Design Controls Page 1 of 2 Purpose: This document presents two overview illustrations of design control requirements. Design controls are the regulated activities used to ensure that the design input requirements are adequately defined, and the design output documentation provides objective evidence that the design input requirements were correctly translated to a labeled product that fulfills user needs and intended uses.
The first page’s illustration is that of a product’s lifecycle from feasibility to retirement. The second page’s illustration depicts how the design controls interact and overlap each other. It also provides an index to the relevant QMS-SOPs.
Product Life Cycle From Feasibility to Retirement
Feasibility Product Established Retirement
Product Requirements Design Changes Technical Specifications DDP Corrective Actions Design Nonconformances
Development Design Control Production and Customer Complaints Fail Design Review Product Support Verification Risk Analysis and Risk Analysis and Pass Management Management Design Change and Design Change and Product Support Document Revision Document Revision Control Control Process Validation Management of Customer Fail Complaints Corrective Actions Product Launch Product Validation Pass Design Transfer Manufacturing Design Controls Page 2 of 2 Overview of Design Controls: The design inputs are the user needs, intended uses, and the technical characteristics required to realize the user needs and intended uses. After successful verification and validation that the design outputs meet the design inputs, product transfer to production can proceed. Design output is the product itself, the labeling, and the specifications and procedures required to make and QC the product. The Project Team is responsible for the application of the design controls.
The set of specifications and procedures required to make and QC the product is the device master record (DMR). The set of records that provide evidence that the design and development activities were conducted as required is the design history file (DHF).
Perform Risk Management - Human Safety
Apply Design Change and Document Revision Control
Design Input Design Output Design Transfer No System Output Product that Intended Use Environment consistently meets Intended Uses Output Product users needs and User Needs conforms to • Usability Evaluation Validation intended uses. • Workflow Acceptability Input? Yes • Product Performance Product • User Guide Requirements Design and Development Technical Output Design History Planning Technical Test File (DHF)
Development Environment
Design Input Output Yes • Formulations and product Design Requirements conforms to acceptance criteria (BHRs) Verification Input? • Material Specification Device Master Sheets (MSSs) Record (DMR) Technical • Traceability Matrix Requirements • Stability Metrics No • Drawings
Conduct Design Reviews
Establish Design History File (DHF)
Develop Design Master Record (DMR)