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  Methods to evaluate manufacturing feasibility for new product or new operations to include capacity planning and proposed changes.

The organization shall maintain process effectiveness, including periodic re-evaluation relative to risk, to incorporate any changes made during process approval, control plan maintenance (see Section 8.5.1.1), and verification of job set-ups (see Section 8.5.1.3).

Assessments of manufacturing feasibility and evaluation of capacity planning shall be inputs to management reviews (see ISO 9001, Section 9.3).