Tag Archives: HACCP

Top 10 GFSI Non-conformances, and How to Avoid Them

By Michael Biros
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Are you ready for audit? Gary Smith, Director of training and improvement solutions at SAI Global, talks about the top 10 GFSI non-conformances for SQF & BRC audits.

1. Business Continuity Plan Components/Annual Testing and Review

Many companies do not know what a business continuity plan is. It is not a recall and performing a mock recall will not count as an annual test and review. It is the continuing of business with a disruption in the supply chain. What are your plans for a key supplier going out of business or being affected by a natural disaster? If there is a fire or accident at one of your facilities, how are you going to ensure that your customers will still get delivery of your product? 

2. Food Safety Plan

HACCP has been around for years, but this is still a major area of focus. HACCP must be implemented and individuals must be properly trained in HACCP. All Critical Control Points (CCPs) must be validated. Review supporting documents during annual check. Is the flow chart current? Is the hazard analysis still correct? Question your employees during your internal audit. Get your employees used to and comfortable with answering questions about the food safety plan. 

3. Equipment and Utensil Condition

Utensils (scoops, shovels, belts, etc), equipment, and all food contact surfaces must be designed and in good condition so as not to be a food safety risk. Implement a foreign material control plan. Have a preventative maintenance schedule. Focus the internal audit program on equipment, not just employees. Use a flashlight when conducting internal audits. Train, empower, and reward production employees to identify equipment defects. Do not have temporary repairs. 

4. Allergen Management

Allergens are the number one cause of recalls. You must have a good allergen control program and this program must be validated. Identify ingredients as allergens at receiving and have a label inspection program. Specific allergen proteins must be validated with surface testing and product testing. Allergens must be listed as hazards in hazard analysis with the control as the allergen management program. 

5. Internal Audit

Have a strong internal audit program that emphasizes proactive solutions to avoid non-conformances. Manage non-conformances with a corrective action program. Take photos of all findings during internal audits. Make the process as formal as possible. Dress like the auditor would and ask employees questions. 

6. Condition of Walls, Doors, Floors, and Ceilings

Tape, cardboard, and construction plastic sheeting must not be used as these surfaces cannot be cleaned. Doors and windows must be properly closed. 

7. Product Traceability and Mock Recalls

If an auditor asks you about a product, you must be able to list all the raw materials, where they came from, and how they were processed to create your product. Keep the recall team current. Have procedures for a mock recall and always perform it. Make the mock recall a real test. Include ingredients and packaging in all traceability programs. Perform product trace exercises during the internal audit. 

8. Records

Make sure that your records are legible, authorized, and that demonstrated activities are taken. 

9. Procedures for Product Disposition when Calibration is Out

This is a new standard. Companies are now required to have documented procedures in place for when calibration equipment is down. 

10. Stay Vigilant!

If you’ve achieved food safety certification, congratulations! However maintaining certification takes commitment and dedication. Be sure to maintain a strong food safety culture within your organization. Communicate well across all levels of the company. Have a strong internal audit program and don’t be afraid to identify issues and focus on corrective action management.

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EQMS and HACCP – Friends or Foes?

By Kelly Kuchinski
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How quality processes can allow companies to take a more preventative approach to product recalls.

HAACP4 300x281 EQMS and HACCP Friends or Foes?I recently spoke to a friend who was a plant manager at a food manufacturing company, and he is all too familiar with today’s manufacturing challenges and product quality issues. We discussed how quality processes allow companies to take a more preventative approach to product recalls. He agreed that if quality and regulatory requirements are met before a product leaves the facility, organizations can be sure that they are providing safe product to their customers. The ability to identify issues before a product is distributed can also reduce additional costs associated with product recalls and the impact on a brand’s reputation and sales.

We then discussed how important HACCP was to his team. Hazard Analysis and Critical Control Points (HACCP) is a process control system that identifies where hazards might occur during the food production process and puts actions into place to prevent such hazards from occurring. By monitoring and controlling each step of the process, there is less chance for contamination or other hazards to occur.

He shared a story on his first experience implementing a HACCP plan at his previous facility. He noticed key areas where sanitation standards were not being met so he identified necessary corrective actions required to keep finished product safe. The process of monitoring these changes was difficult to manage and was draining the already limited resources in the plant.

During a team meeting, he brought up the issue and the QA Director mentioned that they were using a quality management system that managed workflow processes. They discussed how CAPA and complaint management were key processes that they were using in the QA area and it would easily support corrective actions associated with HACCP.

