HACCP and HARPC Plan Management Demands Automation

By Food Safety Tech Staff
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Manual management of HACCP and HARPC plans is often a resource-intensive and inefficient process that can create a data rich vs. information poor sentiment. Next week Dan Bernkopf, vice president of food safety applications at SafetyChain, will share insights on how companies can use automation to help assess risks to effectively create critical control points and preventive controls, during a webinar, “Conquering HACCP/HARPC Plan Management: The Power of Automation”. He will also share insights to help companies learn how automation can ensure that HACCP and HARPC plan components are scheduled, monitored and documented.

How else can automation help companies with their HACCP and HARPC plans?

  • Provide real-time non-conformance reports for CAPAs, minimizing waste and rework
  • Leverage mobile technology to collect food safety data at the source
  • Conduct meaningful trend analysis for continuous improvement with accessible, actionable data
  • Be audit ready for USDA, FDA and customer inquiries

Register for “Conquering HACCP/HARPC Plan Management: The Power of Automation“
Thursday, August 6
1 pm ET / 10 am PDT
The webinar is part of SafetyChain’s FSQA Tech Talk series

Ask the Expert: Looking to Increase Efficiency of Your Pathogen Detection Process?

By Food Safety Tech Staff
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Pathogen enrichment is a critical part of any microbiological testing workflow.

Pathogen detection – made challenging with the increase in numbers of composite samples that require even larger volumes of media per sample – are time-consuming and involve bulky media handling by laboratory personnel. Not only do these factors make life in the lab more difficult, but also, they increase the risk of introducing contamination. 

The following questions provide insight into more efficient ways to prepare media.

Q: What are some ways to manage the increased media production requirements, and what are some of the bottlenecks in the media kitchen when dealing with composite samples for pathogen testing?

A: Composite samples are larger than traditional food samples and therefore require the addition of more culture media before incubation. Larger volumes of media preparation (i.e. sorting, autoclaving) is one of the largest sources of bottleneck for composite samples for pathogen testing. It’s not unusual for several hundred composite samples to be tested daily on a regular basis – this situation is only magnified when managing composite samples that require up to 15 times more than a traditional sample.

The issue with large volumes of media is that media containers and samples are fairly heavy and cumbersome to move, with equally demanding turnaround time. For these reasons, the entire process must be industrialized to maintain lab productivity.

Choosing a media that is composed of premium raw materials ensures high recovery and growth rates of bacteria, which are essential for the subsequent use of rapid testing methods. Additionally, selecting a media that meets industry performance standards as described in ISO 11133, helps reduce required quality control measures.

Q:  How can I increase my media production without having to scale up my media kitchen to handle the workload?

A:  Merck Millipore’s Readybag® media pouches with granulated culture media enable pathogen testing of composite food without making major changes. Readybag media pouches do not require capital equipment investment and involve less labor than both high efficiency and traditional methods for sterile media production. Use of pre-weighed, gamma-irradiated Readybag pouches eliminate all preparation steps and reduce typical sample preparation and autoclaving time by more than 50 percent. Performance tests confirm that Readybag media provides equivalent results compared to non-irradiated, autoclaved culture media.

A study performed by Cherney Microbiological Services (Green Bay, WI, USA) demonstrated the time, utility and space savings using Readybag granulated enrichment media for composite food samples as compared to both high efficiency and traditional preparation methods using autoclaving. The study examined the labor required, media cost, utility and associated electricity costs for each of the three methods (traditional autoclave, high efficiency and Readybag method).  Observations and measurements were made using laboratory personnel within the normal workflow of Cherney’s laboratory.

FDA Proposed Rule, Draft Guidance to Ensure Safe Imported Foods

By Food Safety Tech Staff
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The agency wants to establish a user fee program to facilitate audits.

About 15% of the U.S. food supply is imported. And within that figure nearly 80% of seafood, 50% of fresh fruit, and 20% of vegetables come from outside the United States, according to FDA. Under FSMA, the commitment to ensuring the safety of imported foods is a high priority. FDA is releasing a proposed rule, and a companion draft guidance document, to aid foreign entities in proving that they are meeting food safety import requirements.

The proposed rule, “User Fee Program to Provide for Accreditation of Third-Party Auditors/Certification Bodies to Conduct Food Safety Audits and to Issue Certifications”, is scheduled for publication Friday, July 24. FDA has named the following key groups that would be charged fees:

  • Accreditation bodies (ABs) submitting applications or renewal applications for recognition in the third-party accreditation program
  • Recognized ABs and accredited CBs that are participating in the third-party accreditation program and subject to FDA monitoring
  • Certification bodies (CBs) submitting applications or renewal applications for direct accreditation

In addition to naming those subject to the user fee, the proposed rule defines how the fees would be computed and collected, the agency’s public notification process, and what happens if those subject to the fee do not pay it (i.e., suspension of recognition).

