QASP.pdf

Quality Assurance Surveillance Plan (QASP)

For: Laboratory Accreditation Contract Number: TBD Contract Description: Contract to provide the Defense Centers for Public Health-Aberdeen (DCPH-A) Laboratory Science (LAB) Directorate third party accreditation of the environmental and biological analytical methods performed by the LAB to the International Organization for Standardization (ISO) 17025:2017-General Requirements for the Competence of Testing and Calibration Laboratories, the Department of the Defense (DoD) Environmental Laboratory Accreditation Program (ELAP), and documented compliance to the NELAC Institute (TNI) Volume 1, Management and Technical Requirements for Laboratories Performing Environmental Analysis standard.

Contractor’s Name: TBD (hereafter referred to as the contractor).

1. Vision

Unrelenting pursuit of excellence as we care for our joint force and those we are privileged to serve. Anytime, Anywhere—Always.

2. Mission

The Defense Health Agency supports our Nation by improving health and building readiness–making extraordinary experiences ordinary and exceptional outcomes routine.

3. Purpose

This 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:

• 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. 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 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.

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 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 on technical matters, they are not empowered to make any contractual commitments or any contract changes on the government’s behalf.

Assigned PM/FSM: TBD Organization or Agency:

Telephone:

Email:

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 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 contracts 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: TBD Organization or Agency:

Telephone:

Email:

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 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 help 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: TBD Organization or Agency:

Telephone:

Email:

Alternate Contracting Officer’s Representative (ACOR) The ACOR is authorized to perform the duties of the COR in the absence of the COR.

Assigned ACOR: TBD Organization or Agency:

Telephone:

Email:

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 - TBD

Telephone:

Email:

Contractor Task Manager - TBD Telephone:

Email:

Other Key Contractor Personnel - TBD Title:

Telephone:

Email:

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

6.2. Surveillance Matrix

The Surveillance Matrix (see sample at 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 PGI 222.17. See the DoD CTIP website (http://ctip.defense.gov/).

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 http://ctip.defense.gov/ http://ctip.defense.gov/ 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.

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

Appendix 1 - Surveillance Matrix

Statements Standards/AQLs Inspections Ratings 3.1.3 Contractor will provide certificates and scopes of accreditation with new expiration date for current accreditations and scopes.

Deliverables: Certificate and Scope of Accreditation

Within 3 business days of contract’s award.

AQL: Zero Deviation from Standard

What: Certificate and Scope of Accreditation How: 100% review of documents.

Who: COR

3.2.5 Contractor will provide final written assessment report identifying the outcome of the assessment.

Deliverables: Written Report

Within 30 calendar days of audit completion.

AQL: No more than 1 report later than 30 days after audit completion.

What: Written Assessment Report How: 100% Inspection

3.2.6 The Contractor shall provide documentation of accreditation (to include certificate and scope) with new accreditation dates following completion of assessment.

Deliverables: Certificate and Scope of Accreditation

Within five (5) business days of Contractor acceptance of any corrective actions from the LAB following completion of the assessment.

AQL: Zero Deviation from Standard.

What: Certificate and Scope of Accreditation How: 100%

3.3.3 quote for any requested scope expansions.

Deliverables: Quote

Within 14 business days of request

AQL: No more than 1 quote received after 14 business days of request.

What: Proficiency Testing Final Reports How: 100%

3.3.3 Within 30 calendar

days of receiving complete and

What: Certificate and Scope of Accreditation

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).

The Contractor shall provide an updated scope reflecting scope expansion.

Deliverables: Certificate and Scope of Accreditation accurate scope expansion application or completion of any required onsite or remote assessment and subsequent corrective action resolution as deemed necessary by the Contractor.

AQL: Zero Deviation from Standard.

How: 100% Inspection Who: COR

3.4.5 Contractor will provide final written assessment report identifying the outcome of the assessment.

Deliverables: Written Report

Within 30 calendar days of audit completion.

AQL: No more than 1 report later than 30 days after audit completion.

What: Written Assessment Report How: 100%

3.4.6 documentation of accreditation (to include certificate and scope) with new accreditation dates following completion of assessment.

Deliverables: Certificate and Scope of Accreditation

Within five (5) business days of Contractor acceptance of any corrective actions from the LAB following completion of the assessment.

AQL: Zero Deviation from Standard.

What: Certificate and Scope of Accreditation How: 100%