INTERNAL QUALITY AUDIT CHECKLIST

FOR
CONTROL OF MONITORING & MEASURING
DEVICES











Document: IQAC-018
Issue: 1
Revision: 0
Date: November 23, 2001
QUALITY AUDIT CHECKLIST FOR QMP-018 ISS: 1 REV: 0 Page: 1 of 7

REVIEWED BY: APPROVED BY: November 23, 2001
DOC: IQAC-018 REPORT No.: DATE: AUDITOR(s):



DETAILS
REV
LEVEL
REV
DATE
Page Para.
DESCRIPTION OF CHANGE
0 Nov. 23, 2001 All All Original Issue










QUALITY AUDIT CHECKLIST FOR QMP-018 ISS: 1 REV: 0 Page: 2 of 7

REVIEWED BY: APPROVED BY: November 23, 2001
DOC: IQAC-018 REPORT No.: DATE: AUDITOR(s):



INTERNAL AUDIT NOTIFICATION


TO:

FROM: QUALITY DEPARTMENT

DATE:

SUBJECT: INTERNAL QUALITY MANAGEMENT AUDIT



Please be advised that based on the annual internal audit schedule developed for the company,
the Quality department will be conducting an internal quality audit of CONTROL OF MONITORING
& MEASURING DEVICES on __________________________________.

The scope of this audit shall encompass all aspects and requirements defined within Quality
Management Procedure QMP-018, Issue: 1, Revision: Level O and shall be conducted in
accordance with procedure QMP-020.

The auditor(s) will be __________________________________________________________.

This audit is to start at ___________ a.m., take approximately ________ hrs. and be completed by
___________ p.m.

Please ensure those individuals responsible for the processes covered by the above procedure
are made available and that an Audit Guide is provided.

Thank you for your assistance in this matter.

Should you have any questions regarding the above, please contact the undersigned.



(Insert Name and Title of Quality Mgmt. Rep.)
QUALITY AUDIT CHECKLIST FOR QMP-018 ISS: 1 REV: 0 Page: 3 of 7

REVIEWED BY: APPROVED BY: November 23, 2001
DOC: IQAC-018 REPORT No.: DATE: AUDITOR(s):



EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable

CONTROL OG MONITORING & MEASURING DEVICES (QMP-018)
Para. AUDIT QUESTION CODE OBSERVATIONS
4.0 RESPONSIBILITIES
4.1
Is the Quality Manager responsible for establishing a
system to ensure that Standards, Masters and monitoring
and measuring devices, necessary to evaluate contract
and quality requirements, are available and are of the
accuracy, stability and range appropriate for the use
intended?

4.2 Is the Quality Manager responsible for the development
and approval of all required calibration instructions?

4.3 Is the Quality department responsible for ensuring
required calibrations are performed and for recalling all
monitoring and measuring devices due for calibration?

4.4 Is Production responsible for returning all monitoring and measuring devices for calibration when:
a) notified by the Quality department?
b) the accuracy and precision of an instrument or device is
suspect?

c) calibration performed is believed to be imprecise?
d) the calibration due date is expired?
5.0 PROCEDURE
5.1 General
5.1.1 Are all purchased as well as fabricated monitoring and
measuring devices used within (Insert Company Name)
subject to calibration by the Quality department?

5.2 Personally Owned Equipment
5.2.1
Is the use of personally owned tools and gauges used for
the purpose of evaluating product during production
processing permissible provided that these tools or
gauges have been calibrated and entered into the
Employee Equipment Calibration Log, FRM-727?

5.3 Production Tooling
5.3.1 Are production tools such as jigs, fixtures or templates
subject to accuracy verification by production personnel
prior to usage?

5.4 Calibration Instructions
5.4.1 Is internal calibration of monitoring and measuring
devices performed in accordance with calibration
instructions developed by the Quality department using
form FRM-725 and approved by the Quality Manager in
accordance with procedure QMP-003?

