HACCPEUROPA PUBLICATIONS ISO 22000:2005 FOOD SAFETY QUALITY MANUAL ISO 22000:2005 Quality Manual
QUALITY MANUAL ISO 22000:2005 Food Safety Management HACCPEuropa Publications 2012
Table of Contents Introduction... 1 1.0 The Company Profile... 2 ISO 22000: 2005 Background and History... 3 1.1 Introduction... 3 1.2 Application... 4 1.3 Quality System Control... 4 1.4 Quality System Changes... 5 1.5 Food Safety Policy... 5 1.6 Food Safety Management System Objectives... 5 1.7 Authorization Statement... 6 1.8 Organization... 6 2.0 System Requirements... 8 2.1 Food Safety Team... 8 3.0 Controls and Distribution... 9 3.1 Structure of ISO 22000 Manual... 9 3.2 Responsibility... 10 3.3 References... 10 3.4 Amendment Record Sheet... 10 4.0 Quality Management System... 11 4.1 General Requirements... 11 4.2 Documentation Requirements... 12 5.0 Management Responsibility... 15 5.1 Management Commitment... 15 5.2 Customer Focus... 15 5.3 Food Safety Policy... 16 5.4 Planning... 16 5.4 Responsibility and Authority... 18 5.5 Food safety team leader... 19 5.6 Communication... 20 5.7 Emergency preparedness and response... 21 5.8 Management Review... 21
6.0 Resource Management... 24 6.1 Provision of Resources... 24 6.2 Human Resource... 24 6.3 Infrastructure... 25 6.4 Work Environment... 26 7.0 Planning and Realization of safe products... 27 7.1 General... 27 7.2 Prerequisite programs (PRPs)... 27 7.3 Preliminary steps to enable hazard analysis... 28 7.4 Hazard analysis... 29 7.5 Establishing the operational prerequisite programs (PRPs)... 31 7.6 Establishing the HACCP Plan... 31 7.7 Updating of preliminary information and documents specifying the PRPs and the HACCP plan... 32 7.8 Verification planning... 32 7.9 Traceability system... 33 7.10 Control of nonconformity... 34 8.0 Validation, verification and improvement of the food safety management system... 38 8.1 General... 38 8.2 Validation of Control measure combinations... 38 8.3 Control of monitoring and measuring... 38 8.4 Food safety management system verification... 39 8.5 Improvement... 41
I S O 2 2 0 0 0 : 2 0 0 5 F O O D S A F E T Y M A N A G E M E N T Q U A L I T Y M A N U A L The manual describes how manufacturers will comply with the requirements of the ISO 22000:2005 and HACCP (Hazard Analysis and Critical Control Point). The manual also includes: Codes of Practice; Protocols; Recommended Systems. The Manual is a living document and will be subject to continual improvement. Introduction The company developed and implemented a Quality Management System (QSM) in order to document the company s best business practice, better satisfy the requirements and expectations of its customers and improve the overall management of the company. The Quality Management System (QSM) meets the requirements of the international standard ISO 22000:2005. This system addresses the supply and servicing of the company s products. This manual describes the Quality Management System (QSM), delineates authorities, inter relationships and responsibilities of the personnel responsible for performing within the system. The manual also provides procedures of references for all activities comprising the Quality Management System (QSM) to ensure compliance to the necessary requirements of the standard. This manual is used internally to guide the company s employees through the various requirements of the ISO standard that must be met and maintained in order to ensure customer satisfaction, continuous improvement and provide the necessary instructions that create an empowered work force. This manual is used externally to introduce our Quality Management System (QSM) to our customers and external organisations or individuals. The manual is used to familiarise them with the controls that have been implemented and to assure them that the integrity of the Quality Management System (QSM) is maintained and focused on customer satisfaction and continuous improvement. 1
1.0 The Company Profile 2
ISO 22000: 2005 Background and History ISO 22000:2005 is a food safety management systems developed within ISO by experts from the food industry and for the food industry. It clearly provides a framework of internationally harmonized requirements for the global approach that is needed. ISO 22000 integrates the principles of the Hazard Analysis and Critical Control Point (HACCP) system and application steps developed by the Codex Alimentarius Commission. By means of auditable requirements, it combines the HACCP plan with prerequisite programs. Hazard analysis is the key to an effective food safety management system, since conducting a hazard analysis assists in organizing the knowledge required to establish an effective combination of control measures. ISO 22000 requires that all hazards that may be reasonably expected to occur in the food chain, including hazards that may be associated with the type of process and facilities used, are identified and assessed. Thus it provides the means to determine and document why certain identified hazards need to be controlled by a particular organization and why others need not. Chronology of its development: 1958 -Foundation of the NASA (National Aeronautics and Space Administration) 1959 -Development of the HACCP concept to assure one hundred percent safety of food to be used in space. 1971- The HACCP system was published and documented in the USA. 1985- The National Academy of Science (NAS) recommended the use of the system. Worldwide the system became used and the FAO/WHO Codex Alimentarius (Food and Agriculture Organization/World Health Organization) cited the system in the Codex. 1993- The European regulation 93/43 EG from 14.7.93 provides the use of the system for the production Rule) demands the use of the HACCP system in Germany. 2005 1 September 2005 ISO 22000 Food Safety Management System Requirements for organisations in food chain. 1.1 Introduction 1.1.1 This Quality Management System is established and maintained in order to define and provide an overview of the Quality Management System (QMS) documented and implemented to ensure conformance with the industry standards. Therefore, this Quality System Manual, providing an overview of the Quality Management System is divided into eight sections, modeled after the sectional organization of the ISO 22000:2005. Each subsection of this Quality System Manual defines general policies and basic principles pertinent to the processes, summarizes responsibilities and methods, and references relevant SOPs and other required documents. 3
