Early reliability prediction and simulation: Predict reliability, quality and sustainability early in design to create better products and avoid costly downstream problems.
Failure mode and effects analysis (FMEA): Identify, rank, and mitigate potential design and process failure modes, effects, and causes associated to either a product structure or a process plan. Perform bottom-up failure analysis before a product is fully designed and built.
Fault tree analysis (FTA): Perform top-down failure analysis of undesired events to improve overall quality before a product is made.
Risk analysis: Quantify risk at the system or functional level early in the design process. Mitigate risk by connecting to test, control plans and issue management.
Failure reporting, analysis and corrective action system (FRACAS): Collect and analyze issues (e.g., test incidents, field failures, defects, maintenance, claims, etc.) to identify trends. Ensure problems are resolved using a corrective action process.
CAPA (closed-loop): Institutionalize a standard closed-loop corrective action and preventive action (CAPA) process.
Deviation/waiver management: Allow for deviations and waivers for non-conforming product or processes.
Nonconformance management: Capture, process and manage all nonconformances (NC) internal to a company (e.g., product, material, process) in a closed-loop process.
Complaints and customer feedback: Implement a standard closed-loop customer experience management process. Support intake, reporting, and capture of external quality information such as customer feedback, field product experiences, and customer complaints.
SOP document management: Implement a standard ISO 9001 document control process. Provide easy creation, control, management, and distribution of key corporate SOPs and other controlled documents. Ensure quality by sharing company policies and processes.
Audit management: Ensure key processes, requirement, and directives are being followed with a standard ISO 9001 audit process. Supports internal, external, and third-party audits.
CTQ characteristic management: Track critical-to-quality characteristics (CTQs) identified via FMEA and risk analysis. CTQs are critical dimensions, parameters, or tolerances that must be tracked to ensure acceptance in design verifications (DVPs) and control plans.
Quality driven change management: Drive engineering change based on quality activities and analysis, such as, risk management, reliability analysis, and issue identification.
Certified standards-based development (e.g., APQP, ISO9001, ISO26262, etc.): Execute and deploy industry-specific development processes configured to enable certification. Ensures compliance required in various industries.
Test plan definition (DVP & R): Generate test plans associated to PLM artifacts to ensure high quality products.
PPAP (Production part approval process): Manage deliverables and design records to ensure consistent delivery of high-quality products provided by a supplier.
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