Standard Operating Procedure for Data Quality Metrics

Purpose

The purpose of this SOP is to establish procedures for the systematic measurement and assessment of data quality within the pharmaceutical manufacturing facility. This ensures the accuracy, completeness, and reliability of electronic data used for decision-making and regulatory compliance.

Scope

This SOP applies to all personnel involved in the generation, processing, and assessment of electronic data, including operators, quality control personnel, and quality assurance personnel.

Responsibilities

• Data Owners: Responsible for identifying critical data elements, defining quality metrics, and ensuring data accuracy within their respective areas.
• Quality Control Personnel: Responsible for implementing data quality metrics, conducting routine assessments, and recommending corrective actions when necessary.
• Quality Assurance Personnel: Responsible for overseeing the data quality assessment process, ensuring compliance with regulatory standards, and providing guidance on improvement initiatives.

Procedure

1. Identification of Critical Data Elements: Collaborate with data owners to identify critical data elements that require quality assessment. Prioritize data elements based on their impact on product quality and regulatory compliance.
2. Definition of Quality Metrics: Clearly define quality metrics for each identified data element. This may include accuracy, completeness, consistency, timeliness, and reliability. Document the quality metrics in a standardized format.
3. Quality Metric Plan: Develop a quality metric plan outlining the objectives, scope, timelines, resources, and responsibilities for the assessment process. Include risk assessments and mitigation strategies.
4. Data Sampling: Select representative samples of data for quality assessment, ensuring coverage of different batches, production shifts, or relevant time periods. The sampling plan should be statistically justified.
5. Quality Assessment: Execute quality assessments according to the defined metrics. Document the assessment procedures and results, including any deviations or discrepancies identified during the process.
6. Corrective Actions: If issues are identified during the quality assessment, data owners are responsible for implementing corrective actions promptly. Document the corrective actions taken.
7. Documentation of Assessment Activities: Maintain detailed records of all data quality assessment activities, including the metric plan, assessment logs, corrective action records, and final assessment reports.
8. Communication: Communicate the results of data quality assessments to relevant stakeholders. Provide information on the status of the data and any actions taken to address identified issues.
9. Periodic Review: Conduct periodic reviews of data quality metrics and assessment processes to assess their effectiveness. Address any identified issues and update the procedures accordingly.
10. Training: Provide training to personnel involved in data quality assessment activities to ensure a thorough understanding of the procedures and the importance of data integrity.

Abbreviations

No abbreviations are used in this SOP.

Documents

• Quality Metric Plan
• Assessment Logs
• Corrective Action Records
• Final Assessment Reports

Reference

ISO 9001 – Quality management systems

SOP Version

Version 1.0