How do you handle quality system failures and learn from them?

First, conduct a thorough root cause analysis to identify the underlying issues and their impact on the quality system. Engage cross-functional teams to collaborate on solutions, emphasizing transparency and open communication. Implement corrective actions promptly and ensure they align with industry best practices and regulatory standards. Establish a robust feedback loop to monitor the effectiveness of the implemented solutions and track key performance indicators. Develop a culture of learning from failures,

In the event of a quality system failure, it is essential to conduct a prompt evaluation to assess the severity and mitigate potential harm. A thorough investigation should follow to determine the root cause. Corrective measures should be taken, and communication of the issue with stakeholders is important. Learning from such failures requires a continuous process of improvement with a culture of identifying and reporting potential issues.

Identifier la cause première est effectivement essentiel afin de corriger la source du problème. Il faut s’assurer de regarder au-delà du problème et d’avoir une vue d’ensemble sur les systèmes pour identifier une potentielle problématique qui toucherait potentiellement un ensemble de systèmes beaucoup plus grand, amenant un problème plus complexe.

In my experience Handling quality system failures effectively is crucial to maintaining high standards and driving improvement. this might be great learning if you follow structured system and will leads to continual improvement. the very first step is immediate containment. Prevent further impact by containing the failure. This may include halting production, isolating affected batches, or notifying relevant teams and stakeholders. secondly conduct root cause analysis 5whys,FMEA,Fishbone diagram or other similar process for analysis. once root cause analysis is done followed with corrective and preventive actions and documentations, which will leads to learning and continual improvement.

Una de las claves para gestionar con éxito un fallo externo o interno es implicar en el proceso a esos elementos del ecosistema de tu empresa que serán elementos críticos si no se consideran o no se integran en ese proceso desde el principio en que se detecta ese error. Un fallo en el sistema además de ser una no conformidad con el mismo, es una gran oportunidad para detectar zonas de mejora.

Las acciones correctivas no solo deberían dirigirse a eliminar la causa de la no conformidad identificada, sino que previamente debería revisar si este incumplimiento se repite o sucede potencialmente en otro proceso y/o parte de la organización. Es decir, determinar el alcance de las acciones que se necesita tomar, basándose en el efecto potencial de la no conformidad. La organización debería implementar entonces todas las acciones necesarias basándose en el resultado de esta revisión.

La implementación de acciones correctivas es un paso muy importante en el que se deben considerar como evitar la ocurrencia, no detección y qué debe mejorar el sistema para poder evitar la recurrencia de un problema.

In the process of managing corrective actions, it is crucial to educate those involved about the difference between correction and corrective action. I can illustrate this with the example of a leak in a pipe: applying a patch to stop the leak would be a correction, equivalent to addressing the problem immediately. However, identifying the underlying cause of the leak and taking steps to prevent its recurrence represents a corrective action. This approach not only solves the current issue but also prevents future occurrences and their potential consequences. In my experience, understanding and applying this distinction is essential for ensuring continuous and sustainable improvement in processes.

La clave es que las acciones apunten a solucionar la causa raíz, en ocasiones se falla en esto se cofunden con acciones de corrección. Por otro lado, estas acciones, deben evaluarse en su eficacia, lo cual requiere mecanismos adecuados para ello, y también seguimiento en el tiempo, por si vuelve a aparecer la no conformidad. Un último punto es que estas acciones podrían generar cambios importantes en el sistema que pudieran ser relevantes.

Una debilidad importante en las organizaciones es que después que identifican la(s) causa(s) raíces, proponen acciones correctivas que en ocasiones no coinciden con la causa y su solución. También a nivel de fecha de ejecución, colocan ¨acción permanente¨, cuando en realidad deb tener fecha de inicio y fin. De otra forma pasa formar (en ocasiones) parte de los controles dentro del sistema. Por último, revisar su eficacia, también requiere de métodos y tiempo para evaluarla, no es lo mismo una relacionada con temas administrativos, a una que tenga que ver con las características de un producto tangible

Communication with stakeholders even if quality system fails gives you a great perspective to know and way forward to learn and implement the best method so that quality system failure will not affected again.these stakeholders are either internal or external based on severity and affected area. Even after communication and discussion about root cause analysis by your team and stakeholders it is important to know which stakeholders lead to solve problems and way forward.ultinmately it's overall organisation responsibility to learn and grow after failure of QMS so that same will not repeat in future.

