Those in the U.S. emergency-responder community know first-hand what tools, incident action plans, and gear they need in the field, and are also the most knowledgeable about the performance requirements and standards these products must meet to best serve their community. Yet, like many others in both government and industry, emergency responders need a better grasp of the principles and processes involved in standards development in order to expedite the availability of urgently needed standardized products.
There are many different ways to approach the subject of standards development, rather than waiting to be invited to a “stakeholders table” (typically formed and funded by one or more federal agencies). And stepping outside the box to become more proactive could help provide more control over the schedule and other parameters of standards development. The steps outlined below not only should help to make standards development more understandable to end users but also help expedite the process.
The Basic Principles Involved in the Development of National Standards
There are many different types of standards, but if a particular standard is intended to be used on a national scale, it requires the balanced consensus underpinning of national standards to ensure not only its relevancy but also its acceptability by users. Understanding the principles that guide the development leads to an appreciation of the processes that follow. The National Technology Transfer and Advancement Act (NTTAA) of 1995 and Circular No. A-119 (Revised) (both of which are available at http://standards.gov) are recommended reading. Many other sources are available via the internet for consulting or training on the principles and processes of standards development.
An established standards development organization (SDO) can be used to develop the standard according to its own national standard process and infrastructure. The stakeholder also has the option of independently forming an appropriate infrastructure and process – following the guidelines of the previously mentioned NTTAA and Circular A-119 (Revised) – as well as the most recent edition of ANSI Essential Requirements: Due Process Requirements for American National Standards; that publication, copyrighted by the American National Standards Institute (ANSI), is available at www.ansi.org. If the creation of an independent standards development infrastructure and process is too complex a task, outside experts and SDOs can be recruited to assist.
Defining the Scope of the Standards Requirement
This part of the task is a four-step process, usually carried out in the following order:
1. Determining What Standards Already Exist – To define the scope of the work involved, some research is necessary to discover if the standard needed already exists. This is a fundamental first step required in the process of developing almost any national standard because it: (a) ensures that an adequate standard does not already exist; (b) helps to substantiate the need for a new standard; and (c) may determine the existence of an extant standard that simply needs modification to fulfill new and/or additional needs. Again, established SDOs and/or outside experts and consultants can help with the determination process, if desired.
2. Establishing Acceptable Performance Criteria – The development of performance criteria should start by asking certain relevant questions, including the following: (a) What does the product or system have to do specifically to meet the need, and at what level of performance, and/or with what, if any, permissible margin of error? (b) Should the product first be tested in a laboratory, under pristine conditions, to ensure that it works, before it is subjected to testing in the field? (c) Is training necessary to ensure performance? In answering these questions it is important to note that the standard-development process can stop once a consensus on performance criteria has been reached. Any entity providing a product (gear, threat-detection device, incident action system) must be prepared to prove that that product conforms to the national consensus standard that has been established. Depending on the specific type of standard involved, it may be necessary to solicit the assistance of technical experts, scientists, and/or statisticians to convert the requirements into agreed-upon measurable units. The testing protocol, after it has been approved and validated, would then be used to ensure that manufacturers’ products conform to the performance-criteria standards previously approved.
3. Developing and Using an Acceptable Testing Protocol – If desired, the standard development process can continue to include the development and validation of a testing protocol. In other words, if a standard is developed for a detection device, to cite but one example, that device must be tested to ensure that it conforms to the standard already established. This requirement leads to at least two additional questions, though: (a) What test should be used? (b) How can it be determined that that particular test works as intended? It probably is a good idea to use validation experts and statisticians at this stage, and the final test validation protocol must be approved by the consensus group. Note: There may be additional laboratory testing costs associated with this step, but the stakeholders in standards development groups are often compelled not only to cope with this requirement but also to complete the other steps required to meet the necessarily high expectations established for the development of nationally acceptable standards.
4. Carrying Out Conformity Assessments – If desired, the standards development process can continue to include conformity assessments. After the testing protocol discussed above has been validated and approved, it can be used by manufacturers and other providers to ensure that their products conform to the standard(s) previously established. During the earlier “Performance Criteria” step, it could be up to the stakeholders to determine the importance and/or extent of conformity testing needed. The general rule here is that the greater the conformity testing required, the greater the confidence level in the standard’s performance will be, and that important albeit intangible benefit has to be weighed against the cost of additional testing.
Determination of Stakeholders, Stakes, and Resources
Stakeholder selection is always one of the first considerations in the development of appropriate standards and must be kept in mind at all times during the selection process. Ideally, therefore, stakeholder selection criteria should include not only those with an interest in and knowledge of the standards area, but also outside experts, whose only stake is good science, as well as other stakeholders who might be able to contribute such valuable resources as funding, technical expertise, laboratory facilities, and training to the overall standards development effort.
Diana Hopkins is the creator of the consulting firm “Solutions for Standards” (www.solutionsforstandards.com). She is a 12-year veteran of AOAC INTERNATIONAL and former senior director of AOAC Standards Development. Most of her work since the 2001 terrorist attacks has focused on standards development in the fields of homeland security and emergency management. In addition to being an advocate of ethics and quality in standards development, Hopkins is also a certified first responder and a recognized expert in technical administration, governance, and process development and improvement.