Attch09TOQASP22DEC2020.docx
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- Solicitation number
- W81XWH21R0078
- Issued by
-
Department of the Army Medical Command
About this file
This document is a Quality Assurance Surveillance Plan (QASP) for a task order solicitation to provide regulated activities support services to the U.S. Army Medical Research and Development Command Office of Regulated Activities. The solicitation seeks clinical, nonclinical, manufacturing, and regulatory support services within an integrated product team framework. Key deliverables include regulatory documents, study protocols and reports, data management and statistical analysis plans and reports, quality management plans and procedures, and safety surveillance documentation. Performance standards define the required quality levels for 74 separate deliverables across various technical support areas. Acceptable quality levels and inspection methods are outlined, with incentives based on past performance ratings for meeting or exceeding standards. The QASP establishes the surveillance methods and procedures to be used by the contracting officer's representative to evaluate the contractor's performance and documentation of acceptable or unacceptable performance.
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W81XWH21R0078
Task Order 1 QASP
ATTACHMENT 9: TASK ORDER 1 QUALITY ASSURANCE SURVEILLANCE PLAN
Request for Proposal: W81XWH21R0078
Original Date: 22 Dec 2020 Revised Date: N/A Title: REGULATED ACTIVITIES SUPPORT SERVICES Requiring Activity/Agency Name: Office of Regulated Activities (ORA), U.S. Army Medical Research and Material Command (USAMRMC) Program Name: N/A Task Order Number: < upon award, enter number>
Task Order Description: This task order is for (1) regulatory consultation, (2) regulatory oversight, and (3) Contract Research Organization (CRO) support to include administrative, financial, clinical, nonclinical, manufacturing and regulatory support for drugs, biologics, and devices within an integrated product team framework.
Contractor’s Name: < upon award, enter contractor name > (hereafter referred to as the contractor).
1. PURPOSE.
This Quality Assurance Surveillance Plan (QASP) provides a systematic method to evaluate performance for the stated contract. This QASP explains the following:
1. What will be monitored.
1. How monitoring will take place.
1. Who will conduct the monitoring.
1. How monitoring efforts and results will be documented.
This QASP does not detail how the contractor accomplishes the work. Rather, the QASP is created with the premise that the contractor is responsible for management and quality control actions to meet the terms of the contract. It is the Government’s responsibility to be objective, fair, and consistent in evaluating performance. In addition, the QASP should recognize that unforeseen and uncontrollable situations may occur.
This QASP is a “living document” and the Government may review and revise it on a regular basis. However, the Government shall coordinate changes with the contractor. Updates shall ensure that the QASP remains a valid, useful, and enforceable document. Copies of the original QASP and revisions shall be provided to the contractor and Government officials implementing surveillance activities.
The following FAR clause will apply:
52.212-4 Contract Terms and Conditions--Commercial Items
2. GOVERNMENT ROLES AND RESPONSIBILITIES.
The following personnel shall oversee and coordinate surveillance activities.
a. 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 assure that the contractor receives impartial, fair, and equitable treatment under this contract. The KO is ultimately responsible for the final determination of the adequacy of the contractor’s performance.
Assigned KO: <to be entered by contracting activity upon award> Organization or Agency: <to be entered by contracting activity upon award> Telephone: <to be entered by contracting activity upon award> Email: <to be entered by contracting activity upon award>
b. Contracting Officer’s Representative (COR) - The COR is responsible for technical administration of the contract and shall ensure proper Government surveillance of the contractor’s performance. The COR shall keep a quality assurance file and record all quality assurance activities in the Procurement Integrated Enterprise Environment (PIEE) Surveillance and Performance Monitoring (SPM) system. At the conclusion of the contract or when requested by the KO, the COR shall provide documentation to the KO. The COR is not empowered to make any contractual commitments or to authorize any contractual changes on the Government’s behalf. The contractor shall refer any changes they deem may affect contract price, terms, or conditions to the KO for action.
