document detail 4/26/2006 15.1 critical: any instrument used to inspect, measure, test for or...

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4/26/20061

Document Detail

Document No.: 030467MP[U]

Status:

Title: INSTRUMENT CALIBRATION USING COMPUCAL SYSTEM

Type: Management Procedure

Owner: 890461Tracy WallaceCURRENT

Effective Date: 25-Apr-2006 Expiration Date: 26-Apr-2008

4/26/20062

Document Detail

References

StatusFixed RevRelationDocument No. Content TypeEXPIREDRelated NoDOCUMENT

Title:CALIBRATION DEVICE LISTINGINWORKSNo00081147SO [A] DOCUMENT

Title:OPERATION OF THE NEUTRO VAC SYSTEM IN HIFLOWCURRENTRelated No000771MP [Y] DOCUMENT

Title:SUPPLIER ASSESSMENT, SELECTION & REVIEW PROCEDURECURRENTNo00080067TM [A] DOCUMENT

Title:MANUFACTURE AND CALIBRATION OF CONTROL MEMBRANE STANDARDS FOR DICEEP VISION SYSTEMCAMERAS IN MILLEX33.

CURRENTRelated No0040786SO [H] DOCUMENTTitle:USE OF COMPUCAL/REVIEWING CALIBRATION CERTS IN CHEM/MICRO LABS

CURRENTRelated NoOMS7 [H] DOCUMENTTitle:PRODUCT REALISATION

CURRENTRelated NoOMS8 [G] DOCUMENTTitle:MEASUREMENT, ANALYSIS & IMPROVEMENT

CURRENTRelated NoFRM01492 [A] DOCUMENTTitle:CALIBRATION DEVICE LISTING

CURRENTRelated No030378MP [O] DOCUMENTTitle:PREVENTIVE MAINTENANCE PROC FOR CHEMISTRY, MICRO LAB & A2 LAB

CURRENTNoVQ008362 [1] DOCUMENTTitle:PERFORMANCE QUAL OF CLEANROOM3 PRODUCTION SPACE FOLL EXPANSION

CURRENTNoVQ008382 [1] DOCUMENTTitle:IQ & OQ OF JOUAN CENTRIFUGE GR4I WITH M4 ROTOR & MICRO CARRIER

CURRENTRelated NoVQ005547 [1] DOCUMENTTitle:QUAL OF THE COMPUCLA CAL DAT MAN SYSTEM IN THE FAC AREA.

CURRENTNoVQ007688 [2] DOCUMENTTitle:QUALIFCATION OF THE COMPUCAL CALIBRATION DATA MANAGEMENT SYSTEM

CURRENTNoVQ005538 [2] DOCUMENTTitle:QUAL. OF THE COMPUCAL CAL. DATA MANAGEMENT SYS. IN THE ST. AREA

CURRENTRelated No040306SO [B] DOCUMENTTitle:CALIBRATION OF VERNIER CALLIPERS

CURRENTRelated No040245SO [D] DOCUMENTTitle:CALIBRATION OF BURST TESTER

CURRENTRelated No040238SO [B] DOCUMENTTitle:CALIBRATION OF METTLER WEIGHING SCALES

CURRENTRelated No040145SO [C] DOCUMENTTitle:CALIBRATION: VACUUM GAUGE

CURRENTRelated NoDOCUMENTTitle:CALIBRATION -TEMPERATURE/HUMIDITY CHART RECORDERS- FACILITIES

CURRENTRelated No040591SO [D] DOCUMENTTitle:CALIBRATION OF ON LINE PH PROBES IN THE EFFLUENT PLANT

CURRENTRelated NoDOCUMENTTitle:CALIBRATION OF HYDROMILLEX FLOW TESTER T39 IN MILLEX

CURRENTRelated NoDOCUMENTTitle:CALIBRATION OF OVEN TEMPERATURE IN MILLEX

CURRENTRelated No040649SO [A] DOCUMENTTitle:CALIBRATION OF DIFFERENTIAL PRESSURE INDICATORS IN FACILTIES DE

CURRENTRelated No040577SO [E] DOCUMENT

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Title:CTRL OF NEW INSTRUMENTS IN CHEM/R&D/STERILE RELEASE/MICROLABSCURRENTRelated No040097SO [B] DOCUMENT

