Batch Records and Process Logs
The contemporaneous paper or electronic records that identify a specific lot and show the materials, actual process values, observations, deviations, review and disposition associated with it.
Definition
A batch record follows an identifiable quantity of product through production. A process log records time-sequenced conditions or events, either manually or automatically. They may be combined, but their purposes remain distinct: the batch record links people, materials, process and disposition; the process log shows how variables or events changed over time. Both should use the same batch, chamber or equipment identity so that the evidence can be reconstructed.
Minimum identification
Record the product name, batch or lot code, production date, quantity, formula or process version, responsible operator and relevant equipment. Link the actual meat, fat, curing salt, culture, spice, casing and packaging lots used. If the product is divided between chambers or later combined, preserve the split and merge history. A batch code printed on a label is useful only when it resolves to the supporting records.
Targets and actual values
Preprinted targets guide the operator; they are not evidence of performance. Record actual ingredient weights, times, temperatures, pH, water activity, humidity, weight loss or other values required by the process. Include units and enough method or sampling detail to interpret the result. Automated logger files can be attached or referenced, but the record should identify the file, sensor, location and time period rather than merely state that data were logged.
Contemporaneous entry
Enter a result or observation when the activity occurs. A later transcription should identify the source and preserve it. Reconstructing a sequence from memory after the shift can misstate timing and hide abnormal exposure. Paper entries should remain legible; electronic entries should retain user and time information. Do not complete blank fields in advance or copy yesterday's values into a new batch.
Corrections and missing data
Correct an error without obscuring the original information, and identify the person and date. Give a reason when it is not self-evident. Missing readings, logger gaps, unreadable entries and inconsistent times are deviations from the evidence system. They require evaluation of what can still be established from independent records; inserting an estimated value as though it were measured is not acceptable.
Deviations and product status
Record alarms, out-of-range results, interrupted stages, equipment faults, unauthorised changes and unusual observations. Identify the affected quantity and place it on hold where the process evidence is uncertain. The record should link to the investigation, corrective action and approved product disposition. A note such as fixed or acceptable is not enough unless it states what was assessed and who authorised the decision.
Review
The reviewer should confirm correct versions, completeness, actual-value compliance, calculations, instrument status, logger continuity and closure of deviations. Trend review may reveal a slow drift or repeated short excursion that a single-point check misses. Review should be completed before release when the record supports a safety decision. The reviewer's signature or electronic approval should identify the records and batch covered.
Retention and retrieval
Store the record with its attachments, referenced files and any later investigation. Retention is governed by the applicable product and jurisdiction, not by one global period. Files should remain readable after software changes, and paper should remain protected from damage or loss. Retrieval should work in both directions: from finished lot to inputs and process evidence, and from an ingredient lot or equipment event to every potentially affected batch.
Proportionate use. A home or pilot-scale log can fit on one page or in a structured digital form. It should still record the formula, exact quantities, dates, key measurements, chamber or equipment, observations and disposition. A commercial establishment may need separate HACCP, sanitation, traceability, maintenance and laboratory records. The form can be proportionate; the essential evidence cannot be replaced by memory, appearance or an unlabelled photograph.
Related in the Codex
References
- Codex Alimentarius Commission — General Principles of Food Hygiene, CXC 1-1969 (2022 revision)
- United States Electronic Code of Federal Regulations / USDA Food Safety and Inspection Service — 9 CFR 417.5: HACCP Records
- United States Electronic Code of Federal Regulations / USDA Food Safety and Inspection Service — 9 CFR 417.3: Corrective Actions
- United States Electronic Code of Federal Regulations / USDA Food Safety and Inspection Service — 9 CFR 417.4: Validation, Verification and Reassessment
- USDA Food Safety and Inspection Service — FSIS Directive 5000.2: Review of Establishment Data by Inspection Personnel
- United States Food and Drug Administration / eCFR — 21 CFR Part 117 Subpart F — Requirements Applying to Records
- European Parliament and Council — Regulation (EC) No 178/2002, Article 18: Traceability
- National Institute of Standards and Technology — NIST SP 800-92: Guide to Computer Security Log Management
- United States Food and Drug Administration / National Advisory Committee on Microbiological Criteria for Foods — HACCP Principles and Application Guidelines