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Case for Quality Company D
Risk Management
Risk Management
2
Introduction to Risk Management procedure at Company X
Establishes requirements for
Risk Management of Medical Devices
with regards to Safety
for patients, medical device users, and other persons (as well as property and the environment).
Risk – Combination of the probability of occurrence of harm and the severity of that harm. [ISO 14971]
Risk Management – Systematic application of management policies, procedures and practices to the tasks of analyzing, evaluating, controlling and monitoring risk. [ISO14971].
Safety – Freedom from unacceptable risk. [ISO 14971]
People exposed to medical devices after
production.
Risk Management
3
Scope of Procedure Applies throughout the entire lifecycle
of medical devices
and medical systems
for which Company X is the manufacturer
Lifecycle – All phases in the life of a medical device, from the initial conception to final decommissioning and disposal. [ISO 14971]
Medical Device – Any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of (1) diagnosis, prevention, monitoring, treatment or alleviation of disease, (2) diagnosis, monitoring, treatment, alleviation of or compensation for an injury, (3) investigation, replacement, modification, or support of the anatomy or of a physiological process, (4) supporting or sustaining life, (5) control of contraception, (6) disinfection of medical devices, (7) providing information for medical purposes by means of in vitro examination of specimens derived from the human body; and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. [ISO 14971]
Medical system – System containing at least one medical device
Risk Management
4
Risk Management Team – Team responsible for the review of risk management activities (within a defined scope).
The Risk Management Team is a subset of the Project Team (both pre-launch and post-launch)
Typical roles: Quality Engineer, Design Engineer, Manufacturing Engineer, Marketing Rep, Clinical Affairs Rep, Regulatory Affairs Rep.
Risk Management Board (RMB) – Designated group of subject-matter experts and managers who have responsibility for the supervision of all Risk Management activities at Company X including authorization to balance medical benefits against residual risks to make final decisions regarding the acceptability of Overall Residual Risk (ORR).
Key Terms
Risk Management
5
Risk Table Risk Table – Main table for documenting risk analysis, risk evaluation, and risk control activities.
01 02 03
04 05 06 07 08
09 10 11
Risk
ID #
Functional
Output Hazard
Hazardous
Situation Harm
Person
Affected Causes
Planned/Existing
Risk Control
Measures
Severity
Level
(SHARM)
Occurrence
Level
(OHARM)
Risk
Region
12 13 14 15 16 17 18
Additional Risk
Control Measures
Revised
Occurrence
Level
(OHARM)
Revised
Risk
Region
Risk/Benefit Analysis
(required for
High/Medium risks)
Verification of Risk
Control Measures
(Implementation)
Verification of Risk
Control Measures
(Effectiveness)
Comments/
Rationale (if
necessary)
Risk Management
6
Risk Analysis
Risk Evaluation
Risk Control
Production and Post Production Monitoring
ORR Evaluation
LAUNCH
Risk
Management
procedure
Risk Analysis Techniques
work instruction
Critical Quality Attributes
work instruction
Risk Management
Board
work instruction
Post-Market (Health) Risk Assessment
work instruction
1
2
3
4
5
Risk Management Process: 5 Elements
Risk Management
1
2
Risk Management Process Flow
Risk Management
Yes
Is risk control complete?
(Are all hazards accurately
considered?)
Is further individual risk
reduction necessary or
possible?
Are new hazards/hazardous
situations introduced or existing
risks affected due to additional
risk control measures?
No
Document additional risk
control measure(s)
Overall Residual Risk is acceptable.
Complete Risk Management Report
Risk
reduceable by
inherently safe
design?Risk reduceable by
protective measures in the
device or mfg process?
Risk reduceable by
Information for Safety?
Yes
Yes
Risk reduceable by
restriction of
Intended Use?
Restrict the
Intended Use
(Project Strategy)
Yes
Is further risk
reduction
possible?
Risk Management
Board
No
Yes
Is the
Overall Residual Risk
Acceptable?
Is
re-assessment of risk
necessary?
