Design Controls & Quality Systems Flashcards
What are design controls and why are they important?
Design controls are procedures to ensure that design requirements for a device are established and met throughout product development. They help ensure devices are safe and effective for their intended use by translating user needs into product specifications and validating that the final product meets those needs.
List the key elements of design controls according to 21 CFR 820.30
- Design and development planning
- Design input
- Design output
- Design review
- Design verification
- Design validation
- Design transfer
- Design changes
- Design history file
What is the difference between design verification and design validation?
Design verification confirms that design outputs meet design inputs (Are we building the product right?). Design validation confirms that the device meets defined user needs and intended uses (Are we building the right product?). Validation is performed under actual or simulated use conditions.
What is a Design History File (DHF)?
The DHF contains or references the records necessary to demonstrate that the design was developed in accordance with the approved design plan and applicable regulatory requirements. It includes design and development history for a specific product or product family.
What is a Device Master Record (DMR)?
The DMR is a compilation of records containing the procedures and specifications for a finished device, including device specifications, production process specifications, quality assurance procedures, packaging and labeling specifications, and installation/maintenance procedures.
What is a Device History Record (DHR)?
The DHR is a compilation of records containing the production history of a finished device, including manufacturing dates, quantity manufactured, quantity released for distribution, acceptance records, and identification of primary labels and labeling.
What is ISO 13485 and how does it relate to FDA’s QSR?
ISO 13485 is an international standard that specifies requirements for a quality management system for medical devices. While it has similarities to FDA’s QSR (21 CFR 820), they are not identical. ISO 13485 is recognized globally, while QSR is specific to the US. FDA is working on harmonizing QSR with ISO 13485.
What is a Corrective and Preventive Action (CAPA) system?
A CAPA system is a set of procedures for identifying, investigating, and correcting actual quality problems (corrective action) and preventing potential quality problems (preventive action). It’s a critical component of a quality management system required by 21 CFR 820.100.
What is Process Validation?
Process validation is establishing by objective evidence that a process consistently produces a result or product meeting predetermined specifications. It typically includes installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
What is a quality audit?
A quality audit is a systematic, independent examination of a quality system to determine whether quality activities and related results comply with planned arrangements, are implemented effectively, and are suitable to achieve objectives. It helps identify deficiencies and opportunities for improvement.
