Sample Iso 22000 Manual
Sample Iso 22000 Manual...
Important aspects to be kept in mind while preparing Food Safety & Quality Manual: Policy: Organizations policies to be framed Organizations overall and departmental Quality Objectives in measurable terms to be framed Identifying the positions and competencies (education ,relevant experience) needed for performing the work to be documented Recruiting the personnel meeting the requirements as documented above Organization chart and roles & responsibilities to be documented Total layout of the plant in building to be kept including men and material movement Identifying each machine in plant and preparing inputs to the machine and output from the machine to be documented Process flow chart for manufacturing process from raw material inputs to the finished products and its storage and dispatch to be documented Training programs needed to the personnel as per manufacturing processes and processing of training as per these documented requirements to be ensured Handling of customer complaints on the products and its mechanism to be documented Ensure that all the requirements of the respective standard is addressed in the manual. To ensure this it is better to prepare a matrix indicating the requirements on the one side and compliance documents in the manual can be given
Normally the following procedures will be documented irrespective of the standard being implemented. • Document control
• Control of records • Recruitment of personnel • Training of personnel • Management review meeting • Internal audits • Handling customer complaints • Corrective action • Preventive action • Handling of potentially unsafe product / non conforming product • Verification & validation Raw material and finished product specifications has to framed Procedure for supplier evaluation
eFresh Portal made an effort to prepare a Food Safety Manual Structure based on HACCP guidelines, which is generic and the same can be considered as a first step towards preparation of the Food Safety Manual and incorporating the requirements as applicable in individual case.
SAMPLE -FOOD SAFETY MANAGEMENT SYSTEM MANUAL ISO 22000:2005
TABLE OF CONTENTS S. No 1 2 3 4 5 6 7
Documents Contents Abbreviations Company Profile Declaration Distribution List Amendment List Recognitions/Licenses by Govt. Agencies
Document No FSMS – C FSMS-A FSMS –C P FSMS – D FSMS – DL FSMS – AL FSMS – R
Clause No. -
8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42
Scope of the FSMS References Terms and Definitions Documentation Requirement Control of Documents Control of Records Management Responsibility Food Safety Policy FSMS Planning Responsibility & Authority Food Safety Team Leader Communication Emergency Preparedness & Response Management Review Resource Management Competence Awareness & Training Training & Training Plan Infrastructure & Work Environment Planning & Realization of Safe Product Pre- Requisite Programs Pre. Steps to Enable Hazard Analysis Product Characteristics Intended Use Flow Diagram Hazard Analysis Hazard Assessment Control Measures Operational PRPs HACCP Plan Updating-Verification- Traceability Control of Non-Conforming Product Validation, Verification & Imprv. of FSMS Control of Monitoring and Measurement FSMS verification Improvement
FSMS – S FSMS – R FSMS – TD FSMS – DR FSMS – CD FSMS – CR FSMS – MR FSMS – FSP FSMS – FSMSP FSMS – RA FSMS – FSTL FSMS – C FSMS – EPR FSMS – MR FSMS – RM FSMS – CAT FSMS – T&TP FSMS – IWE FSMS – PRSF FSMS – PRP FSMS – PSEHA FSMS – PC FSMS – IU FSMS – FD FSMS –HA FSMS –HA FSMS –CM FSMS –OPRP FSMS –HP FSMS –UVT FSMS –CNCP FSMS –VVIF FSMS-CMM FSMS-FSMSV FSMS-I
01 02 03 4.2 4.2.2 4.2.3 5.0 5.2 5.3 5.4 5.5 5.6 5.7 5.8 6.0 6.2.2 184.108.40.206 6.3-6.4 7.0 7.2 7.3 7.3.3 7.3.4 7.3.5 7.4 7.4.3 7.4.4 7.5 7.6 7.7-7.8-7.9 7.10 8.1-8.2 8.3 8.4 8.5
CRITICAL CONTROL POINT
FOOD SAFETY MANUAL
FOOD SAFETY MANAGEMENT SYSTEM
FOOD SAFETY STANDARD PROCEDURES
FOOD SAFETY TEAM LEADER
GOOD MANUFACTURING PRACTICES
HAZARD ANALYSIS AND CRITICAL CONTROL POINT
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION
OPERATIONAL PRE-REQUISITE PROGRAMS
P & S
PROCUREMENT & SUPPLIES
QUALITY MANAGEMENT SYSTEMS
STANDARD OPERATING PROCEDURES
STANDARD SAFETY OPERATING PROCEDURES
AMENDMENT LIST Sl. No
Date of Amendment
Reason for Change
About Company: Should cover Geographical details
Number of branches if any
About production facility
At this hotel, all three meals are served – Breakfast, Lunch and Dinner. Variety of cuisines - South Indian, North Indian and International with both Vegetarian and Non-Vegetarian options are prepared at the Kitchen and served in the Cafe. The Kitchen also has a live counter where Pizzas and Pastas are made to order with options. The Menus are displayed in the restaurant so that guests get to know the options available for the day.
At this hotel, we are committed to making constant improvements to the quality and hygiene standards of the food served to our guests.
XYZ Hotels brings out this Food Safety Management System Manual as part of the food safety system under the authority of the Manager. This Manual is the original and authenticated one and the activities detailed in this Manual are true and correct. This FSMS Manual is in compliance with the international standard, ISO 22000:2005 which it is based on. The criteria outlined in this Manual are mandatory and shall be complied with by all the facility staff of this hotel.
Any changes or modifications to be incorporated in this manual shall be made only upon authorization by the MR and the details of the modifications by the food safety team leader will be indicated in the record of Amendments.
Signed by: MR
The Controlled copies of the FSMS Manual are distributed to the following holders: Controlled copy no.
01 02 03
Executive Chef Manager QC Manager (F & B)
The MR holds the “Master Copy” of the FSMS Manual.
AMENDMENT LIST Sl. No
Date of Amendment
Reason for Change
RECOGNITIONS / LICENSES BY GOVERNMENT AGENCIES
a. Form of License No.
SCOPE OF THE FSMS The FSMS system in xyz is applicable to the activities undertaken in the food service establishment at……, Hyderabad. The scope is as follows:
“Food Production and service”
ISO 22000:2005 SYSTEM
We have developed an ISO 22000 based Food Safety Management System which assures the safety of meals prepared at xyz premises .Process control plans developed and operated for all aspects that are applicable to the safety of foodstuffs are described/ referenced in the appropriate ISO 22000 Food Safety System documentation. The Scope of the ISO 22000 System at xyz has been defined as per the position within the food chain, as per process location and line, and per product and includes all classes of hazards viz. Physical, Chemical & Biological.
Food Safety Management Systems – Requirements for organizations through out the food chain. – ISO 22000 : 2005
Joint FAO/WHO Codex Alimentarius Commission
− General Principles of Food Hygiene, CAC/RCP 1-1969, Rev. 4 (2003), amended 2003. − Hazard Analysis and Critical Control Point (HACCP) System and Guidelines for its Application, Annex to CAC/RCP 1-1969, Rev. 4 (2003). •
The Prevention of Food Adulteration [PFA 1954 Act]
TERMS AND DEFINITIONS •
Action-limit value - A value for the product or process parameter under consideration, deduced from the critical limit value, which indicates that an intervention in the process is required.
Aspect- An element of the food business operation (products, processes, PRP, services) that can interact with the food safety.
Cleaning - Removal of soil, food residue, dirt, grease or other objectionable matter
Contaminant - Any biological or chemical agent, foreign matter, or other substances not intentionally added to food which may compromise food safety or suitability
Contamination - Introduction or occurrence of a contaminant in food or food environment.
Control (verb) - To take all necessary actions to ensure and maintain in compliance with criteria established in the Food Safety 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.
Control measure, general- A measure to control a specific part of the PRP.
Control measure, specific- A measure to control a CCP.
Corrective Action - Any action to be taken when the result of monitoring at the CCP indicate a loss of control.
Critical Control Point (CCP) - A step at which it is essential that a specific control measure is applied to prevent or eliminate a Food Safety Hazard or reduce the risk to an acceptable level.
Critical Limit - A criterion, which separates acceptability from unacceptability.
Note- This criterion defines the limiting values for the product or process parameters under consideration for monitoring (see action- limit vales and target value).
Disinfection - The reduction, by means of chemical agents and/or physical methods, of the number of micro-organisms in the environment, to a level that does not compromise food safety or suitability
Establishment - Any building or area in which food is handled and the surroundings, under the control of the same management.
Flow Diagram - A systematic representation of the sequence of steps or operations used in the preparation, processing, manufacturing, packaging, storage, transportation, distribution, handling or offering for sale of a particular food item.
Food business operator- The person or persons responsible for ensuring that the requirements of the food legislation are met within the food business under his/ their control.
Food handler - Any person who directly handles packaged or unpackaged food, food equipment and utensils, or food contact surfaces and is therefore expected to comply with food hygiene requirements
Food Hygiene – All conditions and measures necessary to ensure the safety and suitability of food at all stages of the food chain.
Food safety - Assurance that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use.
Food suitability - Assurance that food is acceptable for human consumption according to its intended use.
HACCP- A system, which identifies, evaluates and controls hazards which are significant for food safety.
HACCP audit- A systematic and independent examination to determine whether the HACCP system, including the HACCP plan and related results, comply with planned arrangements, are implemented effectively and are suitable for the achievement of its objectives. Note- Examination of the Hazard Analysis is an essential element of the HACCP audit.
Food safety 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.
HACCP based food safety system (a HACCP system) - The organizational structure, procedures, processes and resources needed to execute the HACCP plan and meet its objectives.
Food Safety Team- Group of individuals (multi- disciplinary) who develop, implement and maintain a Food Safety Management system.
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 is addressed in the Food safety plan.
Monitoring - The act of conducting a planned sequence of observations or measurements of control parameters to assess whether a CCP is under control.
Pre-Requisite Program (PRP)- Any specified and documented activity or facility implemented in accordance with the Codex General Principle of food hygiene, good manufacturing practices and appropriate food legislation, in order to establish basic conditions that are suitable for the production and handling of safe food at all stages of the food chain.
Preventive action- Any measure or activity that will be used to prevent, to eliminate or to reduce the recurrence of causes for existing deviations, defects or any other undesired situation with respect to food safety.