Ris
k C
on
tro
lO
ve
rall R
es
idu
al R
isk
Ev
alu
ati
on
5
Pro
du
cti
on
an
d
Po
st-
Pro
du
cti
on
Mo
nit
ori
ng
Yes
1
Yes
Yes
Risk Control
Option Analysis
LAUNCH
3
Consult Risk
Management Board
Do medical
benefits outweigh
Overall Residual
Risk?
No
Yes
No
Yes
No
2
No
No
No
4
2
9.4.1
9.4.1
9.4.1
9.4.1
9.4.1
9.4.1
9.4.1
9.4.3
9.4.6
9.5.1 9.5.2
9.5.4
9.6.1
9.4.7
Verify implementation of all risk control measures
Go to
From
Go to
Go to
Go to
From 9.4.5
9.5.3
1
3 2
5
3
9
1
3 2
5
3
9
DR6
Estimate the residual risk assuming
all (planned/existing and additional)
risk control measures will be
implemented
Do medical benefits
outweigh the individual
residual risk?
No
Risk is
unacceptable.
Abort project.
No
Yes
Identify and communicate
failure criticality information pertaining
to risk control measures
DR9
DR10
Review production and post-production information
No
No
9.4.1
9.4.2
Is RMB approval
required?
No
Yes
Yes
9.4.8
Residual risk is judged acceptable
(pending verification)
Individual residual risks are acceptable
9.5.2
Ensure RMF is
released.
9.4.2
9.4.2
9.4.4
9.5.2
9.5.4
9.6.2
9.6.3
9.4.8
DR79.4.6
9.4.7
1 1
7 2
1
1
8
2
Risk Management Process
Part II
Verify effectiveness of all risk control measures
Risk Management Process Flow
(contd.)
3
4
5
Risk Management
Yes
Is risk control complete?
(Are all hazards accurately
considered?)
Is further individual risk
reduction necessary or
possible?
Are new hazards/hazardous
situations introduced or existing
risks affected due to additional
risk control measures?
No
Document additional risk
control measure(s)
Overall Residual Risk is acceptable.
Complete Risk Management Report
Risk
reduceable by
inherently safe
design?Risk reduceable by
protective measures in the
device or mfg process?
Risk reduceable by
Information for Safety?
Yes
Yes
Risk reduceable by
restriction of
Intended Use?
Restrict the
Intended Use
(Project Strategy)
Yes
Is further risk
reduction
possible?
Risk Management
Board
No
Yes
Is the
Overall Residual Risk
Acceptable?
Is
re-assessment of risk
necessary?
Ris
k C
on
tro
lO
ve
rall R
es
idu
al R
isk
Ev
alu
ati
on
5
Pro
du
cti
on
an
d
Po
st-
Pro
du
cti
on
Mo
nit
ori
ng
Yes
1
Yes
Yes
Risk Control
Option Analysis
LAUNCH
3
Consult Risk
Management Board
Do medical
benefits outweigh
Overall Residual
Risk?
No
Yes
No
Yes
No
2
No
No
No
4
2
9.4.1
9.4.1
9.4.1
9.4.1
9.4.1
9.4.1
9.4.1
9.4.3
9.4.6
9.5.1 9.5.2
9.5.4
9.6.1
9.4.7
Verify implementation of all risk control measures
Go to
From
Go to
Go to
Go to
From 9.4.5
9.5.3
1
3 2
5
3
9
1
3 2
5
3
9
DR6
Estimate the residual risk assuming
all (planned/existing and additional)
risk control measures will be
implemented
Do medical benefits
outweigh the individual
residual risk?
No
Risk is
unacceptable.
Abort project.
No
Yes
Identify and communicate
failure criticality information pertaining
to risk control measures
DR9
DR10
Review production and post-production information
No
No
9.4.1
9.4.2
Is RMB approval
required?
No
Yes
Yes
9.4.8
Residual risk is judged acceptable
(pending verification)
Individual residual risks are acceptable
9.5.2
Ensure RMF is
released.
