Verifying the Integrity of Hygienic Design
The term ‘verifying’ reminds
me of the commercial in which a couple of eager consultants assure a slightly bewildered
prospective client ‘Yes, we can do that!’ in response to every question the
prospect asks, with more emphasis each time.
After the sale is made and the client leaves, one consultant turns to
the other and asks ‘How are we gonna do that?’
There is no better time
for processors to make sure they have the policies, procedures and practices in
place to help meet the objectives of new rules on Preventive Controls for Human
Food under the Food Safety Modernization Act. More to the point, are the policies and procedures
adequate to assure the integrity of hygienic equipment design? How are you
gonna do that?
Compliance will be
required in September this year for ‘small’ businesses and in September 2018
for ‘very small’ businesses. Compliance
for businesses subject to the Pasteurized Milk Ordinance was extended until
September 2018 to allow time for changes to the PMO safety standards that
incorporate the requirements of the Preventive Controls rule.
In a previous edition, we
emphasized that requirements under the Preventive Controls rules are sweeping:
Facilities must establish and
implement a written food safety plan that includes an analysis of hazards and
risk-based preventive controls. Further, some provisions of the Current Good
Manufacturing Practices (CGMPs), such as education
and training in the principles of food hygiene and food safety are now binding.
in the FSMA or the Preventive Controls rules specify design requirements, but
the rules do call out the requirements for processor to document how they eliminate
or minimize a number of hazards. Food
manufacturing firms must demonstrate due diligence in manufacturing products in
a sanitary environment and sanitary design is key part of such demonstration.
The integrity of hygienic
design begins with vendor qualification and selection. Can your equipment
supplier provide the equipment or services to the requirements that your
company expects? Vendor qualification is not solely an auditing process but
rather a quality system in itself with several key elements:
Qualification of vendors rests on a clear statement
of critical requirements, such as a checklist of expectations and actions
needed to assess suppliers. An
evaluation process to make this assessment might include vendor site audits,
questionnaires, evaluation of historical performance and recommendations by
must be defined for any
material or product component provided by qualified vendors. Checklists should address specification
criteria, purchase agreements and the change-management process.
Verification is essential to affirm vendor
compliance and conformance with the established materials or component
specifications. Typical verification
methods include some type of physical testing under appropriate controls and
proof in the form of a certificate of analysis or another acceptable form of
Monitoring reflects the type and extent of control
you desire to exercise over your suppliers, based on completed qualification
evaluations. They must establish and implement activities to demonstrate performance
and to assure that the equipment/services they have supplied meets your requirements.
When it comes to the design
of equipment, vendor qualification is critical, and probably more so for
suppliers of ‘non-standard’ equipment or processing systems.
3-A Sanitary Standards for
equipment and 3-A Accepted Practices for processing systems are designed to help
food processors, audit professionals and regulatory sanitarians assure the
integrity of the food processing system and the safety of food. The 3-A Symbol
is available to equipment fabricators on a voluntary basis to signify the
equipment was designed, manufactured and verified by independent inspection to
conform to a 3-A Sanitary Standard.
3-A Sanitary Standards are
the result of decades of collaboration among regulatory professionals at the
Federal and state levels, leading processors and equipment fabricators. The
standards embody objective, verifiable baseline criteria and they are designed
to be compatible with U.S. regulatory criteria and guidelines such as the
European Hygienic Engineering & Design Group (EHEDG). Perhaps most important, 3-A Symbol-authorized
equipment is backed up by the independent Third Party Verification (TPV)
3-A Sanitary Standards
help processors ‘fill the gap’ to document the safety of equipment used in food
processing in many important respects:
of construction, whether metals or non-metals, must be inert, non-toxic,
non-corrosive, non-contaminating, and impervious to moisture.
finishes must be durable, free of cracks and crevices and smooth to a minimum
measure of 32 Ra (roughness average) for a product contact surface.
of various types must be cleanable, crevice-free and bacteria-tight.
– All surfaces must be free draining and properly pitched or sloped to prevent
any liquid pooling.
and Inspectability are fundamental to equipment design, manufacture and
installation. If you cannot see it, you
cannot clean it!
Elements such as dead ends, gaskets, gasket retaining grooves, O-rings and
seals, threads, springs, shafts and bearings must be bacteria-tight and
accessible for cleaning, sanitizing and inspection.
Both preventive controls and
detective controls are essential to an effective internal control system. As the FDA rules attest, preventive controls
are essential because they are proactive and emphasize quality. Detective controls play a critical role by
providing evidence that the preventive controls are functioning as intended.
In the case of
non-standard equipment, the responsibility falls largely to the processor and
the supplier to document the safety of processing equipment. Without proper
hygienic design and construction, validation of cleaning efficacy is difficult,
if not impossible.
You can find 3-A
Symbol-authorized equipment at www.3-a.org, see ‘Search for a
3-A Symbol Holder’.