Dr. Michael Shepherd
2017 TCEQ Environmental Trade Fair
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Significant portions of this presentation were
provided courtesy of
Randy L. Long
Accreditation Manager, Calibration, EMC
Testing/Inspection
ANSI-ASQ National Accreditation Board d/b/a
Laboratory Accreditation Bureau
11617 Coldwater Road Suite 101
Fort Wayne, IN 46845
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TNI 2009/ISO/IEC 17025 Requirements
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A light-hearted case of an ineffective cause
analysis
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Lessons Learned
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General Guidance
◦ This is NOT an exhaustive study of methods
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A Few Examples from STS Archives
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Summary
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Conclusion
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ISO/IEC 17025 Section 4.11.1 requires
calibration and testing laboratories to
establish a policy and procedure for
implementing corrective action when
nonconforming work or departure from
policies and procedures have been
identified that starts with an investigation
to determine the root cause(s).
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Effective cause analysis is the key to determining
corrective actions yielding long lasting results.
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Fix the right problem!
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Definition of “root”: the basic cause, source, or origin of
something.
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•
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"love of money is the root of all evil"
synonyms: source, origin, germ, beginning(s), genesis;
Ineffective cause analysis yield solutions that act as
bandages to the root cause. Often an ineffective
cause analysis will only address the symptoms of a
deeper root cause.
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Let’s walk through a humorous example of an
ineffective cause analysis and corrective
action
An inspector writes the town
council a deficiency for
“water in the street”
where an ordinance
clearly states that “there shall be no standing water in
the street.”
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The town council reviews the deficiency and
comes to the conclusion that the are too many
dogs in town watering the fire hydrant.
The root cause cited is “Too many dogs in town”
The corrective action is “All dogs are banished
from town.”
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After 1 week, the town council sees no dogs
in town and is satisfied that the corrective
action is sufficient.
V1M2: 4.11.4 Monitoring of Corrective Actions
The laboratory shall monitor the results to ensure that
the corrective actions taken have been effective.
Monitoring and follow-up: Good!
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The inspector returns to inspect the town a
year later and once again writes the town a
deficiency for “water in the street.”
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The town council is angry that the assessor
wrote them up again.
(“Repeat Finding”, Therefore Critical Finding)
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The town council reviews the deficiency
and comes to the conclusion that the
water is coming from outside of the
town.
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The root cause cited is “the water is
coming from outside of town”
The corrective action is “dig a drainage
ditch outside of town to divert the water”
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After 1 week, the town council sees no water
in town and is satisfied that the corrective
action is sufficient.
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The inspector returns to inspect the town a
year later and once again writes the town a
deficiency for “water in the street.”
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The town council is REALLY angry that the
assessor wrote them up again.
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The town council reviews the deficiency and
comes to the conclusion that the water is still
coming from outside of the town.
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While trying to determine the root cause, the
dam at the head of the valley bursts, washing
the town into the sea.
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It is useful to know why the standard is in
place.
Effective cause analysis can help to avoid or
prevent a catastrophe.
Ineffective cause analysis wastes time and
money.
Ineffective actions results in Repeat Findings.
Effective monitoring of the results will
identify ineffective actions.
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Establish a policy for corrective action.
◦ The policy is easy
 “It is ACME LABS policy to implement appropriate
corrective action(s) when nonconforming work or
departure from policies and procedures has been
identified.”
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
“The procedure for corrective action shall start with an
investigation to determine the root cause(s) of the problem.”
(TNI V1M2 4.11.2)
 The procedure is a little more difficult to write and it needs to fit well with your
organization.

The investigation will likely lead you to one or more of the
following sections of the standard. (See list in TNI V1M2 5.1.1)
 Human Factors (Section 5.2) also 4.1
 Accommodation and Environment (Section 5.3)
 Test Method or method validation (Section 5.4)
 Equipment (Section 5.5)
 Measurement Traceability (Section 5.6)
 Sampling (Section 5.7)
 The Handling of Test Items (Section 5.8)
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 Some common techniques for getting to the root of the
problem are:
•
The Ishikawa (fishbone) diagram
•
The 5 Whys
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The Ishikawa diagram (or fishbone diagram or also
cause-and-effect diagram) are diagrams, showing
causes of a particular situation. The “bones” of the
diagram are labeled with categories such as;
• 6 M’s: Machine, Method, Materials, Maintenance, Man, and
Mother Nature.
• 4 S’s: Surroundings, Suppliers, Systems, and Skills.
• 8 P’s: Price, Promotion, People, Processes, Place/Plant,
Policies, and Product.
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 Ishikawa
(fishbone) Diagram
◦ The drawing below shows the 4 S’s as 4 red bones with
the results of an investigation’s possible causes in blue.
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Five Whys,
◦ don’t stop with the first response as it is usually a
symptom, keeping asking why until you get to a
real cause.
◦ You may get to a root cause before asking why 5
times.
◦ If you keep asking, you may identify an additional
root cause.
