It deals with requirements for the control of any design activities carried out by design-responsible organization. Design-responsible organization are those with authority from the customer to design a new product specification , change an existing product specification or design a new manufacturing process for product delivered to a customer. Design can be as simple as replacing the motor in an existing vehicle with one of a different specification, or as complex as the design of a new automobile or any of its subsystems. Design can be of hardware , software or both. Before design commences there is either a requirement or simply an idea. Design is a creative process that creates something tangible out of an idea or a requirement. The
controls specified in the standard apply to the design process. There are no requirements that will inhibit creativity or innovation. In order to succeed, the process of converting an idea into a design which can be put into production or service has to be controlled. Design is often a process which strives to set new levels of performance, new standards or create new wants and as such can be a journey into the unknown. On such a journey we can encounter obstacles we haven’t predicted, which may cause us to change our course but our objective remains constant. Design control is a method of keeping the design on course towards its objectives and as such will comprise all the factors that may prevent the design from achieving its objectives. It controls the process not the designer; i.e. the inputs, the outputs, the selection of components, standards, materials, processes, techniques, and technologies. The principles outlined in the standard can be applied to any creative activity and while the standard primarily addresses the design of automotive products for onward sale to customers, the principles can be applied to internal systems such as an information technology system, an inventory control system, and even the quality system.
Error prevention is crucial in the automotive industry to ensure product quality, safety, and customer satisfaction. Here are some steps to follow for error prevention in automotive industries:
- Define clear requirements: Begin by establishing clear and comprehensive requirements for the automotive product or component. This includes functional, performance, and safety requirements. Ambiguous or incomplete requirements can lead to errors during design and development.
- Implement a robust design process: Develop a well-defined design process that includes stages such as concept development, detailed design, and verification. Ensure that the process adheres to industry standards and guidelines.
- Conduct thorough risk assessments: Perform risk assessments, such as Failure Mode and Effects Analysis (FMEA), to identify potential failure modes, their causes, and their effects. Prioritize and address high-risk areas to mitigate potential errors.
- Use advanced quality planning techniques: Apply advanced quality planning techniques, including Design Failure Mode and Effects Analysis (DFMEA) and Process Failure Mode and Effects Analysis (PFMEA). These tools help identify potential failure modes, their causes, and the actions needed to prevent them.
- Foster a culture of quality: Develop a culture that emphasizes quality and error prevention throughout the organization. Encourage employees to take ownership of quality and empower them to identify and address potential errors.
- Implement a robust change management process: Establish a well-defined change management process to control and track changes throughout the product lifecycle. Ensure that changes are thoroughly reviewed, approved, and communicated to all stakeholders to prevent errors from occurring.
- Utilize cross-functional teams: Involve cross-functional teams throughout the design, development, and manufacturing processes. This ensures that different perspectives are considered, potential errors are identified, and appropriate corrective actions are taken.
- Conduct thorough validation and testing: Implement comprehensive validation and testing procedures to verify that the product or component meets the defined requirements. This includes prototype testing, simulations, and rigorous testing to identify and rectify any errors or performance issues.
- Implement effective supplier management: Establish robust processes for selecting, qualifying, and managing suppliers. Ensure that suppliers adhere to quality standards and requirements to prevent errors in the supply chain.
- Continuously monitor and improve: Regularly monitor and measure key performance indicators related to quality, error rates, and customer feedback. Analyze the data to identify trends, areas for improvement, and take proactive actions to prevent errors from recurring.
- Provide training and development: Invest in training and development programs to enhance the skills and knowledge of employees involved in the design, development, and manufacturing processes. This ensures they are equipped with the necessary tools and techniques to prevent errors effectively.
By following these steps, automotive industries can minimize errors, enhance product quality, and improve overall customer satisfaction and safety.
Clause 8.3.1.1 Design and development of products and services
In addition to the requirement given in ISO 9001:2015 Clause 8.3.1 Design and development of products and services, Clause 8.3.1.1 states that the requirement of Design and development of products and services applies to product and manufacturing process design and development and focuses on error prevention rather than detection.The design and development process is required to be documented
Please click here for ISO 9001:2015 Clause 8.3.1 Design and development of products and services
The standard requires the supplier to establish and maintain documented process to control the design of the product in order to ensure that the specified requirements are met. To control any design activity there are ten primary steps you need to take in the design process:
- Establish the customer needs.
