A07_Solicitation_SOW-AttachA_16R0002.pdf

22.1 Exhibit 1 PM SPE FORM 1 Engineering Change Request (ECR)

22.2 Exhibit 2 Production Readiness Review/Audit

22.3 Exhibit 3 PM SPE FORM 11

Quality Management System

(QMS) Crosswalk

22.4 Exhibit 4 PM SPE FORM 3 Corrective Action Request

22.5 Exhibit 5 PM SPE FORM 15 Process Control Plan

22.6 Exhibit 6

PEO Soldier Staging Facility

Peckham Vocational Industries, Lansing, MI, General Vendor

Shipping Instructions Revision # 6, 1 June 2015

22.1 - EXHIBIT 1

PM SPE FORM 1: ENGINEERING CHANGE REQUEST (ECR)

22.2 - EXHIBIT 2

PRODUCTION READINESS REVIEW/AUDIT

Agenda Topics Description of Material to be Verified and Discussed

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

Audit on Production Area Shop-floor visits to key areas by small groups (Contractor and Government)

Audit Meetings Small group discussions between assessment team members and

Contractor Subject Matter Experts (SMEs)

Private meeting of assessment team to record and discuss observations

Out-briefing by assessment team to Contractor

22.3 - EXHIBIT 3

PRODUCT MANAGER SOLDIER PROTECTIVE EQUIPMENT PM SPE FORM 11

ISO 9001:2008 CROSSWALK

Company:

Contracting Officer:

Solicitation Number:

Contract Number:

PM SPE Reviewer:

Date: Click here to enter a date.

EXHIBIT 3

PRODUCT MANAGER SOLDIER PROTECTIVE EQUIPMENT

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.

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.”

ISO 9001:2008 CROSSWALK

ISO 9001:2008 Clause Company Quality

Management System Compliance Statement

Introduction (title only)

General 0.1

Process approach 0.2

Relationship with ISO 9004 0.3

Compatibility with other management systems

0.4

Scope (title only) 1

General 1.1

Application 1.2

Normative references 2

Terms and definitions 3

Quality Management System (title only) 4

General requirements 4.1

Documentation Requirements (title only) 4.2

General 4.2.1

Quality manual 4.2.2

Control of documents 4.2.3

Control of records 4.2.4

ISO 9001:2008 Clause Company Quality

Management System Compliance Statement

Management Responsibility (title only)

Management commitment 5.1

Customer focus 5.2

Quality policy 5.3

Planning (title only) 5.4

Quality objectives 5.4.1

Quality management system planning 5.4.2

Responsibility, authority and communication (title only) 5.5

Responsibility and authority 5.5.1

Management representative 5.5.2

Internal communication 5.5.3

Management review (title only) 5.6

General 5.6.1

Review input 5.6.2

Review output 5.6.3

ISO 9001:2008 Clause Company Quality

Management System Compliance Statement

Resource management (title only) 6

Provision of resources 6.1

Human resources (title only) 6.2

General 6.2.1

Competence, training and awareness 6.2.2

Infrastructure 6.3

Work environment 6.4

Product realization (title only) 7

Planning of product realization 7.1

Customer-related Processes (title only) 7.2

Determination of requirements related to the product 7.2.1

Review of requirements related to the product 7.2.2

Customer communication 7.2.3

Design and Development (title only) 7.3

Design and development planning 7.3.1

Design and development inputs 7.3.2

Design and development outputs 7.3.3

ISO 9001:2008 CROSSWALK

ISO 9001:2008 Clause Company Quality Management

System Compliance Statement

Design and development (title only-continued) 7.3

Design and development review 7.3.4

Design and development verification 7.3.5

Design and development validation 7.3.6

Control of design and development changes 7.3.7

Purchasing (title only) 7.4

Purchasing process 7.4.1

Purchasing information 7.4.2

Verification of purchased product 7.4.3

Production and service provision (title only) 7.5

Control of production and service provision 7.5.1

Validation of processes for production and service provision 7.5.2

Identification and traceability 7.5.3

Customer property 7.5.4

Preservation of product 7.5.5

Control of monitoring and measuring equipment 7.6

ISO 9001:2008 CROSSWALK

ISO 9001:2008 Clause Company Quality Management

System Compliance Statement

Measurement, analysis and improvement (title only)

General 8.1

Monitoring and measurement (title only) 8.2

Customer satisfaction 8.2.1

Internal audit 8.2.2

Monitoring and measurement of processes 8.2.3

Monitoring and measurement of product 8.2.4

Control of nonconforming product 8.3

Analysis of data 8.4

Improvement (title only) 8.5

Continual improvement 8.5.1

Corrective action 8.5.2

Preventive action 8.5.3

Submitting Activity

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

b. TITLE

c. DIGITAL SIGNATURE

X

22.4 - EXHIBIT 4

CORRECTIVE ACTION REPORT FORM

INSTRUCTION PAGE 1

Discipline Category Requested Information

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.

EXHIBIT 4

INSTRUCTION PAGE

Discipline Category Requested Information

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.

Section 8 The following shall be documented:

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: The Final CAR response shall be submitted within fifteen (15) working days. If an extension is required, the contractor shall provide a written extension request to DCMA.

Gov. notification to the Contractor

DAY 1 DAY 2 DAY 3 DAY 4 DAY 5 Day

DAY 7 DAY 8 DAY 9 DAY

DAY

DAY

DAY

DAY

DAY

CAR response Section

4-6 completed

CAR response Section

2-3 completed

Final CAR response updated: Section 7-8, completed

Supplier:

Address:

Point of Contact: Phone Number: Fax Number:

CAR Number: CAR Date: Click here to enter a date.

Status:

Recurrent Failure:

Part Name: Affected Part Number:

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

Name: Position: Phone Number: Email Address:

3. Containment Action

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

Action:

Assignee: Date: Click here to enter a date.

At Government Facility

Verification (Date and result):

Material at Government Facility Disposition

No. RMA:

Material in Transit

Verification (Date and result):

At Supplier’s Facility

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?

1st Cause 2nd Cause 3rd Cause

1. Why?

2. Why?

3. Why?

4. Why?

5. Why?

Why was the failure not detected?

1st Cause 2nd Cause 3rd Cause

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

Actions Date Assignee

Click here to enter a date.

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

Actions Date Assignee

Applicable to non-detection of failure

Actions Date Assignee

6. Validation

Implement and validate to ensure that corrective action does “what it is supposed 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?

Yes (Describe the operation): No (Why not?):

7B. Standardization and Control:

Check if

Applicable

Document Assignee Completion What Changed?

Planned Actual

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______________________________

Effect Date: Click here to enter a date.

Date Submitted: Click here to enter a date.

Government Status:

Government Signature/Title:

X____________________________

Date: Click here to enter a date..

8B. Defense Contract Management Agency.

Reviewed By:

Signature/Title:

X______________________________

Effect Date: Click here to enter a date.

Date Submitted: Click here to enter a date.

DCMA Status:

DCMA Signature/Title:

X____________________________

Date: Click here to enter a date.

Action Item Table

Action Implement and Verify Actions

Action

Number

Fault/item Containment/Corrective

Action

Verify How

Verified

Action Assignee Planned Actual Status

22.5 - EXHIBIT 5

PM SPE FORM 15: PROCESS CONTROL PLAN

Proc.

Step

No.

Process

Name

Machine, Device, Tools for

Manufacturing

Process

Parameters

Product

Characteristics

Class Product /

Process

Specification

Evaluation

Method

Sample

Size /

Frequency

Analysis

Method

Reactions if

Out-of-

Control

Conditions are

Encountered

22.6 – Exhibit 6

The following requirements are the minimum required labeling, packaging, and shipping instructions. Any deviations to these requirements shall be addressed in Section D of the contract.

SHIP TO LOCATION:

Peckham Vocational Industries, Inc.

7100 Millet Highway

Lansing, MI 48917

DODAAC: W912H7

Receiving Hours: Monday – Friday 08:30am – 2:30pm

Deliveries by appointment only, the Points of Contact (POC) for deliveries:

Jim Gustafson 517-316-4072

Sara Moore 517-316-4314

Deliveries outside of these hours must be preapproved by the Supervisor of

Receiving

DD-250 (Packing List):

The DD-250 packing list shall be attached to the lead pallet, inside a packing list envelope.

The packing list shall list each NSN with a quantity for each NSN within the shipment.

Bar Tag Instructions:

Bar codes shall be encoded using the Standard Code 39 representation complying with all commercial requirements. All bar codes shall be readable using commercial bar code scanners. The marking shall be on a durable label such that heavy handling will not cause noticeable degradation which would render the bar code unreadable.

PEO Soldier Staging Facility

Peckham Vocational Industries, Lansing, MI

General Vendor Shipping Instructions Revision: 6

Date: 01 June 2015

Approved By: Michael T. Bell

Sample of a Code 39 Linear Bar Code

Individual Box Instructions:

1. Box dimensions shall be calculated to maximize the space on the skid while aligning all edges (with no more than one inch overhang), but not exceeding 50” wide x 42” deep x 54” high, PEO Soldier prefers 52” max (the 54” includes the height of the pallet).

2. If the products in the boxes are not enclosed in protective wrapping, the box must have a Kraft paper liner inside the box on the top and bottom of the product.

3. Each box shall contain only one NSN

4. There can be only be one single partial (short) box per NSN per shipment, that box shall be clearly identified as a partial box.

5. All boxes within a shipment must be labeled with the label facing the outside of the packed pallet so as to be readable.

6. A single label shall contain, as separate lines, each of the following fields in both human readable and standard Barcode 39 format:

o Vendor’s name optional (Human Readable Only) o Cage Code of the company awarded the contract o Nomenclature that matches the contract nomenclature (Human Readable

Only) o National Stock Number (NSN) o Material Size o Quantity o Contract or order number (including the call number) o Lot number or N/A if not Lot tracked o Serial Number or N/A if not Serialized

7. Unique Box Identification (UBI) - Along with the box label, each box shall have a unique passive RFID box identification. This unique identification shall conform to the “United States Department of Defense Suppliers’

Passive RFID Information Guide” Latest Version (version 10 and higher).

Sample Box Label

Pallet Instructions:

1. All items shall be delivered on a standard 4-way entry Type 1, 48” wide x 40” deep pallet (Wing Tip Pallets preferred).

2. The pallet and packages combination shall not exceed 54” (PEO Soldier prefers

52”) in overall height.

3. The packaging shall not exceed 1” overhang per pallet edges, allowing the final packaged dimensions of the package to be no greater than 50” wide by 42” deep and 54” (PEO Soldier prefers 52”) in height.

4. A pallet may contain multiple National Stock Numbers (NSN). Each NSN must be boxed or wrapped separately, clearly identified, and labeled on the pallet.

5. Loads containing multiple shipments numbers shall not be mixed on a pallet.

6. The pallet label shall contain a bar code label on the outside of the pallet packaging, containing as separate lines, each of the following fields in both human readable and standard Barcode 39 format:

Peckham Vocational Industries Inc.

7100 Millet Highway

Lansing, MI 48917

DODAAC: W912H7

Phone: 517-316-4072 o Vendor’s name optional (Human Readable Only) o Cage Code of the company awarded the contract o Nomenclature that matches the contract nomenclature (Human

Readable Only) o National Stock Number (NSN) o Pallets containing more than one NSN shall be clearly identified as a mixed pallet.

o Contract or order number (including the call number) o Exact total quantity o Contractor Shipment Number, encoded using seven characters or eight if including a suffix, in accordance with the DFARS Appendix F, Part

3. The first three positions will always be alpha, the last three always numeric, and the fourth either alpha or numeric o Pallet number and the total number of pallets o CLIN (encoded using six characters, including zero fillers placed to the left of the number, for example, 0001AB).

o Shipment Number made against the contract

7. A Unique Passive RFID Pallet Identification Tag: In addition to the pallet label, each pallet shall have a unique passive RFID pallet identification tag. This unique identification tag shall conform to the “United States Department of Defense

Suppliers’ Passive RFID Information Guide” Latest Version (version 10 and higher).

8. Any wood pallets used, must be heat treated and contain the international heat treated marking.

9. The boxes on the pallets shall be both stretched wrapped and banded to the pallet.

4-way entry Type 1 Pallet Sized 48” Wide Front x 40” Deep Sides.

Max Height not to exceed 54” PEO Soldier prefers 52” (including

Pallet):

Pallets Shall Be Stretched-Wrapped and Banded

Heat Treated Pallet- ID = HT

Pallet ID Form: Front and Back

Address Label: Front and Left

Heat Treated Pallet- ID = HT