IATF 16949:2016 Clause Design and development validation

In the automotive industry, design and development validation is a crucial phase of the product development process. It involves comprehensive testing and evaluation to ensure that vehicles, components, and systems meet the required specifications, safety standards, and regulatory requirements. This validation process verifies that the automotive products perform as intended, are reliable, and meet customer expectations. It includes various types of testing, such as performance testing, durability testing, crash testing, environmental testing, and more. Through design and development validation, automotive manufacturers ensure the quality, safety, and compliance of their products, leading to enhanced customer satisfaction and confidence in the automotive market. Verification is checking product or process to input requirements, whereas validation is checking product or process is suitable for it’s intended use –  does it perform/function in the way intended by your customer or your organization.Product design Verification includes – design reviews ; comparing the new design to a similar proven design if available; performing alternate calculations; performing tests and simulations; reviewing the design documents before release, etc.Manufacturing process design verification include – design review ; process capability studies; testing various process parameters; performing tests and trials; reviewing the manufacturing process design documents before release, etc.Product and manufacturing process validation includes – design reviews; comparison between customer requirements and internal development plans; d & d validation against customer requirements and d & D input requirements; corrective action and lessons learned from documented process failures and product nonconformities. You must keep records for both verification and validation activities

Design and development validation in the automotive industry is a critical process that ensures the quality, safety, and compliance of vehicles before they are manufactured and released to the market. The validation process involves testing and verifying various components, systems, and the overall vehicle performance to meet regulatory standards and customer expectations. Here are the key steps and considerations in design and development validation:

  1. Requirements Definition: Clearly define the performance, safety, and regulatory requirements for the vehicle. These requirements serve as the baseline for the validation process.
  2. Validation Plan: Develop a comprehensive validation plan that outlines the scope, objectives, testing methods, resources, and schedule for the validation activities.
  3. Simulations and Computer-Aided Engineering (CAE): Use advanced simulations and CAE tools to evaluate the design’s performance virtually. This allows engineers to identify potential issues and make improvements early in the development process.
  4. Component Testing: Validate individual vehicle components (e.g., engine, transmission, brakes, etc.) through rigorous testing to ensure they meet the specified requirements.
  5. Prototype Testing: Build and test vehicle prototypes to evaluate their performance under various conditions and stress factors. This includes testing on test tracks, proving grounds, and in controlled environments.
  6. Environmental Testing: Subject vehicles to extreme environmental conditions such as extreme temperatures, humidity, and altitudes to ensure they can operate reliably in different climates.
  7. Safety Testing: Conduct crash tests and other safety evaluations to ensure the vehicle meets safety standards and protects occupants in the event of a collision.
  8. Emissions and Compliance Testing: Verify that the vehicle meets emissions standards and complies with regulations set by various governing bodies.
  9. Durability Testing: Assess the durability and longevity of components and the overall vehicle by simulating real-world wear and tear over an extended period.
  10. Noise, Vibration, and Harshness (NVH) Testing: Evaluate the vehicle’s NVH characteristics to ensure a comfortable and quiet driving experience.
  11. Software Validation: Validate the functionality and performance of the vehicle’s software systems, including infotainment, connectivity, and advanced driver-assistance systems (ADAS).
  12. User Experience (UX) Testing: Gather feedback from potential users through focus groups and usability testing to improve the vehicle’s overall user experience.
  13. Regulatory Compliance: Ensure that the vehicle design complies with all relevant regulations and safety standards set by the automotive industry and government agencies.
  14. Continuous Improvement: Iterate the design based on validation findings and continuously improve the vehicle’s performance, safety, and efficiency.

Throughout the validation process, detailed records and documentation are maintained to demonstrate compliance with standards and regulations. Additionally, collaboration between different teams, including design, engineering, manufacturing, and testing, is crucial to ensuring the vehicle’s successful validation.By following a robust design and development validation process, automotive manufacturers can produce vehicles that are reliable, safe, and meet the expectations of customers and regulatory bodies.

