Attachment_23_Air_Monitoring_Quality_Control_Plan.pdf

Training Operations and Support

Services – COBRATF

Attachment 23

COBRATF Air Monitoring Quality Control Plan

Air Monitoring Quality Control Plan Revision 6

Effective Date: 2/28/11

1.0 INTRODUCTION

1.1 PURPOSE

1.2 SCOPE

1.3 ORGANIZATION REGISTRATION

1.4 MANAGEMENT COMMITMENT

2.0 QUALITY SYSTEM REQUIREMENTS

2.1 QUALITY POLICY STATEMENT

2.2 ORGANIZATION DESCRIPTION

2.3 MANAGEMENT REVIEW

2.3.1 Review Input

2.3.2 Review Output

2.4 QUALITY SYSTEM

2.4.1 Quality Control (QC) Plan

2.4.1.1 Requirements

2.4.1.2 Exclusions

2.4.2 Quality Planning

2.4.3 Objectives

2.5 CONTRACT REVIEW

2.6 AGENT MONITORING

2.6.1 Standards for Agent Exposure

TABLE 1: AIRBORNE EXPOSURE LIMITS

2.6.2 Categories of Monitoring Systems

2.6.2.1 Near Real Time (NRT) Monitors

2.6.2.2 Sample Media Collection or Grab Sampling with Subsequent Analysis

2.6.3 Instrumentation

2.6.3.1 MINICAMS

2.6.3.2 DAAMS with Subsequent Analysis

2.7 TERMINOLOGY

3.0 RESPONSIBILITIES AND AUTHORITIES

3.1 INTRODUCTION

FIGURE 1: KEY POSITIONS IN THE AIR MONITORING PROGRAM AT THE CDP

COBRATF

3.2 MANAGEMENT REPRESENTATIVE

3.2.1 Resources

3.3 RESPONSIBILITIES AND AUTHORITY OF THE CQAT

3.4 RESPONSIBILITIES AND AUTHORITY OF THE ORGANIZATION

3.4.1 Organizational Managers

3.4.2 Personnel

3.4.2.1 Contractor Project Manager

3.4.2.2 Laboratory Director

3.4.2.3 Air Monitoring Supervisor (Lead Air Monitoring Technician)

3.4.2.4 Certified Air Monitoring Technicians

3.4.2.5 Certified Chemical Laboratory Technicians

3.4.2.6 Responsibilities and Authority of the Quality Manager

3.4.3 Calibration Coordinator

4.0 REFERENCE MATERIALS AND CALIBRATION STANDARDS

4.1 REFERENCE MATERIALS DESCRIPTION AND QA/QC PROCEDURES

4.1.1 Neat CASARMs

4.1.2 Dilute CASARMs

4.1.3 Storage and Use of CASARMs

4.2 STANDARDS FOR CALIBRATION AND SAMPLE SPIKING

4.2.1 Organic Solvents Used to Prepare Standard Solutions

4.2.2 Standard Solutions

4.2.3 Storage and Shelf Life of Standard Solutions

5.0 CERTIFICATION, COMPETENCE AND TRAINING

5.1 INTRODUCTION

5.2 METHOD/INSTRUMENT CERTIFICATION

5.2.1 Certification (P&A) of Type 1 Methods/Instruments

5.2.2 Certifications of Type 2 Methods

5.3 PERSONNEL CERTIFICATION

5.3.1 Training

5.3.2 Analyst Certification Test

5.3.2.1 Analyst Certification for Type 1 Methods

5.3.2.2 Analyst Certification for Type 2 Methods

5.3.2.3 Re-Certification of Analysts

5.3.2.3.1 Type 1 Methods

5.3.2.3.2 Type 2 Methods

5.3.3 Semi-Annual Evaluation of Personnel

5.3.4 Sample Collection Personnel

5.4 CERTIFICATION OF ADDITIONAL INSTRUMENTS

5.4.1 Additional Type 1 Instruments

5.4.2 Additional Type 2 Instruments

5.4.3 Re-Certification of Instruments

5.5 SIGNIFICANT CHANGES IN METHODS

6.0 CALIBRATION

6.1 PERIODIC CALIBRATION OF EQUIPMENT

6.1.1 Linear Mass Flow Controller

6.1.2 Rotameters

6.2 INSTRUMENT CALIBRATION

6.2.1 Frequency of Calibration and Range of Calibration

6.2.1.1 Type 1 Laboratory Methods

6.2.1.2 Type 1 NRT Monitors

6.2.1.2.1 Frequency of Calibration for NRT Monitors

6.2.1.2.2 MINICAMS

6.2.2 Acceptance Criteria

6.2.2.1 Minimum Response Requirement

6.2.2.2 Multilevel Calibration for Type 1 Methods

6.2.2.3 Single Point Calibration for Type 1 NRT Monitors

6.2.2.3.1 MINICAMS

6.2.3 Corrective Action for Unacceptable Calibrations

7.0 SAMPLE COLLECTION, HANDLING, DELIVERY, PRESERVATION AND DATA

GENERATION

7.1 LABORATORY METHODS

7.1.1 Sample Collection for Laboratory Methods

7.1.2 Sample Traceability

7.1.3 Sample Handling

7.1.4 Sample Delivery and Inspection

7.1.5 Sample Preservation

7.1.6 Sample Analysis and Data Generation

7.1.7 Non-Conforming Samples

7.2 NRT MONITORS

7.2.1 Sample Collection for NRT Monitors

7.2.2 Data Generation for NRT Monitors

8.0 QUALITY CONTROL

8.1 CONTROL SAMPLES

8.1.1 Typical Applications of Quality Control Samples

8.1.1.1 Quality Process (QP) Sample

8.1.2 Control Sample Challenge Procedures

8.1.2.1 Type 1 and Type 2 Monitors

8.1.2.2 Type 1 and 2 Laboratory Methods

8.1.2.2.1 DAAMS

8.1.3 Quality Control Sample Frequency

8.1.3.1 Type 1 NRT Monitors

8.1.4 Control Sample Acceptance Criteria

8.1.4.1 Type 1 NRT Monitors

8.1.5 Control Sample Record Keeping Requirements

8.2 TYPE 1 FIXED SITE NRT MONITOR PERFORMANCE CHARTS

8.3 TYPE 1 LABORATORY METHOD CONTROL CHARTS

8.4 EVALUATION OF CONTROL AND PERFORMANCE CHARTS

8.5 QUALITY CONTROL OF SAMPLE LINES

8.5.1 Flow Rates

8.6 CONDITIONING OF DAAMS TUBES

8.7 SPECIAL PROCESSES

8.8 CONFIRMATION OF ROUTINE MONITORING

8.9 CONFIRMATION FOR NON-ROUTINE MONITORING

