Tag Archives: HACCP

Complacency Kills. What To Do Before a Recall

By Maria Fontanazza
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A control point breakdown can lead to a food safety recall. Here’s what to expect, what to do, and how to move forward. But most importantly, this discussion with Alan Baumfalk, lead auditor and technical manager for Eurofins food safety systems, will focus on prevention and re-evaluating whether your company’s current plans will be effective in the wake of a recall.

Food Safety Tech: What is the role of the crisis management plan as it relates to a company’s food safety program?

Alan Baumfalk: The crisis management plan is an interwoven topic. Some people use crisis management or business continuity interchangeably, but they tend to have a bit of a different focus.

First of all, a crisis management plan usually goes together with a food safety plan, and in some cases, it is part of a food safety plan. We are all familiar with the food safety plan, which includes a HACCP plan (Hazard Analysis and Critical Control Points). HACCP consists of seven principles. We’re all involved in HACCP everyday; it’s related to everything we do. We identify the hazards that might be involved in the food we’re producing; we identify the hazards that might be involved in our daily lives (for example, we choose no to drive in rush hour traffic because of the potential hazards that might be involved).

This all fits into our food safety program where we try to eliminate risk through risk assessment. We establish critical limits of what we will and will not accept, and then we monitor and verify them. We take corrective actions when something we monitor is not within that critical limit. Verification involves verifying that what we’re monitoring is indeed being monitored, and finally, there is record keeping.

The crisis management team wants to prevent a recall, which is a crisis to the business, to the brand, and to the health and welfare to the public. No one wants to have a recall. When putting together this plan, you need to make sure you have a multidisciplinary team. It cannot consist of all sales people, nor can it be solely quality control people. You have to bring in people with certain expertise: Include people that are from legal, media/communications, and the business group.

FST: In preparing for a crisis, where does business continuity planning fit into the picture?

Baumfalk: Crisis management has two additional components—the business continuity plan and the food defense plan. They are not exactly the same, and they are not necessarily interchangeable. The business continuity plan is related to how you are going to continue your business if you have a situation that occurs. It can be a crisis that involves a buyer, an environmental hazard, or a physical hazard, for example.

Sometimes people will consider what is happening in the media right now. What happens if there’s an incidence at the local school and your employees have children there. What are you going to do and how will you respond? How will you continue to do business in a safe way?

When putting together a business continuity plan, you need to ask yourself, how are you going to cope with the business crisis and continue doing business.

  • Designate a senior manager who is in control of handling the organization and making the necessary decisions.
  • Identify a multidisciplinary crisis management team. Each person should have a specific responsibility (i.e., medical, regulatory services, contacting customers, suppliers and internal/external communications). Each team member should be prepared to respond to food safety issues.
  • Develop a contact list that includes legal and various experts in the industry.
  • Train employees.
  • Devise a worst-case scenario and practice, practice, practice. The plan should be tested rigorously and on an annual basis.

When we talk about a mock recall, one of the biggest deficiencies is that people don’t rigorously test it. The number one priority should be to have the plans in place and test them, and identify the weaknesses that you can correct. One of the biggest problems that may eventually cause a recall is complacency. The employees think they got it all covered. It’s important to note that an ounce of prevention is worth a pound of cure.

In Part II of this series, Baumfalk will make the connection between crisis management planning and food defense.

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

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.

Listeria Invasion – How is it Creeping into Our Beloved Foods?

By Traci Slowinski
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As a result of several recent high-profile Listeria-related recalls, interest in the foodborne pathogen is increasing and food processors must take preventive measures to keep it out of facilities.

Listeria monocytogenes is a gram-positive bacteria. It has 13 serotypes, three of which have been associated with the vast majority of foodborne infections (called listeriosis). Although it is not a leading cause of foodborne illness, it is among the leading causes of death from foodborne illness. This hardy pathogen is salt tolerant, thrives in cold, moist environments and can grow under refrigeration temperatures. Listeria is found throughout our environment including in soil, water, sewage, decaying vegetation and even some animals. Its presence has most often been identified in foods such as raw or under-pasteurized milk, smoked fish, deli meats, soft cheeses and raw vegetables.

