Pfizer Biotechnology Ireland
A
B
Draft Standard Operating Procedure for Calibration
Pfizer Ireland Pharmaceuticals Maintenance Strategy
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ATTACHMENT F.1
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IPPC Licence Application
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IPPC Licence Application
MAINTENANCE SOP
PFIZER SMALL SCALE MONOCLONAL ANTIBODY FACILITY
SHANBALLY IRELAND
CALIBRATION POLICY
Document No:
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Draft
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This procedure is intended as an overview of the approach to equipment and instrument calibration at the
Shanbally MABS Small Scale Facility.
Role / Department
Name
Author
Engineering
Vincent Coleman
Reviewed By
Engineering
Declan J Murphy
Approved By
Engineering
Signature
Date
Liam OBrien
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Approval
Revision History
Document
Revision
Date
Name
Reason for Update
29/07/08
Vincent Coleman
Original
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IPPC Licence Application
TABLE OF CONTENTS
1.0
PURPOSE 4
2.0
SCOPE
3.0
APPLICABLE PERSONNEL
4.0
DEFINITIONS ACRONYMS AND SYMBOLS
5.0
RULES AND GUIDELINES 8
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Calibrations
8
Instrument Specifications
8
Records
9
Selection and Use of Calibration Standards
11
Calibration Instruction and Instruction Numbers 11
PM Schedule Codes
12
Calibration Labels
12
Instrument Tolerances 12
Calibration Certificates 12
Calibration Intervals
13
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5.1
5.2
5.3
5.4
5.5
5.6
5.7
5.8
5.9
5.10
SAFETY PRECAUTIONS 14
7.0
CREATING/MODIFYING INSRUMENT/PM/CALIBRATION INSTRUCTION RECORD
14
8.0
DEACTIVATING EQUIPMENT
15
9.0
ACTIVATING EQUIPMENT
16
10.0
REQUEST PM EXTENSION
16
11.0
PERFORMING CALIBRATIONS
17
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6.0
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IPPC Licence Application
1.0 PURPOSE
To provide an overview of the approach to instrument calibration at the Shanbally Small Scale
Facility (SSF), which establishes the requirements for calibration of equipment, instruments, and
standards used in production, storage, and testing that may affect the identity, strength, quality,
or purity of product.
2.0 SCOPE
This calibration procedure applies to the SSF, defining the responsibilities, criteria, and
documentation requirements for the calibration of equipment and instruments used on site.
Calibration of all production and facility equipment is included in the scope of the SOP.
Calibration of Laboratory equipment is excluded.
3.0 APPLICABLE PERSONNEL
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This procedure applies to all Pfizer colleagues and to contractors who request, perform or
approve calibration activities.
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4.0 DEFINITIONS ACRONYMS AND SYMBOLS
Calibration
Set of operations that establish, under specified conditions, the relationship between values of
quantities indicated by a measuring instrument or measuring system or values represented by a
material measure or a reference material, and the corresponding values realised by standards.
Calibration Interval
The interval, in days, between successive calibrations.
Calibration Instruction Number
The unique number assigned by the Calibration Co-Coordinator to a new calibration
task.
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Calibration Standard
This is the designated measuring equipment used routinely to calibrate or check
measuring instruments, or material measures. This is also referred to as Working
Standard, Transfer Standard or Reference Standard.
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Calibration Range
Specified range over which the instrument is calibrated. This should at least cover the
normal operating range.
cGMP
Current Good Manufacturing Practices.
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CMMS
Computerised Maintenance Management System. The integrated modular computerised
system used at the SSF to control all maintenance and calibration activities.
Calibration Co-ordinator
Responsible for the overall management of the plant calibration programme.
CMMS Administrator
Responsible for the CMMS administration of all maintenance related activities within the
plant.
Calibration Instructions
A set of instructions which describes the process for calibrating an instrument.
Device Input & Output Range
Range over which instrument is capable of measuring. Provided in manufacturers
specification.
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IPPC Licence Application
Environmental Critical Instruments
An instrument that is used to assure environmental compliance and which have
appreciated environmental implications if it fails on demand.
GMP Critical Instruments
Instruments used directly to manufacture, process, package and/or hold pharmaceutical
products or drug substances and as a result whose failure may directly affect product
quality.
Increment
Smallest difference between indications of a displaying device that can be meaningfully
distinguished.
Instrument/Standard ID Label
The label containing the Instrument/Standard ID Number.
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Instrument/Standard ID Number
The unique number assigned by the Calibration Co-ordinator to each loop or individual
instrument/standard that is not part of a loop.
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Loop Calibration
Calibration of a group of instruments connected together to monitor, or control a process
variable.
Non Critical Instruments
Instruments whose function is important to the operation or efficiency of parent
equipment but whose failure are deemed to have no effect on product quality
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Normal Operating Range (NOR)
Specified range within which the process NORMALLY operates.
