26  Apr, 2022

Common problems and countermeasures in HACCP certification audit

HACCP audit

There are six types of certification  audits, first-stage audits, second-stage audits, surveillance audits,  certificate renewal audits and re-evaluation. The common problems are as  follows.

The audit plan does not cover the full range of HACCP  requirements

The purpose of the first stage audit is to  review the prerequisites of the auditee's HACCP-based food safety system,  including GMP, SSOP plan, employee training plan, equipment maintenance plan  and HACCP plan, etc. Some auditors have left out parts of the HACCP  requirements in the audit plan for the first stage audit.

The department names in the audit plan do not match  the department names in the auditee's org chart

For example, the department names in the  audit plan are the quality department and the production department, while the  department names in the organization chart of the auditee are the technical  quality department and the production planning department; some of the  departments involved omit the packaging material warehouse, auxiliary materials  Warehouses and finished product warehouses; after some audit materials were  reported, the auditors did not find that the audit plan was incomplete.

Ignoring the details of document review

For example, some organizations have  established a HACCP system, but the number of the rat traps is not indicated on  the water pipe network diagram provided, and the flow diagram and logistics  diagram of the production workshop are not provided, and there is a lack of rat  and fly control information, such as rat and fly control. Procedures (plans),  plant site rodent control network diagram, etc. Some auditors are often blind  to these details.

Records of unfilled observations

Some auditors have the requirement of  "whether the HACCP team members conduct on-site verification in order to  ensure the correctness and completeness of the flow diagram" in the column  "Product Description and Process Flow Diagram" for verification, but  they do not fill in the observation results in the "Observation  Results" column. In the "HACCP Plan" column of the checklist,  there is a requirement that "HACCP documented procedures must be  approved", but in the "Observation" column, there is no record  that the document has been approved.

Missing processing steps

For example, the process flow diagram of  the HACCP plan for canned oranges in sugar water provided by the auditee  includes the "cleaning and blanching" process, but the "Hazard  Analysis Worksheet" omits this process, and the hazard of "cleaning  and blanching" is not carried out analyze. Some auditors did not find in  the documentation and on-site audit that the "cleaning and blanching"  process was omitted by the auditee.

The description of the non-conforming item is not  precise

For example, the locker room in the factory  area is not standardized, the workshop is cluttered, and the original records  are incomplete. In this regard, the auditor should describe the specific  fencing that is not standardized in the locker room in the factory area, where  the workshop is messy, and the types and items with incomplete original  records, so that the organization can take targeted rectification measures.

Follow-up verification is not serious

In the first-stage non-conformity report  issued by some auditors, in the column of "Correction and Corrective  Actions to be Taken", although the organization has filled in "modify  the product description of Tangshui orange and Tangshui loquat, increase PH and  AW values, etc. content, but did not provide any witness materials, and the  auditor even signed and confirmed in the "Follow-up Verification"  column.

Incomplete evaluation of HACCP plan

Some auditors did not evaluate the  determination of CCP and the rationality of the formulation of HACCP plan in  the first stage audit report issued. For example, in the first-stage audit  report, it was written, "After the audit team audited, except for the  imperfect parts." Some auditors wrote in the "Audit Summary and HACCP  System Effectiveness Evaluation Opinions" column of the HACCP audit  report. , "Failure to take appropriate corrective action when individual  CCP monitoring deviates."

Some countermeasures

2.1 The auditor should first review whether  the GMP, SSOP, requirements and HACCP documents documented by the auditee meet  the requirements of the standard, such as HACCP plan, documentation, process  verification, critical limits of each CCP point, and whether hazards can be  controlled. Focus on reviewing whether the HACCP plan properly monitors the  critical control points, whether the monitoring and verification measures are  consistent with the system documents, and comprehensively review the management  of the HACCP documents by the auditee.
 2.1.1 Generally, the following documents  must be reviewed:
 2.1.2 Process flow diagram with indicated  CCP and related parameters
 2.1.3 HACCP worksheet, which should include  identified hazards, control measures, critical control points, critical limits,  monitoring procedures and corrective actions;
 2.1.4 Validation worklist
 2.1.5 Records of results of monitoring and  verification in accordance with the HACCP plan
 2.1.6 Supporting Documents for the HACCP  Plan
 2.2 The audit plan prepared by the audit  team leader must cover all the requirements of the audit criteria and all areas  within the scope of the HACCP system, the audit department must cover the  relevant provisions of the HACCP requirements, and the audit schedule must meet  the time limit requirements specified by the certification body. Before the  on-site audit, it is necessary to introduce the auditee's profile and relevant  professional knowledge of food hygiene to the audit team.
 2.3 The preparation of the audit checklist  needs to cover the requirements of the audit plan. When compiling the checklist,  it should be based on the relevant HACCP system and its application criteria  and the organization's HACCP system documents, and pay attention to the way of  review. Auditors should have a full understanding of the organization's HACCP  system documents, compile a checklist based on the actual situation of the  organization, and need to consider sampling principles. Based on the checklist  in hand, the auditor can grasp the audit time and key points in the audit  process, and can quickly or change the content of the checklist when  encountering new situations. If the auditor finds that the content of the audit  plan and the checklist is not accurate, such as omission of audit criteria,  unreasonable audit time arrangement, unclear audit ideas, unspecified number of  samples for sampling, etc., the checklist should be revised in time.
 2.4 At the audit site, the auditor should  conduct an independent hazard analysis on the product based on the verified  process flow and process description, and compare it with the hazard analysis  worksheet established by the HACCP team of the auditee, and the two should be  basically consistent. The auditor should judge whether the potential hazards  have been identified and well controlled by the auditee, and whether the  significant hazards have been controlled by CCP. The auditee shall ensure that  the CCP monitoring plan formulated in accordance with the HACCP plan is  basically effective, the critical limits are scientific and reasonable, and the  correction procedures can cope with various possible situations.
 2.5 Auditors take a representative sample  for audit records and on-site verification. The auditor should judge whether  the product processing process of the auditee can be carried out in accordance  with the process flow and process requirements stipulated in the HACCP plan,  whether the monitoring at the CCP point is basically and effectively  implemented, and whether the CCP monitoring personnel have received  corresponding qualification training and are competent for their positions.  Work. The auditee shall be able to record the monitoring results of the CCP in  a timely manner and review it every other day. The records shall be basically  accurate, true and reliable, and can be traced back; corresponding corrective  measures can be taken for the deviations found in the monitoring of the CCP;  Periodic confirmation and evaluation are required. The on-site audit should  confirm that the GMP, SSOP and prerequisite plans are basically complied with  by the auditee and keep corresponding records; the auditee can timely rectify  the problems found and customer requirements. Comprehensively evaluate whether  the implementation and operation of the HACCP system established by the auditee  meets the specified requirements.
 2.6 The auditor should follow up and verify  the auditee's closure of the non-conformity report in the first stage, and need  to verify the accuracy of its analysis of the reasons for the non-conformity,  the degree of corrective actions and the degree to which the witness materials meet  the requirements, and the accuracy of the verification conclusion of the  follow-up situation, etc. .
 2.7 The HACCP audit report issued by the  audit team leader must meet the specified requirements, the audit report should  be accurate and complete, the language used should be accurate, the  effectiveness of the auditee's HACCP system should be evaluated, and the audit  conclusion should be objective and fair.