Audits & Analytics – Know for Sure

Emily Sohn’s column Peanut Butter’s Checkered Food Safety History chronicles the recent history and scope of bacterial contamination and recalls focusing on four food products – peanut butter, cantaloupe, ground beef and spinach.  Each food stuff has its particular problems be it the rough rind on cantaloupe or the multiple animal sources of ground beef plus their own favorite pathogen problems with Salmonella, E. coli or Listeria.

She rightly points to the large scale extended and complicated food supply chain as a major contributor to the outbreak problems we face in today’s food market. Our experience suggests that best first line defense is the current Food Safety Management System model contained in standards and regulations such as ISO 22000, the Food Safety Modernization Act and the Global Food Safety Initiative.

These depend on a well defined system bolstered by analytics and real-time role specific reporting for timely and well informed decision making. This is summarized by a three step program:

  • Know your production and quality systems
  • Know your supply chain
  • Know for sure – verify with audits and use analytics to get maximum results from audits.

In our direct experience we have observed that integrating HACCP programs and SPC improves food safety results and in the case of ground beef purchase by the National School Lunch Program results in supply chains that delivered ground beef that never tested positive for the pathogens monitored. We also believe the additional step of extracting actionable information from audits with analytics helps maximize the food safety outcome.

Will these strategies eliminate all possibility of food safety events? No. Will they give us the best chance of a good outcome? Yes.

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Surviving Close Encounters with the Committee

Food safety and quality management systems are a necessity if you are going to satisfy customer and regulatory requirements and meet corporate performance goals. While it is easy enough to review current best practices in food safety and quality systems and choose the options that will meet your compliance and performance needs, getting project sign off and budget approval from management committees can be an entirely different matter.

Much of that challenge comes from communication problems between two cultures, the technical and operational staff who develop the proposal and management who must understand it and sign off. The technical staff is most comfortable and fluent with the technical discussion. Management is fluent in the language of business and finance and evaluates the project in the context of corporate goals and ROI. Never were two groups more likely to have a failure to communicate.  

How do you reconcile the two groups to make the project happen?

Several proposal strategies have been used to bridge the gap and move forward to get the job done. The article “Justifying the Manufacturing Intelligence Project examines the most common strategies, where they work and how to maximize your chance of success.

Can You Help With Audit Analytics Case Studies?

ISO 22000 requires the analysis of results of verification activities, and SQF and BRC require annual validation of the Food Safety Management System.  The analysis of the data for either of these two activities can be easily done using SPC. 

John Surak and I presented a poster on this topic at the IAFP annual meeting this summer (http://slidesha.re/uBnW1i  ) and John will present a webinar on the topic, “Applying Process-based Analytics to Audit Results for Process Management and Improvement” on December 15, 2011 ( http://www.nwasoft.com/resources/webinars/applying-process-based-analytics-audit-results-process-management-and-improvement ) .

We are looking for additional data which to develop case studies which demonstrate the power of SPC based analytics in conducting verification activities in the food industry. If you wish to participate in the project contact John Surak at jgsurak@yahoo.com or Jeffery Cawley at jcawley@nwasoft.com.

Process Control and the Food Safety Modernization Act

We have now had about 6 months to study the Food Safety Modernization Act (FSMA). This time has allowed some of the dust to settle. There are several more interesting parts to the act. One part includes the use of the word “verification,” which is mentioned 16 times. The big question is: How will the U.S. Food and Drug Administration (FDA) define verification for interpretation of the regulations? Verification can be defined in several ways.  The new regulations will require verification that the food safety system is working effectively. Finished product testing and environmental testing will be included in the verification process. These verification activities must be recorded, and the records must be made available to FDA upon request.

Read article in Food Safety

FDA Warning Letters: Lessons for Industry

David Acheson has begun a regular feature in the Leavitt Partners blog where he be examining the warning letters that the FDA has issued to the food industry. As he discusses, these should provide an insight into enforcement behavior as the Food Safety Modernization Act comes to bear.  It is instructive that among the FDA warning letters from January 1, 2011 to May 24, 2011. the largest category is for current Good Manufacturing Practices (cGMP) violations. This implies that food processors will be well advised to have their food safety plan up to snuff and that they have implemented a competent Food Safety Management System.

You can view a recording of a webinar “Comprehensive Strategies to Protect Your Brand” we did with David on these topics.

 

 

How Should Packaging Be Addressed in Your Food Safety Program?

The role of packaging in food safety systems and audits seems to be a current front and center issue.  This is probably the result of  food processers working down the list to packaging venders during the last year as they work through their supply chain and what they need for their own GFSI audits.

Rick Stier has contributed to the discussion with his article in the April/May issue of Food Safety Magazine, “How Should Packaging Be Addressed in your Food Safety Program?”   A good comprehensive and pragmatic article.

Convergence – Industry Standards and Government Regulations

“The Food Safety Modernization Act’s preventive approach to food safety may seem obvious in hindsight – and it is already a food industry norm, FDA’s deputy commissioner for foods said on Thursday.” Food Navigator 20-May-2011

 
Industry standards (ISO 22000, GFSI) and government regulations such as the Food Safety Modernization Act all have at their core an auditable HACCP-based Food Safety Management system. Much of the kvetching about FSMA in the popular press has missed the point that the convergence of regulation and good industry practice is a done deal and that all parties recognize that “science based” systems are the best way to maximize food safety.
 
You can view a summary of our webinars on this topic at http://bit.ly/jiUR8t .