Post-license supervision and management control procedures

ost-license supervision and management control procedures




1 the general




In order to supervise and manage the operation of the organization within the validity period of the certificate, and to verify its ability to continuously meet the certification requirements, this procedure is formulated.




2 Scope of application




This procedure applies to the supervision, management and recertification of the certified organization within the validity period of the certificate.




3. Management Responsibilities




3.1 The Audit Department shall be responsible for the supervision after certification and the implementation of re-certification.




3.2 The Marketing Training Department is responsible for the liaison management of recertification.




3.3 The technical committee shall be responsible for reviewing and approving the conclusion of the supervision and recertification audit.




3.4 General Office shall be responsible for the management of non-routine inspection.




4 Management Procedures




4.1 Regular supervision




4.1.1 Quality management system




4.1.1.1 Frequency and time of supervision




The frequency of supervision and audit should be determined according to the quality risk degree or other characteristics of the certified organization's products or services. A supervisory audit shall be conducted at least 12 months after the second stage audit of the initial certification. Thereafter, the time interval for each supervision audit shall not exceed 12 months. When the time limit for supervision and audit is reached and there is evidence that the certified organization does not have the conditions for the implementation of supervision and audit temporarily, the time limit for supervision and audit may be appropriately extended, but the longest interval shall not exceed 15 months.




Supervision and audit should be carried out on the site of the authorized organization. Due to the seasonal reasons of product production, it is difficult to cover all products in each supervision and audit, and the supervision and audit within the validity period of the certification shall cover all products within the scope of certification.




The supervision audit time shall not be less than 30% of the audit time per person/day calculated according to the initial audit.




4.1.1.2 Contents of supervision




At least the following contents shall be reviewed during supervision and audit:




(1) Whether the activities covered by the quality management system and the resources of the operating system have changed since the last audit.




(2) Whether the identified important key points are operating normally and effectively according to the requirements of the quality management system.




(3) Whether the corrective actions taken for the nonconformities identified in the last audit and the corrective actions are still effective.




(4) If the activities covered by the quality management system involve the provisions of laws and regulations, whether they continue to comply with the relevant provisions.




(5) Whether the total quality objectives and quality objectives at all levels have been achieved. If the target has not been realized, whether the certified organization has timely investigated and taken improvement measures during the internal management review.




(6) whether the use of the certification mark or the reference to the certification qualification conforms to the relevant provisions of the certification organization.




(7) Whether the internal audit and management review are standardized and effective.




(8) Whether to receive and handle complaints in a timely manner.




(9) In view of the problems found in the internal audit or complaints, timely formulation and implementation of effective continuous improvement.




4.1.2 Food safety management system




4.1.2.1 Frequency and time of supervision




The supervision audit shall be arranged every 9-12 months since the completion of the last audit. The time interval shall be calculated from the last day of the last audit (the time of the first supervision shall be calculated from the last day of the second phase of the first audit), and the maximum time interval shall not exceed 12 months.




Seasonal products should be supervised during the production season. Each follow-up supervision audit should cover all products within the scope of the food safety management system certification as far as possible. Due to seasonal reasons of product production, it is difficult to cover all products in each follow-up supervision audit, the follow-up supervision audit within the validity period of the certification certificate must cover all products within the scope of the food safety management system certification.




4.1.2.2 Contents of supervision




At least the following contents shall be reviewed during supervision and audit:




(1) Internal audit and management review;




(2) Measures to be taken for the non-conformance determined in the last audit;




(3) Handling of complaints;




(4) the effectiveness of the management system in achieving customer goals;




(5) the progress of planned activities for continuous improvement;




(6) Continuous operational control;




(7) Any changes;




(8) the use of marks and/or references to other certification qualifications.




4.1.3 Organic products: the audit department shall form a written audit plan, please refer to the Audit Program Management Procedure, and the key points of supervision and inspection shall be specified in the inspection plan. During the validity period of the certificate, the audit department shall carry out routine supervision and inspection on the certified enterprises according to the requirements of the audit program. For r inspection of subcontractors of organic production operators, see Inspection Measures for Subcontractors of Organic Production and Processing.




