Risk Management SOP for ISO14971

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Risk Management

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Status of Document Change Control Rev.

ssue Date

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Originator

"!!rove#

%$5 Mar 2014

Second I!e

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&.'

()R(OSE

1.1

&'e (!r(o (!r(oe e of t'i (roce (roce  i to (ecif) (ecif) t'e *or+in *or+ing g ,et'odo ,et'odoog) og) ) *'ic' *'ic' vario! vario! (rod!ct ri+ can e identified/ eti,ated/ eva!ated and controed d!ring t'e vario! deign and (rod!ction ('ae of t'e (roect.

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SCO(E

2.1

&'i &'i (roced! (roced!re re i a((ic a((icae ae to t'e t'e deign deign (roce (roce  !nderta !nderta+en +en for a ne* or or ,odified ,odified (rod!ct.

2.2

&'i (roce (roced!re d!re i i a((ica a((icae e to t'e (rod!ction (rod!ction (roce (roce  !ndert !nderta+en a+en for for a ne* or ,odified ,odified (rod!ct/ *'ere a((icae.

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5.3

&'e Proect "eader 'a e re(onie/ *it' t'e Proce O*ner6 and6or 7o!ndr) Manager/ in defining t'e Ri+ #cce(taiit) d!e to (roce ri+ ,anage,ent/ ta+ing into acco!nt reevant internationa tandard and nationa or regiona reg!ation.

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RS2 M"N"GEMEN/ (ROCED)RES

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(ro#uct Risk Management

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Risk Management (lanning

&'e vario! te( invoved in t'e (rod!ct ri+ ,anage,ent (anning inc!de: 8a9

#vaiaiit) of Infor,ation &'e (artici(ating tea, ,e,er 'a gat'er a((ro(riate tec'nica infor,ation/ !c' a t'oe ca(t!red in Customer Requirements Form and (ot-,ar+et infor,ation/ !c' a co,(aint6incident of t'e (rod!ct fro, (revio! iteration or of i,iar (rod!ct/ etc to identif) (rod!ct ri+.

89

Identif)ing t'e Ri+ Manage,ent Proce &'e (artici(ating tea, ,e,er define t'e co(e of t'e (an a to *'ic' device and t'eir  intended !e.

8c9

#ign,ent of Re(oniiitie

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in ot' nor,a and fa!t condition !ing t'e Product Risk Management *'enever t'ere i a ne* or c'ange in t'e (rod!ct deign of t'e device. (b)

7or eac' 'a
(c)

If it i not/ (roceed to rate t'e 'a
8i9 "i+ei'ood of Occ!rrence 8i.e. O factor9 8ii9 "i+ei'ood of Detection 8i.e. D factor9 8iii9 Severit) 8i.e. S factor9 according to ;.1.38d9 Table 1 - Likelihood of ccurrence () Factor / ;.1.38e9 Table ! Likelihood of "etection (") Factor  and ;.1.38f9 Table # - $e%erit& ($) Factor . (d)

&ae 1 - Likelihood of ccurrence () Factor' Rating Likelihoo# of Occurrence O3 4 annot >e Eti,ated 0  #*a) 7re!ent

Criteria 1 in 10 1 in 100

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Risk Management

(g)

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Mid

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Nor,a

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Negigie

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"eath or $erious n*ur& is +ossible' ?i need t'e !er to ,onitor for i effect. O!tco,e are) ,itigate 'a
7or 'a
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Risk Evaluation

8a9

&'e Ri+ Priorit) N!,er i co,(!ted ) t'e (rod!ct of t'e O/ D and S factor according to t'e 7ME# #((roac' Strateg) of ODS a 'o*n in ;.1.48c9 Table .  Risk  /%aluation Matri0 .

89

&'e va!e of t'e Ri+ Priorit) N!,er *i re!t in t'e identified 'a
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8c9 &ae 5  Risk /%aluation matri0  Always (O =5 ) Remote (D=5)

 ALARP  (RPN=!"

 #ntolerable (RPN=!$"

 #ntolerable (RPN=%!"

