KPIs: OEE, Right-First-Time, and Scan Yield


KPIs: OEE, Right-First-Time, and Scan Yield

Published on 02/12/2025

KPIs: OEE, Right-First-Time, and Scan Yield

Pharmaceutical companies are increasingly focusing on serialization and aggregation as part of their supply chain integrity measures. Key Performance Indicators (KPIs) such as Overall Equipment Effectiveness (OEE), Right-First-Time (RFT), and Scan Yield help organizations gauge their efficiency and compliance with regulations like the DSCSA and EU FMD requirements. This article serves as a comprehensive step-by-step tutorial guide on implementing and utilizing these KPIs in the context of qualification, guidelines, and master data governance.

1. Understanding Key Performance Indicators (KPIs) in Pharma Serialization

In the realm of pharmaceutical validation, KPIs are essential for monitoring the efficiency of packaging lines, enhancing operational excellence, and ensuring compliance with regulatory demands. The KPIs OEE, RFT, and Scan Yield serve as vital tools for tracking the success of serialized and aggregated systems.

1.1 Overall Equipment Effectiveness (OEE)

OEE is a metric that combines availability, performance, and quality to measure the effectiveness of manufacturing equipment. By determining OEE, organizations can identify areas for improvement in their serialization and aggregation processes.

  • Availability: This measures the percentage of scheduled time that the equipment is operational. It is affected by downtime and breakdowns.
  • Performance: This evaluates the speed at which the equipment operates relative to its designed maximum speed.
  • Quality: This assesses the number of good quality products produced versus the total number of products produced.

1.2 Right-First-Time (RFT)

Right-First-Time (RFT) refers to the ratio of processes completed without errors on the first attempt. Achieving a high RFT minimizes rework, enhances efficiency, and satisfies regulatory requirements.

1.3 Scan Yield

Scan Yield represents the percentage of successfully scanned items versus the total items that should have been scanned. It is a crucial metric for ensuring the effectiveness of serialization, particularly for compliance with the Drug Supply Chain Security Act (DSCSA).

2. Implementing KPIs: Steps for Effective Qualification

Establishing KPIs requires a systematic approach to qualification. Qualification here refers not only to the process itself but also to the overall system supporting serialization and aggregation initiatives. The following steps provide a roadmap for effective qualification:

2.1 Define User Requirements Specifications (URS)

Before implementation, it is critical to outline User Requirements Specifications (URS) that detail the expected functionalities and performance criteria of the serialization and aggregation systems.

  • Gather input from stakeholders, including QA, IT, and production teams.
  • Clearly define serialization data requirements, such as compliance with DSCSA compliance.
  • Document the expected performance metrics, including OEE, RFT, and Scan Yield.

2.2 Master Data Governance

Strong master data governance ensures that all serialization data flows accurately and consistently through various systems. Establishing clear governance structures helps mitigate risks associated with data integrity and compliance.

  • Set guidelines for data entry, management, and validation processes.
  • Implement training programs for stakeholders involved in handling master data.
  • Establish audit trails for traceability in line with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).

3. Line and Level Qualification Procedures

Line qualification is essential for ensuring that all equipment involved in the serialization and aggregation process meets predetermined performance standards. Level qualification involves validating the overall system interfaces between various equipment pieces.

3.1 Equipment Qualification

Equipment qualification consists of Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) stages.

  • Installation Qualification (IQ): Verify that the equipment is installed as specified in the URS and that all necessary components are functioning.
  • Operational Qualification (OQ): Assess the equipment’s operational parameters and capabilities against set performance specifications.
  • Performance Qualification (PQ): Execute processes under real-world conditions to verify that the equipment performs as expected.

3.2 Interface Validation

Interface validation confirms the proper interactions between systems, such as the serialization software, packaging lines, and enterprise resource planning (ERP) systems. This is crucial to maintaining data integrity throughout the supply chain.

  • Test data flows between systems to detect any discrepancies.
  • Document validation procedures and outcomes to ensure regulatory compliance.
  • Maintain a system change control log to track modifications and their impacts on interface performance.

4. Exception Handling and Rework Strategies

Developing robust exception handling and rework strategies is critical for maintaining efficiency and compliance during serialization processes. Here’s how to approach this vital aspect:

4.1 Exception Handling Guidelines

Effective exception handling minimizes disruptions and can significantly improve RFT and Scan Yield rates. Establish clear guidelines to identify, document, and resolve exceptions as they occur.

  • Define common exception scenarios, such as misprinted labels or discrepancies in serialized data.
  • Establish protocols for reporting and escalating exceptions promptly.
  • Incorporate automated systems to flag anomalies in real-time.

4.2 Rework Procedures

In the event of errors or exceptions, rework procedures must be efficient and compliant. This involves:

  • Documenting all rework activities in accordance with your quality management system (QMS).
  • Implementing a thorough CAPA (Corrective and Preventive Action) process to mitigate future errors.
  • Training staff on rework procedures to ensure consistency and compliance.

5. Audit Trail Review and Data Integrity Considerations

Audit trail review is a crucial element in ensuring data integrity (ALCOA+) and tracking compliance with regulations related to serialization and aggregation.

5.1 Importance of Audit Trails

Audit trails provide a comprehensive record of data entry and modifications, serving as a defense against potential non-compliance.

  • All data modifications, including user information, timestamps, and changes made, should be captured.
  • Implement periodic reviews of audit trails as part of your continuous compliance strategy.
  • Ensure all records are easily retrievable for regulatory audits.

5.2 Data Integrity and ALCOA+

Data integrity is paramount, especially in serialization. Ensure your systems uphold the ALCOA+ principles as follows:

  • Attributable: Maintain clear records of who performed each action.
  • Legible: All records must be readable and comprehensible.
  • Contemporaneous: Data should be recorded at the time of the activity.
  • Original: Original records should be maintained, and alterations should be documented.
  • Accurate: Ensure accuracy through validation and quality checks.

6. Monitoring and Continuous Improvement

Finally, implementing a culture of continuous improvement is vital for long-term success in serialization and aggregation.

6.1 Analyzing KPI Data

Regular monitoring of KPIs such as OEE, RFT, and Scan Yield will enable organizations to identify strengths and weaknesses in their processes. Use this data to make informed decisions about operational changes.

  • Utilize dashboards for real-time KPI tracking and trend analysis.
  • Conduct periodic performance reviews to assess whether current KPIs align with business objectives and compliance requirements.
  • Engage all stakeholders in feedback discussions to foster a culture of continuous improvement.

6.2 Implementing CAPA from KPI Analysis

Consequently, when performance deviations are identified, implementing a robust CAPA process is essential to resolve issues and prevent recurrence. This ensures compliance across serialization processes and aligns with regulatory expectations.