In the draft guidance, “Third-Party Auditor/Certification Body Accreditation for Food Safety Audits: Model Accreditation Standards”, FDA makes recommendations on third-party auditor/certification body qualifications.  If finalized, the document will remain a companion guidance to the final rule.

Purdue University Wins FDA’s Food Safety Challenge

By Maria Fontanazza
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Today FDA announced the winner of the 2014 Food Safety Challenge. The Purdue University team snagged the $300,000 grand prize for its physical method for concentrating Salmonella to detectable levels via automated microfiltration. The technique can potentially reduce sample preparation time from 24-48 hours to a two- to three-hour timeframe.

Runner-up  Pronucleotein received $100,000 for its portable device that enables rapid pathogen screening via DNA aptamer-magnetic bead sandwich assays.

For more details about the technology, view Food Safety Tech’s coverage: FDA’s Food Safety Challenge a Big Deal for Agency and Industry.

More Food Labs Using Certified Reference Materials

By Karin Pauly
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A notable section of the Food Safety Modernization Act (FSMA) calls for the development and implementation of model laboratory standards.  To ascertain the level of laboratory standards currently employed by food laboratories, a laboratory testing services company commissioned a survey of laboratory directors, quality assurance managers and technical supervisors.  One area of questioning focused on certified reference materials (CRM).

According to a recent survey, more than 50% of laboratory directors, quality assurance managers and technical supervisors report using certified reference materials.
According to a recent survey, more than 50% of laboratory directors, quality assurance managers and technical supervisors report using certified reference materials. (Click to enlarge)

In response to whether their laboratory uses CRM, 65% of respondents said yes. Most of the remaining survey respondents (31%), volunteered that they sometimes use these materials, if required. Only 4% replied “No” (see Figure 1).

The responses are significant in that they provide a glimpse into current food laboratory quality practices.  FSMA tasks the U.S. Department of Health and Human Services with making certain that analytical procedures and quality systems are established and followed.  Yet, it is not clear what procedures and systems are currently employed.  This survey provides a baseline measure from a segment of the food laboratory community, indicating, that a majority of respondents use certified reference materials.

Quality Controls vs. CRM

A food laboratory aims to provide the correct result every time a test is performed. In order to achieve this consistency and reliability, laboratories should use standard measurements, known as quality controls. Quality controls are essentially the stable norm against which testing processes and instruments may be assessed. By using quality controls, it is possible to find areas in the testing process that may be weak or failing.

CRM, used as a form of quality control, are highly characterized, homogenous, authenticated control materials. Food laboratories often have options available for obtaining commercially sourced materials for quality controls, but not all of these options are well characterized or authenticated. CRM are used by laboratories to assess the quality of method validation as well as to trace to an established standard. In the food lab, CRM help provide a level of certainty in the results when instruments and processes are validated and verified. CRM may be obtained from accredited producers, as established under ISO Guide 34.

The survey also asked whether on-site and contract laboratories use quality controls. Interestingly, not all laboratories surveyed are using quality control materials as part of their testing processes and procedures.  For on-site laboratories, 81% of survey respondents acknowledged using quality control materials. For contract laboratories, the number slips to 67%.  For survey respondents not using quality control materials, it is unknown if or how their test results are validated and verified.

Quality control is a basic component of laboratory testing as well as a requirement for accreditation.  Whether CRM or non-certified reference materials are used, quality controls are important components needed to ensure test results are valid and reliable for food consumers and industry alike.  As future FSMA rules on model standards are likely to address this essential provision of laboratory testing, these survey results support the use of CRM.

The survey discussed in this article was commissioned by Microbiologics, Inc.

Ask the Expert: What do processors need for rapid Salmonella detection methods?

By Food Safety Tech Staff
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Rapid technologies address the trend toward environmental testing versus finished product testing.

During the past decade, incidences of Salmonella have failed to drop, and the pathogen continues to pose a serious problem to the food supply. Meredith Sutzko, Product Manager, Food Pathogens at Romer Labs North America discusses current technology needs for the food industry.

Q: What are processors looking for in Salmonella detection methods?

