Category Archives: Risk

Risk management in CAPA

How to Include Risk Management into Your CAPA?

Even though the preventive action is no longer part of the terminology of the ISO 9001:2015 standard, A lot of people still use the phrase CAPA (corrective and preventive actions). CAPA’s have been around for quite a while and are a crucial part of the continuous improvement for a lot companies. With the new risk-based thinking coming in it can be good practice to make risk management part of the CAPA strategy.

Vanila CAPA

CAPA has been used a lot as a way to take action on incidents or issues that happened within a company. By deploying a strategy of corrective and preventive actions, the company tries to prevent these incidents from happening in the future.

The CAPA strategy allows companies to see what went wrong and forces them to think about proper actions on how to solve and prevent it. Because the output is an actionable list, every person involved in resolving the issues knows exactly what to do and when to do it. When all actions are taken the results are verified and checked for effectiveness. This way companies can clearly see the actual impact of the actions on the organization.

Risk Management Within CAPA

By adding the risk-based thinking into the CAPA, companies are allowed to keep their risk management up to date and lively. Whenever a CAPA strategy is created it is crucial to check the risks that are involved in that part of the organization. The very fact that something happened means that there is a risk in that particular part of the organization. Updating the risk management is important to keep the organization in line with the current situation. By incorporating the risk management, new actions are developed to reduce the risk for the company.

How to Do It?

Automation is there not only to help with the CAPA strategy, but also for the risk management strategy. Easily distributing the different corrective and preventive actions to the designated owners helps in tracking the progress of the strategy. Also the ability to directly connect to the different actions to the risks sets for much better traceability of the actions and their origin. This way the people in charge of quality and safety are more in control of the process.

If you want to know how Qooling can help you in managing your CAPA strategies, just drop us an email.

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The Importance of Training

As with every aspect of training employees, training them on the management system and common ways of working is critical to maintain consistency. A management system will never be effective or functional if nobody can find the different procedures and forms. Automation can help here, for example by setting up access restrictions to prevent employees from getting an information overload. However, this will only provide guidance rather than replacing the complete training.

Way of Working

New employees will unfortunately not figure out magically how certain things are done within the organization. They either need to read about it or somebody needs to tell them. A combination of both is the best way.. First a colleague explains the process while the documents are there to check later. This might seems like a time consuming exercise but it is more than worth it. Not giving enough training can cost the company much more due to error and inefficiencies. An improperly trained employee can cost a lot of money either directly due to mistakes or secondary due to keying in the wrong data into systems.

Filling in Data

In order to build a gold mine of data it is important to explain to the employees what kind of data they need to fill in these systems. It is very easy to fill in data for the sake of filling in. When the employees fill in the right data, the analytics of the data can be done immediately without any alteration and cleaning. But keying in the wrong data will cost a lot of repairing and might even lead to misinformed business decisions. By setting up restrictions on what certain people can do, a lot of mistakes can be prevented. This will reduce the room for error significantly.

Awareness of Safety Risks

Especially on dangerous sites such as during construction, in the heavy industry or offshore, it is important to train employees on awareness of risks. Not being sharp throughout day can lead to serious accidents when people are working in dangerous environment. Furthermore, it is important to train the people on how to observe and report unsafe situations. Employees have to understand that sharing this knowledge can help prevent certain situations during other shifts or other locations. When it comes to reporting again great automation solutions allow you to instantly file unsafe situations with your mobile phone. This lowers the barrier to file the report and increases the knowledge of these situations within the organization. When an unsafe situation does occur, make sure that the lessons learned are shared with the employees.

Conclusion

Please prepare a proper training system on how to make sure a new employee is aware of all the different common practices within your company. The time you put into this structured training will pay itself back in the long haul. Having the people working in a structured way will increase the consistency of the output they deliver which will increase safety of the workers and the quality of the product and services.

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How to Handle Risk Management.

An organization cannot exist without taking any risks. The question is, how to manage those risks to improve predictability and reduce the level of risk?

