by 1.0 OBJECTIVE
To describe the procedure for handling of the log books.
2.0 SCOPE
This SOP is applicable for procurement, issuance, usage and storage of log books in the individual department.
3.0 RESPONSIBILI
3.1 QA Shall be responsible for:
Procurement, issuance and storage of log books.
3.2 The section head shall be responsible for:
3.2.1 Issuance of log books within the department & review of log books.
3.2.2 Assigning numbering of log books.
3.2.3 Usage and maintaining the list of logbooks.
3.3 Head QA shall be responsible for
Ensuring the adherence of SOP.
4.0 ACCOUNTABILITY
Head- Quality Assurance
5.0 PROCEDUR
5.1 Procurement and receiving of log books.
5.1.1 Upon receiving of logbooks, assign serial numbers to each type of logbook on the front cover. e.g. 1 of 5 where 1 is number in increasing order with respect to quantity received and 5 is total Quantity received.
5.1.2 Each department shall get the logbooks issued from QA department.
5.2 Numbering of log book
5.2.1 For all logbooks used in the department, assign a number in the following manner;
The log book number shall be of 10 characters.
For Example: QC/LOG/001
Where,
First and second characters shall signify the department code (e.g. in this case it is QC for Quality Control department)
| Name of the department | Code |
| Quality Assurance | QA |
| Quality Control | QC |
| Microbiology | MB |
| Administration and Personnel | AP |
| Stores | ST |
| Production | PR |
| Purchase and Planning | PP |
| Engineering | EN |
Third character stands for”/”.
Forth, fifth and sixth characters stand for “LOG” is for log books.
Seven character stand for” /”.
Eight, nine and ten characters shall signify the subsequent number for logbooks.
5.2.2 Maintain the list of logbooks used in a department according to annexure
5.3 Log books front cover
5.3.1 All instrument logbooks shall have details on front cover according to annexure and Log books other than equipment shall have details on front cover.
5.3.2 Department employee shall prepare the front cover of log books.
5.3.3 Use separate logbooks for each instrument.
5.4 Log books entry
5.4.1 Respective user shall make online entries in the logbook.
5.4.2 Logbooks entries must be done with black ballpoint pens. Pencil entries are not allowed.
5.4.3 Review of log books
5.5.1 Respective section head shall review entries on a daily basis.
5.5.2 The logbook reviewer shall sign against the respective entry.
5.6 Re issuance and storage of log books
5.6.1 Section head must review the complete logbook to ensure completion of each entry.
5.6.2 After completion of logbooks, handover it to department head.
5.6.3 Put the end date on a front cover and department head shall handover to QA department..
5.6.4 QA department shall issue a next logbook to respective department.
5.6.5 Store the completed log book in documentation room.
5.7 Retention of log books
5.7.1 All the logbooks must be retained in a controlled manner as original documents.
5.7.2 Store all the completed logbooks in a secured manner in a documentation room.
5.7.3 The logbooks shall be retained till 5 years form last entry made in the logbook.
6.0 TRAINING
Trainer : Head – Quality Assurance
Trainees: Staff of all the departments
7.0 DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : Quality Assurance
8.0 ATTACHMENT
| Sr. No. | Annexure No. | Title | Format No. |
| 1 | NA | NA | NA |
9.0 REFERENCES
In-house
10.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
11.0 REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
