Quality Assurance (QA) & Quality Control (QC)

in Chemistry: A Detailed Overview

Prepared by

Section Head, chemist: M. Sarwat Fakar

Misr Phosphate Company (MPCO)

Ministry of Petroleum & Mineral resources

Section Head, Chemist |M. Sarwat Fakar Page | 1

 Quality Assurance (QA) in Chemistry: A Detailed Overview

Definition of QA in Chemistry
Quality Assurance (QA) in chemistry involves the planned and systematic processes necessary to provide
confidence that analytical testing and chemical processes will consistently meet predefined quality
standards. QA focuses on preventing errors and ensuring that laboratory practices, methods, and results
are reliable and valid.

Objectives of QA in Chemistry
1. Ensure compliance with regulatory and accreditation requirements (e.g., ISO 17025, GLP).
2. Provide documented evidence of reliable and traceable laboratory operations.
3. Maintain a framework for continuous improvement in laboratory performance.
4. Assure clients of consistent, accurate, and reproducible results.

Key Components of QA in Chemistry

1. Documentation and Record Keeping: Establishing and maintaining detailed records for
procedures, results, and corrective actions.
2. Standard Operating Procedures (SOPs): Written guidelines for all analytical methods and
operational processes.
3. Internal Audits: Routine evaluation of laboratory activities and records to ensure compliance.
4. Training and Competence Assessment: Ensuring personnel are skilled and qualified to perform
analyses.
5. Corrective and Preventive Actions (CAPA): Systematic resolution of non-conformities and
implementation of preventive measures.
6. Continuous Improvement: Regular review of processes to identify opportunities for
enhancement.

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Methodologies in QA for Chemical Laboratories
1. Standard Operating Procedures (SOPs)
• SOPs provide detailed instructions for each laboratory task, from sample preparation to data
analysis.
• Example: SOP for sample digestion in atomic absorption spectrometry (AAS).
2. Method Validation and Verification
• Ensuring analytical methods are suitable for their intended purpose by validating parameters such
as accuracy, precision, linearity, and robustness.
• Example: Validating an HPLC method for the quantification of caffeine in beverages.
3. Internal Quality Audits
• Scheduled audits to check for compliance with laboratory procedures and standards.
• Example: An audit revealing inconsistencies in calibration records.
4. Traceability and Document Control
• All reagents, instruments, and samples should be traceable to their origins and usage.
• Example: Maintaining batch records for standard solutions.
5. Risk Assessment and Management
• Identifying potential sources of error and implementing mitigation strategies.
• Example: Risk assessment for chemical contamination in a cleanroom environment.
6. Corrective and Preventive Actions (CAPA)
• Investigation and resolution of non-conformities to prevent recurrence.
• Example: Investigation of a failed calibration and subsequent retraining of personnel.
7. Proficiency Testing (PT) and Interlaboratory Comparisons
• Participation in external PT schemes to validate analytical accuracy.
• Example: Comparing laboratory results for water sample analysis with other accredited labs.
8. Equipment Qualification (IQ, OQ, PQ)
• Qualification stages to ensure instruments perform as intended.
o IQ (Installation Qualification): Ensures the correct installation of equipment.
o OQ (Operational Qualification): Verifies that equipment operates within specifications.
o PQ (Performance Qualification): Confirms consistent performance under real-world
conditions.

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Examples of QA Practices in Chemistry
Example 1: QA in Pharmaceutical Analysis
• SOPs: Detailed protocols for dissolution testing.
• Method Validation: Validation of HPLC methods for active pharmaceutical ingredient (API)
analysis.
• Audit Findings: Corrective actions taken for inconsistent solvent preparation.
Example 2: Environmental Testing Laboratory
• QA Manual: Documented policies for sample handling and chain of custody.
• Proficiency Testing: Participation in external PT schemes for heavy metal analysis.
• Corrective Action: Investigation of discrepancies in nitrate quantification results.
Example 3: Food Chemistry Laboratory
• Document Control: Version-controlled SOPs for pesticide residue analysis.
• Risk Assessment: Identification of potential contamination sources in sample preparation.
• Continuous Improvement: Implementation of automated sample injection to reduce errors.

Comparison Between QA and QC

Aspect Quality Assurance (QA) Quality Control (QC)

Focus Prevention of errors Detection of errors

Objective Process-oriented Product-oriented

Activities Audits, training, documentation Sample testing, control charts

Timing Before and during processes During and after processes

Responsibility Management and quality teams Analysts and technicians

Importance of QA in Chemistry
• Reliability: Provides confidence in analytical results and data integrity.

• Compliance: Meets regulatory and accreditation requirements.

