Standards creation in laboratory automation

From LabAutopedia

This article is about about the process required to create recognized standards, such as ISO (International Standards Organization) or ASTM ( originally the American Society for Testing and Materials) standards. Persons and groups interested in developing consensus standards are well advised to affiliate with an existing standards development organization (SDO) (See the LabAutopedia list of Standards Organizations). The role of the SDO is to promulgate the standard once written and to provide a fair and legal procedures and practices for the standards development process. While the exact procedures for doing this differ among SDOs, it is essential that the processes involved be open, fair, and free from anti-trust violations.

SDO rules insure a level playing field, but it is the job of the standard's developers to ensure that the stakeholders affected by the proposed standard know that such an activity is taking place and are offered the opportunity to participate in the process. This is essential to ensure fairness, but it is also important for practical reasons. Getting "buy in" and participation from the stakeholders early in the standard development process is the best way to arrive at a standard that gets used and has an impact. A consensus standard does not mean that all those developing it agree with it--it means that none of the developers disagrees with it or can provide persuasive arguments against it. A consensus standard is not a law; however, it can achieve a legal status if it is incorporated into a legal document such as a contract or purchase agreement.

1 Creating a new standard
- 1.1 ASTM
- 1.2 ISO
2 Modifying existing standards
3 How Standards are Produced
4 External Links

Creating a new standard

The first step is to research whether there is an existing standard in the area identified through contact with trade associations, government agencies, or other standards developing organizations (SDOs). Duplication of effort and parallel standardization activities cause marketplace confusion and drain the resources of stakeholders participating in the standards development process. If you are aware of an SDO Technical Committee that appears to be able to cover the scope of the proposed activity, contact the the chair of that committee. If you are unable to identify a committee that covers the scope of the proposed activity, inquire with an SDO that has a relevant focus. Next it is necessary to identify and contact key stakeholders to ensure that there is agreement that the standards area identified has market relevance for the industry and stakeholders are committed to participate on the project.

ASTM

Generally, anyone who identifies a need for standardization can submit a written request to ASTM Headquarters. ASTM staff research the idea to assess if there is adequate interest in the field, to discover if parallel activities exist in other organizations, and to determine where the activity would appropriately fit within the ASTM structure. The staff of ASTM does not determine which standards should be developed.

If the initial research indicates the area of interest is ripe for standardization, it is time to issue a formal request to ASTM to consider formation of a new task group or subcommittee to the appropriate Technical Committee, or if a Technical committee does not exist, establish a new committee. It is appropriate for the proponent to be active, and possibly even chair the task group. Once formed, the task group will be charged with developing a first draft.

The Chairman of the new task group needs to be familiar with the standards development tools available from ASTM. For information visit the Draft Standards Template and Form & Style Manual links on the ASTM International website. The Template link offers a series of standards templates that cover the full range of documents produced by ASTM - specification, test method, practice, guide, classification, & terminology. The templates provide clear and easy to follow links to all mandatory sections for each type of standard, are downloadable to most personal computers, and, once completed, provide the proponent of the activity with an electronic copy of a document ready to begin the journey toward an approved ASTM standard. The Form & Style Manual provides clear and concise information regarding the format for the many different types of ASTM standards, including mandatory sections, legal aspects of standards, and usage of SI units. The completed draft standard should be forwarded to the Chairman of the subcommittee with jurisdiction over the new activity for transmission to ASTM for formal balloting.

Task group members prepare a draft standard, which is reviewed by its parent subcommittee through a letter ballot. After the subcommittee approves the document, it is submitted concurrently to the main committee and the entire membership of ASTM.

All negative votes cast during the balloting process, which must include a written explanation of the voters’ objections, must be fully considered before the document can be submitted to the next level in the process. Final approval of a standard depends on concurrence by the ASTM Standing Committee on Standards that proper procedures were followed and due process was achieved. Depending on a committee’s commitment to timely development and approval, standards can take as little as six months to become full consensus standards.

ISO

In the case of the International Standards Organization (ISO) the process follows six steps:

Stage 0 (preliminary stage): A study period is underway.
Stage 1 (proposal stage): An NP (New Project) is under consideration.
Stage 2 (preparatory stage): A WD (Working Draft) is under consideration.
Stage 3 (committee stage): A CD/FCD (Committee Draft/Final Committee Draft) is under consideration.
Stage 4 (approval stage): An FDIS (Final Draft International Standard) is under consideration.
Stage 5 (publication stage): An IS (International Standard) is being prepared for publication.

