15.5 PROC-ENG: Production and Service Provision
 
 
Last Approval by: Jörg Michael Bareiß, 19/Oct/17
Last Update by: Stefan Husta, 19/Oct/17

  1. Control of Production and Service Provision

R-Tech/EU-VRi establishes and maintains production and service provision under controlled conditions to include the following:

 

  • the availability of information that describes the characteristics of the product
  • the availability of work instructions, as necessary
  • the use of suitable equipment
  • the availability of monitoring and measuring devices
  • the implementation of monitoring and measurement
  • the implementation of release, delivery and post-delivery activities

  1. Validation of Processes for Production and Service Provision

R-Tech/EU-VRi validates processes for production and service provision where the resulting output cannot be verified by subsequent monitoring or measurement, to include processes where deficiencies become apparent only after the product is in use or the service has been delivered. The validation shall demonstrate the ability of these processes to achieve planned results.

R-Tech/EU-VRi establishes arrangements for these processes including:

 

  • defined criteria for review and approval of the processes
  • approval of equipment and qualification of personnel
  • use of specific methods and procedures
  • requirements for procedures
  • re-validation

  1. Identification and Traceability

R-Tech/EU-VRi establishes, implements and maintains the appropriate documented procedures for Product Identification and Traceability, during all stages of product realization.

The PM is responsible for Product Identification and Traceability. Products are identified during all stages of production.

Traceability is provided to the extent that internal and external requirements and/or contracts specify. Traceability records are maintained for items requiring traceability.

  1. Customer Property

R-Tech/EU-VRi establishes, implements and maintains documented procedures for the verification of products/materials provided by the customer for incorporation into finished goods.

Acceptable customer supplied material is stored and maintained to prevent damage, deterioration or loss. The CEO is responsible for the control of Customer-Supplied property and documents damage to such and reports it to the customer.