QualityOne QMS Overview

QualityOne QMS (Quality Management System) is an application that manages and automates global quality processes across an organization and its external partners. QMS aids in defining and improving processes for deviations, internal and external audits, complaints, nonconformances, change controls, CARs, SCAR, risks, inspections, and proactive management initiatives. Additionally, you can address food safety needs through the Hazard Analysis and Critical Control Points (HACCP) and the Foreign Supplier Verification Program (FSVP). The QMS solution also offers complementary mobile applications to supplement the full Vault application to log nonconformances and to perform audit checklists.

QualityOne QMS is part of the Veeva QualityOne family of applications. With a single Vault, your organization can have one (1), two (2), or all of these applications.

Features

QualityOne QMS is built on Vault and includes the features described in Vault Help for Platform. In addition, it provides the following features:

  • Supplier Management: QualityOne QMS enables internal and external organizations to work together through supplier certifications, audits, and performance monitoring in the same solution by:
    • Providing suppliers with a portal to use to collaborate with buyers when participating in the QMS process by reviewing and updating nonconformance details.
    • Enabling organizations to communicate and collaborate between internal staff and suppliers on records by using comments. User mentions help to define specific users to comment on a record to efficiently collaborate with mentioned individuals only.
    • Auto-managing the creation, activation, and inactivation of requested external user accounts for quality collaboration using External Collaboration Management.
    • Tracking and managing the full continuum of internal and external auditing in an Audit Checklist. Use audit checklists to conduct internal and supplier audits to help identify audit findings.
    • Utilizing the complementary mobile application to respond to audit checklists authored in Vault. This application supports offline mode.
    • Preparing and completing Material Verification Checklists by the Audit team for materials that require hazard control verification.
    • Allowing assigned users and External Collaborators to upload COA files to COA Inspection records by email, removing the dependency to train certain users to use Vault. External parties, such as suppliers, can also upload COA files, unprompted by Vault, by emailing to a Admin-specified Vault email address. If configured, you may also upload or email multi-batch COA files.
  • CAR Management: QualityOne QMS provides management of the corrective action process. Such actions originate with nonconformances, customer complaints, audit findings, and other quality-related events. The solution supports the complete corrective action process from problem identification, investigation, and root cause analysis using 5 Whys problem-solving methodology, to action planning, implementing the action plan, and ultimately verifying the effectiveness of the CAR before closure by:
    • Identifying the root cause of a problem using a cause-and-effect technique. Root Cause Analysis uses diagrams to perform the investigation by answering the question “Why?” to analyze each reason until the root cause is identified.
  • Nonconformance Management: QualityOne QMS enables organizations to more effectively manage nonconformances. The ability to easily execute an investigation and root cause analysis ensures that companies are on top of their quality and compliance requirements. Nonconformances are defined as a departure from implied or explicit requirements resulting in non-conforming material or processes. These have the potential to impact product quality, safety, or customer satisfaction. This is done by:
    • Utilizing the complementary mobile application to log nonconformances against Purchase Orders, Production Orders, or Processes. Users can also capture and attach photo evidence of the nonconformance. This application supports offline mode.
    • Identifying the root cause of a problem using a cause-and-effect technique. Root Cause Analysis uses diagrams to perform the investigation by answering the question “Why?” to analyze each reason until the root cause is identified.
    • Conducting risk assessments with visibility into the organization’s risk trends and statistics.
  • Complaint Management: QualityOne QMS enables organizations to manage customer complaints and implement actions to reduce recurrence, including the ability to assign action items based on investigation results.
  • Food Safety: QualityOne QMS allows your organization to configure multiple procedures to identify, prioritize, mitigate, and prevent physical, chemical, and biological risks and hazards within food safety standards. This is done by:
    • Using HACCP as a methodology to ensure that food is manufactured, processed, packaged, and stored in sanitary conditions to prevent post-process contamination in order to ensure that the food is safe, wholesome, and without visible quality deterioration. HACCP Management allows organizations to allocate their resources efficiently by establishing and auditing safe food production practices.
    • Using the HACCP Flow Diagram to verify HACCP plans and perform hazard analysis.
    • Preparing and completing Material Verification Checklists by the Audit team for materials that require hazard control verification.