1.1.2 Further, this Quality System Manual is established and maintained to identify the processes and define the interactions of these processes, and their management, to satisfy specified requirements. 1.1.3 This Quality System Manual is established and maintained to demonstrate Management s commitment to quality, ensuring that both the operation and control of processes are effective; ensuring the availability of resources and information necessary to support the operation and monitoring of these processes; to monitor, measure, where applicable, and analyze these processes, and implement actions necessary to achieved planned results and continually improve these processes. 1.2 Application 1.2.1 This Quality Management System, including this Quality Systems Manual, all interrelated procedures, work instructions, and associated forms and records is applicable to management and personnel with assigned responsibilities having the potential to affect product and/or service quality. 1.2.2 The Quality Management System applies to all products, manufactured or outsourced, distributed by THE COMPANY, and includes, where applicable the design, manufacture, measurement, and distribution of all products, and is established and maintained to demonstrate the ability of THE COMPANY to consistently provide product and services that meets customer requirements. 1.2.3 The Quality Management System is established and maintained to enhance customer satisfaction through the effective application of the system, specifically including processes for continual improvement of the system, and the assurance of conformity to customer requirements and industry standards. 1.2.4 Exclusions: THE COMPANY does not herein claim or justify any exclusion from the sub clauses of the standards. 1.3 Quality System Control 1.3.1 This Quality Manual, along with Quality System Procedures, Work Instructions, Forms, and Drawings will be maintained under document (revision) control. 1.3.2 Document Distribution: The current revision level of each controlled document will be made available to applicable staff via the computer system. Documents may be printed for reference only, and will be considered obsolete at the end of the day, unless otherwise controlled. If controlled paper copies of documents are printed and distributed, it will be the responsibility of the Quality Manger to maintain a list of the documents, along with the recipients. 4
1.3.2.1 Controlled documents are not distributed outside of the organization without the permission of top management. If this Quality System Manual is distributed outside of THE COMPANY (i.e., to a customer), it will be consider uncontrolled, and will not be updated with subsequent revisions. 1.3.2.2 It is the responsibility of each individual using controlled documents to verify the correct revision level in the system. 1.4 Quality System Changes 1.4.1 Notification of Changes (substantive changes), including Management change Organization Structure, Change of Facility, substantive changes to the Quality System Manual, will be provided in writing to the ISO Registrar, if required. 1.4.2 The staff will be notified of changes through the formal change control process, Ref.: Document and Data Control. 1.5 Food Safety Policy It is the policy to produce and supply safe food products of agreed quality to consistently meet customer needs and expectations and enhance customer satisfactions so that there is complete assurance that our customers receive the optimum nourishment, and are unlikely to become ill or injured by foreign objects present in our food. In order to achieve this objective, we will rigorously adhere to relevant Statutory & Regulatory Requirements and with mutually agreed food safety requirements of customers. We will make every effort to maximize customer satisfaction by: Supplying safe and hygiene food products to the consumer Prevention rather than detection / rectification Complying requirements & continually improve the effectiveness of Food Safety Management System. Creating an environment of teamwork as well as involvement and system awareness to all employees. 1.6 Food Safety Management System Objectives Our Food Safety objectives are as follows: State aspects of personal hygiene that relate to food safety Describe proper ways to food safety Describe methods of sanitizing food preparation areas and equipment 5
Identify proper washing practices Explain how to prevent contamination of food Cite examples of food-borne illness 1.7 Authorization Statement THE COMPANY is committed to the establishment and maintenance of Food Safety Management System given in this manual and implemented by THE COMPANY to meet the requirements of ISO 22000: 2005 Food safety management systems. The members of the Organization shall strictly adhere to the various FSMS procedures and work instructions as supported by the policies outlined in this manual. Team leader of food safety has been appointed as Food safety team leader of Organization. The Food Safety Team Leader is responsible for ensuring compliance with the FSMS requirements stipulated in this manual. He is authorized to ensure that the FSMS system is established, implemented and maintained by THE COMPANY. Top Management shall give full support and cooperation Food Safety Team Leader. 1.8 Organization To ensure a formal organizational chart is maintained which clearly defines the organizational structure of the company. This chart defines the reporting structure, hierarchy levels of authority, basic responsibilities. The Operating Procedures supporting this ISO 22000 Manual define individual responsibilities in respect to authority, actions to be taken in the event of errors, corrective action and any re-evaluation necessary to ensure our operations remain in compliance with our policy and objectives, supported by detailed job function descriptions. Ref: Management Responsibility 1.8.1 Resources To ensure adequate resources are provided for the performance of all operations, coupled with trained resources in order to maintain our overall process capability in the best interests of our customers. 6
