Weights and Measures Division

Quality Manual

For

Proficiency Testing and

Interlaboratory Comparisons

Gust, Jeff C. 

Harris, Georgia L.

NISTIR 7214

NISTIR 7214

Weights and Measures Division

Quality Manual

For

Proficiency Testing and

Interlaboratory Comparisons

Gust, Jeff C. (contract)

Quametec Corporation

Harris, Georgia L.

Weights and Measures Division

Technology Services

March 2005

U.S. DEPARTMENT OF COMMERCE

Carlos M. Gutierrez, Secretary

TECHNOLOGY ADMINISTRATION

Phillip J. Bond, Under Secretary of Commerce for Technology

NATIONAL INSTITUTE OF STANDARDS AND TECHNOLOGY

Hratch G. Semerjian, Acting Director
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 TABLE OF CONTENTS 

TABLE OF CONTENTS...................................................................................................iii 

ABSTRACT........................................................................................................................ v 

INTRODUCTION .............................................................................................................. 7 

Scope............................................................................................................................... 7 

Document Retention ....................................................................................................... 7 

References....................................................................................................................... 7 

Definitions....................................................................................................................... 9 

1. ADMINISTRATION................................................................................................ 10 

1.1. Quality System & Policy .................................................................................. 10 

1.2. Organization and Management......................................................................... 11 

1.3. Roles and Responsibilities ................................................................................ 12 

1.4. Collaboration and Subcontracting..................................................................... 13 

1.5. Fees ................................................................................................................... 14 

1.6. Policy for Participation ..................................................................................... 14 

1.7. Document Control............................................................................................. 15 

1.8. Request, Tender or Contract Review................................................................ 16 

1.9. Procurement of Services and Supplies.............................................................. 17 

1.10. Client Feedback ............................................................................................ 17 

1.11. Control of Nonconforming Activities and Corrective Action ...................... 18 

1.12. Preventive Action.......................................................................................... 19 

1.13. Records ......................................................................................................... 19 

1.14. Internal & External Audits............................................................................ 20 

1.15. Management Review .................................................................................... 21 

1.16. Management Staffing and Training .............................................................. 21 

1.17. Collusion and Falsification of Results .......................................................... 22 

1.18. Data Processing Equipment .......................................................................... 22 

2. PLANNING .............................................................................................................. 24 

2.1. Technical Protocol Development...................................................................... 24 

3. IMPLEMENTATION............................................................................................... 25 

3.1. Preparation of the Artifact ................................................................................ 25 
iv

3.2. Packaging/Shipping/Handling .......................................................................... 25 

3.3. Materials Handling and Storage........................................................................ 26 

4. ANALYSIS............................................................................................................... 27 

4.1. Determination of Assigned Reference Values and its Associated Uncertainty 27 

4.2. Performance Evaluation of Participants............................................................ 27 

4.3. Outlier Detection Techniques ........................................................................... 28 

4.4. Assessing the Stability of the Artifact .............................................................. 29 

4.5. Assessing Homogeneity of Artifact.................................................................. 29 

5. REPORTING ............................................................................................................ 31 

5.1. Schedules .......................................................................................................... 31 

5.2. Preliminary Reports .......................................................................................... 31 

5.3. Final Reports..................................................................................................... 31 

APPENDIX A - FORMS.................................................................................................. 32 

Form 1: PT/ILC Planning Checklist ................................................................................. 33 

Form 2: PT/ILC Reporting Checklist ............................................................................... 36 

Form 3: PT/ILC Training & Qualifications...................................................................... 38 

Form 4: PT/ILC Feedback and Complaints...................................................................... 41 

Form 5: WMD Quality System Management Review...................................................... 42 

Form 6: WMD Internal Audits for PT/ILC Activities...................................................... 44 

Form 7: NIST WMD Nonconformance/Corrective Action/Preventive Actions (NCAP) 47 

Form 8: Schedule & Shipping........................................................................................... 49 

APPENDIX B – PROCEDURES & POLICIES .............................................................. 50 

Procedure 1: PT/ILC Software Validation Procedure ...................................................... 51 

Procedure 2: Selection of Delegates ................................................................................. 52 

Policy: NISTIR 7082 "Proficiency Test Policy and Plan (for State Weights & Measures 

Laboratories)" (on-line at http://www.nist.gov/labmetrology)......................................... 53 
v

ABSTRACT 

This document has been prepared by Jeff C. Gust (Quametec Corp., under contract) in 

collaboration with NIST Weights and Measures Division (WMD) to enable State 

Weights and Measures Laboratories to comply with criteria for proficiency testing as 

noted in NIST Handbook 143 and as needed for accreditation programs. This document 

is intended to provide the basic quality system for Proficiency Testing and Interlaboratory 

Comparisons developed by NIST Weights and Measures Division. 

Acknowledgement 

The following individuals participated in the development and review of this document: 

Richard Cote, New Hampshire Department of Agriculture 

Doug Faison, NIST/National Voluntary Laboratory Accreditation Program 

Ken Fraley, Oklahoma Bureau of Standards 

Elizabeth Gentry, Oklahoma Bureau of Standards 

Tom Hale, Pennsylvania General Services Administration 

Georgia L. Harris, NIST/Weights and Measures Division 

Carol Hockert, Minnesota Department of Commerce, Weights and Measures Division 

Van Hyder, NC Department of Agriculture & Consumer Services, Standards Laboratory 

G. Diane Lee, NIST/Weights and Measures Division 

Val Miller, NIST/Weights and Measures Division 

Steve Schultz, Nevada Department of Agriculture, Bureau of Weights and Measures 
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INTRODUCTION 

Scope 

This document has been developed for the NIST Technology Services, Weights and 

Measures Division (WMD) in order to establish and implement a quality system for the 

planning, implementation, analysis, and reporting of Proficiency Tests (PT) and 

Interlaboratory Comparisons (ILC) conducted within the WMD Measurement Assurance 

Program (MAP). This document contains the NIST QMD Quality Manual for 

Proficiency Testing and Interlaboratory Comparisons. This document provides the quality 

system to ensure that all Proficiency Testing and Interlaboratory Comparison activities 

within WMD are compliant with ILAC-G13:2000, Guidelines for the Requirements for 

the Competence of Providers of Proficiency Testing Schemes and ISO/IEC Guide 43-

1:1997, Proficiency Testing by Interlaboratory Comparisons – Part 1, Development and 

Operation of Proficiency Testing Schemes. This document specifies requirements to 

ensure that NIST WMD and associated delegates are technically competent to provide 

specific types of proficiency testing schemes as required by NISTIR 7082, Proficiency 

Test Policy and Plan (for State Weights and Measures Laboratories), 2004. 

 

Document Retention 

This document has no expiration date and remains in effect until revised, replaced, or 

retired. 

References 

Compilation of Federal Ethics Laws (approved through May 27, 2003) – Prepared by the 

United States Office of Government Ethics. [Web page], 

http://www.usoge.gov/pages/laws_regs_fedreg_stats/comp_fed_ethics_laws.pdf. 

Gust, J. C. and Harris, Georgia L. Proficiency Test Policy and Plan (for State Weights 

and Measures Laboratories). National Institute of Standards and Technology, (U.S.) 

NISTIR 7082, 2004 January [Web page] http://www.nist.gov/labmetrology. 

Harris, Georgia. L. State Weights and Measures Laboratories Program Handbook, 4th

Edition. National Institute of Standards and Technology (U.S.) Handbook 143; 2003, 

March. [Web page] http://www.nist.gov/labmetrology. 

Harris, Georgia. L. State Weights and Measures Laboratories: State Standards Program 

Description and Directory. National Institute of Standards and Technology (U.S.) NIST 

SP 791, 2000 Edition; 2000 August. [Web page], 

http://ts.nist.gov/ts/htdocs/230/235/labdirectory/sp791.htm [last updated 10/1/02]. 
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ILAC-G13:2000, Guidelines for the Requirements for the Competence of Providers of 

Proficiency Testing Schemes. International Laboratory Accreditation Cooperation, 2000. 

