ASTM E2107-00

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Designation:E2107–00
Standard Practice for
Environmental Regulatory Compliance Audits
This standard is issued under the fixed designation E 2107; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope findings, disclosure of audit findings intended to be kept
2 confidential under audit privilege laws or attorney - client
1.1 Purpose—This practice identifies minimum require-
privilege or work product doctrine, and inaccurate audit
ments for environmental regulatory compliance audits (audits).
findings.
It also provides information on the terms and procedures
1.2.3 Awareness of Legal Issues—A number of important
associated with audits as practiced in the United States of
legal issues are associated with audits. Example legal issues
America (USA) and other jurisdictions subject to the laws
includethequalificationforoneormoreevidentiaryprivileges,
thereof. It provides a reference to which interested parties may
the qualification for limited immunity, the protection of trade
refer for definition and description of accepted audit terms and
secrets and confidential information, the application of a
procedures.
number of government policies associated with environmental
1.2 Background:
audits (including federal and state programs that provide
1.2.1 Awareness of Benefits Associated with Audits—
incentives for detecting, disclosing, and correcting potential
Various benefits have been attributed to audits. These benefits
violations through auditing), the form and language of audit
may include a better understanding of the compliance status of
reports, the necessity of reporting certain information to the
a facility or organization, identification of opportunities for
government, the potential liability of auditors, and the impor-
environmental management systems improvements, reduction
tance of promptly addressing issues identified during audits.
or elimination of potential legal and financial liabilities when
Prior to initiating and during an audit, interested parties should
implemented as part of a comprehensive compliance manage-
consider potential legal issues and consult legal counsel or
ment program, better communications and improved relation-
other experts as appropriate.
ships with governmental agencies, communities, and other
1.3 Organization—This practice is organized in the follow-
stakeholders, providing information for development of both
ing manner:
short-term and long-term environmental expenditures, and
Section
education of employees.
Scope 1
1.2.2 Awareness of Risks Associated with Audits—It is also
Referenced Documents 2
important to recognize that certain risks have been associated
Terminology 3
Significance and Use 4
with audits. These risks may be managed and controlled by
Responsibilities 5
giving thoughtful consideration to the audit process before
Auditor Qualifications and Staffing 6
beginninganaudit.Theserisksmayincludeincreasedpotential
The Audit Process 7
Evaluation and Report Preparation 8
legal and financial liabilities for the audited entity if audit
Keywords 9
findings are not corrected in a timely manner, disclosure of
confidential business information or trade secrets, inadvertent
2. Referenced Documents
admissions against interest because of the wording of audit 3
2.1 ASTM Standards:
E 1527 Practice for Environmental SiteAssessments: Phase
I Environmental Site Assessment Process
This practice is under the jurisdiction of ASTM Committee E50 on Environ-
E 1528 Practice for Environmental Site Assessments:
mental Assessment and is the direct responsibility of Subcommittee E50.05 on
Wetland Ecosystems.
Transaction Screen Process
Current edition approved Oct. 10, 2000. Published December 2000.
2.2 ISO Standards:
As used herein, a “Standard” is a document that has been developed and
established within the consensus principles of the Society and that meets the
approval requirements of ASTM procedures and regulations. A“ Guide” is a
compendium of information or a series of options that does not recommend a
specific course of action. A guide increases the awareness of information and For referenced ASTM standards, visit the ASTM website, www.astm.org, or
approaches in a given subject area. A “Practice” in contrast, is a definitive set of contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
instructions for performing one or more specific operations that does not produce a Standards volume information, refer to the standard’s Document Summary page on
test result. See Form and Style for ASTM Standards. the ASTM website.
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E2107–00
ISO 14010 Guidelines for Environmental Auditing— 3.1.16 environmental regulatory compliance audit
General Principles (audit)—a systematic, documented, and objective review of an
ISO 14011 Guidelines for Environmental Auditing—Audit audited entity to evaluate its compliance status relative to audit
Procedures—Auditing of Environmental Management criteria
Systems
3.1.17 independence—a condition characterized by organi-
ISO 14012 Guidelines for Environmental Auditing—
zational standing where an auditor is free to conduct an audit
Qualification Criteria for Environmental Auditors
without being controlled or influenced by others.