For a healthy individual, Listeria may cause mild symptoms or have no effect at all. Fever, muscle aches, nausea, vomiting and diarrhea are common signs of infection. For the e  immunocompromised (the very young or old, pregnant women, or adults with weakened immune systems), symptoms can be more severe and include septicemia and meningitis; in pregnant women, it can cause miscarriage. Symptom-onset ranges from a few hours to two–three days, with durations lasting from days to several weeks, depending on the severity of infection.

Keep Listeria Out of Your Plant

The first line of defense against Listeria contamination is to keep it out of a facility, but that may not always be possible, thus a Listeria prevention plan should be integrated into a company’s food safety program, considering the following areas:

    • Employees—can be brought in on shoes and clothing, or through infected workers. Prevention includes:
      • Good Manufacturing Practices
        • Personnel Hygiene—proper hand washing, wearing clean clothes and shoes, wearing proper hair restraints
        • Employee Illness Policy—restriction/exclusion of ill employees
    • Raw Materials—introduction into the environment from raw ingredients (milk, fish, seafood, produce), pallets, cardboard, packaging material. Prevention includes:
      • Supply Chain Management
        • Supplier Approval Program—having strategic partners that ensure only safe, high-quality raw materials
        • Ingredient Management—requesting COAs, letters of guarantee, allergen control
        • Receiving/Storage Procedures—completing incoming inspections, proper nonconforming material handling
    • Processing Aids—harborage in ice, brine solutions, improperly filtered compressed air and HVAC units. Prevention includes:
      • Sanitation Program—proper cleaning/sanitizing of equipment
      • Preventative Maintenance—regular replacement/maintenance on filters/motors
      • Water, Air, and Steam—utilizing potable water, properly filtered air, properly treated steam
    • Equipment Design—contamination of conveyor belts, filling and packaging equipment, slicers/dicers, ice makers, hoses, equipment framework, condensate drip pans, maintenance tools, trash cans, tools for cleaning equipment (brushes and scouring pads). Prevention includes:
      • Sanitary Equipment Design – ensuring that all equipment can be broken down as far as possible and properly cleaned and sanitized to remove dirt, debris and micro-organisms
    • Process Flow—not maintaining segregation of high vs. low risk, clean vs. dirty. Prevention includes:
      • Separation of high-risk vs low-risk areas through time, space or physical barriers
      • Proper garb (smocks, hair restraints, captive shoe policy) and sanitary measures (hand wash and sanitize, shoe sanitizer) to reduce introduction into high-risk areas
      • Proper personnel flow or movement to prevent cross-contamination
    • Plant Environment—common pathogen harborage areas. Prevention includes:
      • Floors/Drains – splash back, biofilms
      • Overhead Structures – condensate, dust/debris
      • Waste Areas – trash buildup
      • Wash Areas – standing water
    • Sanitation Program—insufficient cleaning/sanitizing to remove pathogens. Prevention includes:
      • SSOP’s – comprehensive sanitation SOPs with special focus on hard-to-clean areas and equipment.
      • Drain Cleaning—proper frequency, chemicals and procedures
      • Clean-In-Place Systems—accessibility to hard-to-reach areas
      • Sanitizing Agents—quaternary ammonium compounds, peroxyacetic acid sanitizers (for biofilms)
    • Environmental Monitoring Program—tool to identify gaps and risk used improperly resulting in missed problems. Prevention includes:
      • Robust Sampling Plan—identify zones and sampling areas
      • Effective Track & Trend Tool—identify gaps or risk that require corrective/preventive action
      • Timely Corrective Action— ensure proper follow-up on any issues that arise

First Person: The Listeria Experience and Lessons Learned

The above list is by no means exhaustive when it comes to all the areas you need to consider when completing a gap analysis within your facility. Listeria can be very insidious, and you will need to be ever-vigilant to ensure it does not take hold in your environment. Believe me, I have been there when it has.