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V1M2, 5.10.2(b)
Test reports must contain the location where
the tests were carried out, if different from
the address of the laboratory.
The assessment team observed evidence of
subcontracted tests on final reports where
the subcontracted laboratory
address/location were not clearly identified.
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Response:
“The root cause is that this is a standard we
have never seen or heard of before.”
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One “Why”, any others?
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V1M2, 4.11.1
“The laboratory has not implemented a policy
to perform and document corrective action
when scores of "not acceptable" are received
on proficiency testing (PT) samples, as required
by V1M1 Section 6.1. For example, no
corrective action documentation was available
for failed PT analysis associated with study
SOIL-XX for Toxaphene and Antimony.”
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Response:
“The reason we didn’t do corrective action is
because we didn’t have an SOP for Corrective
Action on PTs. We now have one entered in our
document control system and we will be doing the
corrective actions including the root causes
immediately after receiving the results from out PT
Provider.”
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One “Why”, One “P”
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V1M2, 5.5.2
“Equipment has not been verified to establish that it
meets specified requirements and complies with the
relevant standard specifications, before being put into
service. Examples include (but are not necessarily limited
to):
A. Standard Erlenmeyer flasks are being used as
volumetric devices to measure distillate volumes in the
preparation of samples using EPA Method 420.4. No
records were available documenting the volume accuracy
of these non-Class A items. A quick check of the accuracy
of the flasks against a Class A graduated cylinder
performed during the assessment showed the 500-mL
mark on the flask to be approximately 480 mL.”
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Response:
“Root Cause: Incorrect equipment used.
Volumes were measured using non-class A”
“Corrective Action: All volumes now measured
using class A volumetric ware (i.e., graduated
cylinder).”
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One “Why”..others?
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V1M2, 5.4.1
“The laboratory has made modifications to the
reference methods that are not authorized,
technically justified, or approved. For example:
…B. Temperature is not being recorded or
automatically compensated for when pH is
taken.”
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Response:
“To save money a probe without a
temperature sensor was purchased”
One “Why”, One “M”, One “P”
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V1M2, 4.13.3(a)
“The laboratory's record system does not
produce unequivocal records which document all
laboratory activities. Examples include (but are
not necessarily limited to): …D. Records for the
standardization of sodium thiosulfate titrant
used for sulfide analyses carry an incorrect lot
number for the sodium thiosulfate reagent used
in the analyses. The benchsheet indicates lot
#143002 when the correct lot number is lot
#148488.”
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Response:
“Root Cause: The lot number error was an
oversight on the part of the analyst. She did
not update the lot number on her extraction
log from the previous analysis. A big
contributor is the use of forms where
information from previous use is saved into
the form.”
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Two “Why’s”, 2 “M’s”
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Response continued…
“Corrective Action: (a) In the future, a designated
blank space will be included on the log for the
reagent and all lot number documentation will be
hand written on the log at the time of use. (b) The
Laboratory is in the process of establishing a
written lab-wide document control process where
information can be typed into the form and
printed, but not saved to the form. This should
prevent typed information from previous forms
carrying over to the new printed form.”
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There are many methods for perfroming
Root Cause Analysis a laboratory can adopt,
and some methods may work well in one
organization while another method will be
more effective in another.
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• Laboratories shall designate appropriate authorities
for implementing corrective action. (TNI V1M2 Section
4.11.1).
 Once a root cause has been identified, an effective
corrective action is to be identified and implemented.
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• Laboratories shall monitor the results of corrective
actions to ensure that those actions are effective. (TNI
V1M2 Section 4.11.4).
 The results and the method of monitoring those results
will depend greatly on the root cause and the corrective
action chosen.
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 TCEQ assessors will assess your laboratory for compliance
to TNI V1M2 Section 4.11 by reviewing:
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Your Quality System,
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Corrective/Preventive Action procedures,
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Previous corrective and preventive actions,
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Your Internal Audits,
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And your Management Reviews.
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 Corrective Actions for noncompliances cited during an
assessment.
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Must include ROOT CAUSE (and more…see next
presentation)
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TCEQ staff, during the technical review(s) of your
laboratory’s assessment, assesses compliance by
evaluating the evidence submitted in response to
non-compliances for:
◦ corrective actions with identified root causes,
◦ effective corrective actions which seek to prevent the cited
noncompliance from recurring,
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During subsequent assessments, compliance is
evaluated by:
◦ evidence of the corrective action, and
◦ verification of the effectiveness of the corrective action.
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Cause analysis is required
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An investigation is required
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Determination of root cause(s) is required
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Implementation of corrective action(s) is
required
The goal is to eliminate the problem.
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Effective cause analysis saves money
by solving a problem once.
Thank You
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
EL-V1-2009, ENVIRONMENTAL LABORATORY
SECTOR, VOLUME 1, Management and
Technical Requirements for Laboratories
Performing Environmental Analysis
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ISO/IEC 17025:2005, General Requirements
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LABAG-500:2011, Accreditation Guidance –
for the Competence of Testing and
Calibration Laboratories
Corrective Action and Cause Analysis
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