Resources include capital plant and equipment; working environment and personnel that are basically considered the prerequisites of the ISO 22000. Our Operating Procedures define the resources to be utilized in conjunction with job descriptions, skills matrixes and work instructions. As part of ISO 22000 meetings the adequacy of resources is evaluated and where necessary additional, suitable resources deemed provided. All ISO 22000 meeting held formally or informally should be recorded. 7
2.0 System Requirements THE COMPANY has established documented and implemented ISO 22000 system to ensure that all known potential hazards are identified and that all relevant hazards are controlled in such a manner that the products of the company do not harm the user/consumer. The scope of the quality system covers the organization, responsibilities and authorities, procedures, methods and the resources to achieve and maintain quality of service in accordance with the FSMS policy of the company. THE COMPANY has established and maintained documentation to the effect that the FSMS system is established in compliance with the ISO 22000 requirements of standard. 2.1 Food Safety Team THE COMPANY has established a multi-disciplinary ISO 22000 team is set up to develop, establish, maintain and review the FSMS system. The FSMS team shall have knowledge and experience with regard to the company s products, processes and hazards within the scope and field of application. Documentation to this effect shall be maintained. Where the assistance of external experts is required for the operation of the ISO 22000 system, an agreement shall be made to document the responsibility and authority of such experts with regard to the ISO 22000 system. 8
3.0 Controls and Distribution 3.1 Structure of ISO 22000 Manual This manual is prepared according to the table of contents. Each chapter begins with page 1 and the numbering continues within the chapter and not throughout the manual. This has been done to facilitate future addition / deletion of pages. The manual is supported by documented system covering ISO 22000 procedures and work instructions or test procedures. ISO 22000 system is prepared by ISO 22000 team on the basis of 7- principals of ISO 22000. ISO 22000 manual gives broad guideline for implementation of the Food Safety Management System requirements. Top Management has identified a multidisciplinary ISO 22000 Team represented by heads of respective area. The team conducted hazard analysis (HACCP Principle #1) from the point of consumption. The team further established monitoring system and corrective actions where needed. Based on hazard analysis the team identified the Significant Hazards, for which, Critical Control Points (CCPs)(HACCP Principle #2) & further Critical Limits (CLs) for each of the CCPs were established (HACCP Principle #3). For each established CCPs the team developed procedures with defined responsibilities and details of monitoring i.e. what, when, where, who & how (HACCP Principle #4) while establishing CCPs the team gave due consideration for the quickness effectiveness & ease of monitoring of the respective CCPs. In case of any deviations, the team also identified Corrective Actions to be taken, both on the product & production line, with specific responsibility for corrective action (HACCP Principle #5). To demonstrate & verify that the Food Safety Management System is working satisfactorily, the ISO 22000 team identified records to be maintained defining the components to be recorded for each such record. The responsibility for recording such parameters / components was also identified. Several such records have been defined / crossreferred in the ISO 22000 Food Safety Management System under relevant procedures (HACCP Principle #6). In order to ascertain whether HACCP study has been carried out correctly by & that the HACCP system continuous to be effective, the team established verification methods for each CCPs / CLs. Modes of verification are considered, as appropriate, such as review of HACCP system & its records, review of deviation & products disposition, confirmation that CCPs are kept under control where practicable and validation activities (HACCP Principle #7). Verification process, the details including the responsibility, frequency & method of verification are clearly defined for ensuring the effectiveness of Food Safety Management System. Necessary control features are also addressed in relevant Food Safety Management System Procedure / Work Instructions. The implementation of this manual and related quality procedure is mandatory for all departments. The changes made in this manual are effected through the document control procedures and must be approved by the Top Management. 9
3.2 Responsibility Director approves Front / Cover page of the ISO 22000 Manual. The control and maintenance of this manual is the responsibility of Food Safety Team Leader who is maintaining master list of manual. Also when any changes / amendment are there, then the same page is approved by the Top Management before issue of such changed / amended page to the concerned copyholder. 3.3 References ISO 22000: 2005 Food Safety management system Requirements Requirements for ISO 22000 based food safety system 3.4 Amendment Record Sheet Document History Version Created By Issued to Type Date Reviewed By Approved By Document Controller Item Description Who: Role: Telephone: Email: 10
