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The Truth about QMS platforms vs. alternatives

QMS QHSE QMS Quality safety

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 Implement a QHSE Platform

Qooling QHSE platform ISO14001 ISO45001 ISO9001 QHSE

Buying new a new SaaS solution always requires changes within the way the company works. Sometimes these changes might be minor and sometimes they will be major, but either way they are always for the better. However, not every employee will experience it this way. Some might feel they simply don’t need to change, as most people are resilient to it.

When a new Quality and Safety solution has been purchased, this is no different. Whether you previously worked with Word and Excel files on your server or with an on-premise solution, there will be changes that come along with this new solution.

Key Users

These are mostly the easiest to convince to change. They use the solution quite frequently and have experienced the downfalls of the current way of working. The Key Users are therefore eager to change and might have even been involved or consulted during the selection process. This is relatively easy to do. However, there is another important role for the Key Users and that is a lot harder to convince them of. They should become the internal trainer/consultant. When other people experience problems or difficulties with the solution, they should be able to consult with a Key User. The Key Users are crucial in having a wide adoption on the platform because of this role. Hence, make the Key Users aware of their important role and thank them for this. They are the specialists and they should be made aware of their importance. Everybody wants to feel special in some way, so make sure they feel appreciated.

What Is in It for Me?

The regular users are much more resistant to change. Some might experience the day to day problems but most don’t see many problems with the current way of working. They don’t follow the process completely or somebody else always takes care of this. The introduction of a new solution will force them to do a bit more or simply follow the processes properly. When this is known, make sure you clearly show to the people why it is important that they start to work this way. Explain to them why the solution has been purchased, which problems it solves and how it will help them. For example, now the employees can file issues with their mobile phone thanks to a mobile app. Previously they needed a printed form for this. There is a lot of time saved, not just by the regular user but also by the quality department. Make them not only aware of the time saved for them but also for the entire company. Most people do want what’s best for the company and if they don’t, you have a completely different problem.

Celebrate Success

When the new platform shows good results and gets adopted, celebrate the successes. The success can be big or small, but celebrate them no matter what. When a significant number of hours has been saved or incident costs have been reduced significantly, celebrate this. Order a lunch, get cake or grab a beer with the team. Think of something special and celebrate the success with everybody, not just with the Key Users. Even though you bought a new online solution, in the end you need everybody to make it work.

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Choose the Right QHSE Platform for Your Business

QHSE QMS
When you decide to move your QHSE management system to an online platform, there are quite a number of important points to think about. Implementing such a platform introduces many changes in the company which should be managed properly. However there are several actions you can take beforehand to get a better end result.

Internal Changes Required

Every new platform requires the company to change their way of working. The changes can be small or big, regardless there are changes. To make the transition as smooth as possible, it is crucial to check if the company is ready to change. Talk with people and see if they are open to improving the company’s process. This doesn’t mean you should 100% agree with them, but give them some level of influence, as there are always people who simply reject any new initiative. Involving employees will increase the support for the decision. which will greatly benefit the speed of adoption when the decision has been made to implement the platform.

Way of Working

Every company has certain ways of working that are entrances into the operation. Some are deliberately created, like compliance checks, while others emerged organically. Whether the processes are manual or completely automated, processes will follow each other. A new system will have an impact on the process flow within the company. However, during selection of the platform, make sure there are enough customization options to keep parts of the process as they are right now. A significant number of solutions force companies to work according to a certain way, which seems great until it doesn’t. Processes might need to be changed or improved when the platform doesn’t allow for these changes, so you will end up with lots of resistance from the employees.

User Friendliness

Ease of use is a key component in the adaption of the platform. Of course the platform should be feature-rich, but mainly focused on the key users. The regular user only gets confused when there are a lot of bells and whistles he or she can click on and play with. Elaborate access management should be implemented to give you some great options to tailor the platform based on the roles of the employees.

