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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 [email protected]