Carrie O’Halloran, QA Supervisor
The acronym HACCP (pronounced Hassip) stands for Hazard Analysis Critical Control Point. It is a risk identification and control methodology or plan widely used in the food industry since the mid 90’s in a voluntary and non-voluntary fashion. The basic premise is that the food manufacturing process is analyzed, hazards identified, and critical control points established to mitigate those hazards.
The origins of HACCP go back 30 years ago to an industry one would think far removed from food manufacturing: NASA’s space program. NASA, along with the U.S. Army and Air Force, partnered with the Pillsbury Company to create food that approached 100% assurance against contamination by bacterial and viral pathogens, toxins, and chemical or physical hazards that could cause illness or injury to astronauts.
As effective as HACCP was in ensuring safe food for astronauts, it was not until 1995 that the FDA adapted the concept of HACCP into a HACCP Plan regulation for foods consumed by the general public. This was done specifically for seafood, an industry in which there were growing concerns regarding the quality in production. Shortly after, in 1998, the USDA implemented HACCP for meat and poultry processing plants. In 2001, the FDA required the juice industry to use HACCP as well. The following are the regulations found in the CFR (Code of Federal Regulations) for these industries:
· 21CFR123 Fish And Fishery Products
· 9CFR417 HACCP Meat And Poultry Processing Plants
· 21CFR120 Hazard Analysis And Critical Control Point (HACCP) Systems – Juice
That is an overview of what HACCP is in basic terms and its inception into specific food industries. Now, the seven principles of a HACCP Plan will be explained:
· Analyze Hazards - These hazards could be physical, chemical, or biological in nature.
· Identify Critical Control Points (CCPs) - Identify on a process map all the areas from incoming raw materials to shipping where the hazard could be controlled or eliminated.
· Establish Critical Limits (CL) for Each Control Point - Limits that if exceeded or not achieved could cause the hazard.
· Monitor Critical Control Points - Develop procedures on how to monitor and record actual readings.
· Establish Corrective Actions - Actions personnel will take if Critical Limits are exceeded.
· Verify System Working - Establish calibration and/or check procedures of equipment; record results.
· Document the HACCP Plan - Put it all in writing.
An example to illustrate these seven principles is as follows:
Hazard – Undercooked Meat
CCP – Oven Temp and Time
Critical Limits – 155 degrees F, 15 min.
Monitoring – Temp and Time Checks
Corrective Actions - <155 Reject
Verification – Calibration of Oven
Records – Equipment Log
There is a growing need to establish and maintain control with regards to manufacturing processes in the food industry. About 3,000 products a year are found to be unfit for consumers and are withdrawn from the marketplace, either by voluntary recall or by court-ordered seizure. In addition, about 30,000 import shipments a year are detained at the port of entry because the goods appear to be unacceptable. This is clearly unacceptable and continuance of this trend can weaken consumers’ confidence in the quality of the products they consume. Currently, the FDA is conducting a study in which a wide-range of food companies have volunteered to implement HACCP Plans. Based on these results and taking into account the staggering numbers of recalled and detained products, the possibility exists that all food manufacturers will be required to create and use HACCP Plans sometime in the future.
At NOW Foods, we are implementing a HACCP plan as part of our efforts to comply with the new FDA cGMPs for dietary supplements. It’s not well known, but the new cGMPs have many HACCP-like elements to them. So by preparing and implementing a HACCP plan, not only will we help meet the new cGMPs, but we’ll also have put in place additional safeguards to protect the integrity of our products.