Clause Design and development validation

As per the requirements given by the Customer, applicable industry and governmental agency-issued regulatory standards, design and development validation shall be performed and shall be planned in alignment with customer-specified timing, as applicable. Where contractually agreed with the customer, this shall include evaluation of the interaction of the organization’s product, including embedded software, within the system of the final customer’s product.

Design and development validation in the automotive industry must be performed according to the requirements specified by the customer, as well as the applicable industry standards and governmental agency-issued regulatory standards. These requirements serve as the foundation for the entire validation process and ensure that the final product meets the necessary quality, safety, and compliance standards. The customer’s requirements are essential as they represent the specific needs and expectations of the end-users, whether they are individual consumers or businesses. Meeting these requirements is crucial for customer satisfaction and market success. In addition to customer requirements, the automotive industry has established various standards and best practices that manufacturers must adhere to. These standards cover a wide range of aspects, including safety, emissions, performance, and quality. Adhering to industry standards helps ensure that the vehicles produced are reliable, safe, and perform as expected. Moreover, governmental agencies, such as the National Highway Traffic Safety Administration (NHTSA) in the United States or the European Commission, issue regulatory standards that vehicles must meet to be legally sold in specific regions. These regulations are designed to protect the public’s safety and welfare and often cover areas such as crashworthiness, emissions, fuel efficiency, and more. By aligning the design and development validation process with these requirements, automotive manufacturers can produce vehicles that not only satisfy customer needs but also comply with legal and regulatory obligations. This, in turn, promotes trust and confidence in the automotive industry and contributes to the overall safety and quality of vehicles on the roads.

The standard requires that design validation be performed to ensure that product conforms to defined user needs and/or requirements. Merely requiring that the design output meets the design input would not produce a quality product or service unless the input requirements were a true reflection of the customer needs. If the input is inadequate the output will be inadequate: “garbage in, garbage out” to use a common software expression. However, the standard does not
require user needs or requirements to be specified. User needs and requirements should be specified also as part of the design input requirements, but if they are, design validation becomes part of design verification. Design validation is a process of evaluating a design to establish that it fulfills the intended user requirements. It goes further than design verification, in that validation tests and trials may stress the product of such a design beyond operating conditions in order to establish design margins of safety and performance. Design validation can also be performed on mature designs in order to establish whether they will fulfill different user requirements to the original design input requirements. An example is where software designed for one application can be proven fit for use in a different application or where a component designed for one environment can be shown to possess a capability which would enable it to be used in a different environment. Multiple validations may there fore be performed to qualify the design for different applications. Design validation may take the form of qualification tests which stress the product up to and beyond design limits — beta tests where products are supplied to several typical users on trial in order to gather operational performance data, performance trials, and reliability and maintainability trials where products are put on test for prolonged periods to
simulate usage conditions. In the automobile industry the road trials on test tracks are validation tests as are the customer trials conducted over several weeks or months under actual operating conditions on pre-production models. Sometimes the trials are not successful as was the case of the “Copper Cooled Engine” in General Motors in the early 1920s. Even though the engine seemed to work in the laboratory, it failed in service. Production was commenced before the design had been validated. The engine had pre-ignition problems and showed a loss of compression and power when hot. As a result, many cars with the engine were scrapped. Apart from the technical problems GM experienced with its development, it did prove to be a turning point in GM’s development strategy, probably resulting in what is now their approach to product quality planning. Other examples are beta tests or public testing conducted on software products where tens or hundreds of products are distributed to designated customer sites for trials under actual operating conditions before product launch. Sometimes, commercial pressures force termination of these trials and products are launched prematurely in order to beat the competition. The supplementary requirement stipulates that design validation should occur in conjunction with customer programming requirements and ideally design validation of the original design should be complete before product is launched into production. Thereafter, it may be performed at any stage where the design is selected for a different application. However, for the original design the scale of the tests and trials may be such that a sufficiently high degree of confidence has been gained before the end of the trials for pre-production to commence. Some of the trials may take years. The proving of reliability, for instance, may require many operating hours before enough failures have been observed to substantiate the reliability specification. There is no mean time between failure (MTBF) until you actually have a failure, so you need to keep on test ing until you know anything meaningful about the product’s reliability. During the design process many assumptions may have been made and will require proving before commitment of resources to the replication of the design. Some of the requirements, such as reliability and maintainability, will be time-dependent. Others may not be verifiable without stressing the product beyond its design limits. With computer systems, the wide range of possible variables is so great that proving total compliance would take years. It is however necessary to subject a design to a series of tests and examinations in order to verify that all the requirements have been achieved and that features and characteristics will remain stable under actual operating conditions. With some parameters a level of confidence rather than certainty will be acceptable. Such tests are called qualification tests. These differ from other tests because they are designed to establish the design margins and prove the capability of the design. As the cost of testing vast quantities of equipment would be too great and take too long, qualification tests, particularly on hardware, are usually performed on a small sample. The test levels are varied to take account of design assumptions, variations in production processes and the operating environment. Products may not be put to their design limits for some time after their launch into service, probably far beyond the warranty period. Customer complaints may appear years after the product launch. When investigated this may be traced back to a design fault which was not tested for during the verification program. Such things as corrosion, insulation, resistance to wear, chemicals, climatic conditions, etc. need to be verified as being within the design limits. Following qualification tests, your customer may require a demonstration of performance in order to accept the design. These tests are called design acceptance tests. They usually consist of a series of functional and environmental tests taken from the qualification test specification, supported by the results of the qualification tests. When it has been demonstrated that the design meets all the specified requirements, a Design Certificate can be issued. It is the design standard which is declared on this certificate against which all subsequent changes should be controlled and from which production versions should be produced.

