Case Study: Quality System Optimization
At QualityHub, we have experience in quality systems for several types of companies and situations. Here are nine examples of quality system case studies to give you some background on that experience.
CAPA System Overhaul
When QualityHub is brought on to do CAPA system revisions, it is often more reactive than proactive. However, one particular client — a major international pharmaceutical and medical device company — noticed shortcomings and wanted to take a more proactive approach to their CAPA system.
Compliance Master Plan
QualityHub assisted an international device company with its existing compliance master plan. Working with the project manager and QA director we were able to develop a newer version of the document that was more understandable and more detailed. Using our ex-FDA expertise we determined more emphasis was needed on accountability and responsibilities. We were able to improve the document to more closely hold persons responsible.
We also guided the company to use measurable data for the milestones, thus focusing on the metrics that were needed to demonstrate the success of the milestones via objective evidence. Since numerous project teams were involved in implementation, we worked with the project manager, who held the project team leaders responsible for providing key details in the document.
Based on our guidance and requirements, the teams provided us with improved responsibilities information and information on the objective evidence they would use to demonstrate the accomplishment of the milestones.
Investigation Analysis and Training
QualityHub worked with a major international drug/device corporation to help improve its internal investigation processes and skills. Internal reviews and FDA inspections pointed out weaknesses in that area. We performed a gap analysis by reviewing samples of investigations from divisions across the organization.
Working with company representatives, QualityHub developed a full-day training program on conducting investigations. The course materials were licensed to several thousand users, who became the corporation’s trainers worldwide (using “train-the-trainers”).
QualityHub participated in training the first two levels of trainers and certified the initial cadre. The company trainers presented the training to sites worldwide and initiated other improvements in their investigation programs.
To determine if the program was successful, we performed a second gap analysis of their investigations about six months later and at one-year post-deployment. These gap analyses showed great improvements.
Warning Letter Intervention
QualityHub was contacted by a strategic consulting partner to assist with a drug manufacturer who had recently received an FDA warning letter. Working with the partner company, we assisted in developing the overall compliance plan and writing the FDA update submissions.
The compliance plan included major improvements in the validation program, investigations/CAPA, change control and management controls. Utilizing several specialized contractor consultants and company personnel, we were able to implement a new quality system—and work on culture change initiatives—to ready the company for the inevitable FDA inspection.
CAPA Program Development
QualityHub was contacted by a drug company to assist in the development of a new CAPA program. Working with the company we reviewed their current program and guided them in the development of a new CAPA program. QualityHub also briefed local management and provided training to all applicable personnel on the new system. We also provided some guidance on the role of automation systems for their CAPA information.
Corporate Survey/Gap Analysis – Complaint Handling
QualityHub was contacted by a drug/device company to provide the main office with an analysis of practices company-wide. We visited numerous sites in Europe and the U.S. and provided a report of our findings. Process maps were developed and information was gathered on the strengths and weaknesses of the program. This information will be used for future process improvements as well as organizational analysis.
Corporate Survey/Gap Analysis – MDR and Complaint Handling
QualityHub was contacted by a major international device company to perform an analysis of complaint handling practices company-wide and worldwide. We visited over 20 sites to gather information about their complaint handling and MDR practices. The analysis included an extensive sampling of complaints—both non-MDR reported and MDR reported.
The project included an extensive data-gathering activity using pre-planned sampling plans, questions and analysis tools. Reports were prepared, which the company used to improve its complaint and MDR practices worldwide. We also consulted on their new and improved complaint and MDR procedures.
FDA Preparation Training
QualityHub helped numerous medical device companies in the U.S., Asia and Europe, prepare and handle FDA inspections. Overwhelmingly, the clients reported that our assistance was very helpful in handling the FDA inspections, and also in minimizing the number of FDA 483s the sites received at the conclusion of the inspections. The reduction of FDA 483s resulted in no warning letters for nearly all of these companies.
FDA Inspection Preparation and Back-Room support
We helped a European company plan for handling an FDA inspection. This included pre-inspection gap assessments, SME interviews and SME training, as well as management training and site preparation for the inspection.
During the actual inspection, we helped the back room in orchestrating the documents and SMEs that presented during the inspection. The company passed the inspection with flying colors.