Document No.

VE-QMS-PROD-PRO01

Issue No. 00

Section QUALITY MANAGEMENT SYSTEM Revision No. Draft

Subject
PRODUCTION – Effective Date 30/07/2022
PLANT START UP PROCEDURE

1.0 Purpose
1.1 The purpose of this procedure is to define the requirements for calibration
or verification of equipment used to determine the acceptability of
product.

2.0 Scope
2.1 This procedure applies to all equipment and tools used on site.

3.0 Responsibilities

3.1 The Production Manager has the primary responsibility of making sure this
procedure is developed, implemented and maintained
3.2 The Plant Superintendent has the secondary responsibility of
implementing this procedure
3.3 All Plant operators have the secondary responsibility of adhering to this
procedure
3.4 Top management has the responsibility to provide resources for the
implementation of this procedure.

4.0 Acronyms and Abbreviations

4.1 ASU – Air Separation Unit
4.2 NCP – Non-conforming Product

5.0 Key Definitions

5.1 Calibration is the process of setting or correcting a measuring device
which is usually done by adjusting it to match or conform.

Signatures: Date:
Prepared by: Production Foreman
15/07/2022
Reviewed by: Plant Superintendent
15/07/2022
Approved by: Production manager
15/07/2022
 Document No. VE-QMS-PROD-PRO01

Issue No. 00

Section QUALITY MANAGEMENT SYSTEM Revision No. Draft

Subject
PRODUCTION – Effective Date 30/07/2022
PLANT START UP PROCEDURE

5.2 Defective means having a problem or fault that prevents something from
working correctly.
5.3 Out of tolerance is when calibrated test equipment is found not to be
falling within specific limits
6.0 Process Activities: Procedure

No. Activity Description Responsibility Record

6.1 Devices subject to calibration shall be Instruments Calibration
calibrated by an approved and technician logsheet
accredited outside service provider
and/or by trained VE Gases employees.
When employees perform in-house
calibration, calibration shall be
performed in accordance with
documented procedures for each type
of calibration performed.

6.2 Approved calibration service providers

shall maintain suitable environmental
conditions for calibration and report
temperature and relative humidity on
any calibration test certificates or other
calibration documentation. For in-
house calibration, the Maintenance/
Production Manager shall ensure
suitable environmental conditions for
calibration.

6.3 The Calibration log sheet shall be

maintained by the Production Manager

Signatures: Date:
Prepared by: Production Foreman
15/07/2022
Reviewed by: Plant Superintendent
15/07/2022
Approved by: Production manager
15/07/2022
 Document No. VE-QMS-PROD-PRO01

Issue No. 00

Section QUALITY MANAGEMENT SYSTEM Revision No. Draft

Subject
PRODUCTION – Effective Date 30/07/2022
PLANT START UP PROCEDURE

and this document shall list all devices,

their serial number and their date of
last calibration and next scheduled
calibration date. The frequency of
calibration for each device shall be
adjusted based on the history of the
device and its impact on product
quality.

6.4 Tools calibrated by third party

laboratories shall be returned with a
certificate of calibration showing the
status of the calibration as well as the
condition the equipment it was found
in (e.g., “defective,” “out of tolerance”,
etc.) Such certificates shall have the
identification of any standards used by
the third party and their serial numbers
allowing for traceability.
For tools calibrated in-house, the
results and standards used shall be
recorded on the calibration log sheet
and shall include any standards and/or
procedures used
6.5 Calibrated devices shall be identified
with a calibration sticker that includes
the current calibration status,
calibration due date and device
identification number. Where the
device cannot accommodate a
calibration sticker due to size or
frequency of use, the device shall be
Signatures: Date:
Prepared by: Production Foreman
15/07/2022
Reviewed by: Plant Superintendent
15/07/2022
Approved by: Production manager
15/07/2022
 Document No. VE-QMS-PROD-PRO01

Issue No. 00

Section QUALITY MANAGEMENT SYSTEM Revision No. Draft

Subject
PRODUCTION – Effective Date 30/07/2022
PLANT START UP PROCEDURE

numbered and the Maintenance/

Production Manager shall keep a log of
those devices and their status.
Employees may only use devices that
are current on calibration.

6.6 8 Employees shall submit expired tools

to maintenance/ Production for
recalibration, and/or the maintenance /
Production shall positively recall such
expired tools for recalibration. An
amnesty window of 2 weeks shall be
allowed beyond the due date marked
on the device to accommodate
arrangement of calibration or
verification, or for production capacity
purposes
6.7 Any device failing to meet calibration
standards shall immediately be taken
out of service and the device may then
be sent out for repair or destroyed.
Repaired devices shall be calibrated
before being returned to service.

6.8 When a measuring device is found to

be out of tolerance, and/or reported on
the calibration certificate of having
been found as defective or “out of
tolerance” by the third party provider,
the Production Manager shall be
notified immediately. The Production

Signatures: Date:
Prepared by: Production Foreman
15/07/2022
Reviewed by: Plant Superintendent
15/07/2022
Approved by: Production manager
15/07/2022
 Document No. VE-QMS-PROD-PRO01

Issue No. 00

Section QUALITY MANAGEMENT SYSTEM Revision No. Draft

Subject
PRODUCTION – Effective Date 30/07/2022
PLANT START UP PROCEDURE

Manager or the designated personnel

shall oversee a study to determine the
impact of the out-of-tolerance device
on product.
The results of calibration shall be
recorded and placed in the calibration
file.
6.9 Measuring and monitoring devices shall
be stored and handled in a manner
that does not invalidate their
calibration or ability to function without
error.
6.10 Verification
Where a device cannot be calibrated
against traceable standards, it must be
verified against some known-good
object or method. This shall be done
by comparing the part against another
part or tool which has been evaluated
and validated and proven as
acceptable. Known-good objects shall
be protected so their status is not
altered, either by physical damage or
deterioration and documentation of
such known-good methods shall be
documented with a rationale for their
acceptability being documented.

Signatures: Date:
Prepared by: Production Foreman
15/07/2022
Reviewed by: Plant Superintendent
15/07/2022
Approved by: Production manager
15/07/2022
 Document No. VE-QMS-PROD-PRO01

Issue No. 00

Section QUALITY MANAGEMENT SYSTEM Revision No. Draft

Subject
PRODUCTION – Effective Date 30/07/2022
PLANT START UP PROCEDURE

7.0 Records

No. Title Format Location Retention Disposal

Period Method
7.1 Calibration Log Hard Copy Production
Sheet Filing Cabinet. 3 years. Archive.

8.0 References

8.1 Suppliers’ Manual

8.2 ISO 9001:2015

Signatures: Date:
Prepared by: Production Foreman
15/07/2022
Reviewed by: Plant Superintendent
15/07/2022
Approved by: Production manager
15/07/2022