8.5 Production and service provision
 
 

R-Tech/EU-VRi reviews the processes needed for Product Realization in accordance with the requirements of other processes of the Quality Management System.
The following is determined with output provided in a form according to standard methods of operation:

  • quality objectives and requirements for the product
  • the need to establish processes, documents, and provide resources specific to the product
  • the required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance
  • records needed to provide evidence that the realization processes and resulting product meet necessary requirements

 

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

 

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.

  

Property belonging to customers or external providers

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.

 

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 

 

Preservation

PM's follow the project and product realization procedures which dictates how to document all requirements, assessments and feedback on the file server and Walter.

PROC-GP: Document Management

How to manage documents in the server WALTER 

 

Post-delivery activities

Focusing on customer satisfaction and feedback; please refer to the corresponding chapter.

 

Control of changes

R-Tech/EU-VRi identifies design and development changes, and records are maintained. The changes are reviewed, verified and validated as appropriate and approved before implementation. The review of design and development changes includes evaluation of the effect of the changes on constituent parts and products already delivered.

 

Records of the results of changes and any necessary actions are maintained.