QualityOne QMS Data Model

QualityOne QMS shares some common data model components with other QualityOne applications, which allows you to consolidate data for all of these applications in one (1) Vault. This is not a complete list of all QMS objects but provides some explanation of important core objects in the data model. All objects appear in all QualityOne Vaults, but some will be unused if the user’s Vault does not include all applications. Admins can generate a Vault Configuration Report to see all objects in the Vault.

Depending on your Vault’s configuration, object labels may appear differently than the labels mentioned in this article.

QMS Key Objects

This is not a complete list of all QMS objects but provides some explanation of some important objects in the data model. The following are some key shared objects within the QMS data model:

• Product: Contains all information regarding a product, including the product type, specification group, version information, and a reference to the Formulation object.
• Product Composition: A many-to-many self-reference to Product, contains the composition that makes up a product.
• Formulation: Contains the information regarding a formulation, including version information for the formulation.
• Formulation Composition: A many-to-many self-reference to Formulation, contains the composition that makes up a formula.
• Packaging: Contains the information regarding packaging, including the specification group and version information for the packaging.
• Packaging Composition: A many-to-many self-reference to Packaging, contains the composition that makes up a package.
• Product Packaging: Contains information regarding the product’s packaging.
• Product Batch: Contains information regarding the product’s manufacturing date, expiry date, and batch code.
• Material: Contains all the information regarding a material, product, formulation, and packaging.
• Product Group: Contains information regarding a categorized hierarchy of products using a self-referencing relationship.

CAR Management Key Objects

• CAR: Represents all corrective action request records.
  • CAR: This object type stores corrective action requests.
  • CAR 8D: This object type stores eight (8) discipline corrective action requests.
  • SCAR: This object type stores supplier corrective action requests.
• Material-CAR: Represents the join between Material and CAR.

Root Cause Analysis Key Objects

• Root Cause Analysis: Represents the root cause analysis.
  • 5 Whys Root Cause Analysis: This object type represents the 5 Whys analysis.
• Why: Represents individual Why items.
• Cause Category: Allows Admins to define a library of cause categories which users can assign to leaf Why items marked as Root Cause.
• Cause Sub-Category: Allows Admins to define a library of cause sub-categories which users can assign to leaf Why items marked as Root Cause.

Nonconformance Management Key Objects

• NCR: Represents nonconformances.
  • Process NCR: This object type represents process nonconformances.
  • Product NCR: This object type represents product nonconformances.
  • Supplier NCR: This object type represents supplier nonconformances (SNCR).
• Effectiveness Check: Represents effectiveness checks.
• Action Item: Represents action items.
• Investigation: Represents investigations.
• Root Cause: Represents root causes.
• Root Cause Analysis: Represents the root cause analysis.
• NCR-Risk Event: Represents the join between NCR and Risk Event.
• NCR Mobile Submission: Stores data from the native iOS application.
  • Purchase Order: This object type stores purchase order information.
  • Production Order: This object type stores production order information.
  • Process: This object type stores information about processes.
• Material-NCR: Represents the join between Material and NCR.

Continuous Improvement Initiative Key Objects

• CII: Represents the ongoing improvement process focused on enhancing the activities that generate the most value while removing waste activities.
• Material-CII: Represents the join between Material and CII.

Complaint Management Key Objects

• Complaint: Stores customer complaints and investigation results.
• Material-Complaint: Represents the join between Material and Complaint.

HACCP Management Key Objects

See Configuring HACCP Management for more details.

