Tag Archives: FSMA

How is HARPC Different From HACCP?

HACCP and HARPC share more than just four letters. They’re both food safety standards based on prevention, but they do differ on execution. Their differences and their similarities aren’t as important as the way they fit together for most food processors, though. A HARPC plan shouldn’t be considered as a replacement, but as a necessary upgrade to the conventional HACCP plan. Understanding how the systems fit together is the first step toward implementing both.

HACCP

HARPC

(1) Is the preventative approach based on a standard, guideline or a set of laws?
Based on a guideline recommended by CODEX and NACMCF Based on FSMA act and principally, the Final Rule for Preventive Controls for Human Food
(2) What food safety risks are considered using the preventative approach?
Conventional – Biological, Chemical, and Physical Beyond the conventional risks for actual and potential food safety hazards
(3) What is the goal of the preventative approach?
To prevent, eliminate (or) reduce hazards to a safe level (in that priority) Preventive controls that prevent or significantly minimize “known or reasonably foreseeable” risks
(4) Who is primarily responsible for the development and maintenance of the preventive plan?
Primarily, a competent HACCP coordinator with assistance from multidisciplinary team Trained Preventive Controls Qualified Individual (PCQI) as described in the FSMA Act
(5) At what frequency is the preventive plan being reviewed by the facility?
At least once a year, or when required At least once in 3 years, or when required
(6) The plan is mandatory for what type of establishments?
For FDA and USDA mandated establishments, or when required for certification purposes For all establishments along the food supply chain that serve U.S. consumers, unless exempted
(7) The plan is excluded or exempted for what type of establishments?
Unless mandated or required for certification, HACCP is voluntary, and GMPs are mandatory Exemption list is provided by FDA, but this does not exempt facilities from following at least CGMPs
(8) Who is the interested party here? For whom is the plan for?
Stakeholders: auditors, inspectors, and customers The FDA
(9) What is the documented approach for making the preventive plan?
12 Steps of HACCP (includes 7 Principles) 7 Steps of Developing a HARPC Plan

HARPC as an Upgrade to HACCP

HACCP, or Hazard Analysis Critical Control Points, is already widely used due to requirements from retailers, auditing standards, and inspectors, though the USDA and the FDA only mandate it for meat, seafood, and juice products. As a global standard conceptualized the 1960s, HACCP has been continually developed and updated. HACCP requires a multi-disciplinary team for implementation and follows prescriptive steps.

Continue reading How is HARPC Different From HACCP?

What you need to know about FSMA: Part 1

If you are in the food industry and have had your eyes and ears open, then most likely you have heard the word FSMA being thrown around… a lot. However, some people might find themselves unfamiliar with the term or have limited knowledge of it, so in this entry, we are going to cover some general information regarding FSMA and in upcoming blogs, we will go into further detail about each proposed rule issued by the FDA that supports this legislation.

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The people, pathogens, and food of today are not those of the past. Our population is living longer and with problems that make them more susceptible to foodborne illness complications. Pathogens are evolving and becoming more adaptable and harder to kill. Our food is traveling more than it ever has. For example, the FDA states that 15% of the food we eat is imported. A total 75% of our seafood, 20% of our vegetables, and 50% of our fruit is imported. However, one thing has not changed and that is the threat that foodborne illness presents to the food industry and its consumers. Continue reading What you need to know about FSMA: Part 1

The Birth of Food Safety, the FDA and CGMPs

Lately, we’ve been talking about Current food Good Manufacturing Practices—CGMPs for short—because they are the set of regulations that apply to just about every food processor not regulated by the USDA. CGMPs have also been getting quite a bit of press lately since we may see an update as a result of FSMA. We released an earlier blog article and a white paper on the topic for those who want to learn more.

But did you know that many of the regulations that guide the production of today’s food were largely spawned by the works of investigative journalists? These journalists were referred to as “muckrakers,” and they exposed government and business corruption.

food safety and 1900s meatpackingOne of the most well-known of these journalists was Upton Sinclair, who spent seven weeks working undercover in the Chicago meatpacking district on a research mission to expose the injustices and hazardous working conditions faced by meat industry workers. In Sinclair’s novel, The Jungle, his vivid descriptions of the unsanitary practices of the meatpacking industry captured the attention of the American public and President Theodore Roosevelt.

