I have a HACCP Plan and a Metal Detector – but…

I just received my latest copy of ‘Food Manufacturing Insider’ daily email.  I love glancing over this email because they do a great job of catching your attention with interesting article titles.  The title that caught my attention this afternoon wasn’t at all sensational, but still peaked my interest enough to commit to click and read further.

The article is entitled ‘Gummy Bears Recalled For Metal Contamination’.  I love Gummy Bears and have for quite sometime – so this had an undeniable personal connection.  I’m sure like the dozens of processing facilities I’ve toured in the past year this facility had the requisite HACCP plan duly documented and sitting on the shelf in a three-ring binder – waiting for the auditor to inspect.  I’m sure that the very expensive high-speed in-line packaging line putting thousands of Gummies into their temporary home had a sophisticated metal detector that triggered alarm bells and shut down the line if any amount of metal crossed its path.

So what happened?  The processor packaged on behalf of the Winn Dixie supermarket chain enough metal tainted Gummy Bears to warrant a recall spanning 30 days in various stores across the southeast.  This is one of those potentially company ending incidents that we all read about almost every day.  Very preventable and very serious not only to the consumer but the brand identity of everyone involved – So what happened?

I have a hunch – for many companies the HACCP plan and the metal detector are simply window dressing to satisfy an auditor or a large retail customer but are not part of an integrated preventative approach or attitude to quality.  In order to produce high quality food products that are safe for consumers, food processors need to think differently.  When making children’s candy is it OK to record HACCP data on a clipboard that may or may not get the attention of the QC manager at the end of the shift.  Is it OK that the HACCP plan – which should mitigate the risk of this specific threat – simply gathers dust until the annual review is required.

The obvious answer is ‘No’ – all companies want to do better and should be doing better especially with such a straightforward CCP as metal detection.  My company Plex is changing the way food processors think about ERP systems, food quality and compliance.  We recently received an award from Food Logistics highlighting our progress – click here to read more.

I’d be interested to know how you view this issue – is your HACCP plan more than just a show piece on the shelf?  Is your approach to quality preventative? 

How did we get to the point where I have to now think twice when eating my favorite candy?



The Holy Grail of Food Manufacturing

Plex Systems recently hosted a leading authority on the impact of the Food Safety Modernization Act (FSMA) last week for a webinar titled Food Safety Modernization Act: What It Means to the Food and Beverage Industry. Dr David Acheson, Managing Director, Food and Import Safety Practice at Leavitt Partners, was the first speaker in the Food Safety Seminar Series hosted by Plex Systems. Formerly, Dr. Acheson served in a variety of positions within the FDA – ending as the Associate Commissioner of Foods, which provided him an agency-wide leadership role for all food and feed issues. During this webinar he addressed the impact of the new FSMA legislation.

The Food Safety Modernization Act is the most sweeping regulatory change to the food industry since 1938. The focus of the new legislation is on prevention. Dr Acheson echoed many of the comments made by current Deputy Commissioner of Food for the FDA, Michael Taylor. An excerpt from his speech at George Washington University on May 19 emphasizes the importance of the new law and prevention. According to Michael Taylor, “The Food Safety Modernization Act is historic also because it establishes in law a new public health paradigm for FDA’s food safety program. The new law shifts our food safety focus from reaction and response to prevention…” (FDA Commissioner Speech on Prevention). To ensure prevention, manufacturers will need to:

  • Implement – Preventative controls like Good Manufacturing Practices (GMP’s) within a Food Safety Plan
  • Monitor – to ensure effective controls are in place as well as Corrective and Preventative Actions (CAPA’s).
  • Verify – have a verifiable food safety plan – just having a plan isn’t enough. Manufacturers must VERIFY that the program is working.
  • Document – Documenting the food safety plan is “absolutely critical” according to Dr Acheson

Prevention isn’t the only area of the FSMA that will impact manufacturers. Other key areas of the FSMA include Inspection and Compliance, Response, Imports and Partnerships. This legislation gives the FDA unprecedented authority to visit facilities with more frequency, require recalls, suspend registrations and require certifications of high risk foods from importers.

Dr Acheson ended the presentation with suggestions for staying in front of this change. He stressed the importance of a having a corporate strategy and creating a food safety culture driven from the top of the organization. Meeting these mandates can be a challenge. Dr. Acheson stressed “technology is key” to compliance. While compliance is critical, finding a technology solution that improves overall business efficiencies is equally as important. According to Dr. Acheson, “Combining compliance with efficiency is the Holy Grail”.

Implementing a Food Safety Management and ERP solution can help manufacturers institute an effective food safety plan. This technology can help manufacturers not only react more efficiently in the event of a recall, but helps with prevention as well. Having all this information in one system delivered through the Cloud helps companies drive efficiencies as well as meet compliance standard. Plex Systems can help you find the manufacturing Holy Grail.

Product Traceability – Where are we headed?

I attended the Food Safety Summit a few months ago in Washington, D.C.  It was a typical conference with informative educational sessions, an energetic keynote, and a diverse trade show.  It all changed when I decided to check out the session on Traceability entitled simply, “Traceability”.  The discussion was led by Steve Arens of GS1 US, Jennifer McEntire, PhD, and Craig Wilson of Costco.  I arrived at 2:30 PM which was the scheduled start time of the session and couldn’t find a seat.  While the other sessions had decent attendance – I certainly didn’t have to sit on the floor in the back of the room.  Luckily, the staff at the Washington Convention Center were alerted and more chairs were brought in quickly.  After about 100 additional chairs were brought in the session was well


underway.  I was so impressed by the turn out on this particular topic that I took the standard ‘Before’ and ‘After’ shots of the audience.