8.10 QUALITY CONTROL OF VX CONVERSION PADS

9.0 VERIFICATION OF IN-HOUSE DEVELOPED SOFTWARE

9.1 VERIFICATION PROCEDURES

9.2 CONTENTS OF THE VERIFICATION PACKAGE

10.0 PREVENTIVE MAINTENANCE

11.0 PURCHASING

11.1 EVALUATION OF SUPPLIERS

11.1.1 Routine Suppliers

11.1.2 Quality Service Suppliers

11.2 PURCHASING DATA

12.0 INSPECTION AND TESTING

12.1 RECEIPT INSPECTION

12.2 ACCEPTANCE TESTING

12.2.1 Acceptance Testing of DAAMS Tubes

12.2.2 Acceptance Testing of Preconcentrator Tubes

12.2.3 Acceptance Testing of NOx Pre-Filters

12.2.4 Acceptance Testing of Silver Fluoride Conversion Pads

12.3 IN-PROCESS INSPECTION

12.3.1 Samples

12.3.2 Data

12.4 FINAL INSPECTION

13.0 CONTROL OF NON-CONFORMING SAMPLES AND DATA

13.1 NON-CONFORMING SAMPLES

13.2 NON-CONFORMING DATA

14.0 EXTERNAL/INTERNAL AUDITS

14.1 EXTERNAL AUDITS

14.2 INTERNAL AUDITS

15.0 IMPROVEMENT

15.1 CONTINUAL IMPROVEMENT

15.2 CUSTOMER SATISFACTION

15.3 CORRECTIVE ACTION

15.4 PREVENTIVE ACTION

16.0 DOCUMENTATION

16.1 DOCUMENT CONTROL

16.1.1 Document Approval and Issue

16.1.2 Document Modifications and Changes

16.2 CONTROL OF QUALITY RECORDS

TABLE 2: TYPES OF QC RECORDS FOR THE AIR MONITORING SECTION

17.0 ANALYSIS OF DATA

17.1 STATISTICAL METHODS

17.2 PROCEDURES

18.0 CONTROL OF CUSTOMER SUPPLIED PRODUCT

19.0 LITERATURE CITED

1.0 INTRODUCTION

The Center for Domestic Preparedness (CDP) Chemical, Ordnance, Biological, Radiological

Training Facility (COBRATF) is used to train emergency responders to operate in a chemically contaminated environment. During this training, students are equipped with personal protective equipment (PPE) and trained to conduct various operations in training bays and with the agents

GB and VX. Because of the use of these agents, air monitoring is conducted within the CDP

COBRATF to ensure that agent concentrations in the training bays do not exceed allowable limits, to ensure that unprotected personnel outside the training bays are not exposed to agents, and to ensure that agents are not released into the environment outside the CDP COBRATF.

Air monitoring at the CDP COBRATF is conducted by the Air Monitoring Section and the

Chemical Agent Laboratory. Air Monitoring Technicians in this section are supported in their efforts by the staff of the Chemical Agent Laboratory.

This document describes the quality control (QC) plan for the Air Monitoring Section at the CDP

COBRATF. A separate QC Plan has been prepared for the Chemical Agent Laboratory. Except as noted below and in the QC Plan for the Chemical Agent Laboratory, both QC Plans conform to the requirements of the Chemical Agent Standard Analytical Reference Material Quality

Assurance Plan for Chemical Agent Air Monitoring at Training Facilities (CQAPCAAM at

Training Facilities), May 2010, Revision 0 issued by the CASARM Quality Assurance Team

(CQAT) of the Research, Development, and Engineering Command (RDECOM).

Deviations from the requirements of the CQAPCAAM at Training Facilities that are deemed necessary due to the unique nature of the operations and environment at the CDP COBRATF are included in this plan. The deviations and the sections in which they are found are listed below:

Section 6.2.1.2.2.1 of the CASARM Quality Assurance (QA) Plan requires that each site establish “an acceptable instrument response criterion for each of its NRT agent/monitor combinations” and suggests that these criteria may be “based on an objective and measureable response (e.g., area count or nanoamps) to a specific calibration challenge.” Minimum responses required when calibrating MINICAMS were established at the CDP COBRATF at its inception in 1999. To meet the requirement stated in Section 6.2.1.2.2.1 of the CASARM QA Plan, we simply plan to continue to use these established minimum responses. Thus, we do not plan to conduct any additional studies of MINICAMS response to determine new minimum response criteria.

Section 8.5 of the CASARM QA Plan requires that a “method that differs from the primary method of analysis shall be used to provide confirmation of the presence of agent detected by the primary method.” At the CDP COBRATF, DAAMS samples are collected and analyzed to confirm MINICAMS alarms, as necessary. There are sample locations, however, at which we expect to detect agent. For these locations, we assume the MINICAMS alarm was caused by the presence of agent and take appropriate actions in response to the alarm. For these locations, we do not confirm the presence of agent using DAAMS or any other technique.

