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The Standard Shouldn’t be your starting point

Standard isn't beginning QMS Quality

The several different ISO standards can be great guidance when adding structure to an organization. However, the standard shouldn’t be the starting point for an organization when setting up any kind of management system. When you want to create a QMS it is important to start with the core processes of the organisation and especially the ones that have a direct impact on the quality of the product and services the company provides. A significant number of processes that are required for certification are new anyway such as having some kind auditing process. This approach will have little impact because they should reflect how they do their job already. However, do explain why the processes are formalized and that they should be followed. 

Written in Stone

Procedures and processes are not written in stone. Still the mentality within quite some companies is that they have to do it for ISO. A company doesn’t have to do anything for ISO, except for the couple documents that are required by the standard. In essence the standard wants the organisation to work according to how it is documented or formalized by the organization. When ways or working are somehow agreed within the organisation everybody should work accordingly, when people don’t a NC will be noted during an external audit. In essence the company just needs to do what is agreed upon and when it doesn’t it can simply change the procedure. 

Added value

The added value certification for the organisation diminishes rapidly when the feeling is that everything is done for ISO. Employees get the feeling that actions are taken for ISO instead of for the benefit of the organisation. When this is the paradigm in an organisation it is very hard to get it out of the culture and change the mindset of the people. Try to avoid it from the start and always start with showing the added value to the organisation regardless if ISO requires it or not. 

The added value of the different standards are evident in that they can help organisations to structurize and formalize their processes which can be great. The structidized way of working should always have a consistent quality and safety way of working in mind. When this is clearly communicated to the people in the organisation they will see this value. Always keep the added value in mind when you are going for formal certification on the management system.

Communication

The most important part in setting up a management system is communication. With good communication you will have support from every level in the organisation which will obviously help. Also when people are involved in the processes they will have some kind of

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Quality Management isn’t a One Man Show

Qooling Quality Management QMS Quality

Quality Management isn’t a one (wo)man show. Most of you Quality Managers know this is true, but within a significant number of companies, this is still the default. Phrases like “John is the Quality Manager, he takes care of Quality” is what exemplifies this. Quality is really an organization-wide effort—every level has either a direct or indirect impact on how the customer experiences the goods or services.

Team Effort

We have been saying this a lot, and most of you know it by heart: Quality is a team effort. But let’s rephrase this, Quality Management is a team effort. Everybody in the organization does something that has a direct effect on the Quality the company delivers. This can be the office manager that picks up the phone with a friendly voice or the service engineer that performs services when required, and every step in between. However, the people that don’t work directly with the customer also have a direct effect on Quality, although there isn’t a direct impact by the job they do. This could be the warehouse manager or the financial admin. That is why we make a separation between direct impact roles and indirect impact processes.

Direct Impact

The moment the customer interacts with the organization, there is a direct impact by the employee on the perceived Quality of the company. This can be a person or the product the company provides. It is essential to meet the expectations of the customer at that moment. Of course, things can go wrong and customers will accept that if it is solved in the best way possible. Those with a key role are the service and support people that are in contact with the customer when things go wrong. These are the people that can have a great impact on the relationship with the customer and therefore on the Quality perception of the customer.

Indirect Impact

The indirect impact gets a lot less attention. These are all the processes that don’t have a direct connection with the customer but have a severe impact on the quality perception. Great examples are logistic processes, when delays pile up in the warehouse or when things get messed up in finance. These processes can have a serious negative effect on the Quality perception. The support and service team are then loaded with the burden of fixing this, which can lead to a significant workload. For an organization, it is important to always keep an eye on these processes and not only focus on the processes with direct customer connection.

The Organization

When we look at the direct and indirect impact of the processes, we clearly see that everybody has an important role in the consistent Quality of the products and services. It also makes it pretty clear that Quality Management is a team effort. Your role as the Quality Manager is to guide people into adding value to the management system and give them the right tools to do this. When Quality checks and Quality-related activities become part of their day-to-day routine, it becomes seamless for them. This way, you will get much more input to improve difficulties in processes. This way the organization gets better aligned and there will be less friction.

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Quality 4.0, What Is It?

