1.0 Purpose: To describe the procedure for design, print, issuance, and control logbooks for equipment/ instruments and documents.
2.0 Aim: This Standard Operating Procedure is applicable to design, print, maintain, issue, and control the equipment/instrument or document logbooks about all activities in the Production department.
3.1 Printing and procurement of logbooks shall be done by the production department.
3.2 The issuance and inventory of logbooks shall be controlled and maintained by a responsible person in the QA department.
3.3 The production head shall ensure that the logbooks are filled as per the usage.
4.1 Printing of the logbook:
4.1.1 The first page of the logbook shall be printed with the information as mentioned in Annexure-1.
4.1.2 Each page of the logbook shall be numbered continuously.
4.1.3 The subsequent pages in the logbook shall be printed with the contents as mentioned in the formats of the respective SOP.
4.1.4 The responsible QA person shall maintain the inventory of the logbooks as per the Production department’s requirement.
4.2 Issuance and archival of logbooks:
4.2.1 The responsible person from the production department shall send a requisition for issuance with the details of equipment name, identification number, location, department, room number, and the reference SOP number to the responsible person in QA through a document request.
4.2.2 The responsible person in QA shall fill in the logbook details, e.g., Equipment name, Equipment ID, logbook number, Issued On (Date), Issued To, and Issued By, and shall sign and stamp it before issuing.
4.2.3 On completing the logbook, the production department shall request and submit the completed logbooks to the QA department.
4.2.4 Production department shall request the QA department for issuance of another logbook as per point no. 4.2.1.
4.2.5 QA shall archive the logbooks in the sequence of logbook numbers for each piece of equipment.
4.3 Usage of the logbook:
4.3.1 The logbooks of each piece of equipment shall be kept near the equipment/instruments whenever permitted.
4.3.2 The personnel will fill the logbooks using the equipment /instrument for every single user in real-time.
4.3.3 Any remarks on the equipment or the details of maintenance done shall be entered in the logbook.
4.3.4 The supervisor/in-charge of the respective sections shall check the logbook and sign for each activity performed.
QA: Quality Assurance
SOP: Standard Operating Procedure
No. : Number