You've discovered a systemic quality issue in your organization. How will you address it effectively?

Determine the underlying cause of a systemic quality issue via data analysis and stakeholder involvement before taking any action. Create a clear action plan and carry it out, delegating tasks and establishing deadlines. Key performance indicators (KPIs) are used to track progress and make necessary adjustments. In order to stop recurrence, tighten quality controls and encourage a continuous improvement culture. Lastly, to improve organizational learning and transparency, record and disseminate lessons learned.

I'm a fan of ISO 9001's 'best practices' for addressing quality issues (aka nonconformities). Here are the three key steps: (1) Immediate Actions - take steps to keep the damage from spreading (e.g., put down a bucket to capture water dripping from the ceiling; (2) Root Cause Analysis - the 5 whys technique is the simplest to use - (e.g., why is the water dripping?, oh, there is a hole in the ceiling, why is there a hole in the ceiling? The shingles in the roof are missing. Let's repair the roof!) (3) Evaluation of Effectiveness: You fixed it! Or did you? What do you need to see to have confidence the fix worked? E.g., 'I’ll have confidence the fix worked when it rains and there is no leak.'

To address a systemic quality issue, first identify the root cause by gathering data and feedback. Create a clear plan with steps to fix the problem and prevent it from happening again. Share this plan with your team and provide any needed training or resources. Implement changes gradually and keep track of progress. Regularly review and adjust the plan to ensure it effectively improves quality and meets standards.

To truly get to root cause, you have to include multiple personnel from within the organization. Work within the organization where the “rubber meets the road”.

Nada mejor que utilizar la norma ISO 10009:2024 Gestión de la Calidad: Guía para las herramientas de calidad y su aplicación. Este documento proporciona orientación sobre la selección y aplicación de herramientas que se pueden utilizar, entre otros: para facilitar la resolución de problemas, incluyendo en análisis de causa raíz. Además de los 5 por qué y el diagrama de causa - efecto, nos propone: el árbol de decisiones y el análisis del árbol de fallos.

Once you gather evidence, the next crucial step is to perform a Root Cause Analysis (RCA). RCA is a systematic process used in quality management to identify the true causes of a problem. Techniques like the "5 Whys" or cause-and-effect diagrams help you dig deeper beyond the symptoms to uncover the fundamental issues. Understanding the root cause is vital for developing solutions that effectively address the problem at its core, rather than just treating its symptoms.

In case of a systemic issue a 3 legged 5why is a useful exercise. Each leg focuses on a different aspect of the issue. One is about the process-specific problem, what led to the incident. Another is about how the problem escaped and why it wasn’t detected. And the third is about why it’s a systemic issue and where else in the organisation it could happen again. This leg usually doesn’t get the right attention, especially when the team’s objective is a quick fix. It takes time and effort to analyse it, but in the long term it can prevent more problems and it’s cost effective.

Sure understand root cause is the primary thing after a mistake. in that case is very difficult in a process fill all documents connected with quality issues and take corrective action immediately to put in safety tha products is the first step. then analyse with 5why and other tools is an obligation😄I know is not the perfect way but in many different situations is the reality

Para mi lo importante, además de un buen Root Cause Analysis (RCA) y definir las CAPAs adecuadas (que es la base para solucionar los problemas), es crucial definir también una estrategia de “Lessons Learned” para comunicar a otras áreas de la empresa (Ej.: otras plantas o departamentos) las experiencias obtenidas, para evitar que se repita el mismo problema en otras áreas de la organización.

The only way to address systemic issues is to adapt a "circle of influence" encourage those close to you to adopt different ways of working through demonstrating a better way, then in turn, those that YOU'VE influenced will spread that learning and those healthier practices. Before you know it you've got a swathe of change agents making changes for the right reasons based on understanding and logic, and, almost inadvertently changing the culture in a multi-vectored way.

The best way to prepare solutions at this part is to ensure finding the exact and correct root cause (using one of the methods ) . Unecessary actions can make the quality issue go wild while solutions are sometimes on the simplest levels and not all the time intense ones . This remains a general way while the in reality it can be differently solved . Depends on the quality issue's type and its correlation to other elements/KPI's which makes targetting different KPIs an efficient way to get back on track for the troubled one.

Once identified the root cause, it is crucial to engage key stakeholders and ensure transparency throughout the process. A cross-functional team should be formed to collaboratively address the issue, keeping open communication with all stakeholders about progress and decisions as you work through the issue. This team should develop a corrective and preventive action plan, and ensure that the solutions are sustainable in the long term. Potential solutions should be evaluated and coordinated based on their impact and feasibility, using a risk-based approach, and prioritizing those that offer the most significant benefit.

