Attachment C Change Control Board Procedures.pdf

Information in printed paper copies of this document and any document referred to herein is guaranteed valid for only 24 hours of the print date

Change Control Board Procedure Revision: #2

Blank Cell Document Control Number: 93B-01.0-09 Date: 7/7/16

QUALITY

PROC.

Responsible Organization: Office of Quality Engineering and Management Blank Cell

Blank Cell Approved By: Justin Draheim Signature: <electronically approved>

1.0 PURPOSE:

The purpose of the Change Control Board (CCB) Procedure is to ensure that proposed changes are initiated, reviewed, approved, and documented in a timely and coordinated manner. This includes proposed changes to products, the currency manufacturing process, production equipment configurations, currency manufacturing materials (including the equipment and processes used to manufacture the raw materials) and methodologies (including those used for production, inspection, and testing) that could reasonably be expected to impact the quality of the finished product.

(Note: This procedure applies to changes to the products and manufacturing process as defined above, including proposals for changes to raw materials and material sample evaluations to support the supplier selection process. Where there are exceptions to using full and open competition, the material sample evaluation may be waived. New features, new equipment, and new designs (Level 4) may be processed through the Technology Development Process (TDP), Banknote Development Processes (BDP) and/or Change Control Board for governance.

2.0 SCOPE:

This procedure applies to changes at the Washington, DC Facility (DCF), Western Currency Facility (WCF), testing at contractor facilities (performed by BEP, and critical suppliers.

3.0 ROLES AND RESPONSIBILITIES:

The Office of Quality Engineering and Management is the document owner. The CCB with representation by the CCB Chairperson are the process owners.

All employees carrying out the tasks are responsible and have been deemed competent by Bureau of Engraving and Printing (BEP) management through acquired training, certification and/or experience, as well as observed successfully performing the tasks.

Listed below are the key responsibilities:

93B-01.0-09 Change Control Procedure

Information in printed paper copies of this document and any document referred to herein is guaranteed valid for only 24 hours of the print date

ROLE RESPONSIBILITY

CCB Approve, redirect, or reject Level 2, Level 3, and Level 4 and Feasibility Trials when applicable

CCB Chairperson Responsible for overseeing the Bureau’s Change Control process, voting member, and escalating change requests to Executive Management when applicable

CCB Administrator Confirm categorization of change request Monitor status of change requests and track progress of changes using CCB database Product Manager Advise CCB on changes that could reasonably be expected to have an impact on the quality of the finished product Coordinate with Change Owner to develop success criteria for product changes Work Area Authority Categorize change request according to the CCB Matrix

(guide) and not all inclusive Review all documentation associated with feasibility trial requests, Level 1-4 change requests when applicable for accuracy, completeness, and sufficiency of content Assign Change Owner following receipt of a change request for Level 2-4 when applicable and feasibility trials Change Owner Take CCB training via Serena (if applicable) prior to becoming a change owner and trained tracked via Serena for approval Identify training needs and resources to support the change through implementation Complete Verification & Validation Plans with success criteria (if necessary) Evaluate success criteria results and provide verification and validation reports with recommendation for next step Update Standard Operation Procedures (SOP) and conduct training if applicable Review all feasibility trials requests, change requests, and associated documentation for accuracy, completeness, and sufficiency of content Coordinate product release with Quality

Change Initiator Initiates the first step in the process by completing a change request

NOTE: for Level 1 changes, may also be the Change Owner Supplier Representative Submit request to BEP regarding a proposed process, equipment or raw material change Respond to BEP change requests Provide risk and impact assessment of the proposed change to the material

Information in printed paper copies of this document and any document referred to herein is guaranteed valid for only 24 hours of the print date

ROLE RESPONSIBILITY

Office of Acquisition (OA) Evaluate results of material sample testing

Appoint a COR when contract is awarded Communicate appropriate contract actions for supplier changes in accordance with change control provision in contracts

Technical Working Group

(TWG)

Categorizes supplier change requests according to the Supplier Change Matrix Level 1, 2 or 3 Appoint a supplier change owner to manage the change through implementation Analyze, evaluate, approve, or reject supplier change requests Interagency Currency (ICC) Group

Assess the potential effect of a change on its own processes and uses of currency, or the use or authentication of currency in circulation Approve supplier change requests Receive monthly CCB status reports

4.0 DEFINITIONS:

4.1 Change Control Board (CCB) – a body consisting of standing and ad hoc members that governs changes

4.2 CCB Administrator – central point of contact assigned to the CCB from the Quality Directorate

4.3 CCB Chairperson – assigned to the CCB from AD Manufacturing Directorate to oversee the change control process

4.4 CCB Matrix – an administrative guidance document to recommend the minimum documentation/approval levels requirements for verification and validation activities, it is controlled through Serena and is reviewed during the CCB document review process

4.5 Feasibility – an experiment or developmental study designed to explore an idea or concept for material or equipment compatibility utilizing test or live production work

4.6 Fit – the ability for a banknote component to interconnect, mate with, join, or link to another component of the banknote

