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U.S. Geological Survey Manual

U.S. Geological Survey Instructional Memorandum

No: IM OSQI 2018-01

Issuance Date: March 20, 2018

Subject: Quality Management System for USGS Laboratories

1.  Purpose and Scope.

A.  The reputation of the U.S. Geological Survey (USGS) for scientific excellence, integrity, and objectivity brings authority to data and findings, creates and protects long-term credibility, and ensures public trust to address important societal issues.  A reliable scientific reputation is dependent on the credibility and integrity of employees engaged in scientific activities that are directly tied to consistent adherence to the scientific method and widely accepted scientific practices.  This Instructional Memorandum (IM) establishes a set of core elements of a Quality Management System (QMS) for USGS laboratories.  The QMS provides a comprehensive framework to ensure that USGS laboratories carry out all aspects of quality-assurance and quality-control activities.  Through implementation of the collective set of the core QMS elements described in section 5, the resulting USGS laboratory data will be of known and documented quality that meets the Bureau’s mission and strategic goals, upholds the Bureau’s scientific reputation, and adheres to USGS Fundamental Science Practices (FSP) requirements.

B.  This IM policy describes processes to ensure the reproducibility, impartiality, and reliability of laboratory-generated data and institutionalizes the required set of core QMS elements to be used across the Bureau.  Detailed guidance not included in the IM will be provided through the Survey Manual Chapter and Mission Area documents.  This policy does not apply to field measurements made in-situ and sample collection, nor non-USGS laboratories (as defined in section 3.G). These will be addressed in separate policies.  The USGS laboratory QMS requirements do apply to:

(1)  USGS laboratories as defined in section 3.E. 

(2)  All activities that ultimately result in recorded data generated within USGS laboratories that identify or quantify a parameter. 

(3)  USGS laboratory activities including, but not limited to, application of a published method to generate data for scientific investigations, deviation from a published method, and development of a new method.

2.  Benefits.

A.  Culture and Credibility:  The USGS is committed to a Bureau-wide laboratory organizational culture that continuously strives to improve the quality of data and information provided.  Efforts to maintain credibility require laboratory practices that are well documented.

B.  Management:  The use of defined management processes will result in efficient use of resources in meeting Bureau-wide QMS requirements and help ensure standards and necessary components to be practiced for laboratory activities are established and in place.  The USGS QMS is a means for any laboratory to ensure that requirements are being continuously met.

C.  Improvements and Efficiencies:  Continuous quality monitoring, evidence-based decision making, and documenting processes to detect and identify problems early will allow for quick corrective actions and avoid repeated mistakes. These practices result in quantifiable measures of improvement and increased efficiencies. 

D.  Documentation:  A USGS laboratory QMS ensures that documents are developed, reviewed, tracked, and retained, allowing for reconstruction and verification of reported results in accordance with FSP requirements. 

E.  Competency:  The QMS for USGS laboratories also ensures competency of laboratory personnel through training, periodic demonstration of capability, and continuous compliance with quality-assurance and quality-control plans.

3.  Definitions.

A.  Approved Methods.  Include the processes, procedures, and analyses that are used to produce data of known and documented quality that have been (1) validated and published by the USGS in accordance with FSP and Mission Area requirements, or (2) validated and published by non-USGS entities with similar or more stringent requirements. 

B.  Controlled Documents.  Documents that are tracked, maintained, and updated.  These documents are formally reviewed and approved, they are given a revision number, and their distribution is traceable and tracked to ensure use of the correct version at the location where the prescribed activity is performed and to permanently link a version with its associated data.

C.  Core QMS Elements.  Collectively, are the foundational or fundamental principles that support the QMS, ensure a controlled quality environment for laboratories, and result in recorded data of known and documented quality.

D.  Data.  Observations or measurements (unprocessed or processed) represented as text, numbers, or multimedia.

E.  Laboratory.  A stationary or mobile USGS facility where work in the physical and (or) life sciences is conducted or a non-USGS facility where USGS personnel directly oversee or perform activities or analyses that ultimately result in recorded data.

