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8.3 Design and Development of Products and Services

8.3.1 General

AGE conducts design and development activities to define and deliver products that meet customer and regulatory requirements. Design activities are planned, controlled, and documented throughout the product development lifecycle.

8.3.2 Design & Development Planning

Design Engineering and Project Management, together, plan and document each design project and clearly define design activity. As the design evolves, design and implementation plans are reviewed and updated as required. Control of overall design activities will be maintained throughout the design review process.

Reference: QSP-8.3.2 and QSF-8.3.2 — Design and Development Policy

8.3.3 Design & Development Inputs

Design requirements are identified, specified, communicated and reviewed according to the Design and Development Policy. The design is developed after the contract review is complete. During this phase:

  • Functional and performance requirements are defined
  • Applicable statutory and regulatory requirements essential for design, development and safety are reviewed

8.3.4 Design & Development Control

Design reviews shall be performed in accordance with the design and development plan and shall ensure that the design outputs meet the input requirements. The intention of such reviews shall be to:

  • Check adequacy of the outputs
  • Proactively identify any potential shortcomings prior to release

Formally documented reviews will be held where applicable and the results logged for that project under itemized action lists. The participation of other departmental personnel shall be considered if required. When required by contract terms or by request, a Customer design review meeting shall be held.

  • Design stage outputs shall be verified to ensure they meet the input requirements. Records of verifications are maintained.
  • Design validation shall be performed where applicable to ensure the resulting product meets the requirements specified for its application or intended use. All validation results shall be maintained as Quality records.

8.3.5 Design & Development Outputs

The design and development outputs shall:

  • Meet the design input requirements
  • Provide appropriate information for purchasing, production and, if applicable, product service
  • Specify essential characteristics
  • Specify any applicable test and acceptance criteria
  • Specify any applicable validation tests

Reviews shall be conducted and logged before the release of the documents. These reviews on new designs should include as a minimum personnel from:

  • Manufacturing
  • Quality
  • Sales
  • Purchasing

When appropriate, the customer’s representative shall participate.

Design output data shall be in the form of:

  • Drawings
  • Bill of Materials (BOM)
  • Schematics
  • Mechanical models
  • Assembly data
  • Component data sheets
  • Acceptance criteria

8.3.6 Design & Development Changes

All design changes and modifications must be:

  1. Identified
  2. Documented
  3. Reviewed
  4. Approved before being implemented