Monitoring and Corrective Actions
Detect fast, act on product, fix the cause
Monitoring is the scheduled observation or measurement of a CCP to confirm the CL is met. For each CCP the plan states what is measured, how, when or how often, and who does it. Continuous monitoring (a chart recorder, a metal detector) is stronger than periodic checks because it covers all product; interval checks assure only the moments sampled, so the frequency must be short enough that a deviation is caught before affected product leaves the plant. Instruments need calibration, results must be recorded at the time of measurement, and records signed.
Corrective action has four parts, and exam questions often reward only the first: bring the process back under control; determine the disposition of all affected product (hold, rework, divert, condemn), including product made since the last acceptable reading; find and eliminate the root cause; and record everything with product codes, quantities and the responsible person.
Traps: an answer that adjusts the machine and releases product without a disposition decision; retesting a sample and releasing product on that basis alone; ignoring product produced since the last good check; and vague records such as “reworked as needed” with no lot numbers.
Worked example: a blast cooler reads 8 °C instead of 5 °C or below, and the previous check was four hours earlier. Hold all product from those four hours, evaluate its time-temperature history against shelf life and pathogen growth, and have a qualified person decide disposition before any release.