Formation of supervision and audit scheme for organic products within the validity period of the certificate:




­ — — When applying for review, according to the rotation plan provided by the certification client, if there are multiple production seasons for the varieties of the same certification within the validity period of the certificate, on-site inspection shall be conducted for each production season, and the number and time of supervision and inspection shall be determined when the contract is signed. The results of coordination will be formed into a written audit plan, which is convenient for the implementation of audit scheduling.




— — The technical committee according to the certification of product types and risks, the stability of the production enterprise management system, the overall situation of the local integrity level, in the approval of the certification certificate to determine the reasonable frequency of on-site inspection, and the results of coordination into a written audit program, to facilitate the implementation of the audit scheduling arrangement.




4.1.4 HACCP system:




4.1.4.1 Frequency and time of supervision




The time interval or frequency of supervision and audit should be reasonably determined according to the risks of the products covered by the certified organization and system. When major changes occur in the system or food safety accidents, the frequency of supervision and audit should be increased.




Supervision and audit should be carried out at least once a year. The first supervisory audit after the initial certification shall be conducted within 12 months from the last day of the second stage audit. Each supervision and audit should cover all products within the scope of HACCP system certification as far as possible. Due to the seasonal production of products and other reasons, it is difficult to cover all products in each supervision and audit, the supervision and audit within the validity period of the certification certificate must cover all products within the scope of HACCP system certification.




4.1.4.2 Contents of supervision




Supervision and audit shall include but not limited to the following contents:




(1) Changes and maintenance of the system;




(2) changes in suppliers of important raw and auxiliary materials and entrusted processing;




(3) Product safety;




(4) Maintain and change the organization's good manufacturing practice (GMP), health standard operating procedure (SSOP), critical control points, CLs and their effectiveness;




(5) Customer complaints and handling;




(6) The scope of certification involved in the change;




(7) Corrective measures taken for the non-conformance determined in the last audit;




(8) Consistent compliance with relevant laws, regulations and standards of China and the importing country (region);




(9) The result of the spot check by the quality supervision or industry competent authorities;




(10) Use of certificates.




4.1.5 Dairy HACCP system:




4.1.5.1 Frequency and time of supervision




The changes of the certified dairy enterprises and their HACCP system should be considered, and the tracking and supervision activities of the certified dairy enterprises should be planned to monitor the activities within the scope of the system on a regular basis. Follow-up supervision activities include supervision audit, daily supervision and so on.




The time interval or frequency of supervision and audit should be reasonably determined according to the risks of the certified dairy enterprises and the products covered by the system. When major changes occur in the system or food safety accidents, the frequency of supervision and audit can be increased as the case may be. The first supervisory audit after the initial audit shall be carried out within 12 months from the last day of the second stage audit. The interval between supervision and audit shall not exceed 12 months and shall be supervised under production condition.




Each supervision and audit should cover all products within the scope of HACCP system certification as far as possible. Because of the production period of the product, it is difficult to cover all products in each supervision and audit, the supervision and audit within the validity period of the certification must cover all products within the scope of HACCP system certification.




Where necessary, supervision and audit shall verify the safety of the product. The verification requirements are the same as the initial certification audit.




4.1.5.2 Contents of supervision




Supervision and audit shall include but not limited to the following contents:




(1) Changes and maintenance of the system;




(2) Change of daily supply of fresh milk (when applicable);




(3) Product safety;




(4) Customer complaints and handling;




(5) the scope of certification involved in the change;




(6) Corrective measures taken for the non-conformance determined in the last audit;




(7) the use of certificates;




(8) Other selected scopes, as appropriate.




4.1.6 Dairy products GMP system




4.1.6.1 Frequency and time of supervision and audit




(1) The certified dairy enterprises shall be supervised and audited at least twice a year, and at least one of them shall be without notice.




(2) The audit should be carried out in the production period, and the audit team should observe the production activities of the product on the spot. In the certification of dairy enterprise system major changes or food safety accidents, should be timely implementation of supervision and audit.




(3) Without notifying the supervision and audit, it can provide the audit plan to the certified dairy enterprises 48 hours before the audit, and the certified dairy enterprises shall not refuse the audit without justifiable reasons. The first failure to accept an audit will result in a written warning and the second failure will result in the suspension of the certificate.




4.1.6.2 Contents of supervision and audit




The supervision and audit procedures and contents are the same as the initial certification audit. Supervision and audit shall also focus on (but not limited to) the following contents:




(1) the maintenance and change of the implementation of GMP in the certified dairy enterprises;




(2) Spot checks and customer complaints by quality supervision or industry authorities;




(3) Scope of the changes involved.




