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MAINTENANCE SOP Calibration Policy Pfizer
MAINTENANCE SOP Calibration Policy Pfizer
MAINTENANCE SOP Calibration Policy Pfizer
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MAINTENANCE SOP
PFIZER SMALL SCALE MONOCLONAL ANTIBODY FACILITY
SHANBALLY IRELAND
CALIBRATION POLICY
Document No:
Draft
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This procedure is intended as an overview of the approach to equipment and instrument calibration at the
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Shanbally MABS Small Scale Facility.
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Revision History
Document
Revision Date Name Reason for Update
1 29/07/08 Vincent Coleman Original
TABLE OF CONTENTS
1.0 PURPOSE 4
2.0 SCOPE 4
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5.6 PM Schedule Codes 12 ru
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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.
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approve calibration activities. ru
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Calibration Interval
The interval, in days, between successive calibrations.
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 ru
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Specified range over which the instrument is calibrated. This should at least cover the
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cGMP
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CMMS
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system used at the SSF to control all maintenance and calibration activities.
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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.
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.
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 ru
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variable.
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equipment but whose failure are deemed to have no effect on product quality
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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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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
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11. Measurement instruments will be re-calibrated if dropped jarred or damaged.
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12. Loop components must be individually calibrated prior to installation in the loop or in the
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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
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14. Instrument Specification shall include, and are not limited to:
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calibrated by the due date and the associated equipment is used to manufacturer product.
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21. If a GMP critical instrument is found to be out of tolerance, a QAR must be initiated and
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must include a product quality impact assessment carried out in conjunction with the
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22. A full instrument criticality assessment must be made for all new instruments.
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23. New equipment will be tagged “Do Not Use” until the criticality status and calibration
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24. Instruments already classified as Non Critical are calibrated at the sole discretion of
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engineering.
25. Stationary instruments must be re-calibrated after movement.
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26. Any instrument that has been repaired must be re-calibrated before being returned to service.
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27. Trained personnel only will carry out calibrations and are detailed on file with HR (Human
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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
centre). All subsequent loop calibration certificates will be filed with these. This file will be
the record for loops and the loop components.
36. The calibration files will be organised by Instrument ID number.
37. A calibration certificate will be completed for each calibration carried out and then filed in
the calibration files.
38. Calibration intervals will be specified in days.
39. The next due date for calibration will be calculated from the date done.
40. All calibration activities must be recorded in the relevant Equipment Logbook.
41. 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
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Note: Prefixes relating to nominal test points for weigh scales include:
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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:
• 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.
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46. A calibration standard, when not in use, shall be stored in a secure manner which prevents
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unauthorised adjustment.
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47. Standards must be safe to operate in the specific process area in which the equipment is
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being used. Ensure the standards are clean prior to use to prevent ‘Cross Contamination’.
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48. The storage environment shall meet the standard’s storage requirement.
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49. Calibration Standards used in calibrating measurement equipment will be: Traceable to one
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or more of the following; the National Institute of Standards and Technology (NIST), the
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National Physical Laboratory U.K. (NPL), the United Kingdom Accreditation Service
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(PAT) schedule.
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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.
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.
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recommendations, process requirements, and stability of the instrument, purpose and
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accuracy and/or historical calibration data for similar instruments.
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58. Loop tolerances will be based on the cumulative effect of the individual component
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For example:
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Sensor ± 0.25°C,
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Transmitter ± 0.05°C,
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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
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62. The next due date will be calculated, in days, from the date done.
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instrument, and consequence of calibration failure, purpose and accuracy and/or historical
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64. Calibration interval must not exceed 365 days for instrument classified as GMP critical.
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65. A calibration interval may be lengthened if the instrument or loop remains within tolerance,
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66. A calibration interval may be shortened as a corrective action or part of one if the instrument
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7.0 CREATING/MODIFYING
INSRUMENT/PM/CALIBRATION INSTRUCTION
RECORD
Person Step Action
Responsible
Project/request 1. Tag the instrument appropriately to prevent its use until equipment
originator maintenance and validation/qualification determinations can be
completed. Note this step is only applicable for Instrument entry
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Approver administrator.
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CMMS 5. Enter relevant data from Record Entry/Change form into CMMS
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Prepare the equipment as
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ordinator appropriate.
