A critical control point is defined as a step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
Contents
What are the 4 critical control points?
Formal HACCP Seven Steps – 1. Conduct a hazardous analysis. The purpose of a hazardous analysis is to develop a list of hazards which are likely to cause injury or illness if they are not controlled. Points to be considered in this analysis can include: skill level of employees; transport of food; serving elderly, sick, very young children, immune-compromised; volume cooling; thawing of potentially hazardous foods; high degree of food handling and contact; adequacy of preparation and holding equipment available; storage, and method of preparation.
The next step is to determine if the factors may influence the likely occurrence and severity of the hazard being controlled. Finally, the hazards associated with each step in the flow of food should be listed along with the measures necessary to control the hazard.2. Determine Critical Control Points (CCP’s) A critical control point is any step in which hazards can be prevented, eliminated or reduced to acceptable levels.
CCP’s are usually practices/procedures which, when not done correctly, are the leading causes of foodborne illness outbreaks. Examples of critical control points include: cooking, cooling, re-heating, holding. To determine CCP’s ask the following questions:
At this step in preparation can food become contaminated and/or can contamination increase? Can this hazard be prevented through corrective action(s)? Can this hazard be prevented, eliminated or reduced by steps taken later in the preparation process? Can you monitor the CCP? How will you measure the CCP? Can you document the CCP
3. Establish Critical Limits A critical limit ensures that a biological, chemical or physical hazard is controlled by a CCP. Each CCP should have at least one critical limit. Critical limits must be something that can be monitored by measurement or observation.
They must be scientifically and/or regulatory based. Examples include: temperature, time, pH, water activity or available chlorine.4. Establish Monitoring Procedures Monitoring is a plan which includes observations or measurements to assess whether the CCP is being met. It provides a record of the “flow of food” through the establishment.
If monitoring indicates that the critical limits are not being met, then an action must be taken to bring the process back into control. The monitoring system should be easy to use and meet the needs of the food establishment, as well as the regulatory authority.
- It is important that the job of monitoring be assigned to a specific individual and they be trained on the monitoring technique.5.
- Establish Corrective Actions If the criteria for a CCP is not being met, some type of corrective action must be taken.
- They must meet the standards established in Step 3, must be based on facts for normal working conditions and be measurable.
Corrective actions may range, for example, from “continue cooking until the established temperature is reached” to “throw out the product,” depending on the severity of the situation. HACCP plans should include the following: who is responsible for implementing the corrective action and what corrective action was taken.
- They should be established in advance as part of the HACCP plan.6.
- Establish verification procedures These procedures are activities, other than monitoring, that determine the validity of the HACCP plan and that the system is operating according to the plan.
- An important aspect of verification is to determine if the plan is scientifically and technically sound.
Also, that all the hazards have been identified and that, if the HACCP plan is properly implemented, these hazards can be effectively controlled. Verification can be accomplished by expert advice and scientific studies and observations of the flow of food, measurements and evaluations.
Another means of verification is an on site review of the established critical limits. Each CCP will have one independent authority. This verification step provides an opportunity to make modifications to the plan if necessary.7. Establish record-keeping and documentation procedures Record-keeping and documentation procedures should be simple to complete and include information that illustrates that the established standards are being met.
Employees need to be trained on the record-keeping procedures and why it is a critical part of their job. Examples of records include time/temperature logs, checklists, forms, flowcharts, employee training records, and SOP’s. (“Hazard Analysis Critical Control Point Principles and Application Guidelines”, Adopted August 14, 1997, National Advisory Committee on Microbiological Criteria for Foods)
What are the 7 critical control points in HACCP?
Hazard Analysis and Critical Control Points (HACCP) is a process control system aimed to identify and put a stop to microbial and other hazards in food production. As articulated by the NACMCF, HACCP systems should be based upon seven principles. These seven principles are: (1) hazard analysis, (2) critical control point identification, (3) establishment of critical limits, (4) monitoring procedures, (5) corrective actions, (6) record keeping, and (7) verification procedures.
The Seven HACCP Principles Principle 1 : Conducting a hazard analysis, During this phase, plants determine the hazards tampering food safety; identify the preventive measures to control these hazards. Principle 2: Identifying critical control points. A critical control point (CCP) is a point in a food production process in which control is applied to prevent, eliminate, or reduce food safety hazard to an acceptable level.
