ESTABLISH CORRECTIVE ACTION PROCEDURES FOR EACH CCP

ESTABLISH CORRECTIVE ACTION PROCEDURES FOR EACH CCP (HACCP PRINCIPLE 5)

During the development of the HACCP plan, the HACCP team must establish procedures to be followed if and when the monitoring of a CCP reveals that the critical limits are not respected (i.e., a deviation occurs), and therefore there is a loss of control of the hazard at the CCP. A product that is obtained at a process step where the CCPs are not respected is a nonconforming product and is likely to be unsafe if consumed. The procedures that are established to prevent unsafe product from reaching the consumer are the corrective action procedures or deviation procedures. This HACCP principle recognizes that in spite of the fact that a CCP is operating in a process, it is possible that there could be loss of control at the CCP and this loss of control will be detected during the monitoring procedure.

The following points must be addressed in the corrective action procedures:

• The specific, immediate action to be taken when it is discovered that the critical limits at a CCP are not respected, and therefore there is a deviation from the critical limits

• Identification of the cause of the deviation from the critical limits at the CCP

• The actions to be taken to correct the cause of the deviation so that the deviation does not recur

• Determination of the period of time for which the deviation occurred and the quantity of nonconforming product that was prepared during this time

• The actions to be taken with respect to the nonconforming product to ensure that it does not reach the consumer

• The importance of keeping records of all the actions taken to address the deviation and the nonconforming product

For all of the points listed here, the corrective action procedure must identify the personnel who are responsible for the actions to be taken when there is a deviation from the critical limits at a CCP.

In the event that a deviation from the critical limits at a CCP is discovered only after the non-conforming product has been shipped from the establishment to the customer, then the HACCP prerequisite program Traceability and Recall (Chapter 4) must be used to address this situation.

 ESTABLISH VERIFICATION PROCEDURES FOR EACH CCP AND FOR THE ENTIRE HACCP PLAN (HACCP PRINCIPLE 6)

 

This HACCP principle requires that the HACCP team develop measures that will evaluate (a) the effectiveness of the HACCP plan that has been developed and (b) the effectiveness of the HACCP system on an ongoing basis after its implementation.

• Verification of initial HACCP plan: The verification of the initial HACCP plan involves validation to ensure that the critical limits, the monitoring procedures and the corrective action procedures (HACCP

Principles 3–5, Steps 8–10) established at each CCP are indeed capable of controlling the hazard that is required to be controlled. This validation must be conducted during the development of the HACCP plan; it is therefore an essential part of the HACCP plan development.

The verification activity must also demonstrate that every aspect of the HACCP plan that has been developed must be fully and correctly implemented.

• Verification of the HACCP plan on a continuous basis: The HACCP plan that has been developed must include activities that will demonstrate the following:

The measures (monitoring procedures, corrective action procedures, record-keeping procedures) which have been implemented at each CCP, must continue to be effective and must operate as required by the HACCP plan. The most common form of verification is ongoing review of the required records of monitoring and corrective actions by personnel other than those who were responsible for the monitoring activity or the corrective action.

Supervisory personnel should carry out this type of verification.

Verification activities could also include periodic sampling and analysis to verify the effectiveness of the CCP to control a hazard.

Table 5.5 gives examples of verification activities for some CCPs.

Every aspect of the entire HACCP plan that has been implemented must continue to function as  originally intended; this type of verification is typical of a system audit, and includes an independent review of the entire HACCP plan at a predetermined frequency. In the event this verification activity discovers that there are deficiencies in the HACCP plan, these deficiencies must be corrected immediately.

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ESTABLISH MONITORING PROCEDURES FOR EACH CCP

ESTABLISH MONITORING PROCEDURES FOR EACH CCP (HACCP PRINCIPLE 4)
 

For each of the CCPs that have been determined, the HACCP team must establish the monitoring procedures which will be used to monitor or measure the parameters at the CCP to determine whether the critical limits are being respected. Monitoring can also reveal whether a trend toward loss of control at the CCP is developing so that appropriate action can be taken to prevent loss of control before it actually occurs.

