Who is this for?
Managers / Admins - configuring the Observation Inbox, Quality Event types, and CAPA types
How to do it
Configuration determines who can investigate Observations and how each Quality Event type behaves. You also learn how to configure how the CAPA document type and each CAPA type behave. Configure these settings in organization Settings before the Events module is in use.
Observation Inbox
Observation Inbox Owners are the users and groups who can investigate Observations and escalate them to Quality Events. They are assigned as Owner on newly created Observations.
Open Settings and select Observations.
In Observation Inbox Owners, add or remove the required users or groups, then select Save.
Observation Settings and the Observation Inbox Owners configuration.
šNote: For every observation created all users will be added for the initial investigation and the first person to pick it up can handle it.
šNote: If a user is assigned later in the process, they will only get access to evaluate the observations which were created after they were assigned to become an Observation Inbox Owner.
š”Tip: Use user groups for easier management of Observation Inbox Owners. Newly added members to groups get access to evaluate observations that were created before they were assigned, as opposed to when an individual user is assigned.
Quality Event Types
Quality Event types control ID numbering, the default template, Vigilance Reporting, Owners, Allowed Creators, due date requirements and custom fields.
š” Tip: SimplerQMS now provides standard Quality Event Types by default: Complaint, Nonconformance/Deviation, Audit Finding, and Supplier Issue.
You can use these types as-is or customize them to fit your needs, rather than building each type from scratch. You can also add your own Quality Event Types when needed.
Type list and creation
Open Settings and select Quality Event types. The list displays the Name, Quality Event ID Pattern, sequence scope and the configured setting badges (for example Requires Due Date and Requires Vigilance Reporting).
To create a type, select + New Quality Event Type, enter the Name and select Save. To update a type, open it from the list.
The Quality Event Types list and configuration badges.
Basic information, template and ID numbering
In ID numbering sequence, select the required option, set Number formatting as required, then enter the Document ID Pattern and check the ID Preview.
Select the Default Template (for example the Master Word Template) used when a Quality Event of this type is created.
ID numbering
Field name | Description | Note |
Global sequence | All documents share a single numbering sequence across the organization. |
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Local sequences | The numbering sequence applies only to the selected Quality Event type. |
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Document ID Pattern | The pattern used to generate the Quality Event ID. | An ID Preview is displayed as the pattern is entered. |
Pad number with leading zeros | Pads the generated number to a fixed length. |
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Vigilance reporting, Owners and Allowed Creators
Set Quality event creation to On so users can create events of this type.
Set Enable vigilance reporting to On when reportability must be captured for all events of this type.
In Owners, assign the users or groups responsible for assessing Quality Events of this type. On all Quality events of this type the full list of owners will always be added.
You can restrict who is allowed to create a Quality Event of this type by assigning Allowed Creators. If none are specified, anyone with access to the Quality Events module can create the event.
Quality event creation, Enable vigilance reporting and Owners settings.
Due date and custom fields
Under Requires Due Date, select the applicable option.
Under Custom Fields, add fields for information not covered by the standard properties, then select Save.
Custom field settings
Setting | Description | Note |
Label | The field name shown on the Quality Event (for example Severity or Submission Date). |
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Data type | The field type, for example Multiple Choice (with options such as Minor; Major) or Date & Time. |
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Required | When enabled, the field must be completed before the Quality Event details changes can be saved. | A required custom field gates those transitions. |
Due date options and a required custom field.
CAPA Document Type
Open Settings ā Document Types and select Corrective and Preventive Action. Review the settings and select Save if changes are made.
CAPA Document Type settings
Setting | Description | Note |
ID Numbering Strategy | How CAPA IDs are sequenced. |
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Entity ID Pattern | The pattern used to generate the CAPA ID. |
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Number formatting | Optional padding of the generated number. |
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Classified access | The access model for the document type. |
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Enable document creation | Allows users to create documents of this type. |
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Requires Due Date | Whether a due date is required. | Required is recommended for CAPA. |
Requires periodic review | Whether periodic review applies. | Not recommended to enable for CAPA. |
š”Tip: It is recommended to set Requires Due Date on the CAPA document type and leave periodic review off. A CAPA is a one-time record, not a document you re-review on a cycle.
Under Custom Fields, add fields for information not covered by the standard properties, then select Save.
Custom field settings
Setting | Description | Note |
Label | The field name shown on the CAPA. |
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Data type | The field type, for example Multiple Choice (with options such as Minor; Major) or Date & Time. |
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Required | When enabled, the field must be completed before the CAPA details changes can be saved. |
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CAPA Types
CAPA types determine the template, the review and approval steps in each phase, and the effectiveness check.
š” Tip: Default CAPA Types are provided out of the box as Major and Minor. Use them as a starting point or add your own.
Open Settings and select CAPA types. To create a type, select + Add CAPA type; to update a type, open it from the list.
Enter the Name and Description, and select a Template.
You can configure multiple CAPA templates in your organization, each corresponding to a CAPA type.
Under Planning phase and Execution phase, set Include review and Include approval as required.
Under Assess effectiveness, set the toggle to On to schedule an effectiveness check after the CAPA is closed, then enter the Duration and Unit (for example 30 Days) which determines when the CAPA Effectiveness Assessment is due. Select Save.
Configuring a CAPA type.
CAPA type configuration
Setting | Description | Note |
Planning phase - Include review | Requires a review step before the plan is finalized. | Optional |
Planning phase - Include approval | Requires an approval step before the plan is finalized. | Optional |
Execution phase - Include review | Requires a review step before execution is closed. | Optional |
Execution phase - Include approval | Requires an approval step before execution is closed. | Optional |
Assess effectiveness | Schedules an effectiveness check after the CAPA is closed. | On/Off. When On, set Duration and Unit (for example 30 Days). |
āTo remain compliant, effectiveness assessment of a CAPA is required. Ensure that if the system setting is off, you have a different way of handling the check outside of the normal workflow. This could be done with a separate Quality Document that gets linked to the CAPA. To set a reminder for completion, initiate a To-Do from your My Work tab.
āConfiguration is what makes the workflow enforce your process. Align these with your approved SOPs before go-live, and manage later changes to configuration under change control.
š”Tip: Make key custom fields (such as Severity) Required so they gate transitions thus enforcing data completeness before a record can move forward.
š”Tip: Match each CAPA type's review/approval steps and effectiveness due period to the risk it covers. A Major CAPA type should carry more controls than a Minor one
š”Tip: Restrict Allowed Creators for sensitive Quality Event types so creation stays controlled to the right roles.