qp11-100 e _calibration--control of monitoring and measuring equipment.pdf

8/14/2019 QP11-100 E _Calibration--Control of Monitoring and Measuring Equipment.pdf

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CONTROL OF MONITORINGAND

MEASURING EQUIPMENT

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WEATHERFORD AEROSPACE, INC. DOCUMENT NO.: QP 11-100REVISION LEVEL: E

Calibration Control of Monitoring and Measuring Equipment REVISION DATE: 1-17-2013

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REVISION HISTORY

Rev. Description Date

NC Original Issue March 6, 2007

A Paragraph 5.3 revised to include requirement for February 27, 2008Calibrated thermometer/hygrometer used in calibrationenvironment and recording of calibration environmenttemperature during calibration activity.Paragraph 5.7 changed to Quality Technician to initiateinvestigations, conduct assessments, and determine actionwith regard to out of tolerance device condition. QualityTechnician also identified as responsible for disposition ofout of tolerance devices, unless otherwise directed byQuality Assurance Manager.

B Revised Paragraph 5.16 October 24, 2008

C Add paragraph 5.2.3 May 27, 2010

D Rewrite paragraph 5.13 January 3, 2012

E Add under Paragraph 5.6.1: 5.6.1.6 The number of January 17, 2013points to be checked for each instrument and reference tothe accuracy required and the range to be checked.Add to Paragraph 5.1.2: Purchase orders or proceduresfor calibration services shall identify or provide traceabilityto requirements for the standard to be used, accuracy,range of use and number of points to be checked (3

minimum unless otherwise stated in the applicablemethod standard) encompassing that range.Change references under Section 4.0 AssociatedDocuments:Change ISO 10012-1 to ISO 10012 or ISO 10012:2003Measurement Management Systems Requirements forMeasurement Processes and Measuring EquipmentRemove AP 06-100 & QP 06-200 Substitute QP 7.4Purchasing Procedure and QP 7.4.2 PurchasingInformationRemove QP 09-200 Work Instructions (QP 09-200 hasbeen the identifier number for the DPD procedure sinceAugust 3, 2009)Change QP 13-100 to QP 8.3 Control of NonconformingProductChange QP 17-100 to QP 8.2.2 Internal AuditChange references listed in body of document:Change Paragraph 5.1.4 ISO 10012-1 s/b 10012 or10012:2003Change Paragraph 5.6.2 Remove QP 09-200 (WorkInstructions)Change Paragraph 5.7 QP 13-100 (NonconformingMaterial) s/b QP 8.3


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Change Paragraph 5.8.1 QM 04-100 s/b QMS-001Change Paragraph 5.8.2 QP 17-100 s/b QP 8.2.2Change Paragraph 5.8.3 QP 14-100 s/b QP 8.5.2(Corrective Action)Change Paragraph 5.10 WP 16-100 s/b QP 16-100

Change Paragraph 5.12 Remove QP 06-100 (Control ofSuppliers) and QP 06-200 (Supplier QualityRequirements), Substitute QP 7.4 Purchasing Procedureand QP 7.4.2 Purchasing Information.Change Paragraph 5.16 Revelance Work Instructionss/b Relevant Work InstructionsChange Paragraph 5.16 Make unnumbered paragraph5.16.1Add Paragraph 5.16.2 Calibration procedures may bemaintained as manufacturers calibration instructions,electronic copies, or approved internal documents.


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INDEX

Revision History

Index

1.0 Purpose

2.0 Application

3.0 Definitions/Abbreviations

4.0 Associated Documents

5.0 Procedures5.1 General Requirements

5.2 Adequacy of Measurement Standards5.3 Environmental Controls5.4 Intervals of Calibration5.5 Recall System5.6 Calibration procedures5.7 Significant Out-of-Tolerance Condition5.8 Adequacy of the Calibration System5.9 Calibration Sources5.10 Records5.11 Calibration Status and M&TE Identification5.12 Control of Subcontractor Calibration5.13 Handling and Storage

5.14 Responsibilities5.15 Nonconforming M&TE5.16 Relevant Work Instructions


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PURPOSE

1.1 The Objective of this procedure is to establish and set forth the requirements forcalibration of all precision measurement and test equipment used for acceptance(NDT, Final, Receiving , and In-Process) product or process at Weatherford

Aerospace Inc. and its suppliers.

1.2 The Intent of this procedure is to ensure control of the accuracy and reliability ofmeasurement and test equipment used.

1.3 The Intent of this procedure is to assure that all measurement and test equipment iswithin and conforms to prescribed methodological and technical requirements.

2.0 APPLICATION

This procedure applies to all measurement and test equipment used for product or processacceptance, process control, and all individuals charged with performing the measurements

and tests.

