Quality Assurance Questions and Answers

                  Answers to the Most Commonly
                 Asked QA Questions - Region VII
                           


What is the difference between Quality Assurance (QA) and Quality
Control (QC)?

Quality Assurance is a system of management activities involving
planning, implementation, assessment, and reporting to make sure
that the end product (i.e., environmental data) is of the type
and quality needed to meet the needs of the user.  Some examples
of QA processes include the Data Quality Objectives planning
system, audits, and preparing Standard Operating Procedures
(documents which describe how routine procedures are performed to
ensure they are carried out consistently).

Quality Control is the overall system of operational techniques
and activities that are used to fulfill requirements for quality.
The QC activities are used to produce and document the quality of
the end product (i.e., environmental data).  Some examples of QC
activities include instrument calibrations, chain-of-custody
procedures (they track the sample from collection, through
analysis, to disposal), and performance evaluation samples. 
What is environmental data?

Traditionally, the term environmental data has been defined as
the measurement of chemical, biological, or physical parameters
in the environment (i.e, the collection and analysis of soil and
water samples).  The definition of environmental data has been
expanded to include information produced from models and compiled
from other sources such as data bases or the literature and used
for decision-making purposes.

What is a Quality Management Plan (QMP)?

A QMP is a formal plan that documents an entity's management
system for the environmental work to be performed.   The QMP is
an "umbrella" document which describes the organization's quality
system in terms of the organizational structure, functional
responsibilities of management and staff, lines of authority, and
required interfaces with those planning, implementing, and
assessing all environmentally related activities conducted. 

How often does an organization prepare a QMP?

Quality management plans are generally prepared once for the
organization and are revised as needed to reflect changes to the
organizational structure, responsibilities, lines of authority,
or required interfaces 

Does EPA review and approve the organization's QMP?

EPA reviews and approves the QMP.  The QMP approval by EPA is
valid for up to five years.  However, an organization should
review their QMP annually and submit to EPA any significant
changes made to the QMP as a result of the annual review.

Who in EPA reviews and approves QMPs?

Current regional policy requires that a QMP be reviewed and
approved by the Regional Administrator and the Regional Quality
Assurance Manager (RQAM).

What criteria does the RQAM utilize for QMP reviews?

The RQAM utilizes EPA Requirements For Quality Management Plans,
EPA QA/R-2 (August 1994) and the standard operating procedure for
QMP reviews, QAD/96-1 (January 1996).

Do all organizations that apply for EPA financial assistance 
have to have an approved QMP?

Most applications for financial assistance that involve the
collection of environmental data will require the submission of a
QMP for review and approval prior to award.  However, there may
be some instances (i.e., "small", single grants) when the
development of a QMP may not be applicable and another, more
appropriate QA document can be substituted.  The RQAM should be
consulted on a case-by-case basis to help determine when a QMP
would not be appropriate.  

Can a grant be awarded without an approved QMP?

A grant can only be awarded without an approved QMP when it has
been determined, with the concurrence of the RQAM, that the grant
falls into a category where a QMP would not be appropriate.  An
award can also be made when the grant has been conditioned for
the development of a QMP, or the preparation of the QMP is
identified as a grant activity within the grant application. 
However, a Quality Assurance Project Plan (QAPP) would still be
required before environmental data collection activities begin.

What is a Quality Assurance Project Plan (QAPP)?

A QAPP describes the technical QA/QC elements for a specific data
collection effort.  The elements addressed by the QAPP include
project purpose and objectives, sampling design, analytical
methods, data quality indicators, data review procedures, etc.  A
Quality Assurance Project Plan is project specific.

When is a QAPP required?

All environmental data collection activities performed by or on
behalf of the Agency require the development of a QAPP.

Who approves a QAPP?

All QAPPs prepared by EPA or its contractors for EPA data
collection activities currently require the review and approval
of the RQAM prior to data collection.

State organizations with QMPs can have the primary responsibility
to review and approve their own QAPPs, but EPA retains the
authority to be more involved when appropriate.  The QA office
will still review and comment on QAPPs at the written request of
the program and/or project officer.

Regardless of the assignment of review and approval
responsibilities for QAPPs, all environmental data collection
activities performed by or on behalf of the Agency require the
development of a QAPP.

What criteria does the RQAM utilize to review QAPPs?

The RQAM utilizes EPA Requirements For Quality Assurance Project
Plans For Environmental Data Operations, EPA QA/R-5 (August
1994).

If an organization has an approved QMP, do they still need to
prepare a QAPP?

Yes.  All environmental data collection activities performed by
or on behalf of the Agency must have an approved QAPP in place
before sample collection begins. 

Can a grant be awarded without an approved QAPP?

Yes.  However, no work can be initiated related to environmental
data collection activities until a QAPP has been approved.  In
limited circumstances, EPA may grant conditional approval to a
QAPP to permit some work to begin while non-critical deficiencies
in the QAPP are being resolved.

When should quality assurance requirements be considered during
the grant application cycle?

Quality assurance requirements for grants that involve the
collection of environmental data should be considered in the
early, upfront negotiations process.
Quality Assurance Questions and Answers

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