We all know the old saying, “Failing to plan is planning to fail.” But in the fast-paced and high-pressure food industry, it can be difficult to find all the time you need to prepare for an audit. Resources are often tight and facilities have to focus on keeping up with daily output to protect their bottom line. However, in the current era of FSMA, GFSI, and increased liability exposure, it’s more important than ever to be prepared for the auditor’s knock.
A sustainable management system is essential to meeting the requirements of any audit. With so much at stake and so many competing demands from regulators, customers, and consumers, securing a sustainable GFSI system can be a challenge. It’s safe to say that most companies have a goal to remain audit-ready all the time, but in reality many find themselves playing catch-up and conducting ‘fire drills’ just prior to re-certification. So, how do leading food companies stay audit-ready 24/7?
The Food Safety Modernization Act (FSMA) is the most sweeping reform of food safety laws in over seven decades. Almost four years after it was signed into law, the final rules governing preventive control for human and animal foods were finally published this September. Now, most FDA regulated companies must prepare for compliance by September 2016.
Compliance dates for the new requirements are defined and more flexible to assist industry compliance while still advancing FDA’s food safety goals. Even with that flexibility, it is important for companies to fully understand five key points regarding the final rule:
- Food Safety Plan v HACCP Plan
- Risk Based Preventative Controls
- Qualified Individual & Auditor
- Good Manufacturing Practices (GMP's)
- Supply Chain Program
The Food Safety Modernization Act will soon have a dramatic impact on the food safety and regulatory landscape for facilities producing products regulated by the FDA. The Preventive Controls for Human Foods proposed rule, which is expected to be published as a final rule this month, will significantly change the way food manufacturing companies document their food safety systems.
HACCP Plan reassessments are required to be performed at least once a year. It is not only mandated by USDA and FDA regulations, but also by the Global Food Safety Initiative (GFSI) for companies certified under SQF, BRC, FSSC 22000 or IFS. In short, your HACCP plan should be a living document that continually and accurately reflects current operations. It assures your food safety system is kept up-to-date throughout the year.
Reassessments are necessary whenever any changes occur that could affect your hazard analysis or alter any current HACCP plans.
Example circumstances for HACCP reassessment include:
- Changes to or addition of new ingredients
- Revised formulations
- New equipment
- New packaging
- New production processes
- Changes to the intended consumer population
*Editor's note: this post is the first in an ongoing HACCP series.
The concept of HACCP validation has long been a mysterious and confusing topic for many people. Since it is included as a part of HACCP principle number 6 for verification, the validation requirement is often misunderstood.
There are many advocates, myself included, that feel like the National Advisory Committee for Microbiological Criteria for Foods should revise the standards to clarify the topic and give it the attention it deserves. Until then, I hope to help you learn the elements of validation and how you can prepare for the new Food Safety Inspection Service (FSIS) requirements before enforcement begins in 2016.