• Customer Confidence: Demonstrates a commitment to producing accurate and consistent results.

• Efficiency: Minimizes errors and the need for rework.

• Continuous Improvement: Fosters a culture of excellence and innovation.

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QA Checklist for a Chemical Laboratory
1. Documentation and Record Management

• Ensure all laboratory procedures are documented in Standard Operating Procedures (SOPs).

• Maintain up-to-date versions of quality manuals and method protocols.

• Keep traceable records for reagents, samples, and instrument usage.

2. Personnel Competency and Training

• Verify that all personnel have the required qualifications and training records.

• Conduct regular competency assessments for laboratory analysts.

• Maintain training logs and update as necessary.

3. Equipment and Instrument Management

• Perform routine calibration of analytical instruments (UV/Vis, HPLC, GC).

• Document maintenance schedules and service logs.

• Ensure IQ, OQ, and PQ are completed for all critical instruments.

• Verify calibration certificates for third-party service providers.

4. Method Validation and Verification

• Validate new analytical methods before routine use.

• Document validation parameters (accuracy, precision, LOD, LOQ, robustness).

• Re-validate methods after major changes in instrument conditions or reagents.

5. Sample Management

• Ensure proper labeling and traceability of samples.

• Maintain chain-of-custody records.

• Verify that sample storage conditions are appropriate for the analytes.

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6. Internal Audits

• Schedule and conduct periodic QA audits.

• Verify adherence to SOPs and regulatory requirements.

• Document findings and track corrective actions.

7. Corrective and Preventive Actions (CAPA)

• Investigate non-conforming results and determine root causes.

• Implement corrective and preventive actions (CAPA) to prevent recurrence.

• Monitor and document the effectiveness of CAPA.

8. Control Charts Monitoring

• Create Shewhart or Levey-Jennings control charts for key analytical parameters.

• Establish control limits (mean ± 3 standard deviations).

• Investigate and document deviations beyond control limits.

9. Proficiency Testing (PT) Participation

• Enroll in relevant PT schemes for laboratory analytes.

• Ensure routine participation (at least annually).

• Analyze PT results and document z-score evaluations.

• Investigate and resolve any PT failures.

10. Continuous Improvement

• Regularly review QA and QC data for trends and improvement opportunities.

• Document lessons learned from audit findings and non-conformities.

• Implement innovative solutions to enhance laboratory efficiency and accuracy.

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Additional Insights
Control Charts in Chemistry QA
Purpose:
Control charts help visualize data trends and identify out-of-control events during chemical analyses.
Steps to Create and Use a Control Chart:
1. Select a QC parameter (e.g., absorbance, retention time, recovery percentage).
2. Collect at least 20 baseline data points.
3. Calculate the mean, standard deviation, and control limits.
4. Plot data points over time and draw the control limits.
5. Interpret the chart based on Westgard rules:
o 1 point outside ±3 SD: Investigate immediately.
o 2 consecutive points outside ±2 SD: Investigate for systematic error.
o 4 consecutive points outside ±1 SD on the same side: Investigate bias.

Graphical Control Chart Template

I will generate a simple plot with a dataset for a hypothetical chemical laboratory tracking
absorbance measurement over time at a specific wavelength (540 nm).

Data Used for Control Chart

• Mean absorbance: 0.350

• Standard Deviation (SD): 0.005
• Control limits:
o Upper Control Limit (UCL): Mean + 3 SD = 0.365
o Lower Control Limit (LCL): Mean - 3 SD = 0.335

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Interpretation:

• No points are currently outside the control limits, but if a point were to exceed the red
lines (UCL or LCL), immediate investigation would be required.
• Orange lines represent the alert limits, where a trend toward exceeding control limits may
require attention.

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Proficiency Testing (PT) in Chemistry QA
Purpose:
PT verifies the accuracy and competence of a laboratory by comparing results with those of other
laboratories.
Steps in PT Process:
1. Enrollment: Register with a recognized PT provider.
2. Sample Analysis: Perform routine analysis on PT samples.
3. Data Submission: Submit results within the PT provider's timeframe.
4. Evaluation: Analyze performance based on z-scores.