ISO/IEC Guide 43-1:1997, Proficiency Testing by Interlaboratory Comparisons – Part 1: 

Development and Operation of Proficiency Testing Schemes. International Organization 

for Standardization, 1997. 

ISO/IEC 17025:1999, General Requirements for the Competence of Testing and 

Calibration Laboratories, International Organization for Standardization, 1999. 

National Conference of Standards Laboratories (NCSL) Recommended Practice, RP-15, 

Guide to Interlaboratory Comparisons, 1999 March. 

NIST/SEMATECH e-Handbook of Statistical Methods, [Web page], 

http://www.itl.nist.gov/div898/handbook/, National Institute of Standards and 

Technology (U.S.) Handbook 151, 2002 November. 
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Definitions 

Analyst – Assigned person who is responsible for handling all data related activities for 

the Proficiency Test or Interlaboratory Comparison (PT/ILC). (As used in this publication 

“PT/ILC” is used generically to mean either a Proficiency Test or an Interlaboratory 

Comparison; the specific objectives and context will determine the application and use of 

PT/ILC results.) 

Coordinator – A party who is responsible for implementation of the PT/ILC. 

Delegate – Any party outside of NIST, Technology Services, WMD who volunteers or 

accepts a task related to the PT/ILC from the Technical Manager who works with the 

WMD to accomplish its proficiency testing objectives, whether volunteer or contractor. 

Delegates may include: analysts, coordinators, pivot laboratories, reference laboratories, 

and regional administrators. 

Interlaboratory Comparison – a generic term for the circulation of an artifact, standard, or 

set of standards for the purpose of evaluating measurement results. 

NIST POC – Assigned point of contact within NIST WMD for the PT/ILC. 

Participant – Any organization meeting RMAP (see definition) requirements for 

participation in a PT/ILC. 

Pivot Laboratory – Laboratory organization that determines stability value for the artifact. 

Provider – NIST Weights and Measures Division is considered the “provider.” 

Proficiency Test – A specific interlaboratory comparison that may be used by a 

laboratory or Recognition and/or Accreditation bodies as evidence of staff competence. 

Reference Laboratory – Laboratory organization that determines the reference value for 

the artifact. 

RMAP – Regional Measurement Assurance Program. 

Regional Administrator – Regional coordinator who assists in tracking the status of all 

PT/ILCs within the region. 

Technical Manager – The Technical Manager is the Group Leader for the WMD 

Laboratory Metrology Group. 
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1. ADMINISTRATION 

1.1. Quality System & Policy 

1.1.1. This document establishes, implements and maintains the quality 

system for proficiency testing and interlaboratory comparison activities of 

NIST WMD for the scope of Measurements that are defined in section 1 of 

NISTIR 7082, Proficiency Test Policy and Plan (for State Weights and 

Measures Laboratories). 

1.1.2. This document defines and documents the WMD’s policy, 

objectives and commitment to ensuring and maintaining quality of all 

aspects of proficiency testing. Artifact quality, characterization, and 

assignment of property values are described in PLANNING. Evaluation of 

each laboratory’s performance and statistical treatment of test results are 

described in ANALYSIS. Distribution of artifacts, storage and transport 

procedures are described in IMPLEMENTATION. Reporting procedures 

are described in REPORTING. 

1.1.3. Quality Policy: NIST WMD pledges to provide proficiency testing 

services using metrologically sound practices and the highest levels of 

service quality as documented in this quality system. All staff and 

delegates associated with proficiency testing services pledge to adhere to 

the policies and procedures documented in this quality system, performed 

in accordance with ILAC G13:2000, ISO/IEC Guide 43-1, and relevant 

sections of ISO/IEC 17025:1999. 
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1.1.4. The locations of the applicable sections of ILAC G13 are as 

follows: 

ILAC G13 Requirement, Section 2.1.3, section letter Quality Manual Section 

a Aims Introduction 

a Scope NISTIR 7082 

a Statistical Design Analysis 

a Format Reporting 

b Operational Procedures Implementation 

c Preparation and Issuing of Reports Reporting 

d Policies on Confidential and Ethical Procedures Administration 

e Computing and Information Systems Administration 

f Collaboration and Sub-contracting Administration 

g Fees for Participation Administration 

h Scope of Availability of Proficiency Testing 

Programs 

Regional MAP Programs 

i General Policies on Participation Administration 

j Use of Scheme Results Administration 

k Procedures for Handling Complaints Administration 

1.1.5. Throughout this document, the responsibilities for all activities are 

defined in each applicable section. 

1.2. Organization and Management 

1.2.1. The organization providing proficiency tests within the scope of 

this document is NIST, Technology Services, Weights and Measures 

Division (Division 260.) 

1.2.2. The Technical Manager and Quality Manger (as assigned by the 

WMD Laboratory Metrology Group Leader) task other personnel within 

the WMD Metrology Group and Delegates to complete all aspects of 

PT/ILC within the scope of this program. 

1.2.3. In order to ensure that all management and personnel are free from 

any commercial, financial, internal, or external pressures that may 

adversely affect the quality of PT/ILC activities, all Federal Employees are 

subject to abide by the Federal ethics laws as cited in the “Compilation of 

Federal Ethics Laws”. Additionally, all appointed Delegates must comply 

with all elements contained in POLICY FOR PARTICIPATION which is 
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intended to ensure freedom from external pressures. These policies also 

ensure that all personnel involved in PT/ILC activity avoid involvement in 

activities that might diminish the confidence in the competence, 

impartiality, judgment, or operational integrity of NIST WMD. 

1.2.4. It is the policy of NIST WMD that all PT/ILC activities are 

completely open, with no coded or confidential information. All 

participants must agree to these conditions before being qualified to 

participate in PT/ILC activities. This document may be used to develop 

PT/ILC activities for the NIST National Voluntary Laboratory 

Accreditation Program (NVLAP) at their request. For this special case, 

access to information which results from PT/ILC activities is restricted to a 

minimum number of people and the reported information may be coded to 

ensure the confidentiality of the participants where NVLAP determines 

that it is necessary. 

1.2.5. WMD may occasionally coordinate PT/ILC activities for NVLAP 

or other accreditation bodies when it is in the interest of WMD program 

objectives. In these cases, WMD will follow the confidentiality policies of 

the accreditation bodies if requested. 

1.2.6. NIST WMD has developed organization charts to define its 

Organization and Management structure, its place within NIST, and the 

relations between management, technical operations, support services, and 

delegates. The organization charts also demonstrate the responsibility, 

authority, and interrelationships of all personnel who manage, perform or 

verify work in PT/ILC activities. 

1.3. Roles and Responsibilities 

1.3.1. The Technical Manager has overall technical responsibility for 

each PT/ILC activity. The Technical Manager or Designee from NIST 

WMD reviews and provides final approval on all PT data, analysis, and 

reports. Final approval of PT data, analysis, and reports may not be 

assigned to personnel outside of NIST WMD. 

1.3.2. The Technical Manager must have experience with PT/ILC 

activities that are conducted within the scope of NISTIR 7082. The 

Technical Manager must have the educational and technical background 

required to meet a position for a Physical Scientist ZP III within NIST 

WMD, Laboratory Metrology Group. The requisite background includes 

extensive experience in calibration of standards of mass, length, and 
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volume; experience in developing calibration procedures and methods; 

participation in, or coordination of, round robins or other interlaboratory 

experiments and comparisons; and experience in quality system operations 

and audits. 

1.3.3. The Quality Manager has responsibility for all quality related 

aspects of this program such as the maintenance of records, Internal 

Audits, and ensuring adherence to policies and procedures. 

1.3.4. The Quality Manager must have experience and training as a lead 

auditor in a metrology-related field (e.g., ISO 9000, ISO/IEC 17025). 

1.3.5. The Technical and Quality Managers, and their deputies shall be 

assigned by the WMD Laboratory Metrology Group Leader via email or 

memo, which are retained as a correspondence quality record. 

