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New Product Development: Design of Product and Manufacturing Process
Table of Contents - Detailed Version
Quality and reliability management for photonics and electronics devices
Execution managed as project within a formal product development process – phase concept
Spanning the activities of planning and continuing quality assurance, in conjunction with measurement, feedback and corrective action
Scope of accomplished planning activities
Scope of accomplished quality assurance and quality assurance coordination activities
Relative priorities given to parameters of critical / major importance
Proven resolution of critical issues
Acting in an advisory, problem-solving support and training capacity
§ Quality and reliability management for photonics and electronics devices
§ Execution managed as project within a formal product development process – phase concept
See Page “Program/Project Management”.
× Spanning all phases of new product development,
› From concept and feasibility, prototype design and construction, preproduction through to full-scale production and customer use, and
› Within the sequence of milestones, design completion, prototype release, release for production, release for shipment.
§ Spanning the activities of planning and continuing quality assurance, in conjunction with measurement, feedback and corrective action
× To ensure the achievement of the specified quality and reliability, the enhancement of customer satisfaction and the improvement of manufacturability (process capability, process variations, equipment, operating procedures).
§ Scope of accomplished planning activities – includes
× Creation / optimization of design of product. Basis for all later development steps, including:
› Concept and feasibility studies, competitive analysis, design analysis, reliability analysis, selection of materials for optical and electrical device developments, vendor selection and qualification.
› Modelling of optical / electrical device performance characteristics by employing commercial and own software packages.
› Achievements of two types of product quality characteristics / fitness-for-use parameters. All to be inherent in the basic design of the product and in conformity with customer’s stated requirements.
- Functional capability / performance.
- Other fitness-for-use parameters including reliability, maintainability, safety, producibility, controllability, testability, usability.
ê To be considered: As design of the product is foundation for all later development steps, planning for manufacturing, inspection, transportation, storage and other later steps to be started during product development requiring thorough consideration of, for example, producibility (establishing product tolerance criteria), testability (providing for associated test specifications including a cost-effective screening program), or protection of product during exposure to environment.
› End result: documented in product design specifications and configuration.
× Development / optimization of manufacturing process. End result includes
› Producible design (revised product specifications). Economic, feasible process (process specifications).
› Equipment for wafer growth, processing, test / characterization, reliability qualification, failure analysis.
› Machines and tools capable to meet tolerances.
› Instrumentation capable to control the process.
› Information on how to operate, control and maintain the facilities (clearly specified operation procedures).
› Control stations (process / product) equipped to provide data collection, feedback and adjustment.
› Qualified production workers (selection and training).
› System for control of material.
× Coordination of functional / cross-functional planning activities, including
› Marketing, quality, materials, reliability, procurement, manufacturing, customer representative.
§ Scope of accomplished quality assurance and quality assurance coordination activities
× Quality assurance during product development: Concepts, techniques, tools employed, include
› Cost-effectiveness concept
- To assure for the attainment of fitness-for-use, a balance between competing parameters and life-cycle costs.
› Phase concept of product development.
- With each phase defined in terms of the activities to be carried out and the criteria to be satisfied / milestones to be reached for the completion of the phase and transition to the next phase in the sequence, and to assure that the designs released are adequate, and including
- Engineering change control, configuration management and verification, design reviews and audits.
› Early warning concepts
- For continuously providing design assurance / information essential to achieving a high level of product quality, including
ê Various forms of early warning reviews and tests (e.g. concept / design review, prototype test, environmental test, overstressing), conducted for impending troubles at given checkpoints during the design progression.
› Special quality-oriented tools
- For enhancing forms of early warnings, help evaluate the design and improve the design process itself, including
ê Reliability prediction, failure mode and effects analysis (FMEA), design FMEA, failure modes, effects and criticality analysis (FMECA), value engineering, pilot production lots, failure analysis, data collection and analysis, producibility analysis, process capability quantification.
› Design reviews
- Conducted at pre-determined phases of design progression, such as design concept, prototype design and test, and final design.
- Evaluating designs for all parameters / in terms of all requirements, such as functional capability, reliability, maintainability, producibility, controllability, testability, usability, cost and value.
- To assure that the design will successfully perform during use, can be manufactured at low cost, and is suitable for prompt, low-cost field maintenance.
› Audit of product development
- Including independent evaluation of the design before design is released for full production.
› Quality assurance coordination
- Since many of the early warnings and quality-oriented tools are administered by reliability and other cross-functional specialists.
× Quality assurance during process development: Concepts, techniques, tools employed, include
› Process capability quantification.
- To provide information, essential for manufacturing processes to meet product tolerance.
› Databases including
- Quality Assurance (QA) failure analysis system.
- Manufacturing data system adequate to report defects and yields.
› Design review
- Review of product design for clarity of specifications and producibility.
› Process environment / clean room specifications
- To assure controlled manufacturing conditions.
› Process capability analysis. Process variation analysis. Process compatibility assessment
› Measurement / test capability
- To assure capable instrumentation accurate / adequate to control the process / product.
› Adjustment capability and preventive maintenance
- Providing process adjustments through
ê Identifying the process variables to be monitored for possible adjustments.
