8.3.1 General
The organization shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services.
This requirement mandates the introduction of a design and development process where this activity is required. You should seek and record evidence that, where applicable, your organization has implemented a design and development process to allow effective product or service provision, where the requirements for products and services are not defined by your customers or interested parties. Many companies perform some enhancements or minor reconfiguration of mature designs, such organizations may have to introduce a comprehensive design system and related or processes. If your organization is ‘design responsible’ but outsources all of its design, all records from Section 8.3 must be maintained by your organization, as they are still responsible for design. Determine your organization’s arrangements for establishing, implementing and maintaining the design and development process that includes design and development planning, inputs, controls, outputs and changes.
Design and Development of a product or a service is an important process and quality of your final product or service depends a great deal on the accuracy of the output from this phase. ISO 9001 has defined detailed requirements for this clause which starts with design and development planning, capturing the design and development inputs, review, verification and validation, documenting the outputs of design and development and managing any changes to design and development. All these stages shall be well planned, executed, adequately documented and changes controlled to meet the requirement of this clause. Imagine what will happen to a project where the design output does not meet the acceptance criteria set by the client. The product/service based on a faulty design will obviously not work as per the client’s expectation. This will lead to client dissatisfaction and finally earn you a bad reputation. To ensure that you do not end up delivering something which is not required by the client, an organisation needs to plan the design and development phase in detail. A well-planned design and development process will ensure that the project is completed within the timeframe provided and meets the budgetary requirements. This will require that the design inputs which may be in the form of written documents provided by the customer or explored along with the customer during various meetings, or regulatory requirements, etc are captured and documented well. Another important aspect is to review the progress of the design and development phase and verify that the customer requirements are being met at different stages. Validation also becomes important to ensure that the end product or service meets its intended purpose and works in the desired manner in the end-user environment. All outputs from the design and development phase shall be retained and controlled. Any changes to design and development if not handled in a planned manner can end up in a defective product or faulty service being delivered. Even the minutest change to design shall go through a procedure where the change is evaluated and impact on various other processes, budget, etc analysed to ensure all these impacts are handled well and changes required in other areas or processes is taken care of.
Establishing, implementing, and maintaining a design and development process is a comprehensive undertaking that involves careful planning, execution, and ongoing management. Here’s a step-by-step guide on how an organization can achieve these objectives:
1. Establishing a Design and Development Process:
a. Leadership and Commitment: Gain commitment and support from top management for establishing the design and development process. Leadership buy-in is essential for resource allocation and setting the tone for the organization.
b. Define Objectives and Scope: Clearly define the objectives and scope of the design and development process. What are you trying to achieve, and what will this process cover?
c. Identify Stakeholders: Identify all internal and external stakeholders who will be involved or impacted by the design and development process. Understand their needs and expectations.
d. Allocate Resources: Allocate the necessary resources, including budget, personnel, equipment, and tools, to support the design and development activities.
e. Develop a Plan: Create a detailed project plan for establishing the design and development process. Include milestones, timelines, deliverables, and responsibilities.
f. Cross-Functional Team: Assemble a cross-functional team with diverse skills and expertise relevant to the design and development activities.
g. Requirements and Risk Assessment: Gather and document the requirements for the products, services, or processes you plan to design and develop. Conduct a risk assessment to identify potential challenges.
h. Standards and Regulations: Ensure that your design and development process will adhere to relevant industry standards, regulations, and best practices.
i. Documentation and Procedures: Develop documentation and procedures that will define how design and development activities will be conducted. This includes standard operating procedures (SOPs) and templates.
j. Training and Awareness: Provide training and awareness programs for team members involved in the process. Ensure that they understand their roles and responsibilities.
k. Pilot Test: Pilot test the initial phase of the design and development process to identify and rectify any issues or bottlenecks.
2. Implementing a Design and Development Process:
a. Execution of Plan: Execute the plan developed in the establishment phase. Begin the design and development activities according to the defined objectives and scope.
b. Continuous Improvement Culture: Foster a culture of continuous improvement within the design and development team. Encourage team members to seek opportunities for enhancement.
c. Risk Management: Continuously monitor and mitigate risks associated with the design and development process. Adapt risk management strategies as necessary.
d. Change Management: Implement a change management process to manage and document changes to the design and development process. Ensure that changes are well-documented, reviewed, and approved.
e. Documentation Control: Maintain strict documentation control to ensure that all process documentation is up-to-date and aligns with current practices and requirements.
f. Performance Monitoring: Monitor the performance of the design and development process to ensure that it continues to meet the defined objectives and expectations.
3. Maintaining a Design and Development Process:
a. Ongoing Leadership and Commitment: Continue to secure leadership commitment and support for the design and development process. Leadership should remain engaged and invested in its success.
b. Regular Review and Evaluation: Establish a schedule for regular reviews and evaluations of the design and development process. This could include quarterly, semi-annual, or annual assessments.
c. Performance Metrics and KPIs: Use performance metrics and key performance indicators (KPIs) to measure the effectiveness and efficiency of the process. Analyze these metrics to identify areas for improvement.
d. Continuous Improvement: Foster a culture of continuous improvement within the design and development team. Encourage team members to seek opportunities for enhancing the process.
e. Change Management: Continue to manage and document changes to the design and development process. Ensure that changes are well-documented, reviewed, and approved.
f. Documentation and Records: Regularly update and review all process documentation, including standard operating procedures (SOPs), templates, and guidelines.
g. Feedback Mechanisms: Encourage team members and stakeholders to provide feedback on the process. Create a culture that values constructive feedback and ideas for enhancement.
h. Knowledge Sharing: Encourage the sharing of knowledge and best practices within the team. Create forums or platforms for knowledge exchange.
i. Measurement and Metrics: Continuously measure and evaluate the performance of the design and development process using key performance indicators (KPIs) and metrics.
j. Lessons Learned: Document and share lessons learned from past projects or iterations of the design and development process. Use these insights to inform future improvements.
k. Customer and Stakeholder Feedback: Continuously gather feedback from customers and stakeholders to understand their evolving needs and expectations. Use this feedback to adapt the process as needed.
By following these steps and maintaining a systematic approach, an organization can successfully establish, implement, and maintain a design and development process that evolves to meet changing needs and industry dynamics. Regular reviews, feedback, and improvements are key to ensuring that the process remains efficient and aligned with the organization’s objectives.