1.4. Collaboration and Subcontracting 

1.4.1. The Technical Manager may designate activities from the 

PLANNING, ANALYSIS, IMPLEMENTATION, and REPORTING sections 

of this document to collaborators who will hereby be known as Delegates. 

1.4.2. Delegates are selected based upon an assessment of technical 

qualifications as determined by the Technical Manager or Designee. All 

Delegates are evaluated using procedures and records described in the 

Training section of the ADMINISTRATION section. 

1.4.3. Laboratories that are selected for establishment of the reference 

value or performance of pivot measurements must be either accredited in 

the measurement parameter of concern by an accreditation body that is a 

signatory to the ILAC, MRA (International Laboratory Accreditation 

Cooperation, Mutual Recognition Arrangement http://www.ilac.org), or 

recognized for compliance to NIST Handbook 143 by NIST for the 

measurement parameter of the PT/ILC, and be able to provide a suitable 

level of measurement uncertainty for the proposed PT/ILC. Records of 

competency for any laboratory used for measurement activities are 

maintained in the WMD files and databases. Laboratory qualification may 

include one or more measurement areas and/or PT/ILCs. Laboratory 

recognition/accreditation status and records must be evaluated for accuracy 

and updated as needed, prior to each assigned PT/ILC. 
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1.4.4. Subcontracting, if coordinated, will be performed with 

organizations that are accredited to perform PT/ILCs and/or comply with 

this quality system. 

1.5. Fees 

1.5.1. NIST does not charge fees for participation in any PT/ILC 

activities. Commercial Laboratories that participate in PT/ILC activities 

are to pay costs of shipping to and from their laboratory. This requirement 

may be waived if they are serving as a delegate for the PT/ILC. 

NOTE: Fees charged for attendance at the RMAP meetings are for coordination 

and costs associated with the meeting functions and not those of operating the 

proficiency testing programs. Attendance at the meetings, which is required to 

obtain reports and participation in the discussions, will usually require payment 

of fees associated with the cost of the meetings (distinct from the cost of the 

PT/ILC activity). 

 

1.6. Policy for Participation 

1.6.1. Any laboratory organization (Participant) that would like to 

participate in a PT/ILC activity within the scope of this document must 

agree to operate in accordance with the policies and conditions for 

participation as described in this quality system as follows: 

1.6.1.1. The Participant will follow instructions for each PT and use 

designated procedures when instructed. 

1.6.1.2. The participant must acknowledge that all NIST WMD PT/ILCs are 

considered OPEN and that anonymity is not implied or guaranteed. 

1.6.1.3. The Participant will not use any PT/ILC report for any purpose other 

than internal measurement assurance or accreditation/recognition 

activities (no sales, marketing, or advertising of the results of any 

participating laboratory). 

1.6.1.4. The Participant will not falsify any results submitted to NIST WMD. 

1.6.1.5. The Participant agrees to keep details regarding the PT/ILC in 

confidence. It is inappropriate to share information (specifically 

measurement results) regarding the artifacts provided in the proficiency 

test final report or to seek to obtain measurement information for 
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artifacts prior to participation in the proficiency test (i.e., participants 

will share data only with the coordinator, analyst or NIST staff). 

Exception: Draft En values or notice of significant error/bias may be 

communicated to individual laboratories, with follow-up monitoring by the ILC 

coordinator or by NIST to enable immediate investigation, corrective action, 

and retesting (if needed). 

1.6.1.6. The participating organization will regularly attend RMAP meetings 

and participate in PT/ILC discussions. 

1.6.1.7. Participants and participating organizations will be technically 

qualified for the measurement parameter of interest. 

1.6.2. NIST WMD reserves the right to refuse participation to any 

organization, even if they are technically qualified, if the participant or 

participating organization has violated quality policies, procedures for care 

and handling of artifacts, repeated technical delays, or other technical 

issues that could potentially adversely affect the results for the other 

participants. Prior to WMD issuing a notice of refusal to a laboratory, due 

efforts will be made to notify participants in this category, provide 

guidance, and ensure that the laboratory has an opportunity for corrective 

action. 

1.7. Document Control 

1.7.1. Document control is maintained by NIST WMD, with approved 

documents for this quality system published and available for unlimited 

distribution on the World Wide Web at http://www.nist.gov/labmetrology

(select Proficiency Testing Program). Any paper copies of quality 

documents used for any purpose must match the revision and date of issue 

as the associated document posted at the website. WMD will make 

general announcements to all staff and delegates when updates have been 

made. The approved, controlled copies of publications will be electronic 

and retained on the website. Copies will be retained for local use and backup on NIST or WMD networks. 

1.7.2. All documentation related to the scope of this quality manual is 

reviewed and approved for use by the Technical Manager prior to issue. 

The master list of approved documents is located at 

http://www.nist.gov/labmetrology. 
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1.7.3. All documentation will be technically reviewed for content and 

policy and assigned a publication number as per the requirements of 

NIST’s editorial review and approval process, the Washington Editorial 

Review Board (WERB) in Gaithersburg, MD 

1.7.4. Documentation related to this quality system is reviewed during 

Internal Audits and through regular use by all participants to ensure 

continuing suitability. Documents are also reviewed by personnel during 

each use. Any issues of suitability are communicated to the Quality 

Manager in writing. 

1.7.5. During the document revision process, any document that has been 

revised will be removed from the website and replaced with the most 

current revision. Historical documents may be maintained on the website 

if they have been suitably marked as “OBSOLETE, REFERENCE ONLY” 

so that the historical nature is obvious if used. 

1.7.6. Any invalid or obsolete documents maintained by NIST WMD for 

historical purposes are marked as “OBSOLETE, REFERENCE ONLY.” 

1.7.7. Any revisions to documents will be reviewed and approved by the 

Technical Manager. Minor changes to documentation will be described in 

the revision history for the document. Major changes to the documents 

will be identified by the word processing software “track changes” 

function and maintained by the Technical Manager. Hand-written changes 

will not be used. 

1.8. Request, Tender or Contract Review 

1.8.1. NIST WMD program is not a commercial PT/ILC organization. 

All PT/ILC activities occur as a result of WMD direction and/or RMAP 

participation in the development of PT/ILC. The contract review function 

is completed as a result of all members reaching consensus in the 

development of the PT/ILC as documented on the PT/ILC Planning 

Checklist (Form 1) for the RMAP’s form. All participants must agree to 

abide by all elements of POLICY FOR PARTICIPATION. Any individual 

request for a new member or a member of another RMAP to participate in 

a PT/ILC that has already been developed and is operating must be 

submitted to the NIST WMD office for review, documentation and 

approval by the Technical Manager. Records of the PT/ILC Planning 

Checklist, individual requests to participate, and any associated changes 

are reviewed, approved, and maintained by the NIST WMD office. 
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1.8.2. PT/ILCs are communicated to participants outside of the RMAPs, 

usually via email or the NIST WMD website. The NIST WMD website 

provides an informational overview for each PT/ILC and whether or not it 

has openings for individual requests to participate. Special requirements 

for participation are noted/posted where applicable. 

1.8.3. Any changes in the scheme design or operation of a PT/ILC are 

communicated to all participants in writing. Changes are maintained with 

WMD records for each PT/ILC. 

1.8.4. When PT/ILC functions are coordinated with or on behalf of 

NVLAP, specific changes to the operation of a PT/ILC that are in conflict 

with this quality manual must be documented and retained on file. 

1.9. Procurement of Services and Supplies 

1.9.1. NIST WMD uses the Federal Acquisition Requirement (FAR) 

policies and procedures for procurement of all services and supplies. The 

Technical Manager or Designee develops and documents technical 

specifications, tolerances, and other requirements for all procured services 

and supplies, which are used in selecting suppliers. Upon receipt of items 

that affect the quality of PT/ILC services provided, the items are inspected 

for conformance to the documented technical requirements. For certain 

artifacts the reference laboratory may be required to perform the final 

inspection in order to ensure that the artifact is suitable for use in the 

PT/ILC. Final reports and analyses are reviewed and documented by the 

Technical Manager or Designee. Records of procurement and inspection 

are maintained by NIST WMD. 

