Quality System Document Properties | ||
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Fields
The page also lists the files checked into the document below the properties. For more information, see File List for a Versioning Document for details about the file list section.
| Field Name | Description | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Type | The type of quality system document. | ||||||||
| Category | The category of the document, such as policy, procedure, instructions, and so on. | ||||||||
| Name | The name of the quality system document. The name is often an automatically generated name. | ||||||||
| Revision | The revision level of the quality system document. | ||||||||
| Title | A descriptive title of the quality system document. | ||||||||
| Policy | The policy that governs the lifecycle of the quality system document. The default policy is Controlled Documents. | ||||||||
| State | The current lifecycle state of the quality system document. The available states vary depending on the document type. | ||||||||
| Change Information | Any change order and change action that controls the release of this
document. Click to open the item. Pause over the name to view the description for the item. |
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| Owner | The person responsible for the quality system document. | ||||||||
| Responsible Organization | The organization responsible for implementing and maintaining this quality system document. Click to view the Properties page for the organization. | ||||||||
| Description | A more complete description of the expected usage of this quality system document. | ||||||||
| Controlled Document Template | The template, if any, used to create the quality system document. Click the name to view the template's properties. | ||||||||
| Training Enabled | Indicates whether training is enabled on the quality system document. If the document was created from a template, this value cannot be changed. If the document was not created from a template, the value can be changed by the document owner or the Document Control Administrator while the document is in the Draft, In Work, or In Approval states. | ||||||||
| Periodic Review: | |||||||||
| Periodic Review Enabled | Yes or No to indicate whether this quality system document is subject to periodic review. | ||||||||
| Periodic Review Interval (In Months) | If periodic review is enabled, the interval (in months) between reviews. | ||||||||
| Last Review Date | If periodic review is enabled, the date of the most recent review of this document. For pre-released documents, this field is blank. | ||||||||
| Next Review Date | If periodic review is enabled, the next due date for reviewing this quality system document. For pre-released documents, this field is blank. | ||||||||
| Subject Matter Expert | The name of the Subject Matter Expert, the person responsible for performing the periodic review associated with this document. Click to view the person's properties. | ||||||||
| Assignee | The person assigned to complete the next periodic review. | ||||||||
| Implementation Plan: | |||||||||
| Effectivity Option | Specifies when you can implement the
quality system document based on its effective date:
|
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| Effective Date | This value is empty until the quality system document reaches the Approved state. The effective date is then calculated based on the implementation period (either default or specified) selected as the Implementation Type. | ||||||||
| Implementation Type | Specifies how the implementation date for
the quality system document is determined:
The quality system document's effective date is either the date on which the quality system document is promoted to the Approved state plus the number of days (default or specified) defined for the implementation period; or, if a planned implementation date is specified, then the quality system document's effective date is that date regardless of when the quality system document is promoted to Approved. |
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| Period (in days) | The planned implementation period for the
quality system document, in days.
If the default implementation period is selected as the Implementation Type, this is the number of days that will be added to the quality system document's planned implementation date to determine the planned effective date. If an implementation date is specified, this value is calculated after the quality system document reaches the Approved state. |
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| Implementation Actual: | |||||||||
| Effective Date | The actual date on which the quality system document was completely implemented, promoted to the Released state, and therefore, became effective. | ||||||||
| Period (in days) | The actual number of days that the quality system document remained in the Approved state before it was completely implemented, then promoted to the Released state, and therefore became effective. | ||||||||
| Dynamic Attributes: | |||||||||
| Attribute name | Each attribute group associated with the document has its own named section. The attribute groups are listed alphabetically. All attributes in the attribute group are listed alphabetically, with their values, if defined, for this document. | ||||||||
Actions/Toolbar Commands
| Action | Description | For More Information |
|---|---|---|
Download
|
Downloads the selected files. The files are
not locked on the server. You can open the files, or choose the location on
your local computer for saving the files.
