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Overview

Today, organizations are under tremendous pressure to focus on quality. Among the essential elements of a well-established Quality Management System (QMS) is non-conformance management or deviation handling which plays a key role in product quality assurance and continuous improvement.

Non-conformances can be challenging to manage, particularly across the supply chain where communication with suppliers is not often streamlined. However, if the non-conformances are not identified and corrected in time, they could result in costly customer complaints, regulatory penalties, and product recalls.

An end-to-end non-conformance management application can help overcome these challenges by providing the ability to effectively capture the causes of non-conformances, and facilitate actions to prevent their recurrence.

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MetricStream Non-Conformance and CAPA Management App

The MetricStream Non-Conformance and Corrective Action/ Preventive Action (CAPA) Management App enables you to implement procedures to manage products, materials, or processes that do not conform to the desired specifications. The app supports non-conformance identification and evaluation, as well as segregation and disposition. It also enables root cause analysis and tracking, leading to the CAPA process.

The app standardizes non-conformance and CAPA processes across the enterprise. In addition, it helps conduct investigations, manage interim containment action, as well as long-term CAPAs, and verify the effectiveness of each CAPA.

Through the app, you can facilitate cross-functional teamwork on non-conformance and CAPA management. You can also view related metrics and trends in real time, and efficiently roll up data from across business units for timely reporting and analyses. The app supports organization-specific and industry-standard non-conformance management methodologies (8D, Six Sigma, 5-Why, DMAIC). In addition, it provides end-to-end exception and change management capabilities.

Why MetricStream Non-Conformance and CAPA Management App

The MetricStream Non-Conformance and CAPA Management App provides the following benefits:

  • Ability to Capture Non-Conformances from Different Sources

    The app helps capture non-conformances from processes, products, materials, factories, and suppliers. It also helps determine if these non-conformances are the result of customer complaints, audits, incoming material inspections, or simply routine testing and inspection activities.

  • Efficient Categorization of Non-Conformances and Definition of Severity Level

    Through the app, you can categorize non-conformances (according to pre-defined rules), and trigger automated workflows to resolve them in the stipulated time, based on their severity levels.

  • Standardized Review, Approval, and Disposition

    The app systematically routes each non-conformance for review, analysis, and approval to authorized users (based on pre-configured rules), thereby enabling a consistent approach to non-conformance management.

  • Automated Notifications and Alerts

    Automated notifications and alerts enable users to initiate immediate actions such as product containment or disposal, thus helping ensure that all non-conformances are addressed in a timely manner.

  • Streamlined Root Case Analysis and Cross-Functional Collaboration

    The app facilitates a root cause analysis of each non-conformance, and helps initiate immediate remedial action to contain its impact. It also enables cross-functional collaboration on investigations and root cause analysis.

  • Lower Cost of Poor Quality

    Through the app, you can avoid unnecessary quality costs by identifying high-risk non-conformances, and resolving them quickly within pre-defined risk thresholds.

  • Enhanced Compliance with Quality Standards and Regulations

    The app provides comprehensive information on internal quality, supplier quality, and customer quality, thereby enabling you to identify areas for compliance improvement. The app also generates reports and dashboards that can be shared with regulators and stakeholders.

  • Comprehensive, Real-Time View of Non-Conformances and CAPA Activities

    The app enables real-time tracking of CAPAs, right up to closure. It also provides a comprehensive view of the status of various non-conformances at each stage of resolution.

Initiating a Non-Conformance

Platform Highlights

The non-conformance and CAPA management app is built on the MetricStream GRC Platform, a robust and scalable infrastructure that provides the following core services and capabilities:

  • 1

    Extensibility to Other QMS Apps
    The platform provides the ability to integrate the non-conformance and CAPA management app with other MetricStream apps and solutions for supplier quality management, inspections management, audit management, and customer complaints management.

  • 2

    Configurable Templates and Best Practice Workflows
    The platform streamlines non-conformance and CAPA management processes, and triggers workflows based on best practices. It also provides configurable CAPA templates for various departments, business functions, and locations.

  • 3

    Automated Processes
    Using the platform, you can automate workflows across the non-conformance and CAPA management lifecycle - right from non-conformance identification, to corrective action.