5. Root Cause Analysis: Investigate deviations if the z-score falls outside acceptable limits (-3 to +3).

6. Corrective Actions: Address errors and implement preventive measures.

Proficiency Testing (PT) Report Template

Below is a filled-out sample report based on hypothetical values:

Proficiency Testing (PT) Report

Laboratory Information:

• Laboratory Name: XYZ Analytical Labs

• Accreditation Number: 12345
• PT Provider: Global Chem PT Services
• PT Round Name: PT-2024-HeavyMetals
• Date of Participation: January 15, 2024

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Analyte Results and Evaluation

Assigned Value Lab Result Performance

Analyte z-Score
(mg/L) (mg/L) (Acceptable/Unacceptable)
Lead (Pb) 0.050 0.048 -0.40 Acceptable
Cadmium
0.020 0.023 +1.50 Acceptable
(Cd)
Mercury
0.100 0.120 +4.00 Unacceptable
(Hg)

Performance Assessment

• Acceptable Performance: Lead and Cadmium results fall within acceptable limits (z-
scores within ±2).
• Unacceptable Performance: Mercury result has a z-score of +4, indicating a significant
deviation.

Root Cause Analysis and Corrective Actions

• Root Cause: Instrument calibration drift during Mercury analysis.

• Corrective Action: Immediate recalibration of the ICP-MS system and retraining of the
analyst on mercury-specific calibration techniques.
• Preventive Measures: Implement a bi-weekly calibration schedule and cross-check
analysis by a second analyst.

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 Quality Control (QC) in Chemistry: A Detailed Overview

Definition of QC in Chemistry
Quality Control (QC) in chemistry involves systematic processes, methods, and checks performed to
ensure that chemical analyses and processes produce accurate, reliable, and reproducible results. QC is
essential to maintaining the integrity of laboratory testing and meeting regulatory and customer
requirements.

Objectives of QC in Chemistry
1. Ensure the accuracy, precision, and reliability of analytical results.
2. Detect and correct errors or deviations in measurement processes.
3. Maintain compliance with international standards like ISO 17025.
4. Ensure traceability and reproducibility of results over time.

Methodologies in QC for Chemical Laboratories

1. Use of Reference Standards
• Reference materials with known and certified properties are used to verify analytical methods.
• Examples: Standard solutions for calibration in UV/Vis spectrophotometry.
2. Calibration of Instruments
• Routine calibration of analytical instruments ensures their accuracy.
• Example: Calibrating a spectrophotometer using potassium dichromate standards.
3. Replicate Measurements
• Performing multiple measurements of the same sample to assess precision.
• Example: Triplicate analysis of a sample using titration.
4. Control Charts (Shewhart or Levey-Jennings)
• Statistical tools used to monitor data trends and detect anomalies.
• Example: Monitoring absorbance measurements in a UV/Vis analysis over time.
5. Proficiency Testing
• Participation in inter-laboratory comparisons to assess laboratory performance.
• Example: Analyzing a water sample and comparing results with other accredited labs.

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6. Internal and External QC Samples

• Internal QC involves the use of routine check samples to monitor ongoing operations.

• External QC involves blind samples from external sources to validate accuracy.

• Example: Analyzing certified soil samples to ensure consistent pesticide analysis.

7. Method Validation

• Assessment of analytical methods for parameters like accuracy, precision, specificity, and detection limits.

• Example: Validating an HPLC method for pharmaceutical impurity analysis.

8. Routine Blank Measurements

• Ensures no contamination or background interference affects the results.

• Example: Running solvent blanks during gas chromatography analysis.

9. Recovery Studies

• Checking the recovery rate of an analyte from a matrix to ensure no loss during sample preparation.

• Example: Spiking water samples with a pesticide and analyzing the recovery rate.

10. Statistical Data Analysis

• Evaluating measurement data using statistical parameters to ensure consistency.

• Example: Calculating standard deviation and coefficient of variation for analytical batches .

Examples of QC Practices in Chemistry

Example 1: UV/Vis Spectrophotometry in Pharmaceutical Analysis
• Calibration: Use potassium dichromate at specific wavelengths.
• QC Checks: Periodic measurement of control samples.
• Statistical Analysis: Plot absorbance on a control chart.
Example 2: Environmental Water Testing
• QC Samples: Analyzing duplicate samples for heavy metals like lead and arsenic.
• Internal Standards: Spiking samples with a known concentration to monitor instrument response.
• Recovery Studies: Assessing whether the spiking analyte is fully recovered from the sample
matrix.
Example 3: Chromatographic Analysis (HPLC) in Food Testing
• Calibration Curve: Prepared using multiple standard concentrations.
• Blank Samples: Ensuring no carryover between runs.
• QC Control Charts: Plotting retention time and peak area over multiple analyses.

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Key Metrics for QC in Chemistry
1. Accuracy: Agreement between measured value and true value.
2. Precision: Repeatability of measurements under the same conditions.
3. Limit of Detection (LOD): Minimum detectable concentration of an analyte.
4. Linearity: Proportionality between concentration and response.
5. Recovery Rate: Percentage of an analyte recovered from a sample.