3.1.18 lead auditor—an auditor designated to lead and
3. Terminology
manage the audit.
3.1 Definitions of Terms Specific to This Standard:
3.1.19 objectivity—aconditioncharacterizedbytheabsence
3.1.1 action plan—a plan to address audit findings that
of bias, influences, and conflicts of interest that affect or have
describes planned response actions, parties responsible for
the potential to compromise audit findings.
their execution, and expected completion dates.
3.1.20 open issues—potential audit findings that cannot be
3.1.2 audit authority—the entity or body that authorizes, or
verified or resolved without additional information.
initiates, the audit process. The audit authority may be internal
3.1.21 period under review—the time interval over which
or external to the audited entity.
conditions at the audited entity are evaluated against audit
3.1.3 audit criteria—enforceable environmental require-
criteria.
ments that are applicable to an audited entity. Examples
3.1.22 physical inspection—first hand observation and as-
include laws, regulations, orders, and permits.
sessment of audited entity conditions.
3.1.4 audit data—information obtained during an audit to
3.1.23 records—documentationandotherformsofrecorded
support audit findings.
information.
3.1.5 audit finding—astatementofauditedentityconditions
at the time of the audit compared to audit criteria. Audit 3.1.24 regulatory entities—organizations that have the legal
findings shall be based upon verifiable audit data and may be authority to develop, implement, administer, or enforce audit
either positive or negative with respect to audit criteria.
criteria.Forexample,federal,state,tribal,orlocalgovernment.
3.1.6 audit objective(s)—broad statement(s) of what the
3.1.25 working papers—paper and electronic documenta-
audit intends to accomplish.
tion developed by an auditor from observations, record re-
3.1.7 audit plan—documentation that describes the audit.
views, and interviews during an audit.
Elements that should be included or referenced in the audit
plan are: the audit objective; audit scope; identities of the
4. Significance and Use
auditing entity, audit team, and audit authority; audit schedule;
4.1 Intended Use—This practice is intended for use by
auditor health and safety issues; audit report preparation;
parties who wish to perform or direct an audit, or rely upon
record retention and management requirements; logistics;
audit findings or an audit report. Such use includes audits by
working papers management; a process for promptly commu-
internal and external auditors.
nicating auditor concerns for potential environmental or regu-
4.2 Other Audit Criteria—Other audit criteria may be in-
latory impact including concerns requiring further evaluation;
cluded in the audit scope if specified in the audit plan.
special conditions or requirements; and whatever measures, if
Examples include safety and health requirements, and techni-
any, desired to maximize audit confidentiality.
cal, operational, and management requirements.
3.1.8 audit purpose—reason for the audit.
3.1.9 audit protocol—a list of issues or questions designed 4.3 Related ASTM Standards—This practice is related to
to address the audit objective(s) based upon audit criteria. Practices E 1527 and E 1528 for environmental site assess-
3.1.10 audit report—a written summary of audit findings ments.Anumber of terms and procedures from these practices
that is objective, clear, concise, constructive and timely. are similar to terms and procedures associated with this
practice but they may not be the same.
3.1.11 audit scope—a description of what is to be audited.
The audit scope shall include a description of the period under
4.3.1 Not Interchangeable—Although related to Practices
review, the audited entity, and the audit criteria.
E 1527 and E 1528, this practice is designed to achieve
3.1.12 audit team—one or more auditors responsible for
different results. Therefore, these practices shall not be used
conducting an audit. The audit team may be supported by
interchangeably with, or in place of, this practice.
technical experts and auditors-in-training.
4.4 Related ISO Guidelines—The International Organiza-
3.1.13 audited entity—a facility, organization, or part
tion for Standardization (ISO) has developed guidelines ad-
thereof, that is the subject of an audit.
dressing environmental auditing. These are ISO 14010,
3.1.14 auditing entity—the organization that provides audi-
ISO 14011, and ISO 14012.Anumber of terms and procedures
tors.
from these guidelines may be similar to terms and procedures
3.1.15 auditor—a person qualified to conduct an audit.
associated with this practice but they may not be the same.
