Att_0011_-_Contract_Quality_Requirements_-_PA161_and_PA103A2_Metal_Containers_and_Covers.docx

ATTACHMENT 0011 - CONTRACT QUALITY REQUIREMENTS

This Attachment is to document Contract Quality Requirements for the PA161 and PA103A2 Metal Containers and PA161 and PA103A2 Covers.

1.) GOVERNMENT PROCUREMENT QA ACTIONS: INSPECTION

Government Procurement Quality Assurance (PQA) actions will be accomplished by the Government Quality Assurance Representative (QAR) at: Contractor's Facility

2.) GOVERNMENT PROCUREMENT QA ACTIONS: ACCEPTANCE

Acceptance of supplies will be at: Contractor's Plant The Government's acceptance of FATR (if required) will be at: Destination (Contracting Office)

3.) REWORK AND REPAIR OF NONCONFORMING MATERIAL

a. Rework and Repair are defined as follows:

(1) Rework - The reprocessing of nonconforming material to make it conform completely to the drawings, specifications or contract requirements.

(2) Repair - The reprocessing of nonconforming material in accordance with approved written procedures and operations to reduce, but not completely eliminate, the nonconformance. The purpose of repair is to bring nonconforming material into a usable condition. Repair is distinguished from rework in that the item after repair still does not completely conform to all of the applicable drawings, specifications or contract requirements.

b. Rework procedures along with the associated inspection procedures shall be documented by the Contractor and submitted to the Government Quality Assurance Representative (QAR) for review prior to implementation. Rework procedures are subject to the QAR's disapproval.

c. Repair procedures shall be documented by the Contractor and submitted on a Request for Variance, DD Form 1694, to the Contracting Officer for review and written approval prior to implementation.

d. Whenever the Contractor submits a repair or rework procedure for Government review, the submission shall also include a description of the cause for the nonconformances and a description of the action taken or to be taken to prevent recurrence.

e. The rework or repair procedure shall also contain a provision for reinspection which will take precedence over the Technical Data Package requirements and shall in addition, provide the Government assurance that the reworked or repaired items have met reprocessing requirements.

4.) QUALITY POST AWARD

Post Award Conference (definition) - A first meeting of key Contractor/Government players. This conference is to assure a clear and mutual understanding of the contract between the Government and contractor. The Post Award conference includes discussions on contract terms, conditions and requirements, line items and sequence of events needed for successful execution of the subject contract effort.

The contractor shall host a post award conference/meeting at the contractor’s facility to include contractor and government contracting, management, quality assurance and technical personnel no later than 30 calendar days after contract award. The contractor shall participate with the government to arrange a schedule and agenda for the post award conference prior to the meeting. The contractor shall provide the government with minutes of the post award meeting (DI-ADMN-81505 tailored).

5.) MEASUREMENT SYSTEM EVALUATION (MSE)

(a) Definitions. This paragraph defines specific terms utilized throughout the rest of the addendum and in the accompanying Contract Data Requirements List (CDRL) and Data Item Description (DID) (DI-QCIC-81960). This aids in clarifying the MSE requirements to Government and contractor personnel.

(1) Acceptance Inspection Equipment (AIE). All equipment (includes AAIE defined below), special and standard, including dimensional gages, measuring equipment, test fixtures, electronic and physical test equipment, and other test equipment used for examination and test of a product to determine conformance to the Technical Data Package (TDP) which may include drawings and specifications (e.g., Detail, Performance, Weapon specifications, and QAPs).

(2) Automated Acceptance Inspection Equipment (AAIE). AIE in which the inspection and acceptance determination of the product is performed, in whole or in part, in an automatic manner.

(3) Contractor Inspection Equipment. Government-approved equipment utilized by the contractor to perform examination and tests to assure conformance to contract requirements.

(4) Commercial Inspection Equipment. Industry-developed inspection equipment of universal application, without limitations to a specific part or item, which is advertised or cataloged as available to the trade or to the public on an unrestricted basis at an established price. Examples follow:

(i) Standard Test Equipment. Multi-usage equipment that is specific to a function rather than to an item. It includes such items as hardness testers, tensile strength testers, meters, weighing devices, standard gear testers, ohmmeters, voltmeters, and oscilloscopes.