After reading The Jungle, Roosevelt sent a pair of advisors to assess the truthfulness of the novel’s depictions—and their report swayed the President to believe that Sinclair had provided an accurate representation. Shortly after Sinclair’s works became widespread, the Pure Food and Drugs Act and the Meat Inspection Act were passed in 1906. The passage of these regulations marked a turning point in federal food safety and was the beginning of what we know today as the FDA.

Although Sinclair had hoped that his accounts would improve working conditions for America’s poor laborers, he ended up making a huge and lasting impact on food safety. He was later quoted as saying, “I aimed for the public’s heart, and by accident hit it in the stomach.”

The early regulations were more specific about the standards for pharmaceuticals and accurate product labeling, and policies regarding food were much more ambiguous. Over the next 30 years, gaps in the protections provided to consumers by these regulations were exposed by a new generation of investigative journalists. In 1938, President Franklin D. Roosevelt signed the Food, Drug, and Cosmetic Act, received enthusiastically by an American public that had witnessed one too many food and drug safety disasters. This was the first law that mandated legally enforceable food standards, and CGMPs for food were officially established later on in 1969.

No one can deny that we have come a long, long way for food safety since the days written about by Upton Sinclair. But we may soon see another era of modernization of our food safety regulations. Do you think that the updates proposed by FSMA go far enough in preventing the production of unsafe foods? Are there holes in today’s laws you think should be considered? Tell us your thoughts.

Five Things You Maybe Didn’t Know About HACCP

If you work in food processing, chances are you’re probably familiar with the concept of a Hazard Analysis Critical Control Point or HACCP. Here’s a little about what we’ve learned about HACCP.

HACCP food safety sample verificationAs part of a HACCP Plan, a Hazard Analysis identifies “Critical Control Points” or CCPs — those points, steps or procedures in food manufacturing process at which control can be applied and as a result, a food safety hazard can be prevented, eliminated or reduced to an acceptable level. With CCPs identified, a HACCP Plan provides a series of procedures to control the process and sensitive points in the food chain, with the ultimate goal of producing foods that are safe for consumers’ health.

HACCP is a part of the Food Safety and Modernization Act (FSMA) proposed by the Federal Drug Administration (FDA) in 2011. While FSMA is fairly new, did you know the concept of HACCP has actually been around for some time? Here is the answer to that question along with some other interesting things about HACCP that many people may not be aware of.

1. HACCP is not a new system.

HACCP is a concept that’s been around since the 1960s. It was developed by the Pillsbury Company, the US Army Laboratories and NASA to help produce safe food for space missions. Today, HACCP is a recognized international standard for safe food production. It is endorsed by the Food and Agricultural Organization (FAO), the World Health Organization (WHO), and in the United States by the National Advisory Committee on Microbiological Criteria for Foods (NACMCF).

2. Not every hazard is a CCP.

As part of putting together a HACCP Plan, there’s a thought-process or Decision Matrix one can use to review each step in a food workflow process and determine the likelihood of hazards that could occur. Once a hazard is identified, then it is evaluated whether or not it is a CCP. Going through this evaluation, one will soon discover that not every hazard is a CCP. If a control measure is already in place to address the hazard, then chances are the hazard is not a CCP.

3. It takes a team to put together a HACCP Plan.

Through our experiences working with food processors, we’ve seen that some of the best HACCP Plans are the result of a team effort by the key individuals responsible for food safety within a food processing operation. The team may include managers from quality assurance, plant operations, engineering, maintenance, sanitation, and shipping & receiving. In addition, it’s often advised that someone who works on the line, such as a Line Supervisor and/or Machine Operator, provide input to the HACCP Plan to help assure alignment with day-to-day operations.

4. One person should be responsible for the HACCP Plan.

While it often takes a team to put together a well-structured HACCP Plan, we’ve also observed that maintaining the plan should ideally be the responsibility of just one person within a food processing organization. That person is usually the HACCP Coordinator. However, if there is no HACCP Coordinator, then the responsibility often falls to the Quality Manager, or even the company’s CEO.

5. Review the HACCP Plan regularly.

In a perfect world, anytime something changes within a food process, then the HACCP Coordinator should review the HACCP Plan and update it accordingly. At the very least, it’s suggested that a HACCP Plan be reviewed every 3 to 6 months.

How does your food processing facility deal with HACCP? If you have any additional tips or observations about putting together and maintaining a successful HACCP Plan, we’d love to hear them.