Gap Audit – Nyagatare Maize Processing Factory

ISO/TS 22002:2009 Pre-requisite Programmes on Food Safety Part 1: Manufacturing

Gap Audit Checklist

Food safety management systems — Requirements for any organization in the food chain

Clause Requirements Observations In Compliance

No.
Has the organization determined all external
and internal issues relevant to its purpose and
4.1 Yes No
direction?

What is the process for monitoring and review of Yes No

the external and internal issues?
Has the organization identified all relevant
interested party requirements that are
4.2 relevant to the food safety management
system? Yes No

How is the information monitored?

Yes No
Has the organization determined the boundaries
and applicability of the FSMS to establish its
4.3 Yes No
scope?

Availability of scope as documented information Yes No

Has the organization established,

implemented, maintained, updated and
4.4 continually improves a food safety management
system, including the processes needed and Yes No
their interactions, in accordance with the
requirements of
the standard?
Has the organization defined, documented, and Yes No
5.2.1
communicated its food safety policy
Food safety policy?
5.2.2
Is the established food safety policy:
a. available and maintained as documented Yes No
information.
Yes No
b. communicated, understood, d applied at all
levels within the organization.
c. available to relevant interested parties, as Yes No
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ISO/TS 22002:2009 Pre-requisite Programmes on Food Safety Part 1: Manufacturing

Gap Audit Checklist

appropriate.
Are the responsibilities and authorities defined and
5.3 communicated within the organization?
Yes No
Has the company established an organizational
structure
Yes No
Availability of list of food safety team members
5.3.1
and their qualifications Yes No
Is there a letter of appointment for the food safety
5.3.2 team leader who has the responsibility for:
a. ensuring the food safety management
system is established, implemented,
Yes No
maintained and updated;
b. managing and organizing the work of the
food safety team;
c. ensuring relevant training of and
competencies for the food safety team
(see 7.2).
d. reporting to the top management on the
effectiveness
and suitability of the food safety management
system.
Has the organization considered issues referred
to in 4.1 and the requirements referred in 4.2
6.1 Yes No
and 4.3 to determine
the risks and opportunities that need to be
addressed.
6.1.2 Has the organization planned
a. actions to address these risks and Yes No
opportunities;
b. how to:
1. integrate and implement the actions into its
food safety management system processes; Yes No
evaluate the effectiveness of these actions.
6.1.3 Are the actions taken by the organization to Yes No
address risks and opportunities proportionate
to:
a. the potential impact on food safety Yes No
requirements, and;
b. the conformity of food products and Yes No
services to customers, and;
 Gap Audit – Nyagatare Maize Processing Factory

ISO/TS 22002:2009 Pre-requisite Programmes on Food Safety Part 1: Manufacturing

Gap Audit Checklist

requirements of interested parties in
the food chain.
6.2 Has the organization retained documented
information on the objectives of the food safety Yes No
management system.
6.2.2 When planning how to achieve objectives of
the food safety management system, has the Yes No
organization determined:
a. what will be done;
b. what resources will be required; Yes No
c. who will be responsible;
d. when it will be completed; Yes No
how the results will be evaluated.
Yes No
6.3 Are procedures in place for planning changes
to the food safety management system.
When planning changes, has the organization
considered:
a. the purpose of the changes and their
potential consequences for the supply
and maintenance of safe food production; Yes No
b. the integrity of the food safety management
system; Yes No
c. the availability of resources to effectively
implement the changes;
Yes No
d. the allocation or re‐allocation of
responsibilities and
authorities. Yes No
7.1.2 Has the organization determined and provided Yes No
the competent persons (7.2) that are necessary
to operate and
maintain an effective food safety management
system.
7.1.3 Has the organization provided the resources for Yes No
the determination, establishment, and
maintenance of the infrastructure necessary to
achieve conformity with the requirements of the
food safety management system. (land,
vessels, buildings and associated utilities, ,
equipment, including hardware and software,
transportation resource, information and
 Gap Audit – Nyagatare Maize Processing Factory

ISO/TS 22002:2009 Pre-requisite Programmes on Food Safety Part 1: Manufacturing

Gap Audit Checklist

communication technology)
7.1.4 How will it be demonstrated that the organization Yes No
determines and manages the work environment
needed to achieve conformity to the food safety
management system
7.1.5 Has the organization implemented applicable Yes No
PRPs so as to maintain and continually
improve its FSMS?
Has hazard analysis been done. Yes No
Is the hazard control plan in place.
7.1.6 Evidence for control of outsourced processes Yes No

Personnel competence records Yes No

7.2 Availability of training records for
personnel whose activities have an
impact on food safety.
Availability of training programme
Are persons doing work under the organization’s Yes No
control aware of:
a. the food safety policy; Yes No
7.3 b. the objectives of the food safety
management system relevant to their
task(s);
c. their individual contribution to the Yes No
effectiveness of the food safety
management system, including the
benefits of improved food safety
performance;
d. the implications of not conforming with the Yes No
food safety
management system requirements.
7.4.1 Has the organization determined the internal and
external communications relevant to the FSMS
Yes No
including:
a. on what to communicate;
b. when to communicate
c. how to communicate
d. who to communicate
7.4.2 Is there an appointed personnel to communicate Yes No
externally, are there food safety requirements
from customers and statutory and regulatory
authorities
7.4.3 Is there evidence of internal communication with Yes No
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ISO/TS 22002:2009 Pre-requisite Programmes on Food Safety Part 1: Manufacturing

Gap Audit Checklist

the food safety team on issues related to food
safety?
7.5 Are there procedures in place for control of Yes No
documented information
7.5.2 Is there a procedure for creating and updating Yes No
Documents that is fully implemented
7.5.3 Is there a procedure for control of Documents Yes No
that is fully implemented?
Are records controlled, is there a procedure
8.1 Are adequate actions in place to ensure
effective planning, implementation and control of
the FSMS processes. including, the methods
needed to ensure criteria in place for the Yes No
processes?

