Section 91 of 103
90. Batch, Lot, Serial Number and Production Record
Stable section ID: S05-CON-015-SECTION-91 · 16 content blocks
A Batch is a defined quantity produced during a common manufacturing run or under substantially shared processing conditions.
A Lot is a controlled grouping of items established for traceability, inspection, acceptance, inventory, or disposition. A Lot may contain one or more Batches or selected portions of them.
A Serial Number is an identifier assigned to a particular Product instance where individual traceability is required.
A Production Record is the controlled evidence describing how, when, where, by whom, from what inputs, and under which configuration a Product was produced.
Production Records may include:
facility and equipment identity;
material and supplier information;
Batch, Lot, and Serial relationships;
released design and process versions;
operators, machines, and software;
process parameters;
inspection and test results;
deviations, repairs, and rework;
release and disposition decisions.
Batch or Lot acceptance does not prove that every item is free from defect. Individual serial traceability shall be required where consequences, maintenance needs, regulatory obligations, or lifecycle value justify it.
Identifiers shall not be reused for unrelated production.