Equipment
Issue 5.0
02 Dec 2014
Page 1 of 17
Revision History
Issue Date
1.0
19Aug2008
Description of Changes
Initial issue
Prime
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Table of Contents
Revision History.............................................................................................................................2
1.0 Introduction..........................................................................................................................4
1.1 Purpose and Scope..................................................................................................................4
1.2 Responsibilities.......................................................................................................................4
2.0 Process Description..............................................................................................................6
2.1 Equipment Database...............................................................................................................6
2.2 General Regulations................................................................................................................6
2.3 User Assistance.......................................................................................................................8
2.4 Registering New Monitoring, Measuring and Test Equipment..............................................8
2.5 Monitoring, Measuring, and Test Equipment Calibration......................................................9
2.6 When Test Equipment is Found to be Out of Tolerance.......................................................10
2.7 Monitoring, Measuring and Test Equipment Requiring Repair and Return.........................10
2.8 Equipment at Subcontract Manufacturers.............................................................................10
2.9 Equipment Status and associated requirements:...................................................................11
2.9.1 Equipment that is Active................................................................................................11
2.9.2 Equipment that is InActive.............................................................................................11
2.9.3 Equipment that is Damaged............................................................................................11
2.9.4 Equipment that has been Lost.....................................................................................11
2.9.5 Equipment that has been Sold/Destroyed...................................................................12
Appendix A: References..............................................................................................................13
Appendix B: Glossary of Terms and Abbreviations.................................................................14
Appendix C: Database Definitions for Cal Type...................................................................16
Appendix D: Example of an Equipment Record......................................................................17
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1.0 Introduction
1.1 Purpose and Scope
Ensure that all test and measurement equipment used in formal measurements to regulatory,
industry, or customer standards of parts, products, and systems is controlled and calibrated, or
otherwise verified, to assure product performance and quality system compliance. This document
applies to all test and measurement equipment used in the formal measurements of parts,
products, and systems. This excludes equipment used for reference purposes or not directly
involved in determining performance requirements. Labs outside the US may have procedures that
are equivalent to this procedure. They may be in the local language and address local
governmental requirements.
1.2 Responsibilities
The Calibration/Equipment Prime (hereafter Prime) at each respective location is
responsible for ensuring all MM&T equipment deployed at or from his location is properly
maintained. This includes tracking the equipment and facilitating required commercial calibration
and repair of the equipment.
1.1.1.
Tracking test and measurement equipment calibration and actions related to
calibration.
1.1.2.
1.1.3.
1.1.4.
1.1.5.
Approving requests for changes to calibration intervals as per section 6.1 or
equipment status (e.g. out of service, no calibration required, inactive, or unsuitable for
use).
Engineer/Technician
1.1.6.
Verifying the calibration status of test and measurement equipment prior to
use.
1.1.7.
Notifying Lab Manager if test and measurement equipment has not been
properly labeled.
1.1.8.
Notifying Lab Manager of any change in the status of test and measurement
equipment, including the location of the equipment.
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1.1.9.
Protecting measuring and monitoring devices from damage or deterioration
while in their possession.
1.1.10.
Preventing adjustment to devices that would invalidate calibration.
1.1.11.
Ensuring that test and measurement equipment is handled, used, and stored
within the environmental limits as specified by the manufacturer or in a manner that
would generally be considered industry acceptable.
1.1.12.
Reporting any concerns regarding the validity of a measurement made by
calibrated equipment to the Prime.
1.1.13.
Notifying the Prime when they find calibrated equipment with a past due
date.
1.1.14.
Notifying the Prime should they discover a tamper evident seal on a
measuring device that appears to be compromised.
will follow the ISO 9001:2008 and TL 9000 standards in controlling MM&T equipment by
selecting vendors that calibrate in accordance with measurement standards traceable to international
or national measurement standards. Such standards include:
US facilities: MIL STD 45662A, US10012-1 or ANSI/NCSL Z540 or ISO/IEC 17025
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All Inspection, Measurement, and Test (IM&T) equipment is listed in the Equipment
Database (hereafter database) including many instruments and other devices that do not
require calibration. MM&T equipment the focus of this procedure is a subset of IM&T
equipment. This database is a web application that is accessible by all employees, using the
following link: http://intranet.i.com/apps/equipment
Every item listed in the database has its own Equipment Record that contains the details
of that unit as applicable including: identification (TAG #, Finance Asset #, manufacturer,
model number, serial number, description), current calibration status (last date calibrated,
cal. cycle, next cal. due date), Site Location, and responsible site Contact Person (the
Prime). Pertinent documents are attached to the Equipment Record such as Certificates of
Calibration. Other information is recorded as appropriate in the additional fields provided.
(See Appendix D for an example of an Equipment Record.)
Primes are accorded Coordinator status in the web application and have the authority and
responsibility to create and manage Equipment Records in the database. Equipment
Records are to be updated immediately by the responsible Prime anytime an instrument is
serviced or calibrated, or there is a change in its Contact Person or Status.
When equipment is transferred from one site to another, the Equipment Record must be
updated by the receiving site cal prime. Per QMS0082 Fixed Asset Process, the site
initiating the transfer must process the Fixed Asset Transfer Form (FRM0118) including
approvals. The Fixed Asset Transfer Form should be attached to the Equipment Record.
Every equipment item in the database is associated with a Site Location which identifies
the site that is responsible for that item, not necessarily the actual location of the item.
Where the responsible site and actual location are different, the actual location will be
captured in the Physical Location or Comments field.
The Prime who is responsible for an equipment item is indicated in the Contact Person
field in the Equipment Record. If another person should be associated with that item, his
name should be added in the Physical Location or Comments field.
