FSMA(Food Safety Modernization Act) and Calibration





From the FDA-

"The FDA Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule is now final, and compliance dates for some businesses begin in September 2016."

As pointed out in the FDA Guidance document several Key Requirements must be addressed.

  • Hazard Analysis
  • Preventive Controls
  • Oversight & Management of Preventive ControlsNew Call-to-action
    • Monitoring
    • Corrective actions and corrections
    • Verification

Calibration weighs in heavily in 2 Key Requirements- Monitoring & Verification.

Monitoring- assurance that preventive controls are consistently controlled.

Many processes have specific Temperature and Pressure controls as a means to control pathogens. A 1% error could have a profound impact on food safety.

Verification- validating that a preventive control is capable of achieving its use.

You cannot verify without a robust calibration program.

The failure of proper Supply Chain Management has been evident in the numerous product recalls in the news recently.

It is critical that as part of your supply chain management you read every calibration report and account for measurement uncertainty as part of your preventive controls. Example, your process control requires you to control within 1º F. Take the results stated on your calibration report- add & subtract the measurement uncertainty from the result. Are you still in control?

Is your current calibration program adequate to meet the requirements of the FSMA?

While not exhaustive of every possible scenario, we have put a checklist together to get you started on evaluating your calibration program.

Download The Calibration Audit Checklist


Learn more about Food Safety Modernization Act (FSMA).

You may also want to read: 

7 Questions You Should Ask Your Calibration Company

How To Implement PDCA In Calibration Management

Out of Tolerance or Meets Specifications?

How Do I Know If My Lab is Capable?

Phil Wiseman

Phil Wiseman

Phil Wiseman is Chief Marketing Officer at Alliance Calibration. He earned a B.S. in Chemical Physics from Centre College. Phil is an ASQ Certified Quality Auditor and ASQ Certified Manager of Quality/Organizational Excellence.

Related Posts

Compliant or ISO 17025 accredited: Is there a difference?



Compliant or Accredited? Is there really a difference?

Recently I was having a conversation...


What Air Balancers Need To Know About Accuracy, Tolerance and Resolution.

Air balancing is a crucial step in assuring the efficiency of your heating, ventilation, and air...


Calibration and FDA 483 Letters in 2020


In the event of a violation of the Federal Food, Drug, and Cosmetic Act, depending on...