Category Archives: QMS

Data consistency in Quality Management

Data consistency might not have anything to do with quality management. However, because quality management is getting more and more data-driven it is becoming increasingly important. Consistent data allows for easier and better analysis, which leads to more accurate and suitable improvement plans. In the new quality management era, data consistency is just as important as anything else you do.

Force Fields

One way to improve the quality of the data is by making certain questions a requirement. Employees need to answer the questions before they continue. The approach guarantees information but it doesn’t guarantee usable information. Some employees will simply key in some data to check the requirement, which will not help from an analytical point of view. It is important to find a balance in the number of required fields. This is something that can be explored by trial and error in the field—simply make some fields required and see what happens.

Selection Fields

Predefined selections are a great way to keep the data consistent. Employees have to pick one of the selections. When a selection field is used, make sure the different options are clear and self-explanatory. Options that are too complex will confuse the employees and reduce the value of the data coming out. Furthermore, try to prevent options like “other”, “general”, etc. These options are basically a trash bin for undefined situations. Providing this option makes people lazy and could very well become the most used option. The data will not be usable when 20–30% of the answers are one of these options because of the lack of context that is required.

Connecting Solutions

The best strategy to keep data consistent is by integrating your IT solutions. When data is consistent over the different solutions, you can really start identifying trends throughout the company—not just in quality management. When connecting the supplier issues directly to the suppliers in your ERP system, it is possible to instantly grade the suppliers. This connection also allows for benchmarking locations or product lines. In order to do this the data needs to be unambiguous, hence the integration.

Connecting solutions is key when you want to keep the data consistent over different solutions. Make sure you select platforms that are open and allow you to connect to other solutions when you pick your new partner.

Data Cleaning

Despite all the good efforts, things can still get messy. In case this happens it is important that there are options to clean the data. Your solution should be able to allow for data cleaning either manually or automated. This option allows you to keep the consistency in the data and keep on improving processes with accurate data.

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Employee Competence in ISO 9001:2015 Clause 7.2

According to the standard, all staff that work under your organization’s control are competent, and the evidence of this is documented accordingly. As with much of the ISO language, competence is left for each organization to define. This can become quite a discussion during audits due to a difference in interpretation by the company and the auditor. We try to help out here.

7.2a)    Determine Necessary Competence

The organization must decide what specific competencies are necessary for someone to perform his or her job effectively. To define personnel requirements for a given job position, you might ask the following questions:

  • What job-specific knowledge area(s) must be well understood by someone in this position?
  • What manual, mental, or interpersonal skills must an employee have to do this job well?
  • What natural abilities or talents must someone possess to be effective in this area?

A properly defined job description can help with guiding this process. The description should at least give a basic understanding of what is required and how the employee qualifies for the job. After you have collected the answer to those questions, the hiring process and training and development plans can be created. Also, the selection of the right person will be a lot easier when these requirements are clearly defined.

7.2b)   Ensure Competence

The requirements mandate that everyone who affects the QMS (i.e., everyone in the organization) must be competent. So, what exactly is ‘’competent”? It’s the condition that enables a person to perform a task in a manner that meets the required performance standard. ISO 9001:2015 clarifies this by separating four different variables relating to competence:

  • Education.
  • Training.
  • Skills.
  • Experience.

Of course, it is pretty much up to the organization what they define as competent,—but it should be in line with the job description. Remember you don’t have to follow things that you haven’t documented. However, make sure you set these guidelines in line with the job description. Also be cautious for inconsistencies. When someone is hired that doesn’t really fit the profile, make sure the appropriate training is giving.

7.2c)    Take Action to Achieve Competence

Once competency has been determined for all personnel affecting product conformity, the organization must compare individuals to its competency needs and identify where gaps exist. Options for dealing with a gap between actual performance and required performance include:

  • On-the-job training.
  • Coaching and counseling.
  • Independent study (traditional, audio, video, and internet-based).

7.2d)   Keep Evidence

One more thing that must be in place is records. ISO 9001:2015 specifically requires you to retain documented information (i.e. records) as evidence of competence. This can be accomplished in a single record or multiple records. The fewer individual records, the better—particularly if the records are kept on paper.

