Overview: The HL7 Project Approval Process for TSC Sponsored Projects
In summary, the HL7 project approval process is as follows:
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- Step 1: Create a Project Scope Statement (PSS)
- Step 2: Co-Sponsoring Work Group reviews the Project Scope Statement
- Step 2a: Submit Project Scope Statement for Administrative Review (in parallel with Co-Sponsor Work Group Approval)
- Step 2b: PMO enters the Project Scope Statement into Project Insight (in parallel with Administrative Review above)
- Step 3: Submit Project Scope Statement to TSC for review and / or approval
- Step 4: The HL7 PMO and Project Services Committee insure insures that HL7 project methodology is adhered to
For TSC Sponsored projects, in summary, the TSC approves the project scope “in-committee”, and then circulates it to Administrative Review groups for their review and approval. At the same time, the PSS is sent to co-chairs and international council (as if it were coming from a Steering Division), allowing them a week for review and comment (a formal approval is not necessary). The PSS then goes back to the TSC again for final approval of the project.
What approvals do I need to obtain?
The table below summarizes the approvals needed based on the group sponsoring the project.
If the Project’s Sponsor is a…
Approvals shall be gathered from the following committees…
The following committees will be informed of the project…
TSC
- International Affiliates
- Co-Chairs
- PMO
PSS approvals are typically done via conference calls. However, if desired, the approval can be through email or a poll (say, a Doodle Poll via www.doodle.com), if the Work Group, Committee, or Council has defined an e-Vote process in their Decision Making Practices. When doing this, include the URL to the Doodle poll and indicate a deadline date for the review and approval within the email requesting review/approval. Approvals are by simple majority vote of the approving body.
Shall / Should / May Definitions*
This describes the terminology for expressing the stringency of a conformance statement.
*Sources for the above:
- ISO/IEC Directives document - Appendix H (http://www.iec.ch/members_experts/refdocs/iec/Directives-Part2-Ed5.pdf).
- Version 3 Publishing Facilitator's Guide - Section 5.1.1 Use of SHALL, SHOULD and Other Modal Verbs (http://www.hl7.org/v3ballot/html/help/pfg/pfg.html).
Detailed Steps: The HL7 Project Approval Process for TSC Sponsored Projects
Step 1: Create a Project Scope Statement (PSS)
If the Project’s Sponsor is a…
Actions
Deliverables
TSC
The Project Facilitator shall work with members of the TSC to complete a Project Scope Statement (PSS) using the most recent version of the PSS Template (MS Word document) located at www.HL7.org > Resources > Templates (http://www.hl7.org/participate/templates.cfm).
The Project Facilitator may create a Project Page on the HL7 Wiki using http://wiki.hl7.org/index.php?title=Template:Project_Page.
PSS completed and ready to be reviewed by the TSC and any co-sponsoring Work Group(s).
Project Page created on the HL7 Wiki.
Step 2: Co-Sponsoring Work Group reviews the Project Scope Statement
Reviews should focus on the following within the PSS:
- is this PSS clear in terms of its scope and deliverable(s)
- is it within the scope of the sponsoring committee
- how is it related to other projects
- how is it related to the activities of other committees
PSS approvals are typically done via conference calls. However, if desired, the approval can be through email or a poll (say, a Doodle Poll via www.doodle.com), if the Work Group, Committee, or Council has defined an e-Vote process in their Decision Making Practices. When doing this, include the URL to the Doodle poll and indicate a deadline date for the review and approval within the email requesting review/approval. Approvals are by simple majority vote of the approving body.
If the Project’s Sponsor is a…
Actions
Deliverables
TSC
The Project Facilitator shall submit the completed PSS to the TSC and co-sponsoring Work Group(s)
The TSC and co-sponsoring WG shall review and approve the PSS.
Reviewers should direct any questions / comments to the Project Facilitator.
PSS reviewed and approved by the TSC.
PSS reviewed by co-sponsors.
Step 2a: Submit Project Scope Statement for Administrative Review (in parallel with Co-Sponsor Work Group Approval)
PSS approvals are typically done via conference calls. However, if desired, the approval can be through email or a poll (say, a Doodle Poll via www.doodle.com), if the Work Group, Committee, or Council has defined an e-Vote process in their Decision Making Practices. When doing this, include the URL to the Doodle poll and indicate a deadline date for the review and approval within the email requesting review/approval. Approvals are by simple majority vote of the approving body.
If the Project’s Sponsor is a…
Actions
Deliverables
TSC
While Co-Sponsoring Work Group is reviewing the PSS, TSC Project Manager (TSC PM) shall email the PSS to:
- HL7 Project Management Office (pmo@hl7.org)
- International Affiliates
- Co-Chairs
- US Realm Projects: US Realm Steering Committee Approval
- Family Management Group(s)
The above groups have one week for review/comment; these groups need only review the PSS; approval by them is not necessary.
PSS emailed to appropriate groups and PMO.
Project Facilitator attends appropriate group’s conference call(s), if necessary.