Once upon a time, I worked for a Ready-to-Eat processing plant. We had robust food safety and quality assurance programs. We employed two microbiologists and had a good environmental monitoring program. The sanitation team did a thorough job of cleaning and sanitizing every night, and we completed preoperational sanitation inspections (including ATP testing) every morning.

Then we had a Listeria recall.

It started out small. One sample tested by FDA came back positive. Then another…and another. More intensive environmental testing found Listeria in the plant—in the drains, in the hard to reach areas of the old slicers and MAP packaging equipment, and even in the production room cooling units.

After many, many hours of cleaning, sanitizing, testing and retesting, we determined that the current layout of the facility would never allow for complete elimination of the Listeria. We had one big production room where raw material was brought in and broken down, fed into the processing lines and assembled, and lastly, finished product was placed into the packaging, which then went into cases and onto wooden pallets. There was no separation of high-risk areas from low risk.

So, what did we do? We set up a temporary location for production (which was a major project in and of itself), redesigned the process flow, shut down the plant, and remodeled our production area.

Highlights of the redesign included:

      • Building a cleanroom for the production area. We walled off the raw material handling area by the receiving warehouse, enclosed the packaging area by the shipping warehouse, and made the room that housed the processing lines a cleanroom/high-risk room. Entry into the room required appropriate garb (clean smocks, hair restraints, gloves, captive shoes), use of the hands-free hand wash and sanitizer, and a pass through the boot sanitizer. The temperature of the room was reduced from 50oF to 38oF to discourage pathogen growth.
      • Setting up a raw material handling room. A separate “dirty” area was built to break down raw material components and remove them from their packaging (corrugate cases, plastic wrap). Raw material was then fed through a wall opening where a UV light was mounted to “sanitize” the outside of the material. This helped to reduce the introduction of cardboard packaging and wood pallets into the cleanroom and drive down any pathogens that might be on the surface of the raw material.
      • Adding a packaging room. All sealed, packaged finished product passed through a wall opening into the packaging room where it was boxed up and placed on pallets. This also helped to reduce the introduction of cardboard and wood into the clean room.

The new process flow allowed for employees to move from the “clean” processing room to the raw material or packaging rooms without any extra precautions, but they were required to go back through the clean room procedures prior to going back to the processing area. Raw material and packaging employees were excluded from the cleanroom to minimize potential of contamination from personnel flow.

We also reevaluated our Hazard Analysis and Critical Control Points (HACCP), Sanitation Standard Operating Procedures (SSOPs), and Sanitation and Environmental Monitoring (EM) programs to ensure all potential risk was identified and addressed either through the new facility design or other control measures. One key takeaway was to use the EM program to identify gaps and areas of opportunity rather than to just try to prove that everything is fine. We learned that having a comprehensive EM program that can capture all the necessary data points, analyze trends and drive corrective action helped our team use the program to drive food safety and continuous improvement. It wasn’t good enough to just have an EM program in place; we needed to use the data to address gaps and mitigate identified risks.

Conclusion

Foodborne pathogens are one of the biggest risks to the safety of our foods. Listeria poses a threat to a number of food categories (dairy, protein, and produce) and should be highlighted as a significant hazard to be assessed when developing and implementing your food safety programs. Using risk-based preventive controls within your facility will help prevent adverse events related to Listeria.

How to Use FMEA to Risk Assess Pathogen Testing Methods

By Maria Fontanazza
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All methods are not equal, and companies must understand the testing methods used on a Certificate of Analysis.

A Certificate of Analysis (COA) can provide a company with a level of confidence in the quality and purity of its product.  However, the company should be able to take the document and understand how the results were gathered, says Maureen Harte, President and CEO at HartePro Consulting, and Lean Six Sigma Master Black Belt. Using Failure Modes and Effects Analysis (FMEA) can help a company identify, quantify and assess risks associated with pathogen detection methods, and should be integrated into a HACCP strategy.

Food Safety Tech: What are the challenges a company faces when assessing results on a Certificate of Analysis (COA)?

