Process Change Control SOP

1.0   PURPOSE:

1.1. The purpose of Process Change Control is to be followed while controlling process
        change in ___________Plant.

2.0    SCOPE:

2.1. This procedure is to be followed while controlling process change in ___________


3.1.      All Department Heads
3.2.      QA Officer
3.3.      Admin Officer


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.


SOP will be reviewed at least annually.

Director (Technical) will immediately inform and issue a notice to all concerned regarding product recall.
Director (Technical)

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.
Director (Technical)/
Manager Marketing
 (Recall Action Record)
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
Director (Technical)

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
Director (Technical) (to be assisted by the QC Manager, Production Manager Inv. Control Manager & Admin Manager

Check and record quantity in stock. Immediately stop further distribution.
Inventory Control Manager/Admin Manager
Store Records
Determine the names and addresses of consignees from Finished Goods Distribution Record (including that which may be in transit and inform Director Marketing).
Inventory Control Manager/Admin Manager

Inform Consignees by telephone/fax/courier delivered letter/Email/Whatsapp. Advised to collect & return defective stocks.
Director Marketing /Admin Manager
Office files
Segregate and store the defective product identified by red color labels giving: Name and strength, reported defect, Batch Number, and date received back.
Inventory Control Manager

Review of nonconformance & disposal Instructions
Director (Technical)

Ensure Disposal Instructions are implemented
Director (Technical)