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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: Affection Administration Arrangement for USGS Laboratories
1. Purpose and Scope.
A. The acceptability of the U.S. Geological Survey (USGS) for accurate excellence, integrity, and objectivity brings ascendancy to abstracts and findings, creates and protects abiding credibility, and ensures accessible assurance to abode important civic issues. A reliable accurate acceptability is abased on the believability and candor of advisers affianced in accurate activities that are anon angry to constant adherence to the accurate adjustment and broadly accustomed accurate practices. This Instructional Memorandum (IM) establishes a set of amount elements of a Affection Administration Arrangement (QMS) for USGS laboratories. The QMS provides a absolute framework to ensure that USGS laboratories backpack out all aspects of quality-assurance and quality-control activities. Through accomplishing of the aggregate set of the amount QMS elements declared in breadth 5, the constant USGS class abstracts will be of accepted and accurate affection that meets the Bureau’s mission and cardinal goals, upholds the Bureau’s accurate reputation, and adheres to USGS Axiological Science Practices (FSP) requirements.
B. This IM activity describes processes to ensure the reproducibility, impartiality, and believability of laboratory-generated abstracts and institutionalizes the adapted set of amount QMS elements to be acclimated beyond the Bureau. Detailed admonition not included in the IM will be provided through the Survey Manual Chapter and Mission Breadth documents. This activity does not administer to acreage abstracts fabricated in-situ and sample collection, nor non-USGS laboratories (as authentic in breadth 3.G). These will be addressed in abstracted policies. The USGS class QMS requirements do administer to:
(1) USGS laboratories as authentic in breadth 3.E.
(2) All activities that ultimately aftereffect in recorded abstracts generated aural USGS laboratories that analyze or quantify a parameter.
(3) USGS class activities including, but not bound to, appliance of a appear adjustment to accomplish abstracts for accurate investigations, aberration from a appear method, and development of a new method.
A. Ability and Credibility: The USGS is committed to a Bureau-wide class authoritative ability that continuously strives to advance the affection of abstracts and admonition provided. Efforts to advance believability crave class practices that are able-bodied documented.
B. Management: The use of authentic administration processes will aftereffect in able use of assets in affair Bureau-wide QMS requirements and admonition ensure standards and all-important apparatus to be accomplished for class activities are accustomed and in place. The USGS QMS is a bureau for any class to ensure that requirements are actuality continuously met.
C. Improvements and Efficiencies: Connected affection monitoring, evidence-based accommodation making, and documenting processes to ascertain and analyze problems aboriginal will acquiesce for quick antidotal accomplishments and abstain again mistakes. These practices aftereffect in assessable measures of advance and added efficiencies.
D. Documentation: A USGS class QMS ensures that abstracts are developed, reviewed, tracked, and retained, accepting for about-face and assay of appear after-effects in accordance with FSP requirements.
E. Competency: The QMS for USGS laboratories additionally ensures adequacy of class cadre through training, alternate affirmation of capability, and connected acquiescence with quality-assurance and quality-control plans.
A. Accustomed Methods. Accommodate the processes, procedures, and analyses that are acclimated to aftermath abstracts of accepted and accurate affection that accept been (1) accurate and appear by the USGS in accordance with FSP and Mission Breadth requirements, or (2) accurate and appear by non-USGS entities with agnate or added acrimonious requirements.
B. Controlled Documents. Abstracts that are tracked, maintained, and updated. These abstracts are formally advised and approved, they are accustomed a afterlight number, and their administration is traceable and tracked to ensure use of the actual adaptation at the breadth breadth the assigned activity is performed and to assuredly articulation a adaptation with its associated data.
C. Amount QMS Elements. Collectively, are the basal or axiological attempt that abutment the QMS, ensure a controlled affection ambiance for laboratories, and aftereffect in recorded abstracts of accepted and accurate quality.
D. Data. Observations or abstracts (unprocessed or processed) represented as text, numbers, or multimedia.
E. Laboratory. A anchored or adaptable USGS ability breadth assignment in the concrete and (or) activity sciences is conducted or a non-USGS ability breadth USGS cadre anon baby-sit or accomplish activities or analyses that ultimately aftereffect in recorded data.
F. Class Personnel. Anyone (including USGS employees, and those alive on account of the USGS such as volunteers and contractors) alive in a class who is amenable for any activity ultimately constant in recorded USGS data.
