PWS_Appendix_D-QMS_Req.pdf

Solicitation No. FA4890-16-R-0009

D-1 20 Apr 16

APPENDIX D

QUALITY MANAGEMENT SYSTEM

This Appendix is based on information contained in the PWS and Service Summary.

1.0 SCOPE.

1.1 General.

1.1.1 This contract requirement is based on the HFGCS-PRS PWS. It specifies requirements for a quality management system where an organization (contractor):

a) Needs to demonstrate its ability to consistently provide products/services that meet customer and applicable regulatory requirements, and

b) Aims to enhance customer satisfaction through the effective system application, including processes for continual system improvement and assurance of conformity to customer and applicable regulatory requirements.

1.1.2 NOTE: In this appendix, the term “product” applies only to the product/service intended for, or required by, a customer.

2.0 TERMS & DEFINITIONS.

The term “organization” is synonymous with “contractor” and “supplier” is synonymous with “subcontractor”.

subcontractor contractor customer

3.0 QUALITY MANAGEMENT SYSTEM (QMS).

3.1 Compliance.

3.1.1 The contractor shall develop, document, implement and maintain and continuously improve a comprehensive higher-level Quality Management System (QMS) that assures compliance with all requirements of this PWS.

3.1.2 The contractor shall prepare and submit a QMS summary outline to be evaluated during proposal. The contractor’s QMS summary outline shall include special focus on specific requirements that:

a) Identifies the processes needed for the QMS and their application throughout the organization. Processes should include management activities, provision of resources, service realization, and measurement.

b) Ensures the QMS documents the organization’s quality management structure, personnel authority and responsibility (using a tree diagram), the quality policy, quality objectives, and related documents needed to ensure effective planning, operation and control of its processes.

c) Provides evidence of top management commitment/involvement to development, implementation, and continuous improvement of their QMS with emphasis on customer satisfaction and its interrelationship with the Government’s quality assurance activity.

d) Ensures customer requirements are determined, met, and are validated using effective customer feedback with the aim of enhancing customer satisfaction.

e) Ensures continuous, pro-active, preventive-based monitoring, measurement and analysis program that uses quantifiable metrics and focuses on conformance to the Performance Work Statement (PWS), their QMS, and continuous improvement of PWS requirements.

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3.3 General Requirements: (The term “product” as used in this section of the PWS and its associated publications applies to the HFGCS-PRS.)

3.3.1 The contractor shall:

a) Identify the processes needed for the quality management system and their application throughout the HFGCS- PRS contract

b) Determine the sequence and interaction of these processes

c) Determine criteria and methods needed to ensure that both the operation and control of these processes are effective

d) Ensure the availability of resources and information necessary to support the operation and monitoring of these processes

e) Monitor, measure and analyze these processes

f) Implement actions necessary to achieve planned results and continual improvement of these processes.

3.3.1.1 These processes shall be managed by the contractor in accordance with the requirements of the PWS and Quality Management System Requirements.

3.3.1.2 Where the contractor chooses to outsource any process that affects product conformity with requirements, the contractor shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system.

3.3.1.3 Processes needed for the quality management system shall include processes for management activities, provision of resources, and measurement, analysis, and improvement.

3.3.2 The contractor shall support and not interfere with Contracting Officer Representatives (CORs); state, federal, and other Contracting Officer (CO) designated personnel in the performance of their official duties.

3.4 Documentation Requirements.

3.4.1 General.

3.4.1.1 HFGCS PRS Quality Management System documentation shall include:

a) Documented statements of a quality policy

b) A quality manual

c) Documents needed by the contractor to ensure effective planning, operation and control of its processes

3.4.1.2 Where the term “documented procedure” appears within this PWS, this means that the contractor shall ensure the procedure is established, documented, implemented and maintained.

3.4.1.3 The extent of the HFGCS-PRS Quality Management System documentation shall consider these factors:

a) Size of the organization and types of activities

b) Complexity of processes and their interactions

c) Competence of personnel

The documentation shall be in the form and type of medium that is commensurate with the Government’s standard computer Microsoft operating system and MS Office suite.

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3.4.2 Quality Manual Audit. The contractor shall submit its Quality Manual (QM) to the CO for a desktop audit NLT 90 days after contract award. The contractor’s comprehensive QMS shall be in place and performing NLT 180 days after contract award.