Title:CALIBRATION OF THE TORQUE METERCURRENTRelated No040259SO [B] DOCUMENT

Title:CALIBRATION OF A PULL TEST JIGCURRENTRelated No040150SO [B] DOCUMENT

Title:CALIBRATION OF A TACHOMETERCURRENTRelated No040358SO [B] DOCUMENT

Title:CALIBRATION OF ARO BLISTER BURST TESTER IN MILLEX DEPT.CURRENTRelated No040225SO [D] DOCUMENT

Title:CALIBRATION OF TIMERSCURRENTNoVLD_MP [1] DOCUMENT

Title:VALIDATION DEPT - MANAGEMENT PROCEDURESCURRENTNoIQC_CALIBRATION [1] DOCUMENT

Title:INCOMING QC CALIBRATION PROCEDURESCURRENTNoCALIBRATION_UTILITIES [1] DOCUMENT

Title:UTILITIES - CALIBRATION PROCEDURECURRENTNoMP_CORK [1] DOCUMENT

Title:MEMBRANE PLANT 'GENERAL' MANAGEMENT PROCEDURESCURRENTNoTPL_CALIBRATION [1] DOCUMENT

Title:TOP LEVEL - CALIBRATION PROCEDURESCURRENTNoMQA_MP [1] DOCUMENT

Title:MANAGEMENT PROCEDURES FOR MICROLABCURRENTNoCORK_CALIBRATION [1] DOCUMENT

Title:MEMBRANE PLANT- CALIBRATIONCURRENTNoGENERAL_CORK [1] DOCUMENT

Title:GENERAL CORKCURRENTNoCORK_MIS [1] DOCUMENT

Title:PROCEDURES & POLICIES ON MIS IN CORK PLANTCURRENTNoMU_MP [2] DOCUMENT

Title:MOULDING DEPT MANAGEMENT PROCEDURESCURRENTNoMLX33_MP [2] DOCUMENT

Title:MILLEX 33 MANAGEMENT PROCEDURESCURRENTNoGENERAL-FILTER_CUTTING [1

]DOCUMENT

Title:FILTER CUTTING - GENERALCURRENTNoMLX_MP [2] DOCUMENT

Title:MILLEX DEPT MANAGEMENT PROCEDURESCURRENTNoGENERAL [1] DOCUMENT

Title:GENERALCURRENTNoCQA_MP [1] DOCUMENT

Title:MANAGEMENT PROCEDURES FOR CHEMISTRY LABCURRENTNoCENTRIFUGAL_DEVICES-

ENGINEERING [1]DOCUMENT

Title:ENGINEERINGCURRENTNoTECHNICIAN-STERITEST [1] DOCUMENT

Title:STERITEST TECHNICIANCURRENTRelated No030480MP [A] DOCUMENT

Title:MAINTENANCE & CONTROL OF HEALTH & SAFETY EQUIPMENTCURRENTRelated No030420MP [D] DOCUMENT

Title:VALIDATION MASTER PLAN FOR MEMBRANE MANUFACTURING PLANT

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CURRENTRelated No030399MP [J] DOCUMENTTitle:H.R. DEPARTMENTAL ORGANISATIONAL STRUCTURE

CURRENTRelated No000706MP [S] DOCUMENTTitle:INSTRUMENT CALIBRATION PROCEDURE

CURRENTRelated No040155TM [B] DOCUMENTTitle:OPERATION OF MITUTOYO DIGIMATIC CALLIPERS SERIES500

CURRENTRelated No040153TM [C] DOCUMENTTitle:USE OF GAUGE BLOCKS AND PIN GAUGES

CURRENTRelated No040175TM [A] DOCUMENTTitle:CALIBRATION OF TORQUE DRIVERS

CURRENTRelated No040179TM [B] DOCUMENTTitle:CALIBRATION OF DIMENSIONAL GAUGES

CURRENTRelated NoDOCUMENTTitle:USE OF THE TOOLMAKERS MICROSCOPE

CURRENTRelated No040181TM [A] DOCUMENTTitle:OPERATION OF MITUTOYO DIGIMATIC THICKNESS GAUGE

CURRENTRelated No040154TM [B] DOCUMENTTitle:OPERATION OF MITUTOYO DIGIMATIC MICROMETER SERIES NO.293

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4/26/20065

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Review Purpose: The purpose here is to review the content of the document before releasing it.Review:

Build No.: 1 Closed Date: 4/26/2006 9:40:42PM

Review Note: SYSTEM AUTO CLOSE REVIEWSign-off ByActorOwner RoleLevel

890461890461 Tracy WallaceDoc Control Document Control1

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890394890394 Brian O'HerlihyDoc Approver / Initiator Doc Approver/ Initiator

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Note To Approver:Note From Approver:Document approved.

906789906789 Thomas DillonDoc Approver / Initiator Doc Approver/ Initiator

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Note To Approver:Note From Approver:APPROVED BY: THOMAS DILLON

901719901719 Elizabeth O'SullivanDoc Approver / Initiator Doc Approver/ Initiator

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Note To Approver:Note From Approver:DOCUMENT APPROVED

908010908010 Joe BerginDoc Approver / Initiator Doc Approver/ Initiator

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Document NumberMillipore Documentation 0030467MPTitle

INSTRUMENT CALIBRATION USING COMPUCAL SYSTEMDocument Type Revision Code Page Number

Management Procedure U 1 of 24

NOTICEThis document is proprietary and its contents are the exclusive property of Millipore Corporation.This document may not be reproduced in any form whatsoever, without prior written permission from Millipore Corporation.

Refer to 0000107MP for instructions on using this form Form Number: 00000003FM REV A

Responsible Location Approval Locations Reference Locations Language

R N/A N/A EReferenced Documents Special Notes

0000771MP0030378MP0040577SOFRM01492

N/A

1.0 SUBJECT:

Instrument Calibration Using Compucal System.

2.0 PURPOSE:

The objective of this procedure is as follows:-

To describe the calibration system in place in Millipore Ireland B.V. the purpose of which is:

a) To ensure that all inspection, measurement and test equipment that affects product quality is calibrated at defined intervals against standards traceable to National Standards.

b) To ensure that all calibrations and related activities are documented correctly.

c) To comply with the requirements of the International Quality Standard: ISO9002.