Primary production - those steps in the food chain up to and including, for example, harvesting,
Products, unprocessed- Foodstuffs which have not undergone a treatment, including products which have been, for example, divided, parted, severed, boned, minced, skinned, ground, cut, cleaned, trimmed, husked or milled, chilled, frozen or deep frozen.
Product, processed- Foodstuffs resulting from the application to unprocessed products of a treatment such as heating, smoking, curing, maturing, pickling, drying, marinating, extraction, extrusion, etc or combination of these processes and or products; substances necessary for their manufacture or for giving specific characteristics to the products may be added.
Risk- The probability of causing an adverse health effect caused by the occurrence and the severity of a particular hazard in food when prepared and consumed according to its intended use.
Target value- The value of the product or process parameter(s) to be monitored, targeted within action- limit values (the range of acceptable variations) and certainly within critical limit values, thus securing a safe product.
Step - A point, procedure, operation or stage in the food chain including raw materials, from primary production to final consumption.
Validation - Obtaining evidence (in advance) that the specific and general control measures of the Food Safety plan are effective.
Verification - The application of methods, procedures, tests and other evaluation, in addition to monitoring to determine compliance with the specification laid down in the HACCP Plan and the effectiveness of the HACCP – based food safety system.
Food Safety Management System Documentation Structure: The documentation structure consists of different hierarchical levels as follows: •
Food Safety Policy Manual
Standard Operating Procedures
Work Instructions / operating Rules
HACCP Principles related documents
Formats and Records
LOGIC SEQUENCE FOR THE APPLICATION OF HACCP
4.0 FOOD SAFETY MANAGEMENT SYSTEM 4.1 General requirements: 4.1.1 The Food Safety Management System (FSMS) documented by XYZ in this Food Safety Management System Manual is established, implemented, maintained and updated as and
when required and also its effectiveness is continually improved in accordance with the requirements of ISO 22000:2005.
4.1.2 XYZ has defined the scope of the FSMS as in FSMS Manual – Clause1.0 and has identified the product categories, processes and production sites where this FSMS is implemented.
4.1.3 As part of the FSMS, XYZ has •
Ensured that all food safety hazards expected to occur in the products or processes within the scope of activities of the system are adequately identified, evaluated and controlled based on the HACCP system developed so that the products produced are safe and do not harm the consumer.
Proper communication (external) throughout the food chain within its scope of activities and purview with respect to the food safety issues of the products it produces.
Proper communication (internal) throughout the organization regarding the FSMS development, implementation and updating as required by the standard – ISO 22000:2005.
In place FSMS review meetings (once a year) to evaluate and update it on a regular basis and/or whenever required to incorporate the latest information on the hazards associated with its products and processes which need to be controlled.
4.1.4 XYZ has outsourced some of the processes like external lab services, pest control, water and other materials and calibration of testing and monitoring devices for machine testing of food that are identified and are under the control of XYZ.
The Food Safety Management System documentation consists of •
Documented statements of Food Safety Policy and Food Safety Objectives in this FSMS Manual.
Food Safety Management System Manual
Documented Food Safety Management System Procedures/Food Safety Manual as required by ISO 22000:2005 and other procedures needed to ensure effective planning, operation and control of the processes by the organization are included in this FSMS Manual or referenced here as to where such procedures are documented. Forms and Formatted registers needed to generate records are
indicated. List of records maintained meeting the requirements of ISO 22000:2005 are also part of the XYZ documentation requirements. •
The FSMS Manual is prepared covering - Scope of FSMS, covering the exclusions, if any, with justification. Reference to Food Safety Management System Procedures and Food Safety Manual.
Control of documents Procedure for Document control is established for effective control of documents defining the following controls -
To approve the documents for adequacy prior to the use.
To review and update as necessary and re approve documents
To ensure that changes and the current revision status of documents are identified.
To ensure that relevant versions of applicable documents are available at points of use.
To ensure that documents remain legible and readily identifiable. To ensure that documents of external origin are identified and their distribution controlled and − To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.
The documents are updated with PRPs and HACCP plan
Control of records
Records are considered to be a special type of document, which provide objective evidence to fulfillment of requirements of the Food Safety Management Systems. Effort would be to maintain the records in the electronic media
Records are established and maintained to provide evidence of conformity to requirements and of the effective operation of the Food Safety Management System. The records are maintained in such a way that they are legible, readily identifiable and retrievable.
At XYZ, the Procedure for Control of records has been established with regard to : identification storage protection retrieval retention time disposition
5.0 MANAGEMENT RESPONSIBILITY 5.1 Management commitment The Management of XYZ demonstrates good commitment to the FSMS development and implementation and continually improve its effectiveness •
By communicating the importance of meeting the customer requirements as well as statutory and regulatory requirements through meetings.
By ensuring establishment of Food Safety Policy
By ensuring that Food Safety/Quality Objectives are established
By conducting Management Review Meetings.
By ensuring that all necessary resources are available to carry out the operations.
Food Safety Policy
XYZ has defined and documented its policy with regard to food safety, thereby demonstrating the organization’s commitment to safe food. It is focused on the safety of foodstuffs, and responds to the expectations and needs of its consumers.
XYZ ensures that the policy & objectives are understood, implemented and maintained at all levels of the organization. This is done through suitable means like displaying on boards and conducting meetings, via departmental heads, etc. Employees are advised of the policy & objectives on joining the company and/or during trainings. Food Safety Policy forms the basis for formulation of Food Safety/Quality Objectives.
Food Safety Policy and Food Safety/Quality Objectives are reviewed in Management Meetings once in 6 months to ensure their continuing suitability.
FOOD SAFETY POLICY
Policy statement: The Food Safety Team in M/S.XYS Company is committed to serving food to its guests prepared under hygienic and safe conditions. Our Food Safety Practices shall: • • • • • • •
Ensure that only Trained and Skilled staff are inducted into the kitchen Reflect Food Safety Standards in relation to safety practices, premises and equipment standards Reinforce consistent food safety practices in the service Aim at providing Safe and Hygienic food Reduce the risk of potential food-borne illnesses Comply with legislative requirements while maintaining a flexible approach to meet the best practices Reflects continual improvement in the Food Safety Standards.
This commitment to Food Safety Policy will be demonstrated by the management conforming to Food Safety Management System based on ISO 22000:2005 requirements and the following objectives as mentioned in the table on the next page.
Maintenance in charge
Highlighted is the HACCP team
Stores in charge
Ripening shed in charge
Competency of each position in the organization can be documented in the below format. Any of the employees working in the organization is not complying with the requirements set by the organization as per the standard if any, and the organization’s operational requirements, then the position is not confirming to the requirement. Therefore it is very important that the organization first determines the competency requirement of the personnel, as per the operational requirement and then recruit the people complying with this requirement.
Format for COMPETENCY MATRIX
Sl. Name of No. Employee
Function / Designati on
REQUIRED Academic Total Skill Qualification Experien set ce
ACTUAL Academi Total c Experien Qualifica ce tion
FOOD SAFETY AND QUALITY OBJECTIVES AT FUNCTIONAL LEVELS FOR THE PERIOD OF 2011-2012 S .N O
RESPONSIBILITY LEVEL (Functional Heads)
To give employees, a minimum
of one training program in a month in handling, processing, and serving of the safe food. 2
Purchase / Stores
Nonconforming input materials not more than 5% per supplier of the total consignment per month
Production / Manufacturing To bring down the wastage of
the food to 5 % of the total production. 4
Production / Manufacturing To monitor and maintain safe
temperatures (>63°C) while hot holding of food.
Customer complaints: Not more than 5% per month
Manager F & B
Food Safety Management System Planning The Top Management of XYZ ensures that •
The Planning of the Food Safety Management System is carried out in order to meet the requirements of ISO 22000 standard and Food Safety/Quality Objectives.
The FSMS Planning of XYZ ensures that the requirements (inputs) are clearly documented to ultimately meet the acceptance criteria (output).
The FSMS Planning includes or refers to the Flowchart, Worksheets, Quality Control Plans, Food Product Specifications/Recipes and Hazard Identification.
The integrity of the Food Safety Management System is maintained when changes to the Food Safety Management System are planned and implemented.
On conducting a hazard analysis and Determination of the Critical Control Points (i.e., meeting the first two HACCP principles), the HACCP Plan becomes the input for planning activities with focus on what areas need control and to what level.
The requirements of the product are analyzed and defined with regard to : - Documentation: Flowchart, Worksheets, Quality Control Plans, Food Product Specifications/Recipes and Hazard Identification with Critical Control Points - Equipment: includes the manufacturing / food production equipment - Human resources: All staff has the appropriate skills for the jobs / tasks - Purchased materials: Availability of the raw materials, ingredients to the specified requirements and manufacturing aids
5.4 Responsibility and Authority
The Organization Chart included in this manual shows the relationships between the respective functions. All staff and managers are responsible for the quality of their own work and for advising their respective workers of their work responsibilities, when satisfactory operation of the FSMS is adversely affected. Staff and managers are responsible and have the authority within their defined areas of control for: - The quality of work carried out - Initiating action to prevent the occurrence of product non-conformance - Identifying and recording quality problems - Initiating, recommending and providing solutions to quality problems - Verifying that solutions are effective - Controlling further processing until all conditions are satisfactory
Further details of responsibilities and authorities for personnel who manage and perform the work can be found in the relevant job descriptions or related documents.
In the event of absence, responsibility and authority passes to the next higher level of management, for subsequent delegation, as appropriate.
Food Safety Team Responsibilities •
Making of the flow charts, their hazard analysis and determination of CCP, conduction of HACCP Verification and Validation.
Ensuring that the HACCP system XYZ as per the ISO 22000:2005 standards.
Providing adequate guidance and training to all for carrying out their duties in the raw material reception, pre-preparation areas, processing areas, raw material stores and all other sections as per XYZ approved HACCP Plans, procedures, and operating methods.
Effective implementation and monitoring of cleaning schedule and strict personnel hygiene measures in the XYZ
This is in addition to their existing responsibilities.