9.4.2
9.4.2
9.4.4
9.5.2
9.5.4
9.6.2
9.6.3
9.4.8
DR79.4.6
9.4.7
1 1
7 2
1
1
8
2
Risk Management Process
Part II
Verify effectiveness of all risk control measures
ORR Evaluation After all risk control measures have been verified, the Overall Residual Risk (ORR) posed by the medical device (i.e., all residual risks documented in the Risk Table and displayed on the Risk Matrix) is evaluated to decide if the ORR is acceptable.
Note: It is possible that the ORR can be considered unacceptable even though the individual residual risks are acceptable. This is particularly true for complex medical devices/systems with a large number of individual risks.
Risk Management
Yes
Is risk control complete?
(Are all hazards accurately
considered?)
Is further individual risk
reduction necessary or
possible?
Are new hazards/hazardous
situations introduced or existing
risks affected due to additional
risk control measures?
No
Document additional risk
control measure(s)
Overall Residual Risk is acceptable.
Complete Risk Management Report
Risk
reduceable by
inherently safe
design?Risk reduceable by
protective measures in the
device or mfg process?
Risk reduceable by
Information for Safety?
Yes
Yes
Risk reduceable by
restriction of
Intended Use?
Restrict the
Intended Use
(Project Strategy)
Yes
Is further risk
reduction
possible?
Risk Management
Board
No
Yes
Is the
Overall Residual Risk
Acceptable?
Is
re-assessment of risk
necessary?
Ris
k C
on
tro
lO
ve
rall R
es
idu
al R
isk
Ev
alu
ati
on
5
Pro
du
cti
on
an
d
Po
st-
Pro
du
cti
on
Mo
nit
ori
ng
Yes
1
Yes
Yes
Risk Control
Option Analysis
LAUNCH
3
Consult Risk
Management Board
Do medical
benefits outweigh
Overall Residual
Risk?
No
Yes
No
Yes
No
2
No
No
No
4
2
9.4.1
9.4.1
9.4.1
9.4.1
9.4.1
9.4.1
9.4.1
9.4.3
9.4.6
9.5.1 9.5.2
9.5.4
9.6.1
9.4.7
Verify implementation of all risk control measures
Go to
From
Go to
Go to
Go to
From 9.4.5
9.5.3
1
3 2
5
3
9
1
3 2
5
3
9
DR6
Estimate the residual risk assuming
all (planned/existing and additional)
risk control measures will be
implemented
Do medical benefits
outweigh the individual
residual risk?
No
Risk is
unacceptable.
Abort project.
No
Yes
Identify and communicate
failure criticality information pertaining
to risk control measures
DR9
DR10
Review production and post-production information
No
No
9.4.1
9.4.2
Is RMB approval
required?
No
Yes
Yes
9.4.8
Residual risk is judged acceptable
(pending verification)
Individual residual risks are acceptable
9.5.2
Ensure RMF is
released.
9.4.2
9.4.2
9.4.4
9.5.2
9.5.4
9.6.2
9.6.3
9.4.8
DR79.4.6
9.4.7
1 1
7 2
1
1
8
2
Risk Management Process
Part II
Verify effectiveness of all risk control measures
ORR Evaluation – Risk Management Board
The Risk Management Board (RMB) must be consulted and must decide about the acceptability of the ORR if any of the following conditions is true:
• Any residual risk is in the High Risk (Red) region,
• Any residual risk in the Medium Risk (Yellow) region has severity S3 or higher, or
• The Risk Management Team requests RMB consultation.
Risk Management
RMB Members The Risk Management Board must include, at a
minimum, the following five functions (roles):
1. Head of RA/QA (or authorized designate*)
2. Head of R&D (or authorized designate*)
3. Risk Management Expert
4. Medical Expert (Clinical Expert)
5. Post-Production Monitoring Expert
Note 1: Where a safety representative or comparable function is required by national law, this person or authorized designate must be a member of the Risk Management Board.
Note 2: *Authorized designates must have equivalent or similar organizational responsibility and/or authority.
Risk Management
– Additional functions (roles) may be added to the Risk Management Board as needed, for example:
• Project Leader
• Technical specialist(s)
• Manufacturing representative(s)
• Marketing representative (for perspective on product use)
• Legal representative (typically only for higher risk products)