# Manage PSMF Periodic Reviews SafetyDocs supports scheduling automatic reviews of PSMF documents and binders to ensure they are regularly updated, providing an efficient way of ensuring that your PSMF is always compliant and up-to-date. Regularly reviewing and updating PSMF content is essential for continued compliance with regulatory requirements, and is also aligned with the PSMF's purpose as a living document. ## Prerequisites To use this feature, your Admin must enable the following: * To use PSMF periodic reviews, your Admin must enable PSMF Periodic Reviews. * To assign PSMF review tasks to multiple reviewers, your Admin must enable Support Multiple Reviewers During PSMF Periodic Review. * To track PSMF requests, your Admin must enable PSMF Request Management. ## PSMF Periodic Review Process {#psmf-periodic-review-process} The following points outline the PSMF periodic review process: 1. Your Admin completes a one-time setup of the _PSMF Periodic Review_ job. This job reviews PSMF documents and binders every month on the scheduled date and time. 2. Each time the _PSMF Periodic Review_ job runs, Vault: 1. Detects documents and binders that are due for review based on the following criteria[¹][1] - The document or binder is classified under the [_PSMF Content_ or _PSMF Binder_ document subtype][2] - The document or binder is in a steady state type, such as _Approved_ - The document or binder's _Next Review Date_ is in the current or prior month - The document or binder has a _Review Frequency_ value 2. Creates a [_PSMF Periodic Review_ record][4] 3. Adds each detected document or binder as a [_PSMF Document Review_ record][6] on the _PSMF Periodic Review_ 4. For each _PSMF Document Review_, sends a notification and [assigns a review task][8] to the [appropriate reviewers][6] 3. The assigned users complete their review for the associated document or binder, selecting a review outcome and updating content as required. In addition to the records and tasks created by Vault as part of the _PSMF Periodic Review_ job: * You can manually create ad-hoc [_PSMF Periodic Reviews_][4] and [_PSMF Document Reviews_][6] to trigger document or binder reviews on an as-needed basis. For example, if an inspection is coming up, you can create an ad-hoc _PSMF Periodic Review_ to review any related documents. * Vault can create ad-hoc _PSMF Periodic Reviews_ and _PSMF Document Reviews_ from a _PSMF Request_, allowing you to track and respond to PSMF-related inquiries from health authorities or partners.

Note: 1. If your Admin has enabled Automatic Generation of PSMF Documents from Vault Reports, Vault additionally includes any documents classified as PSMF Generated Reports that have a Report Generation Type value of Periodic. Each time the PSMF Periodic Review job runs, Vault generates a new version of the document from its associated report, adds it as a PSMF Document Review on the PSMF Periodic Review, and assigns review tasks to the appropriate reviewers. Such documents are reviewed every month, regardless of their Last Review Date.

## Include PSMF Documents and Binders in Periodic Reviews {#include-in-reviews} To include a PSMF document or binder in periodic reviews: 1. Upload the document to your library. 2. Classify it using a _PSMF Content_ or _PSMF Binder_ subtype. 3. Populate the applicable [fields][3]. 4. Optional: To allow Vault to generate [_PSMF Document Reviews_][6] for multiple reviewers, add users or groups to the document's _Sharing Settings_ panel. Assign users the **PSMF Periodic Review SME** role. When considering documents and binders for periodic review, Vault includes steady state documents with a [_Next Review Date_][9] in the current or prior month. ### PSMF Document and Binder Fields {#psmf-document-fields} The following fields may be available:

