calibration program

Pfizer Biotechnology Ireland Pfizer Monoclonal Antibodies Small Scale FacilityIPPC Licence Application

ATTACHMENT F.1 A Draft Standard Operating Procedure for Calibration B Pfizer Ireland Pharmaceuticals Maintenance Strategy

J:\C2000-C2099\C2054\3) DOCUMENTS\40\REPORTS\IPPC LICENCE APPLICATION\IPPC ISSUE\PFIZER BIOTECHNOLOGY IPPC ATTACHMENT F.1.DOC

Attachment F.1Page 1

Arup Consulting Engineers 24 September 2008

For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


MAINTENANCE SOP

PFIZER SMALL SCALE MONOCLONAL ANTIBODY FACILITY SHANBALLY IRELAND

CALIBRATION POLICY

Document No: Draft

This procedure is intended as an overview of the approach to equipment and instrument calibration at the Shanbally MABS Small Scale Facility.

Approval

Role / Department Name Signature Date

Author Engineering Vincent Coleman

Reviewed By Engineering Declan J Murphy

Approved By Engineering Liam OBrien

Revision History

Document Revision

Date

Name

Reason for Update 1 29/07/08 Vincent Coleman Original


Attachment F.1Page 2


For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


TABLE OF CONTENTS

1.0 PURPOSE 4

2.0 SCOPE 4

3.0 APPLICABLE PERSONNEL 4

4.0 DEFINITIONS ACRONYMS AND SYMBOLS 5

5.0 RULES AND GUIDELINES 8 5.1 Calibrations 8 5.2 Instrument Specifications 8 5.3 Records 9 5.4 Selection and Use of Calibration Standards 11 5.5 Calibration Instruction and Instruction Numbers 11 5.6 PM Schedule Codes 12 5.7 Calibration Labels 12 5.8 Instrument Tolerances 12 5.9 Calibration Certificates 12 5.10 Calibration Intervals 13

6.0 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


Attachment F.1 Page 3


For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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

This procedure applies to all Pfizer colleagues and to contractors who request, perform or approve calibration activities.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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. 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. Calibration Range Specified range over which the instrument is calibrated. This should at least cover the normal operating range. cGMP Current Good Manufacturing Practices. 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.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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. 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. 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 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.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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. Unit Of Measure (UOM) Unit Of Measure




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


5.0 RULES AND GUIDELINES 5.1 Calibrations

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.

5.2 Instrument Specifications

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.

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.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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.

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




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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 or loop calibration interval Calibration Instruction reference Operating range ( where applicable) Process Control Limit (where applicable)

Nominal Test points

Note: Prefixes relating to nominal test points for weigh scales include:

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:




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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

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.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


5.6 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

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:

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




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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

5.10 Calibration Intervals

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.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


6.0 SAFETY PRECAUTIONS

Ensure you read the relevant Risk Assessments

7.0 CREATING/MODIFYING INSRUMENT/PM/CALIBRATION INSTRUCTION RECORD

Person

Responsible

Step Action

1. Tag the instrument appropriately to prevent its use until equipment

maintenance and validation/qualification determinations can be

completed. Note this step is only applicable for Instrument entry

type changes

Project/request

originator

2. Complete the Entry/Change form and issue to the Engineering

dept.

Engineering 3. Review information and issue to relevant approvers.

Relevant

Approver

4. Review and, if acceptable, approve request and return to CMMS

administrator.

CMMS

Administrator

5. Enter relevant data from Record Entry/Change form into CMMS

and return paperwork to originator.

Project/request

originator

6. Verify that equipment is appropriately tagged with correct

equipment code (only applicable for Instrument entry/changes) and

file paperwork in DCC.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


8.0 DEACTIVATING EQUIPMENT Person

Responsible

Step Action

1. 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.

Request

Originator

Taking out of service

temporarily

Raise a calibration work order in order to calibrate the

instrument prior to removal.

Prepare the equipment as necessary, for inactive period.

Calibration Co-

ordinator

/Designee

2. Deactivate the equipment and associated PM schedules in CMMS as

appropriate.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


9.0 ACTIVATING EQUIPMENT Request

Originator

1. Raise a Calibration work order in order to calibrate the instrument prior to

installation.

Calibration Co-

ordinator

/Designee

2. Activate the equipment and associated PM schedules in CMMS.

10.0 REQUEST PM EXTENSION Person

Responsible

Step Action

Requestor 1. Contact engineering with request for extension

Engineering 2. Make determination on validity of request and amend target date as

appropriate.

3. Record justification in comments section of work order and where

appropriate seek approval by QA.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


11.0 PERFORMING CALIBRATIONS Person

Responsible

Step Action

1. Release a work-order for the scheduled calibration.

2. Distribute the work-order to the colleague responsible for the calibration.

3. Apply for an extension to the work order, if the calibration cannot be

completed by the due date.

If Then

Calibration Co-

ordinator /

designee

Extension is granted The calibration must be completed by

the revised due date & the calibration

label must be replaced.

Extension is rejected Tag equipment DO NOT USE on the

calibration due date and until calibration

is completed.

4. Follow the calibration instruction attached to or referenced by the work-

order.

5. Complete the calibration record and ensure that each person involved in

the work signs the form. Attach a calibration label showing the instrument

ID number, calibration date, next due date and initials.