- Convert the customer needs into a definitive specification of the requirements.
- Conduct a feasibility study to discover whether accomplishment of the requirements is feasible.
- Plan for meeting the requirements.
- Organize resources and materials for meeting the requirements.
- Conduct a project definition study to discover which of the many possible solutions will be the most suitable.
- Develop a specification which details all the features and characteristics of the product or service.
- Produce a prototype or model of the proposed design.
- Conduct extensive trials to discover whether the product or service which has been developed meets the design requirements and customer needs.
- Feed data back into the design and repeat the process until the product or service is proven to be fit for the task.
Documented Process need to address each of these stages. However, control of the design process requires more than process. You will need standards and guides or codes of practice, because design is often a process of choosing solutions from available technologies. You may require two types of design control process, standards, and guides: those for controlling all designs and those for controlling individual designs. You should either use national and international standards and industry guidelines or develop your own, the latter course being more costly but often the only course if you are operating at the edge of technology. You may need to develop lists of parts, materials, and processes that have been proven for your application and from which designers can select with confidence. This general requirement for process introduces uncertainty into what particular process are actually required. The standard does not require the design control process to address each requirement of this clause but were they not to, you would need to demonstrate that the absence of such process had no adverse affect on the quality of design. You need to develop a design strategy that sets out rules for designing your products and services. If your products are grouped into various ranges, you will need standards for each range to ensure that any product added to a particular range is compatible with other products in the range. In other cases you may have modular designs which build designs from existing modules, where the only new design is the “glue” that holds it all together. When planning the Design & Development, consider these requirements:
- Nature, duration and complexity
- Required process stages including reviews
- Required verification and validation activities
- Responsibilities and authorities
- Internal and external resource needs
- Controlling interfaces
- Involving customers
- Requirements for manufacturing/service delivery
- Level of control expected by customers.
- Documented information needed to demonstrate requirements have been met.
To prevent errors in design and development processes in accordance with the International Automotive Task Force (IATF) guidelines, you can follow several best practices. Here are some key steps you can take:
- Establish a robust design and development process: Implement a well-defined and documented process for design and development activities. Clearly define the inputs, outputs, responsibilities, and stages involved in the process.
- Utilize cross-functional teams: Form cross-functional teams consisting of individuals from different disciplines, such as engineering, quality, manufacturing, and procurement. This helps ensure that different perspectives are considered during the design and development phases.
- Conduct risk assessments: Perform thorough risk assessments at various stages of the design and development process. Identify potential risks and their potential impact on product quality, safety, and customer satisfaction. Implement appropriate mitigation measures to address these risks.
- Use advanced quality planning techniques: Apply techniques like Failure Mode and Effects Analysis (FMEA), Design Failure Mode and Effects Analysis (DFMEA), and Process Failure Mode and Effects Analysis (PFMEA) to proactively identify and address potential failures and errors.
- Establish design and development validation processes: Develop robust validation processes to verify and validate the design and development outputs. This may involve conducting prototype testing, simulations, and detailed analysis to ensure that the design meets the required specifications and standards.
- Implement a change management system: Establish a change management system to control and track design changes throughout the development process. This ensures that changes are properly reviewed, approved, and communicated to all relevant stakeholders, minimizing the risk of introducing errors.
- Ensure clear documentation and communication: Document all design and development activities, including specifications, requirements, design decisions, and validation results. Maintain clear communication channels among team members and stakeholders to ensure everyone is aware of the latest information and changes.
- Train and develop employees: Provide training and development opportunities to enhance the skills and knowledge of employees involved in the design and development process. This helps them understand the importance of error prevention and equips them with the necessary tools and techniques to identify and mitigate errors.
- Foster a culture of continuous improvement: Encourage a culture of continuous improvement within your organization. Regularly review and analyze design and development processes, identify areas for improvement, and implement corrective actions to prevent errors from recurring.
- Monitor and measure performance: Establish performance indicators and metrics to monitor the effectiveness of your design and development processes. Regularly review these metrics to identify trends, track progress, and take proactive actions to prevent errors.
By following these steps, you can enhance error prevention in design and development processes, aligning with the IATF guidelines and improving product quality and customer satisfaction.
