Page 68 - Biomedical Engineering and Design Handbook Volume 2, Applications

FDA MEDICAL DEVICE REQUIREMENTS 47

(5) Design transfer
Design transfer is the process of translating the device design into production specifications.
This must be done under controlled written procedures. This step in the design control process
is meant to avoid what engineer’s jokingly call “throwing the design over the wall” to manufac-
turing compatriots. In the regulated FDA environment, this step is critical in ensuring that no
requirements are lost in the transfer. It is critical that the manufacturing procedures and the atten-
dant tests, actually confirm the elements of the design output.

Subpart D: Document Controls. The many references above to written procedures and records
show the importance of controlling documents within a quality system. An essential element of your
quality system is a procedure to control your procedures. Such a system includes a numbering
method for documents, a revision control method for tracking changes and identifying the current
version, and an approval method for review and approval of the original document and changes.
First, you need personnel and a system:

Each manufacturer shall designate an individual(s) to review for adequacy and approve prior to issuance
all documents established to meet the requirements of this part. The approval, including the date and
signature of the individual(s) approving the document, shall be documented.
Id. § 820.40(a).

Then you need a process for making the documents available where needed, and to update as
needed:

Documents established to meet the requirements of this part shall be available at all locations for which
they are designated, used, or otherwise necessary, and all obsolete documents shall be promptly removed
from all points of use or otherwise prevented from unintended use.
Id.

Traditionally, procedures were made available in paper copy. This required vigilance in replacing
manuals as they were updated. Many companies have moved to electronic systems that automatically
update controlled documents so that users can only access the current version preventing mishaps.
Updating the documents can be a time-consuming, and perhaps thankless task, but is required:

Changes to documents shall be reviewed and approved by an individual(s) in the same function or orga-
nization that performed the original review and approval, unless specifically designated otherwise.
Approved changes shall be communicated to the appropriate personnel in a timely manner.
Id. § 820.40(b).

The critical part of system design is to create a change-control system wherein the entire history
of changes to a document can be recorded for later reconstruction:

Each manufacturer shall maintain records of changes to documents. Change records shall include a
description of the change, identification of the affected documents, the signature of the approving indi-
vidual(s), the approval date, and when the change becomes effective.
Id.

Subpart E: Purchasing Controls. Purchasing controls are growing more important since compa-
nies are outsourcing more activities. The modern virtual company is still responsible for its quality