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Section 0.0 Scope of Management System


This management system refers to all processes in the flavour manufacturing including the purchasing of raw materials, the production of finished goods, the packaging and sale of the products. The processes are as follows: receival, inspection, storage, compounding, inspection (of finished products), packaging and distribution.

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Food Safety Management System Section 1.1 TABLE OF CONTENTS

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Food Safety Management System Section 1.2

Revision History
Date Document Revision (e.g page 2) Description of History (details of revision) Sentence construction changes Requested by

2008.01.11

Equipment Program

Page 1 of Version 1

H.A.C.C.P Coordinator/ Q. A Manager

Page 2 of Version 1

No lubricant is used in the mixers and that Production Supervisor had to be eliminated from the document Expansion of the Preventative Maintenance Program H.A.C.C.P Coordinator/ Q. A Manager Auditors from Customer Audit

Equipment Program

Page 5-6 of Version 1

2008.05.30

Quality Manual

Appendix 7, Water Quality Log

Temperature values were removed since no thermometer is used during checks. Verification column was added. Inclusion of the Personal Protective equipment Program (HS-PPE) Updated to include Product recall goods return form (Appendix 22A). Appendix 24 updated to reflect change in QA Manager and production supervisor.

2008.07.24

FSp106 Health & Safety Program FSP109 Recall Procedure

Entire document of version 01 original

Q. A Manager

2011.10.28

H.A.C.C.P Coordinator/ Q. A Manager b `

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2012.03.22 Factory Preoperational Visual Checklist FSP109Recall Procedure Distribution Register original New checklist to ensure that the factory is in good condition before production begins. Changes made to clarify roles of individuals in the recall process. Customer contact# and Invoice # now included. Area and date customer contacted was removed. New form to be used when goods are being returned to XYZ. Quality Assurance Manager

2012.06.12

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General Manager

2012.06.12

Appendix 22

General Manager

2012.06.13

Goods Return Form

Appendix 22B

H.A.C.C.P Coordinator/ Q. A Manager H.A.C.C.P Team

2012.06.15

Safety & Health Procedure

The following were added: - Hazardous Material Warning Labels. - Safety rules - How to lift heavy objects. - Accident Report card. Quality & Technical support removed from the chart and the Warehouse clerk now reports to the production supervisor. Replaces Dock Report. Completion of this checklist will ensure that raw materials are received in good condition.

2012.06.18

Organizational Chart

Appendix 1 Quality Manual

General Manager

2012.06.19

Material Inspection Checklist

H.A.C.C.P Team

2012.06.22 Page 4 of 44

Pest Control Program

-Physical and chemical pest control treatment H.A.C.C.P Team

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done every six weeks. - Inspection of warehouse and production areas for holes now done monthly instead of weekly.

2012.07.31

Internal Scale Record

Appendix 8

Verification column added

Date

Document

Revision (e.g page 2) 04

Description of History (details of revision)

Requested by

2013.01.23

Water testing procedure

Testing method for water softness updated and change in specifications for conductivity updated

Quality Assurance Manager

2013.03.26

Material inspection Checklist Quality Manual Procedures

01

Changes were made to reflect current procedure

Quality Assurance Manager Quality Assurance Manager Quality Assurance Manager

2013.03.26

Minor changes in wording of document 02 Addition of new documents Manual Introduction, Macro process Flowchart, Overview of responsibilities,

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00

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2013.04.29 Hydrometer Calibration Procedure 00 2013.04.29 Equipment Program 2013.05.28 Production Cleaning Procedures
Changecontrol/fsmsm

New hydrometer calibration procedure and log sheet

Quality Assurance Manager

Update document to reflect the new refractometer used 03

Quality Assurance Manager Quality Assurance Manager

04

Changes were made to reflect current procedures

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Food Safety Management System Section 2.1

Manual Introduction
This document describes the food safety Management System at XYZ company. XYZ has developed and documented a food safety management system to better satisfy the needs of its customers and to improve management of the business. This Manual has been prepared to define the food safety system, provide general procedures for all activities comprising the safety system and establish responsibilities of the personnel affected by the system. XYZ recognize its role as a provider of quality products/services. Our high priority placed on food safety is based on our belief and experience that commercial success and good food safety practice and performance are long-term compatible goals.

