- 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.