Iso22000 Documentation Steps

7/29/2019 Iso22000 Documentation Steps

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

1. INTRODUCTION: -

Food safety is related to the presence of food borne hazards in food at the point of consumption. As theintroduction of food safety hazards can occur at any stage of the food chain, adequate control throughoutthe 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??? todo. As per the standard, the Food Safety Management System should be documented and be demonstrablein the manner consistent with the requirements of ISO 22000: 2005 models. The total demonstration in theFood 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 apaper bureaucracy. The detail for documenting above four tiers of documents is described in this paper. Thetotal documentation needed for ISO: 22000 comprises of four tiers as shown above.

2. NEED FOR DOCUMENT CONTROL: -

The Food safety management system consists of a number of documents. Some system should be providedfor 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 anauthorised person, with issue number and issue date. The Food safety team leader should have a list of allcompleted procedures, applicable to the individual departmental activities. Against each listed document thenumber 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 forwardrecommendations 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 thecontrolled copy of the document with an instruction to insert the new page in order and return the replacedpage 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.

* FORMATION OF A SAFETY TEAM FOR DOCUMENTATION ANS HAZARD ANALYSIS UNDERISO:ISO 22000: -

A safety team in a company should be appointed for Hazard analysis huge documentation of system tocomplete 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 TeamLeader???, who should preferably be ???Quality Assurance Manager???. The top management person will

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be responsible in formulating ???Food Safety policy???, management reviews, contract reviews, definingresponsibilities, provide adequate resources for implementation etc.

The ???Food Safety Team Leader??? is responsible for making Documents by giving managementintention to achieve Food Safety with reference to different clauses of ISO 22000 standard and documentmacro level system. He is also responsible for documenting general procedure applicable to all and ensuringeffective 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 hazardanalysis. Based on that also responsible for hazard assessment. Also responsible for approval of variousdocuments and flow diagrams.

4. WHAT IS A QUALITY PROCEDURE MANUAL? : -

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 documentationfor Food safety attainment and assurance. As per ISO 22000: 2005 standard the procedures listed below isrequired.

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 documentsprovides assurance of safe food to consumers. The Food safety team before must approve this bothdocuments to implement.

6. WORK INSTRUCTIONS /OPERATING PROCEDURE: -

The standard requires work instructions to be available, where the absence of such instruction wouldadversely 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 practicaldocuments. Hence the authority for the initiation of work instructions should be given to the supervisor of theparticular area in which he / she is working. The final draft of the work instruction should be checked andapproved by the Head of the department.

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

??? 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 instructionsare needed. These work instructions should be written in the local language, so that the operators easilyunderstand them. For the laboratory or Q.C. activity and calibration of instruments the operating procedureis documented describing how particular activity shall be done.

7. QUALITY RECORDS, FORMS AND OTHER DOCUMENTS: -



Forms, records etc. are supporting documents used by the company to record information for differentprocedures followed. They belong to the last and fourth tier of documentation. They link the activities writtenin the procedure to the records kept in the department. This documentation serves to demonstrate that theFood safety system is operating efficiently to produce the product in accordance with specified requirementsof the Standard. These records should be computerised or written neatly with an ink/carbon pen and not witha 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 thatextensive efforts on the part of each and every person in the organisation are needed for upgrading theexisting system to meet the requirements of ISO: 22000.

The time required for installation of these systems in any company may vary depending upon their presentstatus 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 costinvolved consultancy body, fees of certifying body, resource requirement etc. depending on infrastructureavailable 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.