(ii) Standard Measuring Equipment (SME). Multipurpose equipment and standards used for performing measurements. It includes such items as micrometers, rulers, tapes, height gages, and protractors, etc. Standards include visual inspection equipment such as scratch and dig standards, surface finish comparator, color standards (FED-STD-595), etc.

(5) Nondestructive Testing. The development and application of technical methods to examine materials or components in ways that do not impair future usefulness and serviceability in order to detect, locate, measure and evaluate flaws; to assess integrity, properties and composition; and to measure geometrical characteristics. NDT includes Radiography/Radioscopic, Ultrasonic, Eddy Current, Magnetic Particle, and Liquid Penetrant.

(6) Measurement System Analysis (MSA). Per ASTM E2782 (Standard Guide for MSA), paragraph 3.1.7, MSA is any of a number of specialized methods useful for studying a measurement system and its properties.

(b) Scope. This addendum establishes requirements for design, supply, performance, and maintenance of AIE used for product inspection and acceptance. In addition, this addendum establishes requirements for the preparation, submission, and approval of AIE documentation.

(c) AIE. The contractor shall provide all AIE necessary to ensure conformance of components and end-items to contract requirements. AIE shall include inspection, measuring, and test equipment whether Government furnished or contractor furnished (including commercially acquired) along with the necessary specifications and procedures for their use (see ISO 10012, paragraph 6.2.1). The AIE shall not create or conceal defects on the product being inspected. All AIE documentation shall contain sufficient information to permit evaluation of the AIE’s ability to test, verify, and/or measure the applicable characteristics or parameters (see DI-QCIC-81960).

(d) AIE Designs & Government Furnished Gages. AIE designs are of two types – Government designs (see d.1) and contractor designs (see d.2). When applicable, Government designs or Government furnished gages are designated in the TDP/contract; responsibility for all other AIE is assigned to the contractor. The designs, associated inspection procedures, and theory of operation shall have the level of detail to demonstrate capability of the proposed AIE to perform the required inspection.

(1) Government AIE Designs. Government AIE designs may consist of detailed drawings necessary for the fabrication and use of the AIE. Unless otherwise specified, the contractor may submit alternate or modified contractor designs of Government AIE designs.

(2) Contractor AIE Designs. Contractor AIE design drawings shall meet the requirements of ASME Y14.100, ASME Y14.5 and ASME Y14.43 and may include commercial inspection equipment. [“Commercial inspection equipment” is defined as shown in paragraph a.4 above. It shall be fully described by catalog listings or other means which provide sufficient information to permit identification and evaluation by the Government and may include illustrations and engineering data.] Designs shall be submitted for any special fixture(s) to be used. Unless otherwise specified, Gage Tolerancing Policy shall be in accordance with ASME Y14.43, “Absolute Tolerancing (Pessimistic Tolerancing).”

(3) Visual Inspection. Visual inspection standards used for the acceptance/rejection of product shall be submitted for approval.

(e) AIE Package Submittals. The contractor shall prepare the AIE package submittal in accordance with DI-QCIC-81960 in the applicable Contract Data Requirements List (CDRL – DD Form 1423). In addition, the contractor shall adhere to the following requirements:

(1) Designs for Approval. Contractor designs and/or the submission for the use of Government designs shall be approved by the Government. Partial submission of AIE designs is permissible in order to expedite the approval process; however, the response date for design review will be based on the date of the final complete submission of designs.

(2) Correspondence in English. The contractor shall ensure all AIE correspondence and documentation are submitted in English.

(3) Units of Measurement. The units of measurement within the AIE package submittal shall be consistent with the requirements of the Technical Data Package (TDP).

(4) AIE Flow Down. The contractor shall flow down AIE requirements to sub-contractors at any tier who are performing acceptance inspections.

