FOOD SAFETY AND QUALITY MANAGMETN-MODEL EXAM 1 FOOD QUALITY AND

SAFETY MANAGEMENT (DPTe 573) MODEL FINAL EXAM PART

1. CHOICE THE BEST ANSWER

1. More than _____________disease spread through food A. 100 B. 200 C. 50 D. 10

2. A chemical hazard that produced when foods are cooked at high temperatures such in fried
potato, baked cereals and coffee A. Aflatoxin B. Acrylamide C. Pesticide D. Heavy metal

3 Most pathogenic bacteria grow at:.

A. Acidic pH

B. Neutral pH

C. Alkaline pH

D. Any of the pH

4. Regulatory limit for pasteurized milk for Salmonella should be------------cfu/ml

A. 10 B. 100 C. 0 D. 1

5. Which one of the following bacteria that can grow at cold temperatures

A. Listeria monocytogenes B. E.coli C. Salmonella D. Campylobacter

6. Which one comes first in food safety system pyramid?

A. GMP and Regulatory inspections

B. Food Safety Plan like HACCP and ISO 22000

C. SOPs & SSOPS

7. HACCP has implementation plan has __________steps A. 6 B. 5 C. 7 D. 12

8. Which of these would be a critical limit?

A. Pasteurizing milk to reach a temperature of 161.6°F (72°C) for 15 seconds.

B. Washing vegetables before using them.

C. Checking the use by date on canned ingredients.

D. The temperature food is kept at in a fridge.

9. Which of the following is not true about bacteria;

A. Bacteria multiplies and grows faster in warm environments.

B. Bacteria needs air to survive.

C. Every type of bacteria can give people food poisoning.

D. By freezing food you can kill bacteria.

10. Failure of food manufacturers to comply with GMP regulations:

A. Can result in very serious consequences including recall, seizure, fines and criminal charges.
B. Has no effect on cleanliness or disease control.

C. Has little impact on a company's success.

11. Milk and Milk products like Yogurt, Cheese and butter should not have an aflatoxin M1 of
____________according to 2021 Compulsory Ethiopian Standard

A. 0.05 μg/kg B. 0.5 μg/kg C. 5 μg/kg D. 10 μg/kg

12. Rank order, from first to last, the following steps in the development of a HACCP plan.

1) Identify potential hazards

2) Construct a process flow diagram

3) Describe the product and its intended use

4) Analyze hazards

A. 1, 4, 2, 3 B. 2, 3, 4, 1

C. 3, 2, 1, 4 D. 3, 2, 4, 1

13. When assembling the food safety/HACCP team the MOST important thing to consider is

A. ensuring the team members are food safety experts

B. including individuals from multiple disciplines

C. to assure the team does not include local personnel

D. creating a team of quality assurance and control specialists

14. Calibrating milk pasteurizer to make sure the temperatures are correct is

A. required when monitoring the product line

B. part of a verification exercise

C. part of the record keeping process

D. required when the hazard analysis is performed

15. Microbiological testing of pasteurized milk to confirm the destruction/reduction of pathogens

is an example of:

A. Verification

B. Corrective action

C. Hazard analysis

D. Critical limits

16. Internal audit activity in ISO 22000:2018 is under___________

A. Check B. Plan C. Do D. Act

17. What is an OPRP under ISO 22000?______

A. A control measure of a significant hazard

B. A prerequisite program

C. The monitoring measure of a CCP

According to 1, an OPRP is a control measure that is used to minimize the risk of food safety
hazards. OPRPs are based on risk and hazard assessment and are used to target specific food
safety hazards. Although essential, OPRPs are not critical to the operation and can be removed
without the danger of making the food unsafe.
Therefore, option A is incorrect as an OPRP is not a control measure of a significant hazard.
Option B is correct as an OPRP is a prerequisite program. Option C is incorrect as an OPRP is
not the monitoring measure of a CCP.

