Attachment_32_COBRATF_Quality_Manual.pdf

Training Operations and Support Services – COBRATF

Attachment 32

COBRATF Quality Manual

FEMA MANUAL

Quality Manual for the Center for Domestic Preparedness (CDP) Chemical, Ordnance, Biological, Radiological Training Facility

(COBRATF)

APPROVAL DATE: 2/13/2014

DEPARTMENT OF HOMELAND SECURITY

CENTER FOR DOMESTIC PREPAREDNESS

Denis Campeau Director, Training and Education Center for Domestic Preparedness

Date: ________________________

Foreword

The executive management of the CDP COBRATF recognizes the value of a process approach when developing, implementing and improving the effectiveness of a quality management system. This philosophy enhances the satisfaction of internal and external customers, supplies the best method for understanding and meeting requirements, adds value to the services provided, determines the effectiveness of the quality management system and provides the tools needed for identifying, controlling or eliminating the variation that can negate organizational efficiency and effectiveness.

The CDP COBRATF executive management has reviewed this quality manual prior to its approval and authorized its establishment to ensure successful execution of the goals established for this organization now and in the future.

This quality manual defines and forms a part of the quality system under which the CDP COBRATF operates. It documents the quality policy and objectives and describes how the quality system functions to provide our customers with consistent products and service of the highest possible quality. The CDP COBRATF staff commits themselves to uphold the policies defined herein. By his signature, the Director, Training and Education, has approved the CDP COBRATF Quality Manual.

Table of Contents

Foreword

CHAPTER 1: GENERAL INFORMATION

1-1. Purpose

1-2. Applicability and Scope

1-3. Supersession

1-4. Authorities/References

1-5. Policy

1-6. Definitions and Acronyms

1-7. Responsibilities

1-8. Reporting Requirement

1-9. Forms Prescribed

1.10 Questions

CHAPTER 2: PROCEDURES

2-1. General Requirements

2-2. Documentation Requirements

2-3. Management Responsibility (Federal and Contract)

2-4. Resource Management

2-5. Product Realization

2-6. Measurement, Analysis and Improvement

Appendix A, Organizational Chart

CHAPTER 1: GENERAL INFORMATION

1-1. Purpose

This purpose of this quality manual is to:

Define the scope of the quality management system.

Provide details of and justification for any exclusion.

Include reference to the documented procedures established for the quality management system.

Provide a description of the interaction between the processes of the quality management system.

Provide the system framework for achieving and maintaining certification to the Chemical Agent Standard Analytical Reference Material Quality Assurance Plan for Chemical Agent Air Monitoring at Training Facilities.

NOTE: Throughout the text of this manual, wherever the term “product” is used, it can also mean “service”.

1-2. Applicability and Scope

This quality manual is applicable to all processes documented within the CDP COBRATF document control system.

1-3. Supersession

Record of Revisions

Revision No. Date Details of change Approved by

1 01/04/2006 Update to change format and meet ISO requirements Director, CDP

02/22/2011

Change titles, ISO 9001:2008, organizational chart and approval authority; update members of the Management review team; incorporate changes from Standards Document and CASARM Plan Revisions

Superintendent, CDP

3 02/06/2012 Place in FEMA manual format Superintendent, CDP

02/13/2014

Revise manual to reflect responsibility and authoritative changes within the quality management system and overall focus of the quality program

Director, Training and Education

1-4. Authorities/References

This quality manual defines the policies and principles applied against the requirements of ISO 9001 and applicable service contracts performed at the CDP COBRATF.

1-5. Policy

The CDP COBRATF’s approach to quality is defined in the following directive:

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

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

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

This directive statement is appropriate to the purpose of the CDP COBRATF, shows a commitment to meet requirements and strive for continuous improvement. The directive is communicated and understood within the CDP COBRATF, provides a framework for establishing and reviewing quality objectives, and is reviewed for continuing suitability.

