GlaxoSmithKline

Global Engineering Standard

Title: INSTRUMENT CALIBRATION

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INSTRUMENT CALIBRATION

Any questions or feedback about this Global Engineering Standard should be addressed to
the author:
Stephen Tate, Instrument Engineer, Pharma Supply Chain Engineering

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DOCUMENT REVISION HISTORY

Version
Date Revision Details
No

Section 4.1 Replaced GMS to “with PSC and CH sites. Vaccines

moved to guidance.
Section 4.3 Definitions
• Instrument – removed “or other on-off devices”.
• Overdue maintenance - changed to “Maintenance overdue
date”.
• As-found results – Removed “calibration or”
Section 5.1 Addition of PSC TS 002 – Maintenance and
Calibration
Section 5.2 Changed contamination example
Section 7.3 Re-worded to simplify section
Section 7.3.2 Addition of - Non-critical instruments requirement for
calibrations
Section 7.3.4 Addition of – figure number and description
Section 7.4.1 Addition of – “Fig 7.3.4 - Instrument permitted limits”
Section 7.4.2
4 Mar-21
• Addition of – Maintenance / Calibration interaction
• Addition of “calibrated to national standards”
• Addition of “Quality critical instruments subject to validation:
when”
Section 7.4.3
• Changed from “Period of grace” to “scheduling tolerance”
• Notes added showing exclusions
Section 7.5 Addition of “GES 103 Section 7.12”
Section 7.6 Addition of “To allow calibration of the installed
instrumentation, ensure that the required test equipment is available
on site for the first and future on site calibrations.”

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Section 7.8.2
• Addition of “It is common practice at many sites and across
the pharmaceutical industry to attach labels to instruments, it
must indicate the current instrument calibration status and the
next due calibration date (Notes 1 & 2)”.
• Changed Conform (or Pass) to “Pass (or Conform)” and added
“acceptable” to the requirement.
• Changed Non-Conform (or Fail) to “Fail (or Non-Conform)”
and added “acceptable” to the requirement.
• Addition of “the use of Failed or Overdue equipment” to the
Authorized requirement.
• Addition of “All the above have been the source of regulatory
observations in GSK” to note 1
• Addition of Note 2
Section 7.9 Addition of “appropriately as dictated by their
criticality”.
Section 7.10 Addition of “Incident and Investigation” and inclusion
4 Dec-20 of “appendix 4” reference
Section 7.10.1
• Addition of table number and description
• Addition of “It is important that all calibration deviations with
the potential to have a negative impact on Quality, Safety,
EHS and Compliance are investigated”.
• Addition of Guidance for reportable deviations
• Addition of figure 7.10.1.b
Section 8.3.1 Changed, day off sites to “days off site”. Inclusion of
“time since” explanation note
Section 8.5
• Change “Self-monitoring can be used to enhance confidence
between calibrations and can also be used to justify and
increase calibration interval. However self-monitoring should
not replace calibration activities”.
• Addition of “This can be achieved by Diagnostic and alarm
maintenance management software i.e. PDM (Siemens) or
AMS (Emerson)”

This the third issue of this Global Engineering Standard.

Fundamental review of the document.
Sections 1 & 2 Reword to simplify wording.
3 Mar-17
Section 3 The GES501 is now a daughter of GES103 in a
way that instrument calibration must comply to both GES.

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Sections 4 Integration of GQG 4304 and Vaccines

requirements. Vaccines is now part of scope. Link to CAP45 as per
GQP4304 Calibration.
Section 4.3 added to provide definition around the calibration
terminology in complement of QMS glossary and in replacement of
previous 7.1 definition section.
Sections 5 & 6 Reworded to simplify wording and integrate new
reference.
Section 7.1 Update of workflow to represent the
lifecycle of an instrument and link with all following chapter.
Section 7.2, 7.3.1, 7.3.2, 7.3.3 Minor changes versus
previous 7.3 & 7.4 sections.
Section 7.3.4 Replace previous 7.5 section. Increase
requirements for calibration to be established in relation to the
process (PAR and NOR).
Section 7.4 Replace sections 7.6, 7.7.1 and 7.7.2.
Main changes are to allow the calibration tolerance to be expressed
in percentage of reading and to allow a calendar approach for
scheduling which can be monthly or yearly and not just weekly.
03 Mar-17 Section 7.5 Replace previous 7.11. Requirement
on assessing the impact on device is added and consideration for
buffer solution.
Section 7.6 New section linked to GES103.
Section 7.7 Reword of previous 7.12 to simplify
wording.
Section 7.8 Requirement of data integrity added to
previous 7.75 section. New section on calibration status which give
precision on label management.
Section 7.9 Review of previous 7.10 section, with
common requirements between maintenance and calibration.
Section 7.10 Update of previous 7.8 and 7.73 sections.
Creation of an appendix for guidance on deviation management.
Section 7.11, 7.12, 7.13, 7.15 and 7.16 New sections added.
Section 7.14 Update of previous 7.9 with link from GQG4304.
Section 8 Update of the best practices on Calibration.
Audit checklist put into spreadsheet format.
Expiry / review column removed from template.
02 Feb-14 Expiry date extended by 4 months.
01 Nov-10 This is the first issue of this Global Engineering Standard.