Validation Team Responsibilities
• • • • • • • • •
Ensuring the adequacy, completeness, and (scientific) basis of the potential hazards identified and analysed. Ensuring that the aspects considered while determining the significance of hazards are evaluated using sound scientific and technical knowledge Ensuring that the control measures (general or specific) are appropriate and adequate to control the hazards Ensuring that the fluctuations of the control parameters (equivalent to process criteria) within the defined critical limits will not affect the safety of the product Ensuring the appropriateness of the control measures’ monitoring system Ensuring the appropriateness of the corrective action systems defined, w.r.t. preventing the release of unsafe products, and that they provide evidence that the situation can be corrected immediately. Ensuring that the Food Safety System is validated first and every time prior to issue. Ensuring that all the validated activities are carried out in time and records of the same are maintained. This is in addition to their existing responsibilities.
FOOD SAFETY TEAM LEADER
Executive Chef of M/s.XYZ Company is the nominated FS Team Leader having responsibility and authority to
Ensure that processes needed for the Food Safety Management System are established, implemented, maintained and updated.
Report to the top management on the performance of the Food Safety Management System and any need for improvement
Ensure the promotion of awareness of customer requirements throughout the organization.
Liaison with external agencies on matters relating to the Food Safety Management System
First ensure relevant training and education to FST members
To organize internal food safety audits for FSMS and review corrective action if required, through follow up audits.
5.6. COMMUNICATION 5.6.1 External Communication •
XYZ has ensured that appropriate communication processes are established with the customer, Legal Authorities and External Certifying Agencies.
XYZ communicates with the customers in relation to: -
Product information. Customer feedback, including customer complaints through e-mail or verbal means.
Customer complaints and feedback are documented and Corrective and Preventive Actions are taken accordingly. •
All the data required for Legal authorities and External certifying agencies is recorded and maintained separately.
5.6.2 Internal Communication
XYZ ensures that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the FSMS through: - Management Review Meetings, minimum once in six months - Notices/Mail. - Circulars
The preventive actions identified under hazard analysis and the food product deviations with the related dispositions are made known by communicating at the appropriate levels and functions.
At XYZ communication takes place with regard to the following to promote effective operation of the FSMS: -
recipe improvisations / new recipes changes in raw materials, ingredients changes in food production, manufacturing systems, equipment and surrounding environment changes in the requirements (customer, statutory / regulatory) changes in personnel qualification level and responsibilities New food safety hazards with the new ways of handling and controlling measures. Changes in cleaning and sanitation programmes, storage and distribution systems Complaints indicating food safety hazards associated with the products.
The food safety team ensures that this information is included in the updating of the FSMS.
Top management shall ensure that relevant information is included as input to the management review
The minutes of the Management Review Meetings are maintained by the MR. (Refer Minutes of Management Review meetings)
The minutes of meetings are communicated to the participants of the meeting for taking effective actions and demonstrating continual improvement
5.7. EMERGENCY PREPAREDNESS AND RESPONSE • Objectives of the Plan To identify the possible hazard/ risk this can lead to environmental emergency, property damage and injury to human beings - To prevent, identified potential environmental, food safety related scenarios - To minimize /mitigate consequences wherever possible. - To provide relief to injured persons. - To control the emergency as early as possible.
Potential Emergency Situations.
Location Raw/packing Material storage
Factors leading to emergency Electrical Fire Bidi/Cigarette Fire
Electrical Control Panel Area
Flash due to short Circuiting Overloading and water Spillage
Fire Manual handling of chemicals Accidental spray of hot CIP Solutions Steam burns
Injury to human Beings Air pollution Land Pollution Fire Injury to human beings Air Pollution
Proper connections ‘NO SMOKING’ sign is displayed. Fire extinguishers & pipelines are provided Proper connections Proper load distribution Area to be kept dry ‘NO SMOKING’ sign is displayed.
Water Pollution Air pollution Injury to human beings
Proper maintenance of pipe Fittings Use of safety wears etc.
Fire Leakage of LPG Electrical sparks Fittings & electrical short Circuit Lighted cigarette, match Sticks.
Fire & explosion Air pollution Property damage Injury to human Beings.
Regular maintenance of gas Pipe fittings. ‘NO SMOKING’ sign is Displayed. Fire extinguishers& Pipelines are provided. Monitoring of LPG
Admn.block. Sites of high rise Building Painting/ Construction / Civil work Cleaning of glasses
Slip or fall may lead to an accident
Injury to human beings
Safety belt, proper ladder, Proper scaffolding
Slip or fall may lead to an Accident breakage of glass
Injury to human beings
Safety belt, proper ladder
Potential Food Safety Emergency
Factors leading to emergency
Production/ Kitchen Area
Bio-terrorism, Injury to sabotage, Bird flu Human Beings
Service center Premises
Entry restricted to Production / kitchen area Security Arrangements in the premises round the clock. Raw materials/commodities are accepted only after proper checking. Finished Product is released only after proper checking. Microbiology lab is in the premises; however routine bacteriological used media / culture are disposed off only after auto-claving. Emergency Lights provided at the potential areas. Accidents Product Loss & Standby Generator/Transformer. Timely Delivery effects
Service center Premises
Unhygienic Conditions and hindrances to production.
Proper Maintenance of drainage system & periodically cleaning. Additional pumps provided around the premises to throughout storm water / additional water outside the premises. All the premises is covered with solid brick walls and entry gates are raised, then the road level to stop entry of water from outside.
Emergency Preparedness: - To deal with fire, the whole premises are equipped with fire extinguisher pipelines and fittings etc... Which are installed at various locations as per the law. -
Majority of the persons in the service centre trained in fire fighting and first aid is displayed prominently in every department.
All security guards are trained in fire fighting. Adequate number of first aid boxes are installed and maintained in the service centre. All inflammable materials are stored in isolated place and labeled accordingly. ‘NO SMOKING’ signs are displayed at all important locations Intercom facilities are available all over the building for communication with security department.
Personal protective are kept near potential area by the concerned Section In charge such as hand gloves, masks etc. List of emergency telephone numbers is available in each department.
• • • •
All types of wastages like raw material, packaging material etc is taken by an external agency for disposal of the same. Other waste like cooked leftover food items are taken by an external agency for disposal and records are maintained. For Product recall from customer please refer clause 7.10.3 (handling of potentially unsafe products)of this manual The Food Safety will act as an emergency team in such situations.
5.8 MANAGEMENT REVIEW 5.8.1 General Top management reviews the organization’s Food Safety Management System at least once in every six months to ensure its continuing suitability, adequacy and effectiveness. The review includes assessing opportunities for improvement and the need for changes to the Food Safety Management System, including the Food Safety Policy and Food Safety Objectives. Records of management review are maintained. •
The members of the Management review committee include: Manager QC Manager Purchase & stores Manager Production
5.8.2 Review input The input to the Management review meeting includes the following information. •
Follow-up actions from previous management reviews
Analysis of results of verification activities
Changing circumstances that can affect food safety
Emergency situations, accidents and withdrawals
Results of review and system updating activities
Communication activities including customer feedback and is reviewed monthly.
External audits or inspections
5.8.3 Review output Output of the management review contains the decisions and actions related to • Assurance of food safety • Improvement of the effectiveness of the Food Safety Management System • Resource needs • Revision of organization’s food safety policy and objectives
Management Representative •
The Management Representative, ensures the following: As per standard -
To establish, implement and maintain the FSMS as per ISO22000: 2005 Standards. To ensure that processes needed for the FSMS are established, implemented and maintained understanding the current and future needs of the customers / clients To report to the top management on the continuing suitability and effectiveness of the FSMS and the scope for improvement To promote awareness of customer requirements throughout the organization To plan, schedule and conduct Internal Audits for FSMS To select qualified Internal Auditors To review the Audit Report and follow-up Corrective Action / Preventive Action Reports To initiate modifications of documents based on Corrective action / Preventive Action and to control all the documents related to the FSMS To schedule management review meetings at the defined intervals and record minutes of management review meetings for subsequent reporting on the performance / improvements of the FSMS To liaison with the external agencies related to the FSMS Implementation and Certification
The Management Representative convenes the management review meetings after preparation of the agenda and maintains the minutes of the meeting.
Provision of Resources :
Resources (Human resources, Equipment resources and Work environment needs) required for implementation & maintaining of Food Safety Management System are identified, and determined by MR for carrying out various activities as per budgeted plan.
Resources are provided to implement and maintain the Food Safety Management System and continually improve its effectiveness and enhance customer satisfaction by meeting customer requirements. Resource requirements are reviewed in Management Review meetings.
The resources include : - Adequate trained personnel for management, performance and verification activities. - input materials of the requisite quality - Suitable process equipment, process control equipment and other infrastructure to meet the requirements for the quality of the product. - Work environment (physical and human) suitable for operation / processes to meet up Quantified Quality Objectives.
XYZ provides competent personnel for performing work affecting product quality. Competency of the personnel is based on appropriate education, training, skills and experience and is established in line with the Food Safety and Quality Policy and Plans. All staff working in food areas is adequately trained in hygiene procedures.
Competence, Awareness and Training
a. Competence of personnel for performing the activities having Quality, Safety and Environment impacts has been established on the basis of appropriate education, training and or experience. b. Enhancement of competence is done through training, education and learning involving technical knowledge and skills, management skills and tools, social skills, knowledge of markets and customer needs and expectations, relevant statuary and regulatory requirements, internal and appropriate external standards, and documentation for performing the work as appropriate. Efforts are made to increase the awareness and involvement of personnel through programs which covers: -
the vision for the future of the organization, the Organization’s policies and objectives, organizational change and development, The initiation and implementation of improvement activities, introductory programs for new personnel, and Periodic refresher programs for personnel already organization.
c. Identification of training needs - The Organization analyses the development needs of all its personnel and design training plan for them. This is to provide personnel with knowledge which, together with skills and experience, leads to competence. Preparation of training plan For identified training, training plans are prepared. The training plan covers: - food safety training, - personnel hygiene, - hygiene and sanitation, - pest control, - Operation of equipment (Refer: Training Plan Tables in this Manual)
d. Imparting training and keeping records - In coordination with concerned function training is imparted either by deputing persons to identified institutions outside or by organizing in house training by engaging trainers from outside agencies or from within the organization.
