Begin with the intended use
Describe the operation, expected workpiece range, operating environment and the result the equipment must produce. Separate machine acceptance from the qualification of the customer’s manufacturing process.
Agree the documentation scope
- Operating and maintenance instructions, including troubleshooting and routine checks.
- The agreed machine configuration, utilities and installation requirements.
- Software requirements, configuration and test records appropriate to the scope.
- Factory and site acceptance procedures, responsibilities and open-item closure.
- Any customer-required support for installation, operational or performance qualification.
Make acceptance measurable
Define the workpiece sample set, process conditions, acceptance method and the records to retain. Agree how exceptions are reviewed and closed. A general statement that a machine is suitable for medical-device manufacturing does not establish compliance for every device, site or regulated process.
Define responsibilities before delivery
Identify who supplies utilities, process materials, fixtures, reference standards and qualification protocols. Agree training, spare parts and service arrangements for the proposed installation.
Documentation belongs in the equipment conversation.
Bring your required deliverables into the application review so that scope and responsibilities can be agreed.
Discuss the documentation scope