Reporting, Investigating and Disposition of Incidents in Quality Assurance Department

Reporting, Investigating and Disposition of Incidents in Quality Assurance Department

OBJECTIVE :

To lay down a procedure for reporting, investigating and disposition of incidents in Quality Assurance Department.

RESPONSIBILITY :

Officer-QA to raise Incident Report  to allot number & due date to the Incident Report.

Officer-QA & Head-QA or his designee to investigate and take necessary corrective actions.

Head-QA to dispose the incident.

PROCEDURE

An incident can be defined as an unplanned event that occurs in non-compliance with the designed systems or procedures at any stage of the receipt, storage and manufacture and analysis of a drug product.

Incidents can be classified as

(a)  Quality Impacting

(b)  Quality non- Impacting

Quality Impacting incidents :

Quality Impacting incidents are occurrences/errors during execution of an activity which will affect the quality, purity and strength of a drug product.

Example :

Calculation errors with respect to Assay and LOD values during dispensing.

Major deviation from SOPs.

The Officer, who observes the incident shall immediately inform Head-QA or his designee about the incident.

An Incident Report shall be raised by Officer-QA by briefly describing the nature of incident in Section-I of the Incident Report  (Annexure-1).

Officer-QA shall allot the number & due date, enter the details of incident in the Incident Report register’ (Annexure-2) and forward it to Head-QA or his designee.

Each IR shall be allotted a number consisting of nine characters.

The first two characters are alphabets indicating department code as QA.

The third character is “I” indicating “Incident”.

The next three characters are numerical in sequential order starting from 001 every year.

The seventh character is dash ‘-‘ and last two characters are numerical indicating year. For e.g. : QAI001-20 shall be the first Incident Report in Quality Assurance department in the year 2020.

All the investigations and disposition shall be normally completed within fifteen (15) working days from the date the incident observed. However, if the nature of the incident is such that it requires more than 15 working days, the same shall be justified by Head-QA.

The reference number of the Incident Report shall be mentioned on the document where the incident occurred, whenever applicable.

Head-QA  or his designee along with the concerned Officer-QA shall investigate the reasons for incident. Head-QA or his designee shall describe the findings of  investigation and conclusion in Section-II of the Incident Report.

Head-QA or his designee along with Officer-QA shall take the necessary actions to correct the incident occurred and the same shall be mentioned in Section-III of the Incident Report.

Depending upon the nature of the incident Head-QA may refer to Head-Production or the Divisional Head for corrective measures and mention the same in Section -III of  the Incident Report.

After  the investigation is complete and and corrective actions are taken, Head-QA shall review & dispose the incident by giving his comments in Section-IV and forward the Incident Report to Officer-QA.

If either investigation is incomplete or corrective actions taken are inadequate, Head-QA shall suggest on further course of action. Once the suggested action is complete, he shall dispose the incident.

Officer-QA shall enter the disposition date of incident in ” Incident Report Register” and file the Incident Report in ” File for Incident Reports – QA” kept at QA Office.

Quality Non-impacting incidents :

Quality Non-impacting incidents are occurrences during execution of an activity which  may have no impact on the Quality, Purity and Strength of a drug product.

Examples :

Discrepancies in issuing requested Batch Production Record, Worksheet, Computer generated labels etc.,

Minor Deviations from SOPs.

The above examples of quality non-impacting incidents shall be addressed as per the  SOP on ‘Correction of Documentation Errors’ in the respective document.

DOCUMENTATION

Specimen format of “Incident Report” (Annexure-1).

Specimen format of “Incident Report Register ”  (Annexure-2).