Attachment 26 AMP QC Plan.pdf

September 9, 2019

Table of Contents

1.0 INTRODUCTION

1.1 SCOPE

1.2 PURPOSE

1.3 GOALS

1.4 ORGANIZATION REGISTRATION

1.5 CONTEXT OF THE ORGANIZATION

1.6 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES

1.7 MANAGEMENT COMMITMENT

1.8 CUSTOMER FOCUS

1.9 ORGANIZATIONAL KNOWLEDGE

2.0 QUALITY MANAGEMENT SYSTEM

2.1 QUALITY POLICY STATEMENT

2.2 ORGANIZATION DESCRIPTION

2.3 MANAGEMENT REVIEW

2.3.1 Management Review Inputs……………………………………………………..12

2.3.2 Management Review Outputs……………………………………………………12

2.4 QUALITY SYSTEM

2.4.1 Documented Information………………………………………………………...14

2.4.2 Quality Control (QC) Plan……………………………………………………….14

2.4.2.1 REQUIREMENTS

2.4.3 Planning………………………………………………………………………….15

2.4.3.1 GENERAL

2.4.3.2 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES

2.4.3.3 QUALITY PLANNING TO ACHIEVE OBJECTIVES

2.4.3.4 Planning of changes……………………………………………………………...17

2.4.3.5 `OBJECTIVES

2.5 CONTRACT REVIEW

2.6 CONTROL OF PRODUCTION AND SERVICE PROVISION

2.7 CONTROL OF CHANGES

3.0 AGENT MONITORING

3.1 STANDARDS FOR AGENT EXPOSURE

3.2 CATEGORIES OF MONITORING SYSTEMS

3.2.1 NEAR REAL TIME (NRT) MONITORS

3.2.2 SAMPLE MEDIA COLLECTION OR GRAB SAMPLING WITH SUBSEQUENT ANALYSIS 18

3.3 INSTRUMENTATION

3.3.1 MINICAMS

3.3.2 DAAMS WITH SUBSEQUENT GC ANALYSIS

4.0 LEADERSHIP

4.1 INTRODUCTION

4.2 MANAGEMENT REPRESENTATIVE

4.2.1 RESOURCES

4.3 RESPONSIBILITIES AND AUTHORITY OF THE CQAT

4.4 RESPONSIBILITIES AND AUTHORITY OF THE ORGANIZATION

4.4.1 ORGANIZATIONAL MANAGERS

4.4.2 PERSONNEL

4.4.3 RESPONSIBILITIES AND AUTHORITY OF THE QM/ QAC

4.4.4 CALIBRATION COORDINATOR

4.4.5 QUALITY MANAGER (QM) /QAC

4.4.6 CHEMIST

4.4.7 LEAD MINICAMS TECHNICIAN

4.4.8 LABORATORY TECHNICIANS

4.4.9 MINICAMS TECHNICIANS

4.4.10 INDUSTRIAL HYGIENE OFFICER

4.4.11 PROGRAM MANAGER

5.0 REFERENCE MATERIALS AND CALIBRATION STANDARDS

5.1 REFERENCE MATERIALS DESCRIPTION AND QA/QC PROCEDURES

5.1.1 NEAT CASARM

5.1.2 DILUTE CASARM

5.1.3 STORAGE AND USE OF NEAT CASARM

5.2 STORAGE AND SHELF LIFE OF STOCK AND WORKING STANDARDS

5.2.2 ORGANIC SOLVENTS AND GLASSWARE USED TO PREPARE STANDARDS

5.2.3 STOCK AND WORKING STANDARDS

5.2.3.1 LABELING AND RECORDKEEPING

6.0 CERTIFICATION, COMPETENCE AND TRAINING

6.1 TRAINING

6.2 COMPETENCE

6.3 CERTIFICATION

6.3.1 INTRODUCTION

6.3.2 METHOD CERTIFICATION

6.3.3 CERTIFICATION (P&A) OF TYPE 1 METHODS

6.3.4 CERTIFICATION OF TYPE 2 METHODS

6.4 PERSONNEL CERTIFICATION

6.4.1.1 ANALYST CERTIFICATION FOR TYPE 1 METHODS

6.4.1.2 ANALYST CERTIFICATION FOR TYPE 2 METHODS

6.4.1.3 RE-CERTIFICATION OF ANALYSTS

6.4.1.3.1 TYPE 1 METHODS

6.4.1.3.2 TYPE 2 METHODS

6.4.2 SEMI-ANNUAL EVALUATION OF PERSONNEL

6.4.3 SAMPLE COLLECTION PERSONNEL

6.4.4 PROFICIENCY TESTING PROGRAM

6.5 CERTIFICATION OF ADDITIONAL PERSONNEL AND INSTRUMENTS

6.5.1 ADDITIONAL TYPE 1 INSTRUMENTS

6.5.2 ADDITIONAL TYPE 2 INSTRUMENTS

6.5.3 RE-CERTIFICATION OF INSTRUMENTS

6.6 SIGNIFICANT CHANGES IN METHODS

7.0 CALIBRATION

7.1 PERIODIC CALIBRATION OF EQUIPMENT

7.2 INSTRUMENT CALIBRATION

7.2.1 Frequency and Range of Calibration…………………………………………..39

7.2.1.1 TYPE 1 LABORATORY METHODS

7.2.1.1.1 DAAMS CALIBRATION REQUIREMENTS AND ACCEPTANCE CRITERIA

7.2.1.2 TYPE 1 NRT MONITORS

7.2.1.2.1 FREQUENCY OF CALIBRATION FOR NRT MONITORS

7.2.1.2.2 MINICAMS

7.2.1.2.2.2 SINGLE POINT CALIBRATION FOR TYPE 1 NRT MONITORS

7.2.1.2.2.3 MULTILEVEL CALIBRATION

7.2.1.3 TYPE 2 METHODS

7.2.2 CORRECTIVE ACTION FOR UNACCEPTABLE CALIBRATIONS

7.3 GC- MASS SPECTROMETER (GC-MS)

8.0 SAMPLE COLLECTION, HANDLING, DELIVERY, PRESERVATION AND

DATA GENERATION………………………………………………………..44

8.1 SAMPLE COLLECTOR TRAINING

8.2 LABORATORY METHODS

8.2.1 DAAMS SAMPLE PREPARATION

8.2.2 DAAMS SAMPLE COLLECTION

8.2.3 SAMPLE TRACEABILITY

8.2.4 SAMPLE HANDLING

8.2.5 SAMPLE DELIVERY AND INSPECTION

8.2.5.1 CUSTODY

8.2.5.2 TRANSPORTATION

8.2.6 SAMPLE PRESERVATION/CONTINUING QUALITY CHECKS

8.2.7 SAMPLE ANALYSIS AND DATA GENERATION

8.2.7.1 HOLDING TIMES

