Case Studies'

FSMS Auditor/Lead Auditor (ISO 22000)
Case Study No: 01 Legal and regulatory requirements
Working individually as indicated by your tutor, analyse and discuss regulatory

as per ISO 22000 requirements for the Food Safety system and their application:
A. How can a company identify and research the relevant regulations

requirements? Give 3 available methods.
B. How can the company make sure that it has integrated the demands of
the regulations requirements and is complying with them in the
production of its products? Give 3 available methods.
C. Identify vertical legislation requirements, applicable to one of the

following sectors:
- Meat processing industry;

- Dairy products;
- Baking industry;
Each team must select a leader, who will write down the information in a list.
Preparation Time: 20 Mins (A), (B) and (C)

Presentation Time: 10 Mins
Doc Rev No: FSMS LAC – CS 00 Page 1 of 3

Notes:


Case Study No: 02 Context
Case Study 2
Context
Individual and team work
Note: Keep your work on this case study. You will need it in the next one.
Preparation Time: 25 Mins

Presentation Time: 5 Mins for each group
Each team needs to prepare SWOT analysis for the company Make it Like Home
Help:
SWOT analysis (or SWOT matrix) is a strategic planning technique used to help a person or organization
identify the Strengths, Weaknesses, Opportunities, and Threats related to its context. It is intended to
specify the objectives of the organization and identify the internal and external factors that are favorable
and unfavorable to achieving those objectives.
Strengths and Weakness are frequently internally-related, while Opportunities and Threats commonly
focus on environmental placement.
Strengths: characteristics of the business or project that give it an advantage over others.
Weaknesses: characteristics of the business that place the business or project at a disadvantage relative
to others.
Opportunities: elements in the environment that the business or project could exploit to its advantage.
Threats: elements in the environment that could cause trouble for the business or project.
Major target when utilizing SWOT is to maximize advantages (opportunity) and minimize disadvantages
(risk) in the context (very much in the sense management system standards see the risk management
process).
1. Strengths - Specific features of the organization that represent its competitive edge over other players
in the industry. These may be specific knowledge, patents, high market share, price conditions, access to
resources, innovation skills, etc.
2. Weaknesses - specific features of the organization that prevent it from achieving its goal. This may be
the lack of sufficient competence, limited resources, poor reputation, limited assortment, poor quality,
outdated technology, lack of financial resources, etc.
3. Opportunities – features of the external context that lead to the development of the organization -
technological changes, market niches, change in state regulations, tax relief, low trade barriers, lack of
aggressive competitors, etc.

4. Threats - Difficulties that threaten the organization's market positions. Such may be the emergence of
a new competitor, a change in customer expectations, political instability, economic crises, low market
growth, and so on.
Strengths and weakness represent the internal issues of the organizational context. They are factors that
the organization can control and influence directly.
Threats and Opportunities are part of the external context of the organization. The organization would
have limited influence but has to take them into account when planning its strategy and management
system.
SWOT
Strengths Weaknesses
Opportunities Threats


Case Study No: 03 Scope
Working as a team discuss Scope of Valley Sports as per ISO 22000 requirements
for the Food Safety system:
Give consideration to the below Key Points while developing the scope of the
FSMS:
1. specify the products and services, processes and production site(s)
2. activities, processes, products or services that can have an influence on
the food safety of its end products
3. external and internal issues
4. interested parties that are relevant to the FSMS
5. relevant requirements of the interested parties of the FSMS


Notes:


Case Study No: 04 Standard Operating Procedure on the Core activity
Working as a team determine the core and support processes of the valley sports
In relation with the core activity identify food safety needs and expectations.
1. Listing and core and support process

2. Tabulate the food safety needs and expectations.


Notes:


Case Study No: 05 Food safety policy
Working as team and using the valley sports manual, write down a suitable food
safety policy statement to demonstrate top management’s commitment for
establishing real objectives. This food safety policy shall be included in the food
safety manual.
Choose a Team Leader to present your team’s response at the feedback

session.
Also devise a set of questions, which could be used to establish that an

organisation has a policy that complies with the specification.

The food safety policy must be written in an appropriate format as to become

an integral part of the Food safety manual of the food safety management
system which was provided to you.

