Advantu Case Studies – Bio Pharmaceutical and Medical Device Companies

The following Case Studies describe the Projects successfully implemented by Advantu Team Members.

Our evaluation of R&D/Manufacturing/Supply Processes, enabled our experts to identify Gaps which were effectively re-mediated across entire client operations. This successful approach ensured 100% compliance and ‘best practice’ effectiveness for our clients’ QMS, GMP and Post Release (CAPA/Audit) Processes – which enabled greater product quality & improved customer satisfaction with their products.

Case Study: Invitro-Diagnostic Device

Design Control for OEM and CMO Suppliers

Advantu Process Expert Strategy

  • Created engineering change procedure that accommodated all engineering change types
  • Created one workflow to accommodate all change types
  • Discovered (then closed) Gaps in order to improve manufacturing process & product quality

Project: Perform analysis of Invitro-diagnostic device manufacturer’s Design Control and Engineering Change Management (ECR, ECO, ECN) processes for OEM and Contract Manufacturing. DHF design transfer documentation was not current, and DMR’s did not reflect all ECO’s.


  • Requested current SQA’s and SLA’s with OEM and Contract Manufacturers
  • Requested training records of OEM and CMO personnel to client SOP’s
  • Reviewed pFMEA of ECO, Release to manufacturing, and Doc Control process for Engineering Drawings and Software
  • Review ECO’s cut in by OEM and CMO’s
  • Reviewed existing Design Control and Supplier Procedures

Results of Review:

  • No approved Supplier Quality Agreement’s or Service Level Agreement’s
    • SQA’s hung up in legal department
  • No training records for OEM and CMO personal
    • Training plans for OEM and CMO were not available or missing
  • Incomplete pFMEA for device manufacturing
    • pFMEA was initiated by manufacturer and was to be completed by CMO
  • Changes to QMS procedures for Design Control, Risk management, and Supplier Quality were in a state of ‘flux’
    • Quality group has made changes to Design Control and Risk Management procedures and Supplier Quality procedures
  • Documents are being submitted to two different document control systems
    • One system for engineering documents and the other for QMS & Quality record documentation

Benefits:  Recommendations Successfully Implemented

  • Review quality agreements with OEM and CMO’s. Manufacturer’s processes to be identified and implemented at CMO facility. ECO to be approved by Manufacturer with ECN’s sent to CMO for implementation, cut in dates and lot ID. Manufacturer maintains ECO and design history records while CMO updates DMR’s and provides updates to Manufacturer Quality for review
  • OEM and CMO’s to train to Manufacturer’s procedures and work instructions. Training records to be maintained by Manufacturer
  • Review design control, risk management, and supplier quality procedures. Created one Engineering Change procedure to accommodate all engineering change types and one workflow to accommodate all change types. Make updates as necessary for compliance to ISO-13485:2016, 21CFR830, ISO-14971:2012. Ensure quality agreements are in alignment
  • Reviewed ECO’s with design impact for potential hazards. Reviewed System Hazard Analysis, Device FMEA, and updated based on findings from past ECO’s. Updated Risk file. Reviewed pFMEA, updated. CMO performs pFMEA with guidance from Manufacturer
  • Reviewed doc control procedures and updated. Identified one doc system as Device Engineering and Manufacturing Doc Control and submitted all engineering documentation. Second system used to maintain Quality System
  • Enabled the client to measurably track product quality improvements over time – which directly contributed to improved customer satisfaction feedback

Case Study: Supplier Quality Certification

Design Controls for CMO Suppliers

Advantu Process Expert Strategy

Project:  Project involved upgrading and formalizing Supplier Quality Certifications and Training.  Receiving Inspections were discovering an excessive number of incoming parts being rejected.

Process:  Advantu Process Expert Strategy for Gap Analysis Statement of Work

We have found the most productive SOW engagements are those that are defined through an in-depth Gap Assessment and Risk Based Prioritization.  This is needed to gain a comprehensive understanding of not only the current state but of the desired state.  Through this interaction we are better able to address the most cost-effective changes for you the client.  The basic assessment flow is as follows:

A. Initial Assessments to Identify Possible Gaps

B. Risk Assessment and Cost Benefit Analysis of Identified Gaps

C. Prioritize Gap Assessment Findings

D. Define Statement of Work based upon Prioritized Gap Categorization

A. Initial Assessments (Recommended but determined through Collaboration) to Identify Possible Gaps:

  1. Supplier Certification Procedure
  2. Supplier Certifications (Current and Planned)
  3. Supplier Process Validation Procedure and Records
  4. Supplier Monitoring Process and Records
  5. Management Reviews
  6. Internal Audits
  7. CAPA’s
  8. Cost of Quality Metrics
  9. External Audits
  10. FMEA’s
    1. Process
    2. Design
  11. Supplier Manufacturing Procedures
  12. Manufacturing and Sourcing Procedures and Records
  13. Manufacturing Process Inspection Procedures and Records
  14. Feature Inspection Plan Procedures and Records
  15. Incoming Inspection Procedure and Records
  16. Gage R&R Procedure
  17. Critical to Quality Identification
  18. Change Management Procedure
  19. Metrology Procedure and Records
  20. Health Hazard Analysis Procedure and Records
  21. Supplier Quality Training
  22. Risk Management Procedure and Training Records
  23. Production Transfer Procedures and Records
    1. From Production Sites
    2. To Production Sites
  24. DHF Procedure and Records
  25. Lot Control Procedure and Records as Applicable

B. Risk Assessment and Cost Benefit Analysis of Identified Gaps

  1. Risk
  2. Risk Type
  3. Severity
  4. Likelihood of Occurrence
  5. Possible Mitigations

C. Prioritize Gap Assessment Findings Based Upon Risk

  1. Categorize Prioritized Gaps
  • Immediate
  • Near Term
  • Long Term

D. Define Statement of Work based upon Prioritized Gap Categorization

  1. Process Flow (PERT)
  2. Identify Successor Tasks
  3. Identify Predecessor Tasks
  4. Identify Task Division of Responsibility
  5. Identify Required Inputs
  6. Identify Planned Outputs
  7. Identify Needed Approvals


  1. Outdated Supplier Certification Procedure
  2. Client/Supplier mis-understanding and implementation of Feature Inspection Plan process
  3. Non-conformance to First Article Layout process caused by poorly written procedure and Training
  4. Lack of Cost of Quality Metrics
    1. Client
    2. Supplier
  5. Inadequate Supplier Quality Training
  6. Cursory Audits not providing usable depth for corrective action(s)


  1. Provided a Process Improvement Roadmap based upon client/Advantu perceived cost/benefit analysis – which led to tangible (measurable) cost savings for the client
  2. Fluid Statement of Work accommodated rapid response to changes requested by client. As client situations changed we were able to refocus effort where most needed
  3. By implementing a Gap Analysis process client was able to institute process improvements based upon Cost of Quality Metrics. The Cost of Quality Metrics were developed and built to monitor and measure client unique improvement areas