QP1170 Monitoring-Measuring Resources Control

Policy: Harington Signal Inc. shall provide the resources needed for monitoring results to verify product and service conformity to requirements.
Purpose: To define the criteria, methods, and controls to ensure valid and reliable monitoring results when measuring is used to verify the conformity of products and services to requirements.
Scope: This procedure applies to employees performing monitoring and measurement activities to provide evidence of product and service conformity to requirements.
Responsibilities: The Manufacturing Manager and Equipment/Tooling Maintenance Manager are responsible for the measuring instrument (device) calibration program.

The Quality & Manufacturing Managers are responsible for ensuring subcontractor monitoring and measuring systems are adequate to ensure compliance with safety and quality requirements.
  All Employees are responsible for verifying that instruments they use to monitor processes or measure items are within their calibration periods and for ensuring that such instruments are capable of measuring to required accuracy/tolerances.
Definitions: Calibration – Comparison of a measurement standard or instrument of known accuracy with another standard or instrument to detect, correlate, report, or eliminate by adjustment any variation in the accuracy of the item being compared.
  Calibration period – Period during which a certified calibration is valid (e.g., measuring equipment calibrated in February and certification expires in February of next year, calibration period = twelve months).
  Monitoring – Routine measurement or observation of monitoring/ measuring equipment, to check its functionality.
  Monitoring and measuring resources – People and devices used to collect data and measure, gauge, test, inspect, or otherwise examine items to determine their compliance with specifications.
  Reference standard – Standard of the highest order of accuracy in a calibration system, establishing basic accuracy values for that system; typically traceable to a recognized standards body like NIST (USA) or INMS (Canada).
  Traceability – The ability to relate individual measurement results to national standards or nationally accepted measurement systems through an unbroken chain of comparisons.

 
   

Procedure:

1.0       Monitoring and Measuring – EMPLOYEE requirements

    1. All employees performing monitoring and measurement activities shall receive appropriate measurement training in accordance with QP1070 COMPETENCE AND AWARENESS. Typical training shall include the measuring device that that employee intends to use. Typically, a calibration sticker – listing the calibration date, expiration date, instrument identification number, and initials of the person calibrating or mark of the calibrating company – is attached to the calibrated equipment. If it is impractical to attach the calibration sticker directly to the device, it should be attached to the device container or in the immediate vicinity of (e.g., kept in the same drawer/cabinet) where the equipment is kept.
    2. In all instances, the organization shall keep a record of equipment calibrations
    3. All employees performing monitoring and measurement activities designed to provide evidence of product conformity to quality should verify that measuring instruments they use are within their calibration period prior to using them.

2.0       Storage, Handling, and Maintenance

    1. Inspection, measuring and test equipment, and measurement standards shall be calibrated and utilized in an environment controlled to the extent necessary to assure continued measurements of required accuracy, giving due consideration to temperature, humidity, vibration, cleanliness, and other controllable factors affecting precision measurement.
    2. Monitoring & measurement employees shall ensure the use of measuring instruments in the conditions for which they were designed by the manufacturer.
    3. All inspection, measuring, and test equipment shall be handled, stored, and transported so as not to adversely affect the calibration or condition of the equipment.
    4. It is the monitoring and measuring equipment holder’s responsibility to verify that the calibration sticker is present and that the dates are valid before using the instrument. Monitoring/measuring equipment without a tag is considered out of calibration and the Quality Manager must be notified of such situations.NOTE: Equipment not requiring calibration should be tagged or otherwise identified “No Calibration Required”.
    1. When it is not in use, each portable measuring tool or instrument shall be kept clean and maintained in its protective container or otherwise protected (e.g., shrink wrapped) from environmental debris and abuse.
    2. It is the responsibility of everyone using measuring and test equipment to alert the Tooling/Equipment Maintenance Manager in the event of accidental damage or any irregularity between calibrations. The Tooling/Equipment Maintenance Manager shall ensure the validity of previous measuring results against the CALIBRATION DOCUMENT DATA.
    3. Where possible, monitoring and measuring equipment must be protected from any adjustment that might invalidate the calibration and, hence, invalidate any result.

