QASP_Sciclone.pdf

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

FOR

SUBSTATION MAINTENANCE I & II ILT

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.

The Contracting Officer’s Representative (COR) will monitor the functioning of the instrument. The surveillance plan is site-specific and is designed to provide monitoring, inspecting and reporting of all contractor service support in aspects of the smooth functioning of the instrument at Madison, WI.

2. SCOPE

The QASP is put in place to provide Government surveillance oversight of the Contractor’s quality control efforts to ensure the products/results specified in the PR&C or task order are delivered on time and meet the requirements of the PR&C or task order. The QASP is not intended to duplicate the Contractor’s Management 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 methods of surveillance shall be used in the administration of this QASP.

Customer Feedback – Customer feedback may be obtained from random customer complaints. Customer complaints, to be considered valid, must set forth clearly and in writing the detailed nature of the complaint, must be signed and must be forwarded to the COR. The COR shall maintain a summary log of all formally received customer complaints as well as a copy of each complaint in a documentation file.

Periodic Inspection – The COR shall conduct periodic inspections by verifying documentation from the contractor. For the potential tasks identified in the Performance Work Statement, the COR typically performs the periodic inspection on a monthly basis.

100% Inspection – The method used to evaluate the contractor. All the parts of the service or requirement are monitored for evaluation.

LEVELS AND STANDARDS OF SERVICE

The standards of services are held to and comply with the standards specified in the PR&C, commercial/industry, and military/government standards.

6. IDENTIFIED QA SURVEILLANCE ITEMS

Performance Requirements

Required Services

Performance Objective Performance Requirement

Hardware • Functional 96 Channel Head for Aspirating and Dispensing of reagents and samples

• Volume range of the 96 channel head from 1- 200ul and Process single well, single column, single row or complete plate

• Three temp controlled locators capable of adjusting and holding temperatures at 4- 100°C.

• One shaking locator is capable of adjusting and holding temperature of 4-70°C

• Magnetic bead locator

• Microplate gripper for automated consumable management

• Four-sided environmental enclosure with access doors: prevent access and preserve sample integrity during a running assay.

Opening the doors of the enclosure results in

After service repair, the instrument meets the original, factory performance of all the hardware an immediate soft stop of the robot motions which may be resumed upon closing the doors.

• Instrument enclosure capable of supporting either an optional UV light, HEPA filtration device and/or an active (fan) external fume port.

• Optional LV and NL aspirating & dispense heads

• Optional 8 channel (single well) pipetting option

• Optional barcode reader wand and/or deck mounted reader

• 24 position deck with 4 axis motion control (XYZ/gripper)

• Plate and tip box disposal chute accessible by gripper

• On deck tip disposal chute

Gripper • To ensure the proper function of the gripper that is independent of the multichannel pipetting head, and that enables the instrument to pick up a microplate lid while simultaneously carrying out pipetting operations with the multi-channel pipetting head.

• To ensure The gripper has the ability to stack, de-stack, and transfer plates/equipment among all 24 deck positions.

• To ensure the proper function of a built-in detector which confirms when a plate has been successfully gripped, and if one has not been gripped or has become dislodged, the software pause the instrument and initiate an error condition.

After service repair, the gripper meets the original, factory performance of all the hardware

Sciclone G3

NGS

Workstation Software

• To ensure the Maestro software is regularly updated with the most recent version

• To ensure that Maestro software operates the Sciclone G3 NGS Workstation and coordinates all operational steps

• To ensure the Application Assistant features operates with an intuitive user interface and simplified protocol setup to support users of all levels

• To ensure the proper function of E-mail notification of status

• To ensure the continuation of unattended runs when connected to the internet repair, the instrument software meets the original, factory

LIMS and Analysis Compatibility

• To ensure and maintain the integrated barcode reading capabilities to barcodes on sample, reagent, and other receptacles

• To ensure the ability to write log files with sample tracking information to network folders, specified directories to be uploaded and parsed to database tables repair, the instrument meets the original, factory

7. 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.