- The technical personnel have been trained on principles of ISO: 22000-2005 and are also on the use of documentation related to the Organization's FSMS. - Competence and training records of personnel are maintained on prescribed formats. Effectiveness of the training is assessed and records are maintained. e. It is the responsibility of the Department Heads to identify the training needs of their personnel on the basis of work performance, introduction of new process and technology and recommend them for training such as external training, seminars, workshops etc. The workers have also been trained on basic quality concepts, food hygiene and good manufacturing practices and food safety. f. The food handlers have the necessary knowledge of food handling and preservation principles and practices to be able to judge potential risks and take the necessary actions by effective communications to remedy deficiencies.
g. Training Plan for Professional Skills for the Year 2011
Topics to be covered GMPs – facility issues, food flow, people flow, waste flow, building and structural issues, segregation, cross contamination due to
Apr May Jun
SSOPs – cleaning of all areas/equipments/utensils etc, personal hygiene, cross contamination, pest control, water safety, health issues etc
CCP related – identification, critical limits, monitoring, corrective action, record keeping, verification and validation
Process related – Nonconformity, corrective actions, internal audits, unsafe product handling, control of documents and records, traceability, product recall and emergency situations.
Production related – receiving, issuing, storage, cooking, steaming, baking, frying, dispatch, hot/cold holding, etc
Basic food hygiene – basic principles of handling food Personal hygiene – Hand wash procedures, Uniform, personal grooming, proper use of accessories, reporting illness and medical health HACCP – as per Codex ISO 22000:2005 Awareness Training
ISO 22000:2005 – Internal Auditor’s training Basic Fire Safety Training Basic First Aid Training
6.3 Infrastructure : • XYZ determines, provides and maintains the infrastructure needed to achieve conformity to product requirements. •
Infrastructure at XYZ includes : - Building, workspaces and associated utilities like UPS, generators, air–conditioners, aircompressors, etc. - Calibrated process equipment. - Supporting services like telephones, fax m/c, computers, etc. - Appropriate design and maintenance of the work area, which has a major effect on food safety. The maintenance of the equipment complies with the Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP)
Infrastructure is maintained to ensure their suitability. Equipment maintenance is carried out as per schedule established.
Work environment needed to achieve conformity to product requirements is provided at all working places in the organization.
To ensure safety of personnel, activities related to safety is carried out like periodic medical checkup and safety awareness trainings, hygiene training programmes etc.
PLANNING AND REALIZATION OF SAFE PRODUCT 7.1 General
XYZ Plans and develops the processes needed for Product Realization. Planning of Product Realization is consistent with the requirements of the other processes of the FSMS. The processes are clearly defined with the measurement criteria and the interfacing with the other processes.
The results of HACCP study is taken as input to Process Planning / Food Safety Planning, with the critical areas and shows the correct directions. The results from Food Safety Planning give an indication of the typical controls needed within a process. Food Safety Planning is linked to the HACCP Plan in which the CCP’s were identified.
To ensure Product Realization, consideration is given to associated support functions as well as desired outputs, materials, methods, equipment, control measures, information, training needs and other resources. Support functions include : - Training of people - Availability of infrastructure - Application of Industrial safety / Protective Equipment
XYZ determines the following while planning for product realization: - Food Safety & Quality Objectives and requirements for the product. - The need to establish processes and documents and provide the resources specific to the manufacturing of the food product. - The required verification, validation, monitoring, inspection and test activities of the food product and the criteria for the product acceptance.
Records needed to provide evidence that the realization processes and the resulting product meet requirements.
In planning, the following problems / risks are considered which can occur during processing : Risk of contamination – for raw materials, additives. Work-in-progress, final products and packaging materials
7.2 PRE-REQUISITE PROGRAMS 7.2.1 XYZ has made available a complete and actual description of the pre-requisite program the organization. The PRPs establish
- The likelihood of introducing food safety hazards to the product through the work environment. - All classes of hazards (biological, physical and chemical) of the product/process, including cross contamination between the products. - The level of food safety hazards in the product and product processing environment.
7.2.2 XYZ has identified the PRP’s as per the organizational needs, appropriate to the type of operational and product manufacture along the production system. And PRP’s are approved by Food Safety Team in compliance with PFA too. 7.2.3 XYZ has made available •
The procedures belonging to the PRP are well established (specified and documented), fully operational and integrated with the ISO 22000:2005 system, and verified. Their verification is addressed as a part of the Internal Audits and Verification activities.
XYZ has decided which food hygiene principles, good manufacturing practices and food legislation are to be included into its PRP.
7.3 PRELIMINARY STEPS TO ENABLE HAZARD ANALYSIS 7.3.1 General
The products and the processes, (the procedures belonging to) and the PRP are subjected to hazard analysis in order to identify potential hazards and to decide which way the hazards (risk) need to be controlled. This is demonstrated in the Hazard Identification and Risk Analysis of related products/processes, in the related HACCP/Food Safety Plans, as applicable. All the relavant information is collected, maintained, updated and documented. Records are available for the same.
7.3.2 Food safety team
XYZ has assembled a Food Safety Team in order to develop, implement and maintain the ISO 22000 System. The team definition is available in the Food Safety Team document maintained with the FSTL. The team members have the knowledge, expertise and cover different disciplines available which are required to develop, implement and maintain a Food Safety Management System covering the entire scope of their operation. The competency of Food Safety Team Members is available and maintained with the FSTL, and is reviewed & updated periodically.
The assignment (including tasks, responsibilities and authorities) are documented for the team members of the Food Safety Team as a part of the Responsibility and Authority document maintained with the FSTL.
7.3.3. PRODUCT CHARACTERISTICS
220.127.116.11 & 18.104.22.168 Raw materials, ingredients and product contact materials & characteristics of end products •
The quality specifications are defined for raw materials and ingredients. The product description for various food groups is specified and documented. The description of the safety of the product group encompasses the food chain, ranging from raw materials used to the distribution of the finished products. This is further documented through the Flow Diagrams and Hazard Analysis Work Sheets for the product group respectively
An extensive specification of the end products ensures a comprehensive assessment of the food safety procedures. This specification clearly defines the following product characteristics: − − − − − − −
Product identification and general product description. Raw materials used and composition. General product specifications as per recipe. Specific requirements such as appropriate legislation. General control of (chemical, microbiological and physical) for food safety. Packaging, storage conditions, labeling. Identification of potential mishandling of the product.
7.3.4. INTENDED USE
The intended use of the product is identified and documented for the product groups. Since this has a direct influence on the required product characteristics.
The intended use of the product is continually reviewed.
7.3.5. FLOW DIAGRAMS, PROCESS STEPS AND CONTROL MEASURES
XYZ has made available a complete and actual description of the operation in the form of flow diagrams (process steps), which are included in Food Safety Manual for the Flow Diagram, and layouts (production facilities), which are available with the FST Leader. When applying ISO 22000 to a given operation, consideration is given to steps preceding and following the specified operation, which is evidenced in the flow diagrams and Hazard Identification & Risk Analysis worksheet. These descriptions are drawn up and verified by the Food Safety and Validation Teams.
The Flow Diagrams provide a schematic overview of the operation, and describe all the steps in sufficient detail to provide the Food Safety Team with adequate information for the ISO 22000. They take into account all relevant process steps, such as the manufacturing of the product, including critical points like: − − − −
Disinfection of vegetables before use Pre-preparation Cooking Serving
All facilities which are part of the infrastructure of XYZ, such as the production lines, storage areas and personnel facilities are depicted in layout plans. In the layout plans, the following items have been indicated: − −
The routing of material, personnel. This is shown in the PLANT Layout. The areas and facilities for personnel use. This is shown in the PLANT Layout.
22.214.171.124 Description of process steps and control measures
Prior to the execution of changes in the production process and layout that could adversely affect food safety, these changes are reported to the Food Safety Team in order to evaluate potential hazards to food safety, and take preventive actions accordingly. Prospective changes are reported to Food Safety Team as per the Documentation Control Procedure and its supporting documents.
The accuracy and actuality of flow diagrams and layouts are verified by the Food Safety Team for compliance with the documented situation on a periodic basis (at least annually), in order to identify and document modifications to the process installation and layout. Verified flow diagrams and layouts, with changes marked on them if applicable, are maintained with the FSTL. These periodic verifications are a part of the Internal Audit cum Verification.
7.4.1 General •
XYZ has identified, analysed and evaluated all potential (biological, chemical and physical) hazards that can have an adverse effect on the safety of the products. Wherever XYZ’s operations change in a manner that could adversely affect food safety, all relevant steps of the Hazard Identification and Risk Analysis are updated (as necessary).
7.4.2 Hazard Identification & Determination of Acceptable Level 126.96.36.199
XYZ Food Safety Team has identified and registered all potential (biological, chemical and physical) hazards that can have an adverse effect on the safety of the products. The identification includes all aspects of the operation within the scope of the ISO 22000 system. Potential hazards have been documented in the Hazard Analysis Worksheet.
The operations evaluated include all products, all processes and the pre-requisite program of the legal owner of the products
FS Team Members shall identify and record all the potential hazards during food preparation, processing and delivering (biological, chemical and physical) that may have an adverse effect on the safety and hygiene of the food product.
The hazard identification includes aspects like: -
Raw materials and ingredients: specifications, vendor approval, etc; Characteristics of end products: product specifications, etc; The Pre Requisite Program, including OPRP’s Facilities Layout, Production Lines, Installations and Equipment Locations of rooms, routing, storage and separation of raw materials, end products, etc.
- Production processes, like: purchasing, cleaning and disinfection, packaging, maintenance, pest control, waste management, etc. - Personnel (including arrangements for visitors and external service providers, e.g.: mechanics): hygiene, knowledge with regard to food hygiene and food safety, requirement to notify diseases and infections, etc. - Process Parameters The identification of hazard with details of type, source, and process step and whether it is biological, chemical or physical hazard are defined in hazard analysis worksheet. The source of hazards (i.e, the root cause) at each processing step is subsequently taken up for analysis for elimination of the same.
Hazard Analysis (Risk)
FS Team Members shall identify, analyze and evaluate all potential hazards (biological/microbiological, chemical/ physical) that can have adverse effect on the safety of the food product. - 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 hazard analysis process is for identifying hazards, determining the risks and control/ reduction of the risk is the risk management.
RISK MANAGEMENT PROCESS Hazard Identification Resp: FS Team Members - shall list all hazards and define its characteristics (Refer Hazard Analysis worksheets)
Hazard Analysis (Risk Assessment) Resp: FS Team Members - shall estimate the magnitude of the risk
Risk Control / Reduction Resp: FS Team Members - programme - control measures(Refer Hazard Analysis worksheets
Hazard analysis serves to identify the potential sources and specific points of contaminants by analysis of each step in the food manufacturing process. Hazard analysis shall be applied at all points from incoming material inspection to consumer.
