Tag Archives: HARPC

USP Food Fraud Database

Why Include Food Fraud Records in Your Hazard Analysis?

By Karen Everstine
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USP Food Fraud Database

Food fraud is a recognized threat to the quality of food ingredients and finished food products. There are also instances where food fraud presents a safety risk to consumers, such as when perpetrators add hazardous substances to foods (e.g., melamine in milk, industrial dyes in spices, known allergens, etc.).

FSMA’s Preventive Controls Rules require food manufacturers to identify and evaluate all “known or reasonably foreseeable hazards” related to foods produced at their facilities to determine if any hazards require a preventive control. The rules apply both to adulterants that are unintentionally occurring and those that may be intentionally added for economically motivated or fraudulent purposes. The FDA HARPC Draft Guidance for Industry includes, in Appendix 1, tables of “Potential Hazards for Foods and Processes.” As noted during the recent GMA Science Forum, FDA investigators conducting Preventive Controls inspections are using Appendix 1 “extensively.”

The tables in Appendix 1 include 17 food categories and are presented in three series:

  • Information that you should consider for potential food-related biological hazards
  • Information that you should consider for potential food-related chemical hazards
  • Information that you should consider for potential process-related hazards

According to the FDA draft guidance, chemical hazards can include undeclared allergens, drug residues, heavy metals, industrial chemicals, mycotoxins/natural toxins, pesticides, unapproved colors and additives, and radiological hazards.

USP develops tools and resources that help ensure the quality and authenticity of food ingredients and, by extension, manufactured food products. More importantly, however, these same resources can help ensure the safety of food products by reducing the risk of fraudulent adulteration with hazardous substances.

Incidents for dairy ingredients, food fraud
Geographic Distribution of Incidents for Dairy Ingredients. Graphic courtesy of USP.

Data from food fraud records from sources such as USP’s Food Fraud Database (USP FFD) contain important information related to potential chemical hazards and should be incorporated into manufacturers’ hazard analyses. USP FFD currently has data directly related to the identification of six of the chemical hazards identified by FDA: Undeclared allergens, drug residues, heavy metals, industrial chemicals, pesticides, and unapproved colors and additives. The following are some examples of information found in food fraud records for these chemical hazards.

Undeclared allergens: In addition to the widely publicized incident of peanuts in cumin, peanut products can be fraudulently added to a variety of food ingredients, including ground hazelnuts, olive oils, ground almonds, and milk powder. There have also been reports of the presence of cow’s milk protein in coconut-based beverages.

Drug residues: Seafood and honey have repeatedly been fraudulently adulterated with antibiotics that are not permitted for use in foods. Recently, beef pet food adulterated with pentobarbital was recalled in the United States.

Heavy metals: Lead, often in the form of lead chromate or lead oxide which add color to spices, is a persistent problem in the industry, particularly with turmeric.

Industrial Chemicals: Industrial dyes have been associated with a variety of food products, including palm oil, chili powder, curry sauce, and soft drinks. Melamine was added to both milk and wheat gluten to fraudulently increase the apparent protein content and industrial grade soybean oil sold as food-grade oil caused the deaths of thousands of turkeys.

Pesticides: Fraud in organic labeling has been in the news recently. Also concerning is the detection of illegal pesticides in foods such as oregano due to fraudulent substitution with myrtle or olive leaves.

Unapproved colors/additives: Examples include undeclared sulfites in unrefined cane sugar and ginger, food dyes in wine, and tartrazine (Yellow No. 5) in tea powder.

Adulteration, chili powder, skim milk powder, olive oil
Time Series Plot of Records for Chili Powder (blue), Skim Milk Powder (green), and Olive Oil (orange)

Continue to page 2 below.

ImEpik

ImEpik Launches Food Safety Training

ImEpik

ImEpik is launching an online training course HARPC for the Qualified Individual, and a second option through AIB International as a reseller, HARPC Online for Your Preventive Controls Support Team. The courses delve into the challenges faced by food facilities that must record and verify food safety training in their food safety plans.

“The direct connection between ImEpik’s state-of-the-art interactive learning program and AIB’s proven training and auditing success allows food companies to more efficiently train their personnel, fix gaps and document the content of HARPC training,” said Company CEO Tim Wilson in a press release. “The impact of this partnership on food safety education will be profound.”