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Table of Contents
DOCUMENT REVISION HISTORY...................................................................................... 2
1 RATIONALE ............................................................................................................... 6
2 POLICY ...................................................................................................................... 6
3 PURPOSE .................................................................................................................. 6
4 SCOPE ....................................................................................................................... 6
4.1 Within Scope....................................................................................................................... 6
4.2 Excluded from Scope ......................................................................................................... 6
4.3 Definitions ........................................................................................................................... 7
5 QUALITY COMPLIANCE REQUIREMENTS ............................................................ 10
5.1 Calibration ......................................................................................................................... 10
5.2 Contamination and Cross-Contamination ........................................................................ 10
6 EHS COMPLIANCE REQUIREMENTS .................................................................... 10
7 ENGINEERING MANDATORY REQUIREMENTS ................................................... 11
7.1 Overall Calibration Management Process ........................................................................ 11
7.2 Instrumentation List .......................................................................................................... 12
7.3 Instrument Criticality Assessment .................................................................................... 12
7.4 Set Up Critical Calibration Plans ...................................................................................... 14
7.5 Test Instruments and Working Standards ........................................................................ 16
7.6 Complete First Use Checks .............................................................................................. 17
7.7 Non-Routine Work ............................................................................................................ 17
7.8 Complete Calibration Activities ......................................................................................... 17
7.9 Create & Retain Calibration Records ............................................................................... 19
7.10 Deviation and Failures ...................................................................................................... 19
7.11 Manage Overdue Routines and Exceptions ..................................................................... 21
7.12 Defective Equipment ........................................................................................................ 21
7.13 Temporary Repairs ........................................................................................................... 22
7.14 Review of Calibration Plans .............................................................................................. 22
7.15 Skipping or Discontinuing Calibration Plans ..................................................................... 22
7.16 Out of Service Equipment ................................................................................................. 22
8 ENGINEERING BEST PRACTICE ........................................................................... 22
8.1 Overall Calibration Management Process ........................................................................ 22
8.2 Device assessment .......................................................................................................... 23
8.3 Calibration scheduling ...................................................................................................... 23
8.4 Instrument Verification ...................................................................................................... 24
8.5 Self-Monitoring.................................................................................................................. 24
9 REFERENCES ......................................................................................................... 25
Appendix 1 – Flowcharts for instrument criticality assessment .................................. 26
Appendix 2 - Examples of Critical Instruments by Category ........................................ 27
Appendix 3 – Flowchart for considerations to be taken on event of instrument failure
29
Appendix 4 - Decision Table for Deviation Impacts....................................................... 30
Appendix 5 - Audit Checklist ........................................................................................... 31

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1 RATIONALE
Usage of inappropriately calibrated instruments during manufacturing operations can
adversely affect product quality, data integrity or increase the risk of EHS incidents.
A robust and effective instrument calibration management process is therefore
necessary to minimise the above risks.

2 POLICY
All sites must identify Quality critical, EHS critical and Business critical instruments
they must also define a calibration management process to ensure the calibration of
critical instruments are within appropriate ranges and tolerances.

Sites must also comply with any relevant local legislation or regulatory requirements in
addition to the requirements defined in this Global Engineering Standard (GES).

3 PURPOSE
This GES aligns and supports GES103 (Maintenance), it defines the minimum
mandatory requirements, engineering best practices and guidance for the
management of Quality critical, EHS critical and Business critical instrument
calibrations.

This GES aligns with and supports GSK’s QMS and EHS standards and guidelines.

4 SCOPE

4.1 Within Scope

Business areas included within the scope of this GES are:
• Pharma Supply Chain (PSC) sites
• Consumer Healthcare (CH) sites

This GES provides guidance on the maintenance engineering requirements for

Vaccines, R&D and Commercial sites, which will be delivered through the engineering
standards systems operating in those business units.
It applies to calibrations completed by GSK and outsourced to third party companies.
The mandated and best practice elements of this standard are recommended for use
(not mandated) in managing maintenance in all other GSK facilities.

4.2 Excluded from Scope

This GES does not apply to laboratory based analytical equipment, as they are
managed through Compendium Analytical Procedures / CAP045.

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4.3 Definitions

ASSET
Any physical item or equipment that is maintainable and brings value to the
enterprise. This includes but is not limited to:
• temporary and permanent facilities and equipment,
• Utilities,
• critical monitoring devices, and
• fixed, mobile and portable manufacturing and test equipment

MAINTENANCE
Activities necessary for retaining or restoring an asset to the condition that achieves
its maximum useful life.
It includes corrective, preventative, predictive maintenance, inspection, testing,
calibration, adjustment, refurbishment and/or replacement of asset or components.
It includes routine and non-routine maintenance.

INSTRUMENT
A device that produces an output signal (pneumatic, electronic / electrical, serial
data, digitally encoded etc.) in a defined relationship to a physical variable. For the
purposes of this GES, this definition does not apply to hand / limit switch devices.

QUALITY- Critical Instrument

Any instrument that has a quality impact on product and/or has been validated per
GQMP 1008 / GQP 1204 – Validation Life Cycle.
This may also be referred to as a GxP asset.

EHS - Critical Instrument

An instrument whose principal function is to prevent or protect against an adverse
EHS impact.

BUSSINESS - Critical Instrument

An instrument whose function is to ensure reliable and efficient operation, normally
of manufacturing processes.

CALIBRATION
The demonstration that an instrument or a measuring device produces
measurements within specified limits by comparison with those produced by a
reference or traceable standard over an appropriate range of measurements.

CALIBRATION TOLERANCE

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The maximum acceptable calibration error or difference in readings between the

measurements produced by the instrument under test and those indicated by the
reference standard.

PROVEN ACCEPTABLE RANGE (PAR)

The value of a critical physical parameter which must not be exceeded by the
process (established by knowledge gained through relevant documentation and
actual testing).

NORMAL OPERATIONAL RANGE (NOR)

The range over which the physical parameter needs to be accurately measured
(Between lower and upper process limit).

TEST INSTRUMENTS AND WORKING STANDARDS

A test instrument calibrated from reference standards used to calibrate field or
process instruments.

MAINTENANCE PLAN
A programme of planned maintenance activities completed at regular intervals to
ensure that the asset continues to operate within its required parameters and that
any risks to product quality are eliminated or minimised.

ROUTINE MAINTENANCE
A set of pre-defined activities completed at regular intervals as part of a Maintenance
Plan.

