IATF 16949:2016 Clause 8.3.2.1 Design and development planning

The standard requires the organization to prepare plans for each design and development activity which describe or reference these activities and define responsibility for their implementation. You should prepare a design and development plan for each new design and also for any modification of an existing design that radically changes the performance of the product or service. For modifications that marginally change performance, control of the changes required may be accomplished through your design change process. Design and development plans need to identify the activities to be performed, who will perform them, and when they should commence and be complete. In addition there does need to be some narrative, as charts rarely convey everything required. Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:

• The design requirements
• The design and development program showing activities against time
• The work packages and names of those who will execute them (work packages are the parcels of work that are to be handed out either internally or to subcontractors)
• The work breakdown structure showing the relationship between all the parcels of work
• The reviews to be held for authorizing work to proceed from stage to stage
• The resources in terms of finance, manpower, and facilities
• The risks to success and the plans to minimize them
• The controls (quality plan or procedures and standards) that will be exercised to keep the design on course

In drawing up your design and development plans you need to identify the principal activities and a good place to start is with the list of ten steps detailed previously. Any further detail will in all probability be a breakdown of each of these stages, initially for the complete design and subsequently for each element of it. If dealing with a system you should break it down into subsystems, and the subsystems into equipment, and equipment into assemblies, and so on. It is most important that you agree the system hierarchy and associated terminology early on in the development program, otherwise you may well cause both technical and organizational problems at the interfaces. The ten steps referred to previously can be grouped into four phases, a phase being a stage in the evolution of a product or service:

• Feasibility Phase
• Project Definition Phase
• Development Phase
• Production Phase

Planning for all phases at once can be difficult, as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of four separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases. Your design and development plans may also need to be subdivided into plans for special aspects of the design, such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The design and design verification activities may be performed by the same person. However, it is good practice to allocate design verification to another person or organization as it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines, such as mechanical engineers, electronic engineers, reliability engineers, etc. The responsibilities of all these people or groups need to be identified and a useful way of parceling up the work is to use work packages which list all the activities to be performed by a particular group. If you subcontract any of the design activities, the subcontractor’s plans need to be integrated with your plans and your plan should identify which activities are the subcontractor’s responsibility. While purchasing is dealt with in clause 8.4 of the standard, the requirements apply to the design activities. The standard requires that the design and development plans describe or reference design and development activities. Hence where you need to produce separate plans they should be referenced in the overall plan so that you remain in control of all the activities.

Clause 8.3.2.1 Design and development planning

In addition to the requirements given in ISO 9001:2015 clause 8.3.2 Design and development planning, clause 8.3.2.1 states that all the affected stakeholders including the supply chain are involved in the Design and development planning. A multidisciplinary approach typically includes the organization’s design, manufacturing, engineering, quality, production, purchasing, supplier, maintenance, and other appropriate functions. Areas for using such a multidisciplinary approach include project management for example, APQP or VDA-RGA. It includes development and review of product design risk analysis (FMEAs), including actions to reduce potential risks and development and review of manufacturing process risk analysis for example, FMEAs, process flows, control plans, and standard work instructions. Product and manufacturing process design activities such as Design for Manufacturing and Design for Assembly with the consideration of the use of alternative designs and manufacturing processes.

