Attachment 28 - CDP Quality Management Directive.pdf

CDP Medical Support Services

Attachment 28

CDP Quality Directive (Draft)

DRAFT

Federal Emergency Management Agency

Center for Domestic Preparedness Directives System Directive Number:

CDP 077-1-0

Issue Date: XX/XX/2020

Center for Domestic Preparedness

Quality Directive

I. Purpose

This directive for the Center for Domestic Preparedness (CDP) Quality Directive statement communicates the CDP’s commitment to its customers and to continuous improvement of the effectiveness of the quality management system.

II. Scope

This directive applies to all personnel, Federal and contractor, assigned duties at the CDP. Exception is granted by CDP leadership for the Quality Management System at the Chemical, Ordnance, Biological, Radiological Training Facility (COBRATF) which is managed under a separately.

III. Supersession

This directive supersedes CDP 540-1-01 Quality Directive dated December 17, 2014, CDP 540-2-01 Quality Management System, not dated, and the CDP 540- 2-00 Quality Management System Directive, dated September 11, 2012.

IV. Authority

A. Title 31, United States Code, Sections 712, "Investigating the use of public money"; 716, "Availability of information and inspection of records"; 717 , "Evaluating programs and activities of the United States Government"; 718, "Availability of draft reports"; 719, "Comptroller General reports"; 720, "Agency reports"; and 3523, "General audit authority of the Comptroller General".

B. Office of Management and Budget (OMB) Circular A-50 (Revised), 'Audit Follow-up".

C. OMB Circular A-123 (Revised), Management's Responsibility for Internal Control.

V. References

A. Department of Homeland Security (DHS) Management Directives System, MD

Number: 0004, dated October 28, 2004.

B. Federal Acquisition Regulations (FAR), Part 46 Quality Assurance.

C. Federal Managers’ Financial Integrity Act of 1982 (31 U.S.C. 3512).

D. Office of Management and Budget (OMB) Circular A-123, Management’s Responsibility for Internal Control.

E. Government Performance and Results Act of 1993 (GPRA).

F. Federal Financial Management Improvement Act of 1996 (FFMIA).

G. Department of Homeland Security (DHS) Financial Accountability Act of 2004

(DHS FAA).

H. General Accounting Office (GAO) Standards for Internal Control in the Federal Government, September 2014.

I. Enterprise Risk Management (ERM) for the U. S. Federal Government

(Playbook) dated July 29, 2016.

J. FEMA Directive: Enterprise Governance. FD 304-103-1, October 2, 2020.

VI. Definitions

A. Functional Area: This includes CDP functions from executive leadership (e.g., Directors), managers (e.g., Assistant Directors and Function Managers), and supervisors and leads.

B. Item: An all-inclusive term used in place of any of the following: assembly, component, equipment, material, module, part, structure, subassembly, subsystem, system, unit, or support system.

C. Quality: The condition achieved when a product, service, process, procedure or system meets or exceeds the user’s requirements and expectations.

D. Quality Assurance: The maintenance of a desired level of quality in a service or product by means of attention to every stage of the process of delivery or production.

E. Quality Management System (QMS): The overall program (high level management system). The QMS is a set of fundamental beliefs, norms, rules and values that are accepted as true and can be used as a basis for quality management.

F. Service: The performance of work, such as design, construction, fabrication, decontamination, environmental remediation, waste management, laboratory sample analysis, inspection, nondestructive examination/testing, training, equipment qualification, repair, installation, or the like.

VII. Policy

All CDP organizational functional proponents will strive where possible to achieve, maintain and comply with the ISO 9001 quality management system requirements.

VIII. Responsibilities

CDP senior staff responsibilities shall be in accordance with the ISO 9001 quality management system requirements, and shall include:

1) Ensuring that the Quality Policies are communicated and understood

2) Ensuring that customer requirements are determined and met with the aim of achieving customer satisfaction

3) Reviewing the organization’s quality management system annually, to ensure its continued suitability, adequacy compliance and certifications

4) Committing to quality and continuous improvement throughout the CDP

The CDP Deputy Superintendent is appointed as the CDP Quality Management Representative. In accordance with the ISO 9001 quality management system, responsibilities and authority shall include ensuring that processes needed for the quality management system are developed, implemented, integrated and maintained.

Senior management must be responsible for the Quality Management System (QMS) implementation, assessment, integration and effectiveness.

A. The CDP Superintendent shall be responsible for the following tasks relating to the Quality Management System:

1) Provide executive leadership for quality assurance implementation and integration

2) Charter the Management Review Team (MRT) under the leadership of a chairperson (Director, Quality Assurance) who assists with these responsibilities

3) Resolve disputes concerning corrective actions for quality issues contained in CDP and COBRATF reports

B. The Director, Quality Assurance shall be responsible for the following tasks relating to the QMS.

1) Assist the Deputy Superintendent responsible for leading a CDP MRT comprised of appointed senior managers or designee that will:

i. Identify and resolve quality assurance issues within the CDP.

ii. Develop CDP quality assurance positions and provide appropriate recommendations, advice, and counsel to the CDP Superintendent

iii. Periodically report on the effectiveness of quality assurance initiatives meeting the CDP performance goals

2) Review proposed statutes (where appropriate), standards, directives, and requirements for their application to and potential impact on CDP quality programs.

C. The Assistant Director, Chemical, Ordnance, Biological, Radiological Training Facility (COBRATF) shall be the management representative responsible for the COBRATF Quality Management System that aligns with their annual certifications.

D. CDP Directors, as it relates to their areas of responsibility, shall be responsible for compliance with the QMS.

E. Contractors shall be responsible for their internal quality control plan requirements set forth within their specific contract for CDP owned or leased facilities and associated items and services. This includes work that may take place outside the physical boundaries of a CDP facility or work performed by suppliers and subcontractors (such as design, manufacturing, mobile training, or analytical laboratory services).

IX. Quality Management System (QMS) Organization

The QMS organizational responsibilities and interfaces between CDP elements.

A. The COBRATF QAP should meet the current version requirements of the COBRATF Standards Document, the Chemical Agent Standard Analytical

Reference Material (CASARM and ABSA) Quality Assurance Plan for Chemical Agent Air Monitoring and Biological Laboratory Monitoring, U.S. Army Research Development and Engineering Command (RDECOM) elements.

B. The CDP QAP should meet the CDP quality assurance criteria and coordinate with associated Contracting Officer Representatives (CORs) to ensure their quality programs are supporting the CDP’s QMS.

X. Proponent

Quality Assurance Directorate

XI. Effective Date

This directive is effective immediately.

Tony Russell Superintendent Center for Domestic Preparedness