Management Review Report For 2019: J. Cho, J. Bennett
Management Review Report For 2019: J. Cho, J. Bennett
J. Cho, J. Bennett
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This work performed under the auspices of the U.S. Department of Energy by Lawrence Livermore
National Laboratory under Contract DE-AC52-07NA27344.
CY2019 Management Review Report
LLNL ES&H Analytical Services and Instrumentation Division Analytical Laboratory (ALAB)
Changes in internal and external issues that are relevant to the laboratory
1.1. Status of State of California ELAP regulations
1.1.1 CA ELAP continued to hold stakeholder meetings starting in January 2019 and continuing
throughout the year to listen to the concerns of the regulated community. ELAP released
a Notice of Proposed Rulemaking on Oct 11, 2019 which contained an Initial Statement
of Reasons and a 4th draft of the proposed regulations. A hearing was held in December
to address comments, and another hearing was scheduled for January 2020. CA ELAP’s
intent is to present the proposed regulations to the Water Boards during their spring
meeting.
Additional Discussions: CA Water Boards approved the CA ELAP proposed regulations package
in March of 2020. The regulations do not take full effect until 2022, and labs have until then to
come into full compliance. ALAB plans to become an early adopter. Actions to accomplish this
will be discussed in the 2020 Annual Management Review.
1.1.2 ALAB became accredited by CA ELAP for the additional Fields of Testing to support the
environmental soils testing projects for the Environmental Functional Area on 3/14/19.
Since the CA ELAP program told ALAB that they would not be able to perform an onsite
evaluation of the laboratory for the new fields of testing within a year, ALAB negotiated
with CA ELAP to use a third-party assessor (TPA, i.e. ANAB) to assess ALAB to the TNI
2009 Standard. The only way the TPA would perform the onsite audit was if ALAB
became accredited to the TNI standard through their accreditation process. That
assessment occurred from Feb 12th to 14th There were 12 minor findings from the ANAB
assessment, and all corrective actions were accepted both by ANAB and CA ELAP. CA
ELAP accepted the ANAB TPA accreditation report in lieu of CA ELAP performing an onsite
assessment and ANAB granted TNI accreditation. Much of this information was included
in the 2018 Management Review because of the actions occurring at the end of one
calendar year and the beginning of the next calendar year. Appendix 1 contains the
supporting information.
1.2. Labworks LIMS implementation
1.1.1 The Labworks LIMS implementation for the environmental soils fields of testing was mostly
completed in 2019, and the reporting from Labworks was validated by the ALAB Technical
Manager doing hand calculations to verify the reported results. The in-house Labworks
SME worked with the Labworks implementation specialist and EFA Data Management staff
to develop the EDD to electronically transmit the results to the EFA environmental
database. During the implementation ALAB discovered several idiosyncrasies that were not
expected. Two examples are that if samples from more than one sample receipt group are
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extracted and analyzed in one preparation batch that Labworks can’t associate the batch
OC across the two batches. The analyst must create a second copy of the batch QC results
and rename it so that it is associated with the second batch. The second example is that
Labworks can’t flag sample results to indicate that the analyte is present in the method
blank. The flags must be applied manually.
1.2 Addition of CFF to ALAB AIHA Accreditation
1.2.1 The CFF expect to increase the tempo of operations and inquired about setting up a
satellite laboratory at Site 300 under the ALAB AIHA accreditation to reduce the
analytical TAT. A meeting was held in April and ALAB expressed that the AIHA
requirements for accreditation are that the accreditation is for a single site. There were
discussions about what it would take to set up an AIHA accredited laboratory at Site 300
and discussions about submitting samples to NIF, since the NIF is a 24/7 operation.
There are challenges to each of those approaches that have not been resolved. At the
present time, the CFF is still submitting their samples to ALAB.
Additional Discussions: Michelle mentioned more details were included in the discussions between
CFF then were included on the Agenda. Further discussion details will be included in the CY2020
Management Review.
