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Archive for the ‘ISO 22000’ Category

ISO: 22000 ???2005 Documentation AND STEPS IN DETAILS


Food safety is related to the presence of food borne hazards in food at the point of consumption. 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 personnel.

ISO: 22000 are a generic document and it does not specify ???how??? to do, but only states ???what??? to do. As per the standard, the Food Safety Management System should be documented and be demonstrable in the manner consistent with the requirements of ISO 22000: 2005 models. The total demonstration in the Food safety management System consists of following.

* Interactive communication
* System management
* Prerequisite programmes
* HACCP principle

The total demonstration in the Food safety management System consists of following Documents

* Procedure Manual
* Exhibits / HACCP Plan / Hazard analysis
* Work Instruction/Operating Procedure Manual
* Forms, Records

The amount of documentation should support and efficient quality assurance system without creating a paper bureaucracy. The detail for documenting above four tiers of documents is described in this paper. The total documentation needed for ISO: 22000 comprises of four tiers as shown above.


The Food safety management system consists of a number of documents. Some system should be provided for safe keeping of complex records. It is important to clearly define as to where they should be kept and for how long, and who is responsible for them. Each written procedure should be checked and signed by an authorised person, with issue number and issue date. The Food safety team leader should have a list of all completed procedures, applicable to the individual departmental activities. Against each listed document the number should be shown together with the date of the latest change. It is also called a ???Master Copy???. It is a yardstick against which any other controlled copy can be judged.

From time to time the Committee for Management Review and Corrective Action may put forward recommendations for change in the procedure. The Food safety team leader should be responsible for implementing the change. For making a change, the new page should be circulated to the keeper of the controlled copy of the document with an instruction to insert the new page in order and return the replaced page to the Food safety team leader. Thus outdated documents will be removed from circulation. The staff should know the change, which has been made, and everyone should implement the new procedure.


A safety team in a company should be appointed for Hazard analysis huge documentation of system to complete the work in targeted time with the help of different committees as per details given below.

(A) Steering Committee :-

The Steering Committee should consist of person from top management and a ???food Safety Team Leader???, who should preferably be ???Quality Assurance Manager???. The top management person will be responsible in formulating ???Food Safety policy???, management reviews, contract reviews, defining responsibilities, provide adequate resources for implementation etc.

The ???Food Safety Team Leader??? is responsible for making Documents by giving management intention to achieve Food Safety with reference to different clauses of ISO 22000 standard and document macro level system. He is also responsible for documenting general procedure applicable to all and ensuring effective distribution of the food safety policy, distribution of controlled copies and the amendments in those copies (document control), resolving all food safety matters arising within a company, with customers, vendors and the certifying authority.

(B) Food safety team: –

It should consist of the departmental heads and food safety team leader. They will be responsible for hazard analysis. Based on that also responsible for hazard assessment. Also responsible for approval of various documents and flow diagrams.


It is a manual comprising of a number of quality procedures, each procedure being independent in it. Procedure manual should be made department wise / element wise. Generally the Food Safety Team Leader prepares these quality procedures. They are considered to be the core of the system documentation for Food safety attainment and assurance. As per ISO 22000: 2005 standard the procedures listed below is required.

List of mandatory documented procedures

5. Exhibits / HACCP Plan / Hazard Analysis: –

The standard requires HACCP Plan and Hazard analysis is the main hart of the system. This documents provides assurance of safe food to consumers. The Food safety team before must approve this both documents to implement.


The standard requires work instructions to be available, where the absence of such instruction would adversely affect quality. In the practical sense, work instruction may be written, drawings, photographs, computer menu options, machine care / operation, work production documentation etc. These are practical documents. Hence the authority for the initiation of work instructions should be given to the supervisor of the particular area in which he / she is working. The final draft of the work instruction should be checked and approved by the Head of the department.

Work instructions deals with shop-floor level of activities. Their purpose is to clearly direct the operator as to what has to be done, and what standard of workmanship is required. The instructions must therefore clearly identify:

??? What has to be done?
??? The correct sequence of activities.
??? Any special, environmental conditions, e.g. temperature, humidity cleanliness etc.
??? Reference to standards / codes of practice which must be complied with

In case of special processes, work instructions are a mandatory element and for this, detailed instructions are needed. These work instructions should be written in the local language, so that the operators easily understand them. For the laboratory or Q.C. activity and calibration of instruments the operating procedure is documented describing how particular activity shall be done.


Forms, records etc. are supporting documents used by the company to record information for different procedures followed. They belong to the last and fourth tier of documentation. They link the activities written in the procedure to the records kept in the department. This documentation serves to demonstrate that the Food safety system is operating efficiently to produce the product in accordance with specified requirements of the Standard. These records should be computerised or written neatly with an ink/carbon pen and not with a pencil. They should be legible, easily retrievable and available when asked for by the auditor. List below, gives a list of Records required making a system transparent. On all the forms identification no. And issue no. Of the form shall be required to establish proper document control on them.

List of quality records.

* Records for Management review.
* Records for responsibility and authority
* Records for communication
* Records for Emergency preparedness
* Records of education, training, skills and experience.
* Records needed to provided evidence that the realization of safe products and planning for the same.
* Records of results of Prerequisite programmes (PRPs)
* Records for data collection for Hazard analysis.
* Records for verification of flow diagrams.
* Records for Hazard analysis.
* Records for Hazard assessment.
* Records for Effective monitoring of control measures.
* Records for established Operational PRPs.
* Records for HACCP plan.
* Records for selection and implementation of CCP (Critical control points).
* Records for monitoring of CCP.
* Records for verification activities.
* Traceability (where it is requirement).
* Records for correction.
* Records for corrective action.
* Records for potentially unsafe products.
* Records for release of unsafe products as safe
* Records of authority responsible for release of product
* Records for disposition of nonconforming products.
* Records for withdrawals of unsafe products.
* Records for validation of control measure combinations.
* Results of calibration and verification
* Results of calibration and verification.
* Records of internal audits.
* Records of analysis of verification activities.
* Records of continual improvement.
* Records of system updation.

8. STEPS FOR INSTALLATION OF ISO: 22000 Food safety managementsystems:

All the progressive units in India, which are in the export market today, have adopted some system of obtaining the safe food product. Experience of other industries in India and outside India shows that extensive efforts on the part of each and every person in the organisation are needed for upgrading the existing system to meet the requirements of ISO: 22000.

The time required for installation of these systems in any company may vary depending upon their present status and work culture. An estimate of 4 to 8 months is required for a unit involving over 100 employees. The total cost of 3 to 10 laces is involved in installation of ISO: 22000 series of standard. The total cost involved consultancy body, fees of certifying body, resource requirement etc. depending on infrastructure available with the company establish system and complexity of work involved.

* Conduct HACCP Awareness Programme (Top + Middle + Bottom Level).
* Form a Team for Documentation and HAZARD Analysis.
* Carry out Hazard Analysis
* Prepare Documents and HACCP Plan of HACCP System.
* Implementation & Train All Personnel in the Use of Procedures & Formats.
* Train Internal Auditors.
* Assess the System Through First Internal Audit.
* Take Corrective Actions.
* Apply for Certification.
* Assess the System Through Second Round of Internal Audit.
* Avail Pre-Certification Audit of Certifying Body.
* Take Actions on Suggestions Given by Them.

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