Case Study No: 05 Food safety policy
Valley Sports: Food safety policy
General Manager: (Name)
Date: / /

Case Study No: 06 Planning - Risks and Opportunities

Input from Case Study 2 – Use the completed SWOT in Case Study 2 - Context
Part 2
Use the information on the four SWOT elements (strengths and weaknesses, opportunities and threats)
to move to the next stage of the Planning process (clause 6) and identify specific risks and opportunities
arising from the major source of risk and opportunities - the Organizational Context with its internal
and external issues.
Assistant:
To generate ideas on risk identification, four strategies can be used, based on a
combination of the different elements of the SWOT analysis:
• "Maxi-Maxi" strategy - based on the strengths and opportunities of the organization,
with the goal of maximizing their benefits (this will cover the new requirements for
opportunity identification);
• "Maxi-Mini" strategy - the organization's strengths are used to minimize threats (meets
the requirements for risk identification);
• "Mini-Maxi" strategy - skilfully using the opportunities and focusing efforts to turn
weaknesses into strengths;
• Mini-Mini Strategy - minimizing weaknesses and avoiding threats
Note: Keep your work on this case study. You will need it in the next one.
RISK IDENTIFICATION
Risks Opportunities
Issue 1, April 2019 CQI& IRCA Certified ISO 22000:2018 Auditor Transition Course – CS1
Part 2
Actions to address risks and opportunities

Based on the identification of risks and opportunities in part 2, analyze and assess them in
order to determine and decide on actions to address those risks and opportunities.
Risk analysis and assessment methodology
Factor 1 – Severity (S)

Values: 1=low; 2=medium; 3=high
Factor 2 – Occurrence (O)

Values: 1=least probable; 2=probable; 3=most probable
Formula: Risk Priority Number (RPN) = Severity * Occurrence

Risk Assessment Algorithm (steps) – ISO 31000:2018:
1. Risk Identification – done in part 2 of this case study
2. Risk Analysis – Risk analysis should consider factors such as: the likelihood of events
and consequences; the nature and magnitude of consequences; complexity and
connectivity; time-related factors and volatility; the effectiveness of existing
controls; sensitivity and confidence levels.
3. Risk Evaluation – Risk evaluation involves comparing the results of the risk analysis
with the established risk criteria to determine where additional action is required.
This can lead to a decision to: do nothing further; consider risk treatment options;
undertake further analysis to better understand the risk; maintain existing controls;
reconsider objectives.
4. Prioritization – this I good practice to allow us treat the most significant risks
first.
5. Risk treatment option
Risk S O RPN Actions to address risks and

opportunities/ Risk acceptance


Notes:

Sample Matrix:
Interested External/ Local / Needs and expectations Issues
parties Internal National associated with the identified
/International interested parties
level
Legal - External National 1. Licensing
FSSAI
2. Product specification
compliance
3. Labelling
4. Shelf life
5. Food Adulteration
6. Food Defense / fraud
7. Recall
Issues Probability (Likelihood) of Severity of the issue Risk Control

Identified occurrence of the issue on the needs and Factor Measure
expectations
Control Determine how Decide Action Monitor Review Re-evaluate

Measure frequent the whether risk Plan the the risk
Control could be action results
measure could accepted as plan
be monitored -is,
or measured eliminated,
reduced,
shared,
transferred


Case Study No: 07 Documented Information
Working as an individual and using the ISO 22000 standard, write down the
statements which mentions ‘DOCUMENTED INFORMATION’.
1. Clause Number
2. Clause Name
3. Statement

Discussion Time: 5 Mins

General Manager: (Name)
Date: / /

Make It Like Home (MLH): Food safety objectives

Case Study No: 08 Emergency preparedness and response plan
Working as a team list down the key elements to be covered and sequence order
of these elements in Emergency Preparedness and response plan.
Refer: 8.4.2


Notes:


Case Study No: 9 Flow Chart
Working in your team construct suitable process flow diagrams for the
organization allocated to your team by the tutor.
1.1 Restaurant
1.2 Milk processing plant
1.3 Fresh fruits and vegetables handling
1.4 Meat processing factory
These are to be drawn on A4 paper and copied to flipchart sheets provided for
presentation at the feedback session.
TIP: KEEP IT SIMPLE!
Preparation Time: 30

Date:
Process For: Group:

Appendix 1
1.1 Catering service
This Catering service is preparing the most delicious steaks you’ve ever
tasted. To do this:
1. The steaks are purchased from a trusted farm. They are stored in a
refrigerator at temperature below 4°С. The steaks are cut in slices 3-3.5
cm thick and are packed in stretch folio. The weight is varying between 8-
12 ounces.
2. Preparation of steaks: They are putted in heated pan and the time for
cooking is determined by the Master Chef, depending of the requirement
of the client – bloody, rare, medium-rare, medium, well-done.
3. The dishes used are cleaned in the dishwashing machine with an
approved detergent.
4. The steak is usually served, containing fresh salad, boiled potato, filled
with cream and cheese.
5. The cooked steak is putted in appropriate plate, and together with the
salad and the potato is served to the client.

1.2 Milk processing factory
The pure milk is UHT processed and packed. The shelf life is 6 months at
ambient temperature (before opening). The main process steps include:
1. Purchasing of raw milk.

2. Standardizing system.
3. UHT:
a. Heating up: The preheating temperature is between 70°C – 85°C
b. Degasation: Remove air and impurities in a Degasation container.
c. Homogenization: Under pressure = 200 bar
d. Cooling: Use cooling water to cool the milk to 20-28°C
4. Storage in aseptic container.
5. Filling in – Tetrapak, 6 each are packed in a carton box.
6. Storage temperature - ambient.
7. Delivery: no specific temperature requirements for the truck.

1.3 Meat processing factory
The factory produces sausages. Shelf life is 3 months at temperature below

40C. The main technological operations are:
1. Purchasing of raw materials and ingredients: fresh frozen pork, nitrite,
phosphate, monosodium glutamate, garlic etc.;
2. Processing includes defrosting and removal of bones and impurities;
3. Blending the meat and the additives;
4. Grinding of meat in small pieces;
5. Cleaning and sterilizing the sausage casing;
6. Stuff and inspection of nozzles;
7. Thermal processing;
8. Cooling;
9. Packaging and labeling – the sausages are vacuum sealed packed;
10. Storage - at temperature within the range of 0-4°C;
11. Transport - the end product is transported at temperature from 0ºC to
4°C

Case Study No: 10 Hazard Analysis
You are members of the team who will audit the HACCP plan of Valley Sports.
You have to analyse and assess the quality of the hazard analysis performed by
the organization. Please, consider the described physical, chemical and
biological hazards in the production of frozen pie during:
A. acceptance of raw material
B. heat treatment
C. packaging
D. Sales of the product
Fill your findings in the attached form. Provide a clear statement with an
appropriate motivation if you accept/do not accept the hazard analysis,
performed by Valley Sports Food safety team. The completed forms must be
submitted to the tutor for assessment at the end of the day.
Every team has to define a team-leader who will present the results.

Team Work

Case Study No: 10 Hazard Analysis
Hazard analysis verification form

Fill the columns with Y (yes, if you agree with the analysis), N (no, if you do not
agree), N/A (not applicable). Provide a justification for Y/N/N/A answers in the
Comments column.
Process Hazards Risk Control Comments

identified assessment measures

Case Study No: 11 Identifying clauses for the Non-conformance
Ensure the report is complete and identifiable to your group with the group name
at the top.
The group’s report must be handed-in for assessment at the end of the day.
Working in your group discuss and reach agreement as to which clause or sub
clause of ISO 22000:2018 should a NCR be raised for each of the scenarios listed
below.
Note also the reason for not raising NCR.
Each group will be asked to present some of the answers to the course – ensure
you elect a spokesperson.

Team Work
Scenarios
1. During an audit the auditors establishes that the staff responsible for
hygiene has changed the disinfection detergents for the maintenance of the
equipment without this being in any way recorded on the respective GHP
documentation.
2. At the audit of the management review it is established that there is no

data in it about an audit done based on recommendations by the State
Sanitation Control authorities
3. For the last 3 years the personnel responsible for the corrective actions in
the FSMS has not attended any related training course, workshops or
conferences.
4. No schemes or blueprints for the area for storage of the packaging

materials, approved by the food safety team are available.
Case Study No: 11 Identifying clauses for the Non-conformance
5. The information for the production water (PRP) does not contain the
chemical pollutants, and there is no reference about that in any other
document as well.
6. During the audit, the food safety team leader says that recently changes
have been introduced in some of the PRPs. The new programs are
approved by the FS team and are operational now. However the auditor
was not able to establish any evidence for verifications, performed prior
the new versions of PRPs come into force.
7. When auditing the purchasing department, the auditor cannot establish

from the documents accompanying the raw materials what is their actual
origin.
8. The product contains allergens; however, the labels do not contain any
information about that.
9. The auditor noted, communications were generally good between staff

throughout the organisation but could find no details within the FSMS
system to ensure this occurred.
10.The auditor could not establish that staff had any understanding of their
responsibility as to the extent their own activities are contributing to food
safety.

