Attachment 19 CASARM Quality Assurance Plan.pdf

CDP COBRATF Training Operations and Support Services

Attachment 19

CASARM Quality Assurance Plan

CHEMICAL AGENT STANDARD ANALYTICAL

REFERENCE MATERIAL (CASARM) QUALITY ASSURANCE (QA) PLAN

FOR CHEMICAL AGENT AIR MONITORING

May 2017

Revision 7

RESEARCH, DEVELOPMENT AND ENGINEERING COMMAND

DIRECTORATE OF PROGRAM INTEGRATION

CASARM QUALITY ASSURANCE TEAM

ABERDEEN PROVING GROUND, MD 21010-5424

May 2017 CQAPCAAM Revision No. 7 ii

DISTRIBUTION STATEMENT

Approved for public release: distribution unlimited. Requests for this document may be referred to U.S. Army, Edgewood Chemical Biological Center (ECBC), ATTN: RDCB-DPB-Q, 5183 Blackhawk Road, Aberdeen Proving Ground, MD 21010-5424.

DISCLAIMER

The findings in this report are not to be construed as an official Department of the Army position unless so designated by other authorizing documents.

The English language does not have a pronoun that may refer to both sexes and continuous use of the phrase "he or she" makes awkward and laborious reading. Therefore, this text follows the custom of using "he" or "him" to include both sexes. In no case should this be interpreted as meaning that a given position or job necessarily be filled by a male rather than a female.

May 2017 CQAPCAAM Revision No. 7

CHEMICAL AGENT ST AND ARD ANALYTICAL

REFERENCE MATERIAL QUALITY ASSURANCE PLAN

FOR CHEMICAL AGENT AIR MONITORING

May 2017

APPROVED BY:

HAY 2 6 2on Date lll

May 2017 CQAPCAAM Revision No. 7

FOREWORD

CHEMICAL AGENT STANDARD ANALYTICAL

REFERENCE MATERIAL QUALITY ASSURANCE PLAN

FOR CHEMICAL AGENT AIR MONITORING

The CASARM QA Plan for Chemical Agent Air Monitoring is a document that shall be used by organizations participating in the CASARM program for agent monitoring. Government contractors that support air monitoring operations at these participating sites, but are not located at these sites, shall use this document in conjunction with ISO 9001:2015 to fulfill CASARM QA Plan requirements, as specified by contract. In the event of conflict between this document and the contract, the contract shall take precedence. Organizations will prepare or modify existing quality control (QC) plans to conform to this Plan. The QC plan or referenced procedure(s) shall describe, in detail, how the organization will carry out the concepts prescribed herein.

Changes to this plan will be approved and issued by the CQAT, ECBC, RDECOM.

lV

May 2017 CQAPCAAM Revision No. 7 v

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 and Infrastructure

2.3 Management Review

2.3.1 Management Review Inputs

2.3.2 Management Review Outputs

2.4 Quality System

2.4.1 Documented Information

2.4.2 Quality Control (QC) Plan

2.4.3 Planning

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

2.5 Requirements for Products and Services (Contract Review)

2.5.1 Customer Communication

2.5.2 Determining the Requirements for Products and Services

2.5.3 Review of the Requirements for Products and Services

2.5.4 Documented Information (Documents and Records)

2.5.5 Changes to Requirements for Products and Services

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 with Subsequent Analysis

3.3 Instrumentation

3.3.1 MINICAMS®

3.3.2 GC ATD System

3.3.3 DAAMS

3.3.4 Gas Chromatograph Equipped with a Mass Spectrometer (GC/MS)

May 2017 CQAPCAAM Revision No. 7 vi

3.3.5 LC/QQQ Mass Spectrometer

4.0 LEADERSHIP

4.1 Introduction

4.2 Resource Management

4.2.1 General

4.2.2 People

4.3 Responsibilities and Authority of the CQAT

4.4 Leadership and Commitment

4.4.1 General

4.4.2 Organizational roles, responsibilities and authorities

4.4.3 Organizational Managers

4.4.4 Personnel

4.4.5 Responsibilities and Authority of the QAC/QM

4.4.6 Calibration Coordinator

5.0 REFERENCE MATERIALS AND CALIBRATION STANDARDS

5.1 Reference Materials Description and QA/QC Procedures

5.1.1 Neat CASARM/NON-CASARM

5.1.2 Dilute CASARM/NON-CASARM

5.1.3 Storage and Use of Neat CASARM/NON-CASARM

5.2 Storage and Shelf Life of Stock and Working Standards

5.2.1 Standards for Calibration and Sample Spiking

5.2.2 Organic Solvents and Glassware Used to Prepare Standards

5.2.3 Labeling and Recordkeeping of Stock and Working Standards

6.0 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

6.3.3.1 Method Certification for Non-Training Facilities

6.3.3.2 Method Certification for Training Facilities

6.3.3.3 Handling of P&A data (for both Training and Non-Training Facilities)

6.3.3.4 P&A Acceptance Criteria (for both Training and Non-Training Facilities)

6.3.4 Certification of Type 2 Methods

6.4 Analyst Certification

6.4.1 Analyst Certification Test

6.4.1.1 Analyst Certification for Type 1 Methods

6.4.1.1.1 Analyst Certification (For Non-Training Facilities)

6.4.1.1.2 Analyst Certification (for Training Facilities)

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 (For Non-Training Facilities)

