A07_Attachment_5_W91CRB-16-R-0004_SOW_PM_SPE_Technical_Exhibits.doc

PERFORMANCE WORK STATEMENT (PWS) TEMPLATE

TECHNICAL EXHIBIT LISTING

C.3.13 Attachment/Technical Exhibit List.

C.3.13.1 Technical Exhibit 1 – PM SPE FORM 1 Engineering Change Request (ECR)

C.3.13.2 Technical Exhibit 2 – Production Readiness Review

C.3.13.3 Technical Exhibit 3 – PM SPE FORM 11 Quality Management System (QMS) Crosswalk Matrix

C.3.13.4 Technical Exhibit 4 – PM SPE FORM 3 Corrective Action Report

C.3.13.5 Technical Exhibit 5– PM SPE FORM 15 Process Control Plan C.3.13.6 Technical Exhibit 6- AR/PD 14-01, ACH Gen II, Date TBD.

EXHIBIT 1

PM SPE FORM 1: ENGINEERING CHANGE REQUEST (ECR)

EXHIBIT 1

PM SPE FORM 1: ENGINEERING CHANGE REQUEST (ECR)

EXHIBIT 1

PM SPE FORM 1: ENGINEERING CHANGE REQUEST (ECR)

EXHIBIT 2

PRODUCTION READINESS REVIEW/AUDIT

Introduction

Contractor welcome, review of agenda, assessment schedule and orientation to the facility;

Opening Remarks

a. Introduction of assessment team and Contractor personnel;

b. Briefing to Contractor describing objectives and expectations for the PRR;

c. Contractor overview and discussion of the results of their self-assessment;

· Results and Findings of Internal PRR

· Results and Findings of Subcontractor PRRs

Contract Overview

Contractor must declare their production and documentation readiness level and provide a briefings to support their declaration

· Production Capability

1. Facility Capability/Controls

2. Identification of Manufacturing Personnel

3. Manufacturing Management Personnel

4. Facility capabilities/controls

Open Risk Management/Mitigation Discussion

Delivery Schedule Review

Verification of Subcontractor Awards

a. Purchase Order Review and Verification of Requirements Flow-down

b. Test contract verification/Material verification

Configuration Management

Verification of Production Documentation/Materials

a. Drawings

b. Purchase Descriptions

c. Work Instruction

d. Supply Chain Analysis

· Material availability

· Material proven and validated

· Material special handling requirements

Contractor Subject Matter Experts (SMEs)

Private meeting of assessment team to record and discuss observations

Out-briefing by assessment team to Contractor

EXHIBIT 3

PRODUCT MANAGER SOLDIER PROTECTIVE EQUIPMENT

ISO 9001:2008 CROSSWALK

Company:

Contracting Officer:

Solicitation Number:

Contract Number:

PM SPE Reviewer: MACROBUTTON AcceptAllChangesInDoc Date: Click here to enter a date.

EXHIBIT 3

PRODUCT MANAGER SOLDIER PROTECTIVE EQUIPMENT

ISO 9001:2008 CROSSWALK

This ISO 9001:2008 crosswalk matrix is intended as a clarification map for a Contractor’s Quality Management System (QMS). All Soldier Personal Protective Equipment (PPE) are Critical Safety Items, therefore, the contracts for PPE incorporate FAR Clause 52.246.11 Higher Level Contract Quality and delineates ISO 9001:2008 as the standard for compliance. Contractors are not required to be ISO certified at this time, however, they must be ISO 9001:2008 compliant. The definition of compliance is that they must meet all the standard requirements with exception of 3rd party registration. The Contractor needs to demonstrate how they meet and maintain an ISO 9001:2008 Quality Management System. The Product Manager Soldier Protective Equipment (PM SPE) Quality Assurance (QA) and Defense Contract Management Agency (DCMA) will evaluate, audit, and monitor the Contractor’s QMS to ensure compliance. The crosswalk matrix must be completed and submitted to PM SPE QA for evaluation prior to the initial audit.

