Handling of Returned/ Rejected Goods
1.0 OBJECTIVE:
To
lay down the documented procedure for handling of Returned/ Rejected Goods.
2.0 SCOPE:
This
SOP shall be applicable to define role/ responsibility of various functions
responsible for handling of Returned/ Rejected Goods.
3.0 RESPONSIBILITY:
3.1
Officer/
Executive/ Assistant Manager.
4.0 ACCOUNTABILITY:
4.1
Head of Quality
Assurance Department.
4.2
Head of Production
Department.
4.3
Head of Quality
Control Department.
4.4
Head of Store
Department.
5.0 PROCEDURE:
5.1 Ensure
that all returned products are handling in the following manner:
5.1.1
There are no
mistakes in identity for products and batch numbers.
5.1.2
Defective or
substandard products should not get mixed with good products and become liable
to be offered for sale.
5.1.3
The handling and
disposition of returned products should not contravene any statutory
requirements.
5.1.4
Complete
documentation is available on all operations on returned products from receipt
to final disposal.
5.2 Any
goods which have returned from the market for any one of the following reasons
are treated as a returned good.
5.2.1
Return goods on
advice of Drug Control / Regulatory Authorities from the market customers.
5.2.2
Returned stock from
distribution office, due to:
5.2.2.1 Date
Expired Products.
5.2.2.2 Damaged
of Broken Primary containers.
5.2.2.3 Leaky
or Broken Seals of Closures of Primary Containers.
5.2.2.4 Mutilated
or smudged labeling rendering the product unidentifiable of its name, or batch
number.
5.2.2.5 Soiled
labeling rendering the products unassailable or un-presentable aesthetically,
but otherwise clearly identifiable for product name and batch number.
5.2.3
Returned goods for
any voluntary reason.
5.2.4
Returned goods for
any impairment in analytical report reported by customer.
5.3 The
returned goods will be received by Finished Goods Warehouse. The stock will be
placed in the Secured area under lock and key which is adequately segregated
and labeled with the reason for return as per the reasons mentioned in above,
by Assistant-Finished goods Assistant/Sr. Executive-Production.
5.4 A
description of the condition in which the goods will be entered in the Returned
Good-Assessment Report by Assistant-Finished goods/ Sr. Executive Production.
5.5 The
returned Good-Assessment Report will be sent to QA Executive. QA Executive will
physically inspect the condition of the returned goods and enter his
observations in the Returned Good-Assessment Report and send the report to
GM-QA.
5.6 Based
on the above observation, GM-QA will decide whether:
5.6.1
Re-analysis is
required to consider for reuse or rectification.
5.6.2
The material
should be destroyed.
5.7 If
re-analysis is required, the QA Executive will send the Returned Good
Assessment Report to QC Executive for arranging for sampling and analysis of
the material.
5.8 QC
will collect sufficient sample (Sufficient to perform 3 analyses) individually
from each container if required or a representative sample from all the
containers as per the requirement of the parameters to be checked and also send
the same sample to the external authorized autonomous Laboratory.
5.9 The
QC will test the material as per the laid down specifications.
5.10 An
analytical Report with relevant details will be prepared by QC Executive as
well as by external laboratory to explore the possibilities of consideration
for reuse/ destruction.
5.11 Based
on the analytical report, GM –QA decides whether the returned good can be
reused or destroyed.
5.12 The
Return Good-Assessment Report will be approved by GM-QA.
5.13 The
Report is then sent to the Ware House-Manager who will prepare and coordinate
for the action plans drawn. The action plan should be approved by GM-QA.
5.14 QA
will monitor action plan throughout the operations till the returned good is
re-worked or disposed off.
5.15 In
case of destruction, the ‘Return Good – Disposal Record’ shall be filled in the
format and filed with QA along with Return Good-Assessment Report.
5.16 The
Product Assessment Report along with Return Good Assessment Report should be
sent to G.M-Plant for his authorization and the same shall be filed with QA.
6.0 REVISION LOG:
|
Revision No. |
Effective Date |
Reason |
|
00 |
|
New
SOP |
7.0 REFERENCES:
7.1
Not Applicable.
8.0 ANNEXURES:
Annexure 1: Returned/
Rejected Goods Reports.
Annexure: 1
Returned/ Rejected Goods
Reports
|
Returned/
Rejected Goods Reports Name of Product:
_______________________ Batch no.:
______________________________ Mfg. date:
______________________________ Expiry date:
____________________________ Date of Rejection:
________________________ Date of Received Goods:
___________________ Received from:
___________________________ Reason of Rejection:
______________________ Return Goods Assessment Report:
__________________________________________ ________________________________________________________________________ Analysis report by Q.C Officer:
____________________________________________ ________________________________________________________________________ Return Goods Assessment Report: Approved by Q.A Executive: □ Yes □ No Precise action to be taken:
_________________________________________________ ________________________________________________________________________ Remarks by Manager Q.A:
________________________________________________
|
9.0 ABBREVIATIONS:
|
Abbreviation |
Expanded Form |
|
SOP |
Standard operating
procedure |
|
& |
And |
|
No. |
Number |
|
Ltd. |
Limited |
|
QA |
Quality assurance |
|
QC |
Quality control |
|
F |
Format |
|
GM-QA |
General Manager Quality
control |
|
Mfg. |
Manufacturing |
|
Sr. |
Senior |