ASTM E55
Notes for New Work Item Proposers
These notes are intended to be an informative guide to assist New Work Item (NWI) proposers in completing the NWI Submission form for E55 which will be required from November 2007.
The NWI Submission form is intended to assist the E55 Executive committee in making decisions regarding the relative importance, urgency and priority of the work, and in assessing the capability within E55 (or upon which E55 can draw) to complete the work in a satisfactory and timely manner.
1.Outline of the Process
The approval of an E55 NWI will go through a number of stages as follows :
a)The NWI Submission form is completed as thoroughly as possible by the proposer.
b)The proposer informally approaches the chair of the likely ‘home’ sub-committee for the work and reviews the submission.
Current committee chairs are :-
E55.01 Duncan Low
E55.02 Steve Simmons
E55.03 Dave Radspinner
c)The submission is formally presented to the E55 executive committee. This committee will determine the relative importance and priority of the proposed work in the context of the published E55 roadmap. Proposals may be given one of four statuses :-
i)Approved for immediate start
ii)Approved for delayed start (tied either to a specific time, or a set of conditions, such as completion of an existing work item.)
iii)Held for further review (either for lack of time, or because the committee wants additional information or requires additional commitments before work is approved).
iv)Declined (because the committee does not feel E55 is the appropriate ‘home’ for the work, or because required conditions are not met).
Whilst individuals are free to undertake work in an unofficial capacity, formal work on an E55 document may only be started once approval for the work item has been granted and any attached conditions have been met.
2.Targets for the NWI
It is the objective of the E55 Executive committee to ensure that NWIs meet the following conditions :-
a)They are a good fit to the E55 Vision and Mission statements
b)They can be mapped as a priority item on the E55 roadmap
c)That the work is best done within E55 (that is it is not being done elsewhere, and would not be better done elsewhere).
d)That the appropriate resource (manpower) and capability (experience and/or knowledge) to undertake the work is available within E55, or within a body prepared to work with the ASTM process.
e)That the work will not unduly affect other work already occurring within E55 which has a higher priority
3.Filling in the Submission form
This section seeks to provide additional information for the proposer to assist in the process of preparing for submission.
Proposers are advised to prepare the form in draft as far as possible, and then to approach the chair of the sub-committee they feel is likely to be the ‘home’ of the work. In some cases the chair may redirect them to an alternative committee chair, but normally they will work with them to ensure that the submission is sufficiently complete to be formally presented to the E55 Executive Committee.
The objective is to provide all the information need to the Executive committee to make a quick decision on proposal status and priority.
Question 1
This is general contextual information. The proposer should include information on who (which individuals, which companies, which sectors) need the proposed work, why the work is needed, and what benefit it will provide in terms of consistency, understanding, quality, cost, etc.
Question 2
The Executive committee will review each Work Item Proposal against both the vision and mission statements (the key aspects of which are bulleted in the form). Whilst it is not necessary for a proposal to be a perfect match, the better the match, the more likely the proposal is to be accepted. The proposer should seek to address each of the bulleted items.
Questions 3, 4 and 5
These questions focus upon whether work has already been done (E55 does not wish to reinvent the wheel!) and on whether E55 is the best home for such work (that is does it meet E55 objectives, is it an appropriate work-item for E55, and is E55 able to support the work).
Question 3 seeks to ensure that the proposer has performed the necessary ‘due-diligence’ in assessing the strengths and weaknesses of any work already in the public domain which may address the same subject matter.
Question 4 requests a clear justification for the NWI if work is already underway elsewhere on the subject. It would normally be expected that such justification would only be accepted if E55 could offer something not available elsewhere (e.g. other work will not need to a consensus standard and such a standard is urgently needed by the industry)
Question 6
The proposer should clearly state what type of document is being proposed and why. Available document types are standard guides, standard practices, test methods and specifications. All E55 terminology has, to date, been kept in a central terminology document maintained by E55.91.
