices in place and clearly visible.
Is the facility cleaned and disinfected to prevent contamination?
2.10.6 Training
B.B 3.3
Are qualified, trained people used for cleaning and disinfection?
2.11 Hazard Control - Chemical and Physical Contamination Risks
2.11.1 Hazardous Chemical Control
GFSI
Documented program must address control of non food / hazardous
chemicals.
Must address approved suppliers, use (trained personnel, time of use),
storage, handling, identification and control.
Procedures to prevent possible contamination if chemicals must be used in
plant.
N /A
2.11.2 Hazardous Chemicals
GFSI
Records of control. MSDS on file and available.
Suitable storage practices - locked (access control), clean and neat,
identified.
N /A
2.11.3 Foreign Object Control
GFSI
Documented program must address control of glass, ceramics and hard
plastics, metal and other physical contamination risks that may pose
contamination risk in facility.
(both as part of facility and equipment and as packaging)
Conform
No non - conformances noted at the time of
the audit.
Minor NC
The integrity of the hard plastic soap and
sanitiser dispensers in the Filling room, were
not checked on Foreign Objects control
register, RC 16.002.
Must address control, identification (registers), frequency of inspection and
action in case of defect. Procedure in case of breakage.
2.11.4 Glass and Hard Plastic
GFSI
Register in place (all potential sources listed - consider clocks, gauges,
machine covers, lights, utensils, monitoring equipment, stationary, pallets).
Records of inspection. No damages observed.
No loose glass or plastics in facility.
2.11.5 Glass and Brittle Packaging
GFSI
No damaged glass or brittle plastic packaging present.
Rinse and invert or invert effective.
Inspections of packaging in place.
Damages on line suitably cleared.
N /A
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.11.6 Metal
GFSI
Register in place (all potential sources listed).
Records of inspection and verification.
No damages, missing pieces observed.
No loose metal in facility.
2.11.7 Other Physical Contamination Risks
GFSI
No other physical contamination risk observed.
No permeable materials in higher risk areas.
No damaged pallets.
No pallets without slip-sheets, No wooden pallets in production areas.
2.11.8 Control of Detection and Removal Devices
GFSI
All Detection and Removal Devices identified.
Records of use, inspection and finds.
. Adherence to documented program.
Fully operational (auditor to witness if possible).
2.12.1 Hazard Control - Microbiological Contamination Risks
2.12.1.1 Microbiological Cross Contamination
B.B 4.1
No cross contamination risks.
Separation of processes and facilities.
Separation of raw products, pre-packed products, cooked/ finished products.
Hoses and pipes for ingredients and products properly stored.
Decontamination of packaging (rinse and invert).
Minor NC
Microbiological cross contamination risk
observed: Water was leaking from a plastic
elbow above the stainless steel table on which
a bag of bottles was placed before washing.
Conform
No non - conformances noted at the time of
the audit.
2.12.1.2 Dangerous High Risk Practices
B.B 4.1
High Risk / Care (Ready to Eat / Ready to Heat / Ready to Reheat) products
not manufactured or handled (exposed) in low risk areas.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
2.12.2 High Risk (SANS 10049 requirement 9; Chilled Foods Association)
2.12.2.1 Facility Design - General
CFA
Based on CFA requirements. Specific to plant audited - not generic
High risk / care area segregated and fully enclosed.
Floors, walls and ceilings in compliance with requirements of section 2.4.
No wood, unprotected glass.
High level of hygiene.
No rust, peeling paint, condensation, mould growth.
Drainage (away from high risk / care area).
N /A
2.12.2.2 Facility Design - Entrances
CFA;
Entry to high risk / care areas via specifically designated changing facility and
following specific procedures.
No toilet facilities in the high risk / care area.
Clear signage.
N /A
2.12.2.3 Facility Design - Hygiene Facilities
CFA
Dedicated cleaning equipment.
Dedicated waste bins.
Dedicated washing facility.
N /A
2.12.2.4 Facility Hygiene
CFA
Very high levels of hygiene maintained at all times
N /A
2.12.2.5 Environmental Control - Air
CFA
Air controlled - filtered (Chilled Foods Association),
Records of change of filters, proof of positive flow.
Clear flow from high to low risk areas.
N /A
2.12.2.6 Environmental Control - Temperature
CFA
Actual area temperature, records (12oC +- 3oC for chilled product).
N /A
2.12.2.7 Staff - General
CFA
Records of training in High Risk Practices
Medical certification for workers.