It is assumed that approval of this plan by the CASARM QA Team automatically includes approval of the deviations listed.

1.1 Purpose

Agent monitoring systems at the CDP COBRATF are used to support chemical agent training, to support hot laundry operations, to detect environmental emissions, and to monitor laboratory storage/work-site activities. Also, air monitoring records are intended to demonstrate that all quality and regulatory requirements regarding chemical agent monitoring are being met.

1.2 Scope

This document outlines the purpose, policies, organization, and operations of the QA program that has been established to support sample collection activities and chemical agent analyses conducted in support of routine chemical agent air monitoring activities. Implementation of this

QC Plan will ensure the validity of data and provide a reliable foundation on which to base decisions.

The emphasis of this QC Plan is on activities that generate analytical chemical data. In this context, analytical chemistry includes those aspects of field sampling that may affect the chemical integrity of samples as well as chemical laboratory activities. The scope of this plan covers the Type 1 automatic near real time monitors that are used to analyze air samples as well as the operators of those monitors and overall support of the Air Monitoring Program.

1.3 Organization Registration

The initial certification of the quality system for chemical agent air monitoring operations at the

CDP COBRATF by the CASARM QA Team involved the following steps:

The preparation of QC Plans for the Air Monitoring Section and for the Chemical Agent

Laboratory written to meet the requirements of the CQAPCAAM at Training Facilities and approved by the CASARM QA Team.

Certifying methods, instruments, and operators (air monitoring technicians) according to written methods and procedures.

Conducting air monitoring operations (in the Air Monitoring Section and the Chemical

Agent Laboratory) at the CDP COBRATF for several months to generate records that demonstrated compliance with the QC Plans.

The Air Monitoring Section participates in the CASARM Proficiency Testing Program

(PTP) developed by the CASARM QA Team. PTP samples are received annually by the

Chemical Agent Laboratory at the CDP COBRATF and diluted as necessary for use by the Air Monitoring Section. The diluted samples provided by the laboratory will contain

GB and VX in the range of 0.5 to 1.5 times the concentrations normally used to calibrate the MINICAMS. Air monitoring staff will then determine the response of MINICAMS to the diluted PTP sample in units of Short Term Exposure Limit (STEL), COBRATF

Maximum Concentration Limit (CMCL), or Allowable Stack Concentration (ASC) as appropriate, and report the results obtained to the Chemical Agent Laboratory. Once the laboratory receives the MINICAMS reading, results are calculated and then reported to the CASARM QA Team.

The CASARM QA Team, at a minimum, conducts a yearly surveillance audit of the Air

Monitoring Program at the CDP COBRATF.

1.4 Management Commitment

The management of the CDP COBRATF is committed to the implementation and continuous improvement of the established quality system. This commitment is demonstrated by the establishment of a quality policy and objectives, by conducting management review meetings, and by providing resources.

2.0 QUALITY SYSTEM REQUIREMENTS

2.1 Quality Policy Statement

“It is the policy of the Center for Domestic Preparedness to furnish services to Emergency

Responders that meet or exceed their requirements. This is accomplished through teamwork and continuous improvement as we develop partnerships with members of the emergency response community, as well as state/local, tribal, and federal officials to provide them with world-class services delivered on time, every time, and with the utmost professionalism.

Our expressed goal is a safe, quality, professional environment.”

2.2 Organization Description

The Air Monitoring Program at the CDP COBRATF is comprised of a team of contractor employees, the Federal Emergency Management Agency and RDECOM. Specific responsibilities by title and the organization of team staff members are presented in Figure 1 of this QC Plan.

a. The chemical laboratory and the air monitoring section at the CDP COBRATF are located in the Training Building of the facility. Personnel in the Air Monitoring

Section, Chemical Laboratory Staff, Training Operations Specialists Staff, and

Chemical Hygiene Officer are certified to perform air monitoring sample collection.

This monitoring is accomplished with the use of MINICAMS and DAAMS.

MINICAMS are used to perform the type 1 monitoring and DAAMS are used to perform the type 2 monitoring at the CDP COBRATF.

b. The CDP COBRATF provides and maintains the necessary infrastructure to accomplish the mission requirements of the facility. This includes adequate work and meeting spaces, utilities, computers, software, office equipment, required supplies, and supporting services (such as transportation, communication, and information systems).

c. A work environment is maintained that promotes meeting product, customer, and quality requirements. This includes provision of adequate lighting, climate control, and housekeeping, as well as emphasis on personal safety. Noise and physical hazards should be reduced.

2.3 Management Review

CDP COBRATF management shall review the organization’s Air Monitoring Program Quality

Management System (QMS) annually, to ensure its continuing suitability, adequacy and effectiveness. This review will include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

The Management Representative is responsible for preparing the agenda, handouts and records of these reviews. The management review is completed prior to the annual CQAT audit.

2.3.1 Review Input

The Management Review inputs include results of audits conducted, customer feedback, quality system’s effectiveness, process performance and product/service conformity, status of preventive/corrective actions, follow-up actions from previous management reviews, changes that could affect the QMS and recommendations for improvement.

2.3.2 Review Output

The output from the reviews conducted by the Management Review Team (MRT) shall include any decisions and actions related to improvement of the effectiveness of the quality management system and its processes, improvement of product/service related to customer requirements and resource needs.

2.4 Quality System

2.4.1 Quality Control (QC) Plan

2.4.1.1 Requirements

The CDP COBRATF has developed, implemented and maintains a quality control plan which defines and/or references all plans, standard operating procedures (SOPs), procedures, work instructions, and any internally developed computer programs that comprise the Air Monitoring

Program Quality System. This QC Plan includes the scope of the quality system of the interaction between the processes of the quality management system.