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Food Safety Management System Section 2.2

Organisation Introduction

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Food Safety Management System Section 3.1

Normative References
ISO 9001:2008 Quality Management System Requirements ISO 22000: 2005 Food Safety Management System Codex Alimentarius Commission

Section 3.2

Terms and Definitions


Food Safety: Concept that food will not cause harm to the consumers when it is prepared and/or eaten according to its intended use Food Chain: Sequence of the stages and operations involved in the production, processing, distribution, storage and handling of a food and its ingredients, from primary production to consumption Product: Result of (XYZ) process/activities Batch: A specifically identified quantity of purchased or manufactured ingredient or product material. Management: Coordinate activities to direct and control an organization Testing: Determination of one or more characteristics according to procedure Traceability: Ability to trace the history, application or location of that which is under consideration Validation: Obtaining evidence that the control measures managed by the HACCP plan and by operational pre-requisite programs are capable of being effective. Verification: Confirmation, through the provision of objective evidence, that specified requirements have been fulfilled. The application of methods, procedures, tests and other evaluations, in addition to monitoring to determine compliance with the HACCP plan. Effectiveness: Extent to which planned activities are realized and planned results achieved

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Food Safety Management System Ingredient: Any material whether purchased or manufactured, that is used as a constituent part of another manufactured material. Non-conformance: The failure of a purchased or manufactured ingredient or product material to meet an agreed specification. This failure may occur as a result of violation in the Prerequisite Program or Plan. Objective Evidence: Any documented statement of fact, information or record, either quantitative or qualitative pertaining to the quality of an item or activity, based on observations, measurements or tests, which can be verified.

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4. Food Safety Management System


Section 4.1 General Requirement
The food safety management system at XYZ has been developed to assist the company in its quest for continuous improvement in its food safety performance. The international food safety management system standard ISO 22000:2005 is being used as best practice and provides the structure of this document.

Figure 1. Elements of an Effective Food Safety Management System


Food Safety Policy

Continuous Improvement

Food Safety Planning & Documentation Management review

Food Safety Implementation Validation & Verification

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Quality and Food Safety Policy


XYZ, a major Manufacturer and Supplier of flavours, fragrances, essential oils, spices and food colours is committed to ensuring that its products satisfy all required Food Safety Standards.

The employees at XYZ are personally committed to understand, meet and when possible exceed our customer requirements through continuous improvement of our processes and a team of highly trained staff in an ISO 22000 environment. We are also committed to providing excellent Technical Support Services, to be creative in our product range and to guarantee customer satisfaction by employing a team of dedicated and experienced employees.

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FOOD SAFETY OBJECTIVE


To achieve ISO 22000: 2005 certification by 2015 To reduce the number of customer complaints by 50% in 2014 Not more than 10% of products returned due to the presence of a food safety hazard. To achieve housekeeping scores of 90% and over at the end of each quarter To ensure 100% training of all production and warehouse personnel in GMPs To achieve a 90% pass rate for all swab test each month

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Food Safety Management System 4.2 Documentation Requirements General In order to ensure effective planning, operation and control processes of the FSMS in accordance with the Food safety policy and objectives, the following documentation in four levels is implemented as follow:

Control of Documents The QA Manager and nominee shall ensure that all documents in the FSMS are properly identified and controlled. The QA Manager shall ensure that all documents: Are reviewed and approved for adequacy prior to issue Are available at point of use Are updated, reviewed and approved for re-issue as necessary Are identified with their current version status Are legible, readily identifiable and retrievable Of external origin are identified and their distribution is managed That are obsolete are stored in a history file physically and electronically. Documents defined as records are managed per the Control of Records procedure

Control of Records The food safety management system records are established and maintained to provide evidence that: Products and processes meet specified requirements The FSMS is operated in accordance with documented procedures and that it is effective. Where required, FSMS records also include traceability information. Records are established by personnel performing the task, operation, or activity for which the results need to be recorded, records are dated. Records are normally stored in a dry clean area by the same department that initially establish the record

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Food Safety Management System Retention period of the FSMS records are determined on the basis of the shelf-life of the product or the event to which the record pertains and on regulatory and contractual requirements.

