Workflows around change notification can become complex and involve diverse stakeholders from multiple organizations. Consider a change that arises from a component manufacturer and is being notified by an integrator as shown in figure 1.
This simple case assumes that there is no request for additional information from the biomanufacturer and that the component manufacturer can simply accept any requests for last time buys before the change is initiated which may not always be the case. The key point is that different aspects of a change may be handled by different parts of an organization. Incoming changes may be handled by a different team to outgoing changes, responses to a change from a customer may come from quality functions (accepting the details of the change) and from procurement functions (responding to the customers business continuity needs). These may feedback via quality and/or account management functions at the integrator side.
The team reviewed which functions may need to be considered in implementation of these change notification practices and developed the two documents below. If you are reading this you are likely to be interested in implementing these practices at your organization. Nobody will know your organization as well as you do. You will need to navigate your own organization to implement these practices successfully and bring value to your organization. The tools provided below do illustrate how it may be necessary to consider and engage a broader pool of stakeholders than one might initially consider, they were developed by multiple stakeholders considering the question of who may have a role in this within my organization. They should be used as a pre-populated list of stakeholders for you to consider and challenge your thinking about who needs to be involved/aware of this within your organization. Some stakeholders will be more important to influence than others and you may consider some not necessary within your organization.
Because organizations have different titles for roles within their company and responsibility may be delegated differently the document is organized by role and department/function rather than job title. For example: Owner of company change management policy, corporate quality rather than VP corporate quality or director corporate quality. The intention is that you will download this document and complete the specific name and function of the person responsible within your organization.