Qa Standards and Documents

QA STANDARDS AND
DOCUMENTS
EPA QA, FIFRA GLP, AND ISO/IEC 17025:2005
DISCLAIMER
The views expressed in this presentation are those of the author and
do not necessarily reflect the views or policies of the U.S.
Environmental Protection Agency.
EPA QUALITY ASSURANCE STANDARD FOR NON
EPA ORGANIZATIONS
• Based on ANSI/ASQC E4-1994

• Quality Management Plans
• Quality Assurance Project Plans
• Laboratory Competency Policy
QUALITY MANAGEMENT PLAN (QMP)
• Quality systems supporting environmental programs involving environmental data

or technology conducted by EPA organizations or by organizations funded by EPA
shall be covered by an Agency-approved Quality Management Plan. (EPA
Requirements for QMPs: EPA QA/R-2)
• A Quality Management Plan is a management tool that documents an organization’s
quality system for planning, implementing, documenting, and assessing the
effectiveness of activities supporting environmental data operations and other
environmental programs. (EPA Requirements for QMPs: EPA QA/R-2)
QMP
• In other words: A QMP is a broad and overarching document that explains an
organization’s quality system. It discusses the routine processes and procedures as
they pertain to the production of an organization’s work products.
• This is not the same as ISO 17025 , although ISO 17025 does require documentation
of a laboratory’s quality system and that document would generally meet the intent
of a QMP.
• It is completely acceptable to reference SOPs in the QMP to explain how you
comply with a quality assurance requirement. For example, “The laboratory
calibrates their thermometers in accordance with the procedure in SOP EQ – 2.”
• (https://www.epa.gov/quality/epa-qar-2-epa-requirements-quality-management-plans)
QUALITY ASSURANCE PROJECT PLAN (QAPP)
• All work funded by EPA that involves the acquisition of environmental data generated from
direct measurement activities, collected from other sources, or compiled from computerized
data bases and information systems shall be implemented in accordance with an approved
QA Project Plan. The QA Project Plan will be developed using a systematic planning process
based on the graded approach. No work covered by this requirement shall be implemented
without an approved QA Project Plan available prior to the start of the work. (EPA
Requirements for Quality Assurance Project Plans QA/R-5)
• The QA Project Plan documents the planning, implementation, and assessment procedures of,
and how specific QA and QC activities will be applied during a particular project.
QAPP
• In other words: A QAPP is a project specific document.It goes into detail

about the background of the project, what the data quality objectives are,
and how the lab or organization is going to get there.
• Data quality objectives set out what the end use of the data is, or the purpose
of the work being performed. It describes what success or acceptability looks
like. This will drive decisions about what type of quality control is needed and
what the acceptance criteria for the data will be.
QAPP
• In terms of laboratory analyses, it will cover things like specifics of instrument

calibration (how many points, weighting and linearity), sampling procedures, sample
handling and holding times
• For other types of data gathering it specifies how you will collect and evaluate the
data, what type of secondary, peer and/or management review will be done, and
many more factors.
• (https://www.epa.gov/quality/guidance-quality-assurance-project-plans-epa-
qag-5)
WHAT’S THE DIFFERENCE
BETWEEN QMP AND QAAP
A QAPP differs from a QMP in that it is not intended to cover everything the
lab does, only this specific set of tasks. A QAPP can reference the laboratory’s
SOP for tasks that will be handled the same way that routine lab work is
handled (sample storage, thermometer calibration and certain methods). Then,
the QAPP can chronicle what is different about this task from what the SOPs
specify (i.e. SOP says 5 calibration standards but this project requires 7) or
include things not covered by an SOP. In this way a lab can write an easy to
follow QAPP fairly quickly without sacrificing specificity or quality.
LABORATORY COMPETENCY POLICY
The EPA Policy to Assure the Competency of Organizations Generating Environmental

