200 C Street, S. W.
Washington, DC 20204
August 14, 1996
TO: All Regional Food and Drug Directors
Attn: Regional Milk Specialists
FROM: Milk Safety Branch (HFS-626)
SUBJECT: Guidelines for Making Check Ratings of Milk Supplies
Attached is the document Guidelines for Making Check-Ratings of Milk Supplies which provides instructions to FDA Milk Specialists working in the State-Federal Cooperative Milk Program of the National Conference on Interstate Milk Shipments. These guidelines will be added to the FDA Document "Guide to Inspections of Dairy product Manufacturers" in the Section "Cooperative Programs - Milk Safety".
These guidelines are part of an ongoing FDA effort to inform our state partners and the dairy industry of our efforts to improve the delivery of our services and better fulfill our responsibilities within the Cooperative Milk Program.
These guidelines were developed by a committee of FDA Milk Specialists and were refined and finalized by all of the FDA Milk Specialists during their 1996 Conference held at the California Polytechnic State University Dairy Products Technology Center in San Luis Obispo, California.
The guidelines were generated in order to ratify check rating procedures and improve uniformity between individual specialists and FDA Regions.
Copies of this memorandum are enclosed for distribution to state milk sanitation regulatory agencies and to state milk sanitation rating officers in your region.
Joseph M. Smucker, Chief
Milk Safety Branch
GUIDELINES FOR MAKING CHECK-RATINGS
OF MILK SUPPLIES
Check- rating (CR) results will indicate
- The published ratings are being maintained.
- If a new rating should be made.
- If the State Rating Agency should withdraw certification of the shipper.
They will also be used to gather information and data to evaluate state programs. They are also and should be used as an excellent vehicle for training of state officials and industry.
The selection of dairy farms shall be representative of the total supply and include at least one half (+) of the number of farms required to make a state rating.
Selection of farms is conducted by the Regional Milk Specialists (RMS), who usually meets with he Milk Sanitation Rating Officer (MSRO) and/or the Local Regulatory Inspector (LR) or Certified Industry Inspector (CII) and obtains the lists of producers to draw from.
The random selection of farms can be made by one of three methods which obtains the required number of farms.
- Dividing the number of farms needed into the total number of farms in the shipper listing and picking from the list at that frequency.
- Using random numbers to pick from a sheet or computer list.
- Picking the names/numbers out of a hat.
Alternate farms may be chosen in the event a dairy on the list recently went out of business, or found not to be `Grade A' status when inspected.
The list is given to the LR to map out the best possible routes.
Discussion of Findings:
After the RMS has completed the inspection, debited items are cited and the opportunity is made available for the MSRO, LR, or CII to question or discuss the items.
Major items such as dirty equipment, etc. will be pointed out during the inspection. Any conflicts or disagreements on interpretation are resolved by the RMS before leaving the farm or noted for further clarification. Any violative items, which were not marked, that are discussed after the completion of the inspection, will not be marked as part of the farms' evaluation. There would be the exception of those debitable items found through record review. In most situations, the RMS will not discuss the findings with the producer unless asked to join into the discussion by the MSRO, LR or CII. It is expected that the MSRO. LR, or CII will take appropriate action or notify the producer if major violations are found.
If the MSRO is performing a joint farm evaluation as part of their continuous standardization, items are discussed only after the MSRO has turned in his/her inspection sheet.
If the MSRO has observed and debited an item that the RMS did not see but would have debited the RMS will credit the MSRO with the debit for standardization purposes.
The RMS will ascertain where the milk from a Bulk Tank Unit (BTU) is being shipped. Due to a vast array of state program and marketing situations, many different methods may be employed to accomplish this goal. Records may be from CII files, copies of milk receipts, or other means as determined as adequate. The RMS may request copies of these records to be faxed to a motel, to the MSRO, LR or CII, or to the RMS' office for review. Records may be for a set period of time or random days as specified by the RMS. If it is determined that milk was shipped to a non-IMS facility, it is the responsibility of the BTU to produce Appendix N testing records for a period of time or random dates as determined by the RMS. These records may be available through a site visit or copies may be mailed or faxed.
