Section 14 of 50
12. Manufacturing System Boundaries
Stable section ID: S05-CON-012-SECTION-14 · 26 content blocks
Every System05 manufacturing activity shall define its system boundaries.
Boundaries may separate:
- Engineering design from manufacturing planning.
- Supplier responsibility from manufacturer responsibility.
- Manufacturing from assembly.
- Factory acceptance from site acceptance.
- Product release from building installation.
- Hardware from software.
- standardized Interface from proprietary implementation.
- manufacturer quality control from independent certification.
- temporary production state from released product state.
Each boundary shall identify:
- Inputs.
- outputs.
- responsible authority.
- required information.
- acceptance conditions.
- evidence transfer.
- unresolved risks.
- change-control obligations.
A manufacturer shall be responsible for processes within its declared production boundary and for verifying that received inputs meet the conditions required for its work.
Receipt of a supplier certificate shall not automatically transfer all responsibility to the supplier. The receiving manufacturer shall perform verification appropriate to the consequence, supplier qualification, material risk, and available evidence.
Where multiple organizations contribute to one product, responsibility for final configuration, product genealogy, and production release shall be explicitly assigned.
Site fabrication shall be treated as manufacturing when it creates or materially modifies product characteristics before installation. It shall not escape manufacturing controls merely because it occurs at the construction site.
Field adjustment shall be distinguished from manufacturing. Permitted field adjustments shall be defined in advance, including their limits, tooling, inspection, and recording requirements.
No gap between organizational boundaries shall be allowed to create unowned quality obligations.