by - 0 OBJECTIVE
To lay down a procedure for good documentation practice in quality assurance, quality control, production and other departments.
2.0 SCOPE
This SOP is applicable for all quality system documents. This procedure also describe for correcting errors in documents.
3.0 RESPONSIBILITY
All Employees those who make entries in quality system documents.
4.0 ACCOUNTABILITY:
Head – Quality : For Compliance.
5.0 PROCEDURE
5.1 All Documentation entries shall be made with indelible blue ink in clear and legible handwriting.
5.2 Verification of the documents by QA shall be done by using indelible green ink.
5.3 Green ink shall be used for issuance of daily monthly documents and BMR/BPR by QA.
5.4 Do not leave any column in the record/document unfilled. If any column in a recorded documents is Not applicable, write ‘NA’. If no comments write Nil or put a dash‘——’.
5.5 Time should be expressed, as HH.MM i.e. 2 pm should be recorded as 14:00Hrs.
5.6 While issuing documents and in other record books the date should expressed as DD/MM/YYYY.
While approving documents the date should be expressed as DD/MM/YYYY.
5.7 If any page(s) are left blank , draw a line across the page from left top to right bottom of the page and Write ‘‘CANCELLED’’/‘‘N.A.’’ (Not applicable) across the page and sign with the date.
5.8 If any entire page/paragraph is to be canceled from written documents, QA countersign is required.
5.9 No Pencil entries are allowed.
5.10 Do not use correction fluid in any of the documents.
5.11 All Personnel shall avoid errors during data entry.
5.12 In Case an entryerror has occurred, the dame shall be corrected as described below.
5.12.1Do not overwrite the wrong entries. Cross it out with a line permitting the reading of original entry.
5.12.2Cleaarly write the correct entry near the cross out.
5.12.3Initial / Sign. And put the date, on which the correction was made. Wherever appropriate , the reasons for correction shall be recorded.
5.12.4If the correction is made on a date after the date of original entry, it must be corrected as mentioned
above and countersigned and dated by the supervisor or QA.
5.13 If an entire line/paragraph/page to be deleted from a sequential record (e.g. log book or stock card)
the following steps to be taken.
5.13.1 Cross out with a line.
5.13.2 Write a comment explaining the reason for deletion near the cross out.
6.0 TRAINING
Trainer : Head Quality Assurance
Trainees : Staff of all the departments.
7.0 DISTRIBUTION
Master Copy : Quality Assurance
Controlled Copy : All Department
8.0 ATTACHMENT
Nil
9.0 REFERENCES
In-house
1.0 ABBREVIATION
| Abbreviation | Extended Form |
| EG | Engineering |
| SOP | Standard Operating Procedure |
| QA | Quality Assurance |
| WH | Warehouse |
| NA | Not Applicable |
| MB | Microbiology |
- REVISION HISTORY OF CHANGE
| Sr. No. | Date | Revision Details | Revision No. |
| 1 | NA | New SOP | 00 |
