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医疗器械风险管理培训讲义 龙德医疗器械服务集团
医疗器械风险管理培训讲义 龙德医疗器械服务集团
医疗器械风险管理培训讲义 龙德医疗器械服务集团
2015320
20-21
21
For
1
Long Yang
-
-
AHWP
AHWP
AHWP1
13
CFDA
CFDACE
CEFDA
FDA
Hlongmed
CR
OFDA 510kQSR820
QSR21CFR820
ISO13485
IVDGMP
SFDAFDACE
100
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510
k
CE
ISO13485
QSR
FMEA
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-
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+
+
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2
1
ISO14971
5
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/
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!
.
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1
2
ISO14971
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>
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SFDA
CAs
FDA
HC
MHLW
SFDA
,FDA
NBs
CDRH
3rd Party
HC
3rd Party
MHLW
3rd Party
, ,
IIb,
I, IIa,
III
I, II, III
I, II,VIII, I I, II,VIII, I
CE
510K
PMA
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(Electrical beds)
(Absorbable sutures)
e.g.suture, absorbable, s
ynthetic, polyglyco
Code:GAM
Class:2
Regulation No. 878.4493
Class III
MDD rule 7
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hip, knee and shoulder replacements
Class III
Class IIb
93/42/EEC
(2007.03)
(2010.09)
2005/50/EC
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(ISO 13485)
(ISO 14971)
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Q9: Quality RM
Risk-Based Approach to cGMP
ICH
FDA
ISO 14971:2007
ISO / IEC
IT
ISO / IEC
ISO
IEC 62198
IEC
ISO / IEC
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1997.10
EN 1441:1994
1998.10
2000.12
2007.03
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2
1
ISO14971
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ISO14971
ISO 14971:2007
2007-03-01
ISO 13485:2003
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-
-
-
-
-
10
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A
B
C
D
E
F
G
H
I
J
()
()
()
()
()
()
()
()
()
()
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1 Scope
IVD
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risk
combination of the Probability of occurrence of harm an
d the Severity of that harm.
R = f (P, S)
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harm
physical injury or damage to the health of people, or da
mage to property or the environment.
hazard
potential source of harm.
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hazardous situation
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E.1
P1
P2
P1P2
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life-cycle
all phases in the life of a medical device, from the initial concept
ion to final decommissioning and disposal.
RM
post-production
part of the life-cycle of the product after the design has been co
mpleted and the medical device has been manufactured.
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risk analysis
risk estimation
risk evaluation
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risk assessment
residual risk
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3.1
3.2
3.3
3.4
3.5
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3.1
risk assessment
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3.1
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3.2
a)
b)
c)
d)
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3.3
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3.4
a)
b)
c)
d)
e)
f)
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3.4
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3.5
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3.5
RM
RM
(DFMEA)
(PFMEA)
CAPA
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4.1
4.2
4.3
/
4.4
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4.1
4.2 (Annex C)
4.3 (E.2)
4.4 (E.4)
2 G
3 H
4 I
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4.1
G
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4.1
4.24.34.4123
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4.2
1
2 C
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4.2
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4.2
C
(28C34
C.2.1
C.2.2
C.2.3
C.2.4
C.2.34
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4.3
1. EN 60601-2-X
2.
3.
4.
5.
6.
7.
8.
9.