NON-ROUTINE MAINTENANCE
Any maintenance that is not part of a Maintenance Plan.

NOMINAL MAINTENANCE INTERVAL

The interval between each of the scheduled due dates on a maintenance plan. The
interval may be calendar-based or usage-based.

SCHEDULING TOLERANCE
A defined interval before or after the scheduled due date for completion of
maintenance activities in a Maintenance Plan. This is used to define the earliest and
latest acceptable completion dates for routine maintenance activities.

MAINTENANCE OVERDUE DATE

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The latest acceptable date to complete Routine Maintenance is the date defined by
the scheduled due date plus the scheduling tolerance. Any maintenance plan
activities completed after this date are considered overdue.

HIDDEN FAILURE MODE

An equipment failure mode that is not evident to the operator during normal
operation, but that may cause asset integrity or performance to fall to a level that
potentially impacts product quality.

AS-FOUND RESULTS
The inspection results before any adjustment or other maintenance activities are
applied.
AS-LEFT RESULTS
The calibration or inspection results, after any adjustment or other maintenance
activities have been completed and before returning the asset to service.
If there has been no adjustment or other activities affecting the calibration or
inspection, then no ‘as left’ results are required.

Calibration Management System

A system to manage calibration activities and data. It can be any combination of:
• -a Computerized Maintenance Management System (CMMS) and / or
• -a dedicated calibration software and/or
• -a paper-based system.

CMMS
A Computerised Maintenance Management System used to record asset details
and/or spare part details and to plan and record all maintenance activities / spares
usage.

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5 QUALITY COMPLIANCE REQUIREMENTS

5.1 Calibration
Quality requirements for the calibration of instruments are defined in the following
QMS documents:
• GQMP 1008 – Validation Life Cycle
• GQP 1204 – Validation Life Cycle
• PSC TS 002 – Maintenance and Calibration

5.2 Contamination and Cross-Contamination

You must consider risk of contamination and / or cross-contamination (GQP 4301 –
Facilities Operation) of equipment and process associated to calibration activities.
Especially when:
• A test instrument is used to calibrate instruments in more than one area or for
different processes
• test instruments are sent off-site for external calibration
• the calibration method involves the use of potentially contaminated material to
simulate settings
(example: Pressure simulator (i.e. Druck) connected to a process transmitter
could possibly draw back process fluid into the simulators chamber from the
transmitter)

6 EHS COMPLIANCE REQUIREMENTS

The overall environmental, health and safety requirements for EHS-critical
maintenance are defined in the EHS Standards and Guidelines:
• SG 2.01 – Risk Assessment and Management
• SG 5.16 – Electrical and Machinery Safety
The requirements defined in this GES are aligned with and complement both of these
EHS standards:
• Calibration activities must comply with safe systems of work, as defined in GES
113 – Permit to Work
• Pressurised and electrically-energised systems must be suitably isolated (in
accordance with GES 110 – Machinery Safety and GES 308 – Isolation of
Hazardous Fluids) before some calibration activities.

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7 ENGINEERING MANDATORY REQUIREMENTS

7.1 Overall Calibration Management Process

The flow chart below represents a summary of the overall calibration management
process.
This process applies to all instruments.
If a process or an instrument is modified, the process must be repeated, starting at the
appropriate step, depending on the nature of the change.

Fig7. 1 – Overall Calibration Management flow chart

Create / Update Instrumentation List 7.2

Instrument Criticality Assessment * 7.3

Quality, EHS, Non-critical

Business criticality

Instrument Identification 7.3.3

Range +
Device assessment * 7.3.4 Calibration
Tolerance

Calibration
Interval + Set Up Critical Calibration Plan 7.4 Calibration Schedule
method

Test Instrument & 7.5

working standard

Implement Calibration Plan 7.9 Complete First Use 7.6

Checks

Non-Routine Work 7.7

Complete Calibration Activités 7.8 Deviation and Failures 7.10

Review Calibration Plan 7.14

Out of Service Equipment 7.16

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7.2 Instrumentation List

In application of the GES103 – 7.1 Engineering Asset Register, you must include the
instrumentation in the asset register.

“Assign a unique identification number to every maintainable item on a site and

record this equipment in the Engineering Asset Register of the CMMS.
This register is the basis for all maintenance activities”

The instrument list (DDS 09) is derived from the Asset register and must identify the
hierarchical relationship between parent systems/equipment and child
instruments/loops (as a single item on the register list or include in a parent system).

7.3 Instrument Criticality Assessment

An inappropriate classification can result in too much, or too little calibration effort.
Excessive calibration is costly and insufficient calibrations could cause a risk to Quality,
EHS, and Business functions.

7.3.1 Critical Instrument

A cross functional team (for example engineering, user, quality/EHS) must assess all
instruments on a site to determine their criticality:
• in accordance with Table 1
• by utilising appendix 1 - flowchart
• at the design stage or for new or modified equipment or process

Table 1 – Instrument Criticality Assessment Criteria

Criticality Criteria
Quality Critical Instrument function is to demonstrate or assure:
• product identity or intermediate process control (PAT)
• product quality in manufacture or storage (CQA´s; CPP´s and
Quality PP´s)
• finish products components identity
• compliance with applicable GxP regulations
• conformance with registered details
➢ This definition would also cover test instruments or working
standards which are used to calibrate other quality critical
instruments.
EHS Critical Instrument function is to prevent or protect against an adverse EHS
impact, or to measure or record data in accordance with EHS
regulations or licences.
Business Critical Instrument function is to ensure reliable and efficient operation, such
as manufacturing processes. Failure may impact process or system
performance without affecting final product quality or EHS
Non-Critical Instrument function does not include any of the above.

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Record and approve the results of the instrument criticality assessment, including
rationale for the decision, and retain the record. Quality must approve the Quality
Critical Instrument assessment.

