Analysis, Measurement, and Monitoring of Processes

The organization is required to define criteria and performance indicators to the processes. The objective
is to monitor and measure the processes included in the QMS effectively, as follows:
• To control and ensure the effectiveness of activities and the efficiency of the process
• To verify that processes achieve their quality objectives (quality requirements,
schedules, intended use, etc.) and their intended outputs
• To ensure that the outputs of these processes meet the expectations of the customer
(the receiver—whether internal or external)
• Ensure improvement of these processes
Monitoring is always applicable—one may sample a process and determine its effectiveness. But with
measurement it is more difficult and less practicable because processes might not always provide
objective data. The tactic of measuring processes is to
• Define a method for the measurement and the control
• Define an appropriate criteria
• Collect data
• Analyze and report data that are relevant to the process and the realization of the
product
The analysis shall strive to allow the operators of the process to systematically detect trends and patterns
in the processes and respond to events on time. As a result, the effectiveness of the QMS is maintained.
Specific requirements for this issue are well detailed in clause 9.1—Monitoring, measurement, analysis,
and evaluation.
34 ISO 9001:2015—A Complete Guide to Quality Management Systems
Regarding the process approach you must ensure that the following principles are applied for the planning
and analyzing processes:
• Processes are evaluated for their need to be reviewed, analyzed, measured, controlled, and monitored. Where
subprocesses may affect the main process, they must
be identified and controlled as well.
• The appropriate method for measuring and controlling is defined and applied—a
method that provides you with quantitative or qualitative information about the
effectiveness of the process.
• The appropriate criteria are defined and established. The criteria must allow a comparison to accepted process
results. The criteria must reflect the quality objectives.
Addressing Risks
During the analysis of its processes an organization is required to address risks related to products and
services that may occur when processes deliver unintended outputs or when the interaction between the
processes is ineffective. QMS in its essential is a preventive tool aimed to plan controls and achieve
objectives. Risk refers to the probability of occurrence of not achieving an objective and may result in a
decrease of customer satisfaction due to unintended outputs or ineffective interaction between processes.
The objectives here are as follows:
• To create awareness to risks when planning processes
• To indicate the consequences of the harm of the risks, and how severe it might be
• To initiate controls of these risks while planning your processes
• To plan corrective actions when errors occur
The difference between the last revision of the standard (2008) and this one (2015) is the event of this
analysis. The last revision promoted the discipline of the preventive action—a quality tool for protecting a
product or a service from potential nonconformities—that is, evaluating risks and potential events that
may affect the quality of the product. In practice, it is done after the planning and during the realization
process. The new revision takes it one step backward—to the planning of the process. In other words,
when planning the processes you must address associated risks (or opportunities). This subject is widely
dealt in clause 6.1—Actions to address risks and opportunities where the organization is required to
identify risks that may prevent it from achieving quality objectives, delivering conformed goods or
services, or fulfilling customer satisfaction—and this is what the ISO 9001 Standard is trying to prevent.
Applying the process approach, determining the processes included in the QMS, and identifying their
owners, inputs, and outputs should put you in a position to understand what the intended results are for
each process. The next step will be to understand the relation between the end product or service and the
intended results of processes. Or, more precisely—what is the relation between the conformed products or
services and the intended outcomes of the processes that realize them.
Context of the Organization 35
In practice, you need to develop or use a method that will identify all product or service characteristics
that have an effect on the intended use of the product or service for which verification is required. These
risks may occur throughout the supply chain, the realization of the product, or the provision of a service.
After understanding which risks are potential, you must define the following actions to handle and control
these risks:
• Identify the relevant risks.
• Define the verifications or validations.
• Define the appropriate criteria.
• Plan monitoring and measuring devices and their validations when needed.
• Plan actions for the limitations of nonconforming products.
• Determine the competence of personnel.
Let the experts and process owners decide what the risks to their processes are. You just need to ensure
that it is done when they do the planning for the process. Take a look at the following analysis:
Process Owner Process Delivery of Unintended Results Result/Impact
Sales manager Acceptance of product specifications from the customer
Inadequate communication with the customer
Failure to deliver data and specification to the planning
Inadequate planning of product realization
Development team
Development of the product according to the specifications
Lack of appropriate information for development
Failure to deliver specification of development to the production
Realization of product not according to the specification of the customer
Production team
Realization of the product according to the planning
Lack of appropriate competence for production
Delivery schedules not transferred to the production
Realization of product not according to the specification
Delivery to the customer not according to the contract
Identifying Necessary Changes
Processes must be assessed in order to ensure that they deliver the intended results continuously. So far,
for each process we
• Defined the required inputs and expected outputs of each process
• Defined which responsibilities and resources are needed to accomplish the processes
• Defined which criteria and methods for monitoring are necessary for determining
whether the outputs conform to the specifications
• Identified risks for unintended results
• Monitored the processes and decided whether the intended results were received or not
36 ISO 9001:2015—A Complete Guide to Quality Management Systems
In case a process fails to deliver the intended results, actions must be initiated in order to promote changes
in the processes. The objective is to ensure that these intended results are achieved. Process change relates
to the development of a systematical improvement of processes. This system of changes and improvement
will be integrated into the business process. Let us now move on to the improvement of processes.
Ensuring Improvement of Processes
Improvement of processes enables the organization to align its business processes to its business strategy,
leading to effective performance through the improvements of specific activities. Submitting specific
processes for improvement is an effective approach to achieve quality objectives. Until now, we defined
the processes, the interrelations between them have been determined, objectives have been set, and
activities for monitoring, measurement, and analysis have been implemented. But something is missing.
The loop has not yet been closed. The organization must initiate actions for improvement and
systematically identify opportunities for improvement—situations and processes where planned results,
quality objectives, or criteria were not met. These situations will be analyzed, the root causes will be
identified, and actions for improvement will be applied.
In practice, when designing and defining the processes for the operation of the QMS, the organization
shall implement methods and tools that will allow the identification of opportunities for improvement.
Here are some methods that can be applied:
• PDCA cycle—Applying the plan, do, check, act discipline is an efficient way of
implementing the improvement of processes. This method is dealt in details in
chapter 10.3—Continual improvement.
• Statistical methods—Statistical methods are used to understand and then reduce or
eliminate variability in processes.
• Quality control—Quality control samples process performers and indicates needs
for improvements.
• Modeling of processes—Modeling is considered measuring the current state process
performance and identifying gaps in the current process preventing from achieving
the objectives.
• Redesign and reengineering—Analysis of processes and relevant activities with
the aim to find what is preventing achieving the objectives and suggesting ways to
improve them.
• Process selection—Selecting a small significant group of processes that have a great
influence on achieving the quality objectives in order to improve them.
Usually, but not necessarily, the process owner is responsible for identifying the opportunities for
improvements and initiating them.