It is essential that the monitoring procedures be reliable; if the monitoring procedure involves a measurement, the reliability of the method used should be known. Visual inspection and physical and chemical measurements are frequently used as monitoring procedures. In some situations microbiological analysis may be required; however, this should only be the case if no other appropriate monitoring procedure is available.

The monitoring procedures must address the following points:

• The reliability of the method; in some situations Official Methods or Reference Methods may be required (e.g.; when some chemical or microbiological methods are used)

• The sampling and sample handling techniques, if applicable

• Whether the method is appropriate for monitoring, in some situations continuous monitoring may be required

• The frequency at which the monitoring is done, if the monitoring is not continuous

• The skill and training of personnel responsible for the monitoring activities

• The equipment used in the monitoring procedure; any equipment used for monitoring must be maintained and calibrated, if required (this is also covered in the HACCP prerequisite programs)

The monitoring procedures should be adequately documented to ensure that these points are addressed. In addition, a record must be generated whenever a monitoring procedure is performed; this record shows that the monitoring was done as required, the person who performed the monitoring,and the actual results of the monitoring. The monitoring record is an essential part of an operating HACCP plan for a product since it is the evidence for whether or not the critical limits were respected.

NACMCF Critical Control Point Decision Tree

Question 1: Does this step involve a hazard of sufficient likelihood of occurrence and severity to warrant its control?

(a) If the answer is Yes, go to Question 2

(b) If the answer is No, this step is not a CCP; proceed to the next step of the process.

Question 2: Does a control measure for the hazard exist at this step?

(a) If the answer is Yes, go to Question 3

(b) If the answer is No, is control at this step necessary for the safety  of the product?

(i) If the answer is Yes, modify the step, the process or product, and return to start of Question 2

(ii) If the answer is No, this step is not a CCP; proceed to the next step of the process.

Question 3: Is control at this step necessary to prevent, eliminate or reduce the risk of the hazard to consumers?

(a) If the answer is Yes, this step is a CCP; proceed to the next step  in the process.

(b) If the answer is No, this step is not a CCP; proceed to the next  step in the process.

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ESTABLISH CRITICAL LIMITS FOR EACH CCP

ESTABLISH CRITICAL LIMITS FOR EACH CCP (HACCP PRINCIPLE 3)

For each of the CCPs that have been determined, the HACCP team must establish critical limits which will serve as the criteria for accepting or rejecting a raw material or ingredient that is a CCP, or a semi-finished or finished product that is obtained at a process step that is a CCP. A critical limit is commonly a maximum value of a parameter that must not be exceeded or a minimum value of a parameter that must be reached at a CCP. At a CCP, the critical limits must be respected for the hazard to be prevented, eliminated or reduced to an acceptable level, and therefore for the product obtained at the CCP to be acceptable. If the critical limits at a CCP are not respected, the product obtained at the CCP will not be acceptable.

Codex Alimentarius Critical Control Point Decision Tree

Question 1: Do preventive control measures exist?

(a) If the answer is Yes, go to Question 2.

(b) If the answer is No, is control at this step necessary for the safety of the  product?

(i) if the answer is No, this step is not a CCP; proceed to the next identified hazard in the process

(ii) If the answer is Yes, modify the steps in the process or the product, and return to start of Question 1.

Question 2: Is this step specifically designed to eliminate or reduce the likely  occurrence of the hazard to an acceptable level?

(a) If the answer is Yes, this step is a CCP

(b) If the answer is No, go to Question 3.

Question 3: Could contamination with the identified hazard(s) at this step,  occur in excess of acceptable level(s) or could these hazards increase to  unacceptable level(s)?

(a) If the answer is Yes, go to Question 4

(b) If the answer is No, this step is not a CCP; proceed to the next identified  hazard in the process.

Question 4: Will a subsequent step eliminate the identified hazard(s) or reduce the likely occurrence to acceptable level(s)?