G. Non-USGS Laboratory. Any class at which assignment is conducted on account of the Bureau, by non-USGS personnel, in non-USGS facilities, which accommodate contractor, research, university, production, and added alien laboratories.
H. Achievement Testing. Assay of accepted or alien advertence samples/materials provided by an centralized or alien source, as a bureau to appraise a laboratory’s affection or functionality beneath controlled altitude about to a accustomed set of criteria.
I. Affection Assurance (QA). An chip arrangement of activities that involves planning, implementation, assessment, reporting, and advance to ensure that a process, item, or account is of the blazon and accurate affection that is adapted and expected.
J. Affection Ascendancy (QC).A activity for accepting and advancement a adapted akin of affection in a artefact or account through use of able equipment, allegory with advertence values, connected inspection, and antidotal activity as required.
K. Affection Assurance Manual (QAM). Describes the policies, procedures, requirements, authority, and affidavit of the QMS that assure analyses always accommodated a authentic accepted of affection for an organization. The QAM will specify assay and approval mechanisms for QMS-related documentation. The highest-tiered QAM will be developed at the Bureau or Mission Breadth level. When a lower-level QAM is all-important for an article beneath the Bureau or Mission Breadth to accommodate added entity-specific policies, requirements, authorities, or affidavit that are not covered in the Bureau or Mission Breadth QAM, that article QAM assumes all requirements of the higher-level QAM aloft it. A USGS QAM arrangement that includes specific examples of Accustomed Methods (as authentic above) is available.
L. Affection Administration Arrangement (QMS). A structured and accurate administration arrangement anecdotic the requirements, objectives, principles, authoritative authority, responsibilities, accountability, and accomplishing plan of an alignment for ensuring affection in its assignment processes, articles (items), and casework in laboratories.
M. Annal Management. The creation, receiving, documenting, accessing, safeguarding, preserving, migrating, and administration (as applicable) of Federal annal apropos to bureau activities.
N. Annal Schedule.A certificate accouterment ascendancy for the assimilation and disposition of alternating or nonrecurring Federal annal that is accustomed by the Archivist of the National Archives and Annal Administration (NARA). A almanac agenda may be for one account or assorted items.
O. Accepted Operating Procedures (SOPs). Common and again use of rules, conditions, guidelines, or characteristics for samples/materials or accompanying processes and assembly methods, and accompanying administration systems practices.
(1) Axiological Accepted Operating Procedures (SOPs). Documents that call the processes that are accepted beyond laboratories such as accepted procedures for class support, operation, and aliment of common-use equipment, abundance of assay organisms, biosecurity, QA/QC, training, documentation, and adjustment requirements. Axiological SOPs may be developed and administered at the Bureau, Mission Area, or Science Center level.
(2) Class Accepted Operating Procedures (Laboratory SOPs). Documents the processes of accepted or repetitive class activities performed by a scientist in a analytical abode such that addition analogously accomplished scientist could echo the activity independently. Class SOPs are developed and administered at the class level.
A. All laboratories will apparatus the Amount QMS Elements, provided that the elements are applicative to the assignment actuality performed, as declared in breadth 5. These amount elements collectively aggregate a absolute framework to ensure a controlled class ambiance for breeding abstracts of accepted and accurate quality.
B. QMS affidavit will be developed, reviewed, approved, and maintained at the everyman adapted akin of the Bureau.
C. Advertisement of questions or apropos about laboratory, data, or samples/materials issues, and added issues is done after abhorrence of retaliation, as declared in the No FEAR Act.
D. Requirements accompanying to ensuring the accurate candor of class operations and activities charge be followed in accordance with the Department Manual (DM) and the Bureau’s Survey Manual (SM) accurate candor behavior (305 DM 3 and SM 500.25), including the Code of Accurate Conduct requirements.
E. The FSP foundation activity requirements (SM 502.1) and added applicative FSP activity requirements charge be followed to ensure the accurate affection of all aspects from administering to advertisement class work.
F. The NARA and the USGS annal administration requirements for ensuring able annal administration of USGS class activities charge be met (refer to SM 431.1 and USGS Annal Disposition Schedules).
5. Amount QMS Elements. The afterward account of 11 Amount QMS Elements are analytical for ensuring adapted administration of all activities accompanying to the USGS class collections, analyses, disposition and annal administration requirements. Laboratories will apparatus the amount elements to the admeasurement that the elements are applicative to the assignment actuality performed. Exceptions to a amount aspect charge be acutely articular in either the class SOP or QAM and accustomed by the adapted QA staff.
(1) Class Methods. Analytical methods will be accustomed in accordance with Bureau requirements. Unapproved methods, methods beneath development, or modifications to accustomed methods are adequate for concise projects, custom work, research, and adjustment implementation/modification provided that the complete activity is accurate in a accurate notebook, the abstracts are qualified, and the activity is accurate with the aforementioned affection assurances adapted of accustomed methods.
(2) Class Cadre Training. All cadre training will be accurate and will chase accepted versions of controlled abstracts including the class methods and applicative SOPs. Cadre are to be accomplished in the activities adapted of the job above-mentioned to absolute sample administration and (or) assay and afore advertisement of results. A academic affirmation of adequacy is adapted for anniversary accustomed method.
(3) Class Ambiance and Equipment. The class ambiance will be such that analyses can accommodated QC belief for the applicative methods. The instruments are maintained such that arrangement and achievement accommodated QC criteria. Access to the class areas, apparatus abstracts systems, class records, and samples/materials is controlled adequate with the advised use to bottle sample/materials and abstracts integrity.
(4) Affection Controls, Accepting Criteria, and Qualifications. Affection controls will be activated to sample tracking, receipt, preparation, analyses, abstracts reporting, and any added variables affecting class practices that accord measurably to the all-embracing accurateness and absolute airheadedness aural a authentic range. Anniversary class will advance and advance accepting belief for all QC samples/materials, which authorize the abject qualification.
(5) Achievement Testing. Laboratories will advance advancing centralized and alien achievement testing, including advertence materials, to the admeasurement possible. When certified or accord advertence abstracts are not available, if possible, laboratories will participate in inter-laboratory allegory studies. These activities are a bureau to authenticate capability, believability and reproducibility to assure abstracts affection and candor and to analyze areas for improvement.
(6) Documentation. Class activities will be recorded in an adapted abode for accepting processes utilized. SOPs and methods in development will be accurate in a abode that will accredit added able class cadre to echo an assay application the identical activity to access agnate results. Analytical after-effects will be recorded in such a way that they can be traced and advised through all accomplish of sample processing, analysis, abstracts handling, and abstracts storage. All class operations, parameters, and settings, as authentic in SOPs, will be preserved. Disposition of affidavit is bent by Bureau annal administration requirements. These requirements are to be accepted as beginning requirements; an authoritative assemblage in the Bureau can appoint added acrimonious requirements as accounted necessary.
(7) Administration Oversight. All class operations and cadre will be supervised and evaluated during alternate appointed administration reviews to analyze opportunities for advance and to ensure that accurate behavior and procedures are actuality followed.
(8) Review, Approval, and Release of Results. Class results, affection ascendancy results, and added metadata such as abstracts qualifiers will be advised and absolute by the laboratory. The ambit of abstracts reviews will be authentic in the QAM and (or) class SOPs and shall ensure that abstracts affection is appropriately addressed, affection controls are acceptable, and after-effects are accurately reported. After-effects affair all accepting belief may be appear to abstracts users, labeled as provisional, until all adapted reviews are complete and Bureau approval is accepted (SM 502.8).
(9) Class Reviews. Laboratories will be accountable to alternate centralized and alien reviews advised to appraise acclimation with QMS requirements and accompanying documentation. Reviews charge certificate accounting allegation that are maintained in accordance with USGS annal administration requirements (threshold or higher). (Refer to Amount QMS Aspect 10 for class acknowledgment to reviews.) Requirements for centralized and alien reviews will be developed.
(10) Connected Improvement, Antitoxin and Antidotal Actions. All class cadre will participate in a connected advance activity that utilizes a antitoxin and antidotal activity arrangement to suggest, report, and clue issues; accredit responsibilities; acclaim improvements in acknowledgment to class reviews; analyze deficiencies; actuate basis causes; and analyze antidotal accomplishments to ensure the accident of ceremony is reduced.
(11) Certificate and Abstracts Almanac Archive. All class abstracts and acknowledging affidavit will be created, stored, and preserved in a abode that maintains integrity, control, retrievability, legibility, traceability, and canning in accordance with USGS annal administration requirements.
6. Responsibilities. All USGS advisers and those alive on account of the USGS, such as volunteers and contractors, complex in any aspect of USGS class activities are amenable for advancement the requirements of this QMS policy. The afterward provides specific responsibilities for implementing, administering, and applying USGS class QMS requirements.
A. USGS Director and Deputy Director. The Director has final ascendancy and albatross for USGS science and admonition activities and products. The Deputy Director is amenable for ensuring the able accomplishing of the USGS class QMS, and consults with the USGS Executive Leadership Aggregation (ELT) as bare in these efforts. The Deputy Director authorizes Bureau approval of a USGS class QMS and its accompanying requirements. The Deputy Director designates a Bureau QMS coordinator to baby-sit implementation.
B. Appointment of Science Affection and Candor (OSQI). The OSQI maintains the USGS class QMS activity and additionally provides admonition and admonition apropos FSP, accurate integrity, and belief requirements accompanying to USGS class QMS. The OSQI Director collaborates with the Deputy Director, Associate Directors, and the added ELT associates as bare to abode issues or apropos apropos the beheading of class QMS requirements.
C. Associate Directors (ADs) and Bounded Directors (RDs). ADs are amenable for the development of Mission Breadth QAMs, and of accompanying admonition and procedures. ADs in accord with RDs will baptize a QMS administrator (and all-important team) to alike implementation, support, training, and admonition and to ensure acquiescence of the class QMS. ADs and RDs ensure all mission and bounded breadth agents accede with the QMS requirements.
D. Bureau QMS Coordinator. The Bureau QMS coordinator oversees the absolute USGS class QMS. The Bureau QMS coordinator letters anon to the Deputy Director, provides absolute blank of affection administration at the Bureau level, and chairs a board of Mission Breadth QMS managers who calm ensure the constant accomplishing of the USGS QMS. This alone charge action apart of class management. They accommodate final approval of Mission Breadth QAMs and Bureau-level Axiological SOPs.
E. Mission Breadth QMS Managers. Mission Breadth QMS Managers abode to their corresponding Associate Director’s office, and serve as associates on a Bureau akin board to ensure bendability in Bureau-wide class QMS implementation. They advance Bureau-level Axiological SOPs and Mission Breadth QMS accomplishing plans; action apart of their breadth laboratories and management; and adapt and assay Mission Breadth QAMs. Mission Breadth QMS managers additionally accommodate training, support, and admonition to their breadth personnel; serve as the final approval ascendancy on exceptions to the Amount QMS Elements; and, acclaim the adapted QA agents needed.
F. Science Center Directors. Science Center Directors ensure all class assignment aural their authoritative ambit is conducted and monitored in accordance with the requirements in the USGS class QMS. Science Center Directors (or their designees) coact with their Mission Breadth QMS administrator and the AD and RD as needed. Science Center Directors (or their designees as Center approvers) are amenable for acknowledging class SOPs and accompanying abstracts originated in their authoritative units. Issues affecting the development of affection science are remediated carefully and appear to the Mission Breadth QMS administrator and alternation of command.
G. Class Managers and Supervisors. Laboratory managers and admiral ensure class cadre accept applicative training on class procedures, actualize or accept the conception of class SOPs, acknowledge to class assay allegation and abode recommendations for improvement, drag any affair affecting the development of affection science, and certificate adherence to policy. Only abiding USGS advisers serve as class managers.
H. Affection Assurance (QA) Specialist. QA specialists abetment the Mission Breadth QMS managers, Science Center Directors, and others in all aspects of QMS as needed. The QA specialist assures the affection of class operations by advancement QMS procedures and policies. The QA specialist additionally ensures bendability in class QMS implementation, reviews class SOPs, and provides training, abutment and admonition to class personnel. QA specialists, including those confined a accessory duty, shall be absolute from class and science management, and shall accordingly abode to the QMS Manager.
I. Class Personnel. Class cadre ensure the assignment they accomplish is in acquiescence with USGS class QMS requirements and accompanying documentation. They abode data-quality and accompanying issues to management.
/s/ Craig R. Robinson March 20, 2018 _____________________________________________________________ Craig R. Robinson Date Director, Appointment of Science Affection and Integrity
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