Manufacturing Readiness Review (MRR) Procedure_804a455c - 7.0.pdf

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Manufacturing Readiness Review (MRR) Procedure Abstract or description:

The purpose of this procedure is to define the process to be used for conducting the Manufacturing Readiness Review. The procedure defines the in-depth process for determining that a supplier is ready to begin the manufacture of products in that environment. It establishes the review process to be applied by US ITER and the supplier to ensure requirements are understood, hazards are recognized, the manufacturing operations are properly planned, quality assurance is thoroughly integrated, and US ITER and the ITER Organization (IO) are involved to the degree required.

Workflow Role Name Action Author Bailey Jr H. 06 Oct 22:signed Co-Authors Reviewers Casella F.

Freudenberg K.

Hughes D.

Rossano G.

06 Oct 22:recommended 11 Oct 22:recommended 07 Oct 22:recommended 06 Oct 22:recommended

Approver Wiles S. 17 Oct 22:approved iDOCS UID

US_D_22YBGC

VERSION CREATED ON / VERSION / STATUS

06 Oct 22 / 7.0 / Approved

EXTERNAL REFERENCE

CLASSIFICATION

Unclassified

PA DESIGN DOCUMENT TYPE

Manufacturing Readiness Review (MRR)

ICP Number

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Change Log Manufacturing Readiness Review (MRR) Procedure (22YBGC)

Version Latest Status Issue Date Description of Change v1.0 OBSOLETE

(Signed) 20 Jun 14 v1.1 OBSOLETE (In Work)

18 Sep 14 o Commodity items are excluded from this procedure. It is directed to the manufacture of US ITER designed hardware (not “industry standard” hardware).

o The Systems Engineering Manager has a role for all MRRs (at least for now) to review scope, preparatory materials, and the report.

- The authority of the WBS TL has been expanded commensurate with their responsibility.

v1.2 OBSOLETE (Signed)

19 Sep 14 Fixed section 3 font, referenced an appendix 8 but there are only 7 appendices, corrected that error in this version.

v2.0 OBSOLETE (Signed)

12 Jan 15 This document has undergone a major revision to reflect a less rigorous process for these reviews. The current version in iDocs (v1.2) includes the use of Levels as a guide for the amount of oversight in the review. This newer version (v2.0) instead relies on our MIP and QA programs for many of these reviews but imposes a more rigorous review if the manufacturing operation is state-of-the-art or largely unproven in the industrial environment.

v3.0 OBSOLETE (Approved)

25 Feb 15 Revised to include the division director in the decision loop for determining the necessity of the MRR, other minor changes.

v4.0 OBSOLETE (Approved)

14 Jul 15 Changed roles and responsibilities for CE, SE Manager, WBS TL and QA/ES&H Manager. Added Supplier role. Changed formatting for 5.22

NOTE.

v4.1 OBSOLETE (Approved)

05 Jan 16 Removed out-of-date USIPO Text Box above Table of contents. In Appendix 7.3, replaced excerpt of Issues Form with note to include form (avoiding need to update procedure with changes to form).

v5.0 OBSOLETE (Approved)

03 Jan 17 Added designee option for ES&H/QA, SE Manager and Chief Engineer;

Changed responsibility for Panel selection from WBS TL to Panel Chair;

corrected CAM acronym explanation; changed responsibility to work with Procurement and supplier from WBS TL to RE/CAM (for release of supplier to begin operations) v6.0 OBSOLETE (Signed)

14 Aug 20 Added new Simplified MRR process description, added option to invite IO representative as an observer, replaced Chief Engineer with Fusion Systems Integration role, replaced mentions of RE with TPO, and various other format updates.

v6.1 OBSOLETE (Signed)

25 Aug 20 Incorporated reviewer comments.

Clarified WBS TL responsibility for deciding what type of MRR (Simplified

vs. Full) to perform.

Removed Fusion Systems Integrator role.

Added MRR Plan definition, specified where MRR Type decision is recorded (MRR Plan) and clarified who should write the MRR Plan.

Clarified the slash in TPO/CAM means either role can complete the specified task.

