Calibration Laboratory Audit Preparation Webinar presented on December 10, 2013 by Keith Bennett, Transcat's Directory of Metrology and Quality Systems

1. Calibration Laboratory Audit
Preparation
December 10, 2013

2. Audit Preparation
• Calibration laboratories are subject to many types of
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audits such as ISO 17025 accreditation, Z540.X,
Nuclear 10 CFR 21, FDA, FCC, and many others
• Many calibration laboratories provide services to
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multiple industries that are regulated by many of
these regulatory bodies
these regulatory bodies
• Agenda
– Common factors relating to calibration labs that will keep
this in perspective and manageable
– Some basic concepts of preparing for an audit
– Do’s and Do Not’s during the process of being audited
Do s and Do Not s during the process of being audited

3. What are you being audited to?
Calibration of Measurement and Test Equipment (M&TE) is a
function required by most industries throughout the world.
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Many of these industries have specific requirements for the
calibration of their respective M&TE and the processes by which
the M&TE is calibrated.
the M&TE is calibrated
Although many industries have some unique requirements most
requirements are generic.
req irements are generic
The International Standards Organization (ISO) developed
ISO/IEC 17025 ‐ General Requirements for the Competence of
ISO/IEC 17025 G
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Testing and Calibration Laboratories.

4. Audit Preparation
• ISO/IEC 17025 General Requirements for the
ISO/IEC 17025 General Requirements for the
Competence of Testing and Calibration
Laboratories
– Management Requirements (Section 4)
• Contains all elements of ISO 9001
• 25 Elements
– Technical Requirements (Section 5)
• 28 Elements

5. Quality System
• Quality Manual
Quality Manual
– Standard Operating Procedures (SOP’s)
– Must Adequately Address all Elements of 17025
Must Adequately Address all Elements of 17025
– Must Adequately Address Other Critical Elements

6. Quality System
• Which Elements are important?
Which Elements are important?
– All need to be addressed
– Management Requirements
Management Requirements
• Most customer audits will focus on these
– Industry Specific
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– Technical Requirements
• Metrologist

7. Technical Requirements
The overall goal is to insure that calibrations
The overall goal is to insure that calibrations
performed are correct and reliable.

8. Technical Requirements
• Primary Elements to Produce a Quality
Primary Elements to Produce a Quality
Calibration
– Human Factors
Human Factors
– Accommodation and Environmental Conditions
– Methods
Methods
– Equipment
– Measurement Traceability
Measurement Traceability
– Sampling
– Handling of M&TE
Handling of M&TE

9. Technical Requirements
• Primary Elements to Produce a Quality
Primary Elements to Produce a Quality
Calibration (con’t)
– Assuring the quality of test and calibration results
Assuring the quality of test and calibration results
– Reporting the results

10. Technical Requirements
• Human Factors/Personnel
Human Factors/Personnel
– Competent
• Job Descriptions
Job Descriptions
• Training
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–
–
–
Formal
OJT
Objective Evidence
Qualification Matrix
Qualification Matrix

11. Technical Requirements
• Human Factors/Personnel
Human Factors/Personnel
– Competent
• Proficiency Tests
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– External – ISO 17043:2010
» National Association for Proficiency Testing
www.proficiency.org
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» AB Developed
» National Measurement Institutes (NIST)
– Internal
» Correlation studies

12. Technical Requirements
• Human Factors/Personnel
Human Factors/Personnel
– Undue External Pressures
• Conflicts of Interests
Conflicts of Interests
– Undue Internal Pressures

13. Technical Requirements
• Accommodation and Environmental Controls
Accommodation and Environmental Controls
(Adequate to the level of claimed uncertainties)
–
–
–
–
Temperature/RH
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Lighting
Vibration
Segregation
• Incompatible activities

14. Technical Requirements
• Methods
– Need to meet the requirements of the customer
and must be adequate for the calibrations
performed
– Standard Methods
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Laboratory Developed Methods
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• Must be Validated
– Non‐standard Methods
Non‐standard Methods
• Must be validated
• Generally to meet specific customer requirements

15. Technical Requirements
• Equipment
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Adequate for use
Verified upon receipt
Only operated by qualified personnel
Adequate instructions for use
Adequate instructions for use
Must remain in control of lab
Identify long term stability (Calibration interval)
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–
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• Labeled to identify calibration status
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• Interim checks
Unique identification
Segregated and identified when out of control
Performance verified before the unit leaves and after unit is received back
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into the lab
Documentation is essential
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16. Technical Requirements
• Measurement Traceability
Measurement Traceability
•
Metrological Traceability is the property of a
measurement result whereby it can be related to stated
measurement result whereby it can be related to stated
references, usually national or international standards,
through an unbroken chain of comparisons, each step in
the chain having stated uncertainties. The purpose of
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requiring traceability is to ensure that measurements are
accurate representations of the specific quantity subject
to measurement, within the uncertainty of the
measurement. Traceability is characterized by six
essential elements.
essential elements.

