Assessing Effectiveness of Change Request

Purpose

Learn how to:

• Locate and view the periodic tasks for assessing effectiveness of Change Request
• Assess Effectiveness of the Change Request with 2 options:
  • Change Request Effective
  • Change Request not Effective – Create New Change Request
• Reschedule an assessment
• Review an effectiveness assessment
• Trigger a manual or immediate effectiveness check

Expected Outcome

• Users are equipped to handle the Effectiveness Assessment of Change Request in SimplerQMS
• The Effectiveness Assessment task ensures that Change Request is assessed for effectiveness
• All decisions are captured including electronic signatures

Prerequisites for all

• Must be logged in to SimplerQMS
• 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 Change Requests:
  • All Contributors
  • Change Manager 
• Must be a member of one of these ‘User Groups’ to modify Change Request Settings to Require Effectiveness Assessment:
  • All Contributors
  • Metadata Administrator

Prerequisites for Assessing Change Request Effectiveness

• Must be assigned to the following role(s) in the Change Request:
  • Responsible Person

Section 1: Workflow overview

The flowchart below outlines the Change Request Effectiveness Assessment process.

When a Change Request is approved, it generates an effective version (in PDF format) and a periodic task for the Change Request Effectiveness Assessment. The Change Request state then, changes to “CR Pending Assessment”.

Section 2: Finding and Viewing Effectiveness Assessment task

Step 2.1 – Finding and Viewing Effectiveness Assessment task

To find the Effectiveness Assessment, you can use the following methods:

Option 1: From Detail Listings

1. Select the Change Request document.
2. Navigate to Detail Listings under View Extensions. This displays all related items, including the Effectiveness Assessment.
3. Click the Effectiveness Assessment tab to view the task.

Option 2: Via Search

1. Search for the Change Request document number.
2. Expand the Periodic Task group if it is collapsed.

Option 3: From Effectiveness Assessment View

1. Click Main views > Tasks & Actions > CR Effectiveness Assessments view.

2. Locate the Effectiveness Assessment.

Step 2.2 – CR Effectiveness Assessment Metadata

After locating the Change Request’s Effectiveness Assessment, the Effectiveness Assessment’s metadata will display information about both the Change Request and the Effectiveness Assessment.

Section 3: Starting or Rescheduling a CR Assessment

While the assessment is in the “Scheduled” state, its metadata cannot be modified.

Step 3.1 – Reschedule the assessment

To reschedule an effectiveness assessment, the responsible person must make the necessary changes and provide a justification. 

I. Select the effectiveness assessment, under State Transition, click on Reschedule.

II. Specify the new assessment activation and/or due date according to company’s preferences.

III. Provide mandatory justification for the rescheduling in the “Justification of Decision” field within the Periodic Task Info section.

IV. Click Save.

V. Under State Transition, click Schedule.

Step 3.2- Start the Change Request Assessment

Once the Change Request Effectiveness Assessment is back on “Scheduled”, the responsible person can start the assessment.

There are 2 ways to start the assessment:

Option 1: Manually Initiating a Change Request Assessment

If a Change Request is still scheduled, the responsible person can manually trigger the Effectiveness Assessment at any time before the scheduled activation date.

Manually initiating the assessment does not change the original assessment period end date.

1. Select the Effectiveness Assessment
2. Under State Transition, click Assess Effectiveness Now

Option 2: Assess Change Request based on schedule

The Change Request responsible person will be notified on the activation date. On this day, the Effectiveness Assessment task SimplerQMS will be assigned and an email will be sent to the Responsible Person.

Section 4: Sending an Effectiveness Assessment for Review

(Skip this section if no review is necessary)

Step 4.1 – Send the Effectiveness Assessment for Review

I. Under State Transition, click on “Send for Review” (only when there is an assigned reviewer)

Step 4.2 – Reviewing the Effectiveness Assessment

When the Effectiveness Assessment is submitted for review, it is assigned to the Reviewer, and its status changes to “Review Ongoing.

I. Review the Effectiveness Assessment

II. Review the Change Request. The Change Request may be viewed under the Effectiveness Assessment’s Metadata card or under the Documents group.

III. Once the review is finished, the reviewer should enter their conclusion in the “Your Reviewer Conclusion” field on the metadata card.

IV. To finalize the review, click the “My Review Task Completed” button under State Transition.

Once all reviews are complete, the effectiveness assessment status will change back to “Pending Assessment”.

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

If reviewers are assigned to the document, the Responsible Person or Process Manager has the following options during the review process. They can either close the review immediately, even if not all reviewers have completed their tasks, or modify the reviewer list.

(Skip this Section if there is no reviewer assigned to document)

Option 1: Close Review Immediately

If there are multiple reviewers assigned and one or more reviewer(s) cannot complete their task, the Responsible Person or Process Manager can end the review process without the need for all 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 Effectiveness Assessment will go back to the Responsible Person and its state will change to “Pending Assessment”.

Option 2: Modify Reviewers List

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

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

Section 6: Assessing Effectiveness of Change Request

The responsible person assesses the effectiveness of a Change Request and this assessment requires an electronic signature. 

Option 1: CR Effective

If the Change Request is effective, the responsible person must document the reason and set the status to “CR Effective”.

1. Select the Effectiveness Assessment
2. In the metadata card, enter the “Justification of Decision”
3. Click “CR Effective” under the state transition

IV. The Change Request state will automatically change to “CR Effective”.

Option 2: CR Not Effective

If the Change Request is not effective, the responsible person must document the reason and set the status to “CR Not Effective”.

1. Select the Effectiveness Assessment
2. In the metadata card, enter the “Justification of Decision”
3. Click “CR Not Effective” under the state transition.

IV. The Change Request state will automatically change to “CR Not Effective”.

a. The Change Request assignment description will then indicate creating a new change request.

b. Once the new Change Request has been created, confirm creation using the “New Change Request Created” state transition and signing to verify completion.