WI-G-001 Inspection, Measuring and Test

Equipment

Rev A

Rev Description Reason for Revision Effective Change

of Change Change Author Date Number
A Initial To meet Vanesa 08/25/2015 CN-1016
Release requiremen Fields
ts per 21
CFR 820
and ISO
13485
 WI-G-001 Rev. A
Inspection, Measuring and
Effective Date:08/25/2015
Test Equipment

1. Purpose
1.1. To ensure that all inspection measuring and test equipment is suitable and
capable of producing valid results. This will include but not limited to calibration
of all instrumentation.

2. Scope
2.1. To inspect all instrumentation used in the inspection of products when required.

3. Responsibilities
3.1. It is the responsibility of Engineering and Quality to ensure all inspection and
measuring equipment are in a current state of calibration to verify all test results.

4. References
4.1. 21 CFR 820

5. Definitions
5.1. Accuracy: the closeness of a measured value to its true value; accuracy may be
expressed as a value (e.g. 0.2°C) or as a percentage (e.g. 0.5%). As formula in
percent, Accuracy = [((True Value)-(Measured Value)) / (Full Scale)] x 100%.
5.2. Attribute gage: Any gage that determines if a part is acceptable or not, but does
not indicate the actual measurement of the part. (e.g. thread gage, plug gage,
ring gage)
5.3. Calibration Interval: a period of time designated to IMTE between calibrations.
5.4. Calibration Method: a document that defines how specific types of IMTE are to
be calibrated.
5.5. Calibration Standards: used to calibrate IMTE and other measurement
standards and provide traceability to National Institute of Standard and
Technology (NIST) standards.
5.6. Disposable Attribute Gage: any age that is not adjustable and is destroyed
and;/or discarded if found to be out of specification
5.7. Fixed Scope Gage: Custom fixing that determines if part is acceptable or not,
but does not indicate the actual measurement of the part; gage is not calibrated
to NIST standard rather verified against its own specification
5.8. Holding Fixtures: Gages that have no impact on product specifications; are not
used to accept or reject materials; are not used to set product parameters; are
entered in the calibration system, only if listed in a BOM. Fixtures not listed in
BOMs are not required to be in the Calibration System.

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 WI-G-001 Rev. A
Inspection, Measuring and
Effective Date:08/25/2015
Test Equipment

5.9. IMTE (Inspection, Measuring, Testing Equipment): equipment for which initial
calibration and periodic recalibration is appropriate or necessary.
5.10. Precision: a measure of the variability of data; also called ‘repeatability’ or
“measurement system repeatability”.
5.11. Preventive Maintenance Inspection (PMI): a schedule of planned
maintenance actions aimed at the prevention of breakdowns and failures.
5.12. Variable Gage: Any Gage that provides a measurement in discrete values
and is calibrated to a NIST traceable standard (e.g. CMM, caliper)

6. General
6.1. Any required calibrations may be performed by the original IMTE manufacturer,
a qualified calibration service or a qualified technician.
6.2. Any IMTE calibration performed in house shall be performed according to written
calibration methods which follow the IMTE manufacturer’s recommended
procedures when available.

6.3. Items designated as “For Reference Use Only” shall not be used in establishing
or verifying specifications. For example, thermometers used for general
information regarding work area comfort shall be identified as “For Reference
Use Only” while a thermometer used to record environmental conditions in a
controlled environmental area shall require calibration.

7. Procedure
7.1. All instruments used in the measuring or inspection process will be identified on
a calibration schedule.
7.1.1. IMTE used to determine product specifications or conformance to
specifications shall be calibrated at regularly scheduled intervals in
accordance with manufacturer's specifications, when available.

7.2. It will be determined whether the calibration will be conducted in house or at an

outside lab.
7.2.1. Qualified outside labs will be utilized and documentation to NIST Standards
will be kept on file by Management for a period of seven years.
7.2.2. All available records will be kept on file by Management for a period of
seven years.

7.3. Calibrated instruments will have a sticker identifying calibration period and date
of next calibration.

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 WI-G-001 Rev. A
Inspection, Measuring and
Effective Date:08/25/2015
Test Equipment

7.4. IMTE not maintained in the calibration system may be labeled with "for reference
only" and excluded from the requirements of this WI.

7.5. Any instrument that does not reflect a current state of calibration will be
segregated and either discarded or sent for repair.

7.5.1. Any inspection conducted utilizing this instrument will be reviewed to

determine the effects of work inspected with this instrument.

7.6. Inspector will record calibration data and file for a period of seven years.

7.7. Gages may be removed for the following reasons:

7.7.1. Gage cannot be located within 5 business days of calibration due date
(lost)
7.7.2. Gage damaged beyond economical repair
7.7.3. Gage no longer used (duplicate capabilities, retired, replaced with other
equipment)

8. Documentation
8.1. Documentation and records shall be maintained in accordance with SOP-M-001
Records

9. Issue, Approval and Change

9.1. Issue, approval, and changes to this procedure shall be in accordance with
SOP-D-001 Document Control

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