Process for controlling qualification tests and demonstrations should provide for:

  • Test specifications to be produced which define the features and characteristics that are to be verified for design qualification and acceptance
  • Test plans to be produced which define the sequence of tests, the responsibilities for their conduct, the location of the tests, and test procedures to be used
  • Test procedures to be produced which describe how the tests specified in the test specification are to be conducted together with the tools and test equipment to be used and the data to be recorded
  • All measuring equipment to be within calibration during the tests
  • The test sample to have successfully passed all planned in—process and assembly inspections and tests prior to commencing qualification tests
  • The configuration of the product in terms of its design standard, deviations, non conformities, and design changes to be recorded prior to and subsequent to the tests
  • Test reviews to be held before tests commence to ensure that the product, facilities, tools, documentation, and personnel are in a state of operational readiness for verification
  • Test activities to be conducted in accordance with the prescribed specifications, plans, and procedures
  • The results of all tests and the conditions under which they were obtained to be recorded
  • Deviations to be recorded, remedial action taken, and the product subject to re-verification prior to continuing with the tests
  • Test reviews to be performed following qualification tests to confirm that sufficient objective evidence has been obtained to demonstrate that the product fulfills the requirements of the test specification

The validation results to be recorded and design failures to be documented in the validation records. The corrective and preventive action procedures to be followed in addressing design failures. Preventive action cannot be taken on a failure that has occurred except on other future designs. What is intended is that remedial action is taken to correct the design fault and corrective action taken to prevent the same failure arising again either in the same design or in other designs.