QHSE 4.0 QMS Quality

There have been thousands of articles written about Quality 4.0 in various contexts and for various industries. Some claim that you should gather information, make the SOP digital available and train employees via e-learning. Yes, you should do all of this but that was part of Quality 3.0, not 4.0. If your company hasn’t moved to a Quality Management Cloud Platform, you are not ready for Quality 4.0, unfortunately.

So before you start to even think about a Quality 4.0 strategy, make sure you have a good foundation. You simply cannot try to execute the strategy without a proper QMS Cloud platform. You need to have the infrastructure to gather the data, connect the data and analyze the data. The implementation of the Quality 4.0 strategy can take years, so make sure the platform is able to adapt to changes in the market and allows for adjustment.

Data Is Key

Quality 4.0 is mainly about leveraging a significant amount of data to increase the Quality of the products and services produced. This sounds pretty straightforward because we crunch data every day, but having the right data is actually quite difficult. Most companies do have data, lots of data. However, when they start analyzing it they see big missing chucks, inconsistent data and simply corrupted data.

Having machines that are able to share their data, easy-to-use interfaces to create valuable data and other sensors and IoT solutions that generate data are essential sources. To further enrich your internal data, it is possible to buy datasets from bit Data Management Platform provider. These external sets can be used to benchmark your internal data or find context. The data needs to be vast, but more importantly accurate, so make sure data quality checks are in place to ensure this. In the end, wrong data can lead to wrong conclusions.

Connecting the Dots

When you really want to make sense of the data you are harvesting, it is important to connect it all. When going the Quality 4.0 route, open platforms and systems are key. It should be possible to connect the different systems and platforms with each other without much effort. This way data can easily flow between the systems and they can make sense of it for their particular purpose. The machine data can be used to predict production problems in a badge by the QMS platform. The same data can be used to plan predictive maintenance by the Asset Management platform while the ERP uses it to bill the customer. A single source of data can be interpreted and used in several different ways by different solutions so make sure it flows easily. This is why it is essential to allow for integration between different solutions and platforms.

The important component is that the data should be accessible to multiple departments. Different departments can leverage data in different ways as described by how the machine data can be used. In order to make the data accessible and interpretable for different departments, great BI tools are key. These are the platforms that visualize the data and give them more context to the people.

Make sure the data is not only accessible to management but make it visible to every layer in the company. This will get them informed but also engaged in the performance of the company. Quality 4.0 is not only digital and data, the main component is still and will always be the people.

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Quality as a driver for Growth

data QMS Quality

Quality Management is regularly seen as a cost center. The organization may have the feeling they need to shell out a significant amount of money to set up a Quality Management System and get it off the ground. Then when a certificate is required in order to prove that the QMS somehow functions, more money is needed. This perception is a big struggle for Quality departments all around the world, even though the facts are different. Quality is actually a true profit center if it is done correctly and genuinely incorporated into the fibers of the organization. This is because high-quality products and services are a key driver for added value and business growth. Creating and maintaining a high level of quality should, therefore, be a top priority to everybody in the organization.

Quality as Your Differentiator

The Quality of the products and services is the number one differentiator a company has. Having superior quality products and services will give the company a head start over any of its competitors. With this we mean Quality in the broadest sense of the word—from the first interaction with the sales team to the continuous interaction with the service team and everything in between. When this experience is world-class, people will come back and retaining an existing customer is so much easier than developing new ones all the time. Besides, the market will see the superiority of the products and services and companies want to do business without much effort. Hence when the Quality is high class and above expectation it will become a big driver for growth. This is very different than the cost center as some companies look at it.

The Quality Management System

To be honest, it is at the QMS level where the discrepancy between Top Management and operation starts to happen and where the problems start. Passionate Quality Professionals incorporate the standards in the QMS, which leads to quite some procedures. On the other hand, Top Management, as well as a number of employees, just see a bunch of required documents and procedures without much added value. They have the feeling the QMS is mostly created to please the auditors and not to have the quality in mind, let alone help them. However, these procedures and policies are designed to maintain the high level of Quality the company is striving for. It is crucial to articulate this clearly; leaving out any reference to the standards will be a good start. Next to that, keep talking about the added value of maintaining the Quality. Explain that the checks and balances such as audits and quality checks are created to maintain the Quality of the products and services, not to bother them. This is well known by us Quality professionals but it is not in the heads of Top Management. It is our job as Quality Professionals to get it there and show how the business can reach growth thanks to it.