Within a few days, they were able to setup the system to support his team and automate the process. The most notable difference in using the QMS software was the time savings and reduction in recording errors. The system provided an interface that was easy to use and provided drop down menus for easier navigation through the system, unlike the cryptograms needed to use their ERP system.

As we finished up our call, we agreed that the true benefit of a quality system is visibility. We can now monitor potential hazards in the facility, manage outside supplier and third party manufacturers, and track compliance with regulatory requirements across the enterprise using one centralized system.  It is this visibility across the organization and its supplier network that allows organizations to tie in multiple quality controls, regulatory requirements and HACCP processes to automate and maintain the record of any change and preventative action to ensure consistency and safety of all finished products.

With companies encountering spikes in unforecasted demand, new levels of regulatory scrutiny, and fewer resources than ever before, my friend and I agreed that EQMS systems are more crucial than ever to help manage the complexities of quality process and allow issues to be resolved when they are identified early on.

About the Blogger:

Kelly Kuchinski, Industry Solutions Director at Sparta Systems, has 20 years of product management and marketing experience with a focus on consumer packaged goods, chemicals, life sciences and technology. Prior to joining Sparta Systems, Kelly focused on developing products and solutions to support companies across multiple industries to enhance functionality, increase efficiencies and reduce costs. She held product management and marketing positions at Merck Chemical, GS1, Checkpoint Systems and GE Capital. Kelly has an MBA from LaSalle University and received her Six Sigma Green Belt certification while at GE Capital.

Rick Biros, President/Publisher, Innovative Publishing Co. LLC
Biros' Blog

Two New Proposed Rules. In about a year, it’s HACCP for everybody!

By Rick Biros
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Rick Biros, President/Publisher, Innovative Publishing Co. LLC

Some of the most boring press conferences are when coaches face the press after a game. Most of the questions coming from the press corps are not well thought out. It’s like they are just asking questions just because they can. While the coaches are required to be accessible to the press, I appreciate it when they put some personality and thought into their answers. One time, former Chicago Bears coach Mike Dikta confronted a reporter with “What’s the difference between a three-week-old puppy and a sportswriter? In six weeks, the puppy stops whining.”

The reason some of us watch these press conferences is for the remote possibility the coach actually says something interesting or even better, when they break down under the weight of all the really stupid questions. There was a Coors Light commercial series with coaches completely losing it. Football fans might remember former Indianapolis Colts coach Jim Mora whining “Playoffs?”  See video 

Bill Parcells, former head coach of the New York Giants was classic. Parcells had no patience for stupidity and used to yell at reporters, “That’s a really stupid question. Next question!”

Dr. Margaret Hamburg, Commissioner and Michael Taylor, Deputy Commissioner from FDA held a press conference Friday, January 4 announcing two new proposed food safety rules that I had the pleasure of attending. Hamburg said “This is a very big step in direction of creating a comprehensive prevention-based food safety system.”

The first rule proposed would require makers of food to be sold in the United States, whether produced at a foreign- or domestic-based facility, to develop a formal plan for preventing their food products from causing foodborne illness. The rule would also require them to have plans for correcting any problems that arise. A.K.A. HACCP. 

In the past, FDA enforced HACCP in seafood and juice. USDA enforced HACCP in meat and poultry. In about a year, it’s HACCP for everybody! Here’s the link to the rule: http://www.fda.gov/Food/FoodSafety/FSMA/ucm334115.htm

The second proposed rule proposes enforceable safety standards for the production and harvesting of produce on farms. FDA is targeting the five pathways of microbiological contamination: water, worker hygiene, soil materials, animals and packing houses – http://www.fda.gov/Food/FoodSafety/FSMA/ucm334114.htm

We are now in a 120-day review period for the two proposed rules. Taylor said, it typically takes the agency about a year to review the comments and issue the final rule.  So, we are looking at HACCP being the law of the land in all segments of the food industry in 2014.

The question food companies need to ask is not what will FDA’s HACCP rule look like in 2014, but how good is our HACCP plan now? Hamburg said the preventive controls rule is basic common sense food safety. Use 2013 as the year to revisit your HACCP plan. When was it last revised? What type of records are you keeping? Simply, if you have a good HACCP plan in place now, regulatory compliance should not be difficult. 

In the press conference, Hamburg said that additional rules to follow soon include new responsibilities for importers to verify that food products grown or processed overseas are as safe as domestically-produced food, and accreditation standards to strengthen the quality of third-party food safety audits overseas.

