Milk Plant, Receiving Station or Transfer Station NCIMS HACCP System Audit Report FDA-2359m PSC Publ

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Specifications	Milk Plant, Receiving Station or Transfer Station NCIMS HACCP System Audit Report FDA-2359m PSC Publishing Services
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HACCP Plan MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT DATE FORM FDA 2359m (10/11)EFPSC

Specifications	Milk Plant, Receiving Station or Transfer Station NCIMS HACCP System Audit Report FDA-2359m PSC Publishing Services
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Content	HACCP Plan MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP SYSTEM AUDIT REPORT DATE FORM FDA 2359m (10/11)EFPSC Publishing Services (301) 443-6740 Department of Health and Human Services Food and Drug Administration TYPE OF AUDIT STATE REGULATORY FOLLOW-UPSTATE LISTINGFDA AUDIT OF LISTING FIRM NAMELICENSE/PERMIT NO.IMS PLANT NO. ADDRESS (Line 1) ADDRESS (Line 2)STATEZIP CODECITY IMS LISTED PRODUCT(S) MANUFACTURED AND REVIEWEDPrerequisite Program(s) Issue Date(s) Hazard Analysis STATE REGULATORY* Issue Date(s)Issue Date(s) ITEMS MARKED DID NOT MEET THE NCIMS HACCP PROGRAM CRITERIA DESCRIBED BELOW Starred ★★ Items are Critical Listing Elements NOTE: This regulatory NCIMS System Audit Report of your milk plant, receiving station, or transfer station serves as a notification of the intent to suspend your permit if Items marked on this audit report are not in compliance at the time of the next regulatory audit or within established timelines. (Refer to PMO Sections 3 and 6, and Appendix K. for details.) Section 1HAZARD ANALYSIS A. Flow Diagram and Hazard Analysis conducted and written for each kind or group of milk or milk product processed.* B. Written Hazard Analysis identifies all potential milk or milk product safety hazards and determines those that are reasonably likely to occur (including hazards within and outside the processing plant environment). C. Written Hazard Analysis reassessed after changes in raw materials, formulations, processing methods/systems, distribution, intended use or consumers. D. Written Hazard Analysis signed and dated as required. Section 2HACCP PLAN A. Written HACCP Plan prepared for each kind or group of milk or milk product processed. B. Written HACCP Plan implemented. C. Written HACCP Plan identifies all milk or milk product safety hazards that are reasonably likely to occur. D. Written HACCP Plan signed and dated as required. Section 3HACCP PLAN CRITICAL CONTROL POINTS (CCP) A. HACCP Plan lists CCP(s) for each milk or milk product safety hazard identified as reasonably likely to occur. B. CCP(s) identified are adequate control measures for the milk or milk product safety hazard(s) identified. C. Control measures associated with CCP(s) listed are appropriate at the processing step identified. Section 4HACCP PLAN CRITICAL LIMITS (CL) A. HACCP Plan lists critical limits for each CCP. B. CL(s) are adequate to control the hazard identified. C. CL(s) are achievable with existing monitoring instruments or procedures. D. CL(s) are met. Section 5HACCP PLAN MONITORING A. HACCP Plan defines monitoring procedures for each CCP. (what, how, frequency, whom, etc.) B. Monitoring procedures as defined in the HACCP Plan followed. C. Monitoring procedures as defined in the HACCP Plan adequately measure CL(s) at each CCP. D. Monitoring record data consistent with the actual value(s) observed during the audit. Section 6HACCP PLAN CORRECTIVE ACTION A. Corrective actions when defined in the HACCP Plan were followed when deviations occurred. B. Predetermined corrective actions defined in the HACCP Plan ensure the cause of the deviation is corrected. C. Corrective action taken for products produced during a deviation from CL(s) defined in the HACCP Plan. D. Affected milk or milk product produced during the deviation segregated and held, AND a review to determine product acceptability performed, AND corrective action taken to ensure that no adulterated milk and/or milk product that is injurious to health enters commerce. E. Cause of deviation was corrected. F. Reassessment of HACCP Plan performed and modified accordingly. G. Corrective actions documented. Section 7HACCP PLAN VERIFICATION & VALIDATION A. HACCP plan defines verification procedures, including frequency. B. Verification activities are conducted and comply with HACCP Plan. C. Reassessment of HACCP Plan conducted annually, OR 1. After changes that could affect the hazard analysis, OR 2. After significant changes in the operation including raw materials and/or source, product formulation, processing methods/systems, distribution intended use or intended consumer. D. Calibration of CCP process monitoring instruments performed as required and at the frequency defined in the HACCP Plan. E. CCP monitoring records reviewed and document that values are within CL(s) as required. F. Corrective action record reviewed as required. G. Calibration records and end product or in-process testing results defined in HACCP Plan reviewed as required. H. Records reviewed as required, including date and signature. Page 1
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Milk Plant, Receiving Station or Transfer Station NCIMS HACCP System Audit Report FDA-2359m PSC Publishing Services

Milk Plant, Receiving Station or Transfer Station NCIMS HACCP System Audit Report FDA-2359m PSC Publishing Services