18. Which of the following is NOT a management review output__________

A. Changes to the policy

B. Needs for resource

C. Decisions and actions related to continual improvement opportunities

The outputs of the management review shall include decisions related to

o Actions for improvement or further decision regarding opportunities for improvements

o Any need for changes to the QMS
o Any need for resources
19. An action criteria of an OPRP can be____

A. measurable or observable

B. measurable only

C. observable only

20. Which of the following is NOT considered an EXTERNAL type of communication_______

A. Customers and external providers

B. Statutory and regulatory authorities

C. Food safety team

External communication

What it is: External communication moves information from the inside of the organization to
outside parties, such as prospects, customers, investors, vendors, partners, sponsors, lawmakers,
regulatory bodies, the media, consultants, or the general public.
Lateral communication

What it is: Lateral communication moves across departments and employees or managers of
equal status within the organization.

Downward communication

What it is: Downward business communication flows from management to direct reports.
Messages flow through a predetermined hierarchy, from the top down.

Upward communication

What it is: Upward business communication comes from a direct report to a manager, and from
a manager to a top-level executive or owner. Upward communication allows those in charge to
keep a finger on the pulse of what’s happening on the ground floor

21. Glass breakage on a filling line would rather be considered a

A. PRP

B. CCP

C. OPRP

Glass breakage on a filling line would rather be considered a CCP (Critical Control Point) as it is
a step in the process where control can be applied to eliminate or minimize potential hazards to
an acceptable limit1.
A PRP (Pre-requisite programme) is a measure related to creating the environment for safe food;
measures impacting food safety but not directly related to a specific hazard 2.
An OPRP (Operational pre-requisite programme) is a control step in the process with a
measurement or observation. There is no critical limit beyond a type of yes/no question: visual
checks, present/absent, intact, etc.3

22. Which one of the following is an ISO standard for laboratory managements system?

A. ISO 9001
B. ISO 17025

C. ISO 19001

D. ISO 14001

E. ISO 22000

23. Who is mandated by the government of Ethiopia for the control and ensuring food safety of
processed and semi-processed foods in Ethiopia?

A. Ethiopian Agricultural Authority (EAA)

B. Ethiopian Food and Drug Authority (EFDA)

C. Ethiopian Standards Institute (IES)

D. Ethiopian Public Health Institute (EPHI)

E. All

The Ethiopian Standards Agency (ESA) is the national standards body of Ethiopia. ESA was
established following the restructuring of the Quality and Standards Authority of Ethiopia in
20101. It is responsible for establishing standards for food safety in Ethiopia 2. The Ethiopian
Food, Medicine and Health Care Administration and Control Authority (EFMHACA) is
responsible for enforcing food safety regulations in Ethiopia2.

The Ethiopian Public Health Institute (EPHI) is responsible for ensuring food safety in
Ethiopia. It is accountable to the Federal Minister of Health and conducts research on nutrition,
traditional medicines, and medical practices as well as on the causes and spread of diseases 12.

PART II. WRITE TRUE OR FALSE TO THE FOLLOWING (1 pt each, total 10 pts)

24. When a CCP is breached, a corrective action is mandatory. _____________

25. When planning changes (6.3), the organization shall consider their potential
consequences.________

26. A critical control point (CCP) is a point in the flow of food where a hazard can be prevented,
eliminated, or reduced to safe levels.________________
27. The food safety policy must be dated, signed and posted. _______________

28. Process mapping must be held as a documented information. ______________

29. Competence (7.2) must be identified for all personnel in the organization. ___________

30. Infrastructure resources (7.1.3) include transportation. __________

4 PART III. ANSWER THE FOLLOWING QUESTIONS BRIEFLY (1 pt each, total 15 pts)

31. List three inputs to the management review meeting.

Inputs to a management review meeting can vary depending on the organization and its
management system. However, according to ISO 9001 Procedure & Template, an effective
management review process should focus on the following inputs:

1. Risks and opportunities (Clause 6.1)

2. Possible changes that might affect the system (Clause 6.3)
3. External provider and suppliers performance (Clause 8.4)
4. Customer satisfaction and perception (Clause 9.1.2)
5. Audit results (Clause 9.2)
6. Nonconformity and corrective actions (Clause 10.2)1

32. List 3 PRPs present in ISO/TS 22002-1.

According to ISO/TS 22002-1, there are several PRPs that can be implemented by food
manufacturers to control food safety hazards. Some of these PRPs include:

1. Construction and layout of buildings

2. Layout of premises and workspace
3. Supplies of air, water, energy and other utilities

These PRPs are intended to be used with the ISO 22000 standard and give more detailed
requirements for food manufacturers to follow when developing and implementing PRPs1

33. What is the difference between correction and corrective action?

ISO 9000:2015 defines the correction as follows:
Correction: Action to eliminate a detected nonconformity

What is Corrective Action?