It was obvious to me that traceability is the key issue on the mind of leaders of food & beverage manufacturing / processing businesses as they assess their capability to comply with the Food Safety Modernization Act.  The act doesn’t add additional requirements that weren’t already in place with the Bioterrorism Act or industry driven initiatives.  It does open the door to the idea of extended traceability across the supply chain.  Dr. McEntire presented her ideas that were recently published in a technical report commissioned by the FDA through the Institute of Food Technologists which provide a basis for discussion on how food systems will contribute trace information across the supply chain.

I’ve provided the link to the report below:



If you were at the Food Safety Summit and attended this session – did you have a seat?  What did you think about the outlook on where traceability is going?

How is your company addressing traceability?

Traceability starts with detailed tracking of transactional activity that we discussed in my previous post on Manufacturing Operations Management (MOM).


The Enterprise Food Safety Management System starts with MOM


The idea of shop floor control and data collection systems are nothing new for those involved with manufacturing technology over the years.  The first data collection systems were introduced in the early 1980’s as part of the computer-integrated manufacturing (CIM) model.  Those systems solved a simple problem and preformed a simple task.  Accurately record the movement of ingredients, intermediates, and finished products as they move through the steps of manufacture.   

 The technology has evolved greatly over the years and has become mandatory for processors who seek to comply with today’s food safety certification requirements.  While obviously an important tool for food processors, many find that a stand-alone data collection system falls well short of expectations.  In recent years, technology has moved beyond data collection and raised expectations that an effective system should manage all aspects of Manufacturing Operations Management (MOM).

Example of Plex Online HMI - Control Panel

 The concept of MOM is simply defined as a methodology for viewing an end to end manufacturing process with a sharp focus on optimizing efficiency.  Today’s MOM systems not only enable the collection of shop floor data, but also provide tools for performance analysis and an innovative Human Machine Interface (HMI) far superior to the classic data collection system.  Operators can finally stop the error-prone recording of production and quality measurements in paper log books and turn to a touch-screen interface that captures and reports data in real-time.  Modern MOM systems can accurately process and record production data directly from the machine  and eliminate common operator errors.

 Once implemented a MOM system can provide performance analysis tools like Overall Equipment Effectiveness (OEE) reporting.  The information contained in an OEE report directs process improvement teams to problematic processes or machines that should receive immediate attention.  As part of a continuous improvement initiative – OEE is valuable information that food processors can profit from.      

 Three weeks ago we participated in the 2011 Food Automation & Manufacturing Conference (click here for presentation slides).  There were many presentations given about the benefits of implementing an OEE program.  Each company had experienced significant bottom line results from capturing and analyzing this data and they were excited to share their approach.  While the benefits were significant, the method and cost of implementing an OEE program seemed complicated and expensive.  Each OEE program relied on a separate database and a spider-web of custom connections to other systems requiring an army of people to manage and maintain.  This approach may be typical to the large mulit-national food processors, but it is far from reality for most food processors.

 Are MOM and OEE simply out of the reach of most food processors, or should they expect more from technology providers?

Food processors should expect more.  Today, technology companies like Plex Systems  are delivering the solution.  Plex includes MOM and OEE as a part of its Cloud based Enterprise Food Safety Management System (FSMS).  The playing field has been leveled allowing ALL food processors to benefit from these valuable performance tools.

In the next blog entry we’ll discuss how the Plex FSMS can eliminate paper from the quality and HACCP process, bring together CCP data, inventory and production data, and provide instant traceability and recall management.

Tipping Point – Enterprise Food Safety Management

Recently, I attended a presentation about food safety technology at the Process Expo  in Chicago.  The person giving the presentation proclaimed, “A tipping point has been reached”.  His statement, which caught my attention, was referring to the impending passage of the Food Safety Modernization Act (FSMA).  According to him, it will become physically impossible to continue with the food safety management practices of the past and expect to respond to the FDA within a 4 hour period.

Ironically, a few weeks earlier I had finished reading Malcolm Gladwell’s book Tipping point.  In Tipping point Gladwell examines the idea of why change sometimes happens wildly and unexpectedly. 

Have food manufacturers reached a ‘Tipping Point’ where changes to how food safety is managed are going to happen wildly and unexpectedly?

 Viewed through the prism of Gladwell’s book and his description of the power of context, it’s easy to see how food manufacturers have reached this ‘Tipping Point’.  Is it possible to add more paper-based recordings of production, quality, and CCP measurements to already exploding filing cabinets?  Is it possible to show the complete manufacturing genealogy for a product by accessing various disconnected systems, collating data into reports, and then scramble to respond within a four-hour window?  Food producers are now demanding an Enterprise approach to Food Safety Management that provides total coverage to the organization, eliminates redundancy of data and systems, and allows instant access from anywhere in the world.

In the next four blog posts, I’m going to discuss how Plex Systems is leveling the playing field for all food manufacturers regardless of size by providing a single Cloud based platform for:

How is your business dealing with the changing regulatory environment?  Are you reaching a ‘Tipping Point’?  Post a comment below to join the conversation.