Process Control Limit
The maximum allowable error in the measured reading within the process.
QAR Notification Form
A report generated to notify relevant personnel when GMP critical equipment is found
operating outside of design parameters.
Standard Calibration Label
The label containing the calibration information for a calibration standard.
Safety Critical Instruments
An instrument which is used to assure the safety of personnel and equipment and which
has appreciable safety implications if it fails on demand.
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Traceability
Property of the result of a measurement or the value of a standard whereby it can be
related to stated references, usually national or international standards, through an
unbroken chain of comparisons all having stated uncertainties.
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Unit Of Measure (UOM)
Unit Of Measure
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5.0 RULES AND GUIDELINES
5.1
Calibrations
5.2
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1. The Engineering Department is responsible for the administration of the Calibration System
and that the Calibration program is reviewed on an annual basis. A work order is generated in
the CMMS and the Engineering Department reviews the Calibration System.
2. All calibrations will be scheduled through the CMMS.
3. Calibrations will be loop calibrations where possible.
4. One record will be generated in the CMMS for each instrument or loop.
5. Where applicable the CMMS record will reference the P&ID tag number of the instrument or
loop and the instrument ID number as assigned by the calibration co-ordinator.
6. The instrument ID number will be assigned to the instrument or loop when the CMMS record
is generated.
7. Calibration shall be conducted at a minimum of three points (e.g. upper optional range, lower
optional range and NOR), if possible. For instruments that cannot be calibrated at three
points, the points to be included in the calibration shall be defined and justified.
8. Calibrations will be scheduled and performed in accordance with best calibration and cGMP
practices and applicable safety and environmental policies
9. Instruments will be calibrated over their device Input & Output range, where practical.
10. Where it is not practical to calibrate the instrument over the full range, the instrument must at
a minimum; be calibrated over the normal operating range.
11. Measurement instruments will be re-calibrated if dropped jarred or damaged.
12. Loop components must be individually calibrated prior to installation in the loop or in the
event of overall loop failure during routine calibration of the loop.
Instrument Specifications
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13. Instrument specifications shall be established prior to defining the calibration method for the
instrument and shall be based on the requirements of the application and specific
parameter(s) that the instrument is intended to measure.
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14. Instrument Specification shall include, and are not limited to:
Definition of required tolerance and precision
Expected process parameter values, including unit of measure
Expected NOR of the process parameter values.
Acceptable Tolerance
Instrument stability requirements
Safety and environmental consideration.
The instrument specification record shall be attached to the Instrument Change
Record Form. Prior to removing an instrument from service, a final calibration shall
be performed, if possible (i.e. instrument still functional), to verify that the
instrument is still within tolerance.
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IPPC Licence Application
Initial As found data shall be recorded prior to removing an instrument
from the calibration schedule, performing and upgrade, or before an
instrument is moved. If the instrument is not calibrated prior to a move, the
justification must be documented and approved by the site Quality Authority.
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15. Personnel requesting Corrective Maintenance for GMP instruments are responsible for
completing a QAR form and for releasing a CM work order, as applicable
16. Calibrations shall not be performed unless environmental conditions are suitable for both the
measurement equipment and the calibration standard used.
17. Where a PM is to be extended for greater than 30% of the PM frequency (either single or
cumulative extensions), QA approval must be obtained by opening a planned QAR.
18. Criticality determination for instruments is as per the following: GMP, Safety,
Environmental, GMP and Safety, GMP and Environmental and non-critical are CLS01,
CLS02, CLS03, CLS04, AND CLS09 respectively
19. Instruments will be considered overdue for calibration after the due date if the calibration has
not been completed. A calibration due-date extension may be granted provided that
reasonable assurances can be made based on the instrument calibration history and/or a
statement from the original equipment manufacturer that continued equipment use for a
limited time would not affect performance.
20. A QAR Notification (QAR) form must be completed if a GMP critical instrument is not
calibrated by the due date and the associated equipment is used to manufacturer product.
21. If a GMP critical instrument is found to be out of tolerance, a QAR must be initiated and
must include a product quality impact assessment carried out in conjunction with the
process/manufacturing owner and the person performing the calibration.
22. A full instrument criticality assessment must be made for all new instruments.
23. New equipment will be tagged Do Not Use until the criticality status and calibration
requirements of instruments associated with it are evaluated.
24. Instruments already classified as Non Critical are calibrated at the sole discretion of
engineering.
25. Stationary instruments must be re-calibrated after movement.
26. Any instrument that has been repaired must be re-calibrated before being returned to service.
27. Trained personnel only will carry out calibrations and are detailed on file with HR (Human
Resources) and the Calibration Co-Ordinator.
28. Learning records will be maintained for all personnel engaged in performing and
administering the calibration program.