  • Audit Management: QualityOne QMS allows organizations to perform systematic examinations of various processes and productions of the organization to ensure that requirements are met by:
    • Tracking and managing the full continuum of internal and external auditing in an audit checklist. Users can schedule and plan audits, store pertinent artifacts, issue audit findings and subsequent management of corrective actions, and allow external organizations to respond directly to audit findings.
    • Utilizing the complementary mobile application to respond to audit checklists authored in Vault. This application supports offline mode.
    • Preparing and completing Material Verification Checklists by the Audit team for materials that require hazard control verification.
    • Initiating, planning, and approving audit programs for execution for a determined time period. Users can scope audit programs and execute proposed and unplanned audits against the audit program plan that ensures the organization is in conformance with management system policies and objectives.
    • Managing the process of identifying which personnel are authorized to perform specific roles on an audit. Users can capture key demographic information about auditors, define auditor roles, manage the qualifications for an auditor to perform a given role on various types of audits, and automatically assign qualified auditors to team roles in an audit.
    • Auto-managing the creation, activation, and inactivation of requested external user accounts for quality collaboration using External Collaboration Management.
  • Change Control: QualityOne QMS effectively manages all product and process changes. QualityOne engages all of the relevant parties in the change process including external suppliers and partners as required. This is done by capturing change requests from across the business, engaging the right subject matter experts in impact assessment, following all review and approval before and after change execution, and tracking all implementation actions including seamless linkage to documents that require updates.
  • Risk Management: QualityOne QMS manages the risk associated with enterprise and operational processes in your Vault using risk matrices, risk registers, risk events, and risk studies. Risk Management supports capturing and performing risk studies such as P-FMEA (Process Failure Modes and Effects Analysis). P-FMEA is a risk study that identifies and analyzes potential process failure modes and their causes and effects on business processes.
  • Inspection Management: QualityOne QMS allows organizations to process incoming, in-process, outgoing, and COA (Certificate of Analysis) inspections. Inspection Management supports creating sample records, analyzing samples against inspection plans, and analyzing COA files, including those emailed by external users. Sample records run against defined sample and success criteria using a fixed number or percentage of the total evaluation method, and COA uses an automated process to determine if the measurement values on the COA meet specification limits. Organizations can use Control Charts to visualize related Inspection Management data when assessing whether a material quality and manufacturing process needs additional action for improvement. COA Inspections allows users and External Collaborators to upload COA files to COA Inspection records by email, removing the dependency to train certain users to use Vault. External parties, such as suppliers, can also upload COA files, unprompted by Vault, by emailing to an Admin-specified Vault email address. If configured, you may also upload or email multi-batch COA files.
  • Lab Investigations: QualityOne QMS allows organizations to perform lab investigations for out-of-specification (OOS) and out-of-trend (OOT) inspection sample test results. This feature allows you to document, standardize, and track the process of performing Phase I and Phase II lab investigations and add information to investigations about the initial lab test result, the root cause, risk assessment items, corrective actions, and more.
  • Periodic Reviews: QualityOne QMS allows organizations to perform periodic reviews of a product, supplier, or quality process by enabling users to store and access different types of information in a single place, providing user-friendly templates, and automating binder creation and document generation.
    • Annual Product Quality Review: QualityOne QMS allows organizations to perform an annual evaluation of the quality standard of a product to determine the need for adjustments in product specifications, manufacturing, and control procedures.
    • Supplier Periodic Review: QualityOne QMS allows organizations to conduct regular evaluations of the performance of a supplier’s services.
  • Application Security: QualityOne QMS allows organizations to use the Raw object data store option as support for the growing volume of object records while maintaining Vault performance. Using this data store option, Admins must define record-level security for the object as this data store option cannot be defined by DAC. Admins can define record-level security for these objects by utilizing the Application Security feature.

Data Model

QMS shares some common data model components with other QualityOne applications, which allows you to consolidate data for all of these applications in a single Vault. See QualityOne QMS Data Model for more details.

Learn more about using the QualityOne QMS application in these articles:

Admin Articles

Learn about configuring the QMS application in these articles: