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Author Archives: Florent Kuiper

How to Set Great Quality Objectives

Quality objectives are measurable goals and the base of long-term quality improvement planning. After setting a target, simply hoping that changes occur to achieve the goal is not an effective way to improve a QMS. You need to work towards that goal.

Make it SMART

Once you’ve determined which products or processes you want to monitor, measure, and improve, you need to make sure that your quality objectives are achieved effectively. To have the best chance of achieving these goals, I would recommend you to use the SMART method. This method states that all quality objectives need to be Specific, Measurable, Agreed, Realistic, and Time-based. Here’s how you do this: 

Specific: Describethe quality objective as specific as possible so that everyone in the organization understands it. Rather than striving “to reduce production defects,” a better description should be “to reduce production defects by 10% in the engine assembly line”. To test whether it’s specific enough, you can try to see if your goal could be interpreted differently. If so, your goal is not yet well formulated. 

Measurable: Without measuring your goals, how can you determine if an objective is achieved? To show visible improvement, it’s important to express this in percentages or numbers. For instance:  

  • Reduce production defects by 10%
  • Obtain 90% customer on-time-delivery

Agreed: Objectives can’t be achieved if they’re created inside a vacuum. Top management buy-in is crucial in setting quality objectives, and make sure they’re communicated throughout your organization so relevant parties are made aware. All employees of the organization need to agree that the goals are achievable. 

Realistic: Setting unrealistic goals is never a good idea. You aren’t going to motivate your employees by telling them you want to go from 20% production defects to zero. Especially when you don’t have the resources to support this level of improvement. To keep everybody satisfied, set realistic goals—this will motivate them to put in a little bit of extra effort next time. 

Time-based: Finally, to be truly effective, objectives must have a specific deadline for results. Without a timeline, goals might be easily forgotten when overshadowed by day-to-day activities. For example, “reduce production defects in the engine assembly line by 10% in the next year”. 

Quality objectives can be established for any process and can be specific to a department, team, or project, as long as they are relevant to your QMS. Always make sure that quality objectives are properly communicated throughout your entire organization so relevant parties are made aware. 

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Workshop: Time Pressure and the Effect on Quality & Safety

On Wednesday 22 May, we organized a workshop on time pressure and the effect on quality and safety. Time pressure can have a major impact on quality and safety, which can lead to serious accidents. In most cases where odd jobs have to be completed quickly, there is stress, as a result of which employees no longer think clearly and end up in unsafe situations. 

How can we teach people to deal with time pressure and not to start with an unsafe situation? This happens in all industries, whether you work in construction or in a production company. The business must run, but not at all costs. In this post I will give you a good overview of the topics discussed. 

What Is Time Pressure?

Time pressure can arise during work when a large or too complex job has to be done within a certain time frame. For example, a person might feel under pressure if the demands of their job (such as hours or responsibilities) are greater than they can comfortably manage. Time pressure is a part (or cause) of work-related stress. This often results in accidents, absenteeism, or quality problems.

How Time Pressure Is Related to Accidents

Time pressure is often the cause of accidents in the workplace. A number of common examples of how time pressure can lead to accidents are: 

  • The production must be finished in time in order to achieve the quality objectives and to keep top management satisfied. 
  • Wrong materials that are not intended for this purpose are used to complete a job on time. 
  • Signals about unsafe working are not picked up with the associated risks. 

The Importance of a Safety Culture

To deal with time pressure, it’s crucial to have an overall safety culture in place. Employees must have a shared vision when it comes to safety. Make sure to create an environment in which safety topics are negotiable. It’s key that all employees have faith in each other at all levels of the organization, in particular, top management. Teach me how to build a safety culture in 6 easy steps.  Also, make sure people feel comfortable enough to speak out when they feel stressed. This openness is an absolute must if the company wants to reduce stress. 

Furthermore, it is important that management provides funds for these topics. The safety department needs time and money to come up with improvement plans when things go wrong, or rather, before things go wrong. It is always cheaper to prevent than to cure.

Collaborate

Good collaboration between contractors and clients is crucial to prevent time pressure. The following points apply to both contractors and clients: 

  1. Take enough time to take up an assignment; don’t create your own pitfall!

2.     Make clear agreements about safety (what are your rights and obligations?).

3.     It’s better to ask too many difficult questions than get one after an incident!

4.     Investigate each incident together in detail.

Celebrate 

Last but not least, celebrating success is vital. Reward employees for reporting incidents to encourage reporting rather than hiding issues. Therefore, start by celebrating achievements, such as a successful intervention or a toolbox meeting, to help promote long-term success. Also try to avoid sanctions, but be satisfied as long as your employees want to learn from their mistakes. 

