FSMA’s GMPs: Blocking Risks of Cross-Contamination

Plants and Grounds Best Practices. All areas of the facility must be zoned in order to identify the level of risk associated with each. Areas of the facility where there is no further heat-treatment and where the food is exposed is considered to be RTE, High-­Hygiene, or High-Risk areas. Other areas of the facility should be designated as Non-RTE, Low-Hygiene or Low-Risk, Raw Area, and General Plant. Each area should have unique procedures that ­allow (or not) ingress/egress, uniforms, shoe specifications, vehicular/wheeled traffic designations, and employee departmental determinations. Procedures should be developed for performed activities when unique and risky events such as construction and the removal or introduction of equipment occurs in a high-risk area.

Sanitary Operations

The proposed cGMPs will require that cleaning and sanitizing of utensils and equipment be conducted in a manner that protects against cross-contact and contamination of food, food contact surfaces, or food-packaging materials, as well as non-food contact surfaces. Additionally, it would require that all food-contact surfaces, including utensils and food-contact surfaces of equipment, be cleaned as frequently as necessary to protect against cross-contact and contamination of food.

Sanitary Operations Best Practices. A post-sanitation inspection is needed where equipment used for the manufacture of food is visually inspected for cleanliness and then swabbed. Swabbing may be either for ATP (conducted after cleaning) or for indicator microorganisms such as aerobic plate count, coliforms, Enterobacteriaceae (after sanitation), or a combination of both. The sanitation manager should be armed with the ATP swabs as a management tool to quickly assess cleaning and immediately re-clean when failing tests are returned. Remember to perform a baseline study on the ATP swabs for each plant. Then, immediately after sanitation, the QA team can swab for indicator organisms. Both provide what we described earlier as a verification that the sanitation standard operating procedures are working as intended. Additionally, full equipment disassemblies and inspections (to include swabbing) must be conducted on a routine basis (start with quarterly and readjust as the swabs indicate) for equipment used in support of food manufacturing and starting in the high-risk areas.

click for large version

Figure 1: A Thorough Approach to Managing Food Safety.

Training

FDA analysis of recalls has indicated that ineffective employee training was a root cause of 24 percent of cGMP-related primary recalls in the 2008 to 2009. As a result, proposed provisions will require that supervisors and workers are appropriately trained and possess the necessary knowledge and expertise in food hygiene, food protection, employee health, and personal hygiene to produce safe food products. Specifically, each person who is engaged in food manufacturing, processing, packing, or holding (including temporary and seasonal personnel and supervisors) must receive training as appropriate to the person’s duties. Training must include:

• The frequency of training,
• The principles of food hygiene and food safety,
• The importance of employee health and personal hygiene, and
• Documentation with the date of the training, the type of training, and the person(s) trained.

Training Best Practices. While there is a need for classroom training and presentations, in order to be truly effective, interactive training that is conducted as close to the jobsite as possible is ideal. When evaluating employees for understanding, practical exercises and direct observations is preferred over written tests. Short, frequent training bursts are also a good idea. For example, one plant conducts two four-minute training discussions daily on the plant floor from a list of topics, chosen at random, and documented. Also, while yearly training is important, the really best practice is to provide constant (hour-by-hour/day-by-day) encouragement by on-the-floor management.

Despite FSMA, companies should develop an approach to food safety by combining the efforts of Hazard Analysis and Critical Control Points, preventative controls, and GMPs into one entwined system (see Figure 1) where each part works in concert with the others and the entirety is proven effective through scientific verification. So now again we ask will GMPs alone be enough to control the risk of cross-contamination in food manufacturing operations? What do you think?