ATT_3_-_Appendix_D.pdf

APPENDIX D

MINIMUM STANDARD QUALITY CONTRACT REQUIREMENTS FOR PROCUREMENT,

MODIFICATION, REPAIR OR OVERHAUL OF MATERIAL

DEEP SUBMERGENCE SYSTEMS – SCOPE OF CERTIFICATION (DSS-SOC)

MCD-B SMICs D0 & D4 – REQUIRING TESTING, OQE, AND GSI

STATEMENT OF WORK (SOW) – SECTION C REQUIREMENTS

1. Scope

1.1 The material covered in this contract will be used in a crucial shipboard system. The use of incorrect or defective material would create a high probability of failure resulting in serious personnel injury, loss of life, loss of vital shipboard systems, or loss of the ship itself. Therefore, the material has been designated as SPECIAL EMPHASIS material

(Level I, Scope of Certification, or Quality Assured) and special control procedures are invoked to ensure receipt of correct material.

1.2 In accordance with NAVSEANOTE 5000, Activities Qualified to Perform Submarine

Safety, Fly-By-Wire Ship Control Systems, And Deep Submergence Systems-Scope Of

Certification Work, all activities qualified to perform DSS-SOC work can procure and certify DSS-SOC material procured outside the Navy Special Emphasis Program (NSEP).

This material must meet the specified certification requirements.

2. Applicable Documents

2.1 See Statement of Work (Section C), for specific Equipment, Material, and Component

Drawings and References

Note - All applicable documents shall be listed in a manner which will allow positive identification of the references and shall indicate the revision/change level when the

Statement of Work (SOW) was prepared.

3. Requirements (per SEA 06P Letter, Ser 06/026, 19 June 2015)

3.1 Quality System Requirements - The Contractor furnishing items under this contract/purchase order shall provide and maintain a quality system in accordance with

MIL-I-45208, ISO9001:2008 (except as amplified or modified herein) with the calibration system requirements of MIL-STD-45662 or ISO10012 or ANSI-Z540.1.

Quality systems in accordance with ISO9001:2000, ISO9001:1994, or ISO9002:1994 are acceptable alternates.

3.1.1 The Contractor's quality system and products supplied under the system are subject to evaluation, verification inspection, and acceptance/non-acceptance by the Government representative to determine the system's effectiveness in meeting the quality requirements established in the Contract/Purchase Order.

3.1.2 The Contractor's quality system shall be documented and shall be available for review by the Contracting Officer or his representative prior to initiation of production and throughout the life of the contract. The Prime Contractor shall, upon notification, make his facilities available for audit by the contracting Officer or his authorized representative.

3.1.3 See CDRL DI-QCIC-81110 (Inspection System Procedures) - All suppliers of

Deep Submergence Systems Program (DSSP) material are required to submit a copy of their current documented quality system procedures to the Procurement

Appendix D

SOP-002 (B) (10-18)

MODIFICATION, REPAIR OR OVERHAUL OF MATERIAL

DEEP SUBMERGENCE SYSTEMS – SCOPE OF CERTIFICATION (DSS-SOC)

MCD-B SMICs D0 & D4 – REQUIRING TESTING, OQE, AND GSI

Contracting Officer (PCO) prior to award of any contract/purchase order.

Suppliers that have a copy of their current quality system procedures on file at the

Procuring Activity may request the PCO waive this requirement.

3.1.4 This contract provides for the performance of Government Quality Assurance at source. The place or places of performance may not be changed without the authorization of the Procurement Contracting Officer. Upon receipt of this order, promptly notify the Government representative who normally services your plant so that appropriate planning for Government inspection can be accomplished. If you do not have an assigned Government representative, notify the nearest

Defense Contract Management Agency (DCMA) Office. In the event that a local

Government representative or DCMA Office cannot be located, our purchasing agent should be notified immediately.

3.1.5 Any changes made by the Contractor to a qualified quality system will require re-submittal to the PCO and concurrence by the Government Quality Assurance

Representative prior to adoption.

