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Problem Solver Software for Corrective and Preventive Action (CAPA)

  • Problem Solver Software for Corrective and Preventive Action (CAPA)

Introduction to Problem Solver Software

Problem solving software allows companies to address business problems. This software is an incredibly powerful tool designed to serve as a single repository for all internal and external problem management.

There are various problem-solving methodologies and tools that help identify root causes. Designing problem-solving software provides all these tools to assist in getting to the root of the problem.

Problem solving software is developed based on the CQI-20 standard and is compliant with other standard as follows:

  • ISO 9001:2015
  • IATF 16949
  • Aerospace AS9145
  • ISO 13485
  • ISO 14001
  • ISO 45001
  • FSSC 22000
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Features and Benefits (Problem Solver Software)

Manage Problems and Incidents

  • Problem-solving software is an effective problem solving tool that allows you to standardize the problem management workflow.

Problem Solving Approaches

  • Respond to customers in preferred formats, including 8D, 7D, FRA/PRR/PSD, CAR, L0, Advanced CAR, or “Just-do-it” formats defined by the customer. There are many versions of 8D available to support your 8D formats.

Supplier Corrective Action

  • Empower suppliers to complete supplier corrective action.

Track Closure of Investigations

  • Define timelines and metrics for problem resolution from the problem itself to containment, correction, corrective action, and reporting all the way to closure.

Problem Solving Tools

  • Utilize 5Why, Is/Is Not, 5W2H, Cause and Effect Diagram (Ishikawa/Fishbone) seamlessly.

Escalation to Closure

  • Allows escalation to ensure effective closure.

Linkage to FMEA

  • Connect 8D/Problem Solving to FMEA, linking detection to prevention. Connect 8D/Problem Solving to FMEA by allowing to open a concern directly from FMEA/ Potential Failure mode column and in the end, linking the root causes, Detection and Prevention back in FMEA.
Audit Pro Management Software

Use Cases

  • Problem Solving Management by Mobility: Implement the mobile app Problem Solving. Users can create new concerns directly from shop floors on the go, even in offline mode, ensuring flexibility and enabling real-time data collection. Problem Solving is available in the Google Play Store (Android) and Apple App Store (iOS).

  • Comprehensive Compliance: Use Problem Solver to ensure alignment with various standards such as ISO 9001, IATF 16949, ISO 14001, ISO 45001, CQI 20 and more. Ensure your organization adheres to these standards through robust processes for problem solving management.

  • Supplier Problem Management: Use Problem Solver for Supplier Problem Management. Using Problem Solver will offer you real-time reporting, enabling organizations to make informed decisions about their supply chain partnerships.

  • Saving resources: Using Problem Solving Management software you’ll save resources through improved efficiency and well-structured implemented processes. By resources, we mean all the things involved in the process to achieve the desired results. The EWQIMS system reduced the time needed to solve and close an issue and the paper usage by 100% compared to the previous system. All the issues can be managed in one single place.
  • Management of all types of issues: Using Problem Solver software, can be defined approaches for various scale of problems (e.g., current manufacturing issues, customer claims, audit findings, field failure, supplier issues …) and various types - quality assurance (external and internal), environmental, and health and safety issues.
  • Real-time reporting: The various reports updated in real-time allowed managers to plan future improvements based on the reporting tool built into the software, supported by the easy-to-use dashboard. The occurrence of the problem for other sites can be avoided by the lesson learned that can be shared in real-time with all the company’s sites.

Industry‑Specific Solutions

Problem Solver Software is built to match the way each industry works, with ready‑made steps and one place for every issue:

Automotive

  • Leverage APQP-driven workflows and PFMEA integration to meet IATF 16949 requirements. Use 8D reports, 5 Why analyses and Control Plan linkages to drive down RPNs, manage PPAP submissions, track PPM metrics and close DCT (Disposition, Containment, Temporary) actions in real time.

Aerospace

  • Comply with AS9145 root-cause protocols and AS9115 corrective action plans.
  • Automatically generate NCRs (Nonconformance Reports) and link to DMR (Discrepant Material Reports), flow CAR/PAR tasks to suppliers, and maintain FAA 14 CFR Part 21 traceability throughout the audit lifecycle.

Medical Device

  • Map investigations to your Design History File (DHF) and Risk Management File per ISO 14971.
  • Drive CAPA workflows, log MDR (Medical Device Reports) and UDI-based customer complaints, and validate corrective actions through V&V protocols, ensuring full ISO 13485 and 21 CFR 820 compliance.