(a) If the answer is Yes, this step is not a CCP; proceed to the next identified  hazard in the process

(b) If the answer is No, this step is a CCP

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Determine the critical control points CCP

Determine the critical control points (HACCP  Principle 2)

With the information obtained from the hazard analysis step, the HACCP team must then determine the points at which there will be control of the hazards that present unacceptable risks; this will establish the CCPs of the HACCP plan. A useful tool for the determination of whether a raw material or process step is a CCP, is the CCP decision tree. Examples of CCP decision trees have been proposed by Codex Alimentarius and by the NACMCF. The CCP decision trees consist of a set of either three or four questions, which are asked in a particular sequence for each identified hazard so that the point of control of that hazard within the HACCP plan can be determined.

At the completion of Step 7, the HACCP team should be in a position to determine at which points in the process, the identified biological, chemical and physical hazards associated with the product will be controlled so that the hazard will be eliminated, prevented, or reduced to an acceptable level. It is possible that more than one step could be a critical control point (CCP) for the same hazard (e.g., pasteurization and refrigerated storage can be CCPs for the same microbiological hazard); on the other hand, a single CCP could control more than one hazard (e.g., a screening step in a process can be a CCP for various physical hazards). 

HAZARD EVALUATION

The second stage of the hazard analysis is the evaluation to determine which of the hazards that have been identified in the first stage of the hazard analysis are significant, and therefore need be addressed in the HACCP plan for the product. The identified hazards must be considered for their  likely occurrence, and the severity of the risk that they present if they are not controlled. In assessing the likely occurrence of a hazard, the HACCP team needs to examine published information and data, and previous experiences on occurrence of the hazard in the product. In assessing the severity of the risk presented by a hazard, the HACCP team must address the severity of health consequences to consumers of the product, if the identified hazard is not controlled. In carrying out this stage of the hazard analysis, the HACCP team should take the following into account:

• The methods and procedures of preparation, handling, storage, and distribution of the product

• The effects of both short-term and long-term exposure of the product containing the hazard to the health of consumers

• The people, including any particular groups (e.g., infants, pregnant women, the elderly) who are likely to consume the product and the effect the hazard could have on the health of these individuals

• Information and data from previous reported incidents involving the occurrence of the hazard in the product, including the impact of the hazard on the health of consumers.

IDENTIFICATION OF CONTROL MEASURES
 

As part of the hazard analysis the HACCP team must determine whether control measures for the  hazards that need to be addressed in the HACCP plan are present in the process. If control measures for the hazard do not exist in the process, modification of the process may be required in order to institute a control measure, or some alternate measure should be used to address the hazard. 

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Hazard Analysis

Hazard Analysis (HACCP Principle 1)

HACCP Principle 1  hazard analysis must be performed. The hazard analysis can be an extensive exercise for the HACCP team, since it addresses the three categories of hazards —  biological, chemical, and physical. The hazard analysis should be carried out in two stages; the first stage is  hazard identification, which is followed by hazard evaluation. In addition, the control measures for the hazards that need to be addressed in the HACCP plan should be identified at the completion of the hazard analysis.

HAZARD IDENTIfiCATION

The first stage of hazard analysis is the identification of known potential hazards that are likely to be associated with the product; this covers the ingredients, raw materials, and contact packaging materials used in preparation of the product; every aspect of each step of the process; and the environment used for the preparation of the product. If all the potential hazards are not identified, the HACCP plan that is developed might be inadequate to address the safety of the product. The NACMCF has compiled a list of examples of issues that should be considered during a hazard identification exercise:

• The nature of the product and the product characteristics that have been established during the completion of Step 2

• The safety record of the product and the known hazards associated with the product

• The normal microbial content of the product and changes in the microbiological population during storage and handling of the product

• The hazards that are likely to be present in the product if product characteristics such as pH, composition, water activity, and preservatives are not controlled

• The various raw materials, ingredients, and packaging materials used to prepare the product

• The activities, operations, and personnel involved at each of the steps listed in the process flow diagram, including the equipment that is used and the prevailing environmental conditions at the time the product is produced and stored

• The intended use of the product by customers, consumers, or particular segments of the population.