N /A
2.12.2.8 Staff - Supervision
CFA;
Individual with specific knowledge and formal responsibility of the high risk /
care area.
N /A
2.12.2.9 Staff - Protective Clothing
CFA
Dedicated protective clothing kept completely separate from others.
Readily identifiable appropriate footwear.
N /A
2.12.2.10 Staff - Inspection
CFA
Personnel hygiene high risk / care specific checklist must be in place to
determine compliance to the high risk / care code of conduct.
Minimum daily checks.
N /A
2.12.2.11 Equipment
CFA
Dedicated utensils, equipment and tools.
Clearly marked or colour coded.
No other equipment of same colour or marking in low risk.
Not leaving High risk / care area.
N /A
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
2.12.2.12 Refrigeration
CFA
Refrigeration capacity of chiller suitable.
Stacking practices in chiller suitable.
Condition of shelving and chiller.
No condensation.
No stock below drip trays.
Drip trays not draining to floor and out of high risk / care area.
Drip trays, fans and unit clean.
Temperature records.
N /A
2.12.2.13 Cross Contamination - Product
CFA;
No cross contamination risk;
Only RTE / RTH / RTRH and decontaminated ingredients and products in this
area.
Records on control of decontamination - Time and concentration of sanitizer
per batch.
N /A
2.12.2.14 Cross Contamination - Packaging, Equipment
CFA
Sanitized transfer of packaging, equipment, ingredients etc. into this area.
N /A
2.12.2.15 Product
CFA
Actual product temperature recorded and monitored.
Chilled product - (depending on CFA classification).
Chilling achieved within time period specified in standards or as per customer
requirements.
Cooked / hot fill Product (as per CFA).
Temperature of ingredients in assembly areas. Records.
N /A
2.13 Food Fraud and -Defense
2.13.1 Food Fraud
2.13.1.1 - Vulnerability Assessment
The organization shall document, establish and maintain a documented
procedure for a food fraud vulnerability assessment that:
GFSI
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
a) identifies potential vulnerabilities,
b) develops preventive measures, and
c) prioritizes them against the vulnerabilities.
2.13.1.2 - Fraud Prevention
The organization shall put in place appropriate preventive measures to protect
consumer health.
These processes shall;
GFSI
a) be controlled within the scope of the food safety management system;
b) be in compliance with applicable legislation.
Food fraud mitigation plan shall be supported by the FSMS.
2.13.1.3 - Annual Review
The food fraud prevention procedure shall be reviewed:
GFSI
a) after each actual or potential failure of a preventive measure, and
b) at least annually.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.13.2. Food Defence
2.13.2.1 - Threat Assessment
I.C 4.1;
SANS
10049
Is a documented food defence threat assessment procedure in place?
Have the threats to the product as a result of intentional product tampering or
intentional contamination been assessed?
2.13.2.2 - Defence Controls
I.C 4.2;
SANS
10049
Have those points in the process which are vulnerable to intentional product
tampering/intentional contamination been identified and subjected to
additional access control?
2.13.2.3 - Corrective Actions
I.C 4.3;
SANS
10049
Are measures in place to address what to do with the product, if prohibited
access took place and the product may have been tampered with or
intentionally contaminated?
2.14 Hazard Control - Allergen Management
2.14.1 Documented Program
Documented program must address methods of identification of allergens.
Raw material allergen assessment.
Hazard analysis to identify routes of contamination and cross contamination
(may be part of HACCP).
B.C 2.1
Procedures must address receiving practice, identification, storage, control of
rework and process controls.
Labelling. Legal requirements
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.14.2 Allergen Risk Assessment
Raw material allergen matrix - documented assessment of all raw materials.
Final product allergen matrix - documented assessment of all final product.
Assessment of allergens from unexpected sources
B.C 2.2; Were regulations and appropriate customer requirements addressed in the
development of the allergen control program?
2.14.3 Allergen Identification and Storage
B.C 2.3;
Are potential causes of cross contamination identified and procedures
established for the handling of raw materials, intermediate and finished
products to avoid cross contamination?
All allergenic product clearly identified (Raw, WIP and final product) and
labelled as allergens.
Separate and suitable storage to prevent cross contamination (individual
allergens also separated).
N /A
2.14.4 Allergen Production Control
B.C 2.4
Are procedures relating to the cleaning and sanitation of product contact
surfaces in place and effective to remove all potential allergens from food
contact surfaces?
Proper implementation of allergen production schedules (first or last run for
day, specific days, specific lines, rework etc.).
Records of specific hygiene clearance after allergen production.
