Food Safety

Are you ready for Title III, FSMA 301?

April 6, 2011
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If you’re importing food and beverages or ingredients from a foreign country, you’ll need two years’ worth of records and the ability  produce them in a flash to FDA. Software can help manage this arduous task.


Gary Nowacki, TraceGains CEO.
Section 301 of the new Food Safety Modernization Act (FSMA) affects food and beverage processors in the US that either import and resell products from foreign countries (including Canada and Mexico) or import ingredients used in a product manufactured in the US. Section 301 includes verification activities such as on-site inspections and monitoring lot-by-lot shipment records for compliance, risk-based foreign supplier verification activities to verify that imported food is safe and record-keeping (records must be maintained for two years or more and be readily available to FDA upon request).

It is the record-keeping part that can be a fly in the ointment for several food processors that still may keep records with Excel spreadsheets, clipboards, bills-of-lading, paper-based supplier COAs (certificates of analysis), lab reports, etc., says Gary Nowacki, TraceGains CEO. TraceGains software takes aim at this hodge-podge and focuses on creating all-electronic records of documents, making them searchable and able to be recalled at a moment’s notice. The software is available as SaaS, otherwise known as software as a service. It resides in “the cloud” and, therefore, eliminates the need for installations on-site.

FE asked Nowacki some key questions in an exclusive interview.

FE: In many cases small- and medium-sized food processors need to move away from paper-based record-keeping, but can’t afford capital expenditures for software applications to move them to the next stage. What solutions are available?

Nowacki: We built the whole system to be affordable-software that you don’t purchase. Therefore, you don’t incur expensive, up-front licensing fees. It’s purely subscription; it’s Web-based, and the monthly fee is a fraction of the cost of a full-time employee.

Subscribers pay as they go and can cancel at any time since there are no long-term commitments. There are no related costs such as involvement from the IT department, there is no specialized programming, and it doesn’t need to be integrated or interfaced to a processor’s ERP or SCM systems.

FE: What about the processor’s suppliers that need to connect with the software? Do they have to pay for its use?

Nowacki: No, there is no fee for a processor’s suppliers. That’s a cost we purposely eliminated to get rid of any barriers to suppliers participating.

FE: With all the confusion over the myriad collection of food safety standards, how do you correlate one with another?

Nowacki: First of all, we work with GFSI (BRC, SQF, GAP, etc.) and all the other standards as well. It’s obviously up to each community and each supply chain to pick the standards they want to deploy at each step along the way. We automate many of the key elements related to these standards and compliances.

Here’s a key benefit of automating. Today, most food companies are keeping track of their suppliers to all of these audit standards on a big, manual spreadsheet.

On the left-hand side of the spreadsheet, they have row-after-row of all their suppliers, and it could be hundreds or even thousands of suppliers. Across the top, they have column-after-column with the suppliers’ status against all of the different audits and compliances-e.g., a column for BRC, SQF, ISO, HACCP. Are they current with their HACCP? Are they certified for Kosher? Are they allergen-free? Does the supplier have current policies and certifications in place meeting all the processor’s minimum requirements for insurance, mutual non-disclosure agreements, performance guarantees, etc.?

Our system automates the whole process of tracking suppliers and flags instantly any suppliers that are out of compliance at any point in time. The current way most processors handle this is to open the spreadsheet and scan, for example, who’s getting close to a new HACCP plan. This process is a nightmare. No technology is going to wave a wand and harmonize audit standards, but we can automate the technology to keep all suppliers in compliance to the required standards.

FE: If a US processor already has an on-site lab and is using a LIMS (laboratory information management system), can you help with the integration of LIMS data, ERP data and COAs from suppliers?

Nowacki: We have standardized connections into LIMS. But more important, we treat QA lab results as critical data in the profiling of a supplier’s risk. We take the supplier’s COA results, append the lab test results and compare the two, and then profile the supplier’s risk based on the consistency of what the supplier listed on the COA vs. the processor’s lab results.

Not all of these issues relate to safety. There are a lot of quality issues where, for example, the supplier may be just out of compliance with the processor’s specifications, which can produce headaches in the manufacturing process or in the quality of the finished goods.

FE: This is a hypothetical question. If the FDA had a reporting system, could your software system tie into it?

Nowacki: Yes, we can, but your question is the right question at the wrong time. Currently there is no guidance on this. I would ask this question two years from now when the FDA has issued specific guidance on this subject.

Of course, there is already guidance for the keeping and availability of records. You already discussed that in your introduction: Records must be kept for at least two years and be readily accessible. The software can easily support these requirements.

FE: Can all the data you acquire in your system connect with ERP systems, and can you standardize the reporting of data?

Nowacki: We take all the COAs in whatever their format (electronic, paper, PDF, spreadsheets, fax, etc.) and convert this data into actionable intelligence. COAs contain different data according to the ingredient; e.g., flour will obviously have different parameters than apple juice. This actionable data can then be exported to other systems, such as ERP, as needed or desired.

FE: With the speed of the Internet, shouldn’t it be possible to approve or disapprove a shipment based on the COA that arrives at the processor before the ingredient is shipped from the supplier’s site?

Nowacki: Yes, we’re already seeing this trend with our customers because they realize they don’t have to wait for a shipment to arrive and then review the COA (and perhaps test the shipment), only to find it doesn’t meet specs and has to be sent back. I find that processors would like to see the COA before the product is shipped, have the system automatically notify them of any problem, and if there is a problem, pick up the phone and talk to the supplier. The processor doesn’t want to have to reject a product at the receiving dock if it’s out of spec. And suppliers don’t want to deal with penalties, added shipping and reverse logistics costs.

In the old world, COAs arrived with the product and were thrown into the file cabinet. Most processors would randomly spot check only a very small percentage of COAs. When they’re digitized, however, 100 percent of them are automatically checked for conformance and compliance, in many cases even before the product is shipped.

For more information, contact Gary Nowacki or visit TraceGains website.

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