Field	Description
PSMF Section	For PSMF Core Documents and PSMF Annex documents, select a PSMF section from the picklist. If your Admin has enabled Order PSMF Logbook by Section/Annex, Vault uses this value to determine the order of entries in the PSMF Logbook document.
Last Review Date	Manually enter the date the document or binder was last reviewed, or use the calendar to select the date. For documents or binders captured as part of the PSMF Periodic Review job, Vault populates the current date when: The document or binder is moved to a steady state type, such as Approved A review task is completed for the associated PSMF Document Review with a Review Outcome of No changes needed Note: PSMF Generated Reports with a Report Generation Type value of Periodic are considered eligible for review every month, regardless of their Last Review Date.
Review Frequency	Select the frequency at which the document or binder should be reviewed. This field must contain a value to be included in periodic reviews.
Next Review Date	Manually enter the date the document or binder should be reviewed next, or use the calendar to select the date. For documents or binders captured as part of the PSMF Periodic Review job, Vault populates this field by calculating the Last Review Date plus the amount of time dictated by the Review Frequency. If the Review Frequency is blank, Vault leaves this field blank. For PSMF Binders, Vault clears this field when the binder moves to the Obsolete state.

## Create a PSMF Periodic Review {#create-psmf-periodic-review} Every time the _PSMF Periodic Review_ job runs, Vault creates a _PSMF Periodic Review_. If needed, you can manually create an ad-hoc _PSMF Periodic Review_ outside of the scheduled job: 1. Navigate to **PSMF > Periodic Document Reviews**. 2. Select **Create**. 3. Complete the applicable [fields][5], then select **Save**. Once you have saved the _PSMF Periodic Review_, you can [add _PSMF Document Reviews_][6] for each document and binder you want to review. Depending on your Admin's configuration, _PSMF Periodic Reviews_ may contain a _PSMF Request_ section. Vault populates this section with any related _PSMF Requests_, allowing you to access relevant PSMF requests as needed. ### PSMF Periodic Review Fields {#psmf-periodic-review-fields} The following fields may be available:

Field	Description
Review Type	Select Periodic or Ad-Hoc. For reviews created as a result of the PSMF Periodic Review job, Vault populates Periodic. For reviews created from a PSMF Request, Vault populates Ad-Hoc.
Due Date	Enter the date by which all the document and binder reviews within this review should be completed, or use the calendar to select the date. For reviews created as a result of the PSMF Periodic Review job, Vault populates the last Friday of the current month. For reviews created from a PSMF Request, Vault populates the Due Date from the PSMF Request.
Description	Enter a description for the periodic review. For reviews created as a result of the PSMF Periodic Review job, Vault populates this field.

Field

Description

Review Type

Select Periodic or Ad-Hoc. For reviews created as a result of the PSMF Periodic Review job, Vault populates Periodic. For reviews created from a PSMF Request, Vault populates Ad-Hoc.

Due Date

Enter the date by which all the document and binder reviews within this review should be completed, or use the calendar to select the date.

For reviews created as a result of the PSMF Periodic Review job, Vault populates the last Friday of the current month. For reviews created from a PSMF Request, Vault populates the Due Date from the PSMF Request.

Description

Enter a description for the periodic review. For reviews created as a result of the PSMF Periodic Review job, Vault populates this field.

## Create a PSMF Document Review {#create-psmf-document-review} Every time the _PSMF Periodic Review_ job runs, Vault adds _PSMF Document Review_ user tasks to the _PSMF Periodic Review_ for every document and binder that is detected for review. Depending on your Admin's configuration, Vault creates either: * A single _PSMF Document Review_ for each document or binder, assigned to the document or binder _Owner_ * Multiple _PSMF Document Reviews_ for each document or binder, including one for the document or binder _Owner_ and one for each user with the _PSMF Periodic Review SME_ role on the document or binder Similar to _PSMF Periodic Reviews_, you can manually create _PSMF Document Reviews_ outside of the scheduled job, as needed: 1. Navigate to **PSMF > Periodic Document Reviews**. 2. Select the relevant _PSMF Periodic Review_. 3. Expand the **Document Review Tasks** section, then select **Create**. 4. Complete the applicable [fields][7], then select **Save**. Once you have saved the _PSMF Document Review_, Vault sends notifications and assigns [review tasks][8] to the appropriate users, as identified in either the _Assigned To_ or _Generate Tasks for All Reviewers_ field. ### PSMF Document Review Fields {#psmf-document-review-fields} The following fields may be available:

Field	Description
Document to Review	Select the relevant document from the picklist or select the Advanced Search () icon to use filters and refine your search. For document reviews created as a result of the PSMF Periodic Review job, Vault populates the relevant document. For reviews created from a PSMF Request, Vault populates the document from the PSMF Request.
Version	Vault populates the latest version of the document to be reviewed. To change this selection, select a different version from the picklist. For reviews created from a PSMF Request, Vault populates the Version from the PSMF Request.
Due Date	Enter the date by which this document should be reviewed and approved. Use the calendar to select the date or enter the date manually. For reviews created from a PSMF Request, Vault populates the Due Date from the PSMF Request.
Review Outcome	Once the document has been reviewed, select the appropriate outcome.
Review Rationale	Once the document has been reviewed, enter additional details explaining the review outcome.
Generate Tasks for All Reviewers	Select this checkbox to generate a review task for the document or binder Owner, as well as each user with the PSMF Periodic Review SME role for the document. Alternatively, clear this checkbox to assign a review task to a single reviewer by specifying an Assigned To value. For reviews created from a PSMF Request, Vault determines whether to select this checkbox based on your Admin's configuration.
Assigned To	Select the user to whom the review task should be assigned. For document reviews created as a result of the PSMF Periodic Review job or from a PSMF Request, Vault populates the document Owner when only a single PSMF Document Review exists for the document.
Periodic Review	Vault populates the PSMF Periodic Review in which this review task was created.

## Review a PSMF Document {#review} When a [_PSMF Document Review_][6] is created, Vault assigns it to the selected reviewer as a task so they can review and approve it. For documents with a single reviewer¹, selecting a _Review Outcome_ for a _PSMF Document Review_ then moving the record to a _Complete_ state triggers a series of object record and document updates, depending on the selected outcome: * [_No changes needed_][10] * [_Minor changes needed_ or _Major changes needed_][11] * [_Unable to review_][12]

Note: 1. For documents with multiple reviewers, to ensure your PSMF documents receive timely and appropriate editing, Vault uses the following logic to determine which series of updates to trigger:

When any reviewer selects a Minor changes needed or Major changes needed outcome, Vault handles the document using the Minor changes needed or Major changes needed outcome flow
If all reviewers select either No changes needed or Unable to review outcomes, Vault handles the document using the No changes needed outcome flow

To complete a _PSMF Document Review_ task: 1. Navigate to the _PSMF Document Review_ task. 2. Select the **Document to Review** to open the document or binder and review its contents. Once complete, navigate back to the _PSMF Document Review_. 3. Select **Edit**. 4. Expand the **Review** section and select the relevant _Review Outcome_. Add any comments in the **Review Rationale** field as needed. 5. Select **Save**. 6. Update the lifecycle state of the _PSMF Document Review_ to **Complete**.

Note: For PSMF Generated Reports, the only applicable outcome is No changes needed. Selecting any other outcome will result in an error. If you encounter issues with this step, ensure that the report from which you are generating the document is correct, and then manually generate the document before completing the review task.

