Attachment_06_-_Production_Readiness_Process_Manual_-_01.17.2017.pdf

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Production Readiness Process Manual

Attachment 06

W31P4Q-17-R-0063

DATE – 17 Jan 2017

DISTRIBUTION STATEMENT A. Approved for public release; distribution is unlimited.

Joint Air-to-Ground Missile i

Table of Contents

1.0 INTRODUCTION

2.0 DEFINITIONS

3.0 PURPOSE

4.0 APPROACH

4.1 General Rules

4.2 Planning

4.2.1 Reserved

4.2.2 Product Process Control Plan (PPCP)

4.2.3 Pilot/Production Line Validation (PLV) Plan – See Appendix D

4.2.4 Product/Process Verification Review (PPVR) Plan – See Appendix E

4.2.5 Contract Validation Process (CVP) Plan – See Appendix F

4.3 Documentation

5.0 Production Readiness Process (PRP)

5.1 PRP Team Composition

5.1.1 PRP Team Leader

5.1.2 PRP Team Member Responsibilities

5.2 Pre-Production Requirements Review (PPRR)

5.3 Entrance Criteria

5.4 Exit Criteria

5.5 Subcontracting Process

5.5.1 Prior to Event

5.5.2 At Event

5.5.3 Post Event

5.6 Engineering Process

5.6.1 Prior to Event

5.6.2 During Event

5.6.3 Post Event

5.7 Production Process

5.7.1 Prior to Event

5.7.2 During Event

5.7.3 Post Event

5.8 Quality Process

5.8.1 Prior to Event

5.8.2 During Event

5.8.3 Post Event

5.9 Pilot/Production Line Validation (PLV) Process

5.9.1 When to Perform a PLV

5.9.2 Prior to PLV Start

5.9.3 PLV Conduct

5.9.3.1 Process Risk Determination

5.9.3.2 Witnessing PLV

5.9.3.3 Action Item List

5.9.3.4 First Piece Inspection (FPI)

5.9.3.5 Subcontractor Production Lines

5.9.3.6 PLV Completion

5.9.3.7 Re-Validation/Follow-On Activities

5.10 Product/Process Verification Review (PPVR)

5.10.1 Prior to PPVR Start

5.10.2 PPVR Conduct

5.10.2.1 PPVR Process

APPENDIX A: ACRONYMS

ii

List of Figures

Figure 1: Combining PPV/PLV/PPVR/CVP into PRP 5 Figure 2: Production Readiness Process - Approach #1 (Initial Production) 6 Figure 3: Production Readiness Process - Approach #2 (Periodic CVP) 7 Figure 4: Production Readiness Process - Approach #3 (Tailored) 8 Figure 5: Approach #1 Production Readiness Process (PRP) Flow 9 Figure 6: PPCP Operation Breakdown 13 Figure 7: Pilot/Production Line Validation Process Flow 29 Figure 8: Process Risk Determination Flow 30 Figure 9: Action Item List - Problem Identification 33 Figure 10: Action Item List - Problem Resolution 34 Figure 11: Pilot/Production Line Validation Certificate 36 Figure 12: Product/Process Verification Review (PPVR) Process 39 Figure 13: Product Process Verification Checklist 40 Figure 14: Product/Process Verification Review Certification Package Approval 42 iii

1.0 INTRODUCTION

This Production Readiness Process (PRP) manual establishes the procedures required to successfully perform the Product Process Verification (PPV), Pilot or Production Line Validation (PLV), Product/Process Verification Review (PPVR), Contract Validation Process (CVP) audit, Quality Assurance (QA) audit and Configuration Management (CM) review/audit to meet the Certified Production Line contract requirements of the program (Product Process Validation or Production Qualification is now referred to as Contract Validation Process).

PRP reviews, as defined herein, are performed on all hardware, software1, support equipment (e.g., tooling, fixtures, test equipment) and documentation for each Government assigned Part Number configuration item (CI). CIs are an aggregation of hardware/software or any of its discrete portions which satisfies an end-use function. During development and manufacture of the initial production configuration, configuration items are those specific items whose functions and performance must be defined or specified, validated and controlled to achieve the overall end-use function and performance.

2.0 DEFINITIONS

Production Readiness Process (PRP) o The overarching process that includes PPV, PLV, PPVR, CVP, First Piece

Inspection (FPI), Production Qualification Test (PQT), Initial Production Readiness Reviews (IPRR) and Production Readiness Reviews (PRRs) (See Figure 2: PRP - Approach #1).

o Occurs when the item is transitioning from development to production.

Contract Validation Process (CVP) o The overarching process that includes PPV, Pilot/Production Line

Revalidation (PLR), PPVR and CM/QA audits (See Figure 3: PRP - Approach #2).

o Proves processes are repeatable and yield a quality product.

o Ensures that deliverables meet established specifications when built within the intended manufacturing environment.

o Ensures manufacturing and support elements for production are in place and capable of supporting production requirements.

o Provide confidence that major process changes and relocation do not adversely affect the delivered product.

1 Software includes firmware, software, code, binaries, etc

Tailored PRP o The overarching process that achieves the intent of the PRP Approach #1, with tailoring. (See Figure 4: PRP - Approach #3).

o Item is in production and significant change(s) has been made to products or processes requiring validation of the PRP for the product and/or process changes.

First Article Test (FAT) o The FAT objective is to verify that all applicable specifications and requirements pertaining to the product are satisfied in conjunction with certification of the manufacturing production line.

o Additionally, the objective of the FAT will be to ensure that basic requirements are established and maintained which provide adequate control over the process, provide objective evidence of product conformance to specification and continued effectiveness of the quality management system.

