Page 69 - Biomedical Engineering and Design Handbook Volume 2, Applications

48 MEDICAL DEVICE DESIGN

system and the quality of its products. The actual work involved in creating those products may be
outside the corporate structure. Purchasing controls are what tie together the responsibilities for QSR
compliance.
A purchasing system must have procedures to
(1) Evaluate and select potential suppliers, contractors, and consultants on the basis of their ability to
meet specified requirements, including quality requirements. The evaluation shall be documented.
(2) Define the type and extent of control to be exercised over the product, services, suppliers, contrac-
tors, and consultants, based on the evaluation results.
(3) Establish and maintain records of acceptable suppliers, contractors, and consultants.
Id. § 820.50(a).

You must establish contracts controlling the suppliers that include your quality requirements.
These contracts must specify that the supplier will notify you of any changes that might affect qual-
ity. These supplier contracts are a major link between your quality system and the place of actual
production. It is critical that they correctly lay out responsibilities.

Subpart F: Identification and Traceability. You must have a way to follow your product during
all stages of receipt, production, distribution, and installation to prevent mix-ups. Usually this is done
by either lot control or by individual serial numbers on product. While higher-risk PMA products
usually carry serial numbers, the vast majority of medical devices are traced by lot.
The importance of lot control becomes apparent the first time you have an issue in manufactur-
ing. If you later discover, for example, that you have received a shipment of raw material or compo-
nents that does not meet specifications, it is necessary to trace back and find every product in which
it was used. Without identification procedures this could be impossible. If a recall is needed due to
a bad lot of raw material, you would have to recall all of your product unless you could narrow it
down through your lot-control process.
While the regulation only requires such control for “a device that is intended for surgical implant
into the body or to support or sustain life and whose failure to perform when properly used in accor-
dance with instructions for use provided in the labeling can be reasonably expected to result in a sig-
∗
nificant injury to the user,” it is recommended for all products so that you can trace any problems
back to a limited lot of goods.
Subpart G: Production and Process Controls. This is the part of the QSR with which most lay peo-
ple are aware. It is the heart of the old GMP. This subpart controls the actual manufacturing of devices.
The underlying principle of subpart G is that a manufacturer has to establish and maintain pro-
duction processes that produce devices that meet specification. This control is built into the system
to prevent deviations from specification. Process controls include
(1) Documented instructions, standard operating procedures (SOPs), and methods that define and control
the manner of production;
(2) Monitoring and control of process parameters and component and device characteristics during pro-
duction;
(3) Compliance with specified reference standards or codes;
(4) The approval of processes and process equipment; and
(5) Criteria for workmanship which shall be expressed in documented standards or by means of identi-
fied and approved representative samples.
Id. § 820.70(a).

This system of procedures must include a controlled method for making changes, including doing
all the testing needed to verify or validate a change before it is implemented.

∗
Id. § 820.65.