Global Plasma Collection Process Modernization

Client: CSL Plasma (Contract via Roth Staffing)
Project Duration: May 2022 – May 2025

Challenge

1

CSL Plasma, a global leader in plasma collection and biopharmaceutical manufacturing, needed a unified approach to process documentation and communication across its U.S., German, and Hungarian operations. The existing documentation was fragmented, inconsistent, and lacked visibility across regions - resulting in inefficiencies, compliance risks, and limited knowledge-sharing.

Key challenges included:

  • A decentralized documentation approach with 800+ workflows in need of organization and standardization.

  • Misalignment between Standard Operating Procedures (SOPs), Work Instructions (WIs), and actual workflows.

  • The need for bilingual (German/English) documentation to support cross-regional teams.

  • Limited staff training and adoption of ARIS BPM, the organization’s process documentation platform.

Approach

2

1. Foundation – Building a Central Repository

  • Managed CSL Plasma’s global ARIS-based process repository, consolidating over 800 workflows into a standardized framework.

  • Conducted gap analyses by reviewing existing SOPs, WIs, and workflows to identify redundancies and compliance risks.

  • Established best practices for multilingual documentation to ensure consistency in German/English translations.

2. Enablement – Improving Processes & Engagement

  • Partnered with 20+ subject matter experts (SMEs) and cross-functional stakeholders to redesign outdated workflows and integrate newly developed lab and center procedures.

  • Created and reworked bilingual process flows, narratives, and digital content to enhance compliance, operational efficiency, and staff engagement.

  • Ensured alignment between SOPs/WIs and workflow documentation to close gaps and strengthen quality assurance.

3. Growth – Training & Adoption for Long-Term Success

  • Delivered targeted ARIS BPM training sessions for plasma center staff, enabling teams to independently manage and update documentation.

  • Increased adoption of the ARIS platform by demonstrating its value as a centralized, global knowledge repository.

  • Set the foundation for long-term quality improvement by embedding process visibility and alignment across all three regions.

Results

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Streamlined operations: Over 800 workflows standardized, improving cross-regional efficiency and reducing documentation gaps.

Compliance improvement: Alignment between workflows, SOPs, and WIs strengthened regulatory readiness and audit preparedness.

Bilingual integration: Consistent English/German documentation improved accessibility and collaboration for international teams.

Knowledge adoption: ARIS BPM training empowered staff to maintain and update documentation, fostering a culture of self-sufficiency.

Global alignment: Enhanced communication and visibility across Germany, Hungary, and the U.S. created a unified framework for process improvement.

Impact Statement

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By leading CSL Plasma’s global process communication strategy, a scalable documentation system was delivered that not only improved operational efficiency but also reinforced compliance and quality in plasma center and lab operations worldwide.