As giant food processors and ingredient companies reorganize, acquire, and divest their assets to re-position themselves, quality programs are facing the brunt of some of these changes; many companies are having to modify programs to better align with important changes, such as new leadership, loss of technical expertise, and resources being stripped to bare bones. Activities such as these are becoming commonplace and almost expected in the food industry.
Explore this issueJune/July 2018
Despite these changes, quality and safety are not dispensable in a consumer driven market. Minor changes in quality can influence buyer behaviors; however, safety impacts are not as resilient. As the march continues to further cost reductions through automation in manufacturing, sanitation is on everyone’s radar as a place where innovation may just be the solution we are all looking for.
In just a few months, 2018 has become a record year for listeriosis-related deaths on a global basis. As of mid-May, a record of 204 deaths and 1,033 cases of listeriosis have occurred in South Africa in the largest outbreak in recorded history, where consumers of a popular meat product were struck with illness from consuming the contaminated product. The consequence on employees has been the loss of an astounding 2,000 jobs related to this incident.
Even though approximately 1,600 people are affected by listeriosis each year in the U.S. and 260 of them die, the global burden of Listeria is not as easy to quantify. A 2010 study published in The Lancet estimates 23,150 cases of illness and 5,463 deaths. Listeria contamination has been a sore spot for both frozen and fresh products, both being directly tied to inadequate sanitation practices.
Listeria is the top pathogen being targeted by the vast majority of processing sectors from ready-to-eat dairy products to frozen vegetables, refrigerated and frozen meals, prepared fruits, and numerous foods that can harbor Listeria. While prevalence data is incomplete at best, there are significant gaps in the actual harborage considerations, ecological niches, and biofilm dynamics that support the prevalence and propagation of Listeria, making proper cleaning and sanitization vital to controlling contamination.
Several high-profile outbreaks of listeriosis in recent years, like cantaloupes, packaged salads, caramel apples, and frozen vegetables, have been caused by biofilm accumulation and transfer, or the use of equipment in unintended ways. Moreover, many of these cases could well have been prevented principally by properly planned and executed sanitation programs.
But what does proper planning entail?
Mastering the Master Plan
The U.S. Code of Federal Regulations’ guidance on Good Manufacturing Practices (GMPs) can be supplemented by maintaining a well-documented schedule that aligns everyday hygiene with the overall plant and its equipment.
Develop an equipment inventory containing a coversheet of equipment description in written and graphical form with intended use, equipment specifications, manuals, manufacturer and technical support information, date of installation and history of maintenance events (preventative and restorative), and functional and hygienic inspection records.
A master sanitation schedule should include the master plan for the entire plant and a breakdown of each part that requires cleaning and consists of the following at a minimum:
- Each piece of immovable equipment;
- Moveable equipment and implements/tools (forklifts, bins and carts, etc.);
- Facility structures and items used by operators (personal protective equipment, cleaning tools, handheld equipment, etc.);
- Surfaces including walls, floors, and ceilings;
- Utility inlets and outlets (water, air);
- Sanitary facilities and waste disposal areas for both production related waste and trash from all areas of the facility (sewer, solid waste, liquid waste, liquid treatable waste, recyclables, trash, etc.) and their surrounding areas;
- Daily or weekly activities separate from periodic or deep cleaning plan scheduled activities, which should be visible to all personnel; and
- Details of WHAT needs to be cleaned, WHEN it needs to be cleaned, HOW it needs to be cleaned, WHO will clean it, using what SPECIFIC equipment (color coded brushes, pads, hoses, steam, or jetting equipment), for HOW LONG with what specific PROTOCOLS (time and temperature, scrubbing action, etc.), and PRODUCTS (potency and quantity of detergents, water, sanitizers).
Know Your Targets and Gather Data
Listeria is only one of many organisms to be concerned with. Pathogens such as Listeria, Salmonella, Shigella, Shiga toxin producing E. coli, Vibrio, and Campylobacter are all major targets for sanitation. While these organisms are of economic interest to prevent illness, spoilage organisms that are abundant in processing facilities are not regularly sought after through planned swabbing exercises.
Spoilage, however, is of great concern to brand owners who regularly spend time and great amounts of cash buying refrigerated transport and storage to ship more rapidly, or storage in temperature-controlled warehousing, refrigerator units, or shelf space.
Modern sanitation is getting ready to take a turn towards being more data-oriented and there are several approaches that may be quickly adopted. Bacteria, yeast, and mold species that can potentially cause spoilage are everywhere and naturally occur in our environment. Targeting these species through air and water pathways that enter the facility is one means of prevention. Cleaning activities that entail using the seven steps of sanitation paired with targeted prevention methods can make a difference. The view to microbiological control in many sectors is primarily pathogen focused and is in need of a more holistic approach to spoilage. Shelf life is directly affected by many species that do not cause serious illness. In dairy, fresh produce, and food service operations, equipment cleaning, air, and water are key factors in how soon food needs to be used up or thrown out.