8.2.8 NON-CONFORMING SAMPLES

8.3 NRT MONITORS

8.3.1 SAMPLE COLLECTION FOR NRT MONITORS

8.3.2 Data Generation for NRT Monitors…………………………………………….49

9.0 QUALITY CONTROL

9.1 OPERATIONAL PLANNING

9.2 QUALITY CONTROL SAMPLES

9.2.1 TYPICAL APPLICATIONS OF QUALITY CONTROL SAMPLES

9.2.1.1 QUALITY PROCESS (QP) SAMPLE

9.2.1.1.1 PURPOSE

9.2.1.1.2 DAAMS METHODS

9.2.1.1.3 NRT MONITOR

9.2.1.1.3.1 METHODS

9.2.1.2 QUALITY LABORATORY (QL) SAMPLE

9.2.1.2.1 PURPOSE

9.2.1.2.2 PREPARATION

9.2.2 CONTROL SAMPLE CHALLENGE PROCEDURES

9.2.2.1 TYPE 1 AND TYPE 2 MONITORS

9.2.2.2 TYPE 1 NRT MONITORS

9.2.3 CONTROL SAMPLE ACCEPTANCE CRITERIA

9.2.3.1 TYPE 1 NRT MONITORS

9.2.3.2 TYPE 1 DAAMS METHODS

9.2.3.3 TYPE 2 DAAMS METHODS

9.2.3.3.1 CONFIRMATION ANALYSES

9.2.4 CONTROL SAMPLE RECORD KEEPING REQUIREMENTS

9.3 QUALITY CONTROL OF SAMPLE LINES

9.3.1 FLOW RATES

9.4 CONDITIONING OF DAAMS TUBES

9.5 SPECIAL PROCESSES

9.6 CONFIRMATION OF ROUTINE MONITORING

9.7 CONFIRMATION FOR NON-ROUTINE MONITORING

9.8 CORRECTION FOR METHOD RECOVERY FOR TYPE 1 DAAMS

10.0 VERIFICATION OF IN-HOUSE DEVELOPED SOFTWARE

10.1 VERIFICATION PROCEDURES

10.2 CONTENTS OF THE VERIFICATION PACKAGE

11.0 PREVENTIVE MAINTENANCE

11.1 MINICAMS PM

11.2 GAS CHROMATOGRAPHS AND ACCESSORIES

11.3 RECORD KEEPING

11.4 ROUTINE OPERATIONS

11.5 SPARE PARTS

12.0 PURCHASING

12.1 TYPE AND EXTENT OF CONTROL

12.2 APPROVED /UNAPPROVED VENDORS

12.3 PURCHASING DATA

12.3.1 EXTERNAL SUPPLIERS

12.3.2 PURCHASING INFORMATION

13.0 INSPECTION AND TESTING

13.1 RECEIPT INSPECTION

13.1.1 Purchased Supplies……………………………………………………………...63

13.1.2 PURCHASING INFORMATION

13.2 ACCEPTANCE TESTING

13.2.1 ACCEPTANCE TESTING OF DAAMS TUBES

13.2.2 ACCEPTANCE TESTING OF PRECONCENTRATOR TUBES

13.2.3 ACCEPTANCE TESTING OF NOX PRE-FILTERS

13.2.4 ACCEPTANCE TESTING OF SILVER FLUORIDE CONVERSION PADS

13.3 IN-PROCESS INSPECTION

13.3.1 SAMPLES

13.3.2 DATA

13.4 FINAL INSPECTION

13.5 POST DELIVERY ACTIVITIES

14.0 CORRECTIVE ACTIONS AND CONTROL OF CONTROL OF NON-

CONFORMING SAMPLES AND DATA, PRODUCTS, AND SERVICES

14.1 CORRECTIVE ACTION

14.2 DOCUMENTATION

14.3 NON-CONFORMING SAMPLES

14.4 NON-CONFORMING DATA

15.0 EXTERNAL/INTERNAL AUDITS

15.1 EXTERNAL AUDITS

15.2 INTERNAL AUDITS

16.0 IMPROVEMENT

16.1 CONTINUAL IMPROVEMENT

16.2 CUSTOMER SATISFACTION

17.0 DOCUMENTATION

17.1 DOCUMENT CONTROL

17.1.1 CREATING AND UPDATING

17.1.2 DOCUMENT APPROVAL AND ISSUE

17.1.3 DOCUMENT MODIFICATIONS AND CHANGES

17.2 CONTROL OF QUALITY RECORDS

17.3 IDENTIFICATION AND TRACEABILITY

18.0 ANALYSIS OF DATA

18.1 STATISTICAL METHODS

18.2 PROCEDURES

19.0 CONTROL OF CUSTOMER SUPPLIED PRODUCT

20.0 DATA INTEGRITY AND ETHICS

21.0 LITERATURE CITED

1.0 INTRODUCTION

The COBRATF, FEMA is used to train emergency responders to operate in chemically contaminated environments. During this training, students are equipped with personal protective equipment (PPE) and trained to conduct various operations in the toxic agent training area with the agents GB and VX. Air monitoring for these agents is conducted at the COBRATF to ensure that agent concentrations in the toxic agent training area do not exceed allowable airborne exposure limits, to ensure that unprotected personnel outside the toxic agent training area are not exposed to agents at levels above acceptable airborne exposure limits (AEL), and to ensure agents are not released into the environment outside the COBRATF. Air monitoring at the COBRATF is conducted through the use of miniature continuous air monitoring systems (MINICAMS) and depot area air monitoring systems (DAAMS) with subsequent gas chromatograph (GC) analysis.

The MINICAMS laboratory and the chemical laboratory work together to carry out the air monitoring mission at the COBRATF. The Department of Homeland Security (DHS) Federal FEMA Laboratory Chemist directs all activities performed in the chemical laboratory. The Lead MINICAMS technician, operating under the direction of the Contract Project Manager, directs all activities in the MINICAMS laboratory.

