Attachment_08_-_QASP.pdf

ATTACHMENT 08: Quality Assurance Surveillance Plan (QASP)

USAMMA Sets, Kits, Outfits (SKO) Supply Requirement

1 Vision

USAMMA SKOs Supply requirement is to promote and enhance the Army Medical Department’s (AMEDD) ability to continue its global support to the U.S. Army Medical Force and America’s war fighter at large.

2 Mission

The USAMMA Production Assembly Management Division (PAMD) is organized under the USAMMA FSD. The

FSD has principal responsibility for Army medical force management. Specifically, PAMD is responsible for planning and budgeting wholesale procurement, production, introduction, sustainment, and recovery of medical Sets

Kits and Outfits (SKOs) and individual medical equipment items for the Army’s medical force, as well as nonmedical units with medical requirements (Active, Reserve, National Guard Components, and Army

Prepositioned Stocks). This includes the full range of Planning, Programming, Budgeting and Execution (PPBE), procurement of SKO components and equipment, management of the SKO build process, distribution/fielding of medical sets, kits, and outfits, operational support of the Army medical units, and follow-on logistics support for medical systems and equipment to ensure combat ready forces in peacetime and during times of conflict. These actions are in direct support of USAMMA’s Core Competencies; Equip the Force and Sustain the Force, as well as

Army Force Generation (ARFORGEN).

3 Purpose

3.1. This Quality Assurance Surveillance Plan (QASP) 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:

3.1.1. What will be monitored?

3.1.2. How monitoring will take place

3.1.3. Who will be conducting the monitoring

3.1.4. How monitoring efforts and results will be documented

3.2. 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.

3.3. 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.

3.4. 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 Authorities

The authority for issuance of this QASP is provided under Part 46 of the Federal Acquisition Regulation, Inspection of Services clauses, which provide 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.

5.1 Program / Project Manager

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: To be completed at time of award

Organization or Agency:

Telephone:

Email:

5.2 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 and document the final assessment of the contractor's performance in the Governments past performance tracking system.

Assigned KO: To be completed at time of award

Organization or Agency: USAMRAA

5.3 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 many any contractual commitments or to authorize any contractual change on the Government's behalf.

Assigned COR: To be completed at time of award

Organization or Agency: USAMMA Contract Management Office

5.4 Other Key Government Personnel

This may include performance monitors, inspectors, technical experts, or others who provide information that helps the COR monitor contractor performance.

The designated technical quality assurance personnel are:

Name: To be completed at time of award

5.5 Contractor Representatives

The following employees of the contractor serve as the contractor's Program Manager and Task Manager for this contract.

5.5.1. Program Manager

5.5.2. Task Manager – N/A

5.5.3. Other Key Contract Personnel – N/A

6 Performance Requirements and Method of Surveillance

This section describes the special requirements for this effort. The following sub-sections provide details of various considerations on this effort.

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

6.2.1. The Surveillance Matrix Table 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.

6.2.3. 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 matrix should be used to form the foundation of the COR's inspection checklist. In evaluating the quality of contractor’s performance, the following performance ratings may be used.

Performance

Rating

Criteria

Exceptional Performance meets contractual requirements and exceeds many to the

Government’s benefit. The element being assessed was accomplished with few minor problems for which corrective actions taken by the contractor were highly effective.

Very Good Performance meets contractual requirements and exceeds some to the

Government’s benefit. The element being assessed was accomplished with some minor problems for which corrective actions taken by the contractor were effective.

Satisfactory Performance meets contractual requirements. The element being assessed contains some minor problems for which corrective actions taken by the contractor appear or were satisfactory.

Marginal Performance does not meet some contractual requirements. The element being assessed reflects a serious problem for which the contractor has not yet identified corrective actions.

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

Table 1 - Surveillance Matrix

SON’s Delivery Objectives Delivery Standard Acceptable

Quality Level

Method of Surveillance

Objective 1, SON 5.1

Contractor shall possess product assembly capability for all SKO

Supplies to meet the USAMMA

FSD’s surge capacity requirements during contingency operations.

Product assembly capability means that Contractor shall provide assembly services, space and warehouse shelf when conducting procurement, sorting, assembly, packaging, storage

(if required) and shipment of SKOs to military organizations, civilian organizations and Army Prepositioned

Stock (APS) program.

Procure 100% of SKO components per the

D/O, mark/label components if required, pack/assemble all components, ship in complete SKO configuration per the

D/O.