Measurement Data Under Agency-funded Assistance Agreements, Agency Policy Directive
Number FEM-2012-02, Revision 1 requires that, “Organizations performing activities
involving the use or generation of environmental data under covered assistance
agreements shall provide the Agency with quality system documentation such as a
QMP, and/or other documentation that demonstrates conformance to EPA’s quality
program requirements; and demonstration of competency in the field(s) of expertise.
Demonstration of competency may include but not be limited to:
§ Current participation in accreditation or certification programs
that are applicable to the environmental data generated under the
Agency-funded assistance;
§ Ongoing participation by the organization in proficiency testing
(PT) or round robin programs conducted by external
organizations;
§ Ongoing EPA accepted demonstrations and audits/assessments of
proficiency; and
§ Other pertinent documentation that demonstrates competency
(e.g., past performance to similar statement of work).”
§ (
https://www.epa.gov/sites/production/files/2015-03/documents/competency-policy-
aaia-new.pdf)
INTERNATIONAL ORGANIZATION FOR
STANDARDIZATION: GENERAL REQUIREMENTS
FOR THE COMPETENCE OF TESTING AND
CALIBRATION LABORATORIES
ISO/IEC 17025:2005
ISO/IEC 17025:2005 is an international consensus standard for
laboratories that specifies the general requirements for
demonstrating its competence to carry out tests and/or
calibrations. Basically, it specifies procedures and
documentation of how a laboratory conducts its business; this
includes documentation of its quality system. It is a
certification or accreditation program that requires an on-site
audit at least every two years.
SOME AREAS ISO 17025 COVERS
• Management system and review
• Document and record control
• Cause analysis and corrective action
• Internal audits
• Assuring the quality of test and calibration results
• Subcontracting
Many laboratories explain these parts of their system in a quality manual which would be equivalent to
the EPA QMP requirement. The more specific procedures for these processes are usually documented in
SOPs.
FIFRA GOOD LABORATORY PRACTICES (GLP)
• GLP is a set of standards found in 40 CFR part 160 that lists the requirements
laboratories performing certain types of FIFRA work need to follow.
• GLP is not a certification program but a compliance program.
• Laboratories who perform studies to be submitted to OPP in support of a registration
application or existing registration (some require continued monitoring or additional
studies for registration review) are to follow GLP.
• When a lab does submit a study to OPP the lab might be audited by EPA’s Office of
Enforcement and Compliance Assurance for compliance with the GLP rules.”
Although there are certifications that meet the intent of GLP,
the Office of Pesticide Programs does not recognize
laboratory certifications of any kind at this time. However,
the GLP regulation gives OPP the right to accept or reject
any study or data, with cause, regardless of whether or not
it claims to meet GLP requirements.
(
https://www.gpo.gov/fdsys/pkg/CFR-2011-title40-vol24/
xml/CFR-2011-title40-vol24-part160.xml)
SIMPLE COMPARISON OF THE QA STANDARDS
EPA ISO17025 FIFRA GLP

§ Requirements for QA System of § International accreditation standard § Federal Compliance program
EPA and those who are funded by § Requires documentation of your
EPA
§ Gives specific requirements for
quality system
lab’s quality system
§ Requires QMPs and QAPPs § Can be used to satisfy laboratory
competency policy – but who ever is § Required for studies submitted to
§ Includes a laboratory competency funding the work determines what OPP in support of a registration
component standard you must use application or existing
registration
§ Requires on on-site audit at least
every two years by third party § May result in an audit by EPA
auditors
D. Denise Rice
OPP Director of Quality Assurance
1200 Pennsylvania Ave NW

MC7501-P
Washington, DC 20460
703-347-0282
[email protected]

Qa Standards and Documents

Uploaded by

Copyright:

Available Formats

Qa Standards and Documents

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Qa Standards and Documents

Uploaded by

Copyright:

Available Formats

QA STANDARDS AND

• Based on ANSI/ASQC E4-1994

• Quality systems supporting environmental programs involving environmental data

• In other words: A QAPP is a project specific document.It goes into detail

• In terms of laboratory analyses, it will cover things like specifics of instrument

The EPA Policy to Assure the Competency of Organizations Generating Environmental

EPA ISO17025 FIFRA GLP

1200 Pennsylvania Ave NW

You might also like