Standard Operating Procedures (SOPs) and Active Managerial Control (AMC): A Study on the Impact SOPs have on the Reduction of Foodborne Illness Risk Factors in the Food Service Industry in Michigan

Lucus Pols, R.E.H.S.

Kalamazoo County Health and Community Services - Environmental Health Division

International Food Protection Training Institute

2010 Fellow in Applied Science, Law and Policy:  Fellowship in Food Protection

Abstract

This paper explores the impact that the Standard Operating Procedures (SOPs) have on Active Managerial Control (AMC) in food service facilities within the state of Michigan.  Annex 4 of the Food and Drug Administration (FDA) 2005 Food Code lists SOPs as an effective food safety management system for a food service establishment to ensure AMC (FDA, 2005).  As of December 31, 2010, only 20 states had adopted the FDA 2005 Food Code or the newer FDA 2009 Food Code (FDA, 2010).  The purpose of this study was to determine what impact, if any, the use of SOPs has in promoting AMC and thus reducing foodborne illness risk factors in food service facilities.  A survey was conducted of each local health department within the state of Michigan.  The State of Michigan, which has authority over these local health departments, has adopted the FDA 2005 Food Code.  Of the agencies that responded to this survey, 88.5% utilize SOPs to promote AMC in food service facilities with 80% of these agencies responding that they have seen increased compliance with the foodborne illness risk factors (food from unsafe sources, inadequate cooking, improper holding temperature, contaminated equipment, and poor personal hygiene) (Center for Food Safety and Applied Nutrition, 2006).  A study was also conducted with Kalamazoo County Health Department in Michigan, within the Kalamazoo County Environmental Health Division.  Since 2005, Kalamazoo County has insisted on written SOPs for food service facilities prior to a facility opening, after a facility changes ownership, and as a means of enforcement.  This study looked at food service facility compliance with the five foodborne illness risk factors.  The Kalamazoo County study found that approved written SOPs appear to have a positive impact in reducing violations with the foodborne illness risk factors except for in the area of improper holding violations (such as cooling, cold holding, hot holding, time as a public health control, and date marking). 

Background

The idea of Active Managerial Control (AMC) has been around since the early 1960s in which inspectors would work at encouraging food service managers to take control of the managers’ establishments (R. Hendy, personal communication, February 10, 2011). In the early 1990s a Hazard Analysis Critical Control Points (HACCP) workshop was held for regulatory retail food professionals. During this workshop John Marcello, Retail Food Specialist for the FDA, first contrived the term “Active Managerial Control” (J. Marcello, personal communication, February 23, 2011). AMC was originally part of the FDA 2001 Food Code annex describing HACCP (FDA, 2001) and was later given full attention in the FDA 2005 Food Code under Annex 4. Annex 4 of the FDA 2005 Food Code states that Active Managerial Control “is used to describe industry’s responsibility for developing and implementing food safety management systems to prevent, eliminate, or reduce the occurrence of foodborne illness risk factors” (FDA, 2005). Another definition describes AMC as “the purposeful incorporation of specific actions or procedures by industry management into the operation of their business to attain control over foodborne illness risk factors” (Center, 2006).

Annex 4 of the FDA 2005 Food Code lists SOPs as one of several ways in which a facility can promote AMC in their establishment (FDA, 2005). SOPs are defined as a “written method of controlling a practice in accordance with predetermined specifications to obtain a desired outcome” (Center, 2006). SOPs have been used throughout the world to explain what hazard needs to be controlled, what will be done to control this hazard, who will control the hazard, and how the hazard will be monitored. An example of SOP usage is a document from 2003 which gave advice for school meal programs. One of the pieces of advice was to take the example of Walt Disney World and review Sanitation Standard Operating Procedures to screen food vendors (United States General Accounting Office, 2003). This recommendation shows a brief example of how SOPs are used to help determine the level of food safety in a food establishment. However, according to Alan Tart, an FDA Consumer Safety/Training Officer, FDA has not completed any specific studies showing that the implementation of SOPs reduces the occurrence of foodborne illness risk factors (A. Tart, personal communication, February 15, 2011).