Maureen Harte: [Companies] lack the background information to really understand what goes into a COA, and they trust that what is coming to them is the highest quality.

FST: What questions should a company ask?

Harte: They need to consider everything that goes into the testing method itself.

•    What is the origin of the COA?
•    Who’s doing the testing?
•    What’s the complexity of the method?
•    What is the overall quality of the method?
•    How traceable is it?
•    How well can I trust that this result is the true result (are there false negatives)?

FST: How is FMEA used to evaluate pathogen testing methods?

Harte: FMEA helps us understand the differences between testing methods by individually identifying the risks associated with each method on its own. For each process step [in a test method], we ask: Where could it go wrong, and where could an error or failure mode occur? Then we put it down on paper and understand each failure mode.

For example, most methods have an incubation step. A simple failure mode would be that the incubator isn’t at the correct temperature, or that it has been incubated too long or not long enough. You go across the board for each step, identifying potential failures and the severity. Is there potential that we wouldn’t identify the pathogen? If so, what would happen to the customer? You also rate how often it might happen with the test method. What’s the frequency of it? The last thing we rate is detection. With or without controls, how easy would it be for the personnel in the lab to identify or detect that this problem occurred?

We rate these three factors: severity, frequency and detection, and whether we detect [the pathogen] before it goes out to the retailer or consumer. Then we multiply the ratings and come up with a risk priority number (RPN).  We add all RPNs for each step and figure out risk, and the potential for error, for each test methodology.

 Image courtesy of Roka Bioscience

FST: How does using FMEA integrate into a HACCP strategy?

Harte: It could be integrated into the HACCP strategy. HACCP deals with identifying potential safety risks, and the key to identifying the risks and proactively trying to eliminating them. That’s what the FMEA is doing as well. I think the integration of FMEA could help identify the critical control points and where the failures will occur. That would be the most streamlined approach.

Harte’s Tips

•    Don’t fully trust the COA unless you understand what the result means.
•    Get involved with the labs that are providing the testing to ensure you have the most comprehensive information surrounding the COA.

Harte is presenting “Behind the Certificate of Analysis: Risk Assessment in Pathogen Testing Methods” at the Food Safety Summit on Thursday, April 30, 12:30-1:00 pm.

 

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Lessons Learned from the Implementation of Seafood HACCP for FSMA

By Tim Hansen
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While HACCP has been highly successful and truly promoted seafood safety and consumer confidence in these products, there are several useful lessons that may make your transition to FSMA compliance easier.

One of the tenets of FSMA is the requirement for preventive systems (AKA HACCP) for all food groups regulated by FDA. Up to the time of passage of FSMA, FDA wanted preventive systems only for seafood, fruit and vegetable juices and low-acid canned foods.

Since the requirement for preventive controls is about to be extended to all foods regulated by FDA, it may be instructive for affected food firms to consider some of the common problems experienced by the seafood industry during the implementation of HACCP. This regulation has been highly successful and truly promoted seafood safety and consumer confidence in these products. There are several useful lessons that may make your transition to compliance easier.

1. Unnecessary CCPs. Implementation of the Seafood HACCP regulation came with a great deal of uncertainty for the industry. Their response was to include a hazard as a CCP even when it did not meet the FDA “reasonably likely to occur” standard. This resulted in some cases overly complicated HACCP plans. Firms can avoid this problem through rigorous hazard analysis and following agency guidance for the commodity being processed.

2. Mixing sanitation controls with HACCP controls. The Seafood HACCP Regulation requires that certain aspects of sanitation be properly controlled, monitored and documented through records. While it is feasible to include these controls within the HACCP plan it is much simpler keep sanitation controls separate from HACCP controls. A sanitation SOP is highly recommended that show how sanitation is controlled, monitored and recorded.

3. Monitoring need to be available in their original form in an organized fashion. Inadequate or poorly organized monitoring records were a big problem. Ideally, records should not be rewritten unless absolutely necessary. Rewritten records are a red flag to FDA investigators. If records are missing do not falsify information to fill the gaps. This could be the basis for a severe regulatory action. It is much better to perform a verification review and corrective action that is available to the investigator.

