QASP HPLC-1.pdf

QUALITY ASSURANCE SURVEILLANCE PLAN (QASP)

FOR

High Pressure Liquid Chromatography (HPLC)

Equipment

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 training of Prime Power Soldiers in the aspects of the substation maintenance and assessment. The surveillance plan is site-specific and is designed to provide monitoring, inspecting and reporting of all contractor service support in aspects of the training conducted at Fort Belvoir, VA.

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 MARMC Assessment Director (for assessment task orders) and ship’s force. 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 when required by the contract Performance Requirements Summary (PRS) as noted in Technical Exhibit 1. Using this method of inspection, all the parts of the service or requirement are monitored for evaluation. Such performance requirements cover equipment and practices deemed critical for crane lift support. Failure to properly service these items would certainly have an adverse effect on the crane support.

6. 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.

7. IDENTIFIED QA SURVEILLANCE ITEMS

Performance Requirements

Required Services

Performance Objective Performance Requirement (Vendor)

Contractor travels to worksite to perform PM on HPLC components

Travel to worksite and provide labor for

HPLC PM

Premium PM on two LC-20AD pumps

Premium PM on two LC- 20AD pumps between September 30, 2023, and December 30, 2023

Perform 1 Premium PM on both LC-20AD units including the supply of necessary parts between September 30, 2023, and December 30, 2023.

During the Preventative Maintenance visit service will consist of the following:

• Remove dust from fan and electronics

• Replace plunger seals

• Replace rinse diaphragms

• Replace plungers

• Clean line filter housing

• Replace in-line and suction filters

• Clean pump heads

• Replace inlet and outlet check valves

• Inspect drain valve assembly

• Lubricate oil pads, cams and cam followers

• Perform flow rate check

Service technician will document that all maintenance items have been addressed and verify results of flow rate check. No pulsing should be occurring and pressure variation are within factory new tolerance range.

Liquid-leakage sensor and high-pressure/low-pressure limits must be functioning

Premium PM on one SIL-20AC autosampler

Premium PM on one SIL- 20AC between September 30, 2023, and December 30, 2023

Perform 1 Premium PM on one SIL-20AC unit including the supply of necessary parts between September 30, 2023, and December 30, 2023

Service technician will document that the following services were performed before leaving the work site: Inspect/Clean as needed suction filter, replace injection port needle seal, Inspect/clean HPV stator, replace metering pump plunger seal, Inspect/clean metering pump plunger, inspect needle alignment (adjust as needed), and ensure proper purge operation and test injection

Following service, autosampler must be able to maintain deliver a consistent sample volume in the range of 1 to 100 microliters with a variation of 1% or less.

Autosampler must be able to work with

1.5 ml vial or 96-well plates.

Autosampler must be able to collect and inject samples with a error rate of less than 1 in 1000.

Autosampler must be able to maintain temperature in the range or 4 to 40 degrees Celsius to within 0.25 degrees.

Premium PM on one RID-10A detector

Premium PM on one RID- 10A between September 30, 2023, and December 30, 2023

Perform 1 Premium PM on one RID-10A unit including the supply of necessary parts between September 30, 2023, and December 30, 2023

During the Preventative Maintenance visit service will consist of the following:

• Remove dust from electronics compartment

• Inspect flow path for leaks.

• Inspect for proper operation of the sample/reference solenoid valve.

• Clean detector flow path with appropriate solvent (ex: water, alcohol, <6%Nitric Acid)

• Inspect total energy.

• Replace tungsten lamp if necessary (The service life of the lamp is 20,000 hours.

Replacement is only required when the lamp energy is less than 5000 mV and lamp voltage adjustment (Lamp Volt) is not able to correct the low energy. If lamp replacement is necessary, off-site optical alignment may be required.)

• Perform sensitivity test.

• Ensure drain system adds <30 PSI back pressure at operating conditions. (>30 PSI back pressure may cause solenoid or the flow cell to develop a leak)

Service technician will document that the following services were performed before leaving the work site:

RID lamp intensity must give a stable light output that varies by less than 5% when appropriately warmed up.

RID lamp total energy must be reported.

Results of sensitivity test must be reported.

RID fluid flow lines must be clean and “balance” function must produce a stable baseline.

RID must be free of leaks.

Premium PM on one SPD-M20A detector

Premium PM on one SPD-M20A between September 30, 2023, and December 30, 2023

Perform 1 Premium PM on one SPD-M20A

During the scheduled service visit, Preventative Maintenance will consist of the following:

• Clean dust from instrument

• Replace flow cell gaskets

• Replace flow cell lenses

• Replace D2 lamp

• Replace tungsten lamp

• Perform wavelength accuracy check

• Perform lamp intensity check

• Perform “Set Light Exposure Test” upon completion of maintenance scheduled services were performed and verify wavelength accuracy and light intensity checks with operators before leaving the work site

Premium PM on one CTO-20AC column oven

Premium PM on one CTO-20AC between September 30, 2023, and December 30, 2023

Perform 1 Premium PM on one SPD-M20A

During the Preventative Maintenance visit service will consist of the following:

• Remove dust from fan and electronics

• Perform memory check

• Check for proper temperature control operation

• Check for proper leak sensor operation.

temperature control functions in setting range of 4 and 85 celcius +/- 0.1 celcius and leak sensor detection system is functional

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.