Audit Management Overview (HSE, QMS)

Veeva QualityOne Audit Management allows you to manage internal and external audits. You can support internal and supplier audits by performing audit checklists to address requirements, conducting material verification checklists to control hazards, and validating audit program plans against the procedures you initiated. Audit Management helps your organization ensure processes are effective and appropriate.

Audit Management Objects

QualityOne provides the ability to manage audit details through the Audit object. Audit Management spans across multiple processes and uses the following objects and object types:

• Audit: This object represents audits.
  • Internal Audit: This Audit object type represents internal audits.
  • Supplier Audit: This Audit object type represents supplier audits.
• Audit Finding: This object represents audit findings identified through the Audit Checklist and can also be added independent of the checklist response for a particular audit.
• Auditor Profile: Stores information about Auditors and displays information about an auditor’s history and progress on qualifying for one (1) or various auditor roles.
• Material Verification: This object represents materials that require hazard control verification.
  • Verification by Material: This Material Verification object type represents the verification of a single material.
  • Verification by Material Category: This Material Verification object type represents the verification of a category and sub-category of a material.
• Material: This object represents material code such as raw material and finished material.
• Hazard: This object represents the library of hazards.
• Material-Hazards: This object represents the join between Material and Hazard.
• Material Category-Hazards: This object represents the join between Material Category and Hazard.
• MV Response-Hazard: This object represents the join between MV Response and Hazard.
• Audit Program: This object represents audit programs and their associated proposed audits where they’re initiated, reviewed, and approved.
• Proposed Audit: This object represents the proposed audits planned as part of an audit program plan.
  • Internal Audit: This Proposed Audit object type represents internal proposed audits.
  • Supplier Audit: This Proposed Audit object type represents external supplier proposed audits.

Audit Checklists

You can ensure your audits address the necessary requirements by using an audit checklist. Use audit checklists to conduct internal and supplier audits to help identify audit findings. You can create, edit, and delete audit checklists and automatically create audit findings when completing and submitting a checklist. If configured, you can also perform audit checklists on an Apple iPad and an Android device. See Working with Audit Checklists for more details.

Material Verification Checklists

You can ensure your audits address the necessary requirements for materials by using a material verification checklist. Use material verification checklists to collect internal and supplier responses for all the hazards that need to be controlled for a material. You can create, edit, and delete multiple material verification checklists as part of a single Audit. See Working with Material Verification Checklists for more details.

Audit Program Planning

You can initiate, plan, and approve audit programs for execution for a determined time period using an audit program. Use an audit program to plan your audits and compare the approved plan against what was accomplished by your organization. You can create, edit, and delete audit programs as part of your audit plans. See Working with Audit Programs for more details.

Auditor Profile & Qualification Management

You can identify which auditors at your organization are qualified for an auditor role using auditor profiles. Manage a pool of qualified auditors at your organization, create predefined roles with associated criteria for which auditors can qualify, manage the qualification criteria required for an auditor to perform a given role on various types of audits, and automatically assign auditors to team roles in an audit once they qualify. See Managing Auditor Profiles & Qualifications for more details.

External Collaboration Management

External Collaboration Management automates external user access to your Vault using a pool of shared External User licenses provisioned by creation, activation, and inactivation. You can assign an External Collaborator to respond to your request on a particular record and the External Collaborator is notified of the task by a corresponding email message. See Working with External Collaborators for more details.