Major deficiencies (defined here as the absence of relevant information) were found in
the following elements:
| |
| IA = Included & Acceptable,
NI=Not Included, IU = Included &Unacceptable, NA=Not Applicable |
IA |
NI |
IU |
NA |
Comments |
| A1. Title & Approval Sheet |
|
| Title |
|
|
|
|
|
| Organization's name |
|
|
|
|
|
| Dated signature of project
manager |
|
|
|
|
|
| Dated signature of QA
officer |
|
|
|
|
|
| Other signatures, as
needed |
|
|
|
|
|
| A2. Table of Contents |
|
|
|
|
|
| A3. Distribution List |
|
|
|
|
|
| A4. Project / Task Organization |
|
| Identifies key individuals &
responsibilities (data users, decision makers, project QA Manager,
Subcontractors , etc.) |
|
|
|
|
|
| Organization chart shows lines of
authority & reporting responsibilities |
|
|
|
|
|
| A5. Problem Definition / Background |
|
| Clearly states problem or decision to
be resolved |
|
|
|
|
|
| Historical & background information |
|
|
|
|
|
| A6. Project / Task Description |
|
| Lists measurements to be made |
|
|
|
|
|
| Cites applicable technical, regulatory,
or program-specific quality standards, criteria, or objectives |
|
|
|
|
|
| Notes special personnel or equipment
requirements |
|
|
|
|
|
| Provides work schedule |
|
|
|
|
|
| Notes required project & QA records/
reports |
|
|
|
|
|
| A7. Quality Objectives & Criteria
for Measurement Data |
|
| States project objectives and limits,
both qualitatively & quantitatively |
|
|
|
|
|
| States & characterizes measurement
quality objectives as to applicable action levels or criteria |
|
|
|
|
|
| A8. Special Training
Requirements/Certifications
|
|
|
|
|
|
| A9. Documentation & Records |
|
| Lists information & records to be
included in data report (e.g. raw data, field logs, results of QC
checks, problems encountered) |
|
|
|
|
|
| States requested lab turnaround time |
|
|
|
|
|
| Gives retention time and location for
records and reports |
|
|
|
|
|
| B1. Sampling Process Design
(Experimental Design) |
|
| Types and number of samples required |
|
|
|
|
|
| Sampling network design & rationale for
design |
|
|
|
|
|
| Sampling locations & frequency of
sampling |
|
|
|
|
|
| Sample matrices |
|
|
|
|
|
| Classification of each measurement
parameter as either critical or needed for information only |
|
|
|
|
|
| Validation study information, for
non-standard situations |
|
|
|
|
|
| B2. Sampling Method Requirements |
|
| Identifies sample collection procedures
& methods |
|
|
|
|
|
| Lists equipment needs |
|
|
|
|
|
| Identifies support facilities |
|
|
|
|
|
| Identifies individuals responsible for
corrective action |
|
|
|
|
|
| B3. Sample Handling & Custody
Requirements |
|
| Notes sample handling requirements |
|
|
|
|
|
| Notes chain of custody procedures, if
required |
|
|
|
|
|
| B4. Analytical Methods Requirements |
|
| Identifies analytical methods to be
followed (with all options) & required equipment |
|
|
|
|
|
| Provides validation information for
non-standard methods |
|
|
|
|
|
| Identifies individuals responsible for
corrective action |
|
|
|
|
|
| B5. Quality Control (QC)
Requirements |
|
| Identifies QC procedures & frequency
for each sampling, analysis, or measurement technique, as well as
associated acceptance criteria and corrective action |
|
|
|
|
|
| References procedures used to calculate
QC statistics ( precision, bias & accuracy) |
|
|
|
|
|
| B6. Instrument/ Equipment Testing,
Inspection & Maintenance Requirements |
|
| Identifies acceptance testing of
sampling and measurement systems |
|
|
|
|
|
| Describes equipment needing calibration
and frequency for such calibration |
|
|
|
|
|
| Notes availability & location of spare
parts |
|
|
|
|
|
| B7. Instrument Calibration &
Frequency |
|
| Identifies equipment needing
calibration and frequency for such calibration |
|
|
|
|
|
| Notes required calibration standards
and/or equipment |
|
|
|
|
|
| Cites calibration records & manner
traceable to equipment |
|
|
|
|
|
| B8. Inspection/Acceptance
Requirements for Supplies & Consumables |
|
| States acceptance criteria for supplies
& consumables |
|
|
|
|
|
| Notes responsible individuals |
|
|
|
|
|
| B9. Data Acquisition Requirements
for Non-Direct Measurements |
|
| Identifies type of data needed from
non-measurement sources (e.g. computer data bases & literature files)
along with acceptance criteria for their use |
|
|
|
|
|
| Describes any limitations of such data |
|
|
|
|
|
| B10. Data Management |
|
| Describes standard record keeping &
data storage and retrieval requirements |
|
|
|
|
|
| Checklist or standard forms attached to
QAPP |
|
|
|
|
|
| Describes data handling equipment &
procedures used to process, compile, and analyze data ( e.g., required
computer hardware & software) |
|
|
|
|
|
| C1. Assessments & Response Actions |
|
| Lists required number, frequency & type
of assessments, with approximate date and names of responsible personnel |
|
|
|
|
|
| Identifies individuals responsible for
corrective action |
|
|
|
|
|
| C2. Reports to Management |
|
| Identifies the preparer and recipients
of reports |
|
|
|
|
|
| Identifies frequency and distribution
of reports for: |
|
| Project Status |
|
|
|
|
|
| Results of performance evaluations &
audits |
|
|
|
|
|
| Results of periodic data quality
assessments |
|
|
|
|
|
| Any significant QA problems |
|
|
|
|
|
| D1. Data Review, Validation, &
Verification |
|
| States criteria for accepting,
rejecting, or qualifying data |
|
|
|
|
|
| Includes project-specific calculations
or algorithms |
|
|
|
|
|
| D2. Validation and Verification
Methods |
|
| Describes process for data validation
and verification |
|
|
|
|
|
| Identifies issue resolution procedure
and responsible individuals |
|
|
|
|
|
| Identifies method for conveying these
results to data users |
|
|
|
|
|
| D3. Reconciliation with User
Requirements |
|
| Describes process for reconciling with
DQOs and reporting limitations on use of data |
|
|
|
|
|
