Design Control By Neal Stiemert One of the elements in the ISO 9001:2000 standard is design control. The design control process is very importnat because our products cannot perform their intended function if the design is inadequate. Above all, DO NOT FAIL TO VALIDATE YOUR DESIGN!! Unless you like product recalls, high warranty costs, returns, customer complaints and lawsuits; do not rush a product to the market until you have tested your product in the environment and conditions that it will be used. Unless you design and manufacture atomic bombs or caskets, you should be able to perform validation testing under actual use conditions. This month, I will provide you with a sample procedure to satisfy the design control requirement that may help you to have an effective design control process. Sample Procedure for Design Control: Quality Are Us Operating Procedure Title: Design Control No. XX           Rev. A Approved by:   Johnny Quality                               Date:   2/20/04           SCOPE: This Procedure describes the process that Quality are Us follows to design new products. 1.0       DESIGN INPUT INFORMATION The responsible project manager is responsible for design control and coordination of all design activities for each assigned project. Design requirements for a new design are defined by any or all of the following:   •   Input from Quality are Us personnel.   •   Customer Input Information.   •   Design input information is entered on a Design Input Information Form and is retained as part of the design history record. 2.0       CREATE A DESIGN HISTORY RECORD A design history record is initiated for each design where all design information is maintained. 3.0       CREATE DESIGN PLAN Quality are Us prepares a Design Plan for each design. The interfaces between the participating groups are managed to ensure effective communication and assignment of responsibility. Quality are Us determines and defines the following for each design and development project:   •   The design and development stages including review, verification and validation.   •   The design and development responsibilities and authorities for each stage. Where appropriate, design and development plans, related documents and responsibilities are updated as the design and development evolves. The design plan includes the following:   •   Design timeline.   •   Design activities.   •   Assignment of design responsibilities. 4.0       CREATE DOCUMENTATION The output of design input is the documentation necessary to build the product and to verify the quality characteristics. Designs are documented to contain acceptance criteria in a manner that can be validated and verified against the design-input information. Design output documentation shall meet design-input information. Copies of all documentation are retained in the design history record. Design documents include the following:   •   Performance criteria.   •   Drawings.   •   Specifications.   •   Inspection and test documents.   •   Bill of materials.   •   Product instructions. 5.0       DESIGN REVIEW AND VERIFICATION The design and related documentation is reviewed and verified at stages defined in the design plan by all involved functions. Designs are reviewed to assure that the design is evolving as planned, at intervals prescribed by the Project Manager. Design verifications may be achieved by:   •   Calculations.   •   Testing.   •   Comparison with similar proven designs. Records of the design review and verification are recorded on a Design Review and Verification Form. 6.0       PRODUCT EVALUATION AND VALIDATION Designs are evaluated and validated by inspection and testing of finished product or prototypes. If changes are necessary for the product or documentation, it is done after the evaluation. Results of the evaluation and validation are documented on a Design Validation Form. 7.0       RELEASE FOR PRODUCTION After evaluation and validation, the product is released for production. Design changes are reviewed and approved by the personnel responsible for the changes. Records of design changes are retained by Document Control and/or Engineering. All affected personnel are notified of changes. End of Document Here are copies of the various Design Control forms in PDF format:   Design Control Operating Procedures   Design Input Information Form   Design Plan   Design Validation Form   Design Review & Verification Form I hope this information helps you with your transition. Feel free to contact me with any questions at 800-959-0632. Neal D. Stiemert President Independent Quality Consultants, Inc. About the Author Neal D. Stiemert is President of Independent Quality Consultants, Inc. and holds a Bachelor of Science degree from Indiana University school of business. Neal is an ASQ Certified Quality Engineer, a Certified Lead Auditor and has over 24 years of management, auditing, consulting and training experience in the quality profession. Neal has served as an examiner for the Minnesota Quality Award, an SPC Instructor at Purdue University and an officer and committee member in the Chicago and Minnesota sections of ASQ. Neal also conducts registration audits for Smithers Quality Assessments and SAI Global Assurance Services. Comment on this article