4.7 Form – the shape, size, dimensions, or other parameters of a banknote component

4.8 Function – the purpose of a banknote or its components by how the part should perform and operate (i.e., - authentication or processing by the Banknote Equipment Manufacturers (BEMs), the Federal Reserve System, or acceptance by any of the user groups)

Information in printed paper copies of this document and any document referred to herein is guaranteed valid for only 24 hours of the print date

4.9 Interagency Currency Design (ICD) Group/Interagency Currency Committee (ICC) - a body consisting of stakeholders (BEP, FRB, USSS, CTO) responsible for developing and applying a management framework and developing new banknote designs that address the security and functional requirements of users and stakeholders of Federal Reserve notes

4.10 Product Change – any deliberate alteration to a product target or product specification that impacts the form or fit of a banknote component or the function of a banknote or its components in any manner

4.11 Supplier Change – proposed change to purchased products

4.12 Technical Working Group (TWG) -- A body consisting of stakeholders, (e.g., BEP, FRB, USSS, CTO) that governs the analysis, evaluation, approval and rejection of supplier change requests

4.13 Verification Plan – confirmation through testing that products, equipment configurations, currency manufacturing materials, or methodologies meet identified success criterial and customer requirements

4.14 Validation Plan – confirmation through testing against success criteria that products made from equipment configurations, currency manufacturing materials, or methodologies appropriately meet the designed function or the intended use

5.0 REFERENCES:

MOU between the Board of Governors of the Federal Reserve System and BEP Design Control 93.00-1 (4.4) Portfolio and Project Management Circular Serena SBM (Team Track) for Change Request CCB

6.0 ENCLOSURES:

None

7.0 PROCEDURE:

Note: It is the policy of the Bureau of Engraving and Printing (BEP/Bureau) to meet the requirements of our customer agencies by consistently producing quality products and limiting variations in products in the most cost-effective manner possible. Maintaining this commitment requires continual improvements and refinements in raw materials, equipment configurations and processes. Such changes, including changes at the supplier, will be verified or where appropriate validated, reviewed, approved, and documented prior to implementation in accordance with this procedure.

Information in printed paper copies of this document and any document referred to herein is guaranteed valid for only 24 hours of the print date

7.1 Types of Changes

7.1.1 Changes are categorized into five levels:

7.1.1.1 Level 0 – Routine day-to-day operations or maintenance changes and not required but may be entered in SBM and not approved.

7.1.1.2 Level 1 – Minor non-routine changes that are not expected to impact downstream processes or the final product. The initiator may select themselves as the change owner.

7.1.1.3 Level 2 – Infrequent or moderate changes, which present a medium risk of issuance of defective product

7.1.1.4 Level 3 – Major changes, which present a high risk and could result in the issuance of defective product

7.1.1.5 Level 4 – New technology, features, or new designs

7.1.1.6 A feasibility trial is an experiment or developmental study designed to explore an idea or concept and may include material or equipment compatibility.

Note: A feasibility trial may be performed on live product if testing does not affect the product quality or defined parameters at any point in production (i.e., testing a new camera or sensor’s monitoring capabilities.)

7.2 Submitting and Processing Change Requests

7.2.1 The change initiator completes a change request form in SBM, which captures basic information about the nature or justification for the change, and submits the change request for processing.

7.2.2 The work area authority reviews change requests in SBM, verifies the correct change level has been assigned per the CCB Matrix, and ensures a change owner is assigned from the functional area that will manage the change.

7.2.3 The approval authority for each type of change is defined as follows:

7.2.3.1 Level 0 changes as identified in the CCB Matrix (guide) are not required to be submitted for approval in SBM.

7.2.3.2 Level 1 changes do not require approval from the full CCB, but do require review by the CCB Administrator. (Note: Level 1 supplier changes require review and approval by the work area authority and the initiator may select themselves as the change owner.)

7.2.3.3 Level 2 -4 (when applicable) changes require review and approval by the CCB. When necessary, the change owner will coordinate approval for changes with the appropriate oversight bodies within the U.S. Currency Program (i.e. – ACD, ICD, TWG).

7.2.3.4 Level 4 changes for new features, new designs, and some equipment will follow the Technology Development Process and/or Banknote Development Process and may be assigned to the CCB for governance.

Information in printed paper copies of this document and any document referred to herein is guaranteed valid for only 24 hours of the print date

7.2.4 A series-year change on finished notes must be approved by the ICD/ICC by signature, email concurrence, or annotation in the final minutes.

7.2.5 The change owner processes the change request in SBM and attaches the appropriate documentation, including change notification memos received from suppliers.

7.3 Planning, Verification, and Validation

7.3.1 Feasibility Trial

7.3.1.1. Once the feasibility trial request is approved by the work area authority, the change owner conducts the feasibility trial, collects data, interprets results, and develops a report containing data analyses and all findings.

7.3.1.2 If necessary, upon approval of the Feasibility Plan, the change owner completes a Print Order Request.

7.3.1.3 The change owner submits the report to the work area authority to assess the results.

7.3.1.4 The work area authority will review the results and will collaborate with the change owner to determine next step.