1.9.2. When items are used for PT/ILC activities that do not belong to 

WMD, suitable evaluation and assessment must be conducted and 

documented to ensure that artifacts are of sufficient quality to meet the 

stated objectives of the PT/ILC. 

1.10. Client Feedback 

1.10.1. Feedback from participants is sought during each RMAP meeting, 

in order to improve PT/ILCs that are developed within the scope of this 

document. The PT/ILC Feedback and Complaints Form (Form 4) and the 

WMD Quality System Management Review Form (Form 5) will be used to 
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ensure the uniform collection and consolidation of feedback from all 

RMAPs. 

1.10.2. Complaints and feedback may be recorded by an ILC Coordinator, 

a delegate of the ILC, or the WMD office staff. Records of such feedback 

or complaints and their associated investigation and corrective actions are 

maintained through completion of the PT/ILC Feedback and Complaint 

Form (Form 4) or the WMD Nonconformance/Corrective 

Action/Preventive Action (NCAP) Form (Form 7). Evaluation of criteria 

for conformance and non-conformance is performed by the Technical 

Manager in accordance with Section 1.11. 

1.11. Control of Nonconforming Activities and Corrective Action 

1.11.1. In the event that any aspect of activities within the scope of this 

document is identified as nonconformity to the procedures or the stated 

requirements, it is the responsibility of the Technical Manager to 

investigate and determine appropriate corrective action. The corrective 

action process is applied to all identified nonconformities and shall be 

appropriate to the magnitude of the problem encountered. 

1.11.2. All aspects of the nonconformance are recorded on the WMD 

 Form 7 (NCAP). It is the responsibility of the Technical Manager 

 to: 

1.11.2.1. investigate and determine root cause of nonconformance; 

1.11.2.2. evaluate the significance of the nonconformance; 

1.11.2.3. identify potential corrective actions and select the action most 

 likely to eliminate the problem and prevent it from reoccurring; 

1.11.2.4. ensure work is halted if necessary; 

1.11.2.5. assign a timescale for completion of corrective action; 

1.11.2.6. obtain funding if needed; and 

1.11.2.7. initiate corrective actions as required. 

1.11.3. If necessary, participants are notified in writing and 

nonconforming materials or reports are recalled. Upon completion of 

corrective actions, the Technical Manager may authorize the resumption of 

the process/scheme. 

1.11.4. Any corrective actions are monitored by the Quality Manager 

during the Internal Audits to ensure that the corrective action was 

effective. 
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1.12. Preventive Action 

1.12.1. All operational procedures are reviewed during the Internal Audit 

and upon each use by all staff and delegates in order to identify 

opportunities for improvement. Any preventive actions and their 

associated action plans are identified and recorded on WMD NCAP Form 

(Form 7). Results of preventive actions are monitored and reviewed 

during Internal Audits and Management Reviews in order to understand 

the effectiveness of the preventive action. 

1.13. Records 

1.13.1. The following types of records are identified and indexed as 

quality records for NIST WMD PT/ILC activities. They are collected at 

time of generation, and stored by marked section in file cabinets or in 

electronic version on computer. The retention times for all documents are 

at least ten years after the completion of the test or retirement (or loss) of 

the artifact or proficiency test. After ten years, the Quality Manager may 

dispose of records at his/her discretion. 

1.13.1.1. Master Document List 

1.13.1.2. Previous editions of controlled documents and obsolete documents 

1.13.1.3. Client Feedback 

1.13.1.4. Artifact History Records and Inventory List 

1.13.1.5. Customer Complaint/Feedback Log and Information 

1.13.1.6. Nonconformities 

1.13.1.7. Corrective Actions 

1.13.1.8. Preventive Actions 

1.13.1.9. Proficiency Test/Interlaboratory Comparison Records 

1.13.1.10. Proficiency Test/Interlaboratory Comparison Reports 

1.13.1.11. Internal and External Audits 

1.13.1.12. Management Reviews 

1.13.1.13. Training Schedule and Training Records (i.e., Form 3) 

1.13.1.14. Assignment of Deputy Technical and Quality Manager 

1.13.1.15. Software Validation Records 

1.13.1.16. Correspondence Records 

1.13.2. The storage facilities for records are at the NIST WMD office. 

Back-up copies of electronic records are maintained on the NIST network. 

NIST’s Information Technology (IT) back up services and security features 

are administered following policies and procedures set by the NIST Office 

of Chief Information Officer. 
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1.13.3. The records are stored in the NIST WMD offices so that only 

employees have access to the hard copy records. Electronic copies of 

records are stored on the hard drives and network of NIST WMD 

computers and are appropriately password protected. 

1.13.4. To prevent unauthorized amendment of data, Electronic Data is 

protected via password protection of operational features for each person’s 

PC, and backed up to CD ROM media, to prevent unauthorized 

amendment of data. 

1.13.5. Technical records contain information as prescribed in 

REPORTING and are maintained as a quality record. 

1.14. Internal & External Audits 

1.14.1. An Internal Audit of the quality system related to this document is 

completed annually, as scheduled by the Quality Manager. The audit may 

be performed by sections so that the entire quality system is reviewed 

annually. 

1.14.2. The Quality Manager is primarily responsible for the planning and 

conduct of the Internal Audit. The schedule for the Internal Audit will be 

determined at the time of the Management Review meeting. The Quality 

Manager may designate individuals to perform parts of the Internal Audit 

and will ensure the training and qualifications of such individuals. Internal 

Audit Results are collected and summarized on the WMD Internal Audit 

Form (Form 6). 

1.14.3. The Internal Audit shall review all elements and activities 

associated within the scope of this document. During the Internal Audit, 

all documents and program elements are reviewed for continuing 

effectiveness and potential for improvement. Any nonconformities 

identified throughout the previous year are reviewed for closure and 

effectiveness. Any nonconformities identified during the Internal Audit 

will be addressed by following the policy in ADMINISTRATION - 

Control of Nonconforming Activities and Corrective Action. 

1.14.4. Any External Audits that are authorized and conducted will follow 

appropriate or applicable standards as determined by the Technical and/or 

Quality Manager. Such records will be retained with other auditing 

records and discussed during Management Reviews. 
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1.15. Management Review 

1.15.1. RMAP PT/ILC Quality System Review 

1.15.1.1. NIST WMD conducts management reviews of the quality system 

and PT/ILC activities as applicable within each RMAP during the 

annually scheduled meeting of the RMAP. Any suggestions for 

changes or improvements are summarized in report form (Forms 4 and 

5) for discussion at the annual Management Review meeting. 

1.15.2. NIST WMD PT/ILC Quality System Review 

1.15.2.1. NIST WMD conducts a Management Review meeting of the 

 quality management system annually, as scheduled by the 

 Technical Manager. The Management Review meeting discusses: 

1.15.2.1.1. Suitability and effectiveness of the Quality System 

1.15.2.1.2. The Quality and applicability of PT/ILC Activities 

1.15.2.1.3. Reports from RMAP meetings (Forms 4 and 5) 

1.15.2.1.4. Reports from Internal Audits (Form 6) 

1.15.2.1.5. Reports of External Audits (e.g., NVLAP, A2LA, L.A.B., 

 other requested body) 

1.15.2.1.6. Client feedback/complaints 

1.15.2.1.7. Resources (facilities, standards, and equipment) 

1.15.2.1.8. Outstanding items from previous Management Review 

1.15.2.1.9. Staff Training 

1.15.2.1.10. Other relevant reports 

1.15.2.2. The minutes of the Management Review meeting are recorded and 

any actions or improvement suggestions are assigned to appropriate 

personnel with an estimated completion date to ensure completion 

within an appropriate and agreed upon timescale. 