According to ImEpik, online HARPC training for food processing employees in the food manufacturing industry was nonexistent. As a result, the company created the first interactive assessment-based training that is accessible via desktop, laptop or tablet.  The courses already underwent pilot testing in United States and globally. The course features include animation, self-paced modular content, online supplementary manual, performance assessment for certificate of completion and learning analytics. It can also be integrated into a Learning Management System.

Course enrollment is open for HARPC Online for Your Preventive Controls Support Team through AIB’s website.

Zia Siddiqi, Orkin
Bug Bytes

From HACCP to HARPC, and Integrating Pest Management

By Zia Siddiqi, Ph.D.
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Zia Siddiqi, Orkin

September 19, 2016 is a date that many of you probably had circled on your calendars. It marked the first date in which many food processing companies had to be in compliance with the FSMA preventive controls final rule.

It’s okay if you’re still revising your food safety plan. The regulations are so sweeping that some companies are still struggling to figure out if their plans are in compliance. At the heart of this law is a change in the philosophy of how we deal with contamination. Now, the focus is on preventing contamination rather than responding to it after it occurs.

This proactive approach to safety must be kept in mind when discussing how food safety plan requirements have changed. For many food manufacturing facilities, it means a change from HACCP to HARPC.

Hazard Analysis and Critical Control Points, or HACCP, should be more familiar to you. First developed in the late 1950s and early 1960s to provide safe food for astronauts in the U.S. space program, HACCP became the global standard for food safety in the 1980s, as large, multinational companies sought to ensure that their supply chains were safe.

HACCP evolved over the years into an effective, efficient and comprehensive food safety management approach. The system addresses food safety through the analysis and control of biological, chemical and physical hazards from raw material production, procurement and handling, to manufacturing, distribution and consumption of the finished product.

The seven principles of HACCP include:

  1. Conduct a hazard analysis
  2. Identify critical control points
  3. Set critical limits
  4. Establish monitoring actions
  5. Determine corrective actions
  6. Develop verification procedures
  7. Institute a record-keeping system

How are HACCP and HARPC different?

Following the passage of FSMA, the FDA instituted a new set of food safety standards, known as Hazard Analysis and Risk Based Preventive Controls (HARPC).

HARPC shouldn’t be seen as a replacement of HACCP standards. Rather, it’s an evolution of them. The following are some key changes.

You Must Anticipate Potential Hazards. One of the big changes in moving to HARPC standards is that your food safety plan must identify any and all reasonably foreseeable food safety hazards and include risk-based preventive controls for them. This moves beyond HACCP’s critical control points and asks that food processors look at how to minimize risk from the second food enters their facility to the second it ships out.

This includes naturally occurring hazards as well as hazards that can be intentionally or unintentionally introduced to the facility. The potential hazards that have expanded under HARPC include:

  • Biological, chemical, physical and radiological hazards
  • Natural toxins, pesticides, drug residues, decomposition, parasites, allergens and unapproved food and color additives
  • Naturally occurring hazards or unintentionally introduced hazards
  • Intentionally introduced hazards (including acts of terrorism)

You should review the potential hazards—both seen and unseen—that could impact your facility to determine the risks that you should analyze for your plan.

HARPC Applies to Almost All Food Processing Facilities. The HACCP standards generally did not apply to all food processors. HARPC, however, covers many more U.S. processors. There are six major exceptions, however.

  • Food companies under the exclusive jurisdiction of the USDA
  • Companies subject to the FDA’s new Standards for Produce Safety authorities
  • Facilities that are subject to and comply with FDA’s seafood and juice HACCP regulations
  • Low-acid and acidified canned food processors
  • Companies defined as “small” or “very small” businesses
  • Companies with a previous three-year average product value of less than $500,000

Do these changes mean that your existing food safety plan needs to be scrapped? Not at all. An existing HACCP plan can be modified with the help of a Preventive Control Qualified Individual (another new requirement) to comply with HARPC guidelines. This person needs to be intimately familiar with potential hazards and the risk-based preventive controls for them.

This may sound daunting at first, but moving to HARPC from HACCP will be an easier shift than starting from scratch. The key adjustments that you would need to focus on include identifying risk-based preventive controls for the hazards previously mentioned. Just remember, these hazards should be expanded to include both naturally occurring and unintentionally introduced hazards.

