Sample Calibration Procedure...

1.0 Objective
1.1. This sample calibration procedure defines the calibration program requirements for all Measurement and Test Equipment (MTE).

2.0 Scope
2.1. Measurement and Test Equipment are those devices used to test, measure, evaluate, inspect, or otherwise examine materials, supplies, equipment, and systems, or to determine compliance with specifications.
2.2. This also includes process control devices with the potential to impact product quality.
2.3. This procedure shall provide instructions for the management of calibrations performed on Measurement and Test Instruments by service organizations, original equipment manufacturers, contractors, or laboratories (herein referred to as Contractor) and to ensure traceability to National or International Standards.
2.4. This procedure states the documentation requirements for equipment calibrated by in-house personnel.
2.5. All Measurement and Test Equipment is to be enrolled in the Calibration Program and/or the Preventative Maintenance Program. Enrolment shall include Measurement and Test Equipment designated “Reference Only” and “No Calibration Required”.

3.0 Responsibility
3.1. Measurement and Test Equipment User/Owner
3.1.1. It is the equipment user’s responsibility to verify that the Measurement and Test Equipment is in calibration by checking the label(s) before use.
3.1.2. It is the equipment user’s responsibility to return Measurement and Test Equipment, if portable, to the Calibration Coordinator before the calibration due date expires.
3.1.3. It is the equipment user’s responsibility to alert the Calibration Coordinator if Measurement and Test Equipment requires new batteries.
3.1.4. It is the equipment user’s responsibility to alert the Calibration Coordinator if Measurement and Test Equipment is not functioning correctly.

3.2 Calibration Co-Ordinator 
3.2.1. Shall evaluate and document Calibration Intervals on an annual basis.
3.2.2. Shall publish the calibration status report on a monthly basis.
3.2.3. Shall update the Calibration Database when required.
3.2.4. Shall apply replacement Calibration status labels if the date format is non-conforming.
3.2.5. Shall review and archive all applicable calibration documentation.
3.2.6. Shall apply a, “Do Not Use-Out of Service” label to non-portable Test and Measurement Equipment before the calibration due date expires.

4.0 References
Possible forms or procedures
SOP-xxxx Introduction of New Test Equipment
Form, Test Equipment Installation Qualification
Form Remedial Corrective Action
SOP-xxxx Maintenance Procedure
Form Measurement Instrument Status Change
Good Documentation Practice
Quality Records Retention
Supplier Assessment Procedure
Approved Suppliers List

5.0 Definitions
5.1 Measurement Instrument – Any instrument which monitors or controls a critical parameter of a manufacturing process, controlled environment or used to measure a product or component specification.
5.2 National standard – A reference tool utilized by an internationally recognized standards laboratory representing the country which operates that laboratory.
5.3 Calibration – Verification of a measurement instrument’s performance against a traceable standard.
5.4 Standard – A defined reference tool with traceability to a national standard.
5.5 Traceability – Documented reference of calibration results to a recognized standard.
5.6 Accuracy – The relative agreement of a measured value with an accepted standard.
5.7 Loop Calibration – The calibration of measurement instruments “as installed” in a total system and represents calibration of the instruments “as used”.
5.8 Resolution – The power of discrimination of an instrument. For analogue instruments, it is limited to 1/2 of a minor scale graduation.
5.9 Range – The breadth or span of an instruments capability of measurement.
5.10 Precision – Also known as repeatability and is the variation in readings obtained when repeating the exact same measurement(s).
5.11 Reproducibility – A measure of the ability of a measuring instrument to give the same readings when used by a different operator.
5.12 Calibration Interval – The duration of time between calibrations.

6 Safety
It may be necessary to add in potential safety or environmental considerations.

7.0 Procedure
7.1 Enrolment of Equipment in the Calibration Program
7.1.1 The Requester will notify the Calibration Department of new equipment by completing and returning the Test Equipment Installation Qualification Form to the Calibration Department.
7.1.2 The Requester shall deliver the following to the Calibration Department: Measuring equipment (if portable). Test Equipment Installation Qualification Form. Test Equipment Installation Qualification Form, shall detail the measurement instrument’s suitability for its intended use prior to enrolment. Suitability must consider Accuracy, Test Accuracy Ratio, Precision, Range, Resolution and conditions of use (including environmental conditions). A Test Accuracy Ratio (TAR) of at least 4:1 is required, rationale for exceptions must be documented and approved. A Test Accuracy Ratio (TAR) of at least 10:1 shall be required for standards used for in-house calibration; rationale for exceptions must be documented and approved. A copy of the equipment specifications (if available from manual/catalogue), otherwise calibration requirements will be listed in the special instructions section. Operation and/or Service manual(s) for equipment that is to be, or can potentially be, calibrated in-house (if available). Calibration Certificate(s). Certificates for new Measurement and Test Equipment require at a minimum a statement of traceability to National, or International, or consensus standards and conformance to published specifications.
7.1.3 Active Measurement and Test Equipment that is not Calibrated over the entire measurement range or capabilities shall be identified with a “Limited” Label, or equivalent. Limitations of use shall be affixed on or near the Measurement and Test Equipment. Limitations shall be listed in the “Special Instructions” section of Test Equipment Installation Qualification Form.

7.2 Calibration Intervals
7.2.1 Interval assignment – should be established as recommended below in descending order of preference: Calibration history of the equipment under evaluation, and the intended use, Similar Measurement and Test Equipment enrolled in the calibration system, Documented engineering rationale based on usage, Manufacturer’s Recommendation, In the event none of the above information is available the initial interval shall not be greater than 6 months.

7.2.2 Interval changes – may be requested by the owning department by completing the Interval Change Form. Rationale must be documented on the Form. Approvals should consider the risk of using out-of-tolerance Measurement and Test equipment in the production or inspection process(s). Interval increases – greater than half (1/2) of the current calibration cycle require justification based on recommendations in section 7.2.1. Initial introduction of new Measurement Instruments that have not been used since initial calibration performed by the OEM (Original Equipment Manufacturer), may be extended another full cycle, where permitted by the OEM as documented on the OEM Calibration Certificate.
7.2.3 Calibration intervals – shall be evaluated and documented on an annual basis by the Calibration Coordinator.

7.3 Change of Equipment Status
7.3.1 The Equipment Owner will request changes of equipment/calibration status using the measurement Instrument Status Change Form. Equipment/Calibration Status categories include, but are not limited to, the following: Active – Measurement and Test Equipment that is calibrated over the entire measurement range or capabilities. This equipment shall be labeled with a “Calibrated” Label. Inactive – Measurement or test equipment that is currently not in use and consequently should not be an active part of the calibration program. This equipment shall be labeled with a “Do Not Use-Out of Service” Label and made non-operational if possible. Discontinued – Measurement and test equipment that has been discontinued or destroyed. Reference Only – Measurement and Test Equipment that has a measurement capability but is currently not used for ANY measurement or test activities for determining conformance to any equipment, product, process, design verification/validation, or environmental specifications. This equipment shall be labeled with a “Not Calibrated – For Reference Only” Label. No Calibration Required – Measurement and Test Equipment, which by nature or application does not require periodic calibration. Equipment in this category includes intrinsic standards, and equipment used in specific applications whose output values are verified by other calibrated Measurement and Test Equipment. This equipment shall be labeled with a “No Calibration Required” Label. Lost – Equipment that cannot be located by the owning department.

Discontinued / Disposed Equipment The department owning the equipment to be disposed/discontinued will complete the Measurement instrument Status Change Form. The Calibration ID label will be removed from the equipment by the Owning Department and affixed to the Measurement instrument Status Change Form. The equipment shall be appropriately identified for disposal/destruction by the Owning Department. The Owning Department will obtain approval for disposal of asset. The completed Measurement instrument Status Change Form will be forwarded to the Calibration Department.
7.3.3 Equipment Transfers – Measurement and Test Equipment whose primary use/ownership is being permanently transferred between departments or divisions. The original owning department is responsible for completing the Measurement Instrument Status Change Form for any Measurement and Test Equipment that is being transferred to another department or division, and obtaining the signature of the new owning department.

Calibration Database and Reporting
7.4.1 QA / Engineering / Document Control shall maintain a system for tracking and controlling Measurement and Test Equipment which will prevent the use of expired or unfit Measurement and Test Equipment.
7.4.2 The Calibration database shall outline the calibration method, in the comments section of the equipment history record. e.g., Sub-Contract On-Site calibration. (Performed on-site by approved supplier). Sub-Contractor. (Typically measuring and test equipment sent out to an approved supplier).
7.4.3 The Calibration database shall distinguish company owned standards from Measurement Instruments.
7.4.4 The Calibration Department will issue a calibration status report once every month to the Product Department Supervisors, Department Calibration Representatives, the Quality Assurance Manager and the Production Manager.
7.4.5 Monthly calibration status report shall consist of: Equipment DUE for calibration in the next 30 days. Equipment OVERDUE. Equipment On-Hand. Remedial/Corrective Action Form status.

