CAPA/NCR

Automate the Corrective/Preventive Action Process with CEBOS’ Corrective Action Software (CAPA Software)

One detail that most successful businesses have in common is the ability to solve problems quickly and thoroughly in order to minimize the impact and prevent re-occurrences. All of the internationally-recognized standards for quality, safety and environmental management systems share common requirements for corrective and preventive actions. However, managing the process can be a daunting task.  Specifically, organizations often run into challenges such as:

• Utilization of manual-based systems with Word and Excel based forms which require manual routing and file management
• Inability to effectively manage the overall status of open items and pinpoint bottlenecks
• Data lists are not standardized resulting in a lack of credible data and hesitancy to take required action
• Cost of quality being very difficult to capture and analyze
• Running accurate reports across the entire organization in a timely manner
• Managing multiple customer formats and keeping up with constant report format changes

The CEBOS Corrective Action Software (CAPA Software) module enables best-in-class automation for any and all kinds of problems. The software is a completely closed-loop system that automates the entire problem-solving process. Users are able to configure the system for required problem solving methodologies (e.g., 8D, 5 Why, etc.) and are able to create the resulting output in any desired format. Best practices are supported by configurable checklist and user-defined templates that guide users through a very simple process, ensuring that critical data is captured.

Reporting is one touch away with textual drag and drop capability or configurable graphical reports with more than 15 different chart types to display. The bottom line is: CEBOS’ CAPA software ensures your organization complies with applicable standards while automating the process, which will save enormous amounts of inefficient time. Profitability will increase, as will customer satisfaction by having a systematic, consistent means to drive continuous improvement in product quality and reliability.

Benefits of CEBOS’ Corrective Action Software

• Ensures established disciplined problem solving and approval processes are followed, resulting in efficient and consistent systems for corrective action and preventive actions (CAPA).
• Completely automates the workflow required to complete any type of corrective actions, non-conformances or any problem type.
• Enables the user to define and implement many different problem solving methodologies, ensuring all different problem types (e.g., supplier, customer, warranty, safety, product, audit, non-conformance, etc.) can be managed as the user requires.
• With the CEBOS Supplier Portal, organizations can extend their problem solving workflows to the supply base allowing required tasks to be completed by suppliers on-line, reducing manual process inefficiencies and ensuring accountability with escalation notifications.
• Captures the true cost of quality so the management team may confidently allocate resources to solve the most important problems based on objective data.
• Generates extensive, configurable graphical analysis of all data (e.g., causal, symptom, cost, pareto, pie, trend, etc.) to assist company personnel in viewing and making informed decisions.
• Saves time by integrating E-mail functionality to quickly notify appropriate employees the status of corrective actions, preventative actions or non-conformance issues, making sure all action plans are under the surveillance of qualified employees.
• Increases customer satisfaction by facilitating the resolution of problems and quickly notifying the customer of intended or performed actions in a professional manner.
• Shares knowledge throughout the organization by maintaining an on-line knowledge base of lessons learned, minimizing the re-occurrence of previous problems.
• Ensures all quality requirements including: ISO 9000/9001, ISO 13485, ISO 14000/14001, ISO 14971, ISO 17025, ISO 22000, HACCP, TS 16949; TL 9000; AS 9100; cGxP, 21 CFR Part 11, QSR Title 21 Part 820, A2LA, OHSAS 18001, and many more are met or exceeded.

Features of CEBOS’ Corrective Action Software

• Focuses on high value added activities while the software performs, schedules and tracks all the time-consuming tasks involved in the corrective action process.
• Utilizes configurable reporting formats to conform to customer requirements.
• Preconfigured with the MedWatch form 3500.
• Tracks organization follow-up effectiveness on corrective and preventative actions by recording the trend, assigning the task to an individual (internal or external to the organization) and documenting the response.
• Captures information on all aspects of each problem-generating insightful customized trending analysis, helping organizations to achieve continuous improvement.
• Integrates the “Plan-Do-Check-Act” cycle throughout the organization, making sure problems are dealt with in a timely, systematical and standardized way.
• Resolves corrective actions by creating customized checklists supporting any problem solving approach (e.g., 8-D. 5 Why, etc.).
• Complete configurable electronic workflow routing for review, approval and distribution.
• Comprehensive linkage to failure modes in the APQP module allows for in-depth analysis and adjustment.
• Full functionality for the control of non-conforming material including: user configured non-conformance workflow, notification to the affected supplier requiring disposition, email to the supplier with a link to an on-line portal (MQ1 Supplier Portal Module) for the supplier to complete required tasks (e.g., containment, etc.), escalation through email if tasks are not completed timely.
• User definable graphical internal and supplier scorecards including: Part Per Million Defective (including per supplier), On-Time Delivery (including per supplier), timeliness of corrective action and non-conformance completion, casual/symptom code Paretos and many more.