How Does Integrated Pest Management Fit into a Food Safety Plan?

Much like HARPC, Integrated Pest Management (IPM) focuses on being proactive. It emphasizes prevention, focusing on facility maintenance and sanitation, before considering chemical options for pest management.

An IPM plan is benchmarked with regular monitoring and analysis of effectiveness. This may seem cumbersome, but one shouldn’t overlook the value of documentation as a management tool. Collecting data and putting it in context with detailed analysis can be an effective way to prioritize your pest control efforts.

Detailed analysis accounts for things such as normal seasonal cycles, deficiencies in maintenance, exclusion, sanitation and harborages, just to name a few. This analysis can also help improve pest control efforts by prioritizing areas needing attention, especially when your staff is limited by time or resources.

Integrating IPM into your HARPC plan should include analyzing the risks of what could encourage pests to enter your facility, such as doors left open or incoming product shipments. Consider your pest control provider an expert source in how to assess all risks associated with pests and how to establish preventive controls for them.

Despite preventative efforts, unexpected pests will be inevitable. More emphasis will be placed on establishing action thresholds for different pests. This can be a problematic topic, because there are not scientific or broadly accepted threshold values for food processing pests.

Every facility, and often zones within facilities, will likely be different. Identify logical zones—ingredients, processing, packaging and warehousing—and sensible threshold values for each key pest in these zones. Furthermore, establish what the appropriate response should be at certain thresholds. The escalating responses to different levels of pest activity often include things such as automatic authority for certain limited types of pesticide application, more intensive monitoring and inspection, and, of course, higher management notifications, which might lead to more extensive measures.

IPM plans should be reviewed on an annual basis to ensure your program remains as effective as possible. Written food safety plans that follow the HARPC approach and comply with the FSMA rule should be reanalyzed whenever there is a significant change at the facility that might increase a known hazard or introduce a new one. Review the plan at least every three years, if no significant changes occur.

Even if your facility’s deadline for compliance with HARPC standards is a year or two away, now is the time to take a look at your plan and make sure you’re in compliance.

Rachel Montgomery

Keep Calm and Be Sure You Have a PCQI—Soon!

By Rachel Montgomery
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Rachel Montgomery

You will hear some new abbreviations being tossed around in questions by executives in food manufacturing and processing these days. “Do I need a PCQI? Who is my PCQI? What is a PCQI?”

Strangely, many of these executives do need a PCQI, and they need one very soon. A PCQI is the “Preventive Controls Qualified Individual” needed to oversee implementation of the HARPC rule under FSMA. Last September FDA published the final rule “Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food.” Unless a food manufacturer is specifically exempt, the date for compliance with implementation of the rule’s preventive controls portion is September 19, 2016. A facility’s PCQI is responsible for overseeing the implementation process. For companies that have yet to prepare for compliance, the good news is that several organizations, such as the Food Safety Preventive Controls Alliance, offer training to meet the requirement for having a PCQI.

For large companies (those with more than 500 employees), time is of the essence to meet the September 19 compliance date; for companies with less than 500 full-time-equivalent employees, you have more time to prepare, with September 18, 2017 being the compliance date.

Whether your due date is this year or 2017, your food safety plan is the primary document that guides your preventive controls food safety system. It must be developed using a systematic and risk-based approach that uses scientific principles to identify the hazards that require preventive controls to prevent foodborne illness or injury. It is most effectively prepared not only by a single PCQI but also a cross-functional food safety team that includes individuals with executive support and leadership. In addition to including the hazard analysis in which you must analyze for hazards requiring a preventive control for your product(s), your food safety plan must have preventive controls for your process and for food allergens, sanitation, supply chain and any other appropriate areas where you identified that preventive controls were needed.

Further, your food safety plan must include a recall plan, procedures for monitoring, corrective action and verification when a hazard requiring a preventive control is identified, along with science-based validation for process preventive controls. Of course, Good Manufacturing Practices (GMPs) and other prerequisite programs must be in place to provide a solid foundation for your food safety plan. And there’s more news: FSMA includes significant changes in the GMPs. For example, all formerly non-binding provisions are now binding, including education and training. One of the new GMP requirements is cleaning of non-food contact surfaces “as frequently as necessary” to protect against allergen cross-contact and contamination of food contact surfaces and food packaging.

