// ROBOTICS AND SMART FACTORIES TERM

Batch Record

A batch record is a detailed document that records all steps, materials, and equipment used during the production of a specific batch of a product. It's like a recipe and logbook combined.

Batch Record — illustration from Wikipedia
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TECHNICAL DEFINITION

A batch record, or Device History Record (DHR) in medical devices, is a comprehensive document detailing the complete manufacturing history of a specific batch of product, including raw material traceability, in-process controls, equipment used, personnel, and deviations, ensuring regulatory compliance and product accountability.

BACKGROUND

Manufacturing is the creation or production of goods with the help of equipment, labor, machines, tools, and chemical or biological processing or formulation. It is the essence of the secondary sector of the economy. The term may refer to a range of human activity, from handicraft to high-tech, but it is most commonly applied to industrial design, in which raw materials from the primary sector are transformed into finished goods on a large scale. Such goods may be sold to other manufacturers for the production of other more complex products, or distributed via the tertiary sector to end users and consumers.

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SYNONYMS & ALIASES

  • Production Record
  • Lot Record
  • Manufacturing Record
  • Device History Record (DHR)

USAGE NOTE

Batch records are critical for traceability and investigation in case of product quality issues or recalls.

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