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ISO 9001 Blog

Mark Hammar

Monitoring and Measurement: The basis for evidence-based decisions

Monitoring and measurement comprises a main part of the ISO 9001 standard, and for good reason. One of the main principles of a good quality management system, upon which ISO 9001 is founded, is evidence-based decision making. The most important application for the data gained is to compare the actual results of a process and compare them to the desired results that were set as the quality objectives for that process in order  to see how well the improvement is proceeding (See How to Write Good Quality Objectives for more information on these objectives). In order to have this as a main principle you need to have evidence to use for making decisions. Monitoring and measurement gives you this evidence.

Monitoring vs. Measurement: What is the difference?

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Monitoring and measurement are used together throughout the ISO 9001 standard, but they each have different meanings. To monitor is to watch closely in order to observe, record, or detect; in effect, it’s an act of surveillance. Meanwhile, measurement is the act of determining the actual traits of something (such as dimensions, capacity, etc). So, monitoring could be used as a method to determine if a process is starting to approach a limit (an example would be a monitoring alarm on the process), but measurement would be used to determine the actual value of the characteristic in question and how much it differs from a required value. Both are valuable tools, but give different evidence for decision making.

Here are the main places that the ISO 9001 requires monitoring and measurement to be used.

Monitoring and Measurement of Processes

The processes of the quality management system need to be monitored, and measured if possible, to ensure that they are performing as designed – what the standard calls achieving planned results. Ensuring that your process is behaving as planned is the first step in being able to improve the process, which is the goal of having a QMS. So, for each process, comparing the results to the expected results that were planned per the objectives, and correcting the process when results don’t meet expectations, is crucial. For instance, if you are monitoring your process for corrective actions, which is planned to have no repeat problems after a corrective action is determined to be effective, but your company continues to have problems repeat, the process needs to have the root cause of this problem identified and addressed to achieve effectiveness.

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An important note in the standard relates to the fact that trying to monitor and measure everything to the greatest extent is not only costly, but often close to impossible. For this reason the standard advises that you consider the impact that the process has on product conformity and the effectiveness of the QMS when you decide on the method of monitoring or measurement. If the process is not critical for making the product conform, then a lower level of intensity in monitoring may be acceptable.

Monitoring and Measurement of Product

Since making sure that the product or service requirements have been met is the first step in ensuring customer satisfaction, the requirement on monitoring and measuring product is important. The key parts of monitoring and measuring product are to verify the characteristics against requirements at planned and appropriate stages of the process, then maintain records showing the conformity of the product to the acceptance criteria.

The planned arrangements for the product or service comprise all of the requirements for acceptance and creation of the product or service. An example for a product could include the test requirements that need to be met, requirements for size, weight and dimensional measurement, and sometimes even the environment that the product needs to be created in such as cleanliness requirements for food production.

For the final release of product to the customer, the release is not to proceed until the product or service meets the planned arrangements, sometimes called the product quality plan, and the records approving the release must show who authorized the release. Deviations are only allowed via the approval of a relevant authority and the customer when applicable.

Evidence-based Decisions

As you can see, if your company is to trying to make good evidence-based decisions to improve its effectiveness and efficiency, the evidence needs to be accurate and adequate to assess whatever process or product is being reviewed. Well thought out  application of monitoring and measurement throughout the quality management system can help to ensure that the evidence used to make decisions best meets the needs of those making the decisions. This will help to better improve not only the QMS through improvement activities and the quality objectives, but also how well the customers perceive the company.

Click here to see a free sample of  Matrix of Key Performance Indicators.

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3 responses to “Monitoring and Measurement: The basis for evidence-based decisions”

  1. feroz says:

    the standard says to measure the capability of the process not the results of the process, is the above description relevant

  2. feroz says:

    the standard says “These methods shall demonstrate the ability of the processes to
    achieve planned results.”

    the statement ability of the processes is not related to the output of the process,

    when the planned results are not achieved,
    where i.e. on what the correction and corrective action shall be taken
    do I need to take correction and corrective action on the process (i.e. work flow of the process, ) , or the process will be as it is and take correction and corrective action on the deviated output of the process

  3. Mark Hammar says:

    Feroz,

    I am not completely sure I understand, but what you are measuring is the ability of the process to meet the planned results. For a production process this could very well mean measuring the product, and if it is acceptable then the process meets the planned results. For another process, such as the internal audit process, then the planned results might be to reduce the number of repeat non-conformities found by taking adequate corrective action when a nonconformitiy is found.

    In all cases of a nonconformity you take correction to address the nonconforming output, and you take corrective action on the root cause of the problem that caused the nonconformity (when this is determined to be necessary). This corrective action could be on the workflow of the process if that is where the root cause was found. However, if the root cause was found in the materials used for the product for instance then this could be outside the process that it was found at.

    I hope this answers your question
    regards,

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