IATF 16949:2016 Clause 10.2.3 Problem solving

Problem-solving in the context of IATF 16949, the automotive quality management standard, involves structured approaches to identifying, analyzing, and resolving issues within an organization’s processes, products, or services. IATF 16949 places a strong emphasis on preventing defects, reducing variation, and continuously improving the quality of automotive products. Effective problem-solving is essential for achieving these objectives. Here’s how problem-solving is typically approached within the framework of IATF 16949. Clearly articulate the problem or issue that needs to be addressed. This might involve identifying defects, non-conformities, customer complaints, or other quality-related concerns. Collect relevant data and information related to the problem. This could include data on defects, process outputs, customer feedback, and any other relevant metrics. Use structured methodologies such as the “5 Whys,” Fishbone (Ishikawa) diagram, or Failure Mode and Effects Analysis (FMEA) to identify the underlying root causes of the problem. Develop and implement corrective actions to address the root causes. These actions are designed to eliminate or mitigate the identified causes of the problem. Ensure that the corrective actions are effective in resolving the problem. Verify that the identified causes have been eliminated or controlled and validate that the problem no longer persists. Consider implementing preventive actions to avoid recurrence of the problem in the future. These actions focus on identifying and addressing potential issues before they lead to problems. Document the entire problem-solving process, including the problem statement, data collected, root cause analysis, corrective and preventive actions taken, and the results of verification and validation. Integrate the lessons learned from problem-solving efforts into the organization’s continuous improvement initiatives. Use the information to drive improvements in processes, products, and systems. Involve cross-functional teams in problem-solving efforts. Different perspectives and expertise can contribute to a more comprehensive and effective resolution. Consider the impact of the problem on customers and prioritize solutions that align with customer expectations and requirements. Ensure that top management is informed about significant problem-solving efforts and their outcomes. This helps demonstrate the organization’s commitment to quality improvement. Ensure that employees involved in problem-solving are properly trained in relevant methodologies and techniques. Problem-solving within IATF 16949 is an ongoing and systematic process that aims to enhance product quality, customer satisfaction, and overall organizational performance. It is an integral part of the quality management system and contributes to the organization’s ability to meet automotive industry standards and regulatory requirements.

10.2.3     Problem solving

The organization must have a documented process(es) for problem solving. The process must define approaches for various types and scale of problems (e.g., new product development, current manufacturing issues, field failures, audit findings). The process must include containment, interim actions, and related activities necessary for control of nonconforming outputs ;root cause analysis, methodology used, analysis, and results;implementation of systemic corrective actions, including consideration of the impact on similar processes and products; verification of the effectiveness of implemented corrective actions; reviewing and, where necessary, updating the appropriate documented information (e.g., PFMEA, control plan).   Where the customer has specific prescribed processes, tools, or systems for problem solving, the organization shall use those processes, tools, or systems unless otherwise approved by the customer.

The organization must define process for identifying and using appropriate problem-solving tools to determine the underlying root cause(s) of the nonconformity. Use the customer prescribed problem-solving format (e.g. 8D form), where available. Problem-solving tools may include – analysis of failure mode; capability studies; correlation diagrams; data collection; fishbone diagram (Ishikawa diagram); FMEA review; histograms; Pareto analysis; probability charts; stratification of data; graphic representations; etc. Ensure that personnel applying these tools are competent and trained. Do a Pareto analysis of the root causes of all your corrective actions by type, process, product, etc to prioritize problem-solving resources and applying lessons learned. Also, consider doing a Pareto analysis of cost of poor quality data to prioritize corrective action. Actions taken to eliminate the cause of nonconformity must flow from your problem-solving activity. Actions may involve changes to product, process, resources, documentation, controls, etc or any combination of these. Conduct tests to determine whether these actions have indeed eliminated the cause(s) of the nonconformity and prevented recurrence. You must keep appropriate records of these actions and follow-up activities. You must monitor your corrective action records on an ongoing basis, for any recurrence of the nonconformity, you took corrective action on. If you found that the problem has occurred again, then perhaps your analysis of root cause may have been incorrect or incomplete. There are many tools you can use to help you determine the root cause of problems. These are known as disciplined problem solving methods. Disciplined methods are those proven methods that employ fundamental principles to reveal information. There are two different approaches to problem solving. The first is used when data is available, as is the case when dealing with nonconformities. The sec ond approach is when not all the data needed is available. The seven quality tools in common use are as follows:

  1. Pareto diagrams – used to classify problems according to cause and phenomenon
  2. Cause and effect diagrams – used to analyze the characteristics of a process or situation
  3. Histograms – used to reveal the variation of characteristics or frequency distribution obtained from measurement
  4. Control charts – used to detect abnormal trends around control limits
  5. Scatter diagrams – used to illustrate the association between two pieces of corresponding data
  6. Graphs – used to display data for comparative purposes
  7. Check-sheets – used to tabulate results through routine checks of a situation

Click here on more on seven quality tools

The further seven quality tools for use when not all data is available are:

  1. Relations diagram – used to clarify interrelations in a complex situation
  2. Affinity diagram – used to pull ideas from a group of people and group them into natural relationships
  3. Tree diagram – used to show the interrelations among goals and measures
  4. Matrix diagram – used to clarify the relations between two different factors (eg. QFD)
  5. Matrix data-analysis diagram — used when the matrix chart does not provide information in sufficient detail
  6. Process decision program chart – used in operations research
  7. Arrow diagram – used to show steps necessary to implement a plan (e.g. PERT)

Please click here for more on new seven QC tools

There are other techniques such as force field analysis and the simple “Why? Why?” technique which very quickly often reveals the root cause of a problem. The source of causes is not unlimited. Nonconformities are caused by one or more of the following:

  • Deficiencies in communication
  • Deficiencies in documentation
  • Deficiencies in personnel training and motivation
  • Deficiencies in materials
  • Deficiencies in tools and equipment
  • Deficiencies in the operating environment

Each of these is probably caused by deficiencies in management, its planning, organization, or control. Once you have identified the root cause of the nonconformity you can propose corrective action to prevent its recurrence. Eliminating the cause of nonconformity and preventing the recurrence of nonconformity are essentially the same thing. The key to successful diagnosis of causes is to keep asking the question: why? When you encounter a “don’t know” then continue the investigation to find an answer.

Establishing a comprehensive problem-solving process

Establishing a comprehensive problem-solving process that covers various types and scales of problems is crucial for maintaining effective quality management and continuous improvement within an organization, as required by IATF 16949. Such a process ensures consistency, efficiency, and thoroughness in addressing different challenges that may arise. Here’s how the organization can develop a problem-solving process that encompasses various problem types and scales:

  • Clearly define the types of problems that can occur within the organization, such as new product development issues, manufacturing challenges, field failures, and audit findings.
  • Categorize problems based on their nature and impact. Prioritize problems according to their significance, potential risks, and urgency.
  • Establish cross-functional problem-solving teams that include individuals with diverse skills and expertise relevant to the specific problem type.
  • Define problem-solving methodologies and techniques suitable for different problem types. For example, use advanced problem-solving techniques like Six Sigma, Lean, or DMAIC for complex manufacturing issues, and use root cause analysis techniques for field failures.
  • Provide teams with appropriate problem-solving tools, such as Fishbone diagrams (Ishikawa), 5 Whys, Pareto charts, Process Failure Mode and Effects Analysis (PFMEA), Failure Mode and Effects Analysis (FMEA), and statistical analysis tools.
  • Develop a specific approach for addressing issues related to new product development, including requirements validation, design reviews, prototyping, and testing.
  • Define steps to address current manufacturing challenges, such as deviations from standard operating procedures, variations in processes, and quality control failures.
  • Establish protocols to investigate and rectify field failures, including procedures for analyzing returned products, diagnosing root causes, and implementing corrective actions.
  • Outline procedures for addressing audit findings, including internal and external audit results. Develop a plan to close identified non-conformities and implement corrective actions.
  • Require detailed documentation of problem-solving efforts, including problem statements, root cause analyses, corrective actions, verification of effectiveness, and any preventive measures taken.
  • Incorporate problem-solving outcomes and progress into management review meetings to ensure visibility and alignment with organizational objectives.
  • Continuously review and improve the problem-solving process based on feedback, lessons learned, and the organization’s evolving needs.
  • Provide training to employees on the problem-solving process, methodologies, and tools to ensure that they are equipped to address various types of problems effectively.

By establishing a well-defined problem-solving process that encompasses different problem types and scales, the organization can enhance its ability to identify, analyze, and resolve challenges in a systematic and timely manner. This contributes to the organization’s overall quality management efforts, customer satisfaction, and compliance with IATF 16949 requirements.

