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M-I-04-11: Certification Procedure to be used by FDA when Certifying State Rating Officers to Audit and List Milk Plants, Receiving Stations and Transfer Stations Regulated under the NCIMS HACCP Program

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December 30, 2004 

TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists

FROM: Milk Safety Branch (HFS-626)

SUBJECT: Certification Procedure to be used by FDA when Certifying State Rating Officers to Audit and List Milk Plants, Receiving Stations and Transfer Stations Regulated under the NCIMS HACCP Program

Proposal 316 as accepted by the 2003 National Conference on Interstate Milk Shipments (NCIMS), provided for a voluntary HACCP based alternative to the traditional system of inspections, State Ratings and FDA Check Ratings. This Proposal included a suggested "CERTIFICATION PROCEDURE FOR SRO'S WHO WILL CONDUCT HACCP LISTING AUDITS", and requested that FDA use this procedure when certifying State Rating Officers (SRO's) and that FDA provide the procedure in an M-I.

This M-I is to: (1) Confirm that FDA has accepted this procedure and will use it to certify SRO's to conduct listing audits of milk plants, receiving stations and transfer stations that are regulated under the NCIMS HACCP Program as described in Appendix K. of the Grade "A" Pasteurized Milk Ordinance and other NCIMS documents; and (2) Provide this certification procedure as requested within Proposal 316.

Copies of this memorandum are enclosed for distribution to Regional Milk Specialists, State Milk Regulatory Agencies and State Milk Sanitation Rating Officers in your region. This memorandum should be widely distributed to representatives of the dairy industry and other interested parties and also will be available on the FDA Web site at http://www.cfsan.fda.gov at a later date.

If you would like an electronic version of this document prior to it being available on the CFSAN Web Site, please e-mail your request to Robert.Hennes@fda.hhs.gov.

/ss/

CAPT Robert F. Hennes, RS, MPH,
Chief, Milk Safety Branch


CERTIFICATION PROCEDURE FOR SRO'S WHO WILL CONDUCT HACCP LISTING AUDITS

  1. Candidate Background
    1. Training and Experience
      1. The Candidate shall provide a statement describing their background and experience that qualifies them to perform this work.
      2. Candidates are encouraged to gain practical milk plant experience in the application of HACCP and in conducting milk plant NCIMS HACCP audits by working with SRO's that are certified to perform NCIMS HACCP Listings audits whenever practical.
      3. The Candidate shall complete a basic HACCP training course that is acceptable to the NCIMS and FDA; NCIMS HACCP Orientation; as well as training in general auditing requirements for the auditing of milk plants, receiving stations and transfer stations under the NCIMS HACCP Program.
      4. The Candidate shall be a certified SRO for milk plants.
  2. Original Certification Process
    Note: A SRO who has listed a milk plant under the NCIMS Dairy HACCP Pilot shall not be required to undergo the original certification process but must meet the requirements for continuing certification.
    1. Knowledge of HACCP and NCIMS HACCP auditing standards and requirements
       

      A standardized FDA Regional Milk Specialist (RMS), qualified to conduct HACCP Audits, will accompany the Candidate during the course of at least two (2) mock-listing audits. If a State only has one (1) plant, either entering or already under the HACCP System, the candidate may be conditionally certified to conduct HACCP listings after one (1) mock-listing audit, provided that the conditional certification is valid for a maximum of two (2) years.

      The RMS shall accompany the Candidate during the mock-listing audits and shall evaluate the Candidate's HACCP knowledge and NCIMS HACCP auditing skills. Particular attention shall be given to the Candidate's observations, evaluation, and decision making skills related to planning and conducting the mock-listing, identifying and recording the findings, communicating with industry representatives, and arriving at a listing audit determination. The RMS will categorize the Candidate's HACCP knowledge and NCIMS HACCP auditing skills into one (1) of the following three (3) categories:

      1. The Candidate's work is acceptable; or
      2. The Candidate's work is acceptable with written recommendations identifying areas that need improvement; or
      3. The Candidate is not certified.

        NOTE: The cause shall be documented and provided to the candidate and the State Rating Agency.

    2. Certification
       

      Certification of a SRO to make NCIMS HACCP Listing Audits will be valid for three (3) years unless revoked for cause.

  3.  Continuing Certification
    1. Milk Plant Technical Knowledge
       

      The Candidate shall continue to meet the requirements for certification of a SRO for milk plants.

      During the three (3) year certification period, the SRO, certified to conduct NCIMS HACCP listings, will complete the minimum training requirements established to maintain proficiency regarding the NCIMS HACCP Program.

      Small group training with practical exercises and other appropriate training that may include written examinations will be used to evaluate the SRO's technical knowledge for continuing certification.

    2. Knowledge of HACCP and NCIMS HACCP auditing standards and requirements

      During the three (3) year certification period, a RMS, will accompany the SRO during the course of at least one (1) mock-listing audit. The standardizing official (RMS) shall accompany as a "silent observer" during this mock-listing audit. The RMS shall evaluate the SRO's HACCP knowledge and NCIMS HACCP auditing skills. Particular attention shall be given to the SRO's observations, evaluation, and decision making skills related to planning and conducting the mock-listing, identifying and recording the findings, communicating with industry representatives, and arriving at an audit listing determination. The RMS will categorize the SRO's HACCP knowledge and NCIMS HACCP auditing skills into one (1) of the following three (3) categories:

      1. The SRO is recertified to conduct NCIMS HACCP Listing Audits; or
      2. The SRO is recertified with written recommendations identifying areas that need improvement; or
      3. The SRO is not recertified.  

        NOTE: The cause shall be documented and provided to the SRO and the State Rating Agency.

    3. Paperwork Review

      The MILK PLANT, RECEIVING STATION OR TRANSFER STATION NCIMS HACCP AUDIT REPORT, with attachments, the NCIMS HACCP System Regulatory Agency Review Report, and the PERMISSION FOR THE PUBLICATION OF AN INTERSTATE MILK SHIPPER's LISTING will be submitted with Form FDA 2359i for each NCIMS HACCP Listing Audit to the FDA Regional Office for quality assurance review.

      These reviews will be used to enhance uniformity and strengthen each individual's skills and will be used to assist in identifying needs for future training.