Principle 3 : Establish critical limits for each critical control point, A critical limit is a specific value to which a physical, biological, or chemical hazard must be controlled. CCP separates safe food from unsafe food and also prevent, eliminate, or reduce hazard to an acceptable level.
Notably, critical limits are usually numerical values based on scientific finding. Principle 4 : Establish critical control point monitoring requirements. Monitoring of the food production process is mandatory to make sure that the process is under control at each critical control point and hazards are also in control.
The process of monitoring includes temperature checks, visual inspection, time recording etc. As per the FSIS requirement, monitoring of each process is mandatory and frequency of monitoring has to be listed in the HACCP plan. Related Training on Critical Control Points (CCP’s) – Critical Control Points (CCP’s).
- Where are they? Why? When? Principle 5 : Establish corrective actions.
- In case of identifying deviation in the monitoring phase, corrective actions are to be taken to prevent the hazard.
- Corrective actions ensure that adulterated product injurious to health does not enter markets.
- Principle 6 : Establish record keeping procedures.
As per the HACCP regulations, all plants are required to keep documents including hazard analysis, monitoring of CCP, critical limits and the checking process deviations. Principle 7 : Establish verification procedures. Verification can determine the validity of the HACCP plan and find out whether the system is operating in accordance with the plan.
- On one hand, verification evaluates whether the facility’s HACCP system is functioning according to the HACCP plan and on the other, it validates the HACCP plan to determine that the plan is scientifically and technically sound.
- Also the initial validation of the process ensure that all hazards have been recognized and assures that if the HACCP plan is correctly applied these hazards will be successfully restricted.
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What is the critical control point and control point?
Definition of critical control point now contains the concept that if control of the point is lost, there must be a high probability that a health risk will occur. On the other hand, if control is lost but the risk is low that a health risk will occur, then the concern should be classified as a control point.
What is the difference between CP and CCP?
A CCP is different from a CP (Figure 3). A CCP indicates a high food safety risk (likely to occur) and a CP indicates a low food safety risk (not likely to occur). Food safety relies on identification and control of CCP’s, while, CP’s may be used for quality specifications.
What is an example of a CCP?
Principle 2—Critical control point determination – A CCP is located at any step in the process at which control can be applied and is essential to prevent, control, or eliminate a food safety hazard or reduce it to an acceptable level. The determination of if a step should be a CCP can be aided with the use of a CCP decision tree ( Fig.32.4 ).
Any step in a food process which results in significant pathogen reduction will almost certainly become a CCP. Examples include cooking, chilling, inclusion of an antimicrobial, pasteurization, fermentation, drying, and irradiation. Additional CCPs could include allergen inclusion or other controlled ingredients, or the utilization of metal detection.
For the processing of fresh food which does not include a point of lethality, CCPs can be less definitive, yet USDA-FSIS requires processors to have at least one CCP. Thus, a CCP can often become the opportunity which foods are the most susceptible or the best opportunity to minimize the chance of microbial growth. Fig.32.4, Critical control point determination. Read full chapter URL: https://www.sciencedirect.com/science/article/pii/B9780128195192000062
Is chilled temperature control a CCP?
Critical Control Point (CCP) A step at which control must be applied in order to prevent or eliminate a food safety hazard or reduce it to an acceptable level as it will not be removed at a later step. For example, the chilled storage of high-risk food.
What is HACCP in simple terms?
HACCP is a management system in which food safety is addressed through the analysis and control of biological, chemical, and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product. Dairy Grade A Voluntary HACCP
Including Questions and Answers About NCIMS Dairy HACCP
Juice HACCP
Including Juice HACCP Hazards and Controls Guidance – First Edition and Questions & Answers for the Juice HACCP Regulation Guidance for Industry: Juice HACCP and the FDA Food Safety Modernization Act
Retail and Food Service HACCP Seafood HACCP
Including Fish and Fishery Products Hazards and Controls Guidance and FDA’s Evaluation of the Seafood HACCP Program 2004/2005 Guidance for Industry: Seafood HACCP and the FDA Food Safety Modernization Act
What are the most common CCPs?
