Attch 1 Quality Assurance Surveillance Plan.pdf

QUALITY ASSURANCE AND SURVIELLANCE PLAN

Continuous Flow Thermal Effluent Decontamination

Systems (CFTEDS)

1. Introduction

The U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID) is the Department of Defense’s

(DoD) lead laboratory for medical biological defense research. USAMRIID’s core mission is to protect the warfighter from biological threats; USAMRIID also investigates disease outbreaks and threat to the public health.

The research conducted at USAMRIID leads to medical solutions—therapeutics, vaccines, diagnostics, and information that benefit both the military personnel and civilians. USAMRIID has a mission to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents.

2. Mission

The USAMRIID mission is to provide leading edge medical capabilities to deter and defend against current and emerging biological threat agents.

3. Purpose

3.1. This Quality Assurance Surveillance Plan (QASP) is a Government-developed document used to determine if the contractor's performance meets the performance standards contained in the Contract. The QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process:

3.1.1. What will be monitored?

3.1.2. How monitoring will take place.

3.1.3. Who will conduct the monitoring.

3.1.4. How monitoring efforts and results will be documented.

3.2. The contractor is responsible for implementing and delivering performance that meets Contract standards using its Quality Control Plan (QCP). The QASP provides the structure for the Government's surveillance of the contractor's performance to assure that it meets Contract standards. It is the Government's responsibility to be objective, fair and consistent in evaluating contractor performance.

3.3. This QASP is a living document. Flexibility in the QASP is required to allow for an increase or decrease in the level of surveillance necessary based on contractor performance.

3.4. The Government shall provide a copy of the QASP to the contractor to facilitate open communication. In addition, the QASP should recognize that unforeseen or uncontrollable circumstances might occur that are outside the control of the contractor.

3.5. This QASP applies to all deliverables required by this Contract and reviews of the deliverables will be performed to ensure compliance.

3.6. The QASP shall ensure early identification and resolution of performance issues to minimize impact on mission performance.

4. Authorities

The authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation (FAR), Inspections of Supplies clauses, which provide for inspection, acceptance and documentation of the supplies called for in the Contract or Delivery Orders. This acceptance is to be executed by the Contracting Officer or the

Contracting Officer’s Representative (COR).

5. Roles and Responsibilities

The following Government personnel shall oversee and coordinate surveillance activities.

5.1. Contracting Officer

The Contracting Officer shall ensure performance of all necessary actions for effective contracting, ensure compliance with the Contract terms, and shall safeguard the interests of the United States in the contractual relationship. The Contracting Officer shall also ensure the Contractor receives impartial, fair, and equitable treatment under the Contract, and document the final assessment of the Contractor's performance in the

Government Contracting Performance Assessment Reporting System (CPARS).

5.2. Contracting Officer's Representative

The COR is responsible for providing continuous technical oversight of the contractor's performance. The COR uses the QASP to conduct the oversight/surveillance process. The COR shall keep a Quality Assurance file that accurately documents the contractor's actual performance. The purpose is to ensure that the contractor meets the performance standards contained in the Contract. The COR is responsible for reporting early identification of performance problems to the Contracting Officer. The COR is required to provide an annual performance assessment to the Contracting Officer which will be used in documenting past performance. The QASP is the primary tool for documenting contractor performance. The COR is not empowered to make any contractual commitments or to authorize any contractual change on the Government's behalf.

6. Performance Requirements and Method of Surveillance

This section describes the special requirements for this effort. The following sub-sections provide details of various considerations on this effort.-

6.1. Contract Surveillance

The goal of the QASP is to ensure that contractor performance is effectively monitored and documented. The

COR's contribution is their professional, relationships with the Contracting Officer, PM and the Contractor, which enables positive, open and timely communications. The foundation of this relationship is built upon objective, fair, and consistent COR evaluations of contractor performance against Contract requirements. The COR uses the methods contained in this QASP to ensure the contractor is in compliance with Contract requirements. The COR function is responsible for a wide range of surveillance requirements that effectively measure and evaluate the contractor's performance. Additionally, this QASP is based on the premise that the contractor, not the Government, is responsible for management and Quality Control (QC)/Quality Assurance (QA) actions to successfully meet the terms of the Contract.

6.2. Surveillance Matrix

6.2.1. The Surveillance Matrix Table 2 identifies the performance objectives and standards that must be performed by the contractor. This matrix details the method of surveillance the COR will use to validate and inspect these performance elements. Inspection of each element will be documented in the COR file.

6.2.2. Performance objectives define the desired outcomes. Performance Standards define the level of service required under the Contract to successfully meet the performance objective. The inspection methodology defines how, when, and what will be assessed in measuring performance. The Government performs surveillance, using this

QASP, to determine the quality of the contractor's performance as it relates to the performance element standards.

The matrix should be used to form the foundation of the COR's inspection checklist. In evaluating the quality of the contractor’s performance, Table 1 identifies the performance ratings that may be used.