Assigned COR: <to be entered by COR upon award> Title: <to be entered by COR upon award> Telephone: <to be entered by COR upon award> Email: <to be entered by COR upon award>
c. Other Key Government Personnel –
Name: <to be entered by COR upon award> Title: <to be entered by COR upon award> Telephone: <to be entered by COR upon award> Email: <to be entered by COR upon award>
3. CONTRACTOR REPRESENTATIVES:
The following employees of the contractor serve as the contractor’s Program Manager and Contract Manager for this contract.
a. Program Manager - <upon award, enter name> Telephone: <enter number> Email: <enter address>
b. Contract Manager - <upon award, enter name> Telephone: <enter number> Email: <enter address>
c. Other Contractor Personnel - <upon award, enter name or delete these lines if not applicable> Title: <enter title> Telephone: <enter number> Email: <enter address>
4. PERFORMANCE STANDARDS.
Performance standards define desired services. The Government performs surveillance to determine if the contractor exceeds, meets or does not meet these standards.
The Performance Requirements Summary Matrix, shown below, includes performance standards. The Government shall use these standards to determine contractor performance and shall compare contractor performance to the Acceptable Quality Level (AQL).
| PWS Task Reference |
| Deliverable |
| Indicator |
| Standard |
| Acceptable Quality Level |
| Method of Surveillance |
| Incentive |
6.2
| 1 |
| Monthly Task Progress Report is accurate and complete |
| Contains a comprehensive list of all work being performed. |
| 90% |
| 100% inspection |
| Positive past performance rating |
| 6.10 |
| 6 |
| Verification of Contractor Manpower Reporting |
| Submitted annually by 31 October |
| 100% |
| 100% Inspection |
| Positive past Performance rating |
| 10.0 |
| 7 |
| Non-disclosure Agreements submitted for each employee |
| Submitted for each employee assigned, prior to that employee performing ANY work on this task order. |
| 100% |
| 100% Inspection |
| Positive past performance rating |
| 6.6 |
| 9 |
| Accountability |
| Report received by 9 AM daily |
| 95% |
| 100% Inspection |
| Positive past performance rating |
| 5.2.2 |
| 10 |
| Regulatory Strategy |
| Compliant with all applicable regulatory requirements and delivered within 60 business days of request |
| 95% |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.2 |
| 11 |
| Target Product Profile |
| Per FDA Industry guidance and delivered within 60 days after project assignment |
| 95% |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.3 |
| 12 |
| Study Protocol and Related Documents Review / Revisions |
| Delivered within 10 business days of revision |
| Per internal ORA Standard SOPs for Clinical management |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.3 |
| 13 |
| Sample Handling Instructions |
| Delivered no less than 30 business days after assignment |
| Per internal ORA Standard SOPs for Clinical management |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.3 |
| 14 |
| Study Specific Grading Criteria |
| Complete NLT 5 business days prior to visit |
| Per internal ORA Standard SOPs for Clinical management |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.3 |
| 15 |
| Sample Accountability Log |
| Delivered NLT 5 business days after project assignment update request to previously developed logs |
| Per internal ORA Standard SOPs for Clinical management |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.4 |
| 16 |
| Clinical Monitoring Plan (CMP) |
| Received NLT 21 calendar days of visits |
| Per internal ORA Standard SOPs for Clinical management |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.4 |
| 17 |
| Clinical Monitoring Reports |
| Draft delivered within 10 days of the visit and final reports delivered within 30 days of visit |
| Per internal ORA Standard SOPs for Clinical management |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.4 |
| 18 |
| Protocol Deviation, Violation and Non-compliance Reports |
| Delivered within 24 hours of becoming aware of major deviations/viola-tions/noncompli-ance and within 10 days of becoming aware of minor deviations |
| Per internal ORA Standard SOPs for Clinical management |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.5 |
| 19 |
| Data Management Plan |
| Submit a final Data Management Plan (DMP) that meets Good Clinical Data Management Practice (GCDMP) 14 business days for review and approval prior to study start |
| Approved DMP meets GCDMP |
| 100% Inspection |
| Positive past performance rating |
| 5.2.5 |
| 20 |
| Blank Case Report Form(s) |
| Final CRF submitted 14 business days for review and approval prior to study start |