This document describes the quality control (QC) plan for the Air Monitoring Program at the COBRATF. Except as noted below, the QC plan conforms to the requirements of the current Chemical Agent Standard Analytical Reference Material Quality Assurance Plan for Chemical Agent Air Monitoring (CQAPCAAM), issued by the CASARM Quality Assurance Team (CQAT) of the Combat Capabilities Development Command (CCDC). The COBRATF agrees to follow policies and procedures set by the CQAT TWG which apply to COBRATF. Deviations from this document will require the approval of CQAT.

1.1 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 analysis conducted in support of 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 agent air monitoring data. In this context, analytical chemistry includes those aspects of field sampling that may affect the chemical integrity of samples. The scope of this plan covers the type 1 and the type 2 instruments and operators analyzing air samples participating in the overall support of the Air Monitoring Program. In addition to this QC Plan, the COBRATF participates in the CASARM Proficiency Test Program (PTP) to determine the performance of the participants in the Air Monitoring Program.

The scope of this QC Plan takes into consideration external and internal issues (see 1.2.1), the requirements of relevant interested parties (1.2.2) and the products and services of the COBRATF Air Monitoring Program.

COBRATF does not design or develop monitoring systems on a routine basis; therefore, section

8.3 of ISO 9001:2015 does not apply to COBRATF activities.

1.2 Purpose

Agent monitoring systems at the 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.

1.3 Goals

The goals of this QC Plan are to establish controls to:

Provide a consistent framework with the use of precision and accuracy studies and proper calibration practices for the generation of analytical data in support of agent monitoring activities conducted by the U.S. Army and Government contractors;

Establish standard practices that permit inter-laboratory comparison of data;

Establish procedures for demonstrating that analytical systems are in control and control changes to the procedure with the use of document control system outlined in the

QMP 001.

1.4 Organization Registration

This document is written to demonstrate how the COBRATF Air Monitoring Program will comply with ISO 9001:2015 Quality Management System Standard and the requirements of the CQAPCAAM. The COBRATF will utilize the Plan-Do-Check-Act cycle as described/illustrated in Section 2.4 of the CQAPCAAM.

The certification of the quality system for chemical agent air monitoring operations by the CASARM QAT involved the following steps:

The preparation of an Air Monitoring Program QC Plan; using this QC plan written to meet the requirements of the CQAPCAAM. The QC plan is reviewed and approved by the CASARM QAT.

Certifying methods, instruments, and operators (MINICAMS and chemical laboratory technicians) according to written methods and procedures;

Conducting air monitoring operations at the COBRATF for an appropriate amount of time to generate records that demonstrated compliance with this QC Plan;

The Air Monitoring Program laboratories participate in the CASARM Proficiency Testing Program (PTP) as outlined in the CASARM Proficiency Test Program.

1.5 Context of the Organization

The COBRATF will utilize the scheduled Quality Management Reviews to evaluate internal and external issues that could impact the Quality Management System (QMS). The COBRATF will monitor and review the external and internal issues and will:

Consider both positive and negative factors.

Consider external issues that may arise from legal, technological, competitive, market, cultural, social and economic environments, whether international, national, regional, or local;

Consider internal issues that may arise from values, culture, knowledge, and performance of the COBRATF.