1-6. Definitions and Acronyms

A. CASARM QAPCAAMTF – Chemical Agent Standard Analytical Reference Material Quality

Assurance Plan for Chemical Agent Air Monitoring at Training Facilities; document used by organizations participating in the CASARM program for agent monitoring

B. ISO – International Organization for Standardization; used to promote the development of international standards and related activities and to facilitate the exchange of goods and services worldwide.

C. QMS – Quality Management System

1-7. Responsibilities

Responsibilities are listed throughout manual. See Appendix A, Organizational Chart

1-8. Reporting Requirement

Requirements are listed throughout manual.

1-9. Forms Prescribed

None noted.

1.10 Questions

All questions concerning requirements listed in this document will be directed to the Quality Management System Representative.

CHAPTER 2: PROCEDURES

2-1. General Requirements

A. The CDP COBRATF has established, documented and implemented a QMS that is maintained and continually improved in accordance with the requirements of ISO 9001 and the CASARM QAPCAAMTF. To implement the QMS, the CDP COBRATF will:

1. Identify the processes needed for the QMS and their application throughout the organization.

2. Determine the sequence and interaction of these processes.

3. Determine criteria and methods required to ensure the effective operation and control of these processes.

4. Ensure the availability of information necessary to support the operation and monitoring of these processes.

5. Put procedures in place to manage, monitor, measure, and analyze these processes.

6. Implemented action necessary to achieve planned results and continual improvement.

7. Ensure the integrity of the QMS by establishing the independence of all quality staff personnel from the influence of other operational functions.

2-2. Documentation Requirements

A. The CDP COBRA Training Facility QMS documentation includes:

1. A documented quality policy statement, goals and quality objectives.

2. A quality manual.

3. The documented procedures required by the ISO 9001 series of standards and the

CASARM QAPCAAMTF.

4. Additional documents needed by the facility to ensure effective planning, operation and control of its processes.

5. Records required to provide objective evidence of the effective operation of the QMS.

B. Quality Manual

1. The CDP COBRATF has established and will maintain this quality manual and ensure the inclusion of:

a. The scope of the QMS, including details of and justification for any exclusion.

b. Reference to established documented procedures needed for the QMS.

c. A description of the interaction between the processes of the QMS.

C. Control of Documents

1. The CDP COBRATF has established and documented a quality management procedure for control of documents which defines requirements for:

a. Review and approval of documents for adequacy prior to use.

b. Reviewing, updating as necessary and re-approving documents.

c. Identifying the current revision status of documents.

d. Ensuring that relevant revisions of applicable documents are available at point of use.

e. Ensuring documents remain legible, readily identifiable and retrievable.

f. Ensuring documents of external origin are identified and their internal distribution controlled.

g. Preventing the unintended use of obsolete documents, and applying suitable identification to them if they are retained for any purpose.

D. Control of Quality Records

The CDP COBRATF has documented, in a quality management procedure, the process through which records are generated to provide evidence of conformity to requirements and quality system effectiveness. The documented process defines steps to ensure records remain legible, readily identifiable and retrievable. The procedure defines the controls needed for the identification, storage, protection, retrieval, retention time and disposition of records generated by the QMS.

2-3. Management Responsibility (Federal and Contract)

A. Management Commitment

Management has committed itself to the establishment of an effective QMS. The objective evidence of this commitment is provided through the establishment of a quality policy statement, quality goals and ensuring quality objectives are established, providing the needed resources for operation of the system, ensuring the importance of meeting customer, statutory and regulatory requirements and conducting management reviews of the quality system.

B. Customer Focus

Management ensures customer requirements are identified and met in order to maintain a high level of customer satisfaction.

C. Planning

1. Quality Objectives

Management has established a documented process through which quality objectives are established for relevant functions. The process defined by the procedure ensures the objectives will support meeting of requirements and the goals listed in the quality directive.

