Risk and Quality Management...

Information | Understanding | Best Practice.

Quality Management and Risk Management often operate as two distinct functional areas within a organization. However, they must be intricately linked with continuous two way communication and feedback flows. The decision making processes within both the Quality and Risk Systems need to be based on the experience and measured results from both these critical processes.

If you are working in a regulated industry such as Medical Devices, Pharmaceuticals, Bio-pharmaceuticals, the relevant regulatory bodies will expect risk management and will impose such a requirement. In non-regulated industries, the benefits of assessing risk when implementing a quality assurance program are many, for example:


i) Your customers will have expected product designers and manufacturers to have assessed product and process risks and have minimized (or eliminated) risks to an acceptable level, compared to the expected customer benefits.

ii) Internally employees when performing daily tasks will expect any potential risks to their safety and wellbeing to have been identified and addressed.

iii) People living in the local community will not tolerate risks which outweigh benefits to their community.

iv) In fact all stakeholders potentially impacted by the activities of an organization will expect risks to be addressed to an ALARP level so that the benefits to the organization and all its stakeholders outweigh the potential risks of an unforeseen event arising.


Risk management can be defined as the systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk.

When implementing a quality management system, there needs to be a clear understanding of the risks inherent in the product or process outputs, there needs to be an understanding of the potential severity and likelihood of any unforeseen events arising. With this knowledge gained from the risk process, the focus of efforts within the quality management system will be directed on the areas of greatest risk. The Quality System will manage resultant product and process redesign and revision of process controls with the objective of risk minimization and quality and reliability maximization.

Where-ever risks are identified, then operating procedures, controls and test points will be established. The quality management process will be required to report on test and control points which have been established as a result of the risk assessments performed. Failings in the operation of the Quality System, may result in risk exposure to the business.


Effort expended versus potential risk.

The greater the potential risk to the stakeholders (e.g. customers, employees, shareholders, the community, the environment,…) of an organization, then the greater needs to be the effort to reduce, eliminate and monitor those potential risks.


Applying Risk Management to Quality Management.

The risk management process will identify and prioritize risks. As a result of this prioritization, product and process changes will be implemented. Controls will then be established. All the steps in this risk management process will be performed in accordance with the quality management system.

There will be defined and documented risk management procedures. The steps to be followed to implement any product and process revisions will again be defined, documented and performed in accordance with the quality management system.

On-going monitoring of the risk points will be a requirement of the quality system and will be reported upon as part of the quality system and will input into the quality management review.

The determination of staff competence levels and any training needs will be assessed and updated based on potential risk to the organization in accordance with the requirements of the quality management system.

Feedback from product use, or from the experience of customers to the service provided by the organization, will be collected, collated and reported upon as part of the quality management system and will input into the risk management process.

The effectiveness of the risk management process, in identifying, minimizing and addressing risks will be clearly seen via the output of the quality management system.


In summary.

The risk management and quality management processes are inherently linked within an organization. It is critical to organizational success that both are effectively implemented and both processes “talk” to each other in a seamless manner.

In many organizations, risk management and quality management are functionally divided, however, it is essential that both the quality and risk process are effectively linked with continuous, un-ambiguous, clearly visible two way communication flows.

Risk Management Full Details

Risk Management:


Quality Assurance. Quality Management Systems.