Table 1: Performance Ratings

Performance

Rating

Criteria

Exceptional Performance meets contractual requirements and exceeds many to the Government’s benefit. The element being assessed was accomplished with few minor problems for which corrective actions taken by the Contractor were highly effective.

Very Good Performance meets contractual requirements and exceeds some to the Government’s benefit. The element being assessed was accomplished with some minor problems for which corrective actions taken by the Contractor were effective.

Satisfactory Performance meets contractual requirements. The element being assessed contains some minor problems for which corrective actions taken by the Contractor appear or were satisfactory.

Marginal Performance does not meet some contractual requirements. The element being assessed reflects a serious problem for which the Contractor has not yet identified corrective actions.

Unsatisfactory Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The element being assessed contains a serious problem(s) for which the Contractor’s corrective actions appear or were ineffective.

Table 2: Surveillance Matrix

Deliverable

Standards / AQL

Inspection

What How/Method Who Ratings

Deliverable #2

PWS 3.1.3.1

30 business days after Notice to Proceed

30% Design Drawings

Receipt of electronic submissions

COR

#3

PWS 3.1.3.2

60 business days after Notice to Proceed

60% Design Drawings

#4

PWS 3.1.3.3

90 business days after Notice to Proceed

95% Design Drawings

#5

PWS 3.1.3.4

120 business days after Notice to Proceed

100% Design Drawings

#6

PWS 3.1.5

30 days after contract award

Submission of Equipment list and Components

#7

PWS 3.1.6

16 months after contract award

Factory Acceptance Testing

In person COR

Deliverable #8

PWS 3.1.7

24 months after award

Site Acceptance Testing / Final Acceptance

In person COR

Deliverable #9

PWS 3.1.8

15 days after contract award

Accident Prevention Plan

#10

PWS 6.2

24 months after award

Preventative Maintenance Schedule

CORRECTIVE ACTION REPORT (CAR)

(If more space is needed, use reverse and identify by number)

1. CONTRACTOR 2. CONTRACT NUMBER 3. TYPE OF SERVICES

4. FUNCTIONAL AREA 5. SUSPENSE DATE 6. CONTROL NUMBER

7. DEFICIENCY MAJOR MINOR

FINDING:

FINDING IMPACT:

Please respond with a written corrective action plan that details the corrective action of the cited deficiency, the cause of the deficiency, and actions taken to prevent recurrence by Suspense Date in Block 5. If date was not entered in Block 5, the contractor is not required to provide a response.

8. QUALITY ASSURANCE PERSONNEL (COR)

TYPED NAME AND GRADE

SIGNATURE AND DATE

9. ISSUING AUTHORITY

TYPED NAME AND GRADE

SIGNATURE AND DATE

10. COR RESPONSE TO CONTRACTOR CORRECTIVE ACTION AND ACTION TAKEN TO PREVENT RECURRENCE

11. COR DETERMINATION

ACCEPTED REJECTED

12. CLOSE DATE

CUSTOMER COMPLAINT RECORD

DATE/TIME OF COMPLAINT

SOURCE OF COMPLAINT

ORGANIZATION BUILDING

NUMBER

INDIVIDUAL PHONE NUMBER

NATURE OF COMPLAINT

CONTRACT REFERENCE

VALIDATION

DATE/TIME CONTRACTOR INFORMED OF COMPLAINT

ACTION TAKEN BY CONTRACTOR

RECEIVED/VALIDATED BY

PERFORMANCE ASSESSMENT REPORT (PAR)

(If more space is needed, use reverse and identify by number)

1. Contract/TASK ORDER NUMBER 2. Contractor 3. TYPE OF SERVICES

4. QUALITY ASSURANCE PERSONNEL (COR) SIGNATURE AND DATE 5. COR PHONE 6. SUSPENSE DATE

I. PERFORMANCE

7. DEFICIENCY (CHECK ALL BOXES THAT APPLY)

NEW

REPEAT

NO DEFICIENCY NOTED

8. SERVICES SUMMARY or PWS PARAGRAPH ITEM REVIEWED

9. BRIEF DESCRIPTION OF DEFICIENCY (IF DEFICIENCY BOX WAS

CHECKED)

10. DETAILED PERFORMANCE ASSESSMENT

II. CONTRACTOR VALIDATION

11. CONTRACTOR REPRESENTATIVE CONCUR NON-CONCUR 12. CORRECTIVE ACTION ESTIMATED COMPLETION DATE

13. CONTRACTOR REPRESENTATIVE CORRECTIVE ACTION AND PREVENTION OF RECURRENCE OR REASON FOR NON-CONCURRENCE OF

COR CITED DEFICIENCY

III. ACTION CORRECTED

14. CONCUR NON-CONCUR COR SIGNATURE AND DATE

15. COR REMARKS (REQUIRED)

16. CONTRACTOR REPRESENTATIVE REMARKS