3.4.3 Data, Document, and Records Access. The contractor shall permit the CO, or authorized representative, access to all records, data, and facilities used in performance of contracted services. Access shall be provided as soon as possible but not to exceed 1 workday of the request (unless the CO agrees to an extended time) and shall be for the verification of:

a) Allowable cost

b) Delivery schedule

c) Quality of products/services

d) Risk assessment

e) Verification of personnel qualifications

f) Process audits

g) Contract compliance

h) Legal and statutory requirements

i) Trend analysis

3.4.4 The contractor shall ensure all records that demonstrate or provide evidence to conformance to the requirements in this PWS shall be kept and made available to the government throughout the contract performance period and for the period after contract completion until final settlement of any claims under this contract.

4.0 MANAGEMENT RESPONSIBILITY.

4.1 Customer Focus. Top management shall ensure that customer requirements are determined and met with the aim of enhancing customer satisfaction.

4.2 Internal communication. Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the QMS.

Crosstalk or Cross utilization of communications is a must between sites to further best practices and quality programs.

4.3 Review Input. Input to management review shall include information on:

a) Results of audits

b) Customer feedback

c) Process performance and product conformity

d) Status of preventive and corrective actions

e) Follow-up actions from previous management reviews

f) Changes that could affect the Quality Management System

g) Recommendations for improvement, such as those discussed in Program Management Reviews (PMRs) and Technical Interface Meetings (TIMs)

5.0 MEASUREMENT, ANALYSIS & IMPROVEMENT.

5.1 Quantifiable Metrics. The contractor shall use quantifiable metrics such as Mean Time Between Failure, Mean Time To Repair, Time Awaiting Maintenance, Time Awaiting Parts, Equipment Reliability, number of minor and major non-conformances, and inventory accuracies to indicate performance status of key service requirements. The metrics are considered a quality record and shall be made readily available to the Government.

5.2 Customer Satisfaction. As one of the measurements of the performance of the quality management system, the contractor shall monitor information relating to customer perception as to whether the organization has met customer requirements.

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5.3 Performance Improvement.

5.3.1 Continual Improvement. The contractor shall continually improve the effectiveness of the HFGCS-PRS and Quality Management System through use of mission requirements, quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review. The Government's Quality Assurance reports, notices and corrective action requests shall be an input to the contractor's quality management system for corrective, preventive and continuous improvement actions.

5.3.2 Preventive Action.

5.3.2.1 The contractor shall determine action to eliminate the cause of potential nonconformities in order to prevent their occurrence. Preventive actions shall be appropriate to the effects of the potential problems.

5.3.2.2 A documented procedure shall be established to define requirements for:

a) Determining potential nonconformities and their causes

c) Evaluating the need for action to prevent occurrence of nonconformities

d) Determining and implementing action needed

e) Records of the results of action taken

f) Reviewing preventive action taken

5.3.2.3 The contractor shall be proactive and ensure that all contract compliance deficiency notifications discovered and reported by either the contractor and/or Government or their representative (such as third party), receive the appropriate and necessary corrective and/or preventive actions.

5.3.2.4 The contractor shall ensure all audits/inspections results are analyzed for performance trends.

5.3.2.5 The contractor shall use data analysis tools appropriate for the specific pattern and trend analysis. The analysis is considered a quality record and shall be made readily available to the Government.

5.3.2.6 Performance trends that adversely affect cost, quality, and schedule may result in increased Government quality assurance until confidence has been restored that the adverse affect is corrected and prevented from reoccurrence.

5.3.3 Performance Evaluation Meetings, Conferences, and Workshops. The contractor should meet with the CO, COR, and other government personnel, on a periodic basis or as deemed necessary. The contractor may request a meeting with the CO when they believe such a meeting is necessary. The government may require meeting with the contractor to discuss compliance, performance improvement, quality strategic planning, teamwork, and training opportunities. The purpose of these meetings is to foster proactive continuous improvement by analyzing past performance problems as well as exceptional performance levels. These meetings shall review the contractor’s QMS efforts and the government’s QA function focusing on improved performance through teamwork. The use of DoD and industry best practices and quality tools/methods should be explored and implemented whenever possible.

The Government shall be responsible for recording and documenting the meeting minutes, unless otherwise mutually agreed upon by both parties that the contractor or a third party provide this service. The document (meeting minutes) shall be signed by the contractor and the CO (or their designated representatives). If the contractor does not concur with any portion of the minutes, non-concurrence shall be provided in writing to the CO within ten calendar days following receipt of minutes. Contractor’s non-concurrence will be attached to the official minutes.