RM.9_Authority_Quality_Manual.pdf

California High-Speed Rail Authority

Quality Management Section

Quality Manual (Master Quality Plan)

(MANUAL-1000)

Rev 0

April 2020

California High-Speed Rail Authority MANUAL-1000, Revision 0 2020-04-01 Page i of v

TABLE OF CONTENTS

1 Introduction

1.1 Purpose

1.2 Scope

1.3 Applicability

1.4 ISO 9001:2015 Quality System

1.5 Quality Mission, Vision, and Goals

1.5.1 Mission

1.5.2 Vision

1.5.3 Goals

1.6 Quality Management Principles

1.7 Context of the Organization

1.8 Leadership and Commitment

1.8.1 Quality Objectives

1.9 Quality Policy

1.10 Quality Management Team Organization Structure

2 Planning

2.1 Policy

2.2 Legal and Other Requirements

2.3 Risk Management

2.4 Improvement

2.5 Roles and Responsibilities

3 Support

3.1 Competence, Training, and Awareness

3.2 Communication and Consultation

3.3 Documented Information

3.4 Operational Controls

4 Performance Evaluation

4.1 Measurement and Monitoring

4.2 Management Review

5 improvement

5.1 Improvement Actions

5.2 Change Management

6 Essential Elements of a Quality Management Plan

6.1 Requirements

6.2 Expectations

6.3 Implementation

Appendix A Quality Rlated Polcies, Procedures, and Supporting Documents ... A-1

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Appendix B Quality Management Plan Template ............................................... B-1

Appendix C Guidelines for Developing a Quality Management Plan ................. C-1

Appendix D Sample Illustration of Authority Project Delivery Quality Model ..... D-1

Figures

Figure 1 Quality in the Program Lifecycle Figure 2 QMT Organizational Leadership Figure 3 QMS Framework Figure 4 QMS Documentation Hierarchy

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TERMS AND DEFINITIONS

Baseline A clearly defined starting point for a project plan. It is a fixed reference point to measure and compare the project's progress against. This allows the California High-Speed Rail Authority (Authority) to assess the performance of the project over time.

Continuous Improvement An ongoing effort to improve products, services, or processes seeking incremental improvement over time.

External Customer Entities or stakeholders outside the Authority.

Fabricators Entity making raw materials usable for manufacturing.

Internal Customer Authority staff who will be referring or implementing this document.

Leadership A collection of individuals responsible for the management of one or more functional areas.

One Team A group of people working towards a common goal/culture of values, beliefs, attitudes and behaviors.

Program Delivery Office The Authority office responsible for executing all aspects of the Authority’s program delivery operations, development, and maintenance of the program baseline.

It also provides Quality, safety oversight, administration of Authority contracts, and long-term planning.

Quality Management System Steering Committee (QMS-SC)

Authority Executive Leadership charged with the support and guidance of the QMS. The QMS-SC reviews and provides oversight for the QMS. The committee’s charge is to provide oversight, guidance, and coaching for the

QMS.

Quality The degree to which a product or service meets requirements and expectations.

Quality Assurance (QA) Planned and systematic actions necessary to provide adequate confidence that a product or service will satisfy given Quality requirements.

Quality Control (QC) Techniques used to ensure that a product or service meets Quality requirements and that the work meets the product or service goals. QC is the act of taking measurements, testing, and inspecting a process or product to ensure that it meets specification. A product may be design drawings, calculations, specifications, manufactured equipment, or constructed items. QC also refers to the process of witnessing, attesting to, and documenting such actions.

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Quality Management System (QMS)

A formalized system that documents the structure, responsibilities, and procedures required to manage Quality. The QMS consists of the QP, QM, QMP, procedures, work instructions, and documented information.

Work Plan A document created for the rail delivery partner to capture their scope of work and deliverables.

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Acronyms

ARRA American Recovery and Reinvestment Act BP 2018 Business Plan CAR Corrective Action Report DB Design Build, (Contractor) FRA Federal Railroad Administration FTA Federal Transit Administration ICE Independent Checking Engineer ISE Independent Site Engineer ISO International Organization for Standardization KPI Key Performance Indicators MQP Master Quality Plan (also known as Quality Manual) (MANUAL-

1000) NCR Non-Conformance Report PCM Project and Construction Management PCMM Project and Construction Management Manual (MANUAL-PD-01) PD Program Delivery PMP Program/Project Management Plan (PLAN-PD-01) QA Quality Assurance QAR Quality Action Report QC Quality Control QM Quality Manual (also known as the Master Quality Plan) (MANUAL-

1000) QMP Quality Management Plan QMS Quality Management System QMS-SC Quality Management System Steering Committee QMT Quality Management Team QP Quality Policy (POLI-1006) https://calhsr.sharepoint.com/sites/theterminal/pp/MANUAL-PD-01.pdf https://calhsr.sharepoint.com/sites/theterminal/pp/PLAN-PD-01_Program_Management_Plan.pdf https://calhsr.sharepoint.com/sites/theterminal/pp/MANUAL-1000 https://calhsr.sharepoint.com/sites/theterminal/pp/MANUAL-1000 https://calhsr.sharepoint.com/sites/theterminal/pp/POLI-1006.pdf

