Sample Report Audit SOP



Table of Contents TOC \o "1-2" \n \h \z \u 1.PURPOSE2.SCOPE3.BACKGROUND4.RESPONSIBILITY5.DEFINITIONS6.PROCEDURES7.RELATED DOCUMENTS (includes References, Attachments)8.EQUIPMENT/MATERIALS NEEDED9.SAFETY10.CIRCULATION11.APPROVAL/DOCUMENT HISTORYPURPOSEThis procedure describes the process used by the Minnesota Department of Agriculture (MDA) Food and Feed Safety Division (FFSD) for the annual review of Manufactured and Retail Food Inspection reports that include field compliance actions. The audit is conducted to verify that appropriate field compliance actions are taken correctly during inspections.SCOPEThis procedure applies to the audit of manufactured and retail food inspection reports to ensure compliance with FFSD field inspection, report writing, and field compliance procedures. The audit pertains to inspection reports that contain field compliance action orders, reinspections, and follow-up inspections for manufactured and retail food facilities inspected under MDA authority. Refer to FOOD.60.11 – Retail Establishment File Audit SOP for the audit of retail food establishment files and FOOD.60.12 – Enforcement Case Audit SOP for the audit of enforcement procedures. BACKGROUNDStandard 6 of the Manufactured Food Regulatory Program Standards (MFRPS) requires an annual review of compliance and enforcement actions. Standard 6 of the Retail Food Regulatory Program Standards (RFRPS) requires periodic review of compliance and enforcement actions to ensure they were taken correctly. The results of the review are used to identify improvements, provide training, and modify procedures or processes. Proper use, completion, and submission of inspection reports are key components in assuring that requirements are adequately and consistently being met in the Manufactured Food and Retail Food Programs. Auditing inspection reports can help to identify where deficiencies exist within the current system as well assist in the initiation of corrective actions which are necessary when deficiencies are identified. RESPONSIBILITYBusiness and Quality Management (BQM) Unit Supervisor – The Business and Quality Management Supervisor will assist with auditing and provide oversight as pliance Supervisor - The Compliance Supervisor will assist in determining corrective actions when program-related deficiencies are noted.Electronic Systems Coordinator – The Electronic Systems Coordinator will produce the list of reports in USA Food Safety (USAFS) where a field compliance action was taken or the purpose of the inspection was a reinspection or follow-up inspection.Food Inspection Supervisor - The Supervisor will assist the applicable Food Program Manager in determining corrective actions when deficiencies are noted.Food Program Manager – The Manufactured Food or Retail Food Program Manager will assist in determining corrective actions when program-related deficiencies are noted.Qualified Inspection Report Auditor (Auditor)/Food Standards Coordinator – The Auditor will review the list of reports; gather reports for review; audit reports; and record findings on the Field Compliance Actions Audit Worksheets and the Appendix 6.2-Level of Conformance to Compliance Procedures.DEFINITIONSEnforcement Actions Enforcement actions are informal (non-appealable) or formal (appealable) actions taken outside of an inspection to achieve compliance with regulations. These actions include, but are not limited to, Letters of Information, Warning Letters, Corrective Action Orders, Administrative Meetings, issuance of penalties (civil or administrative), Criminal Prosecution, License Limitation or Revocation, Injunction, or other court actions. These actions are initiated by a firm’s non-compliance with regulatory requirements as evidenced by an inspection report, violative sample results, or other collected documentation of conditions.Field Compliance Actions: Field compliance actions are actions performed during an inspection to achieve compliance with regulations. These actions include, but are not limited to, reinspections, cease and desist orders, and embargos. These actions are initiated by a firm’s non-compliance with regulatory requirements as evidenced by an inspection report, violative sample results, or other collected documentation of conditions.Qualified Auditor (Auditor): A qualified auditor is someone who has:Completed the most current training on the following SOPs: FOOD.30.02 – Reinspection SOPFOOD.30.05 – Inspection Report SOP FOOD.30.01 – Inspection Protocol-Manufactured Food SOPFOOD.30.27 – Field Compliance Actions SOPFOOD.60.10 – Enforcement Trigger and Assessment SOP2. Been assigned by the division and the Manufactured Food and Retail Food Program Managers to conduct the audits.PROCEDURESSelect Inspection Reports for ReviewElectronic Systems Coordinator RoleGenerate separate lists of all GMP Inspection Reports and Retail Food Inspection Reports produced for the quarter requested based on the federal fiscal year (October 1st-September 30th) and identify those with the following inspection reasons:ReinspectionFollow-Up InspectionUse a SQL server report to identify GMP and Retail Food reports that contain the following written orders with the quarter requested:EmbargoCease and DesistCondemnationSanitary NoticeCompile list of reports (designated as either GMP or Retail Food) that meet the criteria outlined in sections 6.1.1 and 6.1.2 and email to the Food Standards Coordinator and Business and Quality Management (BQM) Unit Supervisor.Food Standards Coordinator/Auditor RoleRequest a list of GMP and Retail Food reports to audit from the Electronic Systems Coordinator following the close of each quarter based on the current fiscal year calendar October 1st-September 30th.Save the list of reports to the MFRPS or RFRPS SharePoint site as applicable to the type of report. Enter the quarter and year for which the list was pulled in the naming convention.Randomize the list of reports to be audited using a random number generator (VBA Macros, online random number generator, etc.). Manufactured FoodUsing the randomized lists of field compliance actions, pull a proportional number of actions starting with the first on the randomized list. This will prevent over or under sampling between enforcement cases and field compliance actions for the quarter.A total of 20 enforcement cases and field compliance actions will be audited each quarter. Refer to FOOD.60.12 – Enforcement