The documentation used by the Air Monitoring Section for the CDP COBRATF includes the following procedures, documents, and software:

Air Monitoring Plan for the CDP COBRA Training Facility

CASARM QA Plan for Chemical Agent Air Monitoring (reference only)

QC Plan for the Air Monitoring Section of the CDP COBRATF

The Training Plan for Air Monitoring Technicians

Applicable CDP COBRATF Standard Operating Procedures (SOPs)

Forms for use by air monitoring staff at the CDP COBRATF

Software program for calculating MINICAMS precision-and-accuracy statistics and operator proficiency

Collection of supplier literature for air monitoring equipment and accessories (reference only)

2.4.1.2 Exclusions

The CDP COBRATF does not design and develop monitoring systems on a routine basis and therefore section 7.3 of ANSI/ISO/ASQ∙Q9001:2008 does not apply.

2.4.2 Quality Planning

The purpose of quality planning is to define and document how the requirements for quality shall be met within the Air Monitoring Section and the supporting systems at the CDP COBRATF.

The quality requirements that are prescribed by the CQAPCAAM at Training Facilities are accomplished by tracking established measurable quality objectives consistent with the quality policy of the COBRATF. Once per year the quality system is reviewed in its entirety to facilitate program development and refinement of the system. The purpose is to ensure that the system maintains its integrity when changes to the quality system are required. The CDP COBRATF, at a minimum, performs an annual quality system review, holds management and staff meetings, technical working groups, management reviews and evaluations of statutory and regulatory requirements that are structured to provide successful quality planning.

2.4.3 Objectives

The objectives of agent monitoring are to ensure the protection of all personnel (government and contractor staff, visitors, and responders), to support the training mission of the facility, and to protect the environment as stated in the quality policy.

The specific measurable objectives are as follows:

Ensure continual improvement of air monitoring products and services by measuring the frequency of MINICAMS errors.

Ensure effectiveness in providing air monitoring services by measuring the frequency of out of control situations.

2.5 Contract Review

Neither the CDP COBRATF Air Monitoring Section nor the Chemical Agent Laboratory accepts contracts for the performance of chemical agent monitoring. Therefore, the CASARM requirement for contract review is not applicable.

2.6 Agent Monitoring

Agent monitoring systems are used in conjunction with a variety of engineering and laboratory systems to provide control over agent storage and worksite activity. The overall objectives of agent monitoring are to ensure the protection of the students, workers, and the environment while also providing evidence of the containment of the chemical agent to meet regulatory requirements.

2.6.1 Standards for Agent Exposure

Safety standards have been established by the Department of Defense (DOD) and in some cases the Department of Health and Human Services (DHHS). The exposure limits are listed in Table 1 and are defined as follows:

COBRATF Maximum Concentration Level (CMCL) Concentration. The maximum concentration of nerve agent to which personnel conducting toxic agent training operations may be exposed while wearing a full-face air-purifying chemical protective mask, such as the

M40 mask. At concentrations above the CMCL, personnel must wear either a full-face positive SCBA or a positive pressure airline respirator with an auxiliary SCBA. For practical purposes, the CMCL concentrations replace the IDLH concentrations for chemical agent training purposes.

Short Term Exposure Limit (STEL) Concentration. The maximum concentration of nerve agent to which unprotected chemical workers may be exposed for up to 15 minutes continuously.

Source Emission Limit (SEL)/Allowable Stack Concentration (ASC). This concentration is the maximum concentration of agent that may be present in the effluent or exhaust stack of incinerator stacks. ASC is used because MINICAMS display ASC in place of source emissions limit (SEL). ASC is a non-regulatory ceiling value that serves as a source emission limit and not as a health standard. It is used for monitoring the incinerator stack effluent at the CDP COBRATF.

Airborne exposure limits for GB and VX are shown in Table 1. The AELs given in Table 1 are based on the AEL’s standardized in the Tables of Appendix F of the CQAPCAAM at Training

Facilities. This is done to provide a safety margin to protect workers and the public health. These tables were taken from DA PAM 385-61, Toxic Chemical Agent Safety Standards, 17 December

2008 Table 12-1 and were current at the date of the publishing of this plan.

TABLE 1: AIRBORNE EXPOSURE LIMITS

Concentration

Standard

GB VX

mg/m ng/L mg/m ng/L

STEL

0.0001

0.1

0.00001

0.01

CMCL 0.2 200 0.02 20

ASC 0.0003 0.3 0.0003 0.3

2.6.2 Categories of Monitoring Systems

The CDP COBRATF has near real time monitors (MINICAMS), and grab sampling (Depot Area

Air Monitoring Systems, DAAMS).

2.6.2.1 Near Real Time (NRT) Monitors

Miniature Continuous Air Monitoring Systems (MINICAMS) are field-portable gas chromatographs capable of detecting or monitoring for chemical agents at STEL, CMCL, and

ASC concentrations. At the CDP COBRATF these units are used in the fixed site configuration.

2.6.2.2 Sample Media Collection or Grab Sampling with Subsequent Analysis

The Depot Area Air Monitoring System (DAAMS) is an air sampling and analysis technique designed to capture agents on a sorbent-packed tube, which is then thermally desorbed to elute the agents onto a gas chromatographic column for determination.

2.6.3 Instrumentation

The instrumentation used to perform monitoring is highly sensitive, and proper care is taken to ensure that the appropriate environmental and storage locations have been chosen to protect the equipment.

2.6.3.1 MINICAMS

Chemical agent air monitoring at the CDP COBRATF is conducted using an automated Type 1 monitor, MINICAMS. MINICAMS units automatically determine agent concentrations at the

Short Term Exposure Limit (STEL) concentration in the workplace to warn of the possibility of personnel exposure, as well as in the CDP COBRATF charcoal-filter stack exhaust at the STEL concentration and in the incinerator exhaust stack at the allowable stack concentration (ASC), to ensure environmental protection. The incinerator stack is only monitored when it is in use.