3.0       Calibration System

    1. The Tooling/Equipment Maintenance Manager is responsible for maintaining the monitoring and measuring equipment calibration database; see CALIBRATION DOCUMENT DATA. The purpose of the database is to identify equipment location, calibration status, calibration frequency, range of accuracy, and calibration history.
    2. The calibration database shall also identify those instruments that may be used as working or reference standards to calibrate other instruments.
    3. The annual calibration of equipment is performed by a third party each year.
    • It is generally the equipment holder’s responsibility to return portable monitoring and measurement equipment to the Tooling/Equipment Maintenance Manager for calibration. (The “equipment holder” is the person responsible for the process where the monitoring/measurement equipment is in use.)
    • Calibration employees are responsible for non-portable equipment.
    1. The Tooling/Equipment Maintenance Manager shall ensure that maintenance and calibration of monitoring and measuring equipment is performed in accordance with the manufacturer’s specifications and that environmental conditions are suitable for the calibrations, inspections, measurements, and tests as they are being carried out.
    2. Frequency of calibration for each piece of monitoring and measuring equipment is established by the Quality Manager and Tooling/Equipment Maintenance Manager  and is based on the type of measurements made, the frequency of use, manufacturer specifications, and the calibration history of the device.
    3. A default frequency of once every twelve months shall be used, unless otherwise indicated by the Quality Manager. The Quality Manager may adjust the calibration frequency at any time.
    4. The Quality Manager shall maintain records pertaining to calibration, repeatability, and reproducibility of data in the CALIBRATION DOCUMENT DATABASE. Each document in the database shall include, at a minimum, a unique equipment identifier (e.g., equipment name and ID), calibration date, calibration method, standard used, condition of equipment as received, any adjustments or repairs required, calibration measurement data, and identification of the person or company performing the calibration.
    6. Standards used to calibrate equipment must be traceable to NIST or other recognized national or international standards (see “Additional Resources” for a partial list of standards bodies). If no such standard exists, the basis used for calibration of verification shall be recorded.
    7. Specific written calibration instructions are used for each piece of equipment or family of equipment. Procedures shall include the following requirements as appropriate for the device:
    • The calibration shall be done by comparison to working standards, traceable to NIST or other comparable standard with an accuracy of 4 to 10 times greater than that of the measuring tool being calibrated.
    • The comparisons shall be made at multiple points across the full range of use of the device, to ensure linearity.

References:

Calibration Log

Calibration Records – 2018

4.0       Out-of-tolerance Conditions

    1. If monitoring/measuring equipment is found out of tolerance, the Tooling/Equipment Maintenance Manager or Quality Manager shall contact the appropriate Manager in the department where the instrument is used, to determine what product(s) may be affected.
    2. The Department Manager and the Quality Manager will analyze the effects of invalid measurements, contact affected customers, and, if necessary, take immediate and appropriate remedial action for affected in-process or finished products.Reference Procedures:
      QP1030 CONTROL OF NONCONFORMING OUTPUTS.

5.0       Control of Subcontractor Calibration

5.1       Tooling/Equipment Maintenance Manager and the Quality Manager shall be responsible for assuring that subcontractors’ calibration systems conform to requirements.

Referenced Procedures:

QP1120 EXTERNAL PROVIDER EVALUATION

 

5.2       Calibration may be performed in-house or contracted out to a third party that has been evaluated to ensure that it complies with or exceeds requirements set forth in ANSI/NCSL Z540 or the equivalent (Reference “C”).

5.3       If in-house standards are used by a contractor to calibrate device-related measuring equipment, these standards must be documented, used, and maintained the same as other documented information.

6.0       Test Software

6.1       Where test software is used as a form of inspection or testing, it will be checked to prove it is capable of performing the required verification of product acceptability and will be rechecked (reevaluated) at prescribed intervals.

6.2       Records of the initial check and scheduled rechecks will be maintained in the CALIBRATION DOCUMENT DATABASE.

Effectiveness Criteria:

  • Availability of calibrated monitoring and measuring resources
  • Use of appropriate devices for the measurements required
  • Certification of calibration(s)
  • Calibration records
  • Additional Resources:

 

Revision History:

Revision Date Description of Changes Approved By
0.0 07/03/17 Initial Release Jim Theesfeld
1.0 8/17/18 Digitized version Todd Gifford