What Is a Critical Control Point (CCP)? A critical control point (CCP) is a moment during a production process where an equipment failure or human error could cause food contamination, resulting in customer illness or damage to the business itself. CCPs are times when can be implemented that can prevent a food safety hazard from occurring.
- This may include eliminating the possibility of contamination through cooking temperatures, reducing the chance of microbial growth through storage procedures, or minimizing cross-exposure through sanitation processes.
- The most common CCPs within food safety are in the cooling and heating of ingredients, where products must pass through a temperature zone that can encourage pathogen growth.
It’s critical that food and ingredients during the cooking stages do not remain in those danger zones for longer than a pre-established period of time. : What Is a Critical Control Point (CCP)?
What are critical controls?
Critical control A control that is crucial to preventing the event or mitigating the consequences of the event. The absence or failure of a critical control would significantly increase the risk despite the existence of the other controls.
What is meant by CCP in hazard control?
HAZARD ANALYSIS AND CRITICAL CONTROL POINT (HACCP) SYSTEM AND GUIDELINES FOR ITS APPLICATION
- Annex to CAC/RCP 1-1969, Rev.3 (1997)
- PREAMBLE
The first section of this document sets out the principles of the Hazard Analysis and Critical Control Point (HACCP) system adopted by the Codex Alimentarius Commission. The second section provides general guidance for the application of the system while recognizing that the details of application may vary depending on the circumstances of the food operation.
- The HACCP system, which is science based and systematic, identifies specific hazards and measures for their control to ensure the safety of food.
- HACCP is a tool to assess hazards and establish control systems that focus on prevention rather than relying mainly on end-product testing.
- Any HACCP system is capable of accommodating change, such as advances in equipment design, processing procedures or technological developments.
HACCP can be applied throughout the food chain from primary production to final consumption and its implementation should be guided by scientific evidence of risks to human health. As well as enhancing food safety, implementation of HACCP can provide other significant benefits.
In addition, the application of HACCP systems can aid inspection by regulatory authorities and promote international trade by increasing confidence in food safety. The successful application of HACCP requires the full commitment and involvement of management and the work force. It also requires a multidisciplinary approach; this multidisciplinary approach should include, when appropriate, expertise in agronomy, veterinary health, production, microbiology, medicine, public health, food technology, environmental health, chemistry and engineering, according to the particular study.
The application of HACCP is compatible with the implementation of quality management systems, such as the ISO 9000 series, and is the system of choice in the management of food safety within such systems.
- While the application of HACCP to food safety was considered here, the concept can be applied to other aspects of food quality.
- DEFINITIONS
- Control (verb ): To take all necessary actions to ensure and maintain compliance with criteria established in the HACCP plan.
- Control (noun): The state wherein correct procedures are being followed and criteria are being met.
- Control measure : Any action and activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
- Corrective action: Any action to be taken when the results of monitoring at the CCP indicate a loss of control.
- Critical Control Point (CCP): A step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.
- Critical limit: A criterion which separates acceptability from unacceptability.
- Deviation: Failure to meet a critical limit.
- Flow diagram: A systematic representation of the sequence of steps or operations used in the production or manufacture of a particular food item.
- HACCP: A system which identifies, evaluates, and controls hazards which are significant for food safety.
- HACCP plan: A document prepared in accordance with the principles of HACCP to ensure control of hazards which are significant for food safety in the segment of the food chain under consideration.
- Hazard: A biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health effect.
- Hazard analysis: The process of collecting and evaluating information on hazards and conditions leading to their presence to decide which are significant for food safety and therefore should be addressed in the HACCP plan.
- Monitor: The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control.
- Step: A point, procedure, operation or stage in the food chain including raw materials, from primary production to final consumption.
- Validation: Obtaining evidence that the elements of the HACCP plan are effective.
- Verification: The application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance with the HACCP plan.
- PRINCIPLES OF THE HACCP SYSTEM
- The HACCP system consists of the following seven principles:
PRINCIPLE 1
- Conduct a hazard analysis.
- PRINCIPLE 2
- Determine the Critical Control Points (CCPs).
- PRINCIPLE 3
- Establish critical limit(s).
- PRINCIPLE 4
- Establish a system to monitor control of the CCP.
- PRINCIPLE 5
- Establish the corrective action to be taken when monitoring indicates that a particular CCP is not under control.