MINICAMS are also used as needed to determine that the vapor concentration of agent in bagged decontaminated items or in bagged waste is less than the STEL concentration. This process is referred to as “verifying XXX decontamination,” which means making sure that decontaminated items do not present a vapor hazard. In addition, MINICAMS are used to determine agent concentrations at COBRATF Maximum Concentration Limit (CMCL) levels inside training bays to ensure that students and personnel are immediately evacuated from a given bay any time the agent concentration in the bay approaches the CMCL level.

2.6.3.2 DAAMS with Subsequent Analysis

The Type 2 confirmation method for chemical agent air monitoring at the CDP COBRATF is conducted using the DAAMS.

DAAMS monitoring consists of pulling air at a known flow rate for a known period of time through a tube containing a solid-sorbent material that traps or scrubs agent from the air. The agent present, if any, on the sorbent bed in each DAAMS sampling tube is then determined through analysis by chemical laboratory staff. The primary purpose of DAAMS is to confirm or deny the presence of agent, as reported by MINICAMS, in an area where unprotected personnel may be present, or in effluent stacks at the CDP COBRATF.

2.7 Terminology

Definitions of terms commonly used throughout this plan are given below.

Accreditation – A formal recognition that an organization is competent to carry out specific tests or specific types of tests.

Accuracy – The degree of agreement of a measurement with an accepted reference of true value.

Accuracy is usually expressed in terms of percent recovery.

Airborne Exposure Limits – Allowable concentrations in the air for workplace and general population exposures. AEL’s include worker population limits (WPL’s), short term exposure limits (STELS), COBRATF maximum concentration limits (CMCL’s), and general population limits (GPL’s).

Allowable Stack Concentration (ASC) – This concentration is equivalent to the source emission limit (SEL) and is used in MINICAMS software to describe the SEL monitoring level.

Analyte – The substance that one is interested in detecting and/or quantifying when one performs a chemical analysis of a sample.

Approved Form – A form that has been approved for unlimited use at the CDP COBRATF.

CAR – Corrective Action Request; written description of a major non-conformance, immediate actions taken to correct the non-conformance, impact on air monitoring data, and corrective actions (changes in processes or equipment) that were taken to reduce the probability of the major non-conformance occurring in the future.

CASARM – Chemical Agent Standard Analytical Reference Material. Chemical Surety

Material (CSM) or dilute solutions of CSM used for research, development, testing, and evaluation (RDT&E) whose purity or concentration has been accurately determined, which is stored in a manner that minimizes degradation, and whose concentration or purity is periodically confirmed.

Certification of conformity – Action by a third party demonstrating that adequate confidence is provided that a duly identified product, process, or service conforms to a specific standard or other normative document.

COBRATF Maximum Concentration Level (CMCL) Concentration – The maximum concentration of nerve agent to which personnel conducting toxic agent training operations may be exposed while wearing a full-face air-purifying chemical protective mask, such as the M40 mask. At concentrations above the CMCL, personnel must wear either a full-face positive SCBA or a positive pressure airline respirator with an auxiliary SCBA. For practical purposes, the

CMCL concentrations replace the IDLH concentrations for chemical agent training purposes.

Confidence level – A value corresponding to the probability that a single future measurement will yield a particular result or fall within a particular interval of values.

Confidence limits (or bounds) – The upper and lower bounds of an interval of values within which, the probability that an assertion about the value of a population parameter is correct with a pre-assigned level of confidence.

Confirmation – A second method of detection used to provide verification of the presence of agent detected by the monitoring system. A method different from the primary analytical method shall be used to confirm the presence of agent. The primary factors which distinguish one GC based analytical method from another, are the stationary phase employed and type of detector. Some methods, such as DAAMS require duplicate samples in order to facilitate confirmation.

Control parameter – A parameter whose value depends on the bias and/or precision of a method and whose value is used in a control charting procedure to maintain daily control of method bias and/or precision.

Correlation coefficient – A statistical measurement which when squared gives the degree of association between the values of two random variables. A value of +1 indicates perfect correlation, a value of -1 indicates perfect inverse correlation, and a value of 0 indicates no correlation. As the absolute value of the correlation coefficient increases, so does the strength of correlation.

Customer – The recipient of a product or service provided by the organization.

DAAMS – The Depot Area Air Monitoring System (DAAMS) is an air sampling and analysis technique designed to capture agents on a sorbent-packed tube, which is then thermally desorbed to elute the agents onto a gas chromatographic column for determination.

Detection Limit (DL) – The mass of analyte which gives a mean signal three sigma above the mean of a blank signal, where sigma is the standard deviation of the blank signal.

Found Action Level (FAL) – A population parameter that for future measurements predicts the highest found concentration at which there is a 97.5% level of confidence that the target concentration is less than the hazard level.

Hazard level (HL) – The control limit for a hazardous substance (analyte) in a particular medium (matrix). For example, 1.0 CMCL is a hazard level.

Interferent – any chemical product that causes a false positive (false alarm) when sampled by

MINICAMS.

Limit of Quantification (LOQ) – A population parameter that for future measurements predicts the lowest target concentration that can be statistically differentiated from zero at least 97.5% of the time.

Lowest Concentration Standard (LCS) – The lowest target concentration analyzed during the precision and accuracy study whose concentration is closest to but greater than the LOQ. Note:

In earlier editions of this QA plan, LCS was referred to as the Certified Reporting Limit (CRL).

Low Level Challenge (LLC) – A quality control sample to challenge monitoring equipment that is <0.3 Z for all hazard levels (STEL, ASC and CMCL). The LLC used for MINICAMS at the

CDP COBRATF is 0.25 Z.

Method – A process that begins with the collection of a sample and is followed by the analysis of the sample by an appropriate analytical technique. Method requirements specify the type of sampling media, air flow rates, collection time, the details of sample preparation and the type and set points of the instrument used to analyze the sample.

