Quality Management Systems for Drugs and Devices
25
Quality audits are key elements of any QMS. They
are the means by which an organization can assess
QMS ‘health’ and look to areas needing changes. It is
important to have an annual audit program covering all
QSR aspects. The program is not static changes may
be implemented to address problem areas. An audit
also may be classified as internal or external, depending
on the interrelationships among participants. Internal
audits are performed by employees of your organi-
zation. External audits are performed by an outside
agent. Auditors must be independent of the areas they
are auditing. Further, as noted above, auditors must be
trained appropriately (e.g., ASQ CQA).
Internal (and external) audits can be difficult for
small organizations where “independence” often is not
defined clearly, especially for auditing QMS quality and
regulatory aspects. Typically, small companies engage
external consulting auditors to fulfill both internal and
external audit functions. Any issues (nonconformities)
identified by internal audits should result in corrective
actions. There should be clear input from internal audit
results to management review, and equally clear actions
and justification for those tasks.
The QSR also includes personnel requirements.
There should be sufficient resources for the organiza-
tion’s activities, and the personnel should be educated or
trained appropriately for their roles. Organizations must
have job descriptions for each position, which must be
linked to individual training plans. The QSR has spe-
cific requirements for training personnel to recognize
defects that could occur in relation to the product. This
should be an element of personnel training, and the
link between the potential defects and training to those
issues should be documented. This includes personnel
performing verification and validation activities.
Document and Record Control
When setting up a QMS to meet QSR requirements,
once management has determined the system’s scope,
the document and record control support processes
should be established.
This should include document review and approval
authority and how documents are made available to
all personnel who use them. Changes to documents
also must be controlled and approved, at minimum, by
the same function or personnel approving the original
document. The procedure for record control needs to
include how they are completed to become permanent
records, their retention period in relation to the device’s
life, and how to prevent their destruction. The record
control system must recognize the various types of
records listed in the QSR.
CAPA
The CAPA system is an important QMS element
that the organization must establish and maintain to
meet 21 CFR 820 requirements. Organizations usually
have one CAPA system for action with one procedure.
Organizations can implement very complex systems,
usually based on databases to manage CAPA, but
for smaller organizations, a simpler approach may be
possible. It is important the system inputs come from
all parts of the quality system, not just those related
to product, which often is the focus. The CAPA
processes have defined wide-ranging inputs to cover
all QMS parts. Nonconformity or other potential
quality problem causes that are system inputs must be
investigated and identified in a timely manner. CAPA
processes to prevent recurrence must be planned. It is
necessary to ensure any actions taken will not have an
unanticipated impact on the finished medical device.
CAPA should be linked clearly to management review.
An overview of the issues that are inputs to CAPA,
ensuring they have been implemented effectively,
provides management a real indication of the health of
the QMS for which it is responsible.
Nonconforming product needs to be identified and
controlled to prevent its unintended use or delivery. The
process controls and responsibilities for nonconforming
product must be defined in a documented procedure. This
should include nonconforming product identification,
segregation and disposition. The product must be segre-
gated in a timely manner to ensure it cannot be used, for
25
Quality audits are key elements of any QMS. They
are the means by which an organization can assess
QMS ‘health’ and look to areas needing changes. It is
important to have an annual audit program covering all
QSR aspects. The program is not static changes may
be implemented to address problem areas. An audit
also may be classified as internal or external, depending
on the interrelationships among participants. Internal
audits are performed by employees of your organi-
zation. External audits are performed by an outside
agent. Auditors must be independent of the areas they
are auditing. Further, as noted above, auditors must be
trained appropriately (e.g., ASQ CQA).
Internal (and external) audits can be difficult for
small organizations where “independence” often is not
defined clearly, especially for auditing QMS quality and
regulatory aspects. Typically, small companies engage
external consulting auditors to fulfill both internal and
external audit functions. Any issues (nonconformities)
identified by internal audits should result in corrective
actions. There should be clear input from internal audit
results to management review, and equally clear actions
and justification for those tasks.
The QSR also includes personnel requirements.
There should be sufficient resources for the organiza-
tion’s activities, and the personnel should be educated or
trained appropriately for their roles. Organizations must
have job descriptions for each position, which must be
linked to individual training plans. The QSR has spe-
cific requirements for training personnel to recognize
defects that could occur in relation to the product. This
should be an element of personnel training, and the
link between the potential defects and training to those
issues should be documented. This includes personnel
performing verification and validation activities.
Document and Record Control
When setting up a QMS to meet QSR requirements,
once management has determined the system’s scope,
the document and record control support processes
should be established.
This should include document review and approval
authority and how documents are made available to
all personnel who use them. Changes to documents
also must be controlled and approved, at minimum, by
the same function or personnel approving the original
document. The procedure for record control needs to
include how they are completed to become permanent
records, their retention period in relation to the device’s
life, and how to prevent their destruction. The record
control system must recognize the various types of
records listed in the QSR.
CAPA
The CAPA system is an important QMS element
that the organization must establish and maintain to
meet 21 CFR 820 requirements. Organizations usually
have one CAPA system for action with one procedure.
Organizations can implement very complex systems,
usually based on databases to manage CAPA, but
for smaller organizations, a simpler approach may be
possible. It is important the system inputs come from
all parts of the quality system, not just those related
to product, which often is the focus. The CAPA
processes have defined wide-ranging inputs to cover
all QMS parts. Nonconformity or other potential
quality problem causes that are system inputs must be
investigated and identified in a timely manner. CAPA
processes to prevent recurrence must be planned. It is
necessary to ensure any actions taken will not have an
unanticipated impact on the finished medical device.
CAPA should be linked clearly to management review.
An overview of the issues that are inputs to CAPA,
ensuring they have been implemented effectively,
provides management a real indication of the health of
the QMS for which it is responsible.
Nonconforming product needs to be identified and
controlled to prevent its unintended use or delivery. The
process controls and responsibilities for nonconforming
product must be defined in a documented procedure. This
should include nonconforming product identification,
segregation and disposition. The product must be segre-
gated in a timely manner to ensure it cannot be used, for