Hazard Analysis has been conducted by the Food Safety Team based on the Flow Diagrams. Methodology followed for arriving a hazard is as follows: - Number all steps in the flow Diagrams - Verify each step of flow Diagrams for possible physical/chemical and Biological/Microbiological hazards - Assess the likelihood of the hazard - Asses the consequence / severity of the incident. - Based on the above, level or risks have been evaluated. All the risks are included with the help of group discussions by Food Safety Team and other associates from relevant areas. -
The likely occurrence of the identified hazard, evaluated quantitatively, in terms of Very High, High, Medium or Low and likelihood of occurrence, as follows:
RISK / LEVEL
Improbable (eg. 5- 10 years) 1
1-4/very Low Rarely
Unlikely (eg. yearly) 2
Minor (eg. Light injuries etc.) 1
Occational (eg. Monthly/4-6 Monthly) 3 Likely (eg. Weekly/Monthly) 4
Medium (eg. Injuries, stomach pain, uneasiness ) 2 Major(eg. Illness, Hospitalization) 3
Frequently (eg. Daily/ Weekly) 5
Critical (eg. Death, Permanent disability) 4
(Refer Hazard Analysis Worksheet Annexure-7.4 of this manual on following pages) DETERMINATION OF RISK AND SEVERITY OF HAZARDS 1. Probability of occurrence Very High > automatically happen High
> Likely to happen
> could happen
> Not likely to happen
2. Severity of each hazard Critical
> Will frequently result in unsafe product
> Will likely result in unsafe product
> May result in unsafe product
> Will not result in unsafe product
Determination of significance
PROBABIL ITY LOW
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7.4.3 Hazard Assessment •
The severity of the hazard’s adverse health effects, evaluated quantitatively, in terms of critical, major or minor impact severity, as follows:
The risk rating, in quantitative terms (arrived at by multiplying the probability of occurrence with the severity of impact), and the classification of the identified hazard into significant or nonsignificant category based on the risk-rating factor. A risk rating of 10 or above indicates that the control measure is required to control the identified hazard. SEVERITY
PROBABILITY LOW (unlikely) 2 MEDIUM (occasionally) 3 HIGH (Likely) 4 VERY HIGH (Frequently) 5
An explanation / justification for the risk rating arrived at, together with the general control measures in place for that risk.
A risk level of below 10 is generally considered as permissible and the routine OPRP’s and PRP’s are sufficient to control the hazard.
7.4.4. Selection and assessment of control measures
XYZ food safety team has identified and documented the control measures that are to be applied or implemented when the hazard identification and risk analysis exercise concludes that the risk of an identified hazard is significant and needs to be prevented, eliminated or reduced to an acceptable level.
For each step, including all products, all processes and all parts of the PRP, the assessed aspects have been identified in the Hazard Analysis Worksheet and HACCP Plan. The reasons for deciding whether or not the assessed aspect is a CCP or an Operational PRP, or a PRP have been documented, as answers to the control measure assessment matrix.
In XYZ’s Food Safety System, more than one control measure may be required to control a hazard, and more than one hazard may be controlled by a control measure.
The food safety team has conducted an assessment of every step of the process, and has identified the significant hazards through the use of control measure assessment matrix. The assessment is based on, amongst other things, the varied expertise within the team, and has utilized external and internal information (as needed).
CONTROL MEASURE ASSESSMENT MATRIX
Probability of Failure of Control Measure Very High Frequently- Daily or weekly High Likely – Weekly or Monthly Medium Occasionally – Monthly or 4-6 Monthly Low Unlikely – Yearly Consequence in case of failure of Control Measure Very High
Definitely affects the end product
High affects end product Medium May affect end product Low Marginal impact on end product not affecting the food safety Feasibility / Frequency of Monitoring Very High
High Continuous Medium At defined Frequency Low Once during the process Is Control measure specifically designed Yes More than 10 No Less than 10
If the rating of the control measure assessment exceeds 10 the process step is considered as a CCP. If the rating falls between 7– 10 it is considered as an Operational PRP. And the rating below 7 is considered as PRP.
On completion of the hazard analysis, the hazards associated with each step of the food production shall be listed along with any measures to control the hazards. More than one control measure, if required to control a hazard, shall be identified and documented and more than hazard may be controlled by a specific control measure.
The control measures shall be identified through the Pre-requisite Program/Operational Prerequisite Programs. Any additional measures shall be identified during the HACCP implementation to ensure that the required control is achieved to eliminate or reduce the identified hazard / risk. The reason for deciding a CCP shall be documented.
The level of risk shall guide the Food Safety team in identifying the level of control.
Level of Control
Avoidance/ Special Process
Physical control / Monitoring
TRAINING: Training and teaching of the staff responsible for the process about what is to be done in order to prevent the hazard. INFORMAL CONTROL: Informal control is monitoring or checks of the process with out formal recording.
FORMAL CONTROL: Formal control is management of the condition of an operation to maintain the complaisance with documented criteria. PHYSICAL CONTROL/ MONITORING: Continuous control and monitoring of actual physical process.
The General Control Measures relate to the control measures as part of the Pre- requisite Program and operational Pre- requisite Program, to achieve control at acceptable levels. CONTROL MEASURES
Available knowledge & data
Data & information
System Verification •
The general control measures shall be documented in specifications, instructions and procedures or plans
The Diagrammatic representation for control measure is
- Recipes for the food product specifications - Operations Instruction - Procedures / plans like purchase plan, hygiene plan, cleaning and disinfection plan, maintenance plan, education and training plan, etc.. - Pest control plan - Personnel hygiene practices •
The general control measures shall be validated and shall be subsequently approved by the Food Safety Team. The effectiveness of the general control measures shall be verified at defined intervals through the Food Safety Audits.
Food safety team will identify critical control points and parameters for maintaining the critical points in the specified i.e., PH, aW, temperature, time, pressure, which ever applicable.
The Food Safety Team has identified specific control measures that is CCPs at a step for the identified significant hazard during hazard analysis by applying the decision tree (see Annex at 7.62 of this Manual) and also general control measures related to pre-requisite programme. All hazards that may be reasonably expected to occur, or likely be introduced at each step, have been considered in identifying the CCPs.. While selecting CCPs, care has been exercised that on-line process related parameters which does not require elaborate and time consuming testing but ensures products safety only have been selected.
ESTABLISHING THE OPERATIONAL REQUISITE PROGRAMMES (PRPS)
• The operational PRPs have been documented as under: - Food Safety hazards - Control Measures - Monitoring Procedures - Corrective action to be taken if PRPs not in control - Responsibilities and authorities - Records of monitoring • Control measures related to control of processing environment have been classified as Operational PRP’s. These are actions or activities, often measurable in terms of physical or chemical parameters such as temperature, time, pH, and sensory parameters such as visual appearance. •
Operational PRP’s based on subjective parameters, as in the case of visual inspection of a product, process, handling, etc, are supported by work instructions or specifications, education and training.
The control measures in place for each identified Operational PRP’S have been documented in the HACCP Plan Worksheets. Their monitoring mechanisms, corrective actions provided, validation and verification have also been documented in the same. (Refer to the sections on Monitoring and Measuring, Corrective Actions, Validation, and Verification of Hazard Analysis Worksheet included in this Manual for more details).
Control measures not related to CCPs and Operational PRP’s have been classified as Prerequisite Programmes. In general, these measures achieve control at acceptable levels. Prerequisite programmes are documented in the FSM Manual, specifications (including raw materials, products, etc), instructions (for process, control and operation) and procedures or plans, e.g. purchase procedures, hygiene procedures (including personal), maintenance schedules, cleaning and disinfection schedules, and supported by training plans, supervision, etc. The effectiveness in controlling the identified hazards of the Prerequisite Programmes is verified at pre-defined, regular intervals, as further detailed in the section on verification in this Manual. (Refer PRP Table 1-9 of this Manual)
HAZARD ANALYSIS WORKSHEET S.No. Product Name 1
Non Veg. Curry
Incoming material inspection at receiving stage. Washing
Cleaning of cutting tools &
Biological (Possibility of microbial growth)
Biological (Possibility of microbial growth at low level of chlorine) Biological (Microbial flora)
Parameter Target value -
Critical Limit Acceptable level -
Critical limit -
External Lab Report (Pathogenic m.o.)
Chlorine level (ppm)
< 15 & >20
Swab test for pathogenic Micro
chopping boards Cooking
organisms Biological (Microbial contamination) Biological (Microbial flora) Biological (Microbial Contamination)
Cooking Temp oC
Cooking time minutes Visual inspection
100 < 60
Swab test for Pathogenic Micro organisms Temperature oC
GOOD MANUFACTURING PRACTICES I Primary production 1.1 Environmental hygiene
Hygienic production of food sources
Handling, Storage, and Transport
Cleaning, maintenance and personal
Not applicable Justification: Inspection & testing of incoming stores & raw materials by XYZ commence from receiving stage only; i.e. receiving the items from the suppliers Not applicable Justification : Inspection & testing of incoming stores & raw materials by XYZ commence from receiving stage only; i.e. receiving the items from the suppliers Not applicable Justification : Inspection & testing of incoming stores & raw materials by XYZ commence from receiving stage only; i.e. receiving the items from the suppliers Not applicable
Justification : Inspection & testing of incoming stores & raw materials by XYZ commence from receiving stage only; i.e. receiving the items from the suppliers
2 Establishment : design and facilities 2.1 Location 2.1.1 Establishments (PLANT LAYOUT) 2.1.2
Equipment / Machinery (DESIGN)
2.2 Premises and rooms 2.2.1 Design and layout
Internal structures and fittings
Temporary / mobile premises; vending machines 2.3 Equipment 2.3.1 Food control and monitoring equipment
Containers for waste and inedible substances Containers for waste and inedible substances
2.4 Facilities 2.4.1 Water supply
Drainage and waste disposal
Cleaning (by cleaning detergent /
Plant located in a non polluted, environmentally clean area Refer :Facility(Kitchen) Layout Equipment maintained shall - Permit adequate maintenance and cleaning; - Function in accordance with its intended use; - Facilitate good hygiene practices, including monitoring. Refer : I. Plant equipment layout ii. Cleaning Schedules iii. Equipment Maintenance Records Process areas are clearly demarcated and separated from each other. Where ever there is an opening / door self-closing doors with air curtain facility provided. Refer: Facility Layout Buildings and walls are built in such a manner that there is no physical and chemical hazard with this. Not applicable
Thermometers, humidity meters and pressure gauges will be provided to check the control measures. Refer : (i) Records of calibration (ii) Temperature measuring Records Plastic bags of wastes are disposed off daily from the location to distant place away from food processing area. Containers / Disposers for waste, by-products and inedible or hazardous substances shall be designed / constructed
Water storage at different points is installed with RO and UV System to prevent micro contamination and under strict supervision & control. Refer: (i) External lab reports. (ii) In house Water analysis reports Drainage system constructed so as they always flow from the process area to out side. Solid waste will be collected in plastic garbage bags and moved to garbage collecting area from there collect is done by the MCH. Refer : Plant Layout Adequate facilities are provided for cleaning food utensils and
sanitizer) with surfactant
equipment. Refer : Equipment cleaning and sanitation procedures Toilets, change rooms etc are provided away from the process block. Toilets are provided with Hand wash facility, disinfectant soap solution and drier (Hand). Facilities for heating, cooling or freezing food products, or storing refrigerated or frozen foods are suitable to meet the specified condition for ensuring food safety.