During the hazard identification exercise, the HACCP team should consult appropriate sources of information to determine the known product hazards for which the HACCP plan is developed, as well as known hazards associated with the various raw materials, ingredients, and the processing operations used for the product. A useful database  (Reference Database for Hazard Identification) has been developed by Agriculture and Agri-Foods Canada  (1995). In addition to reference information, valuable information on potential hazards can be obtained by closely observing the process as it is operating. In order for the hazard identification to be successful, it is essential that the HACCP team acquire detailed knowledge of potential hazards associated with every aspect of each step of the process that produces the product for which the HACCP plan is developed.

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The Codex Alimentarius Logic Sequence for the Application of HACCP

The Codex Alimentarius Logic Sequence for the  Application of HACCP

The twelve steps in the Codex Alimentarius Logic Sequence for the Application of HACCP are as follows:

• Step 1: Assemble an HACCP team.

• Step 2: Describe the food product that the HACCP plan will address.

• Step 3: Identify the intended use of the food product.

• Step 4:  Construct a flow diagram of the process that is used to produce the food product.

• Step 5: Conduct an on-site verification of the process flow diagram.

• Step 6: Conduct a hazard analysis of (a) all raw materials and ingredients and (b) each step (in the process flow diagram) used for preparation of the food product (HACCP Principle 1).

• Step 7: Determine which (a) raw materials and ingredients, and (b) process steps, will be critical control points at which unacceptable hazards identified in Step 7, will be controlled (HACCP Principle 2).

• Step 8: Establish critical limits or tolerances for each of the critical control points identified in Step 7 (HACCP Principle 3).

• Step 9: Establish monitoring procedures for each of the critical control points identified in Step 7 (HACCP Principle 4).

• Step 10: Establish corrective action procedures to be followed when monitoring of the critical control points reveals that the established critical limits  have been exceeded or have not been met  (HACCP Principle 5).

• Step 11:  Establish verification procedures to confirm and provide confidence that (a) the critical control points are being monitored effectively and are under control, and (b) the HACCP plan for the product is operating effectively (HACCP Principle 6).

• Step 12: Establish record-keeping and documentation procedures for records and documents that are required by the HACCP plan (HACCP Principle 7).

Maintenance of the HACCP system

After an HACCP system has been developed and implemented, it must be maintained effectively on a continuous basis. This means that the monitoringprocedures, the corrective action procedures (when required), the verification activities, and the record-keeping at each CCP, and for all the HACCP plans in the HACCP system, must operate continuously, and in exactly the manner as they were initially developed and implemented. Any change in any of these activities should only take place after the HACCP coordinator has been informed and has approved the change. For any significant change to the existing HACCP plan activities, the HACCP team should evaluate the change using the same guidelines and principles  (Steps 1 to 12)  that were used in the development of the HACCP system.

The HACCP team should determine whether the HACCP plan for a product needs to be modified after each of the following:

• The intended use of the product has changed

• There is a change in one or more raw materials, ingredients, or packaging materials used for preparing the product

• There is a change in the process for preparing the product

• There is addition, replacement or modification of equipment used in the process If any of the above changes affect the existing CCPs in the HACCP plan for a product, the HACCP plan should be reviewed to determine whether modifications are required for the critical limits, monitoring procedures, corrective action procedures, verification procedures, and recording-keeping and documentation procedures.

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The HACCP system for food safety

The HACCP system for food  safety

The seven HACCP principles

The HACCP system is based on a universally recognized set of seven principles that are used for the development of an HACCP plan for a food. These principles reflect a framework that was developed on the basis of a combination of recognized, science-based, food safety considerations and quality systems characteristics. This integration of basic food safety principles with the quality systems approach has been an important factor in the widespread

recognition of the HACCP principles by food quality professionals.

The universally recognized Seven Principles of HACCP are:

• Principle 1: Conduct hazard analysis

• Principle 2: Determine critical control points

• Principle 3: Establish critical limits

• Principle 4: Establish monitoring procedures

• Principle 5: Establish corrective action procedures

• Principle 6: Establish verification procedures

• Principle 7: Establish record-keeping and documentation procedures

The HACCP system and HACCP plans

Within a particular food processing establishment, the scope of the HACCP system will depend on the number of different food products or different categories of similar food products that are produced. In the case where a single product is produced at a food establishment, the HACCP system is comprised of a single HACCP plan for the product that is produced by a specified process, along with the HACCP prerequisite programs that cover the entire establishment. In food establishments that produce several products, it should be determined whether similar products can be grouped into a family of products that could be covered by a single HACCP plan. In an

establishment at which different products are produced using different raw materials and ingredients, different processes and process parameters, and different processing equipment, it is very likely that the HACCP program for the establishment will consist of several HACCP plans, with an HACCP plan for each product or each family of products.