Please click here for ISO 9001:2015 clause 8.3.2 Design and development planning

This must include the Design and Development of both the product as well as the manufacturing process and extends throughout the product program life. The scope of your Design and Development activity must consider all aspects of the product and product realization processes to ensure its conformity to requirements. This includes product identification, handling, packaging, storage and protection during internal processing and delivery to the customer. Product Design and Development sometimes results in new manufacturing processes or changes to existing manufacturing processes. This clause is equally applicable for designing and developing manufacturing processes. Planning must focus on error prevention rather than detection in product as well as manufacturing Design and Development. You must have an overall plan for your design project. Your plan must specify the design and development stages, activities and tasks; responsibilities; timeline and resources; specific tests, validations, and reviews; and outcomes. There are many tools available for planning ranging from a simple checklist to complex software. Use your customer-specific manuals for APQP as a good starting point. The degree and details of planning may vary according to size and length of contract or project, complexity, risk, product life, customer and regulatory requirements, past experience with similar product, etc. You have flexibility in determining the scope of the stages, review, verification and validation required for your product Design and Development projects. Your plan must be dynamic and updated as requirements and circumstances change. You must track progress against your plan at regular intervals or project milestones and update the plan as activity progresses. You must use a multi-disciplinary approach, that includes as needed, other functions (besides design) such as quality, engineering, purchasing, sales, tooling, production, etc.. Your plan must clearly identify these other functions and their specific role and responsibilities regarding the project. Consider including customer and supplier personnel at appropriate stages to do work and review results or progress. Consideration must also be given to the methods of communication and interaction. Inclusion of these controls in your Design and Development plan is one of many effective ways to achieve this. A multi-disciplinary approach has the benefit of applying collective and relevant knowledge and skills of these different functions to carry out or review Design and Development activities. You must use the multi-disciplinary approach for specific activities such as determination of special characteristics, conducting FMEA’s, developing control plans, and plant and facility planning, etc. The Design and Development project plan serves as both a document and a record as it is updated for completion for various activities. Where some or all of the design responsibility is subcontracted or done off-site, then you must ensure that your organization and the subcontractor or off-site location collectively address all the requirements of clause 8.3 with particular coverage of the interfaces between them. You must review all input requirements; review Design and Development progress; verify product design and validate developed product at various stages of your Design and Development process. The nature, frequency and scope of these controls must be defined in your Design and Development plan or other document. You must carry out these controls according to your plan and keep appropriate records. You must identify and document all processes addressing this clause as part of your QMS. For these processes, you must also identify what specific documents are needed for effective planning, operation and control of production activities . These documents may include – contracts; technical drawings and specifications; a documented plan for Design and Development; work instructions; a documented procedure; etc., combined with unwritten practices, procedures and methods. Look at the risks related to your product, processes and resources in determining the nature and extent of documented controls you need to have . Many organizations use various software tools to document their product or process Design and Development plans. Performance indicators (to measure the effectiveness of design and development processes in meeting requirements and achieving quality objectives) should focus on reducing variation in and improving these processes and related use of resources. Indicators may include reduction in – design cycle time; development cycle time; specification errors, omissions; changes; Design and Development costs; etc., as well as measurable improvements in products developed. Here are the key steps involved in design and development planning in IATF:

1. Scope and Objectives: Define the scope of the design and development activities, including the intended purpose of the product, its intended use, and any specific customer requirements or standards that must be met. Establish clear objectives and expectations for the design and development process.
2. Responsibilities: Identify and assign roles and responsibilities for each stage of the design and development process. This includes a cross-functional team that collaborates on design activities, with representatives from engineering, manufacturing, quality, and other relevant departments.
3. Customer Requirements: Gather and analyze customer requirements, expectations, and feedback to understand the needs of the end-users. These requirements should be documented and used as a basis for the design and development process.
4. Regulatory Compliance: Identify and understand all relevant regulatory and legal requirements that apply to the product. Ensure that the design and development process complies with these requirements and that all necessary certifications and approvals are obtained.
5. Risk Management: Perform a risk analysis to identify potential risks associated with the design and development process. Develop plans to mitigate these risks and address any potential issues that may arise during the product development.
6. Resource Allocation: Determine the resources needed for the design and development process, including personnel, equipment, facilities, and materials. Ensure that the necessary resources are available and allocated appropriately.
7. Timelines and Milestones: Establish a detailed timeline with specific milestones for the design and development process. This will help track progress and ensure that the project stays on schedule.
8. Design Input: Define the design inputs based on customer requirements, industry standards, and other relevant information. These inputs should be specific, measurable, achievable, relevant, and time-bound (SMART) to guide the development process effectively.
9. Design Review: Plan for design reviews at various stages of the development process to assess the progress and verify that the design outputs meet the design inputs. This may include internal reviews and external customer reviews.
10. Verification and Validation: Establish procedures for the verification and validation of the design outputs. Verification ensures that the design meets the specified requirements, while validation confirms that the final product meets the intended use and customer needs.
11. Change Management: Develop a robust change management process to handle any changes to the design and development activities. Changes should be documented, reviewed, approved, and communicated to all relevant stakeholders.
12. Documentation: Maintain comprehensive documentation throughout the design and development process. This includes design plans, specifications, records of design reviews, verification, and validation results, and any other relevant information.
13. Training and Competence: Ensure that all personnel involved in the design and development process are adequately trained and competent to perform their respective tasks. Training records should be maintained and periodically updated.
14. Communication: Establish effective communication channels within the cross-functional team and with external stakeholders, including customers and suppliers. Regular communication ensures everyone stays informed about the project’s progress and any potential issues.
15. Continual Improvement: Implement mechanisms to capture lessons learned and feedback from completed design and development projects. Use this information to drive continual improvement in future design processes.

