The American national standard, ANSI/ASQC E4:1994, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs, has completed its mandatory review and revision process as required by the American National Standards Institute (ANSI). This standard, the first quality management system standard developed expressly for environmental programs, was developed by the ASQ Energy and Environmental Division (EED) and issued in January 1995. ANSI rules require that every American national standard be reviewed at least every five years and, following such a review, be re-issued without change, revised and re-authorized, or withdrawn.
ANSI/ASQ E4:2002 will be published this fall
To comply with the ANSI rules, EED established an E4 Work Group (E4WG) to study the standard and to recommend appropriate action. This work was completed in 1999, and it was recommended that E4 be revised to incorporate lessons learned from its use since the original publication. In addition, E4WG agreed to consider minor additions to the standard to increase compatibility with ISO 9001:2000, then under development. Such additions would largely focus on using similar terminology for the same concept in both standards. To foster increased compatibility, it was decided to re-align E4 in the ISO standard format and style. For added clarity, the requirements (or specifications) were separated from the nonmandatory guidance, with the guidance being moved to an annex. Most importantly, E4WG concluded that there was still a need in the environmental business sector for a dedicated sector-specific standard and that E4 should be revised, re-authorized, and re-titled Quality Systems for Environmental Data and Technology Programs - Specification with Guidance for Use.
With the governing direction of only making minimal changes to the content of the standard, the revision process moved forward smoothly and quickly. The previous version's Parts A, B, and C were retained in the new format as follows:
- Part A, "Management Systems," became Clause 5;
- Part B, "Collection and Evaluation of Environmental Data," became Clause 6; and
- Part C, "Design, Construction, and Operation of Environmental Technology," became Clause 7.
In Clause 5, there were some key additions pertaining to a management representative and organization that related to ISO 9001:2000. Specifically, the clause on management representative states, "Management shall designate a quality assurance manager with defined authority that includes:
- determining that the approved quality system is implemented and maintained in accordance with the requirements of this standard;
- reporting to top management on the effectiveness of the quality system, including needs for improvement; and
- being organizationally located independent of operations directly implementing environmental programs."
This new text is much stronger and more explicit than the 1994 version but is consistent with the original intent.
The new clause on organization requires management to define and approve the relevant organizations, functional responsibilities, levels of accountability and authority, and lines of communication relative to quality assurance and quality control in the quality system. Within the organization, individuals responsible for planning, implementing, and assessing the quality system must have sufficient authority, organizational freedom, and access to management to identify noteworthy practices and quality problems; initiate recommendations or provide solutions to quality problems through appropriate channels; and verify their successful implementation. This text strengthens the original text in the 1994 version, which was less explicit.
Clause 5 now includes a specific requirement for a quality management plan and provides more complete and explicit text. The 1994 text on management assessment is now incorporated into a new clause on "management review" and is more fully explained. The clauses on training and procurement contain few differences from the 1994 text. The clause on documents and records has some minor changes, primarily to make the discussions more explicit.
Clause 5 retains the planning, implementation, and assessment theme from the 1994 version but utilizes several subclauses to more effectively organize and present the text. There are a few additional discussions to clarify requirements. For example, a new section was added on "Deviations from Approved Documents and Procedures," following the text on "Documentation of Procedures," which was largely carried over from the 1994 version. The Clause 5 text on "Assessment and Response" was greatly simplified and given a process focus. As before, subclauses were utilized to organize the text more clearly. New text was added to address due professional care and reliability of findings.
Part B became Clause 6, and few substantive changes were made to the 1994 text. Several notes were added to the text to provide examples and interpretations of the requirements. The same approach was also used for Part C, which became Clause 7. As noted earlier, all of the 1994 material labeled "guidance" was moved to a new annex entitled "Guidelines on the Use of ANSI/ASQ E4."
E4WG completed the changes to the standard in early 2000 and was ready to proceed with the ANSI re-authorization process. Unfortunately, ANSI was just beginning an audit of the standards development process employed by the American Society for Quality (ASQ), including a determination of ASQ's conformity with ANSI policies and procedures. Because of the ANSI audit, ASQ's standards development work slowed to a snail's pace. By the end of August 2002, all requisite reviews and approvals necessary for the re-authorization of E4 were finished. All that remained was to close out the ANSI audit and to submit one form to ANSI to document the work completed. This is expected to occur by the end of September, and ANSI/ASQ E4:2002 is expected to by issued by Thanksgiving.
It is anticipated that the U.S. EPA will revise its policy documents to continue to use E4 as the basis for the agency's quality systems. Other participants in the Inter-Governmental Data Quality Task Force, including the Department of Defense and the U.S. Geological Survey, are expected to utilize E4:2002 as before. Because of the improvements made to the standard, its use is expected to grow in the government and private sectors in the next several years.
The Energy and Environmental Division will continue to monitor
and support E4:2002. The next revision of E4 will occur in