Transcript Slide 1

Importance of
Instrument Validation
for Accredited Food
Export Testing Labs
1
Overview
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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/agilent
Available until March 10, 2014
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Slide 2
Value of ISO 17025
Product shipped from country A to B
Country A
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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Slide 3
Overall Requirements of ISO 17025
Sampling
Sampling plan &
sampling
documentation
Sample
handling
Sample
identification &
protection of
sample integrity
Testing
Monitoring the
quality of test
results
Test reports
Test conditions
& test results, with
estimated
uncertainty
Record
maintenance
Ensure
record
integrity &
security
Controls across all workflow steps
• Validation of analytical
• Qualification of material
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methods & procedures
• Traceability
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• Equipment calibration
• Handling Out-of-specification
validation & maintenance results
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Qualification of personnel
Controlled environmental
conditions
Written procedures
Quality system controls across the laboratory
Documentation 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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Slide 5
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. Qualification
Verification (ISO/IEC Guide 2)
Confirmation by examination and
provision of evidence, that
specific requirements have been
met
Operational Qualification
(Pharma, PDA)
Documented verification, that a
system operates according to
written and pre-approved
specifications throughout all
specified operating ranges
Assumption:
Specific requirements are
defined
Assumption
Requirements are defined for
specified operating ranges
Verification Step:
Examine and confirm that
specific requirements are met
Qualification step
Examine and confirm that preapproved 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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Qualification/Validation Phases 4Q Model
Design Qualification
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Installation Qualification
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Operational Qualification
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Performance Qualification
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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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Slide 9
Qualification Project Plan Template
Scope 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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Slide 10
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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Slide 11
Design Qualification - Template
Function/
Performance
User
Requirement
Supplier
Specification
Comment
yes/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 documentation
User
• 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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Slide 13
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 1+541-64532
services
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 requalification
User
• 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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Slide 15
OQ Test - Example
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
Date
Weight 1 Weight 2
2/3/06 9999.8
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999.9
Weight 3
100.0
o.k.
Test engineer
Name
Signature
yes Hughes
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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 charts
User
• 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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Slide 17
Documentation of PQ Testing
Test
Test
Case
Expected result
Baseline
Noise
T10
<1x10-4 AU
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%
Actual
Result
Pass/
Fail
Pass
Example: HPLC System
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Slide 18
Summary Report Template
Scope 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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Validation Phases – 4Q Model
APPROACH FOR EXISTING EQUIPMENT
Define System Use
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Installation Qualification
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Operational Qualification
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Performance Qualification
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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
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Slide 20
Thank You
I would like to thank
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All attendees for your attention
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Agilent Technologies for invitation and organization
Dr. Ludwig Huber
[email protected]
For links to Instrument Validation references, please check
www.labcompliance.com/agilent
(Available until March 10, 2014)
Ludwig Huber
Labcompliance
Sponsored by
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