Category Archives: ISO9001

Why Digitize our QHSE Management System

A QHSE management system gets built over the years and is mostly done with existing tools. However, a scattered QHSE system does more harm than good. A combination of an inspection app, with some Word and Excel docs and an ERP, is how most QHSE Management systems are running. Bring your QHSE to the next level by leveraging one seamless Digitize QHSE platform,.

Why Digitize a Quality Management System?

Why should we digitize our QHSE Management System on one platform? This is a valid question and one we get asked quite a lot. Well, the efficiency improvements are huge. Search time for documents and forms go down by hours, more data is gathered, errors are reduced. These advantages and much more allow companies to have an ROI on platforms of months every single year.

Current Situation

Over the years, companies have built their QMS within the solutions and tools they have been provided. Documents are stored as Word or PDF on the company server. Production issues might be filed in the ERP system, some basic quality checks are built in the ERP. Due to the rise of the mobile phone usage, there might even be an app to perform some basic checks.

This setup is acceptable for staying compliant, but the company will never utilize the full potential of the QMS, namely as a vehicle to improve Quality. This scattered landscape makes it hard for the employees to find relevant information or data, while the Quality department can’t start effective improvement plans. The system also gets very rigid and hard to align with the changes in the company and its environment.

Changes

The QMS becomes very rigid because changes to existing ERP or other solutions aren’t easy to realize or are simply out of budget. The Excel documents are pretty easy to change; however, with these documents it gets hard to enforce the use of the latest version. Getting actionable data out of these Excel sheets is even harder, let alone getting proper visualization. In the end, maintaining a fractured management system is undoable.

One QHSE Platform

Bringing all QHSE documents and data into one platform allows connecting the different parts of the QHSE system seamlessly. Employees know where they need to be for their documents and forms. No need to search for ages, the QHSE system is tailored to the role they hold in the organization.

Having all the QHSE data in one place and enriching it with other company data allows for finding the real root causes and implementing a data-driven continuous improvement process.

User Engagement

Having one clear platform for QHSE allows for much more user engagement. Mobile apps increase the number of NCRs by hundreds of percentage, data that is crucial for improving the company. Users know where to go to for their procedures and documents and can find them within a couple of clicks. Clear activity logs show who did what when and what are the next required actions.

Conclusions

Scattered QHSE management systems are harming the company. Digitzing the QHSE management on a single solution will allow the company to improve and maybe even go for Operational Excellence.

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You are responsible for poor Quality

Last week part of the roof of a big soccer stadium in Holland collapsed due to a heavy storm. Luckily no one was injured because there was no game at the time. The media storm that came after was almost as heavy as the natural one. Everybody started to blame each other, and no one takes responsibility for it. As with so many of these things, everyone hides behind policies and documents. This really shows the impact of poor quality products.

However, this disaster clearly showed that you don’t want to be the company that delivers a product that has poor quality—for whatever reason.

Manufacturers Are Responsible

The statement was that additional solar panels were installed and the construction wasn’t designed for that, but still the construction company gets lots of negative press. As the company that built the stadium, they are seen as the responsible party.

Most of the time, the company that manufactures a product is responsible for the product when something goes wrong. This might not be legally so, but in the media the company is. Therefore, it is important to find out how customers want to use the product. If the product is wrongly used, try to correct the customer and guide them in how to use the product properly. Alternatively, the company can even deny delivering the product if they don’t trust that it will be used appropriately. No sale can make up for the negative media that can happen. Yes, this is all covered with legal documents but it is still your name in the newspaper. In the end, you as the manufacturer are responsible. The example in Holland proves this.

Customer Demands

Sometimes customers can request solutions that your company is not comfortable with. This can be a lower price, faster delivery, or particular design choices. Whatever it may be, most of the time it impacts the quality of the product. Make sure the customer is well informed about the implication of their demands and explain what the impact can be. In the end, you need to be comfortable with the product you deliver because you are responsible for the poor quality. However, as a company it is essential to establish a baseline with what isn’t acceptable anymore and align this with the company vision and mission statement.

Don’t be afraid to walk away from a customer

Traceability Documentation

When things actually go wrong, make sure you have all the traceability documentation in place. This is of course after the damage has occurred, but it will help a lot when this is in place. Be able to show how materials were bought and that they have been sourced at reliable companies. Also show how the product was built and tested and have all the test results at hand and verified by trustworthy third parties. This will make it a lot easier in court when things go south.

Regardless if the judge eventually releases the company of any blame, most of the harm has already been done. The company is in every newspaper, which will have a long-term impact. The impact of poor quality lasts forever.

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Multicultural impact on your Quality and Safety management

­­The world is getting smaller, which means a more diverse company culture and multicultural organisation with multiple languages. Lots of companies work with people from different countries. Whether it is a trucker, a specialist engineer, or a welder from around the world.

Demand and supply are filled from every corner of the globe. It is amazing we live in a world where this is possible, but it introduces some challenges related to quality and safety management. When we want to keep this on the highest standard possible, we need to make sure that most of the critical information is well understood by everybody. Making all the documents and ways of working understandable for everybody and in every language isn’t always easy. Mistakes in aligning the cultural differences goes way back. However, with a more globalized economy, not just the big enterprises need to mitigate them.

Language Differences

With all those different kinds of people, there are language differences. People might speak English but they could be having difficulties really understanding it. When English isn’t your native language it can be hard really expressing yourself in it. In such a case, make sure all the important instructions are available in the employee’s native language. The risk of mistakes caused by employees not understanding what to do is just too high. Translating the different information and checklists can be hard—especially when you want to keep analyzing all the information regardless of the language. However, not providing the information in the native language introduces risks which are simply unacceptable.