1. First column: ISO Standard clauses

2. Second column: Company Quality Management System – The Contractor shall populate this column by referencing their appropriate company document equivalent to requirement

3. Third column: Compliance Statement – If the Contractor is not certified, explain how your process is in compliance with the standard

4. All Procedures required by ISO 9001:2008 shall be submitted as attachments to the Crosswalk Matrix and three (3) samples of supporting documents/records as they pertain to the Procedures.

Example: ISO 9001:2008 requires a Corrective Action Procedure. The crosswalk shall describe it, the Procedure shall be an attachment to the crosswalk and examples of a Customer driven Corrective Action, an Internal Corrective Action and a Supplier Corrective Action would be supporting documents/records pertinent to the procedure.

Remember, compliance and certification is not the same thing, but they require the same effort and management involvement. Early ISO developed the phrase that is still relevant today, “Say what you do, do what you say, and prove it.”

EXHIBIT 3

PRODUCT MANAGER SOLDIER PROTECTIVE EQUIPMENT

ISO 9001:2008 CROSSWALK

Introduction (title only)

ISO 9001:2008 CROSSWALK

ISO 9001:2008 CROSSWALK

ISO 9001:2008 CROSSWALK

Compliance Statement

ISO 9001:2008 CROSSWALK

Compliance Statement

ISO 9001:2008 CROSSWALK

Submitting Activity

a. Typed Name (First, Middle Initial, Last)

b. TITLE

c. DIGITAL SIGNATURE

EXHIBIT 4

CORRECTIVE ACTION REPORT FORM

INSTRUCTION PAGE 1

Problem Description

Section 1

Problem Description – The following shall be documented:

· A detailed, specific description of the problem

· How many items were initially found that contain the problem

· When was the problem discovered

· Where was the problem discovered

How was the problem discovered

Note: This section will be completed by the CAR Issuing Activity.

Problem Solution Team Section 2 A list of Team Members that includes the following information shall be documented:

· Member name

· Member title

· Member phone number

· Approval authority

· Member e-mail address

Containment Actions / Short Term Corrections Section 3 The quantity of suspect product at the Contractor’s facility (this include Subcontractors and material suppliers). This is to include the method of Quarantine, Quarantine Identification, method of Certification against the problem and Certification Identification. (Example: If product is screened and bad product is removed, good product is re-packaged and the package has a green “Certified” label adhered to it).

The quantity of suspect product in transit. This is to include the method of notification to the recipient. A proposed method of Certification against the problem (Return Authorization, Contractor to go on-site and rework or screen product, etc.). A method of Certification Identification.

The quantity of suspect product in the Government’s possession. This is to include Return Authorization and details of Quarantine and Certification upon receipt back into the Contractor’s facility, or details of arrangements made for Quarantine and Certification at the Government’s facility.

Root Cause Analysis Section 4 Root Cause Analysis – The following shall be documented:

· An explanation of why the failure happened.

· An explanation of why the failure was not detected.

NOTE: Root Cause Verification – Explain in detail what actions were taken to assure the TRUE Root Cause was found

Corrective Action Plan Section 5 Document the specific plan for changes to meet the contract and product requirements for the items that were out of control. This plan shall include the responsible individual for each action plan item along with the expected date of completion.

INSTRUCTION PAGE

Validation Section 6

· Identify each nonconformance individually and include the corrective action implemented.

Applicable to the occurrence of the problem:

· List each Action individually and include the date of implementation and the name of the Team Member responsible.

· Provide detail for each Action of how it was proven that the action taken eliminated the problem. Include the date and the name of the Team Member responsible.

Applicable to the non-detection of the problem:

· List each Action individually and include the date of implementation and the name of the Team Member responsible.

· Provide detail for each Action of how it was proven that the action taken eliminated the problem. Include the date and the name of the Team Member responsible.

The following shall be documented:

· Describe the methods used (i.e. – number of trials with corrections in place, measurements, inspections, etc; this includes data on the number of items inspected vs. number of subject defects found, etc.) to verify the actions taken are effective and will remain effective. Include hard data as applicable.

