Category Archives: iso9001:2015

The Outputs of Design and Development Clause 8.3.5

In the previous post we touched upon the inputs for the Design and Development Clause of the  ISO 9001 standard. The outputs are closely related to the inputs of course, but they have some twists to them. The four outputs that need to be covered are:

  1. Meet the input requirements.
  2. Be suitable for subsequent processes for the provision of products and services.
  3. Include, or refer to, appropriate monitoring and measuring requirements and their acceptance criteria.
  4. Define the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

All the information of the Design and Development outputs needs to be documented either through a register or some other form.

Meet the Input Requirements

This one is pretty straight forward. The product should meet the input requirements. If the product or service doesn’t meet the requirements, it isn’t only useless, but we have also failed to fulfill our customer’s needs—a pretty important part of doing business. To meet the requirements, it is critical that these requirements were very clear in the first place. The clarity of the requirements should be well thought of during the input phase of the design and development process.

Be Suitable for Subsequent Processes for the Provision of Products and Services

The company should be able to have processes in place to realize the product or service according to the specs of the customer. These processes are part of the QMS and should lead to a desired output. It should be very clear that the QMS of the company is able to produce the product within specs and rules and regulations.

Include, or Refer to, Appropriate Monitoring and Measuring Requirements and Their Acceptance Criteria

The company needs to have a strong plan to monitor if the product is designed as expected. This can, of course, be accomplished by very close communication with the customers and other stakeholders in the process. The way the company communicates and how it documents this information should be clearly defined to make it unambiguous.

Define the Characteristics of the Products and Services That Are Essential for Their Intended Purpose and Their Safe and Proper Provision

The products or services should function as intended—this is also closely related to the input requirements. When these are pretty clear, it gets a lot easier to make the product or service function as intended. However, even if the requirements are clear, the company should fully understand if the product or service is safe and properly functioning. The customer can request a car without a steering wheel, but even if the company built such a car, it is mostly likely not safe and not intended to operate like this, except for a self driving car maybe. So even if the specs are clear, the company has the duty to judge if the functions are really what some can expect from the product or service. 

Documented Information on Design and Development Outputs Must Also Be Retained—IE: Records

Lastly, it is crucial to have all the information created during the processes documented in some way. This can be in Word/Excel documents or in specialized platforms. It should be retrievable whenever asked for by someone.

Conclusion

The 8.3.5 isn’t all that hard in essence, it just requires the company to make sure that the product is developed as intended by the stakeholders. The information that is created during the process should be registered in a system as per the company’s choice. 

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The Inputs of Design and Development Clause 8.3.3

Clause 8.3 Design and Development is regularly misunderstood—not just by Quality Managers but by Auditors as well. It is one of the toughest and most confusing clauses and we find a lot of questions regarding clause 8.3. The fact that you need some form of processes for such a creative process can make it very hard. Due to this difficulty, it is probably the most excluded clause. We have even seen companies leaving these activities out of scope to solve this.

The Input

The input requirements by ISO9001 for the Design and Development Process are:

  1. Functional and performance requirements.
  2. Previous design and development activities that are similar.
  3. Statutory / regulatory requirements.
  4. Applicable standards or codes of practice.
  5. Consequences of failure (risk) associated with the potential of failure due to the nature of the products and services

1. Functional and Performance Requirements

Number one should be pretty clear before the company even starts to do anything. There can be formal requirements from the customer like in a “request for proposal” or they can be known implicitly by talking to a group of potential customers or via desk research. Regardless of how the company gathers the information, it should be clear what the customer expects.

2. Previous Design and Development Activities That Are Similar

When there is a history record of all the things the company has done, it should be fairly easy to get at least a starting point of the activities done in the past. Part of the requirements could be mapped to the new projects. Looking for best practices among the past projects should make it easier to come up with a concise way of working.

3. Statutory / Regulatory Requirements

Rules and regulations should be a top priority when you design and develop products and services, regardless of your industry. Having the right knowledge for all the applicable rules and regulations can be pretty tough due to complexity. Investing in this exercise is money and time well spent because the fines can be quite high when it turns out that the company didn’t operate within the law.

4. Applicable Standards or Codes of Practice

This point is in line with the rules