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2011 Lab SMR Audits PDF

The document provides guidance on how to conduct internal laboratory audits. It discusses planning audits, including establishing objectives and scope. Key steps include assembling an audit team, developing procedures, documenting findings, and identifying corrective actions. The goals are to evaluate conformance with quality standards, identify issues, and ensure corrective measures are taken to improve laboratory operations. Regular internal audits are required to maintain accreditation.

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0% found this document useful (0 votes)
109 views90 pages

2011 Lab SMR Audits PDF

The document provides guidance on how to conduct internal laboratory audits. It discusses planning audits, including establishing objectives and scope. Key steps include assembling an audit team, developing procedures, documenting findings, and identifying corrective actions. The goals are to evaluate conformance with quality standards, identify issues, and ensure corrective measures are taken to improve laboratory operations. Regular internal audits are required to maintain accreditation.

Uploaded by

robert
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
You are on page 1/ 90

How to Perform Laboratory Internal Audits

Scott D. Siders
Division of Laboratories
Illinois EPA

1
T i i
Training Di l i
Disclaimer
The material presented in this training session
is for informational p
purposes
p only.
y It is
designed to promote understanding,
consistency and clarification of internal
auditing practices
practices. It should not be
considered a change or alteration of any
accreditation standards,, the published
p
methods, a regulatory agency requirement or
the position of the Illinois EPA. The opinions
expressed by the speaker are his own.own
2
Training Goals

y At the completion of this training presentation


you should have a basic understanding of:
y what an internal audit is,
y why one might perform an audit,
y how to plan and conduct an audit,
y the
h end
d results
l off the
h audit
d process, and
d
y corrective actions.

3
Training Goals (cont.)
y By the end, you should be familiar with the
steps in
i the
h auditing
di i process, iincluding:
l di
y Establishing requirements against which to audit,
y Assembling an audit team,
team
y Developing relevant audit process/procedures,
y Documenting the audit,
audit and indentifying
corrective actions and follow-up activities.

4
Course Agenda
y How to perform and internal audit
y Introduction to internal auditing,
y Planning an audit
y Performing the audit
y Assessment and documentation
y Corrective actions
y Follow-up, and
y Closure

5
Definitions (EL-V1M2-ISO-2009)

y Assessment: The evaluation process used to


measure or establish the performance,
effectiveness and conformance of an
effectiveness,
organization and/or its systems to defined
criteria ((to the standards and requirements
q of
laboratory accreditation).

6
Definitions (EL-V1M2-ISO-2009)

y Audit: A systematic and independent


examination of facilities,
facilities equipment,
equipment
personnel, training, procedures, record-
keeping,
p g, data validation,, data management,
g ,
and reporting aspects of a system to
determine whether QA/QC and technical
activities are being conducted as planned and
whether these activities will effectively
achieve qquality
y objectives.
j

7
TNI Standard – ISO 17025
y V1M2 4.14.1 – The laboratory shall
periodically, and in accordance with a
predetermined schedule and procedure,
conduct internal audits of its activities to
verify its operations continue to comply with
the requirements of the management system.
y V1M2 4.14.1 – The e internal
te a audit
aud t program
p og a
shall address all elements of the management
system, including the testing and/or
calibration
lib ti activities.
ti iti
8
TNI Standard – ISO 17025
y V1M2 4.14.1 – It is the responsibility of the
quality manager to plan and organize audits
as required by the schedule and requested by
management.
management
y V1M2 4.14.1 – Such audits shall be carried
out by trained
t a ed and
a d qualified
qua ed personnel
pe so e who
o
are, wherever resources permit, independent
of the activity to be audited.

9
TNI Standard – ISO 17025

y V1M2 4.14.2 – When audit findings


g cast
doubt on the effectiveness of the operations
or on the correctness or validity of the
laboratory’s
laboratory s test or calibration results
results, the
laboratory shall take timely corrective action,
and shall notify
y customers in writingg if
investigations show that the laboratory results
may have been affected.

10
TNI Standard – ISO 17025

y V1M2 4.14.3
4 14 3 – The area of activity audited,
audited
the audit findings and corrective actions that
arise from them shall be recorded.
y V1M2 4.14.4 – Follow-up audit activities
shall verify and record the implementation
andd effectiveness
ff ti off the
th corrective
ti action
ti
taken.

