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Design & Development Standards Guide

The document outlines the standards and required evidence for design and development processes of products and services. It details various aspects such as planning, inputs, controls, outputs, and changes, emphasizing the need for structured documentation and verification activities. Key elements include performance requirements, risk assessments, design reviews, and configuration management.

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shivanantham m
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135 views2 pages

Design & Development Standards Guide

The document outlines the standards and required evidence for design and development processes of products and services. It details various aspects such as planning, inputs, controls, outputs, and changes, emphasizing the need for structured documentation and verification activities. Key elements include performance requirements, risk assessments, design reviews, and configuration management.

Uploaded by

shivanantham m
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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S.

NO STANDARD REQUIRED EVIDENCE


8.3 Design and development for products and services
8.3.1 General 8.3.2 to 8.3.6
1. work breakdown structure
2.verification and validation activity(trails),
3. Project management, production, sales, procurement , quality finance, customers, end
users(organization interfaces)
4. Level of controls (customer acceptance, safety checks, risk management,
verification/validation activity, product certification)
5. Required document information (Design plan, reviews, design outputs (specification, schemes,
drawings, models, data, reports)),
8.3.2 Design and development planning 6. control plans
1.performance requirements: operating characteristics, performance parameters, safety
usability, reliability, maintainability
2. similar designs, lesson learned, performance data, in-service data, customer feedback, external
provider feedback, best practice, benchmarking,
3. standards, work instructions, policies, guidance, specifications,
4. consequence failure: Risk assessment, safety analysis, FMECA, Fault tree analysis, lesson
learned
5. consequence of obsolescence: source of supply, sustainability, prohibited materials and
8.3.3 design and development inputs substances, conflict minerals, speciality materails, proprietary parts, exposure of counterfeit
8.3.4 design and Development controls 1. design intent, functional and performance requirements, customer/end user expectations
2. design review(functional representation – customer, engineering, production, quality, project
management), review gates(preliminary, detail, critical )
3. verification activity;
4. validation activity(functional testing, performance testing, trails, prototypes, demonstrations,
simulations)
5. management (action registers, ownership, timescales, escalation, changes to risk profile)
8.3.4.1
1. test requirements( product identity, objectives, schedules, plans, specifications,
resources(persons, equipment, infrastructure), parameters, conditions, acceptance criteria,
2. test methods (work instructions, procedures, schedule, checklists, log books, diaries, data
capture)
3. product configuration(item , assembly, module , product ) and test configuration(facilities,
equipment, conditions, software, controlled monitoring and measuring devices)
4. retain documentation:
1. Test plan and test procedures(criteria)
2. Design meets the specified requirements( reports, calculations, test results, data, review,
outputs)
1. check lists, design review records, authorization to proceed, customer acceptance, product
certification,
2. standards, specifications, schemes, drawings, models, part lists, materials, methods,
manufacturing instructions, technical packages, tooling, machine programs, preservation,
handling, packaging, specialist training, user instructions, service manuals, repair schemes,
external provision:
Inspection equipment gages, instruments, environment(Monitoring and measuring),
Acceptance criteria: tolerance, quality acceptance standards
Product/service characteristics: key characteristics, customer critical features, interface features,
inspections, service intervals, operating characteristics
Critical items(identification, key characteristics, special handling, service intervals, component
8.3.5 design and development outputs lifing, cyclic life, life management plans, source and method of change, traceability)
1. customer communication, notification of changes, requests for deviation, contracts
amendments
2. configuration control: alteration requests, notice of change, amendments, deviations, waivers,
concessions, part revision changes, part number changes, change categories, service bulletins,
modification bulletins, airworthiness directives, engineering communication notice, product
8.3.6 design and development changes change boards

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