Importance of QC in Chemistry
• Guarantees compliance with international standards like ISO 17025.
• Enhances customer confidence and trust in the laboratory's results.
• Identifies and mitigates potential errors in analytical processes.
• Supports decision-making for product release, environmental monitoring, and regulatory
compliance.

QC Checklist for a Chemical Laboratory

1. Instrument Calibration and Maintenance

• Daily: Zero and baseline checks for spectrophotometers and chromatographs.

• Weekly: Calibration using primary standard solutions.

• Monthly: Comprehensive maintenance and calibration verification.

• Yearly: Full calibration by certified service providers.

2. Analytical Method Validation and Verification

• Confirm the method meets performance parameters (accuracy, precision, linearity, robustness).

• Document and store all validation protocols and results.

• Cross-validate critical methods across instruments and analysts.

3. Quality Control (QC) Sample Analysis

• Analyze at least one QC sample per analytical batch.

• Use certified reference materials (CRM) when available.

• Record all QC sample results and compare them against acceptance criteria.

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4. Blank Sample Analysis

• Perform blank analysis with each sample batch.

• Ensure analyte-free results for blanks.

5. Replicate Sample Analysis

• Analyze duplicate or triplicate samples to ensure precision.

• Record the relative standard deviation (RSD) and compare it to acceptance limits.
6. Control Charts

• Maintain Shewhart or Levey-Jennings charts for critical parameters.

• Mark control limits (+/- 3 SD) and alert limits (+/- 2 SD).

• Investigate and document any out-of-control points.

7. Statistical Data Evaluation

• Calculate and document mean, standard deviation, and coefficient of variation.

• Perform trend analysis to detect systematic errors.

8. Proficiency Testing (PT)

• Enroll in external PT programs specific to the lab’s analytical scope.

• Participate in PT at least annually.

• Analyze PT results and implement corrective actions for unsatisfactory results.

9. Documentation and Traceability

• Maintain detailed logs of calibration, maintenance, and QC results.

• Ensure all reagents and standards are traceable with proper labels and certificates.

• Review and approve QC records periodically.

10. Personnel Competency

• Regular training and evaluation for analytical staff.

• Document staff competencies and ensure they meet ISO 17025 requirements.

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Control Charts in QC
1. Types of Control Charts
• Shewhart Control Chart: Tracks individual measurements and averages.
• Levey-Jennings Chart: Ideal for monitoring chemical analysis parameters such as absorbance.
• Moving Average Chart: Used for data with inherent variability.
2. Steps to Create a Control Chart
1. Select a QC parameter: Absorbance, retention time, or recovery percentage.
2. Collect baseline data: Measure at least 20 data points to establish control limits.
3. Plot the data: Chart the measured value over time.
4. Set control limits: Use mean ± 3 standard deviations (SD) for control limits.
5. Interpret the chart: Identify trends, outliers, and rule violations.
3. Rules for Chart Interpretation (Westgard Rules)
• One point outside ±3 SD: Investigate immediately.
• Two consecutive points outside ±2 SD: Investigate for systematic error.
• Four consecutive points outside ±1 SD on the same side of the mean: Investigate for bias.

Proficiency Testing (PT) in Chemistry

1. Purpose of PT
• Assess laboratory performance.
• Ensure compliance with regulatory requirements (e.g., ISO 17025).
• Identify and correct deficiencies in analytical processes.
2. Steps in Proficiency Testing
1. Enrollment: Register for a PT program with a recognized provider.
2. Sample Analysis: Analyze PT samples using routine methods.
3. Data Submission: Submit results within the specified timeframe.
4. Evaluation: Compare results with consensus values or z-scores.

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 5. Performance Assessment:
o Z-score between -2 and +2: Acceptable performance.
o Z-score between -3 and -2 or +2 and +3: Questionable result.
o Z-score outside -3 to +3: Unacceptable result.
3. Corrective Actions for PT Failures
• Investigate root causes of deviations (instrument error, human error, matrix effects).
• Implement corrective actions (recalibration, retraining).
• Document findings and corrective measures.