  • 4

    Quality Intelligence and Analytics
    The platform supports both document-based and meta-data driven approaches to capture nonconformance data. It provides comprehensive quality intelligence and analytics to strengthen decision-making.

  • 5

    Ability to Identify Cost of Non-Conformances
    The platform provides the ability to capture internal failure costs, external failure costs, non-value added costs, and disruption costs as required by the CAPA team.

  • 6

    Trend Analysis
    Through the platform, you can link related non-conformances, and provide suggestions for corrective and preventive actions based on past data.

  • 7

    Support for Configurable Root Cause Analysis Methodologies
    The platform provides built-in templates to leverage different types of root cause analysis methodologies such as 5Why, Ishikawa, and DMAIC.

  • 8

    Ability to Integrate with Third-Party Software Applications
    The platform provides powerful adaptors or “Infolets” which integrate with systems for Enterprise Resource Planning (ERP), Product Lifecycle Management (PLM), and Manufacturing Operations Management (MOM) to gather relevant data for non-conformance management.

Risk-Based CAPA Management

Features

The MetricStream Non-Conformance and CAPA Management App provides the following functionalities:

  • Non-Conformance Management

    Through the app, you can efficiently record a non-conformance, and assign a unique case number to track it through various stages. The app captures detailed information about the non-conformance, and supports categorization based on pre-defined criteria, as well as the severity level of the non-conformance and the responsible department or supplier. The app also supports correlation of the non-conformance with past data, thereby enabling quick analysis and decision-making on the need for containment or corrective action. The non-conformance is then routed to authorized users based on pre-configured rules for review, approval, and disposition. A Risk Priority Number (RPN) can be assigned to the non-conformance, based on its severity, occurrence, and detection ranking. The RPN helps you prioritize the non-conformance, and initiate corrective action.

  • Containment Actions and CAPA Planning

    Based on the RPN, the app enables you to plan non-conformance containment actions and CAPAs, and assign tasks to the respective teams. There can be a number of non-conformances that need not be addressed unless they are vital to the business, or unless the frequency of occurrence is on the rise. The procedure for re-work, re-testing, and re-evaluation can be initiated after determining the severity level of the non-conformance. If the initial non-conformance screening exposes the need for immediate action or containment, the app triggers notifications to relevant stakeholders. It also enables the CAPA owner to chalk out a detailed CAPA plan. With an estimated completion date, the CAPA plan can be routed for review and approval to the quality or process manager. Tasks can then be assigned to the relevant owners for execution. In turn, the owners can execute the CAPA plan, monitor its progress, and evaluate the effectiveness of the CAPA over time.

  • Investigations and Root Cause Analysis

    The app enables you to act on non-conformances by facilitating thorough investigations, root cause analyses, and timely remedial actions. It also fosters cross-functional team-work and collaboration across internal teams and third parties (suppliers). The CAPA functionality supports configurable 8D process steps for problem solving (industry standard), as well as 5-Why or Ishikawa methodologies for root cause analysis. It also provides a set of templates for 5-Why and Ishikawa methodologies, along with instructions on how to use and fill the templates. The app gives you the flexibility to select the root cause analysis process for a non-conformance depending on its criticality. You can also choose the process steps based on the non-conformance category or severity.

  • Implementing CAPA

    The app supports the 8D methodology to implement corrective actions, and resolve non-conformances. The process steps can be configured based on your organizational needs, as well as the severity of the non-conformance. The 8D process has been adopted by the app to identify the team, define the problem, identify and implement containment action, determine root causes, prepare and implement the corrective action plan, verify its effectiveness, prevent recurrence of the non-conformance, and congratulate the team. The app provides process flows, specifically mapped to Corrective Action Requests (CARs), Supplier Corrective Action Requests (SCARs), and Preventive Action Requests (PARs). The workflow framework for all of these requests is similar with only some fundamental differences in the origin of the requests i.e. internal, supplier, or preventive.

    • CAR Process Flow

      • Report and Review CAR
      • Assign CAPA Owner/ CAPA team
      • Define Problem
      • Perform Interim Containment Action
      • Investigate and Determine Root Cause
      • Define Action items
      • Implement CAPA
      • Check CAPA Effectiveness
      • Prevent Recurrence

      The CAPA request can be captured by a CAPA initiator, or through integration with other third party systems for quality issue management, product testing, or factory inspections. The preliminary information can be provided by the CAPA initiator, and reviewed by the CAPA manager. If the CAR requires further information, the CAPA manager can push it back to the previous step, and request for additional details.

