FEATURED PRODUCT: Interpretation of FDA's (QSR) With QSIT references
A
complete compendium to FDA's Quality System Regulation (QSR) with relative
references to FDA's Quality System Inspection Technique (QSIT). Now ONLY $99 (limited time)
Search This Site
Design History File (DHF)
There is no specific requirement in ISO 9001 or ISO
13485 for a design history file. However, in order to market a medical device in
the United States, a manufacturer must comply with the U. S. Food and Drug
Administration (FDA) quality system regulation, which requires a design history
file. For this reason, some guidance is provided on the U. S. FDA design history
file.
Other national regulations require some form of documentation and records.
Product documentation required by Canada, Europe, and Japan contain certain
elements of the U. S. FDA design history file requirements without requiring all
the elements to be compiled in a file.
Virtually 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. Throughout this guidance document, suggestions
are made when warranted as to the form and content of documents contained in the
design history file.
The primary beneficiary of the device history file is the device manufacturer.
For example, in one case, a microprocessor-controlled enteral feeding pump was
reported to be behaving erratically in the field. Some of the symptoms pointed
to software problems. But the manufacturer admitted that they did not possess a
copy of the software source code for the product. The software had been
developed by a contractor who had delivered only a master EPROM (memory chip)
which was duplicated by the manufacturer to install the software in each
machine. The contractor had subsequently withdrawn following a contractual
dispute, leaving the manufacturer with no rights to the source code developed by
the contractor, and no practical way to maintain the software. For this and
other reasons, the product was the subject of a mandatory recall and all known
units were collected and destroyed.
This is admittedly an extreme case, but many similar cases have been documented
in which the manufacturer lacked design information necessary to validate a
design and maintain it throughout the product life cycle. This occurs for the
most innocent of reasons-contracts expire, companies reorganize, employees move
on to new projects or new jobs. Even when the designer is available, he or she
may forget why a particular decision was made years, months, or even weeks
before. Since 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.
Except for small projects, it is unusual for all design history documents to be
filed in a single location. For example, 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. 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. These diverse records need not be consolidated at a
single location. 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.
As an example of the level of detail which may be entailed, some manufacturers
have policies covering laboratory notebooks. Manufacturers typically find that
without such written procedures, a breakdown in communications eventually
occurs, resulting in a loss of control. These procedures 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.
There are no requirements on the location or organization of the design history
file. 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.
Based on the structure (or lack thereof) of the product development
organization, more or less extensive controls will be required. For example,
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.
Site Map »
Media package available for advertisers looking to advertise on this site.