API Specification Q1 Tenth Edition 5.4.4 Design Outputs

Outputs shall be documented to allow verification against the design input requirements.
Outputs shall:

• a) meet the input requirements for design.
• b) provide information for purchasing, production, inspection, testing, and servicing, as applicable.
• c) identify or reference design acceptance criteria (DAC).
• d) include identification of, or reference to, products, components, and/or activities deemed critical to the design.
• e) include results of applicable calculations.
• f) specify the characteristics of the product that are essential for its intended purpose and its safe and proper function.

Records of design outputs shall be maintained .
Identification of criticality of products, components, and/or activities can be maintained outside of the design process.

Design outputs in API Q1 refer to the tangible results, documents, and deliverables produced as a result of the design process. These outputs serve as the basis for manufacturing, testing, and validating the final product. Here are some key design outputs typically specified in API Q1:

1. Detailed Drawings and Specifications: Detailed engineering drawings, schematics, diagrams, and specifications that define the physical characteristics, dimensions, tolerances, materials, and manufacturing processes of the product.
2. Bill of Materials (BOM): A comprehensive list of all components, parts, materials, and sub-assemblies required to manufacture the product. The BOM includes part numbers, descriptions, quantities, and sourcing information.
3. Engineering Specifications and Standards: Specifications, standards, and engineering criteria that define performance requirements, design constraints, and quality expectations for the product. This may include industry standards, regulatory requirements, and internal quality standards.
4. Functional and Performance Requirements: Clear documentation of the functional requirements, performance criteria, and design objectives that the product must meet. This includes specifications for performance parameters, operating conditions, and user requirements.
5. Validation and Verification Protocols: Protocols, procedures, and test plans for validating and verifying the design against specified requirements. This includes testing methodologies, acceptance criteria, and performance benchmarks.
6. Prototypes and Models: Physical prototypes, mock-ups, or models that represent the final product design. Prototypes may be used for design validation, testing, and demonstration purposes before full-scale production.
7. Software Code and Algorithms: Source code, algorithms, and software documentation for embedded systems, control systems, or software components integrated into the product. This includes software design specifications, coding standards, and version control records.
8. Technical Reports and Documentation: Technical reports, design documentation, and engineering analyses that provide detailed explanations, justifications, and analyses of design decisions, methodologies, and outcomes.
9. Risk Assessment and Mitigation Plans: Documentation of identified risks, hazards, and potential failures associated with the design. This includes risk assessment reports, hazard analyses, and mitigation strategies to address identified risks.
10. Design Review and Approval Records: Records of design reviews, evaluations, and approvals conducted throughout the design process. This includes meeting minutes, review checklists, sign-off sheets, and action item logs.
11. Regulatory Compliance Documentation: Documentation demonstrating compliance with applicable laws, regulations, standards, and industry guidelines. This includes regulatory submissions, certifications, declarations of conformity, and compliance statements.
12. Manufacturing and Assembly Instructions: Instructions, procedures, and guidelines for manufacturing, assembling, and testing the product. This includes assembly drawings, process instructions, inspection criteria, and quality control procedures.

These design outputs are essential for ensuring that the final product meets customer requirements, regulatory standards, and quality expectations. They provide a detailed blueprint for manufacturing, testing, and validating the product to ensure its safety, reliability, and performance.

Outputs must be documented to allow verification against the design input requirements.

Documentation of design outputs is crucial for enabling verification against the design input requirements. Here’s how documentation facilitates this process:

1. Traceability: Documentation establishes a clear traceability link between design inputs and outputs. It enables stakeholders to track how each requirement or specification from the design inputs is addressed and realized in the design outputs.
2. Verification Criteria: The documentation specifies verification criteria and acceptance criteria for each design output. This allows verification activities to be planned and executed systematically to ensure that the outputs meet the intended requirements.
3. Cross-Referencing: Design output documentation cross-references relevant design input requirements. This enables stakeholders to easily locate and verify how each design output satisfies specific design input requirements.
4. Alignment with Standards and Regulations: Documentation ensures that design outputs are aligned with applicable standards, regulations, and industry best practices specified in the design input requirements. Verification against these standards and regulations is facilitated through clear documentation.
5. Quality Assurance: Documentation supports quality assurance activities by providing evidence that design outputs have been developed in accordance with the design input requirements. It allows for independent review and verification of the outputs’ compliance with quality standards.
6. Change Control: Documentation facilitates change control processes by providing a baseline for managing revisions and updates to design outputs. Any changes made to the outputs can be documented, reviewed, and verified against the original design input requirements.
7. Auditability: Well-documented design outputs ensure auditability and transparency throughout the design process. Auditors can review the documentation to verify that design outputs have been properly derived from and aligned with the design input requirements.
8. Communication and Collaboration: Documentation serves as a communication tool, enabling effective collaboration among stakeholders involved in the design process. It ensures that everyone has access to the same information and understands the requirements and expectations for the design outputs.