Question 7
These are the proposed title and Scope of the document. The title should clearly state the subject area of the document. The scope is generally formatted to allow some flexibility in the development and eventual contents of the document. Once approved, changes to the title or scope will require formal approval by the E55 Executive committee.
Question 8
Details of the proposed team leader. This should include contact information, and detail of experience which is appropriate to the task in hand – that is experience in the area covered by the proposed document, experience in preparing such documents (for any organisation), and experience as a team-leader.
Question 9
Details of those individuals likely to participate in the preparation of the document. Experience within E55 suggests that an ideal workgroup is 4-5 people (with fewer people the workload becomes onerous and input is restricted, with more people the workgroup becomes unwieldy and consensus difficult to achieve quickly.) The actual size of the workgroup is up to the team leader in consultation with the relevant sub-committee chair.
This list will be reviewed for :-
-range of experience
-formal balance (i.e. customers/suppliers/others)
-availability
Question 10
This is intended to demonstrate the wider interest in the document both within and outside E55. Where outside bodies or individuals are listed, some comment about the mechanism of communication with them will be required.
Question 11
The executive committee will expect each proposed NWI to have a project plan giving, as a minimum, target dates for each of the major milestones in preparing the document. These should include at least :
-first ballot
-2 rounds of revision as a result of comments and ballot
-Final approval
It is an objective of the E55 Executive committee that all work items should reach final approval within 2 years of approval of the NWI. Whilst it is possible that very important items may be accepted with longer timescales, these will be very much the exception.
Questions 12, 13 and 14
These will be completed by the sub-committee chair presenting the proposal.
It is the objective of the E55 Executive committee that responses to NWI proposals will be made promptly and clearly. It is hoped that in all cases a decision will be made at the first Executive committee meeting following the submission. This decision, and the associated reasoning, will be formally recorded in the minutes, and will be the subject of a specific notification to the membership (the form of which has yet to be decided).
Should the E55 Executive committee decide not to proceed with a particular item, individuals are, of course, free to approach other ASTM committees and/or other organisations with the proposal.
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ASTM E55 New Work Item Proposal1 / Please provide a summary of the need for the proposed document? / Who? What industry sector? Why? How will it improve matters? Etc.
General summary of need.
2 / Describe how you believe the proposed work fits with the E55 Vision and Mission statements. / Comment on each phrase of the statements.
Vision statement
Facilitates
- Design
- Development
- Understanding
- Evaluation
- Control
- Optimisation
Supports the community in providing
- Cost Effective
- Transparent
Mission statement
Documents that
- Directly Support
- Add Value
- Are Cost-Effective
Standards which codify existing practices will be adopted only if there is clear
- Added Value
- Understanding
3 / Is this general area addressed outside ASTM E55? / What committees? What documents already exist? Are they insufficient? Etc
By consensus standards bodies (e.g. ISO, , etc.)
By other organisations (e.g. ISPE, PDA, Pharma, etc)
4 / If the answer to 3 is yes, then what is the justification for this work being done within E55? / What distinguishes E55 for this work ?
5 / If the answer to 3 is no, are there specific reasons why this work has not been undertaken? / Are there good reasons why work has not been undertaken (lack of consensus, commercial interests, etc) ?
6 / What type of document is being proposed? Why?
Tick one of the following :
Standard Guides
Standard Practices
Test Methods
Specifications
Why ?
7 / What is the proposed Title and Scope of the document?
Proposed Title
Text of proposed scope
8 / Who is the proposed Work Item Leader? / Name, Company, Relevant Background
9 / List of likely Work Group Members / Name, Company, Relevant Background
10 / List of known interested parties / Companies, Organisations, Individuals, Etc.
Inside and outside E55.
11 / Proposed Timescale/Project Plan / Key deliverables and stage timing
12 / Sub-Committee Chair comments
13 / Suggested Work Item mentor
14 / Interactions with other work-items