产品标识和追溯程序-英文版

Customization Notes: delete this section on completion

a) header - enter revision / date & approver(s)

b) 1.0 - change [MyCompany] to your company name

c) 2.x - define your Traceable Items, IDs & numbering preferences

d) global - personalize -

1.0 Purpose and Scope

This procedure establishes the system and instructions for product identification and traceability. It applies to all materials, in-process products and final products purchased and sold by

[MyCompany].

1.1 Definitions

Batch Number: Unique number identifying a volume of “in-process” product. Batch numbers accompany the Operation sheet, which documents its content and inspections. After final batch inspections, this volume is transferred to a Production Lot volume.

Certificate of Analysis (COA): A document listing the specification requirements for the product comprising a unique lot with the actual results obtained from specification testing for that lot. Copies of applicable COAs are provided with customer deliveries, and identify the internal lot number and verification of product conformance to specification.

Lot Number: A homogeneous production volume of finished product that is held in a single container where representative samples are taken and analyzed to provide an authentic certificate of analysis for the specific volume.

Operation Sheets: Official production workorder to manufacture product, which is issued and uniquely identified. Operation Sheets consists of a defined sequence of operational steps

(e.g. routing, batch), which are required to produce, inspect, and track product batches.

Operation sheets further document compliant completion of each step, recording of critical production data ( actual volume vs planned volume) and signoff by person performing task.

Responsibility of each step is defined and typically include ( but not limited to) operations and inspection. Operation sheets are intended to be a simplified checklist of tasks performed and verified on completion. SOPs can be referenced to define details of standard operations.

Raw Material: Purchased (or internally produced) materials which are required to produce the company’s finished products. Supplier, dates, and lot numbers provide traceability.

Further, raw material codes also identify “in-pr ocess” product which is to be transferred, stored, inspected, and/or further processed.

SOP: Standard Operating Procedures. Similar to Operation Sheets, SOPs define a sequence of operation. SOPs are typically posted or accessible at point of use. Compliance to step-by-step actions is procedurally required, but do not require the formal sign-off signature as does the operation sheet. Operation sheets typically call-out SOPs to define details. SOPs are a controlled document ( assigned# & revision).