JIC SDO Standards Development Processes

1

JIC SDO Standards Development Processes

Prepared byDave Iberson-Hurst, CDISC

19th January 2010Second Draft

2

Purpose of Slide Set• The purpose of the slide set is to provide an

overview of the processes employed by the SDOs that constitute the JIC

• The slide set shows the alignment between the processes used by the SDOs and also illustrates the time taken to develop standards using the processes.

3

Notes Regarding the Slide Set• Each “real” slide is preceded by a slide containing

information relevant to the following slide. • These have been included such that this slide set

can be understood without explanation from myself during the JIC meeting on the 20 January 2010 in Phoenix, AZ

• Also, please note, SDOs are ordered in alphabetical order based on the SDOs acronym, there is no deeper meaning intended

• IHTSDO has not been included at this time due to time constraints.

4

Note for Slide “The Generic Process”• This is based on the document “An overview of

SDO processes and processes for common / harmonized standards development (Normative Standards). DRAFT FOR COMMENT. Version 2.1, 24 April 2008”, referred to as the JIC Process Document

• It represents the generic SDO development process

5

The Generic Process

Preliminary Project Assessment

Project Proposal

Project Approval

Develop Initial Version

Membership/Public Review

Final Approval

Publication

Maintenance

Reach Initial Consensus

6

Note for Slide “CDISC Process”• TAC = Technical Advisory Board – A subset of the

elected CDISC board members who provide oversight of the technical work undertaken by CDISC

• TLC = Technical Leadership Committee – Consists of the Team Lead of each CDISC technical teams

• CDISC does not have an equivalent of the Preliminary Project Assessment

• Information sourced from the CDISC document COP-001 Standards Development

• The idea for each of the SDO slides is to map to the generic process so that differences become apparent and visible

7


Project Proposal

Project Approval



Final Approval

Publication

Maintenance


Project Scope

TAC Approval

Team Development

TLC & Expert Review

Public Review

TLC Approval

Publish to Web Site

Maintenance

CDISC Process

8

Note for Slide “CEN Process”• Information presented in based on the JIC

process document and a slide presentation from the CEN web site: “Getting Started ... How to develop a European Standard” by Ashok Ganesh

• There is a gap on the project approval stage (marked by “???”). Needs to be filled in.

9


Project Proposal

Project Approval



Final Approval

Publication

Maintenance


Preliminary Questionnaire

New Work Item approval

Working Draft

Working Draft

Enquiry

Final Vote

Publication (EN)

Maintenance

CEN Process

New Work Item Proposal

10

Note for Slide “HL7 Process”• Based on the JIC process document and personal

experience. Therefore probably needs checking!• TSC = Technical Steering Committee• HL7 does not have an equivalent of the


11


Project Proposal

Project Approval



Final Approval

Publication

Maintenance


Project Scope Statement

TSC Approval

Working Group Development

Committee Ballot

Full Member Ballot

TSC Approval

Publication

Maintenance

HL7 Process

12

Note for Slide “ISO Process”• Based on the JIC process document and the ISO

web site page “Stages of the development of International Standards”,– http://www.iso.org/iso/standards_development/processes_and_procedures/stages_description.htm

• ISO stages of development are the default process– Each TC operates with any number of agreements

which effects document timeline and number of ballots

– Depending on the document, level there may be 2 or more different agreements for one document

13


Project Proposal

Project Approval



Final Approval

Publication

Maintenance


Preliminary Work Item

Approval

Working Draft

Committee Draft

Draft International Standard

Final Draft International Standard

Publication (IS)

Maintenance

ISO Process

New Work Item Proposal

14

15

Note for Slide “Alignment”• The previous slides show each SDO’s process

aligned with the generic one. It allows for aspects of the process to be highlighted.

• The next side puts all of the processes along side each other to allow for a simple comparison to be made.

16


Project Proposal

Project Approval



Final Approval

Publication

Maintenance


User Requirements

Project Proposal

Business Requirements Gathering

Standards Development

Architecture Reviews

Gen Spec Change Notice

Post to Web

Annual Maintenance

GS1 Process

Call To Action

17

ProjectScope

TACApproval

TeamDevelopment

TLC &ExpertReview

TLC &ExpertReview

TLCApproval

Pub. toWeb Site

Maint.

TSCApproval

WorkingGroup

Development

CommitteeBallot

FullMember

Ballot

TSCApproval

Publication Maint.

Preliminary

ProjectAssessm

ent

ProjectProposal

Project Approval

Develop

InitialVersion

Mem

bership/Public Review

FinalApproval

Publication

Maintenance

ReachInitialConsensus

ProjectScope

Statement

PWI

Approval

WorkingDraft

Committee Draft (CD)

DraftIntl

Standard(DIS)

Publication(IS)

Maint.NWIP Approval

Final DraftIntl

Standard(FDIS)

NWIPl Approval Enquiry Final Vote

Publication(EN)

Preliminary Questionnaire

Maint. Working Draft

18

Note for Slide “Where the Time is Spent” Slide• This slide is to show where the relative effort is• The circles represent months of elapsed time• Assumes that a technical standard takes 12 months to write but obviously this could

vary widely depending on complexity and other factors• Where two colours are used the darker colour indicates the minimum time for the

activity with the lighter colour being used to indicate that the activity might well take longer depending on the complexity of the standard, number of comments received etc.

• Symbols– The small clock icon indicates that the activity has time constraints such as review cycles (must start

at the beginning of a cycle or can only be completed at a F2F meeting). This is important as this can have major impact on timelines (e.g. An NWIP can only be approved at a F2F ISO TC 215 meeting, is that true?)

– The small question mark indicates an optional stage.– The small diamond used in place of the circles indicates that the stage is usually a few days in

duration– Black circle with an “N” indicates that the stage is Not Applicable to that SDO

• Slide is not complete, needs extra info on stage durations and also I think some of the stages have time/cycle constraints (ISO & CEN NWIP/ballots happening around F2F meetings)

• Does not, currently, take into account the HL7 DSTU status, which can be 2 years.• CEN and ISO total duration time for the entire process needs to be entered. CEN quotes

3 years. ISO has 3 tracks, 2, 3 and 4 years.

19

Where the Time is Spent

1

1

1

1

1

1

?

?

Preliminary

ProjectAssessm

ent

ProjectProposal

Project Approval

Develop

InitialVersion

Mem


FinalApproval

Publication

Maintenance


12

?

?

2

2

?

11

2

2

3

5

1

?

12

12

12

512 ?

N

N

19

?

?

21

20

Where the Time is Spent - Questions

1

1

1

1

1

1

?

?

Preliminary

ProjectAssessm

ent

ProjectProposal

Project Approval

Develop

InitialVersion

Mem


FinalApproval

Publication

Maintenance


12

?

?

2

2

?

11

2

2

3

5

1

?

12

12

12

512 ?

N

N

19

?

?

21

21

JIC Alignment• Having worked through the above we see the

SDO’s processes in “isolation”• Further issues can arise when JIC tries to co-

ordinated work across SDOs such as:– Alignment of ballots/review– Documentation format issues– Others?

• It may be worth doing some work trying to assess these impacts and describing them on a slide

Documents

JIC SDO Standards Development Processes