In this, the second entry in the series, I will review Gate 2 of the Nine Gate Transfer Process utilized by ProPharma Group for successful technical transfers. Refer to my first entry for further information regarding the importance of pharmaceutical product transfers.
Let’s discuss the Gate 2 Stakeholder Review: Now more than ever, industry professional are being tasked to do more with less. In addition, site leadership is tasked with ensuring the future of the site, the products, while individual departments need to focus on the daily operations as well as new products being transferred into the site. All of these goals depend on the right people agreeing on the transfer process and timeline. Stakeholders are the people who are actively involved in process transfers; they are people who may be positively or negatively affected by the execution or completion of the transfer. The standard definition of a Stakeholder includes a wide variety of titles. Everyone from the people living next to the plant, to the chairman of the board may be considered a stakeholder. Identifying these key individuals may seem daunting, but there is a quick tool to accomplish this task.
How to narrow the Stakeholder list to a manageable size:
- Create a matrix listing each of the affected areas starting with regulatory and continuing until you have gone through each department and area of the plant ending with the shipping area in the warehouse
- Assign a scale of 1 to 5 to each area, for both impact to the daily workload and influence over the project
- Complete a simple calculation of impact x influence allows the appropriate level of impact and influence
- A minimum level of 15 is typically used to determine key stakeholder input needed to achieve Gate 1 approval.
Key Stakeholders need to review the assessment and provided a list of clarifications required to approve the plan. Clarification requests should be shared with the entire team. The final document is then signed by the key stakeholders and key team members.
Most projects fail because incorrect assumptions are made at the start and communication is the key as discussed in our previous blog. Continue the process with Gate 3: The Transfer Plan