Case Study No: 12 Audit Checklist Preparation
Working as a team as directed by the tutor, agree a minimum of eight appropriate

checklist questions, which when interviewing an auditee will establish if the
requirements of ISO 22000: 2018 are compliant with the clauses allocated to your
team by the tutor from the list below.
Clauses
1. Food safety Policy

2. Actions to address Risks and Opportunities
3. Recall and Emergency preparedness
4. Documented Information Control
5. Continual Improvement
6. Externally developed elements of the food safety management
system
7. Cleaning and Sanitizing
Your team is required to submit the questions on the checklist format sheet
provided.
At the end of the session, each team is required to hand in one of completed
checklists – clearly identifying your team’s name in the AUDITOR section.

Team Work

Case Study No: 12 Audit Checklist Preparation
Standard: Type of Audit:
Client: Auditor: Date:
Audit Area:
Requirements: Clause Num, OK CAR Obs N/A Objective Evidence

Name:

Case Study No: 13 Audit Plan
Working in your groups, you are required to plan a third party audit of Valley
Sports .
You have a controlled copy of the organisation’s food safety manual.

You are required to:
Complete a suitable plan for the audit by your group of Valley Sports)’ on the
program.

Team Work

Case Study No: 13 Audit Plan
AUDIT PLAN
COMPANY: Job. No.:
REFERENCE STANDARD:
SITE ADDRESS:
AUDITED SCOPE:
AUDIT DATE:
AUDIT LANGUAGE:
LEAD AUDITOR:
AUDITOR(S):
TECHNICAL/LEGAL EXPERT:
APPROX. TIME ACTIVITY CLIENTS

(30 minute intervals) REPRESENTATIVE

Case Study No: 14 Opening Meeting Agenda
Working in your groups, you are required to plan a third party audit of Valley
Sports .
You have a controlled copy of the organization’s food safety manual.

You are required to:
Prepare an agenda for the presentation of an opening meeting to the senior

management of ‘Valley Sports’ and conduct the opening meeting as per Tutor’s
instructions.

Team Work
Opening Meeting Agenda Group Name:

Case Study No: 14 Opening Meeting Agenda

Case Study No: 15 Non-conformance Report
This is an individual/group activity, team members are required to:

As a group decide/allocate each member with an incident (provided by the tutor).
Individual Activity
❖ Evaluate the incidents

❖ Formally identify and write up a non-conformity report
❖ Complete all the information required (what, where, why, etc.)
❖ Decide on and complete the categorisation level of non-conformity
Group Activity
Discuss the NCRs with your group members and prepare a presentation to
‘management’.
Each delegate shall write up the NCR on an ‘overhead’ sheet provided by the tutor.
Feedback Presentation
The NCRs written up on blank sheets are to be formally presented by each delegate to
all the other course members in this feedback session.
The tutor will advise individual timing of presentation.
Be prepared to answer questions about your NCRs from other delegates during your
presentation.