29. Calibrations performed by vendors or contract services must meet the requirements of this
document.
30. Vendors to be reviewed and audited as deemed necessary by the site quality authority.
31. Vendors/contractors must have procedures that assure the accuracy and traceability of their
reference and test equipment.
32. All efforts should be made to keep instruments as accurate as possible. Thus instruments
should be adjusted even if within tolerance but approaching the limits.
33. Individual calibration tasks must be maintained for each instrument calibrated. These tasks
can be a guideline described in the manufacturers manual or written procedures that may be
contained in CMMS.
5.3
Records
34. An instrument record must be maintained for each loop or instrument. The instrument record
must provide sufficient information to set up a replacement loop and/or instrument, if
necessary.
35. For original loop records, hard copies of the element/transmitter certificates will be attached
and filed with the original loop calibration certificate in the QA DCC (document control
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36.
37.
centre). All subsequent loop calibration certificates will be filed with these. This file will be
the record for loops and the loop components.
The calibration files will be organised by Instrument ID number.
A calibration certificate will be completed for each calibration carried out and then filed in
the calibration files.
Calibration intervals will be specified in days.
The next due date for calibration will be calculated from the date done.
All calibration activities must be recorded in the relevant Equipment Logbook.
The instrument or loop record must include the following
Instrument ID number
Instrument or loop description
System number that the instrument or loop is part of (as applicable)
Criticality
P & ID tag number of the instrument or loop
Date last calibrated ( as applicable)
Type
Manufacturer
Model number
Serial number
Location
Device Input/Output range
Calibration Failure Limit
Device
or loop calibration interval
Calibration Instruction reference
Operating range ( where applicable)
Process Control Limit (where applicable)
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38.
39.
40.
41.
Pfizer Monoclonal Antibodies Small Scale Facility
IPPC Licence Application
Nominal Test points
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Note: Prefixes relating to nominal test points for weigh scales include:
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CTR: Centre (Point)
FRT: Front Right (Load cell)
FLT: Front Left (Load cell)
BRT: Back Right (Load cell)
BLT: Back Left (Load cell)
RPT: Repeatability (Test)
The point of reference for the load cell locations being the local indicator.
42. For in-house standards, a calibration certificate shall be prepared based on supporting
raw data. The certificate shall include, and not be limited to:
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Description of standard
Date the standard was established
Signature of the person preparing the standard
Date standard must be recertified or replaced
Handling or storage conditions for the standard
Reference to a method or task used to establish the standard
Accuracy and precision of the standard.
5.4
Selection and Use of Calibration Standards
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43. Standards used for calibrating measurement equipment will have the capability for accuracy,
stability and range needed for their intended use.
44. The calibration standard must always be more accurate than the instrument under test. Where
possible the uncertainty ratio should be 1:4. Where this is not practical, a less accurate
standard may be used with the approval of site QA.
45. Calibration certificates will support all calibration standards used in the calibration system.
Certificates for Pfizer standards will be filed in Pfizer document control. Certificates for
contractor standards must be available on request.
46. A calibration standard, when not in use, shall be stored in a secure manner which prevents
unauthorised adjustment.
47. Standards must be safe to operate in the specific process area in which the equipment is
being used. Ensure the standards are clean prior to use to prevent Cross Contamination.
48. The storage environment shall meet the standards storage requirement.
49. Calibration Standards used in calibrating measurement equipment will be: Traceable to one
or more of the following; the National Institute of Standards and Technology (NIST), the
National Physical Laboratory U.K. (NPL), the United Kingdom Accreditation Service
(UKAS), the National Standards Authority of Ireland (NSAI) or equivalent institutes.
50. Where applicable all calibration standards must be added to a Portable Appliance Testing
(PAT) schedule.
5.5
Calibration Instruction and Instruction Numbers
51. An instruction for the calibration of each type of Instrument (e.g. pressure gauge,
temperature transmitter, flow meter) shall be reviewed and approved by the system
expert/designee to ensure that the instructions are technically correct and are approved by the
site Quality Authority, Environmental Health and Safety principles shall be consulted if
required.
The format for Calibration Instruction numbers is:
CI-sequential number-revision number
For example, the first revision of the fiftieth calibration instruction would be
numbered: CI-0050-01.
Instructions will be filed in equipment files or calibration task files under calibration
instruction number.
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PM Schedule Codes
52. A PM schedule code will have the same code as the instruction code to which it is linked to
in CMMS.
5.7
Calibration Labels
53. Calibrate before use: the calibration label used for all calibrated loops or instruments that
must be calibrated before use. It contains the calibration date, signature of the person
performing the calibration, and the required calibration interval.
54. Do not use: the label attached to a loop or instrument that has not been calibrated, is over-due
for calibration, is not operating correctly, or must not be used for other reasons.