3.2 Contractor Inspection Requirements - The Contractor shall maintain adequate records of all inspections and tests. The records shall indicate the nature and number of observations made, the number and type of deficiencies found, the quantities approved and rejected and the nature of corrective action taken as appropriate. Inspection records shall be traceable to the material inspected.

3.2.1 The supplier's gages, measuring and test equipment shall be made available for use by the Government representative when required to determine conformance with Contract requirements. When conditions warrant, the supplier's personnel shall be made available for operations of such devices and for verification of their accuracy and condition.

3.2.2 All documents and reference data applicable to this contract shall be available for review by the Government representative. Copies of documents required for

Government inspection purposes shall be furnished in accordance with the instructions provided by the Government representative.

3.3 Subcontractor Inspection Requirements - The Government has the right to inspect at source, any supplies or services that were not manufactured or performed within the contractor's facility. Such inspection can only be requested by or under authorization of the Government representative. Any purchasing documents to a subcontractor must cite the applicable portions of the contractually invoked quality system (e.g. calibration requirements), plus any product requirements that apply to the supplies being purchased.

When the Government elects to perform source inspection at the subcontractor's facility, applicable purchase documents shall be annotated with the following statement: "A

Government inspection is required prior to shipment from your plant. Upon receipt of this order, promptly notify the Government representative who normally services your plant so that appropriate planning for Government inspection can be accomplished. If

MODIFICATION, REPAIR OR OVERHAUL OF MATERIAL

DEEP SUBMERGENCE SYSTEMS – SCOPE OF CERTIFICATION (DSS-SOC)

MCD-B SMICs D0 & D4 – REQUIRING TESTING, OQE, AND GSI you do not have an assigned Government representative, notify the nearest Defense

Contract Management Agency (DCMA) Office. In the event that a local Government representative or DCMA Office cannot be located, our purchasing agent should be notified immediately."

3.3.1 The prime contractor's program shall include procedures to assess the capability of the prospective suppliers to produce the products or supply the services in accordance with the contract, prior to the issuance of any purchase document.

3.3.2 Each sub-tier supplier of material or services for items in Section 3 of this contract shall be subjected to a periodic review or audit by the Prime to determine the continued capability of the supplier to control the quality of the products or services specified in the purchase order or contract.

3.3.3 The prime contractor shall ensure that the purchased product conforms to specified purchase requirements and this contract. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on the end item represented by this contract.

3.3.4 The prime contractor shall evaluate the requirements of the contract and select suppliers based on their ability to supply the product in accordance with the prime contractor's requirements and the contract. Criteria for selection and evaluation shall be established. Records of this effort shall be available for review by the government.

3.3.5 The prime contractor's supplier quality assurance program shall provide for a review of purchase documents to assure applicable quality requirements are included or referenced in the documentation for compliance by the supplier.

3.4 Government Furnished Material and/or Equipment (GFM/GFE) - When material or equipment is furnished by the Government, the Contractor shall develop documented control procedures that require at least the following:

3.4.1 Visual examination upon receipt to detect damage during transit.

3.4.2 Inspection for completeness and proper type.

3.4.3 Verification of material quality received.

3.4.4 Periodic inspection and precautions to assure adequate storage conditions and to guard against damage from handling and deterioration during storage

3.4.5 Functional testing, either prior to or after installation, or both, as required by the

Contract to determine satisfactory operation.

3.4.6 Identification and protection from improper use or disposition.

3.4.7 Reporting to the Government, any GFM or GFE property found damaged, malfunctioning, or otherwise unsuitable for use. In the event of damage or malfunction during or after installation, the supplier shall determine and record probable cause and necessity for withholding the material from use.

MODIFICATION, REPAIR OR OVERHAUL OF MATERIAL

DEEP SUBMERGENCE SYSTEMS – SCOPE OF CERTIFICATION (DSS-SOC)

MCD-B SMICs D0 & D4 – REQUIRING TESTING, OQE, AND GSI

3.4.8 For GFE material, and as required by the terms of the bailment agreement, the supplier must establish procedures for adequate storage, maintenance, and inspection of bailed Government material. Records of all inspection and maintenance performed on bailed property shall be maintained.

3.4.9 Material returned to the contractor shall be handled as GFM.

3.5 Traceability and Certification Requirements - To assure that correct materials are installed in DSSP systems, it is imperative that traceability be maintained from the material to the material certification test report and other required Objective Quality

Evidence (OQE).

3.5.1 The following provides the minimum requirements for maintaining material traceability and supplements the requirements specified elsewhere in the contract/purchase order.

3.5.1.1 Material Traceability - Marking and identification of all material from receipt through fabrication shall be established via tagging, marking or bag and tag. This establishes traceability from the item to the OQE.

Marking/Identification may include such items as nomenclature, part number, technical description, National Stock Number (NSN).

3.5.1.2 When traceability markings on the material would be removed by a manufacturing or fabrication process, the marking shall be recorded prior to removal and be immediately restored upon completion of the process. If this cannot be done or is impractical, an appropriate material control procedure (such as a bag and tag, tagging, and/or tote box control) must be employed. The material control procedure must provide a method of positive control to preclude commingling of material or loss of traceability. The traceability marking shall be reapplied upon completion of the final manufacturing process

3.5.1.3 The material control process shall include requirements for the maintenance of traceability for items sent out for subcontracted operations. If such operations would remove traceability markings on the material, purchase or work orders shall specify a method and marking location for remarking. The contractor shall also ensure that subcontractor production controls are adequate to preclude commingling of materials during processing.

3.6 Final Inspection - The following inspections shall be performed prior to Government inspection and acceptance.

3.6.1 Material Sampling - Material shall be inspected for form, fit, and function. Lot acceptance shall be based on zero defects and lot rejection based on one defect.

The sample size shall be in accordance with the sampling plan(s) in the applicable military specification or standard, federal specification or standard, or drawing to which the material was manufactured. In the absence of such

MODIFICATION, REPAIR OR OVERHAUL OF MATERIAL

DEEP SUBMERGENCE SYSTEMS – SCOPE OF CERTIFICATION (DSS-SOC)

MCD-B SMICs D0 & D4 – REQUIRING TESTING, OQE, AND GSI sampling plans, sampling inspection shall be per ANSI/ASQ-Z1.4, general inspection level II (for sample size selection code), table IIA (for sample size).

SMALL LOT SIZES - For lot sizes of fifty or less, the minimum sample size shall be eight units. For lot sizes of eight or less, the sample size shall be one hundred percent of the lot.

3.6.2 The Manufacturer may elect to use Statistical Process Control (SPC) to assure product quality in lieu of the above attribute sampling plan, provided that the

SPC methodology/system used provides acceptable products to the Government.

However, the Government/Navy Receipt Inspection Activity may perform their acceptance inspection of the material using the attribute sampling plan outlined above.

3.6.3 All OQE required by the Contract and all data concerning material traceability

(OQE to traceability marking) shall be 100% inspected. The certification test reports shall also be 100% inspected for completeness and legibility.

3.7 Test Certification - When test certifications are required elsewhere in the contract, certification documents must be positive and unqualified. Disclaimers such as “to the best of our knowledge" or “we believe the information contained herein is true" are not acceptable.

3.7.1 If material is received without the required test certification papers or with incorrect/missing data on the certification papers, the material will be rejected.

3.8 See CDRL DI-MISC-80678 (Special Emphasis C of C) - The Contractor shall prepare and submit a certificate of compliance certifying that the items/components furnished under this contract comply with the requirements of the procurement document, including any/all invoked specifications and drawings. The certificate of compliance must show traceability to the marking applied on each individual item, and shall contain the following information:

3.8.1 Contractor's name, address, and date.

3.8.2 The contract/purchase order number (i.e. N66604-11-P-FA12).

3.8.3 The National Stock Number (NSN). The 18 character National Stock Number for Special Emphasis material includes the two digit COG, the four digit FSC, the 9 digit NIIN, and the two digit SMIC (i.e. 1H 4820 014532156L1).

3.8.4 Lubricants, sealants, anti-seize, and/or thread locking compounds ("N/A" when

Not Applicable).

3.8.5 Cure date ("N/A" when Not Applicable).

3.8.6 Manufacturer's compound number ("N/A" when Not Applicable).

3.8.7 When weld procedure submittal is required by the contract, a statement that the approval date of the qualification data precedes any production or repair welding performed on this Contract ("N/A" when Not Applicable).

MODIFICATION, REPAIR OR OVERHAUL OF MATERIAL

DEEP SUBMERGENCE SYSTEMS – SCOPE OF CERTIFICATION (DSS-SOC)

MCD-B SMICs D0 & D4 – REQUIRING TESTING, OQE, AND GSI

3.8.8 A statement to the effect that all items furnished on this contract are in full compliance with the specifications and requirements

3.8.9 Contractor's or authorized personnel's signature.

3.9 Configuration Control - The Contractor shall maintain the total equipment baseline configuration. Baseline configuration is the configuration documentation formally designated by the Government at a specific time during an items life cycle. The configuration baseline, plus approved changes to the baseline, constitutes the current approved configuration documentation. For items of proprietary design, Contractor drawings showing the latest assembly configuration shall be provided to the Government in electronic (C4) format. Definitions are provided elsewhere in the Contract/Purchase

Order.

3.9.1 Waivers/Deviations - All waivers and deviations, regardless of significance or classification require review and approval by the Contracting Officer. Waivers and Deviations shall be designated as Critical, Major, or Minor. The Contractor shall provide a copy of this request to the QAR. Requests for

Waivers/Deviations shall be submitted to the PCO.

3.9.1.1 A waiver is defined as a written authorization to accept an item, which during manufacture, or after having been submitted for

Government inspection or acceptance, is found to depart from specified requirements, but nevertheless is considered suitable for use as is or after repair by an approved method.

3.9.1.2 A deviation is defined as a specific written authorization (granted prior to the manufacture of an item) to depart from a particular requirement(s) of an item's current approved configuration documentation for a specific number of units or a specified period of time, and to accept an item which is found to depart from specified requirements, but nevertheless is considered suitable for use "as is" or after repair by an approved method.

3.9.1.2 A Critical Waiver/Deviation consists of a departure involving safety.

3.9.1.3 A Major Waiver/Deviation consists of a departure involving:

Performance.

Interchangeability, Reliability, Survivability, Maintainability, or

Durability of the item or its repair parts.

Health or Safety.

Effective Use or Operation.

Weight, Stability, or Structural Integrity.

MODIFICATION, REPAIR OR OVERHAUL OF MATERIAL

DEEP SUBMERGENCE SYSTEMS – SCOPE OF CERTIFICATION (DSS-SOC)

MCD-B SMICs D0 & D4 – REQUIRING TESTING, OQE, AND GSI

System design parameters as schematics, flows, pressures or temperatures.

Compartment arrangements or assigned function.

3.9.1.4 A Minor Waiver/Deviation consists of a departure which does not involve any of the factors listed as critical or major.

3.9.1.5 All Waivers/Deviation requests shall include the information listed below:

a. A complete description of the contract requirement affected and the nature of the waiver/deviation (non-conformance), including a classification of Critical, Major, or Minor.

b. Number of units (and serial/lot numbers) to be delivered in this configuration.

c. Any impacts to logistics support elements (such as software, manuals, spares, tools, and similar) being utilized by Government personnel or impacts to the operational use of the product.

d. Information about remedial action being taken to prevent reoccurrence of the non-conformance.

3.9.2 ECPs - The Government will maintain configuration control and change authority for all modifications or changes affecting form, fit, function, or interface parameters of the Equipment and its sub-assemblies. The Contractor shall submit an Engineering Change Proposal (ECP) to the Contracting Officer for any Class I or II changes that impact the Equipment covered by this contract.

An Engineering Change (EC) is defined as a change to the current approved configuration documentation of a configuration item at any point in the life cycle of the item. An Engineering Change Proposal (ECP) is defined as a proposed Engineering Change and the documentation by which the change is described, justified, and submitted to the Government for approval or disapproval. A Class I ECP is approved by the Government's Configuration

Control Board and authorized with a contract modification. A Class II change is typically reviewed for concurrence in classification by the local government representative, unless otherwise specified elsewhere in the contract/purchase order. ECPs shall be prepared in Contractor format, and shall include the following information:

3.9.2.1 The change priority, change classification (Class I or Class II), and change justification.

3.9.2.2 A complete description of the change to be made and the need for that change.

MODIFICATION, REPAIR OR OVERHAUL OF MATERIAL

DEEP SUBMERGENCE SYSTEMS – SCOPE OF CERTIFICATION (DSS-SOC)

MCD-B SMICs D0 & D4 – REQUIRING TESTING, OQE, AND GSI

3.9.2.3 A complete listing of other Configuration Items impacted by the proposed change and a description of the impact on those CIs.

3.9.2.4 Proposed changes to documents controlled by the Government.

3.9.2.5 Proposed serial/lot number effectivities of units to be produced in, or retrofitted to, the proposed configuration.

3.9.2.6 Recommendations about the way a retrofit should be accomplished.

3.9.2.7 Impacts to any logistics support elements (such as software, manuals, spares, tools, and similar) being utilized by Government personnel in support of the product.

3.9.2.8 Impacts to the operational use of the product.

3.9.2.9 Complete estimated life-cycle cost impact of the proposed change.

3.9.2.10 Milestones relating to the processing and implementation of the engineering change.

3.10 Mercury Free - Mercury or mercury containing compounds shall not be intentionally added or come in direct contact with hardware or supplies furnished under this contract.

Mercury contamination of the material will be cause for rejection.

4. Procedure Requirements

4.1 The following information provides amplifying detail and aids to clarify the requirements established in Section 3. These specific procedure requirements are necessary to ensure the Certifying Activity has adequate information to support Level I certification.

4.2 Quality System Requirements - In addition to the Quality Systems identified in Paragraph

3.1, ISO 9001:2015 is an acceptable alternate.

4.3 Special Requirements

Note – Any specific technical/operational requirement not clearly identified in this

Appendix or the Engineering Drawings shall be clearly defined in the Statement of Work

(SOW).

MODIFICATION, REPAIR OR OVERHAUL OF MATERIAL

DEEP SUBMERGENCE SYSTEMS – SCOPE OF CERTIFICATION (DSS-SOC)

MCD-B SMICs D0 & D4 – REQUIRING TESTING, OQE, AND GSI

INSPECTION AND ACCEPTANCE OF SUPPLIES – SECTION E REQUIREMENTS

1. INSPECTION

1.1 The contractor is required to perform all inspections to ensure the quality of the finished item and for providing inspection and test equipment necessary to ensure that the results of inspections and tests are accurate.

1.2 Government inspection is required prior to shipment from your plant. This contract provides for the performance of Government Quality Assurance at the source. The place or places of performance may not be changed without the authorization of the

Procurement Contracting Officer.

1.2.1 Upon receipt of this contract or order, the Contractor shall promptly notify the

Government representative who normally services its plant so that appropriate planning for Government inspection can be accomplished.

1.2.2 If the Contractor does not have an assigned Government representative, it shall notify the nearest Defense Contract Management Agency (DCMA) Office.

1.2.3 In the event that a local Government representative or DCMA Office cannot be located, the Procurement Contracting Officer shall be notified immediately.

1.3 Representatives of an assigned Contract Administration Office (CAO) shall make inspection of the supplies and services to be furnished hereunder, at the contractor’s or sub-contractor plant (SOURCE).

Place of Inspection

1.4 Due to the critical nature of this material, a representative of the Certifying Activity (CA) is available to furnish technical assistance on all quality control matters.

1.4.1 The contractor shall agree to notify the CA, when material is ready for inspection so the CA has the option of conducting quality assurance surveillance on the material at the contractor’s plant prior to shipment.

1.4.2 A minimum of seven (7) days is required to arrange such a visit.

2. ACCEPTANCE

2.1 Acceptance of Objective Quality Evidence (OQE) and final certification will be performed by the CA. Final certification by the CA does not relieve the supplier of performing final inspection and test and delivery of the material in accordance with description requirements.