First Piece Inspection (FPI) o The FPI is defined as a complete dimensional review for a new design and re-performed on all subsequent product revisions. FPI includes the collection of empirical data to provide/validate that the hardware meets the engineering.

Production o The process of converting raw materials by fabrication into required material or assemblies.

o Includes production scheduling, inspection, quality control, and related processes.

Production Planning o The broad range of activities initiated early in the acquisition process, and continued through a production decision, to ensure an orderly transition from development to cost-effective rate production or construction.

Production Break o Specified item is not manufactured in excess of 365 calendar days.

Contractor(s) o Prime contractor.

Subcontractor(s) o Suppliers governed by a contract Statement of Requirements (SOR)..

Product Process Control Plan (PPCP) o Identification and development of the top level manufacturing process flow.

o Documents key characteristics and process parameters as defined per

Aerospace Standard AS9103.

o Fulfills the purpose of the process control document (PCD) defined in

AS9103.

o Used to develop work instructions for management of product and process variation for key characteristics.

Product/Process Verification (PPV) – Development of Folders o Collects documentation for the design, manufacture, inspection, and acceptance testing of production hardware in individual folders for each designed detail, sub-assembly and assembly.

o Evaluation of the manufacturer’s Engineering Drawings, Production Planning, Special Manufacturing Equipment (including Numerical Control Programs), Manufacturing Process Controls and Process Methodologies.

o Includes documentation detailing compliance of all in-process and final acceptance test equipment.

o Includes the comparison of production hardware with the product Technical Data Package (TDP).

o Output includes PPV folders for each designed part describing the product/material and processes used to build the part; documentation verifying production work instructions, procedures, tooling and equipment are complete and/or successfully proofed.

o Verifies all functional requirements, as defined on the drawing or engineering specifications, as inspectable/testable, and that test data is traceable to the functional requirements.

o Folders maintained to the current design configuration and are updated after a process change.

The Production Line Validation (PLV) o Validates production line processes, documentation, tooling and equipment, in-process and final acceptance test equipment by witnessing the fabrication inspecting and testing of the product.

o Ensures manufacturing, inspection, and acceptance testing processes reflect the released “as designed” configuration baseline.

o Ensures the hardware’s manufacturing, inspection, and testing processes are documented, agreed to, and validated by Government and contractor representatives.

Product/Process Verification Review (PPVR) o Verifies completeness and adequacy of manufacturing and quality documentation generated during the PPV of all designed tactical hardware detail parts, subassemblies and assemblies. This review is conducted by a contractor/Government PRP Team at the production facility(s).

Production Qualification Plan (PQP) o A plan which describes how the contractor plans to get a product into production (e.g., work instructions, tooling, equipment, fixtures, inspection/testing equipment).

Production Qualification Test (PQT) o A technical test in accordance with (IAW) the requirements of the contract

SOW or subcontractor SOR, completed prior to the full rate production decision to ensure the effectiveness of the manufacturing and inspection processes, equipment, and procedures.

o Output includes data for the independent evaluation required for material release so that the evaluator can address the adequacy of the materiel with respect to the stated requirements.

o These tests are conducted on a number of samples taken at random from the first production lot, and are repeated if the process or design is changed significantly, and on product built by each source/supplier.

3.0 PURPOSE

The PPV, PLV, PPVR, CVP, QA and CM reviews/audits have been consolidated into this single manual to standardize the engineering, production operations, quality assurance, configuration management, and subcontracts administration activities into one process review to incorporate lessons learned and best practices. This is done to minimize the activities that are duplicated in stand alone, independent reviews. The outcome of using this manual is a consistent, comprehensive guide to a successful production readiness assessment.

The functional representatives that make up the PRP Review Team consists of engineering, production, quality, configuration management, and subcontracts management (as applicable).

The PRP maps out the overall flow of activities that relate to the functional members role. Most of the activities are sequential and build upon each other. After reading and implementing this manual, each PRP Team member will understand their role in the PRP and know what is expected of them.

4.0 APPROACH

There are three distinct PRP approaches:

1. Items entering production from development or transitioning to production

2. Performing periodic validation for items already in production (e.g., periodic reviews specified in the SOW) and

3. A change in product/process while in production (e.g., supplier relocation) - see

Figures 2-4.

CM

Combining PPV/PLV/PPVR/CVP into PRP

PPV

Folders

PLV

Witnessing

PPVR

Doc Review

QA/CM/Contracts Audit TDP Validation (CVP)

Folder

Adequate?

Complete?

Updated?

Revisions?

IPT:

Engr, Subcontracts

QA, Prod, CM

IPT:

Engr, Subcontracts

QA, Prod, CM

IPT:

Engr, Subcontracts

QA, Prod, CM

IPT:

Engr, Subcontracts

QA, Prod, CM

Findings:

-By Location -By Checklist Item -By Function

--Engineering --Subcontracts --Production

--QA

--CM

Summarize/ Categorize Findings

-Common Cause -Assignable Cause

Tailor (Focus) Review at Location Based on Findings/

Summaries

Implement

PRP

Approaches

Same Process For Contractor or Sub

New Process:

-PPV Folders Performed First

Existing Process:

-PPV can be Performed After

PLV

1/2 Day 2-4 Days 1 Day 1-2 Days

Docs

QA/CM/Contracts Audit Establish Baseline (CVP)

IPT:

Engr, Subcontracts

QA, Prod, CM

Checklist

1/2 Day

Docs _____

Docs

Docs ECPs

Identify Action Items &

Implement Corrective

Actions

Action

Items

Engineering Subcontracts

QA

Production

CM

CM

Checklist

Engineering Subcontracts

QA

Production

CM

CM

Checklist

Engineering Subcontracts

QA

Production

CM

CM

Checklist

Engineering Subcontracts

QA

Production

CM

CM

Checklist

Engineering Subcontracts

QA

Production

CM

Figure 1: Combining PPV/PLV/PPVR/CVP into PRP

The top-level illustration showing how activities are combined within the PRP is shown in Figure 1. It depicts the multi-functional Integrated Product Teams (IPTs) establishing the product baseline at the beginning of the contract and the development and collection of the PPV folder documentation. This documentation is then compared to the operator’s actions performing the work (witnessing) and any inconsistencies are documented. This documentation is also compared to the actual hardware built to assist in the product baseline establishment. The documented action items of inconsistencies are collected and categorized by location, function and cause where root cause analysis and corrective action can be performed.

