Design Review

A structured evaluation process in the application where all design components are scrutinized to ensure they align with specified requirements and are fit for their intended purpose.

Workflow Diagram

Draft: The initial creation of the form or record. It's where the initial data is input and saved.

Review: After the draft is completed, it moves to the review stage. Here, designated individuals or teams assess the content for accuracy, completeness, and compliance with requirements.

Complete: Once the review is done and all necessary changes are made, the form or record is marked as complete. This signifies that it has passed all checks and is finalized.

Explanation of fields

Fields	Field Explanation
Title	A mandatory text field.
Disabled?	If checked, the form won't be available or visible for linking from another form.
Number	The document system number, which is system-generated.
Revision	The version number, which is system-generated.
Description	A rich text field where you can freely describe the content or add any other pertinent information.
Refresh	A button that, when clicked, updates the form to reflect all changes. However, these changes still need to be saved to be applied.
Product	Read only. The product link which the Design review is created.
Attachment and Comment	The attachment field allows for the addition of any document file. In contrast, the comment field can be used to write any notes or remarks. Multiple items are allowed.

Fields	Field Explanation
Reviewers	The reviewers will be selected from this field. Multi-select drop down.
Include in this Review	This field is where users can select what types of components to review (User Needs, Validation Test Cases, Design Inputs, Design Outputs, Verification Test Cases, Risk Hazard Analysis, and Documents). A multi select checkbox.
Are all the decisions Approved?	A flag that checks if all the review decisions are approved.
Component to be reviewed	The link of the individual component to be reviewed.
Reviewers	The names of the reviewers that will review an individual component.
Comments	Allows reviewer to write any comment about the reviewed component.
Decision	Allows the reviewer to decide to Approve or not the reviewed component.

Fields	Field Explanation
User Needs	Allows for selecting User Needs to be reviewed.
Validation Test Cases	Allows for selecting Validation Test Cases to be reviewed.
Design Inputs	Allows for selecting Design Inputs to be reviewed.
Design Outputs	Allows for selecting Design Outputs to be reviewed.
Verification Test Cases	Allows for selecting Verification Test Cases to be reviewed.
Documents	Allows for selecting Document Control's Main Forms to be reviewed.
Risk Hazard Analyses	Allows for selecting Risk Hazard Analyses to be reviewed.

Initiation of Design Review:

Design review can only be created within the product form when the product is in review stage.
It contains sections corresponding to different design components (User Needs, Validation Test Cases, Design Inputs, Design Outputs, Verification Test Cases, Risk Hazard Analysis, and Documents).
Each section has a button that, when clicked, displays a list of components. These components mirror those linked in the product.
Not all components are automatically up for review. The user must manually select which components from each section they want to be reviewed.
If a user selects an already completed component, the system will create a new version of that component and will get selected instead. And if there’s already and existing newer version which is in draft or review stage, it will select that instead.

Setting Up the Review:

The user must specify the reviewers by selecting them.
The user must indicate which types of components will be reviewed using the "Include in this Review" field.
The user must select the components to be reviewed.
Once all the 3 conditions are satisfied, all selected components are automatically listed in the review section of the form

Submission to Review Stage:

The user submits the "Design Review" to the review stage.
The designated reviewers then begin their assessment of the selected components.
For each component, a reviewer can decide to:

Approve
Fail
Request more information

Concluding the Review:

If all components are approved, the "Design Review" progresses to the "Complete" stage.
If any component isn't approved, the "Design Review" is reverted to the "Draft" stage. The creator then needs to modify and resubmit the draft for review.

This process ensures a thorough review of the design components and provides a mechanism for feedback and iteration.

Reversion to Draft and Logging:

If the "Design Review" is reverted to the "Draft" stage due to any component not being approved, all assessments made during the review stage are logged.
These logs are captured in the comment section of the "Design Review" form, serving as a historical record of the review process.
Once logged, all previous assessments from the review stage are cleared out, allowing for a fresh review after modifications are made.

This ensures that there's a clear record of feedback and decisions made during the review, which can be referenced in future or during the modification process.

When moving the design review to 'Review', components in 'Draft' automatically update to 'Review', and reviewers can access them. If the review reaches 'Complete', components not yet 'Complete' will auto-update. But if the review goes back to 'Draft', component stages stay unchanged.