2 Fulfilment of objectives
2.1 The ALAB’s mission is to provide excellent service and quality analytical results while exceeding
customer’s expectations. The ALAB is committed to using quality practices that require all tests
to be carried out in accordance with stated methods and customers’ requirements.
2.2 The objectives of the ALAB quality system align with the ES&H Directorate objectives which
include:
2.2.1 Applying quality principles throughout ALAB activities
2.2.2 Providing a process for continual improvement in all areas of ALAB performance
2.2.3 Ensuring customer needs are met in a safe, environmentally sound, and cost-
effective manner
2.2.4 Ensuring appropriate planning, organization, direction, control, and support are
provided to achieve ALAB goals
2.3 The ALAB continues to perform high-quality chemical analyses in support of the Industrial
Hygiene Program and the Environmental Functional Area.
3 Suitability of policies and procedures
3.1 Eight procedures were either revised or issued in 2019. Three SOPs are past-due for review,
and two procedures were transferred to RML. Revisions included updates to describe current
laboratory practices, updates to incorporate TNI 2009 and ISO 17025:2017 requirements, and
corrective actions from assessments. New procedures were generated for the new
environmental soil fields of testing 1nALAB.
3.2 The revised standard ISO 17025:2017 was published on 11/30/17, and revised AIHA policies
that incorporated the standard revisions were published 7/2/18 and were effective
immediately. However, the basis of the TNI 2009 requirements for the environmental methods
is still the 2005 version of ISO 17025, so ALAB is maintaining both versions of ISO 17025
requirements in the quality management system because ALAB expects that CA ELAP will
implement the NELAC Standard in the revised regulations. When that occurs, the revised
regulations will be based on the TNI 2016 version of the NELAC standard, and an additional
gap analysis will be required.
3.3 Discussed discontinuing procedure ALAB-lO Metals in Water Samples by Modified EPA Method
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200.7 at the 2018 Management Review meeting. Jack and Ruth were tasked to identify an
accredited lab that can analyze these samples via subcontract. Additional information is provided
in the next section.
3.4 Policies and Procedures continue to be suitable.
4. Status of actions from previous management reviews
4.1 Action items from CY2018 Management Review (ITS 47465):
4.1.1. Review all SOPs that are past-due for review- Revisions completed, need
QA and peer review for three SOP’s.
Additional Discussion: Two of the three SOP’s in Section 4.1.1 were related to the
digestors analysis (Sample Receipt and Metals Analysis). ALAB discontinued those tests in
March 2020. These SOP’s will not be updated. The Sample Receipt SOP was updated by
Debbie Vanorder prior to her retirement and will be transferred to RML because they are
still performing radiochemistry analysis on the digestors.
4.1.2 Work with IT support to resolve the Be Swipes and lH Metals Swipes spike
RPD and reporting issues- Not completed. Ruth contacted ALIMS Support
and was not able to bring this to a close.
Additional Discussion: Jack has recently revived this issue and has emailed back and forth
with ALIMS Support and the issue has fallen off the table again. Michele asked to have
James Arellano brought into the discussions. Jack will revive this issue and include James
on the emails going forward.
4.1.3 Control chart lead wipes and lead paint OC Unknown samples — Completed
(see discussion below)
Additional Discussion: Ruth investigated implementing the control charting of Pb Wipe
and Paint QC Unknowns. She discovered that new programing would be needed in ALIMS
in order for this to work. Since the developers are retired and ESH management has put
obtaining a new LIMS for all AS&l as a priority item, pursuing this is not practical any
longer. Chris Campbell suggested to follow up with the appropriate people to ensure this
stays near the top of the list.
4.1.4 Implement two new networked computers in ALAB Completed.
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4.1.5. Have ALIMS IT support add the required disclaimers regarding sampling and sample
information provided by the customer to ALAB final reports Completed.
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4.1.6. Internally audit the environmental water and sewage analysis methods —
Completed.