After the top-level approach is understood and the structure is implemented, the individual reviews/audits are organized. Figures 2-4 “Production Readiness Process (PRP) Approaches #1- 3” depicts the flow of the individual reviews/audits. The individual reviews/audits are placed in a sequential flow where the previous review supports the following review for PRP approach number 1 identified above. The PRP Checklists are used for each review or audit. There will be one checklist for each of the functional areas, engineering, production or manufacturing, quality, subcontracts management and configuration management. When discrepancies occur, action items will be documented and presented to the PRP Team leader. All action items for a particular review are consolidated and become the out brief materials to the host personnel.

IPRR – Initial Production Readiness Review PPRR - Pre-Production Requirements Review PPV – Product/Process Verification PPVR – Product/Process Verification Review PLV – Production Line Validation FAI – First Article Inspection PQT – Production Qualification Test PRR – Production Readiness Review FCA – Functional Configuration Audit CVP – Contract Validation Process

Production Readiness Process #1 Initial Production

IPRR

Production Go Ahead

- Assesses CM/Procurement/Production systems, etc.

-Witnessing whether the planning matches operator actions -Preliminary PPVR

-Physical Inspection during fabrication & assembly -Update PPV folders

- More strenuous testing performed on sample

- Preparation of folders

•Formal PPV folder review (PPVR) for each CI •Validate Contract requirements

- Summarizes actions from previous events

Sequential:

Output of one event is the Input to the next event

PRP Team:

Engr/Subcontracts

QA/Prod/CM

FCA

Note: Hardware shall be Work In Process at the host plant whilethe process is being performed

•Engineering Process •Subcontract Mgmt Process •Production Process

PRR

PQT

FPI

PLV

PPV

PPRR

- Performed prior to: contract award, materials ordered and finalized production planning

CVPCVP

- Functional verification (as required by contract)

Figure 2: Production Readiness Process - Approach #1

Production Readiness Process #2 Contract Validation Process (CVP)

(Periodic)

PPVR

*PLR

CVP Team Review

PPRR – Pre-Production Requirements Review PPVR – Product/Process Verification Review PLR – Production Line Re-Validation CVP – Contract Validation Process

* Random Sampling & Delta Update

- Witnessing whether the planning matches operator actions

-Validate Contract requirements -Review updated PPV Folders

CVP Team:

Engr/Subcontracts

QA/Prod/CM

Note: Hardware shall be Work In Process at the host plant while the process is being performed

•Formal PPV folder review (PPVR) for each new or revised CI

•Engineering Process •Subcontract Mgmt Process •Production Process

*PPRR - Performed prior to: contract award, materials ordered and finalized production planning

Figure 3: Production Readiness Process - Approach #2

Figure 4: Production Readiness Process - Approach #3

Production Readiness Process (PRP) #3 In Production – Requiring Re-Validation

(Tailored PRP)

PP V

PLV

FP I

CVP

PPRR - Pre- Pro duc tion Requ ire ment s Revie w PPV – Product Process Ve rif icat ion PL V – Produc tion L ine Valid atio n FPI – Fi rst Piec e Inspe ction FAT – First Art icle T est PQT – Producti on Qualif icat ion T est CVP – Cont ra ct Valid atio n Proces s

-Wit nes sin g wh et her the p lan nin g mat che s o pe ra to r ac tio ns -Prelimin ary PPVR

- Phy sica l Insp ec tio n d uring fab r icat ion & ass embly -Up da te PPV f old ers

Co mpo nen t an d Suba ssy T est ing /Valid at ion

- Upda te fo lde rs

PRP Team:

Engr/Subcontracts

QA/Prod/CM

•Eng ineering P rocess •Sub contract M gmt Pro cess •Pr oduction P rocess

= T ailored as N ecessar y

(Team Decision)

• Fo rma l PPV fo lde r CI re view (PPVR)

• Va lida te Con trac t re qui re me nt s

No te : Ha rd wa re sh all be Work In Pro cess a t t he ho st p lant w hile t he pro cess is b eing perfo rme d

Pro du cti on Rev alid ate d

-Perfo rme d p r ior t o con tract a wa rd , mat erials orde re d and f ina lized prod uc tio n p lann in gP PRR

FAT

Sequen tial :

Ou tput of one even t is th e Inpu t t o th e nex t ev ent

FPI

- Mo re st re nu ous tes tin g

- pe rf ormed on s amplePQT

To add more detail to the PRP, a Top-level PRP flow chart is developed (See Figure 5). This flow captures activities starting from producibility requirements and ends with the Production Readiness Review (PRR). The flow also depicts the sequential nature of the PRP and shows other activities like First Piece Inspection (FPI), Production Qualification Test (PQT) and when a production representative unit starts. Production Readiness Risk Assessment (PRRA) is also identified where another PRRA checklist and report are introduced.