By following these steps, organizations can create a structured and efficient design and development planning process that aligns with the requirements of IATF 16949 and leads to the successful development of automotive products.

Multidisciplinary approach in Design and Development planning

A multidisciplinary approach in design and development planning involves bringing together experts and professionals from organization’s design, manufacturing, engineering, quality, production, purchasing, supplier, maintenance, and other appropriate functions to collaboratively work on a project. In the context of the automotive industry, this approach is essential as modern vehicles are complex systems that require expertise from different fields to create successful products. Here’s how a multidisciplinary approach can be applied to design and development planning in the automotive sector:

1. Cross-Functional Teams: Assemble a team that includes engineers, designers, manufacturing experts, quality assurance specialists, marketing professionals, and other relevant stakeholders. Each team member brings their unique perspective, knowledge, and skills to the project.
2. Understanding Customer Needs: Different disciplines can provide valuable insights into customer needs. For example, market research specialists can gather customer feedback, while designers can translate those needs into tangible product features.
3. Innovation and Creativity: A multidisciplinary team fosters an environment where innovative ideas and creative solutions can emerge. Engineers, designers, and other team members can collaborate to find novel ways to meet customer requirements and industry challenges.
4. Early Identification of Issues: A diverse team can identify potential issues and challenges from different angles. This early identification enables proactive problem-solving and reduces the likelihood of costly design flaws later in the process.
5. Integrated Design Process: With experts from various fields collaborating, the design process becomes more integrated and holistic. Decisions consider the implications on manufacturing, quality, and other aspects of the product’s lifecycle.
6. Improved Problem-Solving: When challenges arise during the design and development process, a multidisciplinary team can pool their expertise to find comprehensive solutions.
7. Effective Communication: Communication is enhanced as team members with different backgrounds learn to understand each other’s terminologies and perspectives. This reduces misunderstandings and ensures a smoother workflow.
8. Optimizing Trade-offs: In automotive design, there are often trade-offs between various factors such as performance, cost, safety, and sustainability. A multidisciplinary team can better analyze these trade-offs and make informed decisions.
9. Prototyping and Testing: The expertise of various team members can contribute to designing effective prototypes and conducting relevant tests to validate the product’s performance and safety.
10. Regulatory Compliance: In the automotive industry, meeting regulatory requirements is crucial. With diverse expertise, the team can address safety and compliance considerations effectively.
11. User-Centric Design: A multidisciplinary team can create products that are more user-centric by considering different aspects of the user experience, such as ergonomics, aesthetics, and functionality.
12. Continuous Improvement: The diversity of perspectives in the team allows for continuous improvement, where lessons learned from previous projects can be incorporated into future designs.

In conclusion, a multidisciplinary approach in design and development planning is instrumental in developing successful automotive products. By harnessing the expertise of professionals from different disciplines, companies can create innovative, safe, and customer-focused solutions that meet the ever-evolving demands of the automotive industry.

