Form 403A.2
Assessment Checklist
Module 2 – General Requirements
LABPR 403A - DoD ELAP
DoD Environmental Laboratory Accreditation Program
Laboratory Information
Company Name
Laboratory Location(s)
Completed By / Date
Assessor Information
Assessor Name(s)
Assessment Type
Date of Assessment

This checklist is to be used as part of the LABPR 403A DoD ELAP. This checklist includes the
requirements of:
o ISO/IEC 17025:2005 - General Requirements for the Competence of Testing and
Calibration Labs;
o DoD Quality Systems Manual (QSM) for Environmental Laboratories, V5.0 July
2013, Module 2: Quality Systems – General Requirements;
o TNI Standard Volume 1 – Management and Technical Requirements for Laboratories
Performing Environmental Analysis, Sept 2009 (EL-V1-2009), Module 2 – Quality
Systems - General Requirements.

The requirements identified within this checklist are summarized from the referenced standards.

Highlighted yellow elements are differences from the QSM V4.2 based on information provided
to L-A-B from the DoD EDWQ.
Form 403A.2 – Rev 1 – 04/15/2014
Page 1 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4
4.1
4.1.1
REQUIREMENT
4.1.5 j) i
Management Requirements
Organization
Entity is legally identifiable?
Does entity conduct activities to be compliant with 17025, the needs of the client,
regulators, or recognition bodies?
Does the management system cover all work, including permanent location, and onsite, mobile or temporary facility?
Is the organization structure defined in order to identify potential conflicts of interest?
The lab will:
Provide personnel with the authority and resources to carry out their duties. Including
the implementation, maintenance and improvement of the management system.
Have provisions to assure that staff is free from undue internal and external pressures.
Protect the client’s confidential information and proprietary rights.
Avoid involvement in activities that diminish confidence in competence, impartiality,
judgment or operational integrity.
Define the organization and management structure.
Specify the responsibility, authority and interrelationships of all personnel affecting
quality of work.
Provide adequate supervision.
Have a technical manager.
Have a quality manager (however named) who is responsible for the quality system.
Appoint deputies for key managerial personnel.
(DoD) At a minimum, the following lab management staff (however named) are
considered key managerial personnel:
(DoD) Management (e.g., President, Chief Executive Officer, Chief Operating Officer,
Lab Director);
4.1.5 j) ii
(DoD) Technical managers (e.g., Technical Director, Section Supervisors);
4.1.5 j) iii
(DoD) Quality managers;
4.1.2
4.1.3
4.1.4
4.1.5
4.1.5 a)
4.1.5 b)
4.1.5 c)
4.1.5 d)
4.1.5 e)
4.1.5 f)
4.1.5 g)
4.1.5 h)
4.1.5 i)
4.1.5 j)
4.1.5 j)
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 2 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.1.5 j) iv
4.1.5 j) v
4.1.5 k)
4.1.6
4.1.7
4.1.7.1
4.1.7.1 a)
4.1.7.1 b)
4.1.7.1 c)
4.1.7.1 d)
4.1.7.1 e)
4.1.7.1 f)
4.1.7.1 g)
4.1.7.1 h)
4.1.7.1 i)
4.1.7.2
4.1.7.2 a)
4.1.7.2 b)
4.1.7.2 c)
4.1.7.2 c) i.
4.1.7.2 c) ii.
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) Support systems and admin. managers (e.g., LIMS manager, purchasing
manager, project managers);
(DoD) Customer services managers.
Ensure that personnel are aware of the importance of their activities.
Top management ensures that communication processes regarding the effectiveness of
the management system are established.
(TNI) Additional Requirements for Labs
(TNI) The lab’s Quality Manager and/or designee(s) are:
(TNI) be the focal point for QA/QC and oversee and/or review QC data
(TNI) have functions independent from lab operations for which they have QA
oversight
(TNI) evaluate data objectively and assess without outside influence
(TNI) have documented training and/or experience in QA/QC procedures and the lab’s
quality system
(TNI) have general knowledge of analytical methods for which data review is
performed
(TNI) arrange for or conduct internal audits annually
(TNI) notify lab management of deficiencies in the quality system
(TNI) monitor corrective actions
(DOD) implement, maintain, and improve the management system by using available
tools such as audit and surveillance results, control charts, proficiency testing results,
data analysis, corrective and preventive actions, customer feedback, and management
reviews in efforts to monitor trends.
(TNI) The lab’s technical manager(s) and/or his/her designee are:
(TNI) be a member of the staff of the lab who exercised day-to-day supervision of the
lab operations for appropriate fields of accreditation and reporting of results
(TNI) be experienced in the fields of accreditation
(TNI) have duties that include:
(TNI) monitoring standards of performance in QC and QA
(TNI) monitoring the validity of the analysis performed and data generated in the lab
assuring it is reliable data.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 3 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
REQUIREMENT
4.2.3 a)
(TNI) the Technical Manager(s) is not to have the responsibility and authority of that
position for more than one accredited lab under the state program with the written
consent of the AB.
(TNI) if absent for a period exceeding 15 consecutive calendar days the TM will
designate another full-time staff meeting the same qualifications as the TM. For 35
consecutive calendar days, the lab will notify L-A-B and the primary State authority (if
applicable)
(TNI) Meet qualification requirements in Section 5.2.6.1
Management
The lab will establish, implement and maintain a quality system appropriate to its
scope of activity.
(DoD) Copies of all management system documentation provided to L-A-B are in
English.
The lab’s quality system policies are defined in a quality manual (however named).
The overall objectives are established and reviewed during management review. A
quality policy statement is issued under the authority of the chief executive and
include:
Management’s commitment to good professional practice and quality of its tests and
calibrations.
Lab’s standard of service.
The purpose of the management system related to quality.
Requirement that personnel familiarize themselves with the quality documentation and
implement the policies and procedures in their work.
Management’s commitment to compliance with 17025 and continually improving the
effectiveness of the management system.
Top management provide evidence of commitment toward continually improving the
effectiveness of the management system
(DoD) Defining the minimum qualifications, experience, and skills necessary for all
positions in the lab;
4.2.3 b)
(DoD) Ensuring that all lab technical staff have demonstrated capability in the
activities for which they are responsible. Such demonstration is recorded;
4.2.3 c)
(DoD) Management is responsible for:
4.1.7.2 d)
4.1.7.2 e)
4.1.7.2 f)
4.2
4.2.1
4.2.1
4.2.2
4.2.2
4.2.2 a)
4.2.2 b)
4.2.2 c)
4.2.2 d)
4.2.2 e)
4.2.3
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 4 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.2.3 c) i)
4.2.3 c) ii)
4.2.3 c) iii)
REQUIREMENT
4.2.3 c) iii) b.
(DoD) At least four consecutive lab control samples with acceptable levels of precision
and bias. The lab determines the acceptable levels of precision and bias prior to
analysis;
(DoD) Recording all analytical and operational activities of the lab;
4.2.3 e)
(DoD) Ensuring adequate supervision of all personnel employed by the lab;
4.2.3 f)
(DoD) Ensuring that all sample acceptance criteria are verified and that samples are
logged into the sample tracking system and properly labeled and stored; and
4.2.5
4.2.6
4.2.7
4.2.8.1
4.2.8.1
ASSESSMENT
NOTES
(DoD) If the above cannot be performed, analysis of authentic samples with results
statistically indistinguishable from those obtained by another trained analyst.
4.2.3 d)
4.2.4
N
(DoD) Training courses or workshops on specific equip. recorded
(DoD) Review of analyst work by relevant technical managers on an on-going basis is
recorded or another annual Demonstration of Capability is performed by one of the
following:
(DoD) Acceptable performance of a blind sample (single or double blind to the
analyst);
4.2.3 g)
C
(DoD) Each employee training file contains a cert. that the employee has read,
understands and is using the latest version of the management system;
4.2.3 c) iii) a.
4.2.3 c), iii) c.
LAB
DOCUMENT
REFERENCE
(DoD) Recording the quality of all data reported by the lab.
Top management communicate the importance of meeting customer, statutory and
regulatory requirements
The quality manual includes or makes reference to supporting procedures, and outlines
the structure of the documentation used.
The quality manual defines the roles and responsibilities of the technical and quality
managers for ensuring compliance with 17025.
The integrity of the management system are maintained by top management when
changes are made.
(TNI) Lab has an established and maintained documented data integrity system
(TNI) 1) data integrity training (see 5.2.7)
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 5 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.2.8.1
4.2.8.1
REQUIREMENT
4.2.8.1 c) i)
(TNI) 2) signed data integrity documentation for all lab employees
(TNI) 3) in depth, periodic monitoring of data integrity
(TNI) 4) data integrity procedure documentation. signed and dated by top management
(see 4.16) Reviewed annually by Management
(TNI) Lab Management provide a procedure for confidential reporting of data integrity
including assurance for confidentiality and receptive to private discussion of ethical
issues including reporting items of ethical concern
(TNI) If ethical concerns exist, the procedure includes a process whereby lab
management is to be informed of the need for further investigation.
(DoD) The lab has a documented program to detect and deter improper or unethical
actions. Data is produced according to the project-specific requirements as specified in
the final, approved project-planning documents, such as the approved Quality
Assurance Project Plan (QAPP), when these documents are provided to the lab.
Following are the minimum elements of an acceptable program for detecting and
deterring improper or unethical actions:
(DoD) An ethics policy is read and signed by all personnel;
4.2.8.1 c) ii)
(DOD) Initial and annual ethics training is conducted as described in Section 5.2.7;
4.2.8.1 c) iii)
(DoD) Analysts record an explanation and sign off on all manual changes to data; and
4.2.8.1 c) iv)
(DoD) Where available in the instrument software, all electronic tracking and audit
functions are enabled.
4.2.8.1
4.2.8.1 a)
4.2.8.1 b)
4.2.8 c)
4.2.8.2
4.2.8.2
4.2.8.3
4.2.8.3 a)
4.2.8.3 b)
4.2.8.3 c)
4.2.8.3 d)
4.2.8.3 e)
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(TNI) The Quality Manager is responsible for maintaining the Quality Manual
(DoD) The quality manager reviews (or oversee the review of) the quality manual at
least annually, and update it if needed.
