Quality Systems Compliance 1 FDA Medical Device Quality Systems Compliance.
HCLT Brochure: Device Quality and Compliance
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Safety critical industries need to test for failure detection and provide in-depth coverage to reduce product recall and regulatory compliance issues Consumer industries need to manage short cycle time for testing and release while delivering a high quality of device personalization and UI experience High cost of maintaining product quality due to increased cost of testing resources, CAPEX intensive test infrastructure and the need for highly skilled, cross-functional verification teams Lack of automated and efficient processes Enterprises need to adopt fast evolving technology while ensuring high availability and high performance Domain specific QMS: ASPIRE for DO178 (Aero), TL-9001 compliant QMS (Telecom), ISO/TS 16949:2009 QMS (Auto) Testing Infrastructure: Product certification labs for regulatory compliance (EMI/ EMC, Environment test labs), Mechanical testing lab Test Automation frameworks: Aerospace - Smart ATE; Telecom & Networking - NeTAF; Consumer Electronics - Android Linux Test Platform, HW Engg – ready-to-use BFM models, HW test IP/Frameworks/Investments HCL Value Proposition With more than 150 products and devices successfully tested across various product categories and business verticals, HCL has put together the best of device testing engineering services. Device Quality and Compliance IP/Frameworks/Investments Increasing cost of device quality The challenges in ensuring high quality devices Significant reduction in cost of cover- age – 100% coverage and reduce cost of coverage by 40% for safety critical system Service Components Requirement analysis and validation Design analysis, worst case analysis Simulation, proof of concepts Reliability and risk management services Key Metrics Post design req. creep: 10-20% Requirements coverage increase: 30% Test coverage/requirements: 8% FMEA capability: 10-15% Some of the current trends indicate that device quality and performance are the major reasons for product retention by customers. Product companies are trying to deliver quality offerings in the midst of aggressive release cycles and rapidly changing technologies. Product companies and OEMs are in a squeeze regarding the cost of product quality, including the cost of coverage, the cost of high availability and high performance and a short cycle time for testing and release. Optimizing cost of high availability & high performance - Highest availability and >30%TCO reduction Service Components Performance tuning, product benchmarking, timing and margin verification, reliability analysis, Fault mgmt. testing, interop testing, configuration testing Accelerated testing, new tech integration & test Key Metrics Automating performance testing reduce verification cycle by15–20% DRE: 96% (functional); 99% (regression) Reliability analysis to shorten product development by 15-20% >20% capex reduction and >30% TCO reduction Managing short cycle time for testing & release - 30% effort savings automa- tion and over 30% TCO reduction Service Components ASSeT: KT and transition framework, verification and validation planning, configuration management Value portal, release management, testing automation Key Metrics 30% cost reduction through test automation frameworks On-time delivery: 95% over the last 2 years, up 3% from the prior period Defect to test case ratio: 5-20% WDD: 4–12% reduction Source: Booz Innovation Study
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http://www.hcltech.com/resources/all~ More resources Device Quality and Compliance is one of the major reasons for product retention by customers. Product companies are trying to deliver quality offerings in the midst of aggressive release cycles and rapidly changing technologies. With more than 150 products and devices successfully tested across various product categories and business verticals, HCL has put together the best of device testing engineering services.
Transcript of HCLT Brochure: Device Quality and Compliance
Safety critical industries need to test for failure detection and provide in-depth coverage to reduce product recall and regulatory compliance issues
Consumer industries need to manage short cycle time for testing and release while delivering a high quality of device personalization and UI experience
High cost of maintaining product quality due to increased cost of testing resources, CAPEX intensive test infrastructure and the need for highly skilled, cross-functional verification teams
Lack of automated and efficient processes
Enterprises need to adopt fast evolving technology while ensuring high availability and high performance
Domain specific QMS: ASPIRE for DO178 (Aero), TL-9001 compliant QMS (Telecom), ISO/TS 16949:2009 QMS (Auto)
Testing Infrastructure: Product certification labs for regulatory compliance (EMI/ EMC, Environment test labs), Mechanical testing lab
Test Automation frameworks: Aerospace - Smart ATE; Telecom & Networking - NeTAF; Consumer Electronics - Android Linux Test Platform, HW Engg – ready-to-use BFM models, HW test
IP/Frameworks/Investments
HCL Value Proposition
With more than 150 products and devices successfully tested across various product categories and business verticals, HCL has put together the best of device testing engineering services.
Device Quality and Compliance
Mech Design and
Modeling
Mech Prototype
Requirement Definition
HDD & Analysis
PCB Mft & Assembly
HW Testing
Plan Development
Outline Drawing
HW Conf Index, BOM
Baseline
LLR, SWA Requirement validation
SW implementation
HW, SW Integration,
Build
Interops/ Quality/ System Testing
Certification
Support
Source,SCI, Baseline
FMECA
Test Equipment
Design, Test datasheets
Reliability (Parts Stress)
Test Equipment, Build, Test Procedures
System safety
assessment
Production Acceptance
Testing
Tool Procurement
Assembly Drawings
HW Validation
Validation and
Traceability
SW V&V
System Hazard AN
Test Equipment, Qual, Test
Datasheets
Mech Analysis
Schematics & Layout
Components Procurement
SSD
Reliability (Parts count)
Test Equipment,
BOM, Wiring Drawings
Tool Qualification
Standards compliance/
Protocol compliance
FMECA (component
level)
Article Baseline
Product release
Technology CoEs
Vertical Specific Labs
Alliances andPartnerships
Solution Accelerators
SMEs Large Skill BaseTesting Academy
Domain-Specific QMS
UNIQUE ENABLERS
For a class II medical device firm, we developed a product DFMEA and had complete ownership of SHA and software DFMEA documents. HCL’s efforts resulted in 11% additional coverage, leading to an end-user scenario addition in market requirement specs; higher coverage on safety and product features implementation. Traceability creep in the testing stage was less than 4%, with 95% traceability achieved before V&V start.
