prezentarea 4 cwa 15793 2011.pdf
TRANSCRIPT
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EU CBRN CoE Project 3
Knowledge development and transfer of best practice on bio-safety/bio-security/bio-risk management
ICIS - Insubria Center on International Security
In collaboration with
Belgium, August 2013
Module 4, Part C.
CWA 15793: 2011 !"e co#te#t$!ilippe "troot, !#, $ibios / %B"A
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General presentation
Table of contents
Introductive sessions and contents
Requirements and applicability Exclusions Focus on a few specific requirements as examples
General requirements
olicy
lan! lannin" # resources $ Ris% assessment $ &onformity
'o! Roles and responsibilities $ (perational control
&hec%! &orrective and preventive actions $ Record %eepin"
)ct! *ana"ement review &onclusions
Module 4, Part C Overview
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Table of contents of CWA 15793
Foreword
Introduction+ ,cope
- Informative references
. Terms and definitions
/ 0ioris% mana"ement system requirements
/1+ General requirements
/1- olicy
/1. lannin"
/1/ Implementation and operations
/12 &hec%in" and corrective action/13 Review
olicy
'&)
'&
)
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Foreword
&4) process5 development and availability of &4) +267.
Introduction
)n introduction to the mana"ement system approach
8eys to successful implementation
Inte"ration with other mana"ement systems )pplication5 exclusions and relation to re"ulations
Introductive sections/1
Foreword
Introduction
+ ,cope
- Informative references
. Terms and definitions
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&ommitment of top mana"ement
'efine policies and priorities
rovide appropriate resources
Inte"rate system throu"hout the or"anisation Identify opportunities for improvement
Focus on continuous improvement
*a%e continuous improvement an ob9ective for every one
Use periodic assessment
&ontinuously improve process
rovide appropriate trainin" where needed
Establish measures and "oals for improvement
Reco"nise improvement
Introduction e!s to i"#le"entation
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+1 ,cope
,et requirements necessary to control biolo"ical ris%s
Enable or"anisations to establish and maintain
a bioris% mana"ement system and provide assurance of this
-1 Informative references
The 4:( biosafety and biosecurity "uidance documents
.1 Terms and definitions /7 terms defined
Introductive sections/$
&4) +267. sets out performance;based requirements that put
responsibility on or"anisations to demonstrate that appropriate
and validated ris% reduction measures have been implemented
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resentation and terminolo"y
Requirements presented in boxes usin" the word
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Requirements are mandatory clauses of the system
'eviations considered as non conformities
Requirements that cannot be applied due to the nature
of the or"anisation or its activities can be considered for exclusion &laims of exclusion must be justified and documented
In case of exclusion
@erification not applicable to this requirement
Ao claim of conformity to this requirement is possible
ossibility of exclusion B a door open to some moderate flexibility
(nly to allow implementation and certification of the systemwhile ta%in" into account possible specificities of the institution
A##licabilit! &'clusion
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/1. lannin"
/1.1+ lannin" for haDard identification5 ris% assessment # ris% control
/1.1+1+ lannin" and resources
/1.1+1- Ris% assessment timin" and scope
/1.1+1. :aDard identification/1.1+1/ Ris% assessment
/1.1+12 Ris% mana"ement
/1.1- &onformity and compliance
/1.1. (b9ectives5 tar"ets and pro"ramme/1.1.1+ 0ioris% control ob9ectives and tar"ets
/1.1.1- *onitorin" controls
Plannin(
Ris% assessment of %ey importance in the plannin" phase 'efinition of resources5 control ob9ectives and monitorin" controls
also part of plannin"
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as a note?
; )lso5 indication of situations where ris% assessment should beconducted and areas areas of concern for ris% assessment
roactive ris% assessment! possible chan"es in activities or
emer"ency situations also to be considered
roactivity ! ris% assessment as a real plannin" tool
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/1/ Implementation and operations
/1/1+ Roles5 responsibilities and authorities
/1/1+1. 0ioris% mana"ement committee
/1/1-1/ 0ioris% mana"ement advisor111
/1/1- ersonnel trainin"5 awareness and competence
/1/1. &onsultation and communication
/1/1/ (perational control/1/12 Emer"ency response and contin"ency plans
I"#le"entation and o#erations *+o-./1
,pecific section on roles5 responsibilities and authorities reflects
their importance in the functionin" of the mana"ement system Requirements and recommendations >
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/1/ Implementation and operations/1/1+ Roles5 responsibilities and authorities
/1/1- ersonnel trainin"5 awareness and competence
/1/1. &onsultation and communication
/1/1/ (perational control/1/12 Emer"ency response and contin"ency plans
I"#le"entation and o#erations *+o-./$
ersonnel trainin"5 awareness and competences!
; Aeed to have the people with the appropriate education5 trainin"and experience at the ri"ht position
; Importance of continuity and succession plannin"
; Importance of trainin"
&onsultation and communication; Aeed for up;to;date information and involvement of employees
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/1/ Implementation and operations/1/1+ Roles5 responsibilities and authorities
/1/1- ersonnel trainin"5 awareness and competence
/1/1. &onsultation and communication
/1/1/ (perational control/1/12 Emer"ency response and contin"ency plans
I"#le"entation and o#erations *+o-./3
,ections on operational control and emer"ency response
; Functional requirements rather than technical requirements; Technical measures B usual content of biosafety pro"rammes
and manuals
,pecific subsections on issues li%e biolo"ical inventories5
wor% pro"ramme plannin" and capacity5 chan"e mana"ement5behavioural factors5 personnel reliability5 information security
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on a sub9ect that is mainly technical?
Aotes provide information and recommendations on what to
consider for inactivation5 on validation issues5 on protection
These are still non;technical
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medical? issue that is only considered
from a mana"ement point of view
Requirements are
Identify the need for vaccination on the basis of the ris%
'efine and apply a vaccination policy >not defined in the
document?
Ao conflict with possible re"ulatory aspects
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/12 &hec%in" and corrective action/121+ erformance measurement and analysis of data
/121- Records5 document and data control
/121. Inventory monitorin" and control
/121/ )ccident and incident investi"ation5non;conformity5 corrective and preventive actions
/1212 Inspection and audit
C0ec)in( and corrective action
,ections on operational control and emer"ency response; Functional requirements rather than technical requirements
; Technical measures B usual content of biosafety pro"rammes
and manuals
,pecific subsections on issues li%e biolo"ical inventories5wor% pro"ramme plannin" and capacity5 chan"e mana"ement5
behavioural factors5 personnel reliability5 information security
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includin" in certification audits?
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/13 Review
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,et of performance;based requirements puttin" responsibilityon institutions to demonstrate appropriate bioris% mana"ement
0uilt;in flexibility
*ana"ement and functional requirements
Aot lin%ed to any specific re"ulation or technical approach
,ystem to be adapted to the nature and scope of the activity
&oncrete measures to be based on ris% assessment
ossibility to exclude clauses that may not apply>exclusion to be documented and 9ustified?
'emandin" clauses that tend to be exceed many le"al requirements
Importance of prevention and pro;activity
:i"h level of consideration of human factors
Contents of CWA 15793 Conclusions
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In collaboration with
ICIS - Insubria Center on International Security
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