Team Work

Exercise 1 Scenarios
Scenario 1
Boardstiff Foodstuffs is a company producing starches and syrups using a wet milling and
hot air-drying process to convert the raw maize into fine powder. You are conducting an
audit to FSSC 22000 and are reviewing the Corrective Action log with the Food Safety
Team Leader when you notice the details of an incident from the previous month. It
states that due to the sudden failure of a drier, the Production Manager was forced to
release 20 tones of in-process product through a drain valve into the staff car park. This
was done to prevent the product from solidifying in the pipework with costly repair
implications. This discharge created an offensive noxious odor that attracted complaints
from neighbours before it was eventually washed down the drain. The Corrective Action
consisted of repairing the dryer and purging the pipework with water before restarting
production. The Food Safety Team Leader advised that this purging operation was
standard practice between production runs and the existing critical control points would
suffice.
Scenario 2
You are auditing at the Highland Distillery Company to FSSC 22000 during a second
party audit for a large drinks retailer. The process, which you are auditing, is the
reduction process in which distilled water is added to the final distillate to bring it
down to 63% alcohol by volume prior to loading into casks for the legal minimum
maturation period of 3 years. The alcohol level is determined by automatically
measuring the density of the reduced spirit using an Anton Paar Alcohol Monitor. You
notice that one of the production lines is shut down while a maintenance technician is
servicing its measuring device on a nearby table strewn with assorted tools, machinery
components and an open tub of grease. When you ask about the cleaning treatment
for the device before reinsertion, the technician says, “it is not necessary since the
alcohol will kill any bacteria anyway”. You note from the HACCP plan that there are no
Critical Control Points associated with the spirit reduction process.
Scenario 3
During an audit of internal audits, the auditor is shown internal audit reports from the
last audit. These include a nonconformity report stating that 3 people in the packaging
department had not been trained about their specific food safety responsibilities. The
corrective action taken was to train the 3 members of staff. The audit report has been
closed. The food safety representative tells you that no further investigation was made

as the corrective action was obvious. The internal auditor had checked the training
records of the staff concerned before closing the reports.

Scenario 1
An auditor of Chunky Chicken Products is discussing the Internal Audit process with
the Food Safety Team Leader and asks to see the schedule for Internal Audits and the
required procedure. The auditor reviews the Internal Audit Plan and supporting
documentary evidence confirms that the audits are conducted in accordance with the
plan outlined in the FSMS Manual. The FSMS Manual, version 1 - March 05, states that
each identified process area will be audited, as a minimum, at 6-monthly intervals and
the Internal Audit procedure (reference SOP 14) confirms this. The procedure also
states that that the organisation’s Health & Safety Training Officer will act as the
Internal Auditor. In your review of the Internal Audits conducted you note that 70%
of the issues raised have related to the Production area and have all concerned Food
Handler training and staff competence.
Scenario 2
At an audit of a restaurant the auditor asks how the new supplier for fresh vegetables
was selected. The purchasing clerk explains that the regular supplier could not meet
the delivery date and the order was placed with a supplier that they had never used
before, only because the price quoted was extremely low. The clerk states that no
other evaluation was carried out.
Scenario 3
You are auditing in the purchasing department of Wheatex, a wheat processing factory
and ask a buyer about the identification of food safety hazards from grain suppliers,
having reviewed the hazards list (HZD-05/1 Rev.2) and found that various biological
and physical hazards were listed. The buyer responds, “We are very concerned with
micro-organism and foreign body contamination as you can see from the list”. When
you ask about the use of pesticides, the response is “We ask if farmers are using any
dangerous chemicals in which case, we don’t use them but otherwise trust them since
they know more than we do about such issues”. The auditor made the same enquiry
to an accompanying member of the HACCP team and was told that pesticide
contamination had never been a problem, so it wasn’t really an issue.

Scenario 1
You are auditing production area of KFM Company, producing delicatessen. You check
the temperature monitoring of the auditee. For all cooling and chilling rooms,
temperature targets have been established (targets, critical limits). The monitoring
records are done manually on paper and there is no alarm system. The verification of
the temperature records indicates that at several times, the critical limits have not
been respected. Proof of corrective or preventive actions are absent
Scenario 2
During an audit of the company GoldBean, you are checking the HACCP system. The
company is producing dried beans and peas. The HACCP plan is established and one of
the CCPs is metal. In order to control this CCP, the company has a metal detector in
place. There is no alarm but an automatic rejection system that rejects a non-
conforming product. Every rejected bag is analysed by the QA department. For the last
three months, the metal detector failed to work 5 times.
Scenario 3
In “Big and Tasty” Ltd, a company producing ready-to eat goods, you are checking the
production area. You found out that the HACCP study has identified 2 CCPs. CCP 1 is
temperature control (CL = no more than 4o C) and the CCP 2 is “foreign” bodies. The
CCP 1 is only check manually 2 times a week. The CCP2 concerning “foreign bodies” is
continually monitored visually by the operators on the line.

