How do you update and review FMEA throughout the Six Sigma project life cycle?

start by establishing the project scope, goals, and requirements while forming a cross-functional team. Begin the FMEA by defining the process or product, its functions, potential failure modes, their effects, and causes. Document these elements using worksheets or software, assigning risk priority numbers (RPN) based on severity, occurrence, and detection. Regular updates and reviews are crucial throughout the project. Revise the FMEA during key stages—such as project initiation, design, and implementation—ensuring that all failure modes and risk-mitigation strategies are evaluated. Continuous collaboration ensures accurate risk management and effective problem resolution.

If working with a New Product Development: start with the functional decomposition of the system of interest and/or a product map. If working with a New Process Development: start with the process map. Initializing by a broader view of a complex system (product or process) will help to capture the functions or jobs to be done. Those initial steps will save multifunctional team efforts, and as soon you draft the functions you should deliver you will have a better view on what are the potential failure modes. As you are going deep on FMEA reviews, those functional decompositions and process maps will be reviewed and improved. Remember: FMEAs are cross-functional teamwork. Collaboration is mandatory for a good final result.

Dans la phase de définition de l'AMDEC, il est essentiel de clarifier la portée et les objectifs du projet tout en constituant une équipe interfonctionnelle. Cette étape consiste à identifier les modes de défaillance potentiels, leurs causes et leurs effets sur le produit ou le procédé afin de prioriser les risques et d'établir des actions correctives.

Al inicio del proyecto, es importante realizar un análisis de riesgo. La descomposición del NPR, permite a lo largo del proyecto de ir mejorar y de ir generando los controles y acciones para gestionar el riesgo. Considero que el AMEF no es una herramienta que solo deba estar presente en la etapa de Control, sino de ir perfeccionando la misma a través de la gestión de todo el proyecto.

We have to regularly update FMEA to reflect changes in processes or risks & also review FMEA after each project phase to identify new potential failures. Its also imp to prioritize actions based on risk priority numbers . One thing we often miss is to celebrate successes and address areas for improvement. If we continuously review and update FMEA we can ensure its effectiveness in preventing failures & driving process improvement.

I update and review the FMEA throughout the Six Sigma project life cycle by regularly revisiting it during key phases, such as Measure, Analyze, Improve, and Control. After data collection and analysis, I reassess the RPNs based on new insights and corrective actions. I also ensure that any improvements or process changes are reflected in the FMEA, keeping it a living document. Regular reviews help ensure that risks are mitigated effectively and continuously monitored.

The measure phase is all about data-driven decision making. Gather evidence to validate your FMEA assumptions. Focus on the most critical failure modes by analyzing RPN scores. Compare actual performance to your predictions and adjust ratings as needed. Remember, data is your guide to prioritizing improvement efforts.

In the measure phase, collect and analyze data to validate your FMEA assumptions and ratings. Identify critical failure modes with the highest RPNs for immediate action. Update the FMEA by reviewing data sources and methods, adjusting severity, occurrence, and detection ratings based on actual data. Recalculate RPNs, rank failure modes by risk, and select the top ones to address next.

Dans la phase de mesure de l'AMDEC, on évalue et quantifie les risques associés à chaque mode de défaillance en utilisant des critères comme la gravité, l'occurrence et la détectabilité. Cette étape permet de calculer le niveau de priorité des risques (NPR) afin de hiérarchiser les actions correctives à mettre en place.

In the analyze phase, use root cause analysis tools like 5 Whys, fishbone diagrams, or Pareto charts to identify root causes of failure modes. Brainstorm solutions for each cause, evaluating their impact on severity, occurrence, and detection ratings.

Dans la phase d’analyse de l'AMDEC, on examine les causes profondes des modes de défaillance identifiés pour comprendre pourquoi ils se produisent. Cette étape permet de prioriser les problèmes les plus critiques en fonction de leur impact et de cibler les actions correctives les plus pertinentes.

In the improve phase of FMEA (Failure Modes and Effects Analysis), implement selected solutions, conduct testing, and monitor process or product performance. Update the FMEA by planning and executing implementation, collecting data to measure improvement, comparing actual with expected RPNs, verifying solution effectiveness, and documenting changes for stakeholders.

Dans la phase d’amélioration de l'AMDEC, des actions correctives et préventives sont développées pour réduire ou éliminer les modes de défaillance critiques. Ces solutions sont ensuite testées et mises en œuvre afin d’améliorer la fiabilité et la sécurité du produit ou du processus.

The control phase is about making your improvements permanent. It's like putting a fence around your success to keep it safe. Key actions include: 1. Create a plan: Develop clear steps to maintain your improvements. 2. Monitor closely: Use control charts to track performance and spot issues early. 3.Regular check-ups: Conduct audits to ensure everything is working as planned. 4.Stay updated: Review and update your FMEA as needed to reflect changes. Remember, continuous monitoring is key to sustaining your hard-won gains.

Dans la phase de contrôle de l'AMDEC, les améliorations mises en place sont surveillées pour garantir leur efficacité et leur durabilité. Des plans de contrôle, des procédures standardisées et des outils de suivi sont établis pour prévenir la réapparition des défaillances identifiées.

In a cloud-based bioinformatics platform project, we integrated Statistical Process Control (SPC) into our Six Sigma methodology, allowing real-time data on process variation to automatically update the FMEA. For example, when our SPC charts showed an unexpected spike in data processing errors, we revisited the FMEA to adjust the occurrence rating for failures in the data transformation pipeline. By automating this link between SPC & FMEA, we ensured that the analysis was always up-to-date with the latest process data, enhancing our ability to respond to emerging risks efficiently.

Previously I led an initiative in hard disk manufacturing to improve the substrate production process. During the project, I conducted a comprehensive FMEA to assess potential risks in substrate manufacturing, such as variations in material thickness and defects in coating adhesion. By systematically identifying these failure modes and prioritizing them based on severity, occurrence, and detection ratings, we implemented targeted process improvements. This included refining material handling procedures, enhancing quality control checks, and providing additional training to production staff. As a result, we achieved a significant reduction in substrate defects and improved overall product quality metrics. :-)