Specified Inspection Plan as location of hold point for MRR.

Reassigned responsibility to inform Supplier of MRR disposition from Procurement to TPO/CAM.

Corrected reference to CRN Procedure. Added reference to ITER Quality Plan.

Expanded list of programs in Appendix 7.1. Corrected typos and other minor format updates.

v6.2 OBSOLETE (Approved)

08 Oct 20 1. Section 1, Purpose: revised to be more concise

2. Section 2, Scope: added language to clarify the procedure, “…applies throughout the supply chain to all Primary and Sub-Tier Suppliers manufacturing components under contract by US ITER…”

3. Section 4, Definitions and Acronyms: added acronyms COTS, IO, PA, SOW, SSCs, TRO, and WBS TL. Clarified definition of “Issue” as generic

DISCLAIMER: UNCONTROLLED WHEN PRINTED – PLEASE CHECK THE STATUS OF THE DOCUMENT IN iDOCS term for findings/recommendations.

4. Section 5.0, MRR Process: replaced reference to Quality Assurance Program with reference to Quality in Acquisitions Procedure, added reference to Approved Supplier List Procedure and QA Surveillance Plan and Report Form.

5. Section 5.0, Decision on Type of MRR to Conduct: rearranged paragraphs, added instruction that ASL results can be used as the basis for writing the Simplified MRR Report, and clarified the type of MRR selected is largely based on risk to the project.

6. Step 5.2.16: clarified where Appendix A can be found, clarified Supplier responsibility.

7. Step 5.3.7: clarified where Findings/Recommendations for a Simplified MRR report should come from. Specifically, when leveraging previous ASL results, any remaining findings/recommendations that have not been resolved should be recorded in the simplified report

8. Section 6.0, References: replaced reference to Quality Assurance Program with reference to Quality in Acquisitions Procedure, added reference to Approved Supplier List Procedure and QA Surveillance Plan and Report Form.

9. Section 7.1, Appendix 7.1: moved 1st paragraph to note in step 5.2.16

10. Section 7.2, Appendix 7.2 – Quality: spelled out Deviation Request and Nonconformance Report

11. Section 7.3, Appendix 7.3: added lines in template to record the SOW UID and the Contract Number, added emphasis that the summary of review is based on the Panel’s review of the data for a Full MRR

12. Section 7.4, Appendix 7.4: added lines in template to record the SOW UID and the Contract Number, added emphasis that the summary of review is based on the leveraged documentation for a Simplified MRR v6.3 OBSOLETE (Signed)

10 Feb 22 Updated to align with new organizational positions, and to instruct that submittal to the IO must be information only.

v6.4 OBSOLETE (Signed)

14 Feb 22 Changed to align with new organizational positions, and to instruct that submittal to the IO must be information only. Clarification under Scope for 1st Articles and prototypes.

v6.5 OBSOLETE (Signed)

18 Feb 22 Changed to align with new organizational positions, and to instruct that submittal to the IO must be information only.

Clarification under Scope for 1st Articles and prototypes.

Changed Hold Point for IP to Authorization to Proceed Point.

Removed language also requiring MRR for all sub tier suppliers.

v6.6 OBSOLETE (Revision Required)

22 Feb 22 Changed to align with new organizational positions, and to instruct that submittal to the IO must be information only.

Clarification under Scope for 1st Articles and prototypes.

Changed Hold Point for IP to Authorization to Proceed Point.

Removed language also requiring MRR for all sub tier suppliers.

v6.7 OBSOLETE (Approved)

01 Mar 22 Corrected ATTP to ATPP acronym v7.0 CURRENT (Approved)

06 Oct 22 Revised to involve the IO in response to their concern that they have to be able to demonstrate to the ASN that they have been involved in the manufacture of parts. Also some editorial changes to add some clarity on the Simplified versus Full MRR. Added responsibility for TPO to release ATPP on IP.

US ITER Procedure Manufacturing Readiness Review

Table of Contents

1 PURPOSE

2 SCOPE

3 RESPONSIBILITIES

4 DEFINITIONS AND ACRONYMS

5 MRR PROCESS

5.1 MRR TYPE SELECTION PROCESS

5.2 FULL MRR

5.3 SIMPLIFIED MRR

6 REFERENCES

7 APPENDICES

7.1 Appendix 7.1

7.2 Appendix 7.2

7.3 Appendix 7.3

7.4 Appendix 7.4

US_D_22YBGC v7.0

1 PURPOSE

The purpose of this procedure is to define the process for conducting the Manufacturing Readiness Review (MRR). The MRR is employed to confirm the readiness of a manufacturer to produce systems, structures, and components (SSCs) for use in the ITER facility. This process ensures the Supplier understands product requirements, recognizes the hazards, has properly planned the manufacturing operations (personnel and equipment), and has a fully integrated quality assurance program prior to beginning manufacturing operations.

The MRR is a requirement in our Procurement Arrangements (PAs) and a best business practice that US ITER fully supports.

2 SCOPE

This procedure applies to all primary suppliers manufacturing SSCs under contract to US ITER for use in the ITER facility.

NOTE: This includes first articles and prototypes when those SSCs will be used in the ITER facility.

It does not apply to commercial off-the-shelf (COTS) items where the Supplier is providing an industry standard product.

3 RESPONSIBILITIES

Role Responsibilities

IO TRO

Make recommendation to the WBS TL on the type of MRR to be used. Support Full MRR as Panel member.

Panel Chair Select Panel composition based on this procedure and ensuring the proper level of expertise and independence. Evaluate the Supplier readiness to begin the manufacturing operations.

Panel Evaluate the Supplier readiness to begin the manufacturing operations.

QA/ES&H Manager Make recommendation to the WBS TL on the type of MRR to be used. Support MRR as a Panel member.

Role Responsibilities

TPO/CAM

Liaison between Supplier and Review Panel. Make recommendation to WBS TL on the type of MRR to be used.

Manage the closure of Findings with Procurement and the Supplier.

Signatory on Inspection Plan to release associated Authorization to Proceed Point (ATPP).

Supplier Integrate the MRR into planning and schedule. Demonstrate readiness to begin the manufacture, test, and acceptance of product.

Systems Manager Select type of MRR to be employed. Review information package for completeness. Support MRR as a Panel member.

Systems Engineering Manager

Maintain MRR program and ensure US ITER personnel are properly trained in its application. Ensure correct application of the MRR process within organization. Support MRR as a Panel member.

WBS TL

With input from QA/ES&H Manager, the IO, and the TPO, recommend the type of MRR to the System Manager. Select Panel Chair. Approval authority on Panel Report and closure of Supplier submitted corrective actions.

4 DEFINITIONS AND ACRONYMS

Term Definition

ATPP Authorization to Proceed Point

Corrective Action

An action defined in response to a Finding that corrects the deficiency in a manner that includes addressing the root cause

COTS Commercial Off-the-Shelf

DCR Design Change Request

DMS Document Management System

Term Definition

Finding

Significant issue that if uncorrected has high probability to result with product that does not meet the design, cost, or schedule. (Could constrain the release of manufacturing. The Corrective Action for a Finding must be tracked to closure.)

Information Package

Group of documents provided by the Supplier that are relevant to the manufacture of product and support the MRR.

IO ITER Organization

IP Inspection Plan (formerly MIP)

Issue Statement or concern by MRR panel member concerning some aspect of the manufacturing process. Generic term for Findings/Recommendations.

MRR Manufacturing Readiness Review

MRR Panel A panel comprised of US ITER and IO staff (Full MRR only), supplemented as necessary by SMEs, responsible for evaluating the readiness of a Supplier to proceed with fabrication.

MRR Plan

Document written prior to MRR that identifies:

Scope of the MRR with applicable contract documents List of SSCs in the scope MRR panel members and their roles and responsibilities Primary or Sub-tier suppliers (as appropriate) Input data Package: list of documents and items needed to be assessed Schedule of the MRR Previous MRR details, if applicable

Notice-to-Hold Disposition that constrains Supplier from beginning manufacturing operations.

Partial Release Disposition that conditionally authorizes Supplier to begin some manufacturing operations.

PA Procurement Arrangement

PO Procurement Officer

Term Definition

Recommendation A suggestion for improvement in the manufacturing operation that will improve product quality or reduce cost and/or schedule risk. (Does not constrain the release of manufacturing, not tracked.)

Release-to- Proceed

Disposition that allows the Supplier to begin the manufacturing operation without constraint.

State of the Art Manufacturing methodology that is largely unproven, perhaps applied for the first time to hardware manufactured for US ITER. No or little industrial experience with those processes.

SME Subject Matter Expert

SOW Statement of Work

SSCs Systems, Structures, and Components

TPO Technical Project Officer

TRO Technical Responsible Officer

WBS TL Work Breakdown Structure Team Lead

5 MRR PROCESS

The MRR process utilizes a graded approach that is based upon key considerations of the hardware being manufactured. These considerations and the two routes for the MRR (Full and Simplified) are outlined below.

Note: Per MPA #3 Article 6.4 [6.1.10], this US ITER MRR procedure can be applied to our Procurement Arrangements and is consistent with the IO MRR Manufacturing Readiness Review procedure.

Decision on Type of MRR to Conduct

The type of MRR selected is largely based on risk to the project – mission, cost, or schedule.

Simplified

Many of the systems, structures or components (SSCs) are similar to industry standard or Commercial off the Shelf (COTS) items and do not typically pose a large risk to the project.

Those can be suitably addressed through the Simplified MRR which relies largely on the US ITER QA Program for assessing supplier qualifications and readiness. The US ITER

Quality in Acquisitions procedure [6.1.1] defines the program to ensure quality is maintained and provide direction in the acquisition of items and services for the US ITER project.

An integral part of this program is to evaluate the Supplier to confirm their technical and quality capabilities to provide items and/or services of adequate quality, in accordance with the US ITER Approved Supplier List (ASL) [6.1.2] and the prescribed procurement requirements. This evaluation is documented on the QA Surveillance Plan and Report Form [6.1.3] for each Supplier and is prerequisite to the Supplier being eligible to manufacture hardware for US ITER.

A Simplified MRR is also used when the Supplier has demonstrated exceptional understanding and/or has considerable experience in the manufacture of the component, or a similar item, being procured.

NOTE: Previous audit and investigation reports (e.g. Approved Supplier List audits, etc.)

may be used as a basis to justify assessment of Supplier readiness and for writing the Simplified MRR Report [7.4].

Full

Some SSCs are considered mission critical, could seriously impact project schedule, and/or could result in large unplanned costs. The manufacturing and test/acceptance processes required to fabricate the SSCs are state-of-the-art or even have to be developed for the particular SSC.

These warrant the more in-depth review of the Full MRR to minimize those risks.

NOTE: It is possible for even industry standard or COTS SSCs to pose unacceptable risk to the project for the same reasons.

5.1 MRR TYPE SELECTION PROCESS

TPO

5.1.1 Review options and product conditions to assess which type of MRR is appropriate.

5.1.2 Gather information to support suggestion for MRR type.

5.1.3 Provide recommendation and support information to WBS TL for MRR type selection.

WBS TL

5.1.4 Take TPO recommendation on MRR type and support material into consideration.

5.1.5 With input from QA/ES&H Manager, the IO and TPO, make decision on the type of MRR to be performed (Full or Simplified).

5.1.6 Inform TPO of decision so it can be recorded in the MRR Plan and authorize them to proceed with Planning

5.1.7 Notify the IO, the QA/ES&H Manager, and the WBS TL of the MRR type.

5.2 FULL MRR

TPO

5.2.1 Ensure MRR milestones are included in the planning/schedule for the WBS.

5.2.2 Ensure the Supplier contract clearly defines MRR requirements.

5.2.3 Ensure the Supplier understands the Full MRR process and has an Authorization to Proceed Point (ATPP) in the Inspection Plan constraining those manufacturing operations subject to the MRR.

NOTE: If the Inspection Plan is missing an ATPP, the Supplier is responsible for correcting the document before proceeding with MRR.

