Our Experience: Quality Assurance

Opportunity…

After a significant acquisition by a global biopharmaceutical company, the client requested a turnkey approach to harmonize R&D quality standards and SOPs at the acquired sites, with corporate standards. Acquired sites to be harmonized were located on three continents: Europe, Asia, and South America.

Approach…

• OQSIE structured the approach and resource plan.
• Conducted a gap assessment of current site SOPs.
• Prioritized gaps identified at the site level to manage “red, yellow, green” findings and avoid potential regulatory actions.
• Implementation activities included revision of SOPs and managing the revisions through the client change process to final approval and implementation.
• Our Project Managers developed plans and drove harmonization activities at the various sites.
• Our Subject Matter Experts on quality systems and aseptic manufacturing supported the revision and implementation of SOPs.
• Our QPs helped to upskill local Quality leaders in batch disposition / release requirements.

Outcome…

The QMS Harmonization initiative was completed on-time & on-budget.

Opportunity…

A global Biopharmaceutical client requested a Quality Culture Assessment of its global vaccine franchise with sites in the U.S. and Europe.  

Approach…

• OQSIE structured the approach and resource plan.
• A team of cross functional experts conducted the assessment with expertise in human resources, regulatory, vaccine manufacturing and project management.
• A single team was utilized to ensure consistency of approach at the five sites assessed.
• Deployed multiple data gathering approaches, e.g., one-on-one interviews and group polling sessions.
• Participants ranged from corporate and site leadership to shop floor supervisors and operators.
• All information was kept confidential to facilitate open communication and input from all involved.
• Findings were presented to the client’s sponsor group.
• We facilitated the go-forward planning session with the leadership team, and delivered a short, mid, and long-term execution plan.

Outcome…

The assessment was executed on-time and on-budget. Our client implemented the plans we jointly developed and reported extraordinary improvements in operational performance.

Opportunity…

A client was experiencing significant variability in investigation closure timelines, frequent extensions on due dates, frequent priority changes, very long hours, low morale, and high turnover in QA group.  

Approach…

• OQSIE team broke down the investigation process in five steps.
• We identified the sources of variability in each step.
• Developed a predictive model based on the progression through each of the five steps.
• Implemented an alert and escalation system based on the progression of work and predicted close date.
• The sources of variability and predictability included:
  • Work cadence of assigned investigator
  • Active workload for assigned investigator
  • CAPA agreement cycle time
  • Prior investigations of that product
  • Characteristics of the investigation (e.g. elapsed time from event, functional group launching it, manufacturing process involved)

Outcome…

• Average closure time went from 65 to 35 days.
• Investigations requiring extensions went from 80% to 25%.
• Meetings to discuss priorities went from twice per day to once per week.
• Overtime and turnover were reduced by 90%.

1. For a global client, a Senior Project Manager developed and led execution of the initiative to expand their Quality Management System to integrate requirements for combination products.
2. We provided four Subject Matter Experts to develop the Quality Management System for a new aseptic manufacturing and packaging facility start-up.
3. Two SMEs supported the start-up of a secondary packaging operation and developed SOPs for equipment validation and operational activities.
4. We provided ex-FDA experts in GCP & BIMO for a global Biologics client to perform a gap assessment and lead remediation activities ahead of their PAI.
5. We provided two cGMP training experts to develop and deliver training program for 170 new employees.
6. One SME oversaw SOP development for a warehouse/distribution center operation.
7. A Subject Matter Expert (SME) audited the Quality System of a pharmaceutical client’s transportation system.
8. One SME developed and implemented the Supplier Quality Management program for a pharmaceutical client.
9. One SME redesigned the global change control system for a large generics manufacturer.