The process must include containment, interim actions, and related activities necessary for control of nonconforming outputs ;root cause analysis, methodology used, analysis, and results;implementation of systemic corrective actions, including consideration of the impact on similar processes and products; verification of the effectiveness of implemented corrective actions; reviewing and, where necessary, updating the appropriate documented information (e.g., PFMEA, control plan). Here’s how you can develop and execute this process:

  • When a nonconforming output is identified, the first step is to implement containment actions to prevent further distribution or use of the nonconforming product. This could involve segregating affected products, suspending production, or other appropriate measures.
  • Implement interim actions to minimize the immediate impact of the nonconformity. These actions could include rework, sorting, or temporary workarounds.
  • Conduct a thorough root cause analysis to identify the underlying factors that led to the nonconformity. Use techniques such as the 5 Whys, Fishbone diagrams, or Failure Mode and Effects Analysis (FMEA) to systematically explore the causes.
  • Define the methodology that will be used for the root cause analysis. Clearly document the approach, data sources, and tools employed.
  • Analyze the collected data and evidence to identify the primary and contributing causes of the nonconformity.
  • Document the results of the root cause analysis, including the identified root causes and any causal relationships between factors.
  • Develop corrective actions that address the identified root causes. Ensure that these actions are systemic and will prevent the recurrence of similar issues in the future.
  • Assess the potential impact of the corrective actions on similar processes, products, or areas within the organization. Address any potential ripple effects and take preventive measures if needed.
  • Implement the identified corrective actions, which may involve process changes, procedure updates, training, or other relevant measures.
  • Verify the effectiveness of the implemented corrective actions by monitoring the relevant metrics, performing tests, or other appropriate methods.
  • Review and update documented information that may have been affected by the nonconformity and corrective actions. This could include Process Failure Mode and Effects Analysis (PFMEA), control plans, work instructions, and other relevant documents.
  • Use the lessons learned from the problem-solving process to drive continuous improvement in processes, products, and systems.
  • Ensure that the proposed corrective actions and their potential impacts are reviewed and approved by relevant stakeholders, including management and quality assurance personnel.
  • Keep stakeholders informed about the progress of problem-solving efforts, corrective actions, and their outcomes.
  • Maintain a comprehensive record of the problem-solving process, including containment, root cause analysis, corrective actions, and verification results.

    By following this structured process, the organization can effectively address nonconforming outputs, prevent recurrence, and improve overall process performance. This approach aligns with the requirements of IATF 16949 and contributes to a culture of quality and continuous improvement.

    Customer’s specific prescribed processes, tools, or systems for problem-solving

    Adhering to your customer’s specific prescribed processes, tools, or systems for problem-solving is crucial to maintaining a strong customer-supplier relationship and ensuring that issues are resolved in a manner that aligns with your customer’s expectations. Thoroughly review and understand the problem-solving processes, tools, or systems prescribed by each customer. This may be outlined in contracts, quality agreements, or specific documentation provided by the customer. Confirm that the organization’s existing problem-solving processes align with the customer’s requirements. Identify any gaps or differences between the organization’s processes and the customer’s prescribed methods. If the organization’s existing processes do not align with the customer’s requirements, seek approval from the customer before deviating from their prescribed processes, tools, or systems. This may involve formal communication and documentation. Maintain open communication with the customer regarding problem-solving efforts. Inform the customer about the steps being taken to address the issue, the proposed corrective actions, and any potential deviations from their prescribed methods. If the organization believes that a deviation from the customer’s prescribed processes is necessary and can lead to a more effective resolution, formally request approval from the customer before proceeding. Collaborate with the customer throughout the problem-solving process, seeking their input and feedback. This ensures that the approach taken is aligned with their expectations and preferences. Document any deviations from the customer’s prescribed processes, tools, or systems, along with the rationale for the deviation and the approval received (if applicable).Use insights gained from problem-solving efforts to enhance the organization’s processes and align them more closely with customer requirements over time. Ensure that employees involved in problem-solving are trained in the customer’s prescribed methods and are competent to use the specified processes, tools, or systems. In case of any disputes or challenges in aligning with the customer’s requirements, escalate the matter through appropriate channels to seek resolution. By following these steps, the organization can ensure that problem-solving efforts are conducted in a manner that meets the customer’s expectations and requirements. This approach fosters a collaborative relationship, enhances customer satisfaction, and contributes to the organization’s commitment to delivering high-quality products and services.

    Leave a Reply