USAGE AND MAINTENANCE OF EQUIPMENT LOGBOOK

• OBJECTIVE:

• To lay down the procedure for usage and maintenance of the equipment log books in Quality control department.

• SCOPE:

This SOP is applicable to the procedure for usage and maintenance of the equipment log books in the quality control department at {Company Name} {Location}.

• RESPONSIBILITY:
• Executive/Designee Quality Control For entering the required details in the log book and For Verifying the entries.
• Officer/Designee Documentation QA– For Issue and Control of logbooks.
• ACCOUNTABILITY:

             QA Head shall be Accountable for implementation of SOP.

• PROCEDURE:
• Quality control personnel shall read the instructions provided in logbook before making entries in logbook.
• All equipment user logbooks shall be under the control of Quality Assurance Department.
• The Quality Assurance Department shall issue the log book for all instruments to Quality Control by entering the instrument details like instrument name, format number, Instrument ID No. and book number.
• The respective section in charge of Quality Control shall verify the entries in respective logbook at the end of the analysis/day.
• If any discrepancies noticed in usage log, the same shall be brought to the notice of section In charge for corrective action.
• All the entries shall be made with blue ballpoint pen.
• Date column in equipment logbook shall be entered in DD/MM/YY.
• The Start and End time in the equipment log book shall be entered as 24 hours format. Ex.: 6 AM as 06:00 and 6 PM as 18:00.
• If any column is not applicable enter “NA” in the respective column.
• If any miscellaneous information related to instrument shall be written in remarks column or otherwise write “NIL”.
• Completed logbooks shall be signed off by QC Sr. Executive/Designee and returned to Quality Assurance Department.
• At the end of the year QA Executive/Designee shall retrieve all instruments log books and issue the new books.
• For any error during entry, the following procedure as to be followed:
• In case any wrong entry Strike it out with a single line.
• Clearly write the correct entry near the wrong entry.
• Sign and put the date on which the correction was made.
• If an entire line is to be deleted, strike it out with a single line (horizontal/vertical).
• Write a note explaining the reason for deletion with sign and date. The Section In charge shall verify and counter sign the same.

Note: Ensure always avoid wrong entry and over writing.

Click the link for download word file copy of this document:
https://pharmaguidehub.com/product/usage-and-maintenance-of-equipment-logbook/

• REFERENCES:

Not Applicable

• ANNEXURES: 

Not Applicable

        ENCLOSURES: SOP Training Record.

•  DISTRIBUTION:
• Controlled Copy No. 01  :          Head Quality Assurance
• Controlled Copy No. 02  :         Head Quality Control
• Master Copy                    :          Quality Assurance Department
• ABBREVIATIONS:

• REVISION HISTORY:

CHANGE HISTORY LOG

Frequently Asked Question?

• Q: What should personnel do before making entries in the logbook?
  • A: Read the instructions provided in the logbook.
• Q: Who controls the equipment user logbooks?
  • A: The Quality Assurance Department.
• Q: How are logbooks issued to Quality Control?
  • A: QA issues them, recording instrument details and book information.
• Q: Who verifies logbook entries?
  • A: The respective section in charge of Quality Control at the end of analysis/day.
• Q: What happens if discrepancies are found?
  • A: They are reported to the section in charge for corrective action.

• Q: What pen color should be used for entries?
  • A: Blue ballpoint pen.
• Q: What format is used for dates?
  • A: DD/MM/YY.
• Q: What format is used for times?
  • A: 24-hour format (e.g., 06:00 for 6 AM).
• Q: What to do if a column isn’t applicable?
  • A: Write “NA”.
• Q: What to do if miscellaneous information needs to be recorded?
  • A: Write it in the remarks column or write “NIL” if none.
• Q: Who signs off completed logbooks of QC?
  • A: QC Sr. Executive/Designee.
• Q: What happens to completed logbooks?
  • A: Returned to the Quality Assurance Department.
• Q: When are new logbooks issued?
  • A: At the end of the year by the QA Executive/Designee.

• Q: How to correct a wrong entry?
  • A: Strike it out with one line, write the correct entry nearby, and sign and date the correction.
• Q: How to delete an entire line?
  • A: Strike it out horizontally or vertically, write a reason for deletion with your signature and date, and have the section in charge countersign.
• Q: What is recommended to avoid?
  • A: Wrong entries and overwriting.

Click the link for download word file copy of this document:
https://pharmaguidehub.com/product/usage-and-maintenance-of-equipment-logbook/