3.0 SCOPE:

This procedure applies to all relevant departments, which are using “Compucal Calibration system”.

4.0 RESPONSIBILITIES:

4.1 It is the responsibility of the Production Managers in Assembly, Moulding, & Membrane Plants to ensure this procedure is adhered to.

4.2 There are specific people within each Department (nominated by the responsible Manager) with responsibility for calibration and are referenced in attachment 5. Their responsibilities include completing internal calibrations as scheduled arranging external calibrations and the maintenance of calibration documentation.

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4.3 The Supervisors are responsible for releasing equipment for calibration. In the chemistry and Micro labs it is the responsibility of the individual designated for the chemistry labs as per attachment 5 to release equipment for calibration.

4.4 The Quality Assurance Manager is responsible for regular auditing of the Calibration System.

4.5 The Systems Development Engineer is responsible for the preventative maintenance of the “Compucal” software.

4.6 The Systems Development Engineer is responsible for ensuring that a disaster recovery system is in place.

4.7 The Systems Development Engineer is responsible for the contract which exists with the vendors of “Compucal” for both maintaining the contract year by year and also making sure that the source code is held impartially by a third party This should all form part of the written contract.

4.8 Systems Development Engineer is responsible for the backup of the “Compucal” software as outlined in the record section of this procedure.

5.0 DEFINITIONS:

There are 4 calibration categories of instruments and controllers defined, namely, “Critical”, “Process”, “Indicator” and “reference”.

5.1 Critical: any instrument used to inspect, measure, test for or control a key process or test parameter, i.e. one which can impact directly on product quality and is used to check if a product or process meets specifications or not.

5.2 Process: any instrument or controller, which requires maintenance and calibration for operational purposes.

5.3 Indicator: any instrument or controller not directly linked to the production testing or control of products. ‘Indicator’ devices are not calibrated.

5.4 Reference: any instrument which is traceable to National Standards and is used to Calibrate a Critical or Process instrument.

Note: All instruments membrane manufacturing plants calibration system are regarded as critical.

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6.0 POLICIES:

N/A

7.0 PROCEDURE:

7.1 Safety

Use care when handling hazardous material used in calibration procedure. Ensure that safe access is provided to reach instruments in difficult locations. Poor calibration on safety critical instruments can lead to inaccurate readings and unsafe conditions.

7.2 Environmental

Poor calibration on instruments associated with environmental performance could result in a breach of license requirement or loss of control in treatment system.

7.3 Device listing

7.3.1 The Device listings in departments using “Compucal” are generated by “Compucal”.

7.3.2 FRM01492 is a sample of what is generated from compucal. All header and footer information will not be contained on the printout from compucal. There is no corresponding footer information and header information will be as follows:

• Rev. Status• Form No.

7.3.3 Approval signoff off FRM01492 will be contained on the relevant DCO and is controlled as per 0000745MP.

7.3.4 It is the responsibility of the Systems Development Engineer to ensure the Device listing format that prints from compucal is updated in line with FRM01492.

7.3.5 All device listings should detail reason for change eg. in Millex a new instrument (MX100) added hence device listing should detail ‘MX100 added’

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7.3.6 Reason for change can be added to the device listing on printing the device listing from compucal as follows:

• Select ‘Print Device Listing’• Select ‘Yes’ in the Comments box• Detail Reason for change in the Comments(Device List) box• Select ‘OK’

The device list will now detail reason for change.

7.3.7 The device listing is signed off by the relevant responsible person as per Attachment 5 and one of the following QA personnel:

• QA Supervisor• Vendor Quality Engineer• Quality Systems• Chem/Microlab Supervisor (for labs only)

It is the responsibility of the QA person to determine if any additional signoff’s are required.

N.B. The signed paper copy of the Device Listing is the form that maintains system integrity.

7.4 Calibration Frequency

7.4.1 The frequency of calibration for an instrument/standard depends on a number of factors. These are as follows:

(a) Rate of use of instrument–e.g.every day, once per week, once per month etc.

(b) Type of use - Standard/Test instrument- Release testing of product/raw materials- In-process testing of product- Process Instrument

(c) Calibration history of instrument.

(d) Accuracy of instrument

For a new instrument/standard, the initial calibration frequency is decided by the person responsible for calibration in the area and/or Q.A. by taking into account the factors above (a-d) and the Suppliers recommendations.

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The calibration frequency is reviewed following each calibration and if it is found to be inadequate, it is increased. The frequency is similarly reviewed and if necessary adjusted if there is a significant change in any of the factors above. This process will eventually lead to the establishment of the most appropriate frequency for each device.

In the chemistry /R&D/micro labs the calibration frequency for each instrument is set based on factors (a-d) above and also on the manufacturers’ recommendations. The calibration frequency is not reviewed after each calibration.

7.4.2 In the case of an instrument that is only used occasionally, there may not be a preset calibration frequency. Instead, the item should be calibrated before each use.

7.4.3 Devices may be calibrated outside their scheduled frequency. This situation may arise if an instrument or machine is re-located or damaged during use. A device can also be calibrated at any time if there is a doubt about its performance or if calibration is requested by the QA Dept.

