S105 - Section 184.108.40.206: Manufacturing process audit
| All manufacturing processes must be audited over each three-year period to determine their effectiveness and efficiency using customer-specific required approaches for process audits.
If not defined by the customer, the organization determines the approach used.
Each individual audit, each manufacturing process must be audited on all shifts where it occurs, including the appropriate sampling of the shift handover.
Includes an audit of the effective implementation of the PFMEA, control plan, and associated documents.