Tag Archives: suppliers

FST Soapbox

Inquiries, Responses and Audits: The Chipotle Effect

By Dan Bernkopf
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In an age where news is reported instantly, those outside the food industry have a heightened awareness and concern over their favorite brands’ commitment to food safety. Conversely, every food industry’s safety and quality operations teams are more than likely putting measures in place to tighten up their supply chain controls and re-evaluate their own food safety programs to ensure that their companies don’t become the next headline.

You better believe suppliers and their customers alike are also re-evaluating their ability to quickly, and effectively, respond to such an incident with the data and records needed to determine root causes—and with good merit, especially if you take a step back and really think about what is needed when a response or inquiry comes in surrounding a Chipotle-type food safety incident. Responses to such incidents typically fall along the lines of: 

  • Evidence of current food safety plan, including comprehensive risk analysis, HACCP/HARPC plan, validation studies or documents
  • Inspection data and documents on your suppliers, including onsite inspection, transportation and product receiving inspections, complete with non-compliance reports and CAPAs for the last six months
  • All data records relative to your internal processing CCP(s) or equivalent, including monitoring frequencies and all non-compliance reports, complete with their CAPAs for the last six months
  • All regulatory and non-regulatory audit reports or actions, including non-compliance reports and their CAPAs
  • Additional available internal or external laboratory evidence that demonstrates environmental monitoring of your facilities and resulting continuous improvement and sanitation validation for the last two years
  • Additional internal or external laboratory pathogen monitoring programs for field, transportation, raw material supply and finished products, etc. as evidence to support your food safety program

The sheer volume of records, data and information needed in such an on-demand short timeframe can be extremely overwhelming. Without quick access to the critical records needed to determine root cause or, more importantly, thwart an incident from expanding, food safety and quality operations should be taking a close look at how they are managing their food safety data records and reports.

Are binders full of documents, or a combination of paper/silo data records going to suffice when it comes to inquiries, responses (and audits)? Or, is there a better way to manage food safety and quality data to ensure not only data is accessible, but also that food safety programs are working?

One sure bet is that there will be a higher number of audits and inquiries. Is your team and/or supplier prepared for the increase of these types of activities?

  • Inquiry: A request for a single or series of data and or documents usually related to a specific FSQA event or question
  • Response: The collected data, data reports, document or document reports related to a specific audit or inquiry
  • Audit: An activity that reviews one or many elements of a food safety plan to assure that the plan is complete, performed as described and meets the food safety design as intended. Audits are known and expected activities to review such safety plan elements even though the actual audit date and time may be known or unknown

We all know that audits are often lengthy exercises, yet they are still predictable. On the other hand, inquiries can be more difficult in that information requests may involve a very deep dive into a very specific area of inquiry.

In all honesty, if inquiries or responses or audits have to be planned for in advance, then you are not prepared. In order to always be prepared, it’s imperative to have better systems in place to manage any type of internal or external examination of your food safety and quality information. Regardless of whether it is an audit, response or inquiry, it is important to have easy access to records, verify that your programs are working, have corrective actions in place, and show visibility (and transparency) in your operation.

Thus it all comes back to how you or your suppliers are managing food safety records day in, day out. If FSQA operations are still relying on manual-based food safety and quality management processes versus food safety and quality management technologies, then chances are that you’re reacting to latent results, and you’re not able to identify trends and opportunities for improvement. The burden to manage inquires, responses or audits—as they continue to grow in cadence—will become overwhelming.

Without a doubt, the Chipotle effect is being felt throughout the industry. There will be increased accountability to ensure an adequate food safety program is in place and verification that the program is working. It will become even more imperative—and expected—that data and records are readily available to efficiently respond to inquiries, responses and audits.

Cristin Singer, assurance partner at McGladrey LLP

Security Risks, Protecting Reputation Among Concerns of Food & Beverage Companies

By Maria Fontanazza
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Cristin Singer, assurance partner at McGladrey LLP

In a recent survey of food and beverage executives, nearly half of respondents named product quality as a major risk area and cited product recall capabilities as a priority. However, only about one-third of executives expressed confidence in their companies’ current safety and recall strategies.

