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ESH Manual Page: 12000: Quality Assurance Program

1.0 PURPOSE

This document describes requirements necessary to ensure that quality is integrated into all work conducted at the Sanford Underground Research Facility (SURF). SURF utilizes the requirements of the International Organization for Standardization (ISO) 9001/Quality Management, 14001/Environmental Management, and 45001/Occupational Health & Safety.

The SURF Quality Assurance Program outlines the requirements for implementing and maintaining an effective program throughout the facility, and it provides a system capable of monitoring, controlling and continually improving the facility’s activities, processes and systems.

2.0 SCOPE

This chapter applies to all South Dakota Science and Technology Authority (SDSTA) personnel, Users and Contractors/Subcontractors and applies to all activities at SURF.

3.0 DEFINITIONS

Corrective & Preventative Action: An action to remediate the cause of a detected nonconformity(s) or other undesirable situation. Also, can be obtained as part of a Lessons Learned process.

Note: There can be more than one cause for a nonconformance. Corrective action is taken to mitigate the recurrence whereas preventive action is taken to prevent occurrence.

Graded Approach: A methodology that qualitatively assigns a risk ranking and corresponding set of actions based on prudent management, planning, risk and cost.

International Organization for Standardization (ISO): Independent, non-governmental international organization that provides world-class specifications for products, services and systems, to ensure quality, safety and efficiency.

Lessons Learned: A “good work practice” or innovative approach that is captured and shared to promote repeat application; a lesson learned may also be an adverse work practice or experience that is captured and shared to avoid recurrence.

Quality Assurance: An overarching process that defines the standards and methodologies to be followed to meet the customer requirements. It is a process to create the deliverables.

Quality Control (QC): An activity that ensures that QA processes are followed, and standards are met. Is product oriented and makes sure the results of what you've done are what you expected.

Suspect/Counterfeit Items: When a defect appears, or when inspections identify a misrepresentation of an item (intentional or unintentional) by the vendor, supplier, distributer or manufacturer.

4.0 RESPONSIBILITIES

4.1 Executive Director

  • Approves the QA Program and has ultimate responsibility for all aspects of QA.
  • Holds management accountable for implementation and compliance with this program.
  • Ensures the necessary organizational structure and resources are available to meet QA commitments.

4.2 Department Directors

  • Ensures elements of the SURF Quality Assurance Program are incorporated into department programs and procedures.

4.2.1. Environment, Safety, and Health (ESH) Director‌

  • Appoints the Quality Assurance Manager.
  • Provides oversight for QA related functions.
  • Responsible for ISO certification program.
  • Identifies resource needs and advises the Executive Director.
  • Ensures compliance with this chapter within their areas of responsibility.
  • Ensures that quality requirements are incorporated into designs and equipment.

4.2.2. Science Director

  • Approves expenditures of funds for scientific proposals and establishment of projects.
  • Ensures elements of the SURF Quality Assurance Program are incorporated into Science program documents such as the SURF Experiment Implementation Program.

4.2.3. Engineering Director

  • Responsible for the efforts of all engineers working on a single project.
  • Assure that quality is incorporated into the design development cycle and procedures.
  • Ensures that elements of the SURF Quality Assurance Program are incorporated into Engineering program documents such as the SURF Construction Quality Management Program.

4.3 Managers, Supervisors and Project Managers

  • Ensure compliance with this chapter within their areas of responsibility.
  • Responsible for providing plans, schedules, resources for work and implementing quality in their respective departments.
  • Have the authority, responsibility and accountability for integrating QA and QC into processes and programs.
  • Consult with QA/QC SME’s when appropriate for ensuring quality is integrated into developmental and operational processes.

4.4.Procurement Specialist

  • Manages vendor registration process, solicitation and purchase documents, negotiating terms and conditions, performing subcontract administration and closeout.

4.5 Quality Assurance Manager

  • Responsible for maintenance and effectiveness of the QA Management Program.
  • Ensures that assessments are conducted to evaluate compliance with this program.
  • Ensures that appropriate training is identified and made available for program implementation.
  • Manages ISO support and compliance activities.

4.6 Quality Control Specialist

  • Executes and maintains quality control standards, inspections and audits on specific project deliverables.
  • Provides QC oversight using defined quality processes.

4.7 QC and Compliance Specialist

  • Oversees the ISO compliance efforts and related programs to achieve and maintain ongoing compliance/certifications.
  • Assists with ongoing QA/QC activities.

4.8 On-site Personnel

  • Responsible for performing work in accordance with the requirements of this chapter.
  • Participate and collaborate with the QA/QC department.

5.0 REQUIREMENTS

QA management is established by the QA Manager and achieved through collaboration and support of the individual departments. QA is foundational to the organizational culture and success at SURF.

The QA Program ensures that:

  • SURF operations and services meet or exceed customer and stakeholder expectations.
  • The requirements for implementing and maintaining QA throughout the facility are identified and managed.
  • The system is capable of monitoring, controlling and continually improving SURF activities, processes and systems.

The requirements of the QA Program will address the following:

  • Attain and maintain ISO certification from an accredited registrar and identify and incorporate other codes and standards as applicable.
  • Risk Management to mitigate any risk that could potentially harm projects, products and values commensurate to the severity of the risks.
  • Performance measurements and metrics.
  • Organizational structure, including responsibilities and authorities.
  • Training and qualifications.
  • Document control.
  • Records management.
  • Procurement assurance.
  • Design and engineering assurance, including design validation, change control and configuration management.
  • Risk-based oversight planning and execution that include assessments, inspections, testing, and quality control checks and monitoring of process parameters to ensure requirements are met.
  • Calibration and control of measurement & test equipment used in data collection, inspections and acceptance testing.
  • Management of deficiencies, including the identification, correction/resolution, tracking, closure and effectiveness verification.

5.1. Program

SURF/SDSTA has established an organizational structure along with responsibilities, authority and written procedures that ensure successful implementation and maintenance of the QA Program.

The Executive Director/Laboratory Director and the Directors, Managers and Supervisors ensure that responsibilities and authorities are defined and communicated within the organization. Responsibilities and authorities are recorded as part of employee position descriptions.

Directors, Managers and Supervisors are responsible for developing and managing work plans, schedules and allocation of resources, in addition to the team’s performance and evaluation of work activities.

To facilitate the achievement of the organizational mission and objectives, the following elements of the QA Program are foundational to overall success.

5.2 Quality Monitoring System‌

The Quality Monitoring System is a comprehensive approach using elements that consist of:

  • Procedures and best-practices that enable planning, execution, monitoring and continuous improvement.

  • Proactive management processes, tasks and activities that establish confidence and assurance that requirements of QA, stakeholders and customer expectations for quality are met or exceeded.

5.3 Graded Approach

A risk-based approach used to establish priorities and milestones.

Application of the Graded Approach entails:

  • Identification of activities that present significant quality risk.
  • Defining the activity.
  • Importance of work.
  • Available resources.
  • Unique needs of the organization.
  • Evaluating risk and control choice.
  • Documenting and approving the application of the graded approach.

Quality Levels (QL) in the Graded Approach establish a risk rating such that higher risk activities result in higher rigor and review, as shown in Table 2 (general example).

 

QL-1:

High Risk

Important to safety or mission, high-risk procurement where additional quality controls are needed to verify critical attributes and a high level of assurance is needed to ensure expectations associated with additional quality controls are being met.

QL-2:

Medium Risk

Important to safety or mission, medium-to high-risk procurement where quality controls are needed to verify critical attributes and a moderate level of assurance is needed to ensure expectations associated with additional quality controls are being met.

QL-3:

Low Risk

Important to safety or mission, low-to medium-risk procurement where quality controls are needed to verify critical attributes.

QL-4:

Very Low Risk

Minimal, if any, safety or mission impact—level of controls for those items, services, or processes where no additional quality controls beyond the providers published or stated attributes of the item, service, activity or process are required. General acceptance processes to ensure item, quantity and other characteristics are met.

                               Table 2: Graded Approach Risk Categories - General Sample

 

Directors, Managers and Supervisors shall ensure that a graded approach to quality requirements is applied in accordance with this section for products, projects and services under their control, and is used when establishing levels of control along with QA Manager oversight.

6.1 PERSONNEL QUALIFICATIONS AND TRAINING

Skills and knowledge will evolve over time as organizational needs arise. SDSTA personnel are required to have the necessary experience, knowledge and skills to perform their jobs.

Personnel are qualified to perform their job based on previous experience, education and training; on-the-job training; and completion of training courses or qualification programs.

6.1 Quality Improvement

SURF maintains continuous quality improvement through a variety of activities, including training, design, assessments, observation by walk-through, inspections, tests, monitoring, reviews and analysis.

6.2 Quality Improvement Program

Issues, improvement opportunities and corrective actions generated from the activities listed above are documented and tracked through an incident tracking process.

Management is responsible for encouraging and enabling individuals under their supervision to participate in identifying and analyzing opportunities for improvement; responding to discovery of quality-related issues; following up on required actions; documenting failures and non- conformances; ensuring that significant problems are reported to the appropriate management area and ensure root causes are identified and issues corrected.

SDSTA Management supports quality improvement by leading the strategic planning process, goal setting, project and program oversight, performance planning and oversight processes. Inputs to the planning process include feedback from management reviews, issue resolution, root cause analysis, lessons learned, including specific QA/QC reviews.

6.3 Lessons Learned

During the performance of projects, items may be identified that result in improvement opportunities.

These lessons learned become actionable information and can be applied to future efforts. Formally conducted lessons learned sessions will be held throughout the lifecycle of projects or operations. Lessons learned will be identified and documented to utilize knowledge derived from experience to:

  • Promote the recurrence of desirable outcomes.
  • Preclude the recurrence of undesirable outcomes.

7.0 DOCUMENTS AND RECORDS

SURF documents including policies, prescribed processes, design specifications and requirements are reviewed or created through a QA/QC process. All policies, chapters, procedures, forms, program documents and program implementation plans shall be controlled through the management of change process. Additional document control requirements and review frequency may be required by SURF, as well as outside stakeholders.

Development and review of documents is a shared multi-departmental responsibility based on the hierarchy of documents, e.g. policy, chapter, procedure and forms. Management is responsible for providing the resources necessary to fulfill the document control and records management requirements. SDSTA employees, contractors and users are required to comply with the document control and records management policies and procedures.

Documents are required to safely and effectively manage, perform and assess work. Management identifies those documents needed to accomplish these objectives and determine the level of control required. Controls include activities such as preparation, review, approval, distribution, usage, availability, revision and termination of documents. All policies, chapters, procedures, forms, program documents and program implementation plans shall be controlled through a management of change process.

7.1 Work Processes

Managers and Supervisors ensure adequate resources are available and provided to maintain the site in an operational state and that work controls are in place and effective. Work includes design, construction, operation, quality, support, maintenance, modification and decommissioning of experiments performed by SURF employees. The quality management controls applied to work processes include written procedures for activities of sufficient complexity or potential hazard; periodic monitoring and assessment of performance; personal accountability; and specific provisions for activities not otherwise covered in this document.

Each person is responsible for the quality of their work; reporting issues; contributing to the incorporation of environment, safety, health, and productivity goals; and maintaining items to prevent damage, loss or deterioration.

7.1.1 Work Process Management

A strategic approach to Item Control, Maintenance, Readiness Reviews, Calibration of Process Equipment, and providing a safe and efficient Work Environment utilizing the cyclical Plan, Do, Check, Act Methodology (PDCA-Cycle).

Item Control:

A lifecycle process for physical asset identification managed with traceability and maintained during receipt, shipping, storage, handling, installation, use and disposal. These controls are commensurate with the item's application, usage, value and associated risk.

Maintenance:

This process provides for facilities, laboratory infrastructure and equipment reliability. Maintenance activities are systematically documented, scheduled and tracked. The organization coordinating or performing the maintenance is responsible for ensuring that records of maintenance are kept.