4.1.7. Identify an accredited subcontract lab for the EPA Method 200.7 metals in water
samples Completed (Eurofins Monrovia). See Appendix 2 for the Eurofins CA
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ELAP certificate.
4.1.8. Review the quality programs of ALAB’s subcontract labs (Micro Analytical
Laboratories, Bureau Veritas, and EMLab P&K) Completed. See Appendix 2 for the
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suggested that ALAB and EFA investigate if it makes sense to use the same labs. Jack and Bart
Draper will meet to discuss this.
4.1.9 Place linear range study results in the ALAB QA server folder for improved access
and knowledge retention Completed.
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8.3 The ALAB continued the process of setting up environmental soil analysis methods in 2019. Six
new methods were implemented in 2019. Implementing three new fields of testing included a
new LIMS and was a large undertaking with many steps and moving pieces. Since theLIMS
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implementation occurred during 2018 and 2019, details about the timeline are included in the
2018 Management Report. After ALAB became accredited for the new FOT’s by CA ELAP, the
EFA sent several batches of samples to ALAB and their commercial subcontract laboratory.
Their comparison of results indicated that the ALAB data was comparable to the data received
from the commercial subcontract laboratory.
8.4 In addition to the subcontracted lead wipes discussed above, ALAB analyzed 1080 lead wipes
inhouse during Q2 of this year. That is approximately the same number of lead wipes analyzed
in all of 2018.
Additional discussion: The work breakdown shows that the lH Metals and Pb Wipes are becoming a
higher proportion of ALAB’s work. These tests are more labor intensive, yet ALAB still mostly met
its weekly TAT goals and did meet its overall TAT goal. Although ALAB did get administrative
support for subcontract results data entry, the bulk of it over the course of the year still fell to ALAB
staff. After the Management Review, Jack decided to include the TAT information as part of this
report. Jack also mentioned that AS&l is probably seeing the increased subcontracting costs in our
budget.
9 Customer and personnel feedback
9.1 Customerfeedback
9.1.1 The ALAB Technical Manager received verbal and email feedback from several lH’s over
the course of the year complimenting ALAB on their responsiveness and customer service.
Several instances of this are noted in the quarterly reports, which are provided in Appendix 6.
9.1.2 ALAB was nominated for and received an ES&H Gold Award for the work they did in setting
up for the soils analysis.
9.1.3 To solicit feedback from ALAB customers, a five-question SurveyMonkey online survey was
distributed to all Industrial Hygienists and Health and Safety Technicians. Survey responses
were collected October 15-31, 2019. There were 25 survey responses out of 79 possible
respondents, for a 32% survey response rate. The survey had a 100% completion rate and
took 1 mm 7 sec to complete on average. Survey responses and results are detailed in the
ALAB Customer Feedback Oct 2019 Report (see Appendix 4). The responses in 2019 were
very comparable to those from the 2018 survey, with the average response to all items
greater than 4.5 out of 5. The survey responses provided good suggestions for
improvement ofALAB processes as well as highlighted the need for awareness of some of
the services that are already available.
Additional discussion: Since we now have several years’ worth of data, it might make sense to
start looking at the standard deviation of the data to see if the fluctuations are statistically
significant or just normal variation. Jack said that our response rate is above average for
surveys. Vicki commented that LEO has given similar positive feedback about the response
rate for surveys that the Assurance Office fields.
13.3 Preventive actions and process improvements are recorded in the Record of Planned and
Implemented Changes Logbook and Quarterly QA Reports (see Appendix 6). Ideas to mitigate
risk and improve processes were also captured during work observations of ALAB staff.
13.3.1 During his work observation Matt stated that all the networked computers in ALAB
are somewhat old and slow. Ruth observed some significant lag times while Matt was
working in Labworks. Matt said that ‘30-40% of the work of an environmental
method analysis is done through a networked computer. Matt suggested replacing
the three networked computers currently in ALAB and adding a fourth networked
computer to improve efficiency. Three new PC’s were procured and installed.
