National Conference on Interstate Milk Shipments (NCIMS)

Evaluation of the NCIMS HACCP Pilot Program Phase II Expansion

Appendix IV.
Positive observations and comments from plant visits

(Table of Contents)

Normally, observations from the Evaluation Team were comments identifying shortcomings in the implementation of the Phase II pilot by either the plant, state regulators or FDA Regional Milk Specialist. In order to provide a more balance view of the implementation of the Phase II HACCP pilot, observations that provide positive views have been grouped together and are presented below.

• Plant program met all requirements of the referenced NCIMS programs in the NCIMS HACCP pilot document, i.e. drug residue compliance, labeling of product, state regulatory samples, milk from listed sources, etc.
• The state resources to service the two HACCP pilot plants appear to be sufficient at this time, but the ability to provide updated HACCP training to staff is a problem.
• Two plant personnel participated in the Phase II NCIMS HACCP Training in Baltimore. The HACCP coordinator has a high level of training, experience and understanding of HACCP. All other plant personnel received GMP and general HACCP training annually and was well documented.
• Overall, the prerequisites were in relatively good shape and well documented. Generally, the records of prerequisite programs are some of the best documented of any plant we had visited.
• The records of the addition of boiler water compounds were very complete.
• The plant resources to maintain and keep the HACCP program current appear to be sufficient at this time based on management and corporate commitment.
• The plant seems to have its sanitation program highly organized.
• Participation assisted in transition for a new product.
• Aseptic process records were complete, accurate and properly documented. This is substantially improved from the last time.
• Allergen controls are sound and thorough.
• Great work instructions were used for training.
• HACCP certification has directly affected the plants ability to acquire new business.
• HACCP team divided into development and compliance teams, the evaluation team found this useful (all recent state audits had correction timeliness established.
• Charts have improved substantially since last visit.
• Plant plotted vacuum breakers on a chart and do a vacuum breaker, backflow preventer check monthly.
• Processing area is nice and clean and is improved since last time.
• Condition and cleanliness of food contact surfaces -- every day swabs are conducted.
• Labeling storage and use of toxic compounds PP is excellent.
• Silo charts were excellent.
• The HACCP team was well chosen, HACCP involves everyone in plant and lab. The plant's view is that the HACCP team philosophically includes everyone in the plant.
• Three training sessions for all employees and weekly quality meetings include HACCP issues were scheduled at different times to include all shifts. Plant HACCP training program includes new employee training and annual refresher training. All training was well documented.
• Corrective action form (QS14904) was outstanding. One size fits all approach strongly supports uniformity but may not always be appropriate for minor corrections.
• Management commitment significant and noticeable. Contributed to the rapid development and implementation of the HACCP program. For this early in the program the HACCP system development was very mature.
• Appendix N monitoring and notification program was excellent.
• Appendix N regulatory and oversight program was excellent.
• Commitment to regulatory implementation of HACCP pilot by the state is very strong.
• State records were well organized and complete.
• All municipal and glycol water samples from 2000 till the present met PMO requirements.
• Finished product sample results prior to HACCP listing had limited number of high coliform counts for Past. Skim, with one high SPC count for nonfat dry milk and condensed skim. No high counts post-HACCP.
• The plant work instructions posted in laminated pages in areas throughout the production area clearly defines each operator's job. This includes pictures for labels of products to be dumped and cost.
• Temperature recorder in dry storage area where product ingredients stored.
• The case room has been significantly upgraded since the Evaluation Team's last time. Also dump sinks for discarded product that flowed into processing was removed.
• Flow charts looked very good, complete and matched processes very closely. The internal consistency between the flow charts and HA made things very easy to follow.
• Hazard analysis very well done and include reclaim.
• Business including ______ and one other large account apparently were obtained as the result of NCIMS HACCP pilot participation. Plant manager stated that a HACCP program is a very necessary part of doing business and obtaining large account business. Also noted that _______ and _______ require HACCP and thought it would help with those accounts.
• Congratulate plant on separate PP for allergens and suggest that other pilot plants also do so.
• Separate programs for premise seemed to be related to excellent condition of premise. Suggest other plants also establish a separate premise PP.
• The plant has established prerequisites that are in addition to the eight required by the NCIMS HACCP pilot. This is a positive indication of their understanding of HACCP.
• Plant is physically well maintained.
• The new introduction and use of Process controls forms seemed to be an excellent addition to HACCP documentation system and are appropriate for prerequisite control.
• The state regulatory records were well organized, easy to review and complete. In addition, the extensive HACCP experience of the state HACCP auditors, listing personnel and administrator had a very positive impact on the implementation of the NCIMS HACCP pilot program.
• Like idea of check sheets in PP. Good example for other plants.
• List of documents included in HACCP program at end of HACCP plan very helpful.
• Table of contents for PP made reference very useful.
• Operating under HACCP not only enhanced their existing business but provided other opportunities.
