Dairy Establishment Inspection Manual – Chapter 14 - Aseptic Processing and Packaging Systems
1.14.21 Record Keeping
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It is important that the scheduled process be properly established, correctly applied, sufficiently supervised and documented to provide assurance that the requirements have been met. Production records must consist of the operator's packaging/filling production log and the operator's on-line record of critical parameter testing. These records must be maintained on file for at least 3 years or the shelf-life of the product if longer than 3 years.
1.14.21.01 Packaging Records
A trained operator is responsible for verifying that all critical controls are recorded and meet specifications. Review of records by the responsible individual should be completed before the product is released.
The operator's packaging/filling production log should contain the following information:
- packaging machine number
- product being filled and packaged
- source of product (i.e. from surge tank or sterilizer)
- preparations taken to bring equipment into packaging readiness, e.g. inspection/repairs/replacements of valves, gaskets, gauges, warning lamps etc.; cleaning, preheating and sterilization steps; pressure and temperature checks
To ensure product safety and to provide a historical record of the process, the following information should be recorded:
- hourly filling code
- machine number
- packaging start time
- packaging stop time
- machine downtime and reason, corrective action taken to restart
- intervals at which teardowns conducted
- types of teardowns conducted, classification of defects observed, corrective action taken
- hydrogen peroxide concentration
- production volume
- unusual occurrences
- operator's signature
- signature of individual responsible for review
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