Calibration Master Plan

  • Published on: Oct 27, 2017

1.0PURPOSE

1.1 The purpose of the Master Calibration Plan is to define the requirements necessary for establishing and implementing an effective Calibration Control Program. The aim of the Calibration Program is to ensure that all Measuring and Test Equipment (M&TE) included in the program are calibrated to within the manufacturer’s accuracy specifications or to the tolerances required by the application. Documented trace ability to either the National Institute of Standards and Technology (NIST) or other applicable agency must be maintained.

2.0 RESPONSIBILITIES

2.1 Quality Assurance Personnel:

2.1.1 QA Personnel will establish a mechanism for assuring the adequacy of the calibration program that includes:

  • Re-evaluation of all product acceptance decisions utilizing equipment or instrumentation which was subsequently determined to be out-of-tolerance.
  • Review and approval of decisions to include or exclude M&TE into the calibration and/or service program.
  • Review and approval of calibration and/or service intervals.
  • Review the adequacy of measurement accuracy for product/process/process acceptance and adjustments of product acceptance limits, or other

    actions required to assure adequate measurements.

  • Audit the calibration system and M&TE usage to assure compliance with the intent of this document.
  • Review to ensure that product specification changes, new accuracy requirements, and current GMP requirements have been included in the calibration program.
  • Review calibration agency performance to assure appropriate technical levels are maintained.

2.1.2 Responsible for auditing appropriate functions for compliance to this protocol.

2.1.3 Responsible for assuring that program action items identified in this document are implemented.

2.1.4 Responsible for assuring that all metrology personnel have the proper training and that documentation of the training is kept on file.

2.1.5 Responsible for final approval of all documents relating to metrology department.

2.1.6 Responsible in tracking document revisions and assuring that all documents in use are current.

2.2 Metrology Personnel:

2.2.1 Responsible in implementing the Calibration Program.

2.2.2 Responsible for developing and maintaining a controlled

2.2.3 Metrology Standards Laboratory to support the ongoing cGMP processes at the Facilities.

2.2.4 Metrology and Facilities personnel will be utilized to support all departments, using M&TE, within the company, wherever possible. Outside calibration agencies may be used at the discretion of Metrology, provided that the calibration agency has been pre-audited by Metrology and/or QA and found to be in conformance with this document.

2.2.5 The calibration program must be strictly adhered to and “down-time” of equipment must be kept to a minimum.

2.2.6 Accountable for notifying Production and QA personnel of any discrepancies found in instrumentation during routine maintenance and calibration. All discrepancies must be recorded on a GMP Incident Report which must then be forwarded immediately to the QA Manager.

2.2.7 Metrology and QA shall evaluate the procedures outlined in this protocol annually. This evaluation will include monitoring and updating to ensure compliance with cGMP’s.

2.2.8 Production equipment and calibration programs shall be strictly adhered to and “Down Time” of equipment will be kept to a minimum.

2.3 Instrument Users:

2.3.1 Responsible for ensuring that all instruments which are used in a cGMP process are included in Metrology’s computerized calibration scheduling system. Any instruments which do not have a calibration label affixed are not part of the system. The user must complete an Instrument Form in full and forward to the corporate metrology for entry into the system. The instrument will then be studied, calibrated, and a calibration label will be affixed. The instrument will then be automatically tracked, and the user will be notified when re calibration is due.

2.3.2 Calibrations required on a daily basis or prior to use of the equipment such as balances, and pH meters will be the responsibility of the individual user even though less frequent and more intense calibrations maybe performed by metrology.

2.3.3 To maintain accurate records of calibration for each piece of equipment used in cGMP related activities. These records are to include calibration, repair and maintenance data.

2.3.4 Users wishing to acquire instruments must consult with the corporate metrologist before purchasing to ensure that the instrument is adequate for their application.

3.0 TERMINOLOGY AND DEFINITIONS

3.1 Accuracy – The closeness of agreement between an observed or measured value and an accepted reference value.

3.2 Calibration – The comparison of a measurement system or device of unknown accuracy to another measurement system or device with a known accuracy to detect, correlate, report or eliminate by adjustment any variation from the required performance limits of the unverified measurement system or device.

3.3 Calibration Control Program – A system that provides control of all devices which have been accepted into the calibration and/or service program as measurement standards or M&TE and which includes the approval, maintenance, inspection, handling, transportation, use, calibration, service and repair and cleaning of these devices.

3.4 Calibration Interval – The elapsed time between a calibration and the subsequent calibration.

3.5 Calibration S.O.P. – A Standard Operating Procedure which provides the written procedure for performing the calibration and/or service of M&TE to obtain predefined accuracy and performance requirements.

3.6 Calibration Status – Identification of all M&TE as to the type of calibration or maintenance required and if calibrated, the current calibration validity. This validity is dictated by whether the calibration period has or has not elapsed.

3.7 Family – An instrument of equipment family denotes a population or group of like equipment built to perform the same type of measurements or functions exclusive of manufacturer and model. Grouping equipment into a family does not imply that they will have the same range or accuracy capabilities.

3.8 Good Manufacturing Practice (cGMP) United States – (FDA) Food and Drug Administration Regulations.

3.9 Instruments – M&TE used for confirming measurements related to the product or Validation or used for generating reportable data.

3.10 Measurement Standard – A device, solution, material, or radioisotope sealed source used as a reference for measurement, and which is traceable to NIST or NRC or other recognized source, or derived from accepted values of natural physical constants. Measurement standards designations include reference, certified, and transfer standards.

3.11 Measurement Trace ability – Measurement trace ability is the ability to relate individual measurement results to NIST standards through an unbroken chain of comparisons.

3.12 Measuring and Test Equipment – Devices and instruments used to test, measure, calibrate, evaluate, inspect or otherwise examine materials, supplies, equipment and systems to determine compliance with specifications established in technical documents.

3.13 Metrology – Develops and evaluates calibration systems that measure characteristics of objects. Substances, or phenomena, such as length, mass, time, temperature, electric current, luminous intensity, and derived units of physical or chemical measure: Identifies magnitude of error sources contribution to uncertainty of results to determine reliability of measurement process in quantitative terms. Redesigns or adjusts measurement capability to minimize errors. Develops calibration methods and techniques based on principles of measurement science, technical analysis of measurement problems, and accuracy and precision requirements. Directs engineering, quality, and laboratory people in design, manufacture and evaluation, and calibration of measurement standards, instruments and test systems to insure selection of approved instrumentation.

3.14 Metrology – The reference standards laboratory which possesses and uses M&TE of the required order of accuracy, including reference, certified, and transfer standards to provide measurement support to all applicable in house precision equipment.

3.15 Precision – The quality or state of being precise. Used or intended for precise measurements. Made for the least variation from a set standard.

3.16 Scheduling System – A scheduling system is established to assure that M&TE is calibrated at planned intervals and that instruments which cannot be properly labeled will not miss these intervals.

3.17 Service Inspection – of test equipment, or other calibration equipment or systems, which is intended to detect malfunctions and assure reliable operating during the calibration/service interval and to prevent deterioration due to age or usage. Examples or service are:

  • Visual check for damage, wear and surface quality. Operational tests for secondary functional characteristics such as distortion, ripple, regulation and sensitivity.
  • Also includes preventative maintenance such as cleaning, lubricating, filter replacement and painting.

– All services rendered will be documented.

4.0 GUIDELINES

4.1 Calibration Intervals:

4.1.1 M&TE should be calibrated at intervals established with the intent of achieving and maintaining a desired level of accuracy and quality. All M&TE will be calibrated at the manufacturer’s recommended calibration interval, to assure that M&TE is operating within its accuracy specifications. Calibration data will be recorded and then analyzed, to determine the optimum calibration interval. The calibration interval will then be adjusted to reflect this analysis. All instruments will be calibrated at least annually to assure compliance with cGMP’s. The trending and analysis of calibration data will be a continuous process and if the data shows that an instrument’s accuracy has degraded much faster than expected, the calibration interval must be adjusted to reflect this change.

4.1.2 Interval Applications

Intervals may be applied to single items or groups of items that are reasonably similar with respect to family and responsibility.

4.1.3 Interval Types

Calibration Intervals must be determined for each piece of equipment and may be fixed or variable.

4.1.4 Interval Units

Calibration Intervals must be determined for each piece of equipment and may be based upon calendar, cumulative, utilization time or any other suitable criteria.

4.1.5 Interval Assignment

Calibration intervals shall be assigned to attain a desired probability that M&TE will be within documented accuracy specifications at the time of re-calibration. Initial intervals for new equipment shall be based on the equipment manufacturer’s recommendation, engineering judgment or other appropriate source. Calibration intervals will be set forth in the individual calibration S.O.P.’s and will then be recorded and tracked in the computerized calibration database.

4.1.6 Calibration Intervals may be adjusted, as necessary, on the basis of calibration data or other information which may support a change. Any calibration interval adjustment shall be discussed with the user and Validation Services, documented by Metrology and shall be approved by QA.

4.1.7 Standard Grace

M&TE requiring scheduled calibration will have a standard grace period. Annual calibrations will be performed every 365 days ± 10 days. Semi annual calibrations will be performed every 182 days ± 5 days. Quarterly calibrations will be performed every 91 days ± 5 days.

4.1.8 Temporary Interval Extensions

Calibration Intervals may be temporarily extended beyond the standard grace period due to critical tests, production schedules or other requirements provided that:

4.1.8.1 Extension Limitations

The length of extension shall be limited by documented policy. Only one extension per calibration interval is permitted.

4.1.8.2 Product Acceptance

The batch or product shall be quarantined pending the results of the calibration.

4.1.8.3. Extension Approval

A temporary authority request must be completed and forwarded to QA before an interval extension can be approved and put into effect.

4.2 Measurement Traceability:

The calibration system will provide the means to directly or indirectly trace assigned values of measurement equipment to values in terms of the NIST or equivalent body.

4.2.1 Traceability Documentation

Documentation which substantiates and identifies the means of achieving direct traceability should include information such as:

  • Calibration Agency – Identification of the agency which performed the calibration.
  • Certification Data – The certified values determined by the measurement process, where applicable and required.
  • Date of Calibration and Reference Traceability Report of Certificate.

4.3 Adequacy of Calibration Equipment:

Items should be calibrated using measurement systems having adequate accuracy, stability, and range to completely verify the performance of the calibrated item within its specified uncertainty limits. All calibration shall be performed with test standards that have a minimum accuracy 4 times that of the device under test, wherever possible and will be traceable to NIST or equivalent body. All test standards will be set up and will remain within the controlled environment of the Metrology Laboratory to ensure stability of the instruments and repeatability of tests. Instruments may be removed from the calibration lab by meterologists to be shipped for repair or calibration and for the purpose of performing field calibrations.

4.4 Contractor Control:

When Metrology elects to use an outside contract maintenance and calibration service organization to service its M&TE, it is the responsibility of Metrology and QA to ensure that the contractors’ Calibration Control system complies with all the company’s requirements. Metrology personnel will provide pre-approval of a vendor, however, QA must perform regulatory audit to ensure compliance with cGMP’s. To realize this assurance it is desirable that an agreement be established that assures that the outside contract service organization:

  • Will use approved procedures outlining methodology used in maintaining and calibrating the client’s M&TE.
  • Will provide a complete system calibration and is willing to give a certified report of calibration, complete with all necessary supporting documentation.
  • Will allow periodic audits of facilities and records by their client and/or the client’s authorized representative.

4.5 Records:

Records will be maintained for all M&TE that are included in the Calibration Control Program. The Individual calibration history files will be prepared and maintained for each instrument. These records will be maintained and will be stored in the metrology laboratory.

4.5.1 Content

The records will include:

  • Identification
  • Location
  • Calibration History
  • Calibration Control
  • Traceability Documentation

4.5.1.1 Identification

On receipt of an Instrument Form, a unique non-repetitive identification will be assigned to each item of M&TE in the calibration system.

4.5.1.2 Location

Records will provide information necessary to locate equipment due for calibration.

4.5.1.3 Calibration Control and History

A record system will be maintained on M&TE requiring calibration to provide the information necessary for control, audit, and history of the calibration system. The system will include:

  • The date of each calibration and the date due for recalibration.
  • Signatures of the individual who performed the calibration and of the individual who reviewed and approved the calibration record.
  • Records of out-of-tolerance conditions.
  • Information or location of information necessary to duplicate all graphs, tables, reports, certificates issued with the instrument.
  • The report or location of reports received from outside laboratories indicating instrument accuracy.
  • Identification of the standards used in performing the calibration.
  • Identification of the procedure employed in performing the calibration.

4.5.1.4 Traceability Documentation

The record will provide all documentation that substantiates and identifies the means of achieving direct or indirect traceability in terms of nationally or internationally recognized standards.

4.5.1.5. Logbook

Logbooks will be kept for all M&TE and will contain data covering calibration, repair, maintenance, and cleaning of equipment. These logbooks will be stored in the Metrology laboratory.

4.5.1.6. Retention

The Metrology Laboratory will retain calibration records for a period of not less than five years to allow sufficient time for analysis of data and decisions to be made pertaining to calibration interval adjustments. Calibration records may then be transferred at the discretion of the corporate meterologist to archive filling cabinets stored in the metrology laboratory or other controlled archival areas located on company premises. To ensure compliance with regulatory requirements, these records must then be retained for an additional fifteen years or until the expiration date of products being produced has been reached, whichever is greater.

4.6 Scheduling System:

In order to optimize the management of the equipment inventory, a computerized system will be utilized to maintain a system for scheduling the periodic calibration of equipment. This computerized system will provide for the following:

Scheduling of calibrations of M&TE on the due date or within the Grace period specified in section 4.1.6 of this document. In some cases, it may be appropriate to calibrate M&TE before use, not on a periodic schedule.

  • Allow for user notification of pending calibrations in order to resolve scheduling conflicts.
  • Provide a mechanism for interval extensions in the event that scheduling conflicts cannot be resolved due to production schedules or critical tests.
  • Identifying or removing from service equipment which has exceeded the calibration due date.
  • When new equipment is received, it must be entered into the calibration program before being put into service.

4.7 Labeling Practice:

In order to alert the user to the status of a piece of equipment, all calibrated equipment will be labeled or coded to indicate its status. Labels have been designed and made of materials suitable to the working environment. Examples of labels would be “CALIBRATED”, “CALIBRATION NOT REQUIRED”, and “LIMITED CALIBRATION” labels identifying the equipment status.

4.7.1 Function

Labeling of equipment will be performed to serve the following functions:

  • Alerts the user to its calibration and operation status.
  • Shows that the instrument is part of the inventory and scheduling system.
  • Shows that each piece of equipment has been studied regarding its need for calibration or maintenance.
  • Applies tamperproof seal (where appropriate) to prevent operator adjustment.

4.7.2. Location

Where practical, all labels will be placed in a prominent place on the instrument. This alerts the user to its calibration status.

4.7.3 Content

The calibration labels will include:

  • Date of last calibration
  • Date due (or usage time) for re-calibration.
  • The person responsible for the calibration
  • Calibration certificate number.

4.7.4 Labeling Impracticality

When the size or function of an instrument precludes the application of a label, a coded marking should be applied to indicate calibration status. Where this is not possible, a copy of the Calibration Certificate will be forwarded to the user. It is the user’s responsibility to be aware of its calibration status. The user will be notified by metrology one month prior to the calibration due date of the instrument.

4.7.5 System Calibration

System calibrations involving many individual calibrated components require calibration labels affixed to each calibrated component and a single label affixed to the system as a whole in a prominent location.

4.7.6 Representative Types

The representative types, which will be used, are as follows:

  • Standard Calibration Label – supplied by the applicable Standards Laboratory and applied to metrology references and standards only.
  • Calibration Label – Placed on instruments calibrated, as required, on a periodic basis. Available in Critical and Non Critical formats.
  • Calibration Not Required – Place on instruments which by their nature of use do not require calibration.
  • Calibration Void if Seal Broken – indicates that calibration is invalid if the seal is removed.
  • Do Not Use Until Tested and Calibrated – Indicates that the instrument has not been certified for use and must not be used for GMP activities until certified by Metrology.
  • Rejected – Indicates that the instrument failed calibration and must be repaired or replaced.

4.8 Calibration Procedures:

Standard Operating Procedures (S.O.P.’s) will be prepared containing sufficient information for the calibration of measurement equipment.

4.8.1 Requirements

4.8.1.1. Source – The calibration SOP’s will be prepared internally.

4.8.1.2 Completeness- The SOP’s should contain sufficient instruction and information to enable qualified personnel to perform the calibration.

4.8.1.3 Approval – All internally prepared procedures must be approved before use by the individuals responsible for SOP approval.

4.8.2 Format

The internal procedures should include information such as:

  • SOP Title – Manufacturer, type or model number of equipment to which the SOP applies.
  • Purpose – This will define the purpose of the SOP
  • Required Documentation and Materials – A list of all applicable reference materials, manuals, check sheets, calibration standards, associated equipment and accessories required to perform the calibration.
  • Safety – (As required) describes any safety considerations that must be observed.
  • Procedure – Description of the calibration process with any required references, calibration check sheets, environmental considerations, data sheets, and other information helpful or necessary to perform the calibration.
  • Acceptance Criteria – This will include the acceptable accuracy limits for the instrument under test which will be used to define whether an instrument has passed or failed.

5.0 CALIBRATION QUALITY

The Calibration Control System will be designed to achieve and maintain a high level of quality consistent with the calibration program requirements.

5.1 Calibration Quality Levels:

Quality levels may be determined in terms of equipment groupings with similar characteristics or for individual systems. The quality level of M&TE may be expressed as average in-tolerance rate, acceptable quality level, failure rate, or any other means which provides a meaningful measure. M&TE quality levels will normally be expressed in terms of average in-tolerance rate.

5.2 Deviation From Quality Level:

If a quality level is consistently above or below the specified quality level, actions may be taken to reduce the difference between the specified intended goal and the actual quality level. Typical of such actions are:

Interval Adjustment

– Procedure Change

– Revision

– Removal of Equipment from Service

– Instrument Repair and/or Refurbish

– Instrument Upgrade

6.0 ENVIRONMENTAL CONTROLS OF THE METROLOGY LABORATORY

The calibration environment will be controlled to surpass the parameters required by the most environmentally sensitive measurement performed in the area. To ensure continued calibration accuracy, acceptable ambient operating conditions have been established. Control of essential environmental factors such as temperature, relative humidity, air pressure differentials, vibration, electromagnetic interference, and voltage regulation of electrical power will have been considered during the construction phase.

6.1 Metrology Ambient Operating Condition Limits:

Metrology Ambient Temperature, Relative Humidity, and general cleanliness will be monitored on a continual day-to-day basis. Chart recorder or electronic records of the temperature and humidity will be kept on file for a period of 10 years.

6.1.1 Temperature will be monitored on a continual basis utilizing an NIST or equivalent traceable circular chart recorder.

  • The Metrology Laboratory ambient temperature must be 22ºC ± 2ºC.
  • Relative Humidity must be 20% – 40% with no more than a 5% change in the reading over a one-hour period.

6.2 Cleanliness:

Cleanliness should be maintained to the proper degree in the calibration areas.

This cleanliness condition is to be consistent with “Good Housekeeping Practices”.

6.3 Loss of Environmental Controls:

In the event that environmental control is lost and the ambient operating conditions exceed the established limits, all calibrations within the effected areas shall stop until either; Control is returned and an appropriate stabilization has been achieved.

An evaluation of the effects indicate that the loss of control has no detrimental effect to the area calibration.

NOTE: The length of the stabilization time will be determined by environmental variables. All controlled variables must return to within normal operating parameters and remain constant during three consecutive measurements taken within a 30-minute period to be considered stable.

6.4 Field Calibrations:

Calibrations will be performed under normal laboratory conditions. Temperature and humidity shall be monitored and recorded in the Metrology logbook during the calibration process.

7.0 PERSONNEL REQUIREMENTS

7.1 Selection and Training:

The selection and training of competent personnel is an important consideration in establishing and maintaining an effective Calibration Control Program. Calibrations should be performed by personnel having the necessary education, training, background, and experience.

7.1.1 Technical / Academic Requirements

The following Technical/Academic requirements should be sought in a Metrologist:

– Academic High School Diploma or equivalent;

– Instrumentation Diploma from a recognized Technical Institution or equivalent;

– Journeyman Instrument Mechanic Trade Certificate or equivalent experience directly related to the trade preferred but not required;

– Certified Engineering Technologist (C.E.T.) designation preferred but not required.

7.1.2 Education/Training

Personnel performing calibrations of measurement instrumentation and devices should have technical education and training in the area of job assignment. This includes calibration aspects of GLP and GMP’s, documentation, calibration procedures, calibration adjustments, and use of measurement equipment and standards.

7.2 Qualifications Documentation:

7.2.1 All Certificates, Diplomas or other documentation relating to the qualifications of a metrologist shall be kept in a file to be produced upon request for inspection. This file shall be held separate from the personnel file, which is to remain personal and confidential.

8.0 COMPUTER SOFTWARE

8.1 Calibration Control Program Maintenance

Computer Software will be used to assist in the maintenance of the Calibration Control Program.

8.2 Calibration Data Trending and Analysis:

Commercial software will be used to trend and analyze instrumentation calibration data. This analysis will determine the optimum calibration interval, which is not to exceed one year.

8.3 Automation of Calibration Testing:

Software may be developed or purchased from a vendor to be used in conjunction with M&TE to automate calibration routines and the acquisition of calibration data.

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