Challenges & Solutions 2013

Practical Solutions

A new year is a good time to reflect on the past year’s events. For many, it is a time of different plans and budgets with different challenges and opportunities. What are some lessons learned from 2012? What are three practical solutions in food safety and quality assurance for 2013?

Food safety and quality assurance are subjects of growing interest. Take for example a comparison of Google searches I conducted in writing this article with those I ran in 2008:

  • 2013: food safety and quality returned 232 million results.
  • 2008: the same returned fewer than 6 million results.
  • 2013: food safety, quality, and lessons learned brought more than 49 million results.
  • 2008: fewer than 1 million.



Three Solutions.
Although the Internet is a wonderful resource, it can also be a detriment. Have you Googled your company name or industry along with the word recall? The information superhighway is active with data available via more fingertips than ever before; all enhanced with devices connecting from almost anywhere.

The Food Safety Modernization Act (FSMA) certainly will impact our business in 2013. Although implementation is slower than anticipated, FSMA will move forward. Complexities of compliance with FSMA will be a challenge for you and your supply chain. One challenge is to be in full compliance before a FDA Investigator arrives at your plant. Expect more FDA inspections—with the agents having the power to shut down food facilities. Thus, the first practical solution for 2013 is to conduct a mock FDA visit (training audit). During the mock “for cause” investigation, use the same FDA investigative techniques as if a serious illness claim with one of your products were suspected. Each plant is unique. Numerous FDA mock visits have yet to find a facility without flaws in their documentation, fulfillment, or corrective action.

Auditor's Soapbox

With technology now assisting me to parallel park my car, there is other technology just waiting to revolutionize food safety in our plants and distribution systems. Now is a good time to examine ideas from other industries to improve our food safety and efficiency.

FSMA will impact our business beyond our thinking. The GMPs for pet food and livestock will essentially follow food rules. GMPs from farm to fork are truly on the horizon. Compliance is a concern, as the spirit of the law, and in some cases the language, previously separated feed and food. Expect feed and animal groups to continue opposing a joining of rules for animal feed and human food. The challenge will be the continued difficulty of moving GMP compliance through your supply chain onto the farm. This difficulty will be compounded by the exemption of small and very small facilities from major provisions of FSMA and the extension of implementation time for small and very small facilities. Farmers using precautions against contamination as simple as washing hands frequently and wearing hair restraints and foot covers will require education. A second practical solution, therefore, is to provide management education and employee training in the areas of GMP and FSMA requirements for smaller firms who lack the resources.

Microorganisms are a growing concern in our food, seemingly more so than chemical or physical types of contamination. In the 1970s, Salmonella was a problem in the dry petfood industry and was controlled for many years. In 2012, Salmonella again became a problem in that industry, along with other low-moisture foods. Salmonella infections may cause diarrhea (some bloody), fever, and vomiting, with sometimes fatal infections in young children and those with weakened immune systems. Pathogens are not something to mess around with. The presence of Salmonella in food and subsequent recalls are becoming too frequent. For that reason, the third practical solution for 2013 is to combat microorganisms in a food plant with a formal pathogen control program.


Pathogen Control. A formal pathogen control program should consist of the following seven steps:

  1. Prevent the spread of the target pathogen throughout processing and the entire facility.
  2. Enhance the stringency of hygiene practices/ controls in the primary pathogen control area.
  3. Apply hygienic and good sanitary design principles to the building and equipment.
  4. Prevent or minimize the growth of the target pathogen within the facility.
  5. Establish a raw materials/ingredients control program.
  6. Validate control measures to inactivate the target pathogen.
  7. Establish procedures for verification of the target pathogen controls and actions.


Each step should be tailored for each plant. All food plants need a pathogen assessment, microorganism monitoring of the environment, isolation of raw material, and segregation of processes. The cleaning program; moisture control within the environment and inside the process; lethal cooking temperature/time; and controlled traffic of air, wheels, and humans are a part of any pathogen control program.

A pathogen control program will have a direct impact on GMPs, sanitary design, SOPs, SSOPs, and overall food safety and quality assurance. Don’t assume your plant is in control of microorganisms. Once a pathogen takes hold in a plant, it is very difficult to eradicate it. Buildings have been closed for a lack of pathogen eradication but not lack of effort.

Complying with FSMA in your facilities or those of your supply chain and controlling microorganisms are major challenges in 2013. If needed, bring in an experienced, knowledgeable outside resource to help with each solution. Pathogen-related contamination that violates FSMA can go global in a few seconds. Years of intelligent effort and a good reputation can be ruined in a short time.

February 2013
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