7.3.2 Non-Critical Instruments

Instruments that are not quality, EHS or business criticality are out of scope of the
mandatory requirements of this GES.

If non-critical instruments require calibration it is at the discretion of the site.

Options include:
• periodic calibration
• ad-hoc calibration when required
• no calibration
Non-critical instrument must be calibrated in accordance with a local procedure.

7.3.3 Instrument Identification

Allocate a unique identifier to all quality, EHS and business critical instruments and
use this identifier:
• in all documentation and records associated with the instrument (criticality
assessment, device assessment, calibration plan, calibration records)
• in the calibration management system / Engineering asset register
• on a robust physical label attached to the instrument

Note:
The term “robust” in this sense means that you must consider the environment for the label design:
temperature / humidity may impact the label, sterilization agent in classified room.

7.3.4 Device Assessment

Assess all quality, EHS and business critical instruments in order to:
• confirm the Normal Operational Range (NOR) over which the physical
parameter needs to be accurately measured (Between lower and upper
process limit).
• confirm the Proven Acceptable Range (PAR) or Process Specification Limit:
The true value of a critical physical parameter which must not be exceeded by
the process (established by knowledge gained through relevant documentation
and actual testing).
• determine the required Calibration Tolerance: The maximum acceptable
calibration error (Or MPE: Maximum Permissible Error or Instrument Permitted
Limit).
• check the suitability and capability of the instrument to measure to the required
calibration tolerance.

Critical Process Parameters (CPP) and Process Parameters (PP’s) with Quality Impact
have specified levels or, in some cases, absolute limits for acceptable operation.
Review and update these values when you change the process change or introduce a
new product.
Fig 7.3.4 - Instrument permitted limits

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Maximum Calibration Tolerance

Process Acceptable Range

Nominal Operating Range
Notes: If there is no margin between specified limit (PAR) and process limit (NOR), or if PAR is unknown,
you must still define calibration tolerance. In this case to minimize the risk to impact the process, apply a
capability ratio between the measurement and the operating range (Calibration Tolerance = ¼ of Nominal
Operating Tolerance).

7.4 Set Up Critical Calibration Plans

Please refer to GES 103 Maintenance – 7.4 “Set Up Critical Maintenance Plans”.
In addition, for Quality and EHS criticality instrument, you must:
• Calibrate instruments prior to and through the period of use and on
decommissioning.
• Document and justify any decision that an instrument does not require routine
calibration.
• Establish a calibration frequency using an appropriate risk management
analysis and the performance history of the instrument.
• Design the calibration scheduling to ensure that re-calibration due dates are
readily identified and not exceeded.
Notes:
Define the risk management for calibration frequency through:
-The implications of an instrument found to have been in error to an unacceptable extent.
-The implications of an instrument having an undetected and unacceptable error in operation.
-The procedures associated with the process which would detect an instrument problem. When it
happens, would the procedures detect the problem every time and soon enough?

7.4.1 Calibration Work Instruction

In complement of GES 103 7.4.5 “Work Instruction in Maintenance Routine”, the
calibration work instruction must include:
• the calibration ranges
• the number and value of calibration points
• the type of test instrument / working standard to use
• the calibration tolerance
• the adjustment limits
• the work method

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• the actions to be taken if the instrument is found to be faulty

• the actions to ensure calibration is completed in a safe manner and without
putting at risk the quality of the product

Adjustment Limit is the maximum calibration error, above which you must adjust the
instrument. The ‘As Left’ calibration error, after adjustment, must be less than the
adjustment limit.
Notes:
The adjustment limit needs to consider the uncertainty of measurement, else time will be lost adjusting
the instrument. Therefore, it should be specific for each measurement and part of the calibration system
Alternatively, you can use a generic site approach like “Adjustment limit = calibration tolerance x 50%”

Three points is the minimum number of calibration points to apply

If a single point (Pressure switch) or 2 points (PH) calibration is used, it must be
approved and documented, for example quality or EHS, and a justification containing
a rationale which considers the risks of such a method.

The calibration points must encompass the Proven Acceptable Range in full, (Refer
to Fig 7.3.4 - Instrument permitted limits)
If it is not possible or if the proven acceptable is unknown, the calibration range must
encompass the normal operating range. In this case, you need to define the process
control (alert/alarms triggers) accordingly.

Express the calibration tolerance in engineering units (e.g. oC, kg, mbar, Ohms).
Do not use percentage of full scale as it creates confusion on the scale to consider
(process range, sensor technical capacity, display range).
If you are using percentage of reading, consider the risk of generating out of tolerance
around zero.

Notes:
Setting up the calibration tolerances in the unit used by the process enhance a better understanding for
users and facilitates the unplanned event management.

7.4.2 Implementing the Calibration Plan

Calibration may reveal a need for maintenance, and any maintenance work e.g.
replacement of a major moving mechanical part, will demand the instrument be
calibrated before and after the work is completed.
Note: Maintenance and calibration of instruments are different but related activities.
Maintenance involves the cleaning, inspection, lubrication and replacement of parts,
whereas calibration checks the accuracy of the instrument.

Implement the calibration plan to ensure that:

• All instruments and equipment are calibrated within their predefined calibration
periods
• Calibration is carried out using appropriately specified and controlled reference
standards or instruments, calibrated to national standards
• The calibration status of all equipment or instruments is clearly known and
verifiable

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• There is a fully documented record of all calibration activities and outcomes

Consider in-use performance or calibration checks when implementing the calibration
plan.
Perform the calibration:
• For new or modified asset: during the commissioning phase
• For Quality critical instruments subject to validation: when part of Installation
Qualification (IQ) or Operational Qualification (OQ) and on completion of
validation (PQ)
• Quality critical instrument: before decommissioning
• For EHS critical instruments used to control or monitor environmental
emissions which are reportable to regulatory authorities
• Before any engineering work which could have an impact on the calibration
performance of an instrument
• Before and after moving fixed equipment (Fridges, Balances)

7.4.3 Scheduling Tolerance and Overdues

GES 103 Section 7.4.7 defines the maximum scheduling tolerance (period of grace)
allowed in relation to a nominal maintenance interval.
In that way, a maximum timeframe between the earliest acceptable completion date
and the latest acceptable completion date of the next periodic calibration (due date)
is defined.
If your system works on a different calendar approach (monthly, yearly), ensure that
you don’t allow a longer timeframe between 2 successive periodic calibrations than
the ones defined in GES103.

