Each manufacturer shall establish and maintain a [[Design History File]] (DHF) for each type of device. 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.
!Attention points
* Every section of the design control requirements specifies information which should be recorded.  The compilation of these records is sometimes referred to as the ''design history file''
* These diverse records need not be consolidated at a single location! There are ''no requirements on the location or organization of the design history file.''
** The intent is simply that manufacturers have access to the information when it is needed. 
** If a manufacturer has established procedures for multiple filing systems which together satisfy that intent, there is no need to create additional procedures or records.
* Example documents that can be part of the Design History File:
** The design controls procedures, forms and guidelines
** Executed forms that identify design control departments or activities
** Executed forms that identify design and development teams
** Executed forms that identify design and development interfaces
** Executed forms that identify design and development change requests
** All [[Product Proposals]]
** All general device requirements
** All [[Design Input Documentation Control Matrix]]es
** All detailed [[Design Input]] documents
** All [[Design Input Requirements Control Matrix]]es
** All [[Design Output Documentation Control Matrix]]es
** All general device specifications
** All [[Design Output Specifications Control Matrix]]es
** All detailed [[Design Output]] documents
** All design development stage identification
** All review and approval cover sheets
** All design review checklists
** All design review notes/minutes
** All master verification plans and design verification checklists
** All verification test plans
** All master validation plans and design validation checklists
** All validation test plans
** A copy of the [[Design Transfer Checklist]]
** All change requests and design change checklists
!Project size
Based on the structure (or lack thereof) of the product development organization, more or less extensive controls will be required:
* As design decisions often directly affect the well-being of device users and patients, it is to the manufacturer’s benefit to maintain the knowledge base which forms a basis for the product design.
** Quality system plans applicable to a development project may reside in the quality assurance department, while the chief engineer may be responsible for maintaining design and development plans.
** In some cases, especially for simple designs, the designer will assemble and maintain the entire design history file.
** For larger projects, a document control system will likely be established for design documents, and these files will likely be maintained in some central location, usually within the product development department
!Laboratory notebooks
* Company policy should state unequivocally that all design history documentation is the property of the manufacturer, not the employee or contractor.
** Design and development contracts should explicitly specify the manufacturer’s right to design information and establish standards for the form and content of design documentation.
** Finally, certain basic design information may be maintained in a single project file in a specified location.  This may include the following: 
** Detailed design and development plan specifying design tasks and deliverables.
** Copies of approved design input documents and design output documents.
**  Documentation of design reviews.
** Validation documentation.
** When applicable, copies of controlled design documents and change control records
* Many design engineers maintain laboratory notebooks which are typically retained in the engineers’ personal files.  In addition, the design history may include memoranda and electronic mail correspondence which are stored at various physical locations.
* As an example of the level of detail which may be entailed, some manufacturers have policies covering laboratory notebooks procedures which might address the following points.
** Laboratory notebooks are the property of the manufacturer, not the individual
** A separate notebook is to be maintained for each project, and surrendered to the engineering librarian at the conclusion of the engineer’s active participation in the project.
** Laboratory notebooks are to be surrendered if the employee leaves the company.
** Product development supervisors shall review employees’ laboratory notebooks at specified intervals to ensure that records are complete, accurate, and legible. *
bag
fda_public
created
Sun, 22 Jul 2012 18:36:32 GMT
creator
dirkjan
modified
Sun, 22 Jul 2012 18:36:32 GMT
modifier
dirkjan
tags
CFR
CFR 21-820.30
Design Controls
FDA
Quality System Requirements
Section
creator
dirkjan