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CNCA N-001-2021: (Hazard Analysis and Critical Control Point (HACCP) System Certification Implementation Rules)
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CNCA N-001-2021: (Hazard Analysis and Critical Control Point (HACCP) System Certification Implementation Rules)

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(Hazard Analysis and Critical Control Point (HACCP) System Certification Implementation Rules) - 1 - Number. CNCA -N-001.2021 Hazard Analysis and Critical Control Points (HACCP) System Certification Implementation Rules - 3 - 1.Purpose and Scope 1.1 In order to standardize the hazard analysis and critical control points of food and food-related industries (HACCP) system certification hereinafter referred to as HACCP certification activities, according to the "Chinese Food Safety Law of the People's Republic of China, Regulations of the People's Republic of China on Certification and Accreditation and other relevant regulations to formulate these rules. 1.2 This rule specifies the certification bodies that carry out HACCP certification (hereinafter referred to as certification bodies). certification body) basic requirements for implementing HACCP certification activities. 1.3 Annex 1 of this rule lists the food chain products/ Service classification. 2.Certification basis Hazard Analysis and Critical Control Points (HACCP) System Certification Requirements (V1.0) (Appendix piece 2) Note. When applicable, in order to meet the needs of the importing country (region), the certification body may Developed by the Codex Alimentarius Commission (CAC) The "General Principles of Food Hygiene" as a supplementary certification basis. 3.Certification procedure 3.1 Certification Application 3.1.1 The certification body shall require the certification client to meet the following conditions. (1) Legal persons registered with the national market supervision and administration department or relevant institutions - 4 - Qualification (or its components); (2) Obtain the administrative licensing documents prescribed by relevant regulations (if applicable); (3) Not included in the relevant list of seriously untrustworthy subjects of national credit information; (4) The products produced and operated are in line with the applicable my country and importing countries (regions). the requirements of laws, regulations, standards and norms; (5) According to the certification basis stipulated in this rule, the HACCP system has been established and implemented. system, and the system has been operating effectively for more than 3 months; (6) There is no violation of relevant laws and regulations of my country and the importing country (region) within one year. regulated food safety incidents; (7) Has not been certified for violating clause 4.2.2(4) or (5) of this rule within three years Agency withdraws HACCP certification. 3.1.2 The certification body shall require the documents and information submitted by the certification client. (1) Certification application; (2) A copy of the legal status certificate; (3) Copies of administrative licensing documents and record-filing certificates stipulated by relevant laws and regulations (suitable for time cost); (4) HACCP system documents (including HACCP manual, product description, work Process flow diagram, process description; hazard analysis, corresponding hazard control measures and their confirmation and verification requirements, etc.); - 5 - (5) Description of organization and responsibilities; (6) Location map and floor plan of the factory; floor plan of the processing workshop; processing production line, Description of seasonal production and shifts; (7) Description of the use of food additives, including the name of the additive used, Dosage, applicable products and limited standards, etc. (when applicable); (8) List of multi-sites and description of entrusted processing (if applicable); (9) Relevant evidence that the product meets the safety requirements; (10) Commitment to comply with relevant laws, regulations, certification body requirements and provide materials self-declaration of authenticity; (11) Other required documents. 3.2 Acceptance of Certification 3.2.1 The certification body shall disclose at least the following information to the certification client. (1) The scope of the certification business that can be carried out, and the situation of obtaining the corresponding accreditation; (2) The certification standards and certification processes on which the certification activities are carried out; (3) Relevant certification schemes and certification procedures; (4) Rules for approving, maintaining, changing, suspending, reinstating and revoking certification certificates rules and procedures; (5) The information to be obtained from the organization, and the confidentiality provisions for the relevant information; - 6 - (6) Certification certificates, certification marks and relevant regulations for use; (7) Appeals and complaints about the certification process; (8) Provisions for changes in certification requirements. 3.2.2 Application Review The certification body shall, after the materials submitted by the certification client are complete, the application documents submitted by them. documents and information and maintain review records to ensure. (1) The certification requirements are clearly defined, documented, and understood; (2) The difference in understanding between the certification body and the certification client is resolved; (3) For the scope of certification of the application, the workplace of the certification client and any If there are special requirements, the certification body has the ability to carry out certification services. (4) The certification body shall determine the relevant scope of the organization's application for certification according to Annex 1. The certification body shall not include activities, processes, and processes that could affect the food safety of the final product within the scope of certification. Processes, products or services are excluded from the scope of certification. 3.2.3 Processing of review results If the application materials are complete and meet the requirements, the certification application will be accepted; If the application review is not passed, the certification client shall be notified to supplement and complete the application within the specified time. If you do not agree to accept the certification application, you should state the reasons. 3.3 Sign the certification contract - 7 - The certification body shall sign a legally valid written certification contract with the certification client or equivalent. Clarify the scope of system coverage and the respective Responsibilities, rights and obligations that should be assumed. 3.4 Audit Planning 3.4.1 The certification body shall develop an audit programme throughout the certification cycle to Do not use it to confirm that the HACCP system of the certification client complies with the certification basis or other specifications audit activities required for compliance with the requirements of the Sexual Documents. The audit programme should cover the entire HACCP body Department requirements. 3.4.2 The initial certification audit plan shall include a two-stage initial audit, certification decision Subsequent surveillance audits and re-certification audits before certification expires. first three-year recognition The certification period is counted from the initial certification decision, and subsequent periods are counted from the re-certification decision. audit The determination of the scheme and any subsequent adjustments should take into account the size of the certification client, its management system, Scope and complexity of products and processes, production season and product safety risks, and Demonstrated level of effectiveness of the HACCP system and results of previous audits. 