integrated qa planning in pip-ii - indico.fnal.gov · –consumer quality & supply chain...

In partnership with:

India/DAE

Italy/INFN

UK/STFC

France/CEA/Irfu, CNRS/IN2P3

JEMILA ADETUNJI

P2PEB Meeting

14MAR2019

Integrated QA Planning in PIP-II

• About Me

• Quality Management in PIP-II

• Special Aspects of PIP-II

• Key Elements of the PIP-II QA Plan

• QA Planning with Partners

• Partner Collaboration and Oversight Planning

• Incorporated Lessons Learned

• The Path Forward

Outline

14 March

2019

J. Adetunji | P2PEB Meeting2

• Jemila Adetunji – PIP-II QA Manager

– 15+ years working in various quality-related roles

• 9 years in Consumer Goods and Manufacturing/Operations

– Quality Management / ISO Program Maintenance

– Quality Assurance / Quality Control

– Consumer Quality & Supply Chain Quality

• 3.5 years in Technological Services

– Quality Assurance / ISO Program Implementation & Maintenance

– Quality Planning

– Project Quality

• 5 years at Fermilab

– Quality Management: Head of Quality Assurance

– Project Quality : 413 Project Quality Support

About Me

14 March

2019


• Robust Quality Management is essential to the success of the PIP-II

Project.

• Quality Assurance is a management system to plan, perform, assess and

improve work.

– We should never just assume that the things we buy or build will meet

specifications – despite previous experience.

– Building an experiment that achieves our objectives requires quality

and verification testing to be fully integrated into the design,

fabrication, procurement, and in-kind contribution processes from the

beginning.

– QA requires investment in resources (money, time, people, and tools),

therefore, it must be adequately integrated in Project planning from the

beginning

• It costs more to build a substandard product than one that meets

requirements.

• Early detection and communication of issues saves money and time.

Quality Management in PIP-II

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2019


• PIP-II is the first DOE Accelerator Project with significant

international in-kind contributions and work is spread across

multiple continents in a variety of venues.

– Transportation of critical components, such as cryomodules will

be challenging.

• Critical in-kind contributions from International Partners

creates several interfaces.

• The Project requires a thoughtful and collaborative approach

to roles and responsibilities with Partners.

– It is imperative to find the right balance of collaboration.

• A collaborative, graded approach to QA will be applied to

ensure requirements can be consistently and sufficiently met

throughout the project lifecycle.

Special Aspects of PIP-II

14 March

2019


• Roles & Responsibilities

• Communication Planning

• Training & Qualifications

• Graded Approach

• Quality Improvement & Lessons Learned

• Documents, Records, and Configuration Management

• Performance Criteria

• Procurement (FRA vendors/subcontractors)

• Inspection and Acceptance Testing

• Work Processes and Control

• Software Quality Assurance

• Handling, Storage, Transportation

• Assessments

• QA Planning with Partners

Elements of the PIP-II QA Plan

14 March

2019


14 March

2019


QA Planning with Partners

14 March 20198

Partner QA Plans

• At minimum, the Partner is required to submit a detailed

Quality Assurance Plan in alignment with the PIP-II QA Plan.

• It is imperative that the PIP-II Project and Partners conduct

sufficient collaboration to build confidence that components

and systems will perform as intended as per specifications

and requirements.

• Partners, as well as the vendors and institutions with whom

they work, should demonstrate the ability to minimize process

variation via reliable, repeatable, and documented processes.

Parts, components, equipment, structures, and/or assemblies

must meet expectations throughout the expected lifetime.

J. Adetunji | P2PEB Meeting

14 March 20199

Partner QAP: Roles, Responsibilities, and Authorities

• The Partner should describe roles, responsibilities, and authorities relating to the PIP-II Project which should include the responsibilities for (as applicable):– quality

– project deliverables– design

– procurement

– incoming inspection– fabrication / assembly

– in-process inspection

– acceptance testing– storage

– shipping/transportation

– final acceptance testing


Partner QAP: PIP-II Deliverables

• The Partner should describe the specific deliverables for the

PIP-II Project in their QA Plan, per the specified scope of

work.

• The Partner should also include the method for managing

delivery schedules and the responsibility for communicating

critical events (e.g. change in fabrication site or

manufacturing facility, changes in critical equipment) that

could significantly impact or cause changes to the scope or

performance of the deliverables and/or the delivery

schedules.

14 March 201910 J. Adetunji | P2PEB Meeting

• The Partner is strongly encouraged to follow the

Communications Plan articulated in the Project Planning

Documents that describes the methods of communication to

be utilized while conducting PIP-II work.

– For example, meetings held with the PIP-II Project team and the

method that shall be used to provide notification of issues,

nonconformances, or changes to the design, fabrication,

assembly, key personnel, location of fabrication/manufacturing,

transportation method, vendors or suppliers.