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1 INTRODUCTION

1.1 Purpose

The purpose of this document is to develop a Quality Management System (QMS) to provide products and services that consistently meet program requirements and promote ongoing Continuous Improvement. The Quality Manual (QM) defines the Quality Management Team’s (QMT) role in supporting the California High-Speed Rail Authority’s (Authority) mission, vision, and goals; the 2018 Business Plan (BP); and Program Management Plan (PMP). This document serves the purposes of both the Quality Manual (QM) and MQP and uses the terms interchangeably. The QMT provides the required Leadership and support to attain a certified QMS in accordance with the International Organization for Standardization (ISO) 9001:2015 (refer to Appendix A) that aligns with the Authority’s business and program objectives.

The purpose of this document is to:

• Implement the requirements set by the Quality Policy (QP);

• Describe how the QMS meets customer requirements;

• Define the QMS using system structure, objectives, and processes for the Authority;

• Define the Authority’s roles and responsibilities associated with achieving compliance, high performance, and Continuous Improvement; and

• Establish the requirements for Quality Management by using defined Quality plans.

The QMT will train all Authority staff regarding their roles in complying with the QMS and QM.

1.2 Scope

This QM applies to all Authority activities.

1.3 Applicability

This QM applies to all Authority employees (i.e., state staff) and to the Authority’s integrated team, per contract-specific requirements (herein collectively referred to as “Authority Staff”).

1.4 ISO 9001:2015 Quality System

The QM defines and documents the Quality organizational structure, responsibilities, procedures, processes, and resources needed to meet the Quality Policy (QP) — POLI- 1006 and objectives. The scope of the QMS is as follows: “The planning, designing, and construction management of the California High Speed Rail System”.

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The QMT is engaged in various aspects of Quality Management of the Authority which includes design, operations, maintenance, and certification in the form of surveillance, audits, and training.

Like safety, Quality is a core principle of any part of the Authority’s program lifecycle.

Figure 1 Quality in the Program Lifecycle

1.5 Quality Mission, Vision, and Goals

1.5.1 Mission

To provide a strategically planned, value added, and structured system of cohesive processes that enhance customer and team confidence and increases compliance with Authority and ISO standards.

1.5.2 Vision

Deliver a QMS that demonstrates a commitment to providing a strong Quality Baseline for the Authority program.

1.5.3 Goals

• Quality: A fully implemented QMS that ensures consistency for defined key processes.

• Safety: Safety and security of workers, employees, and customers.

• Stewardship: Protect and conserve public and environmental resources dedicated to this project.

Design

Engineering

Procurement

Construction

Rehabilitation (Replacement)

Operations and

Maintenance

Installation

Planning

Quality

Safety

Safety

Safety

Sa fe ty

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• Performance: Use specific performance measures to track progress and support the development of a robust culture of Quality implementation and accountability.

• Transparency and Engagement: Facilitate collaboration between Authority functional groups to document and implement processes, procedures, and practices.

• Diversity: Develop and support a diverse workforce through engagement and team development, ultimately working towards a common understanding of the QMS goals and objectives.

• Sustainability: Deliver a system that maximizes efficiency through effective training, process implementation, and performance measurement.

1.6 Quality Management Principles

Quality Management principles are key components for the QMS, and they are consistent with the ISO 9001:2015 standard. These principles integrated into the QMT practices lead to internal and external customer satisfaction with respect to performance in every aspect of QMS interaction. The QMT measures success based on effective and efficient Leadership, the engagement of team members, and use of a Continuous Improvement process approach. This success drives evidence-based decisions and enhances relationships internally and externally.

1. Customer Focus: The primary focus of the QMS is to meet customer requirements and expectations.

Key benefits of a strong customer focus include:

• Increased customer satisfaction; and

• Enhanced Authority reputation.

2. Leadership: Executive Leadership at all levels establish unity of purpose and direction and provide guidance to achieve the QMT objectives.

Key benefits of a strong Leadership team include the following:

• Increased effectiveness and efficiency in meeting the organization’s Quality objectives;

• Better coordination of the organization’s processes; and

• Improved communication between the Authority’s functional levels.

3. Engagement of People: Competent, empowered, and engaged people at all levels of the organization are essential to enhance the Authority’s capability to create and deliver value.

Key benefits of engaging the team include the following:

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• Individual understanding of the Authority’s Quality objectives;

• Quality-based thinking in all aspects of day-to-day actions;

• Improved trust and collaboration with each team and team member; and

• Exposure to and participation in improvement activities.

4. Process Approach: Staff trained on documented processes provide consistent and predictable results.

Key benefits of a process approach include:

• Consistent and predictable output from defined processes;

• Ability to improve processes as needed;

• Optimized performance through effective process training and management;

and

• Improved confidence in process understanding, consistency, effectiveness, and efficiency.

5. Continuous Improvement: The Authority recognizes that successful organizations have an ongoing focus on improvement.

Key benefits of continuous improvement include:

• Improved process performance and organizational capability; and

• Enhanced ability to anticipate and react to internal and external risks and opportunities.