Quick tips include:
- Maintain accurate data on water source and chlorination;
- Sanitation verification swabs should be obtained on a risk-based frequency for equipment that is cleaned with water, dry cleaned, and also equipment that is either ozonated, pressure, or spray-cleaned with steam, ice, or chlorine; and
- Take a step back and collaborate with quality and customer facing personnel to track sanitation activities against quality and shelf life performance.
Big Data is the Future of Food Safety
In the past few years, the CDC has used whole genome sequencing (WGS) data to match cases of illness and death from outbreak clusters to facilities and food products, closing the loop on who is to blame. The GenomeTrakr network currently (as of April 2018) has sequenced more than 167,000 isolates and completed more than 175 genomes adding new sequences of over 5,000 isolates each month.
While these powerful investigative tools provide our public health system with unprecedented targeting capabilities potentially curtailing outbreaks before they can spread, they also shine the spotlight on brands when they are implicated in outbreaks; and not in a good way. Using the same tools used by investigators has yet been a slow pickup on the part of industry. However, sanitation provides manufacturers a unique opportunity to use next generation sequencing data in making better decisions about routine and periodic equipment cleaning. For example, WGS data while being highly valuable in pinpointing the IDs of specific microorganisms has little use for business outside of specific product development opportunities and targeted traceability throughout the supply chain.
In looking at environmental monitoring, however, trended data over a period of time between the networks of swabbing sites can provide birds eye views into resident microflora, persistent pathogens, and their niches and track responses to the sanitation cycles, sanitizer rotation, and resilience patterns. These patterns also serve as indicators as to how well equipment has been designed and fabricated.
Equipment Design and FSMA
The Food Safety Modernization Act’s (FSMA) reach via the Foreign Supplier Verification Program additionally puts pressure on importers to ensure suppliers are in compliance with the basic GMP requirements per the rule. As summarized by Food Quality & Safety’s writer Ted Agres in the February/March 2018 Washington Report column, the FDA Office of Regulatory Affairs cites pest control, sanitation monitoring, cleanliness, HACCP plan implementation, and reasonable precautions as key deficiencies that could trip up importers who buy from foreign suppliers.
Foreign suppliers, buyer representatives, and verifying agencies may find it useful to know just how well foreign suppliers align with FSMA and hygienic requirements. In designing a preventive controls plan, the Preventive Controls Qualified Individual, has many responsibilities; one of which should include an assessment of the suitability of the equipment for the task. Since preventive controls rely heavily on properly functioning equipment, it is important to know if equipment is in good working order and hygienically designed. In conducting this quick self-audit of the facility, the following data can be invaluable in further decision making:
- Properly draining (self-draining) designs that slope away, taking advantage of gravity to remove all water after cleaning cycles;
- Evaluating the suitability of the materials used in the construction of the equipment and their suitability to the task and proposed preventive control strategy;
- Removable or movable equipment, and parts and their potential contributions to physical hazards (glass, rubber, metal, wood, etc.);
- A review of equipment inspections and previous findings or failures for all processing and adjacent equipment, packaging, and conveying equipment;
- Gaskets and connectors and conveying equipment that are suitable for the task, environmental conditions, and product;
- Ceiling and roof inspections and swab collection sites and data corresponding these samples; and
- Details about the equipment, their date of manufacture and installation, and list of maintenance activities/events and failures.
Focus on What Matters to the Customer
Changing business models also means that suppliers and contract manufacturers have to engage in closer relationships with buyers and brand owners whose expectations for quality are closely tied to everyday activities. Sanitation schedules, sampling plans, and environmental monitoring data provide both parties with rich information on the performance of a total quality management system.
In working with buyers or contract manufacturers, maintaining the following data can be of value:
- Pre-op cleaning verification swabs for allergens and indicator organisms;
- In-process equipment sampling;
- Storage vats or tank cleaning schedules and verification testing data;
- Filling equipment monitoring activity schedule and monitoring data;
- Compiled reports on relevant in process, end product, or supplier verification sampling data; and
- Shipping containers, hauling or vessel cleaning schedules, and pre-loading inspection reports.
Many organizations share best practices in sanitation to help their customer or suppliers have confidence in business partners. Working on developing these relationships and partnering up with equipment manufacturers and service providers gains trust and can build the data pool necessary to make quicker, more effective changeovers.
Dr. Anandappa is the founding director for the Alliance for Advanced Sanitation, and a research assistant professor with the Department of Food Science and Technology at the University of Nebraska-Lincoln. Reach her at email@example.com.