7.1 Product ID and Traceability

7.1 Product ID and Traceability

Quality System Procedure

7.1 Product ID and Traceability

rev-00 / 01-19-07 - Approved by: enter name(s) here

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 -

1.0Purpose 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].

1.1Definitions

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-process” 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).

2.0Procedure

2.1Purchased Product Identification

2.1.1All purchased materials are identified with unique material codes. The identification is the same as is used on product specifications, bills of materials, purchase orders, etc.

2.1.2Purchasing has visibility of the vendor lot number to each lot of purchased materials. Purchasing is able to tie the receipt of raw material to the Purchase Order, supplier and vendor lot number.

2.1.3Purchasing will maintain a vendor folder for each item that contains certifications, lot control numbers and inspection reports. This documentation will be retained for a required period of time.

2.1.4Suppliers are required to identify product shipments in accordance with instructions on the purchase order. Plant Receiving verifies that products are properly identified. If the supplier identification is not adequate, Receiving is responsible for specifying appropriate identification of purchased products, and to correct all paperwork prior to formally receiving the goods. Purchasing will review all inappropriate identification with the supplier for corrective action.

2.1.5Certain materials are specified which require receiving inspection and approval by the QA Lab. The QA Lab is responsible for providing written instructions regarding such material. When such an item is received, it must be quarantined until the QA Lab approves it for use. The QA Lab will keep a record by material code which includes the material certification and QA Lab Release, as applicable, for a period of two years minimum.

2.2Manufactured Product Identification

2.2.1In-Process productsshall be uniquely identified on the operation sheets, as they are being processed through the plant.

2.2.2Final Production Lots are identified by Lot Numbers. The lot number shall accompany the Operation Sheet which documents the included batch volumes, final inspection, and generation of the COA.

3.0Responsibilities

The functional disciplines listed in the above clauses of this procedure have the responsibility for its execution in their respective areas.

4.0References

4.1Normative References - The following reference contains provisions which through reference in this text, constitute provisions of the procedure. References which are subject to revision shall always be used in the most recent form.

4.1.1QM Policy 7.0 – ID and Traceability.

4.2Documentation/Records–The implementation of this procedure may require the use of the below listed forms and/or systems.

  • Certificate of Analysis
  • Lot Number
  • Operation Sheets
  • QA Check Sheets
  • SOP.

7.1_r00 070119 UNCONTROLLED IF PRINTED page 1 of 3

Top View