Cristin Singer, assurance partner at McGladrey LLP
Cristin Singer, assurance partner at McGladrey LLP

“Mitigating [product] risks starts with tone at the top and leadership within a company,” says Cristin Singer, assurance partner with McGladrey, LLP. “Companies have a strong focus on the diligence associated with quality (especially among employees involved in testing) and building long-standing, trusted relationships with suppliers and vendors.”  Many companies are also increasing their testing of imported products and making sure that their partners are familiar with the cultures of the regions from which they import goods as part of their risk mitigation strategy.

The Food and Beverage Industry survey, conducted by McGladrey, involved 179 executives, owners, and decision makers from food and beverage companies with annual revenues between $10 million and $1 billion.

Respondents consisted of retailers (51.1%), manufacturers and processors (34.8%), distributors (26.4%) and growers (6.7%). Figure courtesy of McGladrey.
Respondents consisted of retailers (51.1%), manufacturers and processors (34.8%), distributors (26.4%) and growers (6.7%). Figure courtesy of McGladrey.

Product Recalls. Some companies are basing their product recall strategy on where they actually fall within the supply chain. “I’ve found that when a company feels that they serve as a middle-man distributor, and depending on the contractual relationship with the co-packer, they look to the processor or co-packer to manage the recall process,” says Singer, who is also a member of McGladrey’s national consumer products team.  In addition, Singer sees a focus on due diligence related to co-packers and suppliers to ensure they have proper certification, and processes and procedures in place to manage risks and recalls.

Ability to respond to reputation risks

Wage and Labor. Food and beverage companies are also facing a variety of wage and labor issues. Larger companies expressed concern with increased labor costs and attracting technical talent; smaller companies are more worried about minimum wage legislation labor costs, and retaining skilled labor workers on the shop floor. Executives also cited that minimum wage legislation and the Affordable Care Act could pose challenges over the next year.

Data Security. As more companies adopt platforms that store sensitive data, the security of these systems is important. Yet only about 42% of executives are very confident that their data and systems are secure from authorized access (about 50% are “somewhat confident”). Improving employee security protocols and providing training, involving data security consultants, and conducting due diligence on vendor data security are among the actions that companies are taking to enhance the security of their platforms. “If there’s a data breach, a lot of sensitive information could be put out there, including product formulations, intellectual property, and employee data (social security numbers or healthcare data),” says Singer.  “Initially a lot of companies on the retail side were focusing on data security. Now we’re educating our clients, especially those on the distribution, processing or manufacturing side. All levels of the supply chain are at risk.”

Randy Fields, Repositrak
FST Soapbox

Despite FSMA Exemptions, Compliance Will Not Be Optional For Small Suppliers

By Randy Fields
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Randy Fields, Repositrak

The product recall at Blue Bell Creameries earlier this year is yet another example of food safety issues negatively impacting food marketers, growers, processers and manufacturers. We all remember the Peanut Corporation of America’s salmonella outbreak in 2008 and the Jensen Farms listeria outbreak in 2011. Salmonella-tainted eggs in 2010, E. coli in strawberries in 2011, and listeria in caramel apples last Halloween combined with dozens of others during the last six years, have sickened thousands and killed dozens of people.

The brand reputation impact from the incidents at Peanut Corporation of America and Jensen Farms was terminal—both companies went bankrupt. The effect on Blue Bell, while likely not fatal, is expected by industry experts to be substantial and include loss of revenue and market share. The company has already announced plans to lay off more than 1,000 workers as a result of the recall.

In addition, growers saw cantaloupe consumption take a nosedive after the Jensen Farms listeria outbreak, which was one of the worst foodborne illness outbreaks in U.S. history in terms of number of deaths. They are only now seeing sales levels return to those before the incident. And because the farm itself went out of business, personal injury lawyers went after the companies that sold the disease-ridden cantaloupes—the retailers. By virtue of last year’s out-of-court settlement by Walmart on the Jensen Farms lawsuit, both suppliers and retailers are now responsible for everything they sell.