Personnel hygiene facilities and toilets
Air quality and ventilation
Ventilation systems are designed and constructed so that air does not flow from contaminated areas to clean areas and they can be adequately maintained and cleaned.
The areas where food is being processed does not have any window panes and also glass fixtures are properly covered to avoid the contamination
The processed food is packed in stainless steel vessels in hot conditions with proper lid/ closures. The articles are then transferred to Food Service area.
Control of operation Control of food hazards
3.2 Key aspects of hygiene control systems 3.2.1 Time and temperature control
Specific process steps
Microbiological and other specifications
Microbiological cross - contamination
FS System is being implemented Refer : ISO:22000-2005
Control systems for temperature and time during heating, cooling and storage are in place where necessary for the production and handling of safe food. Control systems include critical limits, registration and testing of accuracy of measuring equipment. Refer : Temperature calibration record Cooking is the important/ major process step which is to be considered. PFA specifications for physical and chemical parameters, general specifications for micro organisms are being followed. Refer: HACCP Plan and Hazard analysis worksheet Cleaning and sanitation procedures are in place tp prevent the microbiological cross contamination. Refer: (i) Facilities layout. (ii) production area entering procedure (iii) Cleaning Schedules
Physical and chemical contamination
3.3 Incoming materials requirements 3.3.1 Specifications (of Limit of Microbiological organisms)
Control at Receiving stage (of Pathogens and Toxins)
3.4 Packaging 3.4.1 Design and materials 3.4.2
"Food grade" materials and gases
3.5 Water 3.5.1 Water in contact with food
Reuse of re-circulated, treated water
Reuse of re-circulated, non - treated water As an ingredient (Potable water)
The material of construction for cutting trays & plastic crates where unprocessed food is kept are made of non- particle releasing. The crates are washed thoughly to remove any leftover particles/ dust. Refer : (i) Decision tree, Hazard analysis worksheet and HACCP plan
Supplies are XYZ approved; Raw materials are tested and accepted as per the specifications. A well- defined program on incoming material inspection is in place. Monthly supplier assessments in place to ensure supplier integrity. Refer : (i) Program on incoming material Inspection : (ii) External laboratory analysis All the raw materials and ingredients are being tested and accepted only they are found satisfactory. Refer : Incoming material Inspection Report All raw materials and ingredients received are labeled with lot numbers and a first in first out system is followed for the rotation.
Not Applicable because packaging operation is not in the system. Not Applicable because packaging operation is not in the system. Not Applicable because packaging operation is not in the system. Water is purified with RO/ U V water purification system, and then used in the production. Refer : In house Water Analysis Report Not applicable, because re-circulated water is not in use. Not applicable, because re-circulated water is not in use. Refer : In house water analysis report
3.5.5 Ice and steam 3.6 Management and supervision 3.6.1 Type of control and supervision
In house analysis report
All the managerial and supervisory staff is trained and aware of food safety and hygiene.
3.7 Documentation and records 3.7.1 Retain records
Well – defined organization structure is in place. Roles and responsibilities of each and every associate are defined. Refer: Organization Chart and Roles & Responsibilities.
One- year period; after which on revision further retention will be decided.
Effectiveness and credibility
3.8 Recall procedures 3.8.1 Effective procedures
Tracing and tracking
Destroy or reprocess
Documents are maintained & verified regularly by appointments at various sections of operation. A well defined Product Recall Program is in place. Refer : SOP on Product Recall, Tracing & tracking, Destroying. Disposal/ Reprocessing Where a product has been withdrawn because of an immediate health hazard, other products which are produced under similar conditions, and may need to be withdrawn. The need for public warnings shall be considered. Refer : SOP on Product Recall, Tracing & tracking, Destroying. Disposal/ Reprocessing Recalled products shall be held under supervision until they are destroyed/ disposed off Refer: SOP on Product Recall, Tracing & tracking, Destroying. Disposal/ Reprocessing
4 Establishments: Maintenance and Sanitation 4.1 Maintenance and cleaning 4.1.1 General Equipment maintenance and cleaning procedures. Refer: Check list on subject 4.1.2 Cleaning procedures and methods Well defined Refer: Check list on subject 4.2 Cleaning programmes 4.2.1 Specifications Responsibility for Areas, Items of equipment, Utensils, Containers, Method and frequency of cleaning, monitoring arrangements etc are to be well defined 4.2.2 Monitoring and verification Equipment cleaning program- frequency , area, responsibility Refer : check list for supervisors 4.3 Pest control 4.3.1 General
Harborage and infestation
Monitoring and detection
(i)GHP Refer : Standing orders on subject (ii)Effective Pest control Refer: pest control programme. (i) No windowpanes in the production area. (ii) Proper air curtains and facilities are provided to prevent access of pest in production area. (iii) Security person will take care of animals not to enter. (i) Air tight S.S containers are provided to store the food items. (ii) Pest free walk in cooler & refrigerator are there for storing food stuff & raw materials (iii) Good house keeping practices in place. Pest control activity records are available Refer : Program on Pest Control:
4.4 Waste management 4.4.1 Removal, storage 4.4.2 Cleaning 4.5 Sanitation systems 4.5.1 Monitoring
GOOD HYGIENE PRACTICES 5 Establishment : personal hygiene 5.1 Health status 5.1.1 Access prevention
5.2 Illness and injuries 5.2.1 Conditions to be reported
5.3 Personal cleanliness 5.3.1 Protective clothing
Cuts and wounds
Use of Non residual chemical Process areas excluded from use of chemicals Refer : Program on Pest control; Waste is collected in bags and immediately shifted to garbage area, which is being cleared by MCH every day. Cleaning is in place. Sanitation systems are in place. Refer : Cleaning schedules; Daily check lists of KST Supervisors; Sanitation systems shall be periodically verified by inspection or, where appropriate, by microbiological sampling of environment and food contact surfaces and regularly reviewed and adapted to reflect changed circumstances. Remarks: Verification by monthly microbiology monitoring. In case of changes required in procedures only division can change after due validation Refer : In house lab Reports Program on microbiological Monitoring Sanitation system shall be regularly reviewed and adapted to reflect changed circumstances.
Regular Medical Check up to all the associates and Production workers in twice in a year basis. Onsite observation by area supervisors Appropriate procedures are in place Refer : (i) Medical reports (ii) Informatory Sign Boards at places of work (iii) Illness & Injuries Report Register Medical Examination reveals any diseases that are exist at that time. Regular observations by area supervisors will lead to further action required Refer : (i) Medical reports (ii) Informatory Sign Boards at places of work (iii) Illness & Injuries Report Register Protective equipment like shoes, head caps are mandatory where ever applicable inside the Kitchen. Refer: Program on personnel hygiene: Area supervisor will act on these issues as and when arises Refer : program on personnel hygiene:
5.4 Personal behavior 5.4.1 Smoking, eating, sneezing
Visitors Cleanliness and behavior
Wash facilities provided at toilets and at process area entrance. Procedures to clean the hands were provided in place. Refer : Program on good Manufacturing practices: Smoking , spitting, chewing & eating activities are strictly prohibited inside the plant and process areas except designated areas Refer : (i) Program on personnel hygiene / habits (ii) Program on good Manufacturing practices: Personal working in the process areas are not allowed to wear loose jewellery Refer: Program on personnel hygiene / habits Visitors wear caps; sanitize hands and then only lead to the production area. Refer: Visitors policy procedures Closed SS containers are being used during food Serving & Food Dispatch/Serving.
Where necessary, conveyances and bulk containers shall be designed and constructed so that they : - do not contaminate foods - can be effectively cleaned and, where necessary, disinfected; - permit effective separation of different foods or foods from non- food items where necessary during transport (Dispatch/Serving) - provide effective protection from contamination, including dust and fumes ; - can effectively maintain the temperature, humidity, atmosphere and other conditions necessary to protect food from harmful or undesirable microbial growth and deterioration likely to render it unsuitable for consumption; - allow any necessary temperatures, humidity and other conditions to be checked.
Use and maintenance
Regular cleaning of food carrying SS containers is being done.
7 7.1 7.2 7.3 7.4
Product information and consumer awareness Batch identification Not applicable Product information Not applicable Labeling Not applicable Consumer education Being done as on need basis.
Training Awareness and responsibilities
Associates are trained on food safety and their roles and responsibilities in handling food products to prevent any contamination or deterioration.
Instruction and supervision
Training on Food Safety to all associates is being conducted. Refer : Program on Training: The training on FSMS includes all the requirements Refer : Program on Training A well – defined training program is in place and the effectiveness of the training is being assessed periodically. Supervisory and Managerial level Staff is aware of FSMS. Refer : Program on Training: Training programs shall be routinely reviewed and updated where necessary. Systems shall be in place to ensure that food handlers remain aware of all procedures necessary to maintain the safety and suitability of food. Remarks:Based on the skill Gap Analysis the associates are evaluated. Based on the Skill Matrix, the associates being provided with a required awareness/ refreshers training.