4.4.1 Not Interchangeable—Although related to ISO guide-
lines, this practice is designed for a different purpose. There-
fore, these ISO guidelines shall not be used interchangeably
Available from American National Standards Institute, 11 W. 42nd St., 13th
Floor, New York, NY 10036. with, or in place of, this practice.
E2107–00
4.5 Additional Services—Anumber of issues may arise as a 5.3.3 Reviewauditcriteriaandanyprotocolstobeused,and
result of an audit, but are outside the scope of this practice. establish a personal work plan for assigned areas of responsi-
Such issues include, but are not limited to, development of bility;
action plans and cost estimates to address audit findings. 5.3.4 Collect sufficient relevant audit data to support audit
4.6 Conditions—The following conditions shall govern the
findings;
application of this practice.
5.3.5 Develop and document audit findings;
4.6.1 Not Exhaustive—A audit shall not constitute an ex-
5.3.6 Assist in preparing audit reports; and
haustive review of audited entity compliance with all poten-
5.3.7 Maintain audit data and documentation in a secure
tially applicable audit criteria unless explicitly intended and
manner.
stated as an audit objective in the audit plan.
5.3.8 Disclose issues to the auditing entity that may com-
4.6.2 Level of Review is Variable—The audit scope may
promise objectivity.
vary to meet different audit objectives. For example, the audit
5.4 Audited Entity Responsibilities—The audited entity
scope may include only selected audit criteria, selected period
shall:
under review, or selected portions of a facility or organization.
5.4.1 Ensure that the audit is supported, including cooper-
4.6.3 Continued Viability of EnvironmentalAudit—Anaudit
ating with the auditors to ensure that audit objectives are met;
completed in accordance with this practice shall be valid for
5.4.2 Provide the auditing entity with requested background
only the period under review. Because audit criteria and
information in a timely manner;
audited entity conditions may change over time, it shall not be
5.4.3 Ensure audit team safe, timely and complete access;
assumed that an audit report is reliable, or has continued
5.4.4 Inform audit team of relevant health and safety re-
viability, for other than the period under review.
quirements and practices;
4.6.4 Usage of Prior Audits—Information contained within
5.4.5 Provide audit team, for the duration of the audit, with
reportsfrompriorauditsshouldbeusedonlyifithascontinued
secure and reasonable support needs;
viability and if use of that information is appropriate.
5.4.6 Provide the audit team with facility escorts knowl-
edgeable of audited entity operations, to accompany auditors
5. Responsibilities
on physical inspections;
5.1 Audit Authority Responsibilities—The audit authority
5.4.7 Assistauditorinidentifyingpertinentpersonnelandin
shall:
scheduling interviews;
5.1.1 Determine the need for an audit;
5.4.8 Ensure audit team access to documents needed to
5.1.2 Specify or approve the audit purpose;
develop audit findings;
5.1.3 Select the auditing entity and/or lead auditor; and
5.4.9 Ensure those facilities and operations audited accu-
5.1.4 Support the audit process.
rately represent normal and known abnormal conditions;
5.2 Lead Auditor Responsibilities—The lead auditor shall
5.4.10 Inform audit team of abnormal conditions;
ensure the efficient and effective completion of an audit. To do
5.4.11 As specified in the audit plan, evaluate and retain
this the lead auditor shall work through the auditing entity to:
audit reports and determine appropriate follow-up activities;
5.2.1 Develop, with the audit authority, an audit plan;
5.4.12 Take measures to ensure that the audit team is
5.2.2 Gather appropriate audited entity background infor-
provided with accurate and complete answers to questions;
mation;
5.4.13 Promptly notify the audit team if it disagrees with an
5.2.3 Assemble a qualified audit team;
audit finding;
5.2.4 Communicate with the audited entity regarding audit
5.4.14 If requested, provide comments on draft audit find-
plan issues. For example, schedule, logistics, access, availabil-
ings; and
ity of audited entity staff to interview, operating conditions,
5.5 Auditing Entity Responsibilities—The auditing entity
audit team needs, and health and safety precautions;
shall:
5.2.5 Manage the audit team;
5.5.1 Provide qualified auditors,
5.2.6 Serve as the primary point of communication between
5.5.2 S
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