Professional Documents
Culture Documents
Quality Manual
Revision E
REVISION......................................................................................................................................................................3
2.0 REFERENCES...................................................................................................................................................5
6.0 PERSONNEL...................................................................................................................................................11
15.0 OUTSIDE SUPPORT SERVICES AND SUPPLIES THAT AFFECT CALIBRATION RESULTS ................24
16.0 COMPLAINTS..............................................................................................................................................25
1.1 PURPOSE
This document is intended as a system to control the calibration and support of all
measurement standards and test equipment to the extent necessary to assure conformance of
calibration services required to fulfill contractual requirements. This document incorporates the
applicable requirements of ANSI/NCSL Z540-1, ISO/IEC 17025, and NIST Handbook 150.
1.2 SCOPE
This document applies to all aspects of Burns Engineering’s calibration laboratory. It is the
responsibility of all personnel involved to familiarize themselves and adhere to the quality
procedures contained in this document.
ISO/IEC Guide 2 : 1986 General terms and their definitions concerning standardization and
related activities.
ISO/IEC Guide 30 : 1981, Terms and definitions used in connection with reference materials.
ISO/IEC 17025: 1999 General requirements for the competence of testing and calibration
laboratories.
NIST Handbook 150: 2001 Edition, Procedures and General Requirements, NVLAP
NIST Technical Note 1297: Guidelines for Evaluating and Expressing the Uncertainty of NIST
Measurement Results
Burns Engineering SOP C274 Requirements for Measuring and Test Equipment
Burns Engineering SOP C275 Procedure for Handling Customer Complaints Related to
Calibration
• The relevant definitions from ISO/IEC Guide 2, ISO 8402, ISO Guide 30, and the
International vocabulary of basic and general terms in metrology are applicable.
• NVLAP – National Voluntary Laboratory Accreditation Program.
4.1 Organization
The Burns Engineering calibration laboratory organization is shown in Figure 1 below. An
organization chart which contains the names of the individuals can be found on the network at
..\..\..\..\Quality System\Organization Chart\Engineering & Quality Group Org Chart.doc
President
President – Responsible for overall operation of calibration facility including but not limited to
budget, equipment, facilities and people. The president may act as an alternate for the
Engineering and Quality Assurance Manager if necessary.
Engineering and Quality Assurance Manager – Responsible for the quality system and its
implementation. Also assigned as an alternate for the Metrology and Design Engineer when
they are unavailable.
Metrology and Design Engineer – Responsible for all technical aspects of the laboratory
including but not limited to standard selection, calibration method selection, and technical
qualifications of personnel. Also assigned as an alternate for the Engineering and Quality
Assurance Manager as related to the calibration laboratory.
Metrology Technician I, II, III – Responsible for calibration and testing of temperature sensors,
transmitters and related equipment.
A separate written job description, clearly listing responsibilities and authorities, exists for all
calibration laboratory personnel. All metrology technicians are fully supervised until they are
technically competent to perform the work independently.
5.1 Quality-System
The Burns Engineering Inc. quality system is documented in the Burns Engineering Quality
Manual. The intent of the Calibration Laboratory Quality Manual is to supplement and refine the
overall manual as applicable to the calibration laboratory, and to insure the laboratory complies
with the requirements of NIST Handbook 150 Procedures and General Requirements, ISO/IEC
17025 General requirements for the competence of testing and calibration laboratories, and
ANSI/NCSL Z540-1 Calibration Laboratories and Measuring and Test Equipment – General
Requirements . It is the responsibility of laboratory management to ensure all laboratory
personnel are aware of, understand, and implement the elements of the quality system as
defined in the Quality Manual and the Calibration Laboratory Quality Manual. Where conflicts
between these documents exist, the requirements of this document shall take precedence.
To effectively support this quality policy, all calibrations conducted in the calibration laboratory
will be performed in accordance with appropriate calibration methods and procedures.
Development and/or selection of procedures is based on suitability for purpose and customer
requirements. All procedures are developed or selected and approved for use in accordance
with guidelines found in Standard Operating Procedure C273, “Calibration Procedure Selection
and Development”. All procedures are controlled documents and carry the designated approval
signatures and issue date. A listing of the most common calibration procedures used can be
found in section 10 of this document.
Calibration of high quality (secondary standard grade) platinum resistance thermometers and
measuring systems is performed by comparison against a NIST traceable SPRT utilizing a high
accuracy resistance thermometry bridge. Industrial grade RTDs may be calibrated in a similar
manner or may utilize a high performance DMM to measure resistance. Calibration of SPRTs at
the TPW is performed using a TPW cell and a high accuracy resistance thermometry bridge.
Additional calibration and testing performed in the laboratory includes, but is not limited to:
Insulation Resistance, Dielectric Withstanding Voltage, Response Time, Thermocouple
Calibration, and Temperature Transmitter Calibration.
Audit results shall be documented. All non-conformances shall require a response and
corrective action reply within 28 days. The manager will reserve the option to reduce the
allowed response time if concern of the validity of the lab results exists. It is the responsibility of
the Engineering and Quality Assurance Manager to ensure these actions are carried out within
the agreed timeframe.
The maximum interval between internal audits shall be no more than 12 months.
Reviews – Management shall review the quality system to ensure it is adequate for
achievement of the quality objectives on a continuous basis. The maximum interval between
management reviews shall be no more than 12 months. The review should include the
following:
a) matters arising from the previous review
b) reports from audits by clients
c) results of internal audits done since the last review, including corrective actions
implemented.
d) results of in-house quality checks
e) details of any complaints or feedback from clients
f) staff training
g) adequacy of staff, equipment and facility resources
h) future plans and estimates for new work, new staff, new equipment, etc.
i) suitability of policies and procedures
j) reports from managerial and supervisory personnel
k) the results of interlaboratory comparisons or proficiency tests
l) changes in volume and type of work
The findings from the management reviews and the actions that arise from them shall be
recorded. The management shall ensure that those actions are carried out within an appropriate
and agreed timescale.