7.3.1.5 If the feasibility trial is deemed to be sufficient, the need for additional testing may possibly be waived by the CCB.

7.3.2 Level 1 Change

7.3.2.1 The change owner completes the applicable Level 1 checklist (in

SBM) for minor changes to currency manufacturing processes or production equipment configurations.

7.3.2.2. For supplier changes the change owner submits a final report and relevant documentation to the work area authority for approval.

7.3.3 Level 2 or 3 Change

7.3.3.1 The change owner completes the Verification & Validation Plans in SBM to document the testing or experimental design needed to confirm the success criteria for the proposed change. (Note: The change owner is responsible for adhering to BEP project thresholds defined in the Portfolio and Project Management Circular.)

7.3.3.2 If necessary, upon approval of the Verification & Validation Plans, the change owner completes a Print Order Request in SBM.

7.3.3.3 The change owner develops a report in SBM for the CCB, which contains summaries of data analyses and all test findings. (Note:

For supplier changes, the change owner will coordinate with the TWG to review the report and determine the recommendation for approval or rejection of the change.)

7.3.3.4 The change owner may submit a transition plan if applicable for rolling out the change to each BEP facility, specifying dates and deliverables.

7.3.3.5 When necessary, following CCB approval, the change owner will coordinate approval for changes with the appropriate oversight

Information in printed paper copies of this document and any document referred to herein is guaranteed valid for only 24 hours of the print date bodies within the U.S. Currency Program (i.e., – ACD, ICD, TWG).

7.4 Implementing Approved Changes

7.4.1 The change owner updates procedures/work instructions and coordinates training for impacted work areas, in accordance with the Document and Data Control Procedure, prior to implementing any change.

7.4.2 The change owner coordinates and schedules delivery and deployment of new materials, equipment, and equipment configurations (if applicable) for each BEP facility. (Note: Changes to note production or process changes may require a series-year change on the finished notes.)

7.4.3 If necessary, the change owner develops a plan to dispose of excess property (when removing old equipment and assets) and coordinates destruction of test work and/or pre-production validation (PPV) work.

7.4.4 The change owner will notify the CCB administrator of the status of the transition plan if applicable.

7.5 Records Management

7.5.1 Official CCB change records will be maintained in SBM.

7.5.2 Change owner training will be tracked in SBM.

7.5.3 Product changes will be documented in the Product History File and maintained by the Product Manager.

REVISION PURPOSE OF REVISION EFFECTIVE

DATE

Revised structure and composition of Change Control Board; added details regarding verification and validation testing; defined change categories

6/12/15

2016 annual documentation review process and to address internal audit improvements

7/7/16

Blank Cell Blank Cell Blank Cell

PURPOSE OF REVISION

Accessibility Report

Filename:

93B-01.0-09ChangeControlProcedure.pdf

Report created by:

Sandy, sandy@scribedoc.com

Organization:

ScribeDoc.Com, Inc

[Personal and organization information from the Preferences > Identity dialog.]

Summary

The checker found no problems in this document.

Needs manual check: 0

Passed manually: 5

Failed manually: 0

Skipped: 0

Passed: 27

Failed: 0

Detailed Report

Document

Rule Name Status Description

Accessibility permission flag Passed Accessibility permission flag must be set

Image-only PDF Passed Document is not image-only PDF

Tagged PDF Passed Document is tagged PDF

Logical Reading Order Passed manually Document structure provides a logical reading order

Primary language Passed Text language is specified

Title Passed Document title is showing in title bar

Bookmarks Passed Bookmarks are present in large documents

Color contrast Passed manually Document has appropriate color contrast

Page Content

Rule Name Status Description

Tagged content Passed All page content is tagged

Tagged annotations Passed All annotations are tagged

Tab order Passed Tab order is consistent with structure order

Character encoding Passed Reliable character encoding is provided

Tagged multimedia Passed All multimedia objects are tagged

Screen flicker Passed manually Page will not cause screen flicker

Scripts Passed manually No inaccessible scripts

Timed responses Passed manually Page does not require timed responses

Navigation links Passed Navigation links are not repetitive

Forms

Rule Name Status Description

Tagged form fields Passed All form fields are tagged

Field descriptions Passed All form fields have description

Alternate Text

Rule Name Status Description

Figures alternate text Passed Figures require alternate text

Nested alternate text Passed Alternate text that will never be read

Associated with content Passed Alternate text must be associated with some content

Hides annotation Passed Alternate text should not hide annotation

Other elements alternate text Passed Other elements that require alternate text

Tables

Rule Name Status Description

Rows Passed TR must be a child of Table, THead, TBody, or TFoot

TH and TD Passed TH and TD must be children of TR

Headers Passed Tables should have headers

Regularity Passed Tables must contain the same number of columns in each row and rows in each column

Summary Passed Tables must have a summary

Lists

Rule Name Status Description

List items Passed LI must be a child of L

Lbl and LBody Passed Lbl and LBody must be children of LI

Headings

Rule Name Status Description

Appropriate nesting Passed Appropriate nesting

Back to Top dtstamp: 03/25/2020 1:05 pm