Discovering the Value of Working with an Accredited Commercial Laboratory

Moderator

Melissa Gorris

Sales and Marketing Manager

Additive Manufacturing Team

Lead

Speaker

Carm D’Agostino

Chief Chemist

Speaker

Cynthia Hagan

Quality Assurance

Manager

Speaker

Dave van der Wiel

Director, Technology

Development

Speaker

Larry Somrack

President-Emeritus

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Why is laboratory accreditation important?

• Inspires confidence

• Internationally accepted framework

• Ensures test quality

• Consistency of results

• Meet customer industry requirements

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NSL Analytical Services

NSL provides independent laboratory testing services to a diverse array of

customers where testing speed, accuracy and consistency are mission

critical to operations.

Our teams of chemists, engineers and metallurgists provide

scientific expertise in materials testing with a focus on powders,

metals, polymers and technical ceramics used in critical end

markets such as aerospace, oil & gas, energy, chemicals and

manufacturing.

Chemical Analysis Thermal Analysis Physical Properties

Microscopy &

Metallography

Particle

CharacterizationMechanical Testing

Metallurgical /

Failure AnalysisConsulting

Regulatory

Compliance

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What we’ll talk about today…

Lab Selection

Things to considering when selecting a commercial lab

Range of Laboratory Accreditations & Approvals

ISO 17025: Management and Technical Requirements

Framework for Quality Results

Testing Inquiry

Sample Delivery & Receiving – Sample Intake

Sample Testing & Analysis

Round Robins, Uncertainty Studies & Proficiency Testing

Analyzing & Reporting Results

Material & Data Management

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Laboratory Selection

Things to consider when selecting an independent commercial lab

• There are differences in accreditations

– Level of the Quality Management System is determined by the accreditation

• Is the test you need on the scope of the accreditation?

• Does the lab personnel have the level of technical expertise & experience needed?

• Do you require a certified test report?

• Can you get test results in the time you need them?

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Range of Laboratory Accreditations & Approvals

• FDA – GLP, cGMP,

• ELAP

• NELAP

• NVLAP

• ASME NQA-1

• Nadcap - MTL

(Materials Testing Laboratory)

• ISO/IEC 17020 - Inspection Bodies

• ISO/IEC 17034 – Reference Material Producers

• ISO/IEC 17043 - Proficiency Testing Providers

• ISO/IEC 17065 - Product Certification Bodies

• ISO/IEC 13485 – Medical Devices

• ISO 15189 - Clinical Testing Laboratories

• ISO 20387 - Biobanking Accreditation Program

• ISO/IEC 17025 - Testing/Calibration Laboratories

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Let’s Discuss ISO/IEC 17025!

ISO/IEC 17025 is an international standard for the competence of

testing and calibration laboratories.

Benefits:

• Includes a defined scope of approval

• Impartial and confidential reporting

• Enhances reliability of test results

• Established technical competency

• Efficiency of lab

• Process validity and correctness of methods

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ISO 17025 Requirements: Management and Technical

Management System Requirements

Data & Records Management Nonconformances

Contract Review Corrective Actions

Customer Satisfaction Continuous Improvement

Supplier Controls Audits

Risk Assessment Management Reviews

Facility/Environmental Controls

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ISO 17025 Requirements: Management and Technical

Technical Requirements

Instrument validation Method validation

Calibrations (ISO17025) Precision & Range Determinations

Internal & External Round Robins Test Report Requirements

Proficiency Testing (ISO 17043) Training and Competency

Uncertainty Measurements Certified Reference Standards (ISO 17034)

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What It Takes (Organizational Commitment)

Quality Function

Technical Teams

Service Providers

• Training

• IRRs & PTs

• Corrective Actions

• Calibrations

• Preventative Maintenance

• External Testing

• QMS

• Audits

• Reviews & Approvals

• LIMS

• Method Validation

• Service & Repair

Laboratory Operations

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Framework for

Quality Results

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Testing Inquiry

Material Identification

• What is the material being tested

Specifications, ASTM, ISO

• Reporting Limits

Method Identification

• Material composition

• Selecting most accurate appropriate method

• Certified Test Report Requirements

Resource of partner labs

• Subcontractor qualification, customer acceptance

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Sample Delivery & Receiving – Sample Intake

Delivery Options

Maintain Traceability

• Sample Identification

• Contract review (requirement verification)

Laboratory Information Management System (LIMS)

• Sample tracking

• Information sharing

• Instrument integration

• Report generation

• Laboratory metrics

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Sample Testing & Analysis

Personnel

Experienced staff: Educated, Dedicated, Trained

• Training – Ability to operate instruments and follow methods

• Redundancies – Multiple Instruments

• Cross training – Backup capability across Lab

• Competencies – Internal certification that demonstrates capability to run approved

method.