1.16. Management Staffing and Training 

1.16.1. Training 

1.16.1.1. The Technical Manager has responsibility for the management of 

all PT/ILC activities associated with NIST WMD. The Technical 

Manager is responsible for ensuring that all personnel who have any 

responsibilities associated with any PT/ILC activities are sufficiently 

trained. 
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1.16.1.2. The Coordinator, Delegate, and Analyst positions as assigned for 

PT/ILC activities must have adequate training to ensure that they have 

the technical capability to complete the duties as assigned. It is the 

responsibility of the Technical Manager to annually develop a training 

plan and ensure that essential training is conducted to ensure the 

competency of all personnel involved in the PT/ILC activities. 

1.16.1.3. Participant training and qualifications shall be documented using 

the PT/ILC Training and Qualifications form (Form 3) to verify 

adequate training and ensure that they possess the technical capability 

to participate within specific PT/ILC parameters. 

1.16.1.4. Records of training for all personnel involved with PT/ILC 

management activities are maintained using Form 3 and database 

developed and maintained by NIST WMD for training records. 

1.16.2. Staffing 

1.16.2.1. The Technical Manager is responsible for ensuring sufficient 

staffing for each PT/ILC and that all personnel involved in PT/ILC are 

qualified. The Technical Manager reviews the training records of all 

personnel involved to ensure the effective management of all PT/ILC 

activities. Records of training for all personnel involved with PT/ILC 

management activities are maintained using a database developed and 

maintained by NIST WMD for training records. 

1.17. Collusion and Falsification of Results 

1.17.1. Each PT/ILC activity is designed to ensure, as is practicable, that 

the possibility for collusion and falsification of results is minimized. It is 

the responsibility of the PT/ILC Coordinator to monitor the activities of 

the PT/ILC and to ensure that there is no communication of the assigned 

values to or among participants until the results of the PT/ILC activity 

have been collated in a draft report. In addition to the PT/ILC coordinators 

monitoring activities to this end, each participant in PT/ILC activities 

within the scope of this document is required to comply with all elements 

of POLICY FOR PARTICIPATION. 

1.18. Data Processing Equipment 

1.18.1. NIST WMD utilizes personal computers, laptop computers, and 

scientific calculators for data entry and statistical analysis of PT/ILC 
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activities, all of which are adequate for the assigned task. Deficiencies 

noted with data processing equipment are brought to the attention of the 

Technical Manager, and are addressed during Internal Audits and 

Management Reviews as appropriate. 

1.18.2. The IT activities of NIST or the IT Department of Delegate 

organizations are responsible for the effective operation of laptop and 

personal computers. Calculators are a disposable item and are replaced by 

the user if any abnormal operation is detected. Use of appropriate 

significant digits is considered in data evaluation and addressed as needed 

during ongoing training of staff/delegates. 

1.18.3. Commercial Software programs such as Microsoft Excel do not 

require further validation. Sub-programs such as worksheets for the 

analysis, evaluation, and reporting of results for activities within the Scope 

of this document require validation before use as per the PT/ILC Software 

Validation Procedure (Procedure 1). 

1.18.4. Records of objective evidence for the validation and revision date 

of the software are maintained at NIST WMD by the Quality Manager. 

The distribution of any such software is accomplished through the NIST 

WMD website, by email, or by sharing of files through other electronic 

means. The software on the NIST WMD website is the master copy of the 

software and it is backed up routinely by NIST IT procedures. 
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2. PLANNING 

The general PT/ILC requirements are plans developed in accordance with NISTIR 7082, 

during Management Review and RMAP meetings. 

A PT/ILC begins with the planning activities performed by an advisory group. This 

group may be assembled by the Technical Manager for national level PT/ILC activities or 

may consist of an RMAP group (or subgroup). The advisory group plans the PT/ILC 

activity by completing the PT/ILC Planning Checklist Form (Form 1). 

2.1. Technical Protocol Development 

2.1.1. The Technical Manager or Delegate develops the Technical 

Protocol for the PT/ILC based upon the information obtained in the 

associated PT/ILC Planning Checklist form (Form 1). The Technical 

Protocol shall contain the following information, as relevant: 

• Environmental Conditions for Realizing the Measurement Results for the 

Artifact; 

• Environmental Conditions for Storage and Transport for the Artifact; 

• Preparatory Information for the Artifact(s); 

• Packaging and Shipping Information of the Artifact and tracking 

requirements; 

• Communication to the participants to treat the artifact in the same manner 

as routine measurements for the method prescribed or other specified 

instructions on handling; 

• Instructions of the measurement method to be used in the PT/ILC; 

• Reporting Requirements for Participating Laboratories: 

o Units of measurement; 

o Number of significant digits; 

o Date of measurement; 

o Reporting reference/basis of measurement (e.g., environmental 

conditions, reference temperature); 

o Measurement value and its associated expanded uncertainty (the 

reported measurement uncertainty must be the actual calculated 

uncertainty, not just a transfer ratio); 

o Uncertainty analysis (components included or not included); and 

o The laboratory report on the method used if different than prescribed 

in the Technical Protocol; and 

• Directions on how to return or submit the data. 
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3. IMPLEMENTATION 

3.1. Preparation of the Artifact 

3.1.1. The artifact(s) is/are selected (as described in Section 1.9) for the 

PT/ILC based upon requirements documented in the PT/ILC Planning 

Checklist and Procurement of Services and Supplies. The artifact(s) may 

be loaned from organizations such as NIST WMD or other laboratories as 

long as appropriate planning is taken to ensure that the reference value has 

not been previously known by participating laboratories. 

3.1.2. The Reference Laboratory (where used) and Pivot Laboratory 

(where used) are qualified based upon information obtained in the PT/ILC 

Planning Checklist. Records of qualification for the Reference Laboratory 

and Pivot Laboratory are created per Collaboration and Subcontracting 

(Section 1.4). 

3.1.3. The Technical Manager will develop any additional processes to 

determine the stability of the artifact as necessary. The artifact(s) is/are 

then sent to the Reference Laboratory for the establishment of its reference 

value(s) or to the Coordinating Laboratory where the reference value is 

selected using alternative methods. 

3.1.4. The Technical Manager or delegate reviews qualifications for 

potential participating laboratories via training databases maintained by 

NIST WMD and/or completed on the PT/ILC Planning Checklist 

(Form 1). 

3.1.5. The PT/ILC Coordinator then develops a schedule for the PT/ILC 

activity based upon the final list of participating laboratories and the 

number of pivot measurements (when used). The schedule may be 

communicated and tracked in the most convenient and practical way for 

the PT/ILC Coordinator. 

3.1.6. The PT/ILC is initiated according to the schedule. 

3.2. Packaging/Shipping/Handling 

3.2.1. The PT/ILC Coordinator is responsible for shipping the artifact(s) 

using appropriate packaging methods for the particular artifact(s), along 

with any additional considerations that were identified in the PT/ILC 

planning checklist Planning Checklist (Form 1). 
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3.2.2. The PT/ILC Coordinator and each Participating Laboratory is 

responsible for ensuring that: 

• Standards are appropriately packaged; 

• Shipping containers are appropriately labeled; PT/ILC instructions are 

securely attached to the product packaging of individual units and designed 

to remain legible and intact for the period of use in the PT/ILC; 

• The PT/ILC instructions and forms should generally be included in the 

shipping container. A minimum of a packing list and the WMD shipping 

address will be included with all PT/ILC artifacts. 

• Standards are shipped by an appropriate commercial carrier or by other 

methods as identified in the ILC Schedule (Form 8) & shipping instructions; 

and 

• Standards are protected from adverse environmental conditions (i.e., 

protection of heat, cold, x-rays) as appropriate. 

• Any damage or loss sustained by any standards, artifacts, or shipping 

containers, is immediately reported to NIST/WMD. 

3.3. Materials Handling and Storage 

3.3.1. The PT/ILC Coordinator is responsible for short-term storage of 

artifacts during gaps in the schedule, and the Technical Manager is 

responsible for long-term storage of artifacts. Whether artifacts are in long 

term or short term storage, the responsible party is accountable for 

identification, preservation, and segregation of all artifacts from 

incompatible environments or materials such as high humidity, 

uncontrolled temperatures, or chemicals and other items so that the 

artifacts do not deteriorate during storage. 

