QASP.pdf

Quality Assurance Surveillance Plan (QASP)

1. Vision In order to maintain critical biological and pharmaceutical materials, the contractor is required to continue storage of materials at appropriate conditions in anticipation of ongoing and future activities.

2. Mission The mission of this contract is to provide continued storage and distribution of biological and pharmaceutical materials. The contractor shall be required to maintain the required level of quality in their program management, testing, data reporting and tracking and trending data to the requirements listed below in the

QASP.

3. Purpose

This Quality Assurance Surveillance Plan is a government-developed document used to determine if the contractor’s performance meets the performance standards contained in the contract. The QASP establishes procedures on how this assessment/inspection process will be conducted. It provides the detailed process for a continuous oversight process:

What will be monitored How monitoring will take place Who will conduct the monitoring How monitoring efforts and results will be documented

The contractor is responsible for implementing and delivering performance that meets contract standards using its Quality Control Plan. The QASP provides the structure for the government’s surveillance of the contractor’s performance to assure that it meets contract standards. It is the government’s responsibility to be objective, fair and consistent in evaluating contractor performance.

The QASP is not part of the contract nor is it intended to duplicate the contractor’s quality control plan. This QASP is a living document. Flexibility in the QASP is required to allow for an increase or decrease in the level of surveillance necessary based on contractor performance.

The government may provide a copy of the QASP to the contractor to facilitate open communication. In addition, the QASP should recognize that unforeseen or uncontrollable circumstances might occur that are outside the control of the contractor.

Bottom line, the QASP should ensure early identification and resolution of performance issues to minimize impact on mission performance.

4. Authority

Authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation, Inspection of Services clauses, which provides for inspection, acceptance and documentation of the service called for in the contract or order. This acceptance is to be executed by the contracting officer or a duly authorized representative.

5. Roles and Responsibilities

The following personnel shall oversee and coordinate surveillance activities.

Program/Project Manager (PM) – The PM provides primary program oversight, nominates the COR, ensures the COR is trained before performing any COR duties and supports the COR’s performance assessment activities. While the PM may serve as a direct conduit to provide Government guidance and feedback to the Contractor on technical matters, they are not empowered to make any contractual commitments or any contract changes on the government’s behalf.

Assigned PM: Christopher Spiridon Organization or Agency: JPL-CBRND Enabling Biotechnologies Telephone: 301-619-2631 Email: christopher.p.spiridon.civ@mail.mil

Contracting Officer (KO) – The KO shall ensure performance of all necessary actions for effective contracting, ensure compliance with the contract terms, and shall safeguard the interests of the United States in the contractual relationship.

The KO shall also ensure that the contractor receives impartial, fair, and equitable treatment under this contract. Determine the final assessment of the contractor’s performance.

Assigned KO: Richard Totten Organization or Agency: ACC Natick – Fort Detrick Telephone: 301-619-2446 Email: Richard.w.totten2.civ@mail.mil

Contracting Officer’s Representative (COR) The COR is responsible for providing continuous technical oversight of the contractor’s performance. The COR uses the QASP to conduct the oversight/surveillance process. The COR shall keep a Quality Assurance file that accurately documents the contractor’s actual performance. The purpose is to ensure that the contractor meets the performance standards contained in the contract. The COR is responsible for reporting early identification of performance problems to the KO. The COR is required to provide an annual performance assessment to the KO which will be used in documenting past performance. The QASP is the primary tool for documenting contractor performance. The COR is not empowered to make any contractual commitments or to authorize any contractual change on the Government’s behalf.

Assigned COR: Christopher Spiridon Organization or Agency: JPL-CBRND Enabling Biotechnologies Telephone: 301-619-2631 Email: christopher.p.spiridon.civ@mail.mil

Senior Scientist The senior scientist is responsible for providing technical input and oversight of contractor’s performance. While the Senior Scientist may serve as a direct conduit to provide Government guidance and feedback to the Contractor on technical matters, they are not empowered to make any contractual commitments or any contract changes on the government’s behalf.