6.4.1.3.2 Type 1 Methods (For Training Facilities)

6.4.1.3.3 Type 2 Methods

6.4.2 Semi-Annual Evaluation of Personnel

May 2017 CQAPCAAM Revision No. 7 vii

6.4.3 Sample Collection Personnel

6.4.4 Proficiency Test Program

6.5 Certification of Additional Instruments

6.5.1 Additional Type 1 Instruments

6.5.1.1 Additional Instruments (for Non-Training Facilities)

6.5.1.2 Additional Instruments (For Training Facilities)

6.5.2 Additional Type 2 Instruments

6.5.3 Re-certification of Instruments

6.6 Significant Changes in Methods

7.0 CALIBRATION AND TUNING

7.1 Monitoring and Measuring Resources (Including Periodic Calibration)

7.1.1 General

7.1.2 Measurement Traceability

7.2 Instrument Calibration

7.2.1 Frequency of Calibration and Range of Calibration

7.2.1.1 Type 1 Laboratory Methods (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® Calibration Requirements and Acceptance Criteria

7.2.1.2.2.1 Minimum Response Requirement

7.2.1.2.2.2 Single Point Calibration

7.2.1.2.2.3 Multilevel Calibration

7.2.1.2.3 GC ATD System

7.2.1.3 Type 2 Methods

7.2.2 Corrective Action for Unacceptable Calibrations

7.3 Gas Chromatograph-Mass Spectrometer (GC-MS) Tuning

7.4 Liquid Chromatography-Mass Spectrometry (triple quadrupole) (LC-QQQ) Tuning Requirements

8.0 SAMPLE COLLECTION, HANDLING, DELIVERY, PRESERVATION AND DATA

GENERATION

8.1 Sample Collector Training

8.2 Sample Collection for Laboratory Methods

8.2.1 Sample Preparation

8.2.2 Sample Collection

8.2.3 Sample Traceability

8.2.4 Sample Handling

8.2.5 Sample Delivery and Inspection

8.2.6 Sample Preservation

8.2.7 Sample Analysis and Data Generation

8.2.8 Non-Conforming Samples

8.3 Sample Collection for NRT Monitors

9.0 QUALITY CONTROL

9.1 Operational Planning and Control

9.2 Control Samples

9.2.1 Typical Applications of Quality Control Samples

May 2017 CQAPCAAM Revision No. 7 viii

9.2.1.1 Quality Process (QP) Sample

9.2.1.2 Quality Laboratory (QL) Sample

9.2.2 Control Sample Challenge Procedures

9.2.2.1 Type 1 and 2 Monitors

9.2.2.2 Type 1 and 2 Laboratory Methods (DAAMS)

9.2.3 Quality Control Sample Frequency and Acceptance Criteria

9.2.3.1 Type 1 NRT Monitors for Non-Training Facilities

9.2.3.2 Type 1 NRT Monitors for Training Facilities

9.2.3.3 Type 2 NRT Monitors

9.2.3.3.1 Confirmation Analyses

9.2.3.3.2 Primary Method of Analysis

9.2.3.4 Type 1 Laboratory Methods

9.2.3.5 Type 2 Laboratory Methods

9.2.3.5.1 Confirmation Analyses

9.2.3.5.2 Primary Method of Analysis

9.2.4 Control Sample Record Keeping Requirements

9.3 Quality Control of Sample Lines

9.3.1 Sample Lines on Mobile NRT Monitors

9.3.2 Sample Lines on Fixed Site NRT Monitors

9.3.3 Multiple Sampling Lines and Stream Selection Systems

9.4 Conditioning of DAAMS Tubes

9.5 Confirmation Monitoring

9.6 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 AND REPAIRS

12.0 PURCHASING (CONTROL OF EXTERNALLY PROVIDED PROCESSES,

PRODUCTS, AND SERVICES)

