FDA 21 CFR Part 117 Audit Checklist

Kellerman Consulting’s free Food Safety Modernization Act audit checklist can assist your company with understanding which documentation and evidence of implementation are required for compliance with FDA rules 21 CFR 117 subparts C and G. Just click below to download it now!

This Food Safety Modernization Act (FSMA) checklist is tailored specifically for manufacturers of human foods. It will assist in assessing your compliance against the requirements set forth in FSMA for registration of your facility, Hazard Analysis and Risk-Based Preventive Controls and Current Good Manufacturing Practices.

Checklist for Preventive Controls

Food companies that manufacture human food must perform a hazard analysis and risk-based preventive control analysis in order to address potential biological, chemical or physical hazards at their facility, along with creating and implementing a food safety plan designed to address them.

Plan should include procedures and records for monitoring each preventive control, such as heat processes that kill pathogens in foods. Monitoring temperature readings would require record keeping.

Additionally, the plan must identify supplier programs for raw materials and ingredients as well as recall plans to reduce the likelihood that problems reoccur, evaluate affected food for safety, and block problem foods from entering commerce. Furthermore, corrective actions must be implemented upon identification of any problems, such as reestablishing monitoring, assessing affected product for safety assessment purposes and determining their source to prevent their recurrence.

Checklist for Hazard Analysis and Critical Control Points (HACCP)

HACCP stands for Hazard Analysis Critical Control Point and ensures food safety by eliminating biological, chemical and physical hazards in production processes that could make the final product unsafe to consume. HACCP requires you to identify potential hazards at each step in production process and identify how risks can be controlled to guarantee its safety for consumption.

One of the initial steps involves developing a flow diagram of your entire production scheme. It doesn’t have to be an elaborate engineering drawing; simply clearly outline its intended process for your product. Furthermore, on-site plant observations must take place to ensure all aspects have been covered by your operations plan.

Locate and identify critical control points (CCPs). A CCP refers to any point, procedure or operation within your production process which requires accurate assessment of specific factors to eliminate or reduce risks to acceptable levels. Monitoring must then involve conducting planned sequences of measurements and observations against each CCP to assess its efficacy.

Checklist for Good Manufacturing Practices (GMP)

Good Manufacturing Practices (GMPs) are standards food companies must follow to manufacture safe and effective products. GMPs cover every aspect of product production from facility design to sanitization procedures and require thorough investigations of any customer complaints as well as appropriate corrective action plans.

This template was designed with pharmaceutical applications in mind; however, other industries may find use for it as well. It includes sections for assessing general facilities, facility layout (designed to prevent contamination), appropriate floor space and running water availability at the premises; it also covers safety and security considerations like whether adequate safeguards exist against industrial espionage.

All responses must be recorded on a checklist using an “X” for “NO,” “YES,” or “n/a,” with any non-applicable questions receiving no answer. All audit responses should also be recorded in a laboratory notebook that clearly identifies both date and auditor. Throughout its inspection process, this notebook should remain at the facility.

Checklist for Record Retention

Kellerman Consulting’s free Food Safety Modernization Act (FSMA) checklist can assist your food plant in meeting FDA rules 21 CFR 117 Subpart C, G, and D requirements. It will also outline the process for creating and validating a Hazard Analysis and Risk-Based Preventive Controls (HARPC) program. FSMA compliance may not be easy but with our free FSMA checklist it can become much simpler – contact Kellerman Consulting now to request a complimentary consultation for businesses of any size!