(TNI) The Quality Manual contains:
(TNI) document title
(TNI) lab’s full name and address
(TNI) name address (if different from above), telephone number, of individuals
responsible for the lab
(TNI) ID of all major organizational units covered in the quality manual and effective
date of the version
(TNI) ID of the labs approved signatories
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 6 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.2.8.3 f)
4.2.8.3 g)
4.2.8.3 h)
4.2.8.3 i)
4.2.8.4
4.8.2.4 a)
4.2.8.4 b)
4.2.8.4 c)
4.2.8.4 d)
4.2.8.4 e)
4.2.8.4 f)
4.2.8.4 g)
4.2.8.4 h)
4.2.8.4 i)
4.2.8.4 j)
4.2.8.4 k)
4.2.8.4 l)
4.2.8.4 m)
4.2.8.4 n)
4.2.8.4 o)
4.2.8.4 p)
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(TNI) signed and dated concurrence including: quality manager(s), technical
manager(s), and person in charge of the lab activities, such as lab director and lab
manager
(TNI) the objectives of the quality system and reference to the lab’s policies and
procedures
(TNI) the labs official quality policy statement including objectives and commitment
to ethical lab practices and the requirements of the standard
(TNI) table of contents, and lists of references, glossaries and appendices
(TNI) The quality manual contains or reference:
(TNI) all maintenance, calibration and verification procedures
(TNI ) major equip., reference standards, facilities and services used by the lab
(TNI) verification practices including ILCs, PT programs, using reference materials
and internal QC schemes
(TNI) procedures for reporting analytical results
(TNI) the organizational and managerial structure of the lab, how it fits with the parent
organization (if any) relevant org charts
(TNI) procedures to ensure all records required for the standard are retained including
by not limited to SOPs, manuals, documents, clearly indicate the time period they are
in force
(TNI) job descriptions of key staff and reference to job descriptions of other lab staff
(TNI) procedures for achieving traceability of measurements
(TNI) a list of all methods under the lab scope for accredited testing
(TNI) procedure for ensuring the lab reviews all new work to ensure it has resources
before commencing
(TNI) procedure for handing samples
(TNI) procedure for feedback and CA when test discrepancies are found, and/or
departures from policies and procedures
(TNI) policy for permitting departures from policies and procedures or from standard
specs
(TNI) procedures for dealing with complaints
(TNI) procedures for protecting confidentiality (including national security) and
proprietary rights
(TNI) procedures for audits and data review
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 7 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
REQUIREMENT
4.2.8.4 p)
4.2.8.4 p i)
(DoD) The procedures for audits and data reviews specify which records are included
in the review.
(DoD) Internal data reviews consist of a tiered or sequential system of verification,
consisting of at least three tiers, 100% review by the analyst, 100% verification review
by a technically qualified supervisor or data review specialist, and a final admin.
review.
(DoD) The analyst and verification review includes at least the following procedures:
(DoD) Determination of whether the results meet the lab specific QC;
4.2.8.4 p ii)
(DoD) Checks to determine consistency with project specific criteria;
4.2.8.4 p iii)
(DoD) Checks to ensure that the appropriate sample preparatory and analytical SOPs
and methods were followed, and that chain of custody and HT requirements were met;
4.2.8.4 p iv)
(DoD) Checks to ensure that all calibration and quality control requirements were met;
4.2.8.4 p)
4.2.8.4 p)
4.2.8.4 p v)
4.2.8.4 p)
4.2.8.4 p)
4.2.8.4 p)
4.2.8.4 q)
4.2.8.4 r)
4.2.8.4 s)
4.2.8.4 t)
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) Checks for complete and accurate explanations of anomalous results,
corrections
(DoD) The final admin. review verifies that previous reviews were recorded properly
and that the data package is complete.
(DoD) In addition, the quality manager or designee reviews a minimum of 10% of all
data packages for technical completeness and accuracy. This review is considered a
part of overall data review and does not need to be completed before the data package
is issued to the customer.
(DoD) If electronic audit trail functions are available, they are in use at all times, and
associated data is accessible. If the instrument does not have an audit trail, the lab has
procedures to record the integrity of the data.
(TNI) procedures for establishing that personnel are adequately experienced and
receive training
(TNI) policy addressing the use of unique electronic signatures (where applicable)
(DoD) procedures for procurement of standards;
(DoD) procedures for data management including validation, verification, and purging
of electronic data and data systems;
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 8 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.2.8.4 u)
4.2.8.4 v)
4.2.8.4 w)
4.2.8.4 x)
4.2.8.4 x)
4.2.8.4 y)
4.2.8.5
4.2.8.5 a)
4.2.8.5 b)
4.2.8.4 c)
4.2.8.5 d)
4.2.8.5 e)
4.2.8.5 f)
4.2.8.5 f) i.
4.2.8.5 f) ii.
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) procedures for manual entry of raw data from analytical measurements that are
not interfaced to LIMS and the verification and records of the accuracy of manually
entered data;
(DoD) procedures for making changes to electronic data (including establishing the
requirements for a hardcopy or electronic log to record all changes to electronic data
that affect data quality);
(DoD) procedures for how electronic data are processed, maintained, and reported;
(DoD) procedures for ensuring that data review includes all quality-related steps in the
analytical process, including sample preparation, dilution calculations, chromatography
evaluation, and spectral interpretations.
(DoD) The SOP requires that records of data review be maintained and available for
external review;
(DoD) A list of all current cert.s and accreditations that the lab holds and the scope of
cert. or accreditation (with expiration date) for each;
(TNI) The lab maintains SOPs that accurately reflect all phases of the labs activities
(data integrity, CA, complaints, and methods)
(TNI) may be equip. manuals or internally written docs with adequate detail to allow
the procedures to be reproduced
(TNI) SOPs are readily accessible to all
(TNI) SOPs clearly indicate the effective date of the document, the rev number and
signature of authority
(TNI) Documents that contain sufficient info to perform tests do not need to be
rewritten. If changed it will be documented what changed, including the use of a
selected option
(TNI) the lab maintains an SOP for each analyte and/or method on the scope of
accreditation
(TNI) The SOP is a copy of a published method or referenced method or is written by
the lab. In the case where modification to published methods have been made or where
the reference method is too ambiguous the changes or clarifications are clearly
described and where applicable the method includes:
(TNI) ID of the method
(TNI) applicable matrix and matrices
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 9 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.2.8.5 f) iii.
4.2.8.5 f) iv.
4.2.8.5 f) v.
4.2.8.5 f) vi.
4.2.8.5 f) vii.
4.2.8.5 f) viii
4.2.8.5 f) ix.
4.2.8.5 f) x.
4.2.8.5 f) xi.
4.2.8.5 f) xii.
4.2.8.5 f) xiii
4.2.8.5 f) xiv.
4.2.8.5 f) xv.
4.2.8.5 f) xvi.
4.2.8.5 f) xvii
4.2.8.5 f)
xviii.
4.2.8.5 f) xix.
4.2.8.5 f) xx.
4.2.8.5 f) xxi.
4.2.8.5 f) xxii.
4.2.8.5 f)
xxiii.
4.2.8.5 xxiv)
4.2.8.5 xxv)
4.2.8.5 xxvi)
4.2.8.5 g)
4.3
4.3.1
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(TNI) limits of detection and quantitation
(TNI) scope and application, including parameters to be analyzed
(TNI) summary of the method
(TNI) definitions
(TNI) interferences
(TNI) safety
(TNI) equip. and supplies
(TNI) reagents and standard
(TNI) sample collection, preservation, shipment and storage
(TNI) quality control
(TNI) calibration and standardization
(TNI) procedure
(TNI) data analysis and calculations
(TNI) method performance
(TNI) pollution prevention
(TNI) data assessment and acceptance criteria for QC measures
(TNI) corrective actions and out-of-control data
(TNI) contingencies for handling out-of-control or unacceptable data
(TNI) waste management
(TNI) references
(TNI) any tables, diagrams, flowcharts and validation data
(DoD) equip./instrument maintenance;
(DoD) computer hardware and software; and
(DoD) troubleshooting.
(DoD) All technical SOPs (e.g., sample preparation, analytical procedures, sample
storage, or sample receipt) are reviewed for accuracy and adequacy at least annually,
and updated if necessary. All such reviews are conducted by personnel having the
pertinent background, recorded, and made available for assessment.
Document Control
General
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 10 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.3.2
4.3.2.1
4.3.2.1
4.3.2.2
4.3.2.2 a)
4.3.2.2 b)
4.3.2.2 c)
4.3.2.2 d)
4.3.2.2 e)
4.3.2.2 f)
4.3.2.2 g)
4.3.2.3
4.3.3
4.3.3.1
4.3.3.2
4.3.3.3
4.3.3.4
4.4
4.4.1
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Have procedures to control all documents that form part of its quality system, both
internal and external documents.
Document Approval & Issue
Documents issued as part of the quality system are reviewed and approved by
authorized personnel.
Have a master list or equivalent identifying the current revision and distribution of
documents.
The procedure ensures:
Authorized editions of documents are available, where necessary, for the effective
functioning of the lab.
Documents are periodically reviewed and revised as necessary to ensure continued
suitability.
Invalid and obsolete documents are promptly removed from service, or assured against
unintended use.
Obsolete documents retained are suitably marked.
(DoD) Affected personnel are notified of changes to management systems documents
and supporting procedures, including technical documents;
(DoD) Reviews (internal or external) of management system documentation is
maintained and made available for assessment;
(DoD) Any documents providing instructions to lab personnel (e.g., operator aids) are
considered part of the management system and are subject to document control
procedures.
Quality system documents generated are uniquely identified.
Document Changes
Changes are reviewed and approved by the same function. The designated person has
access to background information.
Altered or new text is identified, where practical.
Hand amendments are clearly marked, initialed and dated. The new document is
issued ASAP.
Computerized maintenance for documents are established in a procedure.
Review of Requests, Tenders and Contracts
Procedures for review of requests, tenders & contracts.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 11 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.4.1
4.4.1
4.4.1 a)
4.4.1 b)
4.4.1 c)
4.4.2
4.4.3
4.4.4
4.4.5
4.5
4.5.1
4.5.2
4.5.3
4.5.4
4.5.5
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Any differences between the request or tender and the contract are resolved before any
work is commenced. The contract is acceptable to the lab and the customer.
Policies and procedures for review ensure:
Requirements are adequately defined, documented and understood.
Lab has the capability and resources.
Appropriate method is selected and can meet the client’s requirements.
Records of reviews are maintained. Records of pertinent discussions with clients
should be maintained.
Review includes subcontracted work.
Client informed of deviation from contract.
Contracts amended after work starts have the same review as the original.
Subcontracting of Tests & Calibrations
Subcontracted work is placed with a competent subcontractor.
Client is advised in writing of the intention to subcontract, and where necessary gain
client approval.
Lab is responsible for the subcontractor’s work, except where the client specifies the
subcontractor.
An approved subcontractor list, and evidence of compliance with 17025 exist for all
subcontractors.
(TNI) Subcontracted work is placed with an accredited lab to this national standard or
a lab that meets the applicable statutory and regulatory requirements for performing the
tests ... the name of the lab is indicated in the final report. a copy of the
subcontractor’s report will be made available to the client upon request.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 12 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.5.6
4.5.7
4.5.8
4.5.9
4.5.10
4.6
4.6.1
4.6.1
4.6.1
4.6.1 a)
4.6.1 b)
4.6.1 c)
4.6.1 d)
4.6.1 e)
4.6.1 f)
4.6.2
4.6.3
4.6.4
4.7
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) The lab ensures and documents that subcontracted (sub-tier) labs meet the
requirements of this standard.
(DoD) Subcontracted labs performing analytical services in support of Environmental
Restoration projects are accredited in accordance with the DoD ELAP.
(DoD) Subcontracted labs receive project-specific approval from the DoD customer
before any samples are analyzed
(DoD) The requirements for subcontracting labs also apply to the use of any lab under
the same corporate umbrella, but at a different facility or location.
(DoD) All subcontracted or outsourced management systems elements (such as data
review) or outsourced personnel comply with the lab’s overall management system,
comply with the requirements of this standard, and are subject to review/approval by
the customer.