4. If a new product is introduced to your processing operation the HACCP plan should be amended immediately. Do not wait until a convenient time as a regulator could show up at any time. Also, do not assume that the hazard analysis and HACCP plan for a similar product will be the same. Either can result in a finding of failure to have a HACCP plan. You should start at the beginning with a proper hazard analysis and develop the plan for that product in accordance with the hazards you identify.

5. Scientific studies used to establish a critical limit for a CCP should be readily available to the investigator. For example, a study to show the necessary heat penetration time-temperature parameters of a cooked product to achieve sufficient bacterial kill or the proper mix of salt, water and exposure time to achieve a proper level of water phase salts in a cold smoked fish products are important information for the investigator to evaluate whether the critical limit of a CCP is adequate to control the hazard.

6. Generic HACCP plans should not be used. In the past some operations adopted a generic HACCP plan to cover their processing without performing a hazard analysis. This often resulted in hazards being missed and a faulty plan. FDA expects that each firm will conduct a hazard analysis. Not doing so could result in a serious charge.

This article originally appeared in EAS-e-News, March 2015 edition. 

 

Top Reasons for Warning Letters

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Drug residues, inadequate food safety and HACCP programs for seafood, and nutrition content mislabeling were leading causes of FDA issuing recent warning letters.

The U.S. Food and Drug Administration (FDA) sent warnings to three beef producers, one pork producer, a seafood processor and a biscuit manufacturer in its latest round of warning letters.

Some of the beef producers and dairy farms received warning letters for drug residues found in their meat:

  • Oak Hill Farms of Seward, PA, received a warning letter for selling a bob veal calf in July 2014, testing of which revealed neomycin, a drug that has no acceptable tolerance level.
  • Schneider Dairy of Westphalia, MI, was found to have sold a dairy cow for slaughter in February 2014 that contained more than 10 times the tolerance level for for desfuroylceftiofur, marker residue for the drug ceftiofur. FDA also found that the dairy failed to maintain complete drug treatment records and lacked clear directions from its veterinary clinic on using the drug.
  • Stonegate Farms, sold a cow for slaughter in July 2014 that was found to have 13 times the tolerable level of penicillin in its kidneys and nearly 100 times the tolerable level of sulfadimethoxine in its liver. That dairy also failed to maintain complete treatment records of its cattle, according to FDA.
  • Poeppelman Pork of Yorkshire, OH, was also found to have sold an animal for slaughter with excessive levels of drugs in its tissues. In February 2014, the pork producer allegedly sold a pig for slaughter that was found to have penicillin in its kidneys. FDA’s letter noted there is no tolerance level of penicillin in swine.

Yamahide Shokuhin, a seafood processor and exporter in Miki-shi, Japan, was cited for having inadequate HACCP plans. The company was also found to have “significant deviations” from requirements, including a number of incomplete food safety plans for its dried shaved bonito product.

NP Foods Ltd., headquartered in Riga, Latvia, was cited for having several wafer and biscuit products that were mislabeled, all related to incomplete nutritional information. The company also failed to include the common or usual name of the foods on the labels in English.

In each letter, FDA requested that the companies provide written responses detailing steps taken to bring the facilities into compliance with food-safety laws and regulations, to correct violations cited in the letters, and to prevent their recurrence. The companies are given 15 working days from receipt to outline specific steps they have taken to come into compliance with the law.

Top 5 Reasons Organizations Fail Audits and How to Not Be One of Them

By Chelsey Davis
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When it comes to audits, there are plenty of reasons for failing, especially in the food and beverage industry. To help shed light on some of the reasons companies fail audits and to help prevent future failure, here’s our top 5 reasons to why organizations fail.

When it comes to audits, there are plenty of reasons for failing, especially in the food and beverage industry. Whether it’s an audit for GFSI, FDA or an audit required by any of your customers, the consequences of failing can be very costly. And while the whole team receives praise when an audit is successfully completed, there are a select few that bear the burden of audit failure (QA professionals). To help shed light on some of the reasons companies fail audits and to help prevent future failure, we’ve listed our top 5 reasons to why organizations fail.