      The CAPA manager may either accept or reject a request based on the decision to perform a CAPA. If the CAPA manager rejects the request, the CAPA initiator gets a notification with the reason for the rejection. If a CAR is validated, the CAPA manager can accept and acknowledge the request, and assign a CAPA owner and team to the CAR. The CAPA owner can negotiate the due date with the CAPA manager, and is essentially the person-in-charge to oversee completion of all eight steps of the CAPA implementation.

      The app provides the flexibility to decide on the number of steps that need to be adopted while implementing the CAPA. Once the CAPA owner identifies the team members, they work towards defining the problem, and planning the CAPA based on assigned tasks and milestones. The app also triggers notifications to approve and move to the next step in the workflow. However, if an approval at any step is not defined, the next step will automatically be initiated. If a process or product affects a customer, immediate actions or containment actions can be initiated at any stage of the process.

      The CAPA owner is the initial approver within the system. Once he or she is satisfied with the implementation of the CAPA, it then moves to the final approver i.e. the CAPA manager who evaluates the effectiveness of the CAPA by assigning a quality manager to validate all the steps. A report is generated to determine if the steps are effective, or if they need to be re-performed. Based on the report, the CAPA manager can provide the final approval.

      The app also helps correlate previous CAPA requests to the current CAPA request.

    • SCAR Process Flow

      Through the app, the CAPA initiator reports a SCAR for a process or product. Alternatively, the app can automatically create a SCAR through integration with other third-party systems for inspections management, supplier quality audits and product testing. Based on the priority of the SCAR, the app automatically populates the due dates. The CAPA owner, on behalf of the supplier, can request for the due dates to be revised. Or, the SCAR manager may revise the due dates, if required.

      If the supplier is not registered in the app, the CAPA owner can assign an internal representative to work offline with the supplier. The supplier defines the problem, identifies and implements containment action, determines the root cause, and then implements corrective action.

      The SCAR goes through iterative processes of review and approval before the final approval. It is completed when approved by the CAPA manager. A notification is then sent to the CAPA initiator and other relevant stakeholders regarding the results and closure of the non-conformance.

    • PAR Process Flow

      The process flow followed for PAR is similar to that of CAR with one fundamental difference – the PAR adopts the Six Sigma DMAIC methodology (Define-Measure-Analyze-Improve-Control) for proactive planning and implementation of improvement projects. The PAR can be initiated for any issue or fault determined during ad-hoc inspections. It can also be used to improve a process.

  • Checking CAPA Effectiveness

    If the CAPA manager is not satisfied with any or all of the steps, or finds a discrepancy in the report, he or she can re-assign certain steps or tasks to the team for re-work. The team works towards preventing the recurrence of the issue, after which the final approval can be granted. However, even after the final approval, the CAPA manager has the flexibility to re-initiate the previous steps. Every CAPA has a status attached to it - Urgent (with a turnaround time of 21 days) or Standard (with a turnaround time of 45 days). The CAPA manager can trigger follow-up tasks by assigning a scheduled task to a particular assignee. The RPN identified during the initiation of the process and the value determined after the CAPA implementation can be compared to check the effectiveness of the CAPA. The CAPA manager provides the final approval to close the CAPA. Once the corrective action is implemented, a status notification on the non-conformance is sent to the CAPA initiator, along with the result. As a final step, if required, the CAPA manager can initiate further actions to prevent the recurrence of the non-conformance. The respective action owner is notified about the need to re-assess the non-conformance. He or she can verify if the issue has re-occurred or has been permanently resolved. Based on the findings, the CAPA process can be re-initiated or closed.

  • Reports and Metrics

    The app provides in-depth, real-time visibility into non-conformances, highlighting high-priority cases that need to be addressed quickly. A range of flexible reporting capabilities helps track the status and costs of non-conformances and CAPAs. Graphical executive dashboards with drill-down capabilities provide multiple statistics such as non-conformance severity, and the number of CAPAs by status, category, and priority. The app also makes each case traceable from any desktop in the organization, thereby helping ensure that non-conformance and CAPA management is a predictable and efficient process.

Problem-Solving Using the 8D Methodology

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