3.4.3 Surveillance audits shall be conducted at least annually. First supervision after initial certification Surveillance audits shall be conducted within 12 months from the date of the certification decision. Thereafter, surveillance audits shall be At least once per calendar year (except for the year of recertification) and two surveillance audits The time interval must not exceed 15 months. 3.4.4 The audit team shall observe the activities/processes of product/service realization on site. During the initial certification audit, the product/service realization site shall at least cover the scope of the application for certification - 8 - All product/service subcategories within; re-certification audits or annual surveillance audits during the certification cycle At the time of verification, the product/service realization site shall at least cover all products/services within the scope of certification Category (see Annex 1 for classification). 3.4.5 The time to review the product/service realization process on-site should not be less than the total on-site audit 50% of the time. 3.4.6 Review time The certification body shall develop documentation to determine the timing of the audit. Documentation should take into account industry categories, HACCP program, complexity of product/service realization process, size of certification client and other factors, while meeting the requirements of Annex 3 of this rule. 3.4.7 Form an audit team 3.4.7.1 The audit team should have the corresponding product/service category of the client implementing the certification Competence for HACCP certification audits. When the professional technical ability of the audit team is insufficient, it can be Equipped with technical experts to provide technical support, but not included in the audit time. Audit team members should be good health. 3.4.7.2 The certification body shall reasonably plan the connection between the first and second stage audit teams to ensure that the To ensure the continuity of the two-stage review. The second stage audit team should include at least one first Stage Auditor. 3.4.7.3 The second stage of initial certification or re-certification audit team shall consist of at least two auditors member composition. - 9 - 3.4.7.4 The number of consecutive certification audits performed by the same auditor on the same production site Up to 6 times. Note. Phase 1 audits or other types of special audits do not count. 3.4.7.5 The certification body shall inform the certification client before the on-site audit and provide the audit The name of each member of the core team. If the certification client objects to the composition of the audit team and agrees The certification body shall adjust the audit team when it is time to do so. 3.4.8 The certification body shall prepare an audit plan and premise the on-site audit activities to the certification principal. 3.4.9 When the certification client system covers multiple sites, the certification body shall Conduct on-site audits at all sites including central functions to ensure the effectiveness of the audits sex. 3.4.10 When the certification principal will affect the important production process of food safety, use the commission processing, unless the entrusted processing activities of the entrusted processing organization have obtained Corresponding HACCP certification or food safety management system certification, otherwise it should be commissioned for processing Process implementation on-site audit. 3.5 Audit Implementation 3.5.1 Initial Certification Audit The initial certification audit for HACCP certification shall be carried out in two stages. the first stage and the second stage. Stage two. - 10 - 3.5.1.1 Stage 1 Audit The purpose of the first stage audit is to investigate whether the certification client has the ability to implement the certification. Audit conditions and determine the focus of the second-stage audit, the first-stage audit should focus on but Not limited to the following aspects. (1) Collect the scope, process and site of the HACCP system about the certification client necessary information, as well as relevant laws, regulations, standard requirements and compliance; (2) Fully identify the degree of impact of production activities such as outsourced processing on food safety; Preliminary evaluation of the certification client's factory environment, workshop and facilities, equipment, personnel, sanitary management compliance with the corresponding good manufacturing/hygienic practices; (3) Understand the certification client's understanding of the certification standard requirements, and review the certification commission Suitability of human HACCP system documentation and food safety policy. Key assessment and certification committee Compliance and suitability of trustee system documents, with special attention to critical control points and critical limits determination and supporting evidence. (4) Understand the HACCP system and on-site operation of the certification client, and evaluate the certification The client's internal audit, management review, the specific situation and system of the operation site and site the level of implementation, confirm whether the certification client is ready for the second stage audit, and Negotiate the details of the second-stage audit with the certification client, clarify the scope of the audit, and plan the first phase of the audit. The second stage review provides focus. The first stage should be implemented on the site of the certification client to achieve the audit objectives of the first stage. of. When the certification client has obtained other certifications issued by the same certification body based on the HACCP principle - 11 - Food safety-related certification as the core, and when the certificate is valid, the certification body has passed the wind After the risk assessment, the first stage may not be implemented on-site, but it should be ensured that the purpose of the first stage has been All are implemented and the reasons for not being implemented in the field are documented. Certification clients should be informed that the results of the first stage audit may lead to delays or cancellations Phase 2 review. 3.5.1.2 Stage 2 Audit The second-stage audit shall be carried out on the site of the certification client for the purpose of evaluating the certification client Compliance and effectiveness of human HACCP system implementation. The second stage audit should be carried out under the conditions of implementing the certification audit, the first stage Issues raised by the audit affecting the implementation of the Stage 2 audit should be addressed prior to the Stage 2 audit. to resolve. The second stage audit should focus on, but not be limited to, the following. (1) Compliance with all requirements in the certification basis document; (2) Compliance with applicable laws, regulations and standards of my country and the importing country (region) and compliance with the safety and hygiene requirements of export food production enterprises (if applicable); (3) Fulfillment of management responsibilities, implementation of food safety policies, and achievement of goals; (4) Good manufacturing/hygienic practice requirements for corresponding products within the scope of the HACCP system compliance; (5) The effectiveness of the implementation of the prerequisite plan and HACCP plan, and the impact on product food safety ...