Q: What are the major root causes of QC lab errors?
- Instrument & Equipment Failures: Inadequate instrument maintenance, Calibration issue, Wear and Tear of instrument, Power fluctuation and Software malfunction
- Human errors: Improper training or lack of competency, Fatigue and stress, Misinterpretation of results, Poor documentation practices and SOP non-compliance
- Methodological & Procedural Errors: Unvalidated or outdated test methods, Poor sample preparation, Cross-contamination and Incorrect reagent preparation
- Environmental Factors: Temperature & humidity fluctuations, Vibration or air contamination and Poor lighting or workspace organization
- Data Integrity Issues: Manual data entry errors, Manipulation of results and System errors in LIMS (Laboratory Information Management System)
- Material-Related Issues: Expired or degraded reagents and chemicals, Impurities or inconsistencies in raw materials and Improper storage of standards & reference materials
- Lack of Proper Supervision & Oversight: Insufficient review processes and Lack of audits or self-inspections
Q: What is a common error in HPLC sample preparation?
A: Improper sample dissolution leading to inaccurate quantification, peak area variability, and inconsistent retention times.
Q: What are the root causes of this issue and How it resolved?
A: Incomplete dissolution, inconsistent sample handling, inappropriate solvent selection, and variable extraction procedures. It will be resolved through Standardize sample preparation protocols with detailed SOPs and use validated solvents.
Q: What is a common GC error?
A: Column contamination leading to ghost peaks, false positives, and compromised quantification accuracy.
Q: How can this issue be addressed?
A: Regular column maintenance, bake out procedures, installing guard columns, and verifying column performance.
Q: What error occurs in UV spectroscopy?
A: Baseline drift leading to inaccurate absorbance readings.
Q: What are the common causes?
A: Temperature fluctuations, lamp intensity variations, and dirty optical components and can be resolved through Regular blank measurements, temperature controllers, and scheduled lamp replacement.
Q: What issues arise in IR sample preparation?
A: Variable sample thickness in KBr pellets and moisture interference.
Q: What is the modern solution?
A: Adopting ATR techniques for consistent sample-crystal contact.
Best Practices for Error Mitigation
Implement robust training, Enforce clear SOP, Use LIMS for data management, competency programs, Preventive maintenance, error reporting culture, using automated data capture, audit trails, continuous improvement initiatives and Implement a strong QMS with routine audits and error-tracking.
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Resource Person: Vikas Bedi