Managing Templates

Purpose

Learn how to create and implement templates with and without a change request

Outcomes and Prerequisites

Expected Outcome

  • Users are equipped to implement template in SimplerQMS
  • Be able to implement a template that does not require change request

Prerequisites for all

  • Must be logged in to SimplerQMS 2.8
  • Must be a member of one of these ‘User Groups’ to view records:
    • All internal and external users
  • Must be a member of one of these ‘User Groups’ to create new records
    • All Contributors

Section 1: Workflow overview

The flowchart below outlines the process of creating a template without change request. To see how template processing changes due to a Change Request, refer to Work Instruction: Managing Change Request

Template Conditions:

  1. Templates require a Change Request by default upon creation of the template metadata
  2. Templates can also be set to not require Change Request. To find out more on how to do that, refer to section 3.

Section 2: Creating New Template

Step 2.1 – Create a new template – Initiator/Author

Step 2.1. Can be accomplished by a person who has the All Contributors User Group assigned to them.

Option 1: Create a Template by Drafting – Initiator / Template Author

There are multiple ways to create a Template in SimplerQMS:

  1. In the Create New section, on your Home Tab, click on Template
    1. Click on the Create (+) next to the Home Tab and choose Template from the dropdown list
    2. On the left side of the screen, expand Create and click on Template

2. To create a template from this selection, you need to define the Class as Controlled Template (Working Copy)

3. Select the right template

A Metadata Card will pop up. Proceed to Step 2.2

Option 2: Create a Template by Drag & Drop – Initiator / Template Author

Another way of implementing a template is by dragging an existing file from your local drive into the system.

  1. Select a file from your local drive.
  2. Drag the file into “Checked Out to Me”.
  3. A metadata card will pop up.
  4. Select “Controlled Template (Working Copy)” on the Class dropdown.
  5. Proceed to Step 2.2

Step 2.2 – Filling in the Metadata Card

Fill the following sections on the metadata card:

Part 1: Template Info
Field nameDescriptionNote
Template Responsible Person(s)*The person assigned to the template with broader access rightsSee Section 5 for additional details
Template Author(s)*Person to drafts/authors the template 
Template Reviewer(s)This is optional if a review is needed for the template; this person has the same access/edit rights to the template as the author 
Template Approver(s)*Person to approve the release of the template 
Part 2: Template Information
Field nameDescriptionNote
Short Title*Title of the template – choose a template title that will be easy to look for and outlines what it needs to be used for 
Target Class*Select the target class that is intended for this template between Audit Plan, CAPA, Change Request, Controlled Template (Working Copy), Quality Document & Recorded Issue Template.  The template will be categorized based on this field, and when creating new records it will show up in the Suggested Templates section. 
Site(s)*The legal entity that the template is tied to 
Document TypeThis field will default on a record metadata card when the template is used. Document Type is a determining factor when a Quality Document is created based on a template, as it will determine if it requires a Change Request.See more in Work Instruction: Managing Quality Documents
DepartmentLeave blank; if the documents you wish to initiate from the template always belongs to the same department, select a department 
Process*Select the process that the template belongs to 
ArchiveSelect an archive if necessary 

Disregard the Workflow Process Information and Relations sections, as if they are filled, they will automatically be transferred to the metadata of any record created based on the template. This feature is useful if you wish to always default to the same authors, reviewers and approvers or relations, but can also become cumbersome for templates that are used often.

  1. Click Create after filling out all necessary information in the metadata card.
  1. Working copy of the template launches in MS Word (or in the applications where template was initiated).
  1. Modify or draft the template
  1. Save and check in the template and go back to SimplerQMS
    1. The template should be assigned to the template author. The template name will state “Pending Change Approval” and the state in the metadata will also be “Pending Change Approval”.
    2. Template Requires CR: By default, all templates will require a Change Request. The Responsible Person can set a template to not require CR. Refer to section 3 to learn how.
  1. Select the NEW Template (NAME) (Pending Change Approval), and in the metadata card read the assignment description.

Note: A template controlled by CR will only get a unique ID once the CR Planning phase is completed.

Note: This Work Instruction will follow the flow of a Template without Change Request, but you will find notes referring to the changes that a CR adds to the flow.

Section 3: Setting a Template to NOT Require CR

Step 3.1 – Set template to NOT Require CR – Process Manager/Template Responsible Person

This feature is for companies who feel comfortable not controlling templates via Change Requests and define the process as such in their procedure for Change Control.

(This is NOT recommended by SimplerQMS A/S but a possible choice for companies whose change control is not too tight)

Under State Transition you will see the following options:

  • Not Current – Archive
    • Select if you decide that the newly initiated template is not required
  • Set Template NOT to Require CR
    • Select this option if you would like to create a template without the Change Request Process
  • Set Template to Require CR
    • If selected when the template already requires CR, no change will be carried out
    • If selected after “Set Template NOT to Require CR”, then it will set the template back to require the entire Change Request process

If the template is set to not require CR, it will automatically generate a unique ID, and the template is now ready for drafting and will be assigned to the template author.

State should be New Draft. Read the new assignment description in the metadata card. It describes that the template is now ready to proceed with processing.

Note: If the template is switched back to “Set Template to Require CR”, Change Control will automatically change its status to “Yes”. You will be able to process the Template without adding it to a CR, but once it has been approved, it will not be released until it is tied to a CR that has been approved and closed.