4.0 Quality Management System 4.1 General Requirements THE COMPANY has established, documented, implemented and maintained a Food Safety Management System and continually improves it s effectiveness in accordance with the requirements of ISO 22000: 2005. THE COMPANY has defined the scope of the food safety management system in chapter No. 01 to this Manual. We have identified, evaluated and controlled the food safety hazards so that the products (manufactured in THE COMPANY) do not, directly or indirectly, harm the consumer. We have communicated appropriate information throughout the food chain regarding safety issues related to the products. Necessary information is communicated regarding development, implementation and updating of the food safety management system throughout the organization, to the extent necessary to ensure the food safety required by this International Standard. Necessary periodical evaluation of the safety management system is carried out to ensure that the system reflects THE COMPANY s activities and incorporates the most recent information on the food safety hazards. 4.1.1 QMS processes and sub-processes are defined in this Quality Manual and in associated Quality System Procedures (QSPs) showing both their sequence and interrelationships. QSPs further instruct on how to implement and apply them throughout the organization. 4.1.2 QMS documentation also defines criteria and methods required to ensure that the operations and controls of the quality system processes are effective. This includes assignment of responsibilities and allocation of resources for the process, instructions on how to carry out (or operate) the process, and definition of methods for monitoring and/or measuring the effectiveness of the process, where applicable. 4.1.3 Outsourced Processes: Quality Management System defines how THE COMPANY maintains responsibility for product conformance to specified requirements when processes and/or product is outsourced. 11
Ref. Purchasing 4.2 Documentation Requirements 4.2.1 General The written documents are prepared by THE COMPANY as per list given below: Documented statement of food safety policy and objectives ISO 22000 Procedures ISO 22000 Records HACCP Plan, Hazard Analysis, Work Instructions to ensure the effective development, implementation and updating of the food management system. 4.2.2 Quality System Manual (QM) This top-level document defines quality policy, defines the scope of the Quality Management System; describes the overall quality system, its processes, and their sequence and interrelationships; and further references applicable Quality System Procedures (QSPs). Further, the Quality System Manual identifies the manner in which THE COMPANY addresses each specific requirement of ISO 22000:2005. Quality System Procedures (QSPs): The purpose of QSPs is to guide personnel in the performance of processes, such as carrying out and controlling processes, handling products, maintaining and calibrating, conducting tests and inspections, etc. SOPs are numbered, as illustrated in the table below: Example: QSP Category Document Description Internal Audit Control of Records Management Review Training Purchasing Product Identification and Traceability Product Handling, Storage, Packaging, Preservation, & Delivery Complaint Handling Monitoring and Measurement of Product Control of Nonconforming Materials 12
External Standards and Guidelines: These documents are often referred to as documents of external origin and include industry standards (i.e., ISO 22000:2005) and guidance documents that are indispensable for the application of the Quality Management System. 4.2.3 Control of Documents All the documents relating to the food safety system requirements are controlled as per documented procedure. All proposed changes are reviewed prior to implementation to determine their effects on food safety and their impact on the food safety management system. 4.2.3.1 THE COMPANY has established and maintains Document and Data Control to define the controls needed to: a) Define a standardized process for the development of new documents required by the QMS [i.e., QSPs, WIs, and Forms] b) Review and approved documents for adequacy prior to issue; c) Review and up-date, as necessary, and re-approve documents; d) To ensure that changes and the current revision status of documents are identified; e) To ensure that the relevant revisions of applicable documents are available at the point of use; f) To ensure that documents remain legible and readily identifiable; g) To ensure that documents of external origin [documents such as industry standards and guidance documents indispensable for the application of the TIOT Quality Management System] are identified, their distribution is controlled, and there is an internal process to ensure that the organization s quality management system addresses all required elements of the most current revision of these standards. h) To prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose. 4.2.3.2 THE COMPANY maintains a Document Master List to identify the documents required by the Quality Management System, and their current revision status. 4.2.4 Control of Records All quality records, which are generated in various areas inclusive of those received as "Test Certificates or Calibration Certificates" are maintained to demonstrate the effective operation of the Quality System. Food safety records are maintained to demonstrate the effective implementation of Food Safety Management System. The records are kept legible, identifiable and retrievable. The detail system for identification, collection, storage, protection, filing, retrieval, retention time and 13
Ref. Document and Data Control Ref. Control of Quality Records disposition of quality records is described in the Quality Procedure. The system is applicable for hard copy of records as well as records (soft copy) maintained in electronic media. All the formats used as Quality Records are properly identified and controlled. 14
5.0 Management Responsibility 5.1 Management Commitment Top Management s commitment to the highest quality of products and services to our customers is evidenced in the development and implementation of the Quality Management System in conformance with the requirements of ISO 22000:2005 Quality Management System Requirements, as well the establishment of processes to monitor, measure, and continuously improve it s effectiveness by: Communicating to the organization the importance of meeting customer, as well as statutory and regulatory requirements; Establishing the Quality Policy; Ensuring that quality objectives are established; Conducting management reviews to routinely evaluate the suitability, effectiveness, and degree of implementation of the QMS; Ensuring an annual internal audit of the QMS to verify that the organization continually follows the requirements of the QMS and implement corrective action to continuously improve the system; Ensuring the availability of resources THE COMPANY has identified resource requirements and has provided adequate in house resources in terms of qualified personnel, test equipment and facility for production and testing as per the requirements of safe food practice. Top Management is responsible for providing appropriate resources and trained personnel for effective implementation of the ISO 22000 System in their respective areas. 