Digital training records are the most common approach for organizations. They clearly and quickly show what training has taken place or is planned and make gaps obvious. The long-term costs of digitizing your QMS are usually much less than the cost of administering paper records. Examples of evidence include:

  • Job descriptions/postings (evidence of determination of competency).
  • Employee resume and certifications (evidence that competency was met).
  • Training attendance and agendas ( evidence that competency was met).
  • Test results, certifications, performance evaluations (evidence that actions were effective).
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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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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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How to Build a Quality Driven Culture

We have talked quite extensively about the importance of a good safety culture. It is essential to keep people safe at work and make sure everybody goes home healthy at the end of the day. However, the quality culture is just as important as the safety culture. There needs to be a healthy quality culture in order for the company to thrive.

It All Starts with Passion

Delivering the highest quality comes with a passion for the job. Whether you are a carpenter, banker, or quality manager, when you have a real passion for your job you will do the best you can. Hiring the right people can already prevent some quality problems. The employees form the culture and deliver the end product. Hiring people that don’t really care about the product or service you deliver can lead to some serious issues. Make sure you hire the right ones.

Trust your People

When you have hired the right people and trained them properly, it’s important to trust them. Too many companies have complete encyclopaedias full with procedures, work instructions, and detail step-by-step guides. The workforce simply have to follow these steps to get the products or services out the door. When these guides are too detailed, people won’t feel responsible for their job. They are caught in the processes and will always blame the system instead of looking at their own actions. Yes guidance is good, but try not to make it too rigid as people lose motivation and stop caring.

Feedback

Another great method to create a quality driven culture is feedback. Allow the employees to give feedback on the instruction the company has in place. The people performing the steps know exactly what is going on during the day-to-day operations. They have a feeling of the friction between the steps, so involve them as they hold a lot of valuable knowledge.

Within the same line of reasoning, give the employees feedback. When someone reported an NC, make sure you keep him/her involved and give active feedback. They will therefore feel engaged and see how the company uses his/her input to improve the organization. This will definitely engage the employees.

Platform

To support the culture, a proper quality Management Platform is a necessity. The easy access to the right information allows employees to conveniently interact with the management system. They can grab the right process right away without searching too long and create a NC or other issue by three simple clicks. Furthermore, they should be able to see the progress of the NC/Issue they filled in real time to keep them engaged. When you want to bring the quality culture to the next level, make sure a proper Quality Management Platform is in place.

Celebrate

Lastly, the most important point, celebrate goals. Make sure when quality goals are reached that you take a moment and celebrate them. Get lunch, grab a beer, or just get some cake to share around, but make sure you celebrate reaching goals. This way everybody can feel the excitement and become motivated to reach more goals.

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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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The 7 Essential Quality Tools for Process Improvement

The 7 basic tools of quality (or 7 QC Tools) were conceptualized for the first time by Kaoru Ishikawa, a professor of engineering at the University of Tokyo. They are a set of relativity simple data analysis tools used to support quality improvement efforts.

The 7 basic quality tools are essentially techniques used to identify and fix issues related to product or process quality. When an organization starts the journey of quality improvement, they normally have many low hanging fruits. These could be eliminated with these basic 7 QC tools. The 7 QC tools are fairly simple to understand and implement because they don’t require complex analytical/ statistics to use.

So What Are the 7 Basic Tools of Quality?

  1. Control chart
  2. Flow Chart
  3. Check Sheet
  4. Pareto Chart
  5. Fishbone Diagram
  6. Histogram
  7. Scatter Diagram

Flow Chart

Flow charts are the best process improvement tools that you can use to analyze a series of events. They show you how processes work visually. This tool is mainly used to map out processes to determine where the bottlenecks or breakdowns are in work processes.

Cause and Effect Diagram

The cause-and-effect diagrams can be used to understand the root causes of business problems. This analysis is designed to get into the detailed fundamental causes of the issue, without any bias. The analysis will lead to significant insight into why thingswent wrong.

Check Sheet

A check sheet is a structured, prepared form (document) for collecting and analyzing data to evaluate quality. For example, you can use a check sheet to track the number of times a specific incident occurs.

Histogram

A histogram is a chart that shows how often a value, or range of value, occurswithin a given time period. Histograms provide a visual summary of a large amount of variable data. If the histogram is normal then the graph will have a bell-shaped curve.

Pareto Chart

Pareto charts are charts that contain bars and a line graph. A Pareto chart takes advantage of the 80/20 rule to visually show the categories with the largest impact on a problem. It states that 80 percent of an effect comes from 20 percent of the causes.

Control Chart

A control chart is a graph that displays trends, shifts, or patterns in the output ofa process over time. These charts allow you to identify the stability and predictability of the process and identify whether the process is under control.

Scatter Diagram

A scatter diagram or scatter plot is basically a statistical tool to represent the value of two different variables. The purpose of using this is to find the relationship between the problem (overall effect) and causes that are affecting.

Once a tool is learned, it can be adapted to various problem-solving opportunities. As with everything else, the use of these tools will require some practice and experience. Simply start with the tool that is easiest for you, and over time you will get the hang of it and become a great problem solver!

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6 Key Features Every Quality Management Platform Must Have

Considering a quality management platform for your organization? You’re not alone. Selecting the one that fits your company isn’t easy. Which features are needed to support your processes? How complex does it need to be? Is it user-friendly and intuitive enough for the employees? These are just some questions that you will need to answer during the selection process. In this blog, we discuss six key functionalities that your QM platform must have to support the basics of your QMS.

Automation

The single most important feature of an online platform is the automation. It has to save you and the company a lot of time. Automated notifications can help with staying compliant and reminding people of the areas to focus on. Make sure you come up with these triggers yourself to ensure they work for you and not against you.

Risk Analysis

Managing risks is critical for a proper QMS and at the bare minimum a hard requirement for compliance to the standard. A good quality management platform helps you to list your risks and connect the required actions. The connection between the risks and the actions will give great benefits. Make sure the platform is flexible enough to support multiple Risk Analysis methodologies such as FMEA or Fine & Kinney.

Action Planning

CAPA or action management is the lifeline of your management system. The action list shows how the company improves over time and which steps are taken to prevent issues from occurring in the future. The list can get quite extensive so make sure the interface has enough filters that allow you to find the most important actions that the company is working on.

Non-Conformance Reports / Issues

Another must-have is non-conformance reports (NCR). A lot of analytical data is stored in the non-conformities that happen in the company. A mobile app is a big differentiator for the team. The employees can now easily file an NCR by snapping a picture. When checking for the right solution, always check the analyze features. Running your own custom analysis in the platform will make life so much easier. The flexibility is key, don’t go for pre-defined options—they will become too limited very soon.

Audits and Inspections

Audits are where you can check how the management system functions. A clear interface will save a lot of time. The platform should allow you to have all the information in one screen, like your processes, NC reporting, and the ability to assign points of improvement and other tasks. The inspections are where you can easily make a check on your mobile phone. The inspection should be done on the mobile to save significant reporting time.

Document Management

Effective documentation is important for a well-functioning quality management platform, and every system should have it. Even though it is not required anymore, storing historical information is good for future reference.  With the right document management, you never risk having outdated procedures or work instructions. The system should take care of version control, and make them easily accessible to all

Show me 

Quality management is more than compliance or cost avoidance, it is about making real value out of your quality management system and make it part of your organizational culture. With a quality management platform that supports the above features you come along way with creating real value.

If you want to know how Qooling can help you. Please contact us!

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The Truth about QMS platforms vs. alternatives

It remains a bottleneck for many companies—do we opt for a quality management system or do we prefer one of the many alternatives? All solutions have their strengths, but they aren’t always the right solution to stay compliant and get the most out of your quality management. To give you a better insight into the bad and good sides of these solutions, we will shortly discuss the most common alternatives. 