The Centers for Disease Control and Prevention (CDC) determined in the 1993-1997 surveillance report that five broad categories directly contribute to food safety concerns. These five categories were then termed by FDA as “foodborne illness risk factors.” The five foodborne illness risk factors are:

v Food from unsafe sources

v Inadequate cooking

v Improper holding temperatures

v Contaminated equipment

v Poor personal hygiene

This surveillance report also indicated that regulatory agencies should increase the focus on assessing these foodborne illness risk factors to help determine an establishment’s level of Active Managerial Control (Center, 2006).

            The state of Michigan currently has 45 local health departments, all of which use the FDA 2005 Food Code. One local health department, Kalamazoo County Health and Community Services - Environmental Health Division, has actively promoted the use of SOPs during plan review for new food service facilities, facility change of ownerships, and as an enforcement tool since as early as 2005. In 2010 this agency created SOP software that gives food service establishments an easy way of creating SOPs, thus giving managers a tool they can use to help promote AMC in their facility.  This software was created by Sword Solutions, which also provides Kalamazoo County with a software program where all food service facility evaluation reports are entered.

Research Questions

Are SOPs used and, if so, how are they used by local health departments throughout the state of Michigan? Do approved SOPs promote AMC in food service facilities, thus increasing compliance with the foodborne illness risk factors and thereby decreasing the risk of foodborne illness?

Problem Statement

This study was needed in order to determine if SOPs are currently being used by local health departments to promote AMC in food service facilities. Secondly, this study was considered necessary in order to determine what impact SOPs have on foodborne illness risk factors. Finally, this study was necessary to determine whether or not approved SOPs promote compliance improvement with the foodborne illness risk factors in Kalamazoo County food service facilities as compared to those facilities where approved SOPs were not required (those facilities that have been in existence prior to 2005). 

Methodology

The first part of this research project was conducted by gathering information from an on-line survey, which was sent to each of the 45 local health departments in the state of Michigan. This survey was reviewed by International Food Protection Training Institute subject matter experts and, based on feedback from these experts, modifications in the survey eventually led to a final survey, which consisted of four primary questions. The survey asked four questions: 1) whether or not the agency promotes AMC as defined in the FDA 2005 Food Code Annex 4; 2) whether or not SOPs are used by the agency to promote AMC in food service establishments; 3) how that particular agency utilizes SOPs to promote AMC; and 4) if the agency has seen improvement in any of the foodborne illness risk factors since utilizing SOPs. 

The second part of this study was conducted with the Kalamazoo County Health Department. The study compared facilities that have created SOPs approved by Kalamazoo County and those facilities that have been in operation without approved SOPs due to these facilities having been in existence prior to 2005. Using the computer software program, Sword Solutions, 1,476 facilities were determined as having been licensed in Kalamazoo County.  Of these 1,476 facilities, 339 were new establishments from the years 2005-2010. A random sample study was done on 5% of the total facilities (1,476) which led to 74 facilities being compared from each study group. This study did not require facilities to be actively operating at the time of this research. The facilities were chosen randomly using the Microsoft Excel random number formula. Facilities that were eliminated during this process were those that were listed as schools (high school, elementary, and middle schools), special transitory food unit licenses, mobile unit licenses, and those that have had less than four routine evaluations. The four most recent routine evaluation reports of the randomly chosen facilities were reviewed and foodborne illness risk factor violations were logged and tabulated. 

The foodborne illness risk factor violations were taken directly from a reference sheet which was part of the FDA foodborne illness risk factor report document. Violations categorized for food from unsafe sources included “compliance with approved source,” “receiving in sound condition,” and “records retention.” The inadequate cooking risk factor focused on categories of proper cooking and proper reheating of potentially hazardous foods. The improper holding risk factor categories were proper cooling, cold holding, hot holding, and time (date marking and time as a public health control). The risk factor categories for contaminated equipment focused on separation/segregation/protection of raw and ready-to-eat foods and cleaning and sanitizing of food contact surfaces. Lastly, the poor personal hygiene categories were proper and adequate hand washing, good hygiene practices, prevention of contamination from hands, and hand washing facility functionality (FDA National Retail Food Team, 2009). 