Back to the possibility that you may qualify for a specific exemption, if you heard that processors subject to the low-acid and acidified canned foods regulation are not subject to the preventive controls rule, the exemption is only for hazards that are microbiological. For physical and chemical hazards, including allergens, a hazard analysis must be conducted to determine whether hazards are an issue and whether preventive controls are needed. This analysis must be documented, even if you determine that no preventive controls are needed. And if preventive controls are needed, they must be developed and documented with verification and possibly validation as previously described. Of course the new GMPs also apply to low-acid and acidified canned food manufacturers.

If you heard that warehouses are in the clear due to a specific exemption, there is more to the story. Only facilities such as warehouses that store strictly unexposed packaged materials for which refrigeration is not required are exempt from preventive controls. Facilities that store raw agricultural commodities that are fruits and vegetables are not exempt from hazardous analysis and risk-based preventive controls. All of these facilities, and even those subject to seafood and juice HACCP and not required to do preventive controls, are not exempt from updated GMP requirements.

Take the obvious first or next step for your organization’s compliance with FSMA: Ensure you have a PCQI and start working on your hazard analysis and food safety plan now.

Kassy Marsh, Techni-K
FST Soapbox

The Solution to Combining a HACCP & HARPC Plan

By Kassy Marsh
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Kassy Marsh, Techni-K

Since the publication of the FSMA Preventive Controls Rule for Human Food, the term HARPC has become a common way of describing the type of food safety plan that is needed to comply with the requirements. On first glance its similarities to HACCP could possibly lead one to believe that the requirements for both systems are aligned. But beware, there are a number of fundamental differences and one main contradiction in the requirements, which requires a clarity of understanding when trying to amalgamate the two systems.

With the introduction of the FSMA Preventive Controls Rule, food facilities that have HACCP systems are now faced with the difficult task of trying to adapt their current food safety system to meet the HARPC requirements. These facilities will continue to be required by local law in the countries where they export to, by their customers and by standards such as those recognized by the GFSI to adhere to the HACCP principles. A straight swap from HACCP to HARPC is not going to be an option for many businesses. Therefore, a combined approach is required, one that meets both sets of requirements and has a clear, practical and effective methodology.

Structure of the Controls

One of the consequences of combining the requirements of HACCP and HARPC is that all of the control principles need to come together and work as one. For this reason, the distinctions between pre-requisite controls (PRCs), preventive controls (PCs) and critical control points (CCPs) must be fully understood.

  • Pre-requisite control: A facility-wide generic control, not specific to one particular process step
  • Preventive control: A control that prevents or significantly minimizes the hazard
  • Critical control point: A control that eliminates or reduces the hazard to an acceptable level

There is a hierarchy to the controls, with PRCs being the building blocks for facility-wide general controls; PCs are more specific controls that are typically associated with a particular step in the process; a CCP is one that is above and beyond a PC and is critical to the safety of the food (see Figure 1).

Figure 1.
Figure 1.

A PC is one that either prevents the hazard from occurring in the first place, or if the hazard has occurred, it recognizes it and minimizes the impact of the hazard by controlling it and not allowing it to be released as product.

A CCP controls a hazard that is inherently expected in the product by eliminating it or reducing it to a level at which it is safe.

Key Challenges

There are a number of differences between the requirements of HACCP and HARPC. The PC Rule is not as specific or detailed in the way in which the plan should be documented or designed, as the principles laid out in the National Advisory Committee on Microbiological Criteria for Foods (NACMCF) or Codex Alimentarius. However, the FDA may not have directly stated that certain elements such as product description, intended use or intended user must be included, but they do elude to the fact, as the hazards that must be assessed would require this information to be understood and fed into the system. This means that in order to comply with both systems, the principles of HACCP must be adhered to as well as those of HARPC, so elements such as process flow diagram will still be required.

The key difference between the systems related to how significance is determined within the risk assessment. Both systems require a risk assessment that takes into account the severity of the hazard and the likelihood of the hazard occurring. The results of this should determine if the hazard is a significant food safety risk, where it is, and whether a PC is required. Hazards that are not significant would need to be managed through the application of PRCs.

