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Importance of Instrument Validation for Accredited Food Export Testing Labs

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Overview

• Why laboratory accreditation for food testing• Overall requirements for accredited food testing

laboratories• Quality checks in the laboratory related to analytical

instrument qualification • Qualification vs. Verification• Essential steps and example templates for Instrument

Qualification: DQ, IQ, OQ, PQ• Requalification: when, what

Reference material: www.labcompliance.com/agilentAvailable until March 10, 2014

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Value of ISO 17025

Country A

Product shipped from country A to B

Country B

• Routine testing only tested in one accredited laboratory of country A

• International comparability of test results through traceability to the same standard

• Confidence in test results through estimated and documented measurement uncertainty

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Overall Requirements of ISO 17025

SamplingSample handling

Testing Test reportsRecord

maintenance

Sampling plan & sampling documentation

Sample identification &protection of sample integrity

Monitoring the quality of test results

Test conditions& test results, with estimated uncertainty

Ensure record integrity & security

Controls across all workflow steps

• Validation of analytical methods & procedures

• Equipment calibration validation & maintenance

• Qualification of material• Traceability• Handling Out-of-specification

results

• Qualification of personnel• Controlled environmental

conditions• Written procedures

Quality system controls across the laboratoryDocumentation control, corrective & preventive actions, complaint handling, supplier & subcontractor management, internal audits, change management, management reviews, continuous improvement, product reviews

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Quality Checks in Laboratories• Quality control checks

– Verifies accuracy of sample analysis• System suitability tests

– Verifies that the system performs according to analysts expectations

• Analytical methods validation– Proof that analytical procedure does what it

purports to do• Analytical instrument qualification

– Forms the base for generating quality data– Proof suitability of the instrument for intended

use

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Equipment Calibration, Qualification, Maintenance – ISO 17025• Laboratory equipment should be furnished with correct

performance of tests• Equipment and software shall comply with specifications

relevant to the tests• Before placed into service, equipment should be calibrated or

checked to verify specifications• Shall be operated by authorized personnel• Should be uniquely identified• Procedures for safe handling and preventive maintenance• Defective equipment shall be taken out of service • Shall be labeled to indicate status of calibration

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Verification vs. QualificationVerification (ISO/IEC Guide 2)

Confirmation by examination and provision of evidence, that specific requirements have been met

Assumption: Specific requirements are defined

Verification Step:Examine and confirm that specific requirements are met

Operational Qualification (Pharma, PDA)

Documented verification, that a system operates according to written and pre-approved specifications throughout all specified operating ranges

Assumption

Requirements are defined for specified operating ranges

Qualification step

Examine and confirm that pre-approved requirements are met

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United Nations – Complying with ISO 17025 Guidebook

Equipment •All new equipment must be checked for correct functioning before being placed in routine service. •This should include checks against the manufacturer's specifications and checks to confirm that the equipment gives satisfactory results when used to make the measurements for which it is intended.

DQ – IQ- OQ -PQ

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Design Qualification

Installation Qualification

Operational Qualification

Performance Qualification

Qualification/Validation Phases 4Q Model User requirement specifications Functional specifications Operational specifications Vendor qualification

Check arrival as purchased Check proper installation of

hardware and software Test of operational functions Performance testing Test of security functions

Test for specified application Preventive maintenance On-going performance tests

• Based on official standard (USP <1058)>

• Well known to industry and agencies• Most safe approach for food testing labs

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Qualification Project Plan TemplateScope of the Plan

Product Description

Validation Strategy

Responsibilities

Supplier Assessment

Risk assessment

Testing Strategies

DQ

IQ

OQ

PQ

Traceability matrix

Procedures

Approval

Documentation control

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Design Qualification (DQ) Activities and Documentation

• Vendors– Design, develop and manufacture instruments in quality control environment, e.g., ISO 9001:2008– Develop functional and operational product specifications

• Users– Develop user requirement specifications– Verify that the vendor’s instrument meets user’s requirements: product specifications, delivery

and support– Verify that the vendor operates in a quality system environment

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Design Qualification - Template

Function/Performance

User Requirement

Supplier Specification

Commentyes/no

Function 1

Function 2

Physical Requirements

Construction Requirement

Vendor Requirement

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Installation Qualification (IQ)

Vendor•Provides the user with environmental specifications and a site prep document•Provides •Offers services for IQ with inspection ready documentationUser •Verify that facilities, utilities, and environment meet vendor requirements•Assemble and install equipment•Perform initial diagnostics and testing•For complex equipment: run reference sample •Document installation, including drawings

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Equipment Documentation for IQ

Identification

Manufacturer Best HPLC

Model D4424A

Firmware revision 1.00

Serial Number E4431A

Internal ID (Asset number) D33243

Current location Glab4

Size (w x b x h) (cm) 30x22x7

Condition when installed New

Supplier contact phone for services

1+541-64532

Example: HPLC detector

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Operational Qualification (OQ)

Vendor• Provides services for OQ with traceable tools• Delivers inspection ready OQ documentation• Makes recommendations for frequency of requalificationUser• Test functions to verify that the instrument operates in the

user’s environment as intended by the manufacturer and required by the user.

• Test secure data handling, storage, back-up and archiving• Tests can be holistic or modular. • Tests can be done by users or qualified designees.

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OQ Test - Example

Date Weight 1Weight 2 Test engineerName Signature

Weight 3 o.k.

yes9999.8 999.9 100.0 Hughes2/3/06

Instrument BestBalance

Serial number 55236A

Maximal weight 11 g

Control weight 1 10,000 mg Limit +-10 mg

Control weight 2 1,000 mg Limit: +-1 mg

Control weight 3 100 mg Limit: +- 0.1 mg

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Performance Qualification (PQ)

Vendor• Provides recommendation for PQ tests, e.g., for system suitability

testing• Provides software for PQ testing, e.g., for system suitability and quality

control chartsUser • Preventive maintenance to ensure trouble free operation for the

intended application• Performance checks, based on the instrument’s typical on-site

applications– Test frequency depends on the ruggedness of the instruments and

the criticality of the tests– System suitability and QC tests can imply suitable performance

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Documentation of PQ Testing

Test Test Case

Expected result Actual Result

Pass/Fail

BaselineNoise

T10 <1x10-4 AU Pass

Resolution between compound A and B

T11 >2.0

Tailing factor T12 <1.3

Precision of amount compound A, 6 replicate injections

T13 <1%

Precision of amount compound B, 6 replicate injections

T14 <1%

Example: HPLC System

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Summary Report TemplateScope of the report

Product Description

Qualifiaction Strategy

Responsibilities

Supplier Assessment

Risk assessment

Testing Strategies

DQ

IQ

OQ

PQ

Traceability matrix

Procedures

Deviations

Approval

Documentation control

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Define System Use

Installation Qualification

Operational Qualification

Performance Qualification

Validation Phases – 4Q Model APPROACH FOR EXISTING EQUIPMENT

Document equipment use Document applications Document used functions

Enter all modules and systems in a database

Hardware, Firmware, Software

Document past tests Test of functional specifications Test of performance functions

System test (system suitability testing)

Preventive maintenance

+ Change Control

Ludwig HuberLabcompliance Sponsored by Slide 21

Thank YouI would like to thank • All attendees for your attention• Agilent Technologies for invitation and organization

For links to Instrument Validation references, please checkwww.labcompliance.com/agilent(Available until March 10, 2014)

Dr. Ludwig HuberLudwig_huber@labcompliance.com