ISO 9001:2015 Requirements
The organization shall determine the requirements essential for the specific types of products and services to be designed and developed. The organization shall consider:
- functional and performance requirements;
- information derived from previous similar design and development activities;
- statutory and regulatory requirements;
- standards or codes of practice that the organization has committed to implement;
- potential consequences of failure due to the nature of the products and services.
Inputs shall be adequate for design and development purposes, complete and unambiguous.
Conflicting design and development inputs shall be resolved.
The organization shall retain documented information on design and development inputs.
1) The organization shall determine the requirements essential for the specific types of products and services to be designed and developed.
This clause of ISO 9001 requires that the design and development inputs are identified and if there is any discrepancy in understanding these inputs, it should be resolved before proceeding further with the design process. Typical design inputs include customer contracts, statement of work, drawings and specifications, reusable information from design and development activities of previous projects, industry standards, competitor analysis, any applicable statutory and regulatory requirements, internal or external resource needs, etc. Design inputs may also be obtained considering the potential consequence of failure due to the nature of the product or service and the customer’s and other stakeholders projected level of control of the design and development process. Let’s take an example of an architecture company to understand this better. An architect will typically need inputs in form of Architecture Return Brief, Relevant standards, guides and codes (e.g. ISO, AS/NZS, Greenstar), Local and statutory requirements (e.g. National Construction Code and Development Approval), etc. These shall be gathered, documented and understood well before proceeding with the design. Design inputs requirements may include requirements related to functionality, performance, safety, regulations, maintainability, traceability, etc. from the customer or the regulatory body.
Determining the essential requirements for the design and development of products and services involves a systematic and thorough process. Here are the steps an organization can take to determine these essential requirements:
- Identify all relevant stakeholders, including customers, clients, end-users, regulatory bodies, and internal teams. Gather input from these stakeholders to understand their needs, expectations, and requirements.
- Research and review industry-specific regulations, standards, and legal requirements that apply to the product or service. Ensure compliance with these mandatory requirements.
- Engage with customers and end-users to gather their specific requirements and preferences. This may involve surveys, interviews, focus groups, or direct communication.
- Define the functional and performance requirements of the product or service. Consider what it needs to do, how it should perform, and any technical specifications.
- Identify any quality standards or certifications relevant to the product or service. These may include ISO standards, industry-specific benchmarks, or internal quality guidelines.
- Clearly define the scope of the project. Determine the boundaries of what the product or service will include and what it won’t. This helps prevent scope creep.
- Conduct a risk assessment to identify potential risks and challenges that may impact the design and development process. Consider how to address these risks in the requirements.
- Research industry best practices and benchmark against competitors or similar products or services. Identify features or attributes that are considered essential in the market.
- Assess the technical, financial, and operational feasibility of meeting certain requirements. Ensure that the organization has the capability to fulfill them.
- Consider environmental and sustainability requirements, such as eco-friendly materials, energy efficiency, or recycling initiatives, if relevant to the product or service.
- Ensure that the design and development process includes requirements for accessibility and inclusive, making the product or service usable by individuals with diverse needs.
- Take into account budgetary and resource constraints when determining requirements. Ensure that the project remains financially viable and resource-efficient.
- Document all identified requirements and establish traceability between these requirements and their sources. This ensures that nothing is overlooked and provides a clear audit trail.
- Prioritize the requirements based on their importance, impact on the project, and alignment with the organization’s goals. Focus on essential requirements first.
- Plan for how each requirement will be validated and verified to ensure that it has been met during the design and development process.
- Establish a change management process to handle any changes or updates to requirements that may arise during the project. Ensure that changes are assessed for their impact and feasibility.
- Communicate the requirements to all relevant stakeholders, ensuring alignment and a shared understanding of what needs to be achieved.
- Continuously monitor the requirements throughout the design and development process to ensure that they are being addressed and that any deviations are promptly addressed.
By following these steps, an organization can systematically determine the essential requirements for designing and developing products and services. This process helps ensure that the resulting products and services meet the needs of stakeholders, comply with regulations, and align with the organization’s goals and capabilities.
2) The organization shall consider functional and performance requirements
Considering functional and performance requirements is a crucial aspect of the design and development process. These requirements define what a product or service should do and how well it should perform its intended functions. Here’s how an organization can address functional and performance requirements in the design and development inputs:
- Gather Requirements: Engage with stakeholders, including customers, end-users, and subject matter experts, to gather detailed functional and performance requirements. Ensure that all relevant parties provide input.