| Approved CRF must conform to applicable CDASH/CDISC Standards |
| Random Sampling |
| Positive past performance rating |
| 5.2.5 |
| 21 |
| CDASH/ |
CDISC Compliant Annotated electronic Case Report Forms (eCRF)
| CDASH/CDISC Compliant Annotated Case Report Forms submitted 7 business days prior to database release for production |
| Approved eCRF that is compliant with CDASH/ |
CDISC
| Periodic sampling |
| Positive past performance rating |
| 5.2.5 |
| 22 |
| CDASH/ |
CDISC Compliant Database Specifications
| CDASH/CDISC Compliant Database Specifications submitted 7 days prior to database release to production |
| CDASH/ |
CDISC Compliant Database Specification in compliance with approved DMP
| Periodic sampling |
| Positive past performance rating |
| 5.2.5 |
| 23 |
| Database Testing & Validation Documentation |
| Database Validation Documentation submitted NLT 7 business days prior to database release to production |
| Approved Database Validation Documentation that confirm accurate database validation prior to release to production and in compliance with approved DMP |
| Random Sampling |
| Positive past performance rating |
| 5.2.5 |
| 24 |
| Completed medical coding reports, Case Report Forms and Related Queries and Audit Trail Report |
| Completed Case Report Forms and Related Queries and Audit Trail Report submitted 30 days after study-specific database lock |
| Completed Case Report Forms and Related Queries and Audit Trail Report in compliance with approved DMP |
| Random Sampling |
| Positive past performance rating |
| 5.2.5 |
| 25 |
| Data Quality Evaluation Documentation |
| Data Quality Evaluation Documentation submitted 30 business days after database lock |
| Data Quality Evaluation Documentation per GCDMP and in compliance with approved DMP |
| Random Sampling |
| Positive past performance rating |
| 5.2.5 |
| 26 |
| Data Reconciliation Documentation |
| Data Reconciliation Documentation submitted 5 business days after reconciliation is completed |
| Data Reconciliation Documentation per GCDMP and in compliance with approved DMP |
| Random Sampling |
| Positive past performance rating |
| 5.2.5 |
| 27 |
| Final RAW Data in SAS and compliant to CDASH and applicable CDISC standards |
| Final RAW Data submitted 30 business days after database lock |
| Final RAW Data in SAS and compliant to CDASH and applicable CDISC standards |
| Random Sampling |
| Positive past performance rating |
| 5.2.6 |
| 28 |
| Statistical Analysis Plan |
| Final Statistical Analysis Plan submitted 15 business days for review and approval prior to study start |
| Per internal ORA Standard SOPs for Biostatistical management |
| Random Sampling |
| Positive past performance rating |
| 5.2.6 |
| 29 |
| Statistical Programming Validation Plans (SPV) and Reports |
| Final SPV Plan submitted 15 business days for review and approval prior to study start |
| Per internal ORA Standard SOPs for Biostatistical management |
| Random Sampling |
| Positive past performance rating |
| 5.2.6 |
| 30 |
| Randomization Plan |
| Final Randomization Plan submitted 15 business days for review and approval prior to study start |
| Per internal ORA Standard SOPs for Biostatistical management |
| Random Sampling |
| Positive past performance rating |
| 5.2.6 |
| 31 |
| Statistical Programs for Tables, Listings and Figures (TLFs) |
| NLT due date requested to meet regulatory timelines |
| Per internal ORA Standard SOPs for Biostatistical management |
| Random Sampling |
| Positive past performance rating |
| 5.2.6 |
| 32 |
| Populated TLFs |
| NLT due date requested to meet regulatory timelines |
| Per internal ORA Standard SOPs for Biostatistical management |
| Random Sampling |
| Positive past performance rating |
| 5.2.6 |
| 33 |
| CDISC Validation Plan and Reports |
| NLT due date requested to meet regulatory timelines |
| Per internal ORA Standard SOPs for Biostatistical management |
| Random Sampling |
| Positive past performance rating |
| 5.2.6 |
| 34 |
| Develop CDISC-compliant Datasets |
| NLT due date requested to meet regulatory timelines |
| Per internal ORA Standard SOPs for Biostatistical management |
| Random Sampling |
| Positive past performance rating |
| 5.2.6 |
| 35 |
| CDISC Reviewer's Guide |
| NLT due date requested to meet regulatory timelines |
| Per internal ORA Standard SOPs for Biostatistical management |
| Random Sampling |
| Positive past performance rating |
| 5.2.6 |
| 36 |
| Written responses to FDA requests / queries |
| NLT due date requested by FDA |
| Per internal ORA Standard SOPs for Biostatistical management |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.7 |
