ANSI/ASQC E4:1994-A Quality Management Standard for Environmental Programs
By Gary L. Johnson, ASQ National Director, U.S. EPA Quality Staff
Scope and Application
ANSI/ASQC E4:1994, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs, is an American National Standard developed by the ASQ Energy and Environmental Division (EED) for use by organizations in planning, implementing, and evaluating quality management systems for environmental programs. The standard is intended to be used for activities involving the generation and use of environmental data; the development and use of computerized models of environmental processes and phenomena; and the design, construction, and operation of engineering technologies and processes for pollution control and prevention, waste site remediation, and effluent treatment.
ANSI/ASQC E4:1994 provides the minimum criteria for quality systems applied to specific environmental programs, and their associated management systems, limited to
- the collection, evaluation, and use of environmental data and
- the design, construction, and operation of environmental technology.
The standard is modular in design and organized into three parts. The first section, Part A, describes the quality management elements that are common to environmental programs regardless of their technical scope. The other parts of the standard contain the quality system elements applicable to technical areas. The specific applicability of the standard (or parts thereof) to individual environmental programs is left to the user of the standard to determine. The standard may be used as the sole basis for a quality system or may be used in conjunction with existing quality systems derived from other standards depending upon the needs of the user organization. The contents of each part of the standard are discussed below.
Part A describes the quality management elements needed for managing environmental programs effectively. These include
- management and organization,
- quality system and description,
- personnel qualification and training,
- procurement of items and services,
- documentation and records,
- computer hardware and software,
- implementation of work processes,
- assessment and response, and
- quality improvement.
Part A defines the framework containing the common quality management practices that enable project-specific operations to be planned, implemented, and assessed. These elements are used in conjunction with the other parts of the standard to formulate a complete quality system.
Part B contains the additional quality system elements needed to plan, implement, and assess environmentally related data operations, including the collection, handling, analysis, and evaluation of environmentally related data. The Part B elements must be used in conjunction with Part A to provide an adequate quality system for collecting and evaluating environmental data. Such data include chemical, biological, toxicological, ecological, radiological, and physical data. These data may be obtained directly from the environment or from systems representing environmental conditions, such as laboratories or test chambers. The activities described in Part B have traditionally been associated with environmental monitoring. Part B elements also apply to the collection of environmental data that are used directly to design, construct, or operate environmental technology. The program elements contained in Part B are
- planning and scoping,
- design of data collection operations,
- implementation of planned operations,
- quality assessment and response, and
- assessment and verification of data usability.
Environmental data also include data derived from samples collected from the environment, the results of other analytical testing (e.g., geophysical, hydrogeological) of environmental conditions, and process or physical parameters from the operation of environmental technologies.
Part C provides the additional quality system elements pertaining to environmental technology (and their system components) that remediate environmental contamination; prevent or remove pollutants from process discharges; or dispose of or store hazardous, radioactive, and/or mixed wastes. The Part C elements must be used in conjunction with Part A to provide an adequate quality system for the design, construction, and operation of environmental technology. The program elements contained in Part C are
- design of systems,
- construction/fabrication of systems and components,
- operation of systems,
- quality assessment and response, and
- verification and acceptance of systems.
The Part C elements describe the project-specific activities needed to plan, implement, and assess the design, construction, and operation of such technologies and to ensure that the technologies will perform as intended. Environmental process or condition characterization activities that produce data used in support of the design, construction, and operation of environmental technology shall be conducted according to the elements of Part B.
Use of the Standard
ANSI/ASQC E4:1994 has been used widely for environmental programs since its publication in January 1995. It was adopted as the basis for the quality system for the US Environmental Protection Agency (EPA) and is referenced in several EPA policy documents. Many other organizations, including other federal departments and agencies and states and tribal entities, have adopted the standard for their environmental work.
In 1998, the standard was accepted as a "higher-level" quality assurance standard in the Federal Acquisition Regulations (FAR). Under the regulations in 48 CFR Part 46, the E4 standard may be invoked as an integral part of a federal contract for products or services.
In 2002, the Registrar Accreditation Board (RAB) recognized the E4 revision that is pending as an equivalent to ISO 9001:2000, Quality Management Systems— Requirements. Upon approval of the revision, audits performed under E4 will be accepted by the RAB for the certification of Quality Management System (QMS) Auditor and QMS Lead Auditor grades. Moreover, E4 will be recognized as a sector-specific QMS standard for environmental work.
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). ANSI rules require that every American National Standard be reviewed at least every five years and, following such a review, be reissued without change, revised and reauthorized, or withdrawn.
To comply with the ANSI rules, EED established an E4 Work Group (E4WG) to study the standard and 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, the E4WG agreed to consider minor additions to the standard to increase compatibility with ISO 9001:2000. Such additions would largely focus on using similar terminology for the same concept in both standards. To foster increased compatibility, it was decided to realign 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, the 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, reauthorized, and retitled 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 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, recommend, 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 uses 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 used 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 labeled "guidance" was move to a new annex entitled "Guidelines on the Use of ANSI/ASQ E4."
The revision process has been implemented under the auspices of the ANSI Z1 Accredited Standards Committee. The public comment period on the revision closes on June 30, 2003. Following the E4WG's resolution of any negative comments, the standard will be reauthorized as an American National Standard for another five years.
Frequently Asked Questions
Where can I get the E4 standard? ANSI/ASQC E4:1994, Specifications and Guidelines for Quality Systems for Environmental Data Collection and Environmental Technology Programs, can be obtained from ASQ Quality Press by calling 1-800-248-1946 (United States and Canada only) or by visiting the ASQ Web site.
Is training available in the use of the E4 standard? Generally, yes. The EED has offered training on the E4 standard, and new courses are planned following the reauthorization of the standard later in 2003. Please check this Web site for information on new course offerings. If you are interested in specific training, please contact EED.