ê Providing rules for determining when this is necessary.
ê Providing instructions for determining the amount of adjustment.
ê Providing a convenient physical means for making the adjustment.
› Feedback loop
- Including means to be provided for closing the loop / take remedial action in the event performance does not conform to goals.
› Statistical process / quality control
- Application of statistical techniques, including
ê For measuring / analyzing the variations in processes.
ê For measuring / improving the quality of processes.
› Error-proofing the process
- To assure that the process is designed to be error-free.
› Analysis of out-of-control conditions
- Including follow-up / verification of corrective action.
› Preproduction trials / pilot production, including
- Tool tryout, limited trial lots. Software verification.
- Experimental lots for the attainment of good process yields. Making use of DoE techniques as required.
› Preproduction runs / lots, including
- Production validation tests / lot validation with special provision for prompt feedback and correction of errors as found.
› FMECA for processes, fault tree analysis
- To dissect potential failure modes and their effects on a proposed process.
- To help to identify areas of a process that require error-proofing.
› Overall review of manufacturing planning (Checklist)
- To previously defined criteria and including qualification of the complete manufacturing facility, consisting of process certification, qualification lots and evaluation of technical exposure.
- Requirements for process certification include:
ê Documentation, e.g. all development documents, all manufacturing documents, all quality documents, inspection and test documents, quality program plan, rework procedures, in-process quality defect and yield targets.
ê Tests / process equipment, including maintenance and calibration program, equipment testing to specification, test equipment software level.
ê Manufacturing operations, including: Adequacy of manufacturing procedures and documents, of manufacturing data system to report defects and yields. Stability of manufacturing process (process capability verification). Functionality of QA failure analysis system.
ê Product, including: Incoming parts and approved suppliers. Traceability system. Product meeting performance specifications, quality and yield levels.
› Post-review audit of the quality and manufacturing programs
- To identify any outstanding issues related to product performance, process variation, manufacturability assessment, and process stability.
› Planning process controls
- Based on the feedback loop.
› Planning for evaluation of product, including
- Measuring product for conformance to specifications.
- Taking action on non-conforming product.
- Communicating information on disposition of non-conforming product.
› Quality information equipment (QIE) for measuring processes and products
- Design, construction, procurement.
- Planning for QIE effectiveness parameters incl. reliability, maintainability, accuracy / precision.
› Self-control analysis / controllability
- To prevent both management and worker controllable defects on the manufacturing floor.
› Audit of production quality – systems / product audit
- System audits to determine whether execution follows the plans, systems, procedure.
- Product audit to determine whether the product meets specifications and the needs of fitness-for-use.
§ Relative priorities given to parameters of critical / major importance
× Performance.
× Reliability.
× Manufacturing process capability.
× Supplier quality, materials.
× Cost – effectiveness.
× Human factors aspects, skill levels, personnel training / development.
§ Proven resolution of critical issues
× Optimization of materials and device structures.
× Prevention of design reliability degradation by the manufacturing process.
× Optimization and proof of process capability and process variability.
× Optimization of performance and reliability.
× Progressing process yields. Zero equipment downtime.
× Achievement of an optimum balance between performance and cost.
§ Acting in an advisory, problem-solving support and training capacity
× Quality and reliability management during product progression
› From concept and feasibility, prototype design and construction, preproduction through to full-scale production and customer use, and
› Within the sequence of milestones, design completion, prototype release, release for production, release for shipment.
× Due diligence assessments, including: Technology feasibility studies. Product competitive analyses. Product marketability studies.
× Reviews of product design and manufacturing processes regarding problem detection, resolution, improvement of performance, reliability and manufacturing productivity (yield, cycle times, equipment downtimes).
× Identifying, managing and controlling changes (Configuration management).
× Design, procurement, setting-up of product / process measuring and test equipment (QIE).
› Planning for product effectiveness parameters of the QIE, such as
- Reliability, maintainability, accuracy and precision, operating instructions and training of personnel.
× Establishment of quality and reliability program requirements for suppliers, including supplier evaluation and qualification programs.
× Statistical Process Control (
› Six-sigma quality. Failure mode effect analysis (FMEA). Fault tree analysis. Cause and effect / Ishikawa diagram. Pareto diagram. 80/20 rule. Control charts. Scatter plots. Parts per million (ppm) defective. Process capability index. Cycle time analysis. 8D concept.
× Process improvement, including
› Identification of opportunities for process improvement.
› Design and implementation of measurement system repeatability and reproducibility – Gauge Repeatability & Reproducibility GR&R.
› Identification of critical process parameters.
› Determination of the process capability index (cp and cpk).
› Assignment of measurable indices to process outputs to monitor for continuous improvement.
› Definition of corrective action guidelines and establishment of a tracking system to ensure continuous process improvement.
× Training sessions for designers to become proficient in the use of basic techniques and tools such as
› “Quantification of reliability”, see Page “Reliability” for details.
› “Concept of process capability”, including process capability index, see this Paragraph above.
› “Problem-solving methodology”, including 8D concept.
× Analysis of costs of poor quality.
› Identification of major opportunities for improvement.
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