Sutzko: I think we will see an increase in testing related to the Food Safety Modernization Act, and there’s a trend toward environmental testing as opposed to finished product testing. Instead of waiting to test finished products at the end of a production cycle, we’re finding that processors are taking a lot of environmental samples from the production line in different areas in order to find contamination further upstream so that when they get to the product testing, they have a lot of confidence that the product is going to be pathogen-free.

Processors are looking to identify contamination very early in the process. To do that, they need simple and cost-effective methods, especially ones that will deliver a fast time-to-result and can be used at the production facility so they don’t have to wait to obtain test results. By using test methods on-site, they can immediately take action upon getting the test result.

Q: How is RapidChek® differentiated from other rapid methods currently available?

Sutzko: The RapidChek method is an innovative, simple and easy-to-use test. With this test, we typically focus on the enrichment portion of the rapid method, because if salmonella is present in the environment, it’s going to be present at very low levels. The enrichment portion (or the growth phase), is important to get that pathogen to higher concentrations for detection.

We use innovative bacteriophage technology in our enrichment media. The bacteriophage act as selective agents during enrichment to inhibit the growth of competing microorganisms, which could be present. The phages allow an optimal growth environment for Salmonella, if it’s present, by reducing the growth of these other competitors. It helps to provide a fast time to result. Then we combine the enrichment media with a state-of-the art-lateral flow test, which uses highly purified antibodies that have been optimized for the sensitive and specific detection of Salmonella.

The technology is simple and easy to use. The end user doesn’t need any expensive equipment to run it. The method comes all-inclusive with everything necessary to run it, so there are no additional expenditures on consumables. Producers are able to do a lot more testing using the RapidChek, because it’s so cost effective. If they find contamination or a growth-niche, they can sanitize, take action and do more testing to make sure they’ve gotten rid of the pathogen.

Q: What’s the significance of Salmonella detection right now as it relates to the risk that the pathogen poses to the food supply?

Sutzko: Historically, Salmonella has been associated with meat and poultry. Recently we’ve seen a lot more outbreaks in different types of food products and matrices that historically have not been associated with Salmonella. Also, the food supply is being globalized. We’re receiving a lot of foods from different countries, possibly where their food safety standards are not as stringent as we have in the United States. We’re seeing an increased level of awareness by producers. They look at their suppliers and their raw materials to make sure they’re testing the materials before they put it into their supply chain.

Also with regulations like FSMA, we see retailers driving food safety and quality systems through third-party certification bodies such as GFSI. Retailers are requiring their suppliers to have effective food safety quality management systems in place in order to do business.  These practices will help to ensure safe food is being supplied to the consumer from farm-to-fork.   

Is Your Company Prepared to Fight Food Fraud and Product Adulteration?

By Maria Fontanazza
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Having the ability to detect and identify contamination and adulteration in product is a top priority for companies, especially when working with foreign suppliers. In a discussion with Food Safety Tech, Craig S. Schwandt, Ph.D., director of industrial services at McCrone Associates, discusses how companies, especially those with limited resources, can use technologies to improve contamination detection to be ahead of the FSMA implementation curve.

Food Safety Tech: From your perspective, what key elements of FSMA will have a big impact on manufacturers and processors?

Craig Schwandt: For U.S. manufacturers, more and more of their ingredients are coming from foreign countries. [Companies] are responsible for reporting to FDA what measures they have taken to assure food safety in all aspects. Participating in the Foreign Supplier Verification Program will be critical to [their awareness of] whether their foreign suppliers are meeting those obligations. That critical element hasn’t been realized yet.

FST: Is navigating the foreign supplier relationship more of a challenge for smaller businesses versus larger companies?

Schwandt: Global companies have the resources to address contamination concerns and can monitor the processing that takes place in foreign countries. It’s the small companies that don’t have the financial resources to be present in foreign countries. There will be many more issues for them to address—are they really receiving product that they’re paying for? Is the testing that is being conducted in foreign countries really meeting the requirements.

FST: What steps can small companies take to ensure they have testing programs in place to meet requirements?

Schwandt: This ties in with the difference between testing and investigational analysis. Testing involves identification methods that are done to ascertain what is present—it might be an elemental concentration basis or an organic molecule basis—but they’re bulk analysis that determines whether the product is meeting the expected composition.

Then there might be components for which there are actionable levels, if the concentration exceeds actionable levels. But with bulk analysis testing methods, they only understand that they have a component in their product that exceeds an action level, and those methods don’t really specify where that component might be introduced into the product. This is where microscopy-based investigational analysis can assist smaller companies with understanding at what point the contaminant might have been introduced into the product. It can be isolated in individual particles, establishing a forensic pathway for stage of the process in which the contaminant might have been introduced.