Technician

6. Notify an area rep which instrument was worked on and where possible

request an equipment dry run prior to returning equipment to normal

operation. (only applicable when calibrating a critical parameter)




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


Person

Responsible

Step Action

7. Enter the calibration data into CMMS.

If Then

Technician

As-found data is

un-acceptable and the

instrument is GMP critical

Complete a QAR form in accordance with SOP DEV-1002

Event and Deviation System.

When entering data into the CMMS, enter the QAR number in

the work order Comments field.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


As-left data is un-

acceptable

Tag equipment DO NOT USE and seek a replacement.

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

comments section of the work order.

If the replacement is not a like for like change, complete a change

request form (CRF) and enter the CRF

number in the comments section on the

work order. Request the calibration co-

ordinator / designee to remove the

existing instrument, and setup the

replacement as per Creating/Modifying

instrument records in the calibration

program

8. Record calibration work in appropriate Equipment logbook.

Technician

9. Forward the completed Calibration Record to the Calibration Co-

ordinator/ Designee for approval.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


10. Review the Calibration record and ensure the calibration was carried out

in accordance with the task associated with the instrument. Confirm that

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.

Calibration Co-

ordinator /

Designee

14. Facilitate the execution of calibrations throughout the facility.

15. Generate the following report.

A weekly Calibration due report to review all overdue and due calibrations for the coming month.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


Pfizer Ireland Pharmaceuticals

PIP Maintenance Strategy

Revision 1




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


Table of Contents

Section

Description Page

1.0 Vision 3

2.0 Purpose 3

3.0 Scope 4

4.0 Regulatory Compliance & Environmental, Health and

Safety

4

5.0 Organisation and Administration 5

6.0 Responsibilities 5

7.0 Partnerships 6

8.0 Asset Management 7

9.0 Work Control Systems 7

10.0 Work Planning and Scheduling 8

11.0 Reliability Plans 9

12.0 Predictive and Preventive Maintenance 9

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




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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: 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.

2.0 Purpose This strategy document outlines the elements for performing maintenance at all Pfizer Ireland Pharmaceutical Facilities. 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. 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




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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. These plans shall be developed in partnership with operations and communicated to all stakeholders.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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 and maintenance leaders are responsible for communicating the maintenance

strategy to their maintenance teams, applying the strategy and setting maintenance performance objectives.

Site Maintenance Teams: The site maintenance teams shall be responsible for the following: 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.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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: The operations team are responsible for

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 7.0 Partnerships 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.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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 Engagement in RCFA for recurring issues

8.0 Asset Management Assets shall be uniquely identified using an identification scheme structured into asset classes based on equipment characteristics. 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. 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.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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. 10.0 Work Planning and Scheduling 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. 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.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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. Criticality assessment tools shall be utilised for assets, this provides the basis for the reliability plan of an asset. 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 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.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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) 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: 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




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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

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. 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. Cost data collected as the asset level is preferred as it can be used to aid decisions to repair, refurbish or replace the asset.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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. Metrics must be made visible to operations and be well understood by all maintenance colleagues. 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 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.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


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.

20.0 Communications 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.




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


21.0 Abbreviations CBM

CONDITIONED BASED MONITORING

CMMS COMPUTERISED MAINTENANCE MANAGEMENT SYSTEM

EMU ENGINEERING MAINTENANCE AND UTILITIES

EHS

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




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19


22.0 Approvals

Author/Date: _________________________________ Eugene O Callaghan, GMI Facilitator

Approved By/Date: _________________________________ Michael Cohalan, MTL Ringaskiddy

Approved By/Date: _________________________________ Michael Cleere, ETL LIAPI

Approved By/Date: _________________________________ Ryan Cleary, ESM Dublin

Approved By/Date: _________________________________ Tom Dineen, FCO LODP

Approved By/Date: _________________________________ Jim Conway, MTL LOAPI

Approved By/Date: _________________________________ Michael Boyle, ETL Sponsor

Approved By/Date: _________________________________ Jim Brinkman, PGE Sponsor




For in

specti

on pu

rposes

only.

Conse

nt of

copyri

ght o

wner

requir

ed for

any o

ther u

se.

EPA Export 26-07-2013:01:46:19

1.0 PURPOSE2.0 SCOPE3.0 APPLICABLE PERSONNEL4.0 DEFINITIONS ACRONYMS AND SYMBOLS5.0 RULES AND GUIDELINES5.1 Calibrations5.2 Instrument Specifications5.3 Records5.4 Selection and Use of Calibration Standards5.5 Calibration Instruction and Instruction Numbers5.6 PM Schedule Codes5.7 Calibration Labels5.8 Instrument Tolerances5.9 Calibration Certificates5.10 Calibration Intervals

6.0 SAFETY PRECAUTIONS7.0 CREATING/MODIFYING INSRUMENT/PM/CALIBRATION INSTRUCTION 9.0 ACTIVATING EQUIPMENT10.0 REQUEST PM EXTENSION11.0 PERFORMING CALIBRATIONSAuthor/Date:Approved By/Date:Approved By/Date:Approved By/Date:Approved By/Date:Approved By/Date:Approved By/Date:Approved By/Date:

calibration program

Documents

calibration of equipment

instrument calibration

calibration procedure

calibration labels

calibration intervals

calibration certificates

use of calibration standards

facility equipment