Purchasing Services and Supplies
Have policies and procedures for purchase of services and supplies.
Have policies and procedures for purchase, reception and storage of reagents and lab
consumable materials.
(DoD) Records for services and supplies that may affect the quality of environmental
tests include the following, where applicable:
(DoD) Date of receipt;
(DoD) Expiration date;
(DoD) Source;
(DoD) Lot or serial number;
(DoD) Calibration and verification records; and
(DoD) Accreditation or cert. scopes/certificates.
Purchased supplies and reagents and consumables are inspected or otherwise verified
prior to use. Records of such actions are recorded.
Purchasing documents contain data describing the services and supplies ordered and be
reviewed and approved for technical content prior to release.
Suppliers of critical consumables, supplies and services are evaluated, and records of
the evaluations and a list of those approved maintained.
Services to the Client
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 13 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.7.1
4.7.2
4.8
4.9
4.9.1
4.9.1
4.9.1 a)
4.9.1 b)
4.9.1 c)
4.9.1 d)
4.9.1 e)
4.9.2
4.9.3
4.9.3
4.9.3
4.10
4.11
4.11.1
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Afford clients cooperation to clarify request and monitor performance in relation to the
work performed by the lab, provided confidentiality of other clients is maintained.
The lab seeks positive and negative feedback from its clients for improvement of the
management system, lab activities and customer service.
Complaints
Policies and procedures exist for handling complaints.
Records of complaints and their investigations and corrective actions are maintained.
Control of Nonconforming Work
Policies and procedures implemented when work or the results of work do not conform
to its own procedures or the requirements of the client.
The policies and procedures ensure:
Responsibility and authority for handling of nonconforming work are designated, and
actions are defined and taken when nonconforming work is identified.
Evaluation of the significance of the nonconf.
Corrective action is taken immediately, together with any decision about the
acceptability of the nonconforming work.
Where necessary, the client is notified and work recalled
Responsibility for authorizing the resumption of work is defined.
If nonconf. can recur, or doubt about compliance of the lab’s operations with its own
policies and procedures exists, corrective action IAW 4.11 are followed.
(DoD) The lab upon discovery, notifies all affected customers of potential data quality
issues resulting from nonconforming work. Notification is performed according to a
written procedure.
(DoD) Notification is performed according to a written procedure.
(DoD) Records of corrections taken to resolve the nonconf. are submitted to the
customer(s) in a timely and responsive manner.
Improvement
The lab uses the quality policy and objectives, audit results, data analysis, corrective
and preventive actions and management review to improve its management system
Corrective Action
General
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 14 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
REQUIREMENT
4.11.8
Establish policy and procedure and designate authorities for implementing corrective
action.
Cause Analysis (CA)
Investigate to determine root cause.
Selection and Implementation of Corrective Action
Identify, select and implement appropriate corrective action that is likely to prevent
recurrence.
CA is appropriate to the magnitude and risk of the problem.
Document and implement changes resulting from CA.
Monitoring of CA
Monitor CA to ensure that it is effective.
Additional Audits
Where nonconf.’s or departures cast doubts on compliance with policies, procedures,
or 17025, the area of activity is audited per 4.14 ASAP.
(TNI) the lab has documented procedure(s) to address 4.11.1 and 4.11.3 through 4.11.5
... the procedures include:
(TNI) which individual(s) are responsible for assessing each QC data type
(TNI) which individual(s) or positions are responsible for initiating and/or recomm.
CA
(TNI) cause analysis described in section 4.11.2 apply to failures that indicate a
systematic error (see PR 414)
(DoD) The lab has and uses a record system for tracking corrective actions to
completion and for analyzing trends to prevent the recurrence of the nonconf.
(DoD) Approved corrective actions developed to address findings during L-A-B
assessments are implemented.
4.11.8
(DoD) Any changes to approved corrective action plans are approved by L-A-B, as
appropriate.
4.11.2
4.11.3
4.11.4
4.11.5
4.11.6
4.11.6 a)
4.11.6 b)
4.11.7
4.11.8
4.12
4.12.1
4.12.1
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Preventive Action
Improvements and potential nonconf.s are identified.
When opportunities for improvement are identified or action is required, plans are
developed, implemented and monitored to reduce the likelihood of occurrence.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 15 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.12.1
4.12.2
4.13
4.13.1
4.13.1.1
4.13.1.2
4.13.1.2
4.13.1.3
4.13.1.4
4.13.2
4.13.2.1
4.13.2.2
4.13.2.3
4.13.3 a)
4.13.3 b)
4.13.3 c)
4.13.3 d)
4.13.3 e)
4.13.3 f)
4.13.3 f) i.
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) Records of preventive actions are maintained for review.
Procedures include initiation of actions and controls to ensure they are effective.
Control of Records
General
Establish and maintain procedures for handling of quality and technical records.
Records are legible and stored to be readily retrievable in suitable environments to
prevent damage, deterioration or loss.
Retention times established.
Records held secure and in confidence.
Procedures to protect and back-up electronic records and prevent unauthorized access.
Technical Records
Retain sufficient records to establish an audit trail of work for a defined period.
Observations, data and calculations are recorded at the time they are made and be
identifiable to the specific task.
Mistakes are single-line crossed out, correct entry made, and signed or initialed by
person making correction. Electronic records are handled to prevent loss of original
data.
(TNI) The lab has established a record keeping system allowing the history of the
sample and associated data to the readily understood through the documentation. The
system produces unequivocal, accurate records that document all the lab activities such
as sample receipt, sample prep, or data verification and inter-lab transfers of samples
and/or extracts.
(TNI) Records are retained for a minimum of 5 years from the generation of the last
entry in the record
(TNI) Records are available to the L-A-B and the State Authority
(TNI) Records that are stored only electronically are supported by the proper hardware
and software to assure retrieval
(TNI) access to the archives are documented with an access log
(TNI) information necessary for the historical reconstruction of data is maintained by
the lab
(TNI) raw data, whether hard copy or electronic, for calibrations, samples and quality
control measures, including worksheets and data output records (chromatograms, strip
charts, and other response readout records)
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 16 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.13.3 f) ii.
4.13.3 f) iii.
4.13.3 f) iv.
4.13.3 f) v.
4.13.3 f) vi.
4.13.3 f)vii.
4.13.3 f) viii.
4.13.3 f) ix.
4.13.3 f) x.
4.13.3 f) xi.
4.13.3 f) xii.
4.13.3 f) xiii.
4.13.3 f) xiv.
4.13.3 f)xv.
4.13.3 f)xvi.
4.13.3 f). xvii.
4.13.3 f) xviii.
4.13.3 f)xix.
4.13.3 g)
4.13.3 g)i.
4.13.3 g) ii.
4.13.3 g) iii.
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(TNI) a written description or reference to the specific methods used, including a
description of the specific computational steps used to translate parametric
observations into a reportable analytical value
(TNI) lab sample ID code
(TNI) date of analysis
(TNI) time of analysis is required if the holding time is 72 hrs or less or when time
critical steps are included in the analysis (extractions and incubations)
(TNI) instrumentation ID and operating conditions/parameters (or reference to such
data)
(TNI) manual calculations
(TNI) analyst’s signature/initials or electronic ID
(TNI) sample prep, including cleanup, separation protocols, incubation periods or
subculture, ID codes, volumes, weights, instrument printouts, meter readings,
calculations, reagents
(TNI) test results
(TNI) standard and reagent origin, receipt, preparation, and use
(TNI) calibration criteria, frequency and acceptance criteria
(TNI) data and statistical calculations, review, confirmation, interpretation, assessment
and reporting conventions
(TNI) quality control protocols and assessment
(TNI) electronic data security, software documentation and verification, software and
hardware audits, backups, and records of any changes to automated data entries
(TNI) method performance criteria including expected quality control requirements
(TNI) proficiency test results
(TNI) records of demonstration of capability for each analyst
(TNI) a record of names, initials, and signatures for all individuals who are responsible
for signing or initialing any lab record.
(TNI) all data except those that are generated by automated data collection systems are
recorded legibly in permanent ink.
(TNI) individual making corrections to records date and initial the correction
(TNI) corrections other than transcription errors specify the reason for the correction
(DoD) Records for changes made to data (either hardcopy or electronic) include the
identification of the person who made the change and the date of change.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 17 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.13.3 h)
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(TNI) the lab has a plan to ensure records are maintained or transferred according to
the clients’ instructions in the event the lab transfers ownership or goes out of business.
the appropriate regulatory and state legal requirements are followed
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 18 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.13.4
4.13.4
4.13.4 a)
4.13.4 a)
4.13.4 b)
4.13.4 b)
4.13.4 b)
4.13.4 c)
4.13.5
4.13.6
4.13.6
4.13.7
4.13.8
4.13.9
4.13.9
4.14
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) Permanent, bound lab notebooks (logbooks) or notebooks with measures in
place to prevent the removal or addition of pages are required, if utilized. Electronic
logbooks are acceptable.
(DoD) For permanent, bound logbooks the following applies:
(DoD) Lab notebook pages are pre-numbered, all entries signed or initialed and dated
by the person responsible for performing the activity at the time the activity is
performed, and
(DoD) all entries are recorded in chronological order;
(DoD) All notebook pages are closed when the activities recorded are completed or
carried over to another page.. Closure occur at the end of the last activity recorded on a
page, as soon as practicable thereafter. Satisfactory records of closure include analyst
initials and date;
(DoD) The person responsible for performing the closure is the one who performed the
last activity recorded.
(DoD) Closure occurs at the end of the last activity recorded on a page, as soon as
practicable thereafter. Satisfactory records of closure include analyst initials and date;
(DoD) Each lab notebook has a unique serial number clearly displayed.
(DoD) The lab has procedures for the independent review of technical and quality
records to ensure they are legible, accurate, and complete.
(DoD) The lab establishes a review frequency for all records such as lab notebooks,
instrument logbooks, standards logbooks, and records for data reduction, verification,
validation, and archival.
(DoD) Records of the reviews are maintained and made available for review.
(DoD) If not self-explanatory (e.g., a typo or transposed number), corrections to
technical and quality records include a justification for the change.
(DoD) The records control system SOP address the requirements for access to and
control of the files, including accountability for any records removed from storage.
(DoD) All SOPs are archived for historical reference, per regulatory or customer
requirements.
(DoD) The lab has a procedure for permanent lab closure and disposal of any
remaining records associated with analytical data.
Internal Audits
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 19 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.14.1
4.14.2
4.14.3
4.14.4
4.14.5 a)
4.14.5 b)
4.14.5 c)
4.14.6
4.14.7
4.14.7
4.14.7
4.14.7
4.14.8
4.14.8
4.15
4.15.1
4.15.1
-
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Schedule and procedure for periodic audits of lab’s activities that addresses all
elements of 17025 and the quality system.
When findings cast doubt on operations or validity of results, the lab takes corrective
action and notify clients in writing if investigations show results may have been
affected.
The audits, findings and CA are recorded.
Follow-up activity verifies and record implementation and effectiveness of CA.
