Giving a “post mortem” of equipment design and engineering failures has been done so many times that I’ve lost count. We really don’t find a large number of “showstoppers” during the TPV inspection at facilities. For the most part, equipment manufacturing managers, designers and engineers are conscientious about designing to 3-A Sanitary Standards. We are there to evaluate and independently verify conformance to the standards. A review of the Engineering, Design and Technical Construction File or EDTCF is the beginning of the review process. Occasionally there are differences of interpretation to a specific requirement in a standard. When that happens the CCE draws upon resources within 3-A SSI to resolve the question
We are now into our 19th year of completing TPV inspections. Non-conformities are found and here are some takeaways based on my experience and other CCEs.
While an initial inspection might be considered a good time to orient new staff on the 3-A Symbol program, it is helpful to have experienced staff members on hand who have gone through this review. . With some companies it is common for managers, engineers and designers to be moved to other projects within their product offerings. This practice is certainly good for employee growth. But it does put the CCE in the position of trainer under this type of employee rotation program. Not having the necessary information is a problem for the CCE.
Whenever we visit the manufacturing facility for the follow up inspection required five years after the initial authorization, we usually find numerous changes and new personnel. Many times the responsibility for assuring ongoing conformance lands in the lap of the least senior management staff. This is not always the case but when this happens, managers need to understand the importance of keeping updated information and records in the EDTCF file. More importantly, how to quickly find the required information in the EDTCF is critical. A new employee or company contact who was not engaged in the previous equipment review may not be familiar with the expectation of the standards and the CCE.
Equipment manufacturers typically manage numerous types of certifications which are required for different industry sectors. For many of these companies manufacturing equipment for the dairy and food processing industries is a compatible and lucrative “sideline”. This is especially true for companies manufacturing various types of sensors and related fittings for applications such as aerospace, gas and oil, liquid transport, wastewater treatment, fresh water, compressed air and high-pressure applications.
Standards may include: ASME Boiler and Pressure Vessel Code (BPVC), Electrically Powered Equipment (UL and CE), Department of Transportation (DOT), National Sanitation Foundation (NSF), Occupational Health and Safety Administration (OSHA) and in the case of some equipment such as, metering and/or consumer packaging filler equipment, Federal and State Departments of Weights and Measures. An understanding of other certification systems can be beneficial to meeting the TPV inspection.
A quick word about ISO 9001/2015. CCEs are required to evaluate a fabricator’s QM, QA or QC Program. While an ISO 9001-2015 certificate is not required, having a certified program is considered a plus and is recorded by some CCEs in the TPV inspection report.
The safety of multiple use food contact materials has gained extra attention with the implementation of the Food Safety Modernization Act in the U.S. 3-A Sanitary Standards rely heavily on 304 and 316 grades of stainless steel. These materials must be corrosion resistant and non-reactive in the environment of intended use. Manufacturers must maintain traceability records back to original invoice which includes a “heat number” and an alloy certificate. Heavy metal content including lead, mercury, cadmium and chromium 6 must be below safe levels tolerances and declared on the alloy certificates. Other optional metal alloys are called out in the standards. It is important to ensure that optional alloys meet 3-A SSI standards criterion.
Nonmetals defined as Rubber and Rubberlike Materials (3-A Sanitary Standard 18-20) and Plastics (3-A Sanitary Standard 20-27) are integral materials in food processing equipment. Assuring the acceptance of these materials as “multiple use food contact surfaces” is one of the more difficult areas of conformance for fabricators. Consumer advocates and in turn, governments continue to press the material manufacturing industry to more specific “Safe Levels and Tolerances” in regard to the chemistry used to make these materials which have used successfully for decades. The CCEs must verify that Title 21 of the US Code of Federal Regulations for “Indirect Food Additive” legislation is followed and declared by the manufacturers of these articles.
The short list above is just a primer. The TPV inspection program has produced many benefits for fabricators, processors and regulatory sanitarians and the common goal of advancing food safety through hygienic design. 3-A SSI offers many free resources on sanitary equipment design and evaluation including e-learning modules, papers and meeting presentations in the Knowledge Center at www.3-a.org.