The difficulty enters the picture when assessing the likelihood of the hazard occurring, as the two sets of requirements contradict each other:

The PC Rule asks for the likelihood to be determined in the absence of any controls.

HACCP principle states that the likelihood should be determined, taking the controls into account.

It is acceptable to HACCP principles to follow the requirement for HARPC and carry out the assessment in the absence of any controls, however there are consequences in doing so. The number of significant hazards that will be produced will be substantially higher than in a traditional HACCP plan. Each of these hazards will need to be controlled through a PC, and the CCPs will need to be determined from this set of PCs. Using the typical CCP decision tree is not a practical solution, as the result will likely mean that most of the PCs become CCPs. Nobody wants to go back to the days when facilities had many, many CCPs, as this produces an unmanageable and ineffective food safety system.

A new methodology is required for the determination of CCPs—one that is clear and does not contradict the HACCP principles.

The Benefits of HARPC

Although the introduction of HARPC makes designing and developing a food safety plan more complicated, it does have its benefits. Over time, as pre-requisite programs have developed, the number of hazards that are managed by PRCs have grown—to the point now where most facilities only have a handful, if not one or two, CCPs.

Through a HACCP plan, even very significant food safety hazards can be managed by the PRCs. These significant hazards are therefore managed, just the same as insignificant or low-risk hazards. This may be the reason that the most common recalls and withdrawals today are due to lack of control from pre-requisites.

By introducing the new tier of PCs and assessing significance without taking any controls into account, we mitigate this problem. Ensuring that the key food safety hazards, which perhaps are not critical, are managed through the application of PCs and they thus receive additional focus.

Resources

  1. “Comparing the Standards for HARPC”. Techni-k. Retrieved from http://www.techni-k.co.uk/comparing_the_standards_for_HARPC.
  2. Marsh, K. (2016). Combine Your HACCP & HARPC Plan.
Jill Bender, SafetyChain

GFSI in the Age of FSMA Series Helps Companies Prepare for FSMA Compliance

By Jill Bender
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Jill Bender, SafetyChain

The “GFSI in the Age of FSMA” three-part series wrapped up in early December, providing the food safety community insight on how leading GFSI schemes align with, and help prepare for, compliance with FSMA.  The series was presented by SafetyChain with media partner FoodSafetyTech.

Each GFSI scheme leader from SQF, BRC and FSSC 22000 discussed how their schemes align with FSMA in several key areas, including Supply Chain Controls, migrating Food Safety Plans from HACCP to HARPC, and audit readiness. While each scheme leader provided insights and details on how their scheme aligns with FSMA, common key themes across all three sessions included: 

  • FSMA’s focus on prevention vs. reaction is similar and aligns with GFSI’s objectives; Scheme certifications and ongoing compliance is centered around continuously assessing risks and putting preventive measures in place to mitigate those risks
  • GFSI’s global approach surrounding a company’s food safety program—to ensure better supply chain controls internally, upstream and downstream prepares companies to manage FSMA’s increased focus on both domestic and foreign supplier compliance
  • GFSI stringent documentation and recordkeeping requirements—along with unannounced audit protocols—are a strong foundation to help food and beverage companies prepare for FSMA’s “if it isn’t documented you didn’t do it” mantra

The GFSI scheme leaders also spoke about the importance and opportunity companies have to leverage technology tools to help more effectively manage the complexities and requirements of GFSI and FSMA compliance.  Series participants were able to see an example of how these automation tools work and the impact they can have on managing a robust food safety program via a post session demo of SafetyChain Software.

Archived recordings of all three sessions—SQF in the Age of FSMA, featuring Robert Garfield, Senior VP, SQF; BRC in the Age of FSMA, featuring John Kukoly, Director, BRC Americas; and FSSC 22000 in the Age of FSMA, featuring Jacqueline Southee, U.S. Liaison, FSSC 22000—are available and can be accessed here.