Strengths, Weakness, Opportunities, and Threats (SWOT) analysis, Decision Authority Matrix, and Failure Mode and Effects Analysis (FMEA) are three tools used at COBRATF to review, access, and manage all the factors which influence its QMS. The SWOT analysis, Decision Authority Matrix, and the FMEA methodology are explained in Appendix B of this QC Plan. The SWOT analysis for the COBRATF is updated annually.

1.6 Understanding the Needs and Expectations of Interested Parties

The COBRATF will utilize the scheduled Quality Management Reviews (QMR) to monitor and review information about interested parties, to include their relevant requirements, as related to the QMS.

The information discussed in the QMR meetings will be documented and reported in the annual executive QMR. An analysis of the entire QMS will be presented in the annual QMR meeting.

Relevant interested parties in the COBRATF mission include students, staff, the community, FEMA, CDP, CQAT, Department of Defense (DoD), Human Resources (for hiring), TMDE and regulatory agencies. The work at COBRATF is important to the students who train here and the safety of those students, the staff and the surrounding community must be protected. The guidelines in the following QC Plan are designed to mitigate the risk to the relevant interested parties which the COBRATF serve.

1.7 Management Commitment

Management at the COBRATF is committed to the implementation and continuous improvement of the COBRATF Quality Management System.

This commitment is demonstrated by the establishment of the COBRATF quality policy, quality measurable objectives, by conducting management review meetings, and by providing resources to the QMS. COBRATF management shall ensure customer requirements are determined as defined in the quality policy and Section 16.2 to ensure customer satisfaction.

Management has established a process to ensure adequate communication both internally and externally regarding work relevant to the quality management system to include:

What is communicated;

When to communicate;

With whom to communicate;

How to communicate;

And who communicates.

Communication is accomplished through multiple avenues such as schedules, emails, quality management reviews, documented requirements, purchase orders, etc. Communication requirements are specific but are not limited to various Plans, Manuals, SOPs, and Work Instructions.

1.8 Customer Focus

Management is committed to ensuring customer requirements are met. Customer satisfaction is addressed in Section 16.2 of this plan.

Management ensures that:

a. Customer and applicable statutory and regulatory requirements are determined, understood and consistently met;

b. The risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;

c. The focus on enhancing customer satisfaction is maintained.

1.9 Organizational Knowledge

The COBRATF determines the knowledge necessary for the operation of our processes and to achieve conformity of products and services. The COBRATF Training Plan outlines the knowledge needed for positions held at the COBRATF. Knowledge areas are evaluated based on criticality and what risk would be associated if there were a loss of this knowledge. The COBRATF is committed to retaining this knowledge through customers, regulations/standards, SOPs and WIs, training, mentoring, communications, and lessons learned, individual/group development, results from previous corrective actions/improvement actions, results from previous audits, retired and current documents, technical library, etc.

When addressing changing needs and trends, the COBRATF will consider current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. Current and future knowledge will be considered in anticipation of these needs.

COBRATF will retain organizational knowledge described above to the extent necessary to ensure the proper operation of the COBRATF.

2.0 QUALITY MANAGEMENT SYSTEM

2.1 Quality Policy Statement

The COBRATF staff will provide a safe realistic and challenging training experience for the Nation’s state, local, tribal and territorial Emergency Responders and other Federal response agencies. To do this the COBRATF staff will:

Manage the safe use of nerve agents in training based on applicable laws and regulations

Know the needs of our customer and tailor training to meet those needs

Determine resource requirements, document effective procedures, and monitor and measure effects of process to insure continual improvement

To achieve this policy management will:

Demonstrate a commitment to quality through regular QMS reviews

Identify and mitigate risks to the organization

Identify opportunities to enhance the organizations relevance

Provide clear guidance and establish priorities though management reviews

Make all resources available to insure compliance with applicable laws and regulations

Act on opportunities to improve

Protect the COBRATF brand

To achieve this policy; the staff will:

Follow established procedures

Identify opportunities to improve

Self-report process failures

Protect the COBRATF brand

2.2 Organization Description

The COBRATF is located in Anniston, Alabama as part of, FEMA. The Air Monitoring Program at the COBRATF is comprised of a team of contractor employees and employees of

FEMA.

The Air Monitoring Program (AMP) Laboratories (MINICAMS Lab, Agent Lab, and Chemical Lab) are located within the training building of the COBRATF. The program’s main function is to monitor for the presence of the nerve agents in various samples (solids, liquids and air). The Chemist serves as the technical oversight of the AMP and reports directly to the Assistant Director.

Laboratory Technicians conduct air monitoring operations and receive guidance from the Chemist. MINICAMS Technicians conduct air monitoring operations under the day to day guidance of the Lead MINICAMS Technician. The Lead MINICAMS Technician reports directly to the Project Manager. The Project Manager works with the Chemist, with oversight and coordination from the Contracting Officer’s Representative. Figure 4 in Section 4.1 illustrates the organization of the Air Monitoring Program.

COBRATF Management shall provide and maintain the necessary infrastructure to carry out the mission at the COBRATF. This includes adequate work and meeting spaces, utilities, computers, software, office equipment, required supplies and supporting services (such as transportation, communication or information systems).

COBRATF Management and faculty will provide and maintain a work environment 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.

The work environment is evaluated for noise and other physical hazards and proper steps are taken to reduce any discovered hazards.