5 Management Responsibilities
5.1 Management Commitment Management provides evidence of its commitment to the development, implementation and continual improvement of the food safety management system by: Defining the purpose and objectives of the FSMS, they are documented and communicated in the form of the food safety policy and objectives. Management periodically reviews the FSMS to ensure its continuing suitability, adequacy and effectiveness. The review evaluates current status and performance of the FSMS and initiates actions for further improvement of the system. The process for conducting management review is defined in section 5.8 of this manual and in Management review procedure in the quality manual. Management is committed to ensuring adequate resources are made available, to establish and support food safety initiatives

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Management is committed to communicating the importance of meeting customer as well


as regulatory and legal requirements. Management representative is responsible for implementing this commitment by promoting awareness of customer requirements through the organization.

Customer Focus
Determining customer requirements Customer requirements are understood broadly to include all aspects of product offering and associated services, which are relevant to customer satisfaction. Customer requirements are determined and verified through the process of order review Meeting Customer requirements Nearly all processes and elements of the FSMS are designed and implemented specifically to ensure that that customers requirements are met. This starts with provision of required training and adequate infrastructure and suitable work environment. Next follows planning and implementation of reliable and effective product realization processes (section 7). Finally, activities related to product and process monitoring and verification. Customer Satisfaction Focusing on customer requirements and on meeting these requirements should result in enhancing customer satisfaction. The level of customer satisfaction is used as a measure of the effectiveness of the entire FSMS. Customer satisfaction is measured through: Review of repeat business Supplier performance feedback from our customers Review of our success in resolving customer queries

5.2 Food Safety Policy


Authority

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Food Safety Management System The food safety policy is established by management representative and is approved by the Managing Director. Any changes to the policy must likewise be approved by the Managing Director. Role of the policy The main role of the food safety policy is to communicate the companys commitment and aspirations with regards to the FSMS and to define principal objectives for the management system To establish a culture of food safety management throughout the organization, focusing on customer satisfaction and continual improvement. The food safety policy provides a framework for establishing specific objectives and provides direction for the continual improvement effort. Communication The food safety policy is posted throughout the organization and its role is explained to all employees The food safety policy is also communicated to customers, consumers and other interested parties. Reviews The food safety policy is periodically reviewed within the framework of management reviews of the FSMS. This is to ensure its continual relevance and suitability. The processing for reviewing the policy is defined in the Management review procedure.

5.3 Planning
1. Food Safety Objectives The food safety objectives are established throughout the organization to implement the food safety policy, to meet requirements for products and processes and to improve the FSMS performance. FS objectives define the direction and priority for continual improvement

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Food Safety Management System FS objectives are monitored under agreed time frame for their achievement. These food safety objectives are constantly reviewed and updated. When establishing objectives management considers: The food safety policy Applicable legal, regulatory and other requirements Current business consideration Objectives are measurable and responsible owners are assigned.

2. Food Safety Management System Planning The food safety management system elements and processes are planned to ensure that they system is appropriate for its intended process and it is effective and efficient. The purpose of the FSMS is: To achieve the food safety policy To ensure and demonstrate the ability to provide consistent products that meets customer and regulatory requirements To ensure high level of customer satisfaction To facilitate continual improvement To comply with the requirements of the applicable food safety standard

The output of the FSMS planning is documented in associated procedures/process description and in other reference documents. These documents identify and define all elements of the processes of the food safety management system Changes to the FSMS are planned within the framework of the management reviews. These changes may be in response to changing circumstances such as product, process, capacity or other operational or organizational change; or to improve the effectiveness and efficiency of the FSMS. 3. Product realization and verification planning Planning of product realization, verification and validation is addressed in section 7.1 and section 8 respectively of this manual. 4. Continual improvement planning Improvement of the management system is planned within the framework of the management reviews. The output of this planning is expressed in the form of FS policy objectives and in continual improvement process and management reviews.
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5.4 Responsibility and Authority


The Organisation chart is a graphic presentation of the Management Structure in the Organisation. It defines relationships and identifies the line of Authority and Responsibility. It can be found in the appendix 1of this manual. The responsibilities and authorities of the personnel performing the jobs affecting the product/service are detailed in their respective job descriptions, which is available in their personnel files and a reference kept in the food safety management system folder.

