9.0 Performance Evaluation

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9.1 Monitoring, Measurement, Analysis and Evaluation

9.1.1 General

You should note the additional requirement for your organization to evidence the evaluation of the results of monitoring and measurement, not just their analysis and confirm that your organization has considered what, how and when to measure and that the outcomes from decisions result are ensuring appropriate process control.

Also note a new requirement to monitor the performance and effectiveness of your organization’s quality management system. You should expect to see that your organization has developed a process (method, techniques, format, etc.) to identify, collect and analyze various data and information from both internal and external sources, including:

  1. Monitoring and measuring results;
  2. Process performance results;
  3. Meeting objectives;
  4. Internal audit findings;
  5. Customer surveys and feedback;
  6. 2nd or 3rd party audit results;
  7. Competitor and benchmarking information;
  8. Product test results;
  9. Supplier performance information.

This ‘input’ (information and data) should reflect upon the adequacy, suitability and effectiveness of the quality management system and its processes. The ‘output’ (result of the analysis) must provide information (understanding, insight, awareness, confidence, knowledge of, etc.). The analysis output must provide insight to:

  1. Customer satisfaction and perception;
  2. Product conformance;
  3. Process performance;
  4. Product and process characteristics;
  5. Trends in products and processes;
  6. Opportunities for preventive action;
  7. Suppliers and subcontractors.

Other potential or useful options might include:

  1. Need for corrective action;
  2. Opportunity for improvement;
  3. Competition.

It is important to document and retain as evidence the results of the evaluation of the performance of the quality management system. The quality objectives and the related KPIs established under Clause 6.2 provides useful input into addressing this clause. Monitoring and measuring QMS operations and activities will establish a mechanism to ensure that your organization is meeting its policies, objectives and targets. In order to meet this requirement, your organization must perform six steps:

  1. Identify the activities that can have a significant impacts and risks;
  2. Determine key characteristics of the activity to be monitored;
  3. Select the best way to measure the key characteristics;
  4. Record data on performance, controls and conformance with objectives and targets;
  5. Determine the frequency with which to measure the key characteristics;
  6. Establish management review and reporting.

Establish the monitoring and tracking criteria for each activity that has a significant impact or risk and review the action plan. You should incorporate any monitoring and measurement information to cover these same activities.

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