1. Human Error

It doesn’t matter what industry you’re in, human error is bound to occur. The key here is to be able to minimize the chances of human error as much as possible. As a quality assurance manager, it’s important to make sure all employees are well-trained and fully understand the reasoning for performing certain functions of the job in a particular way. When employees understand the why regarding processes, it will be easier to remember going forward. Additionally, you should have systems and internal audits in place to ensure that what is supposed to happen is happening.

2. Compliance vs. Business as Usual

During audit time, there is often a conflict of interest when it comes to quality assurance managers and making sure the business is still operating as usual. As part of the process to prepping for an audit, management needs to ensure everything is up to standards, and this can possibly include stopping production lines, which interferes with the operation manger’s strict schedules. The important thing to convey here is the fact that compliance should come before anything else. The consequences of failing to meet compliance requirements will surely cost more than a delay in product delivery.

3. HACCP Failure

Hazard Analysis and Critical Control Points (HACCP) is a management system that helps prevent foodborne diseases and essentially operates to protect consumer safety. When it comes to audits, HACCP documentation is incredibly important, which is why it’s crucial to have it complete and comprehensive. Not doing so can be enough to cause your organization to fail. (Download this HACCP checklist as a guide to help you get started).

4. Lack of Supplier Control

All the guidelines and processes in the world you use to keep your organization compliant wouldn’t help much if your suppliers weren’t in sync. And with today’s global food supply chain, it is becoming increasingly difficult to manage risks of food fraud and contamination. One way to help tackle this issue is supplier scorecarding. Automated scorecarding helps both parties examine data and results based on the same information, fostering closer collaboration, information exchange, review of standard and best practices, as well as the occasional review of ingredient specifications, so that all stakeholders involved can work toward the same goals.

5. Lack of Documentation and Organization

“The best part about prepping for an audit is gathering all the required documents,” said no one ever. Not being organized can definitely hinder your chances of successfully completing an audit. And with multiple suppliers providing multiple different documents, staying organized can be a challenge. A filing cabinet just won’t cut it anymore. As a quality assurance manager, you were not hired to be a paper clerk, but agile document management is critical to the success of your business. This is where automation comes into the picture. Are you getting the data and information out of your documents that you need to improve your business? Can you satisfy an auditor with just a few mouse clicks? Automating this process not only helps your organization overall, but also helps you—the quality assurance hero—save time and energy.

Check out our chat with John Paul Williams, Director, Enterprise Solutions and Market Development, Americas, at Polycom, to learn more about why automation is so important for evolving businesses.

FSMA: What to Expect in 2015

By Aaron G. Biros
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Companies should start preparing for FSMA immediately, caution two food safety experts. Between the proposed and final rule, there is some concern for not knowing the future, but companies should conduct FSMA assessments and build a roadmap for compliance on track with FDA timelines. So are you prepared?

Two experts from The Acheson Group – Dr. David Acheson, and Melanie Neumann, in a recent FSMA Friday webinar, discussed what companies should expect from the FDA in 2015 and how they can adjust to comply with new rules as the final deadlines approach. FoodSafetyTech presents some excerpts:

With the FSMA comment deadline closed, what can we expect from FDA in terms of finalizing FSMA?

With the agency still answering questions and conducting FSMA related activities such as dealing with deadlines and proposals, we can expect to see the agency go silent on that. We have gone through multiple comment periods already so we should expect them to stick to their timeline of implementing rules.

What is FDA ultimately seeking to achieve with these rules?

When we look at where FDA is going in 2015, we need to look at what we should be doing in the private sector under FSMA’s prevention scheme. FDA is trying to require companies to think about preventative controls. It is about understanding where your risks are and using the appropriate controls. The main issue surfaces when regulators and suppliers have different senses of what appropriate controls really are. So, thinking about risk-based strategies, whether in the supply chain, internal systems, or whether you are a grower or importer, is going to be key in planning for the future.

