CASE STUDY
A North American Pharmaceutical Company engaged with RCM to assist in developing a Quality Remediation Program to address current quality issues. The objectives were to improve processes, integrate new methods and techniques, and build a Quality Culture of continuous improvement.
OBJECTIVE
A North American Pharmaceutical Company engaged with RCM to assist in developing a Quality Remediation Program to address current quality issues. The objectives were to improve processes, integrate new methods and techniques, and build a Quality Culture of continuous improvement.
Specific Goals:
- Find the ‘root cause’ of poor quality and develop a plan to improve overall quality
- Implement new Techniques to enable continuous improvement
- Introduce new methods, such as Quality by Design, to Quality Assurance (QA) and Quality Control (QC) to aid in building a Quality culture of continuous improvement.
SOLUTION
- RCM Advisory Services – Regulatory Advisory consultant assembled a team and recommended a phased approach to included: remediation planning, root cause identification, remediation with short-term solutions, and continuous improvement training.
- Remediation activities prioritized when data was gathered through findings, comments, and discussions on continuous improvements.
- Improvement techniques included QA and QC training on new methodology, such as Quality by Design.
- Actionable items were tracked, corrected, reported, and eliminated.
- Weekly, Monthly, and Quarterly review with senior management were conducted.
- Documents were revised to meet FDA requirements.
- Additional resources were added as needed to complete the phased approach to remediation.
BENEFITS
- RCM efforts allowed the Client to address the critical remediation activities quickly and completely.
- Client personnel was educated on FDA regulations, CSA and new methods for continuous improvement.
- Through collaboration and teamwork, RCM and Client succeeded in building a Quality culture that embrased continuous improvement.
Key Project Elements
Remediation that mitigated future risk
Quality documents that aligned with FDA
Mandatory Employee Training
Quality culture
that embrases
continuos improvement