Enter the Food Safety Modernization Act, signed in 2011 and about to begin finalization in August. FSMA mandates that retailers and suppliers have documentation that verifies their supply chain’s regulatory compliance is readily accessible for government inspection. Add these records to the business relationship records that retailers and suppliers should already be maintaining (including indemnifications and certificates of insurance that help manage brand risk), and you’d think our risk of foodborne illness is about be eradicated.

Although FSMA represents the most sweeping change to our food safety laws in the last 70 years, it may not have the greatest impact where the supply chain is most vulnerable. Today the largest suppliers that sell the majority of our food have very sophisticated systems to ensure safe food production and transportation. This group will have the easiest path to compliance with FSMA, and they most likely already hold themselves to a higher standard. It’s actually the smaller suppliers, which likely do not have the available resources or sophistication to comply with FSMA requirements, that will be exempt from certain documentation under FSMA based on their size. This group of suppliers is growing rapidly to meet consumer desire for fresh food that is locally grown and produced. Unfortunately for them, it’s only a matter of time before wholesalers and retailers decide that the risk is too great to continue to do business with these small suppliers.

The good news is that technology exists that can help small suppliers reduce risk in their extended supply chains. Affordable, interoperable systems have been developed to address the market need for receiving, storing, sharing and managing regulatory, audit and insurance documentation. Suppliers of any size can also track products as they move through the supply chain and trace them back in the event of a recall. This move to automation will help all suppliers not only meet the demands of FSMA, but also establish a base for retailer and consumer demands for transparency in the supply chain going forward.

Having a comprehensive food safety system is quickly becoming a competitive advantage. Retailers and consumers are looking for those suppliers that have an unblemished safety record and are transparent about their safety processes, so the time is now for small suppliers to hold themselves to a higher standard than FSMA requires for future business opportunities. The stakes are just too high for retailers and wholesalers to not verify that everything they sell to consumers is produced and transported safely.

How Supplier Scorecards Affect You

By Food Safety Tech Staff
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A supplier scorecard allows companies to measure vendor performance as it relates to risk management, quality, and compliance. Having up-to-date and accurate documentation, particularly surrounding foreign supplier verification, is an important part of FSMA compliance. Suppliers must be able to provide immediate and accurate information, especially in the event of an audit. Marc Simony, vice president of marketing at TraceGains, explains why companies should build the scorecard over time, evaluating a supplier’s performance against specific business requirements.

What’s Frustrating for Food Manufacturers?

By Food Safety Tech Staff
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Gary Nowacki, CEO of TraceGains, highlights the concerns that came out of an Ask the Expert discussion about Supplier Qualifications and Management at the 2014 Food Safety Consortium.

“A common takeaway–whether it was small, mid-size or large companies–was the frustration of having to do more audits, and the growing demand for more paperwork. A question that was often asked was that ‘my customer is asking me to subscribe to a different audit, and that defeats the promise of GFSI, that it would lead to fewer audits.’ My advice to them is to not just blindly agree, but ask the customer politely what exactly they are looking for, and see if they can address that. Another frustration related to the increase in paperwork and the time and resources consumed in filling these plethora of forms. So there was a discussion about how we can standardize these. And people are looking to get automated solutions as they are not getting more headcount.”

William L Michels, President, ISM Services

Managing Suppliers: Race to Win, Rather Than to the Bottom!

By Sangita Viswanathan
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William L Michels, President, ISM Services

Continued consolidation of the food supply base will lead to more powerful and assertive customers in some markets. These customers are placing increasing demand on the entire supply chain for reduced cost and higher levels of value delivery.

While many companies focus on price reduction as a solution, they soon realize that there is only so much supplier margin and they soon become in effective in trying to meet the increasing demands of the customer and company management. They also realize that there is a significant cost and time involved in changing and developing new suppliers.