5.2 Customer Focus 5.2.1 The principle objective of the Quality Management System is to identify customers and to focus our organization on the customer, and in particular customer satisfaction. To that end Top Management is committed to achieving high customer satisfaction through an accurate determination and understanding of customer requirements and effective verification that the requirements are met. 5.2.2 Product Customers: The goal of the QMS is stated in the Quality Policy to meet and/or exceed our customer s requirements We will accomplish this objective by carefully listening to the voice of the customer through complaints and customer satisfaction survey reports, and other means of feedback regarding our products and services. We will routinely communicate with our customers, as possible, to understand our customer s stated and implied requirements. We will establish and maintain processes that are reliable to ensure that products are outsourced and/or manufactured in strict accordance with specifications and drawings. 15
5.3 Food Safety Policy Food safety policy has defined, documented and communicated to all employees by the top management. Food safety policy is laid down and is signed by Top Management It is appropriate to the role of THE COMPANY in the food chain. It confirms both statutory and regulatory requirements as well as food safety requirements of the customer. It is communicated, implemented and maintained within organization It is reviewed for continuing suitability. Measurable objectives are identified and put below the food safety policy. It is the policy of THE COMPANY to meet and/or exceed our customer requirements by ontime delivery of the highest quality of products, in strict compliance with safety and regulatory requirements, while providing maximum value and superior customer service during and after the sale of products. 5.3.1 Top Management shall annually review the Quality Policy for continued appropriateness and suitability to the mission and objectives. This annual review of the Quality Policy shall be documented in accordance with Management Review of the Quality Management System. 5.3.2 The Quality Policy provides an overall framework for establishing specific quality objectives, and provides direction for the goal of continual improvement. 5.3.3 Top Management shall ensure that the Quality Policy is known and understood by all employees, is prominently displayed throughout the facility, and is distributed to customers and other interested parties. Ref. Management Review 5.4 Planning The resources needed to achieve the objectives are identified, discussed in the management review meeting and planned. The resource planning is documented. Top Management ensures that planning of the food safety management system is carried out in line with ISO 22000:2005 requirements and objectives. The quality planning includes a) Processes of the Food safety management system b) Resources needed c) Requirements of safe food practices d) Continual improvement 16
Planning and implementation ensures that changes are conducted in a controlled manner. During the change integrity of Food safety management system is maintained. 5.4.1 Quality Objectives Quality Objectives, consistent with the Quality Policy, are established throughout THE COMPANY in order to meet requirements for products and processes, and to improve the quality system and quality performance. Top Management is responsible for establishing and communicating Quality Objectives to relevant functions within THE COMPANY. Quality objectives are: a) Quantitative and measureable; b) Attainable and realistic; c) Consistent with the Quality Policy d) Controlled by the relevant functions e) Monitored and measured. Inputs into the process of establishing Quality Objectives may include relevant findings from management reviews, current product results, customer satisfaction ratings, customer complaints, and process monitoring results. 5.4.2 Quality Management System Planning 5.4.2.1 The ISO 22000:2005 and Quality Management System Requirements are the primary in-puts in determining the requirements of the Quality Management System. Quality Management System processes are planned to ensure that the QMS is appropriate for its intended purpose, and that it is effectively implemented and managed. 5.4.2.2 The Quality Assurance Manager is responsible for ensuring that the QMS process required are implemented, and that the sequence and interaction of these processes are identified. Processes are documented and controlled and monitored through: Quality System Procedures Work Instructions, where specified Flow Charts Product Quality Planning Records 5.4.2.3 The output of Quality System Planning is documented in this Quality Manual, in Quality System Procedures (QSPs), and on Quality Records designed to provide a complete history of activities. 5.4.2.4 Changes to the Quality Management System are planned and controlled in accordance with Document and Data Control, and are reviewed for adequacy before implementation. 17
Ref. Document and Data Control 5.4 Responsibility and Authority 5.4.1. Top Management has defined responsibilities and authorities and their interrelation for all the persons and communicated the same within the organization to ensure the effective operation and maintenance of the food safety management system. 5.4.2. All staff members are responsible for reporting problems with food safety management system to authorized person. 5.4.3. Personnel in THE COMPANY at various level 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 problems. Requirements of safe food practices. Initiating, recommending and providing solutions to problems. To verify the effectiveness of the solutions. Controlling further processing until all conditions are satisfactory. The organization chart for our company, showing the interrelation of all the personnel who manage, perform and verify the work ensuring quality, is given at the end of this chapter. 5.4.4. Authority and responsibility for all the concerned persons is documented in job description and communicated to them in order to facilitate effective Food Safety Management System. Also copies of job description and specifications are given to the concerned. 5.4.5. In case of vacancy / absenteeism the delegation of authority shall be upward and responsibility goes downward unless otherwise specified in the documents. 5.4.6. Interrelationship of all personnel who manage, perform and verify work affecting product quality is identified in an Organizational Chart (see below). 5.4.7. All departments and functions in the company are responsible for implementing, maintaining and improving the Quality Management System. 18