7.4.6 Calibration manager has two main sets of records, which store all pertinent information: Equipment Master and Equipment History. Records are entered in these two corresponding screens by the Calibration Coordinator(s).the Equipment Master stores general information, such as ID ,description and scheduling information, called events, for each piece of equipment. The Equipment History maintains historical information for specific pieces of equipment. Events can be calibrations, repairs, operations etc. Each time an event is performed the result of the event, including any measurement information, is entered as a history record by the Calibration Coordinator(s).

7.4.7 All data is entered by the Calibration Coordinator(s) and Administrator, other users such as the Calibration Representatives have ’ User’ or ‘read only ‘status. All information whether deleted or entered is mapped through an audit trail in the database.

Remedial/Corrective Action Process
7.5.1 The Calibration Department will issue a Remedial/Corrective Action Form to the equipment’s owning department Supervisor when Measurement and Test Equipment is returned from being calibrated with an identified out-of-tolerance condition before calibration. A description of the specific out-of-tolerance parameters will be included or attached to the form.
7.5.2 Any equipment with out-of-tolerance occurrences “before calibration” will be issued a “Do Not Use-Out of Service” Label, or quarantined in the Calibration area, pending completion of the Remedial/Corrective Action Form by the Owning Department.
7.5.3 All Remedial/Corrective Action Forms will address: The impact of the out of tolerance condition on the product(s)/process(s). A concise and detailed explanation for this decision shall be documented. The following should be addressed in the Remedial response: How important the affected feature is to the end user, How the Out of Tolerance condition relates to the product specification(s), Any potential product impact, If product impact has been identified, the product FMEA and/or a Risk Analysis report shall be used to define potential Patient and or User safety impact. This may include ancillary documents such as: handwritten notes, calculations, graphs, tables, sketches, or photographs.
7.5.4 Remedial’s should also address Measurement and Test Equipment disposition: The fitness of the equipment for continued use. The calibration interval of the equipment if a change to the interval is being made as a result of the evaluation. Other changes to prevent the recurrence including: the appropriateness of the equipment for the measurement/test function and operator handling of the equipment.
7.5.5 Any open Remedial/Corrective Actions open more than four (4) weeks will be reported to the Quality Assurance Manager and Department Supervisor by the Calibration Coordinator.

7.6 Labelling, Identification and Storage
7.6.1 A Calibration label must be attached to, or be posted within visual range of, the Measurement and Test Equipment.
7.6.2 Calibrated Measurement and Test Equipment shall be marked with a label to display: The date of the most recent calibration. The date when the next calibration is scheduled. (Note, the aforementioned dates shall be of the format type requirements of SOP-xxx, e.g., Jan/5/2010 or 5/Jan/10 so as to avoid confusion between calibrations performed in the U.S.A and Europe). The initials of personnel or sub-contractor who performed the calibration or the name of the sub-contractor.
7.6.3 If the item is too small for this type of marking, a color code or smaller identifying mark shall be employed and cross-referenced on the Test Equipment Installation Qualification Form for that specific item.
7.6.4 Calibration Seals shall be affixed to Measurement and Test Equipment where a possibility of alteration to calibrated settings could occur. A tamperproof seal is affixed to the setting adjustment area and or access screw, this acts to safeguard against any internal and or external adjustments that could invalidate the calibration settings. Acceptable methods of sealing are, Tamper proof labels. Inspectors Lacquer. Low strength Tread-loc.
7.6.5 Measurement Instruments and Standards, where applicable, i.e., Vernier Callipers, shall be stored in suitable packaging when not in use to avoid damage.
7.6.6 Spare/backup Measurement and Test Equipment (portable), shall be stored in locked cabinets.
7.6.7 These cabinets are identified as “Calibrated Test Equipment”, which contains Standards and Measurement Equipment that are currently suitable for use and “Test Equipment not Calibrated” which contains items due for calibration and inactive Measurement and Test Equipment.
7.6.8 Only the Calibration Coordinator(s) and Administrator shall have access to these storage cabinets.

7.7 Battery Replacement
7.7.1 Measurement and Test Equipment that requires Battery Replacement shall be performed by the Calibration Coordinator using appropriate ESD practices and subsequent replacement of any tamer proof seals/labels.

7.8 Calibration Procedures
7.8.1 Calibration procedures must be application specific and prescribe step-by-step instructions for calibration of Measurement and Test Equipment or categories thereof. These shall be prepared internally, by another agency, the manufacturer or a composite of any of these. Internal calibration procedure part number and current revision shall be referenced on the related Calibration Record/Form.
7.8.2 Calibration procedures must state: the acceptable limits of accuracy and precision; standards required; and sufficient information to enable qualified personnel to perform the calibration.
7.8.3 Equipment used for Calibration(s) shall have a Test Accuracy Ratio (TAR) of at least 10:1, i.e. Calibration Equipment uncertainty will be 10 times greater than the uncertainty of the Measurement and Test Equipment being calibrated, rationale for exceptions must be documented and approved. Rational may include an increase to the calibration frequency to compensate for this lack of compliance.
7.8.4 Calibration procedures and internal calibration records must state; “Calibration performed by trained personnel only”.

7.9 Calibration – Internal
7.9.1 Requirements for calibrations performed by company personnel: Calibration Standards used to perform internal calibration shall be traceable to a National or International Standard(s). Calibrations are to be performed per application-specific written procedures, at the most current revision level, describing the step-by-step method of calibrating specific instruments or categories of instruments. For company manufactured equipment, calibrations will be performed at the revision level applicable to the equipment. Calibrations performed by company personnel require a cross-check to be performed prior to commencing to ensure proper documentation/procedure(s) is/are used. Company personnel performing calibrations must be trained to the proper procedure and revision level as evidenced in the individuals training record. Calibration procedures shall clearly state the ranges of acceptable tolerances or limits. Recorded calibration data shall be recorded to the significant digit expressed in the limits. Environmental conditions for Test and Measurement Equipment calibration such as lighting, vibration, etc, other than temperature and humidity except where defined by the manufacturer’s specification or user manual, shall comply with the manufacturer’s published specification. Environmental conditions shall be monitored by calibration personnel to ensure the following requirements, are meet when performing calibration in-house. Upon completion of calibrating an item, personnel performing the calibration will indicate environmental compliance by checking off the appropriate section on the company Calibration Report. If temperature or humidity exceed the specified limits for a particular calibration type, work for that type will be suspended and a supervisor notified to assess the impact.

7.9.2 Documentation of calibration shall consist of the following: Completed Internal Calibration Report including: Equipment I.D. Number. Description of Equipment. Part number and/or Manufacturer of the equipment. Revision of the equipment (if applicable). Calibration/Test Procedure/Drawing numbers used. Revision of the procedure used. Indication of cross-check performed (if applicable). Identification of person performing calibration/test. Calibration Standard(s) and/or equipment used. Due date(s) of the Standard(s) used. Date the calibration was completed. Next Calibration Due Date. Indication of equipment condition (Pre and Post Calibration).

7.9.3 Personnel training for performing calibrations must also include: Their Trainer signature in the section labeled “Approved by” indicating verification of: Training to, and use of, correct procedure. Cross-check (if applicable) Acceptability of data.
7.9.4 Calibration data (Pre and Post) including acceptable tolerances/limits. These may be recorded on the Internal Calibration Report Fxxx, or on a data sheet specific to the equipment’s calibration procedure. Completed data sheet will be attached to Internal Calibration Report.

7.9.5 The Calibration Department will perform a cursory review of the completed Internal Calibration Report Form and applicable Data Sheets to: Review for completeness. Review for Out of Tolerance conditions. If the results indicate that the pre-calibration condition was out-of-tolerance, issue a Remedial/Corrective Action Form. If the equipment is not fully calibrated to the manufacturer’s or procedural specifications the equipment may be used in a “Limited” status. In these circumstances: Equipment will be identified using the “Limited Calibration” Label. Limitations of use will be clearly identified on or near the equipment.