Real Value

The value created by the platform is an important factor. The value can be quantified by means of a business case to calculate some ROI on the investment. However, the new platform will also give the company possibilities it didn’t have in the past. Calculating the ROI on these options is next to impossible. The real value will always be a combination of the real ROI and the new possibilities for the company.   Keep in mind! Pick a platform that increases the change of adaptation by the company when you really want to generate more data in order to improve the processes. Published by:

A Data Driven Improvement Plan

Data driven QHSE Quality

We have touched upon the importance of data in quality and safety management numerous times. Of course data is important in every aspect of a business, but in quality and safety management it is just a little bit more important than other parts. Why is this? Because of all the standard focus on the continuous improvement abilities of the company. We believe that a good improvement should be based on data. Therefore it is crucial that data is gathered within the operations and in a structured and easy to analyze manner.

Improvement Plans

The improvement plans can be small or big. The most important point is that people always look for methods to improve the way the company operates. When a possible weak link has been found in the company, certain actions need to be taken and measured to see if any improvement has been made. These actions should be tracked by management to make sure the required actions have been taken. The complete improvement plan can just consist of a list of actions, and actually we prefer it not to be a big Word document which most people don’t read anyway. However, if the improvement plan does have a significant impact and requires more, simply create a proper plan but make sure the plan comes with actionable tasks to break it up.

The Start

The data comes mainly at the very beginning of the action plan and at the very end. In order to find a weak link within the company, the best way to back this claim is solid data from within the company. To have this data, proper systems need to be in place to allow employees to provide this data. This can be done with checklists or Non Conformity Reports or any other way. As you probably know by now, a Word document isn’t the best way to gather this information because of the labor required to get the actual information out. When the data has been gathered the analysis allows you to find the weakest link that needs to be fixed. Of course these links might change on a monthly or maybe even weekly basis, so it is important to keep on gathering data.

The Execution

When the problem has been identified all the tasks/actions to fix the problem are delegated. It is important that the responsible managers get assigned certain tasks within their department. It helps for managerial support and prevents the quality department being responsible for everything. They should only guide the different tasks and help when required.

The Results

After all the task are implemented the new results should be studied. Usually it requires a couple of weeks or months to see improvement in the data. Of course this is highly dependent on the amount of data the company generated, but at least a couple of weeks is a good figure. Again gathering the data is crucial in order to see if there has been any improvements after all the actions have been taken. This can be easily done by creating one graph that holds data before and after the improvement plan.

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The QHSE Manager’s role in a Fast-Changing World

QHSE Manager QHSE

The QHSE Manager job is slowly starting to change. Of course the core of the job is still the same, making sure Quality and Safety is at the highest level possible. However, with new technology coming in more and more, the QHSE manager needs to become some kind of a data analyst to find “real” root causes. This changes the role of the QHSE manager quite significantly.

The Past

As a QHSE manager, you are the jack of all trades when it comes to everything related to Quality and Safety. Yes, you do have people helping you such as QHSE officers or maybe even specialists per field of expertise. Still, in the end, you are the one that is managing everything.

In order to perform this role properly, you need to be good with people. To do this you need to have great communication skills to make sure you communicate your results in an appropriate manner to higher management. On top of this, you need to have some serious knowledge of how standards and legislations work to do the job. Of course this doesn’t cover everything, but for the most part these skills are very important for a good QHSE manager.

The Situation

With all the new technologies such as QHSE management platforms and IoT, QHSE managers can really dive into why certain issues happened. Data can come from multiple possible sources: internal processes, machines, suppliers, customers. There are literally hundreds, if not thousands, of possible data sources that can be leveraged by the QHSE managers. Some are just required for staying compliant, while other are a main input for process improvement. Analyzing the data and acting upon the results will benefit the company significantly.

The Future Role

This newly data-overflowing world requires new skills of the QHSE managers. Luckily, quite a few QHSE managers have some form of training in Lean Six Sigma and therefore have affiliation with data and how to interpret it. Though this basic level is a good start, these new technologies are bringing a completely different dimension to analyzing data because of the vast amount of it.

The QHSE of the future doesn’t have to become a full blown data analyst, but (s)he should understand how data can help. The QHSE manager has an advantage, namely his/her experience. It gets more important to think about what kind of causality you are investigating and show if it is there. This expertise of the QHSE manager of the future is crucial to come up with the best relations to analyze. It is the practical knowledge combined with the ability to analyze the data that will lead to the best results. For the analyzing part you can use all kinds of solutions, but it is the ability to apply the data that is the most important aspect.

