QASP_Autoclaves.pdf

QUALITY ASSURANCE SURVEILLANCE PLAN

FOR

Edgewood Chemical Biological Center – Bio Testing Division (ECBC-BTD) - Dugway Autoclaves

1.0 INTRODUCTION

1.1 Purpose. The role of the Government in quality assurance is to ensure contract standards are achieved. The purpose of the Quality Assurance Surveillance Plan (QASP) is to identify the methods and procedures the Government will use to evaluate contractor actions while performing the requirements in the Performance Work Statement (PWS) and the proposal. It is designed to provide an effective surveillance method by monitoring contractor performance for each listed performance objective in the Performance Requirements Summary (Section 7).

1.1.1 The QASP provides a systematic method to evaluate the services the contractor is required to perform for providing the hardware and data item deliverables.

1.1.2 The QASP has been developed by the requiring activity. It is designed to provide direction to personnel performing contract surveillance activities. Personnel surveying the contract terms and conditions and PWS requirements will periodically review the QASP throughout the life of the contract.

2.0 ROLES AND RESPONSIBILITIES

2.1 Contracting Officer’s Representative. The Contracting Officer’s Representative (COR) is responsible for quality assurance guidance and to ensure that contract quality requirements, provisions, standards, and thresholds are defined, practical, enforceable, necessary, and verifiable.

2.1.1 The COR evaluates and documents contractor performance in accordance with the QASP and PWS.

2.1.2 The COR notifies the Contracting Officer of any significant performance deficiencies using a Contractor Discrepancy Report with supporting documentation.

2.1.3 The COR maintains surveillance documentation.

2.1.4 The COR recommends improvements to the QASP and PWS throughout the life of the contract.

2.2 Contracting Officer. The Contracting Officer is responsible for safeguarding the interests of the United States Government in contractual relationships. Only the Contracting Officer is authorized to bind the Government and then, only to the extent of the authority delegated to them through the issuance of a warrant.

2.2.1 The Contracting Officer delegates authority for inspection and/or acceptance in accordance with the terms of the contract.

2.2.2 The Contracting Officer informs the contractor of the names, duties, and limitations of authority for all quality assurance personnel assigned to the contract.

3.0 DESCRIPTION OF SERVICES

3.1 Scope of Work. The scope of this contract is to provide the ability to sterilize equipment and biological test materials with high reliability in accordance with (IAW) the requirements of the Biological Defense Testing and Equipment Program. This capability will provide the sterilization needed to effectively evaluate the performance of referee biological detection and identification equipment and/or systems under test to support National and Department of Defense (DoD) priorities to counter biological threats and attacks.

4.0 QUALITY REQUIREMENTS

4.1 Quality Control Program. The contractor, not the Government, is responsible for management and quality control actions to meet the terms of the contract.

5.0 SURVEILLANCE. The COR will perform monthly surveillance based on the quality and effectiveness of the contractor’s data deliverables as well as the services provided.

5.1 Unacceptable Performance. If the number of complaints/defects exceeds the performance threshold for any objective, the COR will determine the possible cause of this unacceptable performance. Government-caused complaints/defects will not be counted against the contractor. The same applies to any other requirement of the contract when Government-caused complaints/defects are the cause of unacceptable contractor performance. If the contractor’s performance is judged unacceptable for any requirement by the COR, the COR will inform the contracting officer for resolution. Significant performance deficiencies must be submitted to the Contracting Officer using a Contractor Discrepancy Report and include supporting documentation.

6.0 DOCUMENTATION REQUIREMENTS.

6.1 Quarterly Preventative Maintenance Reports

6.2 Quarterly On-Site Calibrations and Certifications

6.3 Service Report (On-Site Assessments and Repair Visits)

6.4 Monthly spore viability reports

6.5 Service Report (on Autoclave control panel modifications)

6.6 Service Report

6.7 Training Materials

6.8 Modification Data

7.0 PERFORMANCE REQUIREMENTS SUMMARY (PRS)

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

7.2 Performance Evaluation. Performance of a service will be evaluated to determine whether or not it meets the performance threshold. Revising and resubmitting the documentation at no cost to the Government is the preferred method for correcting unacceptable performance. The contractor shall provide the Government 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.

7.3 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 SUMMAY (PRS)

Performance Objective

Standard Performance Threshold Method of Surveillance

PRS #1. Quarterly Preventative Maintenance Reports

(PWS Para 1.2, 1.2.1, 3.7; ELIN A001)

Documentation contains required information and is accurate, complete and accepted in accordance with the Data Item Description (DID) and the Government schedule.

95% accuracy and completeness with first draft.

100% accuracy with one correction/rewrite.

100% inspection of deliverables

Objective

Standard Performance Threshold Method of Surveillance

PRS # 2 Quarterly On-Site Calibrations and Certifications

(PWS Para 1.2.2, 3.2, 3.7; ELIN A003) complete and accepted in accordance with the DID and the Government’s schedule.

95% accuracy and completeness

100% accuracy and completeness with one

PRS # 3 Quarterly On-Site Calibrations and Certifications

(PWS Para 1.2.2, 3.2, 3.7; ELIN A003) complete and accepted in

100% accuracy and

PRS # 4 Monthly spore viability reports

(PWS Para 1.2.4, 3.4, 3.7; ELIN A004) complete and accepted in

100% accuracy and

PRS # 5 Service Report (on Autoclave control panel modifications)

(PWS Para 1.2.5;

ELIN A005)

complete and accepted in

100% accuracy and

PRS # 6 Service Report

(PWS Para 1.2.6, 3.6;

ELIN A006)

complete and accepted in

100% accuracy and

PRS # 7 Training Materials

(PWS Para 2.3.3;

ELIN A007)

complete and accepted in

100% accuracy and

Objective

Standard Performance Threshold Method of Surveillance

PRS # 8 Modification Data

(PWS Para 2.3.3;

ELIN A008)

complete and accepted in

100% accuracy and

The evaluation ratings are as follows:

Satisfactory - Performance meets contractual requirements. The contractual performance of the task and sub-task contain some minor problems for which corrective actions taken by the contractor appear or were satisfactory.

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