A03-QASP_Final.pdf

QUALITY ASSURANCE SURVEILLANCE PLAN

Preventive Maintenance and Service for Water for Injection/Pure Steam/Distribution Systems at Pilot Bio Production Facility, WRAIR

1. VISION

The WRAIR aims to conduct biomedical research that is responsive to Department of Defense and US Army requirements and delivers life-saving products including knowledge, technology and medical material that sustain the combat effectiveness of the Warfighter. Our vision is to be the premier DoD biomedical research organization, constantly relevant, integrating basic research and advanced technology that protects, projects, and sustains the Warfighter today, invents global medical solutions for the future, and keeps the Warfighter on point for the Nation. We host two Centers of Excellence for Military Psychiatry and Neuroscience Research and for Military Infectious Disease Research, each center ranging from blast induced neuro-trauma to malaria vaccine development.

2. MISSION

The Pilot Bio-production Facility (PBF) conducts research, development, production, and testing of vaccines and other biological products. Production is performed following and products are tested in compliance with current Good Manufacturing Practices (cGMP). Production is pilot-scale: 500 – 20,000 doses per finished lot of product. Products are released for use in Phase I – II b clinical studies under Investigational New Drug applications (INDs). Vaccines being produced include, but are not limited to, those for prophylaxis against shigellosis, meningitis, malaria, and dengue fever. Conventional as well as recombinant and other genetically engineered vaccines are undergoing development and production at

WRAIR.

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. The Government will monitor the performance of the contractor’s completion of the work required to ensure the final products fulfill the government’s needs.

3.1.2. The Contracting Officer’s Representative (COR) will use direct observation techniques for monitoring the completion of work by the contractor. The COR will also elicit input from the Toxicology (TOX) Directorate staff to determine if the work products provided meets the requirements of the TOX Directorate.

3.1.3. The COR will document the monitoring on the monthly COR report.

3.2. The contractor is responsible for implementing and delivering performance that meets contract standards using its Quality Control Plan. 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. The QASP is not part of the contract nor is it intended to duplicate the contractor's quality control plan.

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 may 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.

Bottom line, the QASP should ensure early identification and resolution of performance issues to minimize impact on mission performance.

4. AUTHORITY

Authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation, Inspection of Services clauses, which provide for inspection, acceptance and documentation of the service called for in the contract or order. This acceptance is to be executed by the contracting officer or a duly authorized representative.

5.1 ROLES AND RESPONSIBILITIES

The following personnel shall oversee and coordinate surveillance activities.

Contracting Officer (KO) - The KO 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 KO shall also assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned KO: Sharew Hailu Organization or Agency: United States Army Medical Research Acquisition Activity Telephone: (301) 619-9201 Email: sharew.hailu.civ@mail.mil

Contract Specialist (CS) - The CS acts as an acquisition consultant and serves as liaison between the contract office and Walter Reed Army Institute of Research (WRAIR).

Assigned CS: Nathaniel Reus Telephone: (301) 619- 9209 Email: nathaniel.a.reus.civ@mail.mil

Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall assure proper Government surveillance of the contractor’s performance. The COR shall keep a “QASP and Performance” file. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.

Assigned COR: Stasya Zarling Bejma Telephone: (301) 319-7143 Email: stasya.n.zarlingbejma.civ@mail.mil mailto:nathaniel.a.reus.civ@mail.mil mailto:stasya.n.zarlingbejma.civ@mail.mil

Other Key Government Personnel – Technical POC: Richard Millward Telephone: (301) 319-9322 Email: richard.h.millward.civ@mail.mil

CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract.

Program Manager - <upon award, enter name> Telephone: <enter number> Email: <enter address>

Task Manager - <upon award, enter name> Telephone: <enter number> Email: <enter address>

Other Contractor Personnel - <upon award, enter name or delete these lines if not applicable> Title: <enter title> Telephone: <enter number> Email: <enter address>

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, non-adversarial relationships with the KO, 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 QC/QA actions to successfully meet the terms of the contract.

6.2 Surveillance Matrix

6.2.1. The Surveillance Matrix Table 1 is the list of 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.

mailto:richard.h.millward.civ@mail.mil

6.2.3. 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 contractor’s performance, the following performance ratings may be used.

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.

7. PERFORMANCE STANDARDS

Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.

The Performance Requirements Summary matrix, shown in Table 1 below and continued within the Performance Work Statement (PWS) for this contract in Section 3, includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).

Table 1 – Surveillance MATRIX - Performance Standards for Preventive Maintenance and Service for Water for Injection/Pure Steam/Distribution Systems at Pilot Bio Production Facility

# PWS

Ref.

Performance Objective

Acceptable Quality Level Performance Measurement Method of

Surveillance Incentive 1 6 The contractor shall complete maintenance in a timely manner.

Meets >95% of the time.

Number of times the contractor completes the objective.

COR surveillance Past performance.

2 6.2 The contractor shall submit maintenance reports in a timely manner.

Meets >99% of the time.

Number of times the contractor completes the objective.

COR surveillance Past performance.

3 6.1.6 The contactor shall perform emergency service work in a timely fashion.

Meets >99% of the time.

Number of times the contractor completes the objective.

COR surveillance Past performance.

4 5.1.2 The contractor shall provide emergency service work when necessary.

Meets >99% of the time

Number of times the contractor completes the objective.

COR surveillance Past performance.

5 6.1.9 The contractor shall provide documentation of Good Documentation Practice.

Meets >99% of the time.

Number of times the contractor complies when requested by the COR.

COR surveillance Past performance.

6 6.1.9 The contractor shall provide work in accordance to cGMP standards.

Meets >99% of the time.

Number of times the contractor shows compliance when requested by the COR.

COR surveillance Past performance.

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

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

INDIVIDUAL

PHONE

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)

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