HACCP PLAN: S Product . Name N o 1 Chicken biryani
Micro biological ; survival of pathogeni c Microorganism s
Critical limit Parameter Value
Cooking time, cooking temp
Min 1 hr, 80 1000c
Procedu re Checking cooking time with stop watch, and tempera ture with digital thermo
Monitoring Freque Resp ncy As and when cooked as per menu
Refer: Time and Temp of food items
Corrective action Procedure Record
i)if found undercooke d increase the cooking time ii)if found over cooked discard the item
Time & Temp record
meter(S S Probe)
Cleaning of rice
Physical: presence of foreign particles
Extraneou s matter/ foreign particles
i)inspect ion of stock arrived ii)superv ising rice cleaning
As and when done
Refer: Raw material data sheet
i)Get the rice cleaning redone ii)Return to supplier if foreign matter is more
ESTABLISHMENT OF HACCP PLAN
7.6.1 HACCP Plan •
The HACCP plan is documented for each CCP which includes food safety hazard critical limit monitoring procedure and corrective actions required with responsibilities and authorities. Refer HACCP Plan…
7.6.2 Identification of CCP •
For each food hazard that is to be controlled by HACCP plan CCPs are determined by CCP decision tree. The CCP decision includes 1. Do preventive measure exist?
i.Reject on record ii.Vendo r, compla nts record
2. Is the step specially designed to eliminate/reduce the likely occurrence of an acceptable level? 3. Could contamination with identified hazard(s) occur in acces acceptable level(s) or could
increase to an unacceptable? 4. Will a subsequent step eliminate identified hazard (s) or reduce likely appearance to an acceptable level? (Refer: CCP-Decision Tree as Annex 7.6.2 of this Manual on next page)
EXAMPLE OF DECISION TREE TO IDENTIFY CCPS
CCP DECISION WORKSHEET:
CCP Decision(yes/ No)
Procurement Perishable items
Physical Chemical Biological
Yes Yes Yes
2 Is the step specially designed to eliminate/reduce the likely occurrence of an acceptable level? Yes Yes Yes
Non- perishable items.
Physical Chemical Biological
Yes Yes Yes
Yes Yes Yes
No No No
No No No
Storage a) Storage of perishable items freezer, walk in cooler b) Storage of nonperishable items in dry storage area.
Type of Hazard
1 Do preventi ve measure exist?
3 Could contamination with identified hazard(s) occur in acceptable level(s) or could increase to an unacceptable? No No No
4 Will a subsequent step eliminate identified hazard (s or reduce likely appearance to an acceptable level? No No No
Determination of critical limits for critical control points •
XYZ has defined the critical limit(s), which must be met at all times during the operation for the various parameters. Also, normal operational target values have been indicated are the various parameters, as well as the action limit values which indicate when intervention in the operation is required in order to continuously meet the critical limits.
The critical limit(s), action limit(s) and target value for each parameter have been documented in the OPRP & HACCP Plan associated with each CCP and or Operational PRP.
When determining the critical limits and the deduced action limits and target value, the requirements of the relevant legislation and regulations and/or internal risk analysis for the safety of foodstuffs has been considered as requirements. These have been identified / referenced in the HACCP Plan associated with each CCP. (Refer: HACCP Plan tables)
7.6.4 SYSTEM FOR THE MONITORING OF CCPs • Monitoring is the scheduled measurement or observation of a CCP relative to its critical limit. • Monitoring details has been elaborated below, through which answer for following four questions are obtained: - What is being monitored? (say temperature) - How the monitoring is done? (say digital thermometer with SS probe, recording thermometer, digital time/temperature data logger or similar device and visual check on time)
- How often the monitoring is being done (frequency)? (in case of digital recording- continuous monitoring, with visual check at least once in cycle/batch but not less than once per day, in case of other type of device- visual check at least once in cycle/batch but not less than once per day) - Who is doing monitoring? (Ex. Chef/Chef/Manager QC /Manager Store) •
Measurement/ observation for each product and for each CCP has been identified and indicated in HACCP plan. Records associated with the monitoring have been indicated in relevant Column.
The Monitoring Devices shall be identified though the list of Monitoring Devices, The methodology for calibrating the monitoring devices shall be calibrated (Refer Records of calibration of Monitoring Devices)
The results of monitoring process parameters (with the calibrated instruments shall be recorded)
7.6.5 ACTIONS WHEN MONITORING RESULTS EXCEEDS CRITICAL LIMITS •
For the identified CCPs, it is ensure that Corrective Actions are initiated and implemented in case action limit value or a critical value is exceeded the cause of the deviations shall be analyzed and documented with the justification for the corrective action initiated and responsibilities and authorities of the personnel involved
The corrective action may include: - With respect to the product- temporary hold of the product/batch, blockades to product recall, identification of nonconforming product, rework, disposal/ destruction of product/batch. - With respect to process- adjusting the process, adjustment/ correction of process conditions.
Specific corrective actions have been established for each CCP in order to deal with deviations when they may occur. The actions taken ensure that the CCP has been brought under control. (Refer: HACCP Plan tables)
UPDATING OF THE PRELIMINARY INFORMATION AND DOCUMENTS SPECIFYING THE PRP’S AND HACCP PLAN)
• The organization has updated the following information: Product characteristic Intended use Flow diagram Process steps Control measures •
Prior to application of HACCP, it has been ensured that:
- The general principles of Food Hygiene as per Codex Standard for the food sector referred in the scope are in place. An audit checklist based on Codex Standard prepared to conform to food hygiene, personnel hygiene and good manufacturing practices for the applicable food sector. - The compliance of which is being ensured during internal audit by the assigned auditor. Note-Like the products and the process, the PRP is subjected to the hazard analysis in order to identify potential hazards and to decide in which way the hazards (risk) need to be controlled. •
Food Safety Legislation [Prevention of Food Adulteration Act] is implemented.
The FS Team Members have been trained on the steps, principles and application of HACCP and Food Hygiene. Training has also been provided to personnel at various levels on principles of maintaining cleanliness and hygiene and this is an on-going activity. As an aid in developing specific training, work instruction and procedures have been prepared.
XYZ’s Food Safety team updates the information of the PRP, Operational PRP’s and HACCP Plan whenever new products are introduced or any new equipment are installed or any change of control measures or process flow or any change in intended use would be required
7.8. VERIFICATION PLANNING •
The main function of verification is to determine compliance with the specification of the FS System and to confirm that the FS System is working effectively through the application of auditing, procedures and tests including random sampling and analysis. The frequency of verification activity which inter-alia include the following should be sufficient to confirm that the FS System is working effectively: - review of the FS System and its records, - review of non-conformities and product disposition, and - Confirmation that CCPs are kept under control.
Verification of CCP Monitoring - In-charge quality assurance reviews the performance of CCP operation with respect to the following:
- Critical Control Limits- This review is to ensure that the records are complete and to verify that the documented values are within the critical limits. This review is done at regular intervals, for each product and is submitted on prescribed format. This report is reviewed by FS Team Leader. - Conducting Test/Analysis- This is to verify that the results of test or analysis corroborate the purpose or intent of the CCP’s. This verification is done at regular intervals specified in for each product and records maintained. VERIFICATION LOG FOR CRITICAL CONTROL POINTS Date/Time
On Going Verification to Show Compliance with Plan FS Team reviews the performance of operation of FS System on quarterly basis. This review includes verification of following records to ensure that FS System is in place and working satisfactorily: - Monitoring activities have been performed at the locations specified in the HACCP plan - Monitoring activities have been performed at the frequencies specified in the HACCP plan - Corrective actions have been taken whenever monitoring indicated deviation from critical limits and also taking into consideration internal and external audit results - Equipment has been calibrated at the frequencies specified in the in quality system procedures - Confirmation that CCPs are kept under control. - Review of Consumer Complaints that have relevance to the performance of FS System - Review of Sanitation Records and GMP - Review of the result of periodic in-process and final product testing.
Comprehensive Food Safety System Verification (Reassessment) •
This verification answers the questions, whether Food Safety plan is controlling hazards? and is the Food Safety Plan still controlling hazards? It is a thorough review of hazard analysis to address specific hazards to determine if they are controlled. A reassessment of the adequacy of the plan is done on any changes that could affect the hazard analysis or alter the plan in any way such as raw materials, source of raw materials, product formulation, processing methods or system, intended use or consumers of the product, product distribution system etc, or at least annually.
In addition, internal audits (Refer: FSMS Manual Doc.No.XYZ./FSMSV-8.4.1) and external audits also provide feed back on effective implementation of the system and provide evidence for verification.
Documentation and Records •
The Food Safety Team has established an efficient documentation and record keeping the relevant FS System Procedures have been maintained separately. Records are kept from all areas, which are critical to product safety to demonstrate that the Food Safety system is in compliance with the documented system, some of them are indicated below:
Food Safety Team Meeting records
Non conforming product record, Traceability record, CCP Monitoring Records, CCP verification records, Corrective Action records if any, Hygiene Audit record Control Measures Record (Time & temp) Agenda & minutes of Management Review Training & Evaluation of Training records, Audit records, Record of Daily check lists Water Analysis record Pest Control records Preventive Maintenance record Cleaning schedules Staff medical reports, In house lab analysis reports, Record of Calibration of measuring and testing equipments
Traceability system •
The product identification and traceability is required because of one or more of the following reasons: Status of the food products at all stages of manufacturing Contractual requirement, wherein the food product is marked by a specific mark or code for subsequent verification by the customer Intended use of application
Food product identification starts with the receipt of the raw materials / ingredients and ends with the delivery and serving of the food product, clearing of the used crockery, housekeeping of the place and disposal of the left-over food. The identification and traceability helps in effective stock rotation and ensures product recall, if called for.
The organization has established a traceability system that enables the identification of product lots and their relation to raw material, processing and delivery record for identifying incoming material for the immediate suppliers. Traceability record shall be maintained for a definite period for system assessment to enable the handling of potentially unsafe product. Record shall be in accordance with the statutory and regulatory requirements
7.10 CONTROL OF NON-CONFORMING PRODUCT
Products not conforming to the requirements are identified and prevented from unintended use or delivery.
Control exercised along with the defined responsibility for handling the non-conforming product is described in procedure for Non Conforming product.
7.10.1 Corrections The following methods are employed if any non-conformity is detected - Action to eliminate the detected non conformities - Authorize its use, release under concession by relevant authority - Preclude its original use. •
Records of nonconformities subsequent corrective actions taken are maintained.