7.4.4 When a “Process” instrument has been found to be in calibration over a minimum of three sequential calibration checks at a defined frequency, the calibration frequency may be adjusted to a maximum of half the original frequency. The calibration frequency for “Critical” instruments will not be extended once the most appropriate frequency has been determined as outlined in section 5.4.1.

7.4.5 Depending on the calibration frequency the actual device calibration must take place within a defined period of the calibration date as indicated below:

Calibration Frequency Calibration within +/-X of the calibration date

Annually> 6 monthly> 3 monthly

X = 2 weeks

3 monthlyMonthly X = 1 week

Weekly X = 36 hours

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7.4.6 Next Calibration Date Calculation

Frequency Next Cal date1 Week On the Same Due day in 1 week.1 Month On the Same Due day in 4 Weeks3 Months On the Same Due day in 13 Weeks6 Months On the Same Due day in 26 WeeksYearly On the Same Due day in 52 Weeks Off site On the same date it was Calibrated, with the

next week being Calculated as above

7.4.7 Request to postpone calibration:

In certain circumstances where it is not possible to complete a calibration within the allowed time, (e.g. if the device is in service and cannot be withdrawn, personnel unavailable etc.,) the ‘Request to Postpone Calibration’ Form (attachment 1) must be completed. This is done in “Compucal” and is printed automatically for the person postponing the calibration from the system. This is signed-off prior to the scheduled calibration date. A Postponement Label is filled out and should be put on the instrument, beside the calibration sticker (See Attachment 4).

The completed forms are held in the relevant Instrument file. N.B. The signed paper copy of the postponement is the form that maintains system integrity.

7.5 Equipment identification and status

All devices within the calibration system are identified with a unique number “tag no”. The different methods of identification site-wide are shown below:

7.5.1 a) Standard Calibration labelThis clearly indicates the calibration status of the device and includes the device identification no., the next calibration date and the identity of the calibrator. These labels are used site-wide however in some instances the device may be inaccessible or in a wet environment and so the label may not be applied.

If the Instrument will be calibrated by an external subcontractor, the subcontractor should be told when the instrument will be next due again so he/she can put the correct date onto his calibration label and this should be put on the instrument.

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When recalibrating an Instrument all old expired Calibration labels should be removed and it should be remembered that the over labeling of calibration labels is not permitted.

All of the instruments on the chemistry lab device listing are calibrated by external contractors. All of the instruments on the Micro lab device listing except for the M Air T guns and compressed air testers are calibrated by external contractors. For this reason the calibration label supplied by the external contractor is used in place of the “standard calibration label” to indicate the calibration status of the device.

Some of the instruments in the R&D lab and Membrane plant are calibrated by external contractors. An external contractor label is used in place of a standard calibration label for these instruments to indicate the calibration status of the device.

In Millex 25 & Stericup, transparent adhesive labels are to be placed over the new calibration label. When an instrument is calibrated on the machine, every other calibrated instrument label on the machine should be checked to ensure the correct label is in place and that it is legible.

b) Tag attached to Device:These permanent silver tags are attached to instruments/equipment. The Tag displays an I.D. number for the item, which is traceable back to the instrument file and Compucal”. The calibration status and history for the item can be found in the file and “Compucal”.All instruments across the plant, which do not contain a silver tag, are for Indication Only.

In Membrane Manufacturing, the first letter of this Tag denotes the type of instrument and its number identifies which instrument it is. This also applies to any reference to Tags on any software system in membrane manufacturing.

In Millex 33 dept the prefix MLX followed by a sequential number determined from Compucal is used when identifying instruments in the dept.

In the Millex Dept the tag number identifies the type instrument or the location of the instrument eg. MX7 denotes instrument on Millex Assembly machine 7 or FM denotes Flow meter.In the Moulding dept a unique number identifies the instrument.

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In Filter Cutting an FC prefix is used followed by unique number.

In Steritest the prefix ST is used followed by unique number.

In Centrifugal Products the Prefix UL is used for Ultrafree instruments, AU for Amicon Ultra instruments.

For HSE instruments the prefix HSE is used followed by a number and EFP for the Effluent treatment plant.

For the sterile Release Lab the prefix SR is used followed by a unique number.

In the Chemistry/Micro/R&D labs each instrument is identified with a tag. Chemistry lab instruments are numbered with a “CI” number. The numbering sequence is sequential, e.g. if the last instrument recorded in the chemistry lab instrument log is CI 1, then the next instrument to be added to the list will be identified as CI 2.

In the same manner Micro lab instruments are assigned an “MI” number and R&D lab instruments are assigned an “RI” number. A record of all instruments and their associated tag numbers are kept in the following logbooks:Chemistry lab – “Chem lab instrument log”Micro lab – “Micro lab instrument log”R&D lab – “R&D lab instrument log”Note: Up to 31-Oct-02 all Chemistry/Micro instruments were identified with an “INT number”. The tags were numbered as follows “INT #” e.g. INT20. The numbering is sequential.

In the Stericup dept. the prefix SC is used followed by a unique number

c) Number etched on a Device:This system is used on some Devices both in the Moulding Dept. and membrane manufacturing plant. The number is traceable back to the instrument file from which the calibration status can be obtained.