FOR CS 15 – EXERCISE 1
If you think there is evidence of a non-conformity, complete this report:
IRCA AUDIT
NON-CONFORMITY REPORT
Company under Audit:
Non-Conformity Number:
XYZ Plc
ISO 22000
Area under Review:
Clause Number:
Category: MAJOR* MINOR* * delete one
Non-Conformity
Auditor:
or
If you do not think that there is sufficient evidence of non-conformity, state the
reasons for your decision and state also what further actions the auditor should take.

IRCA AUDIT
XYZ Plc
ISO 22000
Area under Review:
Clause Number:
Non-Conformity
Auditor:
or

IRCA AUDIT
XYZ Plc
ISO 22000
Area under Review:
Clause Number:
Non-Conformity
Auditor:
or

IRCA AUDIT
XYZ Plc
ISO 22000
Area under Review:
Clause Number:
Non-Conformity
Auditor:
or

IRCA AUDIT
XYZ Plc
ISO 22000
Area under Review:
Clause Number:
Non-Conformity
Auditor:
or

Case Study No: 16 Document Review
Working in groups defined by your tutor, select a leader. The leader may
apportion out the tasks to each team member or work as a group.
Conduct a document review of the food safety manual of Valley Sports. This
audit is a part of stage I of the initial audit. There is insufficient time for detailed
work here, so concentrate on the principal issues that you feel need addressing.
Your report shall include your group’s recommendations, observations and
decisions to:
REJECT THE FOOD SAFETY MANUAL
or
PROCEED WITH THE INITIAL AUDIT
Ensure the report is complete and identifiable to your group with the group name
at the top.
The group’s report must be handed-in for assessment at the end of the day.

Team Work

Case Study No: 16 Document Review
Document Review Report For:

Group Name:
Observations:
Decision to carry out the initial audit:
Date:

Case Study No: 17 Audit interviews
Your Group Name: Your Name:
Working as a group, conduct an audit on the group representing the organisation allocated
to your team by interviewing members of the management team of the auditee organisation.
Use the checklists written during case study 12 or write some new ones.
You will have the opportunity to play both the auditor and the observer roles during this case
study – you will also act as an observer during an Audit interview.
Your group will need an audit team leader during the appropriate interview sessions.
1. AUDITOR
Your team audited: You audited:
Areas audited:
NCR’s raised: Observations raised:
Comments?
___________________________________________________________________________
___________________________________________________________________________
2. OBSERVER
Auditor: Auditee:
NCR’s raised: Observations raised:
Comments?
___________________________________________________________________________
__________________________________________________________________________
 To achieve all of these activities a strict adherence to the time schedule proposed by the
tutor is needed
 You are required to maintain this sheet as a record of your tasks completed – to be
handed to your tutor at the end of the session.

Presentation Time: As allotted by tutor
Team Work

Case Study No: 18 Write up Nonconformities
Individual / team activity continuing from Case Study 18
Overview
Using a Nonconformity Report form attached to this sheet, formally write up a
nonconformity identified during case study 18 and obtain an acceptance signature
from the auditee, adding your own signature when complete.
Activity
The audit team leader shall coordinate the following
 Raise one formal NCR per team member from the audit conducted in Case Study
17.
 Only the first section of the NCR is to be completed - not the Corrective Action
section.
 Delegates should first obtain a signature from the auditee as an acceptance of the
NCR.
 Then obtain an acceptance signature from a Tutor who will act as the Auditee
senior management.

Presentation Time: As allotted by tutor
Team Work

Case Study No: 18 Write up Nonconformities
Company Name: NCR Number: … of ….

Reference Standard: Date:
Clause: Category: MAJOR/MINOR
Auditor:
Description of the nonconformity
Auditee: Auditor: Senior Management:

(name and signature) (name and signature) (name and signature)
Root Cause (to be completed by auditee and agreed with auditor)
Proposed Corrective Action (to be completed by auditee and agreed with auditor)
Proposed Implementation Date

Auditee: Auditor: Senior Management:
(name and signature) (name and signature) (name and signature)
Review of Corrective Action Implementation
Auditor: Review Date:

(name and signature)
Review of Corrective Action Effectiveness:
Auditor: Review Date:

(name and signature)

Case Study No: 19 Audit Team Meeting
Total Time: 40 Mins

Team Work
Your groups tasks are as follows:
1. Conduct an audit team meeting to discuss and agree the non-conformities

identified in Case Study 17.
2. Complete a team draft written report (summary) for presentation at closing
meeting to Valley Sport management.
The audit team shall retain the audit report and NCRs as these shall be required for a
subsequent exercise.