Development and implementation of an HACCP plan

The widespread recognition of HACCP is reflected not only in its science-based, preventive approach, but also in the requirements and guidelines for the development and implementation of an HACCP plan. A model consisting of a sequence of twelve steps for developing and implementing an HACCP plan for a particular food product has been adopted by the Codex Alimentarius and is referred to as the  Logic Sequence for the Application of HACCP. This set of twelve steps includes five preparatory steps that provide guidance and which are also considered necessary preliminary steps by the USNACMCF, followed by seven steps that address the seven principles of HACCP. The worldwide acceptance of the Codex Alimentarius model has resulted in a consistent format for developing and implementing HACCP plans in food establishments around the world, and has contributed to the recognition of HACCP systems to address food safety issues in bilateral and international trade.

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Terms and definitions given in ISO 9000 and 22000:2005

Terms and definitions given in ISO 9000 and 22000:2005

1. food safety-  concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.
2. food chain-sequence of the stages and operations involved in the production, processing, distribution, storage and handling of a food and its ingredients, from primary production to consumption.
3. food safety hazard - biological, chemical or physical agent in food, or condition of food, with the potential to cause an adverse health effect
4. food safety policy-overall intentions and direction of an organization related to  food safety (3.1) as formally expressed by top management
5. end product- product that will undergo no further processing or transformation by the organization.
6. flow diagram- schematic and systematic presentation of the sequence and interactions of steps.
7. control measure - (food safety) action or activity that can be used to prevent or eliminate a food safety hazard (3.3) or reduce it to an acceptable level.
8. PRP- prerequisite programme (food safety) basic conditions and activities that are necessary to maintain a hygienic environment throughout the food chain (3.2) suitable for the production, handling and provision of safe end products (3.5) and safe food for human consumption.
9. operational PRP - operational prerequisite programme  PRP identified by the hazard analysis as essential in order to control the likelihood of introducing  food safety hazards to and/or the contamination or proliferation of food safety hazards in the product(s) or in the processing environment
10. CCP - critical control point (food safety) 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.
11. monitoring - conducting a planned sequence of observations or measurements to assess whether control measures are operating as intended.
12. correction- action to eliminate a detected nonconformity.
13. corrective action - action  to eliminate the cause of a detected nonconformity or other undesirable situation.
14. validation- (food safety) obtaining evidence that the control measures (3.7) managed by the HACCP plan and by the operational PRPs  are capable of being effective.
15. verification- confirmation, through the provision of objective evidence, that specified requirements have been fulfilled.
16. updating - immediate and/or planned activity to ensure application of the most recent information

Food Safety and Standards Authority of India (FSSAI)

The Food Safety and Standards Authority of India (FSSAI)

Download The Food Safety and Standards Regulations, 2011
Food Safety and Standards Act, 2006
FSSAI has been established under Food Safety and Standards Act, 2006 which consolidates various acts & orders that have hitherto handled food related issues in various Ministries and Departments. FSSAI has been created for laying down science based standards for articles of food and to regulate their manufacture, storage, distribution, sale and import to ensure availability of safe and wholesome food for human consumption. 
FSSAI has been mandated by the FSS Act, 2006 for performing the following functions:

• Framing of Regulations to lay down the Standards and guidelines in relation to articles of food and specifying appropriate system of enforcing various standards thus notified.
• Laying down mechanisms and guidelines for accreditation of certification bodies engaged in certification of food safety management system for food businesses.
• Laying down procedure and guidelines for accreditation of laboratories and notification of the accredited laboratories.
• To provide scientific advice and technical support to Central Government and State Governments in the matters of framing the policy and rules in areas which have a direct or indirect bearing of food safety and nutrition .
• Collect and collate data regarding food consumption, incidence and prevalence of biological risk, contaminants in food, residues of various, contaminants in foods products, identification of emerging risks and introduction of rapid alert system.
• Creating an information network across the country so that the public, consumers, Panchayats etc receive rapid, reliable and objective information about food safety and issues of concern.
• Provide training programmes for persons who are involved or intend to get involved in food businesses.
• Contribute to the development of international technical standards for food, sanitary and phyto-sanitary standards.
• Promote general awareness about food safety and food standards.