The workshop was full of practical examples, so that those present could easily relate to the situation. In addition, the presentation contained useful tips to prevent time pressure and the consequences that you may have if you do not. Thanks again to Gerard Beijkirck for sharing his experience and giving the presentation!

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The Outputs of Design and Development Clause 8.3.5

In the previous post we touched upon the inputs for the Design and Development Clause of the  ISO 9001 standard. The outputs are closely related to the inputs of course, but they have some twists to them. The four outputs that need to be covered are:

  1. Meet the input requirements.
  2. Be suitable for subsequent processes for the provision of products and services.
  3. Include, or refer to, appropriate monitoring and measuring requirements and their acceptance criteria.
  4. Define the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

All the information of the Design and Development outputs needs to be documented either through a register or some other form.

Meet the Input Requirements

This one is pretty straight forward. The product should meet the input requirements. If the product or service doesn’t meet the requirements, it isn’t only useless, but we have also failed to fulfill our customer’s needs—a pretty important part of doing business. To meet the requirements, it is critical that these requirements were very clear in the first place. The clarity of the requirements should be well thought of during the input phase of the design and development process.

Be Suitable for Subsequent Processes for the Provision of Products and Services

The company should be able to have processes in place to realize the product or service according to the specs of the customer. These processes are part of the QMS and should lead to a desired output. It should be very clear that the QMS of the company is able to produce the product within specs and rules and regulations.

Include, or Refer to, Appropriate Monitoring and Measuring Requirements and Their Acceptance Criteria

The company needs to have a strong plan to monitor if the product is designed as expected. This can, of course, be accomplished by very close communication with the customers and other stakeholders in the process. The way the company communicates and how it documents this information should be clearly defined to make it unambiguous.

Define the Characteristics of the Products and Services That Are Essential for Their Intended Purpose and Their Safe and Proper Provision

The products or services should function as intended—this is also closely related to the input requirements. When these are pretty clear, it gets a lot easier to make the product or service function as intended. However, even if the requirements are clear, the company should fully understand if the product or service is safe and properly functioning. The customer can request a car without a steering wheel, but even if the company built such a car, it is mostly likely not safe and not intended to operate like this, except for a self driving car maybe. So even if the specs are clear, the company has the duty to judge if the functions are really what some can expect from the product or service. 

Documented Information on Design and Development Outputs Must Also Be Retained—IE: Records

Lastly, it is crucial to have all the information created during the processes documented in some way. This can be in Word/Excel documents or in specialized platforms. It should be retrievable whenever asked for by someone.

Conclusion

The 8.3.5 isn’t all that hard in essence, it just requires the company to make sure that the product is developed as intended by the stakeholders. The information that is created during the process should be registered in a system as per the company’s choice. 

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The Inputs of Design and Development Clause 8.3.3

Clause 8.3 Design and Development is regularly misunderstood—not just by Quality Managers but by Auditors as well. It is one of the toughest and most confusing clauses and we find a lot of questions regarding clause 8.3. The fact that you need some form of processes for such a creative process can make it very hard. Due to this difficulty, it is probably the most excluded clause. We have even seen companies leaving these activities out of scope to solve this.

The Input

The input requirements by ISO9001 for the Design and Development Process are:

  1. Functional and performance requirements.
  2. Previous design and development activities that are similar.
  3. Statutory / regulatory requirements.
  4. Applicable standards or codes of practice.
  5. Consequences of failure (risk) associated with the potential of failure due to the nature of the products and services

1. Functional and Performance Requirements

Number one should be pretty clear before the company even starts to do anything. There can be formal requirements from the customer like in a “request for proposal” or they can be known implicitly by talking to a group of potential customers or via desk research. Regardless of how the company gathers the information, it should be clear what the customer expects.

2. Previous Design and Development Activities That Are Similar

When there is a history record of all the things the company has done, it should be fairly easy to get at least a starting point of the activities done in the past. Part of the requirements could be mapped to the new projects. Looking for best practices among the past projects should make it easier to come up with a concise way of working.

3. Statutory / Regulatory Requirements

Rules and regulations should be a top priority when you design and develop products and services, regardless of your industry. Having the right knowledge for all the applicable rules and regulations can be pretty tough due to complexity. Investing in this exercise is money and time well spent because the fines can be quite high when it turns out that the company didn’t operate within the law.