3.0 DEFINITIONS/ABBREVIATIONS

3.1 Calibration The comparison of measurement and test equipment ormeasurement standard of unknown accuracy to a measurementstandard of known accuracy in order to detect, correlate, report,or eliminate by adjustment any variation in the accuracy of theinstrument being compared.

3.2 Consensus An artifact or process that is used as a defacto standard byStandard agreement of the contractor and the customer when no

recognized U.S. National standard is available.

3.3 Measurement and All devices used to measure, gage, test, inspect, orTest Equipment otherwise determine compliance with prescribed technical(M&TE) requirements.

3.4 Measurement Those devices used to calibrate M&TE or otherStandard measurement standards and provide traceabilty.

3.5 Product The verification of quality requirements as required byAcceptance engineering drawing, customer requirements, and

manufacturing process. This includes Receiving Inspection, In-

Process Inspection, Final Inspection, & Non Destructive Testing(NDT).

3.6 Traceability The ability to relate individual measurement results through anunbroken chain of calibrations to one or more of the following:

1. U.s. national standards maintained by the NationalInstitute of Standards and Technology (NIST) and theU.S. Naval Observatory.


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2. Fundamental or natural physical constraints with valuesassigned or accepted by the National Institute ofStandards and Technology (NIST)

3. National standards of other countries which arecorrelated with the U.S. national standards.

4. Ratio type of calibrations.5. Comparison to consensus standards.

4.0 ASSOCIATED DOCUMENTS

AS 9100/ISO 9001ISO 10012 Measurement Management SystemsRequirements for Measurement

Processes and Measuring EquipmentQMS -001 Quality ManualQP 7.4 Purchasing ProcedureQP 7.4.2 Purchasing InformationQP 8.3 Control of Nonconforming Product

QP 16-100 RecordsQP 8.2.2 Internal AuditQP 20-100 Statistical Process ControlASME B89.19-2002 Gage Blocks

5.0 PROCEDURES

5.1 General Requirements

5.1.1 A thorough inventory is required of all plant locations to assure full andcomplete coverage of all applicable M&TE within the facility. All equipment onthis inventory is subject to this procedure.

5.1.2 Personally owned Equipment All personnel are required to report and submitpersonal owned precision instruments, used to accept product, to QualityControl for inclusion in the calibration program described in this procedures.Purchase orders or procedures for calibration services shall identify or providetraceability to requirements for the standard to be used, accuracy, range of useand number of points to be checked (3 minimum unless otherwise stated in theapplicable method standard) encompassing that range.

5.1.3 All company and personally owned precision measurement equipment, used toaccept product or to monitor process, is periodically calibrated for accuracy andreliability according to the schedule determined by Quality Assurance and this

procedure.

5.1.4 Requests for deviation from the detailed requirements of ISO 10012, withsupporting justification, are submitted to the customer for approval.

5.1.5 All measuring and testing equipment including but not limited to test software,shall be inspected and/or calibrated prior to its use.

5.1.6 All types of equipment shall be checked and certified as applicable to theminimum, nominal, and maximum range of operations.


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5.1.7 All measuring and test equipment purchased shall be calibrated independent ofthe manufacturers or suppliers certification.

5.2 Adequacy of Measurement Standards Measurement standards are traceable andhave the accuracy, stability, range, and resolution required for its intended use.

5.2.1 AccuracyUnless otherwise stated by the customer, the collective uncertaintyof the measurement standards does not exceed twenty five percent (25%) ofthe acceptable tolerance for each characteristic being calibrated.

5.2.2 Deviation The uncertainty requirements described in Paragraph 5.2.1 may bedeviated. Deviation required documented statistical studies to ensure that theoverall adequacy of the calibration is not adversely affected. The deviation isdocumented and maintained as part of the gage file.

5.2.3 Classification of Measurement Equipment If at any time the classification orlength deviation of any Gage Blocks (Level 2) used for the purpose of In-House

Calibration falls below the maximum permitted deviations of length per ASMEB89.1.9.2002. The gage blocks will not be used for In House calibration ofequipment. They will be identified as Reference Only and a new set acquired.

5.3 Environmental Controls To ensure continued measurements of required accuracy,measurement standards are maintained and utilized for the purposes of devicecalibration in a clean and secure environment where the temperature is maintainedbetween 65 and 78 degrees F. Calibration environment temperature shall be verifiedby use of a calibrated thermometer/hygrometer before in-house calibration activity andrecorded in the inventory record and recall system entry for the device to be calibrated.Since &TE must be stored and utilized in the ambient temperature of the productionfacility, in extreme conditions it may be necessary to place the M&TE into the

calibration environment 24 hours in advance of calibration to ensure normalization.This should not normally be a requirement for common hand held measuringequipment.