- Functional Requirements: Clearly define the specific functions and features that the product or service must possess. This includes functionality, capabilities, and the expected behavior under different conditions.
- Performance Requirements: Identify performance criteria that describe how the product or service should perform. This may include parameters such as speed, reliability, accuracy, scalability, and response times.
- Quality Attributes: Consider quality attributes that are important to users, such as usability, security, maintainability, and availability. Define clear requirements for these attributes.
- Use Cases and Scenarios: Develop use cases, scenarios, or user stories that illustrate how the product or service will be used. This helps in defining and validating functional and performance requirements.
- Benchmarking: Benchmark against similar products or services in the market to identify industry standards and customer expectations. This can provide valuable insights into performance benchmarks.
- Prioritization: Prioritize functional and performance requirements based on their criticality and impact on user satisfaction and the success of the product or service.
- Quantitative Metrics: Specify quantitative metrics and thresholds for performance requirements. For example, response times should be less than a certain number of milliseconds under specific load conditions.
- Non-Functional Requirements: Address non-functional requirements, which may include constraints related to technology, compliance with regulations, and resource limitations. Validation and Verification: Define how each requirement will be validated and verified during the design and development process. Establish test cases, scenarios, or validation procedures.
- Traceability: Create traceability links between functional and performance requirements and their sources, such as customer requests, user feedback, or regulatory documents. This helps maintain accountability.
- Change Control: Establish a change control process for handling changes or updates to functional and performance requirements. Ensure that changes are assessed for their impact on the project.
- Documentation and Communication: Document all functional and performance requirements comprehensively. Communicate these requirements clearly to all team members and stakeholders.
- Continuous Monitoring: Continuously monitor and track progress toward meeting functional and performance requirements throughout the design and development process. Address deviations promptly.
- User Acceptance Criteria: Define user acceptance criteria that clearly specify how users will determine whether the product or service meets their functional and performance expectations.
- Validation and Verification Protocols: Develop validation and verification protocols or plans to systematically test and validate that the requirements have been met.
By addressing functional and performance requirements in a systematic and comprehensive manner, organizations can design and develop products and services that not only meet user needs but also perform effectively and reliably in their intended environments. This approach helps ensure customer satisfaction and the successful delivery of high-quality products and services.
3) The organization shall consider information derived from previous similar design and development activities
Considering information derived from previous similar design and development activities is a valuable practice for organizations. Leveraging lessons learned and experience from past projects can lead to more efficient and successful design and development processes. Here’s how an organization can effectively incorporate information from previous similar activities into its design and development inputs:
- Document Lessons Learned: Encourage project teams to document their experiences and lessons learned from previous design and development activities. This documentation should include both successes and challenges encountered.
- Create a Knowledge Repository: Establish a knowledge repository or database where information from past projects is stored, organized, and easily accessible. This can include project reports, post-project evaluations, and relevant documentation.
- Identify Common Patterns and Best Practices: Analyze the information from previous projects to identify common patterns, best practices, and recurring issues. This can help in making informed decisions during the current project.
- Reuse Design Components: If applicable, identify design components, modules, or templates from previous projects that can be reused in the current project. This can save time and resources.
- Risk Mitigation: Use historical data to identify potential risks and challenges that have arisen in similar projects. Develop proactive risk mitigation strategies based on this knowledge.
- Performance Benchmarks: Establish performance benchmarks and targets based on the historical performance of similar projects. This can help set realistic expectations and goals.
- Continuous Improvement: Promote a culture of continuous improvement by encouraging team members to suggest improvements based on their past experiences. Ensure that these suggestions are evaluated and implemented as appropriate.
- Applicability Assessment: Assess the relevance and applicability of information from past projects to the current project. Not all lessons learned may be directly transferable, so prioritize the most relevant insights.
- Documentation Standards: Ensure that documentation standards are consistent across projects, making it easier to compare and extract insights from historical records.
- Benchmarking Against Competitors: Consider benchmarking your design and development efforts against similar projects carried out by competitors or industry peers. This can provide additional insights.
- Training and Knowledge Transfer: Facilitate knowledge transfer sessions or training programs to share insights gained from past experiences with team members who may be less experienced.
- Feedback Loops: Establish feedback loops between current project teams and teams that have worked on similar projects in the past. Encourage open communication and the exchange of knowledge.