General Manufacturing

  • Align problem investigations with ISO 9001 quality requirements and lean Six Sigma practices.
  • Use 5 Why, Ishikawa diagrams, and gage R&R tools to identify defects on the shop floor.
  • Link findings to PFMEA and control-plan updates, track downtime metrics, and manage corrective actions in a single dashboard to reduce scrap and boost throughput.

Semiconductor

  • Embed DFMEA and IPC-guided failure analysis into wafer-level investigations.
  • Manage nonconforming lots, contamination events, and root causes with automated NCR generation and supplier corrective action workflows.
  • Maintain traceability for EHS incidents under ISO 14001 and IATF 16949, and integrate clean-room checks, SPC data capture, and RACI assignments to improve equipment effectiveness.

Environment & Safety

  • Streamline EHS incident management under ISO 14001 and ISO 45001.
  • Log near-misses, HAZOP findings and OSHA recordables, run root-cause analyses (5 Why, Ishikawa) and oversee RACI-driven corrective-action items on a unified problem management dashboard.

Additional Capabilities

Change Requests from Concerns

Initiate formal change requests directly from any identified concern, so updates and approvals happen without delay.

Child-Concern Tracking

Automatically generate child concerns linked to root causes, creating a clear chain from initial finding through corrective actions.

Inspection-Sheet Integration

Raise new concerns straight from your inspection sheets to capture issues at the moment they are detected.

BI Reporting & Dashboards

  • Live KPI Dashboards: View key metrics like open cases, resolution times, supplier response rates—in real time with drill-down charts and heat maps.
  • Custom Reports & Scheduling: Build tailored reports filtered by site, product line, date range, or issue type, then automate their delivery via email or push at your chosen cadence.
  • Threshold Alerts: Define metric thresholds (e.g., maximum open cases) and receive instant notifications when they’re crossed.
  • Mobile Access & Export: Access interactive dashboards on any device; export reports to PDF, Excel, or CSV, and share securely with role-based permissions.

Our problem solving software fits your rules, giving you one home for everything from containment to closure.

Why Choose Us

Omnex’s problem solving software brings key benefits in a simple, all-in-one package:

  • Full Method Set:
    Choose from 5Why, Fishbone, 5W2H, 8D, Advanced CAR or “Just-do-it” formats—every major problem solving tool is ready to use.
  • Standards-Ready:
    Built on CQI-20 and certified for ISO 9001, IATF 16949, AS9145, ISO 13485, ISO 14001, ISO 45001 and FSSC 22000.
  • Live Dashboard:
    A real-time problem management dashboard shows every case, metric and deadline in one view.
  • Supplier Collaboration:
    Let suppliers submit corrective actions, track replies in real time and drive issues to closure.
  • FMEA Linkage:
    Tie root-cause steps back to your FMEA so you spot gaps and prevent repeats.            
  • Custom Templates:
    Use 8D, CAR or your own form—set fields and workflows to fit each customer’s format.
  • Repeated NC Management:
    Identify patterns of recurring nonconformances, automatically flag repeat issues, and enforce corrective actions to stop them from happening again.
  • Aging Analysis:
    Track the age of open cases, highlight bottlenecks with aging reports, and prioritize resolution based on how long issues have been outstanding.
  • Nested Problems Management:
    Create parent-child relationships between concerns and sub-concerns, so you can visualize and tackle complex issues in a structured hierarchy.
  • Time & Paper Savings:
    Cut manual steps and paper use by 100%, so your team can focus on solving business problems.

These features make us your go-to problem management software, with everything needed to solve issues quickly and clearly.

FAQs

Using the software can be defined approaches for various types and scale of problems (e.g., current manufacturing issues, customer claims, audit findings, field failure, supplier issues, etc.)

There are different practical Problem-Solving Tools to address daily to complex issues, like 5 Whys, Fish-bone, 5W and 2Hs, Is – Is not analyze, 8D report.

Through the use of software, templates can be created and adapted exactly to the unique needs of the organization, far exceeding the capabilities of standard products.

Saving resources through improved efficiency or well-structured processes is what we aim for by using software. By resources, we mean all the things involved in the process to achieve the desired results.

The Problem Solving software is developed based on the CQI20 standard and is compliant with other standards such as ISO standards, IATF 16949, AS9145, etc.

Who We Work With

100,000+ globally has embraced Digitalization of Quality

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