55. Instrument ID Labels: for loops, the Instrument ID label will be attached as close as
practicable to the measuring element of the loop.
56. An instruction for the calibration of each type of Instrument (e.g. pressure gauge,
temperature transmitter, flow meter) shall be reviewed and approved by the system
expert/designee to ensure that the instructions are technically correct and are approved by the
site Quality Authority, Environmental Health and Safety principles shall be consulted if
required.
5.8
Instrument Tolerances
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57. Loop and instrument calibration tolerances will be based on manufacturers'
recommendations, process requirements, and stability of the instrument, purpose and
accuracy and/or historical calibration data for similar instruments.
58. Loop tolerances will be based on the cumulative effect of the individual component
accuracies, taking into account the resolution of the display.
For example:
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Sensor 0.25C,
Transmitter 0.05C,
Input card 0.1C,
Display reads out in 0.5C increments,
Loop tolerance should be 1C.
5.9
Calibration Certificates
59. A calibration certificate must be completed for each calibration carried out.
60. The calibration record must include the following:
Instrument ID number
Instrument or loop description
Manufacturer
Model
Serial Number
Location
Device Input/Output Range
Calibration Failure Limit
Nominal test points
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Calibration interval
Calibration Instruction reference
Reference standards used for calibration, identification number and
calibration due date.
As found calibration data
As left calibration data, if applicable
Reference to QAR Form, if applicable
Instrument criticality
Signature of person performing the calibration
Date of calibration
Signature of person approving the calibration
Date of approval
Comments
Calibration Intervals
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61. Calibration intervals will be specified in days.
62. The next due date will be calculated, in days, from the date done.
63. Calibration intervals will be based on manufacturers' recommendations, stability of the
instrument, and consequence of calibration failure, purpose and accuracy and/or historical
calibration data for similar instruments.
64. Calibration interval must not exceed 365 days for instrument classified as GMP critical.
65. A calibration interval may be lengthened if the instrument or loop remains within tolerance,
without adjustment, for 3 successive calibrations.
66. A calibration interval may be shortened as a corrective action or part of one if the instrument
or loop is outside tolerance for two successive calibrations.
67. The new interval should be half the previous interval and cannot be less than 1 day, except
where instruments are designated as Calibrate Before Use.
Note: corrective actions to instrument failure are treated on an individual basis based on the
instruments criticality, use within the process, and closeness to the product, current tolerance
and previous calibration history.
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6.0 SAFETY PRECAUTIONS
Ensure you read the relevant Risk Assessments
7.0 CREATING/MODIFYING
INSRUMENT/PM/CALIBRATION INSTRUCTION
RECORD
Person
Step
Action
Responsible
Project/request
1.
originator
Tag the instrument appropriately to prevent its use until equipment
maintenance and validation/qualification determinations can be
2.
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completed. Note this step is only applicable for Instrument entry
Complete the Entry/Change form and issue to the Engineering
dept.
Engineering
3.
Review information and issue to relevant approvers.
Relevant
4.
Review and, if acceptable, approve request and return to CMMS
5.
Administrator
Project/request
originator
Enter relevant data from Record Entry/Change form into CMMS
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CMMS
administrator.
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Approver
and return paperwork to originator.
6.
Verify that equipment is appropriately tagged with correct
equipment code (only applicable for Instrument entry/changes) and
file paperwork in DCC.
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8.0 DEACTIVATING EQUIPMENT
Person
Step
Action
Responsible
Request
1.
Originator
Identify the equipment to be de-activated and tag it Deactivated
If
Then
Scrapping Equipment
Raise a calibration work
order in order to calibrate the
instrument prior to removal.
Dispose of it
appropriately and inform the
finance department.
Taking out of service
temporarily
order in order to calibrate the
Raise a calibration work
Calibration Coordinator
2.
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instrument prior to removal.
Prepare the equipment as
necessary, for inactive period.
Deactivate the equipment and associated PM schedules in CMMS as
appropriate.
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/Designee
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9.0 ACTIVATING EQUIPMENT
Request
1.
Originator
Calibration Co-
Raise a Calibration work order in order to calibrate the instrument prior to
installation.
2.
Activate the equipment and associated PM schedules in CMMS.
ordinator
/Designee
10.0 REQUEST PM EXTENSION
Person
Step
Action
Responsible
1.
Contact engineering with request for extension
Engineering
2.
Make determination on validity of request and amend target date as
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Requestor
appropriate.
3.
Record justification in comments section of work order and where
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appropriate seek approval by QA.
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11.0 PERFORMING CALIBRATIONS
Person
Step
Action
Responsible
Calibration Co-
1.
Release a work-order for the scheduled calibration.
ordinator /
2.
Distribute the work-order to the colleague responsible for the calibration.
designee
3.
Apply for an extension to the work order, if the calibration cannot be
completed by the due date.
