Quality Management Systems for Drugs and Devices
27
the device development process and ensuring user and
product requirements are met, and, at a management
level, assessing the decisions made allowing the device
to move from one design control phase to the next. The
reviews should consider whether the device is on track
to be safe and effective. Often linked to the reviews,
the device risk analysis will be revisited to ensure risks
remain as expected for the development stage, and no
unresolvable new risks have been introduced.
Figure 1-10 demonstrates these linkages. The inputs
are the user requirements, which also include regulatory
requirements, with the device as part of the output.
Production and Process Control
Production and process control, equipment and facility
control, and material control cover how the device
is manufactured or supplied in a controlled way and
all the processes bringing the device to the customer.
These include purchasing materials and services,
production and manufacturing and device delivery, the
facility and calibration and maintenance of equipment
used in these processes.
Purchasing
Requirements for purchasing materials or services
include identifying, evaluating and managing suppliers.
Supplier management is part of the purchasing
process and includes selecting, evaluating, and moni-
toring (re-evaluating) suppliers. The amount of control
required for suppliers depends on the risk and nature
of the product or service being supplied, e.g., con-
trol over the supply of a catalogue item like a simple
chemical will be very different from a critical medi-
cal device component. New products or services or a
product or service change would need to be considered
during the design and development process or change
Figure 1-10. Design Process
Design
Validation
User
Requirements
Design Input
Design Process
Design Output
Product
Design
Verification
Review
27
the device development process and ensuring user and
product requirements are met, and, at a management
level, assessing the decisions made allowing the device
to move from one design control phase to the next. The
reviews should consider whether the device is on track
to be safe and effective. Often linked to the reviews,
the device risk analysis will be revisited to ensure risks
remain as expected for the development stage, and no
unresolvable new risks have been introduced.
Figure 1-10 demonstrates these linkages. The inputs
are the user requirements, which also include regulatory
requirements, with the device as part of the output.
Production and Process Control
Production and process control, equipment and facility
control, and material control cover how the device
is manufactured or supplied in a controlled way and
all the processes bringing the device to the customer.
These include purchasing materials and services,
production and manufacturing and device delivery, the
facility and calibration and maintenance of equipment
used in these processes.
Purchasing
Requirements for purchasing materials or services
include identifying, evaluating and managing suppliers.
Supplier management is part of the purchasing
process and includes selecting, evaluating, and moni-
toring (re-evaluating) suppliers. The amount of control
required for suppliers depends on the risk and nature
of the product or service being supplied, e.g., con-
trol over the supply of a catalogue item like a simple
chemical will be very different from a critical medi-
cal device component. New products or services or a
product or service change would need to be considered
during the design and development process or change
Figure 1-10. Design Process
Design
Validation
User
Requirements
Design Input
Design Process
Design Output
Product
Design
Verification
Review