approval of iso/iec 17025:2017 suppliers
TRANSCRIPT
15/10/2021 15/10/2021Managed by Triad National Security, LLC., for the U.S. Department of Energy’s NNSA.
Approval of ISO/IEC 17025:2017 Suppliers
Metrology Program & Calibration Lab Kenneth Nadeau, Compliance Officer
Tuesday, April 20, 2021 – 2:30pm EST
LA-UR-21-23763
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Metrology Program and Calibration Process
General
Process
Technical
Survey
Quality
Requirements
Receipt
inspection
of M&TE
• Accredited vs
Non-
Accredited
• Terminology
• Standards
• Quality vs
Technical
• Purpose
• Scope
• Section 6-7
• Outsourced
items
• Calibration
Certificates
• logo
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Module 1:
General Process for Qualification of Calibration Suppliers
1.Determination of Source
1. Scope of work
2. Type of item/service: Not all are created equal.
2.Categorization of Requirements
1. Accredited
2. Non-Accredited
1. PSL/CSL prior approval
2. Technical Survey – QA program vs Technical Calibration Processes
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Module 1 – General Process
Disclaimer: Understand your requirements established per contract with
customers, regulators, etc.
• Example: Triad LLC is a contractor for DOE/NNSA to operate the LANL site.
− Contract imposes quality requirements: 10 CFR 830.120; DOE O 414.1d; NAP-401.1;
− Contract establishes the requirement for a Contractor Standards Laboratory (& PSL)
NA SD M 452.3-1, Chapter 13.2/PSLM – converting to R028.
− Requires work by metrology organizations (Any organization whose primary function involve performing and/or controlling calibration, sampling, testing) to operate in accordance with ISO/IEC 17025:2017, General requirements for the competence of testing and calibration laboratories
− NQA-1 (versions); NAP-401.1; vs. ISO 9001; ISO 14001; ISO 13485; ISO 16949
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General Process
DOE Acceptable Sources – Chapter 13.2 (5.5.5-.6)/PSLM (5.1.2.7)
• NIST
• Another NNSA CSL or PSL
• An approved CCL or DCS*
− Approved for specific fields, ranges and uncertainty.
− If Accredited by an Accreditation Body (ILAC/NACLA), it MAY by accepted for use without additional oversight based upon AB and Scope.
− *requires oversite by the CSL; is not required for measurements performed by the contractor to substantiate subcontractor measurements.
• DoD PSL
• NIST approved State Weights and Measures Facility
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Terminology
• Accuracy: The quality of closeness of a measured or specified value to the true value; quantitatively
expressed by uncertainty.
• CSL: The portion of the DOE/NNSA nuclear weapons contractors metrology organization that
coordinates and oversees the implementation of the Standards Calibration Program.
• Traceability: Ability to relate individual measurement results through unbroken series of calibration to
standards.
• Uncertainty: assigned value to measurements standards or M&TE representing an appropriate
combination of all significant sources of uncertainty associated with the calibration process including,
but not limited to standards, environmental factors, and statistical data analysis.
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Standards
• Weapons: NAP-24/401.1 – Weapons Quality Policy
− CRD – requirements for operation and management of NNSA facilities that are
• Energy Sites: NQA-1, QA Requirements for Nuclear Facility Application
− Affect quality of structures, systems and components of nuclear facilities (power generation, spent fuel storage, waste treatment, waste storage and disposal, fuel processing, plutonium processing, and plutonium fuel fabrication.
• ISO/IEC 17025:2017, General requirements for the competence of testing and
calibration laboratories
− Requirements for laboratories to enable them to demonstrate they operate competently, and are able generate valid results and will facilitate cooperation between laboratories and other bodies and assist in the exchange of information a ndexperience, and the in the harmonization for standards and procedures.
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General Process
• What is needed?
– What is the level of uncertainty or tolerance associated with the TECHNICAL requirements of the product or service?
– What is the degree of difficulty, importance, and/or risk (safety, environment, health, reliability, scheduling,..) associated with performing measurements or calibrations supporting the technical requirements of the product or service?
– How measurements performed in support of the program may be impacted by the CCL/DCS calibration program?
• Who are the available sources?
– Accredited? – if in scope, AB is ILAC/NACLA, and risk is low-moderate – approve*
– Non-Accredited? Perform technical survey of calibration program on the basis of ISO/IEC 17025
– Who is performing the calibration?
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Accredited Calibration Providers
• For the item or services needed; is the potential source Accredited?⁃ If not – then technical survey.
• Is the source of the Accreditation an ILAC/NACLA member?⁃ If not – then technical survey.
• Does the scope of the accreditation for the potential source cover the requested item or service? ⁃ If not – then technical survey.
If yes to all three.. Then approve! … and monitor performance.
Chapter 13.2, 5.6: “NNSA recognizes the value of laboratory accreditation performed by and accreditation body that is recognized by the National Cooperation for Laboratory Accreditation (NACLA). A metrology organization that is so accredited could reduce the need for technical survey… depending on the Scope of Accreditation.”
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Module 2:
Technical Survey• Quality Assessment v Technical Survey
– Quality Assessment: planned and documented activity, performed in accordance with procedures, intended to communicate and effect improvements where needed and maintain cognizance subcontractor performance; provides basis of acceptance of material and/or verifies performance.
– Technical Survey: evaluation of a metrology organization by qualified metrology personnel to determine the organization ability to perform required operations; evaluation also confirms adequate technical and administrative requirements have been implemented.
• Review elements 4.0 General Requirements, 5.0 Structural Requirements, and
8.0 Management system as the ‘Quality Assessment’ + 7.1 Contracts
• Review elements 6.0 Resource Requirements and 7.0 Process Requirements
as the “Technical Survey” for in-house calibration or 6.6/7.1 for outsourced.