3.3.2. The Technical Manager maintains the inventory list of artifacts in 

long-term storage and is responsible for developing schedules of periodic 

inspection for possible deterioration as appropriate for the artifacts. 
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4. ANALYSIS 

4.1. Determination of Assigned Reference Values and its Associated Uncertainty 

4.1.1. The method for determining the assigned value is documented on 

the PT/ILC Planning Checklist (Form 1) prior to beginning the PT/ILC 

activity. The method selected must be based upon sound metrological and 

statistical principles. Documents listed in the REFERENCES section of 

this manual may be utilized, but this list is not necessarily an all-inclusive 

list. Any determination of the reference value must include consideration 

of stability of the artifact as each participant performs measurements. The 

Expanded Uncertainty of the PT/ILC will be the combination of the 

reference value uncertainty and the uncertainty associated with stability. 

Some examples used for determining reference values may be: 

• The Reference Laboratory (such as NIST or an accredited laboratory) 

measured value (stability may be determined by Pivot Laboratory 

measurements); 

• The mean of the Reference Laboratory measured values from the 

beginning and end of the PT/ILC; 

• The median of the results from accredited laboratories; 

• The median of one result from each participating laboratory; or 

• The adjusted median of the participating laboratories 

Documented procedures for selecting reference values will be used. 

4.2. Performance Evaluation of Participants 

4.2.1. The method of evaluating performance for the participants and 

acceptable limits of performance is documented on the PT/ILC Planning 

Checklist (Form 1) prior to beginning the PT/ILC activity. The method 

selected must be based upon sound metrological and statistical principles. 

Documents used in the REFERENCES section of this document manual 

may be utilized, but this list is not necessarily all-inclusive. Some 

examples of determining performance of the Participant may include: 

• Determination of Normalized Error value, En; (En > 1 is considered a 

failure) 

 While an En value > 1 is considered a failure; the analyst may 

recommend additional follow up for an En value between 0.5 and 

1. 
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• Precision Tests (The reported uncertainty must be less than specified 

limits for some applications); 

• Z score value; 

• Participant measurement is within the expanded uncertainty of the 

PT/ILC; 

• Participant value shows a bias even though their reported uncertainty is 

large enough to pass the En analysis; and 

• Participant measurement result(s) and associated expanded uncertainty is 

within the expanded uncertainty of the PT/ILC. 

• Expanded uncertainty (variations due to laboratory capabilities, bias, 

uniformity of methodology employed, etc.) 

4.2.2. When assessing the technical competency of a participating 

laboratory, appropriate technical specialists and statisticians (or technical 

approaches and statistical tools) are used as deemed appropriate by the 

Technical Manager. Each PT/ILC report will contain both individual and 

summary analyses. 

4.2.3. Other Performance Analysis issues to evaluate may be: 

• Overall performance against prior expectations, taking measurement 

uncertainties into account; 

• Variation within and between laboratories, between RMAP results, and 

comparisons with any similar previous schemes or published precision 

data; and 

• Variation between methods, procedures, or equipment used if applicable; 

• Evaluation of a laboratory’s timeliness in conducting and reporting their 

PT/ILC results; and 

• Evaluating the laboratory’s calibration report for compliance with ISO 

17025 (Section 5.10) criteria. 

4.3. Outlier Detection Techniques 

4.3.1. The NIST/Sematech e-Handbook of Statistical Methods provides 

guidance on outlier detection or other special analysis techniques. Results 

of PT/ILC activities within the scope of this document are not discarded. 

Results that could be considered outliers, or results from laboratories 

performing measurements outside of their normal scope of recognition, 

may not be used for statistical summaries, but the information is included 

in draft and final reports. Any suspect data will be verified by the 

Technical Manager or Designee to ensure that the data entry and 
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transcriptions were performed correctly and that any data entry errors were 

identified, documented, and corrected. Data entry errors by participants 

are identified by feedback or reports issued by NIST WMD to the 

participant (or within the report), who will use their corrective action 

process for root cause analysis and response. The Technical Manager or 

Designee is responsible for follow-up of issued nonconformities. 

4.4. Assessing the Stability of the Artifact 

4.4.1. The method for determining artifact stability is documented on the 

PT/ILC Planning Checklist (Form 1) prior to beginning the PT/ILC 

activity. The method selected must be based upon sound metrological and 

statistical principles. Documents described in the REFERENCES section 

of this document manual may be used, but this list is not necessarily allinclusive. Limits of acceptable stability for the artifact are also determined 

and recorded on Form 1 prior to beginning the activity. It is the 

responsibility of the Technical Manager to communicate the limits of 

artifact stability to the Pivot Laboratory so that they can evaluate the 

artifact stability during the PT/ILC and alert the Technical Manager if 

stability limits have been exceeded. If established limits have been 

exceeded, it is the responsibility of the Technical Manager to determine 

how to proceed. 

4.4.2. Some examples of determining stability may include: 

• The measured deviation between the opening and closing measurements 

performed by the Reference Laboratory; 

• The standard deviation of the Pivot Laboratory measurements; 

• The uncertainty of linear regression of the Pivot Laboratory 

measurements; and 

• The standard deviation of participant measurements. 

4.5. Assessing Homogeneity of Artifact 

4.5.1. If homogeneity is determined to be applicable for the PT/ILC 

activity, the assessment of homogeneity is performed after the test material 

has been packaged in its final form and before distribution to participants 

unless, for example, stability studies indicate that it should be stored in 

bulk form. In some cases, an intermediate homogeneity check may be 

necessary, for example, before sealing into appropriate packaging. 
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4.5.2. The provider or its collaborators, where appropriate, shall use a 

statistically random selection of a representative number of samples from a 

batch of test material to assess the homogeneity of the material. This 

assessment procedure shall be documented and conducted in accordance 

with acceptable statistical designs, for example, analysis of variance on 

replicate results under repeatability conditions. In the case of 

measurement artifacts, preliminary stability checks shall be made and 

periodic checks of assigned property values should be carried out 

throughout the course of the scheme. 

4.5.3. If appropriate, limits of acceptable homogeneity for the artifact are 

also determined and recorded on the PT/ILC Planning Checklist (Form 1) 

prior to beginning the activity. 

4.5.4. It is the responsibility of the Technical Manager to communicate 

the limits of artifact homogeneity to the Pivot Laboratory so that they can 

evaluate the artifact homogeneity during the PT/ILC and alert the 

Technical Manager if the established limits have been exceeded. If 

established limits have been exceeded, it is the responsibility of the 

Technical Manager to determine how to proceed. 
5. REPORTING 

5.1. Schedules 

5.1.1. The PT/ILC Coordinator develops and publishes Schedule & 

Shipping instructions based upon the information gathered in the PT/ILC 

Planning Checklist (Form 1). The schedule will be sent to all participants 

and may be posted at the NIST WMD website. 

5.2. Preliminary Reports 

5.2.1. Preliminary or Draft Reports may be issued to the participant(s) at 

the discretion of the Technical Manager. Since such reports may be 

requested before the closing measurement of the reference laboratory, the 

Analyst will need to perform evaluations based upon a given reference 

value or the opening measurement on the artifact by the Reference 

Laboratory and the evaluation of stability performed thus far in the PT/ILC 

activity. All participants are to review their preliminary report to ensure 

that all data on the report corresponds to the data that was submitted by the 

laboratory. 

5.3. Final Reports 

5.3.1. The content of the Final Report will vary depending on the purpose 

of a particular scheme, but each report shall be clear and comprehensive 

and include data on the distribution of results from all participants, 

together with an indication of the performance of individual participants. 

Final Reports are delivered prior to or at the RMAP meeting for discussion 

and comments. 