Retention of documented information to show

process effectiveness, and to demonstrate
conformity of products Yes No
and services to requirements?
8.2.2 Are the PRPs procedures in place Yes No

8.2.4 When establishing PRPs has the organization Yes No

considered
a. construction and lay‐out of buildings and
utilities;
b. lay‐out of premises, including workspace
and employee facilities;
c. supplies of air, water, energy and other
utilities;
d. pest control, waste and sewage disposal
and supporting services;
e. the suitability of equipment and its
accessibility for cleaning, maintenance
and preventive maintenance;
f. supplier approval and assurance
processes (e.g. raw materials,
ingredients, chemicals and packaging);
g. receiving of incoming materials, storage,
transportation and handling of products;
h. receiving of incoming materials, storage,
transportation and handling of products;
i. cleaning and disinfecting;
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ISO/TS 22002:2009 Pre-requisite Programmes on Food Safety Part 1: Manufacturing

Gap Audit Checklist

j. personal hygiene; product
information/consumer awareness;
8.3 Is there an effective traceability system that is Yes No
documented
8.4 Availability of an emergency preparedness and Yes No
response programme.
8.5.1.1 Has a hazard analysis and assessment been Yes No
carried out and control measures selected for all
potential hazards
8.5.1.2 Characteristics of raw materials, ingredients and Yes No
product contact materials
8.5.1.3 Description of end products to the extent needed Yes No
conduct the hazard analysis
8.5.1.4 Has the intended use of the product(s) been Yes No
identified
8.5.1.5.1 Availability of process flow diagrams, plant Yes No
layouts, anddescription of process steps and
control measures
8.5.1.5.2 Confirmation of accuracy of the flow diagrams Yes No

8.5.1.5.3 In conducting hazard analysis, has the

organization described;
a. layout of premises including food and non‐
food handling areas, processing equipment Yes No
and contact materials, processing aids and
flow of materials;
b. existing PRPs, process parameters, control
measures if any and/or the strictness with
which they are applied, or procedures that Yes No
may influence food safety;
c. external requirements (e.g. from
statutory/regulatory authorities or Yes No
customers) that may impact the choice and
the strictness of the control measures.

8.5.2.2 Has the organization identified hazards and Yes No

determined acceptable levels?
8.5.2.2.2 Has the organization identified steps (e.g. Yes No
receiving raw materials, processing,
distribution and delivery) at which each food
safety hazard can be present, be introduced,
 Gap Audit – Nyagatare Maize Processing Factory

ISO/TS 22002:2009 Pre-requisite Programmes on Food Safety Part 1: Manufacturing

Gap Audit Checklist

increase or persist.
8.5.2.3 Has the organization carried out (for each Yes No
identified food safety hazard) a hazard
assessment to determine whether its
prevention or reduction to an acceptable is
essential.
Has the organization put in place control Yes No
measures capable of preventing or reducing the
identified hazards to defined acceptable levels
8.5.3 Has the organization validated control measure Yes No
combinations
8.5.4 Is the HACCP Plan established Yes No

8.5.2.3 Have critical limits been determined and the Yes No

action criteria
for each CCP
Availability of records for monitoring OPRP and Yes No
CCPs.
8.5.3 Has the organization specified corrections and Yes No
corrective actions to be taken when critical limits
or action criterion are not met
8.5.4 Has the organization implemented and Yes No
maintained the hazard control plan
8.5.2.3 Has the information specifying the PRPs and the Yes No
hazard control plan been updated?
Are the monitoring and measuring methods Yes No
and equipment verified or calibrated as
necessary?
Availability of the calibration schedule
Availability of calibration records
8.8.1 Availability of results of analysis of individual Yes No
verification
results by the food safety team
8.8.2 Is analysis of results of verification activities done Yes No
by the food safety team to establish performance
trends
8.9 Are there documented procedures for Control of Yes No
non- conformity (Corrections, corrective actions
and handling of
potentially unsafe products)
8.9.4 Availability of procedures for handling potentially Yes No
unsafe products
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ISO/TS 22002:2009 Pre-requisite Programmes on Food Safety Part 1: Manufacturing

Gap Audit Checklist

8.9.4.3 Availability of procedures for handling non- Yes No
conforming products
8.9.5 Is there a procedure for withdrawal - Availability Yes No
of results of mock recall
9.1 Are procedures in place for monitoring, Yes No
measurement, analysis and evaluation
Records on evidence of results
Records on the performance and effectiveness of Yes No
the food safety management system.
Data analysis and evaluation of information Yes No
arising from the monitoring and measurement,
including results of verification activities related to
PRPs and the hazard control plan
9.2 Are internal audits carried out as per the Yes No
schedule and the findings discussed by the
food safety team and management
Availability of internal audit programme Audit
criteria and scope defined
List of competent auditors
9.3.2 Management review meeting minutes Yes No
9.3.3 Management review output minute Yes No
Are procedures in place for handling of non- Yes No
conforming products and corrective action(s)
10.1.2 Is documented information maintained to show Yes No
the nature of the nonconformity and any
subsequent actions taken, and the results of any
corrective action taken?
10.2 Is the organization continually improving the
suitability, adequacy and effectiveness of the
quality management system?
Are the outputs of analysis and evaluation, and Yes No
the outputs from the management review
process used to identify the areas of
underperformances? How is it demonstrated
that the effectiveness of the food safety
management system is being continually
improved?