### No Changes Needed {#no-changes-needed} Depending on your Admin's configuration, when a reviewer selects a _Review Outcome_ of _No changes needed_ and moves the _PSMF Document Review_ to the _Complete_ state, Vault updates: * The document's _Last Review Date_ to the current date. * The document's _Next Review Date_ to the _Last Review Date_ plus the amount of time dictated by the _Review Frequency_. If the _Review Frequency_ is blank, Vault leaves this field blank. The document's lifecycle state remains unchanged. #### Multiple Reviewer Logic If the _PSMF Periodic Review_ includes multiple _PSMF Document Reviews_ for the same document, when the last _PSMF Document Review_ for the document is complete: * If all _PSMF Document Reviews_ have _No changes needed_ outcomes, Vault handles the document using the _No changes needed_ outcome flow. * If the _PSMF Document Reviews_ have a combination of outcomes, Vault [determines which outcome flow to follow][13]. ### Minor Changes Needed or Major Changes Needed {#changes-needed} Depending on your Admin's configuration, when a reviewer selects a _Review Outcome_ of _Minor changes needed_ or _Major changes needed_ then moves the _PSMF Document Review_ to the _Complete_ state, Vault: * Creates a new minor version of the document or binder so that changes can be drafted * Adds a new _PSMF Logbook Entry_ for any non\-_PSMF Binder_ documents, populating the following fields with information from the _PSMF Document Review_: * **User Making Change**: The user who completed the _PSMF Document Review_¹ * **Document to Review**: The latest version of the document being reviewed * **Summary of Changes**: The text entered in the _Review Rationale_ field Once all _PSMF Document Reviews_ for the document are complete, you can use the PSMF author, review, and approval workflows to make the necessary changes required to update your PSMF document. Once the changes have been made to the new minor version and the document enters a steady state type, Vault updates the document's: - _Last Review Date_ to the date that the document was approved. - _Next Review Date_ to the _Last Review Date_ plus the amount of time dictated by the _Review Frequency_. If the _Review Frequency_ is blank, Vault leaves this field blank.

Note: To move a PSMF Binder to the Approved state, Vault requires certain conditions to be met.

#### Multiple Reviewer Logic If the _PSMF Periodic Review_ includes multiple _PSMF Document Reviews_ for the same document, your Admin's configuration determines when to up-version the document and how to handle any remaining open review tasks for the document. Depending on your Admin's configuration, Vault may: * Create a new minor version of the document and cancel any remaining open _PSMF Document Reviews_. * Create a new minor version of the document and leave open _PSMF Document Reviews_ for other reviewers to complete. Any _PSMF Document Reviews_ completed after this point do not further up-version the document, regardless of their outcome. * Wait until all _PSMF Document Reviews_ are complete before making any changes. Regardless of how many _PSMF Document Reviews_ have _Changes needed_ outcomes, Vault handles the document using the _Minor changes needed_ or _Major changes needed_ outcome flow.

Note: 1. When creating a PSMF Logbook Entry for a document with multiple reviewers, Vault determines the Person Making Changes value based on your Admin’s configuration. If Vault waits until all PSMF Document Reviews are complete to make document changes, the PSMF Logbook Entry is attributed to the last user who selected a Changes needed outcome. Otherwise, it is attributed to the first user who selected a Changes needed outcome.

### Unable to Review {#unable-to-review} Depending on your Admin's configuration, when a reviewer selects a _Review Outcome_ of _Unable to review_ and moves the _PSMF Document Review_ to the _Complete_ state, Vault takes no action. The next time the _PSMF Periodic Review_ job runs, Vault includes the related document or binder in the _PSMF Periodic Review_. #### Multiple Reviewer Logic If the _PSMF Periodic Review_ includes multiple _PSMF Document Reviews_ for the same document, when the last _PSMF Document Review_ for the document is complete: * If all _PSMF Document Reviews_ have _Unable to review_ outcomes, Vault handles the document using the _Unable to review_ outcome flow. * If the _PSMF Document Reviews_ have a combination of outcomes, Vault [determines which outcome flow to follow][13]. [1]: #psmf-generated-reports [2]: #include-in-reviews [3]: #psmf-document-fields [4]: #create-psmf-periodic-review [5]: #psmf-periodic-review-fields [6]: #create-psmf-document-review [7]: #psmf-document-review-fields [8]: #review [9]: #next-review-date [10]: #no-changes-needed [11]: #changes-needed [12]: #unable-to-review [13]: #multiple-reviewers