FDA inspectors plan their inspection of a meat operation.
Michael J. Ermarth

By Lisa Lupo

Following a multistate listeriosis outbreak attributed to its product, Vulto Creameries was shut down due to multiple regulatory violations. Its owner said there was much he did not understand about what it took to run a foodsafe facility. Do you? How do you know?

Upon completion of a food facility inspection, FDA officials will issue a Form 483 if any conditions were observed which may constitute regulatory violations. In this article, we address the top six issues of noncompliance FDA observed at inspections during its 2017 fiscal year (Oct. 1, 2016-Sept. 30, 2017), with recommendations for improvement from two auditing consultants: SQFI Compliance Manager Chris Sinclair and SGS Auditor Mamun Chowdhury.

1. Lack of effective pest exclusion.

Effective measures are not being taken to [exclude pests from the processing areas] [protect against the contamination of food on the premises by pests] (including failure to provide adequate screening or other protection against pests).

Sinclair. With the changes in FDA inspections and third-party audits shifting from pest control to pest prevention, proactive pest management has become increasingly important. This is evidenced in the focus on exclusion with lack thereof being missing/broken screens, open doors, dock door seals that are worn, etc., all of which can lead to pest activity. Good pest prevention starts with good sanitation practices and eliminating any potential food or harborage source. Pest prevention plans should include documented reviews of and actions against identified pest activity and trend reports to identify potential issues and prevention measures.

Chowdhury. To exclude the pest activities within the facility, an Integrated Pest Management (IPM) program with regular inspections should be considered which allows only baits, mechanical devices, and traps inside the facility; no pesticides are used in the building or stored on-site. Weekly to monthly inspections, focused on areas where pests are most likely to appear, are common with some plants inspecting more frequently. Traps should be placed on both sides of all doors leading to the exterior, positioned and placed to prevent contamination of products, packaging, or equipment. Insect light traps (ILTs), with shatter-resistant bulbs, should be located to capture flying insects but not contaminate exposed product, packaging, or equipment or interfere with plant operations. Employees should understand the signs of pest activity and be aware of the need to report any evidence to a designated manager.

2. Sanitation monitoring.

You are not monitoring the sanitation conditions and practices with sufficient frequency to assure conformance with Current Good Manufacturing Practices (such as that related to water, food contact surfaces, cross-contamination, handwashing). 

Sinclair. Water or ice used as an ingredient, processing aid, in sanitation, or for handwashing, should be analyzed. Water samples should be taken at the sources supplying the water for the process or the cleaning, or from within the site. Testing should be completed at least annually using reference standards and methods.

Chowdhury. The cleaning program should be verified and validated and, in general, consider:

  • Restrooms with handwashing stations are maintained in good repair and are near, but do not open directly into, production areas.
  • Hand-sanitizing stations are provided in several locations with signs directing workers to wash and sanitize hands and/or gloves before starting or restarting work and any time they become soiled or contaminated.
  • Lidded refuse receptacles are located appropriately.
  • Only approved chemicals appropriate to the products produced are used, with chemicals secured, and inventory and auto-dispenser calibration records maintained. Water is potable or does not contact product.
  • Sanitation workers are trained on SSOPs, item/area to be cleaned, chemical dilution, method, materials, and verification records, and provided with suitable cleaning tools and personal protective equipment.
3. Floors, walls and ceilings.

The plant is not constructed in such a manner as to allow [floors] [walls] [ceilings] to be [adequately cleaned and kept clean] [kept in good repair].

Sinclair. Many of the issues are in the general upkeep of the site. This includes build-up of dirt and debris, flaking paint, and rust. While this may seem to be minor, the appearance of the facility is an indicator of the site’s commitment to its food safety behavior. Additionally, cracks in the floor provide harborage for environmental pathogens. Thus, facility conditions should be added to the internal audit program as well as the scheduled inspection checks and any needed corrective action implemented.

Chowdhury. Walls, floors, and ceilings should be designed to prevent the entry of pests or water and built of durable material that is easy to maintain and clean. Flooring should minimize potential for contamination, allow adequate drainage, flow from high to low risk areas, slope to a central drain line, and be easy to maintain and clean. Ceilings and overhead fixtures should be accessible for cleaning and minimize the potential for dirt or condensation to fall on production or stored food. Surfaces of walls, partitions, and floors should be made of impervious materials and be smooth. Windows and ventilators should be easy to clean and prevent entry of pests. Doors should have smooth non-absorbent surfaces, be easy to clean and disinfect, and prevent the entry of pests or other contaminants.