12.1 Type and Extent of Control

12.2 Approved/Disapproved Vendors

12.3 Purchasing Data

12.3.1 Information for External Providers

12.3.2 Purchasing Information

13.0 INSPECTION AND TESTING

13.1 Receipt Inspection

13.1.1 Purchased Supplies

13.1.2 Air Monitoring Samples

13.2 Acceptance Testing

13.2.1 Acceptance Testing of DAAMS Tubes

13.2.2 Acceptance Testing of Preconcentrator Tubes (PCT)

13.2.3 Acceptance Testing of NOx Pre-Filters

13.2.4 Acceptance Testing of Silver Fluoride Conversion Pads/Tubes

13.3 In-Process Inspection

13.3.1 Samples

13.3.2 Data

May 2017 CQAPCAAM Revision No. 7 ix

13.4 Final Inspection (Release of Products and Services)

13.5 Post-delivery activities

14.0 CORRECTIVE ACTION AND CONTROL OF NON-CONFORMING SAMPLES,

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 DOCUMENTED INFORMATION (DOCUMENTS AND QUALITY RECORDS)

17.1 Control of Documents

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 AND EVALUATION

18.1 Statistical Methods

18.2 Procedures

19.0 PROPERTY BELONGING TO CUSTOMERS OR EXTERNAL PROVIDERS

20.0 DATA INTEGRITY AND ETHICS

21.0 REFERENCE LITERATURE

APPENDICES

APPENDIX A

TERMINOLOGY

APPENDIX B

LIST OF ACRONYMS

APPENDIX C

FORMAT FOR THE DOCUMENTATION OF ANALYTICAL METHODS

APPENDIX D

TRAINING CHECKLIST EXAMPLES

APPENDIX E

AIRBORNE EXPOSURE LIMITS TABLE FROM DA PAM 385–61, TOXIC CHEMICAL

AGENT SAFETY STANDARDS, 12 November 2012

APPENDIX F

EXAMPLES OF QUALITY RECORDS

APPENDIX G

GUIDELINES FOR PERFORMANCE CHARTS

May 2017 CQAPCAAM Revision No. 7 x

APPENDIX H

GUIDELINES FOR CONTROL CHARTS

APPENDIX I

GUIDELINES FOR DATA INTEGRITY AND ETHICS (GUIDANCE ONLY)

APPENDIX J

METHODS FOR DETERMINING AND ASSESSING RISK/OPPORTUNITIES

APPENDIX K

RRF VERIFICATION OF STANDARDS

FIGURES

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

PROCESS

FIGURE 2: PROCESS STRUCTURE

FIGURE 3: THE PLAN-DO-CHECK-ACT CYCLE

FIGURE 4: ORGANIZATIONAL RELATIONSHIPS OF THE CQAT

FIGURE 6: REGRESSION OF FOUND ON TRUE CONCENTRATIONS WITH 95%

CONFIDENCE LIMITS ON A SINGLE NEW PREDICTED VALUE

LIST OF TABLES

TABLE 5-1: RDT&E DILUTE AGENT STANDARD CONCENTRATION LEVELS

TABLE 6-1: REQUIRED ELEMENTS FOR AN ANALYTICAL METHOD

TABLE 6-2: CONFIGURATION CONTROL PARAMETERS FOR NRT INSTRUMENTS . 35

TABLE 6-3: CONFIGURATION CONTROL PARAMETERS FOR GC INSTRUMENTS

TABLE 6-4: CONFIGURATION CONTROL PARAMETERS FOR LC INSTRUMENTS

TABLE 7-1: EXAMPLE OF EI AUTO-TUNE MASS UNIT RELATIVE ABUNDANCES

TABLE 7-2: EXAMPLE OF EI BFB TARGET TUNE MASS UNIT RELATIVE

ABUNDANCES

TABLE 7-3: EI BFB TUNING VERIFICATION MASS RATIO REQUIREMENTS

TABLE 7-4: CHARACTERISTIC IONS FOR GAS CHROMATOGRAPHY-MASS

SPECTROMETRY EI AND CI MODES

TABLE 9-1: QUALITY CONTROL SAMPLE LOADING FREQUENCY FOR NRT

MONITORS

TABLE 9-2: QUALITY CONTROL SAMPLE LOADING FREQUENCY FOR

LABORATORY METHODS

TABLE 13-1: SAMPLE SIZES FOR NORMAL INSPECTION AT THE GENERAL

INSPECTION LEVEL 1 AND ACCEPTABLE QUALITY LIMIT OF TWO AND A HALF

PERCENT (2.5%)

May 2017 CQAPCAAM Revision No. 7

CHEMICAL AGENT STANDARD ANALYTICAL REFERENCE MATERIAL

QUALITY ASSURANCE PLAN FOR CHEMICAL AGENT AIR MONITORING

1.0 INTRODUCTION

This document addresses agent monitoring activities, sample collection, reference materials and quality control (QC) activities relating to them. The agent monitoring QC procedures identified in this document have been developed and implemented by the Army as a result of extensive experience with chemical agents. Additional monitoring requirements are listed in site-specific monitoring and regulatory documentation.

