A Systems-Oriented Approach to Auditing the Design Controls Process

Abstract

Design Validation Auditors should confirm that the procedures in place controlling design validation are linked with design verification activities from a standpoint of assuring the success of this testing phase versus the essential requirements and acceptance criteria. Failing to assure that this objective evidence is in place can create a major void in the audit plan and the ultimate credibility of the design validation and ensuing data. This particular part of the total design controls process is linked strongly with production of product for use during this validation. Design validation shall ensure that devices conform to defined user needs and intended uses, and shall include testing of production units or their equivalent under actual or simulated use conditions. This rationale for design validation is not only auditable, but sets the stage for a linkage with process validation, ongoing confirmation of acceptable acceptance activities during manufacturing, and a defined basis for establishing the device master record. Design validation also includes software validation and risk analysis as part of the audit planning stage. The actual validation project is commonly protocol-driven and reports are summarily generated. For examples of auditable points during the design validation process, see Figure 1. Design Changes The details of the change-control system are left to the manufacturer to develop, document, and implement. As the design activity progresses toward the final stage, it is expected that the degree of change-control will increase. This is a fact that each audit checklist at every design phase needs to include to assure that changes made during the design control process are controlled and documented. The objective evidence will eventually be located in the design history file (DHF) and must have traceability not only to the change, but also to the ramifications of this change during design and, subsequently, in the quality management system. Because these following elements are under change-control, auditing the effects of the changes A Systems-Oriented Approach to Auditing the Design Controls Process: Part 2