Standards versus guidelines

A number of different organizations throughout the world provide hygienic design standards and guidelines. There is a difference between standards and guidelines, and each of them have their place and fill a specific need.

In general, standards specify uniform uses of specific technologies or configurations. Standards are definitive and measurable courses of action or rules that support the attainment of an objective such as regulatory compliance.

Guidelines, on the other hand, are recommendations to users when specific standards do not apply. Guidelines are open to interpretation and do not need to be followed to the letter.

The FSMA mandates all food establishments, unless specifically exempted, to maintain a written preventive controls (PC) plan. This framework is viewed as more proactive than HACCP and clearly places more emphasis on “performance-based” elements.

While guidelines are intended to help processors show compliance in a PC plan, there is little guidance available when it comes to how to achieve the desired goals for the verification of food equipment and hygienic design.

Further, the interpretation and scrutiny of detailed information on equipment design may vary with the knowledge and experience of the auditor. There is an important gap to be filled when it comes to effectively documenting numerous equipment-related issues of hygienic design and fabrication in a PC plan.

Assembling a PC plan

Let’s consider the documentation of just one hazard — allergens — and some of the challenges of assembling a credible PC plan. The continuing prevalence of food allergies and the severity of such hazards make this an especially important issue to address in any PC plan.

Key elements in an effective allergen control program include dedicate (facility, system, line, etc.), segregate, separate, clean and sanitize. An effective Sanitation Standard Operating Procedure (SSOP) must be implemented for each line, and each allergenic ingredient and each SSOP must be validated.

Equipment design, along with the appropriate cleaning method, represents just one set of many variables to consider in developing the SSOP. The design criteria for processing equipment — from installation, operation and maintenance to cleaning and sanitation — are fundamental to an effective SSOP. This is where the baseline equipment design criteria for processing equipment play an indispensable role.

The American National Standard “3-A Sanitary Standard for General Requirements, ANSI/3-A 00-01-2018” covers the sanitary design, materials of construction and fabrication techniques for food and beverage equipment used to handle, process and package consumable products where a high degree of sanitation is required.

Specifically, the standard provides detailed information about the equipment fabrication/properties of product and solution contact surfaces such as surface texture, joints, coatings, cleaning and inspectability, draining, dead ends, gaskets, gasket retaining grooves, O-rings and seals, radii, threads, perforated surfaces, coil springs, shafts, bearings, openings and covers (other than personnel access ports), and temperature-sensing device connections.

Conformance to hygienic design and construction principles reflected in 3-A Sanitary Standards improves and facilitates cleaning and sanitation programs. It also facilitates validation. Without proper hygienic design and construction, validation of cleaning efficacy is difficult, if not impossible.

It is the responsibility of the processor to know and understand the risk profile of the products it makes, as well as the appropriate equipment and the cleaning/sanitizing techniques necessary for such equipment. A deficiency or weakness at any level — whether in the compliance guidelines or in the resources employed to demonstrate the achievement of the objectives — will jeopardize food safety in the processing system.

The specific benchmark hygienic design criteria in the general requirements standard provide an indispensable compliance resource for processors and equipment fabricators to use in selecting equipment or to help meet the requirements of various third-party auditing schemes that may be employed to support a PC plan. Where the safety of food matters, so does the integrity of hygienic design criteria. The standard is available for purchase at www.3-a.org.