Language Recommended for use in the Milk Plant, Receiving Station or Transfer Station HACCP System Audit Report

Individual items can be cut and pasted into the comments section of the Form FDA 2359m

RECOMMENDED NCIMS HACCP AUDIT DOCUMENTATION LANGUAGE

Section 1. Hazard Analysis
Section 2. HACCP Plan
Section 3. HACCP Plan Critical Control Points (CCP)
Section 4. HACCP Plan Critical Limits (CLs)
Section 5. HACCP Plan Monitoring
Section 6. HACCP Plan Corrective Action
Section 7. HACCP Plan Verification & Validation
Section 8. HACCP System Records
Section 9. HACCP System Prerequisite Programs
Section 10. Other NCIMS Requirements
Section 11. HACCP System Training
Section 12. HACCP System Audit Follow-Up Action

Section 1 - Hazard Analysis

The plant has failed to conduct and prepare a (flow diagram), (written hazard analysis), (flow diagram and written hazard analysis) for each kind or group of milk or milk product processed. Specifically,
* * (CLE)
The plant's written hazard analysis does not identify all potential milk and milk product safety hazards and determine those that are reasonably likely to occur (including hazards within and outside the processing plant environment). Specifically,
The plant failed to reassess the hazard analysis after changes in raw materials formulations, processing methods/systems, distribution, intended use or consumers as evidenced by (This only applies when a plant does not have a HACCP Plan!)
The plant has failed to review records as required, in that they do not have the (signature) (date) (signature and date) of the person conducting the hazard analysis.

Section 2 - HACCP Plan

The plant has failed to prepare a HACCP Plan for each kind or group of milk or milk product processed. Specifically,
* * (CLE)
The plant has failed to (implement) (fully implement) it's HACCP Plan, as evidenced by
The plant has failed to identify all milk and milk product safety hazards that are reasonably likely to occur. Specifically,
The plant failed to have the HACCP Plan (signed) (dated) (signed and dated) by management.

Section 3 - HACCP Plan Critical Control Points (CCP)

The plant has failed to list CCP(s) for each milk and milk product safety hazard identified as reasonably likely to occur. Specifically,
The plant has failed to identify the CCP(s) that are adequate to control the milk and milk product safety hazards identified, in that
The plant has failed to establish control measures at each CCP listed that are appropriate at the processing step involved, in that

Section 4 - HACCP Plan Critical Limits (CLs)

The plant has failed to list CLs for each CCP. Specifically,
The plant has failed to establish CLs that are adequate to control the hazards identified. Specifically,
* * (CLE)
The plant has failed to establish CL(s) that are achievable with existing monitoring instruments or procedures. Specifically,
The plant has failed to meet CL(s). Specifically,

Section 5 - HACCP Plan Monitoring

The plant has failed to adequately define monitoring procedures for each CCP. Specifically, (what, how, frequency, whom, etc.)
The plant has failed to follow the monitoring procedures defined in their HACCP Plan. Specifically,
The plant has failed to define monitoring procedures in their HACCP Plan that adequately measure CLs at each CCP point. Specifically,
The monitoring record data maintained by the plant was not consistent with the actual values observed during the audit. Specifically,

Section 6 - HACCP Plan Corrective Action

The plant failed to follow corrective action procedures defined in the HACCP Plan when deviations occurred, in that they did not
The plant's predetermined corrective actions defined in it's HACCP Plan do not ensure that the cause of the deviation is corrected. Specifically,
The plant failed to take corrective action on milk and milk products produced during a deviation from CLs defined in the HACCP Plan, as evidenced by,
* * (CLE)
The plant failed to (segregate and hold product produced during a deviation) or (perform a review to determine product acceptability) or (take corrective action to ensure that no adulterated or product that may be injurious to health enters commerce) as evidenced by:
The plant failed to determine the cause of a deviation(s), and correct the cause of the deviation(s) as evidenced by,
The plant failed to perform a timely reassessment of the HACCP Plan and modify accordingly as evidenced by,
The plant has failed to fully document corrective action taken. Specifically,

Section 7 - HACCP Plan Verification & Validation

The plant failed to adequately define verification procedures and frequency. Specifically,
The plant failed to conduct verification activities that comply with their HACCP Plan. Specifically,
The plant has failed to have a trained individual(s) reassess the adequacy of their HACCP Plan (annually) (after changes that could affect the Hazard Analysis) (after significant changes in the operation including (raw materials and/or source) (product formulation) (processing methods/systems) (distribution) (intended use) (intended consumer), in that
The plant has failed to perform adequate calibration of their CCP process, monitoring instruments (as required by) (at the frequency defined in) their HACCP Plan to verify that their HACCP Plan is being effectively implemented. Specifically,
* * (CLE)
The plant has failed to have a trained individual review CCP records to verify and document that values are within CLs, as evidenced by
The plant has failed to review corrective action records to ensure that they are complete and that appropriate actions were taken. Specifically,
The plant failed to review records of calibration of process control instruments and end product or in-process testing results listed as verification activities in the HACCP Plan. Specifically,
The plant has failed to review records as required, in that the records do not have the (signature) (date) (signature and date) of the reviewing official. Specifically,