Case Study No: 19 Audit Team Meeting
Report Number:
Summary Audit Report

Date of Audit: Audit Team: Audit Standard:
ISO 22000:2018
Areas Audited (Scope) Auditee Contacts in Area Major

NCRs Raised
Minor
NCRs Raised
Observations Raised
Summary of Findings
Conclusions/ Recommendations
Distribution : Attachments: Auditor’s Signature

Case Study No: 20 Closing Meeting Scenario
Conduct an closing meeting with ‘Valley Sports’senior management using the

material assembled.
When conducting the meeting other course members (and tutor/s) act as
employees of the organisation. Use the closing meeting scenarios.
For this exercise, the team leader is the one you selected for the preparation
exercise.
Each audit team member is expected to participate in the closing meeting by

briefly explaining the department you have been allocated to audit highlighting
any key feature you planned in your audit.
This exercise requires you to ensure that the closing meeting:
 Is complete
 Is accurate
 Is conducted as a team
 Questions are handled well
 Is controlled

Team Work

Case Study No: 21 Corrective Action
Overview
An individual/group activity
In this activity, previously raised NCRs are to be completed with proposed corrective
actions by the auditee and agreed with the auditors.
Detail
Each auditor group is required to pass one of the NCRs (raised subsequent to the audit
session in Case Study 19) from each team member to the auditee group.
On receipt of the NCRs from the auditing group, your auditee group is required to
review the non-conformities, agree appropriate corrective action wording and
complete this section of the non-conformity report and return them to the auditing
group that raised them.
The auditors that raised the NCRs will then review the proposed corrective actions.
 If the corrective action is acceptable the NCR is retained
 If the corrective action is not considered adequate, a representative from your

syndicate will discuss the proposed corrective action with the auditee syndicate
group that proposed the action until an acceptable resolution is agreed.
When advised, the NCRs used for the exercise will be handed to the tutor for review.
Total Time: 30 Mins

Team Work

Case Study No: 22 Continual Improvement
Working as a new group, elect a presenter to prepare your results.

Discuss, agree and prepare a presentation for the feedback session defining ‘the
minimum acceptable policy’ to comply with the requirements for demonstrating
continual improvement for the size of company allocated to your group.
Detail
1.Small Firm of 5 – 10 Staff
2.Medium Firm of 50 – 100 Staff
3.Large Organisation of 500 –1000 Staff
Flip-chart sheets are available.
Your presentation should be between 5 and 10 minutes in length.
Total Time: 60 Mins

Team Work

Case Study No: 23 Final Report
An Individual Activity
You, as an individual, are required to act as audit team leader and provide a brief
report to enable the personnel of ‘Valley Sport’ to provide an interim report to his
management meeting regarding the proposed sponsorship, which can be faxed to:
Mr B Glover – Production manager at ‘valley Sport’.
Detail
The report need only include:
 A brief overview of: purpose, scope and exclusions where applicable
 Number of NCRs raised
 Your conclusions with good points as well as any main concerns
 Your recommendations
The report should not exceed two sheets of A4 paper.
This report is to be handed in on completion, together with any NCRs raised by you,
and will form part of the course assessment.
Total Time: 45 Mins

Team Work
FINAL REPORT

1) REF: ____________________________________________________________
2) COMPANY: ______________________________________________________
3) LOCATION: ______________________________________________________
4) CONTACT: _______________________________________________________
5) AUDIT TEAM: ____________________________________________________
6) EXPERT (Where Applicable): ________________________________________
7) NUMBER OF EMPLOYEES (To be Verified): _____________________________
8) REF STANDARD: __________________________________________________
9) AUDIT DATE(S): ___________________________________________________
10) CONCLUSIONS:
11) SYSTEM IMPROVEMENTS IDENTIFIED:
12) RECOMMENDATIONS:
SIGNED: DATE:
Team Leader

FINAL REPORT (Continued)
13. Please include any additional information to support audit findings, conclusion
and recommendations:
14. Comments/Follow-up Actions:

Case Study No: 24 Revision Quiz
Questions
1) Which standard deals with auditing?
2) Audits can be conducted against what?
3) What information is required to start an audit?
4) What documents are prepared during the planning stage?
5) What should happen during the planning stage of an audit?
6) What is the role of a guide?
7) What does an auditor need to know about a guide?
8) Describe an audit program.
9) Who is responsible for the corrective action when a NCR is raised?
10) What is the purpose of a management review?
11) Which paragraph of the standard requires prerequisite programmes?
12) What is a first party audit?
13) What is a second party audit?
14) What is a third party audit?
15) What is a VERTICAL audit and how does this relate to processes?
16) What is a HORIZONTAL audit?
17) What are the qualities of a good auditor?
18) What is objective evidence?