RECEIVING AND TRANSFER STATIONS
- Enter the plant with state rating officer (MSRO) and local regulatory (LR), identify yourself, produce credentials if necessary, announce that we are on an official check-rating (CR) and explain the Interstate Milk Shippers (IMS) process if needed.
- Meet with the plant manager and staff that he/she wants present to explain what will take place over the course of the CR, which normally last 2 days.
- Inform the plant personnel the functions of the CR that will involve the need for appropriate people to be present. Examples would be HTST tests, opening a press, process flow review, water cross-connection survey, and equipment breakdown inspection. Inform the plant that we will work within their schedule within reason over the CR time frame.
- Explain to the firm that the following information will need to be available by the exit of the CR. Records of the last 30 days of raw receipts, copy of resin letters, information on boiler additives, letters on single service items, copies of last vitamin assays, etc. Production totals, the possible need for breakdown by weights, and explain how that information could be used for pro-rating.
- Ask for any questions or clarifications and go into the plant to start the inspection part of the CR.
Check-Rating Operation Including:
- HTST review and survey: Survey HTSTs, vats, HHSTs, and all pasteurizer systems to determine that the systems are engineered to meet PMO standards.
- HTST testing: Usually do tests 4, all of 5, 9-4, and Mag-Flow part of 11 and others as appropriate.
- Review product flow blueprints: Review flow-prints to determine potential cross-connection areas and to understand product flow through plant.
- Breakdown inspection of processing and sanitary equipment: Inspect for cleanliness and construction of as much equipment as possible including fillers, presses, tanks, pumps, circuits, etc.
- Records review: Review records for HTSTs, vat pasteurizers, HHSTs, CIP systems, raw silos,
Appendix N requirements, Vitamin Quality Assurance (QA), etc.
- Water system survey: Survey water system for any cross-connections.
- Inspect plant for PMO requirements: Inspect facility for storage, protection, handling, construction, ventilation, QA environmental plans, etc.
- Do a label review for all products.
- Do these functions and all the rest of the many things that go into the normal operation of a CR in an open manner. Answer questions as they arise and educate the state people and the industry people during the CR operation.
- First meet with MSRO and LR and do a review of all your notes and observations.
- After MSRO and LR understand the inspection findings, meet with the appropriate plant personnel.
- The MSRO should take the lead in the exit interview. This will empower the MSRO, increase buy-in and acceptance of findings, allow the MSRO and LR to instruct the plant management on how and when to make corrections. This also helps define the role of the state in any action that may result from the CR.
- Answer any questions or make points of clarification as needed during the MSRO review.
- Ask for questions or points of discussion that the plant personnel would like to address and do so.
- Make the proper acknowledgments and give the plant a general sense of the CR results.
- If the plant did well express that and refer to the fact that the final score will depend on the state records review. If the rating is in question express these concerns and explain the process of a Reinspection or a failed CR. If all the aspects of the CR are completed and the RMS is repared to do so give the final score and action to the MSRO and LR.
- Inform and discuss with the MSRO and the state program manager the results of the CR before you leave the state.
Determine the enforcement score in the field or in the office. Methods and timing of records review is critical to the CR and the records must be readily available in a timely manner.
Paperwork and Distribution:
Will be done in the office or in the field. It is preferable to have the 2359H signed by the appropriate state official, but is not required.
The appropriate state official should be verbally notified of the results as soon as the results are available.
Adverse Action or Reinspection:
The cover letter signed by the RMS or Program Director, 2359H, Status Report and Report of Enforcement Methods should be sent to the State Program Director immediately. Copies provided to the MSRO is dependent on each state program. A copy of the 2359 will be sent if requested.
No Action (NA) Letters:
The cover letter, 2359H, Status Report and Report of Enforcement Methods should be sent to the State Program Director within two weeks of completion of the CR. This may be dependent upon travel schedules. Copies provided to the MSRO is dependent on each state program. A copy of the 2359 will be sent if requested.
Reporting to Milk Safety Branch (MSB):
The 2359H, plant 2359L, a copy of any adverse action letter, and the vitamin survey or drug labeling and storage violation survey, as applicable should be sent to MSB.