By documenting design outputs in a clear, systematic manner, organizations can facilitate verification against the design input requirements, ensure compliance with standards and regulations, and ultimately deliver products that meet customer expectations and quality standards.

The design output must meet the input requirements for design.

Ensuring that the design output meets the input requirements is fundamental to the design process. Here’s how this is typically achieved:

1. Requirement Analysis: Before proceeding with design, a thorough analysis of the design input requirements is conducted. This includes understanding customer needs, regulatory standards, industry best practices, and any other relevant factors.
2. Design Planning: Based on the analysis of design inputs, a comprehensive design plan is developed. This plan outlines how each requirement will be addressed in the design process and sets the framework for creating design outputs.
3. Design Creation: During the design phase, engineers and designers work to create the actual design outputs, such as drawings, specifications, prototypes, and documentation. These outputs are developed in accordance with the requirements specified in the design inputs.
4. Verification and Validation: Once the design outputs are created, they undergo thorough verification and validation processes. Verification ensures that the design outputs meet the specified requirements, while validation confirms that the design outputs meet the needs and expectations of the stakeholders.
5. Traceability: Throughout the design process, traceability is maintained between the design inputs and outputs. This ensures that each design output can be traced back to the corresponding requirement in the design inputs, providing accountability and transparency.
6. Documentation and Records: All design outputs, along with their verification and validation results, are documented and maintained as records. These records serve as evidence that the design outputs indeed meet the input requirements and can be referenced during audits and reviews.
7. Iterative Process: Design is often an iterative process, with feedback from verification and validation activities informing revisions to the design outputs. This iterative cycle continues until the design outputs satisfactorily meet all the input requirements.
8. Change Management: Any changes made to the design outputs are carefully managed through a change control process. This ensures that changes are properly evaluated, approved, and implemented, and that they continue to align with the original design inputs.

By following these steps and maintaining strict adherence to the design input requirements throughout the design process, organizations can ensure that the final design outputs meet the intended specifications and deliver the desired functionality, quality, and performance.

The design output must provide information for purchasing, production, inspection, testing, and servicing, as applicable.

The design output serves as a critical reference for various downstream processes, including purchasing, production, inspection, testing, and servicing. Here’s how the design output provides information for each of these activities:

1. Purchasing: The design output includes detailed specifications and requirements for all components, materials, and parts needed to manufacture the product. This information enables the purchasing department to procure the necessary materials from suppliers. Additionally, it may include supplier qualification criteria, preferred vendors, and sourcing instructions.
2. Production: Design outputs provide instructions, drawings, and specifications that guide the manufacturing process. This includes assembly instructions, manufacturing procedures, process parameters, and quality standards. Production teams use this information to fabricate, assemble, and test the product according to the design specifications.
3. Inspection: Design outputs include inspection criteria, tolerances, and quality control requirements that define acceptable product quality. This information guides inspection and quality assurance activities throughout the production process. Inspection teams use it to verify that the product meets the specified standards and requirements.
4. Testing: Design outputs specify testing protocols, procedures, and requirements for validating product performance, functionality, and reliability. This includes test plans, test cases, performance benchmarks, and acceptance criteria. Testing teams use this information to conduct various tests, including functional tests, performance tests, and reliability tests.
5. Servicing: Design outputs provide information on product maintenance, repair, and servicing requirements. This includes service manuals, maintenance schedules, troubleshooting guides, and spare parts lists. Service technicians use this information to diagnose issues, perform repairs, and maintain the product throughout its lifecycle.

The design output serves as a comprehensive reference that enables seamless coordination and alignment across different departments and processes involved in the product lifecycle. By providing relevant information for purchasing, production, inspection, testing, and servicing, the design output ensures that the product is manufactured, tested, and serviced in accordance with the specified requirements and standards.

The design output must identify or reference design acceptance criteria (DAC).

