Design and Development

1. Design and Development ISO 9001 Section 7.3

2. Requirements • Planning • Stages of design • Review, verification and validation appropriate • Responsibilities and authorities • Design Inputs • Performance requirements • Statutory and regulatory requirements • Information from previous similar designs • Other requirements www.rosehillsystems.com

3. Requirements • Design Outputs • Must meet the input requirements • Must provide appropriate information necessary for purchasing, production and service • Must reference product acceptance criteria • Must specify characteristics essential for safe use • Design outputs are usually in the form of an engineering drawing or specification created by the Hope designer www.rosehillsystems.com

4. Requirements • Design review • Must evaluate the ability of the design to meet requirements • Identify problems and propose solutions • Records of design reviews must be maintained • Must involve all concerned parties • Design verification • A verification step must occur that assures that the design outputs meet the input requirements • Design verification records must be maintained www.rosehillsystems.com

5. Requirements • Design Validation • Ensures that the product is capable of meeting requirements • Records of design validation must be created • Design changes • Must be identified • Records must be kept (ECNs) • Effect of changes on components or product already delivered must be reviewed www.rosehillsystems.com

6. Design Planning For organizations whose designs are simple, and products are similar, a design plan could be in the form of a procedure, flow chart or checklist. For organizations whose designs vary widely and / or are complex, a design plan should be created for each design. www.rosehillsystems.com

7. Design Inputs • Design requirements can come from many sources including: • Customers • Sales force • Marketing • Research • Design requirements become the inputs to the design and include: • Performance requirements • Regulatory requirements • Information from previous similar designs • Other requirements • Inputs must be complete, unambiguous and should not conflict with each other • Input reviews must occur www.rosehillsystems.com

8. Design Outputs Design outputs are typically in the form of specifications or drawings The form of the outputs must allow for verification of the outputs against the design inputs (design verification) Design outputs must be approved before they are released Design outputs must provide information appropriate for purchasing, production and service Design outputs must include acceptance criteria www.rosehillsystems.com

9. Design Verification Design outputs must be verified against design inputs Design verifications must be recorded A compliance matrix is a good way to show that all input requirements have been addressed in the design outputs www.rosehillsystems.com

10. Design Review • Design review should include all concerned parties and might include: • Design engineering • Manufacturing engineering • Sales • Marketing • Research • customer • Design reviews should occur as indicated in the design plan and must be documented. • Design reviews should indicate any problems and propose actions to eliminate them. www.rosehillsystems.com

11. Design Validation Design validation involves manufacturing a product to the design and testing it to determine if it meets the performance criteria For a job shop it means build and test the product For a company that will produce a product in volume, it means a pilot production run to determine if the product meets expectations www.rosehillsystems.com

12. Design changes Records of design changes must be maintained Engineering Change Notices (ECNs) are a typical vehicle for recording changes Changes must be verified, validated and approved before implementation The effect of design changes on other component parts of the design must be evaluated. www.rosehillsystems.com