4. Applicable Standards or Codes of Practice

This point is in line with the rules and regulations. A lot of (inter)national standards help companies to uniformly operate. Some great standards are FDA, API, and CE. They serve as a guide for companies when they want to operate in certain markets. Most of the time, customers demand compliance to certain standards as a mandatory requirement in order to do business with them. 

5. Consequences of Failure (Risks) Associated with the Potential of Failure Due to the Nature of the Products and Services

A properly performed risk analysis will help the company to tackle this last point. The company should be aware of all the consequences the products or services can have—not only on the company itself but any other stakeholder. Take time to think thoroughly about these risks. This will help the company to plan out the best mitigation plan possible.

These are the basic inputs required for a functioning Design and Development Process. Next post will dive deeper into the output of the process. Don’t forget to subscribe to stay up-to-date!


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Bring your quality & safety inspections to the next level

Filling out paper forms is very time-consuming. No one enjoys it, especially when it means a lot of extra work after forms are filled in. Usually the forms have to be checked and re-entered to the quality management system, which means hours of additional work every week—for nothing. Using pre-configured and custom mobile forms, your company can easily save hours of valuable time per inspection.

Analysis

It’s hard to monitor progress or draw conclusions from a stack of papers. Manually entering data into a spreadsheet or other document and creating reports is time-consuming and carries the potential for human errors, including inaccurate or omitted information.

On the other hand, digital forms are automatically uploaded into your quality management system, where it is compared to existing data. From there it’s easy to track progress, setbacks, health and safety concerns, and other significant events, allowing quality inspectors to easily create impactful reports.

Incident Reports

Digitizing the management system means that on average 30% more incident reports come in. The ease of use lowers the barriers because it makes it easy for employees to fill in digital forms during their inspection walks on their phone or tablet. Besides that, they also have the possibility to attach a picture with a description of the non-conformity. All these processes have been simplified so that incidents are actually reported.

Take Action

After you’ve collected data and identified a potential problem, it’s time to take action. Plan your corrective and preventive action in a proper manner and make them actionable. By directly assigning the action to the responsible person, it becomes much easier to manage the action that resulted from the inspection. With an online quality management platform you can easily track progress on the tasks and analyze their effectiveness.

Qooling

With Qooling, paper quality and safety inspections are history. The online solution offersyou a simple way to digitize your quality and safety inspections and reduce the dailyworkload. Log in from any location and have real-time insight into the work of your team, anytime and everywhere. Try it today!

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Change Management in Quality Management

The continuous improvement plans created have to be implemented properly to really add value. Coming up with the plan or idea is the easy part. Making sure the plan is fully implemented and supported by the organization is the hard part. To make a plan successful, change management is the key.

Personal Change

Most people resist change and prefer to keep working the way they are used to, regardless of the inefficiencies and struggles during their day-to-day activities. This means that the outcome of the plan comes down to psychology more than actual quality management. This makes it all the harder.

When an employee doesn’t see how the change improves their life, they simply tune out. In an organization this is very complex because of all the interactions. The small loss of time for one can be a huge time saver for the next. This setting makes it hard for people to accept the change because they don’t see the added value for them.

Organizational Change

When we look at the organizational level, change management starts to get very complex. As mentioned above, some people lose and others gain during this change. Certain employees need to do some additional work to make life easier for their colleagues down the hall. The problem is that the people that feel they lose something will resist relentlessly. This can harm the effectiveness of the project significantly. When someone doesn’t see the benefit instantly, it is crucial to show them the current situation and how the workload is divided among the different employees. Besides the workload, you can also show why things go wrong and put a dollar value on the issues that have been logged due to the problems

Also, mapping out the processes and showing the bottlenecks in the process is a great method to open the eyes of the employees. Even then, there will be a number of people that will resist the change. Top Management buy-in can become the key driver to convince the last set of people. When they support the project it will be a lot easier to make sure people move in the right direction.

Prevent Dead Projects

A lot of improvement plans get canceled due to the complexity that comes with change management. Employees don’t support or aren’t willing to change. Projected results are not reached due to poor change management and execution. This cannot be prevented all the time but certain things can be done to increase the likelihood of success.

Engagement

Engage key people in the project. Make them part of the project right when the project is still in the planning phase. When they are part of the project team they feel ownership and take responsibility during the implementation phase. This helps a lot to drive the change through the organization.

Communication

Clearly communicate the implications for the different roles in the company. Don’t sugarcoat it, when people have to do some additional work be upfront about it and show them why. This can be done by showing the actual data you have gathered on what goes wrong in the process. They will see why change is important when the losses are visual.

Use data

Use data to back-up your claims. Show the people how you came to a certain conclusion and why this change will have a positive effect on it. When you actually get the results you anticipated, make sure to celebrate it. This will give some credit for the next project and there will be a lot more in the future. 

