Was tun Sie, wenn Ihr Qualitätssicherungsprozess auf ein komplexes Problem stößt?

1. 3G: Gemba: Go to the spot, Gembutsu: See the actual problem, Genjitsu: Taking realistic actions based on the facts. 2. Use Pareto chart as 80% of the complex problem can be solved by identifying top 3 quality issues (meaning 20% of the total issues contributes to the 80% of the problem) 3. Do the 5 Why Analysis. 5M+1E analysis (Man, Machine, Method, Material, Measurement & Environment) check.

Recommended to use 5W1H (what, who, when, which, where, how) to have clear understanding of problems with a cross functional team. It is important to get the VOC (Voice of Customer) detailed failure description and information from the internal or external customer. Recommended to map the process using Flow Chart to audit by back trailing and diagnose which are the process steps that fail to cordon off the failure (Process Controls), why we fail to capture it beforehand in our Quality Gate (Process Assurance) and identify the origin of failure is coming from. To do this recommended using Why-why Analysis during interviews with our people who are directly working on the process. Now we are ready for next step of RCA to identify Root Causes.

When encountering a complex problem in the Quality Assurance process: 1. Analyze the problem: Understand the root cause and the factors contributing to the complexity. 2. Collaborate with team members: Engage with developers, product managers, and other stakeholders to gain diverse perspectives and insights. 3. Break down the problem: Divide the complex problem into smaller, more manageable components. 4. Utilize problem-solving techniques: Apply methodologies like root cause analysis, fishbone diagrams, or 5 Whys to delve deeper for Solution 5. Experiment and iterate: Implement potential solutions on a small scale and assess their effectiveness. 6. Communicate transparently: Keep informed about the problem, progress, and solutions.

When a problem is identified, the first question is whether this is a patient safety issue or a product quality issue, or both? The next question is whether this affects a need to stop operations and/or to hold product in place? Then determine whether we can control and stop the issue from occurring. Then take immediate action and make any necessary short-term corrective actions. Then assemble your team, conduct an investigation. Make any needed changes and or long-term preventive actions. Then evaluate change effectiveness and whether there has been any problem recurrence? *After saying all of this, I can't think of anything that should be done before assessing potential patient impact. Patient Safety is Job #1. Always...

When faced with a complex problem in the Quality Assurance process, I first assess the situation to understand the root cause and potential impact. I then collaborate with team members to gather insights and explore possible solutions, prioritizing those that align with our quality objectives. Throughout the process, I maintain clear communication with stakeholders, ensuring transparency and alignment. I also leverage data and analytics to make informed decisions and continuously improve our processes.

Engaging the QA team and stakeholders harnesses collective intelligence. Fostering open dialogue and brainstorming sessions fuels innovation, leading to dynamic solutions for complex QA challenges. Together, we excel.

Engage with project managers, developers, and other relevant stakeholders. Discuss the issue openly and seek their perspectives. Sometimes fresh eyes can provide valuable insights.

Uma equipe engajada, capacitada, tem o poder de ter decisões corretas e facilidade para solucionar problemas complexos. Uma equipe com um bom diálogo e postura é muito mais forte.

The answer of the problem lies in the head of the members of the quality team. A good and experienced QA manager is good for a company but the synergistic power of a team is always better. So first of all a brainstorming technique will show the possible causes of the problem and right then a fishbone technique will reveal the source of the problem. Simple things. Simple solutions. As long as brainstorming will be done in the correct way (meaning ALL voices are heard without criticism in the 'green light thinking phase).

Respect, honesty and trust must first be established in order to have an engaged Team. Once in place we are sure to receive valuable feedbacks that will lead to real solutions.

Identifying and analyzing impact of any issue is crucial to solve the problem. Impact analysis can help prioritize the issues which needs immediate resolutions. If there can be any quick workaround, it will help resolve issues while permanent solutions is identified and implemented.

Based on my experience, by following a structured approach, pharmaceutical companies can effectively address complex QA problems, mitigate risks, and uphold the highest standards of product quality, safety, and regulatory compliance. 1. Assessment and Documentation: 2. Root Cause Analysis: To identify the underlying factors contributing to the problem. 3. Engage Cross-Functional Teams and Collaboration. 4. Data Collection and Analysis. 5. Risk Assessment: 6. Implement Corrective and Preventive Actions. 7. Maintain your Site Safe and in Compliance. 8. Communication and Reporting: Clear Communication and transparency. 9. Continuous Improvement: Encourage a culture of continuous improvement.

Analyse the impact so that the solution can be prioritised. For any trivial issues, we can always go with Passive risk acceptance approach. No need of fire fighting mode. If its impact is huge then put your best people to resolve the issue

Once you have a better understanding of the complex problem, it's crucial to assess its ramifications. This involves prioritizing the severity of the issue. Consider how it might affect users, how widespread it could be, and the potential impact on the product's functionality or reputation. By understanding the severity, you can prioritize your next steps and determine if it's a critical issue requiring immediate attention or a lower priority that can be addressed in a future update.

once a understanding is developed on the issue, its impact needs to be identified on the product, this will help to deicide the priority and severity which can be communicated to the stakeholders with the time and resources needed to fix it.

Problem Analysis and Understanding: Thoroughly analyze the complex problem's impact on QA processes and product quality, gathering relevant data for insights. Brainstorming and Idea Generation: Facilitate a collaborative session among cross-functional teams to generate diverse solutions, prioritizing creativity and innovation. Prioritization and Selection of Solutions: Evaluate potential solutions based on feasibility, effectiveness, and impact on project timelines, selecting the most promising options for further development.

When addressing complex problems in Quality Assurance (QA), developing solutions involves a systematic approach to identify, design, and implement effective resolutions. Here's how you can develop solutions to tackle complex QA problems: 1. Root Cause Analysis 2. Brainstorming and Ideation 3. Evaluate Options 4. Design Solutions 5. Prototype and Testing 6. Iterative Improvement 7. Documentation and Knowledge Sharing By following these steps, you can systematically develop solutions to address complex problems in QA, leading to improved software quality, enhanced efficiency, and better outcomes for your projects and stakeholders.

- Once you have got a good handle on understanding of the problem, do white boarding to identify fixes - Analyze each fix for these areas - Speed, cost, feasibility to implement, - Put a concrete plan in place once all above are figured out

Experiment and Test: Develop hypotheses and conduct experiments or tests to validate potential solutions. This may involve trial and error to find the most effective approach.Document and Communicate: Keep detailed records of the problem-solving process, including the steps taken and the outcomes. Communicate regularly with stakeholders to provide updates on progress and gather feedback.

Out of the bubble.... Stepping out of "the bubble" of the complexity can aid in getting a birds eye view of the problem and getting a trusted external point of view may also help. At times the creators of the problem may not be able to easily develop a solution as a group culture of thinking and process execution is already embedded.

Use SDCA approach. Standardize, do, check and act in case of deviation (additional training, standrad update etc.). Pre-defined frequency and way of check for CA part.

While implementing the new solution, it is necessary to monitor the effect of the same in the entire system. Do necessary changes in the documentation to implement it in the process

- **Define and Plan Change**: Clearly define the changes needed to address the complex problem in the QA process and develop a detailed implementation plan. - **Effective Communication**: Transparently communicate the planned changes to all stakeholders, emphasizing reasons, benefits, and expected outcomes. - **Training and Gradual Implementation**: Provide necessary training to QA team members and implement changes gradually to facilitate smooth adaptation and mitigate disruptions. - **Monitor, Adapt, and Document**: Monitor implementation progress, gather feedback, and adapt the approach as needed. Document changes and lessons learned to inform future improvements in the QA process.

Implementing changes in the context of Quality Assurance (QA) involves putting the developed solutions into action to address complex problems effectively. Here's how you can approach implementing changes in your QA process: 1. Plan and Prepare 2. Training and Skill Development 3. Execute Changes 4. Testing and Validation 5. Feedback and Monitoring 6. Change Management 7. Documentation and Reporting 8. Continuous Improvement By following these steps and implementing changes systematically, you can effectively address complex problems in QA, improve software quality, and drive positive outcomes for your projects and stakeholders.

Test Environment Setup: Configure a dedicated test environment to implement and validate proposed solutions without affecting the production environment. Gradual Rollout: Implement changes incrementally, starting with smaller-scale deployments to mitigate risks and monitor their effects.

- Identify metrics to measure the fix or solution provided - seek continuous feedback from involved people - provide alternate solution as and when needed

Key documents 1. Quality Control 2. Incident and accident report 3. Change control and training documents. 4. Final observation and cycle demonstration and standardization report. One must ensure, keep all stakeholders informed about the problem and problem solving process and its progress.

Después de implementar soluciones, monitoree los resultados para asegurar una resolución efectiva del problema. Realice pruebas continuas y esté alerta ante cualquier consecuencia no deseada o regresión. Vigile los indicadores de rendimiento afectados por el problema inicial y los comentarios de los usuarios para confirmar la solución satisfactoria. Además, revise el proceso de control de calidad para identificar debilidades y prevenir problemas futuros. Desde mi perspectiva, esta supervisión continua es esencial para garantizar la calidad y la satisfacción del cliente a largo plazo. #SupervisiónDeResultados #ControlDeCalidad #SatisfacciónDelCliente 📈👀

One key aspect of post resolution activities is a Blameless Post Mortem. The emphasis on blamelessness is critical here to foster a safe space for genuine learning and improvement. Keeping this session action oriented to instill genuine improvement will ensure you, your QA team and Stakeholders can be confident "that bad thing" can't happen again.

- **Define Key Metrics**: Establish specific KPIs to measure the impact of changes, such as defect detection rate and test coverage. - **Regular Progress Tracking**: Implement routine reviews to assess progress against established metrics and identify any deviations or trends. - **Feedback Channels**: Foster open communication channels for gathering feedback from QA team members and stakeholders to capture insights and suggestions for improvement. - **Continuous Improvement**: Use data analysis and root cause analysis to drive continuous improvement efforts, adapting strategies as needed to enhance the QA process.

Best formula is "Make it simple". A complicated issue means several problems linked or Knotty, Tangled, Matted, etc.. Put all the efforts to separate them as much as possible, you will find where the knots are, open or cut them. This will help a lot to do RCA. Make a thorough CAPA for root cause while for associated and matted issues, find the simplest solution and close one by one or in parallel. At the end of the day an issue which was complicated will become comparatively simple and easy to work on closing the CAPA and later monitoring it's effectiveness.

7 Impact of change to business . It's necessary to evaluate the impact of changes to business, for example if the said changes goes for regulatory approval of PAS category probably there is no order after the approval is received then in this case we need to re evaluate all the things from Point No 1 to point no 6. 8) impact of change needs to correlate with Risk Assessment with respect to Patients who is end user . There is always a better solution available

For comprehensive quality issues - the team should do all of the above 1 through 6 to include: -Thoroughly analyzing internal and external source for issue analysis; - Ensuring a well written problem statement that does not include any proposed containment, corrections, corrective actions or systemic corrective actions; - Actively engaging the team to find the true root cause and not just the problem itself; - Maintaining senior management support in order to support true systemic fixes; and - Willingness after implementation of corrective and systemic corrective actions to sustain monitoring and measuring results to make further adjustments if necessary.

It is “us” who drive the improvements and constant changes towards a more robust process. Please consider to constantly invest in good RCA and communication skills, across time zones and cultural differences. If the people don’t find a healthy environment where they can address problems in an open and secured way without fear, there won’t be really sustainable and good solutions.

Consider if the same issue can arrise accros the organization, if yes be preventive and implement the solution in advance. Share the practice that helped you. Include younger team members in the issue as they can gain experience from this.