• Participation in NCIMS HACCP program fulfilled requirement by brand names suppliers of _______, _______ and _______ for a HACCP plan.
• Encourage plant to take credit for the good work they are doing as the result to numerous prerequisite monitoring procedures and monitoring records in place that are not identified or listed as an integral part of their HACCP plant but serve as additional product safety safeguards.
• Flow diagrams very clear, comprehensive and easy to understand.
• Allergen control programs best we have seen. Separate packaging machines, separate scoops, separate rooms. Very good and comprehensive.
• Good automatic hand wash station at entrance to processing area.
• Stick floor pads good idea.
• Iodine beakers at packaging station and use of plastic gloves at same point good idea.
• They do not use water during processing and yogurt packaging in the processing room. Squirt iodine on floor every 15 minutes.
• Vat pasteurization charts are complete, comprehensive, organized and very good examples of industry work. Use of stamp very helpful to assure records are completely filled out.
• Pest control done by _______ and monitoring of pest control activity by the plant is adequate and documented.
• Including examples of many forms with the specific prerequisites was very helpful.
• COP logs have been improved three times demonstrating constant improvement and the fact that this program is living and breathing and at present time they are in excellent shape. Filler logs very good and include swab results crosschecked against filler logs.
• Level of respect enjoyed by HACCP team leader contributes significantly to the effectiveness of the HACCP system.
• Internal oversight and verification of HACCP records is significantly contributing the strength of the HACCP program and its comprehensiveness.
• Tanker seal program and recording of numbers on wash tags very good from security standpoint.
• HACCP team very effective in transferring knowledge and training about HACCP to production employees and supervisors.
• Packaging machine operators give list of activities during shift to oncoming shift operators and this improves communication.
• Finished product samples all within PMO limits for the past 2 years with no violations.
• State regulatory oversight doing very well in carrying out their role under the HACCP pilot.
• Plant reported that they obtained following benefits:
  • Identifies weak points in processing and control systems.
  • Provided access to a wider array of branded ingredients for top cup.
  • HACCP provides more control of processing system.
  • Staff better trained to assist in controlling processing system.
  • Pushes you to do what you know you should be doing.
  • HACCP has made production guys realize how important the things they do are and take more responsibility in sanitation instead of letting this fall back to third shift sanitation crew.
  • Training and additional documentation under HACCP help production staff to betterunderstand records necessity and importance and result is more effort put into records. Also because records receive more review and checking, production staff makes more effort toward getting all necessary information on records.
  • HACCP appears to contribute to the "team" concept as opposed to a more individual approach before. This is especially noted in the shift changeover and information sharing between shifts.
• Plant's documentation and verification program was very complete and effective.
• Product labeling was adequate.
• The plant's ability to update and maintain the HACCP program has been enhanced by a stable workforce. Two years ago, the huge turnover of key personnel in the plant created training and implementation challenges that was partly the cause of pre-mature listing. The re-listing in December and the Evaluation team observations supported this improvement.
• The opportunity for plant and regulatory personnel to receive additional training as part of the Phase II transition has resulted in a strong understanding of the roles and responsibilities of the industry and regulators, contributing to good relationships and cooperative interaction. The FDA original uncertainty noted under Phase I by the state regulatory agency personnel, the FDA Regional Milk Specialist and the plant regarding their individual roles and the criteria for listing or delisting has significantly diminished.
• There was an overall feeling by plant, state and FDA personnel involved in the pilot that there was increased confidence in the safety versus the traditional NCIMS program.
• The Evaluation Team observed extremely strong support at the top levels of plant management which was instrumental in the successful development and implementation of the HACCP pilot program.
• Routine audit reports by the state were well done, complete with continuous follow-up to monitor corrections.
• Corrections to problems noted to PP are generally appropriate and timely. The notice of what is needed is normally written on the PP worksheet or checklist. This is then provided to appropriate plant personnel for correction. No tracking or monitoring of correction for repeat occurrences. A central location for these records would be useful in performing effective root cause analysis. Done.
• Note: PP#6 talks about reconciliation of vitamin usage daily by weight. Most current reconciliation results on 108% and 112% which is excellent.
• The case washer with quaternary ammonia rinse.
• Use stainless steel air lines for air system and have a routine cleaning regime of about once per month.
• COP records are well documented and log used to track concentrations of CIP solution.
• Log for changing air filters is best ever seen because they check every air filter every day.
• Eggnog flow chart is very thorough.
• Overall, the PP are some of the best we have seen, in particular PP#2 on Cleaning and Sanitizing of equipment such as specifying visual inspection monitoring, chemical strength monitoring, frequency of cleaning, broken down by type of equipment, very detailed.

Evaluation of the NCIMS HACCP Pilot Program Phase II Expansion