8) AL-1208-0209C.pdf

ALS-U supplier quality evaluation survey

Release Date: Mar 25 2024 11:44:52 AM PDT

Document Number: AL-1208-0209 Revision: C

Document Status: Released

Document Type: QUALITY ASSURANCE

Category Code: AL7001

ALS-U - GENERAL

QA

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Advanced Light Source Upgrade Project Lawrence Berkeley National Laboratory

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Center release information in the lower-left corner of the document's pages.

Printed hard copies of this document are for reference only.

Table of Contents

Revision History

Abbreviations and Acronyms

1 Purpose

2 Company Overview

2.1 Company profile

2.2 Certifications, registrations, and awards

3 Quality Management System Administration

4 QA/QC for Purchased Items

5 Process QA and Control

5.1 General

5.2 Production QA

5.3 Subcontracts that include design capability (optional)

Appendix A: Certifications, Registrations, and Awards

Appendix B: QMS Documentation

Appendix C: QA/QC for Purchased Items

Appendix D: Process QA and Control Documentation

REVISION HISTORY

Rev. CM Number Description of Change

A Initial release

B Updated the calibration requirements

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ABBREVIATIONS AND ACRONYMS

B2S Build to specification

ERP Enterprise Resource Planning (software)

LBNL Lawrence Berkeley National Laboratory

COC Certificate of Conformance

COTS Commercial off the shelf

QA Quality Assurance

QAP Quality Assurance Program

QC Quality Control

QMS Quality Management System

MIP Manufacturing Inspection Plan

MRP Material Requirements Planning (software)

NCR Non-conformance report

RFP Request for Proposal

SOP Standard Operating Procedures ci al ly R el ea se d to th e

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1 PURPOSE

Lawrence Berkeley National Laboratory’s (LBNL’s) Quality Assurance (QA) policy requires that suppliers are – and remain – in compliance with applicable requirements and standards. Your response to this survey provides the basis for assessing your company’s QA processes. Additional requisites, such as specific documentation or an evaluation conducted onsite, may be requested at a later date.

2 COMPANY OVERVIEW

2.1 Company profile

Company name:

Address:

Project manager:

Email:

Phone:

Production manager:

Email:

Phone:

Quality manager:

Email:

Phone:

Total number of employees that perform QA/quality control (QA/QC) functions at your facility:

Number of full time QA/QC employees:

Number part-time QA/QC employees:

Number of third-party inspectors/evaluators (if any):

QA survey content prepared by:

Title / role:

Date:

Note to preparer:

One way to complete this survey is to export the pdf to MS Word. After completing the survey, pdf the result and add pdfs of the requested documents after the provided cover sheets for Appendices A through D.

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2.2 Certifications, registrations, and awards

In this section, please list your company’s applicable registrations, certifications, and awards of the type requested. Add as many rows as needed and provide supporting documentation, such as a copy of certifications, in Appendix A.

Title Dates in effect / expiration

Provided in Appendix A

Yes No

Certifications, registrations, QA certifications, or distinctive awards (e.g., ISO 9000, Mil-Specs, Six Sigma process controls)

Standards your company’s calibration program meets (e.g., ISO/IEC 17025, (ANSI)/NCSL Z540-1-1994, ANSI/NCSL 540.3-2006)

Certifications under any other applicable licensing or qualification program (e.g., AWS-ASME Welder Qualifications, Nondestructive Test Society) ci al ly R el ea se d to th e

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3 QUALITY MANAGEMENT SYSTEM ADMINISTRATION

For each quality management system (QMS) or quality assurance program (QAP) item, indicate if your company maintains this type of system, documentation, or process (yes, no, or description) in the table below, and provide requested documentation in

Appendix B. Submitted documentation should indicate how QA is incorporated into policies, processes, and work activities – and if lower-tier subcontractors are involved, how these are “flowed down.”

QMS element

Response to questions

Provided in Appendix B

Yes No Yes No

Does your company maintain one or more of the following:

- QMS/QAP

- QA Program Manual

- QA Standard Operating Procedures (QA SOPs)

If yes, please answer items 1 – 2:

1. Attach manual(s) and provide title(s):

2. Does your company maintain a record of training on QA-related policies and procedures for affected personnel?

Are QA processes audited? If yes, please answer items 3 – 4: –

3. Audit frequency:

4. Auditor qualifications type (e.g., certification, credentials, license):

Are all drawings, specifications, work instructions, and SOPs released under change control? If yes, please answer items 5 –6:

5. Software used for document change control:

6. Provide a brief description of your document control and records management process:

Does your company ensure that QMS and QA/QC policies are carried through to lower-tier subcontractors (if any)?

Is there is a QMS element in place at your facility that is not specifically called out above that supports your proposal?