Contractor Representatives

The following employees of the contractor serve as the contractor’s Program Manager and Task Manager for this contract. (Complete this section after the contract award)

Program Manager - <upon award, enter name> Telephone: <enter number> Email: <enter address>

Task Manager - <upon award, enter name>

Other Key Contract Personnel - <upon award, enter name or delete these lines if not applicable> Title: <enter title>

6. Performance Requirements and Method of Surveillance

6.1. Contract Surveillance

The goal of the QASP is to ensure that contractor performance is effectively monitored and documented. The COR’s contribution is their professional, non-adversarial relationships with the KO, PM and the contractor, which enables positive, open and timely communications. The foundation of this relationship is built upon objective, fair, and consistent COR evaluations of contractor performance against contract requirements. The COR uses the methods contained in this QASP to ensure the contractor is in compliance with contract requirements. The COR function is responsible for a wide range of surveillance requirements that effectively measure and evaluate the contractor’s performance.

Additionally, this QASP is based on the premise that the contractor, not the government, is responsible for management and QC/QA actions to successfully meet the terms of the contract.

6.2. Surveillance Matrix

The Surveillance Matrix (Attachment 1) is the list of performance objectives and standards that must be performed by the contractor. This matrix details the method of surveillance the COR will use to validate and inspect these performance elements. Inspection of each element will be documented in the COR file.

Performance objectives define the desired outcomes. Performance Standards define the level of service required under the contract to successfully meet the performance objective. The inspection methodology defines how, when, and what will be assessed in measuring performance. The Government performs surveillance, using this QASP, to determine the quality of the contractor’s performance as it relates to the performance element standards. The Performance Requirement Summary (PRS) should be used to form the foundation of the COR’s inspection checklist.

6.3. Performance Rating Definitions

In evaluating the quality of contractor’s performance, the following performance ratings may be used.

[ If your organization requires that you use a different rating mechanism, insert it here. ]

Performance Criteria

Rating

Excellent / Outstanding

Performance meets contractual requirements and exceeds many to the government’s benefits. The contractual performance of the element or sub-element being assessed was accomplished with no problems and contractor actions were highly effective.

Very Good Performance meets contractual requirements and exceeds some to the government benefits. The contractual performance was accomplished with few minor problems for which corrective actions taken by the contractor were effective.

Good Performance meets contractual requirements. The contractual performance contains some minor problems for which corrective actions taken by the contractor were satisfactory.

Marginal Performance does not meet some contractual requirements.

The contractual performance reflects a serious problem for which the contractor has not yet identified corrective actions.

The contractor’s proposed actions appear marginally effective or were not fully implemented.

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

7. Performance Reporting

7.1. Performance Assessment Report

PARs will be used to report ALL minor discrepancies and will be generated by the COR and sent to the contractor for corrective action. Contractors will be given 10 days to correct PARs unless they have requested an extension. If 3 minor discrepancies are found, combine them and process a CAR.

7.2. Customer Complaint Form

The COR must furnish instructions to the customer receiving the contractor’s service. The customer must retain supporting evidence of complaint or feedback.

After the COR validates feedback or complaint demonstrating contractor noncompliance, the COR processes a Performance Assessment Report (PAR) or Corrective Action Report (CAR) to the KO. ALL Customer Complaint forms WILL be validated by the COR prior to notifying the contractor.

7.3. Corrective Action Report (CAR)

The COR will forward the CAR to the KO for action. A copy will be provided to the contractor’s representative by the KO. Most CARs will be corrected within 30 calendar days depending on the complexity of the finding, the contractor may be allowed up to six months (maximum) correcting a CAR. The contractor will be asked the status of the CAR on a monthly basis. The COR will keep an electronic log of all CARs and will keep a hard copy of CARs in the contract oversight file.

7.4. Contract Performance Assessment Reporting System

(CPARS)

CPARS will be initiated annually, documenting contractor performance for this specific contract. More frequent updates may be made as required to document a significant improvement or degradation of the level of contract performance.

Appendix 1 - Surveillance Matrix

PWS

Paragrap h

Performance Objective / Elements

Standards / AQL Inspection Calculation / Ratings What How/ Method When/

Freq SOO Section 1: Contractor shall submit a monthly status report and hold biweekly meetings. The contractor shall provide a written monthly report to provide an update on the data generated and status of deliverables

COR will ensure that monthly reports are received from the contractor that are accurate and complete and will ensure a biweekly status update call occurs

COR will receive monthly reports from the contractor via email and biweekly meetings will occur via teleconference.

IAW CDRL A001 and CDRL A002

Delivery shall be on the 15th day of the month in contractor format.

Contractor shall receive an unsatisfactory rating if reports are received after the 15th of the month without approval or are inaccurate.

SOO Section 1: The Contractor shall submit testing results and the Standard Operating Protocols (SOP) used for each stability time point.