Barbara Levin, SVP of Marketing & Customer Community, SafetyChain Software

SafetyChain Software Wraps 2015 Food Safety & Quality Enabling Technologies Series with More Than 2,000 Participants

By Barbara Levin
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Barbara Levin, SVP of Marketing & Customer Community, SafetyChain Software

SafetyChain Software recently announced the successful wrap-up of its online series, “FSQA Enabling Technologies – the Food Safety & Quality Assurance Game Changer.” Kicked off in January of 2015 and ending this past October, the series attracted more than 2,000 participants.

Known for offering a wide variety of complimentary online FSQA thought leadership events to the food industry – including its FSMA Fridays and GFSI in the Age of FSMA series – SafetyChain introduced the Enabling Technologies series to begin an important dialogue on the role of emerging technologies in managing key challenges faced by today’s food and beverage companies.

The complimentary series, which featured Leadership Forums, Tech Talks and eBriefs – many featuring recognized industry thought leaders as well as SafetyChain experts – is now available on-demand.

  • Series topics included:
  • Leveraging Technology for Best-in-Class Food Safety & Quality Operations
  • Tackling FSMA Compliance
  • Understanding and Managing Cost of Quality
  • Unleashing the Power of the Cloud on Food Safety & Quality
  • Conquering HACCP, HARPC and Food Safety Program Management
  • Tackling Food Safety Audits
  • The Critical Role of Technology on Today’s Food Safety and Quality Operations
  • FSQA on the Go – the Power of Food Safety & Quality Automation Mobile Applications

Dr. David Acheson, president of The Acheson Group and former Chief Medical Officer for USDA and Associate Commissioner for Foods at FDA – who kicked off the series with a leadership forum on Food Safety Risk Management and Supply Chain Controls, which also featured Nancy Wilson, Director of Quality Assurance, Risk and Safety for Wawa – commented, “With today’s global, complex food supply chain – and increasing regulatory requirements such as FDA’s FSMA – it is becoming increasingly difficult to manage risk while meeting operational KPIs using manual FSQA management systems.” Acheson continued, “There’s an important role for enabling technologies to increase operational efficiencies while sending safer food into commerce, and this was an important series to bring the food safety community into the discussion.”

Added Jill Bender, Vice President of Marketing Communications for SafetyChain, “SafetyChain is a recognized leader in offering online forums that provide insights, and facilitate discussions, on how the industry addresses challenges in sending safe, quality food into commerce – with more than 20,000 registrants for our events.  Deploying enabling automation technologies has become a vital strategy for improving FSQA, creating ROI and protecting brand from risk – and we wanted to promote meaningful dialogue on the impact of technology on key food safety and quality issues. We’re delighted that more than 2,000 safety, quality and operations professionals joined the conversation.”

Series Now Available On-Demand

To access the series’ complimentary Leadership Forums, Tech Talks and eBriefs, visit: www.safetychain.com/2015techseries

FST Soapbox

Risk in Our Supply Chain: Where Do We Start?

By Traci Slowinski
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FSMA has arrived with the launch of the first two preventive control rules – Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Human and Animal Food (or cGMP and HARPC, for short). With these new FSMA rules, the food and beverage industry will now be held accountable for being more proactive versus reactive, and will be responsible for identifying and managing risk throughout their supply chain. Of course, this emphasis on risk can also be seen in other sectors of the industry (i.e., GFSI and ISO), and risk has become the focal point for a number of compliance initiatives.

Supply chain challenges in food safety
Supply chain challenges in food safety (Click to enlarge)

These days a number of supply chain challenges are driving risk. Continued global expansion of the industry is resulting in more import and export activities. We are seeing consumer food trends shift toward riskier food/preparation options. Regulatory agencies continue to work on improving their food safety requirements. And the growing population is putting more demands on our current resources. All of these factors equates to great risk within all stages of the supply chain.

Therefore, it will be important that you understand what risk management entails and have the right tools to identify, assess and control the risks that you find throughout your supply chain.

So where do we start looking for risk? Here are a few examples of where your risk assessments should be performed:

External Partners. You need to build strategic relationships with your external partners (suppliers, contract manufacturers/co-packers, service providers, carriers, etc.) across the supply chain. Building trust through good communication and collaboration is essential to ensure that you can rely on your partners to do the right thing for both parties.

RiskAssessmentSupplyChainRaw Materials. Many hazards can be introduced into a facility through raw materials—whether we are talking about raw ingredients, packaging materials, chemicals, or other components used to produce your product. Some hazards to assess include pathogens, allergens, chemical residues, pests and foreign material.

