Last week we talked about three crucial aspects of a great Management of Change (MOC) program. Those areas were the specificity and detail in the change requests, followed by risk and reward analysis, and the proper selection of a MOC evaluation team. This week we’re going to touch base on a few more important parts to a fully functional MOC program.
The new API Spec Q2 requirements take a risk-based approach to quality management. When making changes, risks must be identified and measured by level of acceptability. Risks that are deemed unacceptable must be paired with mitigation plans. These plans are then designated to be carried out before, during, or after the implementation process. The purpose of the mitigation plans is to help bring the risk down to an acceptable level.
The next area we will address deals with the approval aspect of MOC. Many organizations get into trouble in this area, confusing the need for approval with the need to inform. It’s important to note that every change doesn’t have to have the same approver. A great MOC program should have an approval matrix describing who needs to approve which type of decisions, as well as a list of people who “must be informed”. If your organization gets these steps right, the approval process will be quick and painless.
This leads us to the communication section nicely. As stated before, there are those who need to “approve” and those who “must be informed”. We need to track our communication efforts with respect to the MOC. In other words, any message and corresponding response must be documented. The person responsible for sending the message is also responsible for getting a confirmation from the recipient. This means after the change is communicated, a receipt confirmation should be requested. Also, it is important to make it clear to your organization that an email response should be expected from the recipient. Simply flagging it as “Request a Read Receipt” isn’t going to get the job done. Once the recipient has responded, stating that they have received the message and understand the information, then the responsibility shifts to them to carry out the appropriate action.
Be sure to check back in next week for part 3 of 3 on Accupoint’s overview of Management of Change. For more information on how Accupoint’s solutions can help streamline your MOC program, visit www.accupointsoftware.com or call us at (800) 563-6250.