(TNI) the lab has a policy that specifies the time frame for notifying a client of events
that cast doubt on the validity of results
(TNI) the lab management ensures the actions are discharged within an agreed
timeframe to remedy the problem
(TNI) the internal audit schedule is completed annually
(DoD) The audit schedule ensures that all areas of the lab are reviewed over the course
of one year.
(DoD) Audit personnel are trained and qualified in the specific management system
element or technical area under review.
(DoD) Labs determine the training and qualification requirements for audit personnel,
including quality managers,
(DoD) and establish procedures to ensure that audit personnel are trained and qualified.
(DoD) These requirements and procedures are recorded.
(DoD) Management ensures that sufficient resources are available so that all internal
audits are conducted by personnel independent of the activity to be audited.
(DoD) Personnel conducting independent assessments have sufficient authority, access
to work areas, and organizational freedom necessary to observe all activities affecting
quality and to report the results of such assessments to lab management.
Management Review
Scheduled review of the quality system and testing/calibration activities to ensure their
continued suitability and effectiveness, and to introduce changes or improvements.
The review includes:
Suitability of policies and procedures
Reports from managers and supervisors
Outcome of recent internal audits
Corrective and preventive actions
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 20 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
4.15.2
4.15.3
4.16
5.0
5.1
5.1.1
5.1.2
5.2
5.2.1
5.2.1
5.2.2
5.2.2
5.2.2
5.2.3
5.2.4
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Assessments by external bodies
Results of interlaboratory comparisons or proficiency tests
Changes in volume and type of work
Client feedback
Complaints
Recommendations for improvement
Other relevant factors
Records of findings and actions that arise from them. Management ensures that actions
are carried out in a timely fashion.
(TNI) management reviews are completed on an annual basis
(TNI) Data Integrity Investigations – all investigations resulting from data integrity
issues are confidential until completed, Investigations are documented, and any
affected clients are notified.
Technical Requirements
General
Many factors determine correctness and reliability.
Extent to which factors contribute to total uncertainty differs considerably between
tests and calibrations. The laboratory shall take account of these factors in all steps of
its process.
Personnel
Ensure competence of all who operate equip., perform test/calibrations (t/c), evaluate
results & sign reports/certificates.
Staff undergoing training are appropriately supervised.
Formulate goals for education, training and skill of personnel.
Evaluation of the training actions effectiveness
Policy and procedure to identify relevant training needs and provide training of
personnel.
The lab uses personnel employed by or contracted to the lab. Where contractors or
additional key personnel are used, the lab ensures supervision to evaluate competence
of work.
Maintain current job descriptions.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 21 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.2.4
5.2.5
5.2.5
5.2.6.1
5.2.6.1 a)
5.2.6.1 b)
5.2.6.1 c)
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) The job description elements itemized in the note following ISO Clause 5.2.4
are minimum requirements.
Authorize and maintain records of such authorization for personnel to perform
particular tasks.
The lab maintains records of competence, educational and professional qualifications,
training, skills and experience. Information is readily available.
(TNI) Technical Manager (TM) Qualifications – applicable requirements
(TNI) If lab is engaged in chemical analysis the TM has a BS in chemical,
environmental, biological, physical sciences or engineering with at least 24 college
semester credit hours in chemistry and 2 yrs experience in environmental analysis of
representative inorganic and organic analytes represented on the scope. A masters or
doctoral degree in one of the above disciplines may be subbed for one year experience.
(TNI) A lab limited to inorganic chemical analysis, other than metals analysis has a
TM with at least an earned associate's degree in the chemical, physical or
environmental sciences, or 2 yrs of equivalent and successful college education, with a
minimum of 16 college semester credit hours in chemistry. In addition, the TM has at
least two (2) years of experience performing such analysis.
(TNI) A lab engaged in microbiological or biological analysis has a TM with a
bachelor’s degree in microbiology, biology, chemistry, environ. sciences, physical
sciences or engineering with a min of 16 college semester credit hours in general
microbiology and biology and at least 2yrs of experience in the environmental analysis
of representative analytes on the scope. A master’s or doctoral degree in one of the
above disciplines may be substituted for one 1 year of experience.
A TM with an associate's degree in an appropriate field of the sciences or applied
sciences, with a min of 4 college semester credit hrs in general microbiology may be
the TM of a lab engaged in microbiological analysis limited to fecal coliform, total
coliform, E. coli, and standard plate count. 2 years of equivalent and successful college
education, including the microbiology requirement, may be substituted for the
associate's degree. In addition, each person has 1 yr of experience in microbiological
analyses.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 22 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.2.6.1 d)
5.2.6.1 e)
5.2.6.1 e) i.
5.2.6.1 e) ii.
5.2.6.1 e) iii.
5.2.6.1 f)
5.2.6.2
5.2.6.2 a)
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(TNI) A radiological lab has a TM with a bachelor’s degree in chemistry,
environmental, biological sciences, physical sciences or engineering with 24 college
semester credit hrs of chemistry with 2 or more years of experience in the radiological
analysis of environmental samples. A master’s or doctoral degree in one of the above
disciplines may be substituted for 1 year experience
(TNI) A microscopic lab engaged in the examination of asbestos and/or airborne fibers
has a TM that meets the following requirements:
(TNI) For procedures requiring the use of a transmission electron microscope, a
bachelor's degree, successful completion of courses in the use of the instrument, and 1
yr of experience, under supervision, in the use of the instrument. Such experience
includes the ID of minerals.
(TNI) For procedures requiring the use of a polarized light microscope, an associate's
degree or 2yrs of college study, successful completion of formal coursework in
polarized light microscopy, and one year of experience, under supervision, in the use of
the instrument. Such experience includes the ID of minerals.
(TNI) For procedures requiring the use of a phase contrast microscope, as in the
determination of airborne fibers, an associate's degree or 2 yrs of college study,
documentation of successful completion of formal coursework in phase contrast
microscopy, and 1 year of experience, under supervision, in the use of the instrument.
(TNI) A lab engaged in the examination of radon in air has a TM with at least an
associate’s degree or 2 yrs of college and 1 yr of experience in radiation measurements,
including at least 1 yr of experience in the measurement of radon and/or radon
progeny.
(TNI) Technical Manager Qualification Exceptions
(TNI) Notwithstanding any other provision of this Section, a full-time employee of a
drinking water or sewage treatment facility who holds a valid treatment plant operator's
certificate appropriate to the nature and size of such facility are deemed to meet the
educational requirements as the TM. A TM has 2 yrs testing experience devoted
exclusively to the testing of environmental samples specified in the scope of the
facility’s regulatory permit. In such a case the accreditation for a water treatment
facility and/or a sewage treatment facility is limited to the scope of that facility’s
regulatory permit.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 23 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.2.6.2 b)
5.2.6.2 c)
5.2.6.2 c) i.
5.2.6.2 c) ii.
5.2.6.2 c) iii.
5.2.7
5.2.7
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(TNI) A full-time employee of an industrial waste treatment facility with a min of 2
yrs of experience under supervision in testing of environmental samples taken within
such facility for the scope of that facility’s regulatory permit is deemed to meet the
requirements for serving as the TM of an accredited lab. Such accreditation for an
industrial waste treatment facility is limited to the scope of that facility’s regulatory
permit.
(TNI) Persons who do not meet the education credential requirements but possess the
requisite experience of 5.2.6.1 qualify as technical manager(s) subject to the following
conditions:
(TNI) The person is the TM of the lab on the date the lab applies for accreditation
and/or becomes subject to accreditation under this Standard,
and has been a TM in that lab continuously for the previous 12 months min.
(TNI) The person is approved as the TM for only those fields of accreditation for
which he/she has been a TM in that lab for the previous 12 months or more
(TNI) A person who is admitted as a TM under these conditions, and leaves the lab,
will be eligible for hire as a TM for the same fields of accreditation in another
accredited lab.
(TNI) Data Integrity Training
(TNI) Data integrity training is provided as a formal part of new employee orientation
and provided on an annual basis for all current employees. Employees are required to
understand that any infractions of the lab data integrity procedures will result in a
detailed investigation that could lead to very serious consequences including
immediate termination, debarment or civil/criminal prosecution. The initial data
integrity training and the annual refresher training have a signature attendance sheet or
other form of documentation that demonstrates all staff have participated and
understand their obligations related to data integrity.
Data integrity training requires emphasis on the importance of proper written narration
on the part of the analyst with respect to those cases where analytical data may be
useful, but are in one sense or another partially deficient. The topics covered in such
training are documented in writing (such as an agenda) and provided to all trainees. At
a min, the following topics and activities included:
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 24 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.2.7 a)
5.2.7 b)
5.2.7 c)
5.2.7 d)
5.2.7 e)
5.2.7
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(TNI) organizational mission and its relationship to the critical need for honesty and
full disclosure in all analytical reporting, how and when to report data integrity issues,
and record keeping
(TNI) training, including discussion regarding all data integrity procedures
(TNI) data integrity training documentation
(TNI) in-depth data monitoring and data integrity procedure documentation
(TNI) specific examples of breaches of ethical behavior such as improper data
manipulations, adjustments of instrument time clocks, and inappropriate changes in
concentrations of standards
(TNI) The data integrity procedures may also include written ethics agreements,
examples of improper practices, examples of improper chromatographic manipulations,
requirements for external ethics program training, and any external resources available
to employees.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 25 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.2.7
5.2.7
5.2.7 a)
REQUIREMENT
(DoD) Creating data for an analysis that was not performed (dry lab)
5.2.7 a) ii)
(DoD) Using external analysts, equip., and/or labs to perform analyses when not
allowed by contract
5.2.7 a) iii)
(DoD) Creating information for a sample that was not collected (dry lab)
N
ASSESSMENT
NOTES
(DoD) Improper clock setting (time traveling) or improper date/time recording
5.2.7 b) i)
(DoD) Resetting the internal clock on an instrument to make it appear that a sample
was analyzed within holding time when in fact it was not
5.2.7 b) ii)
(DoD) Changing the actual time or recording a false time to make it appear that
holding times were met, or changing the times for sample collection, extractions or
other steps to make it appear that holding times were met
5.2.7 c)
C
(DoD) Top management acknowledges its support for data integrity by implementing
the specific requirements of the lab’s data integrity program.