7.5.2 Devices on the calibration system that are out-of-service or not in calibration must be identified as such, i.e. ‘Not in Calibration’ or ‘Do not use’ etc. (see att. 5).In the chemistry/micro labs instruments that do not possess one of the aforementioned labels (i.e. a calibration label, “not in calibration label” or “do not use” label) are included on the Preventative maintenance schedule as per 0030378MP.

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7.5.3 The calibration status of devices that are calibrated before use (see 5.4.2) is indicated on the calibration label or in the instrument file if the device is one, which is etched or tagged.

7.5.4 Defective instruments which are replaced will possess a new serial no. (The Tag no. will remain unchanged). Calibration records will indicate any equipment replaced. In the membrane manufacturing plants generic instruments (instruments that do not have a unique serial number) eg. stopwatches and temperature indicators used on test benches, are controlled by assigning an incremental alphanumeric number, assigned by the Systems Development Engineer. The alphanumeric is etched onto the generic device, and will be incremented by ‘1’ each time the device is changed. The unique identification number is controlled through the device listing. In the chemistry/micro labs if a defective instrument is replaced it gets a new tag number as well as possessing a new serial number as per 0040577SO.

7.5.5 The control of the introduction of new or replaced instruments is as follows:

-A new or replaced instrument will require a sign-off on the updated Device List as detailed in section 5.3.7 of this procedure.

7.6 Determination of Tolerances

7.6.1 The acceptable tolerance for a device on the calibration system depends on the particular application for which the device is used. The tolerance for each device is determined by the personnel in the area and/or Q.A. who take into account the Suppliers stated tolerance, the tolerance on the measurements being made with the instrument, and the calibration history of the device.

7.6.2 Each device should have the lowest possible tolerance. The ideal ratio of Product Tolerance to Instrument Accuracy (TUR) = test uncertainty ratio, is 4:1 In situations where this ratio cannot be achieved, the calibration system will compensate for this by having an increased calibration frequency for the particular device. In all cases, the tolerance of a device must be lower than the smallest tolerance on the item that the device is used to measure.

7.6.3 In the case of a Standard/Test instrument used to calibrate a device, the same practice as in 5.6.2 applies. The ideal TUR for a standard i.e. Instrument accuracy: Standard accuracy is 10:1 and again the calibration frequency will reflect the actual TUR in place.

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7.7 Standards/Test Instruments

7.7.1 All standards/test instruments used to calibrate devices are themselves included in the Dept. Device Listing and calibrated at regular intervals. The calibration frequency is dependent on a number of factors as outlined in section 5.4.1.

7.7.2 The calibration of each standard/test instrument must be traceable to National Standards.

7.8 Calibration

7.8.1 In Millipore, the person responsible for calibration maintains the entire schedule for his/her area of plant. A list of instruments requiring calibration is displayed by “Compucal”. The list shall include any incomplete calibrations from previous periods.

7.8.2 Instrument FilesAn instrument file is set up for each device on the calibration system. The file is maintained in the area that is responsible for the device and contains the following:

- Calibration record - Instrument Calibration Check Sheet or entered Calibration Check Sheet.- Corrective Action Records (if applicable)- Request to postpone calibration sheets (if applicable)- Calibration method SOP (optional)- Calibration certificates received from external sources.

In the chemistry/micro labs there are a number of calibration device files where calibration certificates for all instruments on the calibration device listing are stored. These device files contain the following:

• Calibration certificate.• Corrective Action Records (if applicable).• Request to postpone calibration sheets (if applicable).

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7.8.3 Device Calibration

a) Calibrations can either be:-- completed internally in the area by the assigned trained person.- completed internally by an external sub-contractor, or- completed externally by an approved external sub-contractor.

b) All sub contractors utilised by Millipore Ireland BV for calibration purposes must be approved and have recognized qualifications e.g. qualified electrician or instrument technician. (Approval of sub-contractors is performed as per doc no. 0000771MP).

c) Calibrations are carried out in the following circumstances:- Regular scheduled calibration of the device.- Before a new instrument is put in service.- As part of the corrective action following a ‘Non-Conforming’ Calibration- When the device has been damaged in transit or use.- At any point in time when requested by the area or Q.A.

d) Calibrations are carried out over a range of inputs which are specified in the Issued Field Cal Sheet and using the relevant calibration test method. The Calibration Test Method details precisely how a specific instrument calibration should be done. Copies of the relevant test methods for internal calibrations are held in each area.

The issued field calibration sheet is not used in the chemistry/micro labs as all instrument calibrations are performed by external sub-contractors.

e) Following a calibration the relevant records including calibration labels are updated.

7.8.4 Non-Conformance’s

If an out of tolerance result is confirmed during the calibration of a device, the Calibration Corrective Action sheet (attachment 2) is initiated by “Compucal” in that area and the following steps taken:

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a) Instrument Corrective ActionsThe device is labelled ‘Not in Calibration – Do not use’ (attachment 5) and one of the following options is chosen and documented:

- adjust or repair the instrument and recalibrate it to ensure that the adjustments/repairs were sufficient.

- scrap the instrument if it is not possible to adjust or repair it.- replace the instrument with a similar calibrated one.

N.B The signed paper copy of the Corrective action is the form that maintains system integrity.

b) Product Corrective Actions

i) Process InstrumentThe Calibration Corrective Action Sheet is completed in the area and includes the actions from (a) above. It is passed onto Q.A. who decide on one of the following steps and sign-off the sheet.

