FDA offers helping hand in FSMA compliance

As any American food producer knows, the landscape of food safety is changing.

Back in January, President Barack Obama signed the Food Safety Modernization Act (FSMA) into law. The act, a sweeping bill with the most significant changes to food safety in nearly 70 years, will affect thousands of food producers across the U.S. and, in light of some new stringent rules related to imports, around the world as well.

Specific requirements of the act have trickling out of the Food and Drug Administration (FDA) throughout the year, including mandatory recall powers for the FDA, increased protection for whistleblowers, the ability to hold products that may be mislabeled, and more.

But the full scope of the rulemaking that follow the FSMA will only be known as the act is implemented over the course of the next year.

However, businesses who want up-to-the-minute news on implementation progress ought to head to … Read more...

Training and quality: peas in a pod

According to experts, though the connection can seem distant or indirect, proper training has a clear impact on quality, just as it has a clear impact on every aspect of business.

As business process design and ISO 9001 expert Chris Anderson noted in a blog post on the top ten root causes of business problems, poor training is the number one source of business issues. Two decades of business management led Anderson to place poor training ahead of poor methods, poor employee placement and poor engineering and design on the list.

“People don’t make mistakes,” Anderson insists in the post. “Systems make mistakes.”

And just as product and service quality issues arise from systemic deficiencies, employee performance — and its impact on quality — is correlative to the integrity of training management systems.

Training and quality are best thought of as peas in a pod — inseparable elements that should always be … Read more...

First FSMA rules in effect July 3. Are you ready?

Earlier this week the U.S. Food and Drug Administration (FDA) announced the first set of rules under the landmark Food Safety Modernization Act (FSMA), legislation signed earlier this year which gives the FDA sweeping powers to prevent food safety disasters.

The two new rules, which take effect July 3, are pretty logical preventive measures that, in all fairness, probably should have been implemented a long time ago. The new rules are as follows:

  • Order on Administration Detention of Food: The first new rule gives the FDA the authority to hold food products that may be contaminated or mislabeled. Before now, the administration only had the right to detain food when it had sufficient evidence it was mislabeled or contaminated, thereby presenting a threat to humans or animals. Now if the FDA even suspects contamination or mislabeling, it can detain the product.
  • Rule on Imported Food:  Organizations importing food now have
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Five Ws: Avoiding the nightmare of a product recall

Eggs. Toy trucks. Spinach. Meds. And now walnuts.

Recalls — and not the good kind — are a daily reality within an interconnected, modern global economy. But for the unprepared business, a product recall can be a logistical and PR nightmare, costing significant capital, and precious hours of downtime as well as — perhaps most significantly — irreparable damage to delicately nurtured brand image.

Since consumer activist agencies and public awareness at large tend to be a few steps ahead of legislators and regulatory bodies on public safety concerns, it is imperative businesses stay a few steps ahead of the game. For companies that rely on contract manufacturers, this can be easily achieved with a comprehensive quality management system (QMS).

Some essential questions — often rendered complex by the size and scope of large corporations — can be resolved with straightforward answers if an electronic QMS has been put … Read more...