Category Archives: iso9001:2015

How to manage suppliers.

The selection and management of suppliers is an important part of maintaining quality of the product or service you provide. No single company is able to deliver their service or product without suppliers. A company cannot simply produce everything that is needed; therefore managing suppliers is crucial to success. That is also why it has such an important position within a lot of the international standards such as ISO9001. The most important suppliers are of course the critical suppliers. It is vital to manage these suppliers rigorously because the quality of your product/service is dependent on it.

Selecting Suppliers

The first thing in selecting trusted suppliers is having clear and measurable selection criteria. Create a list of criteria the supplier needs to fulfill before even considering the company as a supplier. Some criteria can be:

  • Quality of product/service
    • Are there clear quality checks
  • Skilled personnel
    • Check the employees
  • Time management
    • How is the delivery time
    • Do they come up with acceptable timeframes and stick to them
  • Communication
    • Do they communicate when something is off
    • Is there a clear way of communication

These criteria can be checked via an audit or a pilot purchase. It is important to carry out some tests before making the supplier a critical supplier. The trial purchase can give a good feeling of the quality of the supplier. During the selection process try to avoid the five most common mistakes.

Managing Suppliers

When the supplier has been selected it is important to have a clear method to track your critical supplier. Define KPI’s, track them on a fixed time frame and make sure the supplier gets insight in them. Some KPI’s can be:

  • On time delivery
  • Failure of incoming quality checks
  • Failure of on time communication in case of delay

Of course there can be a lot of different KPI’s but just create 2 or 3 and manage them. An overload of KPI’s will only make it more confusing. These KPI’s can be easily changed. Online quality management systems make it very easy to keep track of these KPI’s.

Good luck managing your suppliers!

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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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Why Quality Management

A quality management system for good and socially responsible business.

With the increasing pressure on efficiency and costs, we see the attention of quality management evaporate. As if it were a luxury, those organizations could hardly afford to keep at least an existing certification. While an efficiently operating quality management system is just as important today as ever before.

The basis

The basis for a quality management system is to make work processes clear in relation to the output (customer service), the effort to be provided, and other resources (money for example) and content quality aspects for the customer and the staff. That transparency, plus and then controllable compliance with what has been specified, provides reliable and certifiable service on a basic basis for financing and customer trust.

At the same time, there is a basis for critical review of the efficiency of those work processes. Are there “lean” terms of “waste”, waste of energy on issues that do not contribute to the customer and the quality to be delivered? Are quality and effort in balance? A quality management system is not ‘complete’ after certification, but must constantly be used for continuous improvement of efficiency, customer satisfaction and quality.

Luxurious

And for those who still find it quite luxurious: it provides a basis for communicating with clients or financing about that balance and reasoned counterweight of pressure to work under the cost price, for example. An organization that has its quality management system in order and insight into its processes is so many times stronger against cuts and irresponsible financiers.

Finally, let’s not forget the staff. Insightful work processes that focus on client and staff interests contribute to motivation and productivity, lower absenteeism and better self-responsibility in the workplace – to self-governing teams.

In short: an efficient quality management system (supported by a good planning / control cycle and a risk management system) is the basis for healthy and socially sustainable business management.

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

 

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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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Root cause analysis: Cause and Effect

A proper root cause analysis can be the difference between making money and losing money. The analysis is designed to get into the detailed fundamental causes of the issue, without any bias. The cause and effect analysis will lead to significant insight in why things went wrong.

It is very easy to come up with a result that describes the person that made the mistake. However, it is important to always go deeper than the particular person. When a person messes up there is almost always a more fundamental problem to the issue. This could include things like:

  • Lack of training
  • Company culture
  • Hiring the wrong people

These things can lead to people messing up for all kind of reasons. However, the company can change these things to reduce the number of issues for example by changing the recruitment plan or sending people to training. In the next part we will describe the Cause and Effect methodology.

Cause and Effect

With a cause and effect diagram you start off with an effect or outcome you want to analyze. This effect may be positive or negative but has to be described as clear as possible. Then the main causes are identified. The main causes that might have lead to the effect could be the following 5M’s for a manufacturing plant:

  • Machine
  • Method
  • Material
  • Man / mind power / personnel
  • Measurement / medium

When the main causes of the issue are identified the next step is to identify as many causes that might have lead to the effect. Classify the causes according to the main causes and place these below them. This will lead to a result like this.