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How to Use Kaizen to Continuously Improve Your Business

Kaizen QHSE Quality

Kaizen, or Kai Zen, is Japanese and stands for ‘continuous improvement’. This means: How can we improve / adjust our products and / or services so that the customer is satisfied and we stay ahead of the competition? Some of such changes require great efforts; which means months of hard work and dedication. But often undervalued is ‘Kaizen’ or the long-term approach to improving systems through small, sustained changes in processes in order to improve efficiency and quality.  

The Six Stages of Kaizen

Kaizen has six steps in the continuous improvement process. The focus is on mapping out waste, inflexibility and uncertainties within the process. A kaizen with the following six clear steps ensures lasting results and motivated employees.

1. Identify

Map out the process, look for information in flowcharts and other work instructions. Make sure to describe your goal as clearly as possible, so that misunderstandings can be prevented. After that ensure that your employees are well trained in the process. 

2. Measure

Collect data by looking at the management system. A well organized management system like Qooling can ensure that data can be easily retrieved, so you can effortlessly see what’s going on in your organization at any time. 

3. Analyze

Analyze the collected data by using the 5 Why & 2 How model. This tool forces you to really think about what went wrong and how to improve it. Learn more about this methodology here. 

4. Innovate

Search for new, better ways to do the same work or achieve the same results. Look for smarter, more efficient routes to get to the same goal that boosts productivity.

5. Standardize

After you have improved your process successfully, make sure that the changes are documented and made part of the clearly defined process, so that everyone using the process can benefit. 

6. Repeat

The circle of continuous improvement states that after completing the steps, you then repeat the cycle by making another small improvement. 

The Six-Step Problem-Solving Process is an easy approach to dealing with issues and problems that you face. It is a systematic way to approach a problem with clearly defined steps so that an individual or team always have a clear grip on the process. 

Need help? 

Wondering how Qooling can help with successfully implementing kaizen? Contact us for a free consultation with one of our experts. 

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How to Perform a Failure Mode Effects Analysis (FMEA) in 10 Easy Steps

FMEA audit QHSE Quality

History of the FMEA

The FMEA analysis is an common used Lean Six Sigma tool. In the past, the FMEA method was initially used by NASA in aerospace and for high-risk technologies. Since the 1980s, the tool has also been used in the automotive industry for Quality improvement. Nowadays the FMEA is a widely used tool for risk assessment & evaluation mainly in the manufacturing industry.

What is FMEA?

The Failure Mode and Effects Analysis (FMEA) is a structured approach for analyzing potential reliability problems at the start of the development cycle. The tool examines what can be done in the product process to ensure that appropriate measures can be taken to eliminate errors and prevent or reduce their impact. The 10 steps of the FMEA process are explained in a simple way below:

STEP 1: Review the Process

It is important to review the processes that are followed within the company. These processes can be stored in documents or maybe you make use of a dedicated solution for this such as Qooling. Then make a list of each process component in an FMEA table. Advanced QMS solutions allow you to connect the procedure directly to the FMEA table.

STEP 2: Brainstorm potential failures modes

Here you investigate what can go wrong. Therefore, study existing documentation and data which you summed up in the previous step. Identify all the ways in which the process can fail for each component. For example with Qooling you can easily assign the process to every potential failure mode.

STEP 3: List potential effects of each failures

Consider the possible failures and the effect these errors would have on the final product or the next steps in the process. It is important to think thoroughly about the potential effects because this allows you to develop some great solutions to prevent it from happening.

STEP 4: Assign a Severity Ranking for each failure mode

Give a ranking score for each effect. For example, a frequently used ranking is that 1 is not serious at all and 10 is extremely serious.

STEP 5: Assign Occurrence Ranking for each failure mode

Estimate the probability of occurrence of the cause. Also use a scale from 1 to 10 to  keep a clear picture of the severity of the causes. Where 10 signifies high frequency and 1 signifies low frequency.

STEP 6: Assign deception ranking for each failures mode or effect

What are the chances the failure will be detected prior to it occuring. Here a score of 1 would mean we have excellent control and 10 would mean we have no control or extremely weak control.

STEP 7: Calculate the RPN (Risk Priority Number) for each effect

To decide where to focus first, multiply the Severity, Occurrence and Detection scores together to find the RPN value.