5.5 Food safety team leader Top Management has appointed Food safety team leader as shown in the Organization structure. Apart from their other duties, he / she has been given the authority for ensuring establishment, implementation and maintenance of the Food safety management system. a) Food safety team leader have responsibility and authority to mange a food safety team. b) Food safety team leader provides training and education to the food safety team members. c) Food safety team leader coordinates with Top Management and Functional Heads and continuously monitors the activities by reviewing records to verify effective implementation and updating of the system. d) He will report to the Top Management on the effectiveness and suitability of the system. e) Authorized person assumes the responsibilities and authorities of the Management Representative during his absence. 5.5.1 Management Representative of the QMS Top Management has appointed the Quality Manager to be the Management Representative of the QMS, who irrespective of other responsibilities has responsibility and authority which includes: a) Ensuring that the QMS is established, implemented, maintained, and continually improved; b) Ensuring that processes needed for the QMS are established, implemented and maintained; c) Promoting quality, regulatory and customer awareness throughout the organization; d) Reporting to top management on the performance of the QMS, including recommendations for improvement; e) Generating, in conjunction with personnel concerned, procedures and instructions defining the organization s general processes, and where necessary; f) Controlling, updating and issuing the organization s QSPs; g) Ensuring that there is a system of verification and audits independent of the person or authority carrying out the functions; h) Analyzing all reported quality problems and ensuring corrective action(s) are taken; i) Coordinating communication with external parties on matters relating to the QMS. j) Ensuring the promotion of awareness of customer requirements throughout the organization. 19
5.6 Communication 5.6.1 External Communication a) THE COMPANY ensures that sufficient information on issues concerning food safety is available throughout the food chain. b) THE COMPANY has established implemented and maintained effective arrangements for communicating with Suppliers and Contractors, Customers or Consumers, in relation to product information which includes instruction regarding intended use, specific storage requirements, shelf life, enquires, contracts order, amendments and customer feedback including customer complaints, statutory and regulatory authorities, other organization that have an impact on, or will be affected by, the effectiveness or updating of the food safety management system. c) Records are maintained for communication, which provide information on food safety aspects of products. d) Food safety requirements from statutory and regulatory authorities and customers are available. e) Top Management has defined responsibility and authority to communicate externally any information concerning food safety. Information obtained through external communication is included as input to system updating and management review. 5.6.2 Internal Communication 5.6.2.1 Internal communication flows two ways: Management communicates to the organization the Quality Policy and Quality Objectives; customer and regulatory requirements; product and process specifications; verification and validation requirements; and instructions on how to implement and maintain the QMS. The organization communicates to Management information and data regarding quality performance and effectiveness of the QMS. 5.6.2.2 Information is communicated as follows: Paper or electronic documents, such as the Quality Manual, SOPs instructions, specifications, quality records, reports, etc. Emails, memos and meetings Verbal communication Training and awareness programs Staff Meetings All employee meetings Special notices provided when there are significant changes to documentation Performance evaluations Employee suggestions and feedback 5.6.2.3 Management Review meetings have a special role in ensuring proper communication between the Quality Council and the organization. The meeting 20
provides a framework for the organization to report on the status of qualityrelated issues and activities, and for Management to formulate and communicate policies and directives to improve the QMS, as defined in QM Section 4.0. 5.6.2.4 Employees are encouraged to provide constructive suggestions and feedback to Management. 5.6.2.5. The organization has established, implemented and maintained effective arrangement for communicating with functional and staff on issues having impact on food safety The organization ensures that the food safety team is informed in a timely manner of changes to maintain the effectiveness of the food safety management system, as follows: a) Products or new products. b) Raw material, ingredients and services. c) Production systems and equipment. d) Production premises, location of equipment, surrounding environment. e) Cleaning and sanitation programmers. f) Packaging, storage and distribution systems. g) Personnel qualification levels and / or allocation of responsibilities and authorizations. h) Statutory and regulatory requirements. i) Knowledge regarding food safety hazards and control measures. j) Customer, sector and other requirements that the organization observes. k) Relevant enquires from external interested parties. l) Complaint indicating food safety hazards associated with the product. m) Other condition that have an impact on food safety. The food safety team ensures that above information is included in the updating of the food safety management system. Top management ensures that relevant information is included as input to the management review. 5.7 Emergency preparedness and response Top management have established, implemented and maintained procedure to manage potential emergency situations and accidents that can impact food safety and which are relevant to the role of the organization in the food chain. 5.8 Management Review 5.8.1 General The system established in THE COMPANY is systematically reviewed for its continuous suitability and effectiveness in confirming the requirements of food safety system management as per documented procedure. The review includes implementation of our food safety Policy and Objectives to identify any areas, which require improvement and evaluate nee d for changes for effective functioning of the system implementation and safe food manufacturing practices. 21