2.2 Final acceptance of the supplies shall be made at destination by {enter activity name below).

MODIFICATION, REPAIR OR OVERHAUL OF MATERIAL

DEEP SUBMERGENCE SYSTEMS – SCOPE OF CERTIFICATION (DSS-SOC)

MCD-B SMICs D0 & D4 – REQUIRING TESTING, OQE, AND GSI

DEFINITIONS

Critical Safety Item (CSI) Any ship part, assembly, or support equipment containing critical characteristic whose failure, malfunction, or absence of which could cause a catastrophic or critical failure resulting in loss of, or serious damage to the ship, or unacceptable risk of personal injury or loss of life.

Deep Submergence System Those systems and components which, when working together, provide the capability for manned underwater operations.

Elements may include a manned vehicle, shore training facilities, designated support equipment, those systems that are a temporary or permanent part of a submarine that are used to disembark or recover personnel such as a Dry Deck Shelter (DDS) or Lockout

Trunk, and handling equipment.

Government Source Inspection

(GSI)

GSI is independent oversight performed by a government representative usually a DCMA Quality Assurance Representative

(QAR) to assure that those unique product quality and system elements, identified by the Contracting Agency as important, are observed and evaluated.

Material Control Division B MCD-B is assigned to any component where failure would require immediate emergency corrective action, the activation of an emergency system, or emergency return to the surface. MCD-B items include, but are not limited to, low pressure (<400 psig) piping and component assemblies in the primary and back-up life support systems; the portion of the electrical power distribution system exposed to sea pressure; instruments and sensors used to monitor external ambient conditions; instruments and sensors used to monitor or control DSS functions; hoses, tethers and umbilicals providing life support or thermal protection; all SOC piping and piping components external to manned spaces, and all other low pressure (<400 psig) SOC piping and piping components within the manned spaces not otherwise classified as MCD-A; mechanical joints and fasteners, not otherwise classified as MCD-A, used on

SOC piping systems and piping components.

Non-Destructive Testing (NDT) All methods of testing used to detect or measure the properties or performance capabilities of material, parts, assemblies, equipment, or structures that do not impair the serviceability of the parts tested.

MODIFICATION, REPAIR OR OVERHAUL OF MATERIAL

DEEP SUBMERGENCE SYSTEMS – SCOPE OF CERTIFICATION (DSS-SOC)

MCD-B SMICs D0 & D4 – REQUIRING TESTING, OQE, AND GSI

DEFINITIONS

Objective Quality Evidence

(OQE)

The quantitative and qualitative data of all mechanical, chemical, and performance tests performed (as required by the applicable specification, drawing, or purchase document) to prove that the material supplied conforms to the specified requirements.

Quality Assurance Letter of Instruction (QALI)

A QALI is a formal document initiated by a government activity (typically the Certifying Activity (CA) or Requesting Department) that provides essential requirements and instructions for contracted materials to be independently verified and accepted by a government representative prior to shipment.

Scope of Certification The SOC of a DSS is comprised of those systems, subsystems and components and the associated maintenance and operational procedures required to provide maximum reasonable assurance that DSS personnel are not imperiled during system operations.

Specification Any directive, whether technical or administrative, in any format, such as instruction, technical manual, drawing, standard, or publication.

Traceability A positive means of identifying material to its associated testing OQE. Traceability shall include the manufacturer's commodity or item level identification for the item(s)

MODIFICATION, REPAIR OR OVERHAUL OF MATERIAL

DEEP SUBMERGENCE SYSTEMS – SCOPE OF CERTIFICATION (DSS-SOC)

MCD-B SMICs D0 & D4 – REQUIRING TESTING, OQE, AND GSI

INSPECTION AND ACCEPTANCE OF SUPPLIES – SECTION E REQUIREMENTS

1. INSPECTION & ACCEPTANCE OF SUPPLIES

1.1 The contractor is required to perform all inspections to ensure the quality of the finished item.

1.2 Inspection and acceptance of Supplies that require Certification Data will be conducted upon delivery by the procuring activity or a designated representative.