When an audit or review finding cast doubt on the correctness or validity of calibration results,
timely corrective action shall be taken. If the investigation finds that calibration results and
issued reports have been affected, customers shall be notified in writing.
Checks – In addition to the periodic audits and reviews, the calibration laboratory shall
implement periodic checks to ensure the proper operation of the calibration equipment. These
checks shall include, but are not limited to, the TPW resistance checks of the SPRT as
described in the appropriate sections of Calibration Standard Operating Procedure (SOP) C263.
This check requires measuring the SPRT resistance at the triple point of water using a triple
point of water cell and one or more SPRTs on a daily basis or prior to use (when practical). The
results collected shall be reviewed and tracked for trends over time.
All personnel assigned to perform technical work in the calibration laboratory shall have formal
education and training relevant to the assigned functions. Records of the relevant
qualifications, training, skills and experience shall be kept on file at Burns Engineering in the
following location:..\..\..\..\Quality System\Process Training Program\Calibration Lab. These
records shall be reviewed periodically by the employee and management to ensure accuracy
and completeness. Additional education and training shall be made available to personnel if the
need arises.
Temperature – The ambient temperature shall be maintained between 17°C and 25°C.
Deviation to these conditions may be permitted if documented in the applicable calibration SOP.
In the event that environmental conditions fall out of the allowable limits and a deviation is not
permitted by the applicable calibration SOP, the Metrology and Design Engineer shall be
notified. The Metrology and Design Engineer must determine the impact of the out of tolerance
conditions on the calibrations and take the necessary actions to correct the situation. Additional
information can be found in SOP C56 – Monitoring laboratory ambient conditions.
A list of key suppliers for the calibration lab equipment and materials can be found at
..\..\..\..\Quality System\Supplier Quality\Key Suppliers for Cal Lab\Key Suppliers for Calibration
Lab Supplies and Services.doc
Note: Equipment and reference materials that do not contain a valid and current label
must not be used for performing calibrations in the laboratory.
11.2 Examination
All calibration items shall be examined prior to calibration for any abnormalities or physical
damage. If any unusual conditions are found which could effect the intended purpose of the
item, the findings shall be documented and the customer shall be notified of the findings. The
customer may be requested to make a decision as to the disposition of the item prior to
completion of the calibration.
17.12 Records
Records shall be kept for all M&TE requiring calibration and verification. The records
shall contain:
a) the identification of each piece of M&TE;
b) the current calibration interval and date of the last calibration;
c) identification of the calibration source (laboratory);
d) calibration procedure used;
e) results of the previous calibrations; e.g., condition found, (in tolerance or out of
tolerance), measured value if a fixed measurement standard, any limitations of
use, etc.;
Note: Equipment and materials that do not contain a valid and current label must
not be used for performing calibrations.
a) The term and logo shall not be used in a manner that brings NVLAP into disrepute or
misrepresents the scope of accreditation or accredited status.
b) When the term NVLAP is used to reference the accredited status, it shall be
accompanied by the NVLAP Lab Code.
c) When the NVLAP logo is used to reference accredited status, it must be accompanied
by the NVLAP Lab Code in an approved caption. The caption shall appear below and in
close proximity to the logo. The following captions are approved:
- “For the scope of accreditation under NVLAP Lab Code 200706-0”
- “NVLAP Lab Code 200706-0”
d) The form of the logo must conform to the following guidelines.
- The logo shall stand by itself and not be combined with any other logo,
symbol, or graphic.
- The aspect ratio (height to width) shall be 1 to 2.25.
- The logo and caption shall be of a size that allows the caption to be easily
read. The size of the caption shall not exceed the size of the logo itself.
- The logo shall appear in black or blue and may be filled or unfilled. In the
case of a filled logo, the same color shall be used for the outline and fill.
e) The name of at least one Approved Signatory must appear on all calibration reports that
display the NVLAP logo or references NVLAP accreditation.
f) When the term and logo are used on a calibration report, such use shall be limited to
reports in which some or all of the data are from calibrations performed under the scope
of accreditation. A calibration report that contains both data covered by accreditation and
data not covered by accreditation shall clearly identify the data that are not covered by
accreditation. The report must prominently display the following statement at the
beginning of the report: “This report contains data that are not covered by the NVLAP
accreditation.”
g) When the term and logo are used on a calibration report that also includes work done by
a subcontracted laboratory, such use shall be limited to reports in which some or all of
the data are taken from calibrations performed by the laboratory under the scope of
accreditation. A calibration report that contains data covered by the accreditation and
data provided by a subcontractor shall clearly identify the data that were provided by the
subcontracted laboratory. The report must prominently display the following statement at
the beginning of the report: “This report contains data that were produced under
subcontract by Laboratory X.” If the subcontracted laboratory is accredited by NVLAP,
then its Lab Code should also be stated. If the subcontracted laboratory is accredited by
a body other than NVLAP, then the name of the accreditation body and the laboratory’s
number or other unique identifier should also be stated. If the subcontracted laboratory
is not accredited, then this must be stated.
h) Each calibration report that bears the term or logo shall include a statement that the
report must not be used to claim product certification, approval, or endorsement by
NVLAP, NIST, or any agency of the federal government.
i) When used in a contract or proposal, the term and logo shall be accompanied by a
description of the laboratories scope of accreditation and current accreditation status.