If the document contains multiple files, they are downloaded as a single zip file, unless any of them are locked. If any file is locked, then you must select the files for downloading (omitting the locked files). |
Document Properties and Files Page |
Checkout
|
Checks out the selected files by downloading them to your local computer and locking them on the server. | Document Properties and Files Page |
Edit Details
|
Edits the details of a quality system document. | Editing Quality System Document Properties |
Configure Document
Effectivity
|
Sets the effectivity date for a quality system document. | Configuring Document Effectivity |
Upload/Check In
|
Uploads new files, or checks in files you previously checked out. | Document Properties and Files Page |
Delete this Version
|
Deletes the selected file. Click
OK to confirm.
For a quality system document that is not a Proposed Change of a change order, you can only delete the file if the quality system document is in the Draft state and you are one of these people:
|
— |
| Delete All Versions
|
Deletes all versions of the selected file
except the latest version; click
OK to confirm.
See Delete this Version for the delete restrictions. |
— |
Detailed Report
|
Creates a consolidated report that summarizes the important characteristics of the document. The Detailed Report opens in a new browser window. | Detailed Report |
Generate PDF
 Only shows if |
When ActivationMode is manual, the
Author, Leader, or Document Center Administrator can generate a PDF for the controlled document. |
|
Periodic Review > Periodic Review 
Only shows if you have the Subject Matter Expert role. |
Allows you to complete the current periodic review. You must enter review comments and your password. | Completing a Periodic Review |
Periodic Review > Reassign 
Only shows if you have the Subject Matter Expert role. |
Temporarily reassigns the quality system
document to another Subject Matter Expert for the current periodic review
cycle.
The selected person will be notified about the reassignment and must accept the assignment before they can complete the periodic review. |
About Searches |
Periodic Review > Remove Reassignment 
Only shows if you have the Subject Matter Expert role. |
Removes a temporary reassignment to review the quality system document
if it has not yet been accepted by from the Temporary Assignee,
or if the assignment has been accepted by a member of a Member
List but should again be available for acceptance by any member
of the Member List. Click OK to confirm. The review responsibility is transferred to the original Subject Matter Expert. You must be either the original Subject Matter Expert assigned to the review, a member of the Member List assigned as the Subject Matter Expert, or be a Document Center Administrator to perform this action. |
— |
Periodic Review > Accept Assignment 
Only shows if you have the Subject Matter Expert role. |
Accepts the temporary reassignment for the
quality system document if someone reassigned the periodic review to you or
accepts the review assignment if it was assigned to a Member List to which you
belong.
Click OK to accept the assignment. If the review was temporarily assigned to you, the responsibility for review lasts for a single review cycle only, then it reverts to the original Subject Matter Expert. The app notifies the original Subject Matter Expert or the Member List that you accepted the assignment. |
— |
Periodic Review > Reject Assignment 
Only shows if you have the Subject Matter Expert role. |
Rejects the temporary reassignment for the quality system document and notifies the original Subject Matter Expert who reassigned it to you. | Rejecting a Periodic Review Assignment |
| Periodic Review > Edit Details
Only shows if you are the document's owner or you have the Document Center Administrator role. |
Allows the document's owner to disable periodic reviews on a document,
change the periodic review interval, and assign a different
Subject Matter Expert to a periodic review that is not in the
Released state. The document's owner and the Document Center Administrator can assign a different Subject Matter Expert to the periodic review and provide a reason for the change when it is in the Released state. Note:
If the quality system document was created from a
template, the periodic review options are copied from the
template and cannot be changed. If the quality system
document was not created from a template, the periodic
review options can be changed. The Subject Matter Expert can
be changed in either circumstance.
|
Editing Periodic Review Details |
| Controlled Print
Only shows if the document is in the Released state and you have the Document Center Administrator role. |
Allows you to create a controlled print of the document and selected files. | Creating a Controlled Print |
Training > Update
Training
|
Marks your progress in training for this document. Only shows if you have been assigned for training for this quality system document and the document has reached the Released state. |
Updating Training |
Training > Complete
Training
|
Completes training for this document. Only shows if you have been assigned for training for this quality system document and the document has reached the Released state. |
Completing Training |
Rerun failed PDF conversion
Only available if the PDF conversion process for the quality system document's attached files failed. |
Reruns the conversion process that failed to automatically generate a PDF for a checked-in file or for a promotion or demotion of a quality system document. | Rerunning the Failed PDF Conversion Process |