Arise Shine Exports & Imports LLP, QSM/ASEI/08

Issue No. : 03
Blue Star Enterprises QUALITY SYSTEM
Date. : 27. 09. 2019
& MANUAL
Rev No. : 01
Arise Shine Minerals & Chemicals LLP Page No. : 1 of 3

8.5.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].

8.5.1. Definitions

a. 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.

b. 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.

c. 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.

d. 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.

e. 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.

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

g. Further, raw material codes also identify “in-process” product which is to be

transferred, stored, inspected, and/or further processed.

h. 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
 Arise Shine Exports & Imports LLP, QSM/ASEI/08
Issue No. : 03
Blue Star Enterprises QUALITY SYSTEM
Date. : 27. 09. 2019
& MANUAL
Rev No. : 01
Arise Shine Minerals & Chemicals LLP Page No. : 2 of 3

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).

8.5.2. Procedure

A.Purchased Product Identification

a. All 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.

b. Purchasing 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.

c. Purchasing 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.

d. Suppliers 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.

e. Certain 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.

8.5.3.Manufactured Product Identification

i. In-Process products shall be uniquely identified on the operation sheets, as they are being
processed through the plant.

ii. .Final 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.
 Arise Shine Exports & Imports LLP, QSM/ASEI/08
Issue No. : 03
Blue Star Enterprises QUALITY SYSTEM
Date. : 27. 09. 2019
& MANUAL
Rev No. : 01
Arise Shine Minerals & Chemicals LLP Page No. : 3 of 3

iii)Responsibilities

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

8.5.4. References

Normative 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.

Number needed QM Policy 7.0 – ID and Traceability.

Documentation/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.