Storage and Handling. When looking at risk during storage and handling, it is important to address several hazards including allergen control, temperature control, foreign material control, proper segregation and product flow.

Processing. A number of areas in processing can introduce hazards and therefore should be included in your risk assessment. These include improper sanitation, cross contamination/contact potential, foreign material contamination, critical control point deviations, pre-requisite program failures and mislabeling.

Shipping and Transport. Lastly, you must safeguard your shipping and transportation procedures in order to account for any potential risk once the product has left your facility. Areas to consider during your risk assessment include temperature control, condition and sanitation of truck and storage units, loading/unloading practices, security/tampering potential, accident/emergency recovery, and traceability.

For more information on risk management within the food and beverage supply chain, register to attend the free webinar “Supply Chain Management: Does What I Eat Put Me at Risk” on October 28, 2015. Speakers will discuss risk throughout the supply chain, focusing on supplier management and some of the new FSMA requirements. They will provide an overview of risk management and some of the tools that can be used to identify and assess risk. In addition, they will discuss how technology can help companies meet FSMA requirements.
Mobile FSQA apps

Are Mobile Apps a Game Changer for Food Safety Professionals?

By Maria Fontanazza
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Mobile FSQA apps

Many food safety and quality assurance (FSQA) professionals are constantly on the go in the workplace. They can be found on the floor of a manufacturing facility, off-site conducting supplier audits, or out in the field performing pre-harvest inspections, just to name a few locations during their busy day. “To benefit from food safety automation, these folks need more than the capability of logging into a system through a desktop,” says Levin. “They need a true mobile app that provides automation support out in the field,” says Barbara Levin, senior vice president of marketing and customer community at SafetyChain.

While other industries have been quick to adopt mobile platforms, the food safety industry has been much slower. Adoption is, however, gaining traction. In a recent conversation with Food Safety Tech, Levin talks about the value of FSQA mobile apps in today’s environment, where access to real-time, actionable data is crucial for the food industry.

Food Safety Tech: What common challenges faced by FSQA teams do mobile apps specifically address?

Barbara Levin: Mobile apps allow collection of FSQA at the point of origin, along with immediate access to the information for analysis, CAPA and reporting:

  1. Getting timely feedback on non-compliances for CAPA. When FSQA data is inspected at the end of the shift on paper, finding non-conformances often means rework. The instances in which this happens are too numerous to count. With mobile apps, you receive timely feedback. Information in the system is immediately analyzed to specs, so you’re catching non-compliances at the earliest point possible.
  2. Consistency in following your FSQA programs. This could be your USDA HACCP plan, FSMA HARPC plan, GFSI program, customer quality attributes and other components of your FSQA programs. Program components change all the time (i.e., Specifications, processes, rules in HACCP, GFSI code, forms, workflow, etc). Are FSQA managers confident that everyone is following the most up-to-date program? Is everyone following the workflow and doing everything in the right order? Are they completing tasks accurately? Using the right forms? Unfortunately companies find out that steps are missed or outdated forms were used during an audit; or when missed steps result in expensive rework or in the worst case, a customer rejection, withdrawal or a recall.

    Mobile apps will always have the most up-to-date forms, processes, specs and more. They act as a coach, leading the FSQA team member through the proper steps. When you enter incorrect or incomplete information on paper, it may not be detected until the end of the day or shift. A mobile app will issue an alert if incorrect information is entered; and it won’t let you submit a form if all fields aren’t complete. Because all of the updates are made in the system and pushed out to the app, if the specification changes while an FSQA team member is on the plant floor, when he or she logs in, the latest spec will always be there. You’re ensured that only the up-to-date program is being followed and that only the most up-to-date forms are being used.

