Other Documentation Needed for Calibration Programs
Documented work instructions must be provided for calibrating each instrument. This step must include steps to verify the efficacy of the protocols. Work instructions for calibration must include the following elements:
- Date of calibration
- Procedures for calibration
- Location of equipment
- Standards used (in-house standards must be calibrated on a regular schedule)
- Tolerances
- Frequency of calibration (frequencies may be determined based on risk assessments,
experience, or through supplier recommendations) - Responsible persons or group
- Record-keeping procedures
- Corrective actions that address the instrument and any product that may have been
affected by an out-of-calibration instrument - Record review.
Any person assigned to conduct calibrations in-house must be trained, and that training must be documented. If the training is provided by a third-party organization (a metrics company, for example), then the company should be selected and approved according to the company’s
vendor quality program. The company must also maintain accurate and updated calibration logs that include records showing that each instrument has been calibrated and that the proper procedures were employed.
Many companies elect to place calibration tags that are water- and oil-resistant onto all instruments or equipment each time they are calibrated. Such tags must include the instrument number, the date it was calibrated, and the date of the next scheduled calibration. It is also a good idea for management to review calibration records for instruments used for monitoring food safety each week. Calibration records will be signed/initialed and dated by the reviewer. If the pepper processor in my HACCP example had done this, it would have saved the company’s whole season.
Auditing a Calibration Program
The calibration program should be audited on a regular basis to ensure that it is operating effectively. Included in this audit are all elements making up the program and the individual work instructions. This is equivalent to the internal audits described in the ISO 22000
standard, “Food Safety Management Systems—Requirements for Any Organization in the Food Chain.”5
Senior management should review the internal audit of the program to ensure that it is operating effectively and to initiate any needed improvements. Remember, every element making up the food safety program should be subject to continual improvement.
In conclusion, proper calibration of all instruments used for monitoring food safety, food quality, and legal issues is essential for protecting consumers and the company’s reputation. It is up to the company to develop, document, implement, and maintain a calibration program that achieves this objective. We do not want to see a repeat of the pepper processor.
KLM HIGH-giene SOLUTIONS can assist with the calibration of various instruments used in the food production facilities used for monitoring food safety and quality. You can contact us for more information and/or quotation.
References
- American Society for Quality. “Quality Glossary: Calibration.” https://asq.org/quality
resources/quality
glossary#:~:text=Calibration%3A%20The%20comparison%20of%20a,from%20the%2
0required%20performance%20specification. - Falkenstein, Drew. “The 2007 Castleberry Farms Botulism Outbreak.” Food Poison Journal. February 25, 2015. https://www.foodpoisonjournal.com/foodborne-illness-outbreaks/the-2007-castleberry-farms-botulism-outbreak/.
- Centers for Disease Control and Prevention (CDC). “Botulism Associated with
Commercially Canned Chili Sauce—Texas and Indiana, July 2007.” Morbidity and Mortality Weekly Report. July 30, 2007. https://www.cdc.gov/mmwr/preview/mmwrhtml/mm56d730a1.htm. - Stier, Richard F. “The Basics of Temperature Monitoring and Importance of Ensuring Accuracy.” Food Safety Magazine. October 29, 2024. https://www.foodsafety.com/articles/9863-the-basics-of-temperature-monitoring-and-importance-of-ensuring-accuracy.
- International Organization for Standardization (ISO). “ISO 22000:2018: Food Safety Management Systems—Requirements for Any Organization in the Food Chain.” Edition 2. 2018. https://www.iso.org/standard/65464.html.
Article by Richard F. Stier, M.S.