21 CFR 117.190 - Implementation Records Required for Subpart C

What it says

Section 117.190 lists the implementation records a facility must keep to show that its food safety plan is being carried out. They include records of the monitoring of preventive controls, corrective actions, verification activities such as calibration, product testing, environmental monitoring and records review, records of the supply-chain program, and documentation supporting a decision not to establish a preventive control under 117.136.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• Implementation records are the evidence an inspector reviews. A plan with no matching records is a plan that exists but is not carried out.
• Records must also meet the general requirements for accuracy, legibility and timing that apply to all records under Subpart F.
• The same activity may be recorded in several systems, such as batch records, sanitation logs and laboratory systems, so it helps to map each required record to where it is kept.

What FDA inspectors look for

• Whether a record exists for every monitoring, corrective action and verification activity the plan requires.
• Whether records are complete, signed or initialed, dated and retained as required.
• Whether records can be produced promptly on request.

Related regulations