IM OSQI 2022-01

Issuance Number:     IM OSQI 2022-01

Subject:                           Quality Management System for U.S. Geological Survey Laboratories

Issuance Date:            September 28, 2022

Expiration Date:        September 30, 2025

Responsible Office:   Office of Science Quality and Integrity

Instruction: This Survey Manual (SM) Instructional Memorandum (IM) replaces IM OSQI 2018-01, Quality Management System for USGS Laboratories, dated March 20, 2018.

Approving Official:    /s/ Craig R. Robinson

                                       Director, Office of Science Quality and Integrity

1.    Purpose and Scope.

A.  The U.S. Geological Survey (USGS) Quality Management System (QMS) provides a foundation to ensure that our laboratory science meets consistent quality-assurance standards, while allowing the flexibility to tailor implementation to address the specific scientific and operational needs of each laboratory and use resources in the areas that are most critical to ensuring the reliability of laboratory results.  Effective implementation, management, and oversight of the QMS and a commitment to continuous improvement result in the reproducibility and traceability of scientific results, strengthen the reliability and defensibility of USGS scientific information products, and support the mission of the USGS.

B.  This policy supersedes IM OSQI 2018-01, establishes central concepts (refer to section 3), and updates the interrelated set of core elements (refer to section 4) that constitute the foundation of a QMS for USGS laboratories. Detailed guidance and requirements not included in this IM are provided in the USGS QMS Manual (available internally).  

C.  The scope of the QMS for USGS laboratories is defined by the central concepts (refer to section 3) and the QMS core elements (refer to section 4).  USGS laboratories are defined as the physical and (or) life science experiments, analyses, or other activities that ultimately produce recorded results and are directly overseen or performed by USGS personnel (or those working on behalf of the USGS) in stationary or mobile facilities.  This policy does not apply to field measurements made in-situ and sample collection in the field.  These will be addressed in future policies.

D.  Organizational units below the Bureau level (e.g., mission area, region, science center, laboratory) have the flexibility to establish additional requirements or procedures that supplement the USGS QMS Manual.  Additional requirements must meet or exceed those of the overarching USGS QMS, and must be reviewed by the organizational unit(s) that are impacted.  The organizational unit that establishes additional requirements must oversee and manage the additional requirements, providing both the support and oversight.

2.    Policy.

A.  Personnel who conduct, support, and manage laboratory science on behalf of the USGS implement and work to the QMS central concepts (refer to section 3) and QMS core elements (refer to section 4) defined in this policy, provided that the elements are applicable to the work being performed.  Additionally, personnel must implement and demonstrate compliance with the requirements outlined in the USGS QMS Manual (available internally).

B.  The USGS maintains a staff of scientists at appropriate levels to create, implement, maintain, manage, and oversee the USGS QMS and ensure the USGS QMS supports the organization’s mission and objectives.

C.  Users of the USGS QMS also comply with other applicable Federal, Departmental, and USGS policies, including those for safety, human resources, ethics, scientific integrity, fundamental science practices, records management, data management, and collections.  A list of these and other policies is included in the USGS QMS Manual.

3.    Central Concepts.

A.  Culture of Continuous Improvement.  The USGS is committed to a Bureau-wide culture that continuously strives to improve the performance of the QMS and the laboratory activities, processes, and services to which the QMS core elements are applied.  Risk-informed decision making, continuous quality monitoring, and documenting laboratory activities enable early detection of problems, timely corrective actions, and implementation of preventive measures to avoid repeated problems.  Implementation of the QMS core elements produces quantifiable measures of improvement, increases efficiencies, reduces risk, enhances transparency, and demonstrates organizational commitment.  Through continuous improvements, the USGS ensures the QMS is responsive to the mission and strategic direction of the Bureau.

B.  Risk-Informed Decision-Making for a Scalable and Tailored Implementation.  Implementation of the USGS QMS can be scaled to address the specific scientific and operational needs of each laboratory or center.  Risk (described further in the USGS QMS Manual) is periodically identified and evaluated at many levels (e.g., science center, laboratory, activity, critical points in a procedure or piece of equipment) to support decision-making for QMS implementation.  Risk inherent to an activity or the use of results is evaluated by the personnel serving in the laboratory management role who have primary responsibility for the activity and approved by center management (Center Director or designee).  Laboratory activities have a higher inherent level of risk if they produce highly visible results (e.g., likely to receive significant attention from one or more groups of stakeholders), results used to make resource decisions, results that are policy sensitive, influential scientific information or assessments, or controversial science or findings.  Laboratory management also identifies critical points in the laboratory, or points within an activity that could result in error or variability, that impact laboratory performance or the quality of laboratory results.  The risk associated with critical points is identified and evaluated as the likelihood and impact for a performance shortfall.  Last, the amount of rigor applied when implementing QMS requirements is scaled according to both the inherent risk and the likelihood and impact of a problem occurring at critical points. Using risk identification and evaluation to prioritize critical points and inform the tailored approach allows laboratories and management to use resources in the areas that are most critical to ensuring the reliability of laboratory results.  In some cases, Mission Areas, Regions, or Centers may have a need to assign higher risk levels to certain laboratory activities based on policy sensitivities or data needs.

C.  Traceable and Reproducible Activities and Results.  Laboratory and QMS activities are documented in sufficient detail to allow reproducibility of the activity and results, and to allow laboratory results to be traced back to procedures, critical equipment, critical materials, sample metadata, personnel training, quality-control results, and other critical points that impact quality.

4.    QMS Core Elements.  The following list of QMS core elements are the quality-assurance principles that provide the foundation for this QMS policy.  Adherence to the QMS core elements is critical for ensuring appropriate management of activities in USGS laboratories.  Personnel implement the core elements that are applicable to the work being performed at a level that aligns with the level of risk inherent to the work.  Requirements and guidance that support the QMS core elements are presented in the internal USGS QMS Manual.  The numbering in this section is intentional to align with the chapters of the QMS manual.

(1)  Roles, Responsibilities, and Management Support.  Center management, in coordination with laboratory management, assigns roles and responsibilities under the QMS.  Management at all levels of the organization supports the QMS by providing direction, oversight, and resources, and by actively promoting continuous improvement.

(2)  Documentation and Document Management.  Laboratory activities and procedures are documented in sufficient detail to allow reproducibility and traceability of results back through critical laboratory processes. Documentation is created, used, managed, and stored for laboratory activities, procedures, results, quality assurance, and quality controls.

(3)  Laboratory Methods.  Laboratories document methods in use, evaluate method performance and the ability of the laboratory to perform the methods, and document evaluations.

(4)  Quality Controls.  Laboratories implement quality controls to measure the performance of an activity against established acceptance criteria and to describe the quality of associated laboratory results.  Quality-control results are documented and traceable to associated sample results.

(5)  Laboratory Environment, Equipment, and Materials.  Laboratory environmental conditions and equipment that are critical to the validity and traceability of results are monitored, maintained, calibrated, and verified, as applicable.  Critical laboratory materials are verified, as applicable, and tracked to ensure traceability to laboratory results.  Access to and use of the laboratory areas are monitored and controlled according to the laboratory’s intended use.

(6)  Laboratory Personnel Training.  Laboratory personnel are trained in the quality management system and the laboratory activities required of their job.  The effectiveness of training is evaluated to ensure that the knowledge and skills necessary to perform laboratory activities are achieved.

(7)  Sample Management.  Laboratories manage sample workflows to maintain sample integrity and ensure the traceability of laboratory results.

(8)  Review and Delivery of Results.  Laboratory results, quality-control results, metadata, and elements from acquiring and processing laboratory results are reviewed to verify accuracy and completeness prior to delivery to the end-user.

(9)  Quality Assessments.  Laboratories perform annual self-assessments and participate in internal and external assessments to verify compliance with QMS requirements. (Note:  Internal and external assessment schedules and procedures for both laboratories and of the QMS itself are under development.)

(10)  Corrective Action.  Laboratories perform corrective actions to correct problems and to the extent possible reduce or eliminate the possibility of recurrence.

5.    Definitions.  A comprehensive glossary for the USGS QMS is available in the internal USGS QMS Manual.

A.  Assessment.  The evaluation process used to measure the performance or effectiveness of a system and its elements, including conformance with policies, procedures, and requirements.  Assessment is an all-inclusive term used to denote any of the following: audit, performance evaluation, management review, review, inspection, or surveillance.

B.  Continuous Improvement.  The systematic and periodic approach to improving the performance of activities, processes, or services in both the QMS and in the laboratory.

C.  Controlled Documents.  Documents that are formally reviewed and approved, uniquely identified, versioned, and their distribution is tracked and traceable to ensure the use of the correct version for the prescribed activity and to trace results back to the specific version in use.

D.  Corrective Action.  A solution meant to reduce or eliminate an identified problem.

E.  Core Elements.  A set of interrelated foundational quality-assurance principles that define the scope of the USGS QMS.

F.  Critical.  Meaning of significant or crucial importance in the success, failure, or existence of some activity or project.

G.  Laboratory.  The physical and (or) life science experiments, analyses, or other activities that ultimately produce recorded results and are directly overseen or performed by USGS personnel in stationary or mobile facilities.  (Note: The definition of a laboratory focuses on the combination of activities, people, and spaces.  It begins with activities because we apply quality-assurance principles to activities.  Defining laboratories by activities makes implementation of the QMS more efficient by allowing decision-making by the laboratory expert at the lowest reasonable level.)

H.  Performance Characteristics.  Properties that indicate in quantifiable terms the extent of quality of the laboratory method or activity.  Examples include accuracy, bias, precision, and uncertainty.

I.  Quality.  The extent to which a service or product meets the stated or implied needs of the intended use.

J.  Quality Assurance (QA).  An integrated system of activities that involves planning, implementation, documentation, assessment, reporting, and improvement to ensure that an activity, process, item, or service is of the type and quality that is required and expected.

K.  Quality Control (QC).  Technical activities used to evaluate performance characteristics by comparing quality-control results to acceptance criteria.  They include positive controls, negative controls, and comparisons.

L.  Quality Management System (QMS).  A structured and documented management system describing the objectives, principles, organizational authority, responsibilities, accountability, policy, and requirements of an organization for ensuring quality in its activities, processes, products (items), and services.

M.  QMS Manual.  Describes the quality management system policy, requirements, roles, and responsibilities to ensure activities meet a defined standard of quality for an organization.  These are sometimes referred to as quality manuals or quality-assurance manuals.

N.  Reproducible.  The extent to which consistent results are generated by different individuals using the same methods, equipment, materials, and conditions over a longer timescale.

O.  Risk.  The likelihood and impact for a performance shortfall.

P.  Traceability.  The ability to follow and track the history of a material, document, activity, process, or result.

6.    Responsibilities.

The success of the USGS QMS depends on the active engagement and participation of all personnel who conduct, support, and manage laboratory science on behalf of the USGS. Specific responsibilities for implementation, maintenance, and oversight of the USGS QMS requirements are as follows:

A.  USGS Director and Deputy Directors.  The Director and Deputy Directors, in coordination with other members of the Executive Leadership Team (ELT), jointly ensure the QMS supports the mission of the Bureau.  As part of this coordination, they demonstrate the organization’s commitment to the QMS through provision of resources, oversight, and support.

B.  Office of Science Quality and Integrity (OSQI).  OSQI is the office of primary responsibility for the QMS, maintains the USGS QMS policy, and provides oversight and assurance over the QMS policy, implementation, and corrective actions from quality-related problems and concerns.  The OSQI Director solicits review from the ELT and other internal stakeholders for major changes to requirements in the USGS QMS Manual, serves as the approving official for the USGS QMS Manual, and holds organizational responsibility for the QMS to ensure it achieves its intended results.  The OSQI Director collaborates with the Deputy Directors, Chief Scientist, Associate Directors, Regional Directors, and other ELT members as needed to address issues or concerns regarding the execution and oversight of the QMS.  The OSQI Director delegates authority to direct and oversee the USGS QMS to the Bureau Laboratory QMS Coordinator.

C.  Bureau Laboratory QMS Coordinator.  The Bureau Laboratory QMS Coordinator reports to the OSQI Director and provides strategic leadership, independent oversight, and assurance over the entire USGS QMS, including implementation, unique applications of the QMS, quality assessments, and corrective actions from the Bureau level.  The Bureau Laboratory QMS Coordinator serves as the senior advisor for quality management in the USGS and represents the Bureau in QMS matters both within and outside the USGS.  The Bureau Laboratory QMS Coordinator leads the national-level USGS QMS Team, which comprises Mission Area and Regional QMS Managers, to ensure consistent implementation, maintenance, and oversight of the USGS QMS.

D.  Associate Directors (ADs) and Regional Directors (RDs).  ADs and RDs provide guidance and oversight for the processes and requirements that govern the laboratory QMS.  They collaborate with one another and with Science Center Directors in their areas of oversight to ensure the level of implementation is appropriate for the level of risk inherent to the laboratory science and results.  They promote consistency and continuous improvement, and ensure resources are adequate to support compliance with the QMS. They designate QMS Managers to coordinate implementation, support, training, discipline-specific applications of the requirements, and assessments of QMS implementation. They ensure quality-related issues and problems identified in their chain of command are prudently and effectively corrected.