It also includes any changes in our food safety system, Hazard analysis, HACCP plans and results of monitoring of critical control points. This review is carried out at least once a year by Top Management or their nominee by holding Management Review Meetings, which are attended by Food Safety Team Leader and all Top Management. It is the responsibility of the Management Representative to prepare the agenda and minutes of management review meeting covering: Discussion held, Action planned, Target date of completion for planned actions. Person responsible to complete planned actions 5.8.2. Management reviews of the QMS are conducted annually, as a minimum, in order to ensure the continuing suitability, adequacy and effectiveness of the QMS in accordance with Management Review of the Quality Management System, 5.8.3 Management Review Input The purpose of Management Reviews is to evaluated collected data from the following sources: Results of audits (internal, 3rd party, and 2nd party customer audits) Customer feedback (Customer complaints, Customer satisfaction reports, reports and analysis of field nonconformities, and other feedback) Process performance and product conformity (NCR trends) Product delivery performance Status of Corrective and Preventive Actions Follow-Up actions from previous management reviews Changes that could affect the QMS Recommendations for improvement Supplier performance Evaluation of changes to documents of external origin Future training requirements Evaluation of resource requirements Facilities and equipment review 5.8.4 Management Review Output The output from Management Review includes decisions and actions relating to: Improvement of the effectiveness of the QMS and its processes Improvement of product related to customer requirements; Resource needs Establishment of Quality Objectives 22
5.8.5 Management Review meetings are documented in minutes and retained as Quality Records. Ref. Management Review of the Quality Management System, 23
6.0 Resource Management 6.1 Provision of Resources Top management determines and provides the resources necessary to implement and maintain the quality management system and for its continuous improvement, as well as for the resources necessary for enhancing customer satisfaction through meeting or exceeding customer requirements [including human resources, infrastructure, work environment, process equipment, IM&T equipment, and supplies]. THE COMPANY provides adequate resources for the establishment, implementation, maintenance and updating of the food safety management system. Adequacies of these resources are reviewed, for example during Management review Contract review Internal quality audit results Customer complaint review 6.2 Human Resource 6.2.1 General The food safety team and other personnel, who carried out activities having impact on food safety are suitably trained, competent, highly skilled and experienced and having appropriate education. Any kind of external experts are not required by THE COMPANY as of now, but whenever needed for assistance of external experts records of agreement or contracts defining the responsibility and authority are maintained. 6.2.1.1. THE COMPANY has established and maintains Competence Awareness and Training to guide the process of determining and providing sufficient personnel of the appropriate education, skills, experience and training to perform work affecting conformity to product requirements. 6.2.1.2. THE COMPANY has established and maintains job descriptions for each position affecting product quality, which identify appropriate education, skills, experience and training for the position. 6.2.2 Competence, Awareness and Training a) The company identifies necessary competency of employees performing activities impacting on food safety. b) Provides necessary training and on the job training for their staff for upgrading their knowledge and skill so that necessary competencies is 24
obtained. Also during routine work due to change in area of work or any other reason the training needs are identified and provided c) Ensures that employees are trained, who are responsible for monitoring, corrections and corrective actions of the food safety management system d) Evaluates the effectiveness and implementation of the training provided as per the established process approach e) Ensures that employees are aware of the relevance and importance of their activities and how they contribute to the achievement of the food safety. f) Ensures the requirement for effectives communication is understood by all personnel whose activities impacting on food safety g) Maintains appropriate records for the education, experience, training and qualification 6.2.2.1 THE COMPANY has established and maintains Competence Awareness and Training to define the process for: Determining the necessary competence for personnel performing work affecting conformity to product requirements, or any other Identifying the training needs, and provide training, including on-the-job training, where necessary for personnel in any new or modified job affecting product quality, including contract or agency personnel; Evaluating the effectiveness of training, or other actions taken; Ensuring that personnel are aware of the relevance and importance of their assigned responsibilities and tasks, and how they contribute to the achievement of the quality objectives of the organization; Ensuring that personnel whose work can affect quality are informed about the consequences to the customer of nonconformity to quality requirements; Documenting training and maintaining records of education, training, skills and experience. Ref. Training 6.3 Infrastructure THE COMPANY provides necessary resources for the establishment, management and maintenance of the infrastructure needed to implement the requirements in accordance with international standard. 6.3.1. THE COMPANY has established and maintains Facilities and Equipment Maintenance, in order to assign responsibility and define the process at for the identification, maintenance and control of all facilities, machines and equipment, including material handling equipment, used in support of product realization processes. Infrastructure includes, as applicable: Buildings, workspace and associated facilities; 25
