Design & Development Requirements

7.3 Design development 7.3.1 Design development planning and and

7.3.2 Design and development inputs

7.3.3 Design and development outputs

7.3.4 Design and development review

7.3.5 Design development verification

and

7.3.6 Design and development validation

This clause is applicable to all product development and also changes to the product and related process changes. Planning of the product development activities. Ensuring that the plan includes identification of various stages of D&D, responsibilities & authorities of development team members identified. Development plan updated as the activities progress. Proper communication or roles between the various groups involved in the development activities. Evidence of the proper inputs identified for the design Identification of Inputs to address issues like functional or performance requirements of the products, applicable statutory & regulatory requirements, comparison with previous designs or experiments (to derive information from previous experiences) or any other information, which may be critical for the product development. Evidence of review of these requirements or verification of the same to ensure completeness and also ensure that these requirements are unambiguous and not in conflict with each other. Evidence of the outputs being identified for the development activities. Evidence of the outputs being prepared as identified. Evidence of review or verification being conducted to ensure that these outputs meet the input requirements, provide adequate information for purchasing, production and service provision (like specifications for the raw materials as well as product, batch sheets, process sheets, product acceptance criteria, methods of safe & proper use of the product, etc.). Evidence of reviews being conducted as planned during development planning stage. Ensure reviews address or provide evidence of issues or problems faced, which critical for meeting the input requirements. Evidence of implementation of the actions being decided during the design and development reviews. Evidence of verification activities performed to ensure that the outputs at various stages of the development activities are inline with the input requirements. Verifications carried out address all issues pertaining to various input requirements identified. Evidence of records of results of verification activities. These validations include both product and process validation activities. Evidence of verification activities performed to ensure that the product meets all the requirements identified. Validations carried out address all issues pertaining to various input requirements identified. Evidence of records of results of validation activities.

Design & Development Requirements

7.3.7 Control of design and development changes

Ensure changes made in the product or process specifications with proper authorization from relevant functions or departments. Evidence of verification and validation of changes before implementation. Changes made and communicated to all the relevant functions or departments for initiating appropriate actions. Records of reviews and approvals of changes maintained.