Project management such as APQP or VDA-RGA in Design and development

Project management methodologies such as Advanced Product Quality Planning (APQP) and VDA-RGA (German Association of the Automotive Industry – Requirements for Project Management in the Automotive Industry) play a crucial role in the design and development process of automotive products. These methodologies help ensure that projects are effectively planned, executed, and controlled, leading to the successful development of high-quality products. Let’s explore each of these project management methodologies:

1. Advanced Product Quality Planning (APQP): APQP is a structured approach to product development widely used in the automotive industry. It focuses on proactive planning, risk management, and ensuring that quality is built into the product from the early stages of development. APQP is commonly associated with IATF 16949 and is required by many automotive manufacturers as part of their supplier development process. The main steps in APQP include:
   • Planning and Definition: Clearly define the scope of the project, identify customer needs and requirements, and set specific goals and objectives.
   • Product Design and Development: Develop detailed product designs based on customer requirements and technical specifications.
   • Process Design and Development: Define the manufacturing and assembly processes required to produce the product. Ensure that these processes meet quality and efficiency standards.
   • Product and Process Validation: Conduct thorough testing and validation to ensure that the product meets design and performance requirements, and that the manufacturing processes are capable of consistently producing quality products.
   • Feedback, Assessment, and Corrective Actions: Continuously monitor the product’s performance and gather feedback from customers and the production process. Implement corrective actions and improvements as needed. APQP involves cross-functional collaboration, risk assessment, and iterative design reviews to ensure that the product meets customer expectations and quality standards.
2. VDA-RGA (Requirements for Project Management in the Automotive Industry): VDA-RGA is a project management standard developed by the German Association of the Automotive Industry. It provides guidelines and best practices for managing complex automotive projects effectively. The key elements of VDA-RGA include:
   • Project Planning: Clearly define project objectives, scope, and requirements. Establish a project team and allocate responsibilities.
   • Risk Management: Identify potential risks and uncertainties that may impact the project’s success. Develop risk mitigation strategies and contingency plans.
   • Resource Management: Ensure that the necessary resources, such as personnel, technology, and materials, are available and allocated effectively throughout the project.
   • Project Control: Regularly monitor and control the project’s progress, budgets, and milestones. Implement corrective actions when necessary to keep the project on track.
   • Communication and Documentation: Establish clear communication channels within the project team and with relevant stakeholders. Maintain comprehensive documentation of project activities and decisions. VDA-RGA emphasizes structured project planning, risk assessment, and proactive management to achieve successful project outcomes.

By incorporating project management methodologies like APQP and VDA-RGA into the design and development process, automotive companies can ensure efficient project execution, reduce risks, and deliver high-quality products that meet customer requirements and industry standards.

Product and manufacturing process design activities

In the design and development process, product and manufacturing process design activities are essential for creating a successful and efficient product. Two critical methodologies used in this context are Design for Manufacturing (DFM) and Design for Assembly (DFA). These methodologies focus on optimizing the product design and the manufacturing processes to improve quality, reduce costs, and enhance overall efficiency. Additionally, considering alternative designs and manufacturing processes allows companies to explore various options to achieve the best possible outcomes. Let’s delve into each aspect:

1. Design for Manufacturing (DFM): DFM is an approach that aims to design products in a way that makes them easier and more cost-effective to manufacture. The primary goal is to simplify the manufacturing process, reduce production costs, and improve product quality. Key considerations in DFM include:
   • Simplify Product Geometry: Design the product with simpler shapes and geometries that are easier to produce using standard manufacturing processes. Minimizing complex features can reduce the number of manufacturing steps and potential sources of defects.
   • Material Selection: Choose materials that are readily available and cost-effective while still meeting the product’s performance requirements.
   • Tolerances and Fits: Define appropriate tolerances and fits that allow for easier assembly while maintaining the required product functionality.
   • Minimize Part Count: Reduce the number of individual parts in the product by using common components and sub-assemblies, which simplifies assembly and reduces the risk of errors.
   • Standardize Components: Utilize standardized and off-the-shelf components whenever possible, as they are often more cost-effective and readily available.
   • Design for Robustness: Ensure that the design can withstand variations in the manufacturing process without compromising quality or functionality.Applying DFM principles results in products that are more easily and economically manufactured, reducing production costs and potentially improving time-to-market.
2. Design for Assembly (DFA): DFA focuses on designing products with the goal of simplifying and optimizing the assembly process. The main objective is to minimize assembly time, reduce assembly errors, and enhance product reliability. Key considerations in DFA include:
   • Assembly Sequence: Plan the product assembly sequence to minimize the number of assembly steps and eliminate any unnecessary complexity.
   • Ease of Handling: Design parts that are easy to handle during assembly, reducing the risk of damage or errors during the process
   • Self-Locating and Self-Fixturing Features: Incorporate features in the design that allow parts to align and fit together easily during assembly, reducing the need for additional tools or fixtures.
   • Modular Design: Divide the product into sub-assemblies or modules that can be assembled independently, simplifying the overall assembly process.
   • Reduced Fasteners: Minimize the number of fasteners and use common fasteners where possible to simplify assembly operations.
   • Design for Automated Assembly: Consider the use of automation in the assembly process and design components that can be easily assembled by machines.By implementing DFA principles, companies can reduce assembly time, minimize errors, and improve product reliability, leading to increased productivity and cost savings.
3. Considering Alternative Designs and Manufacturing Processes: Evaluating alternative designs and manufacturing processes is crucial in the early stages of product development. Companies should explore various options to identify the most suitable approach that aligns with cost, performance, and quality requirements. Utilizing simulation tools, prototypes, and feasibility studies can help in comparing different designs and processes before making a final decision.When considering alternative designs, factors to evaluate include product performance, manufacturability, materials, and the ability to meet customer needs and regulatory requirements. For manufacturing processes, factors such as production rate, quality control, equipment availability, and cost-effectiveness should be taken into account.By considering alternative designs and manufacturing processes, companies can optimize their products’ overall design, reduce risks, and select the most efficient and cost-effective approach for successful product development.

Incorporating Design for Manufacturing, Design for Assembly, and exploring alternative designs and manufacturing processes ensures that products are not only well-designed but also practical to produce, assemble, and deliver to customers. These methodologies play a significant role in improving product quality, reducing production costs, and streamlining the overall manufacturing process.

Development and review of product design risk analysis

The development and review of Product Design Risk Analysis, specifically Failure Mode and Effects Analysis (FMEA), is a critical step in design and development planning. FMEA helps identify potential risks and weaknesses in the product design and manufacturing processes, enabling proactive actions to reduce or mitigate those risks. Here’s how to perform FMEA and implement actions to address identified risks during design and development planning:

1. Assemble the FMEA Team: Form a cross-functional team that includes experts from various disciplines, such as design, engineering, manufacturing, quality assurance, and any other relevant areas. The diverse expertise ensures comprehensive analysis and effective risk mitigation strategies.
2. Identify Failure Modes: Begin by identifying all potential failure modes that could occur in the product’s design and manufacturing processes. A failure mode is a potential way in which the product or process could fail to meet its intended function or requirements.
3. Assign Severity, Occurrence, and Detection Ratings: For each identified failure mode, rate its severity (impact on the customer or end-user), occurrence likelihood, and detection ability (likelihood of detecting the failure before it reaches the customer). Use a numerical scale (usually from 1 to 10) for each rating.
4. Calculate Risk Priority Number (RPN): Calculate the Risk Priority Number for each failure mode by multiplying the severity, occurrence, and detection ratings. RPN = Severity x Occurrence x Detection.
5. Prioritize High-Risk Items: Sort the failure modes by their RPN values in descending order to identify the high-risk items that require immediate attention.
6. Root Cause Analysis: For each high-risk item, conduct a root cause analysis to determine the underlying reasons for the potential failure. Investigate the factors contributing to the failure mode and identify weaknesses in the design or manufacturing process.
7. Implement Corrective Actions: Develop and implement effective corrective actions to address the identified root causes and reduce the risks associated with high RPN values. The goal is to improve the design and processes to prevent the potential failure from occurring.
8. Verification of Corrective Actions: Validate and verify the effectiveness of the corrective actions. This may involve testing, simulations, or other validation methods to ensure that the changes have effectively reduced the identified risks.
9. Reevaluate the FMEA: After implementing the corrective actions, update the FMEA to reflect the changes and recalculate the RPN values. Review the new RPNs to ensure that the risks have been sufficiently reduced.
10. Document the FMEA Process: Thoroughly document the FMEA process, including identified failure modes, RPN calculations, root causes, corrective actions, and validation results. This documentation serves as a valuable reference for future reviews and continuous improvement efforts.
11. Continual Improvement: Incorporate the lessons learned from the FMEA process into future design and development projects. Regularly review and update the FMEA as the product evolves and new risks are identified.