QUALITY AUDIT CHECKLIST FOR QMP-018 ISS: 1 REV: 0 Page: 4 of 7

REVIEWED BY: APPROVED BY: November 23, 2001
DOC: IQAC-018 REPORT No.: DATE: AUDITOR(s):



EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable

CONTROL OG MONITORING & MEASURING DEVICES (QMP-018)
Para. AUDIT QUESTION CODE OBSERVATIONS
5.4.2 Do instructions include the specific measurements to be
made, the acceptance criteria to achieve, the master or
comparator to be used and the environmental
requirements to be maintained during calibration?

5.5 Calibration
5.5.1 Is each monitoring and measuring device employed by
(Insert Company Name) for the purpose of verifying
product quality or monitoring processes assigned a
unique identification control number by the Quality
department and entered into the Monitoring and
Measuring Device Log, FRM-726?

5.5.2 Are Standards and Masters used for the internal
calibration of monitoring and measuring devices
maintained by the Quality department under lock and key
with access restricted to only authorized personnel
performing calibrations?

5.5.3
Are calibration of Standards or Masters performed
Externally by a qualified metrology laboratory with
Traceability to recognized national or international
Standards?

a)
Is the calibration of monitoring and measuring devices
also subcontracted to these same facilities, as required?

5.5.4 Are the certified calibration Standards or Masters, used
expressly for the purpose of calibrating monitoring and
measuring devices, utilized for the verification, measuring
or testing of manufactured items?

5.6 Calibration Frequency
5.6.1 Are all monitoring and measuring devices assigned a
specific calibration frequency?

5.6.2 Are calibration frequencies for new and/or existing
devices established by the Quality department based on
the stability, purpose and degree of usage and increased
or reduced periodically based on comparative analysis of
calibration results obtained to those previously recorded
for the same instrument?

5.6.3 Is computer software used for monitoring and measuring
of specified requirements validated prior to initial use and
reconfirmed every three (3) months while in use?

5.6.4
Are all calibration frequencies defined within the
Calibration Schedule, FRM-723?

QUALITY AUDIT CHECKLIST FOR QMP-018 ISS: 1 REV: 0 Page: 5 of 7

REVIEWED BY: APPROVED BY: November 23, 2001
DOC: IQAC-018 REPORT No.: DATE: AUDITOR(s):



EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable

CONTROL OG MONITORING & MEASURING DEVICES (QMP-018)
Para. AUDIT QUESTION CODE OBSERVATIONS
a)
Does the calibration schedule reflect the current status of
all monitoring and measuring devices used within (Insert
Company Name)?

5.7 Calibration Environment
5.7.1 Is calibration of all monitoring and measuring devices
performed in an environment conducive to assuring
continued measurement of the accuracy required and in
accordance with environmental conditions defined within
approved calibration instructions?

5.8 Calibration Records
5.8.1 Is the calibration schedule used for inventory, recall and
calibration status control?

5.8.2 Are all monitoring and measuring devices recalled by the
Quality department and removed from use by the date
that calibration is due?

5.8.3 Upon completion of calibration, is an Instrument
Calibration Test Report completed using form FRM-724
and filed under the equipment identification control
number?

5.8.4 Are calibration records maintained throughout the life of
each monitoring and measuring device?

a)
Do these records reflect the dates on which calibrations
were performed, the accuracy of results obtained during
calibration and any adjustments or re-adjustments
made?

5.8.5 Are calibration certificates received from outside
laboratories and internally generated Calibration Test
Reports retained on file by the Quality department as
defined within procedure QMP-004 as objective evidence
that all monitoring and measuring devices have been
calibrated and are capable of verifying the acceptability of
item(s) purchased or produced by (Insert Company
Name)?

5.8.6 Are calibration records made available to the customer
by the Quality department upon request?

5.9 Calibration Status
5.9.1
Upon completion of required calibration, is the calibration
status of each device identified by affixing a
calibration sticker to the item calibrated or its container?