Step 2b: PMO enters the Project Scope Statement into Project Insight (in parallel with Administrative Review above)
If the Project’s Sponsor is a…
Actions
Deliverables
TSC
PMO shall review the (at minimum) WG-approved PSS and direct questions / concerns to the Project Facilitator. The primary review of the PSS by the PMO is to insure the PSS is filled out completely.
The Project Facilitator shall resolve any questions/concerns brought forth by the PMO.
If updates are necessary to the PSS, the Project Facilitator shall provide an updated PSS to:
- Sponsoring Work Group(s)
- Co-sponsoring Work Group(s)
- Appropriate Administrative Review Group(s)
- Steering Division(s)
The PMO shall enter the PSS into Project Insight; note that this can occur prior to “leader group” (e.g. SD or EC) approval.
PSS added to Project Insight.
Project Insight assigns a unique Project ID.
Step 3: Submit Project Scope Statement to TSC for review and / or approval
Reviews should focus on the following within the PSS:
- is this PSS clear in terms of its scope and deliverable(s)
- is it within the scope of the sponsoring committee
- how is it related to other projects
- how is it related to the activities of other committees
PSS approvals are typically done via conference calls. However, if desired, the approval can be through email or a poll (say, a Doodle Poll via www.doodle.com), if the Work Group, Committee, or Council has defined an e-Vote process in their Decision Making Practices. When doing this, include the URL to the Doodle poll and indicate a deadline date for the review and approval within the email requesting review/approval. Approvals are by simple majority vote of the approving body.
If the Project’s Sponsor is a…
Actions
Deliverables
TSC
The TSC shall review/approve the updated PSS based on feedback from the Administrative Reviews
Updated PSS reviewed/approved by the TSC
Step 4: The HL7 PMO and Project Services Committee insure that HL7 project methodology is adhered to
NOTE: No definable actions are documented; Project Facilitators are encouraged to attend the ‘Open Forum’ session held at the beginning of every Project Services Work Group conference call if they have any issues to discuss. Upcoming calls can be viewed via the Project Services Work Group page on www.HL7.org.
FAQ – Frequently Asked Questions
How do I search/view HL7 Projects?
There are three ways to view HL7 projects, all located at www.HL7.org > Resources > Tools and Resources > Project Management and Tracking Tools
(http://www.hl7.org/participate/toolsandresources.cfm):
The Searchable Project Database (http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm, located on the www.HL7.org Homepage and titled ‘H7 Project Database’.
An Excel spreadsheet of all HL7 projects is available via GForge > Projects » TSC > Releases > HL7 Project List (http://gforge.hl7.org/gf/project/tsc/frs/?action=FrsReleaseBrowse&frs_package_id=98).
Project Insight (a Project Insight User ID and Password is required – this differs from your HL7 User ID and Password). Contact the HL7 PMO for more information (pmo@hl7.org). The URL is: http://healthlevelseven.projectinsight.net/l.aspx?ReturnUrl=%2fdefault.aspx.
Where can I find the Project Scope Statement Template?
The most recent version of the Project Scope Statement Template (MS Word document) is located at within a Zip file at www.HL7.org > Participate > Templates > Project Scope Statement and Project Approval Process .
Who is the project facilitator?
The Project Facilitator named in the Project Scope Statement serves as the Project Lead; the 'go to' person for the project who can answer questions regarding status, scope, objectives, issues, risks, etc. regarding the project.
How do I know the approval status of my project?
Look up your project using the HL7 Searchable Project Database (http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm), located on the www.HL7.org Homepage). The search results will reflect approval statuses by the various groups.
I’ve submitted my PSS to my Steering Division for approval but haven’t heard anything from them. What should I do?
First, check the Steering Division’s meeting minutes. Look to see if your project was on one of their agendas, and if so, if it was approved or the SD had further questions. Your first point of contact with the SD should be the Steering Division Leaders.
If the SD has approved your project, they will submit it to the TSC for approval via GForge’s tracker system. To view which approvals your project has gathered, find your project by using the HL7 Searchable Project Database (http://www.hl7.org/special/Committees/projman/searchableProjectIndex.cfm), located on the www.HL7.org Homepage).
The scope or objective of my project changed. Do I need to create a new PSS?
You may or may not have to as it depends on the change. Oftentimes, the scope or objectives of a project may change during its lifecycle, perhaps due to regulatory changes or tying back to a different standard. When the scope changes, it is recommended that a new Project Scope Statement NOT be created. By keeping the same Project ID, the ballot site can readily point the same project ID to both STU and Normative ballots.
If the change in scope or objectives is minor, simply update the existing project scope statement, and within Project Insight, indicate the modifications in the appropriate fields. You can also use the ‘Misc. Notes’ text box for documentation.
Best practice: Use Microsoft Word’s ‘Track Changes’ tool to highlight the changes being made to the Project Scope Statement.
However, if the change in scope or objectives is major, the Project Facilitator should submit a new Project Scope Statement, as much of the original information won’t accurately reflect what is being done anymore.
