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QMS 075 Procedure For Product Identification and Traceability Sample

Quality Document - Sample of Procedure for Product Identification and Traceability

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Ali Saifullizan Ismail
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633 views

QMS 075 Procedure For Product Identification and Traceability Sample

Quality Document - Sample of Procedure for Product Identification and Traceability

Uploaded by

Ali Saifullizan Ismail
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Standard Operating Procedure

Title: Procedure Product Identification and Traceability


____________________________________________________________________________________________________________
Procedure
1. Introduction
Product traceability system allows for complete and up to date histories of all batches of products
from the starting materials to the complete final product. Identification and status of materials is
provided by unique and controlled numbering system. The system can be interrogated to provide
reports to allow for full traceability.

2. General Overview

2.1. Inwards goods

2.1.1. Materials/Components are identified at the time of receipt. Each material has a
unique identifying number. At the time of receipt each material shipment is given an
unique Laboratory batch number. QA team maintains the full list of raw material and
component codes, description and approved suppliers/manufacturers.

2.1.2. The vendor’s batch number of the imported raw materials are maintained all through
the process steps associated with the unique Laboratory batch numbers.

2.1.3. The raw material code number is allocated and maintained by the Quality Assurance
Team. Laboratory batch number is given by Warehouse team.

2.1.4. Each shipment of raw material is given an unique Goods Receipt Slip number. The
combination of unique material code, Laboratory batch number and Good Receipt
Slip number allows warehouse team a good traceability during storing and issuing
materials to production.

2.2. Finished Goods Production

2.2.1. All Finished Goods manufactured require two sets of numbers that identify the
product type and the unique batch number. Each manufactured product type is
identified by unique product code. Each manufactured batch is identified by unique
Batch Production Number.

2.2.2. The Finished Goods number is assigned and controlled by the Quality Assurance
team.

2.2.3. The Finished Goods batch number is allocated by the Planner sequentially on
conversion of a Planned Order and a batch production Order. The unique Batch
Production Number is used to trace all processing steps for the Production
Operation.

2.2.4. Product identification is noted on the Certificate of Analysis at testing.

2.2.5. Product traceability is progressively recorded in the Manufacturing Instruction (MI)


system.

2.2.6. The product code, Batch Production Number and Goods booking Slip Number in
combination produce the system which traces the distribution, recall and destruction
of all Finished Goods.

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Standard Operating Procedure
Title: Procedure Product Identification and Traceability
____________________________________________________________________________________________________________
3.10. Goods Booking Slip Number is allocated by production planner to identify each pallet of a
Batch booked out of the production line. Each GBS number is an eight digit number in the
format of YYXXZZZZ, starting with the last two digits of the year, followed by a two digits of
the month. A consecutive four digits number is assigned up to 1000 booking of batches
started from 0001.

th
For example: GBS number for 10 delivery of the month of June, year 2005 will be
05060010.
The storage type and storage bin number for product storage is allocated on the Goods
Booking Slips.

3.11. Pallet IDs are created to identify every pallet of manufactured finished goods, which will
contain information of a unique Product code and Batch Production Number.

3.12. All steps throughout the Manufacturing Process are tracked via Manufacturing Instruction
(MI) documents, maintained by the Technical Service team unique for each product code.

3.13. Full traceability is assured through issuing appropriate documentation and maintaining
records that accompany every step in batch manufacturing.

4. Status

4.1. All components, Raw Materials and Finished Products undergo inspection and testing at
various stages of their processing to verify their adherence or otherwise to standards which
is detailed in relevant documentation.

4.2. On completion of every inspection and test procedure, resulting in a change to the status of
the item a record is generated to attest that the item is allowed to proceed to the next stage
in its processing.

4.3. The change in status of a product/batch can be marked by various ways like Authorised
persons signature and date on the forms and records, applying stickers e.g. RELEASED
sticker.

4.3.1. Only authorised warehouse person will receive incoming goods and sign and date
on the Goods Receipt Slips. Authorised dispensary personnel will sample the Raw
material/component laboratory testing. Authorised production personnel will request
material/component for a BPN through Material Transfer Orders. Authorised
laboratory personnel will test Raw Materials, Components and Finished Goods
according to approved Specification and Test Reports. In each of the case the
material or batch status will be changed, which is reflected by authorised persons
sign and date on the forms and record. Appropriate stickers are applied to mark
those changes.

4.3.2. Goods undergoing manufacturing are continuously in process tested, the status
“done/not done” is noted when the entry is made in the Manufacturing Instructions.

5. Records
The completed Manufacturing Instruction (MI) sheets form the record of batch production.

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