A number of possibly unfamiliar terms and expressions are used in this document. Moreover, other more familiar terms, when taken in the context of this material, may have somewhat different or more specialized meanings than those inferred commonly elsewhere. For this reason, definitions of certain terms are provided in Appendix A, and the reader is encouraged to scan these definitions before proceeding with any of the more technical sections of this document. A list of acronyms is provided in Appendix B.

Program participants shall develop and implement a QC Plan that contains the requirements and procedures outlined within this Quality Assurance (QA) Plan. At some locations, separate organizations are responsible for real time monitoring operations, sample analysis and/or collection of air-monitoring samples. Each organization involved in chemical agent air monitoring shall be included in the scope of the site specific QC Plan or shall establish their own QC Plan that shall be submitted to the CASARM Quality Assurance Team (CQAT) along with any revisions for approval before implementation (required by DA PAM 385-61).

This Plan sets forth minimum quality assurance requirements for chemical agent air monitoring. Organizations may exceed these requirements as long as they are documented in their procedures. No two organizations have precisely the same resources, requirements, or mission. Consequently, the QA/QC practices adopted for use at a given organization must be tailored to their particular circumstances. The QC Plan shall be a detailed document that implements the requirements and procedures described in this Plan.

This Plan is intended to assist participating organizations with the preparation of an agent air monitoring QC Plan and the establishment and maintenance of a monitoring system which will detect agent concentrations at levels specified by regulatory requirements. This plan provides for quantitative and qualitative methods to indicate whether an agent is present at or above a specific concentration.

The CQAT has formed a Technical Working Group (TWG) to resolve issues that arise from the implementation of the QA/QC requirements outlined within this plan. The TWG is comprised of technical experts from each organization participating in the CASARM program and meets on an as needed basis. Policies and procedures set by the TWG shall be documented and take precedence over the QA requirements of this document until such a time as they are incorporated into the Plan.

May 2017 CQAPCAAM Revision No. 7

Deviations from the guidance expressed in this document may be made only after specific approval of the CQAT. Recommended changes to this document shall be addressed to U.S.

Army, ECBC, ATTN: RDCB-DPB-Q, Aberdeen Proving Ground, MD 21010-5424.

If a requirement is not applicable, it must be stated in the organization’s QC Plan.

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 analyses conducted in support of routine chemical agent air monitoring activities. Implementation of this QA Plan will ensure the validity of data and provide a reliable foundation on which to base decisions. The CQAT has also developed a CASARM Proficiency Testing Program (PTP), which uses inter-laboratory test results to determine group performance as well as the performance of individual program participants. The CASARM QA Plan for Chemical Agent Air Monitoring (CQAPCAAM) in conjunction with the Proficiency Testing Program provides participants with an objective means of assessing and determining the reliability of the data they produce.

The emphasis of the QA 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 air monitoring for CSM using quantitative and qualitative analytical methods.

For the purpose of this document, use of the term “CSM” applies to the chemical agent air monitoring of both CSM and Recovered Chemical Warfare Material (RCWM).

The organization shall specify the scope of their quality management system (QMS) and the type of work being performed in their QC plan.

When determining this scope, the organization shall consider:

a. The external and internal issues referred to in 1.5;

b. The requirements of relevant interested parties referred to in 1.6;

c. The products and services of the organization.

The scope of the organization’s QMS shall be available and be documented. The scope shall state the types of products and services covered.

Most participants in this program for chemical agent air monitoring do not design and develop agent monitoring systems. Therefore, if the organization does not design and develop monitoring systems on a routine basis, they should include in their QC plan a statement noting that due to this fact, section 8.3 of ISO 9001:2015 does not apply.

1.2 Purpose

The purposes of this QA Plan are to:

May 2017 CQAPCAAM Revision No. 7

• Provide a consistent framework 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.

1.3 Goals

More specifically, the goals of this QA Plan are to establish controls to:

• Assure that the quality of each analytical system, including precision, accuracy, and sensitivity are sufficient for the needs of each project.

• Assist in the early recognition and correction of deficiencies that may affect the quality of data.

• Enable the user to identify and implement actions that are necessary to ensure the validity of data.

• Require sufficient documentation to verify the quality of data generated.

1.4 Organization Registration

The CQAT will register organizations that conduct agent air monitoring when two conditions have been met. First, the organizations must submit a QC Plan(s) that conforms to this QA Plan for the sampling, analysis, and monitoring of Chemical Surety Materiel (CSM) at their facility. The CQAT shall review and approve these plans for conformance to this Plan.