In my experience certain stakeholders just do not mesh well when communicating with email, chat, phone, video call, reports, dashboards, or online meetings. If that is the case; when possible & if you can go to the stakeholders & have a face-to-face chat over coffee. Conduct communications away from electronics & understand why certain stakeholders prefer face to face justification. As well as listening to their feedback.

During an SGC finding, it is crucial to implement a communication matrix that aligns with the needs and expectations of stakeholders. Disseminating action plans is essential to keep those involved informed about the event, applied corrections, and preventive measures to avoid recurrence. Additionally, if a finding impacts the achievement of expected results or established commitments, it is vital to communicate this transparently. This open and proactive communication contributes to strengthening trust and transparency with stakeholders, fostering a collaborative relationship in quality management.

La comunicación con las partes interesadas es importante para involucrarlos según lo que sea necesario, informándoles según sea necesario de los recursos que se requieran y de qué soporte es importante brindar.

In my experience as an auditor, I emphasize the importance of thoroughly analyzing indicators and their evolution to understand their performance over time. This provides valuable insights into improvements or stagnation. Additionally, it allows for an assessment of whether the set goals remain relevant and if the indicators are still viable or if alternative indicators need to be considered. This detailed analysis contributes to an informed decision-making process and the ongoing adaptation of the Quality Management System.

Weaknesses in Quality Management System ISO9001:2015, are revealed during the Internal Audit (1st party) by internal ISO9001:2015 auditors, and External Audit (3rd party) by certification body auditors. It is categorized as Major Findings, Minor Findings, or Opportunities for Improvement (OFI), reference to the ISO9001:2015 requirements. With those findings, as the Quality Management Representative (QMR) of the company, I co-ordinate with the team here to close the findings. Sounds familiar with some of you? Did you experience the same? 😊

Identifying and learning from quality system failures involves a systematic approach, including root cause analysis, continuous monitoring, training, corrective actions, risk management, compliance with regulations, benchmarking, and fostering open communication for a culture of continuous improvement.

Cuando existe un registro histórico de las fallas por procesos, productos, servicios, no conformidades de diversas fuentes, se cuenta con información valiosa para aprender de las lecciones pasadas. Sin embargo, la realidad organizacional es otra y nace desde la identificación clara y detallada de la falla (problema), seguida de un pincelazo de análisis de causas sin metodología. ¿Cómo podemos cambiar estas prácticas ineficientes? brindando al personal el conocimientos y las herramientas para realizar un proceso de solución de problemas efectivo y sostenible. Una vez superada esta brecha, la organización podría implementar un software para digitalizar esta tarea para hacerla más ágil, dinámica y proactiva.

Los errores son parte de la vida, nadie está completamente a salvo de ellos. De hecho, juegan un papel fundamental en lo referente al crecimiento personal. Ante un error podemos juzgarnos, criticarnos y hundirnos o podemos aprovechar la gran oportunidad que nos surge para conocernos mejor y cambiar de rumbo. Acepta tus errores: Distingue entre las equivocaciones y las malas decisiones. Considera los errores como oportunidades de aprendizaje. Enfócate en tus fortalezas. Ten en cuenta cuánto tiempo lleva volverse experto en determinadas actividades Aprende de los errores: Contabiliza tus errores y éxitos Confía en tus capacidades Diferencias entre razones y excusas Para más info: Liderazgo y management: Notas, consejos y detalles

In my experience, continuous improvement in a Quality Management System (QMS) goes beyond document updates. It involves dynamically managing changes in the organizational context, anticipating stakeholder needs, and complying with evolving legal requirements. Proactive management of risks and opportunities strengthens the resilience of the QMS, integrating audit results strategically. My approach includes training programs for staff, ensuring alignment with best practices and trends. This ongoing commitment has proven crucial for implementing effective and sustainable improvements in a dynamic business environment.