QASP.pdf

QUALITY ASSURANCE SURVEILANCE PLAN (QASP)

FOR

Annual ISO 17025 Accreditation of Biological Operations Laboratory at Aberdeen Proving Ground

1.0 INTRODUCTION

This Quality Assurance Surveillance Plan (QASP) has been developed to ensure that systematic quality assurance methods are used in the administration of the Performance Work Statement (PWS) for the Annual ISO 17025 Accreditation of Biological Operations Laboratory at Aberdeen Proving Ground contract. The intent of this plan is to ensure that the contractor performs their work in accordance with the project tasks identified in their proposal. By extension, the plan also makes sure that the Government receives a quality ‘best effort’ by the selected contractor to accomplish the tasks required under the task order award.

This QASP describes how the Government will observe, evaluate and document the contractor’s performance in meeting the requirements identified in the task order award. Specifically, the QASP will identify the methods for monitoring performance and determining the quality level of services and products delivered under the task order award. The intent is to establish and execute a QASP that will assist the Government in obtaining a maximum quality effort.

2.0 RESPONSIBILITIES

The following Government resources shall have responsibility for the implementation of this QASP:

Contracting Officer – The Contracting Officer will monitor performance of all necessary actions for effective contracting to ensure compliance with the terms of the task order award. It is the Contracting Officer that assures the contractor receives impartial, fair and equitable treatment under the task order award. The Contracting Officer is ultimately responsible for the final determination of the adequacy of the contractor’s performance.

Contracting Officer’s Representative (COR) – The COR is responsible for technical administration of the task order award and assures proper Government surveillance of the contractor’s performance. The COR is not empowered to make any contractual commitments or to authorize any changes on the Government’s behalf. Any changes that the contractor deem may affect task order price, terms or conditions shall be referred to the Contracting Officer for action.

3.0 SURVEILLANCE

The Contracting Officer’s Representative (COR) will perform surveillance based on the contractor’s monthly reports; the final report; SOP status reports; meetings at the contractor’s and subcontractor’s work sites; email exchanges; documented telephone discussions; meetings by the contractor at the U.S. Army Combat Capabilities Development Command – Chemical Biological Center (DEVCOM-CBC) with the COR, Task Manager, Contract Specialist, and/or the Contracting Officer; and, the products delivered. Overall, the COR and the Task Manager will perform a monthly assessment of the contractor’s effort to effectively plan and manage task order award requirements and the quality of support provided to meet cost, performance, and schedule requirements of the task order award.

4.0 PERFORMANCE REQUIREMENTS SUMMARY (PRS)

4.1 Overview. This PRS summary identifies the services required by the PWS over which the Government will exercise surveillance.

4.2 Performance Evaluation. Performance of a service will be evaluated to determine whether or not it meets the performance threshold. Conducting a meeting with all relevant parties at no additional cost to the Government is the preferred method for addressing the plan to correct unacceptable performance. The contractor shall provide the

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Government with a written response as to why the performance threshold was not met, how performance will be returned to acceptable levels, and how recurrence of the cause will be prevented in the future.

4.3 Performance Objectives, Standards, Thresholds, and Surveillance Methods. The services required by the contractor are summarized into performance objectives along with the minimum standards that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

PERFORMANCE REQUIREMENTS SUMMARY

Performance Work

Statement

Performance Objective(s)

Method of Surveillance Acceptable Quality Level

Laboratory Assessments

IAW (PWS 3.1, 3.2)

Annual assessment and accreditation of the laboratory per ISO 17025 requirements

The Government will monitor the effort through telephone discussions; email exchanges; and on-site communication. 100% inspection, deviations documented by COR. If compliance falls below 95%, KO will be notified in writing

100% compliance

Off-Site Assessment Successful Completion ISO 17025 Standards Accreditation (PWS 3.1)

Perform an off-site assessment of the Biological Operations Laboratory management system in accordance with the ISO 17025 standard every other year (years 2 and 4).

100% inspection, deviations documented by COR. If compliance falls below 95%, KO will be notified in writing

100% compliance

On Site Assessment Successful Completion ISO 17025 Standards Accreditation

(PWS 3.2)

Perform an on-site assessment of both the Biological Operations Laboratory and its management system in accordance with the ISO 17025 standard every other year (years 1, 3 and 5).

100% inspection, deviations documented by COR. If compliance falls below 95%, KO will be notified in writing

100% compliance

Detailed Reporting and Documentation Requirements on both On Site Assessment and Off Site Review of Quality Management of ISO 17025 Standards Accreditation.

IAW (PWS 3.1, 3.2)

Deliver comprehensive documentation and reporting for both on-site assessments and off-site reviews of Quality Management Systems, ensuring full compliance with ISO/IEC 17025 accreditation standards

100% Compliance;

Contractor will provide documentation to Quality Manager or COR If compliance falls below 90%, KO will be notified in writing

100% compliance

AS PER FAR 46.309: INSPECTION OF RESEARCH AND DEVELOPMENT (APR 1984)

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The Government has the right to inspect and evaluate the work performed or being performed under the task order award, and the premises where the work is being performed, at all reasonable times and in a manner that will not unduly delay the work. If the Government performs inspection or evaluation on the premises of the Contractor or a subcontractor, the Contractor shall furnish and shall require subcontractors to furnish all reasonable facilities and assistance for the safe and convenient performance of these duties.

The evaluation ratings are as follows:

Excellent (E) – Performance significantly exceeds the Government’s requirements. Numerous performance strengths are identified which significantly benefit the Government. No performance deficiencies or weaknesses are identified.

Good (G) – Performance exceeds the Government’s requirements. Performance strengths are identified which benefit the Government. No performance deficiencies exist. Performance weaknesses may exist, but they have been corrected or are being resolved without substantial impact on performance, cost, or schedule.

Satisfactory (S) – Performance meets the Government’s requirements. No performance deficiencies exist.

Performance weaknesses may exist, but they have been corrected or are being resolved without substantial impact on performance, cost or schedule.

Unacceptable (U) – Performance does not meet the Government’s requirements. Performance deficiencies exist. Actions taken to correct performance deficiencies have not been successful, and recovery is not likely.