Tag Archives: HARPC

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.

FST Soapbox

HACCP, HARPC, and How Using Software Helps

By Steven Burton
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With nearly one in every six Americans falling prey to foodborne illnesses each year, food safety is a major public health issue. For several decades, current Good Manufacturing Practices (cGMPs) provided the basic food safety framework for manufacturers. However, these guidelines were not sufficient to cover all potential food safety hazards. In the 1960s, NASA asked Pillsbury to manufacture the first foods for space flights, and so the Hazard Analysis & Critical Control Point (HACCP) system was born. HACCP was later endorsed by the Codex Alimentarius Commission, which was formed by the Food and Agriculture Organization of the United Nations and the World Health Organization in 1963.

HACCP is a global standard and its principles are the defining elements of ISO 22000, BRC and SQF, all premiere global food safety standards. In 1996, an E. coli outbreak in Scotland claimed 10 lives. The Pennington report in the aftermath of this tragedy recommended use of HACCP by all food manufacturers to ensure food safety. While HACCP is mandatorily used for seafood, juice and USDA-regulated meat processing, it could not win universal acceptance across the food industry; most of the food industry sectors rely on cGMP for providing a food safety framework.

The number of people affected by foodborne illnesses can be attributed to a flawed food safety system. Thinking caps were put on and President Obama’s administration rigorously pursued what it hoped would be an effective food safety paradigm. On July 4, 2012 Hazard Analysis and Risk Based Prevention Control (HARPC) was introduced under FSMA section 103. Although the system is still a work in progress and FDA has yet not disclosed the regulations that will determine the functionality of HARPC, the agency is bound to issue the regulations by August 30, 2015. HARPC will become effective 60 days following this date, and companies will be required to enforce HARPC within a period of 12 to 36 months, depending on the size of a facility.

HARPC is designed along the lines of HACCP but is meant to be more comprehensive. For a “Simple Simon” it would be tough to differentiate between the two, but HARPC provides an all-encompassing food safety structure by focusing on preventive controls to make food safety more iron clad. With the exception of exempted facilities, HARPC will apply to all facilities subjected to FDA’s Bioterrorism Facility Establishment registration. All such facilities will be expected to enforce a functioning and adequate HARPC plan. Failure to do so and FDA would be authorized to take legal actions such as issuing a public warning letter or an import alert (in case of a foreign supplier), initiating criminal proceedings against a non-compliant facility, or suspending food facility registration of a facility until requirements are met. By doing so, FDA has put the onus squarely on the shoulders of respective facilities. Companies will be required to do a lot more and should expect deeper FDA involvement. Expert help to enforce a rather complex HARPC protocol seems unavoidable; there is a fair chance that users could find themselves lost in the translation and may end up facing FDA’s wrath if their plan is inadequate. Let me break it down a bit more and distinguish the main differences between HARPC and HACCP.

Qualified Food Safety Experience. HARPC requires one member of a company to be the qualified individual to complete an entire food safety plan. This means that said individual has undertaken education from a credible institution and gained experience by completing it. HACCP requires at least one person to be HACCP certified, but the plan must be constructed by a team of people.

Process Flow Diagram. Under the HACCP standard, food safety plans must include a clear flow diagram outlining the process, from start to finish, that the ingredients will take throughout your facility. HARPC has no regulations regarding this.

Hazard Variables. Traditionally, hazards were limited to biological, chemical and physical hazards under the HACCP paradigm. Yet, under HARPC, you must also outline Radiological and Terrorism hazards.

Controlling Hazards. Here is largely where the main difference lies: How to control a hazard. HACCP requires companies to mention their critical control points as well as outline a prerequisite program (PRP), although this has no set requirements. HARPC requires you to apply a sanitation preventive control to the hazards, which looks at monitoring, confirmation, corrective action, reviewing records and re-analyzing.

Reviewing the Plan. HACCP requires the individual in charge to review all HACCP documentation every year. This is in comparison to HARPC, which requires a facility to reanalyze its plan every three years.

Recall Plans. Recalls, as required under HARPC, are a special type of incident, with all of the attributes necessary to create and manage a recall plan. HACCP does not have such a requirement.

Use Software to Implement HARPC Plan

Using software can make life easier when it becomes time to implement a HARPC plan. Documentation is an important part of the HARPC system, and software can help generate most of the documents used to establish the plan. Such a system can link regulatory requirements with procedures and customize several aspects of the system during run time.

A risk analysis component of software helps a user identify the likelihood and severity of a particular hazard (a HARPC requirement). HARPC also requires sanitation control procedures at food surface contact points; software features can support cross contamination points to which hazards are assigned and controlled. Software also allows users to define equipment, with a facility to schedule and record calibration, maintenance, and verification activities, including management task assignment to satisfy HARPCs provisions regarding sanitation of utensils and equipment. In addition, it has the provision to document procedures as required by HARPC and can also flag employees for refresher training if they are involved in a violation.

Software also enables users to electronically record inspections, which satisfies the obligation under HARPC to carry out an environmental monitoring program (for pathogen controls). Interestingly, sensors could also be integrated with logging facilities to automatically collect sensor data, which could then be used to send out alerts if there is an abnormality. Software systems can also accommodate coverage of allergen hazards and run a food allergen control plan, including documentation of the process.

An incident management plan can assign and track corrective actions, root causes, employee retraining tasks, and preventive measures to individuals, and recall plans can be created and managed using the system. As many inspectors prefer remote review of documentation, software can provide such remote access, allowing inspectors to conduct off-site document reviews. This process can reduce on-site inspection times from five to three days. A list of approved suppliers can be maintained as well, and these suppliers can be linked to receiving functions, enabling users to receive and maintain a detailed and comprehensive record of ingredients.

HARPC is a reality that will have to be embraced very soon. Using software is a simple solution for the tough times that lay ahead for the food industry. It can serve as an all-encompassing and one-stop-shop for businesses that need help enforcing HARPC plans.

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.