B08. DHA QASP - Water for Injection_Pure Steam Generation + Distribution Systems Maintenance.pdf

DHA QASP Template V1 1

DEFENSE HEALTH AGENCY (DHA)

Quality Assurance Surveillance Plan (QASP)

Version 1

For Water For Injection (WFI) System Repairs and Emergency

Maintenance

Contract Number: TBD Contractor’s Name: TBD

Contract Description: Water for Injection/Pure Steam Generation and Distribution Systems Maintenance.

1. Objective/Vision: The objective of this contract is to perform preventative maintenance (quarterly, semiannual, and annual), calibration, five-year overhaul, and emergency service, including all materials and supplies required to complete maintenance and repairs, for the continued operation of water for injection/pure steam generation and distribution systems (Original Equipment Manufacturer (OEM): MECO) installed and used within the Walter Reed Army Institute of Research (WRAIR), Pilot Bioproduction Facility (PBF) to supply process water to autoclaves, fermenters, various other equipment, and manual use points as well as pure steam for sterilization in support of Current Good Manufacturing Practice (CGMP).

2. Mission: WRAIR’s Center for Enabling Capabilities (CEC) enables medical research and its translation into proven medical capabilities by facilitating the execution of innovative, military relevant medical research protecting and optimizing performance of the warfighter. The mission of WRAIR’s CEC is to advance medical capability and countermeasure development through provision of world class, cost efficient, and professional research support. The PBF within the CEC conducts research, development, production, and testing of vaccines and other biological products. The PBF is a CGMP-compliant pharmaceutical manufacturing facility that specializes in developing vaccines and biologics for military-relevant infectious disease threats. PBF capabilities include process development, scale-up, and CGMP drug substance and drug product manufacturing. PBF support has been critical to development efforts in the advancement of numerous vaccines.

3. Purpose

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 for how this

DHA QASP Template V1 2 assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process to include:

• What will be monitored

• How monitoring will take place

• Who will conduct the monitoring

• How monitoring efforts and results will be documented

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 and their Quality Assurance/Quality Control (QA/QC) actions to assure they meet contract standards. It is the Government’s responsibility to be objective, fair, and consistent in evaluating contractor performance.

The QASP is not part of the contract nor is it intended to duplicate the contractor’s QCP.

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.

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 (FAR), Inspection of Services clauses, which provides 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 (CO) or a duly authorized representative.

5. Roles and Responsibilities

The following personnel shall oversee and coordinate surveillance activities.

Program/Project Manager (PM) or Functional Services Manager (FSM) – The PM/FSM provides primary program oversight, nominates the Contracting Officer’s Representative (COR), ensures the COR is trained before performing any COR duties and supports the COR’s performance assessment activities. While the PM/FSM may serve as a direct conduit to provide Government guidance and feedback to the contractor

DHA QASP Template V1 3 on technical matters, they are not empowered to make any contractual commitments or any contract changes on the Government’s behalf.

Assigned PM/FSM: ***enter name*** Organization or Agency: WRAIR, ***Branch*** Telephone: ***enter number*** Email: ***enter address***

Contracting Officer (CO) – The CO 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 (U.S.) in the contractual relationship. The CO shall also ensure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO shall also determine the final assessment of the contractor’s performance.

Additionally, the CO shall include a requirement in the QASP to revalidate all key personnel annually to determine whether the contractors meet the labor categories specified in the contract.

The CO shall maintain documentation in the contract files that demonstrates their review and approval of initial and replacement contractor employees in key personnel positions.

The CO shall include a requirement in information technology service contract QASPs to review a sample of non‑key personnel quarterly to determine whether the contractor personnel meet the labor categories specified in the contract.

Assigned CO: ***enter name*** Organization or Agency: Defense Health Agency (DHA) Contracting Activity

(DHACA)

Telephone: ***enter number*** Email: ***enter address***

Contracting Officer’s Representative (COR) - 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 CO.

The COR is required to provide an annual performance assessment to the CO which will be used in documenting past performance. The QASP is the primary tool for surveillance of the contractor’s quality program and helps the COR to document contractor performance. The COR is not empowered to make any contractual commitments or to authorize any contractual change on the Government’s behalf.

Assigned COR: ***enter name*** Organization or Agency: WRAIR, PBF

DHA QASP Template V1 4

Telephone: ***enter number*** Email: ***enter address***

Other Key Government Personnel (enter name or delete this line if not applicable) This may include performance monitors, inspectors, technical experts, or others who provide information that helps the COR monitor contractor performance.

Contractor Representatives

The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract. (Complete this section after the contract award)

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

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

Other Key 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

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 CO, 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 QA/QC actions to successfully meet the terms of the contract.