Method or Measurement Accuracy – The degree of agreement of a measured value with the true or expected value of the quantity of concern. Method accuracy depends on both the bias and the imprecision of the method.

MINICAMS – The Miniature Continuous Air Monitoring System (MINICAMS) is a field-transportable, automated gas chromatograph used to monitor for chemical agents.

Near Real Time (NRT) Monitor – An instrument that samples a specific volume of air at a sampling site and performs a near real time analysis of the sample. For the purposes of this document, near real time is defined as a period of 15 minutes or less.

Precision – The degree of mutual agreement characteristic of independent measurements as the result of repeated application of the process under specified conditions.

Product – The result of activities or processes. A product may include a service, hardware, processed materials, software, or a combination thereof. Analytical data and data reports are products of the Air Monitoring Program at the CDP COBRATF.

Quality Assurance (QA) – The total integrated program for assuring and documenting the reliability of monitoring and measuring data as well as, for integrating quality planning, quality assessment, and quality improvement efforts to meet user requirements.

Quality Control (QC) – The routine application of procedures for obtaining prescribed standards of performance in the monitoring and measurement process.

Quality Objective – Something sought or aimed for related to quality.

Quality policy – Overall intentions and direction of an organization related to quality as expressed by management.

Quality-Process Sample (QP) – A quality control sample that has been spiked with a dilute chemical agent and exposed to air from the same environment for the same time and at the same flow rate as actual samples from operations. Upon analysis, the recovery for the QP sample must be within an acceptable tolerance. The purpose of the QP sample is to identify sources of sample contamination or sample degradation at the sample location.

Quality System – The organizational structure, responsibilities, procedures, and resources for the implementation of quality management.

Research, Development, Testing, and Evaluation (RDT&E) Solutions – Solutions of chemical agent in concentrations and quantities reduced by dilution to levels that can be handled with the same precautions associated with industrial chemicals.

Short Term Exposure Limit (STEL) – The maximum concentration to which unprotected chemical workers may be exposed for up to 15 minutes continuously.

Source Emission Limit (SEL) – This is the maximum concentration of agent allowed in the effluent stream from a point source such as an incinerator. The SEL for both GB and VX is

0.0003 mg/m . The SEL is referred to as the allowable stack concentration (ASC) at the CDP

COBRATF because MINICAMS uses the unit ASC rather than SEL.

Target Action Level (TAL) – A population parameter that, for future measurements, predicts the highest true concentration that can be distinguished, with a 97.5% level of confidence, from hazard-level concentrations.

TMDE – Testing and Measuring Diagnostic Equipment (TMDE) used to make measurements

(for example, voltmeters and flowmeters).

Type 1 Method or Monitor – A fully quantitative analytical method or monitor that yields a numerical estimate of the analyte concentration within a working concentration range.

Type 2 Method – A method that is used to indicate whether an analyte is present at or above a specific concentration.

Uncertainty in Found Mass (UIFM) – Uncertainty in found mass is one half the difference between the upper and lower 95% prediction limits of the found concentration (FC) at the target concentration divided by the target concentration. Uncertainty in found mass is expressed as a percent.

Z – The generic designation for the applicable monitoring standard (STEL, ASC or CMCL).

3.0 RESPONSIBILITIES AND AUTHORITIES

3.1 Introduction

The executive management is the Assistant Director of the CDP COBRATF. The Assistant

Director ensures that adequate resources are available to support the Air Monitoring Program at the CDP COBRATF. The Assistant Director requires that all site personnel who perform functions in support of air monitoring understand the Quality Policy presented in Section 2.1 of this plan. The Assistant Director also supports air monitoring staff, chemical laboratory staff, the

Quality Manager, and other personnel involved as needed to ensure a strong Air Monitoring

Program at this facility. (Figure 1)

FIGURE 1: Key Positions in the Air Monitoring Program at the CDP COBRATF

3.2 Management Representative

The Quality Manager, CDP COBRATF, serves as the Management Representative and is responsible for:

Making certain that the requirements of the CQAPCAAM at Training Facilities are established, implemented, and maintained at the CDP COBRATF.

Ensuring that personnel involved in the Air Monitoring Program are aware of the requirements of the quality control plan(s) for this program.

Keeping executive management informed of the effectiveness of the staff responsible for the Air Monitoring Program and of any need for improvements or additional resources.

Ensuring that the Quality Policy is understood at appropriate levels of the organization.

Conducting an annual management review of the Air Monitoring Program to evaluate the effectiveness of the program and for reporting the results of this review to executive management.

3.2.1 Resources

The executive management of the CDP COBRATF plans and organizes their resources to ensure that adequate resources are available for the work to be performed and to satisfy customer requirements. Resources may be people, infrastructure, work environment, information, suppliers and partners, natural resources and financial resources.

3.3 Responsibilities and Authority of the CQAT

The CQAT will:

Certify organizations that are authorized to use CASARM in conjunction with monitoring activities and protection of workers and the environment.

Advise Executive and Organizational Managers on matters relating to QA/QC practices and/or problems for agent air monitoring.

Recommend to Executive and Organizational Managers the QA and QC practices to be used to support agent monitoring.

Review and approve QC Plans submitted by agent air monitoring organizations.

Monitor the effective implementation of QA/QC at organizations and report questionable practices to the appropriate manager.

Conduct on-site quality system audits.

Provide guidance to Laboratory Managers on technical matters.

Coordinate Technical Working Group meetings.

Notify all users of CASARM of any change in status of the CASARM.

Initiate the shipment of dilute CASARM to user organizations.

Certify neat CASARM and dilute CASARM solutions.

Provide written response and pertinent comments to problems discovered by and brought to the attention of the CQAT by program participants.

Manage the CASARM Proficiency Test Program (PTP).