5.3.2. Final Reports issued for PT/ILC activities within the scope of this 

document shall contain: 

• Elements contained in the PT/ILC Reporting Checklist (Form 2); 

• Any other suggestions, recommendations or general comments; 

• Conclusions; 

• Comments on the performance both of individual participants and on 

participation as a whole; and 

• Possible sources of error (with reference to extreme results) and 

suggestions for improving performance. 
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APPENDIX A - FORMS 

Number Title 

1 PT/ILC Planning Checklist 

2 PT/ILC Reporting Checklist 

3 PT/ILC Training & Qualifications 

4 PT/ILC Feedback & Complaint 

5 WMD Quality System Management Review 

6 WMD Internal Audits 

7 WMD Nonconformance, Corrective Action, Preventive Action 

(NCAP) 

8 Schedule & Shipping (nonmandatory) 
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Form 1: PT/ILC Planning Checklist 

Page 1 of 3 

ILC Region & Planned Reporting Year: 

ILC Title: 

ILC Coordinator Name: 

ILC Coordinator Address: 

Names, position, and addresses of any 

other personnel involved in design and 

operation of ILC: 

Form Completed by: 

Nature and Purpose of ILC scheme: 

Identification of the Measurand: 

Identification and description of Artifact(s): 

Description of nature of Artifact and why it was chosen: 

Artifact source (owner): 

Describe any stability issues with the artifact: 

Identification of the test method used by the participants: 

Identification of the type of equipment required by the participants: 

Identification of the approximate uncertainty required by the participants: 

Ranges of values expected from the participant measurements: 
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Form 1: PT/ILC Planning Checklist 

Page 2 of 3

Any potential difficulties in preparation and maintenance of homogeneous materials or 

the provision of a stable reference value for the artifact: 

Describe any homogeneity issues, as applicable: 

Describe any environmental issues with the artifact for storage, transport, or 

measurement: 

Describe any special preparation issues for Artifact(s) as applicable: 

Packaging/Handling issues, Special Containers needed? 

The Criteria for participation in the ILC: 

Reference Laboratory: 

Pivot Laboratory: 

Identification of Expected Participants: 

(identify laboratory and personnel to be 

involved in measurement): 

Are all laboratories and personnel qualified 

to participate (review NIST WMD training 

databases) 

 yes no (if no, explain) 

Design of test (i.e., petal, loop, etc.): 

Describe when artifact is checked and how 

it is distributed: 
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Form 1: PT/ILC Planning Checklist 

Page 3 of 3

Number of significant figures to which 

results are to be reported: 

Precision of test: 

Smallest differences expected between 

participants: 

Statistical Method for determining reference value of artifact: 

Method of performance evaluation: 

Acceptable limits of stability (from pivot measurements and overall): 

Acceptable limits of homogeneity (if applicable): 
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Form 2: PT/ILC Reporting Checklist 

Page 1 of 2 

PT/ILC Identification: 

Coordinator: 

Date of Completion: 

Ensure that Final Report Contains the Following 

Title Page or Introduction 

General Description and title of the ILC 

Names and affiliations of persons involved in design and conduct 

of PT/ILC 

 Included 

Date of issue of the report Included 

Report number and clear identification of the PT/ILC Included 

Dates (Time period of conduct of test from beginning to end) Included 

RMAP group Included 

Who 

Reference Laboratory Included 

Pivot Laboratory Included 

Participants (include address as appropriate) Included 

What and Why 

Objectives Included 

Parameter, Range, Uncertainty (e.g., mass, 1 kg, best calibration) Included 

Clear description of the items or materials used, including, where 

appropriate, details of sample preparation and homogeneity 

testing 

 Included 

Details of the traceability and uncertainty of assigned values Included 

How 

Summary of procedures used to design and implement the scheme 

(which may include reference to a scheme protocol) 

 Included 

Procedures Used Included 

Laboratory Equipment Identification (e.g., which balance, which 

standards, for each lab) 

 Included 

Analysis 

Summary of procedure used to establish any assigned value Included 

Summary of procedures used to statistically analyze the data Included 

Software title and version used in data analysis Included 
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Form 2: PT/ILC Reporting Checklist 

Page 2 of 2 

Tables & Graphs 

Laboratory test results Included 

Statistical data and summaries, including assigned values of 

Artifact(s), and range of acceptable results 

 Included 

Assigned values and summary statistics for test 

methods/procedures used by other participants (if different 

methods are used by different participants) 

 Included N/A 

Tables of data, precision tests, and evaluation data Included 

Graphs of data, standard value/uncertainty charges, Youden plots, 

misc. graphs 

 Included 

Conclusions 

Comments on participants' performance by the provider and 

technical advisors 

 Included 

Summarization of Results Included 

Recommended follow-up and corrective action (by analyst/by 

NIST) 

 Included 

Comments on any technical difficulties raised by participants Included N/A 

Evaluation of the responses of participants performing poorly 

(if feedback is required) 

 Included N/A 

Advice, where appropriate, on the interpretation of the statistical 

analysis 

 Included N/A 

Return to NIST WMD For Archival – Copies and/or originals of: 

Instructions Included 

Schedules Included 

Datasheets Included 

Formal Calibration Report (where requested) Included 

Submitted Data Included 

Analysis and electronic Documents/spreadsheets Included 
NIST WMD Quality Manual for 

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Form 3: PT/ILC Training & Qualifications 

(may be retained in electronic database) 

Page 1 of 3 

Name: 

Laboratory: 

Formal Education 

ATTENDED 

CERTIFICATE 

SCHOOL ATTENDED AWARDED 

FROM TO 

COURSES COMPLETED 

YES NO 

 

Technical Seminars and Workshops Attended 

CERTIFICATE 

RECEIVED 

DATE & PLACE ATTENDED NAME OF 

SEMINAR/WORKSHOP 

ATTENDED 

NUMBER OF 

HOURS OF 

INSTRUCTION YES NO 

 
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Form 3: PT/ILC Training & Qualifications 

(may be retained in electronic database) 

Page 2 of 3 

METROLOGY DISCIPLINE TRAINING 

LEVEL 

YEARS OF 

EXPERIENCE 

IN THIS 

DISCIPLINE 

APPROVED FOR 

PT/ILC FUNCTIONS 

Mass 

Echelon I 

Echelon II 

Echelon III 

Mass, Fluid Flow (Volume) 

Echelon I Gravimetric – 

Large Prover 

 

Echelon II Gravimetric – 

Small Volume (Glassware) 

 

Echelon II Volumetric – 

Large Volume Transfer 

 

Echelon II Volumetric – 

Small Volume Transfer 

 

Length, Dimensional, Linear 

Length Rulers 

Length Tape 

Temperature 

Echelon I 

Echelon II 

Echelon III 

Echelon IV 

Echelon V 

Misc. 

Hydrometers 

Tuning Forks 

Stop Watches and Timers 

Hygrometer/Relative 

Humidity 

Grain Moisture 

Reviewed and Approved By: 

Date of Review: 

See Training Level Codes on the next page. 
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Form 3: PT/ILC Training & Qualifications 

(may be retained in electronic database) 

Page 1 of 3

TRAINING LEVEL CODE LEGEND: 

BLANK: No experience in the particular field

C: Introductory Experience such as on-the-job training (OJT), Computer Based 

Instruction, Informal Instruction, or Formal Instruction that is over ten years old.

B: Intermediate Experience such as formal instruction provided in house or by a NIST 

WMD approved metrology program. 

A: Formal Instruction provided by a recognized subject matter expert such as original 

equipment manufacturer (OEM) training, or NIST seminars. 

APPROVED FOR PT/ILC FUNCTIONS LEGEND: 

The qualifications listed below are in ascending order of ranking (i.e., if the person is 

qualified as a coordinator, they are also qualified as a participant, but are not necessarily 

qualified as an analyst or for reports. A person qualified for reports is qualified for all 

PT/ILC activities for the parameter. 

BLANK: Not approved for PT/ILC activities for this parameter. 

PARTICIPANT: Approved as a participant for parameter. 