5.2.4 Write the MRR Plan with any required SMEs included and specify who is completing the checkpoints.

5.2.5 Confirm with the Supplier that the manufacturing operations are ready for the MRR.

5.2.6 Request WBS TL agreement to initiate the MRR planning, no less than four weeks prior to the MRR.

WBS TL

5.2.7 Assign Panel Chair, no less than four weeks before the MRR.

NOTE: The Panel Chair role can be fulfilled by the WBS TL.

5.2.8 Inform the TPO of the names of Panel members.

TPO

5.2.9 Schedule Review date with Supplier and arrange logistics, including access for Panel.

5.2.10 Work with Supplier to assemble Information Package and distribute to the Panel no later than two weeks prior to MRR.

NOTE: A protected SharePoint or other common file location is an acceptable approach for assembling and sharing relevant review materials to facilitate the Panel’s preparation prior to the MRR itself. The Systems Engineering Manager (or designee) must review this package for completion before the formal review starts. Failure to meet the information package deadline can result in cancelling the MRR if the Panel is unable to properly prepare.

MRR PANEL CHAIR

5.2.11 Select Panel team members no less than three weeks prior to review. Required members include QA/ES&H, the Systems Manager and the Systems Engineering Manager. The IO TRO should always be provided the opportunity to participate as a Panel Member but their availability should not result in supplier delay.

NOTE: Additional persons/subject matter experts can be included on the Panel at the discretion of the Panel Chair. The intent is to include Panel members that bring the proper level of expertise and independence.

5.2.12 Assign Panel member responsibility for areas of review, based on the MRR Plan.

5.2.13 Decide which Panel team members need to be on-site for the review.

5.2.14 Ensure Panel reviews information package and prepare for MRR.

5.2.15 Hold kick-off meeting with Supplier.

5.2.16 Conduct MRR, recording Findings/Recommendations in Appendix A of the Full MRR Report [7.3].

NOTE: It is the responsibility of the Supplier during the MRR to provide a detailed description of the manufacturing operations that are being assessed, to demonstrate that they understand the manufacturing requirements, and are ready to begin the manufacture, test, and acceptance of product for the ITER Plant (see Recommended Format for the Manufacturing Readiness Review in Appendix [7.1]). This is best accomplished through an overview of the proposed operations, following the steps in the approved Inspection Plan [6.1.4]. For Supplier site MRRs, time should be allotted for the Review Panel to visit the areas on the floor where the manufacturing and acceptance operations will be performed.

NOTE: See Appendix [7.2] for recommended lines of inquiry supporting the MRR.

Findings/Recommendations may be recorded using the US ITER Readiness Review Issues Form [6.1.5].

5.2.17 Conduct daily debriefings, as appropriate. The Supplier should be made aware of emerging issues during the MRR so there are no surprises at the end.

5.2.18 On the final day of Review, or at otherwise appropriate time, hold closed door session with Panel to review and agree on Findings/Recommendations, and prepare for Close Out meeting with Supplier. Particular importance will be given to the MRR disposition (Release-to-Proceed, Partial Release, or Notice-to-Hold).

5.2.19 Hold Close Out Meeting with Supplier.

NOTE: The Close Out Meeting provides preliminary feedback to the Supplier on the results and Panel recommendation for the MRR disposition. The Supplier is not released to manufacture until they have formally cleared the Authorization to Proceed Point in the IP.

5.2.20 Referring to Appendix [7.3], compose the MRR Panel Final Report with recommended disposition.

5.2.21 Enter the MRR Panel Final Report into DMS workflow for review and approval, no more than one week after review.

NOTE: The MRR Report is submitted to IDM as Information Only.

WBS TL

5.2.22 Advise the Procurement Officer (PO) to inform Supplier of MRR disposition and appropriate contract authority.

NOTE: If the disposition is a Notice-to-Hold or Partial Release, the Supplier must respond through the TPO to the WBS TL with actions taken and changes made to correct the cited deficiencies. All Findings require a specific corrective action.

TPO

5.2.23 Inform Supplier of reported Findings for their corrective actions, as required.

5.2.24 Manage/track all Findings until they are closed.

NOTE: The completed US ITER Readiness Reviews Issues Form [6.1.5] should be entered into the DMS upon completion of the MRR and updated regularly as corrective actions are identified and accomplished. Findings are closed with approval of the WBS TL indicating approval of the Issues Form with each incremental revision to update the status.

QA/ES&H/SE MANAGER/SYSTEMS MANAGER

5.2.25 Advise WBS TL in acceptance or rejection of Supplier proposed corrective actions, as requested.

WBS TL

5.2.26 Approve/reject Supplier proposed corrective actions.

TPO/PO

5.2.27 Work with Supplier to release operations based upon approved corrective actions.

5.3 SIMPLIFIED MRR

TPO

5.3.1 Ensure MRR milestones are included in the planning/schedule for the WBS.

5.3.2 Ensure the Supplier contract clearly defines MRR requirements.

5.3.3 Ensure the Supplier understands the Simplified MRR process and has an Authorization to Proceed Point in the Inspection Plan constraining those manufacturing operations subject to the MRR.

NOTE: If the Inspection Plan is missing an ATPP, the Supplier is responsible for correcting the document before proceeding with MRR.

5.3.4 Work with the Supplier to assemble the Information Package and the detailed checklist of any necessary inspection points. These inspection points can be based on previous investigation and audit findings.

5.3.5 Necessary elements are requested from and provided by the Supplier.

5.3.6 Conduct Simplified MRR by reviewing documentation and leveraged results.

5.3.7 Any new Findings/Recommendations, along with previous ones from the leveraged documentation that remain open, are recorded in Appendix A of the Simplified MRR Report [7.4] with recommended disposition. Additional SMEs can be used to develop these Findings/Recommendations.

5.3.8 Enter Simplified MRR Report into iDocs workflow for review and approval, no more than one week after review.

NOTE: The MRR Report is then submitted to IDM as Information Only, i.e., it is not submitted for IO Approval.

5.3.9 Work with Supplier to release operations based upon approved corrective actions.

6 REFERENCES

6.1.1 US ITER Quality in Acquisitions Procedure, (US_D_22KGWH)

6.1.2 Approved Supplier List Procedure, (US_D_22ZBBP)

6.1.3 QA Surveillance Plan and Report Form, (US_D_227YCU)

6.1.4 Requirements for Producing an Inspection Plan, (ITER_D_22MDZD)

6.1.5 US ITER Readiness Review Issues Form, (US_D_22CQBW)

6.1.6 Requirements for Producing a Quality Plan, (ITER_D_22MFMW)

6.1.7 Contractor Release Note Procedure, (US_D_22NEFV)

6.1.8 Deviation Request Procedure, (US_D_22A94F)

6.1.9 Nonconformance Reports Procedure, (US_D_22GMTF)

6.1.10 Multi-Party Amendment (MPA) to PA Applicable Documents in the Main and Annex A, (US_D_242X6X)

7 APPENDICES

7.1 Appendix 7.1

Recommended Format for the Manufacturing Readiness Review

A recommended agenda is provided:

– Welcome o Introduce the Supplier Team (names and roles) o Introduce the Review Panel (names and organization)

– Statement of Scope of Review

Clearly define the product and operations that the review will address, e.g. which specific operations the supplier is requesting to be released.

NOTE: These should follow in part or in whole the Inspection Plan for those operations.

– Overview(s) of the candidate operations

This should preferably be a sequential tabletop review of the specific manufacturing and acceptance operations. Institutional programs that span multiple operations could be presented up front or in a manner that avoids redundancy while supporting the process flow.

o Institutional programs include:

Safety Training Configuration Management Non-conforming material Deviation requests Measuring and Test Equipment

(M&TE)/calibration program Maintenance management Operations (logbooks, procedure usage, etc.)

Operating procedures (including alarm response) Chain of custody Statistical Process Quality control Emergency Planning (power outage) Quality control methods and training o Specific manufacturing and acceptance program:

All remaining assumptions Abnormal operating procedures Test/acceptance procedures Raw materials traceability Handling and storage Work process controls (travelers) Intended usage of the Inspection

Plan Cleanliness control Carbon steel/stainless steel separation Welder qualification program Welding materials control QA oversight of manufacturing processes

7.2 Appendix 7.2

Recommendations for Inquiry

The following are intended to be general guidelines, neither restrictive nor all inclusive, to provide the readiness review panel with an overview of the aspects of the manufacturing process that could require inspection during an MRR. This is not intended to be a complete or specific list but should characterize the nature of the MRR and the types of things that would normally be inspected in order to evaluate supplier readiness.

WORK PLANNING

A Quality Plan [6.1.6] has been approved by US ITER and IO.

An IO-specific Inspection Plan [6.1.4] has been approved by US ITER and IO.

An approved working schedule is available and used; one that highlights milestones and other key events and/or resources.

Documented hazards analyses for the manufacturing operations

Use of pre-job briefing.

There are clear lines of authority and responsibility (especially on shop floor).

Where a Notified Body (NB) or Agreed Notified Body (ANB) is required, the NB or ANB is engaged with the supplier.

Provisions for acceptance of product, including completion and approval of Contractor Release Note [6.1.7] are in place.

CONFIGURATION CONTROL

Correct revision of the US ITER documents comprising the SOW in the subcontract (drawings, specifications, etc.).

Proper US ITER approval.

No unapproved or obsolete documents are in the area.

No unauthorized hand-written changes.

Approved deviation requests and/or DCRs are included, as applicable.

Supplier system for controlling documents on the floor is sufficient.

PROCESS

Incoming material is properly identified (traceable to pedigree, procedure, etc.)

A procedures “traveler” is being used, which includes the following:

Procedure that provides clear and sequential steps for the manufacturing and/or test and acceptance process.

Prerequisites are defined as entry conditions before entering the procedure

(ex. valve line-ups, gas inventories, readiness of support systems, etc.)

Record of who performed the operation.

Record of pertinent serial numbers, part numbers, or other unique identifies, to maintain traceability of pedigree to finished component(s).

Test & acceptance criteria, at correct time in sequence.

Record of quality information, as specified in SOW, drawings, and/or technical specifications.

Indication that personnel to be involved in operations have a clear grasp of requirements.

Personnel are trained in procedure usage and demonstrate that they understand the correct action to take when a procedure cannot be followed.

Shift turnover procedures are in place to ensure a smooth and orderly transition of work from one shift to another.

Abnormal Operating Conditions/Emergency Response Personnel on the floor can demonstrate or describe the correct response to off normal events Personnel are well versed in stop work authority (circumstances that might drive this, specific action to take, etc.)

The correct processes are in place to handle these events o Notification/reporting o Machine configuration, etc.

QUALITY

If there are any out-of-tolerance conditions, they are conspicuously marked.

Any non-conforming material has been handled in accordance with our Nonconformance Report Procedure (clearly identified, conspicuously marked, and physically segregated from acceptable material, etc.)

Equipment to be used to accept product is part of an approved Measuring and Test Equipment Program and is in its calibration period.

Materials that contact the product are in accordance with the requirements and are closely controlled (including packing materials).

Clear and unambiguous records are available for personnel training /qualifications.

Any sampling planned for product acceptance will be managed under a statistically based program.

Weld materials are properly stored.

Weld program is in accordance to weld standards.

A plan is in place to collect pedigree/certification records.

Special processes are identified, and any changes are properly controlled.

US ITER Deviation Request [6.1.8] and Nonconformance Report [6.1.9] processes have been properly carried into the operation.

An approved program is in place for receipt/shipping inspections.

PROCESS EQUIPMENT

Machine tools appear to be in good working condition (coolant, general integrity).

On-machine probes for in-process inspection are in calibration program.

Inspection machines appear to be in good working order (clean, free of foreign materials, etc.).

FACILITY

Good housekeeping practices demonstrated throughout.

Hardware can be properly protected from the elements.

Material staging areas are available and located in a manner that protects stored SSCs from the elements, industrial traffic, etc.

Temperature control meets US ITER requirements.

Fire protection is provided and appears sufficient.

Materials segregation is implemented adequately (ex. stainless and carbon steel tools).

FACILITY EQUIPMENT

Overhead cranes are current in an approved certification program.

Portable cranes or lifting devices are in good working condition.

General purpose lifting devices (slings, swivel hoist rings, spreader bars, etc.) are in good condition and included in a formal inspection program.

Defective general-purpose lifting devices are properly removed from service.

Fork-lift trucks, boom lifts, and similar equipment are in good working condition (no hydraulic leaks, controls, etc.).

Auxiliary power/utilities are provided where appropriate.

Lighting is adequate for the work to be performed.

SAFETY

The work process includes pre-job briefs to alert workers to hazards, job status/progress, anomalies, pending hold points, and other issues.

Personnel are wearing appropriate personal protective equipment.

An approved lock out/tag out program is in place.

An approved confined space program is in place.

Walking surfaces are clear of slip, trip and fall hazards.

Lighting is sufficient for the operations.

An approved Hoisting and Rigging program is in place that properly evaluates and approves below-the-hook lifts.

SHIPPING/TRANSPORTATION

Any/all specialized containers are in accordance with an approved design.

Any special shipping/transportation requirements (ex. accelerometer) are understood.

Provisions for transfer of ownership and responsibility for shipping and if necessary interim storage are in place.

7.3 Appendix 7.3

Recommended Format for the Full Manufacturing Readiness Review Panel Report

Title (emboldened) and Sub-Title (non-emboldened)

Subtitle is “Manufacturing Readiness Review”

Date:

Chair: (name)

US ITER Review Team: (names)

WBS Team Lead/TRO: (name)

SOW UID: (#)

Contract Number: (#)

Contract TPO: (name)

IO Observer (optional): (name)

Supplier Team: (names)

Executive Summary

(Standard text) The Manufacturing Readiness Review (MRR) is a US ITER tool intended to confirm that the Supplier is ready to begin the manufacture and acceptance of product for the ITER Plant. Successfully passing the MRR is prerequisite to releasing the manufacturing and acceptance operations to commence.

(Scope of this MRR) A brief statement or paragraph that clearly establishes what scope the MRR addresses, any limitations, etc.

(Issues summary) A total of (#) Issues (Appendix A) were submitted in response to the presentation of materials supporting this review. The breakdown is as follows:

Findings (#)

Recommendations (#)

(Summary of review) A synopsis of the Panel’s discoveries, noting any significant issues and providing a disposition of Release, Partial Release, or Hold for the operations presented.

Appendix A – Issues Summary

(Attach completed Readiness Review Issues Form [6.1.5])

7.4 Appendix 7.4

Recommended Format for the Simplified Manufacturing Readiness Review Panel Report

Title (emboldened) and Sub-Title (non-emboldened)

Subtitle is “Simplified Manufacturing Readiness Review”

Date:

WBS Team Lead/TRO: (name)

SOW UID: (#)

Contract Number: (#)

Contract TPO: (name)

IO Observer (optional): (name)

Supplier Name: (company name)

Reference Documents: (list of leveraged documents with title and UID)

Executive Summary

(Standard text) The Simplified Manufacturing Readiness Review (MRR) is a US ITER tool intended to confirm that the Supplier is ready to begin the manufacture and acceptance of product for the ITER Plant. Successfully passing the MRR is prerequisite to releasing the manufacturing and acceptance operations to commence.

(Scope of this MRR) A brief statement or paragraph that clearly establishes what scope the Simplified MRR addresses, any limitations, etc.

(Issues summary) A total of (#) Issues (Appendix A ) were submitted in response to the presentation of materials supporting this review. The breakdown is as follows:

Findings (#)

Recommendations (#)

(Summary of review) A synopsis of the leveraged results, noting any significant issues and providing a disposition of Release, Partial Release, or Hold for the operations presented.

Appendix A – Issues Summary

(Attach completed Readiness Review Issues Form [6.1.5])