This is part two of design and development of products and services
Design and development controls. The company applies controls to the design and development process to ensure that: a) the results to be achieved are defined; b) reviews are conducted to evaluate the ability of the results of the design and development to meet requirements; c) verification activities conducted to ensure that the design and development efforts meet the input requirements, also; d) validation activities are conducted to ensure that the resulting products and services and meet the requirements for the specified application or intended use; e) any necessary actions are taken on problems determined during the reviews, or verification of validation activities; f) documented information of these activities is retained. Design and development reviews, verification validation have distinct purposes. They can be conducted separately or any combination as is suitable for the products and services and of the company.
Design and development outputs. The company ensures design and development outputs: a) meet the input requirements; b) are adequate for the subsequent processes for the provision of products and services; c) included are reference monitoring measuring requirements, as appropriate, and acceptance criteria; d) specify the characteristics of the products and services and that are essential for their intended purpose and their safe and proper provision. The company retains documented information on design and development outputs.
Design and development changes. The company identifies, reviews and controls changes made during or after, the design and development of products and services to the extent necessary to ensure that there is no adverse impact on conformity to requirements. The company retains documented information on: a) design and development changes; b) the results of review; c) the authorisation of changes; d)the actions taken to prevent adverse impacts.
Ok. Ok. The requirements are really based around 3 phases of design. What design controls are required and in place. What outputs will be generated. How to control the inevitable changes. This is not rocket science and unless there are codes to adhere to, regulations to meet, and heaven forbid, client requirements to jump to, KEEP IT SIMPLE. Document, do and change as and when a project needs to.
Remember that this clause can be deemed Not Applicable. And if you deem it, claim it, then you need to justify it. A simple justification is a statement along the lines of…The company does not design and develop our product / service range. Then you record this in a format that is easily retrievable when asked. I keep such statements in the quality manual, a cross reference tables, management review minutes or business plans.