F.  Laboratory Personnel. Anyone (including USGS employees, and those working on behalf of the USGS such as volunteers and contractors) working in a laboratory who is responsible for any activity ultimately resulting in recorded USGS data.

G.  Non-USGS Laboratory.  Any laboratory at which work is conducted on behalf of the Bureau, by non-USGS personnel, in non-USGS facilities, which include contractor, research, university, production, and other external laboratories.

H.  Performance Testing.  Analysis of known or unknown reference samples/materials provided by an internal or external source, as a means to evaluate a laboratory’s quality or functionality under controlled conditions relative to a given set of criteria.

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

J.  Quality Control (QC).A process for verifying and maintaining a desired level of quality in a product or service through use of proper equipment, comparison with reference values, continued inspection, and corrective action as required. 

K.  Quality Assurance Manual (QAM).  Describes the policies, procedures, requirements, authority, and documentation of the QMS that assure analyses continually meet a defined standard of quality for an organization.  The QAM will specify review and approval mechanisms for QMS-related documentation.  The highest-tiered QAM will be developed at the Bureau or Mission Area level.  When a lower-level QAM is necessary for an entity under the Bureau or Mission Area to provide additional entity-specific policies, requirements, authorities, or documentation that are not covered in the Bureau or Mission Area QAM, that entity QAM assumes all requirements of the higher-level QAM above it. A USGS QAM template that includes specific examples of Approved Methods (as defined above) is available.

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

M. Records Management. The creation, receiving, documenting, accessing, safeguarding, preserving, migrating, and disposing (as applicable) of Federal records relating to agency activities.

N.  Records Schedule.A document providing authority for the retention and disposition of recurring or nonrecurring Federal records that is approved by the Archivist of the National Archives and Records Administration (NARA).  A record schedule may be for one item or multiple items.

O.  Standard Operating Procedures (SOPs).  Common and repeated use of rules, conditions, guidelines, or characteristics for samples/materials or related processes and production methods, and related management systems practices.

(1)  Fundamental Standard Operating Procedures (SOPs).  Documents that describe the processes that are common across laboratories such as general procedures for laboratory support, operation, and maintenance of common-use equipment, welfare of test organisms, biosecurity, QA/QC, training, documentation, and method requirements.  Fundamental SOPs may be developed and administered at the Bureau, Mission Area, or Science Center level.

(2)  Laboratory Standard Operating Procedures (Laboratory SOPs).  Documents the processes of routine or repetitive laboratory activities performed by a scientist in a systematic manner such that another similarly trained scientist could repeat the process independently.  Laboratory SOPs are developed and administered at the laboratory level.

4.  Policy.

A.  All laboratories will implement the Core QMS Elements, provided that the elements are applicable to the work being performed, as described in section 5.  These core elements collectively constitute a comprehensive framework to ensure a controlled laboratory environment for generating data of known and documented quality. 

B. QMS documentation will be developed, reviewed, approved, and maintained at the lowest appropriate level of the Bureau.

C.  Reporting of questions or concerns about laboratory, data, or samples/materials issues, and other issues is done without fear of retaliation, as described in the No FEAR Act.

D.  Requirements related to ensuring the scientific integrity of laboratory operations and activities must be followed in accordance with the Department Manual (DM) and the Bureau’s Survey Manual (SM) scientific integrity policies (305 DM 3 and SM 500.25), including the Code of Scientific Conduct requirements. 

E.  The FSP foundation policy requirements (SM 502.1) and other applicable FSP policy requirements must be followed to ensure the scientific quality of all aspects from conducting to reporting laboratory work.

F.  The NARA and the USGS records management requirements for ensuring proper records management of USGS laboratory activities must be met (refer to SM 431.1 and USGS Records Disposition Schedules).

5.  Core QMS Elements.  The following list of 11 Core QMS Elements are critical for ensuring appropriate management of all activities related to the USGS laboratory collections, analyses, disposition and records management requirements.  Laboratories will implement the core elements to the extent that the elements are applicable to the work being performed.  Exceptions to a core element must be clearly identified in either the laboratory SOP or QAM and approved by the appropriate QA staff.

(1)  Laboratory Methods.  Analytical methods will be approved in accordance with Bureau requirements.  Unapproved methods, methods under development, or modifications to approved methods are allowable for short-term projects, custom work, research, and method implementation/modification provided that the complete process is documented in a scientific notebook, the data are qualified, and the process is supported with the same quality assurances required of approved methods. 

(2)  Laboratory Personnel Training.  All personnel training will be documented and will follow current versions of controlled documents including the laboratory methods and applicable SOPs.  Personnel are to be proficient in the activities required of the job prior to independent sample handling and (or) analysis and before reporting of results. A formal demonstration of capability is required for each approved method.

(3)  Laboratory Environment and Equipment.  The laboratory environment will be such that analyses can meet QC criteria for the applicable methods. The instruments are maintained such that calibration and performance meet QC criteria. Access to the laboratory areas, instrument data systems, laboratory records, and samples/materials is controlled commensurate with the intended use to preserve sample/materials and data integrity.

(4)  Quality Controls, Acceptance Criteria, and Qualifications.  Quality controls will be applied to sample tracking, receipt, preparation, analyses, data reporting, and any other variables affecting laboratory practices that contribute measurably to the overall accuracy and limit variability within a specified range. Each laboratory will develop and maintain acceptance criteria for all QC samples/materials, which establish the base qualification.

(5)  Performance Testing.  Laboratories will utilize ongoing internal and external performance testing, including reference materials, to the extent possible. When certified or consensus reference materials are not available, if possible, laboratories will participate in inter-laboratory comparison studies.  These activities are a means to demonstrate capability, reliability and reproducibility to assure data quality and integrity and to identify areas for improvement. 

(6)  Documentation.  Laboratory activities will be recorded in an appropriate manner for verifying processes utilized. SOPs and methods in development will be documented in a manner that will enable other qualified laboratory personnel to repeat an analysis using the identical procedure to obtain equivalent results. Analytical results will be recorded in such a way that they can be traced and reviewed through all steps of sample processing, analysis, data handling, and data storage. All laboratory operations, parameters, and settings, as defined in SOPs, will be preserved. Disposition of documentation is determined by Bureau records management requirements. These requirements are to be understood as threshold requirements; an organizational unit in the Bureau can impose more stringent requirements as deemed necessary. 

(7)  Management Oversight.  All laboratory operations and personnel will be supervised and evaluated during periodic scheduled management reviews to identify opportunities for improvement and to ensure that documented policies and procedures are being followed.

(8)  Review, Approval, and Release of Results.  Laboratory results, quality control results, and other metadata such as data qualifiers will be reviewed and verified by the laboratory.  The scope of data reviews will be specified in the QAM and (or) laboratory SOPs and shall ensure that data quality is appropriately addressed, quality controls are acceptable, and results are accurately reported.  Results meeting all acceptance criteria may be reported to data users, labeled as provisional, until all required reviews are complete and Bureau approval is granted (SM 502.8).

(9)  Laboratory Reviews.  Laboratories will be subject to periodic internal and external reviews designed to assess conformance with QMS requirements and related documentation.  Reviews must document written findings that are maintained in accordance with USGS records management requirements (threshold or higher). (Refer to Core QMS Element 10 for laboratory response to reviews.) Requirements for internal and external reviews will be developed.

(10)  Continuous Improvement, Preventive and Corrective Actions.  All laboratory personnel will participate in a continuous improvement process that utilizes a preventive and corrective action system to suggest, report, and track issues; assign responsibilities; recommend improvements in response to laboratory reviews; identify deficiencies; determine root causes; and identify corrective actions to ensure the risk of recurrence is reduced.

(11)  Document and Data Record Archive.  All laboratory data and supporting documentation will be created, stored, and preserved in a manner that maintains integrity, control, retrievability, legibility, traceability, and preservation in accordance with USGS records management requirements.

6.  Responsibilities.  All USGS employees and those working on behalf of the USGS, such as volunteers and contractors, involved in any aspect of USGS laboratory activities are responsible for upholding the requirements of this QMS policy. The following provides specific responsibilities for implementing, administering, and applying USGS laboratory QMS requirements.

A.  USGS Director and Deputy Director.  The Director has final authority and responsibility for USGS science and information activities and products. The Deputy Director is responsible for ensuring the effective implementation of the USGS laboratory QMS, and consults with the USGS Executive Leadership Team (ELT) as needed in these efforts. The Deputy Director authorizes Bureau approval of a USGS laboratory QMS and its related requirements.  The Deputy Director designates a Bureau QMS coordinator to oversee implementation.

B.  Office of Science Quality and Integrity (OSQI).  The OSQI maintains the USGS laboratory QMS policy and also provides guidance and advice regarding FSP, scientific integrity, and ethics requirements related to USGS laboratory QMS.  The OSQI Director collaborates with the Deputy Director, Associate Directors, and the other ELT members as needed to address issues or concerns regarding the execution of laboratory QMS requirements.

C.  Associate Directors (ADs) and Regional Directors (RDs). ADs are responsible for the development of Mission Area QAMs, and of related guidance and procedures.  ADs in collaboration with RDs will designate a QMS manager (and necessary team) to coordinate implementation, support, training, and guidance and to ensure compliance of the laboratory QMS.  ADs and RDs ensure all mission and regional area staff comply with the QMS requirements.

D.  Bureau QMS Coordinator.  The Bureau QMS coordinator oversees the entire USGS laboratory QMS. The Bureau QMS coordinator reports directly to the Deputy Director, provides independent oversight of quality management at the Bureau level, and chairs a committee of Mission Area QMS managers who together ensure the consistent implementation of the USGS QMS. This individual must function independently of laboratory management.  They provide final approval of Mission Area QAMs and Bureau-level Fundamental SOPs.

E. Mission Area QMS Managers.  Mission Area QMS Managers report to their respective Associate Director’s office, and serve as members on a Bureau level committee to ensure consistency in Bureau-wide laboratory QMS implementation.  They develop Bureau-level Fundamental SOPs and Mission Area QMS implementation plans; function independently of their area laboratories and management; and prepare and review Mission Area QAMs.  Mission Area QMS managers also provide training, support, and guidance to their area personnel; serve as the final approval authority on exceptions to the Core QMS Elements; and, recommend the appropriate QA staff needed.

F.  Science Center Directors. Science Center Directors ensure all laboratory work within their organizational purview is conducted and monitored in accordance with the requirements in the USGS laboratory QMS. Science Center Directors (or their designees) collaborate with their Mission Area QMS manager and the AD and RD as needed. Science Center Directors (or their designees as Center approvers) are responsible for approving laboratory SOPs and related documents originated in their organizational units.  Issues affecting the development of quality science are remediated prudently and reported to the Mission Area QMS manager and chain of command.

G.  Laboratory Managers and Supervisors.  Laboratory managers and supervisors ensure laboratory personnel receive applicable training on laboratory procedures, create or approve the creation of laboratory SOPs, respond to laboratory review findings and address recommendations for improvement, elevate any issue affecting the development of quality science, and document adherence to policy.  Only permanent USGS employees serve as laboratory managers.

H.  Quality Assurance (QA) Specialist.  QA specialists assist the Mission Area QMS managers, Science Center Directors, and others in all aspects of QMS as needed.  The QA specialist assures the quality of laboratory operations by upholding QMS procedures and policies. The QA specialist also ensures consistency in laboratory QMS implementation, reviews laboratory SOPs, and provides training, support and guidance to laboratory personnel.  QA specialists, including those serving a collateral duty, shall be independent from laboratory and science management, and shall therefore report to the QMS Manager.

I. Laboratory Personnel.  Laboratory personnel ensure the work they perform is in compliance with USGS laboratory QMS requirements and related documentation.  They report data-quality and related issues to management.   

 

/s/ Craig R. Robinson                                                March 20, 2018       
_____________________________________________________________
Craig R. Robinson                                                     Date
Director, Office of Science Quality and Integrity


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