5.4 Intervals of Calibration M&TE used to accept product is calibrated at least annually.The frequency of calibration is based on usage, environment, and calibration history.Intervals may be shortened as required to assure continued accuracy as evidenced bythe results of previous calibrations. Intervals may be lengthened only when the resultsof previous calibrations provide definite indications that such actions do not adverselyaffect the accuracy of the system.

5.4.1 Guidelines for M&TE interval adjustmentAny decision to extend or decrease

intervals must lie with the technician, who is familiar with all aspects of thedevice and its use. However, as a guideline consider the following:

5.4.1.1 Extension of intervalIf, for example, a device is calibrated on amonthly cycle, and four cycles have passed with no adjustmentrequired, that device may be considered for extension to quarterly.

5.4.1.2 Decrease of interval When a specific device is found to be out ofadjustment for two consecutive cycles, the interval may be shortened to1/12 of the maximum interval until the extension rules of 5.4.1.1 aboveallow extension.


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5.5 Recall System A recall system is utilized to ensure mandatory and timely recall of allM&TE and measurement standards for re-calibration, ensuring that instruments arenot used beyond the calibration due date. In those cases where the recalledinstrument is essential to the manufacturing operation and calibration of the device

would seriously affect critical schedule, the Quality Assurance Manager may reviewthe past history and capability of the instrument and determine if production maycontinue using that instrument. This extension must be short term and in no caseexceed 25% of the normal calibration cycle of the device.

5.6 Calibration Procedures Procedures are provided and utilized for the calibration of allM&TE and measurement standards.

5.6.1 Minimum Requirement As a minimum the procedures specify the following:5.6.1.1 Measurement Standards and equipment to be used (manufacturer and

model or generic description).5.6.1.2 The required standard

5.6.1.3 The accuracy of the Measurement Standard5.6.1.4 The acceptable tolerance of each characteristic being calibrated5.6.1.5 Specific instructions to enable the calibration personnel to adequately

calibrate each instrument characteristic or measurement parameter ofconcern.

5.6.1.6 The number of points to be checked for each instrument and referenceto the accuracy required and the range to be checked.

5.6.2 Procedure Format and/or Source Procedures prepared in house are in theformat of Quality Department Operation Instructions and meet therequirements. However, procedure available from the customer, DOD or otherU.S. Government agencies, in manufacturers manuals, or published standard

practices may be used provided they conform to this procedure and allcontractual requirements.

5.6.3 When no recognized standard exist for calibration procedure, measuring andtest equipment shall be calibrated in accordance with manufacturesrecommendations and/or nationally recognized standard or practice.

5.7 Significant Out-of-Tolerance Condition When any M&TE, addressed by thisprocedure, is found to be outside of the normal tolerance or cannot be calibrated,calibration personnel will remove the device from service and identify the status of thedevice in the inventory record and recall system to indicate condition. The QualityTechnician performs a formal investigation and assessment and determines the

appropriate action with regard to material that the device may have accepted in error.If it is determined that suspect material may have shipped to the customer, thecustomer is contacted regarding recall or possible customer MRB disposition of thesuspect product. [Reference the reporting requirements of QP 8.3 (Control ofNonconforming Productl)]. Disposition of out of tolerance devices shall be theresponsibility of the Quality Technician, unless otherwise directed by the QualityAssurance Manager.

5.8 Adequacy of the Calibration System Three specific systems in the Weatherfordaerospace Inc. quality Plan monitors and ensure the adequacy of this procedure andthe calibration system it describes. The are as follow:


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5.8.1 Adequacy Review In accordance with the requirements of QMS-001 (QualityManual) this procedure is reviewed at least annually for adequacy.

5.8.2 Internal Auditing As described in QP 8.2.2 (Internal Audit), this procedure is

audited for conformance as well as adequacy.

5.8.3 Corrective Action QP 8.5.2 (Corrective Action) addresses the methods foridentifying problems in all systems and ensuring corrective action.

5.8.4 Measurement Standards which are used to calibrate measuring and testequipment shall be certified annually by an independent laboratory whichmaintains measurement standards traceable to the National Institute ofStandards and Testing (NIST). Certificates attesting to accuracy, date, etc.,shall be required and kept on file. Independent calibration laboratories shall beWeatherford Aerospace approved and re-surveyed at 1 year intervals.

5.9 Calibration Sources M&TE and measurement standards are calibrated in house orby an outside source suing measurement standards that re traceable. Allmeasurement standards used in the calibration system are supported by:

a. Certificates, reports, or data sheets attesting to the description oridentification of the item.

b. The calibration source;c. Date of calibration;d. Calibration assigned value;e. Statement of uncertainty;f. A statement attesting to the fact that the measurement standards used

to obtain the results were traceable; and

g. Environment or other conditions under which the calibration resultswere obtained.NOTE: In situations where such data is not required, stating N/A on the

certification is sufficient.

5.9.1 Control of Calibration Sources The requirements of QP 06-100 (Control ofSuppliers) applies to all outside calibration sources.

