| Reporting Laboratory Incident/ Discrepancy |
1.0 OBJECTIVE To lay down a procedure for Reporting Laboratory Incident/Discrepancy in quality control lab. 2.0 SCOPE This SOP is applicable for reporting Laboratory Incident/ Discrepancy in Quality Control Lab. 3.0 RESPONSIBILITY QC-officer / Sr. Officer / Executive /Sr. Executive and above. 4.0 ACCOUNTABILITY Head-QC 5.0 PROCEDURE 5.1 Operation: 5.1.1 This procedure is applicable to all Laboratory Incident/ Discrepancy occurring during the Analysis, Calculation, Reporting and storage of sample in Quality Control laboratories. 5.1.2 All laboratory incidents are reportable events; not all reportable events require investigations. All reportable events must be documented, tracked and trended in quality control laboratories. 5.2 The source of incidents/ Discrepancies includes but is not limited to the following examples. 5.2.1 System suitability failing during High Performance Chromatograph (HPLC). 5.2.1.1 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. 5.2.1.2 Analysis Carry over observed. 5.2.1.3 Chromatography – Ghost peak observed. 5.2.1.4 HPLC system interruption due to leakage problem, connectivity problem and power failure. 5.2.1.5 Virus in software or corruption of software, erratic operation system. 5.2.1.6 Mistake in calculation and or reporting. 5.2.1.7 Any contamination during sample / standard preparation / storage of sample. 5.2.1.8 Usage of Instrument before calibration etc. 5.2.1.9 Glassware breakage with sample or standard. 5.2.1.10 Sample spills during the analysis for e.g. Loss on drying(LOD), Sulphated Ash or water content. 5.2.1.11 Power failure e.g. during microbial analysis. 5.2.1.12 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 in quality control lab. 5.3 Analyst responsibility: 5.3.1 Any laboratories incident occurred during analysis above mentioned parameter shall be reported by concerned analyst to his/her section head. 5.4 The immediate supervisor/ section head shall inform to department head or designee; department head or designee shall issue the incident from as per format no.: XXX from QA department. 5.5 Retain the original test preparations such as standard, sample and reagent solutions until the incident has been checked and verified. 5.6 Consideration should be given to retaining solutions, glassware, etc., until the investigation is complete. Due to nature of some analysis (e.g., microbiology), this may not be possible in all cases. 5.7 Document the incident and assist the supervisor in performing the laboratory investigation where appropriate, assist in the implementation of the corrective action(s). 5.8 Checks and verifies (Supervisor or Designee). 5.9 Laboratory Executive, QC Assistant Manager, QC Manager. 5.10 Supervisor (or Designee): 5.10.1 Determine if it is necessary to conduct laboratory investigation and ensuring the investigation is performed. 5.10.2 Develop, document, and ensure implementation of the appropriate plan/protocol as part of the investigation process. 5.11 Section Head or Designee: 5.11.1 Ensure the integrity of data and documentation of laboratory incident in the tracking system. 5.11.2 Be accountable for completion of the LIR and requesting an extension of the target completion date, if appropriate. 5.11.3 Review, rationale, justification and documentation of resample, retest protocols or plans. 5.11.4 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. 5.11.5 Assess effectiveness of corrective and preventive actions. 5.12 Procedure: 5.12.1 A Laboratory Incident/ Discrepancy is a recordable event. 5.12.2 Whenever any unexpected Laboratory Incident/ Discrepancy are observed, the Analyst/Reviewer shall initiate the incident report by entering the details in the Incident Register as per format No. QC01-045/F01 within one business day of discovery of a discrepant laboratory. 5.12.3 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 in quality control lab. 5.12.4 The initiation date, is the date the on which Incident Report Number is assigned. 5.12.5 A 10-digit Incident Report Number shall be assigned as QCI/XX/YYY, Where 1st 2nd and 3rd characters are ‘QCI’ stand QC incident in quality control department. 4th characters are ‘/’ 5th and 6th characters are last two digit of year (‘23’ for year 2023) 7th characters are ‘/’ 8th, 9th and 10th characters are serial no. starting from 001. Serial no. will start 001 every year. 5.12.6 The analyst / reviewer shall write the brief of incident in the incident report in format No. QC01-045/F02 and shall attach all relevant data with report. 5.12.7 The Section in charge / Head of the department shall evaluate the incident and suggest the brief corrective action with justification in the incident report. 5.12.8 The analyst shall report the result obtained and shall attach all relevant data generated during the corrective action. 5.12.9 The Head QA shall evaluate the corrective action and give his decision on disposition of incident. 5.12.10 Corrective and preventive actions not completed prior to the report approval are documented and shall be tracked by QA. 5.12.11 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). 5.12.12 Corrective and preventive action commitments are complete upon verification by the Quality Assurance. 6.0 ABBREVIATIONS SOP – Standard Operating Procedure QC – Quality control KLE – Known laboratory error HPLC – High performance liquid chromatography e.g. – Example No. Number |