4.1.7 The audit department shall formulate the supervision and audit plan, determine the audit date with the auditee, and establish an audit team.




4.1.8 The audit team leader shall be responsible for preparing the implementation plan of supervision and audit, which shall include the name of the supervision and audit organization, the purpose and scope of supervision and audit, the basis and standard of audit, the members of the audit team, the date of implementation of audit and the specific audit schedule.




4.2 Information notification and special audit, unnotified inspection




4.2.1 Information circulation




4.2.1.1 Management system




During the validity period of the certification certificate, the organization shall inform CHTC of the following situations in a timely and active manner:




— — Complaints have been received about approved products.




— — Organize the replacement of the legal representative of the authorized organization;




— — Product change, production process change or area expansion, management right or ownership change;




— — Significant changes have been made to management system documents.




4.2.1.2 Organic products




For organic product certification organizations, CHTC in the contract signed with the certification client, clearly agreed that the certification organizations need to establish an information notification system, timely notify the certification body of the following information:




(1) Information on legal status, business status, organizational status or change of ownership.




(2) Change of management and contact address of the authorized organization.




(3) Information on changes in organic product management system, production, processing, operation status, process or production and processing sites.




(4) information about major animal and plant epidemics and environmental pollution occurring around the production, processing and business sites of the licensed products.




(5) Important product quality and safety information in the process of production, processing, operation and sales, such as serious quality and safety problems or major complaints from consumers found in spot check by relevant departments.




(6) The authorized organization has been punished for violating relevant laws and regulations of national agricultural products and food safety management.




(7) The raw materials or products purchased do not meet the requirements of the certification basis.




(8) Information on the withdrawal and disposal of nonconforming products.




(9) Use of sales certificates and product write-offs.




(10) Other important information.




4.2.1.3 HACCP system for dairy products




In order to ensure the continuous effectiveness of the HACCP system of the certified dairy enterprises, it is required to establish an information notification system with the certified dairy enterprises, and timely obtain the following information of the certified dairy enterprises:




(1) relevant legal status, business status, organizational status or ownership; Organization and management; Address and place of contact; The scope of operation covered by the Certification Management System; Major changes in management systems and processes, including information about major changes in products, processes, key management, decisions or technical personnel;




(2) Changes in the supply of fresh milk (when applicable);




(3) information about consumer complaints;




(4) Information about major animal and plant epidemics in the surrounding area;




(5) Information about food safety accidents;




(6) Information about serious food safety problems found in quality supervision or inspection by industry competent authorities or market spot check;




(7) Information on recall and disposal of nonconforming products;




(8) Other important information.




4.2.1.4 Dairy products GMP system




In order to ensure the continuous effectiveness of GMP in certified dairy enterprises, the certification body shall be required to establish a communication system with the certified dairy enterprises and obtain the following information of the certified dairy enterprises timely:




(1) Information about changes in products, processes, environment and organizational structure;




(2) Changes in the supply of fresh milk (when applicable);




(3) information about consumer complaints;




(4) Information about major animal and plant epidemics in the surrounding area;




(5) Information about food safety accidents;




(6) Information about serious food safety problems found in official inspection or market spot inspection organized by the government;




(7) Information on recall and disposal of nonconforming products;




(8) Other important information.




4.2.1.5 Food safety management system




In order to ensure the continuous effectiveness of the food safety management system of the certification organization, it is clearly agreed through the way of signing a contract with the certification applicant. The certification organization is required to establish an information notification system and inform the following information to the organization in time:




(1) Information on legal status, business status, organizational status or change of ownership;




(2) Information about changes in the organization and management (such as key management, decision-making or technical personnel);




(3) Contact address and location change information;




(4) information on major changes to the food safety management system and process;




(5) Information about changes in products, processes and environment;




(6) Information about major animal and plant epidemics in the surrounding area;




(7) Information about food safety accidents, consumer complaints, etc.;




(8) Information about serious food safety problems found in official inspection or market spot inspection organized by the government;




(9) Information on the withdrawal and disposal of nonconforming products;




(10) Other important information.