When is it anticipated that the FSMA rules will be finalized?

Going from reactive to proactive and preventative strategies is the essence of FSMA’s effect on shifting the regulatory scheme. Therefore we should expect preventative control rules to come out first. We must put together a monitoring program and corrective actions in our food safety plan proactively. The FDA really wants to get these rules rolled out and enforced before the administration changes in 2016 with the next presidential election so we can safely assume they will try to stick to their published timelines (most proposed rules have a deadline in Fall 2015 with the latest in the spring of 2016).

What will some of the biggest challenges be for food and beverage companies as they begin to consider FSMA compliance?

The biggest challenges will deal with how to properly manage, store, and retrieve documentation. All the traceability data, information, and production and supplier documentation that is key in a recall should be readily presentable. Having all this data and documentation, being able to produce it quickly and turn it over to the on demand is the biggest hurdle. Companies need to leverage technology to manage this risk in documentation and data organization.

What should companies be doing now to begin to prepare for FSMA as we wait for the final rules?

Companies should start preparing for FSMA immediately. Between the proposed and final rule, there is some concern for not knowing the future, but companies should conduct FSMA assessments and build a roadmap for compliance on track with FDA timelines.

Supply chain risk control and environmental monitoring are new and challenging ventures. The behavior of FDA in the past few years have shown that any company that needs to comply with preventative control rules should really pay attention to their environmental monitoring program.

HAACP systems are likely to be fairly robust and will translate quickly, but environmental monitoring could be considered the Achilles’ heel. The other Achilles’ heel is the supply chain. This was in the original statute giving FDA the authority to require supply chain risk assessments and controls. This has resurfaced in the re-proposals, which is very reflective of the foreign supplier verification program. Look at what you know about your supply chain. The expectation will be that you control those risks.

The other challenge is FDA is expecting you to look more than one step upstream. If you are buying your ingredients from a distributor, it is your responsibility to institute preventative controls in environmental monitoring Companies need an organized central repository of all upstream, internal, and downstream documentation and data.

GFSI standards compare to the preventative control rules. The standards might be highly robust but that does not necessarily mean you comply with food defense and foreign supplier verification programs. Keep all that in mind when looking strategically toward 2016.

Summarized by Aaron Biros

Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

Top 10 Elements of a Successfully Certified GFSI Program

By Bill Bremer
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Bill Bremer is Principal, Food Safety Compliance at Kestrel Management LLC

GFSIstandardsDec2014The Global Food Safety Initiative (GFSI) relies on a number of benchmarked schemes to establish food safety requirements, all are designed to ensure the quality and safety of a company’s products.

In order to become certified to one of these GFSI-recognized schemes, a company must undergo a third-party audit by a certified auditor. Kestrel’s experience conducting these audits has revealed that companies who successfully achieve certification demonstrate a number of common attributes—regardless of their chosen scheme:

  1. Corrective and preventive actions are up-to-date and current.
  2. Continuous improvement/root cause analysis process is in place to make ongoing improvements and to ensure final resolutions to all out-of-control issues or non-conformances to the Food Safety Program.
  3. Premises, facility, and building programs are established and operating, including controls, signage, direction, job training, and physical evidence of a fully implemented Food Safety Program.
  4. Preventive maintenance system links scheduled maintenance to Hazard Analysis & Critical Control Points (HACCP) critical equipment monitoring requirements.
  5. Approved materials and process specifications are managed and controlled.
  6. Product identification and traceability processes are in place, including complete records detailing all activities for the production of food product.
  7. Document management and control program is updated, validated, and maintained. Developing program management systems helps ensure compliance with document management and control.
  8. Food safety program updates and management are completed through annual and multi-year planning for maintaining the Food Safety Program, including management of change, management review, approvals, and internal audit.
  9. Records and verification management systems provide access to supporting data, as determined by FDA/FSMA and company programs.
  10. Data management of food safety records outlines processes for assuring prompt or immediate access to critical records, as needed, for audit, compliance, or regulatory purposes.