A common solution for a lot of companies is to have a team leader who speaks English and communicates with the team. This works fine, but it also introduces communication problems. Having the important work instructions, safety guides, and procedures in the native language of the employees is the best way forward. This way you give them the option to really understand how to operate in the best possible way.

Managing all the documents in different languages requires a proper document management solution otherwise you will go crazy. However, when you have a significant number of employees with different native languages it is important to do this.

Cultural Differences

Apart from the language differences there are also quite some cultural differences when you work with people from different countries. They have been trained in a different way from a very young age and are used to doing things a certain way. This might not always align with the way the company does these things.

These cultural differences are something that needs to be taking care of the moment the new employee steps into the company. Make sure the person is trained on how the company handles certain things and colleagues should behave. A great example is the handling of NCRs. In some countries this isn’t really accepted because making mistakes is penalized. While maybe in your company you want more NCRs be filed because it helps you to improve the company. When you hire someone from a culture where this isn’t very straightforward, you need to train this new employee on that mindset.

Conclusion

Yes, having multiple cultures in your company introduces additional work and costs but being aware of the risks of not dealing with it is simply too high. Therefore it is essential that crucial information is available in the native language of the employee.

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NCR, Who is responsible for it?

NCRs and issues happen in any company. The way the company handles these is what defines the culture of the organization. More often than not, the responsibility is simply dropped at the Quality/Safety department regardless of their knowledge of the matter. Yes, Quality/Safety should be informed about it, but they cannot and should not be responsible for everything that goes wrong. Check out how we believe NCRs should be handled.

Filing NCRs/Issues

The first step is getting employees to file NCRs/Issues. There should be hardly any boundaries for them to file one. (link to easily creating them). The creation form for an NCR/Issue should be no more than five input fields, including the options to add pictures and be mobile accessible. Keeping this step easy will allow for much more data from the field. The employees on the ground really know what is going on, so make sure you leverage their knowledge.

Responsibility

When the NCR has been filed, not all the information is known yet. The NCR owner has the responsibility to get the report fully filled in and to make sure all the data is collected properly. Quality/Safety shouldn’t be the owner of all the NCRs, however, they should be informed about the issue. Line managers should own the NCRs that have been reported in by someone in their department or team. These managers are close to the operations and therefore able to collect the required information. Also, most of the time they know much better what goes on at the operations level.

owner has the responsibility to get the report fully filled in and to make sure all the data is collected properly. Quality/Safety shouldn’t be the owner of all the NCRs, however, they should be informed about the issue. Line managers should own the NCRs that have been reported in by someone in their department or team. These managers are close to the operations and therefore able to collect the required information. Also, most of the time they know much better what goes on at the operations level.

CAPA Plan

Next to the data that needs to be collected, there will be specific actions. These actions can either be planned by the responsible manager or by the Quality/Safety department. These actions should help to solve the issue immediately or even prevent certain issues from happening in the future.

The actions should be distributed among the employees and no task should be owned by more than one person. This distribution of actions increases the engagement and allows for collecting data from the person that has the most knowledge of the matter.

Feedback

Provide feedback to the person that filed the issue. This feedback can be simply a summary of how the company handled it. The engagement will be so much higher when people get informed because they see that the company really cares and actually does something with their reports.

Next Steps

When all the NCRs are filled, it is up to Quality/Safety to make sense of it all.Analyze the results, find the common root cause, and analyze their financial impact. When the data is structured, you will see how impressive it can be and how much money the company leaves on the table by repeating errors.

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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 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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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

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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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Process Mapping

Every company has their own way of working, and are either implicit or explicit in documented processes. These processes are followed by almost anybody in the company. In order to find efficiencies in processes or during the interaction between them, it is important to map the processes. Make sure every process is included in the exercise.

High Level

It is always good to start mapping the processes at the highest level of processes in the company. Don’t go into much detail of every process, for now just note them down. Some great examples of high-level processes you can think of are, for example, sales, order handling, and project management. Also point out the support process on a high level like HR, IT, quality, compliance, etc. As a guide, you can just answer this simple question:

For every company this can be different, but there are some defined steps someone needs to take in order to become a paying customer. Having a clear overview is key, so create some kind of flowchart to put the process in logical order.

Which process does a person/company following to go from a prospect to a paid customer and what other non-core processes are there in the company?

Dive Right In

When the big picture is clear, it is time to zoom in on the individual processes. Sales can, for example, exist of prospecting and selling and maybe even marketing. It depends on where you draw the line. On the other hand, project management can be just managing the steps to produce the product or maybe also on the side to install/implement it. You draw your own line, but make sure you go one level deeper and check all the steps that are within a high-level process.

The Handover

The points where one process goes into the next are critical points in your company. During the transition from one process to the next, communication is critical. In this part of the processes lots of improvements can be realized by many companies. We will touch upon this point in one of our next posts. For now, it is important to highlight these handover points in your processes to make sure everybody is aware of them.

Audits

A great way to have a feeling if people are working roughly according to the processes is auditing. The different ISO standards forces certified companies to audit their processes, but also for non-certified companies this would be a great practice. There are different kinds of auditing techniques, but the Brown Paper Audit is a great innovative approach. Next week we’ll look more at this technique.

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How to Implement a QHSE Platform

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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