B08. QASP - Water for Injection System Maintenance as of 03.18.2025.pdf

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

For: Water for Injection/Pure Steam Generation and Distribution Systems Maintenance

Contract Description: 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).

Contract Number: To be determined. <enter upon award>

Contractor’s Name: To be determined. <enter upon award>

Contents

1. PURPOSE

2. GOVERNMENT ROLES AND RESPONSIBILITIES

3. CONTRACTOR REPRESENTATIVES

4. PERFORMANCE REQUIREMENTS SUMMARY (PRS) MATRIX

PERFORMANCE REPORT

CONTRACT DISCREPANCY REPORT (CDR)

1. PURPOSE

This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:

• What will be monitored

• How monitoring will take place

• Who will conduct the monitoring

• How monitoring efforts and results will be documented

This QASP does not detail how the contractor accomplishes the work.

Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.

This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.

The following Federal Acquisition Regulation (FAR) clauses may apply depending on contract type:

52.246-4 Inspection of Services – Fixed-Price 52.212-4 Contract Terms and Conditions – Commercial Products and Commercial Services

2. GOVERNMENT ROLES AND RESPONSIBILITIES

The following Government 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:

Organization or Agency: United States Army Medical Research Acquisition Activity

(USAMRAA)

Telephone:

Email:

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:

Telephone:

Email:

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:

Telephone:

Email:

Other Key Government Personnel – N/A

3. CONTRACTOR REPRESENTATIVES

The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract: <Communication should occur with them during QASP development. It will help if they review the draft QASP and accept the final version. You may delete the stated roles or change the naming convention if applicable.>

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>

4. PERFORMANCE REQUIREMENTS SUMMARY (PRS) MATRIX

PERFORMANCE

OBJECTIVE STANDARD

PERFORMANCE

THRESHOLD

ACCEPTABLE

QUALITY

LEVELS (AQLs)

METHOD OF

SURVEILLANCE INCENTIVE

PRS #1 -

Effective Resource Planning (Staffing)

(paragraph 1.10)

The contractor shall manage, retain, replace, and assign capable and qualified contractor personnel in a manner that meets all expressed contractual requirements with no observable degradation of support or impacts to mission requirements.

-The contractor shall maintain a 95% fill rate throughout the PoP and fill vacancies within 30 days.

-The Government shall receive no more than three Contract Discrepancy Reports (CDRs) or similar deficiency reports during the contractor’s performance of the entire contract.

-A get-well plan shall be submitted within five days of identification of deficiency.

-Direct COR observation and CDRs

Past performance

PRS #2 –

Good Documentation Practices (GDP) Compliance

(paragraphs 1.21.7; 5.1.2;

and 5.2.2) provide documentation in compliance with

GDP.

Compliance with GDP >99% of the time.

-100% inspection Past performance

PRS #3 –

Current Good Manufacturing

The contractor shall perform work in accordance with CGMP standards.

Compliance to

CGMP >99%

of the time.

-Direct COR observation

Past performance

Practice (CGMP) Compliance

(paragraphs 1.21.7; 5.1; and 5.1.2)

PRS #4 –

Customer Support

(paragraph 5.1.3) provide professional and responsive customer service.

-Government inquiries shall be responded to within 24 hours, 99% of the time.

-The Government will receive no more than three complaints or negative reviews denoting a customer support or business acumen deficiency during the contractor’s performance of the entire contract.

-Random sampling

-Review of any complaints received

PRS #5 –

Maintenance Service Reports

(paragraphs

5.1.3 and 5.2.2)

- Notification of any major deficiencies/issues and recommendation regarding suitability for use will be communicated to the COR prior to leaving facility.

-The contractor shall submit a finalized maintenance service report within 15 days of completion of maintenance.

Meets reporting requirements >99% of the time.

-Direct COR observation

PRS #6 –

Maintenance Schedule

5.2.1) perform scheduled preventative maintenance in a timely manner in accordance with approved detailed annual maintenance schedule.

-Services performed within 99% of schedule as defined in the approved detailed annual maintenance schedule.

-All reasonable efforts (in the Government’s view) shall be taken by the contractor to adhere to the approved annual maintenance schedule.

-Direct COR observation

Past performance

PRS #7 –

System Operation

(paragraphs

5.2.3 and 5.3)

The contractor shall ensure the systems remain in an operational state (e.g., properly calibrated) outside of scheduled preventative maintenance periods.

System shall attain >85% uptime.

-Direct COR observation

Past performance

PRS #8 –

Emergency Service

5.3.1)

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

-All reasonable efforts (in the Government’s view) shall be taken 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 #9 –

Quality Deliverables

(Technical Exhibit B)

The contractor shall provide quality deliverables;

deliverables shall be provided in

-99% compliance with PWS requirements.

-All deliverables shall be submitted as

-100% inspection Past accordance with PWS requirements.

instructed per the established schedule (due date) with no need for substantive changes.

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

PERFORMANCE REPORT

Contract number: <insert number>

Prepared by: <insert COR’s name>

Date and time of observation: <insert date>

Observation:

<Examples of items to include in a report are:

- Method of surveillance.

- How frequently you conducted surveillance.

- Surveillance results (Exceeds, Meets, Does Not Meet).

- Number of observations.>

Prepared by: <Enter COR’s name>

COR’s Signature Date

CONTRACT DISCREPANCY REPORT (CDR)

< The COR may initiate a CDR at any time, including whenever the number of monthly recorded defects for a performance standard exceeds the allowable number of defects;

anytime unacceptable performance is determined critical in nature and requires formal corrective action; and whenever an unfavorable trend is detected in contractor performance.>

Contract number: <insert number>

Contractor Project Manager: <insert name>

From: <insert COR’s name>

Date and time observed discrepancy:

Contract discrepancy:

<Describe in detail and identify any attachments.>

Corrective action plan:

A written corrective action plan < is / is not > required.

< If a written corrective action plan is required include the following. > The contractor shall provide the COR with the corrective action plan not later than < # days after receipt of this CDR. >

Prepared by: <insert COR’s name>

COR’s Signature Date

Received by: <Enter contractor Project Manager’s name>

Contractor Project Manager’s Signature Date