19) Why hold an opening meeting?
20) Name the agenda items for an opening meeting.
21) What are the three stages of an audit?
22) What are the benefits of a food safety management system?
23) What are the benefits of certification?
24) What are the benefits of conducting audits?
25) Why hold a closing meeting?
26) Give three ways of collecting ‘objective evidence’.
27) What items are on the agenda of a closing meeting?
28) What are the lead auditors responsibilities during the preparation stage?
29) What are the lead auditors responsibilities during the execution stage of an
audit?
30) What are the lead auditors responsibilities when the closing meeting is
finished?
31) What are the points to consider when an internal audit is planned?
32) What is the process you would expect an organisation to take when a NCR
corrective action is not cleared by the agreed date?
33) Give three examples of records.
34) What documents can a NCR be raised against?
35) What records are retained following an audit?
36) Which paragraph of ISO 22000 applies to internal auditing?
37) Which paragraph of ISO 22000 requires auditors to be trained?

38) Which documents go to make up a food safety management system
39) Who should chair a management review?
40) What is the difference between corrective action and emergency preparedness
and response?
41) What information is recorded on a NCR?
42) Give examples of a work environment that is needed to achieve conformity of

product requirement.
43) What are the auditee’s responsibilities?
44) Which paragraphs of the standard specifically state a ‘documented procedure’

is required?
45) Are there activities that could be excluded from a scope of certification against
ISO 22000?
46) How should an organisation that has not yet established an FSMS be audited?
47) Explain what is meant by management commitment and give an example.
48) Explain what is continual improvement. Point the relevant ISO 22000 clause
49) Explain what is meant by ‘involvement of people’ and give an example.
50) Explain what is meant by internal communication and give an example. Point
the relevant ISO 22000 clause.
51) Explain what is meant by emergency preparedness and response and give an
example. Point the relevant ISO 22000 clause.
52) What are the key elements that make up the ISO 22000 standard?
53) What is ISO 22000?
54) How does ISO 22000 define Prerequisite program(s)?

55) What does PDCA stand for?
56) Explain traceability? Point the relevant ISO 22000 clause?
57) What is a food safety hazard?
58) Point three basic types of hazards associated with food safety?

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FSMS Auditor/Lead Auditor (ISO 22000)

Case Study No: 01 Legal and regulatory requirements

Working individually as indicated by your tutor, analyse and discuss regulatory

A. How can a company identify and research the relevant regulations

C. Identify vertical legislation requirements, applicable to one of the

- Meat processing industry;

Preparation Time: 20 Mins (A), (B) and (C)

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Preparation Time: 25 Mins

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Preparation Time: 15 Mins

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1. Listing and core and support process

Preparation Time: 20 Mins

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Choose a Team Leader to present your team’s response at the feedback

Also devise a set of questions, which could be used to establish that an

Preparation Time: 15 Mins

The food safety policy must be written in an appropriate format as to become

Doc Rev No: FSMS LAC – CS 00 Page 1 of 2

Valley Sports: Food safety policy

General Manager: (Name)

Doc Rev No: FSMS LAC – CS 00 Page 2 of 2

Preparation Time: 30 Mins

Actions to address risks and opportunities

Risk analysis and assessment methodology

Factor 1 – Severity (S)

Factor 2 – Occurrence (O)

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Risk Assessment Algorithm (steps) – ISO 31000:2018:

1. Risk Identification – done in part 2 of this case study

Risk S O RPN Actions to address risks and

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6. Food Defense / fraud

Issues Probability (Likelihood) of Severity of the issue Risk Control

Control Determine how Decide Action Monitor Review Re-evaluate

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Preparation Time: 10 Mins

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General Manager: (Name)

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Make It Like Home (MLH): Food safety objectives

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Preparation Time: 30 Mins

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TIP: KEEP IT SIMPLE!

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Process For: Group:

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