- No further action necessary- Review previous calibrations and possibly increase the calibration

frequency.- Request a recheck of some product previously manufactured or

tests previously completed to assess any potential impact on product quality.

ii) Critical InstrumentThe calibration corrective action sheet is completed as for a process instrument and passed to Q.A., who decide on a corrective action step similar to those in (i) above. In addition, Q.A. may decide that a product ‘recall’ is necessary.

If an instrument is found to be operating outside its stated tolerances following a calibration, the person responsible must take the following actions:

- adjust/repair the instrument and re-calibrate it to ensure that the adjustments/repairs were sufficient. Repeat this step if necessary.

- if adjustments/repairs are not possible, the instrument is scrapped and replaced with one already calibrated.

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7.9 Calibration Certificate Criteria:

A Calibration Certificate is received for every calibration carried out by an external subcontractor or carried out internally. This certificate is reviewed by the person responsible for calibration in the Department and should contain at a minimum:

- Identification of the external organization if used- Certificate Number- Date of calibration- Certificate title i.e. Certificate of Calibration- Identification number of the device calibrated.- Identification & serial no. of the test instrument used and/or a statement of

traceability to national/international standards where an accredited calibration lab is used.

- Results of calibration- Tolerance of Instrument- Environmental conditions during calibration

• For internal calibration certificates this is not required as all calibrations are performed in environmental conditions that ensure validity of results.

- Statement of measurement uncertainty• For internal calibration certificates this does not need to be stated as our

calibration procedures are designed to provide a measurement uncertainty of less than a quarter of the specification of the unit-under-test. In these conditions and at 95% confidence level for specification and uncertainty, the chance of incorrect declaration of conformance to specification is 0.8%. Where the objective cannot be achieved because of limitations of national standards, tightened test limits are used to maintain equivalent confidence in the product's compliance to specification.

- Name, title & signature of the person who completed the calibration.- For internal calibration certificates ‘Title’ is not required as all calibrations are

performed by trained personnel.- The Calibration Pass/Fail criteria (specification) may be included in certificate, if it

is not the person reviewing the cert confirms the status of the calibration by writing “Pass” or “Fail” on the certificate.

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For the chemistry/micro labs and R & D Lab the following are not present on all certificates:

• Tolerance of Instrument

If the certificate complies with the Device Listings, the reviewer signs and dates it and updates the relevant instrument file. Any discrepancies with the certificate are investigated immediately.

7.10 Training

7.10.1 Each person who completes internal calibrations must be adequately trained to do so and the training must be documented.

7.10.2 Documented training on “Compucal” is given to all relevant personnel.

8.0 RECORDS

8.1 In Millipore, records of all calibrations are recorded on the Certificate of Calibration (unless the calibrations records are entered directly into Compucal at the time of calibration) and also on the “Compucal system”. The chemistry/micro labs do not use a Certificate of Calibration as all calibrations are performed by external sub-contractors.

8.2 A certificate of Calibration (See Attachment 3) exists for every device included in the plant-wide calibration system. These sheets record the relevant calibration information for the device. This is as per 6.1 above for the chemistry/micro labs.

8.3 There is also a record of all devices within “Compucal”.

8.4 The Systems Development Engineer will back up the data once every week to a suitable media and file in the fireproof cabinet (Membrane Manufacturing) for a period of 5 years.

c) Instrument Calibration Check SheetThese sheets are issued by the Electrician or Technician, who carries out the calibration and verified by the relevant responsible person within the department or Designate. This is as per 6.1 above for the chemistry/micro labs.

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8.5 After the Calibrations are done they are entered into Compucal by the Electrician or Technician for which a Password is required for access. In the case of the control room’s in Durapore and Hiflow the calibration data is entered directly into Compucal using a laptop to access Compucal. In the chemistry/micro labs the calibration information is entered by Senior Lab personnel, (i.e. Senior Analyst, Chemistry Lab or Micro Lab Supervisor).

The person responsible for calibration for that department or delegate as outlined in attachment 5 then verifies the information entered is correct. They then sign and date the raw data if applicable and entered data to confirm they are the same, if this is not the case a reason should be entered into the comments section of the verification screen.

8.6 The test instruments used in calibrations must be referenced with the calibration results. Certificates of calibration for these instruments must be traceable to National Standards.

8.7 All Calibration Certificates are stored in the Calibration file in the relevant department.

8.8 If FRM01492 is revised, the System Development Engineer shall update the system to reflect the new revision and inform all personnel in attachment 5 that a new Device List should be printed to reflect current practice.

8.9 All calibration records and Device Listings for a particular department is filed within the dept. The Records are maintained for at least two years after the instrument has been withdrawn from service.

