1.0 Objective

To lay down a procedure for Logging, Investigating, reporting, and disposing of Microbiology Laboratory Incidents.

2.0 Scope

This procedure is applicable for all the laboratory incidents logged in the Microbiology Laboratory.

3.0 Responsibility

• 3.1 Officer and above (Microbiologists): Responsible for logging and initiating the Laboratory incidents.
• 3.2 Section In-charge (Microbiology): Responsible for investigation, proposal of corrective/preventive actions, and establishing results.
• 3.3 Head (Microbiology): Responsible for final disposition of Laboratory incidents.

4.0 Accountability

Head/Designee – Microbiology.

5.0 Procedure

5.1 General Definitions

5.1.1 Incident: An incident can be defined as an unplanned or uncontrolled event in the form of non-compliance to the designed system or procedures at any stage during receipt, storage, handling, disposal and analysis of samples due to system failure, environmental variations, procedural errors or equipment breakdown or manual error.

5.2 Incident Types

• 5.2.1 Quality Impacting Incident (Deviation): Those occurrences/errors reported during execution of activity, which may affect the Quality, Safety, Efficacy and strength of the product/material or documents with departure from a written and approved procedures or an established standard. For handling of deviations, follow Handling of Deviations SOP.
• 5.2.2 Quality Non-Impacting Incident (Incidents and LIR): Those occurrences/errors reported during execution of activity, which may have no impact on the quality, safety, efficacy and strength of the product/material.
• 5.2.3 Typical examples of quality non-impacting incidents are as follows:
• 5.2.3.1 Sequential number allotment for the media preparation or autoclave serial number.
• 5.2.3.2 Allotting A.R. No. in sequential order.
• 5.2.3.3 Spillage of media while testing or plate preparation.
• 5.2.3.4 Spillage of samples.
• 5.2.3.5 Disturbances such as:
• 5.2.3.6 Power failures/UPS breakdown/Network and software connectivity issues.
• 5.2.3.7 Differential pressure less by 2 Pascal from the limit up to 1 hour in non-critical areas.
• 5.2.3.8 Temperature deviations from specified limits up to 5 hours in microbial testing area or in Microbiology laboratory.
• 5.2.3.9 Errors such as, but not limited to:
• 5.2.3.10 Improper selection of STP/SOP/GTP/media/materials/chemicals/cultures and Methods.
• 5.2.3.11 Dilution errors in solution preparation.
• 5.2.3.12 Obvious errors in calculation/integration and interpretation of results.
• 5.2.3.13 Wrong interpretation of test results.
• 5.3 Logging of LIR & Investigation
• 5.3.1 Upon identification of an LIR, the analyst shall immediately notify the Laboratory supervisor whenever the event has occurred.
• 5.3.2 Head of the Department/Designee along with the analyst shall evaluate the impact of the event on the Quality, Safety and efficacy of the product and severity on laboratory functioning.
• 5.3.3 Analyst shall fill the relevant details in the header of the Incident report form based on the event occurrence and handover to Head of the Department/Designee.

5.4 Numbering of Laboratory Investigation Report (LIR)

5.4.11Numbering Format: LIR/PM/YY/XXX

The unique identification number for an LIR is constructed as follows:

• LIR: The first three characters indicate the document type (“Laboratory Investigation Report”).
• /: The fourth character is a slash separator.
• PM: The fifth and sixth characters indicate the department code (” Pharma Microbiology”).
• /: The seventh character is a slash separator.
• YY: The 8th and 9th characters represent the last two digits of the current calendar year (e.g., 26 for the year 2026).
• /: The tenth character is a slash separator.
• XXX: The last three characters are numerical, assigned in sequential order starting from 001 at the beginning of every year.

Example: The first LIR filed in the Microbiology department for the year 2026 would be numbered as: LIR/PM/26/001 Laboratory supervisor is responsible for assigning the number for LIR in Annexure-01. Note: In the absence of the Laboratory supervisor, the analyst can initiate the LIR.

5.5 LIR Investigation, Closing and Disposition of Incidents

• 5.5.1 If any LIR happens during the ongoing activity, the concerned analyst or observer shall immediately inform the Laboratory supervisor.
• 5.5.2 Laboratory supervisor shall verify the details of the event and allot the Laboratory Investigation Report (LIR) number. Analyst shall write the Brief Description of LIR in Annexure-02 (FMT/MB/199).
• 5.5.3 FMT/MB/ contains an index page for LIR (for numbering and tracking), followed by LIR details.
• 5.5.4 After the LIR is logged, the Laboratory supervisor shall verify the root cause of the event occurrence and immediate corrective action can be proposed. This shall be informed to the Head of Department/Designee and documented in the space provided under the immediate action column in Annexure-02 (FMT/MB/199).
• 5.5.5 It shall be closed by the Laboratory supervisor/Section In-charge and verified by the HOD or designee.
• 5.5.6 The supervisor and analyst together shall investigate the probable reasons liable for any incidents.
• 5.5.7 After evaluation, the raw data of Quality non-impacting incidents shall be disregarded and proceeded for fresh analysis.
• 5.5.8 Quality non-impacting incidents shall be addressed predominantly through training and maintenance of instruments.
• 5.5.9 Head-Microbiology or his designee shall evaluate and investigate the incident.
• 5.5.10 Based on the investigation/evaluation, they shall propose and implement corrective and preventive actions.
• 5.5.11 Investigation and implementation of the corrective actions shall be completed in a maximum of 45 working days.
• 5.5.12 Microbiology Head/Designee and QA Head/Designee shall together investigate, evaluate and dispose of the quality impacting incidents.
• 5.5.13 All relevant data with respect to the incident shall be preserved for reference.
• 5.5.14 If necessary, the Laboratory supervisor shall recommend re-training to the analyst in that technique or event.

6.0 Abbreviations

8.0 Annexures

• 
  ANNEXURE-01: LIR NUMBERING LOG
  
  LOGBOOK: LABORATORY INVESTIGATION REPORT (LIR)
  S. No.
  LIR Number Date of Initiation Brief Description of Incident Name of Analyst(Sign / Date)
  
  
  
  
  
  Instructions for Completion:
  1. LIR Number: Assign in sequential order as per the format: LIR/MB/YY/XXX.
  2. Responsibility: Laboratory Supervisor maintains this log. In absence, Analyst initiates.
  3. Accuracy: Description must match individual LIR report (FMT/MB/199).
  4. Closing: Entries must be verified by HOD/Designee upon completion.
  Prepared By (Sign & Date): Checked By(Sign & Date):
  
  
• 
  Annexure-02: Laboratory Investigation Report
  LABORATORY INVESTIGATION REPORT (LIR)
  
  PART-I: INCIDENT LOGGING (To be filled by Analyst)
  LIR Number: Sample / AR No:
  
  Date: Analyst Name:
  
  
  
  Brief Description of Incident:
  
  
  Immediate Action Taken:
  
  PART-II: INVESTIGATION & ROOT CAUSE
  
  
  Investigation & Root Cause Details:
  
  Prepared By(Sign & Date): Approved By(Sign & Date):
•