1.0
OBJECTIVE:
To lay down the procedure for handling of On-Line
rejected materials.
2.0
SCOPE:
This SOP is applicable to all the On – Line Rejected
Materials at -----------
3.0
RESPONSIBILITY:
3.1
Concern Operator,
Production Officer/designee, is responsible for follow this SOP.
3.2
Production
HOD responsible for complies of this SOP.
3.3
Concern
IPQA/QA designee responsible for complies.
4.0
ACCOUNTABILITY:
The accountability lies upon QA HOD and Plant Head for
implementation and complies of this SOP.
5.0
PROCEDURE:
5.1
The Raw and
Packing materials are rejected ON LINE due to some Problem.
5.2
Raw Materials
may be rejected due to presence of Black Particles, hard particles, or any
other foreign impurities.
5.3
Packing
materials may be rejected due to any quality defects before start of packing
activity.
5.4
Packing materials rejected ON line are as follows:
5.4.1
Foil
rejection due to text matter printing problem, spots on foil, width
problem, registration shifting, damaged core, pin
hole, pocket problem, shade variation, machine setting problem, ink lifting and
sealing problem etc.
5.4.2
Cartons/labels
may be rejected due to printing problem, adhesive/pasting problem, registration
shifting, and color variation.
5.4.3
Bottles/Caps
may be rejected due to Improper sealing, Glass pieces in the bottles, mix up of
two different size bottles, defective
neck height, foreign particles WAD layers variation etc.
5.5
Fill the On
Line Rejection format (Format No.: F/QA-020-01) with all details for such
materials and send to Q.A department.
5.6
The Rejection
Report shall be recorded in Online Rejection Log as per Format No.: F/QA-020-02 and a unique number is allotted to the Rejection
Report. It
is allotted as RR/XXYYY as per e.g. (
RR/20001), where denoted by RR-Rejection Report
XX-Year
e.g. 18 for 2018
YYY-
Serial No. of three digits 001
5.7
IPQA person
shall check and verify the nature of rejection. Then QC will check the rejected
material and mention action plan if required.
5.8
Decision to
return the material to Stores or to use the material after sorting shall be
taken Approval by QA Head/ designee.
5.9
After
investigation and confirmation of rejection, QC will past the rejected label on
the material.
5.10
Destroy the
On Line rejected Packaging material as per SOP No.: SOP - QA- 018.
5.11
Raw material
rejected On Line shall be either destroyed or sent back to the party.
6.0
LIST OF ANNEXURE AND FORMATS:
Sr. No. |
Title of Format |
Format No. |
|
On Line
Rejection Form |
F/QA-020-01 |
|
On Line
Rejection Log |
F/QA-020-02 |
7.0
REFERENCES:
7.1
SOP-QA-001
7.2
F/QA-001-01
7.3
SOP-QA-014
8.0
REVISION HISTORY:
Sr. No. |
Date |
Reason for Revision |
Revision No |
1.
|
31/10/2018 |
New SOP |
R0 |
2.
|
31/10/2020 |
Schedule Revision |
R1 |
9.0
ABBREVIATIONS:
Sr. No. |
Abbreviations |
Details |
|
SOP |
Standard operating procedure |
|
NA |
Not applicable |
|
QA |
Quality assurance |
END
OF DOCUMENT
Report No.:_______________ Date_______________ Initiated By (Sign/date):_________________ Department:_______________ |
||||||
Type of Material (Put the tick mark): |
|
|||||
Product Name (if applicable): |
||||||
Item Name: |
Batch No: |
|||||
Manufacturer: |
Supplier: |
|||||
A.R.No./Date: |
Qty. Issued: |
|||||
Challan No. / Date: |
Qty. Received: |
|||||
Reason for Rejection: _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ _________________________________________________________________________________________________ |
||||||
Checked By: IPQA (Sign/Date): |
Checked By: QC (Sign/Date): |
|||||
Remark: ________________________________________________________________________________________________ ________________________________________________________________________________________________ ________________________________________________________________________________________________ |
||||||
STATUS OF
MATERIAL (Put the tick mark) |
Used after sorting in coordination with QA: |
|||||
APPROVED
BY – QA HOD (Sign/Date): |
||||||
Quantity Rejected: (Put the tick mark) |
|
|||||
IF MATERIAL RECEIVED BACK BY – STORES Received by (Sign/Date): Remark: |
||||||
IF MATERIAL RETURNED TO PARTY Report No /date: Stores In charge (Sign/Date): |
||||||
IF MATERIAL DESTROYED BY – PRODUCTION |
||||||
Destroyed
by production (Sign/Date): (As per SOP No.:
SOP-QA-018.) |
QA (Sign/Date): (In Presence Of QA Person ) |
|||||
CLOSE OUT DATE AFTER COMPLITION Close Out By QA Head / Designee (Sign/Date): |
||||||
Sr. No. |
Rejection
Req No. |
Date |
Item Name |
Initiating
Deptt. |
On Line
Rejection Initiated By (Sign /Date) |
Qty. Issued |
Qty. Rejected |
Approved
By (Sign/ Date) |
Action
taken /Report No |
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Pharmaceutical guideline only