case studies

Five black stars in a row.

Case Study 1: Successful Defense of Five For-Cause Audits

Industry: GxP Service Provider (non-CRO)


Challenge: The client faced multiple for-cause audits from various clients due to concerns about operational service, compliance and quality management. The audits were critical, with potential risks including loss of business, critical findings, and damage to the company's reputation.


Solution: Ascend Consulting Group (ACG) was engaged to provide interim quality oversight and represent the company during these audits. Our approach included:

  1. Preparation and Documentation: We conducted a thorough review of the quality management system (QMS), client complaints, audits results and operational processes ensuring all documentation was up-to-date and compliant with industry standards. This included SOPs, training records, and audit trails.
  2. Training and Support: We provided targeted training sessions for staff to ensure they were well-prepared for the audits. This included mock audits and role-playing scenarios to build confidence and competence.
  3. Audit Representation: We facilitated the audit as staff augmentation, effectively communicating my client’s quality standards and processes to the auditors. We addressed all queries and concerns promptly and accurately.
  4. Continuous Improvement: Ascend Consulting Group implemented a framework for continuous improvement, including regular internal audits and performance reviews to identify and address any potential issues before they could escalate again.


Results:

  • No Loss of Business: We successfully defended all of the for-cause audits, maintaining their business relationships and contracts without any disruptions.
  • No Critical Findings: The audits resulted in no critical findings, demonstrating the robustness of the client’s quality management system and processes.
  • Several Audits with No Findings: Impressively, several of the audits concluded with no findings at all, highlighting the exceptional performance of Ascend Consulting Group despite the prior concerns expressed by the external auditing clients.


Conclusion: Through meticulous preparation, targeted training, and effective representation, ACG helped the client navigate and successfully defend multiple for-cause audits. This case study underscores the importance of a strong quality management system and the value of expert consulting services in maintaining compliance and business continuity.

Five black stars in a row, representing a perfect rating or positive feedback.

Case Study 2: Rapid Overhaul of Imaging Department Processes

Industry: Imaging Core Lab


Challenge: The Imaging Department was struggling with outdated processes and procedures, leading to inefficiencies, frequent work errors, and suboptimal quality outcomes. The department needed a comprehensive overhaul to streamline documentation, reduce errors, and improve overall quality. Typically, such a transformation would take 6-9 months to complete.


Solution: Ascend Consulting Group (ACG) was contracted to evaluate the operational documentation and propose an overhaul solution of processes and procedures. Leveraging our expertise in quality management and process optimization, we implemented the following steps:

  1. Assessment and Planning: We conducted a rapid yet thorough assessment of the existing processes and identified key areas for improvement.
  2. Streamlining Documentation: We redesigned the documentation system to be more intuitive and efficient. This involved creating standardized templates, eliminating redundant paperwork, and implementing digital solutions for easier access and management.
  3. Process Optimization: We restructured workflows to minimize bottlenecks and enhance efficiency following Lean Six Sigma Principles. This included redefining roles and responsibilities, introducing best practices, and ensuring seamless integration of new procedures.
  4. Training and Support: We provided intensive training sessions for the Imaging Department staff to ensure they were well-equipped to adapt to the new processes.
  5. Continuous Improvement: We established a robust framework for continual evaluation and improvement, including regular audits, performance reviews, and feedback mechanisms to ensure ongoing excellence.

 

Results:

  • Streamlined Documentation: The new documentation system significantly reduced the time spent on paperwork and improved accessibility and accuracy.
  • Reduced Work Errors: The optimized processes led to a substantial reduction in work errors, enhancing overall efficiency and reliability.
  • Improved Quality Outcomes: The department saw marked improvements in quality outcomes, with higher accuracy and consistency in imaging results.


Conclusion: Through a rapid and comprehensive overhaul, ACG helped the Client achieve streamlined documentation, reduced work errors, and improved quality outcomes in an unprecedented timeframe, less than 1 month. This case study highlights the importance of expert consulting services in driving efficient and impactful transformations.

Five black stars in a row, rating or feedback.

Case Study 3: Successful ISO Certifications

Industry: Life Sciences


Challenge: The client aimed to enhance their quality management system by achieving ISO 9001 and ISO 13485 certifications. These certifications are critical for demonstrating compliance with international standards and improving operational efficiency. The challenge was to implement these standards seamlessly and achieve certification with no observations, ensuring a flawless audit process.


Solution: Ascend Consulting Group (ACG) lead the implementation of ISO 9001 and ISO 13485 certifications. The approach included:

  1. Initial Assessment: We conducted a comprehensive assessment of the existing quality management system (QMS) to identify gaps and areas for improvement. This included reviewing documentation, processes, and compliance with current standards.
  2. Development of the QMS: We developed a robust QMS suite of documentation tailored to meet the requirements of both ISO 9001 and ISO 13485 certification standards.
  3. Internal Audits: We conducted a series of internal audits to verify the effectiveness of the new QMS and identify any potential issues before the official certification audit; ensuring that all processes were functioning as intended and met the required standards.
  4. Continuous Improvement: We established a framework for continuous improvement, including regular reviews and updates to the QMS, to maintain compliance and drive ongoing excellence.

 

Results:

  • Successful Certification: The client successfully achieved ISO 9001 and ISO 13485 certifications with no observations, demonstrating the effectiveness and robustness of their new QMS.
  • Improved Operational Efficiency: The implementation of the new QMS led to streamlined processes, reduced errors, and enhanced overall efficiency.
  • Enhanced Reputation: Achieving these certifications bolstered the client’s reputation as a leader in quality management and compliance, attracting new clients and business opportunities.


Conclusion: Through meticulous planning, comprehensive training, and rigorous internal audits, the client achieved ISO 9001 and ISO 13485 certifications with no observations. This case study highlights the importance of expert consulting services in achieving and maintaining high standards of quality management and compliance.