About this course
This course covers calibration and preventive maintenance for the instruments and equipment that keep a food safety plan reliable — thermometers, pH meters, scales, metal detectors, and other process control instruments. An uncalibrated instrument can quietly invalidate every monitoring record it produces, which makes calibration one of the most frequently audited areas of GMP compliance.
Under FDA's Preventive Controls for Human Food rule (21 CFR Part 117) and HACCP-based programs generally, any instrument used to monitor a critical control point or preventive control must be calibrated on a documented schedule against traceable reference standards. Equipment overall must be of appropriate design and construction, maintained in sanitary condition, and kept from becoming a source of contamination — and under 21 CFR 117.190, related monitoring and maintenance records must be retained for at least two years, or longer where tied to product shelf life.
This course is written for both QA staff, who own calibration schedules and verification, and maintenance technicians, who service and adjust the equipment itself — since neither role can maintain a compliant program without the other.
After completing this course, learners will understand why calibration accuracy directly affects the validity of monitoring records, know how to build and follow a calibration schedule using traceable standards, be able to recognize when equipment condition (wear, drift, damage) is likely to cause an out-of-calibration finding, and know the documentation needed to demonstrate a compliant calibration and maintenance program during an audit.
Topics covered
- Why calibration accuracy underpins every monitoring record
- Building a calibration schedule with traceable reference standards
- QA and maintenance roles in a shared calibration program
- Recognizing equipment wear and drift before it causes a failure
- Recordkeeping and retention expectations under 21 CFR Part 117
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