Internal Audits
Presented by Charles N. Dyer
Laboratory Association of New Hampshire
March 29, 2011
© 2011 Danbury Assessment & Training Services
References
 Nelac

2003 NELAC Standard. Chapter 5
 TNI

Standards:
Standards
EL-V1M2-2009
NELAC 5.4.13.1 / TNI 4.14.1, 4.14.5c

The laboratory is required to conduct an internal
audit of all elements of its management and
testing activities to verify that its operations
comply to the NELAC/TNI Standard and with the
requirements of the laboratory’s quality system.

The internal audit must be conducted in
accordance with a predetermined schedule and
procedure at least annually.
 It
is the responsibility of the quality
manager to plan and organize the audits.
 The audits are to be carried out by trained
and qualified personnel who are, wherever
resources permit, independent of the
activity to be audited.

If personnel audit their own activities it must
be demonstrated that effective audits were
carried out.
NELAC 5.14.2 / TNI 4.14.2
 When
audit findings cast doubt on the
effectiveness of the operations or on the
correctness or validity of the laboratory's
environmental test results, the laboratory
must take timely corrective action, and
notify clients promptly, in writing, if
investigations show that the laboratory
results may have been affected.
NELAC 5.14.2 / TNI 4.14.5.a
 The
laboratory must specify, in the
laboratory’s quality manual (NELAC) or in
a policy (TNI), the time frame for notifying
a client of events that cast doubt on the
validity results.
NELAC 5.4.13.3 / TNI 4.14.3
 The
area audited, findings, and any
corrective actions taken must be recorded.
NELAC 5.4.13.3 / TNI 4.14.5
 Laboratory
management must ensure that
corrective actions are discharged within
the time frame stated in the quality
manual, SOP or policy
NELAC 5.4.13.4 / TNI 4.14.4
 Follow-up
audit activities must verify and
record the implementation and
effectiveness of the corrective action
taken.
What the Standards Do Not Say
 The
internal audit does not have to be
conducted by one person!
 The entire internal audit does not have to
be conducted at the same time!
 Time frame for corrective actions to be
completed is not stated.
 Time frame for notification of clients of
events that cast doubt on validity of results
is not stated.
These are determined by the laboratory, but
must be included in the laboratory quality
manual, SOPs, or policies.
Schedule for Conducting the Audit

All laboratory activities must be audited at least
annually.
 Planned and organized by the quality manager
(usually with input from supervisors)



All can be done at one time (usually practical only for
small micro or mom & pop lab)
Can be organized by department or analyses
Must be stated in the quality manual, an SOP or
in a policy.

Corrective actions and time frame for them must be
included.
Who Can Conduct Internal Audits?
 Quality
Manager
 Laboratory director
 Supervisor(s)
 Analysts
 Support personnel
 Outside contractors
 Any combination of above
Review of Quality Manual and/or Policies
 Do
they meet the requirements of the
Standards?
 Do they represent what is actually done by
the laboratory?
 Are all personnel following the
requirements of the quality manual and or
policy?
 Are there records to document that they
are being followed?
Review of SOPs






Do they meet the requirements of the reference method?

If the reference method is a Standard Methods for the Analysis
of Water and Wastewater, the SOP must also include the
appropriate general SM Quality Assurance/Quality Control
sections (1020, 2020, 3020, etc.)

“Shall”, “Must”, or similar language indicate that it is a
requirement. “Should”, “Can”, “Recommend”, or similar
language are not requirements (unless made requirements

by rules, regulations or the Standards).
Do they meet the requirements of the Standards?
Do they meet applicable requirements of any state or federal rules
and regulations?
Do they represent what is actually done by the laboratory?
Are all analysts following the SOP?
Are there records to document that they are being followed?
Records of the Audit

Records should include:
1)
2)
3)
4)
5)
6)
Date audit conducted
Areas/activities audited
Personnel conducting the audit.
Findings of the audit.
Any corrective actions taken (Items
numbered 1-3 above must be included).
Documentation of implementation and
effectiveness of corrective actions.
Records of the Internal Audits

Forms may be useful for records



Not required by the Standards
Example illustrated in the next slide.
Checklists may be used for records


NELAC or TNI Quality Systems Checklist
Method Checklists
• Lab prepared
• DES prepared

Notebooks may be used
 Or any combination of above
Auditing of Your Own Activities
 When
possible, must be conducted by by
qualified personnel independent of the
activity to be audited.
 “Personnel shall not audit their own
activities except when it can be
demonstrated that an effective audit will be
carried out”.
Evidence of an Effective Audit

Did the laboratory auditor find and document
any deficiencies?
 Were there follow-up corrective actions taken?
 Did the accrediting authority auditor find any
deficiencies?
If the accrediting authority auditor found very few
deficiencies, the laboratory auditor probably did
an effective audit.