- PRINCIPLE 6
- Establish procedures for verification to confirm that the HACCP system is working effectively.
- PRINCIPLE 7
- Establish documentation concerning all procedures and records appropriate to these principles and their application.
GUIDELINES FOR THE APPLICATION OF THE HACCP SYSTEM Prior to application of HACCP to any sector of the food chain, that sector should be operating according to the Codex General Principles of Food Hygiene, the appropriate Codex Codes of Practice, and appropriate food safety legislation.
- Management commitment is necessary for implementation of an effective HACCP system.
- During hazard identification, evaluation, and subsequent operations in designing and applying HACCP systems, consideration must be given to the impact of raw materials, ingredients, food manufacturing practices, role of manufacturing processes to control hazards, likely end-use of the product, categories of consumers of concern, and epidemiological evidence relative to food safety.
The intent of the HACCP system is to focus control at CCPs. Redesign of the operation should be considered if a hazard which must be controlled is identified but no CCPs are found. HACCP should be applied to each specific operation separately. CCPs identified in any given example in any Codex Code of Hygienic Practice might not be the only ones identified for a specific application or might be of a different nature.
- The HACCP application should be reviewed and necessary changes made when any modification is made in the product, process, or any step.
- It is important when applying HACCP to be flexible where appropriate, given the context of the application taking into account the nature and the size of the operation.
- APPLICATION
- The application of HACCP principles consists of the following tasks as identified in the Logic Sequence for Application of HACCP (Diagram 1).
- 1. Assemble HACCP team
The food operation should assure that the appropriate product specific knowledge and expertise is available for the development of an effective HACCP plan. Optimally, this may be accomplished by assembling a multidisciplinary team. Where such expertise is not available on site, expert advice should be obtained from other sources.
The scope of the HACCP plan should be identified. The scope should describe which segment of the food chain is involved and the general classes of hazards to be addressed (e.g. does it cover all classes of hazards or only selected classes).2. Describe product A full description of the product should be drawn up, including relevant safety information such as: composition, physical/chemical structure (including A w, pH, etc.), microcidal/static treatments (heat-treatment, freezing, brining, smoking, etc.), packaging, durability and storage conditions and method of distribution.3.
Identify intended use The intended use should be based on the expected uses of the product by the end user or consumer. In specific cases, vulnerable groups of the population, e.g. institutional feeding, may have to be considered.4. Construct flow diagram The flow diagram should be constructed by the HACCP team.
- 5. On-site confirmation of flow diagram
- The HACCP team should confirm the processing operation against the flow diagram during all stages and hours of operation and amend the flow diagram where appropriate.
- 6. List all potential hazards associated with each step, conduct a hazard analysis, and consider any measures to control identified hazards
(SEE PRINCIPLE 1) The HACCP team should list all of the hazards that may be reasonably expected to occur at each step from primary production, processing, manufacture, and distribution until the point of consumption.
- The HACCP team should next conduct a hazard analysis to identify for the HACCP plan which hazards are of such a nature that their elimination or reduction to acceptable levels is essential to the production of a safe food.
- In conducting the hazard analysis, wherever possible the following should be included:
- the likely occurrence of hazards and severity of their adverse health effects;
- the qualitative and/or quantitative evaluation of the presence of hazards;
- survival or multiplication of microorganisms of concern;
- production or persistence in foods of toxins, chemicals or physical agents; and,
- conditions leading to the above.
- The HACCP team must then consider what control measures, if any, exist which can be applied for each hazard.
- More than one control measure may be required to control a specific hazard(s) and more than one hazard may be controlled by a specified control measure.
- 7. Determine Critical Control Points
(SEE PRINCIPLE 2) There may be more than one CCP at which control is applied to address the same hazard. The determination of a CCP in the HACCP system can be facilitated by the application of a decision tree (e.g. Diagram 2), which indicates a logic reasoning approach.
Application of a decision tree should be flexible, given whether the operation is for production, slaughter, processing, storage, distribution or other. It should be used for guidance when determining CCPs. This example of a decision tree may not be applicable to all situations. Other approaches may be used.
Training in the application of the decision tree is recommended. If a hazard has been identified at a step where control is necessary for safety, and no control measure exists at that step, or any other, then the product or process should be modified at that step, or at any earlier or later stage, to include a control measure.8.
