IATF 16949:2016 Clause Prototype programme

Prototypes are early samples, models, or releases of products built to test a concept or process.Generally, prototypes are used by system analysts and users to improve the precision of a new design. Prototyping is an essential step in the Design Thinking process and is often used in the final testing phase. Every product has a target audience and is designed to solve their problems in some way. To assess whether a product really solves its users’ problems, designers create an almost-working model or mock-up of the product, called a prototype, and test it with prospective users and stakeholders. Thus, prototyping allows designers to test the practicability of the current design and potentially investigate how trial users think and feel about the product. It enables proper testing and exploring design concepts before too many resources get used.A prototype is a product built to test ideas and changes until it resembles the final product. You can mock-up every feature and interaction in your prototype as in your fully developed product, check if your idea works, and verify the overall user-experience (UX) strategy. Prototyping allows you to build simple, small-scale prototypes of your products, and use them to observe, record, and assess user performance levels or the users’ general behavior and reactions to the overall design. Designers can then make appropriate refinements or possible alterations in the right direction. Design and development of a prototype program can be a challenging and iterative process.

Your design and development project plan must include your prototype program. Use a prototype control plan to manage the development of a specific product. Use existing approved suppliers, tooling and manufacturing processes to save time and risk. Monitor internal and supplier activities to both your design and development project plan as well as your prototype control plan. You must have a process for outsourcing activities (e.g. tooling). You must include this process as part of your QMS.

Clause Prototype programme

When required by the customer, the organization shall have a prototype programme and control plan. The organization shall use, whenever possible, the same suppliers, tooling, and manufacturing processes as will be used in production. All performance-testing activities shall be monitored for timely completion and conformity to requirements. When services are outsourced, the organization shall include the type and extent of control in the scope of its quality management system to ensure that outsourced services conform to requirements.

The standard requires the supplier to have a prototype program when required by the customer and to use the same subcontractors, tooling, and processes as will be used in production. There will be situations where the customer requires a prototype program but when no such requirement has been stated it does not mean you should not produce prototypes. Prototypes will not normally be required when the design is similar to a previously proven design or standard or the design is so simple that sufficient evidence can be obtained during the production trial run. Many different types of models may be needed to aid product development, test theories, experiment with solutions, etc. However, when the design is complete, prototype models representative in all their physical and functional characteristics to the production models may need to be produced. When building prototypes, the same materials, locations, subcontractors, tooling, and processes should be used as will be used in production, so as to minimize the variation.Below is a step-by-step guide to help you design and develop a prototype program effectively:

  1. Identify Objectives:
    • Clearly define the objectives of your prototype program. What problem or opportunity do you want to address with the prototype? What specific outcomes do you hope to achieve?
  2. Research and Analysis:
    • Conduct thorough research to understand the context and background of the problem or opportunity.
    • Analyze existing solutions or similar prototypes to gain insights and avoid reinventing the wheel.
  3. Define Scope and Constraints:
    • Clearly outline the scope of your prototype program, including its limitations and constraints (e.g., budget, time, resources).
    • Identify the target audience or end-users for the prototype.
  4. Conceptualization and Ideation:
    • Brainstorm ideas and concepts for the prototype, considering different approaches and features.
    • Create sketches, diagrams, or wireframes to visualize the prototype’s potential layout and functionality.
  5. Select Tools and Technologies:
    • Choose the appropriate tools, technologies, and programming languages for building the prototype.
    • Consider whether you will develop a software-based prototype, a hardware prototype, or a combination of both.
  6. Development:
    • Start building the prototype based on the concepts and designs from the previous steps.
    • Focus on creating a minimum viable product (MVP) that demonstrates the core functionality and key features.
  7. Iterative Improvement:
    • Test the prototype with real users or stakeholders to gather feedback.
    • Use this feedback to make iterative improvements to the prototype, enhancing its usability and addressing any issues.
  8. User Experience (UX) Design:
    • Pay attention to the user experience and interface design of the prototype.
    • Ensure the prototype is intuitive, user-friendly, and aligns with the needs of the target audience.
  9. Testing and Quality Assurance:
    • Conduct thorough testing to identify and fix bugs, errors, and performance issues.
    • Verify that the prototype functions as intended and meets the defined objectives.
  10. Documentation:
    • Document the entire design and development process, including the rationale behind design decisions and changes made during iterations.
    • Create user manuals or guides for the prototype’s usage.
  11. Presentation and Feedback Gathering:
    • Present the prototype to stakeholders, team members, or potential users.
    • Gather feedback and suggestions for further improvements or potential expansion of the prototype.
  12. Finalize and Refine:
    • Based on the feedback received, finalize the prototype and make any necessary refinements.
    • Ensure that the prototype aligns with the original objectives and requirements.
  13. Deployment and Evaluation:
    • Deploy the prototype in real-world scenarios if applicable.
    • Evaluate the effectiveness of the prototype in achieving its objectives.
    • Use this evaluation to decide on the next steps, such as full-scale development or further refinement.