• HACCP Plan: Represents the food safety-related procedures of a Product.
  • HACCP Plan: This HACCP Plan object type represents the HACCP Plan for a manufacturer.
  • HACCP Plan Design: This HACCP Plan object type represents the HACCP Plan design template.
• HACCP Plan Process Step: Represents a process step in a HACCP Plan.
  • Process Step: This HACCP Plan Process Step object type represents a process step in a HACCP Plan.
  • Material Step: This HACCP Plan Process Step object type represents a process step in a HACCP Plan that introduces a material.
  • Logistics Step: This HACCP Plan Process Step object type represents a logistics process step in a HACCP Plan.
  • Connector: This HACCP Plan Process Step object type represents a connector process step in a HACCP Plan.
• HACCP Plan Ingredient: Represents an ingredient in a HACCP Plan.
• HACCP Plan Process Step Connection: Represents the connection between two (2) HACCP Plan Process Steps.
• Hazard: Represents the library of Hazards.
• CCP Library: Represents a collection of established critical limits for critical control points.
• Process Hazard Analysis: Stores analytical information of hazards and risks of a process step in a HACCP Plan.
• Ingredient Hazard Analysis: Stores analytical information of hazards and risks of an ingredient in a HACCP Plan.
• CCP-Hazard Analysis: Represents the critical limits compared against the Ingredient Hazard Analysis or Process Hazard Analysis.
  • Critical Control Point: This CCP-Hazard Analysis object type represents a hazard analysis associated with a critical control point.
  • OPRP: This CCP-Hazard Analysis object type represents a hazard analysis associated with an Operational Prerequisite Program (OPRP).
  • Preventive Action: This CCP-Hazard Analysis object type represents a hazard analysis associated with a preventive action.

Audit Checklists Key Objects

See Configuring Audit Checklists for more details.

• Audit: Represents audits.
  • Internal Audit: This object type stores internal audits.
  • Supplier Audit: This object type stores supplier audits.
• Audit Checklist: Represents a checklist used for audit purposes.
• Audit Checklist Assignment: Stores a record of an audit checklist template and an auditor user that is responsible for the audit checklist.
• Audit Dependency: Defines the dependencies on audit sections and questions.
• Audit Finding: Represents audit findings identified through the Audit Checklist and can also be added independent of the checklist response for a particular audit.
• Audit Response: Houses types of responses for an audit checklist such as date, multiple choice, number, and text.
• Audit Section: Houses types of sections for an audit checklist such as introduction and question sections.
• Checklist Design: Houses checklist templates to be used.
  • Internal Audit Checklist Design: This object type represents internal audit checklist templates.
  • Supplier Audit Checklist Design: This object type represents supplier audit checklist templates.

Material Verification Checklist Key Objects

See Configuring Material Verification Checklists for more details.

• Material Verification: Represents materials that require hazard control verification.
• Material: Represents materials.
• Hazard: Represents hazards.
• Material-Hazard: Represents the join between Material and Hazard.
• Material Category-Hazard: Represents the join of a Material’s Category picklist and Hazard.
• MV Response-Hazard: Represents the join between MV Response and Hazard.
• MV Checklist: Represents a checklist used for audit purposes of material verifications.
• MV Sub-checklist: Represents an aggregate checklist used for audit purposes of material verifications.
• MV Dependency: Defines the dependencies on material verification sections and questions.
• MV Response: Houses types of responses for a material verification checklist such as date, multiple choice, number, and text.
• MV Section: Houses types of sections for a material verification checklist such as introduction and question sections.

Audit Program Planning Key Objects

See Configuring Audit Program Planning for more details.

• Audit Program: Represents audit programs and their associated proposed audits where they are initiated, reviewed, and approved.
• Proposed Audit: Identifies the proposed audits that are planned as part of an audit program.
  • Supplier Audit: This object type represents external supplier proposed audits.
  • Internal Audit: This object type represents internal proposed audits.

Auditor Profile & Qualification Management Key Objects

See Configuring Auditor Profiles & Qualifications for more details.

• Auditor Profile: This object stores information about individual Auditors.
• Auditor Role: This object represents a role performed by an Auditor in an audit.
• Auditor Role Qualification Criteria: This object joins the Auditor Role and Role Qualification Criteria objects.
• Qualification to Complete: This object stores the required qualification criteria an Auditor must complete.
• Role Qualification Criteria: This object stores the criteria required to qualify for a role in an audit.
• Role Qualification Criteria Status: This object stores the completion status of the Role Qualification Criteria.
• Role Qualification Status: This object tracks an Auditor’s role qualification status.

Change Control Key Objects

• Change Control: Stores change requests to ensure that each proposed change is adequately defined, reviewed, and approved before implementation.
  • Engineering Change: This object type stores change requests made by engineering.
  • Supplier Change: This object type stores change requests made by suppliers.
• Material-Change Control: Represents the join between Material and Change Control.

Risk Management Key Objects

See Configuring Risk Management for more details.