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/Designee
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Engineering 2. ru
Make determination on validity of request and amend target date as
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appropriate.
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calibration due date and until calibration
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is completed.
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order.
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5. Complete the calibration record and ensure that each person involved in
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the work signs the form. Attach a calibration label showing the instrument
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6. Notify an area rep which instrument was worked on and where possible
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Calibration Co- 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.
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Table of Contents
1.0 Vision 3
2.0 Purpose 3
3.0 Scope 4
4.0 Regulatory Compliance & Environmental, Health and 4
Safety
5.0 Organisation and Administration 5
6.0 Responsibilities 5
7.0 Partnerships 6
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8.0 Asset Management 7
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1.0 Vision
The Global Maintenance Initiative is outline as follows:
The PIP Maintenance Team will ensure alignment with the global GMI vision by means of the following:
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2.0 Purpose
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This strategy document outlines the elements for performing maintenance at all Pfizer Ireland
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Pharmaceutical Facilities.
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This document is intended to put the processes in place to allow Pfizer Ireland Pharmaceuticals to strive
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towards maintenance excellence for the purpose of supporting operational excellence through equipment
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reliability, compliance and safety whilst utilising resources in an effective and efficient manner.
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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
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.
These plans shall be developed in partnership with operations and communicated to all stakeholders.
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6.0 Responsibilities
Leadership:
Leadership should promote reliability based maintenance concepts to Operations and across site
partnerships
Engineering 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:
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Ensure that planned equipment maintenance and calibrations are performed in a timely manner to
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prevent unplanned failure of critical equipment and ensure compliance with regulatory
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requirements.
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Perform corrective actions to correct equipment failures, prevent potential equipment failures and
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Project Engineering:
Equipment Owners:
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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Monitoring equipment operation and highlighting potential issues that may impact on
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equipment performance
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Liaising with the maintenance planner and scheduler to ensure that the production schedule
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aligns with the maintenance schedule so that planned maintenance and calibrations can be
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7.0 Partnerships
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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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8.0 Asset Management ru
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Assets shall be uniquely identified using an identification scheme structured into asset classes based on
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equipment characteristics.
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All maintenance activities performed on an asset whether performed internally or externally, planned or
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unplanned shall be recorded in the CMMS to ensure a complete and accurate asset history.
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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.
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.
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.
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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Maintenance work planning and scheduling is essential for maintenance excellence and brings benefits in
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terms of efficiencies through having work available for maintenance resources.
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The role of the maintenance planner and scheduler is to develop job plans for planned work to include
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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
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operations to ensure that equipment and resources are made available for routine maintenance to be
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performed, ensuring that equipment is reliable and regulatory and statutory are met.
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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.
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
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or usage change of an asset shall also trigger a review of the criticality assessment and reliability plan.
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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
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technician’s senses.
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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, ultrasonic’s, 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.
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)
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
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3: Site Specific Metrics – These are metrics that may be defined at a site level and are relevant to the site
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maintenance teams specific needs. These metrics are recorded at the discretion of the site and are utilised
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to assist in tactical decision making in relation to equipment reliability and maintenance processes.
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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)
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Backlog Measurement
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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.
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Budgets shall be developed based upon predetermined maintenance activities including preventive
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maintenance, historical levels of unplanned maintenance, customer support requirements, materials, tools
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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
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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.
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.
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
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All maintenance colleagues will be competent and qualified to perform their duties through a
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combination of their education, training and experience. There will be documented evidence available
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for each individuals training status. Required training for the job will be identified through a job function
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curricula which will be available for each job position. Colleagues will be responsible for ensuring they
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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.
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 leader’s 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, learning’s 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
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maintenance activities at each Ireland site. Communications processes between maintenance teams will
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be essential to promote knowledge sharing, good practices and successes. Communications at site,
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21.0 Abbreviations
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OEE OVERALL EQUIPMENT EFFECTIVENESS ru
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PM PLANNED MAINTENANCE
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22.0 Approvals
_________________________________ _________________________________
Eugene O’ Callaghan, GMI Facilitator Michael Cohalan, MTL Ringaskiddy
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_________________________________ _________________________________
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_________________________________ _________________________________
Michael Boyle, ETL Sponsor Jim Brinkman, PGE Sponsor