SOP For documentation and data control is described in this post which you can follow in the section of the Quality Assurance Department.

OBJECTIVE

To lay down a procedure to provide the guidelines for effective handling of documentation and data control.

SCOPE

This SOP applicable to quality assurance department.

RESPONSIBILITY

QA Officer

ACCOUNTABILITY

Manager Quality Assurance

PROCEDURE

"Controlled" Document

On controlled document stamp must be read as "CONTROLLED" and the color of stamp must be "RED"  to avoid the possibility of a photocopy being used as "Controlled" documents.

"Master Copy"

Original copy of the documents must have "Master Copy" stamp designed by the concerned officials and it must remain in the custody of QA Manager.

NATURE OF CONTROL

The controlled document must have the following details:

  • Logo, Name and address of the organization
  • SOP/Document Title
  • SOP/Document Number
  • The effective date of SOP
  • Revision status.
  • Signature of the approving personnel

Document Approval:

Each document must be verified and approved by authorized personnel prior to their issue and  implementation.

 list of all controlled documents must be maintained.

Master list of all "Controlled" documents showing their latest revision status must  be maintained with Quality Assurance Manager.

Master Copy of each controlled document must be stored/placed in the safe custody of QA Manager 

Any change required in the documents related to production, process and control procedures  must be implemented through "Change Control System" 

Changes made  to the document must be reviewed and approved by the change control committee as per SOP.