2.3 Management Review

Top management has developed procedures for systematic review and evaluation of the quality system to ensure its suitability, adequacy and effectiveness and alignment with the strategic direction of the COBRATF. The Quality Management Review procedures are found in COBRATF QMP 001. Such reviews are conducted annually not to exceed (NTE) 13 months and shall be completed prior to the annual CQAT audit.

2.3.1 Management Review Inputs

The management review shall be planned, carried out, and shall include, but not be limited to the following actions:

Status of actions from previous management reviews;

Changes in external and internal issues such as new technology, changes and risks in the business environment, changing or new regulations, organizational changes, etc., that are relevant to the product and/or quality management system;

Information on the performance and effectiveness of the QMS, including trends in:

o Customer satisfaction and feedback from relevant interested parties;

o The extent to which quality objectives have been met;

o Process performance and conformity of products and services;

o Nonconformities and corrective actions;

o Monitoring and measurement results;

o Audit results;

o The performance of external providers;

The adequacy of resources;

The effectiveness of actions taken to address risks and opportunities (reference section

1.4 and 2.4.3.2);

Opportunities for improvement.

2.3.2 Management Review Outputs

The outputs of the management review shall include decisions and actions related to:

Opportunities for improvement to the quality system, processes, and products;

Any need for changes to the QMS to include the quality policy and quality objectives;

Resource needs.

All action items generated during the management review shall have periodic follow-up reviews (i.e., do intermediate reviews) to verify implementation and evaluate the status of each action until all action items have been completed and documented.

A summarizing statement of the QMS’s suitability, adequacy, effectiveness, product conformity, and process performance shall be made. The organization shall retain records as evidence of the results of management reviews.

2.4 Quality System

The COBRATF has established, implemented, maintained and will continue to improve our quality management system, including the processes needed and their interactions, in accordance with the requirements of the CQAPCAAM and this QC Plan.

The COBRATF has determined the processes needed for the quality management system and their application throughout the organization, and shall:

a. Determine the inputs required and the outputs expected from these processes;

b. Determine the sequence and interaction of these processes;

c. Determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;

d. Determine the resources needed for these processes and ensure their availability;

e. Assign the responsibilities and authorities for these processes;

f. Address the risks and opportunities as determined in accordance with the requirements of

2.4.3.2;

g. Evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;

h. Improve the processes and the quality management system.

FIGURE 1: A SCHEMATIC REPRESENTATION OF THE ELEMENTS OF A SINGLE

PROCESS

1ISO 9001:2015(E) Quality Management Systems Requirements, International Organization for Standardization. 15 Sep 2015. P. 8

The Plan-Do-Check-Act (PDCA) cycle ensures that processes are resourced and that opportunities for improvement are found and acted on. Risk-based thinking allows an organization to determine factors that could cause deviations from its processes and intended results. Risk based thinking helps to prevent negative effects and opens the organization to possibilities and opportunities. See Figure 2.

1ISO 9001:2015(E) Quality Management Systems Requirements, International Organization for Standardization. 15 Sep 2015. P. 8

FIGURE 2 THE PLAN-DO-CHECK ACT

The Plan-Do-Check-Act cycle can be applied to all processes and to the quality management system as a whole3. The diagram numbers correlate to the sections of ISO 9001:2015 and not to sections in the CQAPCAAM.

2.4.1 Documented Information

To the extent necessary, the COBRATF shall follow document control and record management procedures in QMP 001 to:

a. Maintain procedures to support the operation of its processes;

b. Retain records to have confidence that the processes are being carried out as planned.

2.4.2 Quality Control (QC) Plan

The COBRATF has developed, implemented and maintained this quality control plan which defines and/or references all plans, SOPs, local procedures, procedures required by the QC plan, work instructions and internally developed computer programs that comprise the agent monitoring quality system including the interaction among them. The scope and interactions of the process of the QMS are defined in (section 1.1).

Any revisions or changes notices issued to the organization’s QC Plan must be reviewed and approved by the CQAT prior to implementation.

2.4.2.1 Requirements

The COBRATF has developed, implemented, and maintains a QC plan which includes the scope of the quality system and the interaction between the processes of the quality management system. The COBRATF AMP QC Plan implements a quality management system that is in accordance with (IAW) the CQAPCAAM.

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

CASARM QAPCAAM

COBRATF Air Monitoring Plan

COBRATF Air Monitoring Program QC Plan

COBRATF Laboratory Training Plan

Toxic Agent Exposure Plan

COBRATF QMP

Air Monitoring Program SOPs/WIs

Forms for use by Air Monitoring Program staff

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

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

Proficiency Test Plan of the CASARM Quality Assurance Program

2.4.3 Planning

The purpose of quality planning is to define and document how the requirements for quality shall be met within the Air Monitoring Program and the supporting systems at the COBRATF. The quality requirements that are prescribed by the CQAPCAAM are accomplished by tracking established quality 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 of quality planning is to ensure that the system maintains its integrity when changes to the quality system are required. The 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.

2.4.3.1 General

Quality planning must ensure that when changes to the quality system are required, the system maintains its integrity. Tools available for input to quality planning include management and staff meetings, TWG meetings, management review, evaluation of regulations, etc.

2.4.3.2 Actions to Address Risks and Opportunities

When planning for the QMS, the organization shall consider the issues referred to in 1.5 and the requirements referred to in 1.6 and determine the risks and opportunities that need to be addressed to:

Give assurance that the QMS can achieve its intended result(s);

Enhance desirable effects;

Prevent, or reduce, undesired effects;

Achieve improvement.