Design and development applied to manufacturing process
The requirement of design and development of products and services applies to the manufacturing process in the following ways:
- Design for Manufacturing (DFM): During the design and development phase, it is essential to consider manufacturing requirements. Designing products with manufacturability in mind ensures that the manufacturing process can be carried out efficiently and effectively. This includes factors such as material selection, component design, assembly methods, and production feasibility.
- Process Validation: As part of the design and development process, manufacturers need to validate their manufacturing processes. This involves establishing and documenting evidence that the manufacturing process is capable of consistently producing products that meet the required specifications. Process validation ensures that the manufacturing process is well-defined, controlled, and capable of producing high-quality products.
- Quality Planning: Design and development activities should include quality planning measures specific to the manufacturing process. This involves identifying critical quality characteristics, setting quality objectives, and implementing appropriate control measures to ensure product quality during manufacturing. Quality planning may include techniques such as Failure Mode and Effects Analysis (FMEA), control plans, and statistical process control.
- Design Changes and Configuration Management: Throughout the manufacturing process, there may be design changes or updates. It is essential to have a robust change management system in place to control and document these changes effectively. This ensures that changes are properly reviewed, approved, and communicated, minimizing the risk of errors or inconsistencies during manufacturing.
- Supplier Management: The design and development process should also consider the selection and management of suppliers involved in the manufacturing process. Manufacturers need to ensure that their suppliers meet the required quality standards and specifications. This includes conducting supplier assessments, monitoring supplier performance, and maintaining effective communication to prevent errors or quality issues in the supply chain.
- Continuous Improvement: The design and development process should foster a culture of continuous improvement within the manufacturing environment. Regularly reviewing and analyzing manufacturing processes, monitoring key performance indicators, and implementing corrective actions help identify and prevent errors, improve efficiency, and enhance product quality.
By incorporating these considerations into the design and development process, manufacturers can optimize their manufacturing processes, improve product quality, reduce errors, and meet customer requirements more effectively.
Design and development applied to Products
In the context of the International Automotive Task Force (IATF) standards, the design and development of products and services applies to the automotive industry in the following ways:
- Product Design: The design and development process in IATF standards involve creating the design specifications for automotive products. This includes defining the product’s features, functionality, performance requirements, and safety considerations. The design phase considers factors such as materials, dimensions, tolerances, and regulatory requirements to ensure the product meets industry standards.
- Design Validation: IATF standards emphasize the importance of validating the design of automotive products. This involves conducting various validation activities, such as prototyping, simulation, testing, and analysis, to verify that the design meets the specified requirements. Design validation ensures that the product is fit for its intended purpose, meets safety regulations, and performs as expected.
- Design Change Management: IATF standards require a robust change management process for design changes. Any modifications or updates to the product design should be properly controlled, documented, reviewed, and approved. This helps prevent errors, inconsistencies, and unintended consequences that could arise from uncontrolled design changes.
- Risk Assessment and Management: IATF standards emphasize risk assessment and management throughout the design and development process. This involves identifying potential risks, such as safety hazards, functional failures, or compliance issues, and implementing appropriate measures to mitigate these risks. Techniques like Failure Mode and Effects Analysis (FMEA) are commonly used to proactively address and prevent potential failures or errors.
- Cross-functional Collaboration: IATF standards promote cross-functional collaboration during the design and development process. This involves involving stakeholders from various disciplines, such as engineering, manufacturing, quality assurance, and customer representatives. Collaborative teamwork ensures that different perspectives and expertise are considered, leading to a comprehensive and error-free design.
- Supplier Collaboration: IATF standards encourage effective collaboration with suppliers during the design and development process. Suppliers play a crucial role in providing components, materials, and sub-systems for automotive products. Close collaboration with suppliers helps ensure that their inputs are incorporated into the design, and their capabilities and quality management systems align with the required standards.
- Documentation and Traceability: IATF standards emphasize the importance of thorough documentation throughout the design and development process. This includes documenting design decisions, specifications, requirements, test results, and any design-related changes. Documentation ensures traceability and provides a reference for future evaluations, audits, and product improvements.
- Continuous Improvement: IATF standards promote a culture of continuous improvement in the design and development of automotive products. This involves regularly reviewing design processes, analyzing performance metrics, gathering customer feedback, and implementing corrective actions. Continuous improvement drives error prevention, enhances product quality, and fosters innovation.
By adhering to these design and development practices specified by IATF standards, automotive manufacturers can ensure that their products meet the required quality, safety, and performance standards while minimizing errors and customer dissatisfaction.
