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§ 417.4 Validation, Verification, Reassessment.
（a） Every establishment shall validate the HACCP plan's adequacy in controlling the food safety hazards identified during the hazard analysis, and shall verify that the plan is being effectively implemented.
（1） Initial validation. Upon completion of the hazard analysis and development of the HACCP plan, the establishment shall conduct activities designed to determine that the HACCP plan is functioning as intended. During this HACCP plan validation period, the establishment shall repeatedly test the adequacy of the CCP's, critical limits, monitoring and recordkeeping procedures, and corrective actions set forth in the HACCP plan. Validation also encompasses reviews of the records themselves, routinely generated by the HACCP system, in the context of other validation activities.
（2） ongoing verification activities. ongoing verification activities include, but are not limited to:
（i） The calibration of process-monitoring instruments;
（ii） Direct observations of monitoring activities and corrective actions; and
（iii） The review of records generated and maintained in accordance with §417.5（a）（3） of this part.
（3） Reassessment of the HACCP plan. Every establishment shall reassess the adequacy of the HACCP plan at least annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; personnel; packaging; finished product distribution systems; or, the intended use or consumers of the finished product. The reassessment shall be performed by an individual trained in accordance with §417.7 of this part. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan no longer meets the requirements of §417.2（c） of this part.
（b） Reassessment of the hazard analysis. Any establishment that does not have a HACCP plan because a hazard analysis has revealed no food safety hazards that are reasonably likely to occur shall reassess the adequacy of the hazard analysis whenever a change occurs that could reasonably affect whether a food safety hazard exists. Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; packaging; finished product distribution systems; or, the intended use or consumers of the finished product.
§417.4 核查 審核 評價
（a）每個企業都必須核查HACCP計劃在控制危害分析時所確定的食品安全危害的適宜性，還必須審核計劃在有效地實施。
（1） 初期核查
企業必須按照完成的危害分析和制定的HACCP計劃進行預定的工作，以決定HACCP計劃按預期的目的在有效地進行。在此HACCP計劃核查期間，企業必須反復地測試該HACCP計劃中提出的關鍵點，關鍵限值，監測，記錄保存程序和糾正措施的適宜性。核查還包括記錄本身、HACCP系統日常得到的記錄、其它核查活動的檢查。
（2）進行的審核工作
進行的審核工作包括、但不限于：
（i）加工過程中監測儀器的標準；
（ii）直接觀測監測活動和糾正措施；
（iii）按照本部分 §417.5 （a）（3）檢查得到和保存的記錄。
（3）評價HACCP計劃
每個企業至少每年及發生任何可能影響危害分析的變化，或修改HACCP計劃時必須對HACCP計劃進行充分的評價。這種變化可能包括、但不限于：因原料或原料來源，產品配方，屠宰或加工方法或系統，產量，人員，包裝，成品流通系統，或成品預期使用或消費的改變。這種評價必須由按照本部分417.7受過培訓的人員完成。當評價表明該計劃不符合本段417.2要求時，必須立即對HACCP計劃進行修改。
（b）危害分析的評價
因危害分析已表明沒有可能發生的食品安全危害而沒有HACCP計劃的任何企業，當發生變化，不管一種食品安全危害的是否存在都可能受到影響時，都必須對該危害分析進行充分的評價。這種變化可能包括、但不限于：因為原料或原料來源，產品配方，屠宰或加工方法或系統，產量，包裝，成品流通系統，或成品的預期使用或消費的變化。