4. Buildings/sanitary.
Failure to maintain buildings, fixtures, or other physical facilities in a sanitary condition.

Sinclair. As buildings age, the condition of the equipment, fixtures, and structure are prone to issues and decline, leading to potential physical and biological hazards. Preventive maintenance is the key to maintaining plant health. However, sites with damaged exterior walls and dock door assemblies and broken concrete pads that cause water to pool are continually seen. These issues can provide pest harborage sites and indicate lack of management commitment. Preventive maintenance is the key to maintaining plant health. This includes the handling of temporary repairs, ensuring that they do not pose a threat to the operation and include a time period in which they become a permanent fix. Sites should use their internal audit program as a tool and include a focus on the exterior to reduce pest attraction.

Chowdhury. Buildings should be of durable construction, suitable size and location, and maintained to reduce the risk of contamination and facilitate the production of safe and legal finished products. They should provide sufficient space to allow a logical flow of materials, products, and people through the production process, while protecting against contamination sources, unintended mixing of materials or products, and cross-contamination. Openings intended for transfer of materials and products (e.g. transport hoses, conveyors) should be designed to prevent entry of foreign matter and pests. Internal layouts should be designed, constructed, and maintained to facilitate good hygiene and manufacturing practices, and external areas well maintained.

5. HACCP plan implementation.
You did not implement the [monitoring] [recordkeeping] [verification] procedures listed in your HACCP plan. 

Sinclair. Food safety plans are not being properly developed; specifically, critical limits are not being properly established. The HACCP food safety plan should be the foundation, and sites should use the Codex HACCP model and recognize that the HACCP plan must be systematic, comprehensive, and thorough. Often overlooked is the checking of the HACCP plan to ensure the food safety plan is working as established. This requires a walk-through of the facility with the plan to verify the process flow, CCPs, monitoring, and recordkeeping. At least annually, the plan should be checked and FSMA provisions for the food safety plan require a review if there are new products, equipment, or a change in the process flow.

Chowdhury. To identify potential hazards relevant to ingredients, raw materials, process, work in progress, and product produced or delivered, food handlers should apply HACCP along with the hazard analysis and risk-based preventive controls (HARPC) of FSMA. HACCP is based on the principle that hazards affecting food safety can be eliminated or minimized by prevention during production or at any earlier step rather than by inspection of the finished product; its goal is to prevent hazards at the earliest possible point in the food chain. But HACCP is not a stand-alone system; good hygiene practices and other prerequisites for food processing as well as strong management commitment are also necessary. Training is essential for successful implementation of HACCP, and once implemented, it must be re-assessed to ensure its adequacy over the time and improve as needed. HACCP/food safety plan control limits should be supported by regulations or customer or industrial best practices, and monitoring records should be maintained and reviewed by appropriate, trained, and experienced staff.

6. Cleaning and sanitizing operations.
Failure to conduct cleaning and sanitizing operations for utensils and equipment in a manner that protects against contamination of [food] [food-contact surfaces] [food-packaging materials].

Sinclair. The most common cleaning and sanitizing non-conformance originates from not verifying the effectiveness of the methods used. These methods will vary depending on the nature of the operation, and the microbiological and allergen risk. It is important to stress that, regardless of the type of production and risk, all food facilities should have an appropriate, documented, and implemented cleaning program. The program must be verified to ensure its effectiveness. Having a strong pre-operation inspection program can help identify issues with the effectiveness of cleaning prior to them leading to a recall.

Chowdhury. The food operations business should have a regular cleaning process that maintains the food preparation, storage, and adjacent areas. The cleaning and sanitation program should minimally cover cleaning and sanitation schedules, responsibilities, methods, equipment, and cleaning and sanitizing aids. These should be monitored for their effectiveness. Cleaning and sanitizing chemicals should not contaminate food or food contact surfaces.

As we know, methods of cleaning vary from product to product, but typically food processing equipment is cleaned and sanitized by a cleaned-in-place (CIP) or cleaned-out-of-place (COP) system. CIP is used to clean the interior surfaces of pipes, vessels, process equipment, filters and associated fittings, without disassembly; COP cleans other equipment such as fittings, clamps, product handling utensils, tank vents, pump rotors, impellers, casings, hoses, etc.

The chemicals need to be suitable, approved, and effective against the target pathogens, viruses, and bacteria. There also should be a master cleaning program for floors, walls, ceiling, overheads, employee offices, warehouse, breakrooms, etc. ATP testing should be used to evaluate cleanliness of food-contact surfaces prior to start-up; micro-swabs for APC and EB can be performed at least monthly to verify sanitation and ATP results, and can be used at suitable frequency to monitor for hazards in the environment.

The author is Editor of QA magazine. She can be reached at llupo@gie.net.