Alignment with customer-specified timing

The timing of design and development validation in the automotive industry should be carefully planned in alignment with the customer-specified timing. This means that the validation activities should be scheduled and coordinated to meet the deadlines and milestones set by the customer for the project.Here are some key points to consider regarding the timing of design and development validation:

  1. Clear Communication: From the outset of the project, there should be clear and open communication between the automotive manufacturer and the customer regarding the validation process and its timeline. Understanding the customer’s expectations and requirements is crucial for planning the validation activities effectively.
  2. Validation Plan: Develop a comprehensive validation plan that outlines the specific validation activities, their scope, and their respective timelines. This plan should be reviewed and agreed upon by both the automotive manufacturer and the customer.
  3. Milestone Checkpoints: Identify key milestones throughout the design and development process where validation progress can be reviewed. This allows both parties to ensure that the project is on track and that validation activities are being executed according to the planned timing.
  4. Prototyping and Iteration: Utilize rapid prototyping and iteration to address any potential issues early in the development process. This approach enables timely adjustments to the design and validation strategy, reducing the risk of delays.
  5. Collaboration and Coordination: Establish effective collaboration and coordination between different teams involved in the validation process, including design, engineering, testing, and project management. This helps ensure that everyone is working towards the common goal of meeting the customer-specified timing.
  6. Contingency Planning: Develop contingency plans in case of unexpected delays or challenges during the validation process. Having alternative strategies in place can help mitigate risks and keep the project on schedule.
  7. Customer Involvement: Where appropriate, involve the customer in the validation process, especially during critical stages or for user-specific requirements. Their input and feedback can be valuable in refining the design and validating the final product.
  8. Regulatory Considerations: Take into account any regulatory requirements or certifications that may impact the timing of validation. Ensuring compliance with regulatory standards is essential, and it may influence the overall project timeline.

By planning the design and development validation in alignment with customer-specified timing, automotive manufacturers can deliver products that meet customer expectations, demonstrate responsiveness to customer needs, and foster a positive working relationship with their clients. Moreover, timely validation helps bring vehicles to market faster, gaining a competitive advantage in the automotive industry.

Evaluating the interaction of the organization’s product within the final customer’s product system.

The validation of design and development in the automotive industry involves evaluating not only the individual components and systems of the vehicle but also the interaction of the organization’s product within the entire system of the final customer’s product. This aspect is particularly important when considering the increasing complexity of modern vehicles, which often include embedded software and various interconnected systems.Here are some key points to consider when evaluating the interaction of the organization’s product within the final customer’s product system:

  1. Integration Testing: Test the integration of various vehicle systems and components to ensure they work together seamlessly. This involves checking the compatibility and communication between different software and hardware elements.
  2. System-Level Testing: Perform tests that encompass the entire vehicle system, including all software, electronics, mechanical components, and interfaces. This ensures that the entire vehicle functions as intended.
  3. Interoperability Testing: Evaluate how the organization’s product interacts with other components or systems that may come from different suppliers. Ensuring interoperability is crucial to avoid compatibility issues.
  4. Safety-Critical Systems: If the vehicle includes safety-critical systems (e.g., advanced driver-assistance systems), conduct thorough testing to ensure they work reliably and do not compromise overall safety.
  5. User Interface and User Experience Testing: Evaluate how the organization’s product interacts with the end-users, including the usability of embedded software interfaces and controls.
  6. Functional and Non-Functional Testing: Validate not only the functional aspects of the organization’s product but also non-functional aspects such as performance, reliability, and security.
  7. Real-World Scenario Testing: Conduct testing in real-world scenarios to simulate how the vehicle will perform in different driving conditions and situations.
  8. Validation in Customer Environment: If possible, perform testing in the customer’s environment to ensure that the product functions as intended within the specific context of its usage.
  9. Feedback and Iteration: Gather feedback from customers and end-users to identify areas for improvement and iterate the design accordingly.
  10. Compliance with Industry Standards: Ensure that the organization’s product meets relevant industry standards, such as ISO 26262 for automotive functional safety or ISO 16949 for quality management.

By evaluating the interaction of the organization’s product within the final customer’s product system, automotive manufacturers can identify and resolve potential issues early in the development process. This comprehensive approach to validation helps ensure that the vehicle performs as expected and meets both customer requirements and regulatory standards.

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