STEP 8: Develop the action plan

During this step, you must prioritize which failures are processed first on the basis of the RPN scores.

STEP 9: Take action to eliminate or reduce high risk failures modes

Assign new tasks to the responsible person within your organisation. This can be collecting data, changing processes or products, adding or removing functions. A Task Management solutions makes is possible to manage those tasks in clear overviews. The responsible employee and management will receive email notifications whenever important changes are made. This makes it much easier to keep track of the progress.

STEP 10: Calculate the RPN again as the failures modes are reduced or eliminated

It is important to document the changes made to the process. Once the actions are complete, analyze the results. Determine whether the changes have helped and re-score the occurrence and detection. 

Making FMEA Easy

A Quality Management Software can help you understand your business processes so that you can identify problems at an early stage. By means of automated push notifications, the solution keeps you alert of changes in your product / development process. This allows you to quickly intervene and reduce the impact of the error. Qooling has a built-in template for FMEA risk evaluation. Contact us if you want to know more on how to use this.

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A3 Problem Solving Tool

Problem Solving A3 NCR QHSE Quality

An effective and simple approach for problem solving is Toyota’s famous (lean) A3-approach. This problem solving technique is a good example of how problems can be handled in order to be eliminated efficiently. The A3 lean method can be applied in almost any problematic situation, provided that all the steps in the process are completed.

1.   Define the problem (Plan)

To clearly identify the problem, it is important to investigate the underlying problem. A handy tool for identifying the problem is the Kipling Method (What, Where, Who and How) or the 5 Whys, so that you get deeper and deeper into the problem and its cause. In addition, you can also use an application like Qooling, that makes it easy to report problems as soon as they occur. This will save time and help you quickly identify the cause.

2.   Break down the problem (Plan)

Once you have found the current problem, it’s time to capture and analyze the current situation. Make sure all the information of the problem is known. Try to really get to the root cause of the problem and work out what happened by breaking it down into parts.

3.   Set a target (Plan)

Formulate a clear and achievable goal: When will the problem be solved? What is the result and the effect you want to achieve? By setting clear goals, the change to solve a problem successfully is many times greater than when it is not.

4.   Analyze the root cause (Plan)

Now that you have clearly defined your goal, it is time to carry out a root cause analysis. This will help you reach the underlying cause of the problem. Proper issue management solution will support root cause analysis.

5.   Develop countermeasures (Do)

Countermeasures are your ideas for solving the problem. These can be changes in your business processes that bring you closer to solving the root cause. Make sure you create actions to track progress of this phase. Qooling allows you to easily manage these tasks and track the progress.

6.   Implement countermeasures (Do)

Analyze whether the countermeasure introduced has the intended effect. Make sure you have the end results of the tasks searchable.

7.   Evaluate results and processes (Check)

In far too many situations, the A3 process ends with the implementation of the countermeasures. It is crucial to measure results and compare them with the goal you have set. If your actual results differ from what was expected, do an investigation to find out why. Analyze your data and and see how often the same problems occur.

8.   Share new knowledge with employees

Once the results are back, it is important to share your insights with other employees. Qooling makes it possible to easily collaborate online with colleagues and share knowledge through our online solution. This will keep everyone up-to-date and reduces the chance of making the same mistake again.

By implementing this process properly you should be able to get a good feel for the cost of failure and how you can reduce this.

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Problem Solving Approach (8D) Method

Problem solving iso9001:2015 NCR QHSE

The Eight Disciplines (8D) is a problem solving method for product and process improvement. Its purpose is to identify, correct, and eliminate recurring problems. The structured approach provides transparency, drives a team approach, and increases the chance of solving the problem. 8D follows the logic of the PDCA-cycle. The disciplines are:

D1: Use a Team

Gathering together a good and cross-functional team is a crucial part. Due to a varied composition of knowledge, skills and experience, a problem can be looked at from different angles.

D2: Define and Describe the Problem

Define the problem in measurable terminology: Who, What, When, Where, Why, How, How Much (5W2H analysis). This is a good addition to the problem analysis and can help you to get a clear description of the problem.

D3: Develop an Interim Containment Plan

This may be necessary to temporarily solve the obstacle. For example, to help a customer quickly and meet their expectations, or because a deadline has to be met. Finding the definitive solution in that case is of later concern. The point is that the problem getting worse is prevented, but it does have the goal of implementing the final solution later.

