Third-Party Verification (TPV) - Contributed by Gabriel Miller, Pi-FS, LLC

The term ‘Third-Party Verification’ or TPV has a special meaning with respect to the application of 3-A Sanitary Standards for food processing equipment and the related voluntary 3-A Symbol authorization program. The TPV inspection is one of the essential requirements to help assure that specific equipment conforms to a 3-A Sanitary Standard and is qualified to display the 3-A Symbol. The 3-A Symbol has been used for almost 70 years to show that dairy processing equipment conforms to the high sanitary standards required for equipment in the dairy industry. Before 2003, authorization to use the 3-A Symbol was based on self-certification. The holder simply attested that their equipment was fabricated in accordance with the given 3-A Sanitary Standard, sent in their annual licensing fee, and applied the 3-A Symbol to their equipment and marketing claims.

This self-certification created problems in food processing plants, much like telling drivers on the highway that there is no verification of the speed limits and letting everyone verify for themselves that they were driving within the limits. Plant inspectors were seeing problems with equipment bearing the 3-A Symbol that did not actually conform to the standards.

To address this shortcoming, 3-A SSI implemented a TPV inspection requirement as a condition for issuing a 3-A Symbol authorization and solicited independent equipment experts from the industry to obtain accreditation as a 3-A SSI Certified Conformance Evaluator (CCE). A total of 27 individuals passed the first accreditation exam in 2003 and met the requirements for knowledge of the 3-A Sanitary Standards and the processing equipment to inspect. The number of active CCEs has fluctuated since then. A current roster of CCEs is available on the 3-A SSI web site at https://www.3-a.org/evaluators-cce. These CCEs travel to manufacturing locations around the globe to inspect any equipment fabricators who wish to apply for 3-A Symbol authorization. Anyone with the requisite education and/or experience and knowledge of the 3-A standards is invited to apply to become a CCE.

The TPV Inspection Process

The TPV inspection requirements are straightforward and can be found in the 3-A SSI TPV manual, found on the 3-A SSI website at: https://www.3-a.org/documents/manual-for-third-party-verification-tpv. The objective is to ensure that the equipment to be listed on the 3-A Symbol Authorization certificate conforms to the applicable standard.

The first step in the process is to determine which standard applies. There are many standards, such as those for tanks - Insulated Tanks, Uninsulated Tanks, Silos, Batch Processors, and Vat Pasteurizers. If anyone has a question regarding which standard to apply, they can contact a CCE or 3-A SSI directly to affirm that they are referring to the correct standard, because they all have different requirements.

Then the fabricator should purchase the applicable standard from the 3-A SSI to understand the specific design requirements. For fabricators who are sufficiently knowledgeable of the criteria, they can proceed to design and fabrication, but for complex equipment, such as filling machines or homogenizers, it is recommended that they solicit a CCE to review the equipment design before purchasing components or starting fabrication. Manufacturing equipment without verifying that the design meets the requirements of the standard in advance can become costly and frustrating when it is time for the TPV.

The equipment fabricator should select a CCE, if they have not already engaged one, to get a proposal and plan for the TPV inspection. CCEs simply hold accreditation from 3-A SSI to perform TPV inspections; they are not employees or contractors of 3-A SSI. Likewise, CCEs are prohibited from having other business affiliations with their clients for TPV inspection services.  

Prior to the TPV inspection, the equipment fabricator should also compile their Engineering Design and Technical Construction File (EDTCF). This is a compilation of the engineering blueprints essential to verifying conformance. The EDTCF can be a paper document in a binder, or completely electronic, but note that the EDTCF after the TPV inspection must be maintained for 12 years following manufacturing.

This information, which may be compiled from multiple sources, is used by the CCE as the primary source of verification details. Since each EDTCF is unique to the type of equipment and manufacturer, the amount and types of documents will vary accordingly.

Required EDTCF documentation (or reference to file location):

a) Table of Contents

b) A copy of the applicable 3-A Sanitary Standard(s)

c) An overall drawing or general arrangement drawing of the equipment

d) Full detailed drawings, with any calculations, notes, test results, etc. required to check the conformance of the equipment

e) Any technical reports or certificate obtained from a competent testing body or laboratory (i.e. CIPability, riboflavin tests, or EHEDG certification)

f) Detailed instructions for cleaning of the equipment – CIP, COP, or CIP/COP)

g) Material certifications for all materials of construction in product contact, including FDA or 3-A certs for rubber and plastic materials.

h) Manufacturing controls and final inspection process procedures to verify 3-A conformance.

i) Change records

j) Copy of the 3-A certificate (when issued)

k) QA procedures and/or ISO 9001 certificate

l) Other documents as applicable

When all documentation is complete and the equipment has been fabricated, the CCE conducts the TPV inspection of selected representative equipment at the final manufacturing site. They will inspect the equipment and audit the manufacturing plant to ensure that controls are in place to receive, store materials, manufacture, and inspect the equipment model(s) that will be listed on the 3-A Symbol authorization certificate. The CCE also reviews the proposed display of the 3-A Symbol on the equipment to verify that it meets 3-A SS requirements.

The CCE completes the TPV report, listing the equipment models as CIP, COP, or CIP/COP. Equipment that requires removal of components for manual cleaning, such as silo manway door gaskets, must be listed as ‘CIP/COP’, even when most of the equipment is CIPable. This is to inform the end-users and the regulators of the recommended method of cleaning.

The TPV inspection includes the certifications for the materials of construction in product contact, as well as a checklist of provisions in the applicable 3-A Sanitary Standard. Each clause in the standard must be reviewed  by the CCE as in conformance or not applicable (NA) for the report to be complete and approved.

Following completion and approval of the TPV report, the CCE files the report with 3-A SSI for final review and approval. 3-A SSI will then send a notice to the applicant with instructions to submit the 3-A Symbol application with the initial application fee and the licensing fee online. As soon as that is completed, the 3-A Symbol authorization certificate is issued and posted on the 3-A SSI web site, and the equipment fabricator is authorized to apply the 3-A Symbol to the models listed on their certificate.

The 3-A SSI website features on-line access to complete information for all 3-A Symbol authorization holders as well as the related Replacement Parts and System Component Qualification Certificate (RPSCQC) Program. This public information assists regulatory sanitarians, processors, equipment fabricators, and other interested parties. The information is searchable by the unique authorization number, equipment type/standard or company name. The certificate search database is the most frequently visited area of the 3-A SSI web resources.