 #ntolerable (RPN=&$$"

 #ntolerable (RPN=&!"

Frequent (O =4) Probable (D=4)

 ALARP  (RPN=&'"

 ALARP  (RPN="

 ALARP  (RPN=)*"

 #ntolerable (RPN=')"

 #ntolerable (RPN=*$"

Occasional (O =3) Occasional (D=3)

 +A (RPN="

 ALARP  (RPN=&*"

 ALARP  (RPN=%"

 ALARP  (RPN='"

 ALARP  (RPN=)!"

 +A (RPN=)"

 +A (RPN=*"

 ALARP  (RPN=&"

 ALARP  (RPN=&'"

 ALARP  (RPN=$"

 +A (RPN=&"

 +A (RPN="

 +A (RPN="

 +A (RPN=)"

 +A (RPN=!"

Probable (O =2) Frequent (D=2) Remote (O =1) Always (D=1)

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 !dg,ent 'ave a re(oniiit) to !ndertand and ta+e into acco!nt t'e tec'nica/ cinica/ reg!ator)/ econo,ic/ ocioogica and (oitica contet of t'eir ri+ ,anage,ent deciion. In order of (reference/ t'e foo*ing (eo(e 'o!d e e,(o)ed to cond!ct t'e ri+ revie* and ri+6enefit ana)i: 8i9 8ii9 8iii9 8iv9

E(ert or reevant to area of revie* 8e.g. cinician/ reearc'er/ !ect e(ert9 Engineer6Deigner eterna to t'e (roect ro f!nctiona (roect tea, ,e,er 8e.g. Ind!tria Deign/ >io,edica/ EE/ ME9 "iterat!re revie* not dating ac+ ,ore t'an 10 )ear

(χ)

 #n i,(ortant conideration in t'e acce(taiit) of a reid!a ri+ i *'et'er an antici(ated cinica enefit can e ac'ieved t'ro!g' t'e !e of aternative deign o!tion t'at avoid e(o!re to t'e ri+ or red!ce t'e o vera ri+.

(δ)

>enefit can e eti,ated fro, t'e eo* factor:

8i9 t'e (erfor,ance e(ected d!ring cinica !e 8ii9 t'e cinica o!tco,e e(ected fro, t'at (erfor,ance 8iii9 t'e factor reevant to t'e ri+ and enefit of ot'er treat,ent o(tion 8e9

Proviiona !e of t'e (rod!ct can e granted (ending o!tco,e of Ri+6>enefit ana)i for cae *'ere t'e S i rated Serio! or ritica.

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(β)

If an) of t'e aove condition 8i9/ 8ii9 or 8iii9 i atified/ t'e re!t *i e in(!t to t'e ri+ ,anage,ent (roce.

(χ)

If t'ere i a (otentia t'at t'e reid!e ri+ or it acce(taiit) 'a c'anged/ t'e i,(act on (revio!) i,(e,ented ri+ contro ,ea!re 'a e eva!ated and t'e re!t recorded.

1.*

(rocess Risk Management &'e (roce ri+ ,anage,ent i to e inc!ded for t'e in-'o!e (rod!ction (roviion. &'e vario! te( invoved in t'e (roce ri+ ,anage,ent (anning are: 1.*.&

Risk Management (lanning

8a9

#vaiaiit) of Infor,ation &'e (artici(ating tea, ,e,er 'a gat'er a((ro(riate tec'nica infor,ation and (ot,ar+et infor,ation/ !c' a co,(aint6incident of t'e (rod!ct fro, (revio! iteration or of i,iar (rod!ct/ etc to identif) (rod!ct ri+ d!e to (roce ri+.

89

Identif)ing t'e Ri+ Manage,ent Proce &'e (artici(ating tea, ,e,er define t'e co(e of t'e (an a to *'ic' device and t'eir  intended !e.