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comparison between Quality Assurance (QA) and Quality Control (QC) in chemistry and laboratory practices

Aspect Quality Assurance (QA) Quality Control (QC)

A proactive, process-oriented approach to A reactive, product-oriented approach to
Definition
prevent errors. detect errors.
Ensuring that processes are properly Ensuring the accuracy, precision, and
Focus
designed and followed. validity of results.
Ensure that analytical results meet
Objective Consistent quality in operations and outputs.
quality criteria.
Detective (after or during the analysis
Nature Preventive (before errors occur).
process).
Applies to specific tests, measurements,
Scope Applies to all processes in the laboratory.
or batches.
Documentation, audits, training, method Routine sample testing, calibration,
Activities
validation. control charts.
SOPs, internal audits, method validation, Control charts, proficiency testing,
Tools/Methods
training. calibration checks.
Quality manuals, audit reports, validation Test reports, control charts, inspection
Documentation
reports. records.
Responsibility QA Officers and Quality Managers. Laboratory analysts and technical staff.
Performed during and after the analysis
Timing Continuous, starting from process planning.
process.
Ensuring method validation is conducted for Testing a water sample and ensuring
Example
a new protocol. results meet limits.

Summary

• QA ensures the laboratory runs efficiently and follows best practices, minimizing the chances of errors
before they occur.

• QC focuses on testing individual results and identifying outliers or non-conformities during or after
analytical procedures.

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detailed workflow combining both Quality Assurance (QA) and Quality Control (QC) practices for a
chemical laboratory setup. This framework ensures compliance with ISO 17025 and promotes accurate,
reliable results.

1. Planning and Documentation (QA)

• Define the laboratory’s quality objectives aligned with accreditation standards.

• Develop and maintain a Quality Manual, which includes:
o Organizational structure
o Document control procedures
o Roles and responsibilities
• Create Standard Operating Procedures (SOPs) for sample handling, analysis, and reporting.

2. Personnel Competency and Training (QA)

• Identify skill requirements for laboratory staff.

• Maintain training records for each analyst.
• Conduct periodic competency assessments through:
o Observation of test execution
o Proficiency testing participation
• Schedule annual refresher training on quality and technical requirements.

3. Method Development and Validation (QA)

• Select and develop analytical methods based on test requirements.

• Validate methods for parameters such as:
o Accuracy, precision, linearity, robustness, detection limit, and quantification limit.
• Document method validation protocols and reports.
• Maintain updated lists of validated methods.

4. Sample Management and Chain of Custody (QA & QC)

• Define sample acceptance criteria (QA).

• Maintain traceability using unique sample IDs (QA).
• Implement a Chain of Custody (COC) form for critical samples (QA).
• Verify sample integrity (QC):
o Condition on receipt
o Compliance with sample requirements

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5. Equipment Management (QA & QC)

• Ensure equipment is installed, qualified (IQ, OQ, PQ), and calibrated (QA).
• Maintain equipment maintenance schedules (QA).
• Perform daily pre-analysis checks (QC), such as:
o Baseline stability for HPLC
o Wavelength accuracy for UV-Vis
• Document calibration records and out-of-tolerance events (QC).

6. Analysis and Testing (QC)

• Follow validated SOPs for sample testing.

• Ensure that each test includes:
o Use of certified reference materials (CRMs) or standards
o Inclusion of blanks and spiked samples
• Document raw data and calculations.

7. Monitoring with Control Charts (QC)

• Plot Shewhart or Levey-Jennings control charts for critical test parameters.

• Establish control limits (mean ± 3 SD).
• Apply Westgard rules for interpreting deviations:
o Investigate out-of-control points.
o Implement corrective actions for trends or violations.

8. Proficiency Testing (QA & QC)

• Participate in annual or bi-annual PT schemes (QA).

• Analyze PT results using z-scores (QC):
o Acceptable: |z| ≤ 2
o Questionable: 2 < |z| ≤ 3
o Unacceptable: |z| > 3
• Investigate and document corrective actions for unacceptable results.

9. Internal and External Audits (QA)

• Schedule periodic internal audits to evaluate compliance with quality protocols.

• Document audit findings and implement corrective actions.
• Prepare for external audits by accreditation bodies (e.g., ISO 17025).

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10. Corrective and Preventive Actions (CAPA) (QA & QC)

• Corrective Actions: Identify root causes of non-conforming results.

o Example: Failed calibration due to contaminated standards.
• Preventive Actions: Implement measures to prevent recurrence.
o Example: Quarterly review of calibration protocols.

11. Reporting and Data Review (QC)

• Verify results by a peer review process before issuing reports.

• Ensure results comply with acceptance criteria (QC).
• Review trends in data for signs of bias or recurring errors (QA).

12. Continuous Improvement (QA)

• Conduct periodic management reviews.

• Analyze QC data trends to identify improvement opportunities.
• Maintain a log of lessons learned from non-conformities and audits.

Summary Workflow Chart

QA Activities (Pre-Analysis & Process Control)

QC Activities (Sample Testing, Control Charts, PT)

CAPA Investigation and Corrective Measures (QA & QC)

Data Review, Reporting, and Continuous Improvement (QA)

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