The solution to increasing demand for value is to get business alignment across the entire supply chain, which requires value-based relationships. In an upcoming webinar presented by TraceGains, William L Michels, will speak about how a company can build such a process that delivers cost and value improvement year on year, and how you can better understand SRM (click here to register).

Michels is President of ISM Services, a specialty training & consulting company that focuses on procurement and supply chain management. In a chat with Food Safety Tech, Michels provided a sneak-peek into his presentation.

FST: Supplier Relationship Management is critical and challenging. What aspects of this will you be addressing in this webinar? Why are these important to food manufacturers today?

Michels: The food industry has been consolidating for some time, and now it is essential that food companies align with the suppliers that can meet their overall business goals for cost, quality, safety and value delivery. The drive for continued consolidation will ultimately impact supply chains leaving integrated, exclusive and competing supply chains. Only the leanest, most efficient, and aligned supply chains will provide maximum competitive advantage to the end customer.

In the past many companies have focused on price, but as buyers gain transparency on supply chain cost, yields and efficiency, they need to manage the supply chain and optimize value delivery. SRM is the process by which companies can integrate the supply chain and extract real value.

FST: In the webinar you will be speaking about how to identify which suppliers are good candidates for SRM. Can you give us an idea about that?

SRM is a resource-intensive investment with a big pay back, therefore, we need to align with the most strategic suppliers to assure that we can get the maximum value and competitive advantage. The webinar will provide a template for choosing the correct suppliers.

FST: What are some common SRM errors/ omissions that you notice? And how would your webinar help address these?

Companies fail to look beyond the immediate first tier supplier in the supply chain and fail to recognize all aspects of the relationship that will lead to competitive advantage for both firms. Through the SRM process, companies can improve speed to market, total cost of ownership, quality, availability, and risk management. The webinar will detail how every supplier in the supply chain can incrementally add value.

FST: How is SRM evolving and what does this mean to the food industry?

If food companies continue to focus on price, rather that cost and value, the food industry will not progress far. Driving already slim margins lower will not provide the necessary capital to invest, innovate, create new processes and add incremental value. By recognizing the need for transparency and linkages of business objectives across the supply base, there is an opportunity for true transformation. This is an evolutionary process.

Michels will talk more on this topic in the webinar. Click here for details and to register.

Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

FSMA 2nd Review Cycles: A Q&A on Preventive Controls

By Sangita Viswanathan
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Sangita Viswanathan, Former Editor-in-Chief, FoodSafetyTech

On Friday September 19, 2014, FDA finally released re-proposals to four of the main FSMA-related rules: Preventive Controls for both Human and Animal Food, the Produce Safety Rule, and the Foreign Supplier Verification Program. The 75-day comment period will close around mid-December, after the proposals are officially published in the Federal Register.

At a recent FSMA Fridays webinar, presented by SafetyChain, Dr. David Acheson and Jennifer McEntire, Ph.D., of The Acheson Group focused on changes proposed to the Preventive Controls rule (for Human and Animal Foods). We present below some excerpts:

Q: What is the further definition of situations where environmental testing will be required?

Dr. Acheson: This is one of three very predictable components of the reproposals coming out. We have been saying for a long time to expect environmental monitoring to come back into the regulations. We all wish we have environmental monitoring everywhere, but this is not practical, feasible or environmentally focused. So what FDA has done now is to say we expect you to look at your environment, especially if it’s ready-to-eat products, and require you to conduct environmental monitoring in those specific areas. The change proposed is not fully prescriptive, and facilities need to conduct environmental monitoring as appropriate to their food products, the facility etc. It is required it specific circumstances where ready-to-eat product is exposed post-processing, and before packaging. Under this reproposed rule, the agency requires you to have strong environmental monitoring procedures as needed, records of these methods, and proof that you have corrective actions built in, when needed.

Q: What is the role of finished product testing in verification of food safety plans?

