exposed represents little or no additional risk.
Examples:
- Thermal processing, aseptic processing high acid foods - Maple processing
- Honey processing
- Freezing, drying, packaging fruits - Drying, packaging vegetables 18.1.7. Audit preparation
According to the HACCP plan there are certain activities that lead to a proper auditing. These activities constitute the “audit plan” and can be summarised as following:
47. Audit scope: There should be always a definition of the boundaries of an audit (i.e.
what is going to be audited). It may depend by factors such as results of previous audits, establishment profile, consumer complaints and other information.
48. Identification of the Chief auditor and the team members (if it is applicable): The number of auditors required depends on the size of the company and the diversity of the functions carried out within the establishment. The audit team members are selected in relation to specified requirements (training, experiences, etc). They can belong to the plant staff or to an external structure. The auditors must be independent of the function and the department being audited. This is absolutely necessary to prevent conflict of interest.
The plant management should provide the auditor/auditing team with all documentation at its disposal. Specifically the auditor/auditing team, should review one or more of the previous audit reports. It is important to highlight the presence of recurrent non-conformities or if there is any outstanding corrective action request.
In order to avoid the possibility to obtain insufficient or incomplete data, the auditor/auditing team will choose and elaborate all necessary tools. This necessary
documentation to facilitate the auditor’s work and to document and record all results must include:
Check list36 to evaluate HACCP system elements and elaborate a specific segment of the system;
forms to record all findings collected;
forms to document the objective evidence in order to support the auditors final conclusion
18.1.8. Opening meeting
It is necessary for the members of the audit team to be introduced to the management representatives so they can review together the key areas of the planned audit. This meeting allows the establishment of official communication links between the audit team and the management of the plant and confirms that the resources and facilities needed are available for the team. Furthermore it is the proper time and place when all necessary written prerequisite programmes and HACCP plans will be made available to the team.
18.1.9. Gathering information
The audit is necessary to obtain evidence that procedures, documents and other information describing HACCP system are kept up to date, are adequate in order to achieve the required food safety objectives and they meet regulatory requirements. For this reason, the auditor should conduct a series of activities such as questioning, observing, examining records etc.
The auditor will record any audit findings and document it on the audit worksheet. If any audit findings encountered during an audit, have not been audited at that time, then they will be dealt with in the future in the appropriate manner. For example, pest control procedures is not included in audit scope. However, if during the on-site verification pests are seen, the pest control procedure will be added to the audit plan.
Gathering information from on-site verification
On-site verification confirms that the monitoring procedures are carried out as described in the written programme and that they are effective. Individuals are interviewed and should be able to demonstrate that they have an understanding of the critical limits, reason and importance of the monitoring of this CCP and know how to perform the related monitoring procedures, including record keeping. Information is also gathered through physical observation of activities carried out by the responsible employee and conditions found in the selected areas of the plant. The correct records are being used for this CCP.
Personnel responsible of selected areas will be interviewed in order to establish that they have access to what they have understood and they are familiar with the written procedures. A checklist is important to structure the interview. The auditor must be equipped to ask the right questions in order to get the information required. The information gathered through the interview, will be tested, by acquiring the same information from other sources. The auditor will directly observe the plant condition to verify specific procedures.
Gathering information on Establishment
36 Checklist is a tool commonly used for its peculiar characteristics. It permits to standardise the audit procedure, avoid partial, insufficient and improvised audit record.
All valuable information for the establishment is gathered by on-site inspection.
This verifies the real and correct application of the rules described in HACCP manual, which guarantee food wholesomeness and the adequate condition of working areas and equipment/machinery.
Record review
All monitoring activities (deviations and the resulting corrective actions) are recorded and signed by the person doing the monitoring on a timely basis. They are up-to-date and complete for this CCP. Records show that the monitoring procedures are carried out as described in the written programme and that they are effective.
18.1.10. Results
The data provided by audit, need to be analysed in order to discover trends and confirm improvements, to highlight difficulties in the application of procedures or in particular activities or step of the process, and finally to give right information on what types of corrective actions have being carried out and how long corrective actions take to be implemented
In relation to the types and number of non-conformities it is possible to point out the need for a more frequent or specific training of employees (on technical aspects or on food hygiene principles).
It is always necessary evaluating the impact of non-conformities on consumer health in order to decide immediate corrective actions.
18.1.11. Closing meeting
The auditor will communicate all findings to the HACCP co-ordinator. Prior to preparing the audit report, the audit team will meet with management representatives and present the audit findings. In relation to the evaluation of non-conformities identified, the audit team will propose the Corrective Action request and the timetable to solve them. The auditor should be sure that the results of the audit are clearly understood.
18.1.12. Audit report
The audit report has to include the scope of the audit, the identification of the chief auditor and audit members, the identification of the establishment representatives, the identification of the reference documents against which the audit was conducted and of course the audit findings.
The audit findings have to be supported by the “evidence”. This means that the auditor has to report “what” and “where” he detected the non-conformity.
18.1.13. Principal characteristics and subjects of regulatory audit (according to the Council Directive 89/397/EEC “Official control of foodstuffs”).
Characteristics
Regulatory audit is carried out regularly and where non-compliance is suspected; it therefore should be simple, and observable in order to guarantee the effectiveness of the HACCP. It should be carried out in a harmonised way with a frequency more or less related to the risk associated with the premises. Particular attention of the regulatory audit should be given to critical control points identified by food businesses in order to assess whether the necessary monitoring and verification controls are being operated.
Subjects
The subjects of a regulatory audit are numerous including every part of the plant where a Critical Control Point can be established. In general we can classify these subjects under 4 major categories, human, machinery, premises and used material. In particular the regulatory audit is dealing with:
Premises (working areas, storehouses, storage areas, bathrooms etc);
Offices, Plant surrounding, Means of Transport, Machinery and Equipment;
Raw Materials, Ingredients, Technological aids;
Semi-finished products;
Finished products;
Materials and articles intended to come in contact with foodstuffs;
Cleaning and maintenance products and processes (pesticides/detergents);
Processes used for the manufacture or processing of foodstuffs.
Therefore the aim of competent authority is to verify the compliance with planned measures and their efficiency to assure the safety of food. By doing so, the audit target is to evaluate the effective implementation of the measures described in HACCP plans and their efficiency to achieve the objective.
Actual situation
An official reference about a regulatory system audit that explains, in details, how to develop own-checks system verification does not exist. The European Union has not elaborated any procedures for “field activities” and has not defined any tools to gather and record information during own-checks system verification. For these reasons, ISO model is still a point of reference within the European Union
HACCP is a scientific and systematic method, based on prevention, aimed to assure food