COR will ensure that the testing document will show the stability testing data, quality charts, environmental monitoring records, inspection reports for the entire production process for testing of the required materials and a certificate of analysis all reviewed and signed by contractors QA group. IAW CDRL A003 and CDRL A004

Delivery shall be within 30 days of completion of testing

Contractor shall receive an unsatisfactory rating if reports are delayed without approval or are inaccurate, testing not completed according to SOPs, or missing documentation, signature, or data.

Inspection Metrologies:

M1: Periodic. Periodic surveillance/inspection is the type of surveillance that is based upon selecting samples for evaluation on other than 100% inspection or on a statistically random basis. Periodic surveillance can be accomplished, weekly, monthly or quarterly using a checklist method.

M2: Inspection of Reports. All reports shall be reviewed upon receipt. The reviewer will report any flaws in the document and categorize the flaws (Editorial, Format, and/or Substance).

M3: Technical Inspection: Surveillance/inspection is the type of surveillance that will be performed as specified on the project schedule by actually looking at the work being done.

M4: Non-Service Summary. Assessment of Non-SS Items: All other tasks required under the CET may be inspected on a random basis at a frequency determined by the Functional Commander/Functional Director (FC/FD), CO, and/or COR per the Inspection of Services Clause in the contract. Non-SS Items will be verified by the COR at least quarterly or on an event basis as required.

0 BCORRECTIVE ACTION REPORT (CAR)

(If more space is needed, use reverse and identify by number)

1. CONTRACTOR 2. CONTRACT NUMBER 3. TYPE OF SERVICES

4. FUNCTIONAL AREA 5. SUSPENSE DATE 6. CONTROL NUMBER

7. DEFICIENCY MAJOR MINOR

FINDING:

FINDING IMPACT:

Please respond with a written corrective action plan that details the corrective action of the cited deficiency, the cause of the deficiency, and actions taken to prevent recurrence by Suspense Date in Block 5. If date was not entered in Block 5, the contractor is not required to provide a response.

5 B8. QUALITY ASSURANCE PERSONNEL (COR)

6 BTYPED NAME AND GRADE

7 BSIGNATURE AND DATE

8 B9. ISSUING AUTHORITY

9 BTYPED NAME AND GRADE

1 0 BSIGNATURE AND DATE

10. COR RESPONSE TO CONTRACTOR CORRECTIVE ACTION AND ACTION TAKEN TO PREVENT RECURRENCE

11. COR DETERMINATION

ACCEPTED REJECTED

12. CLOSE DATE

CUSTOMER COMPLAINT RECORD

DATE/TIME OF COMPLAINT

SOURCE OF COMPLAINT

ORGANIZATION BUILDING NUMBER INDIVIDUAL PHONE NUMBER

NATURE OF COMPLAINT

CONTRACT REFERENCE

VALIDATION

DATE/TIME CONTRACTOR INFORMED OF COMPLAINT

ACTION TAKEN BY CONTRACTOR

RECEIVED/VALIDATED BY

1 BPERFORMANCE ASSESSMENT REPORT (PAR)

(If more space is needed, use reverse and identify by number)

1. CONTRACT/TASK ORDER NUMBER 2. CONTRACTOR 3. TYPE OF SERVICES

2 B4. QUALITY ASSURANCE PERSONNEL (COR) SIGNATURE AND DATE

3 B5. COR PHONE

4 B6. SUSPENSE DATE

1 1 BI. PERFORMANCE

7. DEFICIENCY (CHECK ALL BOXES THAT APPLY)

NEW

REPEAT

NO DEFICIENCY NOTED

8. SERVICES SUMMARY or PWS PARAGRAPH ITEM REVIEWED

9. BRIEF DESCRIPTION OF DEFICIENCY (IF DEFICIENCY BOX WAS

CHECKED)

10. DETAILED PERFORMANCE ASSESSMENT

1 2 BII. CONTRACTOR VALIDATION

11. CONTRACTOR REPRESENTATIVE CONCUR NON-CONCUR 12. CORRECTIVE ACTION ESTIMATED COMPLETION DATE

13. CONTRACTOR REPRESENTATIVE CORRECTIVE ACTION AND PREVENTION OF RECURRENCE OR REASON FOR NON-

CONCURRENCE OF COR CITED DEFICIENCY

1 3 BIII. ACTION CORRECTED

14. CONCUR NON-CONCUR COR SIGNATURE AND DATE

15. COR REMARKS (REQUIRED)

6. CONTRACTOR REPRESENTATIVE REMARKS