Daniel J. Erickson was raised on a small family farm near the West Central Minnesota Community of Starbuck and holds decades of experience as a regulatory sanitarian. He is a Food Safety Auditor at Harold Wainess & Associates. HWA provides PMO Grade A Dairy Inspection and Single Service Container and Closure Fabricator Certifications in 30 countries around the world.
3-A SSI signed a new distribution agreement with S&P Global Engineering Solutions to market and sell 3-A SSI documents, including subscription and retail sales. The new distribution outlet represents the most important expansion of 3-A SSI document marketing in the history of 3-A SSI. S&P Global announced the new partnership in a standards newsletter that goes out to over 160,000+ subscribers, listing 3-A SSI as the featured SDO and the top five selling standards..
All 3-A content is now available on the IHS Markit Standards Store. You can visit the store at https:// global.ihs.com/standards.cfm?publisher=3-A.
IHS Markit Ltd. provides information, analytics, and solutions to customers in the business, finance, and government sectors around the world. It operates through the following segments: Financial Services, Transportation, Resources, and Consolidated Markets and Solutions. Its products are used by aerospace, agriculture, automotive, chemicals, construction, financial services, government and non-government organizations, and technology industries. The company was founded in 1959 and is headquartered in London, the United Kingdom.
3-A SSI recently received new certificates of registration in Japan for the 3-A Symbol and the 3-A SSI Replacement Parts and System Component Qualification Certificate (RPSCQC) Program design marks and word marks. Protection of the 3-A SSI marks used in international commerce is critical to maintain the integrity of the 3-A brand for regulatory sanitarians, processors and fabricators across the U.S. and worldwide.
3-A SSI previously obtained new legal registration of the design mark and the word marks used for the RPSCQC program in China and the European Union. Registration of the trademarks provides 3-A SSI certificate holders with essential new protection against counterfeits and enhances broader international protection of the 3-A SSI marks.
Trademark applications are currently pending in the United Kingdom, Mexico, India, and Canada. While 3-A SSI is widely regarded as limited to the U.S. and predominantly for dairy equipment/systems, the distribution data suggest much broader international recognition.
U.S. licensees currently account for 48% and international 52% of all current holders.
3-A SSI maintains licensees from a total of 22 other countries from outside the U.S., including. Belgium, Brazil, Canada, Denmark, Finland, France, India, Israel, Japan, Malaysia, Mexico, Netherlands, New Zealand, Poland, Republic of Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, and the United Kingdom.
Recent sales data shows 3-A SSI documents reach customers in 40 countries outside the U.S. and account for nearly half of all sales volume. Customers serve a wide range of applications including dairy, beverages, food processing, pet foods, personal care products, beer/wine, and more.
3-A SSI announced the recipients of its 2022 Volunteer Service Awards and the release of the latest annual progress report at the 3-A SSI Annual Meeting held in Bloomington, MN. The 3-A SSI awards recognize the extraordinary dedication and commitment of individuals who contribute to the development of voluntary standards and the mission of 3-A SSI. Nominations for the awards are made by fellow volunteers from the three stakeholder groups in 3-A SSI – regulatory sanitarians, fabricators, and processors – and others.
3-A SSI Chair Chris Hylkema (NY State Dept. of Agriculture & Markets) announced three award recipients for 2022.
Scott Lodermeier (Powder Process Solutions) received the Leadership Service Award for outstanding service to the voluntary standards development of 3-A SSI and significant contributions to the mission of 3-A SSI.
Gabe Miller (Pi-FS, LLC) received the Richard K. Smith 3-A SSI Advancement Award for outstanding accomplishments performed by any individual or group on behalf of 3-A SSI.
Bryan Downer (Sani-Matic) received the Next Generation Award for leadership, dedication, and significant contributions to the development of 3-A Sanitary Standards or 3-A Accepted Practices by a volunteer who has been engaged in 3-A SSI standards development activities for less than five years.
Highlights of 3-A SSI programs in the latest year are now available in the 2022 Annual Report. The complete report is available at www.3-a.org under ‘News, Events & Updates’ or go to: https://www.3-a. org/News-Events-Updates/Annual-Reports.