• Effective and adequate communication on all sides is the

foundation of collaboration and success.

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Partner QAP: Communications Plan


Partner QAP: Competence, Training, and Awareness

• The Partner should have trained and qualified personnel

assigned to work relating to the PIP-II Project.

• The Partner should have adequate verification methods to

ensure that only adequately trained, qualified, and certified

personnel are assigned to work relating to PIP-II Project,

including personnel at third party vendors or other institutions.

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Partner QAP: Design and Configuration Management

• In instances where the Partner has design responsibilities, the Partner

should describe associated roles/responsibilities relating to the design

of the PIP-II Project deliverable as defined by the Fermilab PIP-II

team.

• The Partner should include the description of the methods used to

assure PIP-II requirements are met throughout each phase of the

design.

• The Partner should also have an established design process and

design change control procedures, including the implementation and

verification of the change.

• If third party vendors or institutions are used by the Partner to fabricate

components or provide a service relating to design for PIP-II, the

Partner should be able to provide the PIP-II Project with the processes

for communicating design requirements and design changes to the

vendor and corresponding plans to assure compliance to

requirements.14 March 2019J. Adetunji | P2PEB Meeting13

Partner QAP: Design and Configuration Management

• Any changes to the design must be submitted to the Fermilab

PIP-II Team for evaluation through the change control

process and decision to approve prior to proceeding.

– This process is described in the PIP-II Configuration

Management Plan.

• Agreed alignment is necessary for the International Codes

and Standards requirements for components or systems

fabricated by the Partner or third-party vendor or institution.

• Any deviations from Fermilab requirements or standards will

be managed on a case-by-case basis and approved by the

Fermilab .

14 March 2019J. Adetunji | P2PEB Meeting14

Partner QAP: Design Verification and Validation

• The Partner should have an established process for the

verification and validation of designs via the development of a

Design Verification and Validation Plan.

• The Fermilab PIP-II Team and the Partner should

collaboratively define the components of the Design

Verification and Validation Plan which may include:

– Requirements Traceability

– Design Failure Mode and Effect Analysis (DFMEA)

– Evaluation Criteria

– Test Procedures

– Test Records

– Qualification Tests


Partner QAP: Vendor/Supplier Management and Assurance

• The Partner should have processes for procuring/receiving parts, components, and services from suppliers, vendors, and other institutions to ensure all technical, safety, and quality requirements can continuously be met.

• If multiple vendors or institutions are used, the vendor/institution oversight management processes used for each vendor or institution should be defined. *interface management is key*

• The Partner should also include a description of how issues and nonconformances that occur at the third-party vendors and institutions are managed.

• All issues and nonconformances should be communicated to the PIP-II L2/L3 Manager for awareness, impact/risk analysis, and aligned corrective action planning.

• The Partner is strongly encouraged to communicate all decisions relating to changes in suppliers, vendors, facilities, or institutions during PIP-II work, including the reasons and associated impact or risks relating to the change (e.g. performance, quality, schedule).


Partner QAP: Manufacturing Inspection Plans (MIPs)

• The Partner should establish and submit Manufacturing

Inspection Plans (MIPs). The MIPs are developed to ensure

that inspection requirements are properly incorporated into

fabrication processes. The plans are should be reviewed and

accepted by the respective PIP-II L2 Manager to ensure all

critical elements are incorporated and agreed upon.

• All nonconformances or issues occurred during fabrication by

the Partner or third-party vendor or institution are to be

communicated to the PIP-II L2/L3 Manager as soon as they

are identified.

• Details are provided in the PIP-II QA Plan.


Partner QAP: Product Acceptance

• The Fermilab PIP-II Team and the Partner will collaboratively establish methods for evaluating the acceptance of components or services from vendors or institutions. If there are multiple levels of acceptance throughout the supply chain, a Product Acceptance Plan must include the acceptance criteria established with each vendor and institution.

• When items and processes do not meet acceptance criteria, these deficiencies will be documented in nonconformance reports (NCR) and dispositioned. The NCRs help facilitate communication of the issue.

• Corrective action documents are included as a part of test documentation. When deficiencies have been corrected, retesting is performed to verify that acceptance criteria are met or agreed resolution is achieved.

• All* deficiencies identified at partnering institutions or vendors shall be immediately communicated to the appropriate L2/L3 Manager for impact analysis and corrective action planning.

– *If there is a need to define major and minor deficiencies, this will be collaboratively done with the Partner for full alignment in terminology.


Partner QAP: Control of Nonconformances

• The Fermilab PIP-II Team and the Partner will collaboratively establish

methods for effectively identifying, controlling, documenting, and

communicating nonconformances identified throughout the entire

lifecycle of the component, system, or service within their scope of

work, from design to fabrication to shipment to Fermilab.

• Nonconformances should be documented in the corresponding

Manufacturing Inspection Plans.

• Nonconformances should be immediately communicated to the

respective L2/L3 Manager, identified, and tracked through closure. All

corrective action plans and timelines for resolution shall be agreed

upon with the respective L2/L3 Manager.

• The communication of nonconformances can result in important

discussions on impact/consequence, acceptability, and resolution.

• A formal procedure for nonconformance handling in the Project will be

established.


Partner QAP: Document and Data Management

• The Partner should: – have an established process for document and data

control plan for review and concurrence. This process

should adhere with the requirements established in the

PIP-II Document Management and Control Plan.

– describe how documents are controlled, how changes to

documents are managed, and the method for integration

into associated processes relating to the PIP-II scope of

work.

– provide assurance that the most current and approved

documents or designs are referenced throughout the

design, fabrication, transportation, and delivery processes.


Partner QAP: Feedback & Continuous Improvement

• The Partner is strongly encouraged to actively participate in

PIP-II processes for continuous improvement such as

assessment activities and lessons learned. The identification

of process improvements, root causes from

nonconformances, opportunities for improvement should be

communicated to the PIP-II Project for input into the PIP-II

Lessons Learned Process.

– The Partner is encouraged to actively participate in assessment

activities either initiated by the PIP-II Project or by the Partner

as a preventive or corrective measure.


Other important topics for the Partner QA Plans

• Software Quality Assurance

– The Partner is strongly encouraged to follow the Software

Quality Assurance processes highlighted in the PIP-II QA Plan.

If software is developed, procured, or used for any aspect of the

PIP-II Project, specific controls must be established.

• Component Handling, Storage, and Transportation

– Inevitably, the Partner will store components or assemblies prior

to shipping to Fermilab, which may include the storage at a

third-party vendor or institution.

• Measuring & Test Equipment (Calibration)

– Process for controlling measuring and equipment used for

inspections and testing should be calibrated and maintained.

Traceability and accountability of this equipment is imperative.


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PIP-II Partner Collaboration & Oversight Planning

• PIP-II is an intricate project with significant in-kind

contributions from International Partners who may have

established processes that will be used to perform the work

under their scope for the PIP-II Project or developing

processes amid prototyping activities.

• It is imperative that the PIP-II Project and Partners have

confidence that all work performed for the PIP-II Project will

meet requirements and expectations.

• Any sound Quality Assurance Program includes elements of

oversight over processes and individuals performing work for

the Project. This is especially critical in instances where the

work is performed outside of the organizational structure.


14 March 201924

PIP-II Partner Collaboration & Oversight Planning

• It is the responsibility of the L2 and L3 Manager to devise an

oversight plan in conjunction with the Partner.

• The ultimate goal of this oversight plan is to ensure all

stakeholders are aligned with key activities, when they will

occur, and the results of the activity to foster and facilitate the

partnership and communication.

• As previously noted, varying levels of in-process inspection

and verification testing are critical to ensuring the final

product, component, or service will meet requirements.

• Interface Management is critical (people and systems).

• This also applies to the Partner’s oversight of their vendors

and collaborators.


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PIP-II Partner Collaboration & Oversight Plan

• The collaboration & oversight plans will include the following elements:

– Activity (e.g. procurement, design change approval, readiness

reviews, hold/witness points, critical meetings)

– Source Document (e.g. link to requirement/specification, MIP, and/or

procedure)

– Where activity will take place (e.g. at Partner or Remotely)

– Responsible Person(s) to perform the activity (e.g. L2M/L3M, Field

Engineer, SME)

– Results of activity (e.g. link to specification and MIP)

– Signature by L2M/L3M/Sub-Project Manager

– Signature by Partner Sub-Project Coordinator


Incorporated Lessons Learned

• Incorporating lessons learned from experts and various previous

experiences is also critical to the success of the Project.

• A few examples include, PIP-II -

– has incorporated prototyping to reduce technological risks.

– has included the requirement to develop Transportation Plans and

included Transportation Readiness Reviews to the PIP-II Technical

Review Process.

– will add a Logistics Manager to the Project team to work

collaboratively with the laboratory’s Import/Export Compliance

Manager.

– will add dedicated quality resources to support L2 Systems with

quality plan implementation.

– is establishing clear roles and responsibilities for requirements

verification and acceptance procedures in collaboration with

Partners.


The Path Forward

• March – April 2019:

– Partners to review DRAFT PIP-II QA Plan and identify

respective processes/procedures that align with PIP-II QA Plan.

• April 2019:

– Fermilab PIP-II Team to visit Partners in late April 2019 to

discuss approaches to align with QA Plan and other Project

Management documents.

• May – July 2019:

– Partners to create DRAFT QA Plans for their respective PIP-II

scope of work and submit to Fermilab for collaborative iteration.