Approach #1 Production Readiness Process Flow (Initial Production)

Producibili ty Requirements

IPRR

Production Line

Validation

(PLV)

Production Facili ty Online

Product/ Process

Verification Review

(PPVR)

Key Mfg

Processes Product Process

Veri fication

(PPV)

Production Readiness

Risk Assessment

(PPRA)

Production Representative

Uni ts Start

PPRA

Report

LRIP

Decision

PQT

Hardware

First Piece Inspection

(FPI )

•Key Manufa cturi ng Proces ses Proofe d •Int ernal Pre liminary PPVR to Verify Key M anufac turing Proc ess es

Key Mfg Process Baseline negotiated

During EMD proposal

•Includes all residual units

•ID Long Lead Items •Assess manufacturing process flows •Update Key Mfg Process Basel ine •Agree on HW and processes requiring PPVR, PLV, & PPRAs

No

Yes

PRR

Determine Engr/Contracts

QA/Prod/CM Requirements

IPT:

Engr/Subcontracts

QA/Prod/CM

PPCP

CVP

FCA

Figure 5: Approach #1 Production Readiness Process (PRP) Flow

4.1 General Rules

The following reviews and associated documents identify general rules. General rules are rules of thumb to keep in mind when performing these reviews or evaluating documentation. The rules also identify who is the lead at various reviews.

Production Qualification Plan (PQP) o Overarching plan that incorporates PPV/PLV/PPVR/CVP/PQT/PRR procedures.

o Contractor may have a PQP for each program o Can tailor for specific locations (e.g. subcontractor).

Initial Production Readiness Review (IPRR) o Government is lead.

o Performed on new contractor or subcontractors as deemed necessary by

Government.

Product Process Verification (PPV) o Contractor is the lead.

o Government may or may not participate.

o Prepare and maintain folders (keep current) o Maintain in fire proof containers o Organized by Configuration Items.

Pilot Line Validation (PLV) o Government is lead at contractor location o Contractor/Government co-lead at first tier suppliers and subcontractors are lead at their subtier suppliers that have a contractual PLV requirement.

o Usually performed on a new line usually in Engineering and Manufacturing

Development (EMD) (formerly known as SD&D) phase.

o Witnessing new processes and reviewing associated documentation is performed.

o Validate in-process and final acceptance test equipment and reviewing associated Operation Instruction (OI)

Production Line Validation (PLV) o Usually performed after production decision.

o Usually performed on new, moved or production break lines or when degradation of quality has occurred.

o Need a PLV Plan for prime contractor and each supplier of a critical process.

o Witnessing new/changed processes, validating new test equipment is performed.

o Accuracy Review of the folders.

First Piece Inspection (FPI) o Required on all Configuration Item parts.

Product Process Verification Review (PPVR) o Government is Co-Lead with contractor.

o Review of PPV folders.

o Periodically performed on existing production lines and IAW Appendix E of this manual.

Contract Validation Process (CVP) o Overarching review that incorporates PPV/PLV/PPVR/QA&CM Audit.

o Government may participate as co-lead.

o Conduct CM/QA Audits as required.

o Uses PRP Checklists (Appendix G).

4.2 Planning

Planning is essential for a successful PRP review. Initial planning is necessary to lay out the activities to be executed in the future. There are two elements to planning: documenting a plan and implementing the plan.

The documenting stage of planning addresses how a particular review or audit will answer the Who, What Where, When and How questions. Who is going to participate in the review or audit, what will be reviewed during the audit, where the review or audit will take place, when will the review occur and how will the review or audit be conducted.

The implementing stage of planning is execution of the plan. This is where the required activities are fulfilled and completed. All of the Who, What, Where, When and How questions need to be answered so activities are not overlooked.

Within the PRP, there are specific plans that include the following:

Pilot/Production Line Validation (PLV) Plan Product/Process Verification Review (PPVR) Plan Contract Validation Process (CVP) Plan

4.2.1 Reserved

4.2.2 Product Process Control Plan (PPCP)

The PPCP identifies the manufacturing, inspection, and testing processes and the sequence (parallel or series) of the operation performed. Typically, a top level manufacturing process flow chart is developed initially which mirrors the organization of work instructions and identifies the key characteristics and critical processes. The PPCP is used to document the variation management plan for each key characteristic in accordance with AS9103.

Control Plan Number: Rev. Level: Cage Code:

Contact: Date: Date (Rev.):

Part Number: Phone: Eng. Approval Date:

Part Nom.: Team: Quality Approval Date:

Supplier: Other Approval Date:

Row No. Oper. Process Operation

Description FCID Draw. ID Characteristic Risk Lvl. PPM Cp/Cpk Spec./Tolerance Gage ID Control Method Sample

Sz. Pln # Responsible

File:

A L Low

A H High

M Moderate

Rev. Lvl.:

Status:

Product/Process

C:\Temp\ControlPlan.xls Risk

Product Process Control Plan Prototype Pre-Launch Production

Supplier: XYZ Company Revision: Date:

Part Nomenclature: Assembly XYZ Part Number:

Machine Device or Tools for

Manufacturing Characteristics Methods

Traceability Method

Analysis Method

No. Process Name Process Parameters Product Characteristics Personnel/Dept

Responsive

Product/Process

Specification Evaluation Method

Sample Size/Frequency

Obtain materials/Verify IR's

N/A N/A N/A Operator/Quality Spec. no. XYZ Visual 100% Traveler N/A reject material

Verify temp/humidity limits

Temperature/Hum idity Chart Recorder

Grains of moisture

35 grains of moisture or less required Operator Spec. No. XYZ

Temperature / Humidity Chart

Recorder 100% Traveler N/A

Hold operation until cell conditions are acceptable

Verify case threads clean and no resin in nozzle throat

N/A N/A N/A Operator Spec. no. XYZ Visual 100% Traveler N/A clean as required

Remove flipped up fiber, if required

Stanley Knife

Trim flipped up fiber to allow motor to pass thru gage

1.0" max allowed fiber length around motor O.D. can be trimmed

Operator Spec. no. XYZ Visual and Gage 100% Traveler N/A Rework as required

Install Igniter Tool no. XYZ

Apply Loctite 242 Sealant to igniter threads, install and torque igniter in motor

MIL-S-46163,

Type II, Grade N / 15 in-lbs torque

Operator Spec. no. XYZ Torque Wrench 100% Traveler N/A Reject part

Install Nozzle Plug

Tool no. XYZ

Apply petrolatum to nozzle plug and install into motor

VV-P-236 Operator Spec. no. XYZ Visual 100% Traveler N/A Rework as required

Repeat igniter and nozzle plug installation for remaining motors

Label Motors Tool no. XYZ Apply Labels N/A Operator Spec. no. XYZ Visual 100% Traveler N/A Reject motor

Package Motors aluminum trays and ammo cans

N/A N/A Operator Spec. no. XYZ Visual 100% Traveler N/A N/A

NDT X-RAY

TFI Bigshoot Film

Radiography Two rotations N/A Quality Spec. no.XYZ NDT 100% Traveler N/A Reject motor

ASSEMBLE MOTOR, FINAL INSPECTION and (V) LATS

Figure 6: Sample PPCP Operation Breakdown

4.2.3 Pilot/Production Line Validation (PLV) Plan – See Appendix D

“What” - The PLV Plan will document the activities necessary to validate the product and manufacturing/inspection processes encompassing the review. The PLV shall be performed at manufacturing facilities on hardware identified on the Process Risk List (See Figure 8). The PLV action item list (See Figure 10) shall be placed in the appropriate PPV folder. Hardware built during the PLV must be fabricated and inspected/tested the production configuration or production representative processes. For similar Configuration Items (CIs), it is possible to use a process representative item. The PLV plan shall be submitted to the designated Government manufacturing and quality assurance representative for approval. Program Management or the designated IPT will determine the need for conducting a PPVR.

“When” – There are two scenarios for identifying when a PLV is needed. The first are planned PLVs and the other include the criteria for a re-validation – see paragraph 5.9.3.7 entitled “Re-validation/Follow-on Activities”. The contractor identifies and schedules known PLVs to be performed. For re-validation (e.g., process change, relocation), PLVs will be scheduled on a case-by-case basis. New developments such as cost reduction initiatives, will also trigger a re-validation scenario. The PLV plan developed by the host contractor shall include a schedule showing the sequence and approximate dates for their PLVs. PLVs should be completed prior to customer acceptance of first deliverable hardware.

“Who” – Engineering Project/Subcontract Administrator and/or Production Operations Leader shall notify the PRP Team leader a minimum of 10 working days before validation is requested.

The PRP Team leader will notify PRP Team members and Government Project Office/DCMA.

“How” - The PLV will be performed IAW the PLV plan. The PLV shall be performed in a non-interference basis to the maximum extent possible (e.g., validations may occur on multiple shifts commensurate with factory schedule).

The following table of contents represents a PLV Plan: See Appendix D for sample PLV Plans.

Paragraph Title

1.0 Purpose

1.1 Contractor Production Lines

1.2 Subcontractor Production Lines

1.3 Exit Criteria

2.0 Validation Process

2.1 Product/Process Verification

2.2 Validation Proofing Process Procedure

2.2.1 Validation Information

2.2.2 Schedule

2.2.3 Notification

2.3 Procedure

2.3.1 Calibration

2.3.2 Validation Demonstration

2.3.3 Inspection

2.3.4 Completion of Validation

3.0 Reference Documentation

Appendix A Production Line Validation Form

4.2.4 Product/Process Verification Review (PPVR) Plan – See Appendix E

The PPV Review Plan provides direction for the PPV Review team to specify the responsibilities and activities necessary to ensure that the design and build documentation accurately and completely identifies the hardware and software configuration items. A PPV Review shall be performed on each configuration item, subassembly and assembly. Successful completion of PPVR will establish the product baseline. Witnessing of hardware assembly, inspection, and test may be performed at the host activity to verify documentation baseline. After the PPVR is completed, any subsequent design changes that occur shall be submitted to configuration management and folders shall be updated to reflect the design change. PPVR team will evaluate the significance of change(s) and make a determination whether or not to perform a delta PPVR.

At the completion of change incorporation, the contractor shall be requested to submit to the customer a drawing revision status sheet identifying all changes from the previous baseline submittal.

“What” - The PPVR is performed on production representative hardware documentation. The PPV folder data for the PPVR shall consist of the documentation developed using released production designs that are planned for production use. The PPVR shall be performed on hardware folders/files at the production facility. Please note that the PPV folders shall be completely compiled before the PPVR.

“When” - The Engineering Project/Subcontract Administrator and/or Production Operations Leader shall develop a schedule showing the sequence and dates for their PPVRs. Initial PPVRs shall be completed before the Production decision. During the CVPs, the PPV folders shall be updated to include any changes to the TDP since the established baseline.

“Who” –The Engineering Project/Subcontract Administrator and/or Production Operations Leader should notify the PPVR Team Leader a minimum of 10 working days before the start of the verification review. The PPVR Team Leader will then notify all team members and the Government Project Office/DCMA.

“How” - The PPVR Plan describes, in sequential detail, all the tasks required to perform the following PPV Review activities:

1. Provide a summary listing of the documentation necessary to conduct the PPVRs

2. Provide location(s) and date(s) information for each PPV Review

3. Provide a schedule of the required PPV Reviews

4. Provide a listing of the personnel necessary to conduct the PPV Review

5. Formally examine each CI's "as-built" configuration against its documentation

6. Furnish copies of each PPV Review action items.

7. Close all PPV Review action items

8. Execute and sign certification

The following table of contents represents a typical PPVR Plan:

PARAGRAPH TITLE

1.0 INTRODUCTION

1.1 Purpose

1.2 Definitions

2.0 PPV REVIEW SCOPE AND SEQUENCE

2.1 Scope

2.2 Sequence of Tasks

3.0 PPV RESPONSIBILITIES

3.1 Primary Responsibilities

3.2 Items Developed by Contractor

3.3 Items Supplied by Subcontractors/Suppliers

4.0 PPV REVIEW TASKS

4.1 Schedule(s)

4.2 Listing(s)

4.3 Locations, Dates, and Personnel

4.4 Documentation

4.5 Performance of PPV Review

4.5.1 Procedures

4.5.2 Verification Procedures and Requirements

4.5.3 Review Action Items, Problems and Responses

4.5.4 PPV Review Folder Storage/Retention

PPV REVIEW CHECKLIST Figure 1 PPV REVIEW ACTION ITEM LIST Figure 2 PPV REVIEW CERTIFICATION PACKAGE APPROVAL Figure 3

4.2.5 Contract Validation Process (CVP) Plan – See Appendix F

The CVP is accomplished by a multi-functional team whose purpose is to validate the contract requirements. It is the final production validation step in approaches #1, #2, and #3 of the PRP Manual. A CVP assesses the progress toward meeting the contract delivery schedule and the contractor/subcontractor’s ability to deliver a quality system/subsystem of the configuration defined in the Contract Product Baseline (CPBL).

4.3 Documentation

Documentation is maintained in individual folders and/or electronic files. PPVRs are conducted on the PPV folders/files at each host facility on items discussed in this Plan.

The following chart identifies the applicable documentation for each review. If an item is transitioning from development to production, all of these documents will be used. If already in production, tailoring of these documents may be required per the applicable contract:

• Production Qualification (PQ)

– Production Qualification Plan

• Initial Production Readiness Review (IPRR)

– IPRR Report

• Pilot/Production Line Validation (PLV)

– PLV Plan

– Action Item List

– PLV Certificate

• Production Qualification Test (PQT)

– Test Plan

– Test Report

• Product Process Verification Review (PPVR)

– PPVR Plan

– Action Item List

– PRP Checklist

• Production Readiness Review (PRR)

– PRR Report

– Standard PRR questions

• Production

– Work Instructions

– Engineering Drawings

– Software

– Test Data

– Calibration Data

– Process Procedures/Flows

– Tooling/Maintenance Records,

• Quality Assurance (QA)

– Parts, Material and Process (PMP) Control Program

– List of in-process and final acceptance test equipment

– Applicable test equipment Operating Instructions (OI)s.

– Test Equipment software.

– Environmental Stress Screening (ESS) Equipment and Procedures

– Failure Reporting and Corrective Action System (FRACAS) Data

– Product Process Control Plan (PPCP)

• Configuration Management (CM)

– CM Plans/Procedures

– Technical Data Package (TDP)

– Change Documentation

– Status Accounting Data

– Data Management Documents

– Deviations/Waivers

• Contracts

– Statements of Work (SOWs)/Statements of Requirements (SORs)

– Purchase Orders

– Procurement Specifications

Note: See PRP Checklists in Appendix G for additional details.

5.0 Production Readiness Process (PRP)

5.1 PRP Team Composition

The PRP Team members are composed of Government and contractor personnel. The following representatives will be participants: engineering, production, quality, subcontracts and configuration management. Collectively, the contractor and the Government will have all of these functions represented. Reviews shall be conducted at the location of the applicable prime or subcontractor, the host contractor will make all required functional personnel available during the review. The Government will have participation from the Government Project Office and the local DCMA (if applicable).

The PRP Government team membership will be approved by the following individuals:

a. Production/Configuration Management – Production Officer Configuration Management Officer

b. Quality Assurance – -QA

c. DCMA – Resident Site Personnel

5.1.1 PRP Team Leader

The PRP Team Leader will be an individual of recognized competency in the fields of manufacturing, configuration management, inspection and/or test, and will be cognizant of the PRP process and program requirements. The PRP Team Leader shall be assigned by the commodity Program/Project Management Office (PMO). There may be a shared or Co-PRP Team Leaders (e.g., first tier subcontractor), one from the Government and one from the contractor. The PRP Team Leaders will select PRP Team members.

For PRPs at the contractor locations, the Government will be the PRP Team Leader. For PRPs at the first tier subcontractor locations, the contractor is the PRP Team Leader. When PRPs are contractually required at suppliers to the subcontractor, the applicable subcontractor will be the lead.

The PRP Team Leader will also have the following responsibilities:

Preparation of the PRP Team and conducting of the required tasks to ensure PRP review is performed in accordance with the PRP manual.

Coordinates with all PRP Team members to ensure a clear understanding of strategy and methodologies for the reviews.

Selecting PRP Team members possessing the skills required to properly assess the documentation and supporting hardware.

Responsibility for all PRP Team activities.

Conducting an orientation meeting for PRP Team members prior to the start of the PRP to introduce the PRP Team members to the methods and strategies to be employed during the verification assessments

Serving as a functioning member of the PRP Team Preparing and documenting Action Items Providing an exit briefing of the PRP review findings to the host contractor Reporting the PRP findings to the host contractor, Project Office and the

Contractor

5.1.2 PRP Team Member Responsibilities

Each of the PRP Team members has the responsibility for assessing production documentation completeness and readiness in their area of expertise. They are tasked to report their assessments to their PRP Team leader by providing objective evidence, to the greatest extent possible, of their findings and observations.

5.2 Pre-Production Requirements Review (PPRR)

A Pre-Production Requirements Review, when required by contract, shall be accomplished to ensure:

1) All requirements are delineated by the contractor and understood by the subcontractor.

This involves the intended use of the component/subassembly, operational requirements, PMP requirements, design, performance requirements, physical characteristics, interfaces, environmental, inspection requirements, and test requirements,

2) Any changes (requirements, design, tooling, facility, personnel, sub-tier suppliers) are clearly defined and understood,

3) All interfaces are defined and documented,

4) Materials/Parts Obsolescence and alternate options are defined,

5) Producibility,

6) Past history of problem areas, root cause, and corrective action are delineated and “lessons learned” (both good and bad) are documented.

The intent of the Pre-Production Requirements Review is to establish a proactive and clear communication between the contractor and subcontractor of all requirements, changes, and

“Lessons Learned” from previous contracts for existing hardware/software or for new items prior to or within one month of production go-ahead. Unless this is accomplished prior to production, subsequent audits/reviews will determine areas of non-compliance or potential problems, but will not be pro-active in preventing problems. This critical review is recommended to be accomplished with sufficient lead time before the subcontractor orders material and finalizes planning for the production fabrication. It is anticipated that the review will require two days, and will involve a “line-by-line” review of the Statement of Requirements (SOR), Specifications, and Contract Purchase Order/Notes. This review is required to be “flowed-down” to subtier suppliers when required by contract.

The PRP Team is comprised of: Engineering, Production, Quality, a “Subject Matter Expert”, Configuration Management, and Subcontract Management. The emphasis of this review will be technical and not contracts/financial. Any contract or financial issues will be addressed in follow-up discussions.

5.3 Entrance Criteria

Before a PRP Review can take place, certain entrance criteria need to be completed. The entrance criteria are defined in the “Documentation” section of this manual where a list is provided. The PLV plan will also identify both entrance and exit criteria. The process under review is a production representative process. The PRP is conducted at the host Production Facility and is conducted on the Production Line including any ESS or critical off-site equipment. The operators will be using Production Factory manufacturing and inspection Equipment, manufacturing and quality work/inspection/test instructions, and tooling. The production personnel who will be performing the build demonstrations are the same or the same skill level as those who will be doing the production and are process Certified where required.

The PRP Review will be conducted uninterrupted in a production-like environment. The host facility will have an approved PLV and PPVR Plans (as applicable) and will use production planning/work instructions.

There are other reasons to perform a PRP Review. The Statement of Work (SOW) between the Government and the contractor may have a requirement to perform a PRP Review. These requirements are then transferred from the contractor to the subcontractors in the form of Statement of Requirements (SOR)/Purchase Order. Either the SOW or SOR can require a PRP Review be performed.

Lastly, the specific conditions that require a PRP Review to be performed need to be addressed again. These conditions include a new production line (for Pilot Line Validation only) or meet the criteria for re-validation: (Production Line Validation only). There are six other generic conditions that require either a PLV or PPVR be performed (see para 5.9.3.7 for additional explanation). These conditions include the following:

a. Production break of more than 12 months

b. Relocation or movement of a Pilot/Production Line

c. Degradation in overall Quality System, hardware quality escapes and/or latent defects discovered in-process or after delivery to Government

d. Significant product or process change, or

e. Substantial change to equipment, facilities or hardware

f. Change in configuration or location of test equipment

g. Required by contract

The following is a list of documentation that needs to be made available for the PRP review and the PRP Team. This list also defines the Entrance Criteria prior to conducting the PRP Review:

1. A complete drawing package with all Engineering Change Documentation

2. Status Accounting Documentation (e.g., Indentured Parts List (IPL), Parts Usage List

(PUL), Generation Breakdown List (GBL), Drawing/Specification Tree, etc.)

3. A copy of the Statement of Requirements or Statement or of Work/Purchase Orders

4. Any process specifications being used

5. Manufacturing flow with inspection points

6. Descriptions of any non-standard processes or test procedures

7. Tooling designs including calibration and usage procedures

8. Test fixture designs including calibration and usage procedures

9. Manufacturing plan with inspection points

10. Inspection methods

11. Test procedures/OIs

12. Capacity evaluation

13. Manufacturing schedule with correlation to the contractor need dates

14. Material Review Board process description

15. Results of any recent Quality Assurance audits including suppliers/subcontractors

16. Identification of any deviations made to accommodate the use of international standards where United States’ standards were used previously

17. Statistical Process Control/Trend Analysis/Rejection History

18. Data Management Documentation (e.g., CDRLs/SDRLs, etc.)

19. Configuration Management Plan

20. Equipment/Tooling Maintenance Data

21. Quality Plan

22. Product Process Control Plan (PPCP)

23. Manufacturing Work Instructions

24. Rate Assessments

Note: Host may be requested to provide specific documentation two weeks before review

5.4 Exit Criteria

A successful PRP Review shall satisfy all exit criteria. Exit Criteria is identified in the PLV and PPVR Plan and the PRP checklists. The checklists, found in Appendix G of this manual, will be used as a guide to generate Observations and Findings for PRP approaches #1, #2 and #3. Some of the PRP checklists may not apply to your selected approach, so note as not applicable or N/A on the checklist form. Selected Findings, as agreed to by the PRP Team, will be documented as action items. During the PRP Review, supporting data will be reviewed and an observation will be performed on supporting hardware by the joint PRP Team. The PRP Team will verify that all inspection/test equipment and procedures, manufacturing documentation, procedures, tooling and equipment are complete and/or successfully proofed. Production Lines will be used to perform key process risk manufacturing component fabrication, sub-assembly, and final assembly process demonstrations. These demonstrations will use certified factory tooling that has yielded acceptable first Articles, standard factory equipment, procedures and processes, manufacturing, inspection, and test instructions and procedures. Demonstrations of capability to meet the exit criteria will be through the use of supporting data as well as witnessing the manufacturing processes by the joint PRP Teams. When all steps in the PRP approaches #1 or #3 are successfully completed and all action items are considered closed by the PRP Team, a PLV Certification is granted to the host contractor. When all steps in the PRP approach #2 is successfully completed and all action items are considered closed by the PRP Team, the CVP is considered complete. Conditional PLV Certification may be granted by the PRP Team prior to closure of all action items.

5.5 Subcontracting Process

5.5.1 Prior to Event

Organize the date of the CVP to include all necessary personnel availability and non-disruption of production (verify hardware is available at the required stages). Request various documents to be provided two weeks prior to review. Send PRP checklists, agenda, and discuss expectations for the event with the supplier. Review the latest specifications, statement of requirements, drawing revisions levels, SDRL delinquencies, Purchase Order (PO) modification acknowledgements, and delivery schedule to the Internal Operating Plan (IOP) dates.

5.5.2 At Event

Review materials checklist (PRP Manual, Appendix H) with the various departments. Write up actions and best practices as appropriate. Participate with other PRP Team member functional audits such as, quality audit, CM audit, production facility walk through, etc. Participate in the debriefing which includes supplier concurrence to findings and actions, identification of responsible person(s) to complete action items, action item due dates and responsible personnel.

5.5.3 Post Event

After an event, brief program management of findings, action items, best practices, and issues as soon as possible. A point of contact to monitor due dates, submissions, approvals and closure for action items should be assigned. Participate in debrief to program management of findings, action items, best practices, and issues from the event. Living document is created which chronicles all open action items, dates action items were closed, personnel who determined closure, and due date extensions with rationale. SCA is the point of contact to monitor action item due dates, submissions, close outs, etc. Open action items are statused weekly with supplier and monthly with appropriate IPT. Close out submissions are routed to the CVP PRP Team leader and the functional PRP Team member that wrote the action. Close out determination is then routed back to the SCA to forward to the supplier. Open action items to be presented at the appropriate IPT at the beginning of the month. Provide monthly report to the Government via the appropriate IPT.

5.6 Engineering Process

5.6.1 Prior to Event

Engineering will review their checklist relative to the supplier and hardware/processes to be validated. Engineering documents related to the event should be reviewed for content and verifying that up-to-date revision levels are in effect.

5.6.2 During Event

The contractor engineering documents will be compared to supplier engineering documents to verify that all contractor engineering requirements are being met in the supplier documentation.

This will include dimensions, dimensional tolerance, drawing/specification note requirements and all other engineering requirements within those documents. Engineering will also assist other PRP Team members as needed to clarify engineering requirements, as they may be applicable to other review/validation documentation. How Drawing requirements are incorporated into the work instructions.

5.6.3 Post Event

The representative will be responsible for reporting the findings of the event to their appropriate chain of command, as required. The representative will also be responsible for tracking of the issues in their area until they are closed and any follow up activities as required. Where engineering changes are required by the finding(s), the representative will be responsible for the steps requiring the initiation, development and implementation of the required change through the IPT process

5.7 Production Process

5.7.1 Prior to Event

The production representative will familiarize themselves to maximum extent possible with the product that is being produced through the use of the technical drawings, flow diagrams, manufacturing plans and etc., if available. In addition, the evaluator will review all production issues since the last CVP by familiarizing themselves with the Supplier Corrective Action Request (SCARs), Q-notes and other documentation relevant to production issues. Finally, the representative needs to ensure they have some understanding of the processes being employed in the manufacturing of the product.

5.7.2 During Event

The production representative will be responsible for ensuring that the items relating to production on the PRP checklists are adequately discussed or witnessed. Also, the production representative will be responsible for a visual review of the production facility while hardware is being manufactured. The representative will also be responsible for writing up all findings related to production and participating in the event out brief.

5.7.3 Post Event

The representative will be responsible for reporting the findings of the event to their appropriate chain of command, as required. The representative will also be responsible for tracking of the issues in their area until they are closed and any follow up activities as required.

5.8 Quality Process

5.8.1 Prior to Event

QA will participate with other functional areas and organizations in order to coordinate the dates and locations for the CVP audits. Firm plans and notifications of an upcoming CVP audit should be established at least 2 weeks before the start of the audit. This will allow for adequate preparation to take place so that the time at the facility being audited can be utilized most effectively. Certain QA related documentation should be requested from the vendor/ subcontractor to be provided to the audit PRP Team for review and assessment the week before the scheduled audit event. The ability to obtain this information for review prior to the audit will depend on negotiation with the vendor/subcontractor and will certainly differ based on company desires/policy, SOR requirements, and in-plant time available. Documentation desired includes:

1. Quality Program Plan (QPP)

2. Reliability Program Plan (RPP)

3. Assembly work instructions (each individual operation, including wave soldering, board cleaning, conformal coating, etc.)

4. Inspection and Test Procedures (including in-process and ATP)

5. Environmental Stress Screening (ESS) procedures and plans (temperature extremes, vibration levels/durations, etc.)

6. Vendor end item assembly drawings and parts lists

7. Sample shop traveler

8. Receiving inspection procedures (sample tests, inspections, etc.)

9. Failure Reporting and Corrective Action Status (FRACAS) or…