COORDINATOR: Approved as a PT/ILC coordinator for the parameter. 

ANALYST: Approved as PT/ILC analyst for the parameter. 

REPORTS: Approved to develop reports under the supervision of the Technical 

Manager for the parameter. 
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Form 4: PT/ILC Feedback and Complaints 

Page 1 of 1

Instructions: Use this form to record any complaint or pertinent communication 

received about NIST WMD’s services as they apply to the conduct of PT/ILC activities. 

If the complaint or comment is received in writing, attach the complaint to this record. If 

the complaint or comment is received by telephone, fill out sections 4 and 5 completely. 

1. Name of Person completing form 

2. Date of receipt of complaint or 

communication 

3. Check one of the following 

 Complaint/communication received in 

writing – copy of documentation attached 

 Complaint/communication received by 

telephone – was caller requested to send 

documentation? 

 yes no 

4. If the complaint/communication was received by telephone, provide the following 

information: 

Name and Address of person making complaint/communication 

Phone number Fax number 

5. If the compliant/communication was received by telephone, describe the issue: 

6. Name of Responsible Manager: 

7. For Quality Manager Use Only 

Date Logged: Complaint Number: 

Date C.A.R. issued (if applicable): Date Closed: 
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Form 5: WMD Quality System Management Review 

Page 1 of 2 

Date: 

Location: 

Personnel Present: 

Agenda Record of Discussion, and Assigned Actions, and 

Estimated Completion Dates 

Suitability and Effectiveness of 

Quality System 

Quality and Applicability of 

PT/ILC Activities 

RMAP Meeting Reports 

Report of Internal Audits 

Report of External Audits 

Client Feedback/Complaints 

Resources (Facilities, Standards, 

and Equipment) 
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Form 5: WMD Quality System Management Review 

Page 2 of 2 

Outstanding Items from Previous 

Management Review 

Staff Training 

Other Reports 

Miscellaneous Topics 
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Form 6: WMD Internal Audits for PT/ILC Activities 

Page 1 of 3 

PART A 

Dates of Assessment: 

Lead Assessor: 

Assessment Team 

Members: 

Quality System Review (all sections are assessed annually, though not necessarily at the 

same time) 

Section 1.1 Assessed Conforming Nonconformities 

Section 1.2 Assessed Conforming Nonconformities 

Section 1.3 Assessed Conforming Nonconformities 

Section 1.4 Assessed Conforming Nonconformities 

Section 1.5 Assessed Conforming Nonconformities 

Section 1.6 Assessed Conforming Nonconformities 

Section 1.7 Assessed Conforming Nonconformities 

Section 1.8 Assessed Conforming Nonconformities 

Section 1.9 Assessed Conforming Nonconformities 

Section 1.10 Assessed Conforming Nonconformities 

Section 1.11 Assessed Conforming Nonconformities 

Section 1.12 Assessed Conforming Nonconformities 

Section 1.13 Assessed Conforming Nonconformities 

Section 1.14 Assessed Conforming Nonconformities 

Section 1.15 Assessed Conforming Nonconformities 

Section 1.16 Assessed Conforming Nonconformities 
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Form 6: WMD Internal Audits for PT/ILC Activities 

Page 2 of 3 

Section 1.17 Assessed Conforming Nonconformities 

Section 1.18 Assessed Conforming Nonconformities 

PART B 

PT/ILC Quality System Review (Select a 10 % sample (minimum 1 per region) of 

PT/ILCs conducted each year and assess all elements of program) 

PT/ILC Region assessed: 

PT/ILC activity assessed: 

Section 2.1 Conforming Nonconformities Not Developed Yet 

Section 3.1 Conforming Nonconformities Not Developed Yet 

Section 3.2 Conforming Nonconformities Not Developed Yet 

Section 3.3 Conforming Nonconformities Not Developed Yet 

Section 4.1 Conforming Nonconformities Not Developed Yet 

Section 4.2 Conforming Nonconformities Not Developed Yet 

Section 4.3 Conforming Nonconformities Not Developed Yet 

Section 4.4 Conforming Nonconformities Not Developed Yet 

Section 4.5 Conforming Nonconformities Not Developed Yet 

Section 5.1 Conforming Nonconformities Not Developed Yet 

Section 5.2 Conforming Nonconformities Not Developed Yet 

Section 5.3 Conforming Nonconformities Not Developed Yet 
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Form 6: WMD Internal Audits for PT/ILC Activities 

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Section 5.4 Conforming Nonconformities Not Developed Yet 

PART C 

Audit for Closure of Previous Deficiencies Conforming Nonconformities 

Attach all nonconformities and comments using the NCAP form and all other supporting 

documentation. 
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Form 7: NIST WMD Nonconformance/Corrective Action/Preventive Actions 

(NCAP) 

Page 1 of 2 

1. Name of Person completing form: 

2. Date: 

3. Check one of the following: 

 Nonconformity 

 Preventive Action 

4. Identification of Nonconformity or Preventive Action: 

5. Source of Discovery: 

6. Investigation Results: 

7. Root Cause: 

8. Evaluation of Significance: 

9. Action Required? Yes No 

10. Does PT/ILC need to be halted? Yes No 

11. If halted, identify location of Artifact/position in scheme: 

12. Action Taken: 

13. Due Date: Participant Notification (in writing): 

14. Name of Responsible Manager: 

15. Date PT/ILC Resumed (if applicable): 
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Form 7: NIST WMD Nonconformance/Corrective Action/Preventive Actions 

(NCAP) 

Page 2 of 2 

16. For Quality Manager Use Only 

 

17. Due Date: 

18. Name of Responsible Manager: 

19. Date PT/ILC Resumed (if applicable): 

20. For Quality Manager Use Only 

Date C.A.R. issued (if applicable) Event Number: 

Date Closed: 

Follow-up Audit Information (as applicable): 
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Form 8: Schedule & Shipping 

(nonmandatory*) 

Page 1 of 1 

PT/ILC Identification: 

PT/ILC Coordinator: 

Scheduled 

Date 

Laboratory Date 

Shipped to: 

Shipper Tracking # Date 

Received 

 

* As long as the coordinator maintains a tracking system for the artifacts or standards, use 

of a form is not required. 
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APPENDIX B – PROCEDURES & POLICIES 

Number Title 

1 Software Validation Procedure 

2 Selection of Delegates Procedure (To be developed). 

3 NISTIR 7082 PT/ILC Policy & Plan 
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Procedure 1: PT/ILC Software Validation Procedure 

Background: All software that has been designed to perform computations associated 

with reporting, analyzing or evaluating acceptance criteria for PT/ ILC activities are 

required to be validated according to this procedure. Commercial software such as 

Microsoft Excel or MathCAD does not require validation, but worksheets created for 

PT/ILC activities do require validation. 

1) Ensure that the Software contains the following information: 

a. Title of Software; 

b. Date of Latest Revision (kept within the electronic file); 

c. Identification information of person who performed the last revision. 

d. Document technical specifications used (i.e., specific formulas for air or 

water density, coefficients of expansions). 

2) The Technical Manager or Designee performs the software validation. Under no 

circumstance is the author of the software to be evaluated allowed to perform the 

software validation. 

3) All computational functions of the software are to be validated after each revision 

(and reviewed at least annually). Validation is accomplished by entering a data 

set into the software to be validated, and comparing the results obtained to results 

obtained by: 

a. Results published in a textbook or other appropriate reference for the 

dataset; 

b. Hand or calculator computations (which are documented); 

c. A program from a different software platform; 

d. A program on the same software platform that is significantly different 

from the software to be validated. 

4) Document the validation method selected, password(s), and supporting 

information for the validation process. 

5) Sign and Date the documents and submit them to the Technical Manager for final 

review and approval. 
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Procedure 2: Selection of Delegates 

To be developed at a later date. 
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Policy: NISTIR 7082 "Proficiency Test Policy and Plan (for State Weights & 

Measures Laboratories)" (on-line at http://www.nist.gov/labmetrology)