9.1.1 General
Measurement, monitoring, analysis, and evaluation are critical for the assessment of the performance of the quality management system (QMS). The goal is to reflect the quantitative and qualitative performance of the QMS and to report the degree to which processes meet their stated objectives. This activity is regarded by the ISO 9001 Standard as one of the tools that promotes improvement of the QMS. Clause 9.1.1—General—lays the required principles to be considered while determining and creating methods for monitoring measurement analysis and evaluation of processes or process results. In other words, when you plan, determine, and define how you will monitor, measure, analyze, and then evaluate a process or its outputs, make sure that you are applying and practicing the following principles (the ISO 9001Standard requirements):
- The organization shall determine which quality elements shall be monitored and measured.
- Methods for monitoring, measurement, analysis, and evaluation shall be determined.
- The methods shall define which activities are needed to ensure valid results of monitoring and measurements.
- The methods shall define the stages and the intervals in the process when activities of monitoring and measurements must be performed.
- The methods shall define when results of monitoring and measuring shall be analyzed and evaluated.
- The results shall enable the evaluation of the performance and the effectiveness of the QMS.
- Documented information on the results of the monitoring, measurements, analysis, and evaluation shall be retained.
Terms and Definitions
Before we begin, let us understand the difference between monitoring, measuring, analyzing, and evaluating a process:
- Monitoring—a continuous inspection or observation of process performance or process output for a special purpose through a defined scope (e.g., with a sample size or over a period of time) and maintaining records of those observations
- Measurement—the activity of delivering data to a method in order to define objectively a quantitative or qualitative measure and capturing a situation without any references to the significance
- Analysis—a set of techniques for examining trends and tendencies of measurements of an output (process or product)
- Evaluation—the action of comparing a process or process output measurements against given criteria to determine the performance of the process or conformity of a process output
Goal of Monitoring, Measurement, Analysis, and Evaluation
The goal of monitoring, measurement, analysis, and evaluation is to provide the decision makers an understanding through a situation report concerning the performance of processes. The data that the monitoring, measurement, analysis, and evaluation provide shall relate directly to the controls suggested by the standard such as supplier evaluations or control of nonconform products. Those activities shall indicate the effectiveness of the QMS and the extent to which the QMS achieves its quality objectives. This type of reporting shall regularly provide the different organizational units data and information regarding quality issues.
These needs should be known and available through the outputs of the process approach—which processes must be measured in order to control their performance and verify their conformity. In clause 4.4—Quality management system and its processes—you were required to
- Determine the processes needed for the QMS
- Evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results
- Improve the processes and the QMS
In other words, for each process, with outputs having an effect on the quality of the product (or service), a suitable method for measuring and monitoring must be planned and applied. The method shall be planned in accordance to the nature of the process and the nature of its outputs. Regarding the quality objectives, for each area in the QMS, the relevant quality objectives are defined. The definition of the quality objectives should relate to specific realization activities. Now it is required to define
how these quality objectives shall be monitored and measured or in other words to break down the quality objectives into operational measurements:
- Which processes and activities must be monitored?
- Which process outputs must be monitored and measured?
- Which methods shall be used for monitoring the activities and measuring the data?
What are the advantages of implementing monitoring, measurement, analysis, and evaluation?
- Implementing a systematic control of the realization processes
- Identifying deviations in time and submitting them to a controlled process for treatment
- Allowing users of the QMS to make decisions regarding results of processes
- Allowing the users of the QMS to prevent nonconformities by identifying gaps in a process and preventing the transition of conconform outputs to the next process
- Determining the effectiveness and efficiency of processes
- Using the monitoring, measurement, analysis, and evaluation as means for continual improvement
- Promoting the achievement of quality objectives through key process indicators related to the objectives of the organization
Defining the Methods for Monitoring, Measurement, Analysis, and Evaluation
Each monitoring and measuring activity must be conducted according to a defined method. The goal is to identify, for each process, the parameters of outputs that affect its quality and determine the activities necessary to ensure valid results, activities that will ensure that the monitoring and measurement deliver results that can be analyzed and evaluated. The methods shall enable a comparison of the results with the objectives, for example, measuring the performance of a machine where the results are ranked in within upper and lower limits. Such ranking provides the status of the process—either within tolerances or not. The new revision of the ISO 9001 Standard (2015) does not separate the requirements for monitoring, measurement, analysis, and evaluation of products or processes. But there are some distinctive requirements that I would like to discuss.
When monitoring and measuring a process, the following issues shall be referred:
- Identification of the processes or process outputs that must be monitored and measured
- Identification of those parameters or outputs that may indicate how the process behaves
- Identification of the function or the role responsible for conducting the activities of measurement (designated employees, a certain department, organizational unit, etc.)
- Definition of parameters for monitoring such as process conditions, interval, sampling rates, batch loads, and quantities
- Description of the stages during the process where measurement activities shall be undertaken
- Tools, equipment, or software required to perform or assist in the measurement
- The activities and the use of techniques of measuring the process
- Where and how the results must be documented
- The criteria necessary for the evaluation of the results (the objectives)
- Action required in case nonconformities are detected
This webpage contains only a fragment of the chapter 9 – Performance Evaluation from the book: ISO 9001: 2015 – A Complete Guide to Quality Management Systems published by:
Why choose the book ISO 9001: 2015?
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