Change management within the project meets the customer's specific requirements.Manufacturing feasibility checks on changes are carried out and documented.Changes are highlighted at the right time and agreed with the customer.All changes are documented using a defined process.Changes not initiated by the customer are discussed and agreed with the customer.Where changes have an influence on product quality the risks must be assessed with the customer.Suppliers are actively involved in change management (for critical aspects).Timings for changes to stop are defined and complied with. Any deviations from this rule are agreed in writing between customer and supplier.The period for changes before SOP does not jeopardize productquality.The implementation of changes must be assessed jointly, depending on the time remaining before SOP."