11
TNI Standard – ISO 17025

y V1M2 4.15.5
4 15 5 a) – The laboratory shall have
a policy that specifies the time frame for
notifying a client of events that cast doubt on
the validity of the results.
y V1M2 4.15.5 b) – The laboratory
managementt shallh ll ensure that
th t these
th actions
ti
are discharged within the agreed time frame.

12
TNI Standard – ISO 17025
y V1M2 4.15.5 c) – The internal audit
schedule shall be completed annually.

13
Oh the troubles I have seen…
y Significant issue for some laboratories
y Lack of senior management
g commitment
y QA Manager wearing to many hats
y Lack of internal audit process
p
y Internal audit too limited to encompass
quality system issues
y Internal audit findings not followed by
corrective action process
y Corrective
C ti actions
ti nott iimplemented
l t d
14
Benefits
y Identify issues and resolve them more quickly
than bi-annual external on-site assessment
y Demonstrates pro-active or continual
improvement quality system approach
y Enhance quality of reported data
y Correct non-conformances before they
become the customers problem
y Helps avoid loss of control (QA, QC or
otherwise)
y Reduces risks to organization
15
Why Audit and When to Audit
y Routine oversight as part of your established
quality system
y Prior to starting a project or “new work”
y During the course of a project
y High visibility project that require extra
High-visibility
attention
y Audit for cause
y Other activities have called practices into
question
y Overall failure to perform
16
Basic Audit Concepts
y Objective
y Scope
y Planning
y On-site
y Reporting
y Corrective Action
y Follow-up
y Closure

17
Planning an Audit - Steps
y Planning the audit objectives
y Planning the audit scope
y Establishing the requirements against which
to audit
y D
Developing
l i fframework k or technical
t h i l approach
h
y Reviewing materials and information
y S l ti
Selecting the
th audit
dit tteam
y Scheduling the audit
y Issuing the audit plan/agenda
18
Planning the Audit Objectives
y Fulfill requirements of your established quality
system
y Opportunity for improvement
y Assess specific non-conformance, data
i t
integrity
it iissue or customer
t complaint
l i t
y Prepare for the future
y Find p
practical
actical sol
solutions
tions (not to affi
affix blame)
y Compliance-based or system-based

19
Planning the Audit Scope
y Scope addresses focus of audit
y Identify key or critical elements and activities
y Are there any sensitive or confidential issues
(proprietary personnel,
(proprietary, personnel data integrity,
integrity etc.)
etc )

20
Scope of the Audit?
y Field sampling operations
y Field testing operations
y (e.g., pH, residual Cl)
y Laboratory operations
y Entire laboratory, or
y Selected department(s)
p ( )
y Test methods SOPs (compliance with SOPs)
y Review data (assess data quality)

21
Audit Scope - what to include?
y Standard operating procedures (SOPs)
y PT Results/DMR QA
y Document control
y Reagent water
y Control charting
y Notebooks
y Sample handling
y Equipment maintenance
y Standard
S d d and
d reagent preparation
i
22
Audit Scope - what to include?
y Quality Manual
y Data review
y Holding times
y Training
y Records management
y Quality control
y Facilities
y Subcontracting
y MDLs
MDL
23
Audit Scope – what type of audit?

y Horizontal Audits follow a process from start


to end. This type of audit would look at
procedures as they support the process itself
and is likely to span many different functions
or departments.
departments
y Vertical Audits look, in depth, at a particular
function
u ct o oro department.
depa t e t Thiss type of
o audit
aud t
would monitor the use of all relevant
procedures as they are used to support the
f
function
ti or activity.
ti it
24
bli hi
Establishing h Requirements
the i
Against which to Audit
y Is there a contract or client requirements?
y Is there a NPDES or Pre-treatment permit?
y Is there a standard (e
(e.g.,
g TNI)?
y Is there a regulatory requirement and/or
mandated test methods (e.g., 40 CFR part 136)?
y Is there a Quality Manual and/or QAPP?
y Are there established policies and/or procedures
(SOPs)?
y Do any of these documents contain performance
criteria?
y N requirements,
No i t then
th it’s
it’ nott an audit!
dit!