Material changes or revisions to approved QC Plans must be reviewed and approved by the CQAT prior to implementation. Second, the organization must demonstrate conformance to their QC Plan(s) and SOPs.

Once registration is achieved by an organization, the CQAT shall assess an organization's performance by conducting quality system audits and reviewing the organization's QC data.

In addition, each organization that is registered by the CQAT shall participate in the Proficiency Test Program (PTP) as outlined in the Proficiency Testing Plan of the CASARM Quality Assurance Program.

1.5 Context of the Organization

The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its QMS.

Appendix J gives an example of a Strengths, Weaknesses, Opportunities, Threats (SWOT) analysis. A SWOT analysis is a tool that can be used to determine the context of the organization and to identify risks and opportunities.

The organization shall monitor and review information about these external and internal issues at least annually or more frequently if needed.

May 2017 CQAPCAAM Revision No. 7

NOTE 1 Issues can include positive and negative factors or conditions for consideration.

NOTE 2 Understanding the external context can be facilitated by considering issues arising from legal, technological, competitive, market, cultural, social, and economic environments, whether international, national, regional, or local.

NOTE 3 Understanding the internal context can be facilitated by considering issues related to values, culture, knowledge, and performance of the organization.

1.6 Understanding the Needs and Expectations of Interested Parties

Due to their effect or potential effect on the organization’s ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

• The interested parties that are relevant to the QMS;

• The requirements of these interested parties that are relevant to the QMS.

The organization shall monitor and review information about these interested parties and their relevant requirements and should include the results of this analysis in the annual management review (section 2.3).

1.7 Management Commitment

Management shall demonstrate its commitment to implementation and continuous improvement of the quality system by establishing a quality policy, establishing quality objectives, conducting management reviews, and providing resources. Management shall ensure customer requirements are determined and met with the aim of enhancing customer satisfaction.

The organization shall establish a process to ensure adequate communication both internally and externally regarding work relevant to the quality management system to include:

• What to communicate

• When to communicate

• With whom to communicate

• How to communicate

• And who communicates.

1.8 Customer Focus

Top management (see Appendix A the definition) shall demonstrate leadership and commitment with respect to customer focus by ensuring that:

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

May 2017 CQAPCAAM Revision No. 7

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

• The focus on enhancing customer satisfaction is maintained.

1.9 Organizational Knowledge

The organization shall determine the knowledge necessary for the operation of its processes and to achieve conformity of products and services.

This knowledge shall be maintained and be made available to the extent necessary. Consider critical knowledge areas and determine what risks there are to loss of that knowledge and then determine how to retain critical knowledge.

When addressing changing needs and trends, the organization shall consider its current knowledge and determine how to acquire or access any necessary additional knowledge and required updates. Consider current and future knowledge needs and what should be done in anticipation of those needs.

NOTE 1 Organizational knowledge is knowledge specific to the organization; it is generally gained by experience. It is information that is used and shared to achieve the organization’s objectives.

NOTE 2 Organizational knowledge can be based on:

a. Internal sources (e.g., intellectual property; knowledge gained from experience;

lessons learned from failures and successful projects; capturing and sharing undocumented knowledge and experience; the results of improvements in processes, products and services);

b. External sources (e.g., standards; academia; conferences; gathering knowledge from customers or external providers).

2.0 QUALITY MANAGEMENT SYSTEM

2.1 Quality Policy Statement

Within the QC Plan, top management shall establish, implement and maintain a quality policy that defines the organization’s purpose and context and supports its strategic direction. The policy shall include a commitment to satisfy applicable requirements and to quality and to the continual improvement of its QMS for chemical agent air monitoring. The quality policy shall provide a framework for establishing and reviewing organizational goals, quality objectives, and the expectations and needs of its customers. The policy shall also include the name of the organization and a statement describing and defining the scope of work performed by the organization.

The organization shall ensure that this policy and quality objectives are communicated, understood, implemented, available within the organization and to interested parties, as appropriate, and maintained as documented information.

May 2017 CQAPCAAM Revision No. 7

The organization shall ensure that personnel are aware of the quality policy, relevant quality objectives, their contribution to the effectiveness of the QMS, including the benefits of improved performance, and the implications of not conforming to the QMS requirements.

2.2 Organization Description and Infrastructure

The QC Plan shall identify the physical location of the laboratory, sample collection, and monitoring organizations. It shall describe any features of the organization or its operation necessary to convey a true picture of the organization such as location, size of groups, number of personnel in each group, types and quantity of equipment, types of services offered, and major fields of activity.

The organization shall determine, provide and maintain the necessary infrastructure to carry out its mission, operate its processes, and to achieve conformity of products and services.

