Veeva QualityOne Inspection Management allows you to process incoming, in-process, outgoing, and COA (Certificate of Analysis) inspections. You can plan material and inspection specifications, analyze inspection samples against the defined requirements, and review inspection results for quality control. You can also control and define which internal and external users can interact with your inspections.

To make the most of Inspection Management, organizations must define and set up all the prerequisite records and configurations to allow seamless quality control.

Inspection Management Objects

QualityOne provides the ability to manage details about inspections through a few core objects. Inspection Management spans across multiple processes and uses the following objects and object types:

  • Inspections: Stores data about inspections.
    • Incoming Inspection: This object type stores information about incoming inspections.
    • In-Process Inspection: This object type stores information about in-process inspections.
    • Outgoing Inspection: This object type stores information about outgoing inspections.
    • COA Inspection: This object type stores information about COA inspections.
  • Material: Stores product information related to product, formulation, and packaging.
  • Product: Stores item master data.
  • Purchase Order: Stores information to help track on-time delivery. Used by Incoming Inspections and COA Inspections.
  • Purchase Order Line Item: Stores information about purchase order line items. Used by Incoming Inspections and COA Inspections.
  • Production Order: Stores information about manufactured products. Used by In-Process Inspections and Outgoing Inspections.
  • Inspection Plan: Stores inspection plan data.
  • Inspection Plan Requirement: Stores the specifications to be used for a particular inspection plan. This includes the Attribute Specification and Variable Specification object types.
  • Master Specification Group: Centralizes all master specifications to be linked to multiple materials and products.
  • Master Specification:Stores the base requirements for an item. This includes the Attribute Specification and Variable Specification object types.
  • Inspection Sample: Stores sample data from an inspection.
  • Inspection Sample Test Results: Stores individual inspection results for each inspection sample. This includes the Test Result Attribute Data and Test Result Variable Data object types.

Control Charts

Inspection Management utilizes a plotted graph of inspection data on the Material object to assess if a material requires any corrections or improvements to its quality process. You can view data using key fields to build the visual results. See Viewing Control Charts for more details.

Analyzing Inspections

There are currently two (2) inspection groupings when working with the different inspection types. For all Inspection object types to function, organizations must set up prerequisite configurations. See Setting Up Inspections for more details.

Incoming, In-Process & Outgoing Inspections

Incoming, in-process, and outgoing inspections provide you with the ability to create sample records and analyzing samples against inspection plans. Sample records run against defined sample and success criteria using a fixed number or percentage of the total evaluation method. See Working with Incoming, In-Process & Outgoing Inspections for more details.

COA Inspections

COA (Certificate of Analysis) inspections provide you with the ability to analyze single or multi-batch COA files. COA uses an automated process to determine if the measurement values on the COA meet specification limits. You can view COA data values based on your local language setting for supported languages. External users can contribute to the COA Inspection record by replying to a workflow task email from Vault to upload a COA file to the COA Inspection record or by sending COA files to an Admin-specified Vault inbound email address. See Working with COA Inspections for more details.

Automated COA Email Intake

You can allow assigned External Collaborators to upload COA files to COA Inspection records by email. This feature removes the dependency of training external users to use Vault so that the external user can directly upload a COA file once it is ready to an existing COA Inspection record. External users can also upload multiple COA files by replying to a Vault email notification. The first valid file is attached to that COA Inspection record, and the subsequent files are attached to a new record each, copying the same field values as the initial COA Inspection record - Vault copies these new records in a similar approach to the Copy Record action. See Working with COA Inspections for more details.