Your manufacturing processes are not meeting your quality standards. How can you find the root cause?

Define the problem: Gather data: Conduct a thorough analysis: Use root cause analysis tools: Involve cross-functional teams: Perform experiments or tests: Prioritize and verify: Continual improvement: It is crucial to maintain open communication with all stakeholders involved and foster a culture of continuous improvement within the organization.

To address a quality issue, start by defining the problem clearly, articulating its impact on fit, function, performance, and appearance, specifying criteria not being met, and outlining desired outcomes. Collect relevant data using statistical tools, process maps, and analysis techniques to comprehend the current state. Engage CFT through Gemba walks and brainstorm potential causes,employing tools like fishbone diagrams, Pareto analysis, scatter diagrams, and regression analysis, utilizing tools like Minitab. Identify correlations and trends among process variables and the quality issue. Take corrective action by closing potential causes with Corrective and CAPA and close the loop. Document findings and communicate with all stakeholders.

The first and foremost step in problem-solving is to correctly define the problem. It seems simple but is where many teams fail. An incorrectly defined problem takes the team on the wrong path wherein they spend the time and resources in solving a wrong problem. This results in wasted resources and the original problem can and will highly likely recur. Using a tool like 5W x 2H along with the right stakeholders who have the relevant experience and skills helps in defining the problem accurately.

There are various tools or framework available to identify the root causes of nonconformity or failure Fish bone diagram Why why analysis 5 why analysis etc

By using different tools like QC tools , by technical analysis,by using different methods like six Sigma and 8D methods we can solve the problems which are impacting the manufacturing process and products.

Dados e fatos s?o a base de boas análises! Medi??o do processo para entender bem a rela??o de causa-efeito e/ou as possíveis interferências e interdependência dos dados é fundamental! Entenda bem as duas pontas do processo, o fornecedor(es) e cliente(s), para que as entradas as e saídas sejam bem estudadas. Por fim, a atividade central deve ser bem avaliada junto ao time para que as a??es sejam bem fundamentadas e o resultado assegurado.

Collect data on key aspects of the manufacturing process, including production logs, quality control records, and feedback from operators. Analyze trends, deviations, and any anomalies. Additionally, inspect equipment for wear and tear, and gather feedback from workers involved in the process. This comprehensive data collection will help pinpoint potential root causes of quality issues.

Once the problem is defined we can start collecting the details to know more about the nature of the problem. This can be done making Control charts, Check sheets, Why- Why analysis etc. Based on data collected from above mentioned methods we can define the target properly as without a target which is not only challenging but realsitic everything would go in vain.

Possible cause of a problem can be identified by firstly making the fishbone diagram which bifurcates the problem in man, machine, material and method category. In some cases environment can also be an important factor in thefishbone diagram.

Potential causes of manufacturing quality issues may include equipment malfunctions, insufficient training of personnel, variations in raw materials, inadequate maintenance, or even external factors like environmental conditions. Investigate each factor thoroughly to determine its impact on the product quality.

Our processes/systems should be designed to identify the cause during failures, unfortunately majority of the cases, investigators struggling to find the cause due to poorly designed processes and systems. Our processes should be designed to deliver the right quality and our systems should ensure to drive the path towards right first time quality. Work first to design the right systems and processes. Be proactive rather than reactive.

One of the very basic and effective way to find the root cause is by doing Why-Why analysis. A why if asked and answered correctly can give us the root cause at Max in 5th why. Forming a cross functional team and brainstorming with them with open mind is equally effective way to get the root cause.

To verify root causes, conduct experiments or tests to isolate and confirm the impact of each potential factor. Cross-reference your findings with historical data and expert opinions. Ensuring a systematic approach will help validate the identified root causes and guide effective corrective actions.

We need to establish clear unit operations in batch execution record, those will give clear directions during root cause analysis. How effectively we designed our process is important for operational ease at floor. As a preventive measure for batch failures, we need to eliminate the human intervention through automation or mechanisation.

It is essential to regularly review process capability against targeted quality standards. This involves assessing the consistency and stability of processes to ensure they are capable of producing products within the required specifications. Utilizing tools such as SPC, or statistical process control, can provide valuable insights into the variation within the manufacturing process, allowing for informed decision-making and targeted improvements. By conducting these reviews, you can identify areas for enhancement, implement corrective actions, and ultimately, improve their ability to consistently meet quality standards.

Apart from identifying problem, setting target for reduction, finding probable cause, finding root cause and solving the problem equally important is standardizing the solution. If standardizing is not done there would be no use of solving the problem because it would be repeated in one form or the other. So after solving the problem and checking it's effectiveness we should standardize the process to eliminate any shortcomings in future. Standardization is the last step in problem solving and closes the loop completely of PDCA cycle.

In addition to equipment, personnel, materials, and maintenance, consider environmental factors, process parameters, and regulatory compliance. Evaluate the entire supply chain for any contributing issues. Communication gaps, outdated procedures, and feedback loops should also be examined. A holistic approach will help ensure a comprehensive understanding of the manufacturing process and identify all relevant factors. Don't overlook the possibility of systemic issues such as organizational culture, communication breakdowns, or inadequate quality control systems. Engage with personnel at different levels to understand their perspectives. Regularly review and update standard operating procedures to adapt to changing conditions.

Direct used 1-Fishbone Diagram 2- Review the scop for operation and Quality dept. 3- VISTEGATE report 4-Meeting with the manager to set the goal. 5-performance