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4.3
E E.1
-
-
-
-
-
-
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4.3
E E.2
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4.4
1 G
2 H 2.4.5E.4
3
P
P1
P2
P1P2
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4.4
E.4
(1)
( )
(1)
(2)
()
(1)
(2)
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4.4
a)
b)
c) (
)
d)
e)
f)
g)
h)
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PowerPoint
Device
Regulation
Description
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4.4
(
)
> 10
-3
10
-3
10
-4
10
-4
10
-5
10
-5
10
-6
< 10
-6
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4.4
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4.4
(
)
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4.4
5
(5
)
R1
R2
R5
R6
R4
R3
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/
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5
(5
)
R1
R2
R5
R6
R4
R3
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5
(5
)
(ALARP)
R1
R2
R5
R6
R4
High Risk
R3
Medium Risk
Low Risk
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:
1) 6.2~6.6
2)
6.2~)
3)
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6.1
6.2
6.3
/
6.4
6.5 /
6.6
6.7
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6.1
6.26.7
6.2: ()
6.3: ()
6.4: ()
6.5: /()
/
(
)
6.6: ()
6.7: ()
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6.2
a)
b)
c)
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6.2
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6.2
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6.3
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6.4
6.2
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6.4
R2
R5
R6
R1
R2
R4
R5
R6
R3
R1
R4
R3
R1,R5,R6
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6.4
D.8.4
:
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6.5 /
Benefit
Risk
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6.6
a)
b)
4.46.5
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6.7
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/
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1 D.7
2 J
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/
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8
,
[3.4
b]
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()
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C
FEMA
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<
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/
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a)
b)
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2
1
ISO14971
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ISO
31010 -
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G.3 FTA
Top down
,
()
(
)
(deductive)
FMEA
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G.3 FTA
FTA
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(FTA)
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(FTA)
(=)
(,,,)
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(FTA)
:
,
:
,
:
mn,
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(FTA)
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G.3 FTA
()
FTA
FTA
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G.3 FTA
C
A
B
D
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G.3 FTA
C
A
B
D
Top
Ft = Fa U Fb U Fe
= 1- (1-Fa)x(1-Fb)x(1-Fe)
= 1- 0.9x0.8x0.94
= 0.3232
0.3232
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(FTA)
:
(FMEA)
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G.4 FMEA
(FMEA)
FMEA
FMEA
FMEAFMEA
F
MEA FMECA
FMEA
:FMEAIEC 60812
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G.4 FMEA
FMEA
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G.4 FMEA
FMEA
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G.4 FMEA
FMEA
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?
1.
2. :
,
:
,
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?
3. ,
3,4,5,610
: 1,2,3,4,
: 1,2,4,8
: 1,10,100,1000
: 1,3,7,10
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?
4.
5.
6.
7.
(,)
,(,
<50)
,(,)
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(Severity)
FMEA
10
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(Occurrence)/
1/2
10
1/8
1/20
1/80
1/400
1/1500
1/10000
1/40000
1/100000
1/1000000
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(Detection)
10
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RPN: Risk Priority Number
(S)(O)(D)
RPN = (S) x (O) x (D)
FMEA 1-1000
RPN RPN
RPN
RPN
(9 10 ) RPN
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(FMEA)-
PRN
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(FMEA)-
PRN
120
112
126
63
40
27
45
:
RPN:= S P D
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(FMEA)-
PRN
PRN
120
48
112
56
126
84
63
42
40
40
27
27
45
45
RPN100
RPN:= S P D
5
;
(FTA)
(FMEA)
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(PHA)
(FTA)
(FMEA)
(DFMEA)
(PFMEA)
(HAZOP)
(HACCP)
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(-?)
(HACCP) (HAZOP)
(FMEC
A/FMECA)
(FT
A)
IS
O 9001
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GMP
FTA
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2
1
ISO14971
5
1
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1.
2.
3.
4.
5.
6. BOM
7.
8.
9.
10.
11.
PFMEA
12.
13.
14.
15. DMRDHF
16.
17.
18.
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ISO14971C
IVDH
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RPNSX O
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FME
A
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()
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FMEA
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2
1
ISO14971
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Design Control
Design inputs come from RM activities
Development of appropriate test methods
Prevent failures as early as in the feasibility phase
Validation of Processes
Material, Equipment, Operations, Test Methods
What & How to validate Master Val Plan, protocol designs
Purchasing/Supplier Management
CAPA complaints, nonconformities, recalls, etc.
Failure mode missed?
Severity or Probability underestimated?
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Equipment Control
Calibration and PM requirements
Internal Auditing
What & How to audit
Auditing the RM Program itself
Training
One of the most critical manufacturing risk controls!
Product Traceability
Which product components require traceability?
Environmental Control
Where to monitor
Acceptable limits
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Design Step
Hazards List
Design input
Design
FTA
FMEA
Design reviews
Design transfer
RM Output
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CAPA
Complaint?
Action required?
Complaints entered
into
Complaint Handling
System
(1)
(2)
Known
Problem?
Action required?
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FMEAFTA
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--
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FMEAFTA
ISO13485FDA
A-D-L-I
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ISO14971
A
D
FMEA
FTA
1.
2.
L
I
3.
ISO13485
FDA
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Thanks
CRO
FDA
510k
QSR820
Mobile: 13510985530
Email
yanglongoscar@gmail.com
http://www.linkedin.com/in/yanglong
QQ:
1795224421
142
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