prepared for 24th annual good laboratory practice
TRANSCRIPT
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Prepared for 24th Annual Good Laboratory Practice Conference Charlottesville, VA July 31, 2018
Presented by Cathy Westerman, VELAP Manager, VA Division of Consolidated Laboratory Services
GOALS
To HIGHLIGHT frequent areas of non-compliance in VA’s regulations for
certification and accreditation of environmental laboratories …
1VAC30-45 or “Chapter 45”, certification for non-commercial
laboratories
1VAC30-46 or “Chapter 46”, accreditation for commercial
laboratories, which incorporates by reference the 2009 TNI
Standard
… then REDUCE these non-compliances!
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BASIS OF PRESENTATION
VELAP records summarized for this presentation:
1VAC30-45: 3-year period (March 2015-March 2018)
1VAC30-46: 1.5-year period (September 2016-March 2018)
Information is grouped by topic
Sometimes more than one finding per topic
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INFORMATION AVAILABILITY
www.dgs.Virginia.gov/dcls
Laboratory
certification/accreditation
“Toolbox” page
Under “Technical assistance”
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#10: PROFICIENCY TESTING (PT)
“When analyzing a PT sample, the lab shall employ the same calibration, QC
and acceptance criteria, sequence of analytical steps, number of replicates,
and other procedures as used when analyzing routine samples.” [1VAC30-45-
510 B]
“When a lab receives a PT result of “not acceptable”, the lab shall determine
the cause for the failure and perform and document corrective action. The
corrective action documentation shall be completed within 30 days of
receiving the “not acceptable” result and be submitted to DCLS upon
request.” [1VAC30-45-520 C 1] 6
Chapter 45
#9: REAGENTS AND MEDIA
[Microbiology] “Documentation for media purchased pre-prepared, ready-
to-use, shall include the manufacturer, lot number, type and amount of media
received, date of receipt, expiration date of the media, and pH of the media.”
[1VAC30-45-796 F]
[Chemistry] “The quality of water sources shall be monitored and
documented and shall meet method specified requirements.” [1VAC30-45-
773 B 2]
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Chapter 45
#8: MANAGERIAL REVIEW
“The laboratory management shall conduct a review, at least annually, of its
quality system and its testing and calibration activities to ensure its
continuing suitability and effectiveness, and to introduce necessary changes
or improvements in the quality system and laboratory operations.” [1VAC30-
45-670 B 1]
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Chapter 45
#7: INTERNAL AUDITS
“The laboratory shall arrange for annual internal audits to verify that its
operations continue to comply with the requirements of the laboratory's
quality system. It is the responsibility of the quality assurance officer to plan
and organize audits as required by a predetermined schedule and requested
by management.” [1VAC30-45-670 A 1]
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Chapter 45
#6: SUPPORT EQUIPMENT (SLIDE #1)
Quarterly check of mechanical volumetric dispensing devices including
burettes, except Class A glassware [1VAC30-45-740 D 1 e]
Microbiology - Volumetric equipment checks:
Quarterly for equipment with movable parts
Once per lot prior to first use for filter funnels, bottles, non-class A glassware
Once per lot for sample bottles and disposable pipettes [1VAC30-45-798 B 3]
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Chapter 45
#6: SUPPORT EQUIPMENT (SLIDE #2)
Support equipment (balances, ovens, refrigerators, freezers, and water baths)
checked on each day of use in the expected use range with NIST traceable
references where available [1VAC30-45-740 D 1 d]
Support equipment calibrated or verified at least annually over the entire
range of use using NIST traceable references where available [1VAC30-45-
740 D 1 b]
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Chapter 45
#5: DEMONSTRATION OF CAPABILITY
From 1VAC30-45-730 F 4, F 5, and G:
DOC requires determination of mean and standard deviation of all results
DOC requires evaluation of mean and standard deviation to acceptance
criteria in the method or, if no established mandatory criteria, then criteria
established by the laboratory
DOC requires detailed documentation specified by the regulation
DOC must be successfully completed before the analysis of actual samples 12
Chapter 45
#4: RECORDS / TRACEABILITY
Recordkeeping system that allows historical reconstruction of all laboratory
activities that produced the analytical data; the history of the sample readily
understood through the documentation. [1VAC30-45-640 A]
Unique identity of samples at all times [1VAC30-45-850 1]
No erasures, overwritten entries; corrections with single line strike-through
and initials/date [1VAC30-45-640 G]
Signature log – names, signatures, initials of staff [1VAC30-45-660 D 3]
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Chapter 45
#3: REPORTING: SUBCONTRACTING
Laboratory reports. “Where the certificate or report contains results of
tests performed by subcontractors, these results shall be clearly identified by
subcontractor name or applicable certification number.” [1VAC30-45-860 B]
“The laboratory shall retain records demonstrating that subcontracting
requirements have been met.” [1VAC30-45-680 C]
