http://www.risk-technologies.comhttp://www.risk-technologies.comhttp://www.eu-vri.euhttp://www.steinbeis.de
 
 
https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2585&pag=627&nr=15#bl4263
Last Approval by: Jörg Michael Bareiß, 19/Oct/17
Last Update by: Eduardo M. Schuch, 27/Aug/14

Engineering, Products and Services

 
 
15.1 PROC-ENG: Planning of Product Realization
 
 
https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2585&pag=627&nr=15#bl1168
Last Approval by: Jörg Michael Bareiß, 19/Oct/17
Last Update by: Stefan Husta, 18/Oct/17

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

 
   
 
 
15.2 PROC-ENG: Customer-Related Processes
 
 
https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2585&pag=627&nr=15#bl1169
Last Approval by: Jörg Michael Bareiß, 19/Oct/17
Last Update by: Stefan Husta, 18/Oct/17

  1. Determination of Requirements Related to the Product

R-Tech/EU-VRi determines the following:

 

  • the requirements specified by the customer, including the requirements for delivery and post-delivery activities
  • the requirements not stated by the customer but necessary for specified or intended use, where such are known
  • statutory and regulatory requirements related to the product
  • any additional requirements determined by the organization

  1. Review of Requirements Related to the Product

R-Tech/EU-VRi reviews the requirements related to the product prior to contracting with a customer and ensures that:

 

  • product requirements are defined
  • contract or order requirements differing from those previously expressed are resolved
  • the defined requirements can be achieved

R-Tech/EU-VRi maintains records of the results of reviews and actions arising from the review.

R-Tech/EU-VRi confirms product requirements with the customer when no documented statement is provided and ensures that relevant documents are amended and relevant personnel are notified of any changes or modifications.

 

  1. Customer Communication

R-Tech/EU-VRi reviews and implements effective methods of communicating with customers in relation to product information, enquiries, contracts or order handling, including amendments, customer feedback and customer complaints.


 
   
 
 
15.3 PROC-ENG: Design and Development
 
 
https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2585&pag=627&nr=15#bl1170
Last Approval by: Jörg Michael Bareiß, 19/Oct/17
Last Update by: Stefan Husta, 18/Oct/17

  1. Design and Development Planning

R-Tech/EU-VRi plans and controls the design and development of products and manages the interfaces between different groups involved to ensure communication by determining:

  • the design and development stages
  • the review, verification and validation that are appropriate to each design and development stage
  • the responsibilities and authorities for design and development

Planning output is updated as the design and development progresses.

  1. Design and Development Inputs

R-Tech/EU-VRi determines inputs relating to product design and development to include:

  • functional and performance requirements
  • applicable statutory and regulatory requirements
  • where applicable, information derived from previous similar designs
  • other requirements essential for design and development

These inputs are reviewed for adequacy and are complete, unambiguous and do not conflict.

  1. Design and Development Outputs

R-Tech/EU-VRi provides the outputs in a form that enables verification against the design and development input, which are approved prior to release.

These design and development outputs shall:

  • meet the input requirements for design and development
  • provide appropriate information for purchasing, production and for service provision
  • contain of reference product acceptance criteria
  • specify the characteristics of the product that are essential for its safe and proper use.

  1. Design and Development Review

R-Tech/EU-VRi performs systematic reviews of design and development in accordance with planned arrangements to:

  • evaluate the ability of the results of design and development to meet requirements
  • identify and problems and propose necessary actions
 
Reviews include representatives of functions concerned with the design and development stages being reviewed and records of the results and necessary actions are maintained.

  1. Design and Development Verification

R-Tech/EU-VRi performs verification of design and development in accordance with planned arrangements to ensure that the design and development outputs have met the design and development input requirements. Records of the results of the verification and necessary actions are maintained.

  1. Design and Development Validation

 

R-Tech/EU-VRi performs validation of design and development in accordance with planned arrangements to ensure that the resulting product is capable of meeting the requirements for the known or specified application, (intended use).

Design and development validation is completed prior to delivery unless otherwise specified. Records of the results of validation and necessary actions are maintained.

  1. Control of Design and Development 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.

 


 
   
 
 
15.4 PROC-ENG: Vertification of Purchased Product
 
 
https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2585&pag=627&nr=15#bl1171
Last Approval by: Jörg Michael Bareiß, 19/Oct/17
Last Update by: Stefan Husta, 18/Oct/17

R-Tech/EU-VRi ensures that purchased products meet specified purchase requirements in accordance with quality procedures. The verification of purchased parts, materials and services, including purchaser-supplied material, are the responsibility of the Receiving Inspection Personnel.

Purchased products that are to be inspected or verified at the supplier's facility require special arrangements from R-Tech/EU-VRi's purchasing department.
 
   
 
 
15.5 PROC-ENG: Production and Service Provision
 
 
https://www.risk-technologies.com/home.aspx?lan=230&tab=339&itm=2585&pag=627&nr=15#bl1172
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.