Check double check the entries to sort the mistakes in documents.
Be sure that document is correct and complete prior to forwarding for next process.
Look at the documentation that essential part of whole job and not as an inconvenience.
Write each word clearly and legibly.
Know the procedure for cross-out the wrong word or sentence.
Never use WHITO/BLANCO .
Proper completion of documentation is important to ensure the traceability and accountability.
Every process must be documented.
Never trust your memory and record all necessary information immediately.
The work is not completed until it is documented.
Don’t use pencil on document.
Back dating on any document is not allowed.
CORRECTION OF WRONG ENTRIES, WRITE OVERS, MISSPELLED WORDS
Use a single line to cross out the mistake.
Never use WHITO/BLANCO.
Never erase or remove wrong written information.
Ensure that original entry is still legible.
Make the correction with initial and dates.
Write a short explanation, if required.
Initial must be done on cutting with date.
If any entry is made wrong in a document for example if batch # of any product is written like 389 instead of 398 then the wrong batch # should be cut as a whole and not partly. It should be initialed and dated.
38 9 -> Wrong practice
389 -> Correct practice
In case if an option is given in production BMR such as a.m/p.m, then one option can be omit/cut without any sign.
Spellings of words in documents are critical especially in case of ingredients, equipments names and technical data. Such information if spelled wrong should be corrected, initialed and dated.
Only the person responsible for the error should be notified to correct the error. In case the person is absent or has left the company only then supervisor/ manager of the person responsible for the error should be contacted to do the correction.
Missing information in a document should be filled only by a person responsible for the job. It should not be done a second person. If the person responsible is absent or has left the company the supervisor/ Manager of person should fill relevant information along with initial and date.
Signatures are required such as BMR, SOP, change control forms, protocols and procedures. In case of working documents Initials can be done such as batch record sheets, in process sheets, QC reports etc.
Blue ink color should be used by production/ QC/ QA for documentation. It should be used for all entries and signatures on original documents such as master BMR, SOP, Change control form, and protocols to distinguish the original signatures.
QA should use different color ink such as green to mark errors in batch record sheets while auditing the documents and also during in process checks.
If a document such as a log guide or a SOP is under review, corrections related to grammar can be done at this stage. If grammar correction is required in an approved document, it should be done whenever next revision is due.