A proper platform can be used as a guide during the change management project. An easy-to-use platform allows people to adopt the new situation more easily and the data coming out of it allows for instant proof why the new way of working is a step forward. Make sure the right solutions are in place to support your improvement projects.

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ERP is not your QMS

Yes, it might seem enticing, all your QMS information into your ERP. We can have all the information in one system, this will make it much easier for the employees. But is it really that simple?

With the ever-complexer environment and fast-changing landscape, is the single ERP approach really moving your company forward? Trying to fit everything into one ERP means that a company needs to cut back on a lot of functions and features. Most ERP solutions originated out of the founder expertise, this can be finance, logistics or HR. However, this also means that a lot of other functionalities simply too basic. Quality is 9 times out of 10 one of these lacking features in ERP. Most ERPs allows you to easily create a data table where you can key in your data- like an Excel sheet and for the more advanced ones, you will have some sort of workflow. But it is the interaction within the QMS that allows companies to really leverage the Management System. Plus the ERP becomes so complex that the adoption of your QMS is really jeopardized by this. This isn’t when the company  is on a path to Operational Excellence.

The connection

The ERP is the backbone of the IT infrastructure for a lot of companies. There is nothing wrong with that, but make sure you can integrate specialist solutions and platforms with it. Too often we talk to companies that have shielded on-premise solutions and therefore are unable to connect the solutions. In this case, consider switching to a connected SaaS solution because these silos can seriously harm the company. Connections and integrations allow you to really leverage data that is already gathered in other solutions like, for example, product data, supplier information, customer information, and employee information. The Quality Management Platform can than enhance this data with the information gather on the Quality Platform. This combination gives companies the possibility to create real enriched dossiers of products, customers, and suppliers. Also, it allows for NCR creation from within different platforms, which can then be synced with your Quality Platform for data consistency and real-time follow up.

Clarity leads to adoption

It may sound counterintuitive, but we have seen companies loving the approach of specialist platforms. They can simply tell their employees that everything related to Quality can be foundwhen you login on this platform. Setting up good user profiles results in a dynamic QMS basedon the role the employee has within the organization. Reducing the information based on the role increases the adoption of the platform and therefore the adoption of the QMS. Adoption is key for an effective QMS, which is needed when the company wants to reach Operational Excellence

Conclusion

Don’t try to fit the QMS in your ERP. Most ERP solutions aren’t build for this and will cost you a lot more than it gains. Make sure, however, that the ERP allows for integration with other solutions to streamline internal processes and prevent redundant work.

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Impact of mental health in Safety Management

Sadly, at any given time, approximately 1 in 5 workers is likely to be experiencing a mental health condition such as depression or anxiety. This is estimated to cost the global economy $16 trillion by 2030. The enormous economic cost is primarily due to the early onset of mental illness and lost productivity, with an estimated 12 billion working days lost due to mental illness every year. Unfortunately, we see too little emphasis on this from an OHS or HSE point of view.

Business performance can be impacted significantly when business managers or their workers, costing businesses time and money through days off work or not working at full capacity, experience mental health conditions. Relationship with stakeholders, other workers, or family members may also be damaged. Mental health problems have a serious impact on the way someone performs his/her daily activities.

Prevention and effective management of mental health conditions in the workplace can reduce the social and financial impact significantly. As a manager, there should be nothing better than knowing that your staff are healthy and happy. The interaction between work-related and personal related stress makes it pretty hard to find the right way to deal with it. However, the fact that it isn’t easy shouldn’t be the reason why the company doesn’t try. Having a great coach or psychologist ready to help out will be a great way to start.

Safety Solution

Implementing a strong occupational health and safety management system is also another way organizations can reduce accidents and mental health conditions. In order to make mental health an important part of the OHS management system, it should be mentioned in the policies and other key values. We still see that most companies don’t even touch upon this topic from an OHS point of view. Yes, we all have KPI like days without injury but mental health incidents are hardly part of this KPI. Start incorporating mental health issues as well as a KPI. You have to do this carefully, of course, with all the personal information—but it gives a clear message on how serious the company takes this.

Safe Workplace

Start with creating a safe workplace with effective processes—a OHS management platform can help you create. By implementing a safety management system, you can easily put processes in place to ensure your employee’s mental health needs are being addressed as well. It can be a great benefit to train people to realize when they feel stressed and what to do when they are. Give them access to help when needed to make them feel accepted, rather than hiding it away.