| 37 |
| Safety Surveillance Plans |
| NLT 30 business days after request |
| Plan approved by Product Safety Surveillance Office (PSSO) |
| 100% inspection |
| Positive past performance rating |
| 5.2.7 |
| 38 |
| Safety Management Plan |
| Approved safety management plan within 30 days of site initiation visit |
| Approved plan in compliance with FDA, ICH, Office for Human Research Protections (OHRP), and DoD regulations. |
| 100% inspection |
| Positive past performance rating |
| 5.2.7 |
| 39 |
| Final Signed Data and Safety Monitoring Board (DSMB) Charter |
| Approved DSMB Charter NLT 1 business day of obtaining all signatures and prior to study start. |
| Provide a DSMB charter in compliance with approved SOP. |
| 100 % inspection |
| Positive past performance rating |
| 5.2.7 |
| 40 |
| DSMB Agenda |
| Agenda NLT 5 business days prior to DSMB meeting |
| Provide agenda with accepted approval by PSSO. |
| 100% inspection |
| Positive past performance rating |
| 5.2.7 |
| 41 |
| DSMB Meeting Minutes |
| Meeting minute draft due 1 business day after meeting and final after DSMB chair approval signature |
| Provide meeting minutes for each DSMB meeting (organizational, open, closed, ad hoc) that includes all discussion, outcomes, recommendations, action items, and responsible party with approval Signatures (DSMB Chair, USAMRMC Representative) |
| 100% Inspection |
| Positive past performance rating |
| 5.2.7 |
| 42 |
| DSMB Chair Recommenda- |
tion
| NLT 1 business day after meeting |
| Provide in writing the DSMB recommendations concerning the continuation, modification, or termination of the clinical trial. |
| 100% inspection |
| Positive past performance rating |
| 5.2.7 |
| 43 |
| Pharmacovigi-lance Document Review, Analysis and Development |
| NLT 15 days business days after request |
| Provide a white paper per industry standard and/or Provide a risk benefit analysis and mitigation plan that describes a systematic approach to risk management to include at a minimum, identifying, assessing, mitigating and evaluation of risk. |
| 100% inspection |
| Positive past performance rating |
| 5.2.8 |
| 44 |
| Written report of Chemistry, Manufacturing, and Controls (CMC) Support and Investigational Product Support |
| NLT 30 business days after project assignment |
| Must be in compliance with all applicable regulatory requirements |
| 100% Inspection |
| Positive past performance rating |
| 5.2.8 |
| 45 |
| Regulatory Submissions Documents |
| NLT 10 business days or as requested by the Government |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.8 |
| 46 |
| IP Storage and Handling Instructions |
| NLT 5 business days after document receipt |
| Must be in compliance with all applicable regulatory requirement and have no more than 5% failure to comply per month |
| 100% Inspection |
| Positive past performance rating |
| 5.2.8 |
| 47 |
| IP Testing Data Review, Analysis and Corrective and Preventive Action Plans |
| NLT 10 business days of document receipt |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.8 |
| 48 |
| IP Shipment, Accountability and Cold Chain Management Documentation and Files |
| NLT 2 business days after document receipt |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.8 |
| 49 |
| Manufacturing Site Visit Reports |
| Review and approve site visit agenda and report |
| Visit agenda provided in advance; Report completed within 30 days of site visit |
| 100% inspection |
| Positive past performance rating |
| 5.2.8 |
| 50 |
| Master Batch and/or Batch Production Record Review and Analysis |
| NLT 30 business days after document receipt |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.8 |
| 51 |
| Stability Protocol and/or Stability Report Reviews and Revisions |
| NLT 10 business days after document receipt |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.8 |
| 52 |
| Bioanalytical/Analytical Method Qualification and Validation Protocol and Report |
| NLT 30 business days of request |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.8 |
| 53 |
| GMP and GLP Audit Support |
| Review and approve audit agenda and report |
| Audit agenda provided in advance; Report completed within 30 days of site visit |
| 100% inspection |
| Positive past performance rating |
| 5.2.8 |
| 54 |
| Equipment Qualification, and Validation Reports |
| Conducted as requested with report due NLT 30 business days after site visit |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.8 |
| 55 |
| Review of IQ, OQ, PQ Protocol and Reports |
| NTL 10 business days after document receipt |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.8 |
| 56 |