• Risk Matrix: Stores the definition of risk based on severity and likelihood used to calculate risk level for a given context.
  • Risk Matrix–Qualitative: This object type represents qualitative risk matrix.
  • Risk Matrix–Quantitative: This object type represents quantitative risk matrix.
• Severity: Defines various levels of risk if it materializes in a given matrix.
• Likelihood (Occurrence): Defines the probability that a risk event will happen.
• Detectability: Defines the difficulty of noticing the issue.
• Risk Level: Defines the risk level based on a combination of Severity and Likelihood.
• Risk Registers: Houses records of risk ledgers that users can use to manage specific risk events and the actions they require with an identified context.
• Risk Assessment: Stores the assessment of a related and identified risk event.
• Risk Event: Defines the potential risk or opportunity that may occur and may require a mitigation activity to reduce the impact of the identified risk.
• Mitigation Action: Tracks mitigation actions that users must complete depending on the response to a risk event to reduce the risk to an acceptable level.
• Risk Study: Stores and performs risk analysis on risk study types such as P-FMEA.
• Risk Analysis: Stores the definition of a risk before and after mitigation for P-FMEA and Risk Matrix.
• FMEA Process Step: Stores the set of process steps to be identified with supporting information when used for P-FMEA risk studies.

Inspection Management Key Objects

See Inspection Management Overview for more details.

• Inspection: Stores data about inspections.
  • Incoming Inspection: This object type stores data about incoming inspections.
  • In-Process Inspection: This object type stores data about in-process inspections.
  • Outgoing Inspection: This object type stores data about outgoing inspections.
  • COA Inspection: This object type stores data about COA inspections.
• Inspection Plan: Stores inspection data and requirements.
• Inspection Plan Requirement: Stores the specifications to be used for a particular inspection plan.
• Inspection Sample: Stores sample data from the inspection.
• Inspection Sample Test Results: Stores inspection results for each sample.
  • Test Result Attribute Data: This object type stores information about test result attribute data.
  • Test Result Variable Data: This object type stores information about test result variable data.
• Attribute Test Result Variant: Stores information about attribute test result variants used to interpret COA data.
  • Attribute Variant: This object type stores information about attribute test result variations.
  • Verdict Variant: This object type stores information about verdict test result variations.
• Characteristic: Stores information about characteristics.
• Component Matching Variant: Stores information about matching variants.
  • Characteristic Matching Variant: This object type stores information about characteristic matching variants.
  • Unit Matching Variant: This object type stores information about unit matching variants.
• COA Header OCR Data: Stores data obtained from the OCR scan of the uploaded COA file.
• COA Test Results OCR Data: Stores test results obtained from the OCR scan of the uploaded COA file.
• COA Matching Rule: Stores a matching rule used to interpret COA data before creating records.
• COA Matching Rule Variant: Stores a matching rule variant used to interpret COA data before creating records.
• Master Specification Group: Centralizes all master specifications to be linked to multiple products.
• Master Specification: Stores the base requirements for an item.

Lab Investigations Key Objects

See Configuring Lab Investigations for more details.

• Lab Investigation: This object represents the Phase I and Phase II lab investigation of an out-of-specification or out-of-trend lab result.
• CAR - Lab Investigation: This object represents the join between Lab Investigation and CAR.
• Lab Investigation - Inspection: This object represents the join between Lab Investigation and Inspection.
• Material - Lab Investigation: This object represents the join between Lab Investigation and Material.
• NCR - Lab Investigation: This object represents the join between Lab Investigation and NCR.

Periodic Reviews Key Objects

See Periodic Reviews Overview for more details.

• Periodic Review Template: This object represents a periodic review template.
  • APQR: This object type represents an APQR type of periodic review.
  • SPR: This object type represents an SPR type of periodic review.
• Periodic Review Template Item: This object represents an item in a periodic review.
  • Document: This object type represents a document template item in a periodic review.
• APQR: This object represents an annual product quality review.
• APQR Item: This object represents an item that is part of an annual product quality review.
  • Document: This object type represents a supporting document in an APQR.
• SPR: This object represents a supplier periodic review.
• SPR Item: This object represents an item that is part of a supplier periodic review.
  • Document: This object type represents a supporting document in a supplier periodic review.