Product Technical Complaints (PTCs)
Optimizing the Product Technical Complaint Management processes is becoming increasingly important, but no less difficult. High complaint rates are becoming an area of increasing focus for the regulators. The PTC process must enable a company to:
- Identify existing and potential causes of nonconforming product, or other quality problems.
- Investigate the cause of nonconformities relating to product, processes, and the quality system.
- Identify and validate the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems.
- Ensure that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of
- product or the prevention of problems.
- Submit relevant information on identified quality problems, as well as corrective and preventive actions, for management review.
- Implement and record changes in methods and procedures needed to correct and prevent identified quality problems.
Foresight Group’s approach is to simplify and optimize Product Technical Complaint Management processes and use Risk-Based Complaint Assessments.
- Reduced lead-times, batch sizes, and cost
- Simple PTC processes with clear roles and responsibilities
- Risk-based assessment to prioritize case handling effort
- Effective signal and trend analysis and management
- Integration with manufacturing, CAPA, PV, Risk Management
- Effective KPIs at global and local levels
- Support by global governance, standards, and technology
The key element of Foresight’s solution is a proven, scientific approach to Product Technical Complaint Management.A risk-based approach is introduced into the complaints management process to reduce the number of unnecessary investigations.Next, risk categories are developed to assess incoming complaints.Decision trees are then developed and implemented to support case triage and identification of near-incidents.A statistical case sampling / QC process is finally introduced to support the risk-based approach.
The solution is physically sustained through implementation of lean, compliant PTC processes.The first step is to produce an E2E “As-Is” process map identifying Value Adding/Non-Value Adding/Sustaining process steps.This is followed by a “Blue-Sky” thinking workshop, the best ideas from which are incorporated into the “To-Be” process with a reduced number of steps.Finally a road map to go from the “As-Is” to the “To-Be” process is planned and the solution is validated and implemented.
Foresight Group has a proven track record in redesigning product technical complaint management processes within the pharmaceutical industry. We have significantly reduced cycle times for our customers, thereby reducing cost of ownership per case and improving compliance. Some of the tangible benefits we have delivered include:
- Reduced case processing cost and leadtime
- Case backlog reduction
- Increased staff and resource efficiency
- Mitigated cost increases resulting from reduction in resource necessity.