Readiness Reviews:

A process used to evaluate the preparedness to progress to the next operational level. This process is conducted prior to the start of new operations or those that have significantly changed, including description of success. The extent and detail of the reviews are commensurate with the scale, value, complexity, hazards and programmatic significance, along with any Advisory Committees that may be required.

Calibration of Process Equipment:

A process used to maintain accuracy and reliability of systems and equipment used to support the monitoring of such assets as buildings, pumps, water supply systems, and building air supply systems. Activities are proactively scheduled, and the results are documented and retained.

Work Environment:

A cultural process that promotes a safe and efficient methodology that allows facilities and work areas to be arranged and maintained in an organized state of cleanliness and repair.

It is everyone’s responsibility to continuously maintain the integrity and cleanliness of their work area, assure they understand and meet the requirements at each building location and follow the expectations of SURF.

The PDCA-Cycle is an iterative four-step management method used for control and continuous improvement of processes and products.

  • Plan: Organizations will plan and establish the process-related objectives and determine the processes that are required to deliver a high-quality end-product.
  • Do: Development and testing of processes including changes in the process.
  • Check: Monitoring of processes, modification of the processes and evaluation to ensure the process meets the predetermined objectives.
  • Act: Implementation of actions that are necessary to achieve improvements in the processes.

7.2 Design

SURF’s design process provides for appropriate control of planning, design inputs and outputs, verification and validation, configuration and design changes, and technical and administrative interfaces. Design work is based on sound engineering judgment; scientific principles; and applicable codes, regulations and standards. The SDSTA Engineering Department prioritizes design work and activities based on organizational needs, lab/science priorities, leadership input, strategic and mission impact, as well as overall time sensitivity related to deliverables and risk.

7.3 Procurement

All materials and services are purchased from technically acceptable and responsible suppliers, including distributors authorized by the manufacturer. Materials and services are acquired per the Procurement Handbook.

The procurement receipt inspection process supports the alignment between materials ordered and those received, preventing the introduction of suspect and counterfeit items. When variations are identified, the affected parties are informed on the noted deviations.

Evaluation and monitoring of supplier's performance during the procurement process are performed to ensure that technically acceptable items are produced, and services continue to meet the quality, specifications, delivery criteria and other performance requirements. Suppliers shall initiate corrective actions in accordance with purchase order terms and conditions should they not perform as required.

7.4 Inspection and Acceptance Testing

Inspections and tests are performed to verify that the physical and functional aspects of items, services and processes meet requirements and are fit for use. The performance expectations, inspections and tests are considered during the design phase and, where appropriate, are specified in the design output and/or procurement documents.

7.4.1 Inspection and Testing Process

Inspection and testing plans identify item characteristics and processes to be inspected or tested. Appropriate corrective actions shall be taken where deficiencies are identified. When appropriate, inspections and tests are performed by personnel who are independent of the activities being inspected.

7.4.2. Control of Nonconforming Items

Items that do not conform to specified requirements are subject to controls to prevent their inadvertent installation or use. Controls include identification, documentation, evaluation, segregation (when practical), item disposition (reject, repair, rework, use-basis) and notification to affected organizations.

7.4.3. Inspection and Test Records

Inspection and test results are systematically documented and retained based on archival requirements. The inspection and test status of items and processes requiring examination are clearly identified to ensure that only items with acceptable results are used. Inspection/test records identify item(s) inspected, the inspection/test procedure used, who performed the inspection/test, the identification number(s) of the measuring and test equipment (M&TE) used to perform the inspection or test, the inspection/test data, the inspection/test criteria and the inspection/test results.

7.4.4. Control of Measuring and Test Equipment

The M&TE used for inspection and acceptance tests are identified, calibrated, maintained and controlled commensurate with their intended use. In addition, third-party / vendor calibration support may be preferred.

Procedures are established by operational areas for testing, adjusting and calibrating the M&TE. Equipment is checked to ensure the proper type, range, accuracy and precision is uniquely identified and traceable to its calibration records. M&TE examples include scales, radiation survey instruments, pH monitors, voltage meters and Non-Destructive Testing (NDT) equipment.

