SOP for Correction of documentation errors
1.0 OBJECTIVE :
To provide a procedure for correction of any documentation error, occurred during documenting data in operating departments (like Quality Control, Production, Warehouse, Engineering, QA, HR etc.
2.0 SCOPE :
The scope of this Standard Operating Procedure (SOP) covers the methodology of correcting the documentation errors in various documents and Ratification procedure for correcting the master documents like BMR / BPR / Protocols / Worksheet for Record of Analysis and any other which are generated at [Company Name]
3.0 RESPONSIBILITY :
3.1 Personnel of concerned department to implement.
3.2 Heads of concerned departments to ensure compliance.
3.3 Documentation Controller to make correction in issued copy and verify the correction in Master and Issued copy.
3.4 Head QA or Designee to make correction in Master as per request and ensure the compliance of this SOP.
4.0 PROCEDURE :
4.1 All personnel shall avoid to make data entry errors.
4.2 In case an entry error is occured, the correct entry is to be made as described below :
4.2.2 Do not over write the wrong entry. Cross it out with a line.
4.2.3 Clearly write the correct entry near the cross-out.
4.2.4 Initial sign and put the date, on which the correction was made.
4.3 If the correction is made on a date after the date of original entry, it must be corrected as mentioned above and counter-signed and dated by the immediate senior.
4.4 Under no circumstances, any artificial corrections be used to correct an error (e.g.., correction fluid etc.).
4.5 If an entire line/paragraph/page to be deleted from a sequential record / BMR / BPR / Worksheet / log book or stock card) the following steps are to be taken :
4.5.1 Cross it out with a line writing “NA” (Not Applicable).
4.5.2 Write a note (if required) explaining the reason for deletion near the cross-out.
4.5.3 Initial sign and put the date, on which the correction was made.
4.6 If the note was made on a date after the date of the initial entry, it must be corrected as mentioned above and counter-signed and dated by the immediate senior.
4.7 If any page(s) left blank, draw a line across the page and, write ” Cancelled” across the page and sign with date.
4.8 Do not leave any column in the record/document unfilled. If any column in a record/document is not applicable, write ‘NA’ or as per the regulatory requirement.
4.9 All documentation entries shall be made with ball point black color.
Note : incase if more corrections are there in one page due to the same reason, mark against “ * ” the correction and give justification at one place.
4.10 Document ratification procedure :
4.10.1 Following procedure shall be followed in case any ratification is required in master documents like VMP / SMF / BMR / BPR / Protocols / Worksheet for Record of Analysis any other document generated at [Company name].
4.10.1.1 Any minor mistakes like typographical error etc. in documents required for immediate use same shall be informed to QA through “Request for Document ratification “(Annexure- I) with proper justification .
4.10.1.2 The “Request for Document ratification “ shall be checked by Head of the concern department and shall be forwarded to Head –QA for approval .
4.10.1.3 After the approval from Head –QA / designee corresponding master document shall be corrected manually with sign & date in blue ink ball pen which shall be done by Head – QA or his designee .
4.10.1.4 The issued copy’s shall be corrected manually with sign & date in black colour ball pen which shall be done by QA personnel preferably Document Data Controller.
5.0 ANNEXURES:
Annexure –1 Request for Document ratification
Request for Document Ratification
From: To: Quality Assurance
Following correction are required to be done in BMR / BPR / Protocol / Worksheet for Record of Analysis / _____________________________________________generated at [Company name].
Of: ____________________________ Ref. No.: _________________________
Point No. / Page No.
Present Status
Required Correction
Reason for Correction
Requested By / Date
Checked By / Date
Approved By / Date
Initiator
HOD / Designee
Head QA / Designee
Corrections done in the master documents and issued copies.
Correction Done By / Date
Verified By / Date (Document Controller (QA)