- Regular Reviews: Conduct regular reviews or retrospectives at key project milestones to assess progress, identify areas for improvement, and incorporate lessons learned into the ongoing design and development process.
- Change Management: Be open to adapting processes, methodologies, and strategies based on the insights gained from past projects. Ensure that change management processes are in place.
- Data Analytics: Use data analytics to analyze historical project data and extract meaningful insights. This can help identify trends, performance patterns, and areas for optimization.
By considering information derived from previous similar design and development activities, organizations can benefit from the collective knowledge and experience of their teams. This approach promotes efficiency, reduces risks, and contributes to the continuous improvement of design and development processes.
4) The organization shall consider statutory and regulatory requirements
Considering statutory and regulatory requirements when determining design and development inputs is crucial for ensuring that a product or system complies with legal and industry standards. Here’s a step-by-step guide on how an organization can effectively consider these requirements:
- Identify Applicable Regulations: Begin by identifying all relevant statutory (legal) and regulatory requirements that pertain to your product or industry. These can include federal, state, or international laws, as well as industry-specific standards and guidelines.
- Create a Compliance Team: Establish a cross-functional team that includes individuals with expertise in regulatory affairs, legal compliance, and product design and development. This team will be responsible for ensuring compliance throughout the design process.
- Document Requirements: Carefully document all identified requirements. This includes both general requirements that apply to your industry and any specific regulations or standards that are relevant to your product.
- Incorporate Requirements into Design Inputs: Review the documented requirements and incorporate them into your design and development inputs. These inputs should serve as the foundation for your product design, guiding decisions about its features, specifications, and performance criteria.
- Risk Assessment: Conduct a risk assessment to identify potential compliance risks associated with the design inputs. Consider how deviations from the requirements could impact product safety, legality, or market acceptance.
- Design Review and Validation: During the design process, conduct regular design reviews to ensure that the product is aligning with the regulatory and statutory requirements. Perform validation tests to verify that the product meets these requirements.
- Document Everything: Maintain comprehensive records of how each design input is linked to specific regulatory or statutory requirements. This documentation will be crucial for audits and regulatory submissions.
- Iterative Process: Design and development are often iterative processes. As you make changes and refinements to your product, ensure that these modifications continue to align with the identified requirements.
- Consult Experts: If needed, consult with subject matter experts, legal counsel, or regulatory consultants to ensure that your understanding of the requirements is accurate and up-to-date.
- Testing and Certification: Once the product design is complete, conduct testing and validation to confirm compliance with all relevant statutory and regulatory requirements. If applicable, seek certification or approval from relevant authorities or certification bodies.
- Monitoring and Updates: Even after product launch, continue to monitor changes in regulations and standards. Update your product design and development processes as necessary to stay in compliance.
- Training and Awareness: Ensure that your team is educated and aware of the importance of regulatory compliance in the design and development process. Training can help prevent compliance issues from arising.
By following these steps, organizations can systematically integrate statutory and regulatory requirements into their design and development processes, reducing the risk of legal issues, ensuring product quality and safety, and maintaining a positive reputation in the market.
5) The organization shall consider standards or codes of practice that the organization has committed to implement
Considering standards or codes of practice that the organization has committed to implement is an essential part of the design and development process. These standards and codes often serve as industry best practices and benchmarks for quality, safety, and performance. Here’s how an organization can effectively consider and implement them:
- Begin by identifying the specific standards or codes of practice that your organization has committed to implement. These could be industry-specific standards, international management standards, safety codes, or any other relevant guidelines.
- Integrate the requirements and guidelines outlined in the identified standards and codes into your design and development inputs. These should become an integral part of the product’s design criteria and specifications.
- Maintain clear documentation that demonstrates how each design input aligns with the relevant standards and codes. This documentation is essential for audits and ensuring that your product adheres to the committed standards.
- During the design process, conduct regular design reviews to ensure that the product is aligning with the standards and codes of practice. Perform validation tests to verify compliance.
- Assess the risks associated with not complying with the committed standards and codes. Non-compliance could result in legal issues, safety hazards, or quality problems. Address these risks in your design and development process.
- If necessary, seek guidance from experts or consultants who specialize in the relevant standards and codes. They can provide valuable insights and interpretations to ensure compliance.
- Ensure that your design and development team is knowledgeable about the standards and codes that apply to your work. Provide training and promote awareness to ensure everyone understands their importance.