Prevention Error Proofing Section 7

· Consider other processes where these Corrective Actions could be of benefit.

· Identify Poke-Yoke’s or error proofing processes implemented for each problem.

Standardization and Control Section 7B The following shall be documented:

· Provide details regarding updates of documents such as – Process Failure Modes and Effects Analysis (FMEA), Process Control Plan, Process Flow Diagrams, Visual Aids, Work Instructions, Operating Procedures, Training Methods / Records, Preventive Maintenance Plans, Etc.

Examples of each, as applicable, should be included with the Corrective Action Report.

· List the Team Members by name, input the date and allow each Team Member the opportunity to comment on the project.

· Secure DCMA signature on CAR response

CAR Timeline:

NOTE: Contractor shall not exceed 15 working days for final CAR response without written request for an extension from DCMA.

Supplier:

Address:

Status:

Recurrent Failure:

1. Problem Description

Description of the problem:

How many parts have the problem?

When were the parts found?

Where were the parts found?

How were the parts found?

2. Problem Solution Team

3. Containment Action

Your action taken to capture all non-conforming product in your inventory, finished goods, WIP, & in transit, prior to receipt

Action:

At Government Facility

Action:

Verification (Date and result):

Material at Government Facility Disposition

No. RMA:

Material in Transit

Action:

Verification (Date and result):

At Supplier’s Facility

Action:

Total Number of parts sorted:

Percentage defective:

Total Number of defective parts:

What is the identification mark to signify?

4. Root Cause Analysis

Use the “5 Why’s Analysis” technique to determine the most basic cause that resulted in a nonconformity that can be reasonably identified, fixed, or eliminated through process improvement.

Why did the failure occur?

1. Why?

2. Why?

3. Why?

4. Why?

5. Why?

Why was the failure not detected?

1. Why?

2. Why?

3. Why?

4. Why?

5. Why?

Verification of Effectiveness Explain in detail what actions were taken to verify that the root cause was found and effective.

5. Identify Solutions

Solutions that address and correct the root cause. Solutions determined to be the best of all alternatives. Document and verify the permanent Corrective Action in the Action Item Table

Applicable to occurrence of failure

Click here to enter a date.

Click here to enter a date.

Click here to enter a date.

How did you validate that the action/improvement measure eliminated the non conformance?

Click here to enter a date.

Click here to enter a date.

Click here to enter a date.

Applicable to non-detection of failure

Click here to enter a date.

Click here to enter a date.

Click here to enter a date.

6. Validation

Implement and validate to ensure that corrective action does “what it is suppose to do.” Detect undesirable side effect. Document this on the action Item Table. Return to root cause analysis, if necessary

Evidence:

7. Prevention (Design/Information System Review)

Determine what improvements in the systems and processes would prevent problem from recurring. Ensure that corrective action remains in place and are successful.

Were Pokes-Yokes (Error Proofing) Implemented because of this failure?

7B. Standardization and Control:

Control Plan

FMEA

Flow Process Diagram

Visual Aid

Operation Standards

Manufacturing Set-up Sheet

Manufacturing Check Sheet

Process Work Instructions

QA Inspection Forms

Preventive Maintenance Plan

Job Certifications/

Recertification requirement

Other

8B. Attach any additional information to end of this report.

Submitted By:

Signature/Title: X______________________________

Government Status:

CONTROL Forms.CheckBox.1 Government Signature/Title:

X____________________________ Date: Click here to enter a date..

8B. Defense Contract Management Agency.

Reviewed By:

Signature/Title: X______________________________

DCMA Status:

CONTROL Forms.CheckBox.1 DCMA Signature/Title:

X____________________________ Date: Click here to enter a date.

Action Item Table

EXHIBIT 5

PM SPE FORM 15: PROCESS CONTROL PLAN

EXHIBIT 6

AR/PD 14-01, ACH Gen II

CAR response Section 4-6 completed

CAR response Section 2-3 completed

Final CAR response updated: Section 7-8, completed

Revision 3.2

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