Quality Management Documents & Templates
Design History File (DHF)
Design Review
A documented, comprehensive, systematic examination of a design to evaluate the adequacy of the design requirements, to evaluate the capability of the design to meet those requirements, and to identify problems.
Design History File
A compilation of Records that describes the design history of a Finished Product.
Design Review Committee
A representative group designated at the initiation of Design Control consisting of all functions supporting the design, development, and manufacturing of a Product.
Medical Device
Medical device, components and finished medical device.
Risk Analysis
A systematic use of available information to identify Hazards and to estimate the Risk.
7 PROCEDURE The Quality System Regulation (QSR) requires that the DHF shall contain or reference the records necessary to demonstrate that the design was developed in accordance with the approved design plan and the requirements of this part. This requirement will be met by maintaining plans that meet the design control requirements. The plans and subsequent updates must be part of the DHF. The results of the design verification, including identification of the design, method(s), the date, and the individual(s) performing the verification, must be documented in the DHF. The DHF contains documents such as the design plans and input requirements, preliminary input specs, validation data and preliminary versions of key DMR documents. These are needed to show that plans were created, followed and specifications were met. 7.1
General Maintenance of Design History File
The DHF must be maintained for each medical devices project once the COMPANY decided to develop under Design Control or as required by 21 CFR Part 820, Quality System Regulation. Project Leader/ Head of Engineering maintains the DHF file while the during the whole design project including successful transfer where applicable and ensures confidentiality of the file and must enter the title of each document that is put into the DHF into the Design History File Table of Contents. All design documentation is stored and organized in a manner to facilitate full traceability and document retrieval and prevent the inadvertent loss of records. 7.2
Content of the DHF
Document Type
Document ID
Version
Status
Page
SOP
XX_WWW_ZZZ_YYYY
1.0
Approved
6/9
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