15.3 PROC-ENG: Design and Development
 
 
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.