5.5 Management Representative


The Quality Assurance Manager is the designated Management Representative for the Food Safety Management System. The Representative has the authority and responsibility to ensure: The food safety management system is implemented, maintained and continually improved Report to top management on the performance of the FSMS, including needs for improvement Promote awareness of customer requirements throughout the organization Coordinate communication with external parties on matters relating to the FSMS and certification bodies Ensures relevant training and education of the FSMS team members

5.6 Communication
1. External Communication XYZ ensures that sufficient information on issues concerning food safety is available throughout the food chain. External communication includes: Where determined by the organization, communicating information about significant hazards and risks to external interested parties. Receiving, documenting and responding to relevant communication from external interested parties.

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Food Safety Management System Communicating with stakeholders, customers, regulatory and statutory authorities as well as suppliers and contractors.

2. Internal Communication Communication regarding the FSMS flows in two ways: 1. Management communicates to the organization the FS policy and Objectives; customer and regulatory requirements; product and process specifications; verification and validation requirements; and instructions on how to implement and use the FSMS. 2. The organization communicates to management information and data regarding customer needs and expectations, customer satisfaction, FSMS performance, the effectiveness of the FSMS and opportunities for improvement The information is communicate through manuals, procedures, process description, instructions, flowcharts, forms, specifications, FS records etc; and through training, on the job instruction and meetings. Control of documents, competency and awareness and training regulate these activities Management review meetings have a special role in ensuring proper communication between the top management and the organization. The meetings provide the framework for the organization to report on the status of the FSMS related issues and activities. This gives management the opportunity to formulate policies and directives to change and/or improve the FSMS. Minutes of all management reviews and operation meetings are recorded Internal mail, fax, phone are also usual modes of communication.

5.7 Emergency Preparedness and response


XYZ has established and maintained a process to encounter emergence situation related to environment, health and safety and food safety.

5.8 Management Review


The purpose of management review is to: Determine the suitability, adequacy and effectiveness of the FSMS

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Food Safety Management System Consider changes to the FSMS policy and objectives Identify opportunities for improvement of the FSMS, processes and products

Management reviews are chaired by the Managing Director or management representative and are attended by the food safety team. Management reviews are conducted on a yearly basis. More frequent reviews are scheduled in periods when organizational or product changes or circumstances require increased attention and input from top management. Review input Input to the meetings is provided in a number of ways as follows: Follow up action from previous management reviews Analysis of results from verification activities e.g. results of internal audits Analysis of changing legislation, standards or best practices Analysis of major incidents involving food safety Organization and business changes External audits, inspections or statutory visits by enforcement authorities Customer focus Customer complaints and rejections Changes that could affect the quality management system Recommendations for improvement

Review Output Management reviews are concluded with actions related to improvement of the effectiveness of the FSMS and updates of policies/process, plans safety and security requirements etc. The review also identifies resource needs to implement these actions. Results of management reviews are documented in minutes of the review meeting. The minutes include improvement actions and assign responsibilities and allocate resources for implementation of these actions.

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6. Resource Management
General Resources required for implementation and improvement of the FSMS and for a addressing customer satisfaction may include people, suppliers, information, infrastructure, work environment and financial resources Determination of Resources Requirements Management representative and other personnel involved in the FSMS are responsible for determining resource requirements for the implementation and improvement of the system.

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Food Safety Management System Managing Director is responsible for determining the resources required to address customer satisfaction. This is based on input from other personnel responsible for activities relevant to particular aspects of customer satisfaction. Provision of resources The Managing Director has the responsibility and authority for the provision of resources Allocation of resources for particular activities is integrated with the process of defining and initiating the activity. It may take the form of personnel assignments, allocation of space or equipment, training, procurement decisions, budgets etc. Allocation of resources may be document in the FSMS manual, operational procedures, minutes of meetings or any other form. Approvals of resource allocation may also be approved verbally. Management review is the principal forum for allocation of resources for the operation and improvement of the system. All action initiated by the review are supported by allocations of specific resources for their necessary implementation.