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Method Assessment - In-house or Outsourced
Technical Survey
• Sample: *O = Observed Test; P = Procedure Reviewed; I = Interviewed Personnel; E = Equipment Inspected; F = Field
(On-Site); NR = Not Running17025 ASSESSOR REPORT
METHOD REVIEW MATRIX
LAB NAME: ASSESSMENT DATE(S): Page ___ of ___
ISO/IEC 17025 Section→
6.2, Personnel
6.3 Fac./Envir.;
6.4 Equip.;
6.6 Externally prov.
7.2.1.1-.7 7.6 6.5 Traceability7.3/7.
47.7 7.5/7.11
7.8.1-.2, .4 Cal; 7.8.3
(Test); 7.8.5 (Sample)
Parameter/ Test Name or
Technology
(7.2.1)
Method(s)
(From Scope)
(7.8.2)
Depth of
Assessment
*see codes
Name(s) of
Personnel
interviewed
Accom &
Environment;
Equipment &
Ref. Mat’ls.
Procedure/
Operating
Instructions
Measurement
Uncertainty
Verification
Traceability;
Verification/
Calibration
Samp
ling;
Handl
ing/
Prep.
Quality
Checks
Records Report/
Certificate
Mass
Calibration
Test
Sample
___ Dir/X Ind
NIST
Handbook 44
O,I,P,E, F John Doe
OK-temp/ humidity
charts reviewed
OK-laboratory
SOP #6
Reviewed/
Acceptable
OK-calibration certificates
reviewed
N/A OK OK-reviewed
records
OK-reviewed calibration
Certificate/report
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Good practice – Purpose and Scope
Evaluation Criteria
• Calibration affects M&TE; M&TE affects determination; Determination affects
use
• For assessments other than 17025, Supplement Calibration sections with
appropriate criteria:
− EG: NQA-1 Requirement 12 (v.2000/2008-09 addend): “tools, gages instruments and other measuring and test equipment used for activities affecting quality shall be controlled, calibrated at specified periods, adjusted and maintained to required accuracy limits.”
− 2017 Subpart 2-19; Quality Assurance Requirements for the Use of Supplier Accreditation for Calibration or Testing Services & NQA-1 2015, Requirement 12: Invokes ISO/IEC 17025 (2005/2017).
− No other Quality Standard indicates How calibration is performed competently –17025 does.
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Module 3
Quality RequirementsSection 6.0 / 7.0 Outsourced Calibration - 6.6*
• 6.0 Resource Requirements
− 6.1 General; 6.2 Personnel; 6.3 Facilities/Environment; 6.4 Equipment; 6.5 Traceability; 6.6* Externally provided product/service
• 7.0 Process Requirements
− 7.1(6.6) Contracts/tender; 7.2 Methods; 7.3 Sampling; 7.4 Handling; 7.5 Technical records; 7.6 Evaluation of Uncertainty; 7.7 Ensuring Results; 7.8 Reporting results; 7.9 Complaint; 7.10 NCR; 7.11 Control of Data
• (6.6.1)Suitable product and service are
used when used in their own activities or
provided to a customer directly from the
external source or used in support of
lab operation.
• (6.6.2) Procedures and records:
requirements for suppliers; eval, select,
monitoring; conformity of results;
corrective actions
• (6.6.3) Communication of requirements:
product/service, acceptance,
competence, outsource.
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Module 4Receipt Inspection of Calibrations
• Did it come from an approved source?
• Is the approved source Accredited or non-
Accredited?
• Does the calibration certificate reflect that
it meets requested requirements?
7.8; certificate authorized? Is
it clear, unambiguous,
objective, does it include all
imformation agreed to
purchase request and
necessary for interpretation
of results and required by
methods used? Is unreported
information readily available?
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7.8.2.1
Common requirements• Title
• Name and address of lab
• Location of the calibration
• Pagination / end
• Customer information
• Method used (procedure)
• Item condition as received
• Sampling plan/method
• Results apply only to UUT
• Deviations (additions/exlusions to method)
• Authorization of report
• Externally provided results
In addition to 7.8.2
requirements for reporting,
requirements for specific
activities also apply…
Test reports = 7.8.3
Calibration reports = 7.8.4
Sampling reports = 7.8.5
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Calibration certificates at receipt inspection:
• Measurement Uncertainty – 7.8.4.1a.– ..certificates shall include.. The measurement uncertainty of the
measureme tresult presented in the same unit (of measure) as that of the measurand or in a term relative to the measurand(e.g. percent)
• No more AB logos (ILAC P14:09/2020)– ILAC Policy for Measurement Uncertainty in
Calibrationhttps://ilac.org/publications-and-resources/ilac-policy-series/
– Based upon GUM (guide to Uncertainty in Measurement)https://ilac.org/about-ilac/partnerships/international-partners/bipm/
– Transcat white paper
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References:
• NAP-401.1, Weapon Quality Policy
• NA SD M 452.3-1, Defense Programs Business Requirements and Process
Manual; Chapter 13.2, Metrolgoy Program; Primary Standards Laboratory
Memorandum (Feb 2006)
• DOE O 414.1d, Quality Assurance
• 10 CFR 830.120, Quality Assurance
• NQA-1-2000 / 2008-’09 Add.; /2017; Quality Assurance Requirements for
Nuclear Facility Applications
• NQA-1-2017, Subpart 2-19, Quality Assurance Requirements for the Use of
Supplier Accrediation for Calibration or Testing Services
• https://prp.sandia.gov/DPManual/d-p_chap13-2.pdf
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Kenneth NadeauLANL Calibration Program Compliance OfficerIQPA-Metrology Program and Calibration Lab Quality Engineer 4PO Box 1663, Bikini Atoll Rd.; MS: D478Los Alamos, NM [email protected]