Click here to view the Food Safety and Standards Act, 2006

http://www.fssai.gov.in/Portals/0/Pdf/FOOD-ACT.pdf

Download The Food Safety and Standards Regulations, 2011

FSS (Licensing and Registration of Food businesses) regulation, 2011

FSS (Packaging and Labelling) regulation, 2011

FSS (Food product standards and Food Additives) regulation, 2011 (part I)

FSS (Food product standards and food additives) regulation, 2011 (part II)

FSS (Prohibition and Restrction on sales) regulation, 2011

FSS (contaminats, toxins and residues) regulation, 2011

FSS (Laboratory and sampling analysis) regulation, 2011

PAS 220 : 2008 Food Safety

PAS 220 Food Safety

Prerequisite programmes on food safety for food manufacturing

Publicly Available Specification (PAS) 220:2008 is a standard which specifies requirements for prerequisite programmes to assist in controlling food safety risks within the manufacturing processes of international food supply chains. This PAS is intended to be used in conjunction with ISO 22000, the internationally recognized standard for food safety management systems. ISO 22000 sets out specific food safety requirements for organizations in the food chain. One such requirement is that organizations establish, 
implement and maintain prerequisite programmes (PRP) to assist in controlling food safety hazards. 
PAS 220:2008 has been developed to be used to support management systems designed to meet the requirements specified in ISO 22000, and sets out the detailed requirements for those prerequisite programmes.

Benefits of PAS 220:2008

• Food industry driven and developed and supported by key manufacturers and trade associations.
• Complements and aligns with ISO 22000, the internationally recognized food safety management system standard.
• Harmonizes prerequisite programmes best practice for food manufacturing.
• Meets the PRP expectations and requirements of food manufacturing stakeholders, including food retailers and foodservice providers.
• Fully integrates with other management system standards such as ISO 9001.
• Auditable - in conjunction with ISO 22000 - so organizations can demonstrate independent compliance with industry best practice.

The Requirements 

PAS 220:2008 specifies detailed requirements to be considered including:

• Construction and layout of buildings and associated utilities
• Layout of premises, including workspace and employee facilities
• Supplies of air, water, energy and other utilities
• Supporting services, including waste and sewage disposal
• Suitability of equipment and its accessibility for cleaning, maintenance and preventive maintenance
• Management of purchased materials
• Measures for the prevention of cross contamination
• Cleaning and sanitizing
• Pest control
• Personnel hygiene 

It also adds other aspects that are considered relevant to manufacturing operations:

• Rework
• Product recall procedures
• Warehousing
• Product information and consumer awareness
• Food defence, biovigilance and bioterrorism.

standard operating procedure (SOP)

What is SOP (standard operating procedure) 


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An important aspect of a quality system is to work according to unambiguous Standard Operating Procedures (SOPs).A SOP is a compulsory instruction. If deviations from this instruction are allowed, the conditions for these should be documented including who can give permission for this and what exactly the complete procedure will be. 
The original should rest at a secure place while working copies should be authenticated with stamps and/or signatures of authorized persons.


General requirements of SOP


The SOPs should at least mention:


a. who can or should make which type of SOP;
b. to whom proposals for a SOP should be submitted, and who adjudges the draft;
c. the procedure of approval;
d. who decides on the date of implementation, and who should be informed;
e. how revisions can be made or how a SOP can be withdrawn.


