Attachment IX QASP - Preventative Maintenance of Above Standard Equipment at FDA White Oak (1).pdf

FOOD AND DRUG ADMINISTRATION

The Office of Facilities Engineering and Mission Support Services (OFEMS) Division of Operations Management and Community Relations (DOMCR)

Logistics and Transportation Management Branch (LTMB)

Preventive Maintenance of FDA Above Standard Equipment at the White Oak Campus

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

Version Number: 0.1

ATTACHMENT IX

Quality Assurance Surveillance Plan (QASP)

Contract Number:

Contractor’s Name:

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, and

• How monitoring efforts and results will be documented.

This QASP is a “living document” and the government may review and revise it on a regular basis.

However, the government will coordinate changes with the contractor. Copies of the original QASP and revisions shall be provided to the contractor and government officials implementing surveillance activities.

2. Government Roles and Responsibilities:

The following personnel shall oversee and coordinate surveillance activities.

a. 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 in the contractual relationship. The CO shall also ensure that the contractor receives impartial, fair, and equitable treatment under this contract. The CO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Assigned CO: Monifa Coleman Alternate CO: TBD Contract Specialist: TBD Organization Federal Drug Administration (FDA)

b. Contracting Officer’s Representative (COR) – The COR is responsible for technical administration of the contract and shall ensure proper government surveillance of the contractor’s performance. The COR will keep a quality assurance file. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the government’s behalf.

Assigned COR: TBD Agency: FDA

3. Contractor Representatives:

The following employees of the contractor serve as the contractor’s program manager and contract manager for this contract:

a. Program Manager: TBD

b. Contract Manager: TBD

c. Quality Assurance POC TBD

4. Performance Standards:

Performance standards define desired services that are documented in the contract Performance Work Statement (PWS). The government performs surveillance to determine if the contractor exceeds, meets, or does not meet these standards.

The Performance Standards Matrix below lists the performance standards for this contract. The government will use these standards to determine contractor performance quality and will compare contractor performance to the performance threshold.

Performance Standards Matrix

PWS

Section

Evaluation Category

KPI Description Objective

Frequency Data collection Point

Weight

5.4.1 Certifications Certification Dates 100 Monthly Contractor Logs 40% 5.4.2

Work Clearances

Medical Requirement Documents 100 Monthly COR

15%

Participation in Inspections 100 Ad Hoc

Project Management

Report Computer Training

Annually

Center Specific Training Lab Etiquette Training Semi-Annually Certifications Training:

Mandatory Annual

Refreshers / Ad Hoc

FDA Internal Reporting • BSL-3 / ISO /

AAALC

5.1

Management Performance

Program Management 90 Monthly FDA Internal

Reporting

15%

• Contractor Efficiency Rating

Problem Responsiveness

95 Monthly ARCHIBUS

• Service Call (SC)

Response Time

• Service Call

Efficiency (SCE) Quality of Product or Service 98 Monthly COR

Cost Performance 95 Monthly Project

Management Reports

5.2.1 Proper Lab Etiquette 100 Monthly COR 15%

PWS

Section

Evaluation Category

KPI Description Objective

Frequency Data collection Point

Weight

Customer Notification

Email Notifications (2 Month Notice) 100 Monthly

Email Notification (1 Month Notice) 100 Monthly

Door post notification (1 Week Notice) 100 Monthly

5.2.3 Preventive

Maintenance

Preventive Maintenance Efficiency (PME) 95 Monthly

Contractor Logs

5%

5.2.4 Proactive Maintenance

Tour Performance Rating (TPR) 95 Monthly 5% Proactivity Rating (PR)

5.2.6 Parts

Management Inventory 98 Monthly 5%

5. Incentives and Disincentives: Upon satisfactory performance of all performance objectives, the contractor shall be eligible for favorable past performance rating.

6. Method of Surveillance: The following surveillance methods may be used to verify the performance methods listed above.

100% Inspection:

Means what the title implies – inspection of every requirement stated in the contract each time it occurs.

Periodic Inspection/Random Sampling:

The type of surveillance that is based upon selecting samples for evaluation, other than 100% inspection, on a random basis.

7. Procedures:

The COR and/or designated FDA staff will perform scheduled and/or impromptu inspections in accordance with the frequency and standards contained in the QASP – Performance Standards Matrix. FDA staff will monitor contractor compliance in accordance with the appropriate sections of the PWS and will record the results of inspection, noting the date and time of inspection. If inspection indicates minor discrepancies, the COR will notify the contractor of the discrepancy.

If inspection indicates unacceptable performance, the COR will notify the Contracting Officer, who in turn will notify the contractor of the deficiencies for correction. The Contractor will be given a reasonable amount of time after notification to correct the unacceptable performance, if such correction is possible. The length of time allowed to correct the problem will depend upon the requirement and the deficiency. The contractor will be notified of the time allowed for correction when the deficiency is reported to the contractor. Should the COR and contractor reach an impasse on any matter dealing with inspection and correction, the Contracting Officer will be consulted for resolution.

The COR will inspect and accept contractor services at the completion of each contract payment period, usually monthly. The COR will certify services actually received under this contract via a letter to the Contracting Officer or by certification and acceptance on the Contractor's invoice.

8. Audit Reports: The Contractor shall provide full cooperation with the auditor(s) and respond to all audit reports by the required response date, taking corrective actions, if necessary. The findings of each audit will affect recommendations for past performance and whether or not option years will be exercised. The emphasis being that the accuracy of all performance measures, as well as invoicing by the Contractor, will be closely observed.