25
Developing the Framework or
Technical Approach
y Planning audit data collection
y Results-based information
y Records
y Reports
y Data
y Performance-based information
y Real time observations
y Interviews
y Performance indicators (e.g., metrics)
y Program-based information
y Policies,
l procedures,
d plans
l ((e.g., Q
QAPP))

26
Audit Materials and Resources
y Get Prepared and allow time to prepare!
y Obtain documents/records upfront and review
prior to on
on-site
site
y Quality manual, SOPs, QAPP, etc.
y Permit conditions (
(required
q test methods,,
discharge limits)
y PT and/or DMR QA performance
y Major equipment list
l
y Organization and staffing information
y Previous audits and corrective actions

27
Selecting the Audit Team
y Senior management should decide who is in
charge of the audit.
y Preferably,
Preferably it
it’s
s someone with QA
responsibilities.
y The subject matter experts may take the lead
in asking questions during the audit, but the
audit team leader is in charge overall.
y Is more than one person needed?
y How complex is the work being performed?
y What disciplines are involved?
y Who are the subject matter experts?

28
Selecting the Audit Team (cont.)

y Auditors need to understand the requirements


and work being performed (i.e., knowledge of).
y Others can participate in support roles.
roles
y Attributes of auditors:
y Technical knowledge (whole team covers all
aspects)
y Auditing skills (particularly lead auditor)
y Independent and objective
y Professionalism and sound judgment
y Competence, integrity, fairness, use of due
diligence, respect for confidentiality
y Respectful and courteous toward all

29
Auditors Role
y Understand quality system
y Knowledge of expectations and requirements
y Gather objective information
y Report on observations
y In some cases,
y Provide recommendations
y Conduct follow-up activities (verify)

30
Scheduling Audits
y Routine audits generally can be more flexible in
their scheduling.
g
y Need to balance convenience of the organization
being audited against the need to perform an
audit.
audit
y Provide potential dates for the audit, but
understand that not all staff may y be present
p at
that time, or that critical activities take place on
schedules other than those convenient to the
auditors (particularly an issue for field audits).
audits)

31
Scheduling Audits (cont.)
y Audits for cause should be scheduled quickly
to avoid
d generating more questionable
bl ddata.
y Unannounced audits may be needed (e.g.,
Section 308 of the Clean Water Act allows EPA
to show up any time to audit a lab performing
NPDES compliance
p monitoring)
g)

32
Scheduling Audits
y When to audit: e.g., 200.8 by ICP-MS
yT
Take
k iinto
t consideration:
id ti
y Laboratory workload
y External audit schedule
y Analyst(s) schedule
y Auditor’s
ud to s sc
schedule
edu e
y Other?

33
Issuing an Audit Plan/Agenda
y Depending on the purpose of the audit, this may be
informal or formal.
y Prepare and distribute appropriate documentation
(communications schedules,
(communications, schedules etc.).
etc )
y Outline for formal audit plan:
y Subject
y Objective
y Scope
y Audit team members
y Detailed schedule
y Checklist(s)
y Data collection responsibilities
y Affected organizations
g and interfaces

34
Quiz – An Audit Is:
y A formal activity that requires forethought
and
d planning
l
y Quick and simple to perform
y C iti l ffor every project
Critical j t
y A good way to fix flawed environmental data
y A goodd excuse for
f a roadd trip
t i

35
Answer #1 – An Audit Is:
y A formal activity that requires forethought
and
d planning
l

Anything
A thi worth
th doing,
d i is
i worth
th doing
d i
well, and that takes planning!

36
Q i #2 – To
Quiz T b d auditor
be a good di
you need
eed to
o be
be:

y An expert in all aspects of


sampling and analysis
y A QA expert
y Sherlock Holmes
y Observant,
Observant logical,
logical able to
think on your feet, and
impartial
p

37
Answer #2 – To be a good
auditor,
auditor you need to be:

y Observant, logical, able to think on your feet,


and impartial

Nobody knows everything and there is


plenty of room for the “non-experts,”
non experts,
especially if they are willing to learn.

38
Short Break

See you back in 5 minutes! ☺

39
Performing the Audit:
On site Steps
On-site
y Conducting the opening meeting
y Examining the overall system and processes
y Documenting g the various p
processes
y Examining the data or products of the
organization
y On-site
On site deliberations
delibe ations
y Conducting the closing meeting

40
Opening Meeting
y Review objectives and scope
y Review agenda and schedule
y Review internal audit process
y Process for identifying findings
y Confirmation of information
y Time for closing meeting

41
Examining the Overall Process
y Common approach is to follow the data
generation process
y “Treat
“T t me like
lik a sample”
l ” in
i lab
l b situations,
it ti
starting with sample receipt.
y Audits tend to follow the p
processes in a sample
p
flow, data flow and/or chronological order.
y Speak to everyone involved in each step, if you
can.
y For larger organizations, speak to someone at
each step, and all of the supervisory staff.

42
Documenting the Process
y Checklists are a common approach, but not
always ideal.
y If there
th are clear-cut
l t requirements,
i t use those
th to
t
develop checklists during the planning phase.
y Checklists can help assure completeness and
logical observation format.
format
y Don’t be bound by a checklist –ask yes/no and
open-ended questions based on what you
observe.
observe
y Don’t make checklists so detailed that you spend
all your time trying to fill them out and rush
through the process
process. They are a tool.
tool

43
Tools: Checklists
y In-house Management System Checklists
y Method-specific Checklists
y Regulatory and/or Accreditation Checklists,
Checklists for
example:
y http://www.deq.state.va.us/vpdes/checklist.html
y http://www.cdph.ca.gov/services/boards/eltac/Pages/MethodAu
ditChecklists.aspx
y http://www.dnr.state.wi.us/org/es/science/lc/OUTREACH/Check
lists.htm

All are good for notes, recording observations,


etc.
t
44
E l Ch
Example kli t
Checklists

45
Example Checklists (cont.)

46
E l Checklists
Example Ch kli t ((cont.)
t)

47
Tools: Interviewing

y Information gathering
y Discussion
y Build rapport
y Interviewee does most of the talking
y Attitude of interviewer

48
Successful Interviews

y Comfortable for Interviewee


y Trust
y Mutual Respect
y Acceptance
y Open atmosphere
y Professionalism, and
y Smile ☺

49
Types of Questions

y Yes or No
y Short answer
y Probing
y Open-ended
y What..,
What Why..,
Why When..
When

50
Documenting the Results
y Complete the checklists or make notes as
questions asked and if needed then dig
deeper
y Where responses are not clear or where
observed procedures not in keeping with what
the staff or supervisors say they do.
y Take good notes and take time to record
observations
b ti (don’t
(d ’t bbe rushed)
h d)
y If a problem is found, stop and try to find out
why it occurs

51
Examining Data or Products
y Schedule time to review any data or records
on-site (e.g., calibration, QC, data review)
y Request space to spread out paper or products
y Should be able to trace all results back to specific
actions byy the field or lab staff
y Doing this on-site allows you to ask questions
about the data, presentation of the results,
exceptions you uncover, etc.
y Take notes or ask to make copies of information
for further review (off-site) or to support your
findings

52
Deliberations
y Audit team should meet privately after reviewing
all
ll aspects
t off th
the process to
t discuss
di the
th situation.
it ti
y On-site (e.g., conference room) or off-site
y Even one
one-person
person audits require some time for
deliberation
y Decide who on the audit team will lead the closing
meeting, and who will present any detailed
findings, observations and any recommendations

53
Closing Meeting
y Review scope
y Review follow-up schedule
y Review internal audit process
y Review findings
y Positive (mention good and best
practices observed)
y Negative (non-conformances)
y Address
Add Questions
Q ti and
d Concerns
C
(but be prepared to say “let me
think about that some more”))

54
Closing Meeting (cont.)
y Don’t forget to:
y Listen to their responses and observe their
reactions
ti to
t any information
i f ti you present.
t
y Were they surprised?
y Defensive?
y Eager to address non-conformance?
y Aware of the issues?
y D managers and
Do d staff
t ff reactt differently?
diff tl ?
y Do they appear to take your concerns seriously?
y Do they disagree with a finding(s)?

55
Evaluation and Documentation

y As a team, finalize plans for whatever final


report you need to provide.
y Level of detail depends on the purpose of the
audit and any subsequent use of the findings.
y Compile everyone’s notes and checklists and
any relevant information or data collected on-
site.
y Draft the report and circulate within the audit
team and the auditing organization.

56
Evaluation and Documentation
y Minimum audit report content includes introduction
(why the audit was conducted), list of auditors,
findings requiring corrective action, requirement
finding was made on on, and any due date for completion
of corrective actions.
y Possibly include recommendations for improvement.
y Address internal comments and prepare a draft for
broader circulation.
y Provide copy of the report to the audited organization.
As appropriate, ask them for comments.
y Goal is to allow them to correct any factual errors in
the report.
y Their comments are NOT p part of any
y corrective
actions.