For a consumer electronics major, HCL handles product testing for multiple release models with total variants crossing 200 by centralizing the testing resources. HCL invested over $1.6 Million up-front to set up a complete product testing signal generation lab which will be amortized over multiple years. We used in-house automation frameworks to reduce testing by 25%.
For a semiconductor equipment company, HCL established a dedicated test CoE focused on product enhancements and NPI. The CoE replicates the device usage environment, and HCL’s test engineering team has built 15 frameworks in the last three years (overall 42 in five years) to optimize test time (28% of frameworks), performance measurements (42%) and system availability (30%). The CoE developed a defect prediction tool that enables teams to estimate the defect range and aids in estimation of the test engineering investment.
IP/Frameworks/Investments
Test engineering services for complete product lifecycled t lif
Medical Devices
Consumer electronics
Semi Conductors
Our Infrastructure Investments Case Studies
Increasing cost of device quality The challenges in ensuring high quality devices
Significant reduction in cost of cover-
age – 100% coverage and reduce cost of coverage by 40% for safety critical system
Service ComponentsRequirement analysis and validationDesign analysis, worst case analysisSimulation, proof of concepts Reliability and risk management services
Key MetricsPost design req. creep: 10-20% Requirements coverage increase: 30% Test coverage/requirements: 8% FMEA capability: 10-15%
Some of the current trends indicate that device quality and performance are the major reasons for product retention by customers. Product companies are trying to deliver quality offerings in the midst of aggressive release cycles and rapidly changing technologies.
Product companies and OEMs are in a squeeze regarding the cost of product quality, including the cost of coverage, the cost of high availability and high performance and a short cycle time for testing and release.
Optimizing cost of high availability &
high performance - Highest availability and >30%TCO reduction
Service ComponentsPerformance tuning, product benchmarking, timing and margin verification, reliability analysis, Fault mgmt. testing, interop testing, configuration testingAccelerated testing, new tech integration & test
Key MetricsAutomating performance testing reduce verification cycle by15–20%DRE: 96% (functional); 99% (regression)Reliability analysis to shorten product development by 15-20%>20% capex reduction and >30% TCO reduction
Managing short cycle time for testing
& release - 30% effort savings automa-tion and over 30% TCO reduction
Service ComponentsASSeT: KT and transition framework, verification and validation planning, configuration managementValue portal, release management, testing automation
Key Metrics30% cost reduction through test automation frameworksOn-time delivery: 95% over the last 2 years, up 3% from the prior periodDefect to test case ratio: 5-20% WDD: 4–12% reduction
EMI/EMC Lab
RF Antenna Lab
HumidificationChamber
Handler Lab
Device Testingrelated activities
Analysis
Source: Booz Innovation Study
Mech Design and
Modeling
Mech Prototype
Requirement
HDD & Analysis
PCB Mft & Assembly
HW Testing
Plan Development
Outline Drawing
HW Conf Index, BOM
Baseline
LLR, SWA Requirement validation
SW implementation
HW, SW Integration,
Build
Interops/ Quality/ System Testing
Support
Source,SCI, Baseline
FMECA
Test Equipment
Design, Test datasheets
Reliability (Parts Stress)
Test Equipment, Build, Test Procedures
System safety
assessment
Production Acceptance
Testing
Tool Procurement
Assembly Drawings
HW Validation
Validation and
Traceability
SW V&V
System Hazard AN
Test Equipment, Qual, Test
Datasheets
Mech Analysis
Schematics & Layout
Components Procurement
SSD
Reliability (Parts count)
Test Equipment,
BOM, Wiring Drawings
Tool
Standards compliance/
Protocol compliance
FMECA (component
level)
Article Baseline
Product release
Technology CoEs
Vertical
Alliances andPartnerships
Solution Accelerators
SMEs Large Skill BaseTesting Academy QMS
UNIQUE ENABLERS
resulted in 11% additional coverage, leading to an end-user scenario addition in market requirement specs; higher coverage on safety and product features implementation. Traceability creep in the testing stage was less than 4%, with 95% traceability achieved before V&V start.
For a consumer electronics major, HCL handles product testing for multiple release models with total variants crossing 200 by centralizing the testing resources. HCL invested over $1.6 Million up-front to set up a complete product testing signal generation lab which will be amortized over multiple years. We used in-house automation frameworks to reduce testing by 25%.
For a semiconductor equipment company, HCL established a dedicated test CoE focused on product enhancements and NPI. The CoE replicates the device usage environment, and HCL’s test engineering team has built 15 frameworks in the last
performance measurements (42%) and system availability (30%). The CoE developed a defect prediction tool that enables teams to estimate the defect range and aids in estimation of the test engineering investment.
Test engineering services for complete product lifecycle d t lif
Medical Devices
Consumer electronics
Semi Conductors
Our Infrastructure Investments Case Studies
EMI/EMC Lab
RF Antenna Lab
Chamber
Handler Lab
Device Testingrelated activities
Analysis
Hello, I'm from HCL's Engineering and R&D Services. We enable technology led organizations to go to market with innovative products and solutions. We partner with our customers in building world class products and creating associated solution delivery ecosystems to help bring market leadership. We develop engineering products, solutions and platforms across Aerospace and Defense, Automotive, Consumer Electronics, Software, Online, Industrial Manufacturing, Medical Devices, Networking & Telecom, Office Automation, Semiconductor and Servers & Storage for our customers.