Infrastructure can include adequate work and meeting spaces, buildings, equipment, utilities, hardware, software, office equipment, required supplies, and supporting services (such as transportation, communication or information systems).

The organization shall determine, provide, and maintain the environment necessary for the operation of its processes and to achieve conformity of products and services. This includes provision of adequate lighting, climate control, and housekeeping, as well as emphasis on personal safety. Noise and physical hazards should be reduced. A suitable environment can be a combination of human and physical factors such as social (e.g. non-discriminatory, calm, non-confrontational) and psychological (e.g. stress-reducing, burnout prevention, emotionally protective) factors.

2.3 Management Review

The top management shall review and evaluate the organization’s entire quality management system at planned intervals to ensure its continuing suitability, adequacy, effectiveness, and alignment with the strategic direction of the organization. The QC Plan or referenced procedure shall specify the requirements and responsibilities for the review/evaluation. Such reviews shall be conducted a minimum of annually (not to exceed 14 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;

May 2017 CQAPCAAM Revision No. 7 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 organization shall establish, implement, maintain, and continually improve a QMS, including the processes needed and their interactions, in accordance with the requirements of this document and shall:

• Determine the inputs required and the outputs expected from these processes (For an example, see Figure 1);

• Determine the sequence and interaction of these processes;

• 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;

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

• Assign the responsibilities and authorities for these processes;

• Address the risks and opportunities as determined in accordance with the requirements of 2.4.3.2;

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

May 2017 CQAPCAAM Revision No. 7

• Improve the processes and the QMS.

FIGURE 1: A SCHEMATIC REPRESENTATION OF THE ELEMENTS OF A

SINGLE PROCESS1

This document is designed to assist participating organizations in meeting the requirements of the quality management systems standard ANSI/ISO/ASQ Q9001:2015. The standard promotes a QMS approach through which an organization’s activities are linked to form a process.

This plan is based on the quality management principles of customer focus, leadership, engagement of people, process approach, improvement, evidence-based decision making, and relationship management. ISO 9001 and this plan incorporate the process approach, which includes the Plan-Do-Check-Act cycle and risk-based thinking. This approach allows an organization to plan its processes and their interactions. Understanding and managing processes as a system helps the organization remain effective and efficient.

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

15 Sep 2015. P. 8

The Plan-Do-Check-Act 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. It helps to prevent negative effects and opens the organization to possibilities and opportunities. See Figures 2 and 3.

PLAN DO CHECK ACT

4.0

Context of the Organization

5.0 Leadership 6.0

Planning

7.0 Support

8.0 Operation

9.0 Performance Evaluation

10.0 Improvement

Understanding the Organization & Its Context

Leadership & Commitment

Action to Address Risk Opportunities

Resources Operational Planning & Control

Monitoring, Measurement, Analysis, & Evaluation

Nonconformity & Corrective Action

Understanding the Needs & Expectations of Interested Parties

Quality Policy Quality Objectives Competencies

Determining Requirements for Products & Services

Internal Audit Continual Improvement

Determining the Scope of the QMS

Scope of the

QMS

Planning of Changes Awareness Design &

Development Management Review

QMS & Its Processes

Role, Responsibility, & Authority

Communication

Control of Externally Provided Products & Services

Documented Information

Production & Service Provision

Release of Product &

Control of Nonconformin g Processes, Product, &

FIGURE 2: PROCESS STRUCTURE2

2 Jay P. Patel, Risk Management in ISO 9001:2015 (Quality & Productivity Solutions, Inc., 2016), Table 2

May 2017 CQAPCAAM Revision No. 7

FIGURE 3: THE PLAN-DO-CHECK-ACT CYCLE

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 organization shall:

• Maintain procedures to support the operation of its processes;

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

3 ISO 9001:2015(E) Quality Management Systems Requirements, International Organization for Standardization.

15 Sep 2015. P. viii.

May 2017 CQAPCAAM Revision No. 7

2.4.2 Quality Control (QC) Plan

Each organization shall develop, implement and maintain a quality control plan which defines and/or references all plans, SOPs, local procedures, procedures required by this QA plan, work instructions and internally developed computer programs that comprise their agent monitoring quality system as well as the interaction among them. The QC Plan shall also include the scope (section 1.1) of the quality system and a description of the interaction between processes of the QMS.

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

2.4.3 Planning

2.4.3.1 General

The purpose of quality planning is to define and document how the requirements for quality shall be met within the organization. The CQAPCAAM defines the quality requirements for organizations performing chemical agent monitoring.

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.

The organization 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.

May 2017 CQAPCAAM Revision No. 7

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 J for information on how to determine and evaluate actions taken to address risks and opportunities.

