Document No.

SK/QA/F/24

Change Impact Assessment Revision No. 01

Effective No. 02.01.2024

Change Initiation
Process change Material change Engineering Change New Product Addition
Scope of change Existing Product Organization Restructure Roles & Responsibilities Change in Product Design
Design History File (DHF) Labelling Supplier System (s)
Other (*if any) ……………………………
Initiation date of
Impact Assessment Assigned Change Control No.

Initiator Department

Title of Change

Existing Proposed
Description of Proposed Changes
Changes
Justification/ Reason for
change

Impact & Risk analysis

SHINKWANG ELECTRONICS PVT.LTD.

 Document No. SK/QA/F/24

Change Impact Assessment Revision No. 01

Effective No. 02.01.2024

Department Review Contents Y N N/A

Does it conform to legal requirements?   
Is the changes subject to the relevant permit change, declaration/annual report or internal control? (Relevant
institutions such as MFDS, CE, MDSAP, WHO)   
*In case of change? (If applicable, write it in the ‘Comment’)
Regulatory Affairs Are there any amendments to the documents/information related to permit registration (REF No, TCF, FSC, etc.)?   
Department Are there changes to the standard document/from?   
As a result of risk assessment, Is it necessary to take risk control measure due to this change?   
Other (if any specified)   
Comment

Does it affect sales?   

Does it affect usability?   
Does it affect the product packaging?   
Marketing Department Are there changes to the standard document/form?   
Other (if any specified)   
Comment

Impact & Risk analysis

Department Review Contents Y N N/A
Does it conform to legal requirements?   

SHINKWANG ELECTRONICS PVT.LTD.

 Document No. SK/QA/F/24

Change Impact Assessment Revision No. 01

Effective No. 02.01.2024

Does it require change in registration, (period/ country / requirement) by countries?

  
Does the customer approve the change?   
Sales Department Other (if any specified)   
Comment

Is it easy to purchase and procure new materials?   

Is it necessary to assign a new material item code?   
Are there changes to the standard documents / from?   
Purchase Department Is it a supplier that can trade continuously?   
Other (if any specified)   
Comment

Is it necessary to identify the stock of existing materials (raw and subsidiary materials, marked materials and half- finished products)?

Logistics Department Other (if any specified)

Comment

Impact & Risk analysis

Department Review Contents Y N N/A
Can existing facilities be used?   

SHINKWANG ELECTRONICS PVT.LTD.

 Document No. SK/QA/F/24

Change Impact Assessment Revision No. 01

Effective No. 02.01.2024

Is it necessary to invest in new facilities   

Manufacturing Department Are there changes in work method?   
Are there changes to the standard document /from?   
Are there impact on the validation of processes or equipment?
(The need for re-validation)   
As a result of risk assessment, Is it necessary to take risk control measure due to this proposed change?   
Does the production plan need to be changed?   
Is it possible to exhaust the inventory of the existing materials (raw and subsidiary materials, marked materials and
half – finished /finished products)?   
Other (if any specified)   
Comment

Does the infrastructure need to be change?   

Does the Preventive maintenance schedule need to be revised?   
Does the change require preventive maintenance of any equipment?   
Purchase Department Is the change to affecting the utility or the facility?   
Are there changes to the standard document/form?   
Does the change required information to customer &/ or regulatory authorities regarding addressing the change?   
Does the role of organization is affected by the change?   
Other (if any specified)   
Impact & Risk analysis
Department Review Contents Y N N/A
Comment   
Etc.   

SHINKWANG ELECTRONICS PVT.LTD.

 Document No. SK/QA/F/24

Change Impact Assessment Revision No. 01

Effective No. 02.01.2024

Assessment By Other Departments for Proposed Changes

Departments Accepted/Rejected HOD (Sign/Date) Comments (if any)

Manufacturing Accepted/Rejected

Regulatory Affairs Accepted/Rejected

Quality Control Accepted/Rejected

Engineering Accepted/Rejected

Warehouse Accepted/Rejected

Purchase Accepted/Rejected

HR/Admin Accepted/Rejected

Marketing Accepted/Rejected

Quality Assurance Accepted/Rejected

Note: In case, recommendation form other departments are required, more columns can be added as per the requirement

SHINKWANG ELECTRONICS PVT.LTD.

 Document No. SK/QA/F/24

Change Impact Assessment Revision No. 01

Effective No. 02.01.2024

QA Decision
QA Progress Approval Check Box Final Decision Comments (if any)
(Name)
 Proceed

 Reject

Provide Justification
(If rejected)
Sign& Date

SHINKWANG ELECTRONICS PVT.LTD.