57
Quiz #3 – On-site Audits
y Follow a rigid standardized approach and
schedule
y Require that you develop a detailed
checklist
h kl
y Take months to plan and schedule, so why
b th
bother
y Apply only to lab work

58
Answer #3 – On-site Audits

None of these!!!

y Planning is critical, but audits can happen in


days or weeks when necessary
y Auditors need to be flexible
y Checklists are tools, not the only way to
perform an audit

59
Quiz #4 – The goal of an audit is to:

y Find out what’s wrong and fix it


y Make
M k everyone d
do it the
th same way (preferably
( f bl
your way)
y Examine the overall process of data
generation, understand how it works,
determine if it meets the needs and goals of
the project, and perhaps identify areas for
improvement

60
Answer #4 – The goal of an audit is to:

Examine the overall process of data


generation, understand how it works,
determine if it meets the needs of the
client and goals of the laboratory
laboratory, and
perhaps identify areas for
improvement

61
7 th g Stretch
Inning
See you back in 5 minutes! ☺

or

62
Corrective Actions
y Remember:

y All audit findings and any corrective actions that


arise from them shall be documented.
y The internal audit does not stop with the audit
report!
y Now the important work starts!

63
TNI Standard – ISO 17025
y V1M2 4.11.1 - The laboratory shall
establish a policy and a procedure and
shall designate appropriate authorities for
implementing corrective action when
nonconforming work or departures from
the policies and procedures in the
managementt systemt or technical
t h i l
operations have been identified.

64
TNI Standard – ISO 17025
y V1M2 4.11.2 - The procedure for corrective
action shall start with an investigation to
determine the root cause(s) of the problem.
problem

NOTE: Cause analysis is the key and sometimes most


diffi lt partt in
difficult i the
th corrective
ti action
ti procedure.
d Often
Oft
the root cause is not obvious and thus a careful
analysis of all potential causes of the problem is
required Potential causes could include customer
required.
requirements, the samples, sample specifications,
methods and procedures, staff skill and training,
consumables, or equipment and its calibration.

65
TNI Standard – ISO 17025

y V1M2 4.11.3 - Where corrective action is


needed, the laboratory shall identify potential
corrective actions. It shall select and implement
the action(s) most likely to eliminate the problem
and to prevent recurrence.

66
TNI Standard – ISO 17025
y V1M2 4.11.3 - Corrective actions shall be to a
degree appropriate to the magnitude and the risk
off th
the problem.
bl
The laboratory shall document and implement any
required changes resulting from corrective action
investigations.

y V1M2 4.11.4 - The laboratory shall monitor the


results to ensure that the corrective actions taken
have been effective.

67
Responsibility for Corrective Action

y Establish responsibility on both sides for


following up on the audit
y Who in the audited organization is responsible
for communicating g and documenting g the
corrective actions to the auditors?
y Who on the audit team is responsible for saying
it’s
it s fixed? (could be audit team leader or other
team member)

68
Corrective Action Steps
y Identify problem, non-conformance, concern,
etc.
y Includes all internal audit findings
y Investigate the problem
y Determine the root cause(s)
( )
y Is it a systematic or random problem
y Select and implement corrective action
y Follow-up
ll to ensure the
h problem
bl is ffixed
d
y Evaluate process to ensure that the fix
prevents recurrence of problem

69
Corrective Action
y Important 1st Question: Were there any critical
findings
g that affect the quality
q y or validity
y of the
data and/or test results reported to clients ?
y If so, identify required corrective actions to be
taken by the laboratory.
y Iff the
h corrective
i actions
i are b
basedd on specific
ifi
requirements, identify those requirements.
y If appropriate, call on the laboratory to spell out the
corrective actions that they will take.
take
y Identify a timetable for taking corrective actions
and the format for showing that they have taken
p
place.

70
Time Frame for Corrective Action
y The laboratory management shall ensure
that these actions are discharged within a
reasonable and agreed time frame as
indicated in the quality manual and/or
SOPs.
SOPs
y What is the agreed upon timeframe for taking
actions?
act o s
y Where is this found (QM, Corrective Action SOP
and/or Internal Audit SOP)?

71
Correction vs. Corrective Action
y Correction - the quick fix (i.e., superficial fix)
y Get it out the door
y May cause other problems

y Corrective Actions - the thoughtful fix


y Correct the underlying cause
y Do
D nott cause other
th problems
bl
y Permanent fix to problem – does not reoccur

72
Laboratory Needs to Consider

y Were there recommendations for improvements


made by the assessor that should be
implemented?
y Be careful to distinguish these from required
corrective
i actions.
i
y “Do it better” does not mean “Do it my way.”
y Both sides can learn from one another.
another

73
Root Cause Analysis
y Working Definition

“Root Cause Analysis is determining what


happened how it happened and why it
happened,
happened”

74
Root Cause Analysis
y Goal

“The goal of root cause analysis is to


d t
determine
i what
h t can be
b done
d to
t preventt
it from happening again”

75
Characteristics of Root Causes
y Root causes are specific underlying causes
y Root causes are those that can reasonably be
identified
y Root causes are those management has control to
fix
y Root causes are those for which effective
recommendations for preventing occurrences can
be generated

Quoted from “Root Cause Analysis


Q y for Beginners”,
g , Rooney
y and Vanden Heuvel,, Q
Quality
y Progress,
g , July,
y, 2004

76
Process of Root Cause Analysis

y Collect data
y Determine
i causall ffactors
y Identify root causes
y Generate recommendations and implement

77
Root Cause Analysis
y One approach to root cause analysis is to:

“Asking Why Five Times”

Example: ICP-MS instrument maintenance was not


documented

1. Why didn’t the analyst know the maintenance


required documentation?
Action – Read the SOP

2. If the analyst didn’t have access to the SOP, why not?


Action – Get access to SOP

78
Root Cause Analysis (cont.)
3. If the Metals Coordinator was supposed to
update
p the SOP,, why
y isn’t it complete?
p
Action – Get the Coordinator to finish the
SOP update.

4. If the Coordinator is too busy, Why is


the Coordinator too busy?
Action – Delegate duties

79
Root Cause Analysis (cont.)
5. If there is no one to delegate some of
Coordinator’s duties to,, Why
y not?
Action – Examine work load, review
work requests.

80
Benefits of Root Cause Analysis

y Typical Results of Root Cause Analysis

y Improved training procedure


y Updated SOP
y Evaluation of staffing levels and work load
y Changes
g in p
procedures
y Prevent a repeat deficiency

81
Implementing Corrective Actions
y Use your laboratory’s current corrective action
documentation procedures, or
yC
Create
eate a spreadsheet
sp eads eet o
or ot
other
e docu
document
e t to ttrack
ac
progress
y Finding/Deficiency
y Assigned responsible person(s)/laboratory
department ideally mutually agreed to)
y Corrective action to be taken
y Implementation
p Date ((ideally
y mutuallyy agreed
g to))
y Completion Date (ideally mutually agreed to)
y Verification Date (i.e., monitor the results)
y Comments

82
T ki
Tracking C ti
Corrective A ti
Actions

83
Verifying Corrective Actions
y Verify corrective actions for
implementation and effectiveness.
y This is one of the places that corrective
action p
processes fail.
y Verify implementation and effectiveness
(suggest 30
30-45
45 days after completion date)

y Monitor over the next several months (old


habits a
are
e ha
hard
d to break)
b eak)

84
Closeout – “It ain’t over ‘til it’s over.” Y. Berra

y The audit team is responsible for notifying all


involved that:
y An audit took place
y The results or findings were reviewed
y The resolution of those findings
y The final conclusions:
y It’s OK, or
y Problems still remain that affect closure

y The findings and report are filed with all other


audit documentation, and maybe subject to an
external audit.
audit

85
Remember

Internal Auditors gather objective evidence


of conformance to the quality system and
other
th applicable
li bl requirements.
i t

86
Remember
y Need to audit entire laboratory annually
y Audit must be organized and planned
y Performed by trained and qualified personnel
y Must remedy findings through the corrective
action process
y Notify clients if necessary due to any negative
impact on reported data/results.

87
Desired Outcomes
of Internal Audits
y Management effectiveness
y Sound scientific approach
pp (g
(good science))
y Decision with documented rationale
y Efficiency
y for laboratory
y
y Improvements to operations, organization
and implementation
y Reduce organizational risks and cost of non-
compliance
y Enhanced customer satisfaction and loyalty
88
Answer and Question Time

Great opportunity to have


an open discussion
d and
d
learn from others in
audience.
audience

First person to ask a


question wins the door
prize(i.e., they get to go out the door first for lunch)

89
Thank you
y Special thanks to the IWEA Laboratory
Committee for inviting me to speak.
y Thank you to MWRD-GC
MWRD GC for hosting us. us
y Wish to thank the following individuals for
their contributions to this presentation:
p
y Betsy Kent, RCID Environmental Services
y Cathy Westerman, Virginia ELAP, and
yM
Marlene
lene Moore,
Moo e Advanced
Ad n ed Systems,
S tem Inc.
In
y [email protected]

Contact me at: [email protected]

90

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