6.2. Surveillance Matrix

DHA QASP Template V1 5

The Surveillance Matrix (see Attachment 1) is the list of performance objectives and standards that must be performed by the contractor. This matrix details the method of surveillance and frequency the COR will use to validate and inspect these performance elements. Inspection of each element will be documented in the COR file.

Defense Federal Acquisition Regulation Supplement (DFARS) 222.17 mandates including surveillance for ensuring compliance with Combatting Trafficking in Persons (CTIP) in the QASP. Use the CTIP sample checklist from DFARS Procedures, Guidance and Information (PGI) 222.17. See the DoD CTIP website.

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 Performance Requirement Summary (PRS) should be used to form the foundation of the COR’s inspection checklist.

6.3. Performance Rating Definitions

The performance ratings below reflect definitions at FAR 42.1503 Table 42-1. The COR will use these rating to evaluate the quality of contractor’s performance.

Performance Rating

Definition

Exceptional

Performance meets contractual requirements and exceeds many to the Government’s benefit. The contractual performance of the element or sub-element being evaluated 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 contractual performance of the element or sub-element being evaluated was accomplished with some minor problems for which corrective actions taken by the contractor were effective.

Satisfactory

Performance meets contractual requirements. The contractual performance of the element or sub-element 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 contractual performance of the element or sub-element being evaluated reflects a serious problem for which the contractor has not yet identified corrective actions. The contractor’s proposed actions appear only marginally effective or were not fully implemented.

http://ctip.defense.gov/

DHA QASP Template V1 6

Unsatisfactory

Performance does not meet most contractual requirements and recovery is not likely in a timely manner. The contractual performance of the element or sub-element contains a serious problem(s) for which the contractor’s corrective actions appear or were ineffective.

Note 1: Plus or minus signs may be used to indicate an improving (+) or worsening (-) trend insufficient to change the evaluation status.

Note 2: Not Applicable (N/A) should be used if the ratings are not going to be applied to a particular area for evaluation.

7. Performance Reporting

7.1. Corrective Action Report (CAR) - Describes how discrepancies are reported and resolved (see sample CAR below).

7.2. Customer Complaint Form (see sample customer complaint form below).

7.3. Performance Assessment Report (PAR) (see sample PAR below).

DHA QASP Template V1

Objective

PWS Reference Acceptable Quality Level

(AQL)

(maximum error rate)

Method of Surveillance

Incentive

PRS #1

CGMP

Compliance

The contractor shall perform work in accordance with CGMP standards.

Paragraph 5.1.2 Compliance to

CGMP >99%

of the time.

-Direct COR observation

Past performance

PRS #2

GDP Compliance

The contractor shall provide documentation in compliance with

GDP.

Paragraph 5.1.2

Compliance with GDP >99% of the time.

-100% inspection

Past performance

PRS#3

Pump Replacement and Certification

The contractor shall provide a replacement distribution pump that meets the MECs.

Paragraphs 5.2; 5.2.1;

5.2.2; and 5.2.3

Delivers replacement pump for installation no later than eight weeks after receipt of order;

replacement pump shall pass certifications outlined in PWS paragraph 5.2.3

-100% inspection

Past performance

PRS #5

System Operation

The contractor shall ensure the systems remain in

Paragraph 5.3 System shall attain >85% uptime.

-Direct COR observation

Past performance

Appendix 1 - Surveillance Matrix / Performance Requirements Summary (PRS)

(AQL)

(maximum error rate) an operational state (e.g., functional) outside of scheduled preventative maintenance periods.

PRS #6

Emergency Services

The contactor shall respond to emergency service requests within 24 hours and complete emergency service in a timely fashion.

Paragraphs 5.3 and 5.4.1

All reasonable efforts (in the Government’s view) shall be made by the contractor to bring the system back to an operational state as quickly as possible >99% of the time.

-Direct COR observation

Past performance

PRS #7

Quality Deliverables

Part 7, Attachment 2 95 percent compliance with deliverable requirements.

The contractor shall submit all deliverables as instructed by the established schedule (due date) with no need for substantive changes. The COR will have 10 days to review draft deliverables and

Random sampling

CPARS and past performance

(AQL)

(maximum error rate) make comments.

A revised deliverable shall be submitted within five days of identification of deficiency.

Inspection Metrologies:

M1: Inspection of Reports. All reports shall be reviewed upon receipt. The reviewer will report any flaws in the document and categorize the flaws (Editorial, Format, and/or Substance).

DHA QASP Template V1 10

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

DHA QASP Template V1 11

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

DHA QASP Template V1 12

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