T he COBRATF shall plan:

Actions to address these risks and opportunities;

How to:

o Integrate and implement the actions into its QMS processes (section 2.4);

o Evaluate the effectiveness of these actions.

Actions taken to address risks and opportunities shall be proportionate to the potential impact on the conformity of products and services.

NOTE 1: Options to address risks can include avoiding risk, taking risk in order to pursue an opportunity, eliminating the risk source, changing the likelihood or consequences, sharing the risk, or retaining risk by informed decision.

NOTE 2: Opportunities can lead to the adoption of new practices, providing new products and services, opening new markets, addressing new customers, building partnerships, using new technology, and other desirable and viable possibilities to address the organization’s or its customers’ needs.

NOTE 3: See Appendix B for SWOT analysis and the method used by COBRATF to determine and evaluate actions taken to address risks and opportunities. QMP 001 contains other methods to assess risks.

2.4.3.3 Quality Planning to Achieve Objectives

The development, implementation, and maintenance of organizational QMSs must include specific measureable quality objectives that are documented. The organization shall establish quality objectives at relevant functions, levels, and processes needed for the QMS.

The quality objectives shall:

Be consistent with the quality policy;

Be measurable;

Take into account applicable requirements;

Be relevant to conformity of products and services and to enhancement of customer satisfaction;

Be monitored;

Be communicated;

Be updated as appropriate;

The documented information on the quality objectives is provided to the quality manager every quarter by the process owner. When planning how to achieve its quality objectives, the organization shall determine:

The reports are kept on file in the quality office The quality manager and contract quality manger review the reports The process owners are responsible for filing quality measurable objective reports with the quality office Quality Measurable objective reports are handed in every quarter The results are reported in QMR meetings

2.4.3.4 Planning of changes

When the organization determines the need for changes to the QMS, the changes shall be carried out in a planned manner.

COBRATF shall consider:

The purpose of the changes and their potential consequences;

The integrity of the QMS;

The availability of resources;

The allocation or reallocation of responsibilities and authorities.

Unplanned change requires controlled action to mitigate any adverse consequences.

2.4.3.5 Objectives

The objectives of the Air Monitoring Program 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 for the Air Monitoring Program are referenced in a memorandum approved by the Assistant Director.

2.5 Contract Review

The COBRATF Air Monitoring Program does not accept contracts for the performance of chemical agent monitoring. Therefore, any requirement for contract review in Section 2.5 is not applicable to COBRATF.

2.6 Control of Production and Service Provision

The COBRATF has implemented production and service provisions under controlled conditions defined in QCP. Controlled conditions shall include, as applicable:

The availability of documents that define:

o The characteristics of the products to be produced, the services to be provided, or the activities to be performed (sections 5.0 - 15.0);

o The results to be achieved (section 9.0);

The availability and use of suitable monitoring and measuring resources (sections 5.0 thru 11.0);

The implementation of monitoring and measurement activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met (sections 7.0 and 12.0);

The use of suitable infrastructure (section 2.2) and environment for the operation of processes;

The appointment of competent persons, including any required qualification (sections

4.2 and 6.0);

The validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement (section 9.0);

The implementation of actions to prevent human error (section 16.0);

The implementation of release, delivery and post-delivery activities (section 13.0)

2.7 Control of changes

The COBRATF shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements

The COBRATF shall retain documented information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review.

3.0 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 is 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.

3.1 Standards for Agent Exposure

Airborne exposure limits for GB and VX are listed in the Toxic Agent Exposure Control Plan.

These standards are based on values from the Centers for Disease Control (CDC) and, in some cases, the Department of Health and Human Services (DHHS).

3.2 Categories of Monitoring Systems

The COBRATF utilizes near real time (NRT) monitors (MINICAMS), and grab sampling with subsequent GC analysis (DAAMS).

3.2.1 Near Real Time (NRT) Monitors

MINICAMS are field-portable gas chromatographs capable of detecting or monitoring for chemical agents at multi-level concentrations. At the COBRATF these units are used in a fixed site configuration.

3.2.2 Sample Media Collection or Grab Sampling with Subsequent Analysis

The DAAMS air sampling and GC analysis technique is designed to capture agents on a sorbent-packed tube, which is then thermally desorbed to elute the agents onto a GC column for determination

3.3 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.

3.3.1 MINICAMS

MINICAMS are one instrument type used for chemical agent air monitoring at the COBRATF.

MINICAMS units automatically determine agent concentrations at the STEL concentration in the workplace to warn of the possibility of personnel exposure, as well as in the COBRATF charcoal-filter stack exhaust at the STEL concentration 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 means making sure that decontaminated items do not present a vapor hazard. In addition, MINICAMS are used to determine agent concentrations at IDLH and MUC levels inside training bays to ensure that students and personnel are immediately evacuated from a given bay any time the agent concentration reaches the IDLH level.

3.3.2 DAAMS with Subsequent GC Analysis

DAAMS sampling with GC analysis is another technique used for chemical agent air monitoring at the COBRATF. The DAAMS employs a solid-sorbent tube through which sampled air is drawn. The agent is adsorbed on the sorbent bed, then desorbed and subsequently analyzed in the laboratory on a GC equipped with a suitable detector such as a flame photometric detector

(FPD).