Results

Of the 45 state of Michigan local health departments, 26 responded to this researcher’s survey. All 26 respondents indicated that they promoted AMC in food service establishments as defined in the FDA 2005 Food Code Annex 4. Twenty-three of these survey participants (88.5%) indicated that the facilities use SOPs to promote AMC, with 11.5% responding that the agencies do not. Of the agencies that utilize SOPs, 91.7% use SOPs for plan review, 66.7% use SOPs in enforcement, and 20.8% use SOPs for food service facility change of ownerships, new ownership of a food service facility, Risk Control Plans, or for a menu change. The following chart (Figure 1) shows the response to the fourth question, which asked if the agencies that utilize SOPs had seen improvement with the foodborne illness risk factors since utilizing SOPs to promote AMC.  As can be seen in Figure 1, the greatest areas of compliance improvement were improper holding temperatures and poor personal hygiene, while 20% of those responding saw no improvement.

The data compiled from the Kalamazoo County study indicated some interesting results differing from the results found above. These results can be seen in Figure 2 below. As Figure 2 indicates, facilities that have approved SOPs differ little from those that do not have approved SOPs in the areas of food from unsafe sources and inadequate cooking. The facilities that were not required to have approved SOPs had a greater number of violations in the areas of contaminated equipment and poor personal hygiene compared to those that do have approved SOPs. The greatest disparity was in the area of improper holding (cold holding, hot holding, date marking, time as a public health control, and cooling). The facilities with approved SOPs had 159 improper holding violations compared to 114 violations for those facilities with unapproved SOPs. A statistical test was not done to determine the statistical significance of these results.

Conclusions

The survey that was conducted would seem to indicate that local health departments in Michigan believe that the use of SOPs has increased compliance with the foodborne illness risk factors and in promoting AMC. The study done within Kalamazoo County would seem to indicate increased compliance in many of the foodborne illness risk factors due to approved SOPs except for the difference in violations with improper holding. In addition to these conclusions, other factors may have contributed to these trends. One of these factors may be that many of the facilities that have approved SOPs may have created them to satisfy the health department and then stored them on a shelf without properly training staff and implementing the SOPs. Also, many of those facilities that do not have approved SOPs have a mental or verbal SOP instead. Furthermore, the results indicated above may not have as much to do with SOPs as they have to do with other factors that are lacking or that promote AMC. These factors that may play a role include having a certified food manager, monitoring procedures, on-going quality control and assurance, equipment and facility design and maintenance, and employee training. If employees are not trained to follow a set of procedures and managers do not verify that procedures are being done, then lack of AMC can become evident in a facility. Another factor that may play a role is the enforcement policies of the health agency. Many agencies have stiff fines for violations or grading systems in place, neither of which are utilized in Kalamazoo County. However, fines or grading systems may or may not promote AMC in a food service facility. All of these factors may play a role, but the results of this research project would seem to indicate that approved SOPs do help promote AMC in many of the foodborne illness risk factor areas within a food service establishment. 

Recommendations

Further research will need to be done in order to understand the role approved SOPs play in reducing foodborne illness risk factors and in promoting AMC. Further research also is needed to determine why such a large discrepancy exists in improper holding violations between facilities with unapproved SOPs and those facilities with approved SOPs. Studies would need to be done in other counties within Michigan, similar to the one done in Kalamazoo County, to determine if varying enforcement strategies (such as fining), play a role in promoting AMC in food service facilities. Also, more information is needed to examine areas that have grading systems or those jurisdictions that follow a previous Food Code where the annexes do not indicate steps to promote AMC. Furthermore, food service facilities need to be more aware of the foodborne illness risk factors in this constant drive to promote AMC and reduce foodborne illness in the United States.   

Acknowledgements

I would like to extend my many thanks to the International Food Protection Training Institute (IFPTI) for allowing me to take part in this first annual fellowship; to Dr. Craig Kaml and Dr. Kieran J. Fogarty of IFPTI for methodological consultation, for editing this document, and also for providing quick responses to all my questions; to my mentor and subject matter expert, Dan Sowards, for providing great input on my ideas for this paper, for the careful editing done to this paper, for the quick responses, and for the constant encouragement; to all of the IFPTI fellowship members and instructors for mutual support as we wrote our papers; to my supervisor, Vern Johnson, and Kalamazoo County for granting me the time necessary to take part in this fellowship and complete this research paper; and to the local health agencies that took the time to respond to the survey. 

Corresponding Author:

Lucus Pols, Kalamazoo County Health and Community Services, Environmental Health Division.  Email: ldpols@kalcounty.com

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