Expectations & Benefits of an Effective QMS
NQA Auditor Kevin Gunn, discusses expectations and benefits of an effective QMS and how monitoring and measurement has always been a key element of both ISO 9001:2008 and ISO 9001:2015.
Although monitoring and measurement have always been key elements of the ISO 9001:2008 and ISO 9001:2015 Standards; these crucial disciplines are often overlooked by clients.
One common misunderstanding amongst clients is that this only relates to the act of physically measuring and the necessary control of calibration involved.
It is not uncommon to hear clients still state that they are claiming exclusion from Clause 7.6 or 22.214.171.124 therefore they don’t measure the product/service or the process(es) related to that product/service!
Monitoring vs. Measurement: What’s the difference?
Let’s look at the definitions first:
Monitoring: to watch closely in order to observe, record, or detect; in essence, it’s an act of surveillance
Measurement: the act of determining the actual traits of something such as dimensions, capacity, pass or fail etc.
One of the main principles of a good quality management system is evidence-based decision making.
In order to have this as a main principle of your QMS, you need to have evidence to use for making decisions.
Depending on the nature of their business and the assumption of getting things right 100% of time, clients need to think what would damage their reputation the most if they started to get it wrong as the process of product/service was not being measured or monitored!
Monitoring and measurement gives you this evidence and allows you to make important risk based decisions about the effectiveness of your QMS.
Areas which ISO 9001 requires monitoring and measurement to be utilized include:
Monitoring and Measurement of Processes
The processes of any 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 and correcting the process when results don’t meet expectations, is crucial!
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 impracticable. For this reason the standard allows a company to consider the impact that a process has on product/service conformity and the effectiveness of the QMS when you decide on what to monitor or measure and the method to be adopted.
Although it is recognized that they don’t all apply to certain clients/industries, examples of process monitoring and measurement include:
- Right First Time
- Service Level agreements to reply to customers within a typical Contract Review process
- Number of Non-Conformances/Corrective Actions raised by Process*
Improvement in these typical Quality Metrics/KPIs should be seen as potential, measurable Quality Objectives for clients!
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.
Monitoring and Measurement of Product/Service
Since making sure that the product or service requirements have been met is the first step in ensuring customer satisfaction, the requirement for monitoring and measuring the product or service is vital.
The key parts of monitoring and measuring product/service are to verify the characteristics against requirements at planned and appropriate stages of the process, then maintain records showing the conformity of the product/service to the acceptance criteria.
Although it is recognized that they don’t all apply to certain clients/industries, examples of product/service monitoring and measurement include:
The test requirements that need to be met e.g. requirements for:
- dimensional measurement
- surface finish
- expected life cycle
The environment that the product needs to be created in or inspected in e.g. requirements for:
- lighting levels
Products and materials conform to specified requirements throughout the product realisation process by identifying appropriate:
- references e.g. specifications or legal and regulatory requirements
- methodology e.g. random sampling, non-destructive testing or in-process monitoring
- documentation e.g.
- Quality/Test Plans - these must define the stages at which various monitoring and measurement will be carried out e.g.
- incoming receipt of materials from suppliers or outsourced work
- internal production processes
- finished product
- despatch & shipping
- post installation
- acceptance criteria e.g. defined by ISO standards, technical standards, legal, regulatory or customer specific requirements
- responsibilities e.g. authority for acceptance
Number of non-conformances/corrective Actions raised by process*
Final release criteria (materials, components, subassemblies and finished products should be prevented from use, assembly or dispatch until the required inspections are completed).
* If you choose to just monitor your process/product/service for the need for corrective actions but your company continues to have issues, the process needs to have the root cause of these issues identified and addressed to achieve the desired effect.
Should I document our Monitoring and Measurement of Product/Service realisation process?
It is not a mandatory requirement to document your monitoring and measurement of product process. However, you should always look to adequately define and control any operational processes that directly impacts upon product quality.
Therefore, the implementation of an inspection and testing procedure will be appropriate to the majority of businesses where the characteristics of the product must be verified prior to release to the customer.
Think about developing and implementing a procedure that defines the responsibilities for:
- Goods receipt inspection and test
- In-process inspection and test
- Final inspection and test
- Maintaining inspection and test records
- Dealing with non-conforming inspection and testing results
As you can see, if clients are 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 throughout application of monitoring and measurement and a well throughout quality management system can help to ensure that the evidence used to make decisions best meets the needs of those making the decisions.
Adopting these practices now will not only provide clients with a value-adding and effective QMS through on-going improvement activities and measureable KPIs/Quality Objectives, but also help to heighten how well the customers perceive their company, which is becoming increasingly important as industry becomes even more competitive.
Author: Kevin Gunn, NQA Auditor