What defines a ‘major’ or ‘significant’ change in scope?
Since ‘major’ and ‘significant’ are subjective terms, examples may provide better comprehension of a “major” or “significant” change to a project scope statement.
A “major” or “significant change” in project scope includes the following:
Creating a new Release of a Normative or Informative artifact (excludes STU, refer to TSC Policy and Guidance to Work Groups on STU Updates vs. STU Ballots)
The Project End date extends by 24+ months
Additional HL7 funds are required
The Project Intent changes (i.e. the project changes from “Revising a Standard” to “Creating a Standard”)
The change in scope will result in an item that qualifies as ‘substantive change’ as defined in HL7 Essential Requirements. (Normative ballot)
The Realm changes from ‘Realm Specific’ to ‘Universal’ (since additional project resources may be necessary to support that change)
The deliverable’s backwards compatibility changes from ‘Yes’ to ‘No’ (excludes STU, refer to TSC guidance documents on the TSC Wiki Main Page)
What approvals are needed if I revise my existing PSS, say the project’s scope changes?
The same approval process should be followed whether it’s a new project or a scope change to an existing project.
When the scope is changed in a project, the modified Project Scope Statement will be approved by the primary WG and the SD, providing the TSC using the same time line and deadlines as submissions for new projects. When the scope changes, it is recommended that a new Project Scope Statement NOT be created. By keeping the same Project ID, the ballot site can readily point the same project ID to both STU and Normative ballots.
Best practice: Use Microsoft Word’s ‘Track Changes’ tool to highlight the changes being made to the Project Scope Statement.
What ballot types are required to go through the project approval process?
Projects for all ballot types (Comment Only, Informative, Normative, STU) need to go through the project approval process, however, as identified in the Project Scope Statement, a single project can define ballot plans for multiple types of ballots for the project, for example, Comment Only > STU > Normative or Informative > Normative.
Should a Work Group create a new PSS when creating a new Release of a Standard?
Yes, in all cases, a new PSS should be created whenever work on a new Release of a Standard is being done and go through the appropriate approval process. Do not modify the PSS that refers to a prior Release. In most all cases, there will be a significant enough change in the newer Release of the Standard to warrant a new PSS. Also, a new PSS helps for tracking and historical purposes, as a new PSS assists HQ in keeping a one-to-one relationship of standards to projects.
When reaffirming a standard, does a PSS need to be created and go through the review/approval process?
Yes. Reaffirmation of a standard requires a normative ballot.
When withdrawing a published standard or a standard that has gone through balloting, does a PSS need to be created and go through the review/approval process?
Artifacts that have been balloted AND published at any level (normative, informative or STU) MUST have a PSS created and go through the review/approval process.
Artifacts that have balloted at any level (normative, informative or STU) but were NOT published, do NOT require a new PSS be created.
For further information, see Appendix A in the Notice of Withdrawal of a Protocol Specification template.
When withdrawing or retiring an artifact balloted at any level (except Comment Only), a Notice of Withdrawal of a Protocol Specification form must be completed and submitted to the TSC. This form can be found via www.HL7.org > Resources > Templates > Notice of Withdrawal of a Protocol Specification.
In this case ‘withdrawing a standard’ refers to many things, such as choosing not to extend a standard that has reached its 5 year end-of-life or identifying the need to sunset a standard.
Do I need to go through the project approval process if a standard has expired and will not be reaffirmed?
No. When a work group has balloted a standard at STU, informative, or normative ballot, and decides the standard will be withdrawn, the withdrawal form at www.HL7.org > Resources > Templates > Notice of Withdrawal of a Protocol Specification is needed for ANSI notification and must be approved by the Work Group and then submitted to and approved by the TSC.
Do I need to update the PSS if I discover after it’s approved that I need to coordinate ballots with other HL7 Work Groups?
Yes, we recommend updating the Ballot Strategy section of the Project Scope Statement as well as Project Insight. Include the ballot name and release/version your project is coordinating with.
What is the approval process for HL7 projects that collaborate with ISO or the JIC?
Follow the process documented on via www.HL7.org > Resources > Balloting > HL7's Collaboration with ISO and JIC .
Do I need additional approvals when creating or modifying an HL7 Policy/Procedure/Process?
Yes. Work Groups should also have the Architectural Review Board review/approve the PSS. Work Groups should include the ArB when sending the PSS to their Steering Division for review/approval. For additional information on creating or modifying HL7 processes, refer to the document Introducing New Processes to HL7.
How should a Work Group document the voting results after seeking approval for the PSS?
Record the approval of the project team; approval shall be recorded in the Work Group’s minutes.
What should I do if an approval group is unresponsive?
For an unresponsive co-sponsor, raise the issue to the co-sponsor's Steering Division, indicating that if the co-sponsor is unable to review the PSS in an acceptable time period (~2 weeks), that they will be removed.
For other unresponsive groups, raise the issue to the TSC.