Hazard Analysis Critical Control Point (HACCP)

Question 1

What is the FDA?

Answer 1

The FDA or USFDA is an agency of the United States Department of Health and Human Services responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics.

Question 2

What does the FDA regulate?

Answer 2

The FDA regulates a wide range of products including food additives, infant formulas, dietary supplements, human drugs, vaccines, blood products, and other biologics, medical devices, electronic products that give off radiation, cosmetics, feed, drugs, and devices used in pets, farm animals, and other animals.

Question 3

What types of products are regulated by the USDA instead of the FDA?

Answer 3

The USDA regulates most meat and poultry products

Question 4

What is the FDA responsible for regulating in terms of medical devices?

Answer 4

The FDA is responsible for regulating all medical devices, from simple items like tongue depressors to complex technologies such as heart pacemakers.

Question 5

What types of products are included under the FDA’s regulation of cosmetics?

Answer 5

The FDA regulates cosmetics, which include items such as makeup, lotions, soaps, shampoos, hair dyes, and other personal care products.

Question 6

Does the FDA regulate tobacco products?

Answer 6

the FDA regulates tobacco products, including cigarettes, cigars, and smokeless tobacco products.

Question 7

What is the FDA or USFDA responsible for regulating and supervising?

Answer 7

The FDA is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, cosmetics, and tobacco products.

Question 8

What is the Canadian Food & Drug Act?

Answer 8

The Canadian Food & Drug Act prohibits the sale of any article of food that contains any poisonous or harmful substance, is unfit for human consumption, consists of any filthy, putrid, disgusting, rotten decomposed or diseased animal or vegetable substance, is adulterated, or was manufactured, prepared, preserved, packaged, or stored under unsanitary conditions.

Question 9

What is the traditional quality control approach?

Answer 9

The traditional quality control approach involves inspecting goods and services at the end of the operations or process, which often doesn’t ensure quality and results in defective or non-acceptable goods being received by the customer. It is costly, done too late in the process, and often by separate “quality inspectors” rather than by the workers themselves.

Question 10

What is a recall?

Answer 10

A recall is when a product is removed from the market or a correction is made to the product because it is either defective or potentially harmful. It can be initiated by a company or the FDA

Question 11

Who is W. Edwards Deming and what was his philosophy on quality control?

Answer 11

W. Edwards Deming was a statistician and quality control expert who believed that quality comes not from inspection but from improvement of the process. He believed that inspecting goods and services to find the bad ones and throwing them out is too late, ineffective, and costly.

Question 12

What is HACCP and what are the steps involved in the process?

Answer 12

HACCP (Hazard Analysis Critical Control Points) is a food safety management system that is internationally acknowledged and preventive, not reactive. It is used to protect the food supply against biological, chemical, and physical hazards and involves analyzing hazards, identifying critical control points, establishing preventive measures with critical limits, establishing procedures to monitor the critical control points, establishing corrective actions to be taken when monitoring shows that a critical limit has not been met, establishing procedures to verify that the system is working properly, and establishing effective record-keeping procedures.

Question 13

What are the seven principles of HACCP?

Answer 13

The seven principles of HACCP are:
1. to analyze hazards,
2. identify critical control points,
3. establish preventive measures with critical limits for each control point,
4. establish procedures to monitor the critical control points,
5. establish corrective actions to be taken when monitoring shows that a critical limit has not been met,
6. establish procedures to verify that the system is working properly,
7. Establish effective record-keeping procedures.

Question 14

What is HACCP and why is it important?

Answer 14

HACCP stands for Hazard Analysis and Critical Control Points, it is a food safety management system designed to identify, assess and control potential hazards in the food production process, from raw materials to finished products. It is important because it helps to ensure that the food produced is safe for consumption by identifying and preventing hazards that may cause foodborne illnesses.

Question 15

What are the benefits of implementing a HACCP system in a food manufacturing company?

Answer 15

1. improving customer confidence,
2. protecting employees,
3. enhancing company reputation,
4. improving product quality,
5. increasing productivity, cost savings, due diligence/liability, and reducing business risk.

Question 16

What are GMPs and why are they important before implementing HACCP?

Answer 16

GMPs stand for Good Manufacturing Practices, they are a set of basic hygiene and sanitation requirements designed to enhance food safety. They are important before implementing HACCP because they provide the foundation for the HACCP system, decrease the number of critical control points, and ensure that management commitment, adequate resources, and suitable facilities are provided.

Question 17

What are the twelve stages of HACCP?

Answer 17

(1) Assemble a HACCP team,
(2) Describe the product,
(3) Identify intended use,
(4) Construct a flow diagram,
(5) Confirm on-site,
(6) Identify and list all relevant hazards and preventative hazards,
(7) Identify CCPs and apply the decision tree,
(8) Establish target levels and critical limits for CCPs,
(9) Establish a monitoring system,
(10) Establish a corrective action plan,
(11) Establish verification procedures, and
(12) Establish documentation and record keeping.

Question 18

What are some of the hazards that can be identified through hazard analysis in HACCP?

Answer 18

Hazards can be biological, chemical, or physical contaminants with the potential to cause harm. Biological hazards include bacteria, viruses, and parasites; chemical hazards include toxins, pesticides, and allergens; physical hazards include glass, metal, and plastic fragments.

Question 19

What is Principle 4 in HACCP implementation and what information should be included?

Answer 19

Principle 4 in HACCP implementation is the monitoring of control measures at CCPs. This involves checking that the process is under control and critical limits are not being exceeded. The information that should be included in monitoring control measures at CCPs are the critical limits and target levels, how the monitoring should be done, where the monitoring should be done, when the monitoring should be done, and who is responsible for monitoring.

Question 20

What is Principle 5 in HACCP implementation and what information should be included in establishing corrective actions?

Answer 20

Principle 5 in HACCP implementation is the establishment of corrective actions to be taken when critical limits are breached. This involves two distinct actions, dealing with affected product and bringing back CCP and process back under control. The information that should be included in establishing corrective actions are what action is to be taken, who is the person responsible, and who should be notified.

Question 21

What is Principle 6 in HACCP implementation and what are the different verification procedures that should be established?

Answer 21

Principle 6 in HACCP implementation is the establishment of verification procedures using methods, procedures, and tests, in addition to those used in monitoring, to determine compliance with the HACCP plan. The different verification procedures that should be established are validation to obtain evidence that elements of the HACCP plan are effective, auditing to determine the validity of the flow diagram and proper implementation of the HACCP plan, and periodic review of the HACCP plan.

Question 22

What is Principle 7 in HACCP implementation and what should be included in documentation and record keeping?

Answer 22

Principle 7 in HACCP implementation is the establishment of documentation and record keeping. This involves creating records such as CCP monitoring activities, deviations and corrective actions, audit reports, customer complaints, calibration of instruments, and prerequisite programmed monitoring activities. All documents should be signed and dated, and document control procedures should be in place. Additionally, a written HACCP plan should be established that details the responsibility of the HACCP team, scope and terms of reference, product and process descriptions, hazard analysis and CCP determination, critical limits and evidence to establish these limits, monitoring and record keeping procedures, actions to be taken when target levels are exceeded, corrective action to be taken, and validation, verification, and review procedures.

Question 23

What are some reasons for failure of HACCP implementation?

Answer 23

Some reasons for failure of HACCP implementation include poor general hygiene standards (prerequisite programmes), lack of management commitment or poor management, lack of knowledge (especially science-based knowledge), too complex to be understood by staff, too much paperwork or poor inaccurate records, not science-based, lack of resources, and too many control points identified as critical control points.