- Conduct thorough testing and validation processes to confirm that your product meets the requirements outlined in the standards and codes. This may include laboratory testing, simulations, or field trials.
- Stay vigilant about changes in standards and codes over time. Continuously monitor updates and revisions to ensure that your product remains compliant throughout its life-cycle.
- If applicable, seek certification or issue compliance statements that confirm your product’s adherence to the committed standards and codes. This can enhance your product’s credibility in the market.
- Maintain records of compliance with standards and codes for regulatory, legal, and customer reference. Proper documentation is crucial for demonstrating compliance and resolving any disputes.
By considering and implementing the standards and codes of practice that your organization has committed to, you not only ensure compliance but also enhance the quality, safety, and reliability of your products or services. This commitment can also improve your organization’s reputation and competitiveness in the marketplace.
6) The organization shall consider potential consequences of failure due to the nature of the products and services.
Considering the potential consequences of failure is a critical aspect of the design and development process for products and services, especially when they have the potential to impact safety, health, the environment, or other significant factors. Here’s how an organization can incorporate this consideration into its design and development inputs:
- Identify Critical Product or Service Characteristics: Begin by identifying the specific aspects or characteristics of your product or service that could have significant consequences in the event of failure. This could include factors like safety, reliability, performance, and environmental impact.
- Conduct Risk Assessments: Perform thorough risk assessments to evaluate the potential consequences of failure for each identified characteristic. Consider both the likelihood and severity of these consequences. This may involve techniques such as Failure Modes and Effects Analysis (FMEA) or Hazard Analysis.
- Set Design Criteria and Requirements: Based on the results of the risk assessments, establish design criteria and requirements that explicitly address the potential consequences of failure. For example, set performance targets, safety standards, and environmental impact limits.
- Document the Consequences: Clearly document the potential consequences of failure for each characteristic and the corresponding design requirements. This documentation serves as a reference point throughout the design and development process.
- Incorporate Mitigation Measures: Develop and integrate mitigation measures into the design to reduce the likelihood or severity of failure consequences. These measures could include redundancy, fail-safes, protective systems, and quality control processes.
- Continuous Monitoring and Testing: Continuously monitor and test the product or service during the development process to ensure that it meets the established design criteria and effectively addresses potential failure consequences.
- Cross-Functional Collaboration: Involve cross-functional teams in the design process, including experts in areas like safety engineering, quality control, and environmental impact assessment. Collaboration ensures a comprehensive approach to addressing failure consequences.
- Regulatory Compliance: Ensure that the design and development process aligns with any relevant regulatory requirements related to the consequences of failure. Regulatory agencies often have specific standards for safety, quality, and environmental impact.
- Feedback Loops: Establish feedback loops to capture and analyze data from real-world use or testing. This data can inform design refinements and improvements to further mitigate failure consequences.
- Emergency Response Planning: Develop contingency plans and emergency response procedures to address potential failures that could have severe consequences. Ensure that your organization is prepared to respond appropriately in case of such events.
- Customer Communication: Communicate the potential consequences of failure and any relevant safety or usage instructions to customers, where applicable. Transparency can help manage expectations and reduce risks.
By systematically considering the potential consequences of failure during the design and development phase, organizations can enhance the safety, reliability, and overall quality of their products and services. This approach not only mitigates risks but also demonstrates a commitment to customer satisfaction and responsible business practices.
7) Inputs shall be adequate for design and development purposes, complete and unambiguous.
Ensuring that Design and Development Inputs are adequate, complete, and unambiguous is a fundamental aspect of a robust design and development process. Ambiguity or inadequacy in inputs can lead to misunderstandings, errors, and inefficiencies in the development process. Here’s how the organization can achieve this:
- Gather Comprehensive Requirements: Thoroughly gather all relevant requirements, specifications, and expectations from stakeholders, including customers, regulatory bodies, and internal teams. Consider all aspects, such as functionality, performance, safety, and quality.
- Clarify Ambiguities: If any requirements or inputs are unclear or ambiguous, work closely with stakeholders to clarify them. This might involve holding meetings, conducting interviews, or seeking expert opinions.
- Document Inputs in Detail: Document all inputs in a clear, structured, and detailed manner. Use precise language, avoid jargon, and provide examples or illustrations where necessary. This documentation should serve as a reference point throughout the design and development process.
- Validation and Verification: Ensure that the inputs are validated and verified for accuracy and completeness. Validation involves confirming that the requirements meet the needs of stakeholders, while verification ensures that they are correct and free from errors.