4.2.1.6 HACCP system




In order to ensure the continuous effectiveness of the HACCP system of the certified organization, the certification body shall establish an information notification system with the certified organization, and timely obtain the following information of the certified organization:




(1) Information relating to legal status, business status, organizational status or ownership change;




(2) Information about changes in the organization and management (such as key management, decision-making or technical personnel);




(3) Contact address and location change information;




(4) HACCP system and process major change information, product process environment change information;




(5) information about food safety accidents and consumer complaints;




(6) Information about major animal and plant epidemics occurring in the region;




(7) Information with serious food safety problems is found in the official inspection or market spot inspection organized by government departments, or exported


The product is notified by the competent authority of the importing country (region) due to safety and health problems;




(8) Information on recall and disposal of nonconforming products;




(9) Other important information.




4.2.2 Special audit




4.2.2.1 Expand the scope of certification




For certification granted, the contract reviewer shall review the application for an extension of the scope of certification and determine any audit activities necessary to determine whether the extension can be made in conjunction with an oversight audit. For the audit of expanding the scope of certification, the audit department shall formulate a special audit plan, including the standard terms and contents of the inspection. Make sure you have the capacity to expand your scope.




The change notice of the certified enterprise shall be reviewed by the audit department to decide whether on-site inspection is needed and notify the certified enterprise of the decision. The certified enterprise shall not publicize the changed product certification information to the outside world in any form before receiving the notice. In particular for organic products, the operator shall not release any modified licensed product without prior notice from the CHTC.




4.2.2.2 If the following major changes occur, affecting the operation of the management system certification or can not meet the certification standards, the inspection can be conducted without notice, the inspection shall not notify the certified enterprises in advance, the inspection time can not be predicted by the enterprises, according to the supervision results to determine whether the need for certification qualification suspension, retraction and other processing:




---- occurred a major product quality accident;




---- The ownership, organization and management of the supplier have changed;




— — A wide range of departments and personnel do not implement the adopted standards;




---- the country is not qualified in the product quality supervision and spot check;




---- Changes that significantly affect the product design or specification;




---- Other information indicating that the product may no longer meet the requirements of the certification system;




— — Organizational change of the authorized organization or individual.




4.2.3 No notice of inspection (applicable to organic products)




4.2.3.1 On the basis of risk assessment, the audit department shall compile the non-notification inspection plan or list in January every year. The audit department shall be responsible for the implementation of the non-notification inspection plan. The number of enterprises that do not notify the inspection shall not be less than 5% of the number of certified organizations in the previous year. The result of the planning shall be a written "Annual Notification Inspection Plan", which shall include a list of enterprises not to be notified for inspection and shall be arranged for implementation.




4.2.3.2 Planned non-notice inspection shall be completed before the end of each year. If necessary, the proportion of non-notice inspection shall be increased. The contents of non-notification inspection shall be carried out according to the Implementation Form for Non-notification Inspection of Organic Product Certification Enterprises, and the inspection records shall be uniformly archived and kept by the Technical Committee.




4.2.4 Tracking investigation (HACCP system is applicable)




4.2.4.1 Method of follow-up survey




The audit department should plan the follow-up investigation on the basis of the risk analysis, and can organize and implement the follow-up investigation on the certificate by means of on-site audit without notice, product sampling inspection on the production site, market sampling inspection, questionnaire survey, etc. The proportion of follow-up organizations should be no less than 5% of the total number of certified organizations annually. If the number of certified organizations is less than 100, the number of follow-up investigations should be no less than 5.




4.2.4.2 No notification of on-site audit




Without notifying the site audit, the audit plan can be provided to the authorized organization 48 hours before the audit. The authorized organization shall not refuse the audit without justifiable reasons.




The first failure to accept an audit will result in a written warning and the second failure will result in the suspension of the certificate.




4.3 recertification




4.3.1 Three months before the expiration of the certificate, the enterprise applying for certification shall apply to CHTC for re-certification and sign a re-certification contract. The audit control shall be carried out according to the Audit Implementation Control Procedures and Inspection Implementation Control Procedures, but the following contents shall also be paid attention to:




— — Evaluate the effectiveness of the entire management system by combining the internal and external changes of the certification organization (whether the certification coverage is still supported after the changes);




— — The suitability, compliance and effectiveness of the management system related certificates;




— — Whether the operation of the certification management system promotes the realization of organizational policies and objectives (overall performance);




— — Use management system performance information (past audit nonconformance, report, etc.) to improve the efficiency and effectiveness of audit;




— — A situation in which an organization improves itself to promote its sustainable development.