2. Quality Management System Planning

Management recognizes the importance of planning when developing and implementing the QMS. The belief of the management team is that failure to plan is effectively planning to fail. The details of quality planning activities are communicated through the Management Review Team, Quality Control Plans, Quality Management Procedures and Standard Operating Procedures. The objective evidence of planning effectiveness is generated by applicable quality records such as inspection and testing results, internal audits and process audits/verifications.

D. Responsibility, Authority and Communication

1. Responsibility and Authority

An organizational chart has been developed and is maintained which defines the responsibilities and authorities of management team members. The detailing of responsibilities and authorities for all personnel is conducted in plans, procedures and instructions.

2. Management Representative

a. Executive management has documented the appointment of a QMS representative.

Executive management has ensured the appointed representative has the required authority to:

(1) Ensure processes needed for the effective operation of the QMS is established, implemented and maintained.

(2) Report to executive management on QMS status and performance including the need for improvement.

(3) Ensure the promotion of awareness of customer requirements throughout the organization.

(4) Ensure the awareness of applicable requirements from external agencies that affect the QMS.

b. The management representative is the Assistant Director, or an ascending position.

The management representative cannot be a person serving in a temporary replacement role for the Assistant Director position or a member of the quality staff due to the possibility of compromising of the QMS’s integrity.

3. Internal Communication

Management ensures appropriate communication processes are established and that communication takes place regarding the effectiveness of the QMS. The organizational chart (Appendix A) establishes appropriate routes of communication and multiple types of media are provided to facilitate effective communication. The communications directly affecting QMS performance will be documented when possible.

E. Management Review

1. General

A process is established and documented through which management reviews the quality system to ensure continued suitability, adequacy and effectiveness. The review process, defined in a quality management procedure, facilitates assessment for improvement and/or change to the QMS, quality directive, goals and quality objectives.

2. Review Input

A quality management procedure is established and maintained to define the inputs used for QMS review. The inputs documented, at a minimum, meet requirements defined in both the CASARM QAPCAAMTF and ISO 9001 standard.

3. Review Output

A quality management procedure is established and maintained that ensures documentation and communication of review outputs. The outputs documented, at a minimum, meet requirements defined in both the CASARM QAPCAAMTF and ISO 9001 standard.

2-4. Resource Management

A. Provisions of Resources

Management shall determine and provide the resources needed to effectively implement and maintain the QMS, continually improve its effectiveness and enhance customer satisfaction.

B. Human Resources

1. General

Management ensures personnel performing work affecting the QMS are competent based on education, training, skills and/or experience.

2. Competence, Training and Awareness

Management determines the required competence level for personnel performing work affecting the QMS by requiring documentation of the required knowledge and communication of the requirement to the personnel affected. Provisions shall be made for supplying of training needed to elevate personnel to the identified level of competence and evaluate the effectiveness of the training provided. This approach ensures personnel are aware of the significance of their contribution to the QMS.

Records of education, training, skills and experience are maintained.

C. Infrastructure

Management determines, provides and maintains the infrastructure necessary to support the QMS goals and objectives. This infrastructure includes, but may not be limited to, buildings (workspaces) and associated utilities, process equipment and supporting services.

D. Work Environment

Management identifies and implements the work environment needed to ensure conformity for all requirements.

2-5. Product Realization

A. Planning of Product Realization

Management shall plan and develop processes needed for product realization. Planning for product realization shall be consistent with the requirements of the other processes of the QMS. Management shall determine the following, as appropriate:

1. Quality objectives and requirements for the product or service.

2. The need to establish processes, documents, and provide resources specific to the product or service.

3. Required verification, validation, monitoring, measurement, inspection and test activities specific to the product and the criteria for product acceptance.

4. Records needed to provide evidence that the realization processes and resulting product fulfill requirements.

The output of this planning shall be in a form suitable (and measurable) for the method of operations.

B. Customer-Related Processes

1. Determination of Requirements Related to the Product

CDP COBRATF management shall determine:

a. Requirements specified by the customer, including the requirements for delivery and post-delivery activities.

b. Requirements not stated by the customer but necessary for specified use or known and intended use.

c. Statutory and regulatory requirements related to the product.

d. Additional requirements determined by management or process owner and approved by management.