- Use Standard Templates and Formats: Standardize the format and templates used for documenting design and development inputs. This consistency makes it easier to understand, review, and update the inputs.
- Cross-Functional Review: Involve cross-functional teams in reviewing the design and development inputs. Different perspectives can help identify gaps, inconsistencies, or potential issues that may not be apparent to a single department.
- Traceability: Establish traceability matrices that link each input to specific design and development elements. This traceability ensures that all requirements are addressed and that changes are managed effectively.
- Regularly Review and Update: Design inputs may evolve over time due to changes in customer needs, regulatory requirements, or project scope. Regularly review and update the inputs to ensure they remain relevant and aligned with project goals.
- Version Control: Implement version control for design and development inputs to track changes and revisions. This prevents confusion and ensures that the latest requirements are being used.
- Communication: Foster clear communication channels between all relevant stakeholders. Encourage open dialogue to address any questions or concerns related to the inputs promptly.
- Training and Awareness: Train employees involved in the design and development process on the importance of clear and complete inputs. Make them aware of the potential consequences of inadequate or ambiguous requirements.
- Continuous Improvement: Continuously seek feedback from teams involved in design and development to identify areas where inputs can be improved. Use lessons learned from previous projects to refine your approach.
By following these steps and emphasizing clarity, completeness, and lack of ambiguity in design and development inputs, organizations can reduce the risk of errors, rework, and misunderstandings, ultimately leading to more efficient and effective product development processes.
8) Conflicting design and development inputs shall be resolved.
Resolving conflicting design and development inputs is crucial for maintaining the integrity and efficiency of the design process. Conflicts can arise from differing stakeholder perspectives, changing requirements, or misunderstandings. Here’s how an organization can effectively address and resolve these conflicts:
- Identify Conflicts Early: Encourage open communication among all stakeholders involved in the design and development process. Actively seek out conflicting inputs, and establish a mechanism for reporting and addressing conflicts as soon as they arise.
- Document Conflicting Inputs: Clearly document the conflicting inputs, specifying the source of each conflicting requirement or expectation. This documentation serves as a reference point for resolution efforts.
- Convene a Cross-Functional Team: Assemble a cross-functional team that includes representatives from all relevant departments, including design, engineering, marketing, quality assurance, and any other areas with a vested interest in the project.
- Analyze the Nature of Conflicts: Investigate the reasons behind the conflicting inputs. Understand whether conflicts stem from technical limitations, differing stakeholder priorities, or miscommunications.
- Prioritize Requirements: Work with stakeholders to prioritize conflicting requirements based on their importance to the project’s overall success, customer satisfaction, and compliance with regulations.
- Seek Compromise and Consensus: Encourage stakeholders to engage in constructive discussions to find compromises or common ground. Be prepared to make trade-offs and concessions when necessary to resolve conflicts.
- Apply Decision-Making Frameworks: Utilize decision-making frameworks such as cost-benefit analysis, risk assessment, or impact analysis to objectively evaluate conflicting inputs and make informed decisions.
- Document Resolutions: Document the resolutions to conflicting inputs, including the rationale behind each decision. This documentation should be shared with all stakeholders to ensure transparency and understanding.
- Update Design Inputs: Revise the design and development inputs to reflect the agreed-upon resolutions. Ensure that these updates are communicated clearly to the entire team.
- Implement Change Management: If resolving conflicts results in changes to the project scope, requirements, or timelines, implement a robust change management process to ensure that all relevant parties are informed and aligned with the changes.
- Continuous Monitoring: Continuously monitor the project to ensure that the resolved conflicts do not re-emerge or lead to new conflicts. Address any emerging issues promptly.
- Lessons Learned: After project completion, conduct a post-project review to identify the root causes of conflicts and the effectiveness of the resolution process. Use these lessons learned to improve conflict resolution in future projects.
- Stakeholder Communication: Maintain open and transparent communication with stakeholders throughout the conflict resolution process. Keep them informed of progress and decisions.
By proactively addressing and resolving conflicting design and development inputs, organizations can maintain project momentum, reduce the risk of delays and rework, and ensure that the final product or service meets the needs and expectations of all stakeholders.
9)The organization shall retain documented information on design and development inputs.