D4: Determine and Verify Root Causes

Before a definitive solution is found, it is important to identify underlying causes that may be at the root of the problem. Use the 5 Whys and cause and effects diagrams to map causes against the effect or problem identified.

D5: Verify Permanent Corrections (PCs)

As soon as the cause of the problem is known, the best solution can be found. From here, permanent corrections can be chosen and checked to solve the problem. It is also important to check whether the chosen solutions have any unwanted side effects. That is why it is necessary to also develop emergency measures that come in handy for unexpected events.

D6: Implement and Validate Corrective Actions

As soon as the definitive solution is clear, you can start with the implementation. By scheduling recurring audits, with a solution like Qooling for example, underlying problems can be eliminated prematurely. You also need to monitor long-term effects and take unforeseen events into account.

D7: Prevent Recurrence / System Problems

Prevention is better than cure. Therefore, additional measures must be taken to prevent you from making the same type of problems in the future. Often it is best to carefully review management systems, operation systems and procedures, and change them where necessary.

D8: Congratulate Your Team!

Recognize the collective efforts of the team. Formally thank team members for their involvement. Use approaches that appeal to each individual member, as not every employee is the same. This is therefore the most important step within the 8D method. Because without the team, the problem could probably not be found and solved. Make sure you celebrate achievements.

The 8D method is a great method to not only reduce product and processing concerns, but also to increase customer satisfaction. A practical workflow solution like Qooling can help you with this in many ways. Experience the many possibilities of Qooling and ask for a free demo.

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PESTEL analysis – Context of the organisation

Context of the organisation audit QHSE

As an addition to our previous published blog about the SWOT analysis, I decided to give you more information on another effective tool for identifying the context of the organization of clause 4.1. Just like the SWOT, the PESTEL is one of the tools that is most used by companies to identify the external aspects of the organization. You’re probably thinking that you don’t need to use both the SWOT and PESTEL analysis, and you’re right as the SWOT analysis already takes care of the external factors. Although, business environmental scanning is best achieved when using both tools in collaboration. It may be a cumbersome task, but it gives your organization the full view of defining the context.

ISO Ask for Context Analysis

The new requirements of ISO 9001:2015 state that you need to carry out an analysis that indicates the internal and external factors that affect the organization. To help you further, I’ll show you examples of each factor so that you can apply them to your business.

(P)olitical factors

By examining the political factors, you should look at government decisions. Legislation and regulations are very important here. A change in these can affect your organization in the upcoming 3 to 5 years. Ask yourself the following questions:

(E)conomic factors

You will have to examine which economic factors may affect your organization. These factors are determinants of an economy’s performance that directly impact your organization and have resonating long term effects. Use the following questions to find out the important factors:

  • How stable is the current economy? Is it in an period of growth or recession?
  • How is globalization affecting the economic environment?
  • Do consumers and businesses have easy access to credit? If not, how will this affect your organization?

(S)ocio-cultural factors

The consumer is mapped out by means of socio-cultural factors. This makes it possible to determine, among other things, how far the power lies with the consumer. The socio-cultural factors can be examined by asking yourself the following questions:

  • Are people changing buying habits?
  • How do religious beliefs and lifestyle choices affect the population?
  • Are there any new social trends?

(T)echnological factors

Depending on the industry, these factors will have more impact or less impact. Assess any big technological developments and determine how they can impact your organisation. These questions can help you further:

  • Are there new technologies that you could be using?
  • Do any of your competitors have access to new technologies that will result in a competitive advantage?
  • Are there other technological developments that could affect your industry?

(E)nvironmental factors

The level at which you should identify environmental aspects will depend on your intended purpose. A company can determine that they have environmental aspects consisting of:

(L)egal factors

This factor takes into consideration all legal aspects. This point is closely related to political factors but focuses more on the actual laws and not on the political directions of a country or region. This can include:

  • Are their new environmental permitting requirements for your sector?
  • Could any industry-specific regulation affect your organization?
  • Are there changes in employees’ law?

TIP:

Do not collect large amounts of data without properly analyzing and understanding them first. After that you can carefully consider which factors are important to your organization. This allows you to create an actionable plan that is prepared for upcoming changes.

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