Section 8 - HACCP System Records

The plant has failed to keep adequate HACCP related records. Specifically, these records fail to (bear the name and location of the processor) (include the date and/or time of the activity the record reflects) (bear the signature/initials of the person performing the operation) (show the identity of the product and the production code, if any, where appropriate)
The plant failed to enter processing/other information on the records at the time observed, as evidenced by
The plant has failed to retain all HACCP records as required (at location approved by the regulatory authority) (for one year for refrigerated products) (for two years for preserved, shelf-stable or frozen products). Specifically,
The plant has failed to retain HACCP records, which relate to the general adequacy of equipment or processes used by the plant, including scientific studies and evaluations, for at least two years. Specifically,
The plant has failed to have all required HACCP records, accurate, complete and available for official (review) (copying) (reviewing and copying). Specifically,
The plant had HACCP records in which information was falsified. Specifically,
* * (CLE)

Section 9 - HACCP System Prerequisite Programs

The plant has failed to write and implement required PPs that are in substantial compliance with the NCIMS HACCP regulation. Specifically, the plant has failed to monitor and comply with the NCIMS HACCP regulation for:
1. Safety of water that comes or may come in contact with milk or milk products, product contact surfaces (including steam and ice);
2. Condition and cleanliness of equipment milk or milk product contact surfaces food contact surfaces;
3. Prevention of cross-contamination from insanitary objects and/or practices to milk or milk products, packaging materials and other product contact surfaces, including utensils, gloves, outer garments, etc. and from raw product to processed product;
4. Maintenance of hand washing, hand sanitizing and toilet facilities;
5. Protection of milk and milk products, milk packaging materials and milk contact surfaces from adulteration with lubricants, fuel pesticides, cleaning compounds, sanitizing agents condensate and other chemical, physical and biological contaminants;
6. Proper labeling, storage and use of toxic compounds;
7. Control of employee health conditions that could result in the microbiological contamination of milk, milk products, milk packaging materials and milk or milk product contact surfaces; or
8. Pest exclusion from the milk plant.
The plant has failed to write and implement adequate PPs required or justified by the hazard analysis. Specifically,
The plant has failed to monitor required PP conditions, as evidenced by
The plant has failed to monitor at a frequency to ensure conformance. Specifically,
The plant failed to perform corrections in a timely manner when PP monitoring records reflect deficiencies or non-conformities, Specifically,
The plant failed to monitor PPs. Specifically,
The plant's PP records did not adequately reflect the conditions observed during the audit. Specifically,
The plant failed to properly document PP activities in it's HACCP records. Specifically, the records (do not have the signature) (date) (date and signature) of the person performing the activity.

Section 10 - Other NCIMS Requirements

The plant failed to conform with the NCIMS requirement of obtaining the raw milk supply of the plant from a NCIMS listed source, in that
* * (CLE)
The plant failed to adequately implement the required NCIMS drug residue control program. Specifically,
* * (CLE)
The plant failed to adhere to the NCIMS requirements for drug residue control records. Specifically,
The plant failed to comply with labeling requirements, as evidenced by
The plant failed to prevent adulteration of milk and milk products. Specifically,
(Plant's Regulatory Sample were not in compliance with NCIMS standards) (plant failed to document action taken on violative Regulatory Samples), as evidenced by
The plant pasteurization equipment design and construction failed to conform with applicable requirements. Specifically,
An approved laboratory was not used as required by NCIMS requirements. Specifically,
The plant failed to comply with other NCIMS requirements. Specifically,

Section 11 - HACCP System Training

The plant failed to adequately train employees in monitoring operations, as evidenced by
The plant failed to have the HACCP record review performed by a trained individual. Specifically,
The plant failed to adequately train their employees in PP operations, as evidenced by,

Section 12 - HACCP System Audit Follow-Up Action

The plant failed to correct findings noted on previous audits in a timely manner. Specifically,
The plant failed to take action to prevent a reoccurrence of findings noted on previous audits, as evidenced by
The state regulatory agency has failed to (issue comprehensive audit reports) (establish realistic timelines for correction of problems) (follow-up to ensure that plant makes appropriate corrections in a timely manner). Specifically, (Applies to HACCP Listing Audits and FDA Audits only)
A series of observations made during the audit led to the finding of a potential HACCP system failure that is likely to result in a compromise to milk or milk product safety. Specifically,
* * (CLE)