| Review of CMC Deviation Reports |
| NLT 5 business days after receipt of report |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.8 |
| 57 |
| OOS Reports / Documentation Review |
| NLT 5 business days after receipt of report |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.8 |
| 58 |
| Validation Protocol and Report Review and Analysis |
| NLT 5 business days after receipt of report |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.9 |
| 59 |
| Non-Clinical Study Designs, Protocols and Reports |
| NLT 5 business days after receipt of report |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.9 |
| 60 |
| GLP and non-GLP Protocols and Reports |
| NLT 30 business days after request of document |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.9 |
| 61 |
| Nonclinical Documents |
| NLT 30 business days after request and document receipt |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.2.10 |
| 62 |
| Regulatory Documents for FDA Submission |
| NLT 5 business days after project assignment or as requested by the Government |
| Must be in compliance with all applicable regulatory requirements and sponsors standards |
| 100% inspection |
| Positive past performance rating |
| 5.2.10 |
| 63 |
| Writing Product Tracker |
| Delivered bi-weekly |
| Must be in compliance with all applicable regulatory requirements and sponsors standards |
| Periodic Inspection |
| Positive past performance rating |
| 5.3.1 |
| 64 |
| e-submission ready documents |
| NLT 10 business days after submission workflow initiation |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.3.1 |
| 65 |
| Initial Published outputs and validation report of eCTD dossiers |
| Completed with no errors |
| Must be in compliance with all applicable regulatory requirements |
| 100% inspection |
| Positive past performance rating |
| 5.3.1 |
| 66 |
| Quality assurance and re-published eCTD Dossiers Review Comments |
| Completed within 2 calendar days with no errors |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.3.1 |
| 67 |
| FDA gateway submission acknowledge-ment |
| Delivered upon receipt |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.3.2 |
| 68 |
| Audit ready sponsor's electronic regulatory files |
| Gap Analysis of the TMF |
| Accurate and contemporaneous, Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.3.2 |
| 69 |
| Log of Sponsor File Tracking |
| Delivered within 5 business days of request |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.4.2 |
| 70 |
| Quality Audit Plans and Reports |
| Plans delivered complete & accurate as requested by the Government, report due NLT 30 business days after site visit |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.4.3 |
| 71 |
| Clinical Quality Assurance Management Plans |
| Plans delivered complete & accurate as requested by the Government, report due NLT 30 business days after site visit |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.4.4 |
| 72 |
| Cold Chain Management Plans |
| Plans delivered complete and accurate and within the time frame as requested by the Government |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.4.6 |
| 73 |
| Quality System and Procedure SOPs |
| Complete and accurate and within the time frame as requested by the Government |
| Must be in compliance with all applicable regulatory requirements |
| Periodic Inspection |
| Positive past performance rating |
| 5.6 |
| 74 |
| Certified Translated Documents |
| Complete and accurate |
| Translated document and certification of each translation |
| 100% inspection |
| Positive past performance rating |
5. INCENTIVES.
The Government shall use past performance as incentives. Incentives shall be based on exceeding, meeting, or not meeting performance standards.
6. METHODS OF QA SURVEILLANCE.
Various methods exist to monitor performance. The COR shall use the surveillance methods listed below in the administration of this QASP.
Regardless of the surveillance method, the COR shall always contact the contractor's task manager or on-site representative when a defect is identified and inform the manager of the specifics of the problem. The COR shall be responsible for monitoring the contractor’s performance in meeting a specific performance standard/AQL.
PERIODIC INSPECTION: Uses a comprehensive evaluation of selected outputs. Inspections may be scheduled [Daily, Weekly, Monthly, Quarterly, or annually] or unscheduled, as required.
100% INSPECTION: Evaluates all outputs. Most applicable to small quantity, but highly important services. May be used where there are written deliverables and stringent requirements such as tasks required by law, safety, or security.