Process equipment (both hardware and software); and Supporting services (such as information systems). 6.3.2. Top management is responsible to ensure that facilities are of suitable size, construction, and location with adequate control systems to facilitate operations. 6.3.3. Top management is responsible to ensure that facilities are maintained in a good state of repair. 6.3.4. Preventive Maintenance of essential facilities and equipment is planned, implemented and documented. 6.3.5. Department managers/supervisors are responsible for identifying the need and requirements for new and/or modification or repair to existing infrastructure and facilities. Requests for changes are submitted to the General Manager for review and approval. 6.3.6. Maintenance of facilities and equipment is performed by internal personnel, where specified, and by outside contracted services. 6.3.7. Infrastructure requirements are evaluated as a component of Management Review. 6.4 Work Environment Appropriate work environment is identified to achieve conformity of product and provided considering human and physical factors. Considering nature of our products all necessary care for food safety as well as pest control and personnel hygiene practices are followed. The entire necessary environment as per PRP programs and international standards are implemented. 6.4.1. It is the responsibility of top management to determine and mange the work environment needed to achieve conformity to product requirements, which includes ensuring that the facility is maintained in a good state of repair, organization, and cleanliness consistent with the product and manufacturing requirements. 26
7.0 Planning and Realization of safe products 7.1 General Planning for sequence of processes and sub processes is consistent with safe food practice requirements of THE COMPANY and documented in the HACCP Plan / Process Approach Documents. The process flow chart of THE COMPANY is given in annexure III of this manual. Through effective PRP s and HACCP plan THE COMPANY has implemented, operated and ensured the effectiveness of the planned activities and any changes to those activities. 7.1.1 Planning of Product Realization In order to establish processes and responsibilities for performing quality planning in order to ensure all applicable customer and other external and internal product requirements are identified and satisfied, THE COMPANY has established and maintains Product Quality Planning, which defines how determines the following: Quality objectives and requirements for the product; The need to establish processes and documents, and to ensure appropriate resources are provided specific to the product; Required verification, validation, monitoring, measurement, inspection and test activities specific to the product, and the criteria for product acceptance; Records needed to provide objective evidence that the realization process and resulting product meet requirements. 7.2 Prerequisite programs (PRPs) 7.2.1 THE COMPANY has established, implemented and maintained (PRPs) to assist in controlling the food safety hazards to the product through the work environment. The biological, chemical and physical contamination and cross contamination between products Food safety hazards levels in the product and product-processing environment. 7.2.2 The PRP(s) Food safety team members have identified, prepared and implemented PRPs throughout the production system considering the size of operation, type of operation, nature of the product. THE COMPANY has identified statutory and regulatory requirements related to the products and described in product description. 7.2.3 THE COMPANY has considered following while establishing the PRPs Construction and lay-out of buildings and associated utilities; Lay-out premises, including workspace and employee facilities; Supplies of air, water, energy and other utilities; Supporting services, including waste and sewage disposal; 27
The suitability of equipment and accessibility for cleaning, maintenance and preventative maintenance; Management of purchased materials, supplies, disposals and handling of products (e.g. storage and transportation); Measures for the prevention of cross contamination; Cleaning and sanitizing; Pest control; Personnel hygiene Other aspects as appropriate. Records are maintained for verifications and medication. 7.3 Preliminary steps to enable hazard analysis 7.3.1 General All relevant information is available to collect, maintain, update and document hazard analysis. 7.3.2 Food safety team Top management has appointed food safety team considering knowledge and experience of personnel. 7.3.3 Product characteristics 7.3.3.1 Raw materials, ingredients and product contact materials Raw materials, ingredients and product contact materials documents consist following as appropriate; Biological, chemical and physical characteristics. Composition of formulated ingredients. Origin Method production Packaging and delivery method Storage condition and shelf life Preparation and / or handling before use or processing Food safety related acceptance criteria or specification of purchased materials and ingredients appropriate to their intended use 7.3.3.2 Characteristics of end products The product description of finish products includes following as appropriate; Product name or similar identification; Composition; Biological, chemical and physical characteristics relevant for food safety; Intended shelf life and storage conditions; Packaging; 28