Identifying or referencing Design Acceptance Criteria (DAC) in the design output is crucial for ensuring that the design meets the required standards and specifications. Here’s how DAC is typically incorporated into the design output:

1. Specification Documents: DAC is explicitly stated within specification documents, which outline the specific criteria that the design must meet to be considered acceptable. These criteria may include performance thresholds, dimensional tolerances, material specifications, and regulatory requirements.
2. Drawings and Diagrams: Design drawings and diagrams may include annotations or notes that reference DAC for critical features or dimensions. These annotations provide clear guidance to manufacturers, inspectors, and testers on the acceptable limits and requirements for each design element.
3. Test Plans and Procedures: Test plans and procedures developed as part of the design output often reference DAC for defining the acceptance criteria of the tests. This ensures that the testing process is aligned with the desired outcomes specified in the design requirements.
4. Quality Control Documentation: Quality control documentation, such as inspection checklists and quality assurance records, may include DAC as reference points for evaluating the conformity of the design output during manufacturing, inspection, and testing processes.
5. Validation Protocols: Validation protocols used to verify the performance and functionality of the design may include DAC as the basis for determining whether the design meets the intended objectives and requirements.
6. Compliance Certifications: Documentation related to regulatory compliance, such as certifications and declarations of conformity, may reference DAC to demonstrate that the design output complies with applicable standards and regulations.

By clearly identifying or referencing DAC within the design output, stakeholders can easily understand the criteria that must be satisfied for the design to be accepted. This ensures consistency, clarity, and transparency in the evaluation and verification of the design against the specified requirements, ultimately leading to a successful and compliant product design.

The design output must include identification of, or reference to, products, components, and/or activities deemed critical to the design.

Identifying or referencing critical products, components, and activities in the design output is essential for ensuring that these elements receive appropriate attention and scrutiny throughout the design process. Here’s how this can be achieved:

1. Specification Documents: Critical products, components, and activities are explicitly identified or referenced within specification documents. This ensures that their specific requirements, characteristics, and performance criteria are clearly defined and communicated to all stakeholders.
2. Design Drawings and Diagrams: Design drawings and diagrams may include annotations or callouts highlighting critical products, components, or features. This helps to draw attention to these elements and ensures that they are accurately represented in the design output.
3. Bill of Materials (BOM): The BOM includes a list of all components and materials required for the design. Critical products or components can be flagged within the BOM to ensure that they are properly identified and prioritized during procurement, manufacturing, and assembly processes.
4. Risk Assessment and Management: Critical products, components, and activities are identified through a comprehensive risk assessment process. Risks associated with these elements are carefully evaluated, and mitigation strategies are developed to address any potential issues or concerns.
5. Quality Control Documentation: Quality control documentation, such as inspection checklists and quality assurance records, may include specific criteria for evaluating critical products, components, and activities. This ensures that they undergo thorough inspection and testing to verify their compliance with design requirements.
6. Verification and Validation Protocols: Verification and validation protocols incorporate specific tests and procedures tailored to assess the performance, functionality, and reliability of critical products, components, and activities. This ensures that they meet the necessary standards and specifications before being incorporated into the final design.
7. Change Management: Any changes or updates to critical products, components, or activities are carefully managed through a change control process. This ensures that changes are properly evaluated, approved, and implemented, and that their impact on the overall design is thoroughly assessed.

By including identification or reference to critical products, components, and activities in the design output, organizations can prioritize their attention and resources on these key elements, thereby mitigating risks, ensuring quality, and ultimately delivering a successful design.

The design output must include results of applicable calculations.

Including the results of applicable calculations in the design output is crucial for documenting the engineering analysis and ensuring the accuracy and integrity of the design. Here’s how this can be accomplished:

1. Calculation Sheets: The design output may include dedicated calculation sheets or tables that document the results of relevant calculations. Each calculation should be clearly labeled, and the assumptions, input parameters, and methodologies used should be described to provide transparency and traceability.
2. Engineering Reports: For complex calculations or analyses, detailed engineering reports may be prepared as part of the design output. These reports provide a comprehensive overview of the calculations performed, including the theoretical background, computational methods, and results obtained.
3. Design Drawings and Diagrams: Design drawings and diagrams may incorporate annotations or callouts that reference specific calculations. For example, structural drawings may include notes indicating the calculated loads, stresses, or deflections for various components or assemblies.
4. Simulation and Modeling Results: If computer-aided design (CAD), finite element analysis (FEA), or computational fluid dynamics (CFD) simulations are used during the design process, the results of these simulations should be documented in the design output. This may include contour plots, graphs, or tables summarizing the simulation results.
5. Validation Protocols: The results of calculations may also be included in validation protocols or test plans to verify that the design meets the specified requirements. For example, if a certain component is expected to withstand a certain load, the results of the relevant stress analysis calculations may be referenced as part of the validation process.
6. Compliance Documentation: In some cases, regulatory compliance documentation may require the submission of calculations to demonstrate compliance with applicable standards or regulations. These calculations should be included in the design output to support regulatory submissions and certifications.