(DoD) The following practices are prohibited:
(DoD) Fabrication, falsification, or misrepresentation of data
5.2.7 a) i)
5.2.7 b)
LAB
DOCUMENT
REFERENCE
(DoD) Unwarranted manipulation of samples, software, or analytical conditions
5.2.7 c) i)
(DoD) Unjustified dilution of samples
5.2.7 c) ii)
(DoD) Manipulating GC/MS tuning data to produce an ion abundance result that
appears to meet specific QC criteria
5.2.7 c) iii)
(DoD) Changing the instrument conditions for sample analysis from the conditions
used for standard analysis (e.g., changing EM voltage)
5.2.7 c) iv)
(DoD) Unwarranted manipulation of computer software (e.g., forcing calibration or
QC data to meet criteria, removing computer operational codes such as the “M” flag,
inappropriately subtracting background, or improperly manipulating the
chromatographic or spectrophotometric baseline)
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 26 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
REQUIREMENT
5.2.7 c) v)
(DoD) Turning off, or otherwise disabling, electronic instrument audit/tracking
functions
5.2.7 d)
C
N
ASSESSMENT
NOTES
(DoD) Misrepresenting or misreporting QC samples
5.2.7 d) i)
(DoD) Representing spiked samples as being digested or extracted when this has not
been done
5.2.7 d) ii)
(DoD) Substituting previously generated runs for a non-compliant calibration or QC
run to make it appear that an acceptable run was performed
5.2.7 d) iii)
(DoD) Failing to prepare or analyze method blanks and the lab control sample (LCS) in
the same manner that samples were prepared or analyzed
5.2.7 d) iv)
(DoD) Tampering with QC samples and results, including over spiking and adding
surrogates after sample extraction
5.2.7 d) v)
(DoD) Performing multiple calibrations or QC runs (including CCVs, LCSs, spikes,
duplicates, and blanks) until one meets criteria, rather than taking needed corrective
action, and not documenting or retaining data for the other unacceptable data
5.2.7 d) vi)
(DoD) Deleting or failing to record non-compliant QC data to conceal the fact that
calibration or other QC analyses were non-compliant
5.2.7 e)
LAB
DOCUMENT
REFERENCE
(DoD) Improper calibrations
5.2.7 e) i)
(DoD) Discarding points in the initial calibration to force the calibration to be
acceptable
5.2.7 e) ii)
(DoD) Discarding points from an MDL study to force the calculated MDL to be higher
or lower than the actual value
5.2.7 e) iii)
(DoD) Using an initial calibration that does not correspond to the actual run sequence
to make continuing calibration data look acceptable when in fact is was not
5.2.7 e) iv)
(DoD) Performing improper manual integrations, including peak shaving, peak
enhancing, or baseline manipulation to meet QC criteria or to avoid corrective actions
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 27 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.2.7 f)
5.2.7 g)
5.2.7 h)
5.3
5.3.1
5.3.2
5.3.3
5.3.3 a)
5.3.3 b)
5.3.3 c)
5.3.3 c)
5.3.3 c)
5.3.3 c)
5.3.4
5.3.5
5.4
5.4.1
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) Concealing a known analytical or sample problem
(DoD) Concealing a known improper or unethical behavior or action
(DoD) Failing to report the occurrence of a prohibited practice or known improper or
unethical act to the appropriate lab or contract representative, or to an appropriate
government official.
Accommodation & Environmental Conditions
Facilities do facilitate correct performance of t/c.
Monitor, control and record environmental conditions where necessary to maintain
quality of t/c.
Effective separation between areas that are incompatible and to prevent crosscontamination.
(DoD) When cross-contamination is a possibility samples suspected of containing high
concentrations shall be isolated from other samples.
(DoD) A Storage Blank is stored with all volatile organic samples. Labs shall have
written procedures for evaluating storage blanks. The storage Blanks are analyzed at a
minimum every 14 days.i
(DoD) If contamination is discovered ,
(DoD) the lab has a correction or action plan in place to identify the root cause and
eliminate the source;
(DoD) determine which samples may have been impacted and
(DoD) implement measures to prevent recurrence.
Access to controlled areas limited.
Good housekeeping ensured.
Test & Calibration Methods and Method Validation
General
The lab uses appropriate methods and procedures.
Instructions on use and operation of all equip. and handling and preparation of t/c
items, where absence would jeopardize results.
Instructions, standards, manuals, and reference data available where necessary.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 28 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.4.2
5.4.3
5.4.4
5.4.5
5.4.5.1
5.4.5.2
5.4.5.3
5.4.6
5.4.6.1
5.4.6.2
5.4.6.3
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Deviation from methods only occur if deviation has been documented, justified,
authorized, and accepted by the customer.
Selection of Methods
Use appropriate t/c methods, preferably international, regional or national standards.
Ensure use of latest valid edition of standards, unless it is not appropriate or possible to
do so.
Lab selects appropriate published methods when client has not specified method.
Lab methods or methods adopted may be used if appropriate for the intended use and
validated. Client informed of method selected.
Confirm that it can perform standard methods before introducing the t/c. If standard
method changes, confirmation is repeated.
Lab-developed Methods
When necessary to use methods developed by the lab, the activity is planned and
development assigned to a qualified person equipped with adequate resources.
Plans updated and communicated to personnel involved.
Non-standard Methods
Subject to agreement with the client, and include a clear specification of client’s
requirements and purpose. Methods are validated.
Validation of Methods
Validation definition
Validate non-standard and lab-developed methods, those used outside their intended
scope and amplification or modifications of standards methods, to confirm fitness for
use.
The range and accuracy of the values obtainable from validated methods are relevant to
the client’s needs.
Estimate of Uncertainty of Measurement
Calibration labs or test labs performing their own calibrations have and apply a
procedure to estimate uncertainty.
Testing labs have and where necessary apply procedures for estimating uncertainty.
All uncertainty components are taken into account.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 29 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
REQUIREMENT
5.4.6 a)
(DoD) The exact nature of some test methods may preclude rigorous, statistically valid
estimation of analytical uncertainty. In these cases:
5.4.6 a)
(DoD) the lab attempts to identify all components of analytical uncertainty and make a
reasonable estimation
5.4.6 a)
(DoD) the lab ensures that the form of data reporting does not give a wrong impression
of the uncertainty.
5.4.6 a)
(DoD) A reasonable estimation is based on knowledge of method performance and
previous experience.
5.4.6 a)
(DoD) When estimating the analytical uncertainty, all uncertainty components which
are of importance in the given situation are taken into account.
5.4.6 b)
(DoD) In those cases where a well-recognized test method specifies limits to the values
of the major source of uncertainty of measurement and specifies the form of
presentation of calculated results the laboratory may follow the test method and
reporting instructions.
5.4.6 c)
(DoD) As stated in Section 5.10.3.1.c test reports include a statement of the estimated
analytical uncertainty only when required by the customer.
(DoD) If a project requires analytical uncertainty to be reported, the lab reports the
estimated uncertainty based on project-specific procedures or, if not available, any
other scientifically valid procedures.
(DoD) For testing labs, the lab ensures that the equip. used can provide the analytical
portion of measurement uncertainty needed by the customer.
5.4.7
5.4.7.1
(TNI) Control of Data
Calculations and data transfers are checked.
5.4.6 c)
5.4.6 c)
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 30 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
REQUIREMENT
5.4.7.1 a)
(DoD) To ensure that the reported data are free from transcription and calculation
errors;
5.4.7.1 b)
(DoD) To ensure that all quality control measures are reviewed and evaluated before
data are reported;
5.4.7.1 c)
(DoD) To address manual calculations; and
5.4.7.1 d)
5.4.7.1
5.4.7.1
5.4.7.1
5.4.7.2
5.4.7.2 a)
5.4.7.2 b)
5.4.7.2 c)
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) To address manual integrations
(DoD) When manual integrations are performed, raw data records include a complete
audit trail for those manipulations (before and after chromatograms). This requirement
applies to all analytical runs including calibration standards and QC samples.
(DoD) The person performing the manual integration signs and dates each manually
integrated chromatogram and record the rationale for performing manual integration
(electronic signature is acceptable).
(DoD) Records for manual integrations may be maintained electronically as long as all
requirements, including signature requirements, are met and the results can be
historically reconstructed.
When computers or automated equip. are used, the lab ensures that:
Developed software is documented and validated.
Procedures are established and implemented for protection of data.
Computers and automated equip. are properly maintained and in an environment that
ensures proper functioning.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 31 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
REQUIREMENT
5.4.7.2 d)
(DoD) The lab has a procedure to ensure individual user names and passwords are
required for all LIMS users. LIMS passwords are changed on a regular basis, at a
minimum of once per year.
5.4.7.2 e)
(DoD) Upon employment, lab employees have initial training in computer security
awareness and have ongoing refresher training on an annual basis. Records of the
training are maintained and available for review.
5.4.7.2 f)
(DoD) Periodic inspections (at least annually) of the LIMS are performed by the
Quality Manager or designee to ensure the integrity of electronic data. The Quality
Manager or designee maintain records of inspections and submit reports to lab
management, noting any problems identified with electronic data processing stating the
corrective actions taken.
5.4.7.2 g)
(DoD) The lab has a procedure to notify the customer prior to changes in LIMS
software or hardware config. that will adversely affect customer electronic data.
5.4.7.2 h)
(DoD) Spreadsheets used for calculations are verified before initial use and after any
changes to equations or formulas, including software revision upgrades, and records
are available for review. Printouts from any spreadsheets include all information used
to calculate the data.
5.4.7.2 h)
(DoD) Formula cells are write-protected to minimize inadvertent changes to the
formulas.
5.4.7.2 h)
(DoD) Printouts from any spreadsheets include all information used to calculate the
data
5.4.7.2 i)
(DoD) The lab has SOPs for:
5.4.7.2 i) i)
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) Software development methodologies that are based on the size and nature of
the software being developed;
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 32 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) Testing and QC methods to ensure that all software accurately performs its
intended functions, including:
5.4.7.2 i) ii)
a.
Acceptance criteria;
b.
Tests to be used;
c.
Personnel responsible for conducting the tests;
d.
Records of test results;
e.
Frequency of continuing verification of the software; and
f.
Test review and approvals.
5.4.7.2 i) iii)
(DoD) Software change control methods that include instructions for requesting,
authorizing, requirements to be met by the software change, testing, QC, approving,
implementing changes, and establishing priority of change requests;
5.4.7.2 i) iv)
(DoD) Software version control methods that record the software version currently
used. Data sets are recorded with the date and time of generation and/or the software
version used to generate the data set;
5.4.7.2 i) v)
(DoD) Maintaining a historical file of software, software operating procedures,
software changes, and software version numbers;
5.4.7.2 i) vi)
(DoD) Defining the acceptance criteria, testing, records, and approval required for
changes to LIMS hardware and communication equip..
(DoD) Records available in the lab to demonstrate the validity of lab-generated
software include:
i) Software description and functional requirements;
5.4.7.2 j)
ii) Listing of algorithms and formulas;
iii) Testing and QA records; and
iv) Installation, operation and maintenance records.
5.4.7.2 k)
5.4.7.2 k) i)
(DoD) Electronic Data Security measures ensure:
(DoD) Individual user names and passwords have been implemented;
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 33 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
REQUIREMENT
5.4.7.2 k) ii)
(DoD) Operating system privileges and file access safeguards are implemented to
restrict the user of the LIMS data to users with authorized access;
5.4.7.2 k) iii)
(DoD) All LIMS Users are trained in computer awareness security on an annual basis;
5.4.7.2 k) iv)
(DoD) System events, such as log-on failures or break-in attempts are monitored;
5.4.7.2 k) v)
(DoD) The electronic data management system is protected from the introduction of
computer viruses;
5.4.7.2 k) vi)
(DoD) System backups occur on a regular and published schedule and can be
performed by more than one person within an organization;
5.4.7.2 k) vii)
(DoD) Testing of the system backups is performed and recorded to demonstrate that
the backup systems contain all required data; and
5.4.7.2 k)viii)
(DoD) Operating system privileges and file access safeguards are implemented to
restrict the user of the LIMS data to users with authorized access;
5.5
5.5.1
5.5.1
5.5.2
5.5.2
5.5.2
5.5.3
5.5.4
5.5.5
5.5.5 a)
5.5.5 b)
5.5.5 c)
5.5.5 d)
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Equipment
Lab is furnished with all items of equip. required for correct performance of t/c.
Equip. outside its permanent control are controlled to meet 17025.
Equip. and software meet the accuracy necessary for the t/c and comply with
specifications.
Calibration program established for key quantities or values of the equip. where these
properties have a significant effect on results.
Equip. is calibrated or checked to establish that it meets the specification requirements
and complies with relevant standards before being put into service.
Equip. operated by authorized personnel. Up-to-date instruction on the use and
maintenance readily available to operating personnel.
Equip. and software uniquely identified.
Records are maintained for each item of equip., and include:
Identity of item
Manufacturer’s name, type identification and serial number or other unique
identification.
Checks that equip. complies with the specification.
Current location, where appropriate.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 34 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.5.5 e)
5.5.5 f)
5.5.5 g)
5.5.5
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Mfr.’s instructions, if available, or reference to their location.
Dates, results and copies of reports and certificates of calibration, adjustments,
acceptance criteria, and due date of next calibration.
Maintenance plan, where appropriate, and maintenance carried out to date.
(DoD) The following are implemented in addition to ISO Clause 5.5.5 a) through g):
h) Date placed in service;
i) Condition when received (e.g., new, used, reconditioned);
j)
Operational status; and
k) Instrument config. and settings.
5.5.5 h)
5.5.6
5.5.7
5.5.7
5.5.8
5.5.9
5.5.10
5.5.11
5.5.12
5.5.13
5.5.13.1
5.5.13.1 a)
Damage, malfunction, modification or repair to Equip..
Procedures for safe handling, transport, storage, use and planned maintenance of
equip..
Overloaded or mishandled equip. that gives suspect results taken out of service until
repaired and calibrated.
Examine the effect of the defect or departure on previous t/c and initiate “Control of
nonconforming work” procedures.
Equip. is labeled, coded or otherwise identified to indicate status of calibration,
including date calibrated, and date or expiration criteria when calibration is due.
If equip. goes outside the control of the lab, it is proven that the function and
calibration status are satisfactory before being returned to service.
Procedure for intermediate checks.
Procedure to ensure that correction factors are updated correctly.
Equip. and software are safeguarded from adjustments that would invalidate the t/c
results.
(TNI) Additional requirements and Clarifications
Calibration requirements for analytical support equip. are this section while
requirements for instrument (testing) calibration are included in the technical modules.
(TNI) Support equip. are devices that may not be the actual test instrument, but are
necessary to support the lab operations and test (see PR 414 for example list)
(TNI) Support equip. is maintained in proper working order. Records of all repair and
maintenance activities, including service calls are kept
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 35 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.5.13.1 a)
5.5.13.1 b)
5.5.13.1 b) i.
5.5.13.1 b) ii.
5.5.13.1 c)
5.5.13.1 d)
5.5.13.1 d)
5.5.13.1 e)
5.5.13.1 f)
5.5.13.1.f)
5.5.13.1 f)
5.6
5.6.1
5.6.2
5.6.2.1
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) The lab has procedures for recording catastrophic failure of support equip. (e.g.,
refrigerators, freezers) and addresses identification of affected samples and customer
notification.
(TNI) Support equip. is calibrated or verified annually (see L-A-B PR414 and Policy
001 for acceptable calibration service providers)
(TNI) if equip. is deemed non-conforming then it is removed from the service until
repaired
(TNI) the lab maintains records of established correction factors to correct all
measurements
(TNI) raw data records are retained to document equip. performance
(TNI) On each day the equip. is used, balances, ovens, refrigerators, freezers and water
baths are checked and documented. The acceptability for use or continued use is
according to the needs of the analysis or application for which the equip. is being used
(DoD) These checks are performed in the expected use range using reference standards
that are obtained, where available, from an accredited third party or a NMI (e.g., NIST)
traceable to the SI, International System of Units.
(TNI) Volumetric dispensing devices (except Class A glassware and Glass microliter
syringes) are checked for accuracy on a quarterly basis.
(DoD) The results of calibration and verification of support equip. be within the
specifications required of the application for which this equip. is used or the equip. is
removed from service until repaired.
(DoD) Calibration and verification records, including those of established correction
factors are maintained.
(DoD) In the absence of method-specific requirements, the minimum requirements are
as follows: SEE TABLE in QSM 5.0
Measurement Traceability
General
Programs and procedures for the calibration of t/c equip. that has a significant effect on
results.
Equip. calibrated before being placed in service.
Specific Requirements
Calibration (includes internal Calibration)
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 36 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.6.2.1.1
5.6.2.1.1
5.6.2.1.2
5.6.2.1.2
5.6.2.2
5.6.2.2.1
5.6.2.2.2
5.6.3
5.6.3.1
5.6.3.2
5.6.3.3
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Calibration lab’s program for calibration ensures traceability to the International
System of Units (SI).
Calibration certificates contain the measurement results, including the measurement
uncertainty and/or a statement of compliance with an identified metrological
specification.
Certain calibrations cannot be strictly made in SI units. In these cases, calibration
provides confidence in measurements by establishing traceability to appropriate
measurement standards such as:
Use of certified reference materials provided by a competent supplier.
Use of specified methods and/or consensus standards that are clearly described and
agreed by all parties concerned.
Participation in a suitable program of interlaboratory comparisons is required where
possible.
Testing
Test labs’ requirements given in 5.6.2.1 apply for measuring and test equip., unless it
has been established that the calibration contributes little to the overall uncertainty of
the results.
Where traceability to SI units is not possible or relevant, certified reference materials,
agreed methods and/or consensus standards are required as for calibration labs (see
5.6.2.1.2).
Reference Standards & Reference Materials
Reference Standards
Programs and procedures for calibration of reference standards.
Reference standards are calibrated by a body that can provide traceability, as described
in 5.6.2.1
Reference Standards used for calibration purposes only, unless shown that their
performance as a standard is not invalidated.
Reference standards are calibrated before and after any adjustment.
Reference Materials
Where possible, traceable to SI units, or to certified reference materials.
Internal reference materials are checked as far as technically and economically
possible.
Intermediate Checks
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 37 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.6.3.4
5.6.4
5.6.4.1
5.6.4.1 a)
5.6.4.1 b)
5.6.4.2
5.6.4.2 a)
5.6.4.2 a)
5.6.4.2 a)
5.6.4.2 b)
5.6.4.2 c)
5.6.4.2 d)
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Carried out according to defined procedures and schedules.
Transportation and Storage
Procedures for safe handling, transport, and use of reference standards and materials.
(TNI) Additional Requirements and Clarifications
(TNI) Reference Standards and Reference Materials
The lab provides evidence of correlation of results, for example, by participation in
suitable program of inter-laboratory comparisons, PT, or independent analysis.
(TNI) Reference Standards (where commercially available, this traceability is to and
national standard of measurement
(TNI) Reference Materials (where possible, traceability is to a national or international
standard of measurement or to national or international standard reference materials.
Internal reference materials are checked as far as is technically and economically
practicable.
(TNI) Documentation and Labeling of Standards, Reagents, and Reference Materials
Procedures exist for the purchase, receipt and storage of consumable materials used by
the lab
(TNI) The lab retains records for all standards, reagents, RM, and media including the
manuf./vendor, the manuf. Certificate of Analysis or purity (if available), the date of
receipt, and recommended storage conditions
(DoD) Records for standards, reagents, and reference materials include lot numbers.
(DoD) Documentation for reagents and solvents are checked to ensure that the stated
purity will meet the intended use and the supporting records of the checks are filed in a
manner that is retrievable.
(TNI) For original containers, if an expiration date is provided by the manufacturer or
vendor it is recorded on the container. If an expiration date is not provided by the
manufacturer or vendor it is not required
(TNI) Records are maintained on standard, reference material, and reagent preparation.
These records indicate traceability to purchased stocks or neat compounds, reference to
the method of preparation, date of preparation, expiration date and preparer's initials.
(TNI) All containers of prepared standards, reference materials, and reagents bear a
unique identifier and expiration date.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 38 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.6.4.2 d)
5.6.4.2 d)
5.6.4.2 e)
5.6.4.2 f)
5.6.4.2 f)
5.6.4.2 g)
5.7
5.7.1
5.7.1
5.7.1
5.7.1
5.7.1
5.7.1
5.7.1
5.7.2
5.7.3
5.7.4 a)
5.7.4 b)
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) The expiration date of the prepared standard shall not exceed the expiration date
of the primary standard.
(DoD) All containers bear a preparation date.
(TNI) Procedures are in place to ensure prepared reagents meet the requirements of the
method.
(TNI) Standards, reference materials, and reagents are not used after their expiration
dates unless their reliability is verified by the lab
(DoD) If a standard exceeds its expiration date and is not re-certified, the lab will
remove the standard or clearly designate it as acceptable for qualitative purposes only.
(DoD) Standards and reference materials are stored separately from samples, extracts,
and digestates and protected in an appropriate cabinet or frig.
Sampling
Where necessary, a sampling plan and procedures. Where possible, based on statistical
methods
Sampling plan and procedure are available where sampling takes place.
(DoD) Sample handling procedures address lab practices for recording the presence of
extraneous materials (e.g., rocks, twigs, vegetation) present in samples in the case of
heterogeneous materials.
(DoD) To avoid preparing non-representative samples, the lab does not “target” within
a relatively small mass range (e.g., 1.00 ± 0.01 g) because such targeting will produce
non-representative subsamples if the sample has high heterogeneity.
(DoD) The lab does not manipulate the sample material so the sample aliquot weighs
exactly 1.00g ± 0.01g, as an example.
(DoD) The handling of multiphase samples are addressed in specific sampling
procedures, as appropriate.
(DoD) The lab’s sampling procedures complies with recognized consensus standards
where available.
Client-required deviations, additions or exclusion from the documented procedure are
recorded in detail, with actual sampling data, and included in the documents containing
the results.
Procedures for recording sampling data.
(TNI) Documentation includes the date and time of sampling
(TNI) Deviations from sampling procedures are documented
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 39 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.8
5.8.1
5.8.1
5.8.2
5.8.3
5.8.3
5.8.4
5.8.4 a.)
5.8.4 b)
5.8.4 c)
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Handling of Test and Calibration Items
Procedure for transporting, receipt, handling, protection, storage, retention and/or
disposal of items
(DoD) Personnel dealing with radioactive samples are trained in radioactive sample
receipt, radioactive waste management, radioactive materials shipping (49 CFR 172)
and handling, and radioactive material control.
Items identified and identity retained throughout life of item in lab.
Upon receipt of item, abnormalities or departures from normal or specified conditions
are recorded. When suitability is in doubt, the client is notified.
(DoD) The lab has a procedure addressing instances when it receives samples that
require non-routine or additional sample preparation steps.
Procedures and facilities to avoid deterioration, loss or damage to t/c item.
(DoD) The lab has SOP(s) in place to address the use of ventilation hoods or suitable
containment for opening shipping containers, radiation screening of samples, lab
notification, and labeling requirements for radioactive samples.
