Streamline Deviation Management with BizPortals QMS

What is Deviation Management?

A deviation in quality management refers to any instance where a process or operational workflow diverges from predefined standards or established procedures, impacting the quality, safety, or efficacy of the product or service.

An effective deviation management solution provides a systematic approach to identify, record, assess, and address deviations to minimize their implications. While digitizing and optimizing the deviation management workflow, it empowers organizations to determine the root causes and implement adequate corrective and preventive measures to avoid its recurrence.

Deviation Management Features in BizPortals QMS

BizPortals deviation management offers a centralized repository to store, access, and retrieve deviation requests. Leverage customizable metadata columns to get a complete summary including deviation status, description, related records, and priority.

From initiation to final closure, easily simplify the document routing for improved efficiency. Add automated reviews and approvals, set email notifications and reminders, and utilize digital signatures for various stages of the deviation management process.

Access an intuitive deviation dashboard to view key analytics and matrices in understandable charts and graph formats and apply custom categories like status, departments, risk, suppliers, and more for an in-depth trend analysis and informed decision-making.

Configure a personalized deviation handling process to reduce delays and improve overall efficiency. Create customizable forms and reporting templates to capture precise data, add custom fields and dropdowns, define permissions, and add predefined rules to automate the workflow.

Experience seamless deviation management with the cross-module integration feature offered by BizPortals QMS. Easily access deviation documents, assess potential risks, and collaborate on CAPA without leaving the deviation environment.

Ensure data integrity by controlling who can access, modify, review, or approve your deviation documentation. Add role-based permissions for stakeholders or define groups with specific permissions to facilitate effective collaboration and prevent unauthorized access.

Seamless Deviation Tracking
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A comprehensive solution to streamline business processes and manage all your documents, projects, tasks, and employees together in a secure workplace environment.
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Automated Approval and E-signature
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A comprehensive solution to streamline business processes and manage all your documents, projects, tasks, and employees together in a secure workplace environment.
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Customizable Dashboard
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A comprehensive solution to streamline business processes and manage all your documents, projects, tasks, and employees together in a secure workplace environment.
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Tailored Processes and Form Configurations
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A comprehensive solution to streamline business processes and manage all your documents, projects, tasks, and employees together in a secure workplace environment.
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Integrated Deviation Management
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A comprehensive solution to streamline business processes and manage all your documents, projects, tasks, and employees together in a secure workplace environment.
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Secure Permission Management
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A comprehensive solution to streamline business processes and manage all your documents, projects, tasks, and employees together in a secure workplace environment.
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Deviation Management Process Flow

1

Deviation Identification & Logging

A deviation is detected when any process, product, or service deviates from the predefined standards, often detected through routine inspections and audits or process observations. Ready templates for deviation reporting with customizable fields like deviation type, description, affected areas, and location to ensure a swift, accurate, and consistent reporting process.

2

Deviation Documentation

Once reported, the deviation forms must be stored in a centralized deviation log to facilitate quick retrieval and review of deviation records. It helps quality assurance teams track user action, thereby enhancing audit readiness. In the deviation library, users can manage access, automate workflows, set alerts, or even mark their favorites for enhanced efficiency.

3

Deviation Assessment

A thorough impact assessment is crucial for prioritizing deviations and outlining a clear action plan. A detailed assessment template with customizable fields for findings, impacted departments, comments, and attachments assists teams in navigating the assessment process. Users can automatically route deviation records to the designated approvers for consistent evaluation.

4

Root Cause Analysis

Identifying the underlying cause is essential to prevent the recurrence of the deviation. Thoroughly studying deviation records and analyzing visual reports and deviation history can help identify the pattern of recurring issues. Also, ensuring efficient cross-functional collaboration to facilitate communication, discuss findings, and recommend corrective actions can help prevent future issues.

5

CAPA Implementation

Outlining effective corrective and preventive actions based on the root cause analysis is necessary to address the deviation. A deviation management solution by digitizing CAPA implementation allows teams to easily track progress, monitor deadlines, generate detailed reports, and record CAPA details to ensure the process complies with the regulatory standards.

6

Review and Closure

Reviewing the effectiveness of the implemented CAPA and formally closing the deviation records is considered the final stage of the deviation management process. Ensure proper deviation records, capture detailed actions, and archive them for future reference and audits, contributing to ongoing process improvement and knowledge retention within the organization.

Deviation Management Process Flow

Deviation Identification & Logging

1

Deviation Documentation

2

Deviation Assessment

3

Root Cause Analysis

4

CAPA Implementation

5

Review and Closure

6 Importance of Deviation Management Solution in the Quality Management Process

Enhances Quality

Effective deviation management workflow addresses the root cause and facilitates effective CAPA implementation, which contributes to prompt resolution of issues, reduces their impact, and fosters continuous process improvement.

Strengthens Risk Management

A robust deviation management solution enables early detection of risks, allowing organizations to address them before they escalate. Its comprehensive analytics and reporting capabilities enable organizations to monitor trends, facilitating proactive risk management.

Accelerates CAPA

A collaborative platform for deviation management accelerates CAPA by simplifying task management, progress tracking, and automating the review and approval process, ensuring all steps are documented and aligned with the regulatory framework.

Boosts Organizational Resilience

With a robust deviation management solution, organizations can quickly respond to potential issues, ensure cross-functional collaboration, and create an audit trail, reducing overall downtime and minimizing their impact on quality operations.

Enhances Regulatory Compliance

The centralized platform offered by a deviation management solution not only consolidates your deviation-related documentation but also ensures the process is appropriately tracked, documented, and automated, reducing the risk of non-compliance.

Documentation and Traceability

Right from detecting issues to executing corrective and preventive actions, each stage is documented and records stakeholders’ actions, providing a clear audit trail for inspections.

Deviation Management Solution

What is Deviation Management?

Deviation Management Features in BizPortals QMS

Deviation Management Process Flow

1

Deviation Identification & Logging

2

Deviation Documentation

3

Deviation Assessment

4

Root Cause Analysis

5

CAPA Implementation

6

Review and Closure

Deviation Management Process Flow

Deviation Identification & Logging

1

Deviation Documentation

2

Deviation Assessment

3

Root Cause Analysis

4

CAPA Implementation

5

Review and Closure

6

Importance of Deviation Management Solution in the Quality Management Process

Enhances Quality

Strengthens Risk Management

Accelerates CAPA

Boosts Organizational Resilience

Enhances Regulatory Compliance

Documentation and Traceability

Other Dedicated Modules Offered by BizPortals QMS

Change Control

Document Control

Incident Management

CAPA Management

Form 1

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