8c9

#ign,ent of Re(oniiitie

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condition !ing t'e Process Risk Management (-$P-21#-!) *'enever t'ere i a ne* or c'ange in t'e (rod!ction (roce of t'e device. 89

7or eac' 'a
8c9

If it i not/ (roceed to rate t'e 'a
8i9 "i+ei'ood of Occ!rrence 8i.e. O factor9 8ii9 "i+ei'ood of Detection 8i.e. D factor9 8iii9 Severit) 8i.e. S factor9 according to Table 3 - Likelihood of ccurrence () Factor4 Table 5  Likelihood of  "etection (") Factor  and Table 6 - $e%erit& ($) Factor . Table 3 - Likelihood of ccurance () Factor  Rating Likelihoo# of Occurance O3 4 annot >e Eti,ated 0  #*a) 7re!ent + Occaiona * Proae & R t

Criteria 1 in 10 1 in 100 1 in 1/000 1 in 10/000 1 i 100 000

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Risk Management S3 0

ritica

-

Serio!

+

Mid

*

Nor,a

&

Negigie

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8Customer9 7ai!re affect c!to,er afet) or invove nonco,(iance to govern,ent reg!ation ig' degree of c!to,er diatifaction d!e to fai!re of (rod!ct f!nction. 7ai!re ca!e o,e deterioration of (rod!ct (erfor,ance/ !t *i not re!t in fai!re of (rod!ct f!nction. 7ai!re ca!e ig't deterioration of (rod!ct (erfor,ance. Gnreaonae to e(ect t'at fai!re *i 'ave an) noticeae effect on (rod!ct (erfor,ance.

100F of t'e (rod!ct ,a) 'ave to e cra((ed.

100F of t'e (rod!ct ,a) 'ave to e re*or+ed.  # (ortion of t'e (rod!ct ,a) 'ave to e re*or+ed6 cra((ed.

Ma) re!t in ig't inconvenience *it' a !e!ent (roce or ae,) o(eration. Gnreaonae to e(ect t'at t'e fai!re *i 'ave an) noticeae effect on !e!ent (roce or ae,) o(eration.

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(oie/ a ri+6enefit ana)i 'a to e cond!cted. Refer ao to ;.2.3 Ri+ ontro and ;.2.4 Reid!a Ri+ Eva!ation te(. 8iv9 >road) #cce(tae 8>#9/ 1 @ RPN @  No In!r) or da,age to eat' i (oie. No contro ,ea!re need to e i,(e,ented and t'e (rod!ct can e !ed *it'o!t an) dir!(tion. 1.*.0

Risk Control

8a9

&'e c!rrent (roce contro and an) additiona reco,,ended (roce contro are to e i,(e,ented are ited. >aed on t'e contro ,ea!re/ t'e Ri+ Priorit) N!,er  'a e revie*ed once again.

89

&'e effectivene of t'e contro ,ea!re i refected ) t'e ,agnit!de of t'e red!ction in t'e Ri+ Priorit) N!,er. 1.*.1

Resi#ual Risk Evaluation

8a9

If/ after ri+ contro 'a een i,(e,ented/ t'e o!tco,e i ti Intoerae/ ,ore contro ,ea!re need to e i,(e,ented.

89

If ot'er 'a
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1.+

Generating Risk Management Re!ort

(α)

&'e Product Risk Management (-$P-21#-1) 'a contain t'e record of t'e (roceeding on t'e cond!ct of t'e (rod!ct ri+ ,anage,ent (roce.

(β)

&'e Process Risk Management (-$P-21#-!) 'a contain t'e record of t'e (roceeding on t'e cond!ct of t'e (roce ri+ ,anage,ent (roce.

1.-

Evaluation of Risk Management (rocess

(α)

&'e tea, 'a revie* t'e re!t of ri+ ,anage,ent activitie d!ring t'e Deign Revie* ,eeting or *'en re!ired.

5.'

RECORDS

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#((icae record (ecified in !-(aragra(' 4 of t'i (roced!re 'a e retained in accordance to (roced!re -SOP-002: ontro of Record.