If
Then
Extension is granted
The calibration must be completed by
the revised due date & the calibration
label must be replaced.
Tag equipment DO NOT USE on the
.
Extension is rejected
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calibration due date and until calibration
Technician
4.
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is completed.
Follow the calibration instruction attached to or referenced by the workorder.
5.
Complete the calibration record and ensure that each person involved in
the work signs the form. Attach a calibration label showing the instrument
Notify an area rep which instrument was worked on and where possible
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6.
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ID number, calibration date, next due date and initials.
request an equipment dry run prior to returning equipment to normal
operation. (only applicable when calibrating a critical parameter)
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Step
Action
Responsible
Technician
7.
Enter the calibration data into CMMS.
If
Then
As-found data is
un-acceptable and the
accordance with SOP DEV-1002
instrument is GMP critical
Event and Deviation System.
Complete a QAR form in
When entering data into the
CMMS, enter the QAR number in
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the work order Comments field.
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Technician
As-left data is un-
acceptable
and seek a replacement.
Tag equipment DO NOT USE
If replacement is like for like
follow the procedure,
Creating/Modifying Instrument records
in the Calibration Program outlined in
this SOP. Record the calibration results
for the replacement instrument in the
left results section of the certificate.
Enter the serial number of the original
and replacement instrument on the
work order. Clearly identify that the
replacement was carried out in the
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comments section of the work order.
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like change, complete a change
request form (CRF) and enter the CRF
number in the comments section on the
work order. Request the calibration coordinator / designee to remove the
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existing instrument, and setup the
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replacement as per Creating/Modifying
instrument records in the calibration
program
8.
Record calibration work in appropriate Equipment logbook.
9.
Forward the completed Calibration Record to the Calibration Coordinator/ Designee for approval.
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10. Review the Calibration record and ensure the calibration was carried out
ordinator /
in accordance with the task associated with the instrument. Confirm that
Designee
the data on the record is accurate and corresponds to the data entered into
the CMMS.
11. Approve the calibration work order.
12. Forward the completed calibration records to the QA Document Control
Centre (DCC). Scheduled calibrations are filed by Instrument ID number.
13. Monitor the completion of calibrations throughout the scheduled period to
notify relevant colleagues if calibrations are overdue.
Generate the following report.
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15.
Facilitate the execution of calibrations throughout the facility.
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14.
A weekly Calibration due report to review all overdue
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and due calibrations for the coming month.
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Pfizer Ireland Pharmaceuticals
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PIP Maintenance Strategy
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Revision 1
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Table of Contents
Section
Description
Page
1.0
Vision
2.0
Purpose
3.0
Scope
4.0
Regulatory Compliance & Environmental, Health and
Safety
Organisation and Administration
6.0
Responsibilities
7.0
Partnerships
8.0
Asset Management
9.0
Work Control Systems
10.0
Work Planning and Scheduling
11.0
Reliability Plans
12.0
Predictive and Preventive Maintenance
13.0
Maintenance Metrics
10
14.0
Materials Management
11
15.0
Cost Management
11
16.0
Maintenance Interface
12
17.0
Maintenance Evaluation and Continuous Improvement
12
18.0
Training and Development
12
19.0
Maintenance Teams and Knowledge Sharing
13
20.0
Communication
13
21.0
Abbreviations
14
22.0
Approvals
15
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5.0
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1.0 Vision
The Global Maintenance Initiative is outline as follows:
Program to implement Reliability Based Maintenance practices consisting of assessments, master
planning, training, tool implementation, and continuous improvement.
The PIP Maintenance Team will ensure alignment with the global GMI vision by means of the following:
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Develop processes to enable Continuous Improvement of all aspects of Maintenance as a
Business; through the use of both RFT and GMI tools.
Utilise a data driven approach to enhance the quality and compliance of maintenance operations.
Ensure safety of colleagues and facilities through effective and compliant operation of
maintenance activities.
Promote leadership in maintenance departments and increase job satisfaction
Engage with other functions across product Value Streams to ensure Maintenance continues to
deliver value and ensure strong customer service.
Maintenance functions will deliver cost savings to the overall business in PIP.
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2.0 Purpose
This strategy document outlines the elements for performing maintenance at all Pfizer Ireland
Pharmaceutical Facilities.
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This document is intended to put the processes in place to allow Pfizer Ireland Pharmaceuticals to strive
towards maintenance excellence for the purpose of supporting operational excellence through equipment
reliability, compliance and safety whilst utilising resources in an effective and efficient manner.
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The expected outcomes of this strategy include:
Optimised asset life cycle costing and overall equipment effectiveness. (OEE)
Reliability plans based on reliability practices and techniques.
Reduced risk in areas including regulatory compliance, environmental, health and safety.
Improved organisational effectiveness and engagement of maintenance colleagues.
