IATF 16949:2016 Clause 8.3.4.1     Monitoring

The standard requires that You shall define, analyze and report measurements at specified stages of Design and Development to the management and customer at different stages . A design represents a considerable investment by the organization. There is therefore a need for a formal mechanism for management and the customer to evaluate designs at major milestones. The purpose of the review is to determine whether the proposed design solution is compliant with the design requirement and should continue or should be changed before proceeding to the next phase. It should also determine whether the documentation for the next phase is adequate before further resources are committed. It is that part of the design control process which measures design performance, compares it with predefined requirements and provides feedback so that deficiencies may be corrected before the design is released to the next phase. Although design documents may have been through a vetting process, the purpose is not to review documents but to subject the design to an independent experts for its judgement as to whether the most satisfactory design solution has been chosen. By monitoring, flaws in the design may be revealed before it becomes too costly to correct them. It also serve to discipline designers by requiring them to document the design logic and the process by which they reached their conclusions, particularly the options chosen and the reasons for rejecting other options. The monitoring process involves systematic observation, measurement, and evaluation of the design and development activities to ensure they are progressing as planned and producing the desired outcomes. Here are some key aspects of monitoring design and development in IATF 16949:

1. Performance Metrics and Indicators: Define key performance indicators (KPIs) and metrics to measure the progress and effectiveness of the design and development process. These metrics could include design cycle time, number of design changes, customer feedback on prototypes, etc.
2. Project Management Techniques: Utilize project management techniques, such as Gantt charts, milestone tracking, and progress reports, to monitor the status of design and development projects and ensure they are on schedule.
3. Design Reviews: Conduct regular design reviews at specified stages of the development process to evaluate the design’s completeness, compliance with requirements, and potential risks.
4. Risk Assessment and Mitigation: Continuously assess risks associated with the design and development process and implement appropriate mitigation strategies to address potential issues.
5. Traceability and Documentation: Ensure proper traceability of design decisions, changes, and approvals through well-maintained documentation, such as design records, change logs, and version control.
6. Validation and Verification: Monitor the validation and verification activities to ensure that the design outputs meet the intended requirements and are validated against customer needs.
7. Customer Input and Feedback: Regularly gather customer input and feedback throughout the design and development process to validate the design’s alignment with customer requirements and expectations.
8. Compliance with Requirements: Monitor compliance with IATF 16949 requirements and any applicable statutory and regulatory requirements related to design and development.
9. Corrective and Preventive Actions: Monitor the implementation of corrective and preventive actions identified during design reviews or other assessments to address issues and improve the design process.
10. Continuous Improvement: Foster a culture of continuous improvement by analyzing data and feedback from design and development activities to identify opportunities for enhancing efficiency and quality.

By effectively monitoring the design and development process, automotive organizations can identify potential issues early, ensure compliance with requirements, and deliver products that meet customer expectations and industry standards. Monitoring helps in timely decision-making, risk management, and ultimately contributes to the successful realization of high-quality automotive products.

Clause 8.3.4.1 Monitoring

At specified stages during the design and development of products and processes measurements such as appropriate quality risks, costs, lead times, critical paths, and other measurements must be defined, analysed, and reported with summary results as an input to management review. Also at specified stages as agreed by the customer these measurements will be reported to the customers.

At one or more milestones of the Design and Development project, depending on customer requirements, the size, complexity and risks involved, measurements of Design and developments must be analysed and reported to the management and the customers. The purpose is to evaluate results to requirements, check project progress and costs to plan and take actions on any problems encountered. You must take multi-disciplinary approach for doing these reviews and keep appropriate records of issues discussed, actions to be taken, responsibilities and timeline for completion. This must be included in your Design and Development plan.The summary of measurements at specific stages of Design and Development must be added to the management review agenda .

Scheduling of Design and Development monitoring

A schedule of design measurement should be established for each product/service being developed. In some cases there will need to be only one design review after completion of all design verification activities. However, depending on the complexity of the design and the risks, you may need to measure the design at some or all of the following intervals:

Design Requirement — to establish that the design requirements can be met and reflect the needs of the customer before commencement of design
Conceptual Design — to establish that the design concept fulfills the requirements before project definition commences
Preliminary Design — to establish that all risks have been resolved and development specifications produced for each sub-element of the product/service before detail design commences
Critical Design — to establish that the detail design for each sub-element of the product/service complies with its development specification and that product specifications have been produced before manufacture of the prototypes
Qualification Readiness — to establish the configuration of the baseline design and readiness for qualification before commencement of design proving
Final Design — to establish that the design fulfills the requirements of its development specification before preparation for its production

Participants at design monitoring
The input data for the monitoring should be distributed and examined by the team well in advance of the time when a decision on the design has to be made. Often analysis may need to be performed on the input data by the participants in order for them to determine whether the design solution is the most practical and cost effective way of meeting the requirements. The standard requires that participants at each design review include representatives of all functions concerned with the design stage being reviewed, as well as other specialist personnel as required. The team should have a collective competency greater than that of the designer of the design. Design reviews are performed by management than the designers, in order to release a design to the next phase of development. A review is another look at something. The designer has had one look at the design and when satisfied presents the design to the management and customer so as to seek approval and permission to go ahead with the next phase. A designer may become too close to the design to spot errors or omissions and so will be biased towards the standard of his/her own performance. The designer may welcome the opinion of someone else as it may confirm that the right solution has been found or that the requirements can’t be achieved with the present state of the art. If a design is inadequate and the inadequacies are not detected before production commences the consequences may well be disastrous. A poor design can lose a customer, a market, or even a business so the advice of independent experts should be valued. The team should comprise, as appropriate, representatives of the purchasing, manufacturing, servicing, marketing, inspection, test, reliability, QA authorities, etc. as a means of gathering sufficient practical experience to provide advance warning of potential problems with implementing the design. The chairman of the team should be the authority responsible for placing the development requirement and should make the decision as to whether design should proceed to the next phase based on the evidence substantiated by the team.

