Prezentarea 4 CWA 15793 2011.pdf

8/11/2019 Prezentarea 4 CWA 15793 2011.pdf

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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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Funded by the European Union

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




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




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

Co#tact$ %&t" aut"or: '"&l&''e.$troot()&*&o$.eu

EB+A %e*$&te: "tt':%%%.e*$a%e*.eu

Prezentarea 4 CWA 15793 2011.pdf

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