Managing maintenance as a business based on metrics, monitoring and reporting.
Effective cost management
Effective partnering between maintenance and operations.
Increased sharing of knowledge and expertise across Pfizer Ireland Pharmaceuticals
Alignment with Right First Time (RFT)
Continuous improvement
3.0 Scope
This document applies to the following at all Pfizer Ireland Pharmaceuticals Facilities
Site Engineering/Maintenance Teams
Equipment Owners
Operations
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Site Leadership Teams
Right First Time
Quality Operations
EHS
4.0 Regulatory Compliance & Environmental, Health and Safety
Maintenance activities performed by internal and external parties must be developed, planned and
executed in compliance with all regulatory guidelines, standards and policies.
Maintenance teams should promote a safe, compliant and clean working environment. Quality and
compliance should be addressed in the execution of all maintenance activities. Furthermore, contingency
plans must be in place to deal with unexpected adverse events.
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These plans shall be developed in partnership with operations and communicated to all stakeholders.
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5.0 Organisation and Administration
All maintenance roles should be clearly defined and documented.
Resource plans should be developed from metrics to determine staffing levels and shift allocations.
Insourcing/outsourcing decisions should be based upon customer requirements, core competencies,
associated risks, local market conditions and other relevant factors.
6.0 Responsibilities
Leadership:
Leadership should promote reliability based maintenance concepts to Operations and across site
partnerships
Engineering
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and maintenance leaders are responsible for communicating the maintenance
strategy to their maintenance teams, applying the strategy and setting maintenance performance
objectives.
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Site Maintenance Teams:
The site maintenance teams shall be responsible for the following:
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Ensure that planned equipment maintenance and calibrations are performed in a timely manner to
prevent unplanned failure of critical equipment and ensure compliance with regulatory
requirements.
Perform corrective actions to correct equipment failures, prevent potential equipment failures and
ensure equipment safety.
Perform root cause failure analysis on equipment failures.
Continuous improvement in maintenance activities through equipment modification, PM
optimisation, introduction of reliability techniques and implementation of RFT techniques.
Maintaining the CMMS system to ensure that equipment, instruments, maintenance schedules,
personnel and spare parts are correctly set up and maintained.
Development of asset care plans for new equipment.
Ensure that colleague training, development and performance management systems are in place
and effectively delivered.
Ensure that training plans are based on an overall training program that is developed in
conjunction with the needs of the business and maintenance colleagues.
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Project Engineering:
Project Engineering shall be responsible for
Providing relevant details for set up of equipment on the CMMS system.
Engaging with maintenance colleagues for design and selection of new equipment.
Providing necessary handover documents for equipment.
Engaging in the development of asset care plans for new equipment.
Equipment Owners:
Equipment owners shall be responsible for
Notification to maintenance of equipment issues that may affect the reliability of that
equipment.
Engage in RCM, FMEA and RCFA activities in relation to the equipment.
Operations:
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The operations team are responsible for
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7.0 Partnerships
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Operating equipment in a manner that supports reliability
Monitoring equipment operation and highlighting potential issues that may impact on
equipment performance
Liaising with the maintenance planner and scheduler to ensure that the production schedule
aligns with the maintenance schedule so that planned maintenance and calibrations can be
performed within their required target dates
Engaging in RCM, FMEA & RCFA activities in relation to equipment
Equipment reliability and maintenance excellence is dependant on the partnerships between site
maintenance teams, equipments owners and equipment operators. Partnership agreements will ensure that
all stakeholders understand their role in the maintenance excellence process.
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Partnership agreements shall contain the following:
Operations expectations of maintenance
Response times to emergency situations
Production Support requirements
Use of RCFA to eliminate recurring issues
Measures of reliability
Optimisation of planned maintenance activities to reduce impact of maintenance on equipment
availability
Prioritisation of work
Maintenance expectations of operations
Methods of reporting equipment issues
Agreements for equipment downtime to perform maintenance
Identification of potential equipment issues
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Engagement in RCFA for recurring issues
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8.0 Asset Management
Assets shall be uniquely identified using an identification scheme structured into asset classes based on
equipment characteristics.
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All maintenance activities performed on an asset whether performed internally or externally, planned or
unplanned shall be recorded in the CMMS to ensure a complete and accurate asset history.
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9.0 Work Control Systems
A computerised maintenance management system (CMMS) shall be deployed to ensure proper work
control, regardless of who actually executes the work. The CMMS is essential for scheduling work and
resources, gathering equipment history reports for improvement purposes and managing maintenance
costs.
The work orders generated from the CMMS will contain sufficient information to enable a standardised
workflow that moves through eight phases: Request, Confirm, Plan, Schedule, Execute, Completion,
Review and Close out.
Approvals at the appropriate stages in the process shall ensure the quality and cost effectiveness of the
process.
Work Order Types:
Work order types are categorised as follows
Planned preventive work: This is work that is placed on a work schedule based on timed intervals or
equipment usage. This work is performed so that potential issues can be addressed prior to those issues
causing an unplanned equipment failure.
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Planned corrective work: This is corrective work that has been identified that could cause a potential
unplanned equipment failure but the potential failure is not imminent and this corrective work can be
placed on the work backlog and planned and scheduled.
Emergency Work: This is work that is required to be performed immediately to prevent failure or
restore operation of critical equipment.
Production Support Work: This is non repair work that is required to support the production operation
such as line set up, equipment operation assistance, scheduling assistance, etc.
Calibration: Periodic instrument calibrations.
Administration: Non repair work such as data retrieval, training, meeting attendance, etc.
CBM / Predictive: Work carried out utilising technologies that will monitor equipment performance and
identify potential failures based on results.
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10.0 Work Planning and Scheduling
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Maintenance work planning and scheduling is essential for maintenance excellence and brings benefits in
terms of efficiencies through having work available for maintenance resources.
The role of the maintenance planner and scheduler is to develop job plans for planned work to include
task lists, spare parts requirements, special tools required, work prioritisation and resource requirements.
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The planner and scheduler shall also be responsible for liaising with maintenance supervisors and
operations to ensure that equipment and resources are made available for routine maintenance to be
performed, ensuring that equipment is reliable and regulatory and statutory are met.
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11.0 Reliability Plans
Reliability plans shall be developed in accordance with the Pfizer Ireland Pharmaceutical reliability
strategy (*TO BE DEVELOPED)
The reliability plans shall incorporate reliability based maintenance principles, namely:
Asset identification
Criticality assessment
Asset performance standards and requirements
Determination of failure modes and effects
Periodic evaluation and continuous improvement.
Reliability plans are the specific tasks performed on an asset. These plans shall address all elements of
asset utilisation and performance including quality, safety, environmental protection, uptime
requirements and throughput.
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Criticality assessment tools shall be utilised for assets, this provides the basis for the reliability plan of an
asset.
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Periodic reviews of criticality assessments and reliability plans shall be performed and any modification
or usage change of an asset shall also trigger a review of the criticality assessment and reliability plan.
12.0 Predictive (PdM) and Preventive (PM) Maintenance
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Proactive maintenance activity shall be promoted by maintenance teams. Inspections based on actual
measurements and data are preferred because they are typically more effective than those based on a
technicians senses.
Predictive maintenance techniques are most effective and shall be utilised where possible. These
techniques are intended to identify the onset of a specific failure mode objectively through the
monitoring, measuring and trending of changes in equipment condition.
Vibration analysis, ultrasonics, thermography and electrical circuit evaluation are among the most
common PdM tools that can be applied by maintenance teams.
In addition, preventive maintenance practices such as inspection, adjustment, cleaning and lubrication
shall be utilised in the reliability plan.
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13.0 Maintenance Metrics
Metrics will allow the maintenance team and partners to evaluate performance and target areas of
opportunity for continuous improvement in equipment reliability and maintenance processes.
Maintenance metrics are essential in the approach of managing maintenance as a business in order to
provide the best value to our partners and customers.
Maintenance Metrics can be divided into three categories:
1: PGE Core Metrics These are metrics that have been pre-defined by the Global Maintenance Team as
base metrics for a maintenance organization. The purpose of these metrics is to assist in strategical
decision making at a global, PIP and local level. These metrics are reported monthly to ILT, PGE,
Engineering Team Leaders and Maintenance Team Leaders. These metrics are also generally shared with
maintenance organisations elsewhere in the globe for knowledge sharing purposes. (*METRICS TO BE
DEFINED)
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2: PIP Additional Metrics These metrics are defined by the PIP maintenance team leaders as metrics
that would provide benefit for the operating environment of the PIP Sites. The purpose of these metrics is
to assist in strategic decision making at a PIP and local level. These metrics are reported monthly to ILT,
PGE, Engineering Team Leaders and Maintenance Team Leaders. (*METRICS TO BE AGREED BY
MTLs)
3: Site Specific Metrics These are metrics that may be defined at a site level and are relevant to the site
maintenance teams specific needs. These metrics are recorded at the discretion of the site and are utilised
to assist in tactical decision making in relation to equipment reliability and maintenance processes.
Site specific metrics may include but should not be limited to the following:
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OEE Measurement
Maintenance Cost Reports (By site, department and asset)
Past Due Work
Backlog Measurement
Percent Production Support
Stock outs of critical spares
Environmental releases attributable to maintenance
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14.0 Materials Management
An effective materials management program is necessary to ensure the availability and delivery of parts,
tools, equipment and materials for the execution of the reliability plans.
This program balances inventory levels and the cost of inventory. It also ensures suppliers are managed
to provide Pfizer Ireland Pharmaceuticals with the best possible supply agreements.