5.10 Records The requirements of this procedure are documented with records thatestablished schedules and procedure were followed to maintain the accuracy of allM&TE and measurement standards. The records are retained in accordance with QP16-100 (Records). The records contain as a minimum:

5.10.1 An individual record of calibration on a computer or other means of controlfor each item of M&TE and measurement standards.

5.10.2 A description and/or identification of the item.5.10.3 Calibration Interval5.10.4 Date Calibrated5.10.5 Person performing the calibration or review of certifications5.10.6 Identification of the calibration standard5.10.7 Calibration procedure used5.10.8 Calibration results and calibration actions taken.5.10.9 Calibration certificate or report number if applicable.


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5.11 Calibration Status and M&TE Identification

5.11.1 Numbering For consistency in identification of all M&TE, each item in thecalibration system is identified with a unique identification number.

5.11.2 Labeling All M&TE, is labeled to indicate calibration status with acalibration label that includes, as a minimum, the following information:

Date of calibration

Calibration Due Date

Identification of Calibrator

5.11.3 Limited Use M&TE Items not calibrated to their full capability or haveother limitations of use, are labeled or otherwise identified with specificlimitations.

5.11.4 Label Location When it is impractical to attach a calibration label directlyto the device, the label is attached to the item storage container or a tagaffixed to the item.

5.11.5 Measurement Devices which are not in system Measurement equipment,which is not used to accept product or control process and are notconsidered to be in the calibration system, is so identified.

5.11.6 Any measuring or test instrument that is found without a current calibrationsticker will be removed from service immediately pending investigation, re-calibration, and/or re-certification after successful calibration.

5.12 Control of Subcontractor Calibration The requirements of this procedure are passeddown to all applicable Weatherford Aerospace Inc. suppliers in accordance with therequirements of QP 7.4 (Purchasing Procedure and QP 7.4.2 (PurchasingInformation). All subcontractor requested calibration is requested by purchase order.Records retained in Quality Assurance Office.

5.13 Storage and Handling All M&TE and measurement standards are handled, stored,and transported in such a manner as to not adversely affect calibration or condition ofthe equipment

5.14 Responsibilities

5.14.1 Quality Assurance is responsible for: calibrating; sealing all operatoraccessible controls or adjustments, that if moved could affect the calibrationof the device; identifying each instrument; establishing calibration intervals;arrangements with outside sources for calibration services, as required;determining when repair or replacement of a damaged instrument isrequired; disposition of outdated or damaged instruments; notifying eachdepartment or individual, in writing, when calibration is due on instruments intheir control ;and maintaining all records relative to J&TE and measurementstandards as required by this procedure.


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5.14.2 Production is responsible for upkeep, handling, and storage of allinstruments in productions control; delivery, when notified, of M&TE due forcalibration to Quality Control. It is the responsibility of each operator tocheck his/her instruments daily to ensure that they are not due forcalibration, damaged. If an instrument has passed its calibration due date,

is damaged, the operator notifies his/her immediate supervisor and thatinstrument is removed from production and returned to Quality Control. Anyinstrument that cannot be removed because of size, delicacy of theinstrument, or type of installation, is red-tagged and Quality Controlcalibrated or makes arrangements to have the item calibrated. Productionplaces all material, which has been inspected with a gage that is pastcalibration date, significantly out of tolerance, damaged, or one whosetamper-resistant seals have been damaged on hold the pending formalinvestigation described in Paragraph 5.7.

5.14.3 All measuring and test equipment shall be made available to the customerand/or regulatory authority representative for inspection when requested.

The customer and/or regulatory authority shall assume responsibility for thecondition of the measuring and test equipment while in their custody.Inspection personnel will be made available to the customer and/orregulatory authority to operate specialized measuring and test equipment orassist as needed.

5.15 Nonconforming M&TE

5.15.1 M&TE that is found to be out of calibration or out of the calibration cycle isimmediately calibrated or removed from service. If the instrument cannotbe calibrated, due to wear or damage, the instrument is removed fromservice, re tagged and store din a secure area for disposition by Quality

Control.

5.15.2 If equipment used to verify dimensional control is found to be out-of-tolerance or does not conform to acceptable standards, Quality Assurancewill determine if the out-of-tolerance condition has an impact on the qualityof parts accepted with said equipment. If there is an impact of quality, partschecked with said equipment will be re-inspected after equipment is re-calibrated or with a current calibrated equipment. If the parts are someasured have been shipped, customer will be notified of discrepancy.

5.16 Relevant Work Instructions (Calibration Instruction)

5.16.1 Refer to Gage Pack on desktop computer. All instructions are listed foreach instrument for procedures.

5.16.2 Calibration procedures may be maintained as manufacturers calibrationinstruction, electronic copies, or approved internal documents.


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