Process Change Control SOP
1.0
PURPOSE:
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1.1.
The purpose of Process Change Control is to be followed while controlling
process
change in
___________Plant.
2.0 SCOPE:
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2.1.
This procedure is to be followed while controlling process change in
___________
Plant.
3.0 RESPONSIBILITY:
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3.1. All Department Heads
3.2. QA Officer
3.3. Admin Officer
4.0 CRITICAL PROCESS:
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4.1
Following are the critical processes in which change need control in order to
control
Process variability & for smooth
operation:
4.1.1 Change
of source / supplier for starting & Packing Materials
4.1.2 Change
in standard Batch Size.
4.1.3 Change
in Product Master Formula.
4.1.4 Abrupt
change in running manufacturing / packing process.
4.1.5 Batch
break up during packing. / delay of packing of particular batch for
More
than 1 month.
4.1.6 Any
change in Engineering Process.
4.1.7 Change
in measuring & / or monitoring frequency.
4.1.8 Any
other change in Production process.
4.1.9
Changes due to Marketing Department.
5.0
REVIEW FREQUENCY:
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SOP will be reviewed at least annually.
ACTIVITY
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RESPONSIBILITY
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RECORD
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Director (Technical) will immediately inform
and issue a notice to all concerned regarding product recall.
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Director
(Technical)
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Director (Technical) recommends recall action
to the Director Marketing who initiates product recall.
In case of Products Exported, Manager
International Marketing to initiate for destruction of Goods in the country
of export under supervision of authorized Agent.
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Director
(Technical)/
Manager
Marketing
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(Recall Action Record)
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Recall action by Director (Technical) and the
following personnel or their assistant are called to participate in the
recall activity:
Quality Control Manager
Production Manager
Inventory Control Manager
Quality Assurance Manager
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Director
(Technical)
|
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Ascertain and
verify identification of the products to be recalled. Include the following
information on F-07-011
Name of the product, its strength and pack size
Product Batch Number
The Nature of Defect
Total Quantity
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Director
(Technical) (to be assisted by the QC Manager, Production Manager Inv.
Control Manager & Admin Manager
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Check and record quantity in stock. Immediately
stop further distribution.
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Inventory
Control Manager/Admin Manager
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Store
Records
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Determine the names and addresses of consignees
from Finished Goods Distribution Record (including that which may be in
transit and inform Director Marketing).
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Inventory
Control Manager/Admin Manager
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Inform Consignees by telephone/fax/courier
delivered letter/Email/Whatsapp. Advised to collect & return defective
stocks.
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Director
Marketing /Admin Manager
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Office
files
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Segregate and store the defective product
identified by red color labels giving: Name and strength, reported defect,
Batch Number, and date received back.
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Inventory
Control Manager
|
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Review of nonconformance & disposal
Instructions
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Director (Technical)
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Ensure Disposal Instructions are implemented
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Director (Technical)
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