The steps for a Appraisal Team Lead (ATL) to scope an appraisal for a participating facility are as follows:
- Intake Call: this is the introductory call between an ATL and a participating facility. During this time, the ATL will ask a series of questions to better understand the facility, what it does, how it does it, the work culture, etc.
- Products: The ATL will want to get an understanding of the amount and types of devices manufactured by the participating facility. For example, are finished products or components? Do devices undergo sterilization or packaging or labeling? Is there a software or drug component? Etc.
- Processes: Next, the ATL will look to understand the processes that go into manufacturing the devices and where there are similarities and/or differences. For example, do a sub-set of devices all go through the same machine tool under different configurations? Are the processes for two sets of devices the same except that one has an added drug component? Etc.
- Sampling: Once the ATL has a better understanding of the participating facility's products and processes, then he or she can determine a representative sample for the majority of processes at the facility.
- Participants: Using the practice areas (in scope) as context for functional grouping of staff, and the product sampling, the ATL will work with the Appraisal Sponsor to identify which employees should participate in which discussion sessions.
- Schedule: The number of appraisal participants that have been identified (might be more with larger organizations or large sample size) will determine how many discussion sessions are needed (max of approximately 6 people per session) throughout the appraisal.
- Team Size: The number of determined discussion sessions will inform how many appraisal team members are needed to complete the discussion sessions within the allotted time of one week.