Stage 1: A proposal for a new work item (NP) can be submitted by JTC 1, a National Body (NB) (USA, UK etc.), a subcommittee (SC) or Technical Committee (TC), or certain liaison members of JTC 1. An NP document includes enough information about the project to allow a NB to decide if it is going to participate in a project. This information includes the obvious things like title, scope, and program of work as well as a business case that sets out the purpose and justification for doing the standardization. Once an NP is submitted, all the NBs in JTC 1 have to vote on accepting the work. This is a three month ballot. In order to be accepted, a majority of the P (Principal) members of JTC 1 must approve the work and at least five P members must agree to participate in the work. (Not every NB must participate in every standard at the working level, though all P members have a vote to approve the work).

Stage 2: After approval of the NP, it is assigned to a subcommittee for the work to be done. The subcommittee establishes a workgroup to take responsibility, and work starts on the project. The workgroup identifies a project editor for the project, and work commences to create a document. This working draft (WD) will typically go through several revisions as more of the technical detail is created and consensus of the group is achieved. This process can take some time, and so JTC 1 has some procedures to flag anything that is still in this stage at the third year anniversary of the NP date. At some point the workgroup decides that the document is materially complete (main elements included), it is in a format approximating a standard, and there is consensus as to its content. At this point the workgroup recommends that the WD be sent for registration as a Committee Draft (CD).

Stage 3: The document is forwarded by the SC into JTC 1 for registration as a CD. With this recommendation is a letter which states whether this is a Committee Draft (CD) or a Final Committee Draft (FCD). If the workgroup considers that this document is basically complete and that there are unlikely to be any changes suggested during the ballot process then it may recommend that this is an FCD immediately. However, if changes are likely, the CD is the route to go. The document is put up for CD ballot as many times as needed to get enough consensus to get it through the FCD ballot. A CD ballot is a 3 month ballot, whereas a FCD ballot is a four month ballot. However, if a document fails FCD ballot it must go back to the CD ballot stage, so it is better to be sure of the consensus before submitting to FCD. In both cases, votes may be for or against the document, though negative votes must include reasons. After the close of the ballot the workgroup is required to consider every comment made and produce a disposition of comments report that explains their reasons for their actions (the workgroup is not required to accept all the comments, but they must explain their decisions). Following a successful FCD ballot the document is registered for Final Draft International Standard (FDIS) ballot.

Stage 4: The document is now sent out for a FDIS ballot. This is a two month ballot, that requires at least two thirds of the P members approval, along with no more than one-quarter of the total number of cast votes being negative. The vote can only be approval or disapproval (for stated technical reasons) and abstention. If the vote fails, the document goes back to the CD stage. If it passes only minor editorial changes are possible to the document before it goes to the next stage and is published.

Stage 5: The document is finally sent to JTC 1 to be published.

The ISO process takes time. The balloting process alone takes a minimum of 12 months, assuming that there are no needs for multiple CD of FCD ballots. With the extra time taken to actually write the technical details of the standard and get consensus about the content, you can see that the standardization process is not a quick one.

Modifying existing standards

Should you have the need to revise an existing International standard, your first step is to contact the Chairman of the subcommittee with jurisdiction over the document in question to explain the rationale for your proposed change and request a task group be formed to develop a revision.

Once you have received approval to begin the revision from the subcommittee, register your new work item with the SDO. In the case of ASTM, this is done on their members only website. An electronic version of the ASTM standard will be sent to you in Word. Ballot submittal instructions will be included along with the Word document

When making changes to the document clearly indicate the nature of the proposed changes. The preferred format is underlined text for additions,stricken text for deletions, and revision bars clearly placed in the margin of the document. Microsoft Word has a utility in .Tools. called .protection. that provides this function.

If you are only interested in changing a small portion of the standard, you may choose to only submit those specific sections. Please copy and paste the relevant sections into a separate document. NOTE: Please verify that the standard designation number and the exact year date are clearly located on the revision.

How Standards are Produced

Once a standard has successfully cleared the appropriate levels of peer review (three in the case of ASTM (subcommittee, main committee, and Society), it is assigned a fixed alphanumeric designation and receives an official approval date. The document is now considered to be an SDO standard and is capable of being cited in contractual language, referenced by a code body, or mandated by a state or local government.

Approximately eight weeks after a standard is approved, it is available for distribution as a stand-alone document in a variety of media (email, fax, hard-copy). ASTM publications may be purchased from ASTM International via customer service (610-832-9585) or the ASTM International website (www.astm.org). All ASTM International standards are housed in specific volumes of ASTM's annual book of standards. Information regarding the complete book of standards is located on the ASTM website BOS Availability Calendar. ISO publications are available directly from many ISO member organizations or can be ordered from IHS Inc.