McEntire: When FSMA rules were initially announced, there was a lot of uncertainty whether FDA would require finished product testing, as in many cases, this would be like looking for a needle in a haystack. Now FDA is asking you to do finished product testing as necessary, as a verification activity to check if your overall food safety system is working well. Companies will need to look at the types of preventive controls that in place, at areas such as sanitation, employee hygiene (hand washing) etc., aspects that FDA does not require to be validated, and use finished product testing as a way to make sure that these are being done the way they are supposed to be. If you think it’s appropriate and if you choose to have finished product testing as part of your verification, make sure to have written procedures, documentation, corrective actions etc.

Q: What are the requirements and responsibilities for controlling suppliers along a company’s supply chain?

Dr. Acheson: Everybody recognizes that controls supply chain risk is an important part of controlling brand risk, AND it is a huge challenge. So it makes logical sense, and we know from experience, that suppliers have and will continue to send out food and ingredients that are not suitable, cause problems and cause recalls. Another reason is based in the Foreign Supplier Verification Program, which is essentially a different take on Supply Chain control. The only difference is that FSVP is a risk control requirement for imported, FDA-controlled foods. It looks at who you are getting food from, is there a hazard in it, and how is that hazard controlled? With the FSVP, we had set a different bar for imported foods than for foods sourced domestically. So this new addition rule tries to align Preventive Controls rule with the FSVP, by adopting a similar approach. So now it doesn’t matter if you source domestically, or from outside, you need to have a strong supplier controls program, and this has to be risk-based.

So look at your ingredients or materials. Do they contain a significant risk? If so, who’s controlling that risk – you or the supplier? For instance, if you are sourcing an ingredient like an herb, which has been associated with a Salmonella outbreak, then yes, there is a risk associated with it. So this ingredient that you are sourcing from different places is a significant hazard, but what you are doing with it is putting it in a blend and then cooking it in a product. So you are controlling that risk, and you don’t need to document that from the suppliers. However, the same ingredient, if you are just using it as a garnish, without a kill step, the control falls back on the supplier. And you as the user, have to make sure that the supplier is controlling that risk. The agency is giving some options, such as audits, testing, verification of supplier programs etc. to manage this requirement. For instance, if your analysis says there’s a significant risk, and it can lead to a significant adverse effect or death, Class 1 type situation, if that ingredient poses that level of risk and you are not controlling it, then an annual audit will have to be conducted of that supplier.

Where does GFSI fit into this? In my view, GFSI will align with this. So if you have a GFSI audit of the supplier, then you are going to be in pretty good shape.

Dan Okenu, Ph.D., Food Safety Manager, H-E-B
Retail Food Safety Forum

Food Spoilage and Food Loss in Retail Environments

By Dan Okenu, Ph.D.
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Dan Okenu, Ph.D., Food Safety Manager, H-E-B

It can be frustrating to consumers to discover some rotten fruits or not-so-fresh vegetables in their grocery packs in spite of due diligence at the stores. It also leaves a bad taste in the mouth while in your favorite restaurant, you’re served cold food, observe that the taste is just not right, the color of your favorite menu is not the same again or become suspicious that the food texture has been compromised and it doesn’t feel crispy or crunchy any more.

These are the tell-tale signs of food spoilage that customers are confronted with on a daily basis. In foodservice and retail environments, food spoilage constitutes a major food safety and food quality hazard with far reaching regulatory implications as well as being an economic burden with considerable food loss and profit loss. Food manufacturers and processors have achieved a high level of food preservation through several advanced technologies including heat treatment, temperature and water control, pasteurization and canning, specialized packaging like reduced oxygen packaging, fermentation and antimicrobial preservatives. However, food spoilage remains a major challenge in retail and food service. This is mostly as a result of the many food processing and preparation activities, food storage practices, repackaging and food portioning that are required in retail.

In addition, the modern consumers’ preference for fresh foods and the backlash on the use of unnatural preservatives leave foods more vulnerable to spoilage resulting in substantial food loss. Here, we discuss some of the challenges of food spoilage and how to minimize its impact on food safety, quality assurance and profitability in retail food operations.