Unlike many coaches after a game, Hamburg and Taylor did a good job communicating their points. However, it was the consumer press with their questions that brought to mind how well composed Hamburg and Taylor stayed handling questions such as “How many foodborne illnesses will be prevented if these rules are carried out,” “How much does this cost,” and the best one, “How will FDA make sure farms will prevent wildlife from contaminating fields?” They remained cool and politely answered the questions. I guess they have more patience than me.

That last question made me think, how would Bill Parcells answer that? Picture this old grouchy guy who doesn’t care what anybody thinks of him rephrasing the question: “You want me to tell you how my agency will make sure farms are preventing wildlife from walking through or flying over the fields?? Next question!”

Rick Biros, President/Publisher, Innovative Publishing Co. LLC
Biros' Blog

The Then and Now of Food Safety

By Rick Biros
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Rick Biros, President/Publisher, Innovative Publishing Co. LLC
I just finished reading “Steve Jobs,” the biography by Walter Isaacson, on my iPad, of course! Jobs would have celebrated his 57th birthday on February 24. 
 
Jobs did not invent many things, but he was a master at putting together ideas, art and technology in ways that invented the future. He was instrumental in changing how we interact with all sorts of content, how we listen to music, interact with our phones, read books and consume content. We still listen to music. We still talk on the phone. We still read books and we still consume content. We just do it differently now. 
Think then and now. What’s the same and what’s different in your life?  
 
Then, again, think then and now. What’s the same and what’s different in food safety? There are still food safety challenges but how are they different?
 
In 1993, in the Pacific Northwest part of the US, three children died from eating hamburgers contaminated with E.coli O157; one more child died from being exposed to the bacteria through cross contamination in a day care facility. Sixty people had liver failure as a result of the contaminated food.  
 
The E. coli O104 bean sprout outbreak in Europe last summer showed us that Mother Nature continues to challenge food safety professionals with new strains of pathogens, this time even more deadly. The statistics from this outbreak are more than 10 times greater than what happened in 1993 in Seattle with more than 60 people dead and over 600 affected by liver failure.
 
In 1994, the World Trade Organization was established to help countries have improved access to export markets. They identified the need to ensure confidence in the safety of the food supply.  “Quality assurance systems such as Hazard Analysis Critical Control Point (HACCP) system will encourage the food industry and government alike to control food production by concentrating on the critical factors to ensure food quality and safety.”1
 
Now, we have increased world trade in the food industry, yet today, U.S. food companies tell us that one of their biggest fears is contaminants coming into their facility from foreign suppliers. We’ve got more trade but with even more food safety challenges, though the WTO had hoped to avoid such an issue.
 
The genesis of Food Quality 
In December 1994, I launched the first trade magazine focused on food quality assurance, Food Quality. We printed 22,000 copies and dropped them in the mail, hoping people would read it. The premiere issue had Moses in a lab coat carrying two tablets with HACCP chiseled on them. I wrote a Publisher’s Column for every issue. Some were pretty good such as “Playing With Fire” which I wrote in December 2003, which warned about the potential of Bovine Spongiform Encephalopathy (BSE) or Mad Cow Disease coming into the North American meat supply because of the continued use of feed with ruminant additives. The column was published 10 days prior to the first case of BSE was reported in the U.S. and was later recognized by the American Business Publication Editors with an award. (Food Quality is now published by Wiley, and since 2009, I am no longer affiliated with it.)
 
In the 18 years since Food Quality’s premiere, pathogens and contaminants continue to rear their ugly heads with a trail of death and injury in their wake. Have things gotten any better?  
 
Yes. I believe food safety technology has advanced significantly empowering the industry with the ability to detect contaminants, faster and more accurately. Food safety awareness in the food industry as well as education has increased. Food safety professionals have earned the respect from the C-level suite and are seeing increased support. That’s a big step forward from 1994, however, food safety is a marathon with no finish line in sight and there is still much more work to be done!   
 
In a conversation I had with Dr. David Acheson this summer, we discussed the state of the food industry and several new food safety “game changers” that will affect the industry. 
  1. Here in the US, the Food Safety Modernization Act (FSMA) is changing the way FDA will monitor and enforce food safety standards and controls. Most of the food industry is unprepared for FSMA. FDA will no longer be an annoying gnat that a food company can just swat away.  
  2. The bean sprout outbreak in Europe last summer was a game changer. What’s the next strain? When will it hit and how hard? 
  3. GFSI supplier audits are all the rage but are they the foolproof tool that food companies can put blind faith into? Perhaps not. The cantaloupe incident last year showed us that. GFSI audits can be good tools when used right. But there is a lot more to supplier controls that food companies need to prepare for… trust but verify!
  4. HACCP is not just for meat, dairy, seafood vertical industries anymore. Thanks to FDA, it will be applicable across the food industry. Yes, many verticals have the same level of knowledge about HACCP that the meat industry had in 1998; i.e. HACCP = Have a Cup of Coffee and Pray!
  5. Severe drought in Texas and the Southwest and unusually wet summers in the Mid-Atlantic sections of the U.S. affects not only agriculture but also food processing. How will this affect supply and quality, and what other impact will climate change have on food safety?   
The food industry certainly has its challenges ahead and there is a growing need for information, education and knowledge, on a global scale.  
 
