SOP on Reporting Laboratory Incident

1. Objective

  To lay down a procedure for the handling of Incident or Discrepancy.

• Scope

This SOP is applicable for the handling of any Incident or Discrepancy in the Quality           Control.

• Responsibility

  QC – Chemist / Officer / Executive.

• Accountability

  Department Head.

• Procedure
  • Operation:
  • This procedure is applicable to all Incidents / Discrepancies occurring during the Analysis, Calculation,

Reporting and storage of sample in Quality Control laboratories.

• All laboratory incidents are reportable events; not all reportable events require investigations. All reportable events must be documented, tracked and trended.
  • The source of incidents/ Discrepancies includes but is not limited to the following examples.
  • System suitability failing during analysis of High Performance Chromatograph (HPLC) & Gas Chromatograph.
  • Known Laboratory Error (KLE): This type of an incident is an error that is known to be caused by the analyst (such as a spill) or laboratory instrument failure.
  • Analysis Carry over observed.
  • Chromatography – Ghost peak observed.
  • HPLC and GC system interruption due to leakage problem, connectivity problem and power failure.
  • Virus in software or corruption of software, erratic operation system.
  • Mistake in calculation and or reporting.
  • Any contamination during sample / standard preparation / storage of sample.
  • Usage of Instrument before calibration etc.
  • Glassware breakage with sample or standard preparation.
  • Sample spills during the test for e.g. Loss on drying, Sulphated Ash or water content.
  • Power failure e.g. during microbial analysis.
  • An unexpected or unplanned event outside of the control of the laboratory. This type of an event includes, but is not limited to: Damaged Samples, Power outages or variances, Environmental conditions.
  • Wrong vial numbering in the HPLC and GC sequence.
  • Missing of bracketing standard.
  • Bracketing standard failure, system suit failure.
  • Inadequate or improper integration.
  • Analyst responsibility:
  • Based upon sound scientific principles or test procedures, discontinue testing and immediately notify supervisor or designee if an incident, problem or error is suspected or recognized.
  • Document and describe the incident in detail and any immediate action(s) taken.
  • Retain the original test preparations such as standard, sample and reagent solutions until the incident has been checked and verified.
  • Consideration should be given to retaining solutions, glassware, etc., until the investigation is complete. Due to nature of some testing (e.g., microbiology), this may not be possible in all cases.
  • Document the incident and assist the supervisor in performing the laboratory investigation where appropriate, assist in the implementation of the corrective action(s).
  • Checks and verifies (Supervisor or Designee).
  • Laboratory Executive, QC Assistant Manager, QC Manager.
  • Supervisor (or Designee):
  • Determine if it is necessary to conduct laboratory investigation and ensuring the investigation is performed.
  • Generate the Laboratory investigation number in.
  • Develop, document, and ensure implementation of the appropriate plan/protocol as part of the investigation process as per format Number
  • Laboratory Manager or Designee:
  • Ensure the integrity of data and documentation of laboratory incident in the tracking system.
  • Be accountable for completion of the LIR and requesting an extension of the target completion date, if appropriate.
  • Review, rationale, justification and documentation of resample, retest protocols or plans.
  • Ensure the design, implementation and completion of corrective actions as a result of the assignable cause of an incident (e.g. instrument malfunction) are documented and verified.
  • Assess effectiveness of corrective and preventive actions.
  • Procedure:
  • A laboratory incident or discrepancy is a recordable event.
  • Whenever any unexpected Incidents/Discrepancies are observed, the Analyst/Reviewer shall initiate the incident report by entering the details in the Incident Register within one business day of discovery of a discrepant laboratory.
  • The checker shall review and approve the incident report within 30 business days of the initiation date unless the Quality Manager approves an extension. The reasons and rationale for any extension will be documented.
  • The initiation date, is the date the on which Incident Report Number is assigned.
  • A 10 digit Incident Report Number shall be assigned as QCI/YY/NNN,

Where 1st 2nd and 3rd characters are ‘QCI’ stand QC incident.

4th characters is ‘/’

5th and 6th characters are last two digit of year (‘08’ for year 2008)

7th characters is ‘/’

8th, 9th and 10th characters are serial no. starting from 001. Serial no. will start 001 every year.

• The analyst / reviewer shall write the brief of incident in the incident report in Annexure-II and shall attach all relevant data with report.
  • The Section in charge / Head of the department shall evaluate the incident and suggest the brief corrective action with justification in the incident report.
  • The analyst shall report the result obtained and shall attach all relevant data generated during the corrective action.
  • The Head QA shall evaluate the corrective action and give his decision on disposition of incident.
  • Corrective and preventive actions not completed prior to the report approval are documented and shall be tracked by QA.
  • Under appropriate circumstances corrective and preventive actions must be completed prior to resumption of laboratory related activities that directly impact product quality (e.g., instrument malfunction).
  • Corrective and preventive action commitments are complete upon verification by the Quality Assurance.
• TRAINING:

              Trainer   : Manager – Quality Control

             Trainees: Staff of the QC departments

• DISTRIBUTION:

              Master Copy                 :           QA Department

               Controlled Copy           :           QC Department

               Display Copy                 :          QC Department

•  ATTACHMENTS:

01.

NA

NA

•  REFERENCES:

         In-House

1. ABBREVIATIONS:

Abbreviations	Extended Form
SOP	Standard Operating Procedure
NA	Not Applicable
QC	Quality Control
Sr. No.	Serial Number
QA	Quality Assurance
DEPT.	Department

1. REVISION HISTORY OF CHANGE:

Sr. No.	Date	Revision Details	Revision No.