Establish critical limits for each CCP (SEE PRINCIPLE 3) Critical limits must be specified and validated if possible for each Critical Control Point. In some cases more than one critical limit will be elaborated at a particular step. Criteria often used include measurements of temperature, time, moisture level, pH, A w, available chlorine, and sensory parameters such as visual appearance and texture.9.
Establish a monitoring system for each CCP (SEE PRINCIPLE 4) Monitoring is the scheduled measurement or observation of a CCP relative to its critical limits. The monitoring procedures must be able to detect loss of control at the CCP. Further, monitoring should ideally provide this information in time to make adjustments to ensure control of the process to prevent violating the critical limits.
- Where possible, process adjustments should be made when monitoring results indicate a trend towards loss of control at a CCP.
- The adjustments should be taken before a deviation occurs.
- Data derived from monitoring must be evaluated by a designated person with knowledge and authority to carry out corrective actions when indicated.
If monitoring is not continuous, then the amount or frequency of monitoring must be sufficient to guarantee the CCP is in control. Most monitoring procedures for CCPs will need to be done rapidly because they relate to on-line processes and there will not be time for lengthy analytical testing.
- Physical and chemical measurements are often preferred to microbiological testing because they may be done rapidly and can often indicate the microbiological control of the product.
- All records and documents associated with monitoring CCPs must be signed by the person(s) doing the monitoring and by a responsible reviewing official(s) of the company.10.
Establish corrective actions (SEE PRINCIPLE 5) Specific corrective actions must be developed for each CCP in the HACCP system in order to deal with deviations when they occur. The actions must ensure that the CCP has been brought under control. Actions taken must also include proper disposition of the affected product.
- Deviation and product disposition procedures must be documented in the HACCP record keeping.11.
- Establish verification procedures (SEE PRINCIPLE 6) Establish procedures for verification.
- Verification and auditing methods, procedures and tests, including random sampling and analysis, can be used to determine if the HACCP system is working correctly.
The frequency of verification should be sufficient to confirm that the HACCP system is working effectively. Examples of verification activities include:
- Review of the HACCP system and its records;
- Review of deviations and product dispositions;
- Confirmation that CCPs are kept under control.
- Where possible, validation activities should include actions to confirm the efficacy of all elements of the HACCP plan.
- 12. Establish Documentation and Record Keeping
(SEE PRINCIPLE 7) Efficient and accurate record keeping is essential to the application of a HACCP system. HACCP procedures should be documented. Documentation and record keeping should be appropriate to the nature and size of the operation.
- Documentation examples are:
- Hazard analysis;
- CCP determination;
- Critical limit determination.
- Record examples are:
- CCP monitoring activities;
- Deviations and associated corrective actions;
- Modifications to the HACCP system.
- An example of a HACCP worksheet is attached as Diagram 3.
- TRAINING
Training of personnel in industry, government and academia in HACCP principles and applications, and increasing awareness of consumers are essential elements for the effective implementation of HACCP. As an aid in developing specific training to support a HACCP plan, working instructions and procedures should be developed which define the tasks of the operating personnel to be stationed at each Critical Control Point.
- Cooperation between primary producer, industry, trade groups, consumer organizations, and responsible authorities is of vital importance.
- Opportunities should be provided for the joint training of industry and control authorities to encourage and maintain a continuous dialogue and create a climate of understanding in the practical application of HACCP.
DIAGRAM 1. LOGIC SEQUENCE FOR THE APPLICATION OF HACCP DIAGRAM 2. EXAMPLE OF DECISION TREE TO IDENTIFY CCP S (answer questions in sequence) DIAGRAM 3. EXAMPLE OF A HACCP WORKSHEET The Principles of the HACCP System set the basis for the requirements for the application of HACCP, while the Guidelines for the Application provide general guidance for practical application. Since the publication of the decision tree by Codex, its use has been implemented many times for training purposes.
At what temperature is food considered to be in critical point?
Image descriptions – Figure 1 image description: At 100°C (or 212°F), water boils. Above 74°C (or 165°F), bacteria die, although spores and toxins may survive. Food that is being cooked or reheated should hit 74°C (or 165°F). You can hold hot food for service at 60°C (or 140°F).