2. Review of Requirements Related to the Product

Management reviews product requirements prior to supply of the product to the customer. Management ensures that:

a. Product requirements are defined to ensure understanding by functional areas contributing to product realization.

b. Any differences of requirements from those previously expressed are resolved prior to being provided to the customer.

c. The CDP COBRATF has the ability to meet the defined requirements.

d. Where the customer provides no documented statement of requirement, the CDP COBRATF confirms the customers’ requirements before product realization occurs.

e. When changes to requirements occur, the changes are communicated to relevant personnel and relevant documents are amended to include the new requirements.

f. Records of activities related to product requirements, including any actions that arise as a result, are maintained.

3. Customer Communication

Management establishes processes through which effective customer communication is conducted in relation to:

a. Product requirements.

b. Changes that affect the final product delivery.

c. Customer feedback, including customer complaints.

C. Design and Development

NOTE: Design and development activities are not conducted within the Air Monitoring Program, therefore, this provision is excluded in reference to the CDP COBRATF Air Monitoring Program.

Design and development activities are conducted in relation to infrastructure and/or facilities alterations and upgrades. All references to design and development activities henceforth will be understood to be addressing these infrastructure and/or facilities alterations and upgrades.

1. Design and Development Planning

Management plans and controls the design and development of infrastructure and facilities. During this planning management determines:

a. The design and development stages.

b. The appropriate review, verification and validation for each stage.

c. The responsibilities and authorities for design and development.

2. Design and Development Inputs

Management ensures inputs relating to requirements are determined and records maintained, including inputs relating to:

a. Functional and performance requirements.

b. Applicable statutory and regulatory requirements.

c. Information obtained from previous, similar designs where applicable.

d. Any additional requirements deemed essential for design and development.

3. Design and Development Outputs

Management ensures design and development outputs are verified against the inputs and approved prior to release. Outputs:

a. Meet the input requirements for design and development.

b. Provide appropriate information for purchasing, production, and service provision.

c. Contain or reference product acceptance criteria.

d. Specify characteristics of the product that are essential for its safe and proper use.

4. Design and Development Review

Management ensures systematic reviews of design and development are conducted at appropriate stages. The reviews:

a. Evaluate the ability of the results of design and development to meet requirements.

b. Identify any problems and propose necessary actions.

5. Design and Development Verification

Management ensures design and development verifications are performed to verify the design and development outputs have met the design and development input requirements. Records of results of the verification and any necessary actions are maintained.

6. Design and Development Validation

Management ensures design and development validation is performed to establish that the resulting product is capable of meeting the requirements for the specified application or intended use. Wherever possible, validation is conducted prior to the release of the product for use. Records of the validation and any subsequent actions are maintained.

7. Control of Design and Development Changes

Management ensures any design and development changes are identified and records are maintained. A review of the changes occurs prior to implementation and includes evaluation of the effect of the changes on any related products or processes.

D. Purchasing

1. Purchasing Process

Management establishes a documented process through which:

a. Purchased product conformity to specified purchase requirements is ensured.

b. The type and extent of supplier control is clearly specified.

c. A method of supplier evaluation is established which includes clear criteria for selection, evaluation, and re-evaluation.

d. Records of evaluations, results of the evaluations and actions taken as a result of evaluations are captured and maintained.

2. Purchasing Information

The documented purchasing process provides for documented description of all relevant product/service requirements to include, where appropriate:

a. Requirements for approval of product, procedures, processes and equipment.

b. Requirements for qualification of personnel where applicable.

c. QMS requirements.

3. Verification of Purchased Product

The documented purchasing process provides the mechanism through which verification of purchased product is conducted, documented, and results are captured for future supplier evaluations.