6.2 Human Resources


The Managing Director is responsible for recruiting new staff

1. Competence, awareness and training The Managing Director is responsible for identifying training needs and awareness programs such as general orientation, rules and regulations, FSMS, safety and other issues. The Quality manager is responsible for internal training. This internal training focus on increasing the level of skill in conducting inspections, good manufacturing practices and the importance of adhering to the procedures outlined in the FSMS. In addition training needs are often identified in response to corrective or preventive action request as nonconformities may be caused by inadequate training. 3. Awareness and training program XYZ provide or support the following categories of training and awareness program:

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Food Safety Management System General Orientation: All new employees are given training (to an extent necessary as per their responsibility) regarding the companys business, food safety policy, food safety objectives and routine job practices. External training: External seminars, conferences and courses are provided to individual employees on as needed basis. Self-Study: Reading magazines, books and reports. While employees are encouraged to broaden their knowledge through reading, in some cases self-studying may be required as formal training. Departmental training in specific skills is often provided as on the job training. Effectiveness of training Effectiveness of training is evaluated using the following approaches: Performance evaluation of trained employees. Review of overall performance in areas relevant to particular training programs. Consideration of competency and training when investigating causes of FSMS failures and/or process nonconformities.

Training Records Training records are established for all types of training. Internal training are normally established and maintained by the quality department. The company maintains as-hired qualification records, external training records and may also have copies of some departmental training.

6.3 Infrastructure
Planning of new and/or modification of existing infrastructure and facilities are usually conducted in conjunction with product or process changes, capacity and other such events. Facilities may also be expanded or modified to improve productivity and/or FSMS, or to improve the work environment. Maintenance of buildings and facilities is performed by external contractors. This includes maintenance of air conditioning, landscaping and cleaning. Repairs of buildings and other such facilities are contracted as needed.
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Food Safety Management System Process Equipment maintenance Key process equipments and machines are regularly maintained by internal maintenance schedule. Maintenance of software and computer equipment is contracted.

6.4 Work environment


1. Human Factors The Managing Director is responsible for ensuring suitable social and psychological conditions in the workplace. This includes such aspects as interaction and communication between employees, employee harassment, conflict resolution and so forth. Relevant workplace policies are implemented mainly through training and awareness programs and where necessary, disciplinary actions. 2. Physical Factors The Managing Director, Quality Manager and Production Supervisor are responsible for identifying those operations where extreme environmental conditions could impact personnel and result in product nonconformities. Where appropriate, limits of exposure and/or mitigating measures shall be defined and implemented for these operations. Safety, hygiene, fire protection, work space and walkway are identified. 3. Prerequisite programs The Quality manager is responsible for establishing prerequisite programs in order to assure food safety throughout the operation. The Quality manager shall consider and utilize appropriate information such as legal, regulatory and applicable standards (local/international).

7. Product Realization and Planning


7.1 General In order to realize safe products during storage and distribution of food the company has developed a food safety management system based on the requirements of ISO 2000:2005 which is described in this document. The company has developed a food safety manual that provides guidance and direction to the business to help implement the food safety policy. Section 4.1 of this document summarises the company food safety elements. These elements provide the structure of the company food safety
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Food Safety Management System procedure manual. Each element is documented in a procedure and some elements may comprise a number of procedures and additional guidelines. 7.2 Prerequisite programs (PRPs) In order for the food safety management system to be effective a number of programs are considered essential prerequisites, see figure 2. Figure 4 Prerequisite Programs Good hygiene practices Pest control Preventative maintenance Sanitation premises

7.3 Preliminary Steps in enabling hazard analysis


The following seven (7) step approach is adopted to enable effective hazard analysis, refer to figure 3 below. 1. 2. 3. 4. 5. Collate all relevant information needed to conduct hazard analysis Develop a food safety (HACCP) team Establish and identify packaging and delivery methods Establish and identify storage conditions and shelf life Establish and identify statutory and regulatory food safety requirements

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Food Safety Management System 6. Develop flow diagrams to provide a basis for evaluation of food safety hazards. 7. Establish and document existing control measures for each process step

Figure 3. The Seven Steps of Hazard Analysis and Critical Control Points (HACCP)

7.4 Hazard Analysis


The principles of HACCP are used to: Identify food safety hazards and determine acceptable levels. Assess hazard to determine, for each food safety hazard identified whether its elimination or reduction to an acceptable levels is essential to food safety. Select and assess an appropriate combination of control measures capable of preventing, eliminating or reducing food safety hazards to acceptable levels. Control measures may be managed through PRPs or HACCP plans.

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Food Safety Management System Establish a documented HACCP plan.

