QP1180 Monitoring – Measurement

Policy: Harrington Signal Inc. shall provide suitable monitoring systems (and, if applicable, measurement systems) to ensure the quality of products and processes and to produce evidence that systems are producing planned results.
Purpose: To establish the methods Harrington Signal Inc. uses to monitor and, where possible, measure the effectiveness of Quality Management System processes.
Scope: This procedure applies to all Quality Management System processes.
Responsibilities: Department Managers are responsible for producing and using process monitoring and measuring data to continuously improve Harrington Signal Inc.’s Quality Management System.

The Quality Manager is responsible for the accuracy of all process monitoring and measuring devices.
Definitions: Monitoring and Measuring Equipment – Devices used to collect data and measure, gauge, test, inspect, or otherwise examine items to determine their compliance with specifications.

 

 

 

Procedure:

1.0           General Monitoring & measuring requirements

    1. Department Managers shall identify process parameters to be monitored and/or measured to ensure effective, ongoing control of processes they manage.
    2. Additional process parameters shall be monitored and/or measured and recorded as specified in relevant written operating instructions.
    3. All personnel performing monitoring and measurement activities that are needed to provide evidence of control of processes must use calibrated equipment, in accordance with QP1170 MONITORING-MEASURING RESOURCES CONTROL.
    4. Where the output of a process cannot be verified by monitoring/measurement and, as a result, deficiencies appear only after the product is in use, the Manufacturing and Quality Managers shall:
  • Develop and implement a plan for validating the process;
  • Develop definite criteria for reviewing and approving the process;
  • Review and approve process-related equipment and training of production personnel;
  • Ensure that specific methods and procedures are developed for use;
  • Develop validation record requirements and ensure that validation records are maintained; and
  • Establish arrangements for revalidation.

2.0           Reporting MONITORING/MEASUREMENT DATA

    1. Department Managers shall maintain reports on process monitoring and measuring data for periodic analysis, in accordance with QP1200 DATA ANALYSIS-CONTINUAL IMPROVEMENT. If monitoring/measurement data are automatically logged, reports shall also be available for data analysis review.
    2. The Departmental Manager shall periodically review monitoring and measurement data available, summarize its analysis, and report to Top Management. This should be done at least annually at Management Review meetings (see below); more frequent analysis and reporting may be required.

3.0           PROCESS NONCONFORMITY

    1. In the event of process nonconformity, the affected Department Manager shall immediately notify the Quality Manager of the situation.
    2. If necessary, the Quality Manager and the Department Manager shall locate, identify, segregate, test, and dispose of all potentially affected materials, components or products in accordance with QP1030 CONTROL OF NONCONFORMING OUTPUTS.
    3. If appropriate, the nonconforming process should be shut down until the nonconformity is identified and appropriate action is taken in accordance with QP1040 NONCONFORMITY AND CORRECTIVE ACTION.
    4. However, if the Quality Manager and Department Management determine that shutting down the nonconforming process poses unacceptable costs or risks, they may elect to continue production, in which case process operators shall identify and treat all resulting materials as Nonconforming Product, in accordance with procedure QP1030, until the nonconforming condition is corrected.

4.0           Review OF PROCESS MONITORING/MEASUREMENT

Process monitoring and measurement reports and results shall be reported to Management at Management Review meetings, in accordance with QP1060 MANAGEMENT REVIEWS.

 

Effectiveness Criteria:

      • Records of process monitoring and measurement exist and are being analyzed to improve those processes
      • All materials, components, and products processed under out-of-control conditions are located, identified, tested, and positioned appropriately
      • Frequency and severity of out-of-control conditions are reduced or eliminated

 

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