Category Archives: ISO9001

Quality Management, does a certificate help?

Previously we touched upon whether or not a certificate is worth it. This post led to quite some discussion, with strong opinions from both sides. However, looking at Quality Management in general you can ask the question, “Does a certificate add value, and if so, how?”

As you might know, we believe Quality Management is important for everybody in the company. Every person has an influence on the Quality of the product or service the company produces. But to do this, is a certificate required other than a customer requirement? Lots of companies deliver high-quality products, but most of them are not certified.

Certificate

Of course, a certificate is not required to produce high-quality products. Every company that has a great focus on Quality will be able to produce high-quality products and services regardless. The people in the organisation mainly determine quality, not by the certificate. However, the certificate can give a certain kind of guidance and structure that can help a lot. There are certain things that need to be formalized, such as continuous improvement. Having the Management System audited on a regular basis puts back the focus on it. In the end, it all depends on how the management system is set up and how the employees use it. Nevertheless, there are always industries where you simply cannot operate without the certificates.

Structure

A standard forces a certain structure in the Management System. Yes, with most standards, you have quite some freedom on how to set up the Management System, but there are certain requirements for a company to work accordingly. A great example is the focus on continuous improvement. These can feel rigid in a way but they also give a great framework when you are trying to get some kind of structure in the organization. This structure can also work great as a playbook for expansion when the company wants to keep a certain level of Quality throughout different branches in different parts of the world.

Force for Change

In every company, there is room for improvement. However, convincing people to move and change the way they work isn’t easy. An advantage of having an auditor coming in every year is that as a Quality Manager, you can leverage them to force internal change. When speaking with hundreds of Quality Managers, we hear over and over again that they do this. However, when you use this tactic, never tell the people that the auditor is forcing this change, as this will not go very well. Not being certified makes it harder or even impossible to use this practice.

Conclusion

At the end of the day, a certificate isn’t really required, but it can help the company quite a lot in structuring the Quality Management within the company. Also, the external audits can be some kind of leverage to create change.

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Quality can sometimes feel ungrabbable

Quality can feel immeasurable sometimes. By immeasurable, we don’t mean all the KPIs we defined within our management system. We have great KPIs to measure company performance, which include things like:

  • Customer satisfaction
  • Production fail rates
  • Recalls
  • Costs of Quality

We say Quality is immeasurable more in the sense of soft output—things like how Quality culture is and how our employees see their work in relation to Quality.

Measuring Quality

Quality Controls in production environments are crystal clear, it either falls within range or doesn’t. If the product doesn’t fall within acceptable levels, it will be rejected. However, Quality Control in more interpersonal activities is much harder to measure. How do you rate the support of a company, for example? Not picking up the phone is a clear bad sign, but the tone of voice of the employee can also have a big impact. Especially the service departments of companies face these interpersonal complexities. Companies and business gurus came up with all kinds of measuring tools to get a good feeling about this, but the fallacy is still embedded in it. What if the person on the other end of the phone is just having a bad day? We cannot easily compensate for this other than in a statistical way. Also, most of these methodologies are making use of the average from lots of data, which is great, but doesn’t say anything on individual cases. Just measure the things that are important and acknowledge that there is bias in the data. And always check for the biggest impact, not only the average of all the data.

Outside Process

To make it even more complex, there are certain outsourced processes that also have a significant impact on the quality perception of the customer. A great example is the delivery guy/girl that delivers the packages for your company. He or she just drops the package over the fence without much care or wasn’t able to deliver it. The customer would get annoyed at the company while you weren’t able to complete control the process. Yes, again, there are ways to measure suppliers, but there is no way for the company to control this process because there are no internal resources for this. In order to have a good feeling of control, make sure critical suppliers are regularly audited and allow customers to easily file a complaint on your website. Use this data to manage and control the outsourced processes. This gives at least some form of control.

Conclusion

Get comfortable with having these immeasurable and hard to define KPIs within the company. There will always be certain outputs that are hard to measure; just make sure there is clear guidance within top management, as well as within the workforce, on how to perceive them. Getting the Quality mindset adopted throughout the company will ensure a much better feeling on the Quality within the company. Create measurable KPIs where possible to back things up with data.

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Buying an ISO Certificate: Is It Worth It?

After interviewing a couple dozen auditors, we heard the expression “Buying Certificates” quite a lot. It basically comes down to companies only caring about the certificate and not about the management system. In general, it happens more often with smaller companies than bigger ones—but it happens everywhere.

Most of the time, ISO certification is simply forced upon by a new customer that requires an ISO certificate. The real question is, is it worth it? It depends on the industry you are in, of course, because some industries you simply cannot do anything without. In general, it isn’t really worth all the things you are required to do if you really only care about the certificate.

The Situation

A new project or customer requires ISO certification, and the company starts to look into the requirements. A consultant gets contacted and a plan is created. Most companies have some form of Quality and Safety controls, so these are extended and adjusted to fit more into the requirements of the standard. A responsible person is appointed internally and he/she is working together with the consultant to get the management system in place.

The Pain

Because of the lack of support and awareness of the importance of the Quality and Safety management, it will start to feel like a big burden on the company. During the audit there should be some sort of proof that the team follows the procedures and processes described and that they are somehow involved in the stakeholder analysis and risk management. This can be quite challenging and lead to lots of irritation, with the most common phrase:

“We have to do it for ISO”

This of course is nonsense because the standard doesn’t write your procedures.

The Numbers

If you only do it to get a project/customer, which we don’t recommend, then it should at least make economical sense. Getting certified isn’t really hard, the real pain lies in maintaining the management system. Let’s make a small calculation. (These figures highly fluctuate among sectors and countries and therefore you should always make your own.) Just make sure you not only include the certification and the auditor but also the internal resources.

We expect 3 months of consulting by an in-house consultant.

  Year 1 Year 2 Year 3
Consultant € 10000 ,- € 4000,- € 4000,-
Internal Resources 200 hours 1 year (100 hours year 2 & 3) € 9000,- € 4500,- € 4500,-
External Audits (3 years) € 2000 € 2000 € 2000
Grand Total €42000,- For 3 years  

This is just a simple, relatively small company but it already turns out to be some significant costs.

The Real Implications

Because the management system isn’t really part of the company and not integrated into the operation, the audits will be a real pain every year. Things will be forgotten or aren’t up to date and control measures aren’t checked on effectiveness or simply don’t exist. This will lead to very frustrating situations during the audits.

A Good Thing

To finish with a positive note, we do see lots of companies that start to see and embrace the value of the management system when they have to implement it. They start to use it as a vehicle to improve Quality and Safety and structure their organization. If this is what you plan for, ISO is most definitely a good framework to do this and the ROI on the certificate will be great. So even if a company starts off as a Certification Buyer, it can still become a company that really leverages the standard to improve the business.

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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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