Standard Operating Procedure for raising File Note

1.0 OBJECTIVE:

To lay down the procedure of raising the File Note by Concern Department.

2.0 SCOPE:

The scope of the SOP covers the procedure for the raising the File Note by Concern Department at [company name].

3.0 RESPONSIBILITY:

3.1 Responsible person from any department for preparing file note based on the matter with justification. 

3.2 Head – Quality Assurance to give final approval in file note.

4.0 PROCEDURE :

4.1 File Note shall be raised for the matter, which cannot be handled through Incidents, Deviation, Out of specification or change control procedure.

4.2 During review of any documents, if any discrepancy is found shall be handled through file note, which shall also be known as decision note.  

4.3 The initiator Department or affected department shall prepare the file note indicating the real cause and concern.

4.4 File note shall be prepared in the format as per annexure –II

4.5 After preparing the file note the same shall be submitted to QA department where QA member will provide the number to file note.    

4.6 File note numbering shall consist of thirteen character as example follows, 

FN/Department Code/Sr. No./Year  

4.7 The list of various department shall be as per the annexure – I.

4.8 After the file note is allocated with the number the same shall be forwarded to QA head for his reference and recommendation on the issue. 

4.9 Once the file note is Approved by QA head the QA member shall log the file note number in the file note register as per annexure – III. 

4.10 The QA member shall take the one photocopy of the file note. Photocopy shall be submitted to respective concern department for filing in the respective documents and the original shall be retained with the QA department in the File Note file.

4.11 File note need to be prepared with proper justification.

5.0 ANNEXURES 

Annexure-I List of codes for various departments

Annexure-II Format for the File Note

Annexure-III Format of register for logging the File Note details 

Annexure – I: LIST OF DEPARTMENT CODES

Sr. No.

Department

Department code

Annexure – II: Format for File Note

Date:

File Note No.:

Subject: 

Summary and Justification

Prepared By:

Approved By:

Annexure – III: Format of register for logging the File Note details

Sr. No.

File Note No.

Date

Department

Remarks