Possess the ability to provide product assembly services:

procurement of all components, label/mark all components if required, pack/assemble in

SKO

configuration based on D/O, and ship as directed by D/O.

Random inspection. CTA will assist the COR in accomplishing this surveillance by evaluating inventory data from the

USAMMA Materiel

Fielding Team (MTF) site visit, inventory data received from customer, Quarterly report (attachment

8), Certificate of conformance, and historical data. .

Objective 2 – SON 5.2.

Contractor shall provide completed

SKO Supplies as specified in Delivery

Orders issued under this

CONTRACT. The completeness in building of medical unit assemblages or SKO Assemblages is critical to the

USAMMA’s core competencies in equipping and sustaining the U.S.

Army Medical Force during surge operations.

Procure 100% of all accessories and supplies included in the SKO component list identified on the

D/O.

Provide 100% complete SKOs unless pre-approved by the

USAMMA.

100% inspection by the

CTA. Inspected through examination of the component shortages and components packed based on the contractor provided

Master Pack List

(attachment 6), Certificate of Conformance, Quarterly

Report, and historical data.

Objective 3 – SON 5.3.

The contractor shall ensure that all assemblages will be shipped at 100% fill, unless otherwise approved by the

USAMMA, within time and delivery requirements of the DO.

Ship SKO assemblages at 100% fill of all components per the D/O.

Less than 100% is not accepted without 45 days notice prior to the RDD (5.3.4) and approval from the

USAMMA and

COR.

100% inspection. Evaluated through Certificate of

Conformance, Percent Fill

Reports (attachment 4), Quarterly Report, and historical data.

Objective 4 – SON 5.4. Contractor shall comply and acquire healthcare products that have been approved by

Food and Drug Administration (FDA), Defense Health Agency (DHA), DLA

Medical Supply Chain, Defense

Medical Materiel Office (DMMO), AMEDD Directorate of Combat and

Doctrine Development (DCDD), USAMMA FSD and USAMMA

Project Management (PjM) Office

Provide only those items that are 100% compatible in meeting government standards in accordance with healthcare products approved by agencies listed in objective 4.

Only 100% compatible items are acceptable per the approval of the

USAMMA.

Determined from inventory data provided by the

USAMMA MFT, customer inventory data, Master Pack

List, Percent Fill Report, Quarterly Report, and the

Certificate of Conformance.

Objective 5– SON 5.5.

Contractor shall mark individual components with National Stock

Number (NSN), short nomenclature, make, model, manufacturer, quantity and unit of issue. Shall ensure all assemblages are packed and labeled as specified for each DO issued under the

CONTRACT. The accuracy of the information marked and labeled on components and assemblages is vital in the readiness and expedience of meeting surge requirements.

Accurately mark/label individual components with specified information as required.

100% (all) individual components are marked/labeled with the precise

National Stock

Number (NSN), short nomenclature, make, model, manufacturer, quantity and unit of issue.

Assessed from inventory data provided by the

USAMMA MFT site visit, inventory data from customer, Quarterly Report, and Certificate of

Conformance.

Objective 6 – SON 5.6.

Contractor shall meet or exceed standards in special handling, packaging, temperature sensitive medical products during shipment of

SKO Assemblages to mutually defined locations.

Promptly and properly pack components in completed SKO configuration to mitigate the risk of damage during shipment.

Pack and Ship

100% completed

SKOs per the delivery order with no damage to components.

Evaluated based on inventory data provided by the USAMMA MFT, customer inventory data, Percent Fill Report, and

Certificate of Conformance.

CORRECTIVE 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.

8. QUALITY ASSURANCE PERSONNEL (COR)

TYPED NAME AND GRADE

SIGNATURE AND DATE

9. ISSUING AUTHORITY

TYPED NAME AND GRADE

SIGNATURE 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

INDIVIDUAL

PHONE

NATURE OF COMPLAINT

CONTRACT REFERENCE

VALIDATION

DATE/TIME CONTRACTOR INFORMED OF COMPLAINT

ACTION TAKEN BY CONTRACTOR

RECEIVED/VALIDATED BY

PERFORMANCE 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

4. QUALITY ASSURANCE PERSONNEL (COR) SIGNATURE AND

DATE

5. COR PHONE 6.

SUSPENSE

DATE

I. 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

II. 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

III. ACTION CORRECTED

14. CONCUR NON-CONCUR COR SIGNATURE AND DATE

15. COR REMARKS (REQUIRED)

6. CONTRACTOR REPRESENTATIVE REMARKS