(f) Characteristics for Inspection. AIE documentation for Critical, Special, and Major characteristic inspections shall be submitted to the Government for approval in accordance with (IAW) the CDRL (DI-QCIC-81960). AIE for Minor characteristic inspections shall be submitted to the Government for approval IAW CDRL (DI-QCIC-81960) and as required below:

☐ (1) Listed Minor (characteristics displayed on specifications and/or drawings

☐ (2) Government selected list (as attached or as provided herein)

☒ (3) Not submitted

(g) Automated Acceptance Inspection Equipment. The AAIE shall accept only conforming material. All characteristics requiring AAIE per the TDP shall utilize inspection equipment with a minimum demonstrated reliability of 99.8% at a 90% confidence level to detect non-conforming material unless otherwise specified below.

(1) Reliability of 99.8% at a 90% Confidence Level for Critical/Special Characteristics

(2) Reliability of 99.8% at a 90 % Confidence Level for Major Characteristics

(3) For inspection of major and minor characteristics where contractor utilizes AAIE when it is not required by the TDP, the AAIE package shall be submitted to the Government for approval. If the Minor characteristic is not listed in paragraph f.2 or not required for submittal in paragraph f.3, then the AAIE requirements (e.g., verification, calibration, prove-out, etc.) of the inspection shall still be performed.

(4) All AAIE packages submitted to the Government for approval shall be in accordance with MIL-A-70625 (Automated Acceptance Inspection Equipment Design, Testing and Approval of). Furthermore, the contractor shall be responsible for producing the acceptance and rejection verification standards/masters representative of the characteristics the AAIE is designed to inspect. The verification standards and frequency of use require Government approval prior to use. When verification standards are used for the VL-VII “sampling plan” per MIL-STD-1916 paragraph 4.4, verification standards and frequency of use shall require Government approval prior to use.

(5) If the AAIE accepts a critical characteristic “reject” standard the contractor shall notify the Government and act in accordance with paragraph f of the Critical Characteristic Control Addendum. In addition, if the AAIE accepts a major and/or minor characteristic “reject” standard the contractor shall act in accordance with paragraph 8.3 of ISO 10012 or paragraph 5.2.3 of ANSI/NCSL Z540.3.

(6) All AAIE shall be required to pass a Government-approved Acceptance (Prove-Out) Test. The contractor shall conduct this test per the approved test plan and shall submit a test analysis report for approval. See applicable CDRL (DI-QCIC-81960). This test shall be performed at the contractor’s facilities who’s manufacturing system has had the AAIE fully integrated and calibrated as per paragraph (j) of this addendum. The contractor shall allow Government personnel access to this facility and unobstructed monitoring of this test.

(7) The contractor shall notify the Government prior to a modification and/or relocation of the Government-approved AAIE. The modified AAIE designs shall be submitted for approval. The modified and/or relocated AAIE shall require submission of the acceptance test plan (prove-out) and results for review and approval prior to use. The modified and/or relocated AAIE shall be in accordance with paragraphs (g)(1) – (g)(6).

(i) Robust AIE System. The contractor shall ensure the AIE and its use is not negatively affected by any manufacturing/inspection environmental stimuli including, but not limited to production rate, noise, temperature, humidity, and vibration.

(j) AIE Calibration and Verification. The calibration system shall be in accordance with ISO 10012 or ANSI/NCSL Z540.3. All AIE shall be subjected to scheduled calibration intervals to ensure that the equipment will accept only conforming product and reject all non-conforming product for the duration of the approved calibration period. AIE shall be subjected to periodic verification to ensure that the equipment will continue to accept and reject product with the same consistency as it did at the time of its previous calibration.

6.) FIRST ARTICLE TEST (CONTRACTOR TESTING)

a. The first article shall be examined and tested in accordance with contract requirements, the item specification(s), Quality Assurance Provisions (QAPs) and all drawings listed in the Technical Data Package.

b. The first article shall be representative of items to be manufactured using the same processes and procedures and at the same facility as contract production. All parts and materials, including packaging and packing, shall be obtained from the same source of supply as will be used during regular production. All components, subassemblies, and assemblies in the first article sample shall have been produced by the Contractor (including subcontractors) using the technical data package applicable to this procurement.

c. The first article shall be inspected and tested by the contractor for all requirements of the drawing(s), the QAPs, and specification(s) referenced thereon, except for:

(1) Inspections and tests contained in material specifications provided that the required inspection and tests have been performed previously and certificates of conformance are submitted with the First Article Test Report.

(2) Inspections and tests for Military Standard (MS) components and parts provided that inspection and tests have been performed previously and certifications for the components and parts are submitted with the First Article Test Report.

(3) Corrosion resistance tests over 10 days in length provided that a test specimen or sample representing the same process has successfully passed the same test within 30 days prior to processing the first article, and results of the tests are submitted with the First Article Test Report.

(4) Life cycle tests over 10 days in length provided that the same or similar items manufactured using the same processes have successfully passed the same test within 1 year prior to processing the first article and results of the tests are submitted with the First Article Test Report.

(5) Onetime qualification tests, which are defined as a one-time on the drawing(s), provided that the same or similar item manufactured using the same processes has successfully passed the tests, and results of the test are on file at the contractor's facility and certifications are submitted with the First Article Test Report.

d. Those inspections which are of a destructive nature shall be performed upon additional sample parts selected from the same lot(s) or batch(es) from which the first article was selected.

e. A First Article Test Report shall be compiled by the contractor documenting the results of all inspections and tests (including supplier's and vendor's inspection records and certifications, when applicable). The First Article Test Report shall include actual inspection and test results to include all measurements, recorded test data, and certifications (if applicable) keyed to each drawing, specification and QAP requirement and identified by each individual QAP characteristic, drawing/specification characteristic and unlisted characteristic. Evidence of the QAR's verification will be provided. One copy of the First Article Test Report will be copy furnished to RDAR-EIQ-PE.

f. Notwithstanding the provisions for waiver of first article, an additional first article sample or portion thereof, may be ordered by the Contracting Officer in writing when (i) a major change is made to the technical data, (ii) whenever there is a lapse in production for a period in excess of 90 days, or (iii) whenever a change occurs in place of performance, manufacturing process, material used, drawing, specification or source of supply. When conditions (i), (ii), or (iii) above occurs, the Contractor shall notify the Contracting Officer so that a determination can be made concerning the need for the additional first article sample or portion thereof, and instructions provided concerning the submission, inspection, and notification of results. Costs of the additional first article testing resulting from any of the causes listed herein that were instituted by the contractor and not due to changes directed by the Government shall be borne by the Contractor.

7.) USE OF MIL-STD 1916

a. The Government will not accept lots whose samples submitted for acceptance contain nonconformances unless appropriately documented and approved by the contracting officer. The contractor shall use MIL-STD 1916, DOD Preferred Methods of Acceptance of Product. The Verification Level (VL) shall be:

VL IV for major characteristics and

VL II for minor characteristics.

b. MIL-STD HDBK-1916 provides guidance on the use of MIL-STD 1916. This handbook is not contractually binding.

8.) PROCESS CAPABILITY, CONTROL & IMPROVEMENT REQUIREMENTS (PCCI)

a. The Contractor shall establish a Process Control System that includes, but is not limited to, procedures, systems and software. This Process Control System shall complement the requirements of an ISO 9001 or equivalent Quality Management System as well as all contract quality requirements. Statistical Process Control (SPC), when utilized, shall be implemented in accordance with ISO 11462-1 and ANSI/ASQC B1, B2, and B3 or equivalent. A Process Control Plan (PCP), which describes actions and methods to assure production processes are in a state of control, shall be submitted to the Government for review and approval as stipulated on DD Form 1423. Demonstration of process capability in accordance with the approved PCP shall be accomplished prior to or at first article (if required) or prior to start of production. The Government reserves the right to withhold acceptance of product when there is evidence of noncompliance to the PCP. Should a finding of noncompliance to the PCP be made, a corrective action plan shall be submitted to the Government for approval.

b. Characteristics for process control (CFPC) are as follows:

(1) CFPCs are features whose variation have a significant effect on product fit, form, function, performance, service life or producibility, that require specific actions for the purpose of controlling variation. CFPCs result from an in depth Government-only review and analysis as specified in Technical Data Package (TDP) documentation as required below:

[ X ] (1.1) Government selected list, see paragraph g below [ ] (1.2) As listed key characteristics

[ ] (2) CFPCs are features whose variation have a significant effect on product fit, form, function, performance, service life or producibility, that require specific actions for the purpose of controlling variation. CFPCs shall be determined using an in-depth Contractor review and analysis as specified in the PCP documentation. The Government reserves the right to identify any CFPCs as well as any additional characteristics identified in paragraph g.

[ ] (3) CFPCs are features within a product, subassembly, part and process whose variation from nominal (i.e., target value) significantly impacts safety, performance in terms of customer’s requirements, or final cost of a product. Special controls should be applied where the cost of variation justifies the cost of control. These shall be developed from an in depth Government-Contractor review and analysis of design as specified in paragraph g below.

c. The Contractor’s analysis shall include processes and operations under the control of the prime Contractor and those under the control of sub-Contractor including subtier suppliers. The Contractor shall create a process flow chart for the entire process (including manufacturing, inspection and material handling) and also perform a Process Failure Modes and Effects Analysis (PFMEA) for processes identified on the process flow chart affecting CFPCs. The Contractor shall identify, define and document specific controls applicable for each process and operation that affects all CFPCs. The Contractor shall: (a) conduct process capability studies on all process and operation parameters affecting CFPCs; (b) verify that all automated inspection equipment used to validate process capability has been properly calibrated and certified; and (c) conduct Measurement System Analysis (MSA) studies on all applicable corresponding measurement systems utilized to monitor process capability.

d. The Contractor shall prepare and implement a PCP. The PCP shall be based upon and include the process flow chart, PFMEA, process capability studies and MSA studies for all process and operation parameters affecting CFPCs. For each CFPC, the PCP shall describe the entire process (including manufacturing, inspection and material handling), control methods and action plans for all out of control conditions and process capability at the stated production rates. When utilizing statistical methods, a process capability index such as Cpk shall be calculated. A CFPC shall be considered to have an acceptable (and capable) process if it has a Cpk of at least 2.00 for Critical characteristics, 1.33 for all other CFPCs, or as stated as follows: N/A. The Contractor shall notify the Government when the minimum process capability values (Cpk) of 2.00 for Critical characteristics and 1.33 for all other CFPCs, or the alternative established minimum Cpk values, are no longer being maintained.

e. In accordance with MIL-STD-1916 the Contractor may request, in writing, that alternate methods of acceptance be evaluated once the processes and applicable operation parameters have been demonstrated to be both stable and capable. Any alternate methods may not be implemented until approved by the Contracting Officer.

f. Corrective Action Requests (CAR) and Requests for Variance (RFV) generated for identification of product nonconformances shall result in an evaluation of the PCP. The evaluation shall consider addition of new CFPCs to the contractually required process control list and require implementation of actions per paragraphs (c) and (d) above with submittal to the Contracting Officer for Government approval. If the CARs and RFVs are related to characteristics, processes and / or operations already identified in the PCP, then those actions required by paragraphs (c) and (d) shall be reassessed and submitted to the Contracting Officer for Government approval. The Government reserves the right to withhold acceptance of product until the revised PCP is approved by the Government.

g. If box b (1.1), b(2) or b(3) are checked above, the selected characteristics and applicable tools, techniques, control methods or method of analysis to obtain these are specified as follows:

Key Characteristics

[.35 to .38] Ensure proper dimensions of gasket. Essential to container seal.

[.13 to .15]

[.255 to .275

[.705 to .745]

2x places Ensure proper height of shaft to gasket surface; tight tolerance for multiple part assembly. Essential to container seal.

[.875 to .895]

4x places Ensure proper height of bayonet slot to sealing edge tight tolerance for multiple part assembly. Essential to container seal.