Question

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4.4 HACCP计划的验证
4.4.1 HACCP计划的审核
审核是指HACCP计划验证中收集验证所有信息的一种有组织的活动，需对最具有代表性的过程或步骤进行评估，因此，审核是验证中一种有组织收集信息的过程，是HACCP体系活动中对代表性控制过程或因素进行检查的一种方式；其组织方式可参照《内部审核程序》；审核的形式包括现场观察和记录复查两部分。
a 现场观察：
---查200L无菌袋装番茄的工艺描述和生产流程图的准确性。
---监控活动是否在HACCP计划规定的关键控制点进行。
---检查CCP是否按HACCP计划的要求得到监控。
---检查关键控制点是否在规定的关键限值（CL）内运行。
---监控活动是否按HACCP计划规定的频率进行。
---当监控发生偏离关键限值（CL）时是否执行了纠偏行动。
---设备是否按照HACCP计划规定的频率进行校准。
b 记录复查：
---检查记录是否准确、按时填写。
---检查记录的完整性、连续性。
c 审核要求：审核应无偏见、有非负责执行监控活动的人员完成；审核频率应以确保HACCP计划持续执行为准，一般每年一次，如果工艺过程和产品波动大，发现问题较多时审核频率应相对提高。
4.4.2 HACCP系统的验证频率
审核频率应以确保HACCP计划持续执行为准，一般每年一次，如果工艺过程和产品波动大，发现问题较多时审核频率应相对提高。
4.4.3 抽样检验：
HACCP系统的验证还须抽取成品送实验室检验农药与重金属残留、细菌总数、大肠菌数及致病菌等，检测结果符合有关要求（标准）时，才能证明HACCP系统有效。农药与重金属残留、微生物的检测应选用国际公认的方法、国家标准等依据。例如CAC、AOAC、FDA的细菌分析手册以及我国国家标准等。

Answer 1

Verification of HACCP plans 4.4
4.4.1 HACCP plan audit
Audit HACCP plan validation refers to collect all the information in the authentication of an organization's activities, the most representative of the procedure or the procedure for assessment and, consequently, the audit is to verify that an organized collection of process information is HACCP system activities representative control procedure or factors are checked one way; its organization may refer to the internal audit procedures; audit forms including on-site observation and record review in two parts.
A field observation:
---Find 200L aseptic bagged tomato process description and production flow chart accuracy.
-Monitoring activities is in the HACCP plan provides the critical control points.
---Checking CCP is HACCP program requirements monitoring.
-Check whether the critical control points at key limits (CL).
-Monitoring activities according to the HACCP plan frequency.
---When monitoring key limit deviation (CL) rectification action performed.
---Equipment are in accordance with HACCP plan frequency calibration.
B record review:
-Check whether the records are accurate, complete and on time.
---Check the record completeness, continuity.
C audit requirements: audit should be unbiased and non-responsible for the implementation of the monitoring activities should be completed; audit frequency to ensure continued implementation of the HACCP plan, usually once a year, if the process and product price and found the problem more audit frequency should be improved.
4.4.2 HACCP system verification frequency
Audit frequency should be to ensure the sustainable implementation of HACCP plans, usually once a year, if the process and product price and found the problem more audit frequency should be improved.
4.4.3 sampling inspection:
Verification of the HACCP system should also be taken from the finished product laboratory testing of pesticides and heavy metals, total coliform bacteria, and pathogens, and test results meet the relevant requirements (standard), in order to prove that the HACCP system to be valid. Pesticides and heavy metals, microbiological testing should use internationally accepted methods, standards, etc. For example, FDA, AOAC, CAC's bacteriological analysis manual, and our national standards, etc.

Answer 2

field observation:
---Find 200L aseptic bagged tomato process description and production flow chart accuracy.
-Monitoring activities is in the HACCP plan provides the critical control points.
---Checking CCP is HACCP program requirements monitoring.
-Check whether the critical control points at key limits (CL).
-Monitoring activities according to the HACCP plan frequency.
---When monitoring key limit deviation (CL) rectification action performed.
---Equipment are in accordance with HACCP plan frequency calibration.