PERIODIC SAMPLING: Relies on the user of the service to identify deficiencies. Complaints are then investigated and validated. Highly applicable to services provided in quantity and where quality is highly subjective.
RANDOM SAMPLING: Designed to evaluate the outputs of the award requirement by randomly selecting and inspecting a statistically significant sample. Highly recommended for large quantity repetitive activities with objective and measurable quality attributes.
7. RATINGS.
Metrics and methods are designed to determine if performance exceeds, meets, or does not meet a given standard and acceptable quality level. A rating scale shall be used to determine a positive, neutral, or negative outcome. The following ratings shall be used:
| EXCEPTIONAL: |
| Performance significantly exceeds contract requirements to the Government’s benefit. |
| SATISFACTORY: |
| Performance meets contractual requirements. |
| UNSATISFACTORY: |
| Performance does not meet contractual requirements. |
8. DOCUMENTING PERFORMANCE.
a. ACCEPTABLE PERFORMANCE.
The Government shall document positive performance. A report will be generated each month in the Wide Area Work Flow Contracting Officer’s Representative Tracking (CORT) Tool. Any report may become a part of the supporting documentation for fixed fee payments, award fee payments, or other actions.
b. UNACCEPTABLE PERFORMANCE.
When unacceptable performance occurs, the COR shall inform the contractor. This will normally be in writing unless circumstances necessitate verbal communication. In any case the COR shall document the discussion and place it in the COR file.
When the COR determines formal written communication is required, the COR shall prepare a Contract Discrepancy Report (CDR) and present it to the Program or Contracts Manager. A CDR template is attached to this QASP.
The contractor shall acknowledge receipt of the CDR in writing. The CDR will specify if the contractor is required to prepare a corrective action plan to document how the contractor shall correct the unacceptable performance and avoid a recurrence. The CDR will also state how long after receipt the contractor has to present this corrective action plan to the COR. The Government shall review the contractor's corrective action plan to determine acceptability.
Any CDRs may become a part of the supporting documentation for contract payment deductions, fixed fee deductions, award fee nonpayment, or other actions deemed necessary by the KO.
9. FREQUENCY OF MEASUREMENT.
a. Frequency of Measurement.
During contract performance, the COR shall take periodic measurements, as specified in the AQL column of the Performance Requirements Summary Matrix, and shall analyze whether the negotiated frequency of measurement is appropriate for the work being performed.
b. Frequency of Performance Assessment Meetings.
The COR shall meet with the contractor quarterly to assess performance and shall provide a written assessment.
10. REVISIONS.
The QASP is subject to change at any time at the Government’s discretion. The QASP is not incorporated into the contract order, therefore changes, if made, do not necessitate a contract modification. However, if there are changes to this QASP, the contractor will be notified promptly and provided a copy of the changes.
Prepared by:
Jami Clevenger Contracting Officer’s Representative
PERFORMANCE REPORT
1. CONTRACT NUMBER: <insert number>
2. Prepared by: (Name of COR) <insert name>
3. Date and time of observation:
4. Observation:
<Examples of items to include in a report are:
- Method of surveillance.
- How frequently you conducted surveillance.
- Surveillance results.
- Number of observations.>
Prepared by: <Enter COR’s name>
| _____________________________ | ________________ | |
| Signature – Contracting Officer’s Representative | Date |
CONTRACT DISCREPANCY REPORT (CDR):
<This report is to be completed by the COR if a performance issue arises>
1. Contract Number: <insert number>
2. TO: (Program Manager or on-site representative) <insert name>
3. FROM: (Name of COR) <insert name>
4. Date and time observed discrepancy:
5. DISCREPANCY OR PROBLEM:
<Describe in detail. Identify any attachments.>
5. Corrective action plan:
A written corrective action plan < is / is not > required.
< If a written corrective action plan is required include the following. > The written Corrective Action Plan will be provided to the undersigned not later than < # days after receipt of this CDR. >
Prepared by: <insert name>
| _____________________________ | ________________ | |
| Signature – Contracting Officer’s Representative | Date |
Received by:
| _____________________________ | ________________ | |
| Signature - Program Manager or on-site representative | Date |
File details come from the government source that posted it. Updated .