Implement an ISO 9001 quality management system in accordance with the

CQAPCAAM at Training Facilities at the CDP COBRATF.

3.4 Responsibilities and Authority of the Organization

3.4.1 Organizational Managers

The organizational managers responsible for day-to-day operations in the Air Monitoring

Program at the CDP COBRATF are Contractor Project Manager and the Contractor Project

Lead. The Director of the Chemical Agent Laboratory is responsible for providing guidance to the chemical laboratory technicians.

The Contractor Project Manager’s staff includes the Lead Air Monitoring Technician, the Air

Monitoring Technicians, Lead Chemical Laboratory Technician, and the Chemical Laboratory

Technicians. The Contractor Project Manager is responsible for providing these personnel and for their performance in the Air Monitoring Program.

3.4.2 Personnel

3.4.2.1 Contractor Project Manager

The Contractor Project Manager and the Contractor Project Lead are responsible for:

Submitting a QC Plan for Air Monitoring and any subsequent material revisions to the

CQAT for review and approval (through the Quality Manager)

Implementing the QC Plan for Air Monitoring (through the Lead Air Monitoring

Technician) and informing the Air Monitoring Section personnel of the importance of meeting customer, statutory, regulatory and quality system requirements.

Hiring and training the Lead Air Monitoring Technician (with the assistance of the

Quality Manager)

Hiring air monitoring technicians and documenting required training (with the assistance of the Lead Air Monitoring Technician)

Hiring the chemical laboratory technicians

Ensuring that air monitoring technicians undergo semi-annual evaluation (with the assistance of the Lead Monitoring Technician and through the Quality Manager)

3.4.2.2 Laboratory Director

See CDP COBRATF Laboratory QC Plan.

3.4.2.3 Air Monitoring Supervisor (Lead Air Monitoring Technician)

The Air Monitoring Supervisor serves as the Lead Air Monitoring Technician and is responsible for the day-to-day, hands-on operation of the Air Monitoring Section at the CDP COBRATF and for helping to resolve any air monitoring problems that would impact the mission of the facility—the training of first responders—or that would compromise the safety of staff and visitors.

The responsibilities of the Lead Air Monitoring Technician include:

Ensure that all air monitoring technicians are in compliance with the training and certification requirements of the documented Air Monitoring Program at the CDP

COBRATF.

Keep abreast of technical advances in air monitoring and new regulatory requirements.

Ensure that all MINICAMS used to collect air monitoring data are properly certified.

Ensure that all MINICAMS methods used to generate automated air monitoring data are properly certified.

Ensure staff that plan to collect DAAMS samples and operate MINICAMS are properly trained and certified.

Serve as the Quality Control Representative (QCR) for the Air Monitoring Section to ensure that air monitoring records are accurate and complete, and prepare CARs, as necessary.

Recommend air monitoring technicians and DAAMS sample collectors for certification, decertification, suspension, or reinstatement, as necessary.

Conduct a review of information provided by the Calibration Coordinator approximately once per month to help ensure that only TMDE items with current calibration certificates are used to make measurements.

Maintain a list of MINICAMS interferences based on data generated by air monitoring technicians.

Ensure that all working standard solutions are properly labeled, and stored as required.

Make certain that each MINICAMS is calibrated and challenged as required and that the criteria for passing calibration and QP challenges are met.

Ensure that responses to all equipment malfunctions are handled according to the stated requirements of the CDP COBRATF Air Monitoring Plans and SOP’s.

Ensure that the required alarm reports, malfunction reports, related memos and all other necessary communications to upper management are properly prepared and maintained as part of the permanent chemical records of the CDP COBRATF.

Notify the Contractor Project Manager, Contractor Project Lead, and the Quality

Manager of problems that may affect the status or the quality of air monitoring operations.

Notify the Assistant Director of the CDP COBRATF, Contractor Project Manager, Contractor Project Lead, and the Quality Manager of any situation where the hydrogen leak detector system becomes inoperable.

Train air monitoring technicians on the hands-on skills necessary to operate, maintain, and repair air monitoring equipment and accessories, to conduct quarterly sample line challenges, etc.

Perform preventive maintenance and repair of MINICAMS and associated equipment to include accurate and complete maintenance and repair records.

Maintaining a stock of repair parts, supplies, and calibrated test equipment (as required).

Participate in external and internal audits as required.

The Lead Air Monitoring Technician may be assisted in completing these responsibilities by other certified air monitoring technicians.

3.4.2.4 Certified Air Monitoring Technicians

The hands-on activities of the certified air monitoring technicians are directed by the Lead Air

Monitoring Technician. Certified air monitoring technicians are responsible for:

Following procedures and documenting air monitoring activities according to the QC

Plan for Air Monitoring, Standard Operating Procedures (SOPs), and approved forms.

Operating and maintaining air monitoring equipment and accessories and conducting preventive maintenance according to established schedules.

Reporting any problems, concerns, etc. that may affect the quality of air monitoring data or that may be a violation of procedures to the Lead Air Monitoring Technician to ensure that these problems are properly reported, documented, and corrected.

3.4.2.5 Certified Chemical Laboratory Technicians

See the CDP COBRATF Laboratory QC Plan.

3.4.2.6 Responsibilities and Authority of the Quality Manager

The Quality Manager is responsible for working closely with the organizational unit managers at the CDP COBRATF to ensure compliance with the established quality system for the Air

Monitoring Program at the CDP COBRATF. The Quality Manager is assisted, as necessary, by a QC Assistant and the Lead Air Monitoring Technician. The specific responsibilities of the

Quality Manager include:

Maintaining the CDP COBRATF document control system, to include maintaining master lists of controlled documents, maintaining files of original documents (or copies, as appropriate), review and approval of newly prepared or modified CDP COBRATF documents, and tracking the progress of document review and approval by others.

