Clause 9.1 Monitoring, Measurement, Analysis and Evaluation (secrets)

Table of Contents

Requirements For Processes
Specific Requirements For Clause 9.1
ISO 45001 Specific

9.1 Monitoring, measurement, analysis and evaluation (secrets)

Measurement, monitoring, analysis, and evaluation is the process used to critically evaluate the effectiveness of the management system. A management system is designed to promote continual improvement, and the process that you use to gauge if this is happening is by monitoring, measuring and analysing the results. Of course, what you choose to monitor and measure is entirely up to you and there could be hundreds of items on your list. Ultimately, it will depend upon your organisational context and the items will differ between management systems. For example, for ISO 14001:2015 you would be monitoring your controlled discharges, for ISO 45001:2018 you would be monitoring your accident rates and for ISO 9001:2015 you might choose to monitor the frequency of non-conforming products.

This clause requirement is ensuring that you have a plan for your monitoring, measurement, analysis and evaluation processes. These planned processes will need to become part of your documented management systems. Roles, responsibilities and authorities will need to be assigned and your internal audit function will need to incorporate these processes into its schedule. Monitoring might include visual observations including people and/or machines, gauges or the analysis of automated data on a computer screen such as the operating temperature of a machine.

I think it would be a good idea to define the language for monitoring, measurement, analysis and evaluation;

Monitoring: determining the status of a system, a process, a product, a service or an activity (ISO (9000).
Measurement: process to determine a value (ISO (9000).
Analysis: a detailed examination of anything complex to understand its nature or to determine its essential features.
Evaluation: To determine the significance, worth, or condition of usually by careful appraisal and study.

From a high-level perspective, we perform monitoring, measurement, analysis and evaluation to determine if a task, procedure or process is achieving its intended outcome. The requirement is also asking you to assess if your management system is achieving its intended outcomes and also demonstrating continual improvement. Is the management system achieving its quality objectives? Are products exceeding an acceptable tolerance limit? Are you failing to deliver on the terms of a customer service contract? Only by implementing a monitoring, measurement, analysis and evaluation process are you able to answer these questions.

Requirements For Processes

In clause 4.4 – Quality management system and its processes you were required to:

(d) Determine the processes needed for the QMS
(g) Evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results.
(h) Improve the processes and the QMS.

Determine: a systematic analysis of the task, and its intended outcomes will be required so that processes can be designed to ensure the task is performed without error.

Evaluate: use evaluation methods to assess if your process control designs are functioning effectively.

Improve: where faults in process control are identified, perform root-cause analysis and corrective action procedures as part of your continual improvement process.

Does this sound like Plan, Do, Check, Act? It should because this is what is happening here. Plan, do, check, act is the energy and driving force that feeds the concept of continual improvement in the management system. This isn’t rocket science, and I would imagine that you are doing all of this on a day-to-day basis. The management system is simply asking you to formalize your monitoring, measurement, analysis and evaluation activities into a planned, documented process and with assigned roles, responsibilities and authorities. Implementing this process does have advantages including:

Better customer service
Reduction of nonconforming outputs
Reductions in waste
Reductions in the use of materials
Savings in energy costs
Savings in time
Using monitoring, measurement, analysis and evaluation for continual improvement
Determining the effectiveness of processes

You monitor and measure tasks, activities and processes to determine the effectiveness of process controls so that tasks and activities can achieve their intended results. The data produced from monitoring and measuring is the input to the analysis and evaluation processes. The final output is used to measure against objectives that have been set and to indicate if the objectives are being achieved effectively.

I’ve mentioned already how the requirement of clause 4.4 relates to this requirement. Other clauses within the standard are related to monitoring, measurement, analysis and evaluation including; 6.2 requirements for the monitoring of objectives, 7.1.5 monitoring and measuring resources and 8.6 the release of products and services. Let’s not forget, the internal audit requirements of clause 9.2 are essentially a form of monitoring how your processes are performing according to their intended outcomes. The specific requirements for monitoring, measurement, analysis and evaluation are clause 9.1 are as follows;

Specific Requirements For Clause 9.1

You shall determine:

What needs to be monitored and measured; as mentioned earlier, this list here is endless and will be dependent upon your organisational context. For ISO 9001:2015, and high on the list, you will definitely want to monitor your customer focus processes (5.1.2). The customer is at the heart of your QMS and every single activity that you perform must, in some way, contribute to improving the products and/or services that you provide to them. For ISO 14001:2015, you will want to monitor your objectives at reductions in energy and waste to landfill. I’m mentioning these first only because these are very obvious target objectives that a 3^rd party auditor will be assessing. For ISO 45001:2018, you will be monitoring your accidents, incidents and near misses. As these processes feed directly through to the corrective actions process, you will also monitor this for effectiveness. Again, I’m mentioning these processes first as they will be the focus of a 3^rd party auditor. When determining what to monitor and measure, think in terms of risk and what would be the severity of the consequences should the process fail. Begin by making a list of your high-risk processes first, and move backwards from there. The progress towards achieving objectives is essential. Don’t forget to monitor the needs and expectations of interested parties
The methods used to monitor and measure; are you monitoring by the use of observation? This might include observing an operative performing and completing a specified task, or observing a mechanised robotics machine performing a task. Are you using a sound meter to monitor noise levels in a production environment? Are you observing and recording a pressure gauge or a temperature gauge? Are you monitoring live traffic flows on a motorway or the queues at a supermarket till? Are you monitoring a live feed to a computer monitor that displays fluctuations on the stock market? Monitoring will often require real-time active monitoring but can also involve the passive monitoring of captured data such as video recordings etc. The method required by you in your particular context will be dictated by the data requirements. If you are using calibrated instruments to perform a monitoring activity such as a humidity analyser, be sure it conforms to the requirements of clause 7.1.5
When to monitor and measure; this will often be controlled by the related levels of risk. A high-risk process might require constant, real-time monitoring such as a high-pressure system for example. The data from the system will be fed through to a data display where the current status can be monitored. Another good example of this is the screen display of an aircraft controller. The task of the controller is to monitor, in real-time, the status of air traffic movements. An example of a monthly monitoring activity could include the gauge readings from a controlled release valve. These readings are normally required by your local regulating authority (UK). Monitoring might only be formed as and when required for a specific task such as the particulate levels in an explosive environment before a cleaning or maintenance task. Monitoring activity is required after a corrective action has been implemented so that the effectiveness of that action can be assessed.
When will the results be analysed and evaluated; will the results need to be evaluated in real-time? Referring back to my previous example, the measuring of particulates in an explosive atmosphere will normally take place very quickly. This is because atmospheres can change due to fluctuations in humidity and temperature. Evaluating and analysing the data on the air traffic controllers display is performed in real-time as you can imagine. The results from a sound meter used to measure the noise in a production environment are monitored in real-time. In this example, a safe noise threshold will permit the process to continue, however, if the safe threshold is exceeded causing danger to persons working within the environment, the process will be stopped. Data gathered from other sources such as a customer survey, for example, will be analysed at a later date. The frequency between the data collection, and the subsequent evaluation will also be affected by risk. Annual evaluation of data is normally discussed during a management review meeting where data is presented in the form of pie and bar charts etc.
Evaluate the effectiveness and performance of the management system; I would imagine the reason you have adopted a management system is to help with continual improvement. The management system is controlling everything that you and consequently, you need to monitor how effectively the management system has been implemented and is being maintained. Your primary tool for this is the internal audit process. I’m not a fan of only auditing once per annum. I prefer audits to be happening continuously across many processes in various departments. This is being highly proactive and catches problems early before that can cause negative consequences. This requires many staff to receive internal audit training and the roles, responsibilities and authorities to be assigned. A management system is a living breathing entity that can and will change daily. It requires monitoring, maintaining and updating frequently so that it can continue to improve.

Finally, you are required to retain records of your monitoring, measurement, analysis and evaluation activities. These are best stored as records and must be maintained according to the documented information requirements of clause 7.5. The data can be stored using any media and should be controlled and maintained by your document control person.

ISO 14001:2015

The requirements are the same except for the following addition:

(c) The criteria against which the organisation will evaluate its environmental performance, and appropriate indicators; criteria might include measurements of weight for material sent to landfill, levels and parameters for acceptable environmental noise, kilowatts of energy used and acceptable quantities of controlled releases e

tc.

ISO 45001 Specific

ISO 45001:2018

The requirements are the same except for the following addition:

The extent to which legal requirements and other requirements are fulfilled; in the UK you are operating under the Health and Safety At Work Act 1974 and under various European regulations (currently). You might be listing your legal requirements in something called your risk register. Are persons assigned the roles, responsibilities and authorities for monitoring your status against these requirements? I hope so! The ‘other requirements’ is referring to things such as the requirements of a contract or the requirements of an interested party such as a customer.
Your activities and operations related to hazards, risks and opportunities; these are the items that you will have identified during your early PESTLE analysis and made plans to control by implementing the clause 6 requirements. These monitoring requirements are the inputs to your management review meetings.
The progress towards objectives; is an obvious one for management review.
The effectiveness of operational controls; is much the same as the requirements of clause 4.4. This could be discussed in a daily meeting with line managers and shift leaders etc. The results of this discussion will be fed through a management review meeting.

For auditors:

ISO 9001:2015

Check for a documented process that describes: what, when and how monitoring will take place.
Check when and how the monitoring and measuring results are analysed.
Check if the results are being fed through to management review.
Check to see if roles, responsibilities and authorities have been assigned and communicated.
Check for any non-conformances that might have been caused due to monitoring or measuring errors.
Check the internal audit process to ensure the monitoring, measurement, analysis and evaluation process is included.
If specialist monitoring equipment is being used, check it conforms to the requirements of clause 7.1.5

ISO 14001:2015

As for ISO 9001:2015

ISO 45001:2018

As for ISO 9001:2015 except for the following additions:

Check that roles, responsibilities and authorities have been assigned for the monitoring of legal and other requirements. Check the competence requirements for this role.
Check that a process exists for hazard identification and the control of risks. Check that opportunities for improvement are included within the process. Check the competence requirements for this role.
Check the progress towards achieving objectives are included within a management review meeting.
Check if there are daily, weekly or monthly meetings that discuss effective process control. Check to see that the results are fed through to a management review meeting.

Some further questions that I will be answering in future articles include:

What is monitoring measurement, analysis and evaluation?
What are the three main aims of monitoring and measuring a QMS?
What is monitoring in ISO 9001?
How is ISO 9001 used to measure customer satisfaction?
What is involved in monitoring and measurement of processes?
What are the differences between monitoring measurement and evaluation?

References: www.iso.org

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