Remember that prototyping is an iterative process, and it’s normal to make changes and improvements along the way. Stay open to feedback and be willing to adapt your prototype program to achieve the best possible results.

Using the same suppliers, tooling, and manufacturing processes in prototyping as in Productions.

Using the same suppliers, tooling, and manufacturing processes during prototyping as will be used in production is a best practice in product development. This approach is commonly known as Design for Manufacturability (DFM) or Design for Manufacturing (DFM). It aims to ensure a smooth transition from the prototyping phase to full-scale production by minimizing potential issues and risks that may arise during the transition.Here are some key reasons why using the same suppliers, tooling, and manufacturing processes in both prototyping and production is beneficial:

  1. Consistency: By using the same suppliers and manufacturing processes, you can maintain consistency in the materials, components, and methods used in both prototyping and production. This reduces the chances of unexpected variations and ensures that the final product matches the prototype closely.
  2. Early Issue Identification: Using production-intent tooling and processes during prototyping allows you to identify any potential manufacturing issues early in the development cycle. Addressing these issues at the prototyping stage is generally more cost-effective than discovering and resolving them during full-scale production.
  3. Time and Cost Savings: By minimizing changes between prototyping and production, you can save time and money. Revising tooling or changing suppliers after prototyping can lead to delays and additional expenses.
  4. Improved Product Quality: Ensuring that the same suppliers and manufacturing processes are used helps maintain the quality of the final product. Lessons learned during prototyping can be directly applied to the production process, resulting in a higher-quality end product.
  5. Supply Chain Management: Using the same suppliers allows you to establish a relationship and understanding of their capabilities. This enables better communication and coordination throughout the development process and in the long term.
  6. Faster Time to Market: When the transition from prototyping to production is smoother, it shortens the overall product development timeline, helping you get the product to market faster.

However, it’s important to note that in certain cases, especially for complex or high-tech products, initial prototyping might involve using different methods or suppliers to quickly test concepts or feasibility. Once the concept is validated, the shift to using the production-intent suppliers and processes should be made to ensure the advantages mentioned above.Overall, using the same suppliers, tooling, and manufacturing processes during prototyping and production is a strategic decision that helps ensure a successful product launch and efficient production process.

Monitoring of performance-testing activities of Prototyping

Monitoring performance-testing activities during prototyping is essential to ensure that the testing is conducted effectively and meets the necessary requirements. Proper monitoring helps identify potential issues early in the development process, allowing for timely adjustments and improvements. Here are some key aspects of monitoring performance-testing activities during prototyping:

  1. Timely Completion: Performance-testing activities should have well-defined timelines and milestones. Regular monitoring allows you to track progress and identify any delays or bottlenecks in the testing process. By addressing these issues promptly, you can ensure that the testing stays on schedule and does not impact the overall development timeline.
  2. Conformity to Requirements: Each performance-testing activity must be aligned with specific requirements and objectives. By closely monitoring the testing process, you can verify that the tests are conducted according to the established criteria. This ensures that the results are meaningful and accurately reflect the prototype’s performance in meeting its intended purpose.
  3. Quality Assurance: Monitoring helps maintain the quality and integrity of the performance-testing process. It allows you to spot any deviations or inconsistencies that may arise during testing. Addressing these deviations promptly ensures the reliability of the test results and prevents potential issues from carrying over into production.
  4. Issue Identification and Resolution: Performance testing may reveal flaws or weaknesses in the prototype’s design or functionality. Monitoring the testing activities enables the identification of such issues early on, making it easier to resolve them during the prototyping phase. This can lead to significant cost savings compared to addressing issues in later stages of development or during production.
  5. Feedback Loop: Monitoring provides valuable feedback to the development team and stakeholders. This feedback helps improve the understanding of the prototype’s performance and aids in making informed decisions about design changes or optimizations.
  6. Documentation and Reporting: Proper monitoring facilitates comprehensive documentation of the performance-testing activities. This documentation serves as a valuable reference for future iterations of the prototype and can also be used to demonstrate compliance with testing requirements to relevant stakeholders.
  7. Risk Management: Monitoring performance-testing activities allows you to identify potential risks that may impact the success of the prototyping process. By recognizing these risks early, appropriate risk mitigation strategies can be put in place to minimize their impact.

In conclusion, monitoring performance-testing activities during prototyping is crucial for successful product development. It ensures that the testing is completed on time, aligns with the specified requirements, and helps identify and address issues before moving into full-scale production. This proactive approach contributes to the overall quality and reliability of the final product.

Outsourcing of Prototyping service

It is essential to establish a robust quality management system (QMS) that includes clear guidelines for controlling the outsourced services. This ensures that the outsourced prototyping aligns with the organization’s requirements and maintains the desired level of quality. Here are key steps and considerations for including outsourced prototyping within the scope of the QMS:

  1. Define Requirements and Expectations: Clearly specify the requirements and expectations for the outsourced prototyping services. This should include technical specifications, performance criteria, timelines, and any other relevant criteria that the prototype must meet.
  2. Select Qualified Suppliers: Thoroughly evaluate potential suppliers before outsourcing the prototyping. Consider factors such as their experience, capabilities, track record, and adherence to quality standards. Choose suppliers who demonstrate the ability to meet the organization’s requirements and deliver high-quality prototypes.
  3. Documented Agreements and Contracts: Establish formal agreements or contracts with the chosen suppliers that clearly outline the scope of work, responsibilities, quality requirements, and any other relevant terms. These agreements serve as a reference point to ensure that the outsourced services align with the organization’s expectations.
  4. Risk Assessment and Mitigation: Conduct a risk assessment to identify potential risks associated with outsourcing the prototyping activities. Develop appropriate risk mitigation strategies to address these risks and ensure the continuity of the project.
  5. Communication and Collaboration: Foster open and clear communication channels with the outsourced suppliers. Collaboration and regular communication are essential to address any issues, provide clarifications, and keep track of progress.
  6. Monitoring and Performance Evaluation: Implement a system to monitor and evaluate the performance of the outsourced prototyping services. Regularly review the progress, quality of deliverables, and adherence to requirements. This evaluation helps identify any deviations or potential areas of improvement.
  7. Quality Audits and Inspections: Conduct periodic quality audits or inspections of the outsourced prototyping processes. These audits verify compliance with the organization’s quality standards and identify any non-conformities that need corrective actions.
  8. Non-Conformance Management: Establish a process for handling non-conformances identified during the outsourced prototyping. This should include corrective and preventive actions to rectify issues and prevent recurrence.
  9. Training and Competency: Ensure that personnel involved in overseeing the outsourced prototyping understand the quality requirements and are competent to assess the quality of the delivered prototypes.
  10. Continuous Improvement: Continuously improve the outsourcing process by learning from past experiences, feedback, and performance evaluations. Implement corrective actions and drive process enhancements to enhance the effectiveness of outsourced prototyping.

By incorporating these measures into the organization’s QMS, the organization can ensure that outsourced prototyping services conform to the required quality standards and align with the organization’s objectives, ultimately contributing to the successful development of the final product.

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