The action plan should address specific actions to be taken, as well as responsibilities and timeframes for their implementation. The roll out of the CAPA plan should be gradual to minimize operational disruptions and allow for quick adjustments if necessary. It is really important to monitor their implementation according to the established planning, and also to measure their effectiveness using key performance indicators (KPIs).

• The concept of "Implement Changes" is crucial for addressing systemic quality issues by taking concrete steps to put developed solutions into action. • It involves creating a detailed plan for implementation, overcoming resistance to change, establishing metrics to track progress, and promoting a mindset of continuous improvement. • By effectively implementing changes, organizations can resolve systemic quality issues and create a more resilient and efficient operating environment.

A primeira ação seria entender a raiz do problema e criar uma estratégia que permita continuar as atividades sem impacto com este cenário, fazendo o próximo passo envolver as áreas com interface e de suporte para solucionar o problema de maneira definitiva.

During implementation, it’s essential to manage the process carefully to avoid disruption. I would focus on clearly communicating the changes, explaining why they’re needed, and highlighting the benefits. Providing proper training and resources is key to ensuring a smooth transition. Setting clear timelines and assigning responsibilities helps keep everything on track. The success of implementation depends on how well the plan is put into action, so attention to detail is crucial.

Create a detailed implementation plan that outlines the steps, timelines, and responsibilities. Ensure that the changes are communicated clearly to all affected employees. Provide necessary training and resources to facilitate a smooth transition. Pilot the changes in a controlled environment, if possible, to test their effectiveness before a full-scale rollout.

Tracking the implementation of actions should be done by defining a monitoring program, and establishing key performance indicators (KPIs) to measure the effectiveness of the implemented solutions. Regular reviews should be conducted to ensure that solutions are working as expected and make adjustments as needed. Fostering an organizational culture that values quality and continuous improvement will make the difference, encouraging employees to proactively identify and resolve quality issues.

Now the solution is implemented. We need to verify the effectiveness of this solution. This can be through periodic reviews or internal audits. At the same time, inputs from these reviews can support in improving the process further

Establish key performance indicators (KPIs) to track the effectiveness of the implemented changes. Regularly review these metrics to ensure that the solutions are delivering the desired outcomes. Be prepared to make adjustments if the data indicates that the issue is not being fully resolved.

Implementation of a change is only the first step in making changes. The influence of a new change should be monitored and additional changes may be implemented in order to achieve the desire target.

Monitoring progress is an ongoing process that ensures the solutions implemented are yielding the desired outcomes. Key performance indicators (KPIs) and metrics are essential tools for tracking progress, enabling teams to evaluate how well the changes are addressing the systemic quality issue. Regular reviews and check-ins with stakeholders provide opportunities to discuss what’s working and what isn’t, offering insights for continuous improvement. Data-driven decision-making allows the team to make necessary adjustments to enhance effectiveness or efficiency. By closely monitoring progress and maintaining transparency, the organization can course-correct when necessary and ensure long-term success, preventing a recurrence of the issue.

A systemic (or systematic) issue demands systemic answers. At the end of the day, your QMS is only a HOW (don't confuse it for a WHAT). It is HOW Management converts its intentions into actions and monitors them. So Management must be engaged (ah, the answer to so many quality issues). How do you engage Management in an issue like this? My advice is to apply the tools of Change Management: -create a shared need (Management must understand that there is an issue, what the issue is and that it needs to be addressed) -create a shared vision (a Team addresses the issue, enhances the QMS to avoid a repeat and you have some lessons learned--to apply them elsewhere) -then and only then is it time to "mobilize resources" and get to the fixing.

The first reaction on coming across a systematic quality issue is the correction of the issue. This has to followed by a systematic root cause analysis by applying various established techniques. Based on the inputs of the RCA, past data/ evidence and involvement of stakeholders, the corrective actions have to be taken. These corrective actions are further required to be monitored periodically for their effectiveness and course corrections may be made, where required.

There are different techniques to resolve such issues. But I would prefer the following. 1. RCA the very first action. 2. CA-PA approach to address the issue.

Creo que hay una buena cultura de calidad en la empresa es justamente esto involucrar a tod@s, pero no solo en la solución sino también para ver los posibles errores que se puedan llegar a cometer antes de que estos sean una No conformidad

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