Note: The use of scheduling tolerances must ensure that:

• Proof testing of any SIL loop is as per the intervals defined in the verification
documentation, AND
• Statutory maintenance activities are completed within the period specified in
the regulatory requirement.

7.5 Test Instruments and Working Standards

Test instruments and working standards are devices used to calibrate field
instruments, either in the field, in an on-site calibration laboratory or by a third party in
an off-site laboratory.
Test instruments and working standards must be:

• Classified as quality critical instruments

• Uniquely identified in the calibration management system and labelled
• Capable of measuring to a greater degree of accuracy than the calibration
tolerance of the field instruments which they are used to calibrate
• Calibrated in accordance to a define calibration plan, with a defined calibration
tolerance
• Traceable through a hierarchy of calibration by successively more accurate
standards, to a recognised national, international or industry recognised
physical standard

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•Traceable in order to allow identification of all the devices that have been
calibrated with the test instrument, in case it is found to be out of tolerance,
damaged or lost
When an out of tolerance or an overdue calibration occurs, you must:
• investigate in the same way as for field instruments as described in GES 103
Section 7.12
• assess the impact on all the device that were calibrated with the test instrument

Notes:
If there is no recognised national, international or industry recognised physical standard, you must use an
independent reproducible standard. Where no applicable standard exists, you must establish an in-house
standard)
Wherever possible, the calibration tolerance of any test instrument or working standard should be less
than 25% of the calibration tolerance of the field instrument which it is being used to calibrate.
Similarly, the reference standard which is used to calibrate the test instrument or working standard should
be at least four times more accurate than the test instrument, and so on up through the traceability ladder.
It is recognised that this may not be possible in all cases (e.g. relative humidity measurement).
If the working standard is a buffer solution, the traceability is required, especially to ensure that it must be
purchased from accredited laboratories, storage and use before expiry date.

7.6 Complete First Use Checks

Please refer to GES 103 Maintenance – 7.6 “Complete First Use Checks”

To allow calibration of the installed instrumentation, ensure that the required test
equipment is available on site for the first and future on-site calibrations.

7.7 Non-Routine Work

Please refer to GES 103 Maintenance – 7.7 “Non-Routine Work”

In addition, for non-routine calibration, if the instrument is damaged and needs to be

replaced, the two alternatives for the new instrument are:
a) Calibrate immediately before usage
b) Use a spare calibrated instrument if
• Certificate calibration record is available and
• Time from last calibration is lower than the interval required for this instrument
in calibration plan and
• The error linked to the loop connection is under control (perform a calibration
of the electrical loop or use a digital connection)

7.8 Complete Calibration Activities

Please refer to GES 103 Maintenance – 7.8 “Complete Maintenance Activities”
In addition, for instrument calibration activities, the following applies:

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7.8.1 Calibrations Performed Off-Site

The equipment supplier, third party calibration service provider or specialist calibration
laboratory which perform an off-site calibration, must provide the calibration results in
the form of a calibration certificate with both as-found and as left findings.
Prior to any instrument leaving site all configurable parameters must be backed up /
recorded to ensure on return there is no configurable parameter differences.
On return to site you must:
• Approve certificate
• Verify configurable parameters
• Record the date of the calibration and the PASS / FAIL result in the site
calibration management system.
(There is no requirement to transpose calibration results from the calibration
certificate into the site calibration management system)
• Scan a copy of the supplied certificate and record it in the site/area calibration
records file to allow review of passed findings for the technician / supervisor /
engineer.
• Keep the original certificate of any quality critical instrument as an original
document and store as a GMP document (Data integrity consideration) Refer
to PSC TS 002 Maintenance and calibration - section 5.5

Note:
It is recognised for specialist calibration laboratories to provide a test certificate showing the raw calibration
data, but not a PASS / FAIL result. In these cases, you must determine and record the PASS / FAIL result
on receipt of the test certificate in relation to the defined internal calibration tolerance.

Where new instruments are supplied with a calibration certificate, this may in certain
circumstances and with agreement be used as the first calibration without the need to
carry out a first calibration on site.

7.8.2 Calibration Status

It is common practice at many sites and across the pharmaceutical industry to attach
labels to instruments. Such labels, if used, must indicate the current instrument
calibration status and the next due calibration date (Notes 1 & 2).

The status includes the following requirements:

• PASS (or Conform): if asset defined for periodic calibration is acceptable

• FAIL (or Non-Conform): if asset defined for periodic calibration is not acceptable
• AUTHORISED: if a Quality / EHS approved rationale authorises the use of Failed or
Overdue equipment
• OUT OF SERVICE: status of the equipment following decommissioning

Note:
1. The recommendation (not mandatory) is to remove the labels for the follow reasons:

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- labels may become detached

- labels may become illegible due to exposure to sunlight, water, chemicals etc.
- discrepancies may arise between dates in the calibration management system and dates on the
labels
All the above have been the source of regulatory observations in GSK.

2. Several highly regulated sites in GSK do NOT use calibration date labels and have successfully
demonstrated to some regulators that a robust calibration management system is adequate to control
calibration completion dates, due dates and overdue calibrations.

However, the removal of calibration labels will require site representation approval i.e. Quality, EHS etc
and, must be accepted by all and agreed with regulatory agencies impacted by the site activities.

7.9 Create & Retain Calibration Records

Please refer to GES 103 Maintenance – 7.9 “Create & Retain Maintenance Records”
In addition, record the following for instrument calibration:
• Reference of SOP, working instruction or method used
• Identification of all test equipment, working standard or reference standard
used, with expiry date, unless it comes from an accredited calibration laboratory
(for example UKAS, COFRAC, ISO17025)
If calibration information is transposed from paper records into the site calibration
management system, consider all paper calibration certificates or paper WO as the
original primary records and must be retained appropriately as dictated by their
criticality.

7.10 Deviation and Failures

Please refer to GES 103 Maintenance – 7.10 “Incident and Investigation”
In addition, apply the decision table in appendix 4 and the following:

7.10.1 Satisfactory and Unsatisfactory Calibration Checks

A calibration activity will produce one of the following results:
1. The instrument is accurate and does not require adjustment.
2. The instrument requires adjustment to measure within its adjustment limits but is
not outside the calibration tolerance
3. The instrument has drifted outside its adjustment limits and beyond the calibration
tolerance or the instrument is in error (deterioration of failure). In these cases:
• Report this event as a Quality deviation, for Quality critical instrument
• Report this event as an EHS event, for EHS critical instrument
• Consider implications for past use
• Determine the root cause of the calibration failure (use the flowchart in
appendix 3 for guidance)
• Review if the calibration frequency is still appropriate
If you cannot perform a successful as left calibration, you must notify the instrument
owner to restrict the usage.

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You must indicate that the instrument is “non-conform” or “Out-of-service”

IF:
• A second failure raised during a time period equivalent to 3 periodic calibrations
• On the same instrument, on the same equipment
• With the same root cause
THEN you must classify this deviation as a recurrent deviation.

Table 7.10.1a - Describes the action which must be taken in event of a calibration FAIL

It is important that all calibration deviations with the potential to have a negative
impact on Quality, Safety, EHS and Compliance are investigated.

Guidance for reportable deviations:

• Any device found to be “Out Of Tolerance” upon inspection “As Found”
• Any device that was not calibrated by its required due date

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• Any device that was not found or was unavailable for calibration.
• Any of the above that have an impact to GxP, Statutory or EHS

The following flowchart (Fig 7.10.1b) gives guidance on how to appropriately

determine if a calibration has an undesirable event that must result in an
investigation.

Fig 7.10.1b - Deviation Guidance flow chart

Note: Y3 is only applicable for sites with MERPS CMMS

7.11 Manage Overdue Routines and Exceptions

Please refer to GES 103 Maintenance – 7.11 “Manage Overdue Routines and
exceptions”.

7.12 Defective Equipment

Please refer to GES 103 Maintenance – 7.12 “Defective Equipment”.

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7.13 Temporary Repairs

Please refer to GES 103 Maintenance – 7.13 “Temporary Repairs”.

7.14 Review of Calibration Plans

Please refer to GES 103 Maintenance – 7.14 “Review of Maintenance Plans”

In addition, in order to increase the calibration interval, you must consider the following:
Where loops have a number of successive successful calibrations (without adjustment)
then you can extend the calibration interval in line with the diagram below not by more
than two thirds of the time period over which the loop has proven itself.
Fig 7.14 - Increasing the calibration interval
Original Interval

6 Months Third Successive Calibration

6 Months
6 Months

1 Year

Proposed New Interval

Always consider the point where deteriorative effects of age could affect the instrument
and the potential impacted period to investigate when the instrument will actually break
or drift.
Before an extension to a quality critical instrument interval, you must consider with
quality the potential impact to Production batches, if the instrument were to fail its
calibration.

7.15 Skipping or Discontinuing Calibration Plans

Please refer to GES 103 Maintenance – 7.15 “Skipping or Discontinuing Maintenance
Plans”.

7.16 Out of Service Equipment

Please refer to GES 103 Maintenance – 7.16 “Out of Service Equipment”.

8 ENGINEERING BEST PRACTICE

8.1 Overall Calibration Management Process

8.1.1 Key performance indicators
• Calibration deviation Usual target <2%

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It represents the percentage of calibration failures with potential product impact. Only focus
on As Found value. Consider Out Of Tolerance result or no result (broken, lost).
• Late execution (overdue) Usual target <3%
This ratio corresponds to the number of expired work order divided by the number of work
orders planned (equal to the invert of the schedule adherence).
Example: 100 work orders of calibration have been planned for January, 2 work orders have
not been completed. The late execution ratio is 2% (schedule adherence of 98%)

8.2 Device assessment

8.2.1 Good practice for field or process instrument:
To define calibration tolerances, you can use regulatory rules or guidance (United
State Pharmacopeia, Organisation Internationale de Metrologie Legale) in addition to
data from process validation and supplier recommendations.
Nevertheless, if there is no margin between specified limits (PAR) and process limit
(NOR), you can use a ratio of 4 between Nominal Operating Tolerance and the
Calibration Tolerances.
Calibration tolerance < 1:4 (NOR tolerance)
Example: for a fridge regulating between 2.0 and 8.0 degree, the normal operating
range is 5.0 +/- 3.0°C. The recommend calibration tolerance if no process acceptable
range is known will be 3 divided by 4, therefore 0.75°C. Then you should consider this
tolerance in the definition of Alert/Alarm threshold.

8.2.2 Good practice to determine metrological specification for equipment

Calibration Optimisation Blueprint used as a step by step guide to measure, analyse
and optimise calibration activities. (refer to section 8.3.2)

The Vaccines SPC 130 “Technical specification for Determination of adjustment limits
and calibration tolerances” suggest pre-established sensor criticality and tolerances
for standardized equipment and provide rationales. It provides a criticality analysis
method applicable to Calibration activities which can be used to prioritize and review
calibration plan / metrological specification

The CAP045, compendium of analytical procedures for Analytical Equipment

Performance/Maintenance requirements and Standard Platforms covers laboratory
measurement equipment and applies to computerised and non-computerised GxP
analytical equipment.