Food Safety Tech: A new digital platform
With that said, I am happy to premiere Food Safety Tech, a new digital platform for knowledge and information of food safety, food quality, food business and food sustainability! The goal is to not only provide you with the information you need, but to provide it in one convenient place. While the task at hand of informing the food industry is still the same as it was in 1994, the way we deliver content is more in line with the way people consume content now.  
 
Using a core team of food industry subject matter experts, editors with both life science and journalism degrees coupled with decades of B2B publishing, events and management experience, we have built Food Safety Tech from the ground up as a new media online solution balancing both the readers’ informational needs along with advertisers marketing objectives.  
 
When I say subject matter experts, I’m not kidding! Food Safety Tech has some the best names in the industry advising us on editorial topics and direction:
 
  • David Acheson, MD, Managing Director – Food and Import Safety, Leavitt Partners
  • Gary Ades, Ph.D., President G&L Consulting Group, LLC
  • Jeff Bloom, Executive VP, The Dairy Practices Council
  • Patrick Brown, Senior Director of Food Safety, Rite Aid Corporation
  • Marcos Cantharino, Global Business Director, DuPont Qualicon
  • Mark Carter, CEO, QC Laboratories
  • Jeffery Cawley, VP Industry Leadership, Northwest Analytics
  • Ben Chapman, Ph.D. Asst. Professor, Food Safety Specialist, North Carolina State University
  • Larry Cohen, Food Safety Director, Saputo Cheese U.S.A. 
  • Philip Elliot, Ph.D, Food Safety, Global Quality Assurance, W.K. Kellogg Institute
  • Larry Epling, Divisional QA/Food Safety Manager – FPP, Perdue Farms, Inc.
  • Bryan Farnsworth, VP, Quality Management, Hormel Foods Corporate Services, LLC
  • Jennifer McEntire, Senior Director, Leavitt Partners
  • Steven Niedelman, Lead Quality System & Compliance Consultant, King & Spaulding
  • Kathleen O’Donnell, Chief Scientist, Wegmans Food Markets, Inc.
  • Doug Powell, Ph.D, Professor Food Safety, KSU
  • Mansour Samadpour, President, IEH Laboratories
  • Donald W. Schaffner, Ph.D., Rutgers, The State University of New Jersey
  • Jhana Senxian, President and CEO, Sustainability Guild International, LLC
  • Bill Snyder, Sr. VP, Supply Chain, Hormel Foods Corporate Services, LLC
  • John Surak, Ph.D., Consultant
  • R. Craig Wilson, Assistant VP, GMM, Food Safety and Quality Assurance, Costco Wholesale
With a digital delivery, we are not confined to North America as we were with print. We expect to see the discussions take on a global perspective. There are several benefits of the digital platform and a key attribute is reader engagement.  For example, if you agree or disagree with my opinions in my blog, or any other article on Food Safety Tech, then share them in the comments section.   
 
Also, you can join in the lively discussions and polls in Food Safety Tech’s LinkedIn group. Currently, there are several discussions with polls including “Is attorney, Bill Marler, a friend or foe to the food industry?” Click to comment and/or to vote. 
 
You can find us (and friend us) on Facebook and Twitter, where I’ll be tweeting Food Safety Tech eNewsletters and content. 
 
We encourage you to become an active member of the Food Safety Tech community.  If you are so inclined to write and would like to contribute an article, please contact us through the links at the bottom on the page.  
 
In order to continue to receive content for Food Safety Tech, please click on this link and become a member of the Food Safety Tech community. Forward to friends as well!
 
Lastly, Food Safety Tech is more than an eMagazine. We are developing educational webinars as well as conferences. Look for announcements in the next several weeks about our first conference on Supply Chain Vulnerabilities in the Food Industry.
 
Thank you for the time and attention.  I’m looking forward to the next leg of the journey (with no finish line) and hope that our efforts educate and entertain you along the way. By doing so, Food Safety Tech can fulfill it’s mission to contribute to a safer, better and more sustainable global food supply.
 
All the best!
 
 
Rick Biros
Publisher/President
 
 
 

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