This clause outlines the requirements for defining and documenting the inputs necessary for the design and development of products and services. Here are the key documents and records required in ISO 9001:2015 Clause 8.3.3:
- Customer Requirements: You must document and record all relevant information regarding customer requirements. This includes specifications, expectations, needs, and any other relevant information that defines what the customer expects from the product or service.
- Regulatory and Statutory Requirements: Ensure that you have documented and recorded all applicable laws, regulations, and standards that apply to your product or service. This may include safety standards, industry-specific regulations, and legal requirements.
- Functional and Performance Requirements: Document the functional and performance requirements of the product or service. This includes any specific features, capabilities, or performance criteria that need to be met.
- Risk Assessment: Document the results of risk assessments related to the design and development process. This should include identification of potential risks, their impact, and any mitigation measures planned.
- Scope and Objectives: Clearly define the scope and objectives of the design and development process. This helps ensure that everyone involved understands the purpose and goals of the project.
- Standards and Guidelines: Document any relevant industry standards, guidelines, or best practices that need to be followed during the design and development process.
- Resource Requirements: Identify and document the resources needed for design and development. This includes personnel, equipment, materials, and facilities.
- Interactions and Interfaces: Document any interactions or interfaces with other processes, products, or services that are relevant to the design and development process.
- Change Control Procedures: Establish and document procedures for managing changes to design and development inputs. This includes how changes are reviewed, approved, and communicated.
- Traceability: Establish a system for tracing the design and development inputs throughout the entire process. This ensures that you can track how each input is addressed and incorporated into the final product or service.
- Validation Criteria: Define the criteria for validating the design and development outputs. This helps ensure that the final product or service meets the specified requirements.
- Records of Inputs: Maintain records of all documented design and development inputs. These records should be readily accessible for review and audit purposes.
It’s important to note that the level of documentation and record-keeping may vary depending on the complexity of the product or service and the organization’s specific needs. ISO 9001:2015 emphasizes the importance of maintaining documented information while allowing flexibility to tailor the documentation to the organization’s size and context. Always consult the standard and consider the guidance of a quality management expert when implementing these requirements in your organization.
Conceptual Design Statement (CDS)
The Conceptual Design Statement (CDS) includes a design statement that declares the inputs to be used in the design and the proposed design solution. A design statement illustrates the principles concepts and input data relevant to the design and allows relevant stakeholders to understand the thinking behind any chosen design solution. The Design Team will normally produce a Conceptual Design Statement that states the standards and requirements against which the design is to be developed, the processes to be applied and the level of independent checking to be carried out (if any) that is proportionate to the level of risk. The design activities are then carried out by the Design Team using the CDS as the basis. Design and development inputs are documented and controlled. Design and development inputs can be in any form, including data sheets, customer drawings and specifications, photographs, samples, references to standards, etc.
Design standards baseline
All designs are based on a list of approved design standards, referred to as the Standards Baseline. This list is owned and managed by the Engineering Manager. The Standards Baseline is made up of a combination of National and International Standards, National Engineering Specifications, and Approved Codes of Practice. The Standards Baseline should be reviewed monthly and any changes are controlled by the Engineering Manager. At the commencement of any given design package, the Design Team is required to specify the Standards Baseline that will be used in the design. The Engineering Manager should be responsible for checking that the correct design standards have been specified and for verifying that the design output complies with these standards and design requirements. Due to the continuous review and updating of standards, the baseline between different design instructions may vary so a strict configuration control is maintained and only agreed changes are used in the assurance process. Once a design package has been instructed, the baseline for that element of work becomes fixed and will not reflect any subsequent changes in standards.
Assumptions will normally be statements to fill uncertainties in available information. They are generated by the Design Team in order to allow designs to continue in the early stages. The anticipation is that assumptions are temporary and are closed out either by obtaining data or updating documents to confirm or change the assumption. Assumptions have the potential to be incorrect, and are therefore a source of risk, that require management. Any associated risk is identified and raised through the Risk Register. The assumption management activity is coordinated by Design Manager, with input from the Design Team. Assumptions regarding domain knowledge include facts about the application of the end product or service that allow requirements to be developed in a particular context. The assumptions are normally traceable to gaps or inconsistencies in the design inputs e.g. incomplete or conflicting functional requirements, inconsistencies between the applicable Standards, unclear scope of work, or demarcation issues. The Responsible Body; which might be another company, organisation, person, or team against which an assumption has been made or who are responsible for providing a feature or undertaking an action to resolve an assumption agreed by them. Qualifying criteria for design assumptions are based on the following:
- Assumptions on scope and allocation;
- Assumption regarding gap or conflict in the stated capabilities, systems or operational aspects;
- Conflict between standards;
- Assumptions due to missing design data;
- Assumptions regarding a design decision;
- Assumptions relating to interface issues.
