QASP - Quanterix.pdf

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

FOR

Quanterix SR-X and Microplate Washer Service

1. PURPOSE

This Quality Assurance Surveillance Plan (QASP) is a Government developed and applied document used to make sure that systematic quality assurance methods are used in the administration of the Performance Based Service Contract (PBSC) standards included in this contract and in subsequent task orders issued there under. The intent is to ensure that the Contractor performs in accordance with performance metrics set forth in the contract documents, that the Government receives the quality of services called for in the contract and that the Government only pays for the acceptable level of services received.

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 SOW requirements will periodically review the QASP throughout the life of the contract.

2. SCOPE

The QASP is put in place to provide Government surveillance oversight of the Contractor’s quality control efforts to ensure the results specified are delivered on time and meet the requirements identified in the plan.

3. GOVERNMENT RESOURCES

The following definitions for Government resources are applicable to this plan:

Contracting Officer - A person duly appointed with the authority to enter into, administer, or terminate contracts and make related determinations and findings on behalf of the Government.

Contracting Officer’s Representative (COR) - An individual designated in writing by the Contracting Officer to act as his authorized representative to assist in administering a contract. The source and authority for a COR is the Contracting Officer. COR limitations are contained in the written letter of appointment.

4. RESPONSIBILITIES:

The Government resources shall have responsibilities for the implementation of this QASP as follows:

Contracting Officer – The Contracting Officer ensures performance of all necessary actions for effective contracting, ensures compliance with the terms of the contract and safeguards the interests of the United States in the contractual relationship. It is the Contracting Officer that ensures the Contractor receives impartial, fair, and equitable treatment under the contract. 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 project and ensures proper Government surveillance of the Contractor’s performance. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. Any changes that the Contractor deems may affect contract, price, terms, or conditions shall be referred to the Contracting Officer for action.

5. METHODS OF QA SURVEILLANCE

The below listed method of surveillance shall be used in the administration of this QASP.

Inspection at the Time of Service – The method used to evaluate the contractor when required by the contract Performance Requirements Summary (PRS) as noted in paragraph 7.

Using this method of inspection, all the parts of the service are monitored for evaluation.

6. LEVELS AND STANDARDS OF SERVICE

The standards of services are held to and comply with the standards specified in the Performance Requirements Summary (PRS).

7. IDENTIFIED QA SURVEILLANCE ITEMS

Performance Requirements Summary

Required Services Performance Objective Performance Requirement

Service Contract Complete basic service and warranty package for one Quanterix SR-X System (includes the SR-X and Microplate Washer for a period of 12 months)

Instrument is clean, fully operational and meets factory specifications – BASE YEAR.

Preventative Maintenance Service

43201-2859 Assy, Oil Pump 103187 RQT Kit (5 plates) 103080 Buffer Combo Pack (A&B) 103077 Disc Kit (PM includes Parts, Labor and travel)

Instrument is clean, fully operational and meets factory specifications – BASE YEAR..

Preventative Maintenance Service

New Software Upgrade Upgrade system to the most current version of software – BASE YEAR.

Emergency Maintenance

Contractor will provide telephone and/or on-site technical support

Emergency support will be provided by factory trained engineers – BASE YEAR..

Service Contract Complete basic service and warranty package for one Quanterix SR-X System (includes the SR-X and Microplate Washer for a period of 12 months)

Instrument is clean, fully operational and meets factory specifications – OPTION YR1.

Preventative Maintenance Service

43201-2859 Assy, Oil Pump 103187 RQT Kit (5 plates) 103080 Buffer Combo Pack (A&B) 103077 Disc Kit (PM includes Parts, Labor and travel)

Instrument is clean, fully operational and meets factory specifications – OPTION YR1..

Preventative Maintenance Service

New Software Upgrade Upgrade system to the most current version of software – OPTION YR1.

Emergency Maintenance

Contractor will provide telephone and/or on-site technical support

Emergency support will be provided by factory trained engineers – OPTION YR1..

Service Contract Complete basic service and warranty package for one Quanterix SR-X System (includes the SR-X and Microplate Washer for a period of 12 months)

Instrument is clean, fully operational and meets factory specifications– OPTION YR2.

Preventative Maintenance Service

43201-2859 Assy, Oil Pump 103187 RQT Kit (5 plates) 103080 Buffer Combo Pack (A&B) 103077 Disc Kit (PM includes Parts, Labor and travel)

Instrument is clean, fully operational and meets factory specifications . – OPTION YR2.

Preventative Maintenance Service

New Software Upgrade Upgrade system to the most current version of software – OPTION YR2.

Emergency Maintenance

Contractor will provide telephone and/or on-site technical support

Emergency support will be provided by factory trained engineers– OPTION YR2.

Service Contract Complete basic service and warranty package for one Quanterix SR-X System (includes the SR-X and Microplate Washer for a period of 12 months)

Instrument is clean, fully operational and meets factory specifications– OPTION YR3.

Preventative Maintenance Service

43201-2859 Assy, Oil Pump 103187 RQT Kit (5 plates) 103080 Buffer Combo Pack (A&B) 103077 Disc Kit (PM includes Parts, Labor and travel)

Instrument is clean, fully operational and meets factory specifications – OPTION YR3..

Preventative Maintenance Service

New Software Upgrade Upgrade system to the most current version of software – OPTION YR3.

Emergency Maintenance

Contractor will provide telephone and/or on-site technical support

Emergency support will be provided by factory trained engineers – OPTION YR3..

Service Contract Complete basic service and warranty package for one Quanterix SR-X System (includes the SR-X and Microplate Washer for a period of 12 months)

Instrument is clean, fully operational and meets factory specifications – OPTION YR4.

Preventative Maintenance Service

43201-2859 Assy, Oil Pump 103187 RQT Kit (5 plates) 103080 Buffer Combo Pack (A&B) 103077 Disc Kit (PM includes Parts, Labor and travel)

Instrument is clean, fully operational and meets factory specifications– OPTION YR4. .

Preventative Maintenance Service

New Software Upgrade Upgrade system to the most current version of software – OPTION YR4.

Emergency Maintenance

Contractor will provide telephone and/or on-site technical support

Emergency support will be provided by factory trained engineers– OPTION YR4.

8. DOCUMENTATION

The COR shall, in addition to providing documentation to the Contracting Officer, maintain a complete Quality Assurance file. All such records will be retained for the life of this contract.