Contents: Conducting Analytical Work in Support of Regulatory Programs

Effective Date: 07/2008
Point of Contact: Quality Engineer for Regulatory Programs

PNNL-SA-63118

This plan is designed for use by Project Managers who utilize PNNL organizations to provide analytical support to programs that require compliance to the Hanford Analytical Quality Assurance Requirements Document (HASQARD), Volumes 1 and 4. This plan is applicable only when client requirements dictate the need for compliance to these requirements, the Project self-selects this approach, or an individual analytical function or organization self-selects this approach due to the markets it serves.

This plan is based upon the requirements of U.S. Department of Energy (DOE) Order 414.1C as described in SBMS, the HASQARD, as well as recognized industry standards (e.g., U.S. Environmental Protection Agency, ASTM, American National Standards Institute). This plan may meet the needs of other industry standards/regulatory guidelines. However, a review would need to be performed to make that determination.

Important: Staff who plan to implement this plan should request their name be added to the revision notification list by contacting the Quality Engineer for Regulatory Programs.

Contents

SECTION
NUMBER
TITLE
1 Organization and Personnel
2 Planning
3 Receiving and Handling Samples
4 Instrument Calibration
5 Quality Control
6 Common Data Quality Calculations
7 Procedures
8 Reporting Analytical Data
9 Records Management
10 Document Control
11 Assessments
12 Equipment and Maintenance
13 Corrective Action and Continuous Improvement
14 Quality Assurance Reporting
15 Software Systems
16 Procurement

Exhibits

Analytical Requirements for Gas Chromatography
Analytical Requirements for Semivolatile (Gas Chromatography/Mass Spectrometry) Quality Control
Analytical Requirements for Total Carbon, Total Inorganic Carbon, and Total Organic Carbon Quality Control
Analytical Requirements for Volatile (Gas Chromatography/Mass Spectrometry) Quality Control
Analytical Service Request Form
Calculations for Assessing Data Quality
Calibration Requirements for Inorganic Analyses
Calibration Requirements for Organic Analyses
Calibration Requirements for Radiochemistry
Chain of Custody Form
Definitions/Acronyms
General Laboratory Quality Control
Inorganic Analytical Quality Control Requirements
Inorganic Preparative Quality Control Requirements
Inorganic Quality Control
Interim Change Notice
Minimum Calibration Requirements for Externally Calibrated Equipment
Minimum Ion Abundance Requirements for Semivolatile Organic Analysis
Minimum Ion Abundance Requirements for Volatile Organic Analysis
Organic Quality Control
Physical Testing Quality Control (Differential Scanning Calorimetry, Thermogravimetric Analysis, and Differential Thermal Analysis/Thermogravimetric Analysis)
Preparative and Analytical Requirements for Radiochemistry Quality Control
Preparative Requirements for Volatile, Semivolatile, and Gas Chromatography Quality Control
Project Planning Checklist
Project Specific R2A2s
Radiochemistry Quality Control
Sample Inspection Form
Self-Assessment Report
Suggested Preventive Maintenance Frequencies for Specific Instruments
Thermometer Verification

Related Information

40 CFR 136, EPA Test Methods for Evaluating Solid Waste (SW-846)
Calibration subject area
Document Control subject area
Handbook for Analytical Quality Control in Water and Wastewater Laboratories, EPA-600/4-79-019, March 1979
Purchase Orders/Subcontracts subject area
Assessment Management subject area
Procedures, Permits, and Other Work Instructions subject area
Project Management subject area
Purchasing Through Business to Business subject area
Purchasing Cards (P-Cards) subject area
Records Management subject area
Issue Management subject area
Roles, Responsibilities, Accountabilities, & Authorities (R2A2s)
Sample Handling, Archival, and Disposal subject area
Software subject area
Safety Software subject area
Stopping and Restarting Work (Safety Rights and Responsibilities). subject area
Suspect/Counterfeit Items and Misrepresented Products, Reporting and Handling subject area
Training and Qualification for Staff and Non-Staff subject area
Unclassified Cyber Security
Waste Managing subject area