(DoD) The lab has a procedure and records to verify ventilation hood contamination
control on a semiannual basis, such as a smoke test or flow meter measurements.
Materials submitted for industrial hygiene or asbestos analysis are opened in an
established manner to prevent worker exposure.
(DoD) Shipping containers are opened inside a ventilation hood or other designated
area that provides adequate ventilation for personnel. All shipping containers from
known radiological areas are surveyed for radiological contamination on all external
surfaces. The lab develops and implement admin. policies for the receipt of
radiological shipping containers and samples. Radiological surveys of sample shipping
containers are performed as soon as possible from the time of receipt by the lab.
5.8.4 c) i)
Instrumentation and equip. used for monitoring is:
(DoD) Maintained and calibrated on an established frequency;
5.8.4 c) ii)
(DoD) Appropriate for the type(s), levels, and energies of the radiation encountered;
5.8.4 c) iii)
(DoD) Appropriate for existing environmental conditions; and
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 40 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
REQUIREMENT
5.8.4 c) iv)
(DoD) Routinely tested for operability (10 CFR 835.401(b)).
5.8.4 d)
5.8.5 a)
5.8.5 b)
5.8.5 c)
5.8.5 d)
5.8.5 e)
5.8.6
5.8.6 a)
5.8.6 b)
5.8.6 c)
5.8.6 d)
5.8.6 e)
5.8.6 f)
5.8.6 g)
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) The lab has a system in place to record incidents involving spillage of customer
samples or significant spillage of chemicals.
(TNI) The lab has a documented system for uniquely identifying the samples to be
tested, to ensure that there can be no confusion regarding the identity of such samples
at any time. This system includes identification for all samples, sub-samples,
preservations,
sample containers, tests, and subsequent extracts and/or digestates.
(TNI) This lab code maintains an unequivocal link with the unique field ID code
assigned to each sample.
(TNI) Lab ID code is placed as a durable mark on the sample container.
(TNI) Lab ID code entered into the lab records and linked that associates the sample
with related lab activities such as sample prep.
(TNI) In cases where the sample collector and analyst are the same individual, or the
lab pre-assigns numbers to sample containers, the lab ID code may be the same as the
field ID code.
(TNI) Additional Requirements - Sample Acceptance Policy
The lab has a written sample acceptance policy that includes:
(TNI) proper, full, and complete documentation, which includes sample ID, the
location, date and time of collection, collector's name, preservation type, sample type
and any
special remarks concerning the sample
(TNI) proper sample labeling to include unique ID and a labeling system for the
samples with requirements concerning the durability of the labels (water resistant) and
the use of indelible ink
(TNI) use of appropriate sample containers
(TNI) adherence to specified holding times
(TNI) sufficient sample volume to perform the necessary tests
(TNI) procedures to be used when samples show signs of damage, contamination or
inadequate
preservation
(TNI) qualification of any data that do not meet the above requirements
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 41 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.8.6 h)
5.8.7
5.8.7.1
5.8.7.1
5.8.7.1
5.8.7.1
REQUIREMENT
(DoD) Continued preservation of the sample is in question ; or
5.8.7.1 b)
(DoD) Deterioration of the preservation is suspected.
5.8.7.2
5.8.7.2 a)
5.8.7.2 b)
5.8.7.2 b)i.
5.8.7.2 b) ii.
5.8.7.3
5.8.7.3 a)
C
N
ASSESSMENT
NOTES
(DoD) A clear outline of the circumstances under which samples are accepted or
rejected.
(TNI) Additional Requirements - Sample Receipt Protocols
(TNI) The lab implements procedures for verifying and documenting preservation
(DoD) Sample temperature measurement is verified through the use of one or more
temperature blanks for each shipping container, if provided. If a temperature blank is
not available, other temperature measurement procedures may be used.
(DoD) Chemical preservation is matrix specific. The lab refers to the Chain of
Custody (COC) for the matrix definition. In the case where the matrix is not identified
on the COC, the lab contacts the customer prior to proceeding.
(DoD) Chemical preservation are checked at the time of sample receipt for all
samples, unless it is not technically acceptable to check preservation upon receipt If
any of the following conditions exist, chemical preservation are rechecked in the lab.
5.8.7.1 a)
5.8.7.1
LAB
DOCUMENT
REFERENCE
(DoD) The lab has procedures in place that ensure that the appropriate lab personnel
are notified when samples are received with a quick turn-around time request, short
hold times, or a short amount of hold time is remaining.
(TNI) If the sample does not meet the sample receipt acceptance criteria listed in this
Standard, the
lab either
(TNI) retain correspondence and/or records of conversations concerning the final
disposition of rejected samples; or
(TNI) fully document any decision to proceed with the analysis of samples not meeting
acceptance
criteria
(TNI) The condition of these samples is noted on the chain of custody or transmittal
form and lab receipt documents
(TNI) The analysis data is appropriately qualified on the final report
(TNI) The lab utilizes a permanent chronological record such as a logbook or
electronic database to document receipt of all sample containers.
(TNI) This sample receipt log records the following:
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 42 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
REQUIREMENT
5.8.7.3 a)i.
5.8.7.3 a) ii.
5.8.7.3 a) iii.
5.8.7.3 a) iv.
(TNI) client/project name
(TNI) date and time of lab receipt
(TNI) unique lab ID code (see Section 5.12.1.b) i.
(TNI) signature or initials of the person making the entries
(TNI) During the login process, the following information is unequivocally linked to
the log record or included as a part of the log. If such information is
recorded/documented
elsewhere, the records are part of the lab's permanent records, easily retrievable
upon request and readily available to individuals who will process the sample
NOTE: The placement of the lab ID number on the sample container is not considered
a permanent record
(TNI) The field ID code, which identifies each sample, is linked to the lab ID code in
the sample receipt log.
(TNI) The date and time of sample collection is linked to the sample and to the date
and time of receipt in the lab
(TNI) The requested analyses (including applicable approved method numbers) are
linked to the lab ID code
(TNI) Any comments resulting from inspection for sample rejection is linked to the lab
ID code
(TNI) All documentation, such as memos, chain of custody, or transmittal forms that
are transmitted to the lab by the sample transmitter, are retained
(TNI) A complete chain of custody record form, if utilized, is maintained
(TNI) Additional Requirements - Legal Chain of Custody Protocols
Legal chain of custody procedures are used for evidentiary or legal purposes. If a client
specifies that a sample is to be used for evidentiary purposes, then the lab has a written
SOP for how that lab will carry out legal chain of custody
5.8.7.3 b)
5.8.7.3 b)i.
5.8.7.3 b) ii.
5.8.7.3 b) iii.
5.8.7.3 b) iv.
5.8.7.4
5.8.7.5
5.8.8
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 43 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.8.8
5.8.8
5.8.8
REQUIREMENT
N
ASSESSMENT
NOTES
(DoD) The COC records account for all time periods associated with the samples.
5.8.8 b)
5.8.8 c)
DoD Guidance only
5.8.8 d)
DoD Guidance only
5.8.8 e)
DoD Guidance only
5.8.8 a)
C
(DoD) Legal/Evidentiary Custody
When the legal Chain of Custody (COC) protocols are not provided by a state or
federal program and legal custody is required to be maintained for a given project, the
following protocols are incorporated.
(DoD) Basic Requirements
The legal COC protocol records establish an intact, continuous record of the physical
possession, storage and disposal of used sample containers, collected samples, sample
aliquots, and sample extracts or digestates, collectively referred to as “samples”.
(DoD) Required Information in Custody Records
Tracking records shall be maintained until final disposition or return of samples to the
customer. Tracking records include, by direct entry or linkage to other records:
a) Time of day and calendar date of each transfer or handling
b) Signatures of all personnel who physically handled the samples
c) All information necessary to produce unequivocal, accurate reports that
record the lab activities associated with sample receipt, preparation, analysis,
and reporting; and
d) Common carrier records.
A sample is in someone’s custody if
i) it is in one’s actual physical possession;
ii) it is in one’s view, after being in one’s physical possession;
iii) it has been in one’s physical possession and then locked or sealed so that
no one can tamper with it;
iv) it is kept in a secure area, restricted to authorized personnel only.
(DoD) The COC records identify all individuals who physically handled individual
samples.
5.8.8
LAB
DOCUMENT
REFERENCE
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 44 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
REQUIREMENT
5.8.8 f)
(DoD) Legal COC begin at the point established by the federal or state oversight
program. This may begin at the point that cleaned sample containers are provided by
the lab or the time sample collection occurs.
5.8.8 g)
(DoD) The COC forms remain with the samples during transport or shipment.
5.8.8 h)
(DoD) If shipping containers and/or individual sample containers are submitted with
sample custody seals and any seals are not intact, the custodian notes this on the COC.
5.8.8 i)
DoD Guidance only
5.8.8 j)
5.8.9 a)
5.8.9 a)i.
5.8.9 a)ii.
5.8.9 b)
5.8.9 c)
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) Once received by the lab, lab personnel are responsible for the care and
custody of the sample and be able to testify that the sample was in their possession
and within view or secured in the lab at all times.
(TNI) Samples are stored according to the conditions specified by preservation
protocols
(TNI) Samples that require thermal preservation are stored under refrigeration that is
+/-2°C of the specified preservation temperature unless regulatory or method specific
criteria exist. For samples with a specified storage temperature of 4°C, storage at a
temperature above the freezing point of water to 6°C is acceptable.
(TNI) Samples are stored away from all standards, reagents, and food. Samples are
stored in such a manner to prevent cross contamination
(TNI) Sample fractions, extracts, leachates and other sample preparation products are
stored
according to Section 5.8.9 a) above or according to specifications in the method
(TNI) The lab has SOPs for the disposal of samples, digestates, leachates and
extracts or other sample preparation products
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 45 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
REQUIREMENT
5.8.9 d) i)
(DoD) Disposal of the physical sample occurs only with the concurrence of the
customer who submitted the sample if those samples are disposed of prior to any
project specified time limit.
(DoD) Samples that are completely consumed during analysis are recorded as such for
their final disposition.
(DoD) All conditions of disposal and all records and correspondence concerning the
final disposition of the physical sample are recorded and retained.
(DoD) Records indicate the date of disposal, the nature of disposal and the name of the
individual who performed the task.
(DoD) Access to all evidentiary samples and subsamples are controlled and recorded
for all samples associated with legal chain of custody:
(DoD) A clean, dry, isolated room, building, and/or refrigerated space that can be
securely locked from the outside is designated as a custody room.
5.8.9 d) ii)
(DoD) Where possible, distribution of samples to the analyst performing the analysis
are made by the custodian(s).
5.8.9 d) iii)
(DoD) The lab area is maintained as a secured area, restricted to authorized personnel
only.
5.8.9 c)
5.8.9 c)
5.8.9 c)
5.8.9 c)
5.8.9 d)
5.8.9 d) vi)
5.8.9 e)
5.9
5.9.1
5.9.1 a)
5.9.1 b)
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(DoD) Once the sample analyses are completed, the unused portion of the sample,
together with all identifying labels, be returned to the custodian. The returned sample
is retained in the custody room until permission to dispose of the sample is received
by the custodian or other authority.