Don’t make risk management an expensive and time consuming project.

Too often risk management is seen as a time consuming exercise. I personally believe that this is unnecessary.  When we talk about strategic risk management, it is possible to have just one or two sessions of about 1.5 hours with the top management to list all the risks.

Focus on the top 10 risks

Make sure the focus is on the top 10 most important risks and don’t bother working on all the risks for the moment. It is important to assess the risks by next year, as by then you can focus on the other risks to the organization.

Align the company objectives with the risks

To accomplish this, start with the stakeholder analysis including the objectives of every stakeholder related to the company. This helps you focus on the important risks that have a direct effect on the stakeholders and the objectives.

Internal communication

It is very important that the employees support the risk management. In order to increase support it is essential to communicate the importance of the risks and that people understand why certain actions are taken.

Have a clear division of tasks

After all risks are registered it is important to assign owners to certain tasks, preferably people in higher management positions. They will then be responsible for the corrective and preventive actions taken to reduce the risk levels. The managers can give certain tasks to other employees but they are responsible for the risk.

Go further than only financial risks

Most companies have the financial risks in order due to the yearly check by an accountant. There are more than just direct financial risks for an organization. Make sure you also think about the broader picture than pure financial risks.

Use risk management as a guide for management

Risk management is much more than just listing all the risks. It is an instrument to help management get a good picture of the risks involved. Next to this, it is a great tool to perform and manage corrective and preventive actions based on these risks. Furthermore, it holds some great input for the yearly management and the actions give a good measure on how management performs.

 

This article has been written by Jantina van Rossum of iConact.

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Risk assessment done, now what?

Risk analysis has become a vital exercise for a lot of international standards. A large majority of certified companies are required to have a  risk assessment methodology and should be aware of the risks within their company and operations. Some companies have been creating this analysis with a lot of passion using all the knowledge they have. However, a lot of companies just perform the analysis for the certification and simply check it yearly or twice a year during an audit or management review. So how is it possible to make sure risks are really embedded in the company culture?

Risk Treatment Plan

A good way to start is by creating a Risk Treatment Plan. The purpose of a Risk Treatment Plan is to define exactly who is going to do what. You can also call this document an ‘Implementation Plan’ or ‘Action Plan’. It is crucial to get your management approval on the plan because it will take considerable time and effort (and money) to implement all of the actions. Furthermore, management approval also gives you the mandate to ensure things happen. Make sure you have clearly defined tasks for people to perform.

Issues

Next to the Plan, a great way to make the risk assessment more dynamic is by embedding it into the issue management or CAPA. When an issue has occurred, check the risk analysis and see if there is something mentioned about this specific issue. The issue could be a minor problem or a major problem, either way it is best to check the risk assessment. When the issue has some serious impact on the company, modify the risk assessment and add the risk. This way the company is able to use the risk analysis as a dynamic document that holds valuable lessons learned of the company.

Big Changes

When big changes happen within the company, you can use the risk assessment as guidance. Yes, companies should take risks to strive for a better future. But companies should make sure they take calculated risks. By embedding these big changes within the company’s risk assessment, the top management has a feeling of what could go wrong if no precautions are taken. This way, the top management can plan and prepare for the big change and manage it much better. The role of the quality manager is to ask the right questions for management.

Working environment

A big part of the risk assessment includes risks in the workplace. Of course the most obvious ones are included such as the risks with lifting machines and the other heavy-duty machinery, but the less obvious are the ones that can cause danger. The big risk comes when a routine of the work activity kicks in. When people are doing the same job every day and completely understand how to do it, less care is taken and something can be out of place. That is when the danger starts. Make sure that the employees that perform inherited dangerous tasks always perform a quick Risk assessment before they start to prevent any problems from happening. Having people sick at home is a great risk in and of itself. Next to the physical risks, psychological risks shouldn’t be neglected. The psychological risks of the stress heavy jobs should be monitored on a regular basis also.

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