By including the results of applicable calculations in the design output, engineers and stakeholders can verify the correctness of the design, assess its feasibility and performance, and make informed decisions during the design process. Additionally, documenting calculations enhances traceability, facilitates peer review, and provides a basis for future design iterations and improvements.

The design output must specify the characteristics of the product that are essential for its intended purpose and its safe and proper function.

Specifying the characteristics of the product that are essential for its intended purpose and safe and proper function is crucial for ensuring that the design meets the requirements and expectations of stakeholders. Here’s how this can be achieved:

1. Functional Requirements: The design output should clearly define the functional requirements of the product, including its intended purpose, primary features, and performance criteria. This ensures that the product will fulfill its intended function and meet user needs.
2. Performance Specifications: Specifications for key performance parameters, such as speed, capacity, accuracy, and durability, should be specified in the design output. These characteristics are essential for ensuring that the product performs reliably and meets performance expectations.
3. Safety Requirements: The design output should specify safety requirements and considerations to ensure that the product can be used safely by operators, users, and bystanders. This may include ergonomic design features, safety interlocks, protective barriers, and hazard mitigation measures.
4. Regulatory Compliance: Characteristics related to regulatory compliance, such as conformity to applicable standards, certifications, and regulatory requirements, should be specified in the design output. Compliance with relevant regulations ensures that the product meets legal and safety requirements.
5. Environmental Considerations: The design output should address environmental considerations that are essential for the product’s safe and proper function. This may include requirements related to temperature, humidity, vibration, shock, and other environmental factors that could affect product performance.
6. Compatibility and Interoperability: Characteristics related to compatibility with other systems, components, or interfaces should be specified in the design output. This ensures that the product can seamlessly integrate with existing systems and operate effectively in its intended environment.
7. Reliability and Maintenance: The design output should specify characteristics related to product reliability, maintenance requirements, and serviceability. This includes mean time between failures (MTBF), mean time to repair (MTTR), preventive maintenance schedules, and spare parts availability.
8. Usability and User Experience: Characteristics related to usability, user interface design, and user experience should be specified in the design output. This ensures that the product is intuitive to use, user-friendly, and meets the needs and expectations of its intended users.

By specifying the characteristics of the product that are essential for its intended purpose and safe and proper function, the design output provides a clear and comprehensive description of the product requirements. This information serves as a blueprint for the design and development process, guiding engineers, designers, and stakeholders in creating a product that meets quality, safety, and performance standards.

Example of Design output record

Document ID	Title	Description
ENG-DRW-001	Structural Drawings	Detailed engineering drawings depicting the structural design of the oil and gas production platform.
ENG-SPEC-001	Engineering Specifications	Specifications outlining design requirements, materials, and construction methods for the platform.
BOM-001	Bill of Materials (BOM)	Comprehensive list of all components, materials, and equipment required for the platform.
ENG-ANALYSIS-001	Structural Analysis Report	Report documenting structural analyses and stability assessments for the platform.
HSE-REPORT-001	Hazard Identification Report	Report outlining hazards and environmental considerations associated with platform construction.
REG-COMPLIANCE-001	Regulatory Compliance Documentation	Documentation demonstrating compliance with industry standards and regulatory requirements.
VAL-PROTOCOL-001	Validation Protocol	Protocol outlining testing procedures for validating platform performance and safety.
QC-DOCUMENTATION-001	Quality Control Documentation	Documentation of quality control measures, inspection reports, and non-destructive testing.
OP-MANUAL-001	Operational Manual	Manual providing instructions for platform operation, maintenance, and safety procedures.
CHANGE-LOG-001	Change Log	Log of changes, revisions, and updates made to the design output throughout the project.
DESIGN-REVIEW-001	Design Review Minutes and Approvals	Records of design reviews, evaluations, and approvals conducted during the design process.
LESSONS-LEARNED-001	Lessons Learned Report	Compilation of lessons learned and recommendations from previous projects or similar designs.