Where possible, the Ireland sites should regionalise stockrooms and/or leverage availability of parts and
suppliers.
The materials management program shall address items including:
Material identification and storage
Inventory management
Controls
Replenishment systems
Stock codes linked to assets
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15.0 Cost Management
Budgets shall be developed based upon predetermined maintenance activities including preventive
maintenance, historical levels of unplanned maintenance, customer support requirements, materials, tools
and equipment needs etc.
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The EMU cost template shall be used as a tool to capture and trend costs. Cost tracking and reporting
shall be performed on a monthly basis and compared against targets and benchmarks.
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Cost data collected as the asset level is preferred as it can be used to aid decisions to repair, refurbish or
replace the asset.
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16.0 Maintenance Interfaces
Maintenance organisations are partners in the operations that they support, it is expected that
maintenance teams will have regular communications and meetings with their partners.
Reliability plans shall be reviewed with the asset owners to establish appropriate service levels and user
requirements.
17.0 Maintenance Evaluation and Continuous Improvement
Continuous improvement is enabled by measuring performance, setting improvement goals, tracking and
reporting progress towards those goals.
Pfizer Ireland Pharmaceutical maintenance teams will measure, track and report key performance metrics
as recommended by the Global Maintenance Team.
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Metrics must be made visible to operations and be well understood by all maintenance colleagues.
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Regular assessments of maintenance operations shall be conducted to identify progress against each sites
maintenance master plans, good practices and external benchmarks.
18.0 Training & Development
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All maintenance colleagues will be competent and qualified to perform their duties through a
combination of their education, training and experience. There will be documented evidence available
for each individuals training status. Required training for the job will be identified through a job function
curricula which will be available for each job position. Colleagues will be responsible for ensuring they
are adequately trained prior to undertaking any task.
Every colleague will be encouraged to identify developmental opportunities to enhance their skills and
qualifications; this will be done with the support of maintenance leadership.
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Pfizer Biotechnology Ireland
Pfizer Monoclonal Antibodies Small Scale Facility
IPPC Licence Application
19.0 Maintenance Teams and Knowledge Sharing
To leverage the depth and breath of maintenance knowledge at Pfizer Ireland Pharmaceuticals,
maintenance teams shall be established and will regularly meet to share experiences and knowledge.
Leveraging items such as criticality assessments, toolkit applications such as PM optimisation, planning
and scheduling, supply and service agreements etc, is essential to strive towards a maintenance
excellence organisation.
The PIP maintenance leaders team shall work together on tactical implementation of their goals and
objectives and stay closely linked to the Global Maintenance Team.
Individual maintenance team leaders are expected to support the Ireland Maintenance Team by:
Participating in meetings
Staying abreast of activities
Providing input in the form of good practices, learnings etc
Utilising communications vehicles such as E-room/Sharepoint.
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20.0 Communications
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Communications vehicles shall be used to keep all stakeholders informed and to seek feedback on all
maintenance activities at each Ireland site. Communications processes between maintenance teams will
be essential to promote knowledge sharing, good practices and successes. Communications at site,
regional, area and global levels should be utilised.
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Pfizer Biotechnology Ireland
Pfizer Monoclonal Antibodies Small Scale Facility
IPPC Licence Application
21.0 Abbreviations
CBM
CONDITIONED BASED MONITORING
CMMS
EHS
COMPUTERISED MAINTENANCE
MANAGEMENT SYSTEM
ENGINEERING MAINTENANCE AND
UTILITIES
ENVIRONMENTAL, HEALTH AND SAFETY
FMEA
FAILURE MODE AND EFFECTS ANALYSIS
OEE
OVERALL EQUIPMENT EFFECTIVENESS
PdM
PREDICTIVE MAINTENANCE
PIP
PFIZER IRELAND PHARMACEUTICALS
PM
PLANNED MAINTENANCE
RCFA
ROOT CAUSE FAILURE ANALYSIS
RCM
RELIABILITY CENTRED MAINTENANCE
RFT
RIGHT FIRST TIME
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EMU
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Pfizer Biotechnology Ireland
Pfizer Monoclonal Antibodies Small Scale Facility
IPPC Licence Application
22.0 Approvals
Approved By/Date:
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Eugene O Callaghan, GMI Facilitator
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Michael Cohalan, MTL Ringaskiddy
Approved By/Date:
Approved By/Date:
_________________________________
Michael Cleere, ETL LIAPI
_________________________________
Ryan Cleary, ESM Dublin
Approved By/Date:
Approved By/Date:
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Author/Date:
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Jim Conway, MTL LOAPI
Approved By/Date:
Approved By/Date:
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Michael Boyle, ETL Sponsor
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Jim Brinkman, PGE Sponsor
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Tom Dineen, FCO LODP
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