Change Management can be overwhelming and at a minimum drives the need for a documented Change Management procedure. Qualio customers with access to the Events feature can assist team members adherence to their Change Management procedure by using the Events workflow within Qualio.
Within the Quality industry, the need for Change Management may arise when:
A process needs to be updated or corrected
A document(s) needs to be updated or corrected
A new piece of equipment has been acquired that affects manufacturing
A new supplier is providing an active pharmaceutical ingredient (API)
A supplier change for services of your SaMD
In this article, we will describe in detail how organizations can use the Events feature as a ‘solution’ to remove Change Management friction and pitfalls. You’ll see that we break down Change Management into three digestible phases.
To take advantage of the workflow and approval benefits built into Qualio Events, you will first need to create an event template for Change Requests. The template will provide the basic structure and flow for your overall Change Request process and can be built and customized to your specifications.
We recommend the following steps and structure for a Change Request event and will use this structure throughout this article as we describe the solution.
Click here to learn how to create an event template, or click here for a broader overview of Events in Qualio.
The initiator, typically a Quality team member or the process owner, begins the change management process by creating a Change Request event in Qualio. The change request would be a specific type of event where they provide known information about ‘the ask’ and ‘the need’ for the change. The Request portion would be the first step of your Change Request event that will need to be approved in order to continue with the Assessment of the change and final Approval. You may want to include the list of questions below in your Change Request template to help initiators provide enough context for the request.
Common elements of a Request:
What is the change being requested? (Be specific with as many details as possible)
Why is the change needed?
Is this change the result of a CAPA or NCR?
What stakeholder should be involved in the assessment of this potential change?
Are there known risks?
The Request should provide stakeholders with the information they need to approve the request and begin the Assessment process.
Once the Request step is approved, it’s time to begin assessing what impact this change will have. Here are some common areas of impact (depending on the type of change).
What related processes will this impact?
Which departments will be impacted, and therefore will require input and/or retraining?
What document(s) will need to be updated based on this change?
Is there a Regulatory impact to making this change?
Will this affect any existing suppliers and/or my supplier policy?
Depending on the significance of the change, it may also result in an overall risk assessment or may require additional changes to be made.
All areas of impact should be documented as tasks in the Assessment step to ensure that each aspect of the change request is fully documented and can be assigned as tasks to different individuals who are involved with the change. By creating individual tasks and assigning to responsible individuals, this helps Quality Team members share the workload and keeps a well documented history of when tasks are created, assigned and completed.
Once the Assessment of the change has been completed, the Approval should summarize the change. Be sure to call out the impacted areas from the Assessment, along with what was done regarding each impact.
Using Qualio Events means that you can identify multiple reviewers and approvers of the Change Request Approval step. Sending the event for review allows reviewers to validate the impact and leave comments, and the same is true for the final approval. The Audit Log will clearly identify dates, times, and names of approvers as part of your official record.