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ATTACHMENT 1 (Pg 1 of 1)

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NOMINATED DEPARTMENTAL PERSONNEL RESPONSIBLE FOR CALIBRATION

Individual Department/Area

JOHN MULCAHY MEMBRANE MANUFACTURINGBARRY MCGRATH FACILITIESSTEVEN BYRNEBREDA O’SULLIVAN

CHEMISTRY LAB

CATHERINE O’CALLAGHANMAUREEN KAMUKWEDEDAWN HOULIHAN

MICRO LAB

JACKIE FOLEY INCOMINGMARK DUNPHY STERITEST, IVEX, CENTRIFUGAL PRODUCT

& FILTER CUTTING, MULTIWELLMARTIN CAGNEY MILLEX

CON CAREY Moulding Process Equipment

MICHAEL HICKEY MOULDING METROLOGY

BREEDA COMYNS EFFLUENT TREATMENT PLANT

ANN MARIE GANNON HEALTH AND SAFETY EQUIPMENT

EILEEN HANNIGAN R&D LAB

AMANDA BERGIN DURAPORE TEST EQUIPMENT

DEIRDRE O’BRIEN HI-FLOW TEST EQUIPMENT

MICHAEL O’DONOVAN MILLEX 33MARY O’RIORDAN STERILE RELEASE LAB

BRIAN O’ HERLIHY STERICUP

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REVISION SHEET

DATE REV.NATURE OF CHANGES CHANGED BY

27/Jul/01 AAdd attt s 1 & 9 from 0000706MP as atts 5 & 6 and the addition of new att 4 Device Listing.6.5 Also has been added to reflect the change in practice whereby passwords are used to sign in to the system and it also highlights that the raw data must also be verified (renumber accordingly). 5.4.4 change word increased to adjusted and twice to half. 6.8 change to reflect how the device list should be maintained within epts..Attachment 6 change name Ger Lombard to Con Carey person responsible for calibration in Moulding Process equipment.

G. Flynn

J. Gill

11/Dec/01 BAdd ‘Use care when handling hazardous material……unsafe conditions.’ To Section 5.1Add ‘Poor calibration on instruments…treatment system.’ To section 5.2.Add Ann Marie Gannon to attachment 6.Change Kevin Kennelly to Grainne Cusack.Change Vincent Dunleavy to Mark Dunphy and add Filter Cutting to ‘Responsibility’. Remove Colm O’Brien.

AM. Gannon

V. Clarke

19/Mar/02 C Addition of ‘with Device Listings’ to Records subsection 6.7.D. Murphy

15/Jul/02 D On attachment 6 replace Triona Nagle with Barry Goulding.G. Flynn

28/Mar/03 E Change Calibration Development Technician to Systems Development Engineer through outMove section 6.4 and 6.5 and in its place put ‘If 0030467MP is revised, the System Development Engineer shall update the system to reflect the new revision and inform all personnel in Attachment 6 that a new Device List should be printed to reflect current practices’.

G. Flynn

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REVISION SHEETDATE REV.

NATURE OF CHANGES CHANGED BY09/Jul/03 F Referenced documents Added 0030378MP and 0040577SO

5.3/5.5.5 Added appropriate device listing sign-off’s for chemistry lab and R+D lab5.3 Removed reference to e-mailing of device listing by compucal5.4.1 Defined method of setting calibration frequency for chem/R+D labs5.4.5 Changed “overleaf” to “below”5.4.6 Changed “technician” to “person postponing the calibration”5.4.6 Removed reference to e-mailing of request to postpone calibration” by compucal5.5.1(a) Included section to state that the calibration label supplied by the external

contractor is used in place of the standard cal label for the chem lab5.5.1(b) Clarified instrument identification procedure for chem/micro and R+D labs to

reflect use on CI/MI/RI numbering system since 31-Oct-025.5.2 Removed reference to attachment 15.5.2 Stated that instruments that do not possess one of the mentioned labels are

included on the PM listing as per 30378MP5.5.4 Stated that all new instruments in the chem lab receive a new tag number5.8.2 Defined calibration cert filing method for the chemistry lab.5.8.3 (d) Stated that the issued field cal sheet is not used by the chem lab5.8.4 Removed reference to e-mailing of “corrective action sheet” by compucal5.8.4(b) Changed “at the limit of an instruments tolerance” to “outside its stated tolerance”5.9.2 Changed “Technicians” to “Relevant personnel”6.1/6.2/6.4©Stated that the chem lab do not use an instrument calibration check sheet6.5Defined responsibility for entering calibration data to compucal for chem lab6.5 Changed reference to attachment 4 to attachment 66.7 Defined required contents for chem lab calibration certificates

Attachment 6 Added Eileen Hannigan as responsible person for the R+D lab4.4 Included reference instrument and description5.4.6 Added next calibration date calculation section, subsequent renumbering of all

other sections. TN 13/Jun/035.4.6 Added reference to placing a postponement label on the relevant instrument

beside the calibration label5.5.1(a) Include reference to inform external contractor of next calibration due dateAttachment 5 Remove calibration cert from attachment 5 & include new calibration cert &

postponement certAttachment 6 Added Sinead Eustace as responsible person for Durapore test equipment and Deirdre O’Brien as responsible person for HI Flow test equipment6.7 Added line “and/or a statement of traceability to national/international

standards where an accredited calibration lab is used”3.3 Detailed responsibility for releasing equipment in the chem lab5.8.3 (d) Removed reference to attachment 85.3 Added production supervisor to device listing approval sign-off’s5.5.5 “Process Engineering Supervisor” to “Process Engineer” and added production

manager.4 Changed number of categories of instruments from 3 to 4 and added reference

instrument.5.5.1 (b) Added R & D lab

B. Goulding/G. Flynn

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REVISION SHEETDATE REV.

