J-7 _NSSA_Quality_System_(non-complex_IDIQ_contracts).pdf

QUALITY SYSTEM

For NON-COMPLEX IDIQ CONTRACTS

Revision 5

(These are the minimum requirements for an acceptable Quality System to perform work via NSSA Non-Complex IDIQ contract)

Reviewed by:

Daniel J. Kee

Quality Assurance Programs and Audits Division Head, Code 132

Reviewed / Approved by:

J.M. Aldridge

Quality Assurance Director Code 130

September 12, 2013

QUALITY SYSTEM (NON-COMPLEX IDIQ CONTRACTS), Rev.5

1. SCOPE:

1.1 Title: Quality System; Provide

2. REFERENCES:

a. ANSI/NCSL Z540, Requirements for the Calibration of

Measuring and Test Equipment

b. NAVSEA Standard Items

c. ISO/IEC 17025, General Requirements for the Competence of Testing and Calibration Laboratories

d. SSPC QP1 Application, Instructions, and Program Rules

3. QUALITY SYSTEM

3.1. Quality System Requirements

a. Establish, document, and maintain a Quality System to ensure product conformance to task order specifications.

The responsibility, authority, and the interrelation of personnel who manage, perform, and verify work affecting quality shall be defined and documented (to include organizational structure). The system shall, as a minimum, comply with the requirements of this attachment and all additional contract requirements. The documented

Quality System shall be submitted to the SUPERVISOR for a document review and acceptance. The organization shall have an acceptable documented Quality System in place to receive an award of a Task Order. The Quality System shall be subject to periodic conformity audits by the

SUPERVISOR throughout the contract. Changes or revisions to the accepted Quality System shall be submitted to the

SUPERVISOR within 7 days of contractor approval. The contractor shall maintain their Quality System in accordance with the latest revision of this document throughout the contract. The SUPERVISOR shall notify the contractor in writing or electronically when revisions are incorporated. The Quality System shall define and document, through written procedures, how the following contents of this document will be accomplished:

3.1.1 Quality Planning

The organization shall define and document how the requirements for quality will be met. Quality planning shall be consistent with all other requirements of the organization’s quality system and shall be documented in a format to suit the organization’s method of operation. The organization shall give consideration to the following activities, as appropriate, in meeting the specified requirements for products, projects, or contracts:

a. the preparation of quality plans;

b. the identification and acquisition of any controls, processes, equipment (including inspection and test equipment), fixtures, resources, and skills that may be needed to achieve the required quality;

c. ensuring the compatibility of the production process, installation, servicing, inspection and test procedures, and the applicable documentation;

d. the updating, as necessary, of quality control, inspection, and testing techniques, including the development of new instrumentation;

e. the identification of any measurement requirement involving capability that exceeds the known state of the art, in sufficient time for the needed capability to be developed:

3.1.2 Control Of Documents

The process used to control all documents and data

(procedures, technical manuals, drawings, etc…) shall be defined. The process as a minimum shall:

a. Ensure documents and data are reviewed and approved for adequacy by authorized personnel prior to use.

All changes/revisions to documents and data shall be reviewed and approved prior to use.

b. Ensure a master list identifying the current revision status of internal and external documents is established and readily available to preclude the use of invalid and/or obsolete documents.

c. Ensure that obsolete and/or invalid documents are promptly removed from all points of issue and are suitably identified if they are retained for historical purposes.

3.1.3 Control Of Quality Records

a. The organization shall establish and maintain documented procedures for identification, collection, indexing, access, filing, storage, maintenance, and disposition of quality records.

b. Quality records shall be maintained to demonstrate conformance to specified requirements and the effective operation of the quality system.

Pertinent quality records from the subcontractor shall also be an element of this data.

c. All quality records shall be legible and shall be stored and retained in such a way that they are readily retrievable in facilities that provide a suitable environment to prevent damage or deterioration and to prevent loss. Retention times of quality records shall be established and recorded. Quality records shall be made available for evaluation by the customer, or his representative through the contract and warranty period.

d. Any needed corrections to records shall be accomplished per the requirements of reference (b).

3.1.4 Required Training/Certifications

a. Organization shall establish a documented procedure to define methods and requirements for training of all employees.

b. Organization shall establish records to track required employee training.

c. Training requiring documented certification shall be maintained by the organization.

3.1.5 Product ID and Traceability

a. The organization shall establish a documented procedure for identifying the product by suitable means from receipt inspection, during all stages of production, delivery and installation.

b. Where traceability is a specified requirement, the organization shall establish and maintain documented procedures for unique identification of individual product or batches. The identification shall be recorded.

3.1.6 Process Control

a. All processes for which a procedure has been developed and directly affects quality shall be identified. Procedures required by the contract shall be submitted as part of the Quality System. Procedures and Process Control Procedures (NAVSEA Standard Item

009-09) invoked by NAVSEA Standard Items, MIL-STDs, drawings, and specifications although an integral part of the Quality System, are to be submitted and approved by the cognizant Regional Maintenance Center

(RMC) representative prior to use, independent of the

Quality System.

3.1.7 Purchasing

a. The contractor shall define the method used to evaluate and control subcontractors/suppliers.

Establish and maintain quality records of acceptable subcontractors including evaluations and re-evaluations. Discrepancies found with subcontractor/supplier performance shall be documented per the contractors Quality System.

b. Purchasing documents shall contain data clearly describing the product ordered, including where applicable:

1. the type, class, grade, or other precise identification;

2. the title of other positive identification, and applicable issues of specification, drawings, process requirements, inspection instructions, and other relevant technical data, including requirements for approval or qualification of product, procedures, process equipment, and personnel;

3. the title, number, issue of the quality system standard to be applied.

c. The organization shall review and approve purchasing documents for adequacy of the specified requirements prior to release. Signatures/dates documenting review and approval shall be on all purchasing documents.

d. When specified in the contract, the organization’s customer or the customer’s representative shall be afforded the right to verify at the subcontractor’s premises and the organization’s premises that subcontracted product conforms to specified requirements. Such verification shall not be used by the organization as evidence of effective control of quality by the subcontractor. Verification by the customer shall not absolve the organization of the responsibility to provide acceptable product, nor shall it preclude subsequent rejection by the customer.

e. Purchasing documents shall contain the following statement when government inspection is requested by the SUPERVISOR: “Government inspection is required prior to shipment from your plant. Upon receipt of this order, promptly notify and furnish a copy to the government representative who normally services your plant so that appropriate planning for government inspection can be accomplished. In the event the government representative or office cannot be located, our purchasing agent shall be notified immediately.”

3.1.8 Receipt Inspection

a. The organization shall ensure that incoming product is not used or processed until it has been inspected or otherwise verified as conforming to specified requirements. Verification of the specified requirements shall be in accordance with documented procedures. In determining the amount and natures of receiving inspection, consideration shall be given to the amount of control exercised at the subcontractor’s premises and the recorded evidence of conformance provided.

b. Unless otherwise specified in a higher tier document, receipt inspection of Contractor Furnished

Materials shall be based on supplier/vendor performance history and one or more of the following:

certificate of compliance, vendor material test certification data, manufacturer's mill certificate, or testing using sampling techniques.

Discrepancies found during receipt inspection shall be documented per the contractors Quality System.

c. Use of black-oxide coated brass threaded fasteners

(BOCBTF) is not authorized in the accomplishment of any work under this task order/contract.

3.1.9 Control of Inspection, Measuring, and Test Equipment

a. The organization shall establish and maintain documented procedures to control, calibrate, and maintain inspection, measuring, and test equipment

(including test software) used by the organization to demonstrate the conformance of product to the specified requirements in accordance with reference

(a). Inspection, measuring, and test equipment shall be used in a manner, which ensures that the measurement uncertainty is known and is consistent with the required measurement capability.

b. Where test software or comparative references such as test hardware are used as suitable forms of inspection, they shall be checked to prove that they are capable of verifying the acceptability of product, prior to release for use during production, installation, or servicing, and shall be rechecked at prescribed intervals. The organization shall establish the extent and frequency of such checks and shall maintain records as evidence of control.

c. Where the availability of technical data pertaining to the measurement equipment is a specified requirement, such data shall be made available, when required by the customer or customer’s representative, for verification that the measuring equipment is functionally adequate.

d. The organization shall determine the measurements to be made and the accuracy required, and select the appropriate inspection, measuring, and test equipment that is capable of the necessary accuracy and precision.

e. The organization shall identify all inspection, measuring, and test equipment that can affect product quality, and calibrate and adjust them at prescribed intervals, or prior to use, against certified equipment having a known valid relationship to internationally or nationally recognized standards.

Where no such standards exist, the basis used for calibration shall be documented.

f. The organization shall define the process employed for the calibration of inspection, measuring, and test equipment, including details of equipment type, unique identification, location, frequency of checks, check method, acceptance criteria, and the action to be taken when results are unsatisfactory.

g. The organization shall identify inspection, measuring, and test equipment with a suitable indicator or approved identification record to show the calibration status.

h. The organization shall maintain calibration records for inspection, measuring, and test equipment.

i. The organization shall establish a means to assess and document the validity of previous inspection and test results when inspection, measuring, and test equipment is found to be out of calibration.

Organization shall also take appropriate action on the equipment and any product affected.

j. The organization shall ensure that the environmental conditions are suitable for the calibration, inspections, measurements, and tests being carried out.

k. The organization shall ensure that the handling, preservation, and storage of inspection, measuring, and test equipment is such that the accuracy and fitness for use are maintained.

l. The organization shall safeguard inspection, measuring, and test facilities, including both test hardware and test software, from adjustments which would invalidate the calibration setting.

3.10 Customer Satisfaction

Organization shall establish a documented procedure for monitoring and measuring customer satisfaction.

3.11 Test and Inspection Plan (TIP)/Records

a. The organization shall develop a Test and Inspection Plan (TIP) incorporating each task order. The initial TIP shall include all inspections and tests required by zero-tier and first tier references as well as (I)(V) test/inspections and (G) government notification, and any additional tests and inspections the contractor deems necessary to substantiate product conformance. Submit one legible copy, in hard copy or approved transferrable media of initial TIP to the SUPERVISOR prior to productive work for non-CNO availabilities, and no later than 5 days prior to the start of the availability for CNO availabilities. Organization shall establish and maintain records which provide evidence that the product has been inspected and/or tested. These records shall show clearly whether the product has passed or failed the inspections and/or tests according to defined acceptance criteria. Where the product fails to pass any inspection and/or test, the procedures for control for nonconforming product shall apply. Records shall identify the inspection authority responsible for the release of the product. Test and Inspection records shall:

1. Include the ship’s name and hull number, contract and Task order numbers, date, and signature of the contractor’s authorized representative who witnessed or performed the inspection or test.

2. Be maintained at a contractor location accessible to the site of the work required by the task order. Be revised prior to the start of productive work and updated as work proceeds on each Task Order. It shall be available upon request by the SUPERVISOR. Supporting data for tests and inspections requiring government notification (G), including accept/reject criteria, shall be available at the location of each test and inspection. Include provisions for documenting the date, time, and identification of the SUPERVISOR's representative notified and government representative attending each (G)-

Point on the TIP.

3. Include the appropriate design criteria for each attribute or measurement required by the basic item for initial condition of equipment, structure or ship system reports.

4. Be documented within 24 hours of accomplishment or prior to the subsequent tests or inspections, whichever is less. Records shall be incorporated into the Test and Inspection Plan and the PCP within 72 hours after completion of each test or inspection.

5. For tests and inspections involving (G) points, records shall be documented upon acceptance or rejection and a hard copy provided to the SUPERVISOR at the conclusion of each G-

Point. For test and inspections utilizing

Coatings QA Tool Kit (CQATK) paperless QA program in accordance with 009-32, the data must be downloaded into the computer at the time and location of inspection.

6. Required reports resulting from tests or inspections shall include the appropriate design criteria for each attribute or measurement required by the Work Item.

7. Contain all partial inspections, unsatisfactory inspections and final inspections.

8. Provide identification of the item to be inspected by name, number, and location (e.g., number 3 main feed pump, 5-180-0-E).

9. Provide identification of each characteristic of the items to be inspected and provide criteria for acceptance for each characteristic

(e.g., air test; 2 PSIG for 10 minutes; no drop).

10. Inspect and test the product as required by the Test & Inspection Plan, documented procedures and reference (b) requirements.

11. The T&I plan and documented procedures for final inspection and testing shall require that all specified inspection and tests, including those specified either on receipt of product or in-process, have been carried out, and that the results meet specified requirements.

12. No product shall be dispatched until all the activities specified in the quality plan and documented procedures have been completed and the associated data and documentation are available and authorized.

13. Accomplish (I) and (V) tests/inspections, that do not have associated (G)-points, with qualified and/or currently certified personnel where required by the technical documents (e.g., NBPI, NACE, nondestructive testing, electrical cableway inspection, etc.) as follows:

a. (I) inspections require verification by a separate individual, other than the person who has accomplished the work, qualified as an inspector.

b. (V) inspections require verification by the qualified tradesperson, trade supervisor, or inspector.

14. Accomplish government notification, identified by the symbol (G), requirements as follows:

a. (G) is a symbol inserted in a Task order, or NAVSEA Standard Item, or Process

Control Procedure to establish a point in the sequence of accomplishment of work at which time the SUPERVISOR representative shall be notified to permit observation of a specific inspection or test by the government.

b. Notify the SUPERVISOR representative via FAX, hard copy, or by electronic method, as directed at least four hours, but not more than one working day, prior to commencing the specific requirements in the paragraph annotated with the symbol

(G). Notify the SUPERVISOR representative no later than four hours before the end of the last preceding day shift, when inspections or tests following a (G) point are scheduled after normal day shift working hours, on a weekend, or on a federal holiday. Notify the SUPERVISOR representative at least 48 hours, but not more than 72 hours, prior to commencing (G) points at contractor’s/subcontractor’s plants located in excess of 50 miles by the most direct roadway from the contractor’s/subcontractor’s plant nearest to the place of performance of the contract. Document the date, time, and identification of the SUPERVISOR personnel notified.

c. For G-points scheduled after normal day shift working hours, on a weekend, or a

Federal holiday, notify the SUPERVISOR to cancel a scheduled test or inspection as soon as known, but no later than 2 hours prior to the scheduled event.

d. A qualified contractor representative shall be present to accept or reject inspections or tests annotated with the symbol (G).

e. When the symbol (G) precedes inspections or tests in a Task order which are applicable to more than one action, the symbol (G) shall identify the action required, e.g. (G) “Hydrostatic Test”.

When more than one unit is involved, the

(G) notification requirement applies to each unit.

f. Proceed with the test or inspection if the SUPERVISOR representative is not present, provided the required advance notice has been furnished.

g. A partial (G) notification may be accomplished in the event that work cannot be completed and work progress would be delayed in waiting for total completion of work to the (G) notification. When the incomplete work is completed and ready for the remainder of the inspection or test. Record

Partial inspections on the inspection form and Final inspection on the final inspection form.

h. Invoke (G) notification requirements for inspections or tests involving a subcontractor in purchase orders or otherwise described such that the requirements of reference (b) have been met.

15. The SUPERVISOR representative will consider the Task Order incomplete if the contractor’s documentation and records are not complete.

16. The qualified contractor’s representative shall witness or perform and document all inspections and tests within a 50-mile radius of the place of performance of the contract.

a. The authority to witness or perform and document inspections and tests may be delegated to subcontractors who are MSRA and

ABR agreement holders and have a current

Quality System accepted by the SUPERVISOR representative. (G) point notification requirements shall not be delegated.

17. The contractor may delegate responsibility to subcontractors for inspections and tests performed at plants located outside a 50-mile radius of the contractor’s plant, nearest to the place of performance of the contract; however, the (G) point notification requirements shall not be delegated.

18. Submit one legible copy of the technical specification portion of these purchase orders, or a report identifying the applicable information, which involve (G) notification, to the cognizant Regional Maintenance Center (RMC) representative prior to the start of work by the contractor/subcontractor.

19. Submit one legible copy of those purchase orders for work being accomplished by contractor/subcontractor located outside a 50-mile radius of the place of contract performance to the SUPERVISOR representative prior to shipment of purchase order and equipment. For contractors with facilities outside the 50-mile radius, a report identifying the applicable information may be submitted in lieu of a purchase order.

20. Maintain a current list, for reference by the

SUPERVISOR representative, designating the contractor’s qualified inspectors who witness or perform and sign for symbol (I) inspections, indicating the type of inspections and tests for which each inspector is qualified.

21. Contractor/subcontractor shall notify the

SUPERVISOR within 24 hours when aware of any preliminary SSPC audit findings for critical audit items that result in a rating of one (1)

(i.e., major CAR or deficiency) as referenced in reference (d). These notifications shall be submitted, as required, in addition to the final

SSPC audit report.

3.12 Control of Non-Conforming Product

a. Organization shall establish a documented procedure to establish controls and responsibilities for handling nonconforming product.

b. The contractor shall ensure that products which do not conform to specified requirements are prevented from unintended use or installation. The control shall provide for the identification, documentation, and segregation of nonconforming products.

c. Records of all nonconformities and actions taken shall be maintained.

3.13 Corrective Action

a. A corrective action program and a documented procedure shall be established that provides for prompt correction of defects whether found by the government, contractor, or subcontractor personnel.

The program shall require that defects found and reported by the government will get prompt written response indicating corrective action taken or date specific action will be complete. The program shall also provide for identification and correction of the cause of defects in work required by the Task order.

A copy of the written response of internal corrective actions shall be provided to the SUPERVISOR when requested.

b. Respond in writing to each SUPERVISOR issued Method

B/C/D Corrective Action (CA) within 3 business days unless otherwise specified by the SUPERVISOR. Initial response shall include immediate corrective action taken and a plan of action for CA completion. Final response shall include preventive action for recurrence of identified nonconformance, root cause analysis and Objective Quality Evidence (OQE) for corrective action completed.

3.14 Preventative Action

a. Organization shall establish actions needed to prevent nonconformities from occurring in a documented procedure. Evaluation of nonconformities, their occurrences and any actions taken shall be documented.

b. Attend fact-finding/investigative meetings when requested by the SUPERVISOR.

1. Submit one legible copy, in hard copy or approved transferrable media, of a report with responses for root cause analysis, and short term and long term corrective actions on all contractor-responsible problems identified to the SUPERVISOR within 5 calendar days after completion of meeting.