6. Evidence-Based Decision Making: Decisions based on the analysis and evaluation of data and information are more likely to produce effective results.

Key benefits of evidence-based decision making include:

• Improved decision-making processes;

• Improved operational effectiveness;

• Increased ability to review, question, and influence opinions and decisions;

and

• Ability to demonstrate the effectiveness of past decisions.

7. Relationship Management: The Authority recognizes that sustained success has a direct correlation with how an organization manages relationships.

Key benefits of relationship management include:

• Common understanding of objectives and values; and

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• Increased capability to create value for the customer.

1.7 Context of the Organization

The Authority is an integrated team, trained in procedures and QMS requirements. The training empowers program Leadership and guides their team in support of the BP, PMP, and QMS.

Authority Leadership sets the stage for establishing a unified purpose and the Authority’s day-to-day direction. Members of the QMS-Steering Committee (QMS-SC) are responsible for engaging people to achieve the Authority’s business, program, and Quality Objectives.

The unity of purpose, direction, and engagement enables the organization to achieve its objectives by aligning its strategies, policies, processes, and resources.

1.8 Leadership and Commitment

1.8.1 Quality Objectives

Executive leadership has established the following Quality Objectives:

• Develop and implement the QMS in accordance with the ISO 9001:2015 standard;

• Use a One Team mentality to promote Quality awareness and performance accountability throughout the Authority program;

• Provide Quality deliverables as defined in work plans;

• Identify business, Quality, and compliance requirements;

• Provide Leadership, guidance, and training for the development and implementation of the QMS;

• Identify QMS metrics to facilitate performance measurements and data-driven decisions; and

• Identify improvement opportunities and utilize the Lean Six Sigma methodology to improve processes.

To achieve the QMT objectives, Authority Leadership must do the following:

• Provide visible hands-on involvement in launching and sustaining the Quality program;

• Create a One Team culture and methodology for all functions;

• Provide Quality training for all functional groups;

• Align Authority Staff with a new set of objectives and revised methods;

• Align the QMT work with the organization’s goals, mission, vision, and values;

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• Provide Authority Staff with training regarding the organization’s goals, mission, vision, and values;

• Provide engaged support for the implementation of the QP, QM, and Quality objectives;

• Communicate and train the QP and Quality objectives to the Authority;

• Define and implement the QMT processes and procedures;

• Promote Quality and Continuous Improvement;

• Monitor the effectiveness of the QMS;

• Promote a process and risk-based approach to decision making; and

• Ensure that adequate resources required by the Quality Management Team (QMT) for the QMS are available.

1.9 Quality Policy

The Authority recognizes that effective Quality and performance management is critical to the delivery of a successful program and, thus, has instituted a QP. The QP reflects the commitment to making Quality a part of how the Authority conducts business every day. The policy is as follows;

The Authority is committed to:

• Implementing and maintaining an effective QMS that will support the Authority’s goals as outlined in the BP; and

• Complying with the Authority’s contracts, policies, and procedure requirements.

The Authority’s executive Leadership is actively involved in and strives for continuous improvement of the California High-Speed Rail Program by:

• Establishing and analyzing key performance indicators for the QMS;

• Assessing the program in order to identify opportunities for improvement; and

• Empowering all employees to take responsibility for Quality in their specific areas.

The Authority’s Quality goal is to achieve 100% compliance with its policies, procedures, and ISO 9001 standards.

Authority leadership will establish a QMS-SC to provide oversight and guidance on the QMS. This committee includes executive leadership as team members. The QMS-SC reviews the QP on an annual basis, at a minimum, to determine its continuing suitability for the program. As part of its review, the committee also identifies potential improvements to the QMS.

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The organization demonstrates its support to the QMS by communicating the QP and its objectives to the employees. The QMT uses multiple avenues to communicate details of the QMS. Methods include the use of the Process and Program Development Branch (PPDB) Newsletters, memos, trainings, and team meetings to encourage and support the Authority’s implementation and maintenance of the QMS within the Authority. QMS training includes the QP and QM concepts.

1.10 Quality Management Team Organization Structure

The Auhtority’s QMT is startegically aligned to support both Headquarters and Central Valley teams as illustatred in Figure 2. The Headquarters team focuses on setting us a QMS aligned with ISO satndard for Auhtoruty, whereas the Central Valley team oversees and provides support to all the Construction Packages.

Figure 2 QMT Organizational Leadership

Program Delivery Quality Manager

Chief of Process & Program Development

Field Quality Implementation Team

Headquarters ISO Quality Implementation Team

Quality Engineer Quality Engineer Quality Engineer Quality Analyst

CP 1 CP 2-3 CP 4

QMS Charter, Process Procedures Development, QMS Training, Document Hierarchy Creation and Implementation, QMS Implementation Plan, Key Performance Indicator (KPIs), Metrics, Reporting, Organization Support, Process Training

CP = Construction Package

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2 PLANNING

The QMS uses the structure shown in the diagram below and is based on the internationally recognized standard ISO 9001:2015 (Figure 3).

Figure 3 QMS Framework

Figure 3 illustrates the 13 sections that enable the Authority to achieve the commitments made in the QP. Authority office or section-specific procedures, forms, and tools support each standard within the QMS.

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2.1 Policy

The QP, outlined in Section 1.8, commits the Authority to serving the public by delivering and operating a system that meets industry and government Quality standards. Leadership demonstrates its commitment to Quality by communicating the QP and its objectives throughout the organization through various means, such as newsletters, training, and staff meetings to encourage and maintain high standards within the program.

2.2 Other Requirements

The Authority has established a QMS in accordance with ISO 9001:2015.

The Program Delivery (PD) Office is responsible for the identification, documentation, and effective communication of relevant project-specific requirements. The QMT and System Safety and Security team are responsible for monitoring the central valley project site for project updates. These teams use various online tools, resources, and subscriptions to monitor the site. The PD Office communicates relevant changes to employees, management, contractors, and other interested parties, as required.

2.3 Risk Management

Risk logic and management is an integral part of the ISO 9001:2015 standard. The processes documented in the Quality Action Report (QAR), Non-Conformance Report (NCR), and Corrective Action Report (CAR) identify associated risks captured within the overall project. The QAR, NCR, and CAR procedure and risk management process realize risk related actions. The Authority Program Risk Management Plan (PLAN- RISK-01) defines the process for handling project related risks.

The Project Safety Plan (PLAN-SAFE-01) identifies the process for handling project health and safety risks. The Program Risk Management Plan defines the management of office related health and safety risks, per the requirements of emergency preparedness and response. Additional information relating to risk management is available in the Associated References list below.

2.4 Improvement

The QMS-SC reviews and provides oversight for the QMS. The committee’s charge is to provide oversight, guidance, and coaching for the QMS. Oversight includes strategic improvement plans by reviewing and setting program objectives and targets. Each year, the executive management establishes goals, objectives, and plans to reflect the high-priority needs. These goals, objectives, and plans are based on customer requirements, policy commitments, market and stakeholder considerations, relevant performance issues (incidents, audits, etc.), consideration of legal and other requirements, hazard identification, and risk assessments.

https://calhsr.sharepoint.com/sites/theterminal/pp/PLAN_RISK_01_Program_Risk_Management_Plan_March_2017.pdf https://calhsr.sharepoint.com/sites/theterminal/pp/PLAN_RISK_01_Program_Risk_Management_Plan_March_2017.pdf https://calhsr.sharepoint.com/sites/theterminal/pp/PLAN-SAFE-01.pdf

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2.5 Defining Roles and Responsibilities

Quality is the responsibility of each staff member. The QMT and Leadership will ensure implementation and execution of QMT policies. Authority staff must conform to the management systems described in this document. Functional area managers or Office Chiefs have the overall accountability and authority for the effective development, implementation, and maintenance of the management systems.

The Program Delivery Quality Manager is accountable for establishing, implementing, and maintaining the QMS processes. The Program Delivery Quality Manager reports to the QMS-SC on performance of the management systems and identifies opportunities for improvement.

Appendix D illustrates a sample of the Program Delivery Quality model, illustrating the responsibilities for each element of the Quality framework. These elements include the independent assurance program, statistical sampling and testing program, verification and validation management, and due diligence check for civil-structural design build contracts. Note that the diagram shown is an example and the setup shown does not apply universally across the program. For instance, Independent Checking Engineer /Independent Site Engineer (ICE/ISE) sometimes falls under the Design Builder (DB), not the Authority.

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3 SUPPORT

3.1 Competence, Training, and Awareness

Process training is a key component of the QMS. The ISO Standard requires full implementation and training of process definition and risk-based systems. The QMT defines and implements training as a formal process. Training of all employees associated with the program captures the Authority’s commitment to Quality.

3.2 Communication and Consultation

The QMT shall actively communicate and consult with internal and external customers as required. Internal customers include, but are not limited to, the Risk Management and Audit offices and the Safety and Security Branch within the PD office. External customers can include the public, communities impacted by the Authority, and outside vendors who contribute to the program.

QMT will continuously seek feedback and resolve any project related issues promptly and appropriately. All stakeholders shall use the QMT electronic mailbox to report feedback, observations, and support needs. The QMT monitors the mailbox (Quality.requests@hsr.ca.gov) and will utilize the PPDB Newsletter to keep the Authority informed of key Quality-related efforts, progress, and challenges.

3.3 Documented Information

The Authority QMS consists of the QP, QM, QMP, procedures, work instructions, and documented information. These create the framework for the QMS. Documented information includes records internally recorded that ensure the effective planning, operation, and control of the QMT processes. Document Control procedure(s) provide the procedural requirements for the control of Authority documented information.

Figure 4 illustrates the hierarchy of QMS documentation, with document types at the top of the pyramid taking precedence over the document types listed below them.

mailto:quality.requests@hsr.ca.gov

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Figure 4 QMS Documentation Hierarchy

The Quality Policy: A Policy level document that defines the overall QMS and references the formal QM defining the Quality system and is the basis for all other documents.

The Quality Manual/Master Quality Plan: Documents the Authority’s overall framework for the QMS and aligns with the PMP as required under the American Recovery and Reinvestment Act (ARRA) Cooperative Agreement with the Federal Railroad Authority (FRA). It also documents the Quality requirements for contracted services, such as the Project and Construction Management (PCMs), DBs, and their sub-contractors, in support of the Authority’s QMS.

• The QM is a living document reviewed for adequacy and improvements on a periodic basis by the QMT;

• The QM applies to the entire Authority, including its consultants and contractors;

and

• The QM uses the ISO 9001:2015 standard as its guideline for establishing and implementing the Authority QMS.

Quality Policy Policy Establishes Quality Commitment

Examples

Level 4 Documents Quality Activities

Level 1 Defines Quality Objectives And Responsibilities

Level 2 Defines Quality Activities:

Who, What, and When

Level 3 Describes How

Quality Records Performance Measures

Dashboards and Reports

Quality Management Plan Regional Consultant QA Plan

Design-Build Quality Plan

Quality Procedures

PCM, DB, and Regional Consultant QMPs Process Work Instructions

Work Instructions

Documented Information

Procedures

Quality Plans

QM

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3.4 Operational Controls

The PMP provides the framework for operational planning and controls. This includes, but is not limited to, project planning, project execution, project closure, and program delivery.

The Project and Construction Management Manual (MANUAL-PD-01) provides the procedural requirements to ensure the proactive and effective management of risks associated with the engagement and management of contractors, subcontractors, consultants, and vendors.

The Authority’s level of responsibility for the management of these external providers will vary depending on its contractual and actual site role. The PCM’s Quality role identified in the Project and Construction Management Manual (PCMM) is to define Quality-related flow-down requirements to the PCMs. Specific language within the PCMM defines the Quality Assurance (QA)/Quality Control (QC) responsibilities and required documentation.

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4 PERFORMANCE EVALUATION

4.1 Measurement and Monitoring

The regular measurement and monitoring of performance indicators include qualitative, quantitative, lead, and lag indicators. This measurement and monitoring include progress toward goals and objectives, as well as reporting on the status of preventative and corrective actions.

The QMT captures the Key Performance Indicators (KPIs) for its processes. The QMT analyzes, reports, and acts upon the collected date for continuous improvement.

The QMT monitors and documents the results of internal/external Quality processes (QAR/NCR/CAR) and audits to assure that elements of the QMS comply with requirements and implementation. An audit plan and schedule define periodic internal and external Quality audits. The QMT updates and posts the audit plan bi-annually on the QMT’s SharePoint. The QMS-SC defines the targeted areas of audits with inputs from the program regarding specific areas that require audit review and documented performance measures.

Audit planning uses inputs from program stakeholders to include Authority functional departments, the state Audits team, project-specific audits in the field, as well as trend-based audits in support of nonconformance, corrective action verification, and validation follow-up.

4.2 Management Review

The QMT uses the Quality Management System Review Procedure (PROC-1011) to inform the Authority leadership about the wellness of the QMS system. The Quality Manager, with support from the QMS-SC, leads a management review meeting to communicate the system status. The purpose of the formal management review meeting is to share KPIs for functional processes with the designated Authority leadership team. The QMT shares objective evidence, data, and reports to ensure the continuing suitability, adequacy, and effectiveness of the QMS.

Management review meetings must:

• Occur at least annually or when a significant organizational change occurs;

• Have active participation by Program Delivery Committee members;

• Consider customer and employee feedback, benchmarking from similar organizations, incidents, monitoring activities, profit margins, and process efficiency;

• Have an agenda based on the requirements of ISO 9001 (Refer to Appendix A);

• Produce meeting minutes with action items; and https://calhsr.sharepoint.com/sites/theterminal/pp/PROC-1011

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• Consider progress against the current year’s objectives and targets, as well as agreed upon objectives and targets for the coming year, based on the information considered within the meeting.

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5 IMPROVEMENT

5.1 Improvement Actions

The QMT ensures adequacy and continual improvement of the QMS by acting on opportunities from workplace nonconformance processing, hazard reports, audits, visitor feedback, stakeholder inputs, incident investigations, and problems.

Improvement actions follow a timeline to evaluate for effectiveness. The QMT escalates risk-based issues for further processing and decisions to the Authority’s executive Leadership team when close-out actions are overdue.

5.2 Change Management

The Contract Change Management Procedure (PROC-CADM-07) provides the procedural requirements to ensure that changes are timely identified, reviewed, justified, and formally incorporated by the Contract Managers as an amendment to a contract.

The QMT manages risk to identify and assess proposed and actual changes. The changes to address risk can be legislative, design-related, structural, organizational, etc.

https://calhsr.sharepoint.com/sites/theterminal/pp/PROC-CADM-07_Contract_Change_Management_Procedure.pdf

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6 ESSENTIAL ELEMENTS OF A QUALITY MANAGEMENT PLAN

6.1 Requirements

The QM is one part of the PMP as required under the ARRA Cooperative Agreement with the FRA. The QMT prepares the PMP in accordance with the ARRA Agreement, Section C3 of Attachment 1 to Amendment Six, in compliance with the requirements of Section 49 of United States Code §24403(a).

The QP requires the implementation of a QMS that utilizes the following industry standards:

• National Institute of Standards and Technology (NIST) Baldrige Excellence Framework (2015-2016);

• International Organization for Standardization (ISO) 9001:2015 – Quality Management Systems Requirements; and

• Federal Transit Administration (FTA) Quality Management System Guidelines, Dec. 2012.

The QMT regularly reviews the requirements described in the ARRA Cooperative Agreement and maintains a list of requirements. Authority positions that are responsible to a requirement of the ARRA Cooperative Agreement must satisfy the requirement.

This section further outlines expectations of a QMS and provides a guide on how to implement these standards. If required by their contract, consultants and contractors that perform work for the Authority must create a QMP that documents their QMS in accordance with their contract and that is consistent with this QM. The QMT directs consultants and contractors to Appendix B for QMP template and Appendix C for guidelines to developing a QMP.

6.2 Expectations

The steps below are minimum expectations of an effective QMS to meet customer requirements and provides continual improvement.

Step 1

Identify any contractual, customer, statutory, and/or regulatory requirements and an individual accountable to meet those requirements.

Step 2

Develop a plan that identifies the steps and/or milestones necessary to meet those requirements and the roles and responsibilities involved. The plan should include performance measures to evaluate progress and success. Identify risks, opportunities, and mitigation strategies as appropriate.

https://www.iso.org/standard/62085.html https://www.iso.org/standard/62085.html https://www.transit.dot.gov/funding/grant-programs/capital-investments/quality-management-system-guidelines https://www.transit.dot.gov/funding/grant-programs/capital-investments/quality-management-system-guidelines

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Step 3

Identify support needed to ensure the plan is successful, including but not limited to internal and external communications, document control, resources, and a training program to ensure competence.

Step 4

Develop a process to identify, report, manage, and resolve issues including trends, nonconformances, and opportunities for improvement. This process should include a method to capture and share lessons learned, project knowledge, and best practices.

Step 5

Develop processes and procedures that support the implementation of the plan. These procedures address what to do, who does it, and when to complete it. Procedures should include methods to ensure Quality by training the workforce to follow the procedures.

Step 6

The QMT monitors performance measures ensuring validation of requirements. The QMT also evaluates procedures for efficiencies and effectiveness, and identifies, reports, and manages any identified issues.

Step 7

The QMT evaluates performance measures and plans for effectiveness. The QMT also identifies, reports, and manages any identified issues.

Step 8

The QMT evaluates training programs and workforce performance and verifies that required certifications are up to date. The QMT also identifies, reports, and manages any identified issues.

Step 9

The process of analyzing results and planning changes should be ongoing. Implement mitigations, improvements, and corrective actions as appropriate after performing Step 6 through Step 8. The QMT documents mitigations, improvements, and corrections and externally and internally communicates to ensure consistency and standardization.

6.3 Implementation

The QMS consists of the QP, QM, QMP, procedures, work instructions, and documented information. Figure 4 in Section 3.4 illustrates the hierarchy of QMS documentation, with documents at the top of the pyramid taking precedence over the document types listed below them.

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QMPs document the requirements, plans, performance measures, procedures, training, and resources identified in Steps 1 through Step 9 of Section 6.2. This document uses the term “QMP” inclusive of other related documents including, but not limited to, Quality Management Plans, quality assurance plans, quality control plans, and quality plans.

QMPs should be consistent with the QM and articulate critical components of a work team, acceptable level of Quality, and the establishment of this level of Quality.

If required by their contract, consultants and contractors must submit a QMP in accordance with their contract and consistent with this document.

Procedures define what is to be done, who should do it, when it should be done, and how to ensure requirements are met. The QMT documents procedures in QMPs, manuals, or other management plans.

Work Instructions detail step-by-step guidelines for implementing/executing work. The person responsible for the QMP develops Work Instructions on a case-by-case basis. A Work Instruction limits process variability by defining the occurrence of specific activities.

The QMT controls and maintains documented information. The QMT uses this documentation as evidence of conformance and assists with activities such as training.

CONTACT

For questions or training for this procedure, please contact the QMT at quality.request@hsr.ca.gov.

mailto:quality.request@hsr.ca.gov

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Appendix A QUALITY RELATED POLCIES, PROCEDURES, AND SUPPORTING

DOCUMENTS

References

Authority Document Control Number Document Title

MANUAL-PD-01 Project and Construction Management Manual PLAN-PD-01 Program/Project Management Plan

PLAN-RISK-01 Authority Program Risk Management Plan

PLAN-SAFE-01 Project Safety Plan

POLI-1006 Quality Policy (QP) PROC-1000 Quality Action Report (QAR), Nonconformance Report

(NCR) and Corrective Action Report (CAR) Procedure

PROC-1011 Quality Management System Review Procedure PROC-CADM-07 Contract Change Management Procedure

Supporting Documents

Authority Document Control Number Document Title

External Document ISO 9001:2015 Standard

External Document U.S. Department of Transportation, Federal Transit Administration, Quality Management System Guidelines, December 2012 https://calhsr.sharepoint.com/sites/theterminal/pp/PLAN-PD-01_Program_Management_Plan.pdf https://calhsr.sharepoint.com/sites/theterminal/pp/PLAN_RISK_01_Program_Risk_Management_Plan_March_2017.pdf https://calhsr.sharepoint.com/sites/theterminal/pp/PLAN-SAFE-01.pdf https://calhsr.sharepoint.com/sites/theterminal/pp/POLI-1006.pdf https://calhsr.sharepoint.com/sites/theterminal/pp/PROC-1000.pdf https://calhsr.sharepoint.com/sites/theterminal/pp/PROC-1011 https://calhsr.sharepoint.com/sites/theterminal/pp/PROC-CADM-07_Contract_Change_Management_Procedure.pdf https://www.iso.org/standard/62085.html https://www.transit.dot.gov/funding/grant-programs/capital-investments/quality-management-system-guidelines https://www.transit.dot.gov/funding/grant-programs/capital-investments/quality-management-system-guidelines https://www.transit.dot.gov/funding/grant-programs/capital-investments/quality-management-system-guidelines

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Appendix B QUALITY MANAGEMENT PLAN TEMPLATE

PURPOSE:

A QMP is an important component to any organization or project. It provides clarity of direction and articulates critical components of a work team such as requirements, roles and responsibilities, key processes, and performance measures. A QMP defines an acceptable level of Quality, describes the establishment of this level of Quality, and defines how to measure the Quality level. The following template serves as a framework to initiate and guide the QMP discussion, development, and completion.

GENERAL GUIDELINES:

• When filling out the template, do not delete any sections. If the section does not apply, type “Not Applicable” in the appropriate section;

• Gray and italic text is a prompt and should not remain in the final QMP document;

• Use a consistent writing style compatible with Authority guidelines to issue effective, useable instructions and procedures; and

• Spell out all words at least once in the document (when first used) and/or define the abbreviation in the “Definitions and Acronyms” section.

TEMPLATE:

• Quality Management Plan - Template https://teams.cloudhsr.com/ent/QMS/FormServerTemplates/Quality_Management_Plan_Template.docx

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Appendix C GUIDELINES FOR DEVELOPING A QUALITY MANAGEMENT PLAN Quality Management Plan Section

Project Planning Preliminary Engineering / Final Design Construction/Procurement Testing/Start-Up

1.

Organization

Determine external and internal issues that are relevant to the Authority’s purpose that affect its ability to achieve the intended results of its QMS and strategic direction.

Determine external and internal issues that are relevant to the Authority’s purpose that affect its ability to achieve the intended results of its QMS and strategic direction.

Determine external and internal issues that are relevant to the Authority’s purpose that affect its ability to achieve the intended results of its QMS and strategic direction.

Determine external and internal issues that are relevant to the Authority’s purpose that affect its ability to achieve the intended results of its QMS and strategic direction.

2. Leadership Describe the Quality responsibilities of the project team and how the organization responsible for Quality will communicate and integrate with the Authority and all other entities within the Program.

Identify the QP and objectives.

Identify the project Quality Manager and other key personnel responsible for the development and implementation of the QMS and the QMP.

Describe the responsibilities of the Project Quality Manager and key personnel.

Promote process approach and risk-based thinking.

Describe the Quality responsibilities of the project team and how the organization responsible for Quality will communicate and integrate with the Authority and all other entities within the Program.

Identify the QP and objectives.

Identify the project Quality Manager and other key personnel responsible for the development and implementation of the QMS and the QMP.

Describe the responsibilities of the Project Quality Manager and key personnel.

Promote process approach and risk-based thinking.

Describe the Quality responsibilities of the project team and how the organization responsible for Quality will communicate and integrate with the Authority and all other entities within the project and the Program.

Identify the QP and objectives.

Identify the project Quality Manager and other key personnel responsible for the development and implementation of the QMS and the QMP.

Describe the responsibilities of the Project Quality Manager and key personnel.

Identify Quality oversight activities and those responsible for carrying them out.

Promote process approach and risk-based thinking.

Describe the Quality responsibilities of the project team and how the organization responsible for Quality will communicate and integrate with the Authority and all other entities within the project and the Program.

Identify the QP and objectives.

Identify the Project Quality Manager and other key personnel responsible for the development and implementation of the QMS and the QMP.

Identify the key personnel responsible for acceptance, demonstration, and integration testing.

Describe the responsibilities of the Project Quality Manager and key personnel.

Identify the testing program requirements and those responsible for carrying them out.

Promote process approach and risk-based thinking.

3. Planning Develop a plan to identify potential risks to project delivery and address them.

Establish Quality objectives for relevant functions, levels, and processes as needed for the QMS.

Describe methods of design and development change control within Quality plans.

Develop a plan to identify potential risks to project delivery and address them.

Establish Quality objectives for relevant functions, levels, and processes as needed for the QMS.

Describe methods of design and development change control within Quality plans.

Develop a plan to identify potential risks to project delivery and address them.

Establish Quality objectives for relevant functions, levels, and processes as needed for the QMS.

Describe methods of design and development change control within Quality plans.

Develop a plan to identify potential risks to project delivery and address them.

Establish Quality objectives for relevant functions, levels, and processes as needed for the QMS.

Describe methods of design and development change control within Quality plans.

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4. Operation Specify requirements for review & sign-off for design.

Specify required design reviews during the PE and Final Design Phase.

Specify any contract Quality requirements for PE or Final Design consultants.

Describe the procedures for design changes, including sign-off and documentation.

Describe the procedure for ensuring that the various planning and design efforts integrate so that the high-speed rail functions as one system.

Describe requirements for product identification and traceability.

Describe requirements for process control and procedures for special processes and specify any sequencing of work requirements within these procedures.

Describe requirements for inspection and testing. State the types and frequency of tests required and the standards and specifications of those tests.

Describe the procedures for ensuring system integration testing and the ability of various subsystems and facilities to work together.

Describe requirements for calibration and maintenance of inspection, measuring, and test equipment.

Describe where these requirements are appropriate.

Describe requirements to identify the inspection and test status of work during production and installation.

Describe where these requirements are appropriate.

Describe the procedures for the development, revision, and sign-off for designs and specifications and the documentation of these processes.

Describe the procedures for obtaining waivers of requirements during design and construction. Responsible parties must sign and stamp all developed designs and specifications.

Identify the requirements for “as-built" documents.

Describe the procedure for ensuring that the various planning and design efforts integrate so that the high-speed rail functions as one system.

Describe requirements for product identification and traceability.

Describe requirements for process control and procedures for special processes and specify any sequencing of work requirements within these procedures.

Describe requirements for inspection and testing. State the types and frequency of tests required and the standards and specifications of those tests.

Describe the procedures for ensuring system integration testing and the ability of various subsystems and facilities to work together.

Describe requirements for calibration and maintenance of inspection, measuring, and test equipment.

Describe where these requirements are appropriate.

Describe requirements to identify the inspection and test status of work during production and installation. Describe where these requirements are appropriate.

Describe the procedures for the development, revision, and sign-off of designs and specifications and the documentation of these processes.

Describe the procedures for obtaining waivers from requirements during construction. Responsible parties must sign and stamp all developed designs and specifications.

Identify the requirements for “as-built" documents.

Describe the procedure for ensuring that the various planning and design efforts integrate so that the high-speed rail functions as one system.

Describe requirements for product identification and traceability.

Describe requirements for process control and procedures for special processes and specify any sequencing of work requirements within these procedures.

Describe requirements for inspection and testing. State the standards, types, and frequency of required tests required.

o Specifications must indicate the standards, types, and frequency of required tests.

Describe the procedures for ensuring system integration testing, the ability of various subsystems and facilities to work together.

Describe the procedures for independently reviewing tests that affect system safety to ensure the identification and remedies of potential hazards.

Describe requirements for calibration and maintenance of inspection, measuring, and test equipment for each contract.

Describe requirements to identify the inspection and test status of work during production and installation. Describe where these requirements are appropriate.

Describe the procedures for fixing problems uncovered during final testing.

Identify and follow configuration management practices.

Describe requirements for product identification and traceability.

Describe requirements for process control and procedures for special processes and specify any sequencing of work requirements within these procedures.

Describe maintenance procedures.

Describe requirements for acceptance testing, demonstration testing, and integration testing of the system and equipment.

State the standards, types, and frequency of required tests.

Verify that performance of all delivered equipment is in conformance with specifications using acceptance tests.

Demonstrate the reliability of the system equipment using demonstration tests.

Describe the procedures for ensuring system integration testing, the ability of various subsystems and facilities to work together.

Describe the procedures for independently reviewing tests that affect system safety to ensure the identification and remedies of potential hazards.

Describe requirements for calibration and maintenance of inspection, measuring, and test equipment.

Describe requirements to identify the inspection and test status of work during final testing. Describe where these requirements are appropriate.

5. Support Identify specific training required for personnel.

Identify specific training required for personnel.

Identify specific training required for personnel.

Identify specific training required for personnel.

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Quality Management Plan Section

Project Planning Preliminary Engineering / Final Design Construction/Procurement Testing/Start-Up

Describe the tracking and maintenance of training, certification, and license requirements.

Describe the procedures for establishing and maintaining documented information.

Describe procedures for the control of project documents following the Authority’s Records Management and Document Control Plan.

Submit a QMP within 60 days of receiving Notice to Proceed or as stipulated within the contract.

Incorporate all Quality procedures applicable to the project.

Reference all applicable procedures for QMP elements.

Describe procedures to obtain qualified personnel/contractors/consultants/mater ial.

Describe the process ensuring the review and approval of purchasing documents by the designated personnel prior to release.

Describe the tracking and maintenance of training, certification, and license requirements.

Describe the procedures for establishing and maintaining documented information.

Describe procedures for the control of project documents following the Authority’s Records Management and Document Control Plan.

Submit a QMP within 60 days of receiving Notice to Proceed or as stipulated within the contract.

Incorporate by reference all Quality procedures applicable to the project.

Construction and/or equipment manufacturing related procedures are particularly relevant.

Reference all applicable procedures for QMP elements.

Describe procedures to obtain qualified personnel/contractors/consultants/materi al.

Describe the process ensuring the review and approval of purchasing documents by the…