Conclusion

Somebody’s mental health is just as important as your physical health and safety in the context of overall health and wellbeing. Make sure the company start to take it as seriously as any other part of the human body and make it part of the OHS Management system.

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Key IT consideration When Selecting a New Quality Platform

Quality management is a key target for digital transformation, and while adoption of quality systems is growing, it’s important to address IT concerns before you make your final decision.

If you’re considering to invest in a quality management platform for your organization, it’s essential to think about the security, ease-of-use, and integration with other systems. Today we’re looking at each of these, so that you can make a well-considered choice.

Cloud vs. On-Premise

By 2020, Gartner expects that Software as a Service (SaaS) will officially surpass on-premise software solutions. The main reasons so many companies are opting for cloud, and SaaS inparticular, comes down to the total cost of ownership. Updates are part of the package and most of the time on a regular basis, so updating your system isn’t required anymore.

Easily Deployable

SaaS solutions are much faster to deploy than the on-premise solutions. Most SaaS solutions start right away without any requirements for installation. You simply login and are ready to go. This will cut deployment time by at least a couple of weeks, or even months, depending on thecapacity of the server.

Security and Reliability

The SaaS platforms put a lot of time and effort in the security and reliability of the system. These security standards are at least on the same level and regularly higher than most on-premise servers. Due to the infrastructure of these platforms, they have big incentives to keep the platform secure and reliable. Security and reliability shouldn’t be a reason to move to SaaS any-more. The infrastructure of the major data centers allows these platforms to have new serversalmost instantly.

Ease of Use

Enabling people to really add value to the management system can only be accomplished whenthe solution is easy to use. The employees have to have access to the platform from anywhere in the world and with any device. These characteristics are critical when you want to reach massadoption among the employees.

Integrate with Business Intelligence Tools

Most SaaS solutions come with API’s to easily integrate with other solutions like BI tools. The data has to be structured in such a way that the other solutions can interpret the information. The API is the unified way to accomplish this. When selecting your next solution, make sure the solution has an API to connect to.

Conclusion

There are a number of important points to look at, but when selecting a new Quality Management solution make sure you start to move towards a SaaS solution.

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The Impact of Poor Quality on Organizations as shown by Boeing

Boeing is facing big challenges these days. You bring a new product to the market and suddenly this seems to be the cause of several flight accidents. Since then, all the airplanes are grounded and the impact is huge, not only for Boeing, but also for the airlines.

This example clearly shows what a tremendous impact, a lack of quality can have on an organization. This can range from inefficiencies to lower customer satisfaction and even plain legal issues. As well as how important it is to invest in good quality control to prevent issues from happening. Hence, we use this article to highlight three possible effects, on how poor quality can affect your organization. 

Influencing Customer Satisfaction

Poor-quality products and services can have a significant impact on customer satisfaction. Such products and services cause a business to lose customers faster than they can gain new ones. In Boeing’s case, the crash will result in lower customer satisfaction because many countries around the world, have banned the 737 MAX from their airspace. The airlines aren’t allowed to use these plains anymore which will have some serious financial impact. Boeing’s product failed to meet customer expectations, which harms the company and the brand. Therefore, losing potentially business and revenue. 

Impact on Company’s Profitability

Poor quality can have a significant impact on a company’s profitability. This could be a lack of quality in human, physical, financial or knowledge factors that are needed to perform business processes. Boeing for example, delivered a product that was not up to mark, which will lead to significant costs. All the errors needs to be fixed, this leads to unbillable hours and delivering free components. These recalls have significant impact on the brand on the long term and on the profitability in the short term. An efficient and high-quality QMS platform can help prevent this in the future. Patterns can be analyzed and errors can be reduced.

Also all the financial litigations after the fact will have some serious impact on the bottomline of Boeing. There will be legal cases by airlines due to diminished revenue potential. The costs for this problem will be very high.

Causing Problems with Productivity

Poor quality costs a company a significant amount of money in terms of productivity problems. If quality is not a proactive measure, employees will spend their time on inefficient process and fixing incidents on a regular basis. It is crucial to find out which processes are inefficient and how to improve them. A correctly implemented QMS platform enables quality managers to access real-time productivity information, in terms of errors or incidents. With this information you can look for smarter, more efficient processes to get to the same goal and boosts productivity.

The solution

Investing in proper quality control is key to reduce poor quality. An effective QMS platform can help you to collect data and perform analyzes. Therefore, increasing the quality of your products and services over the long term. Ultimately, the cost of working with an ineffective system are exponentially higher than the cost of working with a proper quality management platform. Now let’s take a closer look at the benefits of a good quality management platform.

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