Equipment (utensils) used for allergens clearly identified and separated.
N /A
2.14.5 Allergen Labelling
B.C 2.5
Label checked against specification and recipe for legal compliance.
Precautionary statements acceptable but must be accompanied by full
allergen control program. (R146: 43-46)
N /A
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
2.14.6 Allergen Verification
SANS
10049
Records of validation (ELISA, PCR or other suitable detection method) of any
or all claims relating to absence of allergens.
Validation of cleaning if same lines are used for both allergen and non allergen manufacturing.
N /A
2.15 Process Control - Receiving
2.15.1 Documented Program
Documented program must address receiving of raw materials, packaging,
ingredients and processing aids.
Clear criteria for acceptance.
Procedures must address the handling of temperature sensitive at receiving.
Address rejections and handling thereof.
Documented procedures for inspection, hold and release.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.15.2 Control of Receiving
Records of delivery - approved suppliers, Food safety related acceptance
criteria (vehicle inspections, temperature monitoring, product inspection
and/or COA's / COC's, , compliance to specifications (available at receiving),
identification and accept / reject criteria.
Sampling and testing. Receiving practices.
Receiving areas adequate, separated, temperature control records.
Hold and release (isolation) area.
2.15.3 Temperature Control of Sensitive Product
Observed control of movement of temperature sensitive product.
No temperature sensitive product standing in receiving.
2.16 Process Control - Storage
2.16.1 Documented Program
Documented program must address methods to maintain product safety and
quality during storage.
Must address all listed aspects relating to ambient, chilled and frozen storage
of ingredients, additives, processing aids, packaging and other products.
Must address storage and identification of Work in Progress (WIP)
Relevant to plant - not generic.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.16.2 Storage Areas
B.B 9.2
Suitable facility (as per Section 2.2).
2.16.3 Storage Practices
Suitable storage practices (clean and dry, away from walls and off the floor,
dust free, slip sheets on pallets, no contact with overhead structures, no open
or exposed product, stacking height controlled to prevent damage).
Adequate labelling.
B.B 9.1
No product below chiller / freezer units, no leaking drip trays, no ice build-up.
Records of control of temperature if relevant (in line with regulatory
requirements. FIFO principles. No expired stock. Raw materials stored outside
suitably protected. No storage of ingredients in processing areas.
2.17 Process Control - Dispatch and Transport
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
2.17.1 Documented Program - Dispatch and Transport
I.B 9.1
Documented program for the dispatch and transport of product.
Must address dispatch, loading and transport requirements, stock protection,
inspection of stock, temperature recording if required.
2.17.2 Dispatch and Transport
Dispatch storage suitable for product dispatched. Suitable storage practices.
Only final product stored in area. Temperature control in place (with records) if
applicable. No WIP or returns unless clearly demarcated.
Doors not standing open. Access control in place.
I.B 9.1
Records of dispatch temperature monitoring, product inspection, compliance
to specifications and identification. Clients, quantities and batch numbers
clearly recorded.
2.17.3 Documented Program - Transport Vehicles
Documented program for the control of transport vehicles including third party
distributors. Must detail transport requirements, stock protection, condition
and suitability of vehicles, verification of temperature control, contingency
planning for breakdown.
I.B 9.2
Signed contracts in place addressing food safety / regulatory requirements.
R 638 for vehicles in place for outsourced transport.
2.17.4 Transport Vehicles
Are there maintenance and hygiene processes for vehicles and equipment
used for loading and unloading? Are they effectively implemented?
I.B 9.3
Vehicle inspections - Hygiene, Maintenance, Suitability for transport of food,
Temperature control equipment.
2.17.5 Protection against Deterioration during Transport
B.B 9.3
Is the food transport appropriate to minimize deterioration of food (e.g., by
temperature and humidity control).
Records of maintenance of cold chain to furthest point of delivery.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
2.18 Process Control - Processing
2.18.1 Documented Procedures - Processing
GFSI
Clear documented procedures in place for ALL processes.
Procedure clearly indicates method of processing.
Clear process and quality criteria.
Compliant to customer requirements.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Program must address control of rework if it is done.
Must address identification, storage, handling, approval for use and levels of
incorporation.
2.18.2 Control of Processing
Records to provide proof of compliance to procedure.
Records promptly and correctly completed.
GFSI
Records in place for any rework.
Visual observation of correct implementation of procedure.
Rework clearly identified and stored separately.
Trend analysis done of process control records.
Trend analysis records in place.