7.10.2 Corrective action •
It includes: - Necessary corrective actions are taken up by the respective chefs to prevent recurrence of nonconformities noticed. - Corrective actions are carried out as per procedure for corrective and preventive action which includes: -
Reviewing non-conformities, including customer complaints Determining the causes of nonconformities Evaluating the need for action to ensure that nonconformities do not re occur Determining and implementing action needed Records of the results of action taken Reviewing corrective action taken
For each critical control point, in the associated OPRP & HACCP Plan, XYZ has documented (or referenced) the corrective actions to be taken if an action limit value or critical limit is exceeded. The procedure includes the process to investigate the cause of the deviation.
The Food Safety Team is considered as Emergency Team for responding to critical limit deviations. The team evaluates the causes of deviation and decides which additional preventive actions are to be taken.
7.10.3 Handling of potentially unsafe products
XYZ has also established arrangements that provide for recall of the products from the market place and/or from end consumers. Proper product identification and a “tracing and tracking” system are operational. These are detailed in the Handling of Potentially Unsafe Products Procedure. Evaluation for release
All corrective actions taken, the causes and consequences, and the individuals involved in the corrective action are recorded. The effectiveness of the corrective action (for both process and product) is evaluated. Disposition of non conforming product Any product resulting from the process while the critical limit has been exceeded is treated as non -conforming product. The corrective actions with respect to product might include: − Actions ranging from raw material to product / batch / lot recall. − Identification of the non-conforming products / batches / lots. − Disposal / destruction of the product / batch / lot.
Withdrawals • •
XYZ has established a procedure for withdrawal of end product which have been identified as unsafe The withdrawal activity in XYZ is initiated by FST Leader.
8 VALIDATIONS, VERIFICATION & IMPROVEMENT OF THE FOOD SAFETY MANAGEMENT SYSTEM 8.1
General Validation is done to ensure that the hazards originally identified are complete and correct and that the hazards are effectively controlled
Necessary validations of control measures are planned and implemented to: -
Demonstrate conformity of the product to the specified requirements Ensure conformity to Food Safety Management System Continually improve effectiveness of Food Safety Management System
Food Safety Team shall plan and implement the processes needed to validate control measures, combinations and verify and improve the system.
Validation of The Control Measures Combinations •
Validation is activity prior to authorizing HACCP Plan. For this, organization has constituted a Validation team comprising of following:
It is the responsibility of the validation team to review that effectiveness after supporting evidence used in the HACCP study i.e., control measures, monitoring system for PRP , OPRP and CCP & corrective actions taken for any deviations a) Initial Validation
The HACCP Plan prepared by the FS Team has been validated for its adequacy and completeness by the validation team. Validation has been performed on the basis of the quantifiable and objective historical results from on-line quality control monitoring, end product testing, and customer complaints and by demonstrating that: - the established list of potential hazards is based on sound scientific data and has included all hazards, - questions used to assess the significance are answered using sound scientific and technical knowledge, - the control measures(general and specific) are appropriate to control the hazards, - fluctuations of the control parameters(equivalent to process criterion) within the defined critical limits will not affect the safety of the product, - parameters and methods used to monitor the control measures are appropriate, - corrective actions are appropriate and will prevent the release of unsafe products and provide evidence that the situation can be corrected immediately
Note- Food business operators produced safe food for many years before the introduction of the HACCP system. Therefore, historical results from on-line Quality Control monitoring, end product testing, customer or consumer complaints are used as evidence when validating HACCP plans. It is important to note that the data must be quantifiable and objective if it is to be useful. b) On going validation •
Critical Control limits are validated once in a quarter to confirm whether they are still valid. If not providing the degree of confidence envisaged, new limits are established. The FS system is also validated by the team whenever: CCP,s are changed/modified, Process changes takes place affecting food safety, Equipment changes/replacement occur affecting food safety, Major system failures occur
Validation of the CCP
REMARKS IF ANY
COMPLAINT IF ANY
CORECTIVE ACTION IF ANY
MONTH & YEAR OF REVIEW
8. VALIDATIONS, VERIFICATION AND IMPROVEMENT OF FSMS 8.1 General •
Necessary validations of control measures are planned and implemented to: - Demonstrate conformity of the product to the specified requirements - Ensure conformity to Food Safety Management System - Continually improve effectiveness of Food Safety Management System
Validation of control measure combinations
The objective of validation is to ensure that the hazards originally identified by the Food Safety Team are complete and correct and that they will be effectively controlled under the proposed plan.
To meet the objectives of validation, the effectiveness of the supporting evidence used in the HACCP study as well as the general and specific control measures, the monitoring system and the corrective actions have been reviewed.
Each time XYZ operation changes in a manner that could adversely affect food safety the corresponding OPRP & HACCP Plan/s is/are updated. Validation is performed by the Validation Team’s independent review of the following: − − − − −
The established list of potential hazards is based on sound scientific data and has included all hazards. The questions used to assess the significance are answered using sound scientific and technical knowledge. The control measures (OPRP’s & CCP’s) are appropriate to control the hazards, i.e. to prevent or eliminate, to reduce or maintain at an acceptable level Fluctuations between target values and action limits will not affect the safety of the product. The parameters and methods used to monitor the control measures are appropriate
XYZ have produced safe food in their earlier assignments. Therefore, historical results from on-line quality control monitoring, end product testing, and customer or consumer complaints have been used as evidence when validating OPRP & HACCP Plans.
8.3 CONTROL OF MONITORING AND MEASURING •
XYZ demonstrates the : - Conformity of the food product - Conformity of FSMS - Continual Improvement of the effectiveness of the FSMS
XYZ has established and maintained a monitoring (and/or measuring, as appropriate) system for effective and efficient control of the Critical Control Points. The monitoring and measuring system is defined in the OPRP & HACCP Plan associated with each CCP, and includes all planned measurements, observations and analysis of the control parameters determining that the CCP is under control.
The Plan associated with each CCP documents (or references) the following aspects: − The development of the monitoring system. − The identification of monitoring (measuring) devices. − The methodology of measurement and/or the instructions for measuring and recording of measurements.
The method for establishing the reliability of the measurements and/or the equipment (calibration).
Where measurements and product tests by subcontractors are used as a means of monitoring / measuring, these are generally done from recognized laboratories.
The results of the monitoring are documented by means of records (as indicated in the Plan) and the practices are described in process control plans (as referenced in the Plan).
The records include: − Monitoring Reports (dated and signed) − Records of Deviations which have occurred (action limits and critical limits) and corrective actions taken are available.
8.4. FSMS VERIFICATION •
XYZ has established and implemented procedures for the verification of the Food Safety Management System. The main purpose of verification is to determine compliance with the specifications of the Food Safety Management System and to confirm that the system based on ISO 22000:2005 standard is working effectively through the application of (auditing) methods, procedures, tests (including random sampling and analysis) and other evaluation, in addition to monitoring.
8.4.1 Internal audit: •
Internal audits are conducted based on the schedule drawn up to determine whether the Food Safety Management System -
Conforms to the planned arrangements for meeting the product realization, ISO 22000:2005 and Food Safety Management System requirements.
Is effectively implemented and maintained
XYZ has defined an internal audit program, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined generally in the Internal Food Safety Audits
Selection of auditors and the conduct of audits are done in such a way as to ensure objectivity and impartiality of the audit process. Auditors do not audit their own work.
Internal Audits are planned taking into consideration the importance of the processes and
activity being audited and results of the previous audits. 188.8.131.52
Scope, audit criteria, frequency and methods of auditing are defined in procedure for internal
food safety audits.
This procedure also identifies the responsibility and requirements for planning and
conducting audits, for reporting the results and maintaining the records. 184.108.40.206
Trained personnel to ensure objectivity and impartiality conduct internal audits.
The personnel responsible for the area audited identify and implement the necessary
corrective actions to eliminate the recurrence of the reported nonconformance. The corrective actions taken up by the auditee are verified and the verification is recorded. • XYZ determines whether the FSMS: •
Conforms with the planned arrangements: With the “Requirements for an ISO 22000-based Food Safety System” and With the requirements established by XYZ itself, and reflected in the current food safety system. Is effectively implemented and maintained.
Verification aspects are covered under the Internal Food Safety Audits. The Internal Audit Procedure describes the internal audit and verification methodologies which are carried out as per the Verification plan at XYZ, together with the responsibilities and requirements for planning and conducting audits, for reporting results and maintaining records. Evaluation of individual verification results. Each department compiles data to demonstrate the suitability and effectiveness of Food Safety Management System and identifies improvements for effectiveness of Food Safety Management System in respect of operation of each department.
The data includes information generated through measurements and monitoring and other relevant sources. This includes monitoring and review of the objectives at the department level and also includes a. Existing procedures and communication channels b. HACCP plan , OPRP’s and hazard analysis conclusions c. The PRP’s d. The training plan and training effectiveness of food handlers
8.4.3 Analysis of results of verification activities •
The analysis of data by Food safety team including internal and external audits provides information relating to - Customer satisfaction - Product conformity - Characteristics and trends of processes and products including opportunity for preventive action - Suppliers
The analysis is carried out a. To confirm overall performance of FSMS as per the established requirements by the organization b. To update or improve the FSMS c. To identify trends with a higher degree of incidence for potentially unsafe products d. To upgrade and plan internal audit program as per the status and importance of FSMS e. To provide evidence for any corrective action as per FSMS that have been taken are effective
The results of analysis and the resulting activities are recorded
Record are maintained
Based on the analysis of data and results of audit, areas needing improvement are identified to initiate necessary corrective and preventive actions.
Where appropriate, the relevant Food Safety Objectives and Food Safety Policy are revised and reviewed in meetings to focus on improvement
XYZ continually improves the effectiveness of the Food Safety Management Systems through the use of : -
Evaluation of individual verification results Validation of control measure combination Food Safety Policy Food Safety Objectives Internal Audits Analysis of Data Corrective Actions Preventive Actions Management Reviews FSMS Updating
UPDATING OF FSMS
XYZ ensures that FSMS is continuously updated by evaluation and updating activities like a. Inputs from communication, information with reference to FSMS b. Input from information concerning the suitability, adequacy and effectiveness of the FSMS and Statutory and regulatory bodies c. Outputs from verification activities and management review. d. Output from management review meetings
Records of these activities are reported as an input to the management review.