(ro#uct Risk Management  Cover Sheet Doc No:

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(7-digit 89$)

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 -- 

(ro;ect<(ro#uct Name: Date: ("":MM:;;)

Per -SOP-04/ Section ;.5.1/ the nstructions For
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Name of Revie=er  (at least !4 one of =hich must be the customer)

Designation

,unction
>ualification

When printed, this document is uncontrolled unless identified as controlled by the Document Controller.

Signature

Date ("":MM:;;)

S
Name of Revie=er  (at least !4 one of =hich must be the customer)

Designation

(ro#uct Risk Management  Cover Sheet

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,unction
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>ualification

5 Mar 2014  14 of 21

When printed, this document is uncontrolled unless identified as controlled by the Document Controller.

Signature

Date ("":MM:;;)

(ro#uct Risk Management  ,ME"

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Catastro!hic 8C 9: B - BeH N  No Likelihoo# of Occurrence 8O9:  - annot >e Eti,ated H 1 - Re,ote H 2 - Proae H 3 - Occaiona H 4 - 7re!ent H 5  #*a) Likelihoo# of Detection 8D9:  - annot >e Eti,ated H 1 - #*a) H 2 - 7re!ent H 3 - Occaiona H 4 - Proae H 5  Re,ote Severit% 8S9: 1 - Negigie H 2 - Nor,a H 3 - Mid H 4 - Serio! H 5  ritica "cce!ta$ilit%: Intoerae C  ; or 32 > RP, > 1!3  H #"#RP 8# "o* # Reaitica) Practicae912 > RP, > .7  H ># 8>road) #cce(tae91 > RP, > ?

RS2 "N"L?SS (RP,   0 " 0 $) Risk A

Com!on ent

,ailure Mo#e

RS2 E@"L)"/ON ,ailure Causes

,ailure Effects

C

O D

S

R(N

RESD)"L RS2 E@"L)"/ON

RS2 CON/ROL "cce!ta$ilit%

O!tions

O!tion m!lemente#

References

O

D

S

R (N

Identify all applicable mechanical risks below: M-1 M-2

Identify all applicable electrical risks below: E-1 E-2

Identify all applicable software risks below: S-1 S-2

When printed, this document is uncontrolled unless identified as controlled by the Document Controller.

"cc e!t a$ ili t%

(OS/ (ROD)C/ON N,ORM"/ON

Identify all other applicable risks below: O-1 O-2

(ro#uct Risk Management  ,ME"

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When printed, this document is uncontrolled unless identified as controlled by the Document Controller.

(ro#uct Risk Management  Risk enefit "nal%sis

Risk A

enefits

Risks

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Bu#gement

 e.g. M-1

When printed, this document is uncontrolled unless identified as controlled by the Document Controller.

(rocess Risk Management  Cover Sheet

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(7-digit 89$)

(ro;ect<(ro#uct Name: Date: ("":MM:;;)

Per -SOP-04/ Section ;.5.1/ the nstructions For
S
Name of Revie=er  (at least !4 one of =hich must be the customer)

Designation

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Catastro!hic 8C 9: B - BeH N  No Likelihoo# of Occurrence 8O9:  - annot >e Eti,ated H 1 - Re,ote H 2 - Proae H 3 - Occaiona H 4 - 7re!ent H 5  #*a) Likelihoo# of Detection 8D9:  - annot >e Eti,ated H 1 - #*a) H 2 - 7re!ent H 3 - Occaiona H 4 - Proae H 5  Re,ote Severit% 8S9: 1 - Negigie H 2 - Nor,a H 3 - Mid H 4 - Serio! H 5  ritica "cce!ta$ilit%: Intoerae C  ; or 32 > RP, > 1!3  H #"#RP 8# "o* # Reaitica) Practicae912 > RP, > .7  H ># 8>road) #cce(tae91 > RP, > ? RISJK: 7or Soft*are ri+/ n!,ering goe S-1/ S-2/ S-3 e tc. 7or Eectrica ri+/ n!,ering goe E-1/ E-2/ E-3 etc. 7or Mec'anica ri+/ n!,ering goe M-1/ M-2/ M-3 etc. 7or ot'er ri+/ n!,ering goe O-1/ O-2/ O-3 etc.

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