If any M&TE is found to be out of tolerance, appropriate evaluations shall be performed to assess any adverse impact on previous inspection, testing, collected data or calibration using that equipment. The evaluation, including conclusions, should be documented and appropriate notifications made. When M&TE equipment or associated computer programs are identified as not operating to specifications, they shall be removed from service or locked out and not returned to service until passing calibration requirements.

7.5 Assessments

The assessment process is used to identify and correct problems that hinder the organization from achieving its objectives. Assessment activities shall be monitored to ensure that the corrective actions are finalized and supported with appropriate objective evidence.

Issues and opportunities for improvement that are identified as the result of an assessment are provided to the appropriate level of management for review and concurrence and evaluated to determine the level of follow-up required. Findings are reported specific to best-practices, successes and opportunities for improvement. Corrective actions and opportunities for improvement shall be aligned with best practices and corrective actions are recorded and tracked to closure through the Action Item Tracking process. 

SURF utilizes two types of assessments:

  • Internal
  • Third-Party

7.5.2 Internal Assessments

Internal assessments are performed to evaluate quality management processes for the implementation of noteworthy practices and to uncover issues, identify corrective actions and ensure that the work being performed is aligned with requirements. Additionally, internal assessments may be utilized to support and prepare for future third-party reviews.

7.5.3 Third-Party Assessments

Third-party assessments are conducted to ensure adequate implementation and ongoing effectiveness of the QA Program (these assessments compliment section 5.10). The ESH Department has the responsibility and authority for:

  • Planning assessments.
  • Organizing the necessary resources to conduct assessments.
  • Status tracking and reporting of any associated corrective action plans.

Management is responsible for:

  • Providing resources for assessments.
  • Implementing identified corrective actions.

SURF/SDSTA shall establish annual third-party reviews of its QA Program implementation and performance effectiveness and respond to findings, comments and recommendations from these reviews. A DOE Office of Science QA Subject Matter Expert shall serve as an observer on such reviews. SURF/SDSTA will be responsible for identifying and engaging other qualified participants in such reviews. The ISO 9001/14001/45001 certification audits by an accredited registrar may serve as such a third-party review.

SURF/SDSTA shall monitor and provide QA-related status and performance information to the DOE Contracting Officer on a quarterly basis. This report shall include a status for any open finding from DOE, other external or third-party reviews/assessments/audits, internal/self- assessments, any improvements to the QA Program, and any substantive changes or updates to the QA Plan. Further, the report shall include a summary of the reported quality-related findings/deficiencies and non-conformances, including corresponding corrective actions that occurred over the previous reporting period. SURF/SDSTA will provide DOE with a copy of the ISO 9001/14001/45001 certification audit and recertification audits, along with documentation of any resulting corrective actions and evidence of their resolution.

The QA Program is reviewed at least annually. Revisions to the QA program that change commitments to the program will be submitted to the DOE for review and approval. If no revisions are necessary, or if only minor editorial changes are made, the DOE will be notified that a review has occurred and resulted in no changes.

7.6 Suspect/Counterfeit Items Prevention

SURF has established a process for the identification, control and disposition of suspect/counterfeit items (S/CI’s). Managers and supervisors shall identify individuals requiring training, ensure they receive this training and provide necessary resources for maintaining the program.

Designers provide appropriate specifications and controls to safeguard SURF against the introduction of suspect or counterfeit items. Procurement is responsible for selecting technically acceptable and responsible suppliers including distributors authorized by the manufacturer. All requestors are made aware of the need to purchase from reputable suppliers and distributors.

7.6.1. Prevention

Methods to prevent the purchase of S/CI’s are based on making all purchases from reputable suppliers and distributors.

7.6.2. Detection

The primary means of detecting S/CI’s is through inspections and audits to identify any defects, misrepresentation or counterfeit items by the vendor, supplier, distributer or manufacturer.

7.6.3. Reporting

If S/CI’s are discovered, procurement is notified. Reporting also includes notifying the area supervisor, which may include the ESH Director and QA Manager.