March 6, 2012
by Kerri Harris and Jeff Savell
The Food Safety and Inspection Service’s proposed rule entitled “Shiga Toxin-Producing Escherichia coli in Certain Raw Beef Products,” which was released on Sept. 20, 2011, states that establishments should reassess their Hazard Analysis and Critical Control Point plans, Sanitation Standard Operating Procedures, or other prerequisite programs when they have a first-stage screen positive (stx and eae) because they may not be adequately controlling a reasonably likely to-occur food-safety hazard.
Simply stated, reassessment is the process of reviewing and evaluating the HACCP plan and related programs to ensure they are effective and implemented correctly. However, proper reassessment is not as simple as it sounds.
Reassessment is not a new requirement. The Pathogen Reduction; Hazard and Critical Control Point System (9 CFR 417) includes the following statements for reassessment:
■ 417.2(d)(2) – The HACCP plan shall be dated and signed: (iii) At least annually, upon reassessment, as required under § 417.4(a)(3) of this part.
■ 417.3 (b) – If a deviation not covered by a specified corrective action occurs, or if another unforeseen hazard arises, the establishment shall (4) Perform or obtain reassessment by an individual trained in accordance with § 417.7 of this part, to determine whether the newly identified deviation or other unforeseen hazard should be incorporated into the HACCP plan.
■ 417.4 (a)(3) – Reassessment of the HACCP plan. Every establishment shall reassess the adequacy of the HACCP plan at least annually and whenever any changes occur that could affect the hazard analysis or alter the HACCP plan.
Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; personnel; packaging; finished product distribution systems; or the intended use or consumers of the finished product. The reassessment shall be performed by an individual trained in accordance with § 417.7 of this part. The HACCP plan shall be modified immediately whenever a reassessment reveals that the plan no longer meets the requirements of 417.2(c) of this part.
■ 417.4 (b) – Reassessment of the hazard analysis. Any establishment that does not have a HACCP plan because a hazard analysis has revealed no food-safety hazards that are reasonably likely to occur shall reassess the adequacy of the hazard analysis whenever a change occurs that could reasonably affect whether a food-safety hazard exists.
Such changes may include, but are not limited to, changes in: raw materials or source of raw materials; product formulation; slaughter or processing methods or systems; production volume; packaging; finished product distribution systems; or the intended use or consumers of the finished product.
As with many other aspects of the HACCP regulation, it seems that the expectations for reassessments have changed over time.
Each year we dread our annual reassessment because it is a painful process and one that we question if we are performing correctly.
In addition, we are often asked for reassessment tips or to assist other establishments with their reassessments, and now establishments are asking how they should handle the non-O157 STECs.
We do not have a tool or a list of tips, but we do encourage establishments to consider the following questions when reassessing their HACCP programs.
■ Are there any additional chemical, physical or biological hazards that should be addressed in the hazard analysis?
■ Have there been any unforeseen hazards?
■ Have there been any recalls, illnesses or outbreaks with this type of product, even though it was not our product?
■ Has FSIS issued any reassessment notices for this type of product?
■ Have changes occurred or is there any new information for the hazard analysis that a previously identified hazard does not need to be addressed in the HACCP plan?
■ Do we have data or documentation to support removing a hazard?
■ Has our process changed to prevent the hazard from being an issue for this process?
■ Do our pre-requisite programs, including purchase specification programs, still support the decisions that we made in the hazard analysis?
■ Are the CCPs and control measures being used to control the identified hazards appropriate?
■ Have we documented the use of the CCP decision tree?
■ Is the CCP adequately controlling the identified hazard or does it continue to occur in the product?
■ Do we need additional CCPs or controls to prevent, eliminate, or reduce the hazard to an acceptable level (or in the case of E. coli O157:H7, to an undetectable level)?
■ Are the current critical limits adequate?
■ Is the support still appropriate for the selection of the critical limits?
■ Is new support available?
■ Have we had critical limit failures that did not result in unsafe product, and if so, does this mean that our critical limit is not set correctly?
■ Are the critical limits based on food safety or on operational requirements?
■ Are the monitoring procedures sufficient? Are the frequencies supportable?
■ Are monitoring procedures based on continuous or batch processes?
■ If they are based on continuous processes, are there provisions to ensure that production at the end of shift or end of day are accounted for?
■ How are monitoring activities that occur around the clock (e.g., cold storage) handled to ensure proper documentation?
■ Do the monitoring frequencies closeout the end of production shift or day to prevent products from the next shift or day from being impacted if the critical limit is not met?
■ Have we had deviations, and were the corrective actions appropriate?
■ Were the actual causes of the deviations identified and eliminated in each case?
■ How were the measures to prevent recurrence handled? How often was “retraining” listed?
■ How was product handled to ensure proper disposition?
■ Are the verification procedures appropriate?
■ What are you learning from the direct observation and record review activities?
■ Are “process-monitoring instruments” (usually thermometers) in calibration or are adjustments or replacements routine?
As you can see, reassessment is a major component of a HACCP program and should not just be something that is performed when mandated by FSIS either through a notice or rule.
When performed correctly reassessment activities result in continuous improvement of an establishment’s HACCP plan, and, hopefully, greater confidence in meeting customer and regulatory requirements for safe food.