8.3 Calibration scheduling

8.3.1 External calibration
To manage the complexity of external calibration, you can use 2 work orders:
• One to remove equipment from site (and send it externally)
• And one to realize the external calibration

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In this case, take into consideration the full scheduling (due date and calibration
interval of both work orders).
Using “days off site” can also be option, considering the maximum timeframe accepted.
Note:
Working with “Time Since” schedule for external calibration increases equipment’s availability. Schedule
dates will shift one transport period each year.
“Time since” = when the unit has been calibrated and returned to site, the date on the calibration certificate
is the schedule start date. So, if the off-site calibration takes 1 month then each year the removed
equipment / calibration date would move forward one month to allow the equipment’s full years calibration
period to be utilised

8.3.2 Calibration Optimisation Blueprint

The Calibration Optimisation Blueprint contains:
• guidance on determination of initial calibration intervals for new instruments
• tools for optimisation of calibration intervals based on performance and
calibration history of the instrument
https://myconnect.gsk.com/sites/gms_engineering/worldclassmaintenance/pages/case_studies.aspx

8.4 Instrument Verification

Verify instruments on a regular / periodic basis to detect a drift and start a calibration.
For example, weight scales, pH-meter, temperature probes and allow reducing the
impact assessment in case of out of tolerance result obtained during the calibration.
Consider the number of test points (single point) and the target (versus full operating
range) and the limit. If the results exceed the adjustment limit, you should start a full
calibration.

8.5 Self-Monitoring
Self-monitoring can be used to enhance confidence between calibrations and can also
be used to justify and increase calibration interval. However self-monitoring should not
replace calibration activities.
One practical way to realise it is to define one business critical instrument which
realizes the same measurements to a quality critical instrument and to monitor the
difference between the measurements. When this difference gets too large, start a
calibration to check which sensor has drift.
Smart instrumentation can also provide a similar benefit through detecting unusual
tendencies, when the instrument drifts. This can be achieved by Diagnostic and alarm
maintenance management software i.e. PDM (Siemens) or AMS (Emerson)

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9 REFERENCES
GQP 3201B Data Management and Control
GQP 4301 Facilities Operation
GQP 4303 Maintenance
GQP 4304 Calibration (Retired)
GQP 4309 Cosmetic Products: Maintenance and Calibration
GQP 6302 Deviation Handling
GQMP 1005 Change Control
GQMP 1008 The Validation Life Cycle
GQMP 6007 Deviation Handling
GQP 2101 Organisation, Personnel Management and Training
GQMP3001 Documents and data – life cycle management
GQMP 4006 Outsourcing of engineering And facility services: assessment and
control of risks
PSC TS 002 Maintenance and Calibration
EHS SG 2.03 Investigation and Reporting
EHS SG 2.01 Risk Assessment and Control
EHS SG 5.16 Electrical and Machinery Safety
GES 101 Commissioning & Qualification
GES 102 Plant Modifications
GES 103 Maintenance
GES 110 Machinery Safety
GES 113 Permit To Work
GES 114 Contractor Management
GES 502 BPCS Alarm Design & Management
GES 503 Safety Instrumented Functions
GES 601 Design of Document Archives
POL-GSK-506 Global Records Retention Policy
POL-GSKF-507 Computerised System Validation
SPC130 Technical specification for Determination of adjustment limits and
calibration tolerances for manufacturing equipment
Calibration Optimisation Blueprint
CAP045 Compendium of Analytical Procedures for Analytical Equipment
Performance/Maintenance requirements and Standard Platforms

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APPENDIX 1 – FLOWCHARTS FOR INSTRUMENT

Instrument Identified
CRITICALITY ASSESSMENT

Is instrument used to registered

show compliance with process
details? (i.e.: direct impact on
YES
the product quality or preserve a
system critical status)

NO

Is instrument used to assure

Process Parameters (PP’s) YES
(quality/GMP) of production or
product? (i.e., measure, monitor
or record a parameter)

NO
N

Are measurements by this

O
instrument kept to show product YES
quality, GMP or meet regulatory
demands? (i.e. determine the
Quality Attribute) Is there a “parallel” or
“downstream” instrument / NO
NO measurement that will
detect malfunction of this
instrument?
Could instrument
malfunction result in YES
unacceptable product being
considered acceptable? YES

NO
N Is this “parallel” or
Could instrument O “downstream”
malfunction result in product YES instrument/measurement a NO
being misidentified? Quality Critical
instrument/measurement

NO

Could malfunction of this YES

instrument result in YES
mistaken indication of GMP
compliance?
Is this “parallel” or
“downstream”
NO instrument/measurement YES
providing a double “quality
check/control of the
Is this instrument used to YES process?
calibrate critical
instruments?

NO
NO

Instrument is not Instrument is

Quality Critical Quality Critical

See next page

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Instrument is Not Quality Critical

Does the instrument act as a final

check against the release of YES
hazardous materials, waste or
sewage?

NO

Does the instrument monitor a

parameter that could pose a YES
possible adverse impact on human
health?

NO

Does the instrument monitor a

YES
parameter that could pose a risk of
fire or explosion?

NO

Instrument is Instrument is
Not EHS Critical EHS Critical

Could the instrument have an

adverse effect on operational cost YES
or time to release product without
directly affecting product quality?