13.3.2 During her work observation Cora raised the issue of needing rapid approval of purchase
requests and what to do if both Jack and Michele are unavailable to give approval. Cora
suggested having two more people be authorized to give those approvals if needed or
wondered if an order could be submitted directly to the TRR with no approvals required
if the approvers were not available. Michele clarified that other Group leads could
approve purchase requests in the event that she or Jack were not available.
13.3.3 Not having a control chart for lead wipes and lead paint QC Unknown samples was
identified in the last management review as being a risk. However, it requires IT
support to accomplish. Since the recoveries of the QC Unknowns are still within limits
and since it is not a requirement but a best practice, this is a low risk to operations.
13.3.4 Resolve ALIMS Be Swipes Method spikes RPD calculation and reporting issues This is still
a risk being carried over from the 2018 report. Ruth contacted ALIMS support, but did
not have success in resolving the issue.
13.3.4.1 ALIMS inconsistently/incorrectly calculates spike sample relative
percent difference (RPD) values.
13.3.4.2 The ALIMS Precision Spike Recovery report does not show spike , ieand RPD
results for spikes 1 and 2, only for spikes 3 and 4.
Additional discussion: The Record of Planned and Implemented Changes Logbook serves its
purpose but is a somewhat cumbersome way of doing things. Items 13.3.3 and 13.3.4 have been
discussed elsewhere in this report. The largest risk to operations comes from Item 13.3.4, but it is
still negligible because the correct RPD values are monitored in the control charts generated using
data from the instruments.
14 Outcomes of the assurance of the validity of results
14.1 AIHA ELPAT Rounds 106411: Acceptable results for all rounds. Round 106 had one
unacceptable result (see NCR 10002205) but passed with a % overall score. Round 109 had
one unacceptable result (see NCR 1002368) but passed with a % overall score. On average, a
slight negative bias was observed in the data for both wipes and paint samples. The magnitude
of the bias does not impact the usability of the data.
14.2 AIHA ELPAT-Air Rounds 106-111: Acceptable results in all rounds.
14.3 AIHA IHPAT Rounds 216-221: Acceptable results in all rounds.
14.4 AIHA BePAT Rounds 49-52: Acceptable results in all rounds from both ALABand HIF HPL
methods.
14.5 WP-291 Trace Metals in Water acceptable results for all reported elements
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14.7 Metals in Sewage Sludge CRM acceptable results for all reported elements
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14.8 ERA Soil-108 Metals in Soil: Acceptable results for all metals reported.
14.9 Environmental soils PT round (Millipore-Sigma QT-0024202):
14.9.1 Metals in Soil: 100% Acceptable
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bromide were not acceptable (see NCR 1002355). Retested new ampule from the
study and Acetone and 2-Butanone results for both samples were within acceptable
window of assigned value. A make-up PT was ordered.
14.11 NSI Lab Solutions SQCO-OO8LB Low Level VOCs in Soil (Make-up PT): 100% Acceptable for
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16.4. Investigate options for Document Coordinator/admin help with SOPs Michele/Thom
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(12/31/20).
16.5. ICP remain on infrastructure investment list as a plan to replace —Jack/Michele (Completed).
16.6. Address ALIMS Be RPD and lH Metals RPD calculation issue and add James to help with IT
needs —Jack (12/31/20).
16.7. Diana to send a reminder to HSTs to continue to submit sample descriptions with asbestos
samples to ALAB Diana (9/30/20).
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16.8. Perform gap analysis between NELAC 2009 and 2016 Standards Jack/Jennifer (10/31/20).
16.9. Add annual TAT information to Annual Management Review—Jack (Completed)
16.10. Investigate if creating a PIT for normal subcontracting will make it easier to track
subcontracting expenses Jack -9/15/20.
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ALAB CY2019 Management Review
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