Paper-Based Systems (Supported by Excel/Word)

Many companies still have a paper-based QMS system in combination with Word, Excel, and other Microsoft Office files to keep track of their documentation. The problem in a paper-based system is that companies constantly battle to make sure they are up-to-date with the latest procedures, copies, and more. Such systems require a lot of maintenance and are time-consuming to administer, which does not favor the benefits of a certificate. This approach also has a lot of time-consuming activities such as keying over the information from paper to Excel sheets. This not only costs a lot of time but also introduces lots of errors.

ERP Solutions

The use of ERP “solutions” for QMS has the potential to minimize the number of IT systems and offers “special” modules for certain aspects within QHSE compliance management. However, the fact is these systems are not built to be used as a compliance platform and certainly do not favor the functionality, flexibility, and support of a specialist system. These solutions can work for you, but they come at a cost of missing features and functionalities.

In-House Development

Of course, it is possible to develop a complete management system in-house. Choosing this route is usually the most expensive one. Not only does it cost scarce resources of developers, but it also requires a lot of input from operations. The developers have no idea what to develop. This needs to be analyzed and clarified by the people in the operations. When they help out, they cannot do their own job so the cost gets doubled. An other downside is the requirements of updates. Every time something needs to change the developers need to be available. This will lead to some serious costs to the company.

Specialized QMS System

A specialized QMS system such as Qooling provides the right tools to improve your business so that you can make decisions based on data from within your organization. These platforms are continuously improved based on feedback from customers and other specialists in the field. The updates are part of the package and don’t require additional costs. The fact that these platforms are built for compliance only, means that all the features are present and all aspects from different standards are embedded. The other big plus is that they run out of the box, which leads to an implementation time of weeks, not quarters or even years.

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How to identify ROI for an QMS

It isn’t an unreasonable question for anyone to ask, especially if you are going to ask them to spend money on quality. If you want your business to invest in a quality management platform, you should have some idea of what the costs currently are and how long it takes before you earn back your investment. 

‘’60 percent of organizations don’t know or don’t measure their financial impact of quality’’

Measuring ROI on QMS

There are countless benefits of implementing a quality management platform. Some can easily be measured, while others are more intangible and take place over time. However, the most important fact is that quality management platform can significantly improve the efficiency and consistency within your organization, resulting in improved overall quality. 

To help you understand the ROI on quality management platform, I’ll give you some key success metrics that you can use to track your improvement. 

Paperless Workplace

Manual or cumbersome processes take up resources and slow down productivity. No matter if this is in man-hours or administrative work, this is time spent on the system, rather than the business. A lot of time can be saved in the preparation of paper forms and documents. This could be incidents, work orders, work instructions, toolbox meetings, and so on. 

Greater Client Satisfaction

Quality management platform improves response and customer satisfaction while ensuring that customer reported quality issues are always properly documented and effectively resolve. The possibility of losing a customer based on the problems is very hard to measure but we all know when we screw up too often we will get burned. Having a clear overview of these issues, big or small, will help you get a better feeling of the likelihood of this happening.

Up-To-Date

Keeping employees up-to-date with the latest processes, procedures, and other documents is not only very labor intensive; it is also prone to mistakes. Forgetting to train somebody can lead to serious costs when old formats are used or processes followed. This could lead to missing out on a deal or even losing a customer.

Increased Productivity

The real hard ROI can be measured on time saved. Here also lies quite a number of challenges. Most companies have no idea how many hours are lost with an unstructured management system. Companies don’t track the hours people spend on searching for documents to use or training on new procedures. These are seen as the normal costs of running a business. However, saving on these activities directly impacts the bottom line of the company and therefore can have a significant impact. Try to find a reasonable amount of hours people spend searching for documents within your organization in order to benchmark.

Real Time Insight

A manual or Microsoft Office based management system lacks the real time insight. Data needs to be structured from a Word document to an Excel sheet in order to do some kind of analysis. Besides the time it takes, mistakes are also made. When the data is used and input for business decisions, this means that they are made on the wrong data. Every time data needs to be keyed over to other documents, mistakes are introduced. Make sure you have a single source of truth that can be analyzed in real time.

Get Started 

If you’re at the point where you are ready to find the right quality management system for your business, we can help you. Through a short phone call, our product specialist will look at the problems you are currently experiencing, and will advise you with choosing the right solution that fits your needs. Get started today!

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