NATURE OF CHANGES CHANGED BY

21/Jul/03 G 5.5.1 (a) Guidelines for the update of labels on Instruments add ‘When recalibrating…….not permitted

G. Flynn.

10/Oct/03 H Add to 5.3. ‘a minimum of any three of the following from the department effected. G. Flynn

29/Dec/03 J Add to 5.5.1 a) ‘Some of the …….device’ E. Hannigan

30/Apr/04 K - Corrected typo’s in Section 5.4.1- Added detail to last sentence of 5.5.1 (a) paragraph 1- Added detail to 5.5.1 (b) on tagging system used in various depts..5.8.2Instrument files File may contain Instrument Calibration Check Sheet OR Entered

Calibration Check Sheet5.8.3(b) corrected typo5.8.4s (a) corrected typos- 6.5 Added second sentence and changed last sentence of para 1 to say ‘They then sign and date the raw data if applicable - 6.7 Included R & D Lab as well as Chemistry lab and changed bullet one For the chemistry Lab to delete Disposition of calibration results, i.e. pass/ fail to read ‘tolerance of instrument’ - 6. 1 Include ref to calibrations records being entered to compucal.

N. Buckley

25/Aug/04 L -5.3 Complete rewrite of section.-5.5.4 Add details for identifying generic instruments in membrane plant.-5.8.3(a) Specify ‘trained’ person complete internal calibration.-5.9 Previous section 6.7 updated and renamed as section 5.9-All sections, Replace any reference to ‘Instrument Calibration Check sheet’ with ‘Certificate of Calibration’.-6.7 All calibration certificates are stored in the calibration file in the relevant department. Replaces previous section.-6.8 Device list to be assigned a new form number, FRM01492, and referenced on printed device list from compucal.-5.3 Complete rewrite.-Add from FRM01492 to referenced documents section.-Removal of attachment 4 to from FRM01492. Renumber subsequent attachments.-6.1 / 6.2 / attachment 3, change ‘Instrument Calibration check sheet’ to ‘Certificate of calibration’.-6.8 Change 0030467MP to FRM01492.-5.9 New, Move information from 6.7 to 5.9, subsequent renumbering of other sections.-6.7 Rewrite.-5.9 Removal of Calibration Criteria from list of requirements and Chem lab requirements. New item relating to calibration criteria included.

B. Williams

T. Nagle

J. Slattery

10/Mar/05 M 5.5.1 (a) Add ‘In Millex…it is legible. B. O’Herlihy

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REVISION SHEET

DATE REV. NATURE OF CHANGES CHANGED BY31/May/05 N 3.2 Change attachment 6 to attachment 5

3.3 Insert Micro lab5.3.7 Remove ‘QC Supervisor’ and replace with ‘QA Lab Supervisor’5.4.1 Insert ‘Micro’ in sentence ‘ In the chemistry /R&D/Micro labs----‘ 5.4.7 Replace 5 with 4 to read (See Attachment 4)5.5.1 Insert new sentence ‘ All of the instruments------by external contracto0rs’. 5.5.2 Reference ‘ Not in Calibration’ label to att 4. Insert ‘Micro lab’5.5.4 Insert ‘Micro lab’ in section ‘ In the chemistry and Micro labs----‘5.5.5 Insert ‘ Micro lab’, ‘Microbiologist’ & ‘ Micro lab supervisor’ in section5.8.2 Insert ‘Micro lab’ to section5.8.3 Insert ‘Micro lab’ to section 5.8.3 (d)5.8.4 Change attachment reference to (attachment 4)5.9 Add new sentence ‘ ie measurement results before and after calibration has taken place’, ‘--- and authorized signature’, ‘/micro labs’ to section

6 Insert ‘Micro lab’, ‘ Microbiologist’ &’Micro lab supervisor’ to show record keeping responsibilities to Micro lab.5..3.7 Replace ‘QC Supervisor’ with Chem/Micro Lab Supervisor (for labs onlyAttachment 5 Replace Barry Goulding with ‘Steven Byrne/Cathriona O’Dowd/Breda O’Sullivan’ and ‘Mary Breen’ with ‘Elaine Ellard’.

M. Kamukwede

04/Jul/05 P Attachment 5: Addition of ‘Jacyln Good and Catherine O’Callaghan’ under Microlab section. M. Kamukwede

14/Sep/05 R Attachment 5: Addition of ‘Maureen Kamukwede’ under MicroLab section.M. Kamukwede

17/Nov/05 S 5.3.7 Delete note ‘Currently the Device Listing has the following signoffs.’Attachment 5: Update nominated departmental personnel responsible for calibration.

As a result of transfer of document to new smartdoc template 3FM, original document numbering was changed to coincide with new template content.

B. Williams

Doc. Control

22/Feb/06 T Attachment 5: Addition of "Dawn Houlihan" Delete Jaclyn Good and Elaine Ellard under Micro Lab section. Delete Cathriona O’Dowd from Chem Lab.

D. Houlihan

19/Apr/06 U - Addition of " & Stericup" to section 7.5.1(a) Addition of to section 7.5.1 (b) "In the Stericup dept. the prefix SC is used followed by a unique number"

B. O’Herlihy