Measurements for Design and development of products and processes

When it comes to the design and development of products and processes, there are several essential measurements that organizations use to ensure efficiency, quality, and successful outcomes. Here are some key measurements to consider:

1. Quality Risks: Identify and assess potential risks related to the product or process design. This includes evaluating risks associated with materials, manufacturing processes, technological challenges, and compliance issues. Utilize risk assessment techniques like Failure Mode and Effects Analysis (FMEA) to prioritize and mitigate risks.
2. Costs: Keep track of all costs involved in the design and development process, including research and development expenses, materials, equipment, labor, and any other associated expenses. Regularly review and analyze cost data to manage budgets effectively.
3. Lead Times: Measure the time taken to complete different stages of the design and development process. This includes lead times for conceptualization, prototyping, testing, and final production. Shortening lead times can improve time-to-market and increase competitiveness.
4. Critical Paths: Identify the critical path in the product or process development. The critical path is the sequence of activities that determine the project’s overall timeline. Any delays in critical path activities will directly impact the project’s completion date.
5. Design and Development Cycle Time: Measure the time taken from the initial design concept to the final implementation and launch. This metric helps identify inefficiencies and bottlenecks in the development process.
6. Product Performance Metrics: Define and measure specific performance metrics related to the product’s functionality, reliability, durability, and user experience. This includes factors like product failure rates, warranty claims, and customer satisfaction.
7. Design Efficiency Metrics: Assess the efficiency of the design process, including the number of design iterations, the time taken to finalize designs, and the proportion of successful designs to failed ones.
8. Innovation Index: Develop a metric to gauge the level of innovation in the product or process design. This could be measured by the number of new patents, breakthrough features, or novel manufacturing techniques introduced.
9. Customer Feedback and User Testing: Gather feedback from customers and conduct user testing to understand how well the product meets their needs and expectations. This data can guide continuous improvements.
10. Return on Investment (ROI): Calculate the return on investment for the design and development effort. Compare the costs incurred with the benefits obtained, such as increased sales, cost savings, or competitive advantage.
11. Environmental Impact: Evaluate the environmental impact of the product or process design. This could include assessing carbon footprint, resource usage, and waste generation, aiming for more sustainable practices.

Regularly reviewing these measurements and key performance indicators (KPIs) throughout the design and development process enables organizations to make data-driven decisions, identify areas for improvement, and optimize their strategies for success.

Reporting to the customers

When reporting product and process development activities to customers at specified stages, it’s essential to provide clear and concise information that highlights progress, milestones, and key performance metrics. Here’s a structured approach to reporting:

1. Define Reporting Stages: Determine the specific stages at which you will provide updates to customers. Common stages may include project initiation, concept development, prototype completion, testing/validation, and final production.
2. Executive Summary: Start each report with a brief executive summary that gives an overview of the current stage’s progress, achievements, and any significant developments since the last report.
3. Key Objectives: Outline the objectives of the current stage. Specify what the team aimed to accomplish during this phase of the development process.
4. Progress Overview: Provide a summary of the progress made in the development process. Mention any completed tasks, achieved milestones, and deliverables. Use bullet points or visuals like charts to make the information more accessible.
5. Quality Metrics: Report on the quality measurements and risk assessments conducted during the stage. Highlight any potential risks identified and the steps taken to mitigate them. Include data on quality checks, tests performed, and outcomes.
6. Costs and Budgets: Present the financial aspect of the project, including the budget allocated for the current stage, actual expenditures, and any budgetary changes or challenges encountered.
7. Lead Times and Critical Paths: Communicate the time taken for various activities during this stage and how they relate to the critical path. Address any delays or issues affecting the overall timeline.
8. Design and Development Cycle Time: Report on the total time taken from the start of the stage to its completion. Compare this with the planned timeline to assess whether the project is on track.
9. Product Performance Updates: Share data on product performance metrics, such as functionality, reliability, and user experience. Include any user testing results and feedback gathered from stakeholders.
10. Customer Feedback and Satisfaction: If applicable, summarize customer feedback collected during the stage and indicate how it influenced decisions and improvements.
11. Innovation and Unique Features: If there have been any innovations or unique features introduced during the development, highlight them and explain their potential benefits.
12. Next Steps: Provide an outline of the upcoming activities and goals for the next stage. Discuss any changes in the project plan and their implications.
13. Challenges and Mitigation Plans: Be transparent about any challenges faced during the stage and the measures taken to address them.
14. Conclusion: Conclude the report by summarizing the overall progress, reiterating key achievements, and expressing gratitude for the customer’s ongoing support and collaboration.
15. Appendix (Optional): If there are detailed technical specifications, additional data, or supporting documentation, include it in an appendix for interested stakeholders to reference.

Remember that the reporting format and level of detail may vary based on the nature of the project, the preferences of your customers, and the complexity of the development process. Always tailor the reports to meet the specific needs and expectations of your audience.