To go one level deeper you can ask why a certain cause happened. This will give more detailed insight into this cause. Create another layer of causes that are linked to this for example speed or temperature.

When the diagram is ready you can analyze the information. The main causes with a significant number of causes under them need some further investigation. Also, when a certain cause shows up multiple times this might be the root cause. Then look for clusters, when there are a couple of causes close to each other, then that is something that needs your attention. The same is true when there are very little causes, you might need to further investigate these and why there are so few. To really start improving, identify the causes you can take actions on and put these actions in the action list with clear owners of each action.

Next post we will dive deeper into the 5 Why’s.

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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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How to handle objectives in your management system.

Objectives are pretty vital to the Management System. With objectives you can measure how the company is doing against a benchmark set by the company itself. Of course the company can do much better or worse. But, setting clear objectives is crucial in creating this benchmark. In line with the objectives are of course the KPI’s which you should setup and track.

How to come up with objectives

Most of you have probably been on this trajectory. Goals come back every year and you try to rephrase them every time to make them look new. Especially for companies with low environmental impact, limited risks to employees, or excellent customer satisfaction, creating new objectives can be hard. Where do you find new inspiration?

Look at other companies/competitors for objectives. A lot of companies place some management system related documents open on the web as part of their CSR program. You can find quite some potential KPI’s in these documents.

Look closely at your organization and try to pinpoint the crucial mistakes that are made. Set goals to goals these parts of the organization.

Last but not least, don’t make it too hard on yourself. Often you think too hard and too deep and you just can’t think of anything at all. The longer you have to think about an objective, the more you will get stuck. Just answer a simple question: what do you want to achieve at the end of the year(s)?

SMART

Make sure your objectives are described SMART in order to manage them.

  • Specific – target a specific area for improvement.
  • Measurable – quantify or at least suggest an indicator of progress.
  • Assignable – specify who will do it.
  • Realistic – state what results can realistically be achieved, given available resources.
  • Time-related – specify when the result(s) can be achieved.

A clear description of the objectives is important in order to manage each objective. Also the assignability part is very important. When multiple people are responsible for an action, it can end up where nobody takes responsibility to complete the task and start to point towards each other.

Managing objectives

Try to not make the objectives an annual exercise. More often than not the data is just gathered at the end of the year and benchmarked against the goals. Please don’t apply this type of strategy. In order to really take advantage of goals you should manage them properly. This can be done by checking progress on a regular basis, every month for example. In order to set a good interval you should check the impact and the volatility of the data. For example, profits and revenues are measured on a monthly basis so calculating indicators based on this data on a daily basis isn’t very helpful.

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stakeholder analysis: ISO9001-2015

With the new ISO9001:2015 the stakeholder analysis has got a much more prominent position in the Quality management system. Of course, every company knows their most important stakeholders. However, not every stakeholder is always well understood or taken into consideration when major decisions are taken. A good stakeholder analysis gives the company an up to date list of all stakeholders and how to manage them.

Identify stakeholder

Identifying the most important stakeholders isn’t all that hard. Most companies have stakeholders like:

  • Customers
  • Suppliers
  • Employees
  • Government
  • Neighbors
  • Competitors
  • etc.

The list can get quite long depending on how specific you get.

Classification of stakeholders

The analysis becomes slightly harder when companies start to classify or order these stakeholders. It is important to give every stakeholder a type of ranking depending on how big the influence on the company is. Yes, customers are among the most important stakeholders but for example, what about the government? Companies that have a big impact on the environment have a different relationship with the government compared to a trading company. It is important to find out which stakeholders are most important. You can ask a question like “How easy is it for this stakeholder to close the doors of the company?”

Action plan

When the stakeholders are identified and classified, an action plan needs to be created on how to manage the different kind of stakeholders. The plan should include ways how the company will inform the stakeholders and regarding which activities every stakeholder is informed of. This can be structured in a communication plan, or very easily and straight forward in the analysis document. When some concrete actions need to be taken, make sure you always assign one single person as the owner of the task. This prevents people from pointing to each other when nothing is happening.

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