| Multidisciplinary approach including risk identification and risk mitigation methods for developing and improving plant, facility, and equipment plans. In designing plant layouts, the organization shall:
Optimize material flow, material handling, and value-added use of floor space including control of nonconforming product, and
Facilitate synchronous material flow, as applicable.
…Manufacturing feasibility assessments shall include capacity planning
Periodic re-evaluation relative to risk, to incorporate any changes made during process approval, control plan maintenance (see Section 220.127.116.11), and verification of job set-ups (see Section 18.104.22.168).
Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to management reviews