QUALITY AUDIT CHECKLIST FOR QMP-018 ISS: 1 REV: 0 Page: 6 of 7

REVIEWED BY: APPROVED BY: November 23, 2001
DOC: IQAC-018 REPORT No.: DATE: AUDITOR(s):



EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable

CONTROL OG MONITORING & MEASURING DEVICES (QMP-018)
Para. AUDIT QUESTION CODE OBSERVATIONS
a)
Does the sticker indicate the equipment or Instrument
identification control number, the date on which
calibration was performed, the individual who performed
the calibration and the next date on which calibration is
due?

5.9.2 To ensure that only appropriate monitoring and
measuring devices are used in accordance with their
measurement capability, are measuring uncertainty,
limitations or restrictions regarding usage identified on
each device, or its container, when so required?

5.10 Nonconformities
5.10.1 Is any monitoring and measuring device identified during
calibration as beyond the acceptance criteria limits
established for that equipment type or group, removed
from service and processed in accordance with
procedure QMP-023?

5.10.2 Are previous documented inspection, measuring and test
results generated for which the device was used, re-
evaluated to assess the validity of the results obtained?

a)
Are these re-evaluations documented and, when
required, is corrective action initiated as defined within
procedure QMP-026?

5.11 Invalidation of Calibration
5.11.1 Are monitoring and measuring devices removed immediately from use and forwarded to the Quality
department for verification or calibration when:
a) a failure in operation occurs?
b) There is evidence of physical damage?
c) the accuracy is suspect?
d) the calibration due date has passed?
e) Notified by the Quality department?
5.12 Reference Standards
5.12.1 Are monitoring and measuring devices calibrated against
Standards and/or Masters whose calibration is certified
as traceable to a nationally or internationally recognized
standard?

5.12.2 Is equipment that cannot be calibrated internally by
(Insert Company Name) sent to a specialized laboratory
having adequate proof that all Standards and Masters
used to perform calibration have been calibrated and are

QUALITY AUDIT CHECKLIST FOR QMP-018 ISS: 1 REV: 0 Page: 7 of 7

REVIEWED BY: APPROVED BY: November 23, 2001
DOC: IQAC-018 REPORT No.: DATE: AUDITOR(s):



EVALUATION CODE: AC = Acceptable IR = Improvement Required UN = Unacceptable N/A = Not Applicable

CONTROL OG MONITORING & MEASURING DEVICES (QMP-018)
Para. AUDIT QUESTION CODE OBSERVATIONS
traceable to recognized standards?
5.12.3 Does each piece of equipment sent out for calibration
require a calibration certificate to be issued to (Insert
Company Name)?

5.12.4
For equipment for which no nationally or internationally recognized standard exists, is the basis for calibration
documented and one of the following:
a)
The manufacturer's recommended method for
calibration?

b)
The comparison to a standard of which the accuracy and
precision has been confirmed?

c)
Customer requirements?

5.13 Storage and Handling
5.13.1 Are all monitoring and measuring devices including test
hardware and software kept in a designated area within
the Quality department when not in use?

5.13.2 While in use, are monitoring and measuring devices
safeguarded from adjustments that would invalidate the
measurement results and protected against damage or
deterioration by the responsible individual during handling
and maintenance?

5.14 Control of Suppliers
5.14.1 Does the Quality Manager verify that all major suppliers
have an adequately maintained calibration system that
essentially meets the requirements of this procedure?

5.14.2 Is registration of a supplier's quality management system
by an accredited Registrar accepted as objective
evidence that the supplier's calibration system is
compliant?


NOTE TO AUDITOR(S)

Upon completion of this audit, you must:

1) Ensure that this checklist has been completed and all observations have been entered;
2) Complete a Quality Audit Summary Report using form FRM-811; and
3) Complete any necessary CARs to be issued using form FRM-836.