17. Technical Requirements
•
Measurement Traceability
– An unbroken chain of comparison: Traceability begins with an unbroken chain of
comparisons originating at national, international or intrinsic standards of measurement
and ending with the working reference standards of a given metrology laboratory;
– Measurement uncertainty: The measurement uncertainty for each step in the
traceability chain must be calculated according to defined methods and must be stated
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at each step of the chain so that an overall uncertainty for the whole chain can be
calculated;
– Documentation: Each step in the chain must be performed according to documented
and generally acknowledged procedures and the results must be documented, i.e., in a
and generally acknowledged procedures and the results must be documented i e in a
calibration or test report;
– Competence: The laboratories or bodies performing one or more steps in the chain
must supply evidence of technical competence, e.g., by demonstrating that they are
accredited by a recognized accreditation body;
accredited by a recognized accreditation body;
– Reference to SI units: Where possible, the primary national, international or intrinsic
standards must be primary standards for realization of the SI units;
– Recalibrations: Calibrations must be repeated at appropriate intervals in such a manner
that traceability of the standard is preserved.
that traceability of the standard is preserved.

18. Technical Requirements
Measurement Traceability
easu e e t aceab ty

19. Technical Requirements
• Methods
– Need to meet the requirements of the customer
and must be adequate for the calibrations
performed
– Standard Methods
– L b
Laboratory Developed Methods
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• Must be Validated
– Non‐standard Methods
Non‐standard Methods
• Must be validated
• Generally to meet specific customer requirements

20. Technical Requirements
Sampling
Sampling
Not discussed in this presentation
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21. Technical Requirements
• Handling of M&TE
Handling of M&TE
–
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Shipping
Receiving
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Storage
Safeguards against damage

22. Technical Requirements
• Assuring the quality of test and calibration results
Assuring the quality of test and calibration results
– Quality review of completed product
• Logging the results to catch trends
ogging the results to catch trends

23. Technical Requirements
• Reporting the results
Reporting the results
– There are multiple elements/requirements for what
needs to be presented on certificates and data sets of
needs to be presented on certificates and data sets of
the calibrated M&TE. ISO 17025 is a good standard to
develop this.

24. Scope of Capabilities
• Also know as the Scope of Accreditation identifies your
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capabilities by discipline and sub‐discipline and how capable
you are (Uncertainties) in these each respective quantity
• Th
The scope is used internally as a snapshot of what your
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capabilities are and is a useful marketing document so
customers know what your capabilities
• The quantities and associated uncertainties are also called
Calibration and Measurement Capabilities (CMC’s)
• Th
These are generally considered your Best Measurement
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Capabilities

25. Scope of Capabilities
• Developing your scope will take practice Some
Developing your scope will take practice. Some
things to consider are:
– What is my target
What is my target
– What are the capabilities of my standards
– Where do my capabilities need to be
Where do my capabilities need to be
– Are my capabilities in line with others
– Good source documents to develop scopes are
Good source documents to develop scopes are
ILAC P14 and the “Guide to the Expression of
Uncertainty of Measurement
Uncertainty of Measurement”

26. Scope of Capabilities

27. Uncertainty Analysis
• Guidance Document
Guidance Document
– “Guide to the Expression of Uncertainty of
Measurement (GUM)
Measurement” (GUM)
• Recommend training by a respected body or
person
• This will take a lot of practice

28. Uncertainty Analysis

29. Internal Audits
• After initial development of Quality System
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• On a recurring basis
– Generally on an annual schedule
• Performed by a designated quality representative
– Impartial
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Should have reporting structure independent from
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Operations
• Internal audits should be the most stringent of all
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external audits
• Should audit all elements of the Quality System

30. External Audits
• Customer
• Accreditation
• Industry Specific
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31. External Audits
Regardless of what body is performing the audit,
Regardless of what body is performing the audit
there is a common goal.

32. Do’s during an Audit
• Appearance – Initial Tour of the Lab
Appearance Initial Tour of the Lab
– Facilities
–E i
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– Personnel
• Identify Common Areas

33. Do’s during an Audit
•
•
•
•
Give the auditor your undivided attention
Give the auditor your undivided attention
Give the auditor mutual respect
Acceptance of findings
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Presenting a challenge to a finding

34. Do’s during an Audit
• Give the auditor your undivided attention
Give the auditor your undivided attention
– Facilities
–E i
Equipment
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– Personnel

35. Audit Preparation
Scope of Capabilities
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Internal Audits
External Audits
Do’s and Do Not’s
Initial walk through
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Etiquette
Personnel appearance
Mutual respect
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Acceptance of findings
Challenges (Professional)
Findings
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Types
Addressing
Using to your advantage
Using to your advantage

36. Calibration Laboratory Audit
y
Preparation Webinar
Questions?
Contact us at:
www.transcat.com
800.828.1470