Providing quality orientation training for Air Monitoring Section and Chemical Agent

Laboratory staff, to include the document control system, the corrective and preventive action systems, the role of purchasing procedures in quality control, the purpose of management reviews, and preparation for internal and external audits.

Providing oversight of the QA/QC aspects of the purchasing system at the CDP

COBRATF.

Periodically receiving and ensuring adequate storage of monitoring records from the Air

Monitoring Section and the Chemical Agent Laboratory.

Administering a system for handling corrective action requests (in response to major non-conformances), to include notification of executive management, the organizational unit managers, and others, as necessary; participating in the root cause analysis; participating in the determination of appropriate corrective action; and verification of implementation.

Administering a system for handling preventive action requests, to include notification of executive management, the organizational unit managers, and others, as necessary;

participating in the root cause analysis; participating in the determination of appropriate preventive action; and verification of implementation.

Measuring customer satisfaction for the Air Monitoring Program and reporting the results to executive management and the organizational unit managers.

Tracking and reporting the results of inspections by QC representatives of the various functional groups at the CDP COBRATF that impact the quality of the Air Monitoring

Program, and meeting with these QC representatives not less than once per quarter to discuss, document, and follow through on the resolution of quality problems identified by the QC representatives that may affect the Air Monitoring Program.

Conducting an internal audit of the entire Air Monitoring Program no less than once per year, to include audit reports and follow-up audits.

Working with the appropriate Management Review Team members, to complete an annual management review of the CDP COBRATF quality system, to include the Air

Monitoring Section, the Chemical Agent Laboratory, the QA/QC function, purchasing, calibration, and management. The management review will include all of the actions listed in Section 2.3, Management Review, of the CASARM Quality Assurance Plan.

Working with the Contractor Project Manager, the Contractor Project Lead and the Lead

Air Monitoring Technician to ensure that the proper number and type of control samples are analyzed and that out-of-control situations are documented.

Serving as a point of contact for external auditors and assisting in corrective actions in response to external audits.

The Quality Manager, with the assistance of a QC Assistant, also maintains a system to ensure that all air monitoring quality system records are properly identified, maintained, filed, stored, and available for review and audit. This system includes a retention index for each type of air monitoring record, which addresses duration of record retention and disposal.

3.4.3 Calibration Coordinator

Within the CDP COBRATF, the Calibration Coordinator is responsible for:

Maintaining a calibration system, to include maintaining a master file (list) of Testing and

Measuring Diagnostic Equipment (TMDE) items, and notifying air monitoring and laboratory staff of items for which calibration is due.

Maintaining the location and status of TMDE items used by the Air Monitoring Section and the Chemical Agent Laboratory (based on information supplied by staff in these groups).

Keeping a current, temporary record (list, memo, or hand receipts) of equipment submitted to TMDE calibration facilities, to include equipment names, serial numbers, and dates submitted.

Taking or shipping TMDE items to the calibration facility, and ensuring that proper calibration documentation is received from the TMDE calibration facility.

Ensuring that each TMDE item received from the calibration facility has the required calibration label.

Incorporating calibration information provided TMDE items calibrated by the

Government, by a supplier/manufacturer, or by a non-Government, third-party calibration service into the TMDE master file.

4.0 REFERENCE MATERIALS AND CALIBRATION STANDARDS

This section of the QC plan describes the approach to the preparation, handling, and storage of analytical standards (working standard solutions) used by the Air Monitoring Section to calibrate

MINICAMS and to conduct daily challenges (that is, QC injections to demonstrate proper operation).

4.1 Reference Materials Description and QA/QC Procedures

4.1.1 Neat CASARMs

Neat CASARMs are not used at the CDP COBRATF for the production of working standards.

4.1.2 Dilute CASARMs

Chemical Agent Laboratory staff at the CDP COBRATF periodically receives chemical agent standard analytical reference material (CASARM) and non-CASARMs, RDT&E solutions, from the Edgewood Chemical and Biological Center (ECBC), Aberdeen Proving Ground (APG), Maryland. Each solution received from ECBC is supplied with documentation showing the concentration of agent in the solution.

4.1.3 Storage and Use of CASARMs

4.2 Standards for Calibration and Sample Spiking

The concentrations of GB and VX in the standards depend on the mode of operation of the

MINICAMS and the regulatory limits for each agent as shown below:

STEL: 0.01 ng of VX per liter of air; 0.1 ng of GB per liter of air

Sample period: 8 min

Sample flow rate: 450 mL/min

Working standard: 0.009 ng of VX per microliter and 0.09 ng of GB per microliter

(uL)

ASC: 0.3 ng of VX per liter of air; 0.3 ng of GB per liter of air

Sample period: 8 min

Sample flow rate: 40 mL/min (from the incinerator stack)

Working standard: 0.024 ng of VX per microliter and 0.024 ng of GB per microliter

(uL)

CMCL: 20 ng of VX per liter of air; 200 ng of GB per liter of air

Sample period: 2 min

Sample flow rate: 250 mL/min

Working standard: 2.5 ng of VX per microliter and 25 ng of GB per microliter (uL)

The amount of agent injected into the MINICAMS when conducting a 1.0-Z calibration or a 1.0-

Z daily challenge is equivalent to the amount that would enter the MINICAMS during its sample period when sampling air containing agent at the hazard level (STEL, ASC, or CMCL).

NOTE: A working standard solution labeled with a capital “C” and with a red border on the label must be used to calibrate the MINICAMS. After the calibration, 0.25- and 1.0-Z

QP challenges must be made to determine whether the calibration was performed correctly. These two QP challenges must be made using a working standard solution labeled with a capital “Q” and with a blue border on the label.

Air monitoring staff will inspect the labels of the working standard solutions when they receive vials from the Chemical Agent Lab to verify that the stated concentrations meet the concentrations listed…