Case Audit SOP for more information regarding selecting and auditing enforcement cases. For example, if the quarterly average of closed enforcement cases is 10 and the quarterly average of completed field compliance actions is 30: enforcement cases: 10/(10+30)=0.25%0.25%*20 total for auditing=5 enforcement casesfield compliance actions: 30/(10+30)=0.75%0.75%*20 total for auditing=15 field compliance actionsRetail FoodUse Table 1 below to determine the sample size code letter needed to determine the number of cases to audit based on the overall number of enforcement cases closed during the quarter. General Inspection Level II will be used. For example, if 60 Retail Food field compliance actions were completed in the quarter, sample size code letter E would be used:Table 1: Sample Size Code LettersUsing the sample size code letter obtained from Table 1, determine the sample size to be audited based on Table III below:Table III: Double Sampling Plans for Normal InspectionIf the acceptance number in the 25% Acceptance Quality Limits column in the table are exceeded (meaning less than a 75% compliance rate), a second subset of field compliance actions will be audited to determine the overall compliance rate. This subset will be taken from the next available Retail Food field compliance actions on the randomized spreadsheets produced in Section 6.1.6.For example, sample size code letter E determined from Table 1 based on 60 completed Retail Food field compliance actions would require 8 cases to be audited:If 4 or more of the first 8 audits result in overall Needs Improvement, the auditor will audit another 8 field compliance actions.If 8 or fewer audits in total result in overall Needs Improvement, a compliance rate of at least 75% has been achieved.If 9 or more audits in total result in overall Needs Improvement, a compliance rate equal to or less than 60% has been achieved and will require a corrective action.If the 75% compliance rate is not met based on the double sampling plan, an appropriate corrective action will be determined in coordination with the Retail Food Program plete the Field Compliance Actions Audit Form – Food Standards Coordinator/AuditorComplete the Field Compliance Actions Audit Worksheet for each report to be audited. Refer to all applicable SOPs and other reference documents when completing form. Upload the completed Field Compliance Actions Audit Worksheet for each audited report to the MFRPS-RFRPS SharePoint site in separate folders for Manufactured Food and Retail Food plete Appendix 6.2 – Level of Conformance to Compliance Procedures - Food Standards CoordinatorManufactured FoodEnter the information from each Manufactured Foods Field Compliance Actions Audit Worksheet into Appendix 6.2-Level of Conformance to Compliance Procedures on an on-going basis.Review Appendix 6.2 – Level of Conformance to Compliance Procedures when all audits are complete (at least an 80% overall performance rating is required to meet the requirements in MFRPS Standard 6).Email completed Appendix 6.2 – Level of Conformance to Compliance Procedures to the Manufactured Food Program Manager, Compliance Supervisor, and BQM Unit Supervisor upon completion.Retail FoodEnter the information from each Field Compliance Action Audit Worksheet for Retail Food actions into a spreadsheet on an on-going basis. Save the spreadsheet to the VNRFRPS SharePoint site under Standard 6. Calculate the conformance rating to procedures and document on the spreadsheet on a quarterly basis.Review of Audit Findings and Completion of Corrective Action PlansFood Standards CoordinatorFor Manufactured Food, schedule a meeting with the Compliance Supervisor, Manufactured Food Program Manager, BQM Unit Supervisor, Assistant Division Director, Division Director, and other interested parties to review the Appendix 6.2 – Level of Conformance to Compliance Procedures within thirty (30) days of completion (all enforcement cases and field compliance actions have been audited for the year). Topics of discussion should include:Effectiveness of the inspection and compliance programs and current procedures based on performance ratings.Best practices used to achieve quality compliance activities supported by sound judgment, adequate evidence, and appropriate documentation.Identify improvements and modifications needed to procedures.Corrective Action Plan needs if the overall performance rating is below 80%.Resolve any audit disputes.Enter comments into the Appendix 6.2 – Level of Conformance to Compliance Procedures regarding improvements needed to follow procedures at the close of the meeting.For Retail Food, provide the completed spreadsheet to the Retail Food Program Manager, Supervisors, Assistant Division Director, Division Director, and the Business and Quality Management Unit Supervisor at the end of each quarter. Coordinate the completion of a corrective action plan with the Retail Food Program Manager if the quarterly compliance rate is below 75%.Documentation – Food Standards Coordinator RoleRetain all Worksheets and documentation related to the inspection report audits and corrective actions in an electronic file.RELATED DOCUMENTS (includes References, Attachments)Field Compliance Actions Audit WorksheetAppendix 6.2 – Level of Conformance to Compliance ProceduresFOOD.30.05 – Inspection Report SOPFOOD.30.02 – Reinspection SOPFOOD.30.27 – Field Compliance Actions SOPFOOD.60.10 – Enforcement Trigger and Assessment SOPFOOD.60.12 – Enforcement Case Audit SOPUSAFS Guidance/Work InstructionsEQUIPMENT/MATERIALS NEEDEDN/ASAFETYN/ACIRCULATIONThis policy will be circulated to the following individuals: Manufactured Food Program Staff, Retail Food Program Staff, Compliance Supervisor, Compliance Officers, Business and Quality Management Unit Supervisor, Food Standards Coordinator, Assistant Division Director, and Division Director. The current version will be stored electronically on the FFSD document control site.APPROVAL/DOCUMENT HISTORYDocument HistoryVersion #Status(I, R)Change History1IInitial Policy Drafting. (12/8/2016)2RUpdated procedure to audit both Manufactured Food and Retail Food field compliance actions on a quarterly basis. Added randomizing the list of reports to be audited and auditing a proportional number of actions each quarter. (12/05/2017)Approved By: DateApproved By: DateI = Initial document; R = Revised document ................
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