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 GC analysis. The purpose of DAAMS sampling is to ensure the presence of agent is captured in areas where unprotected personnel may be present, in effluent stacks at the COBRATF, or to determine that the vapor concentration of agent in bagged decontaminated items or in bagged waste is less than the appropriate AEL concentration to ensure that decontaminated items do not pose a vapor hazard.

4.0 Leadership

4.1 Introduction

The executive management is the Director of Training and Education. The Director of Training and Education ensures that adequate resources are available to support the Air Monitoring Program. The COBRATF has considered capabilities of and the constraints on internal resources needed for the establishment, implementation, maintenance and continual improvement of the QMS when creating the organizational chart below:

FIGURE 4: Key Positions in the Air Monitoring Program at the COBRATF

4.2 Management Representative

The COBRATF Assistant Director serves as the Management Representative. MR serves as QMS Representative and is responsible for:

Making certain that the requirements of the CQAPCAAM and QC Plan are established, implemented, and maintained

Ensuring that personnel involved in the Air Monitoring Program are aware of the customer requirements and the requirements of the quality control plan(s) for this program, and their contribution to the effectiveness of the QMS, including the benefits of improved performance, and the implications of not conforming to the QMS requirements.

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 the Quality Policy and Quality Measurable Objectives (QMOs) are understood, implemented, maintained, reviewed, and communicated through all levels of the organization. The Quality Policy and QMOs must be aligned with the context and the strategic direction 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

Ensuring the integration of the QMS through all levels of the organization through use of the process approach along with the promotion of risk-based thinking;

Ensuring processes are obtaining their intended outputs;

Evaluation of the QMS to ensure it achieves its intend result;

Communicating the importance of meeting customer, statutory, regulatory, and quality system requirements;

4.2.1 Resources

The executive management of the COBRATF plans and organizes their resources to ensure that adequate resources are available for the work to be performed and to satisfy customer requirements, implement and maintain the quality system and continually improve its effectiveness. Resources may be people, infrastructure, work environment, information, suppliers and partners, natural resources and financial resources. Resources shall be allocated to ensure the QMS achieves its intended result, and processes are achieving their intended outputs.

The COBRATF shall plan for resources required for outsourced services such as TMDE equipment calibration, PM and maintenance of analytical equipment, and provision of CASARM standards.

4.3 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 users of this plan on matters relating to QA/QC practices and/or problems for agent air 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 organizational managers on technical matters and QA/QC practices to be used to support agent monitoring;

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 response and pertinent comments to problems discovered by and brought to the attention of the CQAT by program and participants;

Manage the CASARM PTP;

Ensure the organizations implement a QMS IAW this CQAPCAAM;

4.4 Responsibilities and Authority of the Organization

4.4.1 Organizational Managers

The organizational managers responsible for day-to-day operations in the Air Monitoring Program are the Chemist and Contractor Project Manager(s). The Chemist is responsible for providing technical guidance to all staff working within the Air Monitoring Program. The responsibilities of these positions include taking accountability for the effectiveness of the QMS.

4.4.2 Personnel

Follow procedures and document actions according to the QC plan

Call to the attention of the QAC and appropriate leadership any aspect of the sampling, monitoring, and analysis functions of the organization that may be detrimental to obtaining accurate monitoring results;

Make recommendations for improvements to QC procedures;

Prepare and maintain adequate documentation concerning QA/QC activities;

Cooperate with the Quality Manager and/or QAC when preparing reports addressing out of control situations, and conducting other QA/QC activities;

Follow the most current plans, procedures, SOPs, work instructions, job aids, and other relevant controlled documents;

Perform preventive maintenance on laboratory and air monitoring equipment according to established schedules;

Ensure appropriate internal communication is available regarding the effectiveness of the quality system;

Respond to and implements, where appropriate, the recommendations of the QAC and the CQAT.

4.4.3 Responsibilities and Authority of the QM/ QAC

The QM/QAC has the responsibility to:

Establish, oversee, and audit specific procedures for documentation and controlling analytical data quality; other individuals will execute many of the procedures, but the QAC must ensure that procedures are being implemented properly and that the results are interpreted correctly;

Inform management (AD COBRATF, Operations Officer, and Quality Manager) of non-conformance with the QC plan;

Recommend improvements of the Air Monitoring Program to management;

Identify that the proper number and type of control samples are analyzed and maintain documentation of out-of-control situations; report any potential non-conformance to the Quality Section.

4.4.4 Calibration Coordinator

Within the COBRATF, the Logistics Specialist serves as the Calibration Coordinator and is responsible for:

Maintaining a calibration system that includes maintaining all TMDE records, maintaining a master file (list) of TMDE items, and notifying Air Monitoring Program staff of items for which calibration is due;

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.

4.4.5 Quality Manager (QM) /QAC

The Quality Manager is responsible for:

Serving or providing oversight to QAC;

Overseeing the annual internal audit of the Air Monitoring Program;

Maintaining a document control system, including submitting a QC plan and subsequent revisions to CQAT for approval;

Providing oversight to ensure that findings and corrective actions are effective and properly implemented;

Maintaining a system to document and track quality improvement actions as defined in

COBRATF QMP 001;

Managing the entire Quality Management System at the COBRATF to ensure compliance with the latest ISO 9001 Standards, the requirements of the CQAPCAAM, and the COBRATF QMP 001;

Ensuring personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of quality measurable objectives;

Informing CQAT of difficulties encountered in the implementation of the QC Plan and being or providing a representative at Technical Working Group Meetings.