E.  QMS Managers.  Mission Area and Regional QMS Managers collaborate with one another, the Bureau Laboratory QMS Coordinator, and OSQI QMS staff to set strategic and programmatic priorities for the USGS QMS, ensure that effectiveness may be evaluated from a Bureau scale, and provide critical oversight and evaluation of center and laboratory QMS implementation.  They serve on the national-level USGS QMS Team and report QMS implementation effectiveness, efficiencies, and corrective actions to the Bureau Laboratory QMS Coordinator and their chain-of-command ELT member.  They provide training, assist with implementation, encourage enterprise-wide consistency to increase efficiency and transparency, assist with risk evaluations, develop corrective action plans, perform assessments, and work closely with Center Directors to determine the appropriate level of QMS support needed.  They function independently of laboratories and laboratory management to minimize competing interests.

F.  QMS Team.  The QMS Team is a national group of Mission Area and Regional QMS Managers led by the Bureau Laboratory QMS Coordinator and supported by OSQI QMS staff. The QMS Team works collaboratively to review the effectiveness of the QMS, manage the QMS, ensure consistency across the Bureau, and ensure the QMS aligns with the mission and strategic direction of the USGS and supports laboratory science enterprise wide.  The QMS Team approves recommendations for improvements to the USGS QMS.

G.  Center Directors.  Center Directors, along with designated center management and supervisors, provide oversight to ensure laboratory work within their organizational purview is conducted and monitored in accordance with the requirements of the USGS QMS.  Center Directors collaborate with their chain of command, and appropriate members of the QMS Team to ensure the effectiveness of the QMS in their center.  Center Directors evaluate and document real or perceived internal competing interests when assigning personnel to roles under the QMS and, to the extent possible, take steps to minimize them.  Together with their chain-of-command QMS Manager, Center Directors determine the appropriate level of QMS support necessary in the science center and hire or designate that support (see Center QMS Support below).  Center Directors (or designee) approve written risk-based justifications (following review by the appropriate Mission Area or Regional QMS Manager) for implementation approaches or non-compliances so the QMS implementation in the science center aligns with the amount of risk inherent in each laboratory activity.  Center Directors (or designee) are responsible for approving controlled documents originated in their centers.  Center Directors (or designee) prudently report issues or problems affecting the quality of laboratory activities and results to the Regional and Mission Area QMS Manager (if applicable) and chain of command and ensure that effective corrective actions are taken to correct the problem and reduce the likelihood of recurrence.

H.  Laboratory Management (e.g., Laboratory Managers, Supervisors, Principal Investigators).  Laboratory management includes those with technical oversight of laboratory activities and represents the person or group of people responsible for making decisions for how the laboratory implements the QMS.  Laboratory management evaluates inherent risk in laboratory activities and results and risk associated with critical points in the laboratory to inform implementation of the QMS requirements.  Laboratory management decides and oversees quality-assurance approaches, ensures laboratory personnel receive applicable training on the QMS and laboratory activities, creates or approves the creation of laboratory documents, performs annual self-assessments, responds to laboratory assessments, elevates issues and problems affecting the quality of laboratory science to center management, and documents adherence to the QMS policy requirements.  Laboratory management must include at least one permanent employee who is ultimately responsible for the quality of the work being performed in the laboratory.

I.  Center QMS Support.  Center QMS Support positions provide center-level QMS support to laboratory personnel and center management and communicate with their Regional and (or) Mission Area QMS Manager on QMS topics. Duties for Center QMS Support personnel vary depending on the complexity of the laboratory activities in the center.

J.  Laboratory Personnel.  Laboratory personnel ensure the quality of the work they perform, participate in continuous improvement, and comply with the USGS QMS requirements.  They report quality-related problems to management or any member of the QMS Team. 

K.  All Personnel.  USGS personnel and others working on behalf of the USGS are responsible for reporting quality-related questions or concerns without fear of retaliation, as described in the No FEAR Act.  Personnel may report concerns to any member of the QMS Team, the Bureau Laboratory QMS Coordinator, the personnel’s chain of command, or any member of regional or mission area leadership.  Concerns submitted by email may be sent to the Bureau Laboratory QMS Coordinator at gs_help_qms@usgs.gov.  Reporting of scientific misconduct is addressed in SM 500.25, Scientific Integrity.