E. Production and Service Provision

1. Control of Production and Service Provision

The CDP COBRATF staff performs production, and provides services under controlled conditions. The conditions are controlled through implementation of documented procedures, processes and work instructions where necessary. These controls include:

a. The availability of information that describes the characteristics of the product or service.

b. The availability of work instructions, as necessary.

c. The provision of a suitable working environment.

d. The availability, use and maintenance of suitable monitoring and measuring equipment.

e. The implementation of monitoring and measurement activities.

f. Suitable methods for product/service release, delivery and applicable post-delivery or on-site activities.

2. Validation of Processes for Production and Service Provision

Management shall validate any processes for production and service provision where subsequent monitoring or measurement cannot verify the resulting output and, as a consequence, deficiencies become apparent only after the product is in use or the service has been delivered. Validation shall demonstrate the ability of these processes to achieve planned results. Management shall establish arrangements for these processes including, as applicable:

a. Defining criteria for review and approval of the processes.

b. Approval of equipment and qualification of personnel.

c. Use of specific methods and procedures.

d. Requirements for records.

e. Revalidation.

3. Identification and Traceability

Management establishes the processes required to ensure product identification and traceability where appropriate and possible. Inspection status of product is also indicated.

4. Customer Property

Management takes the necessary action(s) to protect any customer property that is under the control of the COBRATF. Allowances are made for identification, verification and protection of customer property whether it is intended to be incorporated into a product or not. The loss or damage of any customer property is reported to the customer and records of the subsequent actions taken as a result are maintained. This process applies to both internal and external customers.

5. Preservation of Product

Management ensures preservation of product where the conformity to requirements of the product can be compromised. Preservation is understood to include identification, handling, packaging, storage and protection where deemed applicable.

6. Control of Monitoring and Measuring Equipment

Management determines the monitoring and measurement to be utilized and the equipment required to successfully monitor and measure product for conformity to requirements. The process established ensures the monitoring and measurement conducted is consistent with the requirements for the same. Management establishes and documents a process through which monitoring and measuring equipment is:

a. Calibrated and/or verified at specified intervals or prior to use, against measurement standards traceable to national or international standards. (Where no such standard exists, the basis used for calibration or verification is documented.)

b. Adjusted or re-adjusted as needed.

c. Identified with current calibration status.

d. Safeguarded from adjustments that would invalidate the measurement result.

e. Protected from damage and deterioration during handling, maintenance and storage.

This documented process also provides guidance for:

a. Assessment of validity of measurement results when equipment is found not to conform to requirements.

b. Taking appropriate action on any equipment and/or product that is affected by a non-conforming measurement equipment.

c. Collection of records showing the results of calibration and/or verification.

In the event computer software is used to produce monitoring and/or measuring results, the software is confirmed prior to initial use and re-confirmed as necessary.

2-6. Measurement, Analysis and Improvement

A. General

The CDP COBRATF implements monitoring, measurement, and analysis processes needed to ensure that customer requirements are achieved, and that the effectiveness of the QMS is continually improved. This includes determination of applicable methods, including statistical techniques, and the extent of their use.

B. Monitoring and Measurement

1. Customer Satisfaction

Management ensures information indicating customer perception is monitored and methods are established for obtaining and using this information to promote the meeting of customer expectations.

2. Internal Audit

Management establishes and documents an internal auditing process that ensures:

a. Internal audits are conducted at planned intervals.

b. Responsibilities and requirements for planning and conducting audits, collecting and maintaining records of audits and reporting audit results.

c. Audits are planned with consideration of status and importance of processes/areas audited, as well as the results of previous audits.

d. Audit criteria, scope, frequency and methods are defined.

e. The QMS conforms to the planned arrangements.

f. The QMS conforms to the ISO 9001 standard and the CASARM QAPCAAMTF.

g. The QMS is implemented and maintained.

h. Auditors are trained, objective, impartial and independent of the areas they audit.

i. Documented corrective action is taken by process owners to eliminate detected non-conformities and their causes and the action(s) are verified.

3. Monitoring and Measurement of Processes

Management applies suitable methods for monitoring and, where applicable, measurement of the QMS processes to demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, corrective action is taken and documented, as appropriate, to ensure conformity of the product or service.