Spoiled ApplesThe most important proactive measure against food spoilage is a tight managerial control on Supplier Food Safety and Quality Assurance. The condition of the food items upon delivery to the retail units will impact the overall shelf life, taste, texture, structural integrity and pathogen level during storage and food preparation activities. Food transportation best practices, cold chain requirements, temperature monitoring system, freeze-thaw detection, appropriate packaging, adulteration prevention and food tracking should be addressed at the supplier level to ensure that deliveries are wholesome safe quality foods. Integrated pest management at suppliers’ facilities and delivery trucks are also essential. Random testing of food products for pathogen content and quality control will assist in compliance with FDA/USDA regulations and internal corporate standards.Thus, a comprehensive evaluation and verification of the supplier food safety and quality assurance programs will help to ensure compliance with all relevant federal/State/local regulations (see previous blog on Supplier Qualification and Compliance using GFSI Benchmarking).

After suppliers deliver safe quality foods, in-store food safety and quality assurance control measures must be activated immediately to maintain safe quality food status until food is served to the customer.

At the retail units, appropriate food handling and storage practices to eliminate cross-contamination is key.

The use of rapid cleanliness monitoring test swabs to validate clean and sanitary food contact surfaces will enable timely corrective actions that would eliminate potentially hazardous food cross-contamination.

Proper hand hygiene by all foodservice employees should be mandatory.

Keeping cold food cold and warm food warm is a food safety mantra that ensures foods don’t get to the temperature danger zone. Temperature monitoring systems for freezers and refrigerators using wireless technologies will ensure a better food storage control even during non-business hours.

Emergency preparedness training for natural disasters and power outages should be in place to avoid surprises.

Compliance with FDA regulations for safe refrigerated storage, hot holding, cooling and reheating of food within the time and temperature criteria will help eliminate spoilage organisms and preserve the taste, texture and overall quality of food throughout its shelf life, especially for meat and poultry products.

Proper management of products’ shelf life, expiration dates and observing the principle of first in first out (FIFO) should be encouraged. In fact, the food code requires a system for identifying the date or day by which food must be consumed, sold or discarded. Product date marking enables compliance with this food code requirement to date mark all prepared food products, and to demonstrate a procedure that ensures proper discarding of food products on or before the date of expiration. Local health inspectors reference these product date marking labels and enforce them, in addition to food prep activities that may lead to cross-contamination, adulteration or spoilage. Inventory control, forecasting and Lean Six Sigma are important tools for managing food supplies, storage, preparation, stock replenishing and elimination of excess food items that may get past their shelf life.

Raw proteins (meat, sea food and poultry) are arguably the largest cross-contamination sources for pathogens in foodservice. Any novel pathogen reduction or elimination process like the potential production of pathogen-free chicken would be a welcome relief, and will not only save money and labor; it would protect the public health as well.

Produce (fruits and vegetables) remains the largest source of foodborne illness outbreaks in United States, because it’s a ready-to-eat food that doesn’t get the benefit of cooking at high sterilizing temperatures. An effective pathogen kill step for produce using consumer-friendly natural washes like electrolyzed water may serve as a gate keeper in case the safety system fails at the plant level. Ice-cold electrolyzed water is also known to refresh produce and may extend their shelf life as well.

GMO-food products could be engineered to resist pests and spoilage organisms with improved shelf life, but its general acceptability and the FDA labeling disclosure requirements are still contentious issues.

While industry is racing to develop several promising anti-spoilage technologies, active managerial control of the various components of an effective food safety and quality assurance system remains the best practice against food spoilage and associated food losses in retail food operations.

Food Safety and Sleepless Nights

By Food Safety Tech Staff
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Trust in suppliers. From a global perspective, it’s about experiences. Do you trust your suppliers? Do we silo ourselves such that we forget we’re the ones who add value ? Never underestimate the importance of adding value. As business owners, it’s important to completely integrate yourself into the business. Break down the silos and integrate yourself into the business. You can’t expect everyone else to learn your language; you need to learn industry’s language. What else keeps food safety experts up at night?