NO

Is the instrument the back up of a

product critical instrument and it
YES
hasn´t been installed to have a
quality double check and it will be
used just for internal information

NO

Instrument is Instrument is
Not Critical Business Critical

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APPENDIX 2 - EXAMPLES OF CRITICAL INSTRUMENTS

BY CATEGORY
QUALITY CRITICAL QUESTIONS
Is instrument used to registered show
Upstream temperature probe on WFI distillation unit where
compliance with process details? (i.e.: direct
the outlet temperature and conductivity probes confirm good
impact on the product quality or preserve a
WFI; Speed (rpm) in a blender process
system critical status)
Is instrument used to assure Process
Parameters (PP’s) (quality/GMP) of production Particle counters and air samplers used for environmental
or product? (i.e., measure, monitor or record a monitoring.
parameter)
Are measurements by this instrument kept to Ph in a liquid process, Filling volume, weight. Visions
show product quality, GMP or meet regulatory system to read/check variable data printed in primary/
demands? (i.e., determine the Quality Attribute) secondary pack
Vision systems to check cosmetic defects in primary and
Could instrument malfunction result in secondary pack.
unacceptable product being considered
acceptable? QC lab incubator where the incorrect temperature could
result in inaccurate incubation results.
Could instrument malfunction result in product
Analytical equipment
being misidentified?
Could malfunction of this instrument result in
QC lab conductivity analyser.
mistaken indication of GMP compliance?
Is this instrument used to calibrate critical
Calibration reference standard.
instruments?

Is there a “parallel” or “downstream” instrument /

Drain temperature inside an autoclave compare to the
measurement that will detect malfunction of this
chamber temperature. Level gage versus weighing system
instrument?
Is this “parallel” or “downstream”
instrument/measurement a Quality Critical Contra control systems in reject station
instrument/measurement
AND Systems to check the number of cartons into cases even we
Is this “parallel” or “downstream” have an upstream check at the end of the line weight of
instrument/measurement providing a double cases
“quality check/control of the process?
BUSINESS CRITICAL QUESTIONS
Could the instrument have an adverse effect on
operational costs or time to release product Upstream conductivity sensor on a reverse osmosis system.
without directly affecting product quality?
2 temperature sensors are in a tank, one is product critical,
Is the instrument the back up of a product critical
the second one is business. The second is only used to trig
instrument and it hasn´t been installed to have a
a calibration on the first if different values are displayed. This
quality double check and it will be used just for
second sensor is not use for any other purpose, trend,
internal information
deviation….
EHS CRITICAL QUESTIONS
Does the instrument act as a final check against
the release of hazardous materials, waste or Discharge flowmeter in wastewater treatment plant.
sewage?
Does the instrument monitor a parameter that
could pose a possible adverse impact on human Oxygen sensor where liquid N2 is being used.
health?
Does the instrument monitor a parameter that Explosive gas sensor where flammable materials are being
could pose a risk of fire or explosion? stored.

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APPENDIX 3 – FLOWCHART FOR CONSIDERATIONS TO BE

TAKEN ON EVENT OF INSTRUMENT FAILURE

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APPENDIX 4 - DECISION TABLE FOR DEVIATION IMPACTS

X Measurement or calculated error between measurement and standard
AL Adjustment Limit
CT Calibration Tolerance
EQUIPMENT
BUSINESS
STATUS
RULES FOR
AS FOUND AS LEFT AFTER EXPLANATION / COMMENT
QUALITY
USAGE
MANAGEMENT
DECISION
GMP EQUIPMENT
No deviation Conform As found and As left all parameters correct
X< AL < CT X< AL < CT
generated (PASS) No comment.
Product critical sensors and/or qualification activities managed in C&M system

As Found: Adjustment limit greater than X,

As left: corrected
No deviation Conform
AL < X < CT X< AL < CT Adjustment actions need to be followed for
generated (PASS)
optimization purpose, not through deviation
system.
AL < CT < X
Deviation As Found: adjustment limit and Calibration
or
generated, Conform Tolerance greater than X, As left: corrected
no X< AL < CT
deviation level to (PASS)
measurement be assessed Deviation generated due to As Found
realized
As Found: adjustment limit greater than X,
As left: unable to correct but still within the
calibration tolerance
No deviation Not conform
AL < X < CT AL < X < CT Not conform status as probability to have
generated (FAIL)
an OOT is higher regarding current
frequency. No deviation requested but an
engineering investigation should be done
AL < CT < X
Deviation As Found: adjustment limit and Calibration
or Tolerance greater than X, As left: improved
generated, Not conform
no AL < X < CT to within adjustment limits
deviation level to (FAIL)
measurement be assessed Deviation generated due to As Found:
realized
AL < CT < X
As Found: adjustment limit greater than X,
or As left: unable to correct unit unserviceable
No deviation Not conform
AL < X < CT no generated (FAIL) Deviation are only generated on as-found
measurement result.
realized
AL < CT < X AL < CT < X
Deviation As Found: adjustment limit and Calibration
or or Tolerance greater than X, As left: unable to
generated, Not conform
no no deviation level to (FAIL) correct unit unserviceable
measurement measurement be assessed No comment.
realized realized
activities managed

For EHS/Business, status of equipment

EHS/ Business
sensors and/ or

in C&M system

follows same rules as for Product Critical.

qualification

No deviation generated as no impact on

FOR ALL CASES No deviation According to quality.
generated above decisions Adjustment actions & OOS results need to
be followed through appropriate KPI &
system for optimization purpose & EHS
actions, not though deviation system.

Deviation Deviation generated:

ALL

OVERDUE generated, Not conform or -Event if equipment is not in use

deviation level to expired -Deviation level to be assessed if
be assessed equipment is in use.
Non-GMP EQUIPMENT

For EHS/Business, status of equipment

FOR ALL CASES No deviation According to follows same rules as for Product Critical.
generated above decisions No deviation generated as no impact on
quality.
ALL

OVERDUE Adjustment actions & OOS results need to

Not conform or
be followed for optimization purpose & EHS
expired
actions, not though deviation system.

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APPENDIX 5 - AUDIT CHECKLIST

Appendix 5 is the Audit Check list which must be used.
An editable downloadable version of the Audit checklist can be found in the
Engineering Technical Library folder alongside this GES document.

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