It is a requirement for organizations to track changes in a GMP environment. Effective and efficient change control processes are key to achieving quality and compliance. At this month’s Blue Mountain Customer Lab, we took a few polls of our audience to determine how customers are currently tracking changes. The results were as follows:
- 39% use a hybrid solution (a combination of paper and electronic solutions)
- 33% use a paper solution
- 22% use one computerized system
- 6% use multiple computerized systems
Of these responses, only half believe their current process is efficient. Let’s take a look at using Blue Mountain RAM to enhance change control processes.
Utilizing Blue Mountain RAM for Change Control
Blue Mountain RAM can be used as one of multiple computerized systems that make up a change control process, as it has the ability to link to a Quality Management System (QMS). It is common for customers to report a need for a change in Blue Mountain RAM via a Change Request, yet use a separate system, such as a QMS, to handle change control. On the other hand, Blue Mountain RAM can also be used as a component of a hybrid solution or as the single computerized system for a change control process.
Utilizing Blue Mountain RAM for change control is efficient and effective, as it ties all change control items together. For instance, once a Change Request is submitted, that Request is attached to the corresponding Asset. Once Work is attached to the Request, the Work is also attached to the Asset. Additionally, the Request # is captured on the Work Order itself.
Steps for Submitting a Change Request in Blue Mountain RAM
1) There are several ways to create a Request in Blue Mountain RAM:
- Select the “Add Request” action item within My Workspace
- Go to Queries > Request > All Request > click “New”
- Go to Queries > Assets > open an Asset record > Actions menu > click “Submit Request”
2) Once you have the Submit Request window open, select “Change Request.” NOTE: The Change Request Workflow must be in the Active State.
3) After the Change Request record opens, fill in the necessary fields:
- Need Action By date
- Request Type
- Submission Comments
NOTE: You will only be able to edit the fields that you have rights to. Some fields are grayed out as a means of controlling who can enter what data.
4) Save and enter an audit reason. This will move the Change Request into the Draft state (or the next state defined by your custom workflow).
5) Submit the Change Request by electronically signing it. This will move the Request to the Pending Approval state (or the next state defined by your custom workflow).
Adding Additional Information to a Change Request
Information on the initial Change Request cannot be changed once it is in the Pending Approval state. However, additional information can be added by putting the record in “Edit” mode. You can then include:
- Approval Comments – such as identifying that a calibration is required after a piece of equipment is moved
- Change Control # – as a means of linking change requests when an organization uses multiple systems for change control
Before moving forward, be sure to click “Save” and enter audit reason.
Steps for Adding and Attaching Work to a Change Request
1) From the Change Request record, go to the Actions menu > “Add & Attach Work”.
2) Select the type of Work you would like to attach:
- Choose Event – Brings over Work Plan Templates (WPTs), Measurement Data Templates (MDTs), and other information from a selected event, and updates the Due Date on the schedule once the work is completed.
- On Demand, Event-Based – Brings over WPTs, MDTs, and other information from a selected event without updating the schedule after the work is completed.
- On Demand – Creates a blank Work record (does not bring over any information from any events).
3) Click “Next.”
4) Select your Rule and click “Finish.”
To see the Work you have added, go to the View menu and select “Attached Work.”
Whenever you have questions, consult your Blue Mountain RAM User and Administrator Manuals. If necessary, please contact our friendly Support Technicians at firstname.lastname@example.org with questions. Also, please enjoy calling and speaking with your Regional Sales Manager (RSM) at 800-982-2388 if you are interested in Blue Mountain RAM training or services.