Chapter 1: Setting up a Quality Management System
28
control process. The Global Harmonization Task Force
(GHTF) guidance, GHTF/SG3/N17:2008 Quality
Management Systems—Medical Devices—Guidance on the
Control of Products and Services Obtained from Suppliers,
describes the process of establishing controls for prod-
ucts and services obtained from suppliers and includes
a process flow detailing more information related to
the six phases of working with suppliers throughout a
medical device’s lifecycle.31
Traceability and Identification
Traceability and identification are linked: identifying
the materials and equipment used to provide a product
or service makes traceability possible. Identification
comprises the product lot number or material status.
The QSR documents procedures for identification
throughout product realization, from the organization’s
receipt of materials through finished device delivery and
customer use. The QSR requires an organization to have
a documented traceability procedure. Often, organiza-
tions have a combined traceability and identification
procedure. Where traceability is required, the organiza-
tion must have a record of the item’s identification. The
traceability record will need to be maintained for the
device’s lifetime, and normally the organization’s man-
ufacturing system maintains batch records that provide
lot identification as required in the DHR.
FDA now requires finished, high-risk medical
devices to have unique identification numbers (UDIs).
The facility must be appropriate to maintain the
device’s quality. When a manufacturing facility is being
established, considerations should include:
• how the facility is constructed
• how the equipment is installed
• proper equipment maintenance
• facility cleanliness
• how the product will flow through the facility to
ensure segregation
• facility, utilities, equipment and cleaning
qualification
• work environment influences on product qual-
ity—how the work environment is established,
the process equipment used and the personnel
working within that environment, relating the work
environment to the product, the impact the envi-
ronment can have on the product and the impact of
the health of the employees on the medical device
• equipment and facility calibration and maintenance
Process validation32 means establishing by objective
evidence that a process consistently produces a result or
product meeting its predetermined specifications:
• Where the results of a process cannot be fully
verified by subsequent inspection and testing,
the process shall be validated with a high degree
of assurance and approved according to estab-
lished procedures. The validation activities and
results, including the date and signature of the
individual(s) approving the validation and, where
appropriate, the major equipment validated, shall
be documented.
• Each manufacturer shall establish and maintain
procedures for monitoring and control of process
parameters for validated processes to ensure that
the specified requirements continue to be met.33
Verification confirms by examination and objective
evidence the specified requirements have been fulfilled.
Process validation demonstrates processes’ ability to
meet the planned results. A validation protocol or plan
has to be established and must be approved before
starting validation. This protocol or plan must include
defined criteria the process must meet for successful
validation, including:
• approval of equipment and personnel qualification
• use of specific methods and procedures
• records requirements
• revalidation
A validation master plan is useful in defining the
validation approach for a site or product range as well
as individual processes. For complex or large systems,
a plan can be used to define what processes require
validation and what validations will be performed
28
control process. The Global Harmonization Task Force
(GHTF) guidance, GHTF/SG3/N17:2008 Quality
Management Systems—Medical Devices—Guidance on the
Control of Products and Services Obtained from Suppliers,
describes the process of establishing controls for prod-
ucts and services obtained from suppliers and includes
a process flow detailing more information related to
the six phases of working with suppliers throughout a
medical device’s lifecycle.31
Traceability and Identification
Traceability and identification are linked: identifying
the materials and equipment used to provide a product
or service makes traceability possible. Identification
comprises the product lot number or material status.
The QSR documents procedures for identification
throughout product realization, from the organization’s
receipt of materials through finished device delivery and
customer use. The QSR requires an organization to have
a documented traceability procedure. Often, organiza-
tions have a combined traceability and identification
procedure. Where traceability is required, the organiza-
tion must have a record of the item’s identification. The
traceability record will need to be maintained for the
device’s lifetime, and normally the organization’s man-
ufacturing system maintains batch records that provide
lot identification as required in the DHR.
FDA now requires finished, high-risk medical
devices to have unique identification numbers (UDIs).
The facility must be appropriate to maintain the
device’s quality. When a manufacturing facility is being
established, considerations should include:
• how the facility is constructed
• how the equipment is installed
• proper equipment maintenance
• facility cleanliness
• how the product will flow through the facility to
ensure segregation
• facility, utilities, equipment and cleaning
qualification
• work environment influences on product qual-
ity—how the work environment is established,
the process equipment used and the personnel
working within that environment, relating the work
environment to the product, the impact the envi-
ronment can have on the product and the impact of
the health of the employees on the medical device
• equipment and facility calibration and maintenance
Process validation32 means establishing by objective
evidence that a process consistently produces a result or
product meeting its predetermined specifications:
• Where the results of a process cannot be fully
verified by subsequent inspection and testing,
the process shall be validated with a high degree
of assurance and approved according to estab-
lished procedures. The validation activities and
results, including the date and signature of the
individual(s) approving the validation and, where
appropriate, the major equipment validated, shall
be documented.
• Each manufacturer shall establish and maintain
procedures for monitoring and control of process
parameters for validated processes to ensure that
the specified requirements continue to be met.33
Verification confirms by examination and objective
evidence the specified requirements have been fulfilled.
Process validation demonstrates processes’ ability to
meet the planned results. A validation protocol or plan
has to be established and must be approved before
starting validation. This protocol or plan must include
defined criteria the process must meet for successful
validation, including:
• approval of equipment and personnel qualification
• use of specific methods and procedures
• records requirements
• revalidation
A validation master plan is useful in defining the
validation approach for a site or product range as well
as individual processes. For complex or large systems,
a plan can be used to define what processes require
validation and what validations will be performed