ISO 9000:2015 defines the corrective action as follows:
Corrective Action: Action to eliminate the cause of a nonconformity and to prevent recurrence.

What is Preventive Action?

ISO 9000:2015 defines the preventive action as follows:
Preventive Action: Action to eliminate the cause of a potential nonconformity or other potential
undesirable situation.

34. List three EXTERNAL interested parties that are relevant to the FSMS.

According to 2200: 2018, interested parties can be anybody such as regulators, customers,
employees, landlords, consumers, distributors, trade suppliers, shareholders etc. Identifying and
analyzing the interested parties is essential in helping to know how they could affect the
realization of the main goals of the FSMS that’s intended to ensure food safety.

Some examples of internal interested parties are employees, management and owners. External
interested parties can be suppliers, society, government, customers and consume

35. List 3 examples of verification of the food safety management system effectiveness.

According to an article on sciencedirect.com, there are many examples in the real world where
food companies while implementing a food safety system, failed to control or eliminate some
food safety hazards. It is obvious that HACCP is a dynamic system and its continuous effective
implementation is what can help a food company to produce safe products in the long run.

Another article on food-safety.com states that verification comprises a series of planned

activities that are designed 1) to determine whether the food safety management system is
operating properly; 2) to show where the food safety management system needs improvement; 3)
to identify data for trends to determine whether the process is weakening and take corrective
action before a food safety incident occurs.
Lastly, an article on qualityassurancemag.com suggests that verification activities should include
documented evidence to confirm the efficacy of all elements of the food safety system. For
example, a science-based environmental monitoring program may be used as a verification
activity in some segments of the food industry.

36. List the main clauses and sub clauses found in ISO 22000: 2018 as much as you can.

ISO 22000:2018 specifies requirements for a food safety management system (FSMS) to enable
an organization that is directly or indirectly involved in the food chain to plan, implement,
operate, maintain and update a FSMS providing products and services that are safe, according to
their intended use1.

The standard consists of 10 core clauses which are:

1. Scope
2. Normative references
3. Terms and definitions
4. Context of the organization
5. Leadership
6. Planning
7. Support
8. Operation
9. Performance evaluation
10. Improvement2

PART 4. Based on your group assignment on developing a HACCP Plan for a processing
company, list down the twelve (12) steps used to implement HACCP and explain each step
briefly using pasteurized milk as a product (10 pts).

Hazard Analysis Critical Control Point (HACCP) is a risk management protocol developed to
ensure food safety through a precautionary approach that is believed to offer assurances in
producing safe food products1. The 12 steps used to implement HACCP are as follows2:

1. Assemble the HACCP team

 2. Describe the product
3. Identify intended use and consumers
4. Develop a flow diagram
5. Verify the flow diagram
6. Conduct a hazard analysis
7. Determine critical control points (CCPs)
8. Establish critical limits
9. Establish monitoring procedures
10. Establish corrective actions
11. Establish verification procedures
12. Establish record-keeping and documentation procedures

For pasteurized milk, some of the hazards that could be identified include biological hazards
such as bacteria, viruses, and parasites, chemical hazards such as antibiotics, pesticides, and
cleaning agents, and physical hazards such as glass fragments 1. The CCPs for pasteurized milk
could include pasteurization temperature and time, storage temperature, and packaging 1. Critical
limits could be set for each CCP such as minimum pasteurization temperature and time,
maximum storage temperature, and maximum time between pasteurization and
packaging1. Monitoring procedures could include temperature checks during storage, while
corrective actions could include discarding milk that does not meet critical limits 1. Verification
procedures could include regular testing of milk samples for contaminants while record-keeping
could include keeping records of temperature checks, corrective actions taken, and test results 1.