To lay down a procedure for correction of documentation error(s) occurred during documenting the data.
1.0 OBJECTIVE
1.1 To lay down a procedure for correction of documentation error(s) occurred during documenting the data.
2. RESPONSIBILITY
2.1 All personnel who are entering the Data.
2.2 Deputy Manager – Quality Assurance
3. ACCOUNTABILITY
3.1 Head – Quality Assurance & Regulatory Affairs
4. PROCEDURE
? All personnel should avoid making entry errors.
4.1 In case if an error has been occurred during documentation, the same shall be corrected as follows:
• Do not over write the wrong entry.
• Strike it out with a single line.
• Clearly write the correct entry near the wrong entry.
• Initial and put the date on which the correction was made.
• Under no circumstances any artificial correction fluid be used to correct the wrong entry.
• Write reason for correction, where results etc. are corrected, such as yield, analytical result, date etc.
4.2 If an entire line or paragraph or page is to be deleted from a sequential record / document, the following steps to be taken:
• Strike it out with a line (Horizontal / Vertical)
• Write a note explaining the reason for deletion with sign and date.
• Initial and put the date near the strike out.
If a note is made on a date after the date of original entry it must be corrected as
mentioned in section 4.1/4.2 and counter signed by the immediate senior.
4.3 Based on the Quality of the product, errors are divided into two types;
4.3.1. Quality Impacting errors.
4.3.2. Non Quality Impacting errors.
? If the correction is done on the date before approval document/material/product, the correction shall be done as mentioned in section 4.1/4.2 and counter signed by the immediate senior with sign and date.
? If the correction is done on a date after approval, of a document / material / Product it shall be corrected based on the Quality impacting error..
4.3.3. Quality Impacting Errors
For the corrections, which are required after the release of the document / material / Product into the market, the correction shall be done as follows.
If a note is made correction shall be carried out as follows:
? A request shall be raised by the Initiator Department, if an error has been observed. The request shall be raised in Annexure -1 by giving the details of the Error and its Corrective actions.
? Concerned department head shall give comments/ Justification and request for the approval of the correction.
? Deputy Manager -QA shall approve the request for document ratification with comments.
? Head-Quality Assurance and Regulatory Affairs shall authorize the correction(s) of error with comments.
? After receiving the authorization from Head-Quality Assurance and Regulatory Affairs, the concerned In-charge shall correct the error by signing on the date of correction made with cross check from departmental head sign and date.
? The request for document ratification shall be filled along with the concerned document till retrieves.
? Based on the Quality of the product, the final decision shall be taken by Head-Quality Assurance and Regulatory Affairs by receiving the comments from the concerned department head through a process of investigation (if required).
? Based on the decision, the product can be recalled by giving Internal communication from Head-Quality Assurance and Regulatory Affairs to Head-Marketing.
? In absence of any In-charge, the department head can write the In-charge name and the document shall be ratified
4.3.4 Some of the identified Quality Impacting errors are;
a. Numerical numbers, which affect the final end, value result or yield.
b. Words or Phrase that give adverse meaning.
c. Over writing / whitening of letters / rubbing / artificial corrections of the entries.
d. Wrong calculations that affect the final end value
e. Correction(s) required, if any, in any approved document.
f. Formulae symbol which are typed wrongly in masters
g. Any correction required in a document after release into the market
4.3.5 Non-Quality Impacting errors
Getting authorization from In-charge of the respective department can do as correction.
END OF DOCUMENT
Documentation errors, quality assurance, correction