FST: Can you expand on the technologies and methods that can be used to detect fraud or adulterated product?

Schwandt: In the case of intentional adulteration and fraud, current technologies include ultrahigh pressure liquid chromatography, liquid chromatography, and mass spectrometry, and the food industry is doing a great job of using them.

In the case of intentional adulteration or fraud, the level of adulteration has to be fairly high, otherwise there isn’t an economic incentive to adulterate it. A great example is with pomegranate juice—if you’re going to intentionally adulterate pomegranate juice with grape juice to cut it down, a fairly large percentage of the final juice will be grape juice in order to make that intentional adulteration process economically motivating. It’s not really so difficult to identify it with [current] technologies.

Where the technologies need to be improved is in instances in which there might be more unintentional adulteration or contamination at trace levels:

  • When there are solid phase particulate contaminants, use of microscopy-based methods (which isn’t new technology) where you isolate the contaminant particles of interest; they occur at trace level. Because we isolate them from the matrix, we can analyze them and [detect] if there were metal particles from processing machinery; we can identify them to the alloy level and give clients a way to trace back to what part in the process stream those particles may have originated.
  • Likewise, Liquid chromatography and mass spectrometry, especially for pesticide residue analysis, will be increasingly more valuable using the QuEChERS program FDA has outlined for quick, safe, reliable and easy analysis of trace contaminants in food products.

FST: What factors are contributing to under-use of microscopy-based methods?

Schwandt: I think the expensive–instrument vendors would like you believe it is as simple as pushing a button to receive your complete quantitative answer. In many cases, the instruments, even though they might be designed with the best intentions, actually do require expert chemists to use them for complete success. There’s a push on the part of instrument manufacturers to provide instrumentation that they sell as providing the complete answer. And there’s a willingness in the food industry to believe it would be as simple as putting a less-skilled person in front of the instrument to run the analysis, push the button, and get the answer, as opposed to hiring an analyst with a lot of expertise.

FST: What industry partnerships/collaborations are essential in testing and analysis?

Schwandt: The partnerships are productive in this area when they’re between production and quality assurance branches of companies and third-party laboratories that can offer niche solutions and third-party verification.

Compliance Deadline for ObamaCare’s Menu Labeling Rule Extended One Year

By Maria Fontanazza
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FDA gives establishments another year to comply with the controversial rule.

Whether it was Congressional pressure or the heat felt from large retail businesses and industry associations, FDA decided to extend the date for compliance with the menu labeling rule by one year. The final rule, “Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments”, was published on December 1, 2014 with the effective compliance date originally set for December 1, 2015. As announced in a Federal Register notice last week, covered establishments now have until December 2016 to make sure they comply with the requirements.

“The FDA agrees additional time is necessary for the agency to provide further clarifying guidance to help facilitate efficient compliance across all covered businesses and for covered establishments to come into compliance with the final rule,” said Michael Taylor, FDA deputy commissioner for foods and veterinary medicine, in an FDA notice.

“The final rule requirements are intended to ensure that consumers are provided accurate, clear, and consistent nutrition information for foods sold in covered establishments in a direct and accessible manner to enable consumers to make informed and healthful dietary choices.” Source: Federal Register

“Covered establishments” are restaurants or similar retail food establishments that are part of a chain and have 20 more locations that conduct business under the same name and offer the same menu items. This can include individual franchises. 

Since February, FDA has received four requests for an extension of the final rule’s compliance date. These concerns, which were submitted by a large retailer and industry associations, stated that there wasn’t enough time to fully implement requirements. The requests also detailed the extensive steps involved in compliance, which include:

  • Developing software and information systems that provide nutritional information
  • Training staff
  • Rolling out standard operating procedures
  • Developing and installing updated and consistent menus (across retail chain operations)

FDA plans to issue a draft guidance next month that will answer questions it has received about complying with the rule. The agency will also offer educational and technical help to businesses covered under the rule and will work with state, local and regulatory partners to support nationwide compliance.

Animal Feed Industry: Steps to Success to Meet FSMA Requirements

By Maria Fontanazza
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As industry awaits next month’s final rule on preventive controls for animal food, companies in the animal feed business must be prepared for the changes, especially as it relates to having an aligned system with HACCP principles. In a Q&A with Food Safety Tech, Victor Muliyil, food technical project manager at SGS SSC North America, and Mary Williams, a quality assurance and regulatory affairs expert at Land O’Lakes, Inc, discuss where companies should be looking for gaps in their systems.

Food Safety Tech: What critical changes does FSMA introduce to the animal feed industry?