– Continued competency checks

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Internal Round Robin Studies

ICP-MS #1

ICP-MS #2

ICP-MS #3

ICP Chemist 1

ICP Chemist 2

ICP Chemist 3

• Uses a Certified Reference Material

• Analyst tests for multiple elements

• Specifies uncertainty estimates from separate method uncertainty study

• Four repeated measurements for each analyte

• Relative Standard Deviation compared against established acceptance criteria

Every year, alternating between Operator RR and Instrument

RR studies:

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Sample Testing & Analysis

Facilities/Environment

• Temperature, humidity control

• DI Water controls

• Fume Hoods – exhaust controls

• Hazardous Waste Management

• Safety protocols

• Cleanliness

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Sample Testing & Analysis

• Instrument Validation

• Method Development & Validation

• ISO 17034 CRMs

• ISO 17025 Calibrations

• Instrument Maintenance plans

• Precision and Range

• Uncertainty Study

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Day Technician 1 Technician 2 Technician 3 Technician 4

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Std. Dev.

Average

Variance

Repeatability

Reproducibility

Uncertainty Studies

• Does not require a CRM

• Repeated measurements over 20 days

• At least two operators

• Detailed estimation of uncertainty by

propagation analysis

Conducted for every new method, including

validation of new instruments

Uncertainty Contributor Type Distribution

Reproducibility A Normal

Repeatability A Normal

Reference sample variation B Expanded (95.45% k=2)

Instrument/Device Resolution B Resolution

Sampling process, if applicable (random) B Normal

Uncertainty Results Estimate

Combined Uncertainty (uc)

Effective Degrees of Freedom

Coverage Factor (k)

Expanded Uncertainty (U)

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Proficiency Testing

Proficiency testing determines the performance of individual laboratories for

specific tests or measurements and is used to monitor laboratories' continuing

performance. Proficiency testing is also called interlaboratory comparison.

Proficiency Test Programs

• ISO 17043 PT providers

• Covers all items on the scope over a scheduled time

• Corrective action required for any outliers

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External Proficiency Test Programs

Example of Statistical Data

RESULT PRIOR YEARSZ

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Analyzing & Reporting Results

Integrated instruments with the LIMS

• Data Transfer

• Reduces data entry and calculation errors

Multi-level Reviews / Report Generation

• Analytical Results

• Analyst Review of Specific Data

• Technical Review of Overall Data and requirements

• Report Generation

• Report Review of all information required on final certification report

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Material & Data Management

Samples retained or returned

• NSL keeps samples for 90 days

• Samples can be returned per customer requirement

Data Retention – industry driven timeframes

• LIMS and other electronic data - server & cloud back ups

• Historical Data – off-site storage

Data Control and Information Management

• Ongoing method review and updates

• Specification library

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Summary

Why Laboratory Accreditation is Important

Laboratory Accreditations and Approvals

ISO 17025 Technical Requirements

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ResourcesANAB https://anab.ansi.org/

A2LA https://www.a2la.org/

The Complete Nadcap Guide: Auditing, Accreditation, Requirements, and More

https://www.mpofcinci.com/blog/complete-nadcap-guide/

Guidance on CPSC Acceptance of Third Party Laboratory Accreditation

https://www.cpsc.gov/Business--Manufacturing/Testing-Certification/Lab-Accreditation/Guidance-on-CPSC-Acceptance-of-Third-Party-Laboratory-Accreditation

Quality Management Systems for Laboratories and External Quality Assurance Programs

DOI: 10.5772/intechopen.73052

ISO 17025 vs. ISO 9001 – Main differences and similarities

https://advisera.com/17025academy/blog/2019/07/11/iso-17025-vs-iso-9001-main-differences-and-similarities/

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Q & A

Speaker

Carm D’Agostino

Chief Chemist

Speaker

Cynthia Hagan

Quality Assurance

Manager

Speaker

Dave van der Wiel

Director, Technology

Development

Speaker

Larry Somrack

President-Emeritus

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Join Us For Our Next Tech Talk!

March 4, 2021

Additive Manufacturing Standardization

Updates from ASTM and SAE

Hosted by

Dave van der Wiel, NSL Analytical

Special Guests: Leaders of ASTM,

SAE

Let’s Talk Tech!

Cynthia Hagan

Quality Assurance Manager

chagan@nslanalytical.com

216.438.5208

Carm D’Agostino

Chief Chemist

cdagostino@nslanalytical.com

216.438.5216