Challenges in practice
Deviations are documented in the various areas of your company and their causes are identified as far as possible. Whether deviations in the initial sampling process with your suppliers, errors in your SPC tests in the production area, or quality defects reported by your customers: the use of common error cause analyses is a prerequisite for a quick and systematic cause analysis.
In practice, however, media breaks, decentralized documentation, and inconsistent procedures make it difficult to achieve consistent transparency. Measures are often not followed up consistently, responsibilities are unclear, or their effectiveness is not sufficiently documented.
Your customers often require standard-compliant, traceable presentations of the associated risk analysis for the correction and preventive elimination of deviations, such as the 8D report. At the same time, auditors expect complete traceability from the error to the cause to the sustainable effectiveness test.
In the GxP environment in particular, special regulations and standards for handling error analyses in the form of CAPA (Corrective and Preventive Action) processes are essential for an effective correction and prevention system. Missing audit trails, insufficient documentation, or unclosed CAPAs pose a significant compliance risk here.
Solution QS1
Error analysis according to IATF 16949, CAPA according to ISO 13485, or FRACAS in the aerospace sector—QS1 provides you with the tools you need to efficiently identify errors in products, services, and processes, analyze them in a structured manner, and eliminate them permanently.
You can analyze the causes of actual errors that have occurred or potential deviations from internal audits, complaints, or your FMEA using common methods such as Ishikawa diagrams or the 5 Whys method. Standardized templates and guided workflows support a uniform, standards-compliant approach throughout the company.
The integrated action and workflow management system allows you to plan, control, and monitor your error analyses and CAPA processes across locations and departments. Clear role and rights concepts, escalation mechanisms, and automatic reminders ensure that actions are implemented and completed on time.
To verify the effectiveness of the measures and evaluate their success, you have access to functions for validating analysis processes, key figures, and reports, as well as—especially in regulated environments—digital signatures and audit trails for your “qualified person.”
By consistently linking deviations, causes, risks, and measures, QS1 creates full transparency, reduces repeat errors, and provides you with long-term support in meeting normative and customer-specific requirements.
- Error analysis/CAPAs, including root cause analysis with freely configurable action plans, even across multiple production stages
- Support for common root cause analysis methods such as Ishikawa, 5-Why, and structured problem-solving approaches (e.g., 8D)
- Workflow-based action management for coordinating responsible parties, deadlines, and escalations
- Complete overview of all error analyses/CAPAs, including status, deadline, and effectiveness tracking
- Integration of FMEA results for deriving preventive measures
- Standard-compliant forms (e.g., xD report, FRACAS, CAPA documentation)
- Integration into balanced scorecards and dashboards – on the client, intranet, and mobile devices
- Integration of ERP processes such as logistics processing, rework, and commercial processing
- Support for cost controlling and trend analyses for continuous improvement processes
Does this sound familiar?
- Deviations are documented, but the actual root cause analysis remains inconsistent: methods, depth, and quality of results vary greatly depending on the person, department, or location.
- 8D/xD reports are created “for the customer,” not as an internal control tool: a lot of effort, little lasting effect, unclear evidence of effectiveness.
- CAPA processes in regulated environments (e.g., GxP) create additional pressure: formal requirements, approvals, signatures, and complete traceability must be correct at all times.
- Measures are initiated but not consistently managed: deadlines slip, responsibilities are diffuse, status is not transparent, and escalations happen too late.
- The connection to risk and system logic is missing: deviations, FMEA, internal audits, and supplier/customer cases are handled separately, even though they should address the same cause patterns.
This should be achieved through a robust process
- Uniform CAPA standard across all sources: Actual errors, potential errors from audits, deviations from SPC/production, and customer and supplier cases must be processed according to the same logic.
- Systematic root cause analysis using established methods: Ishikawa, 5-Why, etc. are not “nice to have,” but must be managed and documented in a structured manner.
- Standards-compliant, audit-proof documentation: 8D/xD reports, risk analyses, decisions, and approvals must be traceable, versioned, and verifiable at all times.
- Workflow-based action control: Responsible parties, deadlines, escalations, status, and effectiveness checks must be mapped in the process.
- Secure internal and external communication: Customers/suppliers must be able to be integrated in a standards-compliant manner without media breaks or loss of control.
Coverage in QS1
- Provides standards-compliant error analysis and CAPA processes, including forms (e.g., xD reports) and consistent process logic across all sources of deviation.
- Performs root cause analysis methodically using integrated approaches such as Ishikawa and 5 Whys, so that “analysis” does not become a free-text exercise.
- Controls measures and deadlines via workflow-based measure management with clear responsibilities, status transparency, and escalation mechanisms.
- Enables effectiveness testing and success evaluation of measures, including validation of analysis processes and digital signatures (e.g., for “Qualified Person”) if required.
- Integrates relevant processes and stakeholders: standards-compliant communication with customers and suppliers via portal solutions, as well as integration into key figures/dashboards and cost controlling.
The result: Faster, more consistent error correction, fewer repeat errors, audit-proof CAPA evidence (even in regulated environments), transparent action management, and measurably higher effectiveness instead of merely “fulfilling reporting obligations.”
Your advantages
- Determine and communicate causes
- Standards-compliant processing and communication with your customers and suppliers via the QS1 portal solutions
- Fault analyses / CAPA's incl. root cause analysis with freely configurable action plans, if required across several production stages
- Complete overview of all defect analyses / CAPA's incl. status overview
- Integration into your balanced scorecards/dashboards, on the client, on the intranet, on mobile devices
- Different methods of root cause analysis such as Ishikawa and 5-Why
- Integration of FMEA
- Coordinate measures and deadlines via workflow-based measures management
- Standard-compliant forms (xD report, etc.)
- Cost controlling
- Online integration of the necessary ERP processes such as logistics processing, reworking, commercial processing