If yes, please provide a list and/or attach examples:

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4 QA/QC FOR PURCHASED ITEMS

For many LBNL projects, the materials or components used to fabricate, manufacture, or assemble items must meet precise specifications. Please provide information that demonstrates your company’s ability to meet the required level of QA/QC for purchased materials and/or commercial of the shelf (COTS) items. Include any supporting documentation in Appendix C.

Supplier QA/QC element

Response to questions

Provided in Appendix C

Yes No Yes No

Does your company use a Material Requirements Planning (MRP) and/or Enterprise Resource Planning (ERP) system for planning, identifying, labeling, and tracking components?

If yes, please provide the software product in use:

(e.g., Asana, SharePoint, JobBOSS, Oracle Cloud, SAP, Katana, Oracle NetSuite)

In use since (date):

Does your company track certificates of conformance (COCs) for purchased items including materials, components, and hardware?

Does your company follow a documented process for qualifying suppliers and/or subcontractors?

If yes, please attach supporting documentation and provide the title:

Does a representative from your company visit subcontractor facilities to ensure QC measures are in place?

If yes, provide threshold(s) for a site visit (e.g., initial, routine):

Do you have a process for ensuring that your supplier's test reports and records are accurate?

If yes, briefly describe the process:

Will materials received for this project be inspected for quality? If yes, please answer items 1 – 3:

1. Is defective material identified and segregated? –

2. Indicate the type of inspection records that will be available for LBNL review and/or provide an example:

3. Describe your company’s process for identifying and isolating suspect or counterfeit parts or materials (or attach an example of such a process):

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5 PROCESS QA AND CONTROL

The information requested in this section addresses your company’s ability to provide time-critical communication and ability to ensure that processes are in place to manage quality control throughout the manufacturing process, final inspection, and shipping.

Please respond as indicated (yes, no, and description). Include requested supporting documentation in Appendix D.

5.1 General

This section applies to all types of products and services.

Process element (general)

Response to questions

Provided in Appendix D

Yes No Yes No

Is it your company’s practice to regularly provide status reports during the fabrication / manufacturing / production process?

If yes, please state the typical status reporting timeframe for the type of project described in this RFP:

When conditions warrant, does your company have a formal process for initiating a request for modifications or proposing potential design improvements? If yes, please answer questions 1 – 3:

1. Which role is responsible for initiating such requests:

2. Describe your notification process:

3. Does your company have a standardized form for change control?

If yes, please provide a copy and title:

Is there a process for identifying an item or product your company produces that fails to conform to defined specifications?

If yes, please answer questions 4 – 7:

4. Describe your company’s system for identifying nonconforming materials:

5. Are reworked materials or components re-inspected? –

6. Are defective components or assemblies segregated? –

7. Does your company have a standard non-conformance report (NCR) form?

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Process element (general)

Response to questions

Provided in Appendix D

Yes No Yes No

If yes, please provide a copy and title of NCR form:

If requested, can your facility provide a sequestered and controlled area for sensitive components and/or assemblies?

Describe your company’s process for responding to customer feedback / concerns / or matters that may require corrective action:

5.2 Production QA

This section applies to all fabrication / production / manufacturing / testing facilities.

Process control element

Response to questions

Provided in Appendix D

Yes No Yes No

Does your facility keep calibration records? –

If yes, please attach documentation that indicates the frequency and method of calibration for equipment relevant to this RFP.

Does your company keep equipment maintenance records? –

If yes, please attach a form for the type of equipment relevant to this RFP.

Does your company maintain an up-to-date manufacturing inspection plan (MIP) for ongoing and new processes and products?

Is there a system for implementing updates to specifications and/or inspection requirements provided by the customer?

Are in-process tasks systematically documented for all work activities? –

If yes, please attach an example (e.g., a job traveler) for a work process similar to one required in this RFP.

Does your company provide a COC for your final product (e.g., certification that the item was produced in accordance with project specifications or drawings when other quality verification methods are not employed)?

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5.3 Subcontracts that include design capability (optional)

This section applies to build to specification (B2S) subcontracts and/or if the subcontract has the potential to include design elements. This section is optional.

Design element

Response to questions

Provided in Appendix D

Yes No Yes No

Does your company have the capability to produce shop drawings and/or design tooling? If yes, please answer items 1 – 3:

1. CAD platform:

2. List the editable 2-D (e.g., DWG, DXF) and 3-D CAD (e.g.,STP, ASM) file types that your company can provide:

3. Please provide an example of a drawing and/or design tooling comparable to the requirements in the RFP.

Drawing or design title:

Does your company have the ability to convert customer specifications and/or CAD models into shop specifications and inspection instructions?

If yes, please attach an example comparable to the requirements in this RFP.

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APPENDIX A: CERTIFICATIONS, REGISTRATIONS, AND AWARDS

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APPENDIX B: QMS DOCUMENTATION

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APPENDIX C: QA/QC FOR PURCHASED ITEMS

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APPENDIX D: PROCESS QA AND CONTROL DOCUMENTATION

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