Make It Measurable

When making compelling arguments to Top Management but also to other employees, it is essential to have data to back up claims. Data such as customer satisfaction, referrals from current customers, services call reductions, recall reductions, production error reductions, etc. When using data it is important to put them into perspective for Top Management. When, for example, production errors went up by 10 percent but production itself went up by 50 percent, the 10 percent isn’t really that bad. In this case it is better to make use of ratios. For numbers such as referrals from existing companies, they can be presented as they are. This also shows that it is important you get this data and you get involved in the sales organization as well to make sure you can trace back these referrals.

In Quality we might not impact the numbers directly but we create the road for others to excel and growth for the business.

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How a good Quality Management System helps the company.

https://www.qualitymag.com/ext/resources/Issues/2018/August/Cost-of-Quality/QM0818-FT6-Management-p1FT.jpg?1532630417 data QMS Quality

Everybody in Quality knows that having a functioning Quality Management System will reduce costs. Maybe not the next day, but in the long haul it will make the company money if it is functioning properly—and this is where the real problems lie. A significant number of Quality Management Systems don’t function correctly, either due to a lack of resources or due to a lack of involvement by management. However, when it does function properly, the company can really streamline operations and get a better position in the market.

Lack of Importance

This is probably one of the biggest struggles for Quality Managers. Top Managers may understand the importance of having Quality Standards, but they don’t really understand Quality Assurance and how it can help the bottom line.

Top management isn’t always willing to invest in proper platforms and tools to manage all the data and allow for detailed analysis. They don’t see why the company needs such a platform. They will come up with things like, “we have already an ERP system”. This really shows they need to be educated because an ERP system is not going to help with structuring the QMS and improving the processes.

The Impact

Top management looks at the production rate and how much has been produced over the last month. They look for possibilities to increase the output with the same number of people. Yes, it might be possible to increase the output but it will have an effect on the quality. The issue is that these implications aren’t always instantly clear. Problems might start to occur weeks or months after the products have been delivered to the customer. So for a period of time, it looks like the production increase had a positive impact on the number. However, when the warranty claims start to come in, increasing production might not have been such a great plan.

The point is that a significant number of companies cannot even track these basic numbers, because their QMS isn’t working properly. Warranty claims aren’t properly logged in the QMS which makes it very hard to find this correlation. This is just a simple example but there can be a range of different correlations within your company. The company cannot see the implication of their choices because the QMS is simply ineffective here.

The Importance

Having a functioning Quality Management System in place is important to keep the Quality of products high. In order to really reduce the production costs, some parts are critical in a QMS.

Structured Way of Working

Documenting the ways a company operates is a good technique to get a feeling of what the company actually does and what comes to building the products or providing the services. This can be a process, procedure, work instruction, SOP, etc. It doesn’t really matter how it is called, as long something is documented and easily transferable to a new employee. The documented way of working is crucial in maintaining a certain level of quality within the company. It would be very weird if every employee can decide for themselves on how to assemble a piece of machinery. Make sure these documents are easily accessible and transferable.

Improvement Plans

A proper Quality Management System will harvest data on everything that goes wrong within the company. This data can be leveraged by the Quality Department to come up with improvement plans that are based on facts. This will directly lead to better products, shorter production time, less rework, etc. Having the actual data at the fingertips and being able to track it over time allows the Quality department to measure if the improvement plans actually work or if they need changing. Data-driven improvement plans enable companies to reduce a lot of costs.

Historical Data

Data is, like in most parts of business, key for Quality Management. As touched upon before, having data to correlate issues to change in the production flows allows for finding the root cause for the problems. It also allows for finding correlations during certain seasons. The data is golden for starting off the right improvement plans.

When combining the Quality data with data from other platforms, the company can really start to streamline the organization. Connecting planning data to the Quality data allows for finding correlations between shifts and issues. These things can only be realized when the data is within the company.

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You are responsible for poor Quality

poor quality ISO9001 QMS

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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Data consistency in Quality Management

Data Consistency in Quality Management ISO9001 QMS

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

ISO9001 QMS

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

https://smartwerksusa.com/articles/business-objectives/ Management QHSE QMS

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

https://www.freshbooks.com/blog/pick-business-structure-business erp QMS Quality

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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