Assumptions must not be raised on programme and cost related matters. The requirements or the design statement will be verifiable against the raised assumption or the origin of the assumption. Assumptions are accepted by the Resolving Body; they may be turned into design requirements or project risks. The process for managing design assumptions is summarised as follows:
- Assumptions are managed using an Assumptions Register;
- The Design Team propose an assumption to fill an uncertainty;
- The Engineering Manager reviews the suitability of the assumption against the criteria;
- Once agreed with the Resolving Body, the Design Team updates the assumption register;
- Action owner closes out assumption by agreed date, this could be done either by establishing additional data or confirming a decision;
- The Engineering Manager monitors that action owners are closing out assumptions and takes action to expedite if necessary;
- Any assumption remaining at the end of the design phase must be clearly recorded in the Assumptions Register and transferred to the Risk Register.
Assumptions are considered closed when they are successfully resolved i.e. accepted by the Resolving Body and the Resolving Body has taken an action that is documented in a resolving document. This resolving document must be properly reviewed, verified and issued before the closure of an assumption is accepted. The respective Gate Review Authority are the final authority to accept or reject the closure of an assumption. The confirmation of closure is noted in the Assumptions Register and a reference to the resolving document with the relevant clause is provided for verification purposes.
The design management process is geared towards meeting customer requirements, while providing a product cost, which enables organizations to have a satisfactory return on investment. The physical and performance requirements of a product used as a basis for product design and development; includes user requirements, regulatory requirements, and system requirements. The customer and user requirements are translated into design requirements and may either be hardware or software (according to intended use) and included in the design specifications and other design documents. The requirements are reviewed for adequacy by a cross functional, multidisciplinary team involving Design, Engineering, Sales, Manufacturing, Procurement, Sales and Quality to ensure the requirements are complete, unambiguous and not in conflict with each other. The Design Team notifies Engineering Manager if the requirements are ambiguous or conflict with each other. The Design Team produces evidence of the capture of and compliance with the requirements. This evidence is presented in the Requirements Register. The Design Team should provide compliance matrices and verification reports to demonstrate how the designs meet the requirements, supported by the compliance rationale, evidence, models and analysis as required, whilst ensuring that:
- All requirements are traceable to the identifier, author, rationale, source, requirement owner, allocation and stakeholder;
- All requirements have been validated and approved by identified personnel;
- All requirements set been reviewed and agreed with the customer;
- Are requirements are recorded into the project applicable database;
- All allocated requirements are understood and accepted by all the recipients.
In order to progress their close-out and acceptance, compliance statements are prepared and allocated to each requirement, commensurate to the design stage e.g. Gate 1, 2, or 3. Links and references to supporting drawings and documents are provided as the design progresses.
Customer supplied user requirements are transferred to the Requirements Review Checklist and additional requirements are addressed with the customer. The Marketing Manager and the Sales Manager should identify and document the markets’ need for new solutions in a requirement statement which serves as the input for design and development work. The requirement statement includes the following:
- What is required (features/functions, etc.);
- Why it is needed (customer demand);
- When it is needed;
- Assumptions needed to progress the design;
- Risk and opportunity, and hazard analysis;
- Requirements for performance, reliability, safety, statutory and regulatory, etc.;
- Pricing targets and design project milestones.
When a product is designed or modified to meet specific customer requirements, the Engineering Manager receives from Marketing Manager and the Sales Manager an outline design order with customer requirements and specifications. The Design Team translates the needs and expectations from the requirements and design statements to technical specifications for materials, products, services and processes.
Where necessary, the Design Team should form working groups to develop interface control documents and record agreements for interfacing stakeholders in order to elicit their requirements and to provide feedback that may be important to your designs. Their emphasis should be on the identification and co-ordination of the important characteristics, parameters and configurations that need to be developed to deliver effective interface designs. The level of detail documented must be proportionate with the level of detail being developed in the design outputs.
- Identify, specify and manage interfaces;
- Assist in the resolution of interface issues relating to commercial or contractual issues;
- Assist in the production of and agree interface documents with interfacing parties;
- Ensure that the process of interface management is fully supported during the development of detailed designs;
- Review and monitor the development of interface identification.