7.9.6 If the calibration is found to be acceptable, the Calibration Department shall: Sign or Stamp and date the Calibration Report as evidence of completion in the section labeled “Reviewed by”. Apply, or issue, an updated calibration label. Note: If changing the equipment status, the equipment owner must complete a Measurement Instrument Status Change Form. The Calibration Department shall file the Calibration Report and relevant data sheets in the equipment’s history folder.

7.10 Calibration – External
7.10.1 Calibration Method Calibration performed by Contractors shall be conducted by approved Suppliers (registered on the Approved Supplier List, ASL). The methods and criteria used to perform calibration of Measurement and Test Equipment shall comply with the manufacturers specification and shall be traceable, through certification, to a National or International Standard, e.g., NIST, UKAS or equivalent. Method of Calibration for linear Measurement Instruments such as External Micrometers, Vernier Callipers and Dial Gauges may use the methodology outlined in the British Standards in Engineering Metrology, e.g., BS 870, BS 887, BS 907, etc. Special instructions for calibration shall be detailed in the Test Equipment Installation Qualification Form, where applicable.

7.10.2 Documentation Requirements. All documentation provided by the Contractor shall include at a minimum: Measurement Instrument identifier. The date of Calibration. Tolerances or specified Accuracy. Pre-Calibration Data. Post-Calibration Data (if adjusted). Identity of Standards used. Calibration due-date of Standards. Ancillary measurement documentation (graphs, tables, photos, etc.), if applicable. Statement of acceptability (pass/fail). Signature or stamp of person performing the Calibration, or Contractor’s name and address.

7.10.3 Repairs. For equipment identified as requiring repairs by the Contractor, the Calibration Department will: Request the Contractor to provide a quote for the cost of the repair and provide an estimated time for completion of repair. Notify the owning department of the need for equipment repair and request approval for repairs. Approval of repairs: The owning department will provide a signed and dated purchase request for the cost of repair. The Calibration Department will inform the Contractor to proceed with repairs and provide an account number or purchase order number. Disapproval of repairs: Inform the Contractor to return the equipment, un-repaired, if offsite.

7.10.4 Receiving Equipment. Upon receipt of the equipment from the Contractor, the Calibration Department will: Physically examine the Measurement and Test Equipment for any damage. Review all calibration documentation for required information by checking off blocks on the Calibration Return Checklist as conformance to requirements is verified. Measurement and Test Equipment with Documentation missing or insufficient information shall be detained in the Calibration Storage Cabinet (“ Test Equipment not Calibrated”), or label “Do Not Use-Out of Service”. Measurement and Test Equipment with documentation missing or insufficient information shall require approval of Calibration Department QE prior to releasing equipment for use. QE will print name, sign or stamp, and date the Discrepancy Approval section of the Calibration Documentation Return Checklist upon acceptance or approval of documentation, as well as document rationale in the ‘Remarks’ section for any deficient Certificates accepted. If QE approval is denied, contact the Sub-Contractor, requesting the deficient information. Repeat section Compare specific values (data) to acceptance criteria (tolerances/accuracy specifications), or review statement of acceptability for out of tolerance conditions. Owing departments of equipment having a Pre-Calibration condition of being out-of- tolerance shall be issued a Remedial/Corrective Action Form. If the Calibration Certificate indicates that the equipment is not calibrated over the entire range of measurement or the “post-calibration” condition was out-of-tolerance, the equipment may be: Discontinued. Placed in “Not in Use” or “Inactive” status. Used as “Reference Only”. Used in a “Limited” status. In these circumstances Equipment will be identified using a “Limited Calibration” or “Special Calibration” label. Limitations of use will be clearly identified on or near the equipment. Verify dates on the Calibration Label and Calibration Certificate concur as well as comparing the due date to the calibration interval. Check for Calibration Seals in place, where appropriate.

7.10.5 Finalizing Print name, Sign or stamp, and date the Form, Return Checklist as evidence of review and availability for use. The form will be placed with equipment calibration certificate records in the designated cabinet. Update the Calibration database to include all newly received information, such as next Calibration due date and status etc. File the Certificate of Calibration and relevant documents as part of the equipment’s Calibration History records. Place the equipment in the calibrated equipment storage cabinet if not required for immediate use. Notify the owning Department if applicable.

7.10.6 External Calibration Company Supplier Survey/Audits Accreditation by a recognized body may be accepted by in lieu of an audit, e.g., ILAB. If an audit is not deemed necessary, a copy of the current certificate of accreditation will be maintained in the supplier audit file.

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