Section 4: Drafting a new Template

Note: If the template is controlled by a Change Request, the CR Plan needs to be approved before moving on to the next steps! Refer to Managing Change Request

Step 4.1 – Draft Template and Route for Review – Template Author

  1. Check out the template, launches in Word (or other applications the template was initiated from)
  2. Draft the template including all the necessary layout changes, formatting, codes, and information
  3. Click Save and close the template, check in to SimplerQMS
  4. Send the template for review, under State Transition, click on “Route for Review” (only when there is an assigned template reviewer)
    • Alternatively, if no reviewer is assigned or the template ends up not needing a review, click on “Route for Approval without Review”

Section 5: Additional State Transitions for a Responsible Person under Review

(Skip this Section if there is no template reviewer assigned. Proceed to Section 7)

Step 5.1 – Close Review Immediately

If the review is no longer necessary, the Responsible Person can end the review process without the need for reviewers to press “My Review Task Completed”

  1. Click on “Close Review Immediately” under State Transition
  2. This will require an electronic signature
  3. The template will be assigned back to the template author and can move on to approval

Step 5.2 – Modify Reviewers List

When the template has been routed for a review, and the assigned template reviewer(s) need to be changed, the Responsible Person can modify the reviewers list.

  1. Click on “Modify Reviewer List” under State Transition
  2. At this stage you can add other reviewer(s), remove, and reassign reviewer(s) on the metadata. You can see this highlighted on the Assignment Description
  3. Once done, click on “Continue Review” under the State Transition

Section 6: Reviewing the Template

(Skip this section if no review is necessary)

Step 6.1 – Complete the review of the template – Template Reviewer

When the template has been routed for a review, it assigns to the Template Reviewer and the State in the metadata is “Review Ongoing”.

  1. Check out the template, launches in Word (or other applications the template was initiated from).
  2. Review the template
  3. Template reviewer has the same level of access rights to the template as the template author when it is on the “Review Ongoing” state.
    1. Save and close the template. Check in to SimplerQMS.
    2. When the review has been completed, click on “My Review Task Completed” under State Transition if the number of modifications needed are acceptable
    3. If there are too many modifications needed after the review process, it is recommended to reject the template by pressing “Reject Template – Send Back to Draft for Editing”

State should change to “Review Closed”

Section 7: Finalizing the Template

Step 7.1 – Final draft of the Template – Template Author

When the template has been reviewed, it assigns back to the Template Author to finalize the drafting of the template and route it for approval.

  1. Check out the template, launches in Word (or other applications the template was initiated from).
  2. Write the final changes in the template.
  3. Save and close the template. Check in to SimplerQMS.
  4. Set the effective date in the metadata card (template cannot be routed for approval without the effective date).
  5. Under State Transition, the author has the options to
    1. “Reject Template – Send Back to Draft for Editing” – if the author is not satisfied with the template, they can restart the process from Section 3 by pressing this button
    2. “Route for Another Review” – if too many changes have been made in the template, it is recommended to send it for another review
    3. Route for Approval” – to move forward with the template and proceed to Section 8

Note: If your template is controlled by a Change Request, the effective date field will not be available, as the effective date of the Change Request will be carried over to the template once the CR has been closed.

Section 8: Approving the Template

The template should now be assigned to the Template Approver(s) and the state is” Awaits Approval Signature(s)”.

At this stage, no changes can be made on either the template or the metadata.

Step 8.1 – Approve the Template – Template Approver(s)

  1. Select the template and under State Transition click on “Approve Template”.

2. Approve the template with your electronic signature using your SimplerQMS log-in and password

a. If the Template Approver is not satisfied with the content or the layout of the template, they can reject the template which will go back to draft and the process from Section 4 starts all over again.

b. In case of multiple template approvers, it is enough if only one of them rejects the template for it to go back to draft and be reassigned to the template author.

3. If the effective date is set to be on the day of approval, the template will be released as a PDF and in state “Effective”. It can be used immediately for creating documents based on this template.

a. If the effective date is set in the future, the template will go under State “Awaiting Effective Date”. Proceed to Section 8.

Note: If your template is controlled by a Change Request, it will be under the state “Awaits CR Approval”. You can now proceed with the Implementation and Closure of the Change Request. Refer to Work Instruction: Managing Change Request, Section 6 and onward. The template will become effective once the Entire Change Request has been approved and released.

Section 9: Make effective immediately – Responsible Person

(Skip this section if the effective date is not set in the future)

If the effective date of your template was set in the future, the PDF copy of the template will not be released, and therefore the template will not be available for use until the effective date is reached. This will put the template in “Awaiting Effective Date” state.

If the template is needed to be released earlier than the set effective date, the Responsible Person has the option to make a template effective immediately.

  1. Click onthe PDF version of the document. It should be on state “For Learning”.
  2. Under State Transition click on “Make Effective Immediately”

3. Enter your electronic signature and then click OK.

a. An “Exceptions” box is available to write an explanation as to why the template needs to be effective immediately.

4. This will release the template as a PDF and in state “Effective”. It can be used immediately for creating documents based on this template.

Section 10: Route for Update – Author / Responsible Person / Process Manager

 These commands are available for the author, responsible person, and process manager.

  1. If the template needs to be updated to a new version, select the released version (PDF file) and under State Transition click on “Route for Updates”.

2. The state should change to “Await Template Update” and the title should update to include the next version number (e.g., v2)

3. Go through the actions described in Section 4, 6, 7, and 8

Note: If your template is controlled by a Change Request, updating it will require you to create a new Change Request. You will need to go through the entire Change Request flow for an update. Editing the template will only become available once the Change Request Plan has been approved.

Section 11: Route for Retirement –Responsible Person / Process Manager

  1. If the template needs to be retired, select the released version (PDF file) and under State Transition click on “Route for Retirement”.

2. A Retire Date will need to be entered in the metadata

3. Click on Submit Retirement Date under State Transition.

4. The state should change to “Retired Template”

Note: If your template is controlled by a Change Request, retiring it will require you to create a Retire Request. You will need to go through the entire Change Request flow for the retirement but will not need to process the template as the system will automatically move it to state “Retired Template” once the CR is approved.

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