By performing FMEA and implementing actions to address potential risks in the design and development planning phase, automotive companies can proactively identify and mitigate potential issues. This approach ensures that the final product meets high-quality standards, satisfies customer requirements, and performs reliably in the field.

Development and review of manufacturing process risk analysis

The development and review of manufacturing process risk analysis are crucial steps in design and development planning to ensure the efficient and reliable production of automotive products. Several tools and methodologies are commonly used in this process, including Failure Mode and Effects Analysis (FMEA), process flows, control plans, and standard work instructions. Let’s explore how each of these elements contributes to manufacturing process risk analysis during design and development planning:

1. Failure Mode and Effects Analysis (FMEA): FMEA is a systematic approach used to identify and evaluate potential failure modes and their effects on the manufacturing process. The goal is to proactively address and mitigate risks before they impact product quality or production efficiency. Here’s how FMEA is applied in manufacturing process risk analysis:
   • Identify Process Steps: Create a process flow diagram that outlines the various steps involved in manufacturing the product. This provides a clear understanding of the entire manufacturing process.
   • Identify Failure Modes: For each process step, identify potential failure modes, which are the ways in which the process step could fail to meet its intended outcome.
   • Assess Severity, Occurrence, and Detection: Rate the severity of the impact of each failure mode, the likelihood of its occurrence, and the likelihood of detecting it before it reaches the customer. Assign numerical values to these ratings.
   • Calculate Risk Priority Number (RPN): Calculate the RPN for each failure mode by multiplying the severity, occurrence, and detection ratings. RPN = Severity x Occurrence x Detection.
   • Prioritize and Address High-Risk Items: Prioritize high-RPN failure modes and develop appropriate corrective actions to reduce their risks. The corrective actions may involve process changes, additional inspections, or improvements to equipment and tools.
   • Reevaluate and Monitor: After implementing corrective actions, reevaluate the FMEA to determine the effectiveness of the changes and monitor the process for further improvement opportunities.
2. Process Flows: Process flows are graphical representations of the manufacturing process, illustrating the sequence of steps, activities, and decision points involved in producing the product. Process flows help identify potential bottlenecks, inefficiencies, and areas where the risk of errors or defects may be higher. Reviewing the process flow allows the team to optimize the manufacturing process and make it more robust and reliable.
3. Control Plans: Control plans outline the specific actions and measurements needed to ensure that the manufacturing process operates within specified quality standards. Control plans detail inspection points, process controls, sampling plans, and measurement methods to monitor and maintain product quality. The control plan is essential for managing risks related to variability in the manufacturing process.
4. Standard Work Instructions: Standard work instructions provide step-by-step guidelines for operators and workers to follow during the manufacturing process. These instructions help ensure consistency and reduce the risk of errors or variations in the product. Regularly reviewing and updating standard work instructions can improve process efficiency and minimize the potential for defects or nonconformities.

By incorporating FMEA, process flows, control plans, and standard work instructions in design and development planning, automotive companies can identify and address potential manufacturing process risks. This proactive approach results in higher product quality, reduced production delays, and increased overall efficiency in the manufacturing process. Regular reviews and continual improvement efforts based on the analysis contribute to better outcomes and customer satisfaction.