The Quality Manager may be assisted in completing these responsibilities by other quality section personnel (for example he may appoint a QAC).

4.4.6 Chemist

The responsibilities of the Chemist include:

Provide oversight to all quality control and analytical activities of the Air Monitoring Program;

Ensure that personnel have the proper training and resources to perform quality work;

Ensure that all laboratory personnel and analytical methods are certified by completing a successful precision and accuracy (P&A) study or operator certification;

Ensure laboratory conformance with authorized SOPs, work instructions, QC Plans, and sound practices. The Chemist recommends improvements as necessary;

Ensure 100% CASARM dilute standards are inventoried on a semi-annual basis (or as needed);

Respond to and implement, where appropriate, continuous improvement recommendations;

Document and ensure the quality of purchased products that affect the quality system for the laboratories;

Ensure only certified instruments and analysts generate and report data;

Periodically evaluate the proficiency of analysts/operators;

Request CASARM dilute standards and PT samples from CQAT at least sixty (60) days before the need for such materials;

Report any CASARM lot problems to the CQAT, such as receiving cracked or broken vials;

Notifies the CQAT of any CASARMs stored above 4°C for more than ninety-six (96) consecutive hours;

Ensure that all working standard solutions used by the Chemical and MINICAMS laboratories contain the correct concentrations of GB and VX and that these solutions are stored properly and replaced, as required;

Respond to and implement, where appropriate, the recommendations of the QAC, and the CQAT.

4.4.7 Lead MINICAMS Technician

The responsibilities of the Lead MINICAMS Technician include:

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

Respond to agent alarms in areas outside the training area, (to include DAAMS sampling, as required) and equipment malfunctions and prepare drafts of alarm reports, call-out reports, memos, etc., as necessary;

Notify the Project Manager, Quality Manager, and Chemist of problems that may affect the status or the quality of air monitoring operations;

Train air monitoring technicians in the hands-on skills necessary to operate, maintain, and repair air monitoring equipment and accessories, and to conduct quarterly sample line challenges and ensure certifications are maintained;

Schedule and/or perform preventive maintenance and repair of MINICAMS and associated equipment to include accurate and complete maintenance and repair records;

Maintain a stock of repair parts, supplies, and calibrated test equipment;

Participate in external and internal audits as required;

Participate in CAR process;

Perform routine maintenance of DAAMS sampling systems;

Respond to and implement, where appropriate, the recommendations of the QAC, and the CQAT.

The Lead MINICAMS Technician may be assisted in completing these responsibilities by other certified MINICAMS Technicians.

4.4.8 Laboratory Technicians

Prepare stock, calibration and working dilute standard solutions and reagents;

Calibrate the analytical systems;

Maintain the accountability, safety, and security for dilute standards;

Analyze samples;

Calculate the sample concentration;

Record the data on appropriate data sheets;

Maintain the analytical systems;

Assist and coordinate in ensuring that all laboratory TMDE is calibrated;

Maintain accurate and detailed records of samples used in all aspects of the quality control;

Notify the Chemist when an out-of-control situation exists or when conditions exist that might jeopardize control of the analytical systems;

Prepare QP and/or QL samples;

Receive, inspect, and login operational samples and sign the chain-of-custody record received from sampling personnel;

Complete appropriate chain-of-custody forms correctly.

4.4.9 MINICAMS Technicians

The hands-on activities of the certified MINICAMS Technicians are directed by the Lead MINICAMS Technician. Certified MINICAMS Technicians are responsible for:

Following procedures and documenting air monitoring activities according to this plan, SOPs, work instructions and approved forms;

Operation and maintenance of air monitoring equipment and accessories in accordance with 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 MINICAMS Technician to ensure that these problems are properly reported, documented, and corrected.

4.4.10 Industrial Hygiene Officer

The Industrial Hygiene (IH) Officer provides technical oversite to the Air Monitoring Program by:

Determination of AELlevels and sites to be monitored;

Reviewing program documentation;

Ensuring accuracy of hazard assessment;

Providing guidance on risk assessment relative to safety.

4.4.11 Program Manager

The Program Manager provides:

Trained personnel;

Management of daily operations Quality Section support as needed

5.0 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 Program staff to challenges. See COBRATF AMP SOP 006.

5.1 Reference Materials Description and QA/QC Procedures

5.1.1 Neat CASARM

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

5.1.2 Dilute CASARM

Reference materials and calibration solutions used at the COBRATF to prepare quality control samples and to calibrate gas chromatographs and MINICAMS are derived from separate dilute CASARM and/or non-CASARM solutions of VX and GB, calibration standards (C) and quality standards (Q). If CASARM grade agent is not available, the highest grade agent available will be used. Certificates of analysis for CASARM material and memorandums for record for non- CASARM material are received to document the quality of the solutions that accompany each shipment of dilute obtained from Chemical Biological Center (CBC).

Upon receiving a dilute CASARM shipment, the recipient shall complete section II of the SSR that accompanies each shipment and return it to the CQAT. If appropriate storage and handling procedures are used for dilute CASARM standards their shelf life should extend to fifteen (15) months.

5.1.3 Storage and Use of Neat CASARM

The COBRATF does not receive Neat CASARM agent for the use of preparing working standards. If, for any reason, Neat CASARMS are received for that purpose, all requirements stipulated in the CQAPCAAM would be adhered to in the manner in which they are stipulated.

5.2 Storage and Shelf Life…