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 organization shall maintain documented information on the quality objectives.

When planning how to achieve its quality objectives, the organization shall determine:

• What will be done;

• What resources will be required;

• Who will be responsible;

• When it will be completed;

• How the results will be evaluated.

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.

The organization shall consider:

• The purpose of the changes and their potential consequences;

May 2017 CQAPCAAM Revision No. 7

• The integrity of the QMS;

• The availability of resources;

• The allocation or reallocation of responsibilities and authorities.

2.5 Requirements for Products and Services (Contract Review)

Organizations that receive contracts (customer requests to perform chemical agent air monitoring services) for the performance of chemical agent air monitoring must establish a system of contract review prior to acceptance of the work and must implement an effective means of communicating with the customer for all matters relating to the contract.

The QC Plan or referenced procedure shall identify who is responsible for performing the contract review.

The following are examples of situations for which immediate clarification or feedback shall be sought from the customer:

• The customer has specified incorrect, obsolete, or improper methods.

• Methods require modifications to ensure achievement of project-specific objectives contained in planning documents (e.g., difficult matrix, poor performing analyte).

• Project planning documents are missing, or requirements (e.g., action levels, detection and quantification capabilities) in the documents require clarification.

• The laboratory has encountered problems with sampling or analysis that may impact results (e.g., improper preservation of sample).

Customer feedback and clarification can be sought in other situations not listed above.

2.5.1 Customer Communication

Communication with customers shall include:

• Providing information relating to products and services;

• Handling inquiries, contracts or orders, including changes;

• Obtaining customer feedback relating to products and services, including customer complaints;

• Handling or controlling customer property;

• Establishing specific requirements for contingency actions, when relevant.

2.5.2 Determining the Requirements for Products and Services

When determining the requirements for the products and services to be offered to customers, the organization shall ensure that:

• The requirements for the products and services are defined, including:

o Any applicable statutory and regulatory requirements;

o Those considered necessary by the organization;

May 2017 CQAPCAAM Revision No. 7

• The organization can meet the claims for the products and services it offers.

2.5.3 Review of the Requirements for Products and Services

The organization shall ensure that it has the ability to meet the requirements for products and services to be offered to customers. The organization shall conduct a review before committing to supply products and services to a customer, to include:

• Requirements specified by the customer, including the requirements for delivery and post-delivery activities;

• Requirements not stated by the customer, but necessary for the specified or intended use, when known;

• Requirements specified by the organization;

• Statutory and regulatory requirements applicable to the products and services;

• Contract or order requirements differing from those previously expressed.

The organization shall ensure that contract or order requirements differing from those previously defined are resolved.

The customer’s requirements shall be confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements. Where no written statement of the contract requirements is available, the organization shall ensure that there is full understanding and agreement of the unwritten requirements prior to acceptance.

NOTE In some situations, such as internet sales, a formal review is impractical for each order.

Instead, the review can cover relevant product information, such as catalogues, formalized lists of services, or quotes.

2.5.4 Documented Information (Documents and Records)

The organization shall retain documented information

• On the results of the review;

• On any new requirements for the products and services.

Records of contract review and actions arising from the review shall be maintained.

2.5.5 Changes to Requirements for Products and Services

The organization shall ensure that relevant documented information is amended, and that relevant persons are made aware of the changed requirements, when the requirements for products and services are changed.

The organization shall identify how an amendment to a contract is made and how the information regarding the amendment is transferred to the appropriate personnel within the organization.

May 2017 CQAPCAAM Revision No. 7

2.6 Control of Production and Service Provision

The organization shall implement production and service provision under controlled conditions. 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 organization shall review and control changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements

The organization 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 quality objectives of agent monitoring are to ensure the protection of the workers and the environment while also providing evidence of the containment of chemical agent to meet regulatory requirements.

3.1 Standards for Agent Exposure

These are safety standards that 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 defined as follows:

May 2017 CQAPCAAM Revision No. 7

Airborne Exposure Limits (AEL) - Allowable concentrations in the air for workplace and general population exposures. AELs include worker population limits (WPLs), short-term exposure limits (STELs), immediately dangerous to life or health values (IDLHs), vapor screening levels (VSL) and general population limits (GPLs).

Immediately Dangerous to Life and Health (IDLH) - An atmosphere that poses an immediate threat to life, would cause irreversible adverse health effects, or would impair an individual’s ability to escape from a dangerous atmosphere, regardless of PPE use. For planning purposes, the respirator wearer will be unaffected by the environment for up to 30 minutes without any respirator being worn. IDLH also includes atmospheres where oxygen content by volume is less than 19.5 percent. (DA PAM 385–61, Toxic Chemical Agent Safety Standards, 12 November 2012)

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

Time Weighted Average (TWA) - A maximum level or concentration of a chemical agent, averaged over a specified length of time, to which employees may be exposed, for example, STEL is a 15-minute time-weighted average.