If no application is made to CHTC before the expiration of the certificate, the comprehensive office will issue a notice to cancel the certificate and stop using the certification mark and require the enterprise to return the original certificate.




4.3.2 The validity period of certificates of quality management system, HACCP system and food safety management system is 3 years, the validity period of HACCP and GMP certificate of dairy products is 2 years, and the validity period of organic product certification certificate is 1 year. Three months before the expiry of the certificate, apply for authentication enterprise to CHTC recertification the renewal application, the certification contract and sign again, its audit control reference to "audit control procedures", does not apply to the CHTC prior to the expiry of the certificate, the office sent its the cancellation certificate and stop using the certification mark notice and require companies to return the original certificate.




4.3.3 Recertification shall review the operation of the certified enterprises within the validity period of the certificate. In case of major changes in the recertification organization, such as legal changes, changes in production sites, production processes and production equipment, a one-stage audit shall be carried out. When conducting a recertification site audit, ensure that the audit organization is:




— — Whether the operation of the management system promotes the realization of the organizational policy and objectives;




— — The effective interaction of all elements in the system;




— — The overall effectiveness of the system in the face of operational change;




— — A proven commitment to maintain the effectiveness of the management system and to improve the management system to improve overall performance;




— — Proven commitment to meet the requirements of laws and regulations;




— — Effectiveness of management review and internal audit;




— — Check the effectiveness of the certification scope management system and the continued relevance and suitability of the certification scope in combination with internal and external changes;




— — Performance evaluation during the previous certification cycle.




4.3.4 The performance evaluation of the certification cycle shall be led by the contract management personnel, and the audit department, technical committee and marketing personnel shall be organized to conduct the evaluation, and the Performance Evaluation Form of the Certification Cycle of Recertification Enterprises shall be completed.




4.3.5 Special requirements for recertification of organic products




If the organic product management system and production and processing process of the certified organization have not been changed, the application review and document review procedures can be appropriately simplified. Organic products shall be re-certified and inspected within the validity period of the certification certificate. If the re-certification inspection cannot be carried out within the validity period of the certification certificate due to force majeure, the certificated organization should submit a written application to the certification body within the validity period of the certificate, explaining the reasons. Once confirmed by the certification body, re-certification can be carried out within three months after the validity of the certification certificate, but no more than three months. The products produced within the extension period shall not be sold as organic products. Production units that cannot carry out on-site inspection within the validity period of the certification and are recertified within the extension period of 3 months without justifiable reasons shall be recertified again.




4.4 Supervision, recertification and results




4.4.1 Audit Control Procedures shall be followed for the procedures of supervision, audit and re-certification audit. For the certification organization found in the recertification of non-conformity or lack of evidence of conformity, should be completed within the validity period of the last certification certificate, to ensure the continuity and conformity of the two certification.




4.4.2 The shortest period for the auditee to carry out internal quality audit and management review shall not exceed 12 months. The audit report shall conclude whether CHTC should be recommended for continued certification.




4.4.3 The audit department signs the conclusion of the supervision and re-certification audit team.




4.4.4 The technical committee shall be responsible for reviewing and approving the supervision and audit report, re-certification audit report, system evaluation records and complaints of certification use within the certification cycle, and draw certification conclusions. If the certified customers continue to meet the requirements of the management system standards, the certification shall be maintained. In the event of major changes or major problems in the system operation of the audIt 'organization, it shall put forward the handling opinions of taking corresponding measures such as replacement of certificate, suspension, cancellation and so on, and report to the general manager for approval. See "Approval, Maintaining, Expand, Narrate, Suspension, Revocation, Cancel and Resuperation of Certification Registration Control Procedures".




4.4.5 The audit records, decisions and relevant materials of supervision and recertification shall be maintained.




5 Relevant documents




Control Procedures for Audit Implementation




Control Procedures for Approving, Maintaining, Enlarging, Narrowening, Suspending, Revoking, Canceling and Restoring Certification Registration




6 Related Records




Recertification Enterprise Certification Cycle Performance Evaluation Form




"Non-routine Inspection Implementation Form for Organic Product Certification Enterprises"

 

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