Victor Muliyil: FSMA introduces the primary change that all feed manufacturers must have a feed safety hazard control program that is in line with HACCP principles. Hazards likely to occur must be identified and controls implemented; and [although] hazards related to medications and prohibited material must still be controlled, the responsibility is on the manufacturer to identify all hazards and controls. The focus is on prerequisite programs, not just on critical control points.

In addition, feed industry recalls can now be mandated by FDA, not just recommended. HACCP certification is not mandated by FDA, but several feed and food industry customers are looking for competent independent audit and certification of feed safety control programs. Trained internal auditors are required to verify the system. Traceability is required to the next level of distribution, as well as backward to key ingredients such as medications.

Mary Williams: Food industry leaders must now show they have “planned to work safely,” and this plan must be written down with documented evidence of training. This is a fundamental shift in approach, as FSMA indicates that all feed manufacturers must control feed safety hazards consistent with principles many of us have learned in HACCP. This speaks to prevention vs. reaction, so the prerequisite programs as a foundation must be in place first. This is a time of unprecedented change in the U.S. Food/Feed industry plus global supply chains that are expanding. While it is widely accepted that zero risk is unattainable, the approach that companies take to prevent having an issue, and to prepare for efficient and effective response in the event of a problem is seen as critical.

Product Safety Culture must be leadership driven and reinforced and furthermore, a strong product safety culture is a “choice”.  Leaders of an organization set the tone and must proactively reinforce the expected outcome because it’s the right thing to do, not just because it is the newest food safety law.

While many feed companies are moving toward HACCP certification, it is not mandated by the FDA.  Regardless of whether you build a HACCP plan or a Food Safety Plan, it is important for feed/food companies to start now. The cGMPs, new GMPs and most FSMA requirements are generally understood thus having more time to live and practice the programs implemented allows time for adjustments.

FST: Regarding GFSI certification, in what areas are companies in the animal feed industry the most under-prepared?

Muliyil:  Management commitment, understanding and communication are key. Better training is needed to understand feed industry specific hazards and realistic controls. Currently, internal auditing is not very thorough and must be more structured. Corrective actions are not followed through to gauge effectiveness and are often not documented in adequate detail. Finally, validation is not well understood, nor is there specific guidance on this topic.

Williams: Management does not always clearly understand the need and requirements of “Management Commitment”.  It requires active and visible participation at all levels of management. Managers must “walk the walk” and “talk the talk”.  It may also require an investment in resources such as staffing, capital improvements, and training, to name a few. Management commitment is essential to support the development of a strong product safety culture. Failures in product safety culture increase the potential risk of outbreaks and deaths from foodborne illness.

The skills needed in the industry to meet these new expectations are different than what we needed before. It is not enough to just adopt new standards.  We have to train and educate those who implement them.

We need to train for behavior – what do we want the trainee to be able to do? The training needs to be clear and practical. In addition, we need to educate for increased knowledge across the employee base.  Don’t just send the managers and supervisors to HACCP class or auditor training, make sure we educate a multi-disciplined team including production employees.

Continuous improvement is an everyday concept and involves having a strong corrective action/preventive action program. Often deficiencies are corrected quickly, but not prevented over the long term, and this requires increased due diligence.

FST: Are companies with FSSC 22000 certification more prepared for the preventive controls rule?

Muliyil: FSSC 22000 is one of the GFSI benchmarked schemes that offer effective integrated food safety management, covering:

  • Specific controls and scheme criteria for animal feed and pet food
  • Global buy-in and adoption by many of the world’s leading feed and food manufacturing companies
  • A top-down focus, including defined roles for management, requirements for policies and regular management review
  • Prerequisite programs focused on hazard control, in line with HARPC and FSMA
  • The HACCP system approach to structured food safety control, focused on medications & prohibited material control
  • Traceability from suppliers through to customers
  • Communication:External: Consumers, customers, service providers, suppliers, associations and regulators.
    • Internal: Within a company and between all elements of the system
    • Internal audit of the entire food safety management system and follow up
  • Regular system updating to maintain rigor

Williams: A company certified in FSSC 22000 or one of the other GFSI benchmarked standards has implemented Codex HACCP and hygiene principles in their foundation programs. These same HACCP and foundation programs overlap with the requirements in the preventive controls rule and will support compliance to FSMA.  It will be important to review all the FSMA requirements to ensure all elements are effectively covered in the current company program.

FSSC 22000 requires annual recertification and an annual self-audit. These two elements of review ensure that internal and external eyes are always looking for program compliance before a failure occurs.  These are solid “prevention” elements that support FSMA compliance as well.

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.”