Worker Population Limits (WPL) - Maximum allowable 8-hour time weighted average (TWA) concentration that an unmasked worker could be exposed to for an 8-hour workday and 40 hour week for 30 years without adverse effect.

General Population Limit (GPL) - A time weighted average that represents the maximum concentration to which the general population may be exposed 24 hours per day, 7 days a week, for a 70-year lifetime. Applies to the entire general population, including all ages and medical conditions.

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 stacks.

ASC is a non-regulatory ceiling value that serves as a source emission limit (SEL) and not as a health standard.

Vapor Screening Level (VSL) - The level to which an item is monitored to determine the level of cleanliness. Typically done by containing the item in an enclosed space to limit incoming dilution.

The AELs and other exposure limits given in the Tables of Appendix E are set conservatively and 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, 13 November 2012 and were current at the date of publication of this Plan and must be monitored for changes.

May 2017 CQAPCAAM Revision No. 7

3.2 Categories of Monitoring Systems

Most organizations have an extensive network of chemical agent detection systems to meet agent monitoring requirements. These systems fall into two major categories: near real time monitors (NRTs) and specific sample media collection with subsequent analysis.

3.2.1 Near Real Time (NRT) Monitors

NRT monitors are automatic detectors that will provide a direct read, an audible alarm, and sampling results in less than or equal to 15 minutes. These detectors are used in areas where there is potential for presence of agent. Monitoring provides the earliest indication of potentially unsafe conditions. Some NRT monitors currently in use include the MINICAMS and the GC ATDs like the Dynatherm GC monitoring systems for nerve agents and mustard.

Section 3.3 provides information on these systems.

If an NRT monitor alarms, confirmation sampling shall be in accordance with site specific requirements. Confirmation analyses are described in detail in Section 9.5.

NRT monitors are used in both mobile and fixed site configurations. Since mobile monitors may be subjected to relatively more severe working conditions, the QC requirements for NRT monitors used in this configuration differ from those used in the fixed site configurations.

Section 9.0 defines the QC requirements for each configuration.

3.2.2 Sample Media Collection with Subsequent Analysis

Sample collection media with subsequent analysis are used when real time monitoring technology is not available for a given agent, to provide historical samples and/or to perform routine monitoring. Air is passed through the sample collection media (e.g., Depot Area Air Monitoring System (DAAMS tube) for a specified time period using a specified flow rate.

After aspiration is completed, the samples are taken to a laboratory for subsequent analysis. In the event of an NRT alarm, the samples provide the required information to confirm the presence of agent. Section 3.3 provides additional information about these systems.

3.3 Instrumentation

The instrumentation used to perform monitoring is highly sensitive, and proper care should be taken to ensure that the appropriate environmental and storage locations are chosen to protect the equipment. Below are some examples of systems that can be used for chemical agent sampling and analysis.

3.3.1 MINICAMS®

The MINICAMS® can detect G agents, VX, or HD at various AELs using a flame-photometric detector (FPD). It is an automated gas chromatograph (GC) that is used to collect organic chemical vapor from an air sample onto a solid sorbent and then thermally desorb the

May 2017 CQAPCAAM Revision No. 7 analytes into a GC for separation and analysis. The components eluting from the separation column are detected by the FPD, which can respond to compounds containing either phosphorus (e.g, GB and VX) or sulfur (e.g., mustard). Because of the low volatility of VX, a conversion pad or tube must be used for the detection of VX. The pad converts VX to a more volatile compound (the G-analog of VX, ethyl methylphosphonofluoridate), which can be quantitatively transferred through the sampling and analysis system. A direct readout, in units of the hazard level (HL), is given on the front panel of the instrument. An audible and a visual alarm are provided. MINICAMS® equipped with a halogen selective detector (XSD), are used to detect HD, Lewisite, and other halogen containing analytes. In order to efficiently transmit lewisite through a GC column, it must be converted to a Lewisite derivative (LD).

The conversion of Lewisite to LD is performed by mounting a sample reactor probe onto the sample inlet of the MINICAMS® or at the end of the sample line. The sample probe introduces the derivatizing agent (typically ethanedithiol) during the sampling period.

3.3.2 GC ATD System

The GC ATD consists of a sample collection unit, a gas chromatograph with a flame photometric detector and a computer system for recording the analysis and reporting results.

The system draws air through a sorbent tube, dries the sample, desorbs it onto a focusing tube and then thermally desorbs it onto the gas chromatograph. The system then repeats the cycle.

Data reports are generated by the computer system.