  3. A lack of information for continuous improvement trending. If you have multiple facilities and products (resulting in mountains of FSQA paper), it’s a huge, manual task to make all of the data useful and relevant. With mobile apps, all FSQA data is entered “once and done,” making it accessible and actionable for immediate FSQA result tracking, daily KPI reporting and continuous improvement.
  4. Audit readiness. Mobile apps take audit readiness to a different level. With FSMA and GFSI, the saying is, if it’s not documented, you didn’t do it. By collecting FSQA data at the point of origin, all data is time and data stamped and uploaded to your permanent FSQA record. There’s no redundant data entry, mistakes are avoided, and there’s greater record efficacy that helps companies be audit ready, on demand.
Mobile FSQA apps
Mobile forms capture safety and quality data at the point of origin; data is actionable and then uploaded into a central repository for reporting and audit readiness. Image courtesy of SafetyChain Software. (Click to enlarge)

FST: What is the biggest benefit that FSQA mobile apps offer? 

Levin: The first benefit is real-time feedback. If you think about how things were done in the past, using an example of a pre-harvest inspection, you’re out there with a clipboard, making observations and recording non-compliances. Then you have to go back and enter the information into a spreadsheet, or turn it into a PDF, and send it to the food safety manager, who may or may not be sitting at his or her desk. Waiting to get a response equals time lost. And in the food industry, time equals money.

When you’re entering information into a mobile app, it analyzes that information in real-time and according to specifications. When there are non-compliances, alerts are pushed to the FSQA manager – wherever [he or she is located]. The manager can then generate a CAPA, which can then be completed, documented on the mobile device and electronically signed off by the manager. The process is expedited, and expensive rework is avoided.  

The second benefit involves data efficiencies. When data is collected on a mobile device, it’s entered only once and is then immediately available for multiple uses, such as a customer’s certificate of analysis, attachment to GFSI code for audit, or to be produced upon demand for a regulatory inspector. With a manual system, there’s a tremendous amount of redundant data entry. We hear this all the time from food safety folks— that they feel like they’re managing paper instead of food safety programs. When data is entered into a mobile app, it’s accessible immediately to FSQA, operations, vendor purchasing, management – any stakeholder who has a need.

“The Power of FSQA Automation Via Mobile Applications” Download the whitepaperFST: What approach should be taken to encourage the investment in and implementation of an on-the-go FSQA mobile platform?

Levin: I would love to think that in an ideal world, the creation of operational efficiencies that enable a higher level of confidence that you are sending out safer food is enough. Food companies are businesses, and they have obligations to consumers, which they take very seriously. But they also have obligations to their shareholders. When we talk to folks who really want this, it’s very easy to create a business case to senior management based on ROI. When you can close the gap by hours and days in the food industry, that time equals money. Avoiding rework also saves money.  And there’s ROI in faster sales throughput and increased shelf life by reducing hold and release times. We’ve heard from our customers that the solutions have paid for themselves and started to create ROI within three to six months.

How GFSI Schemes Align With FSMA Compliance

By Food Safety Tech Staff
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With publication of the first set of final rules for FDA’s Food Safety Modernization Act (FSMA) expected any day now, food safety teams are busy strategizing as to how they are going to prepare for compliance and be “FSMA-ready” on Day 1.

Across industry, it is generally agreed that being certified to a GFSI scheme is a solid foundation for FSMA compliance. In a new three-part online series,  “GFSI in the Age of FSMA: How GFSI Schemes Align With and Prepare You for FSMA”, the North American leaders of the three major GFSI schemes – SQF, BRC and FSSC 22000 – will discuss the following topics:

  • How certification to their scheme prepares a company for FSMA compliance in terms of alignment with:
    • Supplier Controls
    • Building a food safety plan
    • Migrating from HACCP to HARPC
    • Being audit ready all the time
    • Environmental monitoring … human & animal food rules … and much more
  • What changes to the scheme have been made (or are planned) to better align with FSMA
  • Gaps the leaders see in FSMA that are filled by their scheme
  • What companies who are, or plan to be, GFSI certified should be doing now for Day 1 FSMA compliance

The series, which launches September 25 is complimentary. Learn more and register at: http://www.safetychain.com/GFSI-Webinar-Series

SafetyChain webinar series
(left to right) John Kukoly of BRC, Jacqueline Southee of FSSC 22000, and Robert Garfield of SQFI are the featured speakers of the GFSI series.

Food company teams working in Regulatory, Food Safety & Quality Assurance, Operations, C-Suite, Legal and other related positions in companies who are – or are planning to become – certified in a GFSI scheme are encouraged to attend one, two or all three sessions.

The series is being sponsored by SafetyChain Software with media partner Food Safety Tech.