4. Monitoring and Measurement of Product

Management establishes and documents processes through which meeting of product requirements is monitored and/or measured. The processes ensure:

a. Monitoring/Measuring is conducted at appropriate stages of the realization process.

b. Evidence of conformity with established criteria is maintained.

c. Release of product and or delivery of service for use by the customer does not occur until planned arrangements have been realized or the release is authorized by relevant authority which should include the customer.

d. Records of authorization given for release of product for use.

C. Control of Nonconforming Product

Management establishes and documents a process which ensures:

1. Product that does not conform to requirements is identified and controlled to prevent its unintended use.

2. The responsibilities and authorities for control of non-conforming material is defined.

3. Action is taken to preclude the original intended use or application.

4. Non-conforming product that is further processed is only done so as the result of release by relevant authority. (Relevant authority should include the customer whenever possible.)

5. Action that is appropriate to the effects, or the potential effects, of the non-conformity when detection occurs after delivery or use has started.

6. Corrected non-conformities are re-verified by proper authority.

7. Records of actions taken in relation to non-conforming material are maintained.

D. Analysis of Data

Management establishes a documented process for analysis of relevant data. The procedure(s) makes provisions for:

1. Collecting and analyzing data that demonstrates the suitability and effectiveness of the

QMS.

2. Collecting and analyzing data generated as a result of monitoring and measurement activities or other relevant sources.

3. Collecting and analyzing data indicating customer satisfaction levels.

4. Collecting and analyzing data which demonstrates conformity of product to requirements.

5. Collecting and analyzing data which indicates characteristics and trends of processes and products including opportunities for improvements and/or preventive action.

6. Collecting and analyzing data related to suppliers.

E. Improvement

1. Continual Improvement

Management establishes a documented process to promote the continual improvement and increased effectiveness of the QMS. Inputs to the process are, but are not limited to:

a. Management Reviews

b. Corrective and Preventive Actions

c. Analysis of Data

d. Audit Results

The method of implementation and communication of improvements realized are:

a. Quality Directive (when applicable)

b. Quality Objectives

c. Procedures

d. Administrative Actions

2. Corrective Action

Management establishes a documented process for the administration of corrective action. The documented process makes provisions for:

a. Reviewing non-conformities (including customer complaints).

b. Determining the cause of non-conformities.

c. Taking action to eliminate the cause of non-conformities to prevent recurrence.

d. Ensuring corrective action taken is appropriate to the effects of the non-conformities detected.

e. Determination and implementation of action taken to eliminate non-conformities.

f. Reviewing the effectiveness of the corrective action taken.

g. Collecting and maintaining records of corrective actions taken.

3. Preventive Action

Management establishes a documented process for the administration of preventive action intended to eliminate potential non-conformities. The documented process makes provisions for:

a. Determining potential non-conformities and their causes.

b. Taking action to eliminate the cause of potential non-conformities to prevent recurrence.

c. Ensuring corrective action taken is appropriate to the effects of the non-conformities detected.

d. Determination and implementation of action taken to eliminate potential non-conformities.

e. Reviewing the effectiveness of the preventive action taken.

f. Collecting and maintaining records of preventive actions taken.

Appendix A, Organizational Chart

Assistant Director COBRATF

Management Representative

Center for Domestic Preparedness

Executive Management

Director, Training and Education

Industrial Hygienist

Quality Manager

Calibration

Coordinator

Contracting

Officers

Representative

ECBC Liaison

Chemical Surety

Officer TOMS Project

Manager

TOMS Quality

Manager

Air Monitoring

Technicians

Operations Officer

Chemical Agent

Lab Manager

Physical Science

Technician

Biologist

Administrative

Support

Occupational

Health Nurse

Practical Nurse

Training Operations

Support

Contracting

Officers

Representative

Medical Support

Services

Contracting

Officers

Representative

Security Services

Operations and

Maintenance