Analysed and communicated to management.
2.18.6 Documented Control of Returns
GFSI
Documented program in place for handling/processing of returns.
Must address identification, storage, handling, approval for rework, disposition
or resale.
Must link to rework program.
Documented statement in place if no returns are taken.
2.18.7 Control of Returns
GFSI
Records in place.
Visual observation of correct implementation of procedure.
Returns identified properly and stored separately.
Non - conformance and corrective actions documented.
3. HACCP IMPLEMENTATION (R908; SANS 10330; ISO 22000)
3.1 Preliminary Steps To Enable Hazard Analysis
3.1.1 Regulatory and Customer Requirements
B.C 1.1;
Has the business identified regulatory and customer requirements related to
the product and product categories and are they compliant with these ?
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
3.1.2 Food Safety / HACCP Team
Have top management appointed a HACCP / Food Safety team leader.
Are documented Letters of Appointment available?
B.C 1.2
Is the team multi-disciplinary, suitably trained and are records available to
demonstrate that the team has the required knowledge and experience.
Has a team with different responsibilities for food safety undertaken the tasks
described in this section?
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
3.1.3 Product Descriptions
Is there a complete product description available of all the products / product
categories produced, including all ingredients, raw materials, packaging,
B.C 1.3
finished product and conditions for storage and distribution?
Note: May be included in specifications.
3.1.4 Intended Use
The detailed intended use and potential abuse of each product must be
documented.
B.C 1.4
Must identify target consumer and address vulnerability of potential
consumers. Likely uses and abuses of the product after it has left the control
of the food handling organization and potential hazards relating to this must
be identified.
3.1.5 Site Maps
Detailed floor plan indicating all process areas
(Including
food- and non-food handling areas)
provide a
basis for evaluating the
possible occurrence, increase
or
SANS
introduction of food safety hazards resulting from cross flows
10330
Indicating access points, travel routes of staff and product, process flows,
waste removal and rework flows, service and sewage reticulation, water
reticulation.
True reflection of actual site, activities and process flows.
Cross flows identified and carried over to hazard analysis.
3.1.6 Process Flow Diagrams
B.C 1.5
Process flow diagrams in place - specific not generic.
Must indicate every process including rework and outsourced processes.
Steps preferably numbered.
Parameters detailed.
Packaging and service streams in, waste streams out.
True reflection of actual activities.
In place for all products / product groups.
3.1.7 On-site confirmation of Flow Diagram
B.C 1.6
Has the process flow diagram(s) been compared to assure it accurately
reflects the process?
Process flows verified on site and signed as verified.
Verified by complete HACCP Team.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
Minor NC
Chemical contamination with cleaning
chemicals in filler and pipeline was not
consider as a risk.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit. (System based on SANS 10330 and
SANS 10049 - No CCP's identified.)
3.2 Hazard Analysis
3.2.1 Hazard Analysis
Was a hazard analysis conducted for each process step in the manufacturing
of the food item?
All relevant biological, physical, chemical and allergenic hazards identified.
Sources of Hazards
All Processes, Environment, Raw materials, Packaging material, Adjuvants,
additives and processing aids, Facility, Equipment, Personnel and Regulatory
Requirements.
I.C 3.1
Routes of Contamination
Presence, Introduction, Growth, Survival, Cross - contamination.
Risk Assessment
Risk of all hazards shall be determined.
Likelihood shall be considered.
Severity shall be considered.
Methodology (matrix) used for determination of risk shall be available.
3.2.2 Control Measures
I.C 3.12
Control measures shall be identified for each identified hazard.
Control measured shall be assessed to determine level of control needed.
Control measures shall be linked to control programs (PRPs / OPRPs)
More than one control may be required.
3.2.3 Competence
I.C 3.2
Was the hazard analysis conducted by a competent team?
3.2.4 Acceptable Levels
ISO
22000
Acceptable levels of relevant physical, chemical, biological and allergen
hazards shall be indicated.
All acceptable levels shall be justified (supported by evidence).
3.2.5 Determination and listing of CCPs / oPRP's
Have significant hazards identified during hazard analysis (hazards not
minimized or eliminated by Good Manufacturing Practices (GMP's)) been
identified as Critical Control Points (CCP's) or operational Pre-requisite
Programs (oPRP's)
I.C 3.3
A decision tree analysis shall be in place for each significant hazard.
Records of each analysis shall be available.
Results of analysis shall be clearly indicated.
A copy of the decision tree used shall be available.