It should be established and recorded who is responsible for the proper distribution of the documents, 
the filing and administration (e.g. of the original and further copies). 
Finally, it should be indicated how frequently a valid SOP should be periodically evaluated (usually 2 years) and by whom. 
Only officially issued copies may be used, only then the use of the proper instruction is guaranteed.
The make-up of the documents should meet a minimum number of requirements:


Each page should have a heading and/or footing mentioning:


a. date of approval and/or version number;
b. a unique title (abbreviated if desired);
c. the number of the SOP (preferably with category);
d. page number and total number of pages of the SOP.
e. the heading (or only the logo) of originals should preferably be printed in another colour than black.


The first page, the title page, should mention:


a. general information mentioned under 2.3.1 above, including the complete title;
b. a summary of the contents with purpose and field of application (if these are not evident from the title); if
desired the principle may be given, including a list of points that may need attention
c. any related SOPs (of operations used in the present SOP)
d. possible safety instructions
e. name and signature of author, including date of signing. (It is possible to record the authors centrally in a register)
f. name and signature of person who authorizes the introduction of the SOP (including date).


The data which should be stored per document are:


- SOP number
- version number
- date of issue
- date of expiry
- title
- author
- status (title submitted; being drafted; draft ready; issued)
- department of holders/users
- names of holders
- number of copies per holder if this is more than one
- registration number of SOPs to which reference is made
- historical data (dates of previous issues)
The SOP administrator keeps at least two copies of each SOP; one for the historical and one for the back-up file. This also applies to revised versions. Superseded versions should be collected and destroyed (except the copy for the historical file) to avoid confusion and unauthorized use.




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What is ISO 22000 food safety management system

What is ISO 22000 food safety management system and what are its requirements?

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Food safety is related to the presence of food-borne hazards in food at the  point of consumption (intake by th consumer). As the introduction of food safety hazards can occur at any stage of the food chain, adequate
control throughout the food chain is essential. Thus, food safety is ensured through the combined efforts of all
the parties participating in the food chain.
Organizations within the food chain range from feed producers and primary producers through food
manufacturers, transport and storage operators and subcontractors to retail and food service outlets (together with inter-related organizations such as producers of equipment, packaging material, cleaning agents, additives and ingredients). Service providers are also included.
This International Standard specifies the requirements for a food safety management system that combines the following generally recognized key elements to ensure food safety along the food chain, up to the point of final consumption:
— interactive communication;
— system management;
— prerequisite programmes;
— HACCP principles.
Communication along the food chain is essential to ensure that all relevant food safety hazards are identified
and adequately controlled at each step within the food chain. This implies communication between
organizations both upstream and downstream in the food chain. Communication with customers and suppliers about identified hazards and control measures will assist in clarifying customer and supplier requirements (e.g.with regard to the feasibility and need for these requirements and their impact on the end product).
          Recognition of the organization's role and position within the food chain is essential to ensure effective
interactive communication throughout the chain in order to deliver safe food products to the final consumer. An example of the communication channels among interested parties of the food chain is shown in Figure 1.
The most effective food safety systems are established, operated and updated within the framework of a
structured management system and incorporated into the overall management activities of the organization.
This provides maximum benefit for the organization and interested parties. This International Standard has
been aligned with ISO 9001 in order to enhance the compatibility of the two standards.
This International Standard can be applied independently of other management system standards. Its
implementation can be aligned or integrated with existing related management system requirements, while
organizations may utilize existing management system(s) to establish a food safety management system that
complies with the requirements of this International Standard.
This International Standard integrates the principles of the Hazard Analysis and Critical Control Point (HACCP) system and application steps developed by the Codex Alimentarius Commission. By means of auditable requirements, it combines the HACCP plan with prerequisite programmes (PRPs). Hazard analysis is the key to an effective food safety management system, since conducting a hazard analysis assists in organizing the knowledge required to establish an effective combination of control measures. This International Standard requires that all hazards that may be reasonably expected to occur in the food chain, including hazards that may be associated with the type of process and facilities used, are identified and assessed. Thus it provides the means to determine and document why certain identified hazards need to be controlled by a particular organization and why others need not.
During hazard analysis, the organization determines the strategy to be used to ensure hazard control by
combining the PRP(s), operational PRP(s) and the HACCP plan.


Contact me at reet.gmp@gmail.com for further information and requirements