Prior to use, a user will verify that the test equipment has a current calibration sticker or a
Calibration Not Required (CNR) or No Calibration Required (NCR) label/tag. If a unit
is suspected to be out of calibration or in need of repair, the calibration prime will be
notified and the equipment labeled accordingly using a visual indicator (Repair Required
tag, red tag, alert sticker, etc.) obtained from the sites Prime. Such equipment will be
removed from use.
For those cases where test and measurement equipment receive a limited calibration,
calibration cycles may be extended after careful evaluation based on factors such as past
calibration results, frequency of use, environmental conditions, purpose, and the degree of
accuracy needed.
Rental Equipment shall have a valid calibration label and calibration cert.
To maintain accuracy, all IM&T equipment must be handled and stored in such a manner as
to protect it from damage and deterioration If equipment needs to be returned to the
manufacturer or elsewhere for service or transported to another site for use there, it must be
packaged and preserved to maintain its fitness.
Certain types of test instruments employ software for conducting test measurements. When
use of such instruments is specified in feature tests, the feature test plan will identify the
requirements for the test instrument software. Prior to conducting the feature test plan, the
test engineer must verify, through the manufacturer if necessary, that the version of software
loaded on the test instrument is capable of performing the feature test. If an updated version
is required the user will download the updated version from the equipment manufacturer.
Internal software (firmware) that drives test equipment is verified during the calibration
process.
Test software used within ATS and MCS product families is generated, validated, and
maintained by SQA/Development, in accordance with QMS0014.
Test software used by ATS and MCS contract manufacturers (or internal manufacturing) is
generated, validated, and maintained in accordance with QMS0089, QMS0050, or
QMS0117.
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Manufacturer
Calibration Date**
Model #
Description
Serial #
Department / Location
Calibration Certificate**
Purchased or rented
** Where applicable
Shall contain vendor identifier, equipment I.D., last calibration date, calibration
interval or due date unless an alternant approach is used, condition of equipment
as received by calibration lab, and any parameters related to limited calibrations.
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Shall contain the current status of the equipment such as: calibrated, inactive,
limited calibration, and also the location.
calibration. Where multiple equipment items are due at the same time and affected by the same
delay, those items may all be listed in a single FRM0136. The manager of the department where the
equipment is in use (or their designee) must approve the extension request. It is then incumbent on
that same manager to ensure that the equipment is returned to the Prime for calibration as soon as it
is available and not later than the end of the approved extension.
If the test equipment is under warranty or leased it will be returned to the manufacturer or
rental company.
If the equipment is out of warranty, it will be sent to either the manufacturer or a third party
repair facility.
The Prime will obtain necessary shipping documentation*, package the equipment in such a manner
as to properly protect it, ship it, and notate the status of the equipment (such as out for repair) in
the database Equipment Record.
* Reference QMS0034 Return to Vendor Process.
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There will be an agreement between and the subcontractor stating that the subcontractor will
provide for the calibration of MM&T equipment located at its facility per the procedures
specified in the subcontractors Quality System (unless other arrangements have been made).
Copies of all calibration and repair records, including but not limited to certificates of
conformance, repair action reports, and traceability certificates, will be forwarded by the
subcontractor to the site Prime (responsible for the equipment deployed at the subcontractor)
who will maintain them in the Equipment Database (unless other arrangements have been
made).
Any regular audits of the subcontractor should include an audit of the subcontractor's MM&T
equipment calibration process and compliance to this section.
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The site Prime will inform by e-mail or equivalent notification the manager of the Department
and/or Site where the instrument was last known to be located (and the CM or third-party
Repair Service when applicable) that the instrument is now Lost. Details will include full
identification of the equipment as per the items Equipment Record.
The Status of that equipment item will be changed to Lost in its database Equipment Record
and the date that it was determined to be missing entered into the Comments field. Such
equipment will continue to appear in Recall Lists and general equipment queries.
If the Lost equipment is subsequently found it first must be checked for current calibration (if
applicable) before being returned to use, or otherwise dispositioned. The items Equipment
Record will be changed to indicate its current Status.
Any equipment item that has been in the Lost Status for one (1) year will be removed from
company assets following standard Finance Department requirements and means. (See
QMS0082 and FRM0119.)
Once the Lost equipment item has been removed from assets, its Equipment Record Status will
be changed to Archive, after which that item will no longer appear in Recall Lists or general
equipment queries. However, the Equipment Record can always be retrieved by a TAG # or
Serial # query.
The Prime will confirm that the sold or destroyed equipment item has been removed from
assets following standard Finance Department requirements and means. (See QMS0082 and
FRM0119.)
The Status of that equipment will be changed to Archive in its database Equipment Record
and the date that it was determined as such entered into the Comments field. Such equipment
will continue to appear in Recall Lists and equipment searches.
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Appendix A: References
QMS0082
FRM0119
FRM0136
FRM0137
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Cal Type
Calibration Interval
CM
CNR/NCR
Contact Person
EMP
Equipment Record Unique Equipment Database entry for each item that identifies the
equipment, Site Location, Contact Person, Status, and provides other
details and links to pertinent documentation / records like Calibration
Certificates and repair details.
I M&TE
In-Warranty
Inactive Equipment
MM&TE
NIST:
OEM:
Out-of-Warranty:
Prime
Recall List
Repair Service
RMA
Site Location
Equipment Record entry that identifies the site that is responsible for
the equipment item regardless of its physical location
Status
TAG #
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Description
ONST On Site
MFG Manufacturer
DPT Depot
INTR Internal
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