When our product Realization team facing a quality deviation during product launch which was really crucial situation, we as a team managed well & successfully launched product in reality. Here are key actions we took to avoid same in future. 1.stop production/supplier process in our case due to which deviation occurs. Risk assessment conducted based on severity and impact. 2.communicate all stakeholders for the issue & technique of solving problem. 3. RCA and actions 4. mitigation plans & actions 5.decison based on new solution 6. Pilot run production proto based (time availability) 7.communication of results. 8. lessons learnt strive for quality culture for preventing deviation empowering employees to identify, report potential problems.

COMMUNICATION: Pause the launch, and communicate transparently the said deviation to the people involved. ROOT CAUSE ANALYSIS: Identify the root cause of the deviation, and how does this deviation affects the quality of the product, its impact to the safety of the consumers, and does it influences compliance of the product. CAPA: Once identified, plan-out a solution that will be feasible, including time frame, resources needed to be used for the correction, and include preventive actions in planning out solution to ensure that the deviation will not occur again. DOCUMENTATION: Ensure to properly document EVERYTHING, so that if there is some problem that will be encountered, you have something to look back into to see where it go wrong.

1. Immediate Assessment and Containment 2. Root Cause Analysis (RCA) 3. Develop and Implement Corrective Actions 4. Review and Reassess Production Readiness 5. Make a Go/No-Go Decision 6. Mitigate Impact and Manage Expectations 7.Implement preventative actions Key Takeaways: • Act decisively and promptly. • Focus on root cause analysis. • Develop a structured action plan. • Communicate transparently with all stakeholders. • Learn from the deviation and prevent future occurrences. By following these steps, you can navigate a quality deviation effectively and increase your chances of a successful product launch, despite the unforeseen challenge.

Quickly assess the impact of the deviation on product performance and user experience. Determine whether the issue is critical enough to delay the launch or if it can be fixed post-release. Identify the root causes of the problem and develop a corrective action plan. Keep stakeholders informed about the issue, the resolution process, and any potential changes to the timeline. If the launch is slightly delayed, providing clear explanations will help reduce concerns and maintain trust. After the launch, hold a review session to extract key lessons learned. Finally, identify areas in the quality assurance process, development cycle, or communication channels that need improvement to prevent similar deviations in the future.

- Analyze and Prioritize Conduct a thorough Root Cause Analysis to identify the source of the deviation. Assess the impact on product quality, safety, compliance, and customer expectations. - Corrective and Preventive Actions Develop and implement a solution to address the root cause of the deviation. Update processes and training to prevent future occurrences. - Transparent Communication Keep all stakeholders informed. Be proactive about managing expectations if timelines need adjustment. - Review and Decision Conduct a final quality assurance audit to ensure the product meets standards. - Postmortem Analysis After resolving the issue, review the entire process to identify lessons learned and make systemic improvements.