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Chapter 45
#2: SOP / QUALITY MANUAL (SLIDE #1)
SOPs: All requirements of 1VAC30-45-730 C 2 are met for Standard
Operating Procedures. [1VAC30-45-730 C 2]
SOPs: Document control for SOPs: effective date, revision number, signature
of responsible laboratory manager(s) [1VAC30-45-610 C13]
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Chapter 45
#2: SOP / QUALITY MANUAL (SLIDE #2)
QM: Reviewed and approved by quality assurance officer, laboratory
manager, and responsible official at least annually [1VAC30-45-610 D 2]
QM: Communicated to, understood by, available to, and implemented by all
laboratory personnel [1VAC30-45-610 A 3]
QM: Contains a list of the certified testing addressed by the manual
[1VAC30-45-610 C 13]
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Chapter 45
#1: TEST METHODS
The laboratory shall use appropriate test methods and procedures (including
sample handling, transport and storage, preparation and analysis). The
method and procedures shall be consistent with the accuracy required and
with any standard specifications relevant to the tests. [1VAC30-45-730 D 2]
Frequently:
QC specified within method
40 CFR 136 requirements for preservation/storage
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Chapter 45
#10: MICROBIOLOGICAL TESTING
Sterility checks on dilution water [V1M5 1.7.3.1.b.iv]
Sample duplicates performed per method requirements [V1M5 1.7.3.3.b]
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Chapter 46
#9: INTERNAL AUDITS
Annual schedule [V1M2 4.14.5.c]
Timely corrective action for internal audit findings [V1M2 4.14.2]
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Chapter 46
#8: SUPPORT EQUIPMENT
Calibrated or verified at least annually, bracketing range of use [V1M2
5.5.14.1.b]
Quarterly verifications of volumetric dispensing devices [V1M2 5.5.13.1.e]
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Chapter 46
#7: SUBCONTRACTING
Records of evidence that laboratories used for subcontracted work meet
the requirements of the Standard [V1M2 4.5.4]
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Chapter 46
#6: CORRECTIVE ACTION
Monitor the results of implemented corrective actions to ensure that the
corrective actions taken have been effective [V1M2 4.11.4]
Perform corrective action for failed proficiency tests [V1M1 6.1]
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Chapter 46
#5: SERVICE TO CLIENT
Seek feedback, both positive and negative, from the laboratory’s customers
and
Use and analyze the feedback to improve the management system, testing
activities, and customer service [V1M2 4.7.2]
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Chapter 46
#4: MANAGEMENT
Quality policy statement – includes management’s commitment to comply
with the 2009 TNI Standard and to continually improve the effectiveness of
the management system [V1M2 4.2.2.e]
Designation of technical manager authority in the absence (>15 consecutive
calendar days) of a technical manager [V1M2 4.1.7.2.e]
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Chapter 46
#3: CONTROL OF RECORDS / TRACEABILITY (SLIDE #1)
Recordkeeping system that allows history of sample to be readily
understood through the documentation [V1M2 4.13.3.a, f]
Record specifications for standards/reagents/media [V1M2 5.6.4.2.a, c]
Recordkeeping corrections with single strike-through [V1M2 4.13.2.3]
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Chapter 46
#3: CONTROL OF RECORDS / TRACEABILITY (SLIDE #2)
Procedures to protect and back-up electronic records and prevent
unauthorized access/amendment [V1M2 4.13.1.4]
Observations, data, and calculations recorded at the time they are made
[V1M2 4.13.2.2]
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Chapter 46
#2: DOCUMENT CONTROL / SOPS / QM (SLIDE #1)
All required elements of SOPS and Quality Manual [V1M2 4.2.8.5.f and V1M2
4.2.8.3 and V1M2 4.2.8.4]
Documents communicated to, understood by, available to, implemented by
appropriate personnel [V1M2 4.2.1]
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Chapter 46
#2: DOCUMENT CONTROL / SOPS / QM (SLIDE #2)
Establish and maintain procedures to control all documents that form part
of its management system (internally generated or from external sources)
such as regulations, standards, other normative documents, test methods,
drawings, software, specifications, instructions, manuals [V1M2 4.3.1]
Master list or equivalent document control procedure identifying the current
revision status and distribution of documents in the management system to
preclude the use of invalid and/or obsolete documents [V1M2 4.3.2.1]
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Chapter 46
#1: METHODS
Deviation from test methods shall occur only if the deviation has been
documented, technically justified, authorized, and accepted by the customer
[V1M2 5.4.1]
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Chapter 46
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Methods SOP/QM Traceability
Records Management
Reviews Internal Audits
Subcontracting Support
Equipment DOCs
Service to Client
Corrective Action
Proficiency Testing
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Prepared for 24th Annual Good Laboratory Practice Conference Charlottesville, VA July 31, 2018
Presented by Cathy Westerman, VELAP Manager, VA Division of Consolidated Laboratory Services
Questions?