Between 4°C and 60°C (or 40°F and 140°F) is the “Danger Zone.” Keep food out of this temperature range because bacteria will multiply rapidly. Between 0°C and 4°C (or 32°F and 40°F), most bacteria will survive but will not multiply quickly. Water freezes at 0°C (or 32°F). Between 0°C and −18°C (or 0°F and 32°F), most bacterial will survive but not grow.
Frozen food is stored at −18°C (or 0°F).
- Figure 2 image description:
- Improper cooling, 30%.
- Advance preparation, 15%.
- Infected person, 12%.
- Inadequate reheating, 10%.
- Improper hot holding, 8%.
- Contaminated raw food, 4%.
- Unsafe source, 3%.
- Use of leftovers, 2%.
- Cross-contamination, 2%.
- Inadequate cooking, 1%.
- All other causes, 3%.
A mnemonic to remember the conditions that affect the growth of bacteria: food, acid, temperature, time, oxygen, moisture Temperature zone in which bacteria will grow the fastest: between 4°C and 60°C (40°F and 140°F) Bacteria that require oxygen in order to grow Bacteria that only grow in environments where oxygen is not present Foods that will allow the growth or survival of pathogens OR foods that may be contaminated by pathogens Lowering the temperature of a food from 60°C (140°F) down to 20°C (70°F) in two hours or less AND then from 20°C (70°F) down to 4°C (40°F) in four hours or less Large metal pans that are usually not deeper than 10 cm (4 in.) that are useful for cooling foods Reusable, hollow, plastic, sealable containers that are filled with water, sealed, and then once frozen, can be put in a liquid food to help cool the food quickly Any food that can be eaten without cooking or any other additional preparation, and is expected to be served this way Plastic, latex, or rubber gloves that, when worn while handling food, will eliminate direct hand contact with the food Small plastic or rubber tubes that, when inserted over a finger, will form a waterproof cover over a cut or sore To hold foods at 60°C (140°F) or hotter; at these temperatures, pathogens will not grow The temperature range where pathogens will grow very quickly, between 20°C and 49°C (70°F and 120°F) to apply heat or chemicals on a clean food contact surface (e.g., cutting board, countertop) to destroy most pathogens The temperature taken with a thermometer in the centre of the food; in the case of whole poultry or large cuts of meat, the temperature should be taken in the thickest part of the flesh without the thermometer touching a bone : 4 Preventing Foodborne Illness
What is CQP in food industry?
A CQP is a step (point, procedure, operation, or stage) in food production at which control can be applied and where control is essential to prevent or reduce quality loss in a product.
How many types of CCP are there?
Food Purchasing – This details information such as food suppliers and the types of foods purchased. Some critical control point examples for food purchasing might be:
Checking suppliers – look at their food production, sourcing and traceability, particularly for raw meats, poultry, etc. Also look at their ability to maintain acceptable HACCP practices. Menu creation – go right back down the chain to the original food producers and suppliers, Packaged and frozen foods – put processes in place for properly managing labelling, storage and temperature control.
Is a CCP a preventive control?
In developing a HACCP plan, the hazard analysis leads to the identification of critical control points (CCPs) where essential process controls are needed to prevent a foodborne hazard from causing illness or injury.
What is an example critical limit for CCP?
5. Is there a target value? – Target values may be selected which are more stringent than the critical limit values required to control the hazard to assist in the early detection of potential process failures. For example:
The critical limits for controlling Salmonella in chicken pieces at the cooking step (CCP) could be 70°C for 2 minutes. However, a target value of 72°C could be set to provide extra assurances that the minimum temperature will be consistently achieved.
Where a target level is set, the difference between this target and the critical limit is known as the tolerance.
How can you identify a critical control point?
1. Thorough hazard analysis – An extensive hazard analysis should form the basis of identifying critical control points. In a hazard analysis, all the physical, chemical, and biological hazards that could potentially occur must be identified. Physical hazards could entail the contamination of the product with metals, glass splinters, bones, etc.
What kinds of contamination may occur during production? What is the probability of occurrence of these contaminations? What are the possible consequences of these contaminations?
Do all materials have a critical point?
Every substance has a critical temperature.
What are the critical controls?
Critical control A control that is crucial to preventing the event or mitigating the consequences of the event. The absence or failure of a critical control would significantly increase the risk despite the existence of the other controls.