Proposal on the Development of Principles and Guidelines for the Conduct of Foreign on-site Audits and inspections Regarding the elements that should be included in the document on Principles and Guidelines for the Conduct of Foreign on-site Audits and Inspections, and considering the text in the Attachment 1 of the CX/FICS 07/16/6, México proposes the following: Definitions: This Section should take into account the definitions that already exist in CCFICS texts. Principles: Among these, the following should be considered: Transparency in the process, including the following aspects: o Purpose and scope of the audits/inspections, both have to be perfectly defined and agreed by importing and exporting countries; o Systematic evaluation procedure; o Execution based on a predetermined, correctly structured program/agenda, and consistent with the audit’s purpose; o Clearly defined criteria for evaluation; Purpose/Scope and rationale for conducting on-site audits/inspections Purpose and scope of foreign on-site audits/inspections will be considering those elements within the food inspection and certification systems that are involved in the surveillance/evaluation procedures applied in the production chain of the products that will be commercialized between trading partners, that will be specifically certified by the exporting country, and which the importing country could eventually recognize are enough in order to accept that the products fulfill the requirements. The purpose and scope for conducting foreign on-site inspections related to the judgment of equivalence for sanitary measures should be determined specifically by the elements that will be object of evaluation and which may require further clarifying. Regarding the information that could be exchanged between importing and exporting countries, and considering the aspects that should be agreed, before the execution of a foreign on-site audit/inspection, other than those described in Attachment 1 of CX/FICS 07/16/6, it is possible to include a list of elements of the inspection and certification system that will be taken into account by the importing country through the audit/inspection. The importing country should provide a list of these elements. The use of a previous questionnare may be considered for this purpose. Information submitted by the exporting country may consider the above mentioned list of inspection and certification system’s elements and should include only aspects related to specific elements involved in the surveillance/evaluation procedures applied in the production chain of the product(s) that will be commercialized between the importing and exporting countries.
The aforementioned will also allow both countries to generate a specific working agenda. Regarding the attachment 1 in CX/FICS 07/16/6, particularly letter f in paragraph 4, it is needed to clarify in order to know the elements that must be justified by the exporting country (sanitary measures, procedures, application and decision criteria) Relating letter d in paragraph 4, it is to be noted that a national law may give faculties to an authority for conducting audits/inspections abroad, these national laws have no legal effect abroad, so they are not valid towards executing an audit, and are not an international criteria to validate the procedure. Their function is just to enable the authority to act. So, the foreign onsite audits/inspection always needs to be agreed between importing and exporting countries. There are situations in which the law imposes an audit of the inspection and certification system of the exporting countries as a requirement for export to an importing country. In fact this is a situation that may become a comercial barrier for many countries which have to wait until they have been audited in order to be able to export their products. When this occurs, audits must be performed within a reasonably period of time, and an alternative way to demonstrate the requirements of the importing country should to be applied, in order to not delaying/stopping the trade in an unjustified way. Procedures before on-site audits/inspections. México suggest that the administrative procedures before audit/inspections (determination on who will support the costs or the way how these expenses will be shared, frequency of audits/inspections) be considered in a separate section. It may be considered that this subjects be part of a general framework applied in successive audits/inspections in the same country, in order to do not repeat the process every time. We consider there are three stages that should be defined clearly before execute on-site audits/inspections: 1. Preparing the audit/inspection.– It includes the initial request, as well as determination on the auditors/inspectors and officials that will be accompanying the audit/inspection; notification of the audit; and agreement about the program/agenda. 2. Execution of the audit. –Since the opening meeting until the closing one. 3. Preliminary report of findings; dispute resolution process, corrective plan communication; follow-up verification if needed; and final report. Reporting findings and conclusions of on-site audits/inspections. It is a sugestión that this section be joined with Part 3 of the above section (Procedures before on-site audits/inspections) This section should clearly outline: Format and timeframe in which preliminary reports should be delivered. Format and timeframe for receiving comments/clarification from the audited country, including the corrective actions plan, if it is required. Agreements reached regarding the corrective plan. Format and timeframe for deliver the final report. Considerations regarding on follow up verification and timeframe for its execution.
Additionally, México suggest to consider audits/inspections related on food emergency situations, where had been identified that imported products are involved in public health problems. In these cases the audits/inspections are used to collaborate in the investigation of the origin of the problem and to verify that corrective actions are being putting in place by the exporting country. Finally, importing and exporting countries could consider the information from audits/inspections developed by other countries, in order to determinate if it is needed to perform an audit/inspection as well as to reduce its scope, as appropriate. In these cases should take into account the application of harmonized execution procedures and evaluation criteria.