A HACCP plan will be established which will, as a minimum include the following for each critical control point a) Food safety hazards to be controlled at the CCP b) Control measures c) Critical limits d) Monitoring procedures e) Corrections and corrective actions to be taken if critical limits are exceeded. f) Responsibilities and authorities g) Records of monitoring 7.5 Establishing the Operational

7.5 Establishing the Operational Prerequisite Programs


Operational prerequisites will be documented and will form an integral part of the food safety management system. Food safety hazards controlled by the program will be established and monitored.

7.6 Established the HACCP plan


Information regarding establishment of the HACCP plan can be found in section 7.4

7.8 Verification The food safety team will operate on a predetermined frequency, conducting complete inspection of the entire facility once per year. Records will be maintained and follow-up inspections will be done to ensure that items corrective actions or effective. The food safety team leader will regularly monitor documentation that may indicate trends of non-conformance and recommend corrective actions.

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Food Safety Management System Results from external audits will also be considered in verification activities. All staff members are made aware of the food safety system in place, and that food hygiene maintains a high standard. 7.9 Traceability System XYZ allocate unique codes to some supplier products while maintaining the supplier coder for others. These codes and description are common to all generated documentation. A system of product codes ensure traceability of product from any delivered batch, throughout the food chain from goods received to subsequent delivery to customer.

7.10

Control of nonconformity

Products that are identified as non-conforming are placed on hold in the quarantine area, they will be clearly labeled. Examples of reasons for products to be in the quarantine area include but are not limited to: Products identified on hold due to recall Products not meeting customers specifications Products rejected due to poor quality Damages identified after receipt into warehouse

Procedures are in place for the control of non-conforming materials including rejection, acceptance by concession or rework. Such procedures are implemented and employees made aware. All non-conforming products are handled or disposed of according to the nature of the problem and/or the specific requirements of the customer. Procedures are in place to investigate (i.e. root cause analysis) and ensure final disposition by authorized persons. Corrective action systems are established to identify and eliminate the cause of detected nonconformities, to prevent recurrence and to bring the process or system back in control after nonconformity is encountered. Corrective actions are document and effective records maintained. Such actions will include: Reviewing nonconformities (including customer complaints)

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Food Safety Management System Reviewing trends in the monitoring results that may indicate development towards loss of control. Evaluating the need for action to ensure that nonconformities do not reoccur Determining and implementing the actions needed Recording the results of the action taken Reviewing corrective actions taken to ensure they are effective.

Corrective actions will be discussed and agreed at regular food safety meetings.

8.0 Validation, Verification & Improvement


The food safety team will assess and evaluate the plans and associated PRPs and will validate that the established control measures and other programs are capable of being effective. This will be done prior to the implementation of the HACCP plan. Validation of Control Measures The validation process will be documented and will include evidence Examples of validation methods include but are not limited to: Process walkthrough to assess whether plans are realistic and achievable. Review actual results against requirements to determine whether parameters are acceptable, i.e. they meet company and legislative requirements. Review of recording methods to determine where data can be recorded and how and if forms are appropriate. Is the defined means of what to do when things go wrong appropriate and achievable?

8.4 Food safety Management system Verification


Internal Audit Audits are carried out in accordance with an annual audit schedule and performance is measured against an established criteria. The audit report provides an opportunity for the employees to state their findings and to add their comments.

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Food Safety Management System Audit reports will be collated, analyzed and distributed according to a established distribution list. The Quality Assurance Manager maintains records of audit and self-assessment audit results.

8.5 Improvement
Continual Improvement Following a review of current food safety issues, management may identify actions designed to improve the food safety system. Such actions may be in the form of individual action items; through to establishing working groups, projects, initiatives or programs Food safety performance is measured and monitored to determine whether: Food safety policy statement and related objectives are being achieved. Corrective and preventive actions are implemented and are effective Lessons are learned from food safety failures Awareness, training and communication are effective. Information and data from review and monitoring processes are being produced and being used.

Continual improvement is facilitated through the use of the food safety policy, food safety objectives and analysis of data In addition to management reviews improvement opportunities are identified continually based on daily feedback from their operations and other activities. Employees are also encouraged to come forward with ideas for improving products, processes, systems, productivity and working environment. These improvement opportunities are evaluated and prioritized and where appropriate are implemented through the system of corrective and preventive actions.

Updating the Food safety management System The management system documentation is reviewed or discussed at management review meetings. Changes are request and approved the updated documents are issued to control copy holders. These individuals are informed to the nature of the change made and its impact on the business.

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