Note: oPRP's are only applicable to ISO 22000 based systems
3.3 HACCP and if relevant oPRP Plans
3.3.1 Determine Critical Limits
I.C 3.4
Clear critical limits shall be documented for each CCP identified (OPRP's
have no critical limits).
Based on scientific evidence and must be effective.
Shall be sensible and quickly and effectively measurable.
Upper and lower limits clearly defined.
Where relevant shall comply to regulatory or customer requirements
Rationale for each critical limit shall be documented.
N /A
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
3.3.2 Monitoring Procedures - CCPs / oPRP's
Documented procedures shall be in place for the monitoring of each identified
CCP or oPRP
I.C 3.5
Control
Procedure shall clearly define:
Method of monitoring
Equipment used for monitoring
Calibration and verification of such equipment
Frequency of monitoring
Responsibility of monitoring
Recording requirements
N /A
Note: oPRP's are only applicable to ISO 22000 based systems
3.3.3 Records of Control - CCP's / oPRP's
I.C 3.6
Records to provide proof of compliance to procedure
. Practices in line with procedure - observed by auditor.
Records promptly and correctly completed.
Handling of non - conformances and corrective action.
N /A
Are CCP's effectively implemented?
Note: oPRP's are only applicable to ISO 22000 based systems
3.3.4 Documented Procedures - CCP / oPRP Failure Corrective Action
Documented procedures shall be in place for corrective action if CCPs should
fail.
I.C 3.7
Procedure shall clearly define
Who is responsible
Actions to be taken
Handling of non - conforming product
Decision making
Fate of product
Recording requirements
N /A
Note: oPRP's are only applicable to ISO 22000 based systems
3.3.5 Records of Corrective Action for CCP's / oPRP failure
Are records in place for every instance where critical limits (CCP's) were
exceeded?
I.C 3.7
Records to provide proof of compliance to procedure
. Practices in line with procedure - observed by auditor.
Records promptly and correctly completed.
Handling of non - conformances and corrective action.
N /A
Note: oPRP's are only applicable to ISO 22000 based systems
3.3.6 Hazards not Identified as CCP's / oPRP's
Has the business implemented specific control measures for all relevant steps
not identified as CCPs or oPRP's?
I.C 3.12
Conform
These hazards have been considered significant and appropriate control
measures must be in place.
No non - conformances noted at the time of
the audit.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted
Ref.
Requirements
Outcome
Comments / Nonconformities
3.4 HACCP Validation and Verification and Review
3.4.1 Validation of control measure combinations
The organization shall validate that:
a) the selected control measures are capable of achieving the intended
control of the food safety hazard(s) for which they are designated.
ISO
22000 b) the control measures are effective and capable of, in combination, ensuring
control of the identified food safety hazard(s) to obtain end products that meet
the defined acceptable levels.
Records of validation shall be available.
N /A
3.4.2 Verification Procedures
Are documented verification procedures in place ?
Verification procedures shall define the purpose, method, frequencies and
responsibilities for the verification activities.
I.C 3.8
Examples of verification activities include:
Internal and External Audits
Evaluation of random sampling and testing results
Evaluation of CCP and OPRP performance results
Review of the HACCP system and its records
Review of deviations and product dispositions
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Conform
No non - conformances noted at the time of
the audit.
Where possible, verification activities shall include actions to confirm the
efficacy of all elements of the HACCP plan.
3.4.3 Verification Records
Are verification procedures effectively implemented?
I.C 3.9
The frequency of verification shall be sufficient to confirm that the HACCP
system is working effectively.
Records to clearly indicate verification activities.
3.4.4 HACCP Review
ISO
22000
Procedures shall be established for the review of the HACCP plan.
This procedure shall include events that will automatically trigger a HACCP
plan review (internal and external factors shall be considered).
The HACCP plan shall be updated after such a review.
The following automatic triggers for a HACCP review shall be listed:
a) Marketplace place reports indicating health risk (consumer complaints);
b) an anticipated change in customer and consumer use.
c) a change in raw materials or product formulation.
d) a change in the food handling process activities.
e) a change in layout and environment.
f) any modification to food handling equipment.
g) a change in the cleaning and disinfection program.
h) a change in the packaging, storage and distribution system.
i) changes to staff levels and responsibilities.
j) changes in legislation.
k) results of validation and verification activities.
3.4.5 HACCP Review Records
ISO
22000
Records of HACCP plan review by the food safety team must be in place.
© 2021 Intertek Services is the copyright owner of all material contained herein. No unauthorized reproductions, use or distributions are permitted