(DoD) Transfer of samples, subsamples, digestates or extracts to another party are
subject to all of the requirements for legal COC for all samples associated with legal
chain of custody.
Assuring the Quality of Test and Calibration Results
QC Procedures for monitoring validity of t/c results; which may include:
Regular use of certified reference materials and/or internal qc using secondary
reference material.
Participation in interlaboratory comparison or proficiency testing.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 46 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.9.1 c)
5.9.1 d)
5.9.1 e)
5.9.1
5.9.2
5.9.3
5.9.3 a)
5.9.3 a) i.
5.9.3 a) ii.
5.9.3 a) iii.
5.9.3 a) iv.
5.9.3 a) v.
5.9.3 a) vi.
5.9.3 a) vii.
5.9.3 a) viii.
5.9.3 b)
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Replicate t/c using same or different methods.
Retesting or recalibration of retained items.
Correlation of results for different characteristics of an item.
(DoD) Quality control samples are processed in the same manner as field samples.
They are analyzed and reported with their associated field samples.
Analyze quality control data. If found outside predefined criteria, action to correct and
prevent incorrect results from being reported is taken.
(TNI) Essential Quality Control Procedures
(TNI) The lab has a detailed written protocol(s) in place to monitor the following
quality controls:
(TNI) positive and negative controls (see technical modules), chemical or
microbiological as
applicable to the test type, to monitor tests such as blanks, matrix spikes, reference
toxicants
(TNI) tests to define the variability and/or repeatability of the lab results such as
replicates
(TNI) measures to assure the accuracy of the method including calibration and/or
continuing calibrations, use of certified reference materials, proficiency test samples,
or other measures
(TNI) measures to evaluate method capability, such as limit of detection and limit of
quantitation or range of applicability such as linearity
(TNI) selection of appropriate formulae to reduce raw data to final results such as
regression analysis, comparison to internal/external standard calculations, and
statistical analyses
(TNI) selection and use of reagents and standards of appropriate quality
(TNI) measures to assure the selectivity of the test for its intended purpose
(TNI) measures to assure constant and consistent test conditions (both instrumental
and environmental) where required by the method such as temperature, humidity, light
or specific instrument conditions
(TNI) All quality control measures are assessed and evaluated on an on-going basis
and quality control acceptance criteria is used
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 47 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.9.3 c)
5.10
5.10.10
5.10
5.10
5.10.1
5.10.2
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
(TNI) The lab has procedures for the development of acceptance/rejection criteria
where no method or regulatory criteria exist.
The quality control protocols specified by the lab’s SOP are followed (see Section
4.2.8.5 in this Standard). The lab ensures that the essential standards outlined in
Technical Modules or mandated methods or regulations (whichever are more stringent)
are incorporated into their method manuals. When it is not apparent which is more
stringent, the QC in the mandated method or regulations is to be followed
Reporting the Results
(TNI) Exceptions
Some regulatory reporting requirements or formats, such as monthly operating reports,
may not require all items listed below; however, the lab provides all the required
information to their client for use in preparing such regulatory reports
Labs operated solely to provide data for compliance purposes (in-house or captive labs)
will have all applicable information specified in Section 5.10 readily available for
review by the accreditation body. However, formal reports detailing the information
are not required if: (See L-A-B PR414 for exceptions)
(DoD) The requirements of Appendix A in the standard are used for reporting results
for unless client specified reporting requirements are invoked.
(DoD) Labs have a written procedure for communicating with the customer for the
purpose of establishing project-specific data reporting requirements, including 1)
conventions for reporting results below the LOQ and 2) specification for the use of
data qualifiers. The basis for the use of all data qualifiers is adequately explained in the
test report.
General
Results reported accurately, clearly, unambiguously and objectively, IAW instructions
in the method.
Results reported in test report or calibration certificate includes information requested
by the client and necessary for interpretation of results.
For internal clients, or with written agreement with client, results may be reported in a
simplified way. All information required by 5.10.2 to 5.10.4 is readily available in the
lab that performed the T/C.
Test Reports and Calibration Certificates
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 48 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.10.2 a)
5.10.2 b)
5.10.2 b)
5.10.2 c)
5.10.2 d)
5.10.2 e)
5.10.2 f)
5.10.2 g)
5.10.2 h)
5.10.2 i)
5.10.2 j)
5.10.2 k)
5.10.2 l)
5.10.2 m)
5.10.2 n)
5.10.2 o)
5.10.3
5.10.3 a)
5.10.3 b)
5.10.3 c)
5.10.3 d)
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Test reports and calibration certificates include 17025 listed information, unless they
have a valid reason for not doing so.
Title
Name and address of lab and location where T/C was performed, if different from lab.
(DoD) The name of a contact person and their phone number is included in the lab
information.
Unique identification of report or certificate, on each page and identification that the
page is recognized as a part of the whole and a clear indication of the end of the report
or certificate.
Name and address of client.
Identification of the method(s) used.
Description, condition, and unambiguous identification of the item tested or calibrated.
Date of receipt of item(s), where critical to results. Date(s) of performance of T/C.
Reference to the sampling plan and procedure.
T/C results with, where appropriate, the units of measure.
Name(s), functions(s), and signatures of personnel authorizing the report/certificate.
Where relevant, a statement that the results relate only to the items t/c.
(DoD) Any failures identified;
DoD) For Whole Effluent Toxicity, identification of the statistical method used
to provide data;
(DoD) The date of issuance
(DoD) For solid samples, a statement of whether the results are based on a dry
weight or wet weight basis.
Test Reports
Where necessary for the interpretation of results, the following is included in test
reports:
Deviations, additions, or exclusions from the test method, and information on specific
test conditions.
Where relevant, a statement of compliance/non-compliance with the
requirements/specification.
Where applicable, a statement of the estimated uncertainty.
Where appropriate and needed, opinions and interpretations.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 49 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.10.3 e)
5.10.3.1 f)
5.10.3.1 g)
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Additional information required by methods, clients or groups of clients.
(DoD) Information on any non-standard conditions that may have affected the quality
of the results, including the use and definitions of data qualifiers;
(DoD) Where management system requirements are met, a statement of
compliance/noncompliance requirements and/or specifications, including identification
of test results derived from any sample that did not meet sample acceptance
requirements such as improper container, holding time, or temperature.
(DoD) In the absence of project-specific requirements, the minimum standard data
qualifiers to be used by labs are:
U – Analyte was not detected and is reported as less than the LOD or as defined by the
customer. The LOD has been adjusted for any dilution or concentration of the sample.
J – The reported result is an estimated value (e.g., matrix interference was observed or
the analyte was detected at a concentration outside the quantitation range).
5.10.3.1.1
B – Blank contamination. The recorded result is associated with a contaminated
blank.
N – Non-target analyte. The analyte is a tentatively indentified compound using mass
spectrometry or any non-customer requested compounds that are tentatively identified.
Q – One or more quality control criteria failed (e.g., LCS recovery, surrogate spike
recovery, or CCV recovery).
5.10.3.1.1
5.10.3.2
5.10.3.2 a)
5.10.3.2 b)
5.10.3.2 c)
5.10.3.2 d)
(DoD) The lab may use additional data qualifiers, or different letters or symbols to
denote the qualifiers listed above, as long as they are appropriately defined and their
use is consistent with project-specific requirements
Sampling in reports include:
Date of sampling.
Unambiguous identification of the substance, material or product sampled.
Location of sampling.
Reference to sampling plan and procedure.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 50 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.10.3.2 e)
5.10.3.2 f)
5.10.4
5.10.4.1
5.10.4.1 a)
5.10.4.1 b)
5.10.4.1 c)
5.10.4.2
5.10.4.2
5.10.4.2
5.10.4.3
5.10.4.4
5.10.5
5.10.5
5.10.6
5.10.6
5.10.7
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Environmental conditions during sampling that may affect the interpretations of
results.
Standard or specification for the sampling method or procedure, and deviations,
additions to or exclusions from the specification concerned.
Calibration Certificates
Calibration certificates also include:
Conditions (e.g. environmental) under which the calibrations were made that
influenced the results.
Uncertainty of measurement and/or a statement of compliance with an identified
metrological specification or clauses thereof.
Traceability of measurements.
Certificates relate only to quantities and results of functional tests. If a statement of
compliance with a specification is made, it identifies which clauses of the specification
are met or not met.
When a statement of compliance is made omitting the results and associated
uncertainties, the lab records those results and maintain them for future reference.
When a statement of compliance is made, the uncertainty is taken into account.
When an item for calibration is adjusted or repaired, the results before and after
adjustment or repair, if available, are reported.
Calibration certs and labels shall not contain recommendation on the cal interval,
except where agreed with the client.
Opinions and Interpretations
Basis for opinions and interpretations. Opinions and interpretations clearly marked in
report.
(DoD) When included, opinions and interpretations will be contained in the case
narrative.
Testing and Calibration Results Obtained from Subcontractors
Subcontracted test results clearly identified.
On subcontracted calibrations, the lab performing work issues the calibration
certificate.
(DoD) The lab will make a copy of the subcontractor’s report available to the customer
when requested by the customer.
Electronic Transmission of Results
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 51 of 52
Form 403A.2 - LABPR 403A – Module 2: Quality Systems – General Requirements - Assessment Checklist
ELEMENT
5.10.8
5.10.9
5.10.11
5.10.11 a)
5.10.11 a)
5.10.11 a)
5.10.11 b)
5.10.11 c)
5.10.11 d)
5.10.11 e)
REQUIREMENT
LAB
DOCUMENT
REFERENCE
C
N
ASSESSMENT
NOTES
Results transmitted by telephone, telex, fax, or other electronic or electromagnetic
means follow the requirements of 17025.
Format of Reports and Certificates
Designed to minimize the possibility of misunderstanding or misuse.
Amendments to Reports or Certificates
Made in the form of a further document which includes statement: “Supplement to
Test Report [or Calibration Certificate}, serial number [or as otherwise identified] or
equivalent wording.
Amendments meet the requirements of 17025.
(TNI) When necessary to issue a complete new report or certificate, it is uniquely
identified and contain reference to the original that it replaces.
(TNI) Additional Requirements
(TNI) Time of sample preparation and/or analysis if the required holding time for
either activity is
less than or equal to seventy-two hours
(DoD) The date and time of sample collection, preparation, and analysis are required to
be included as part of the lab report, regardless of the length of holding time. If the
time of the sample collection is not provided, the lab assumes the most conservative
time of day.
(DoD) For the purpose of batch processing, the start and stop dates and times of the
batch preparation are recorded.
(TNI) Results that are reported on a basis other than as received (e. g., dry weight).
(TNI) Any non-accredited tests are clearly identified as such to the client when claims
of accreditation to this Standard are made in the analytical report or in the supporting
electronic or hardcopy deliverables.
(TNI) Clear identification of numerical results with values outside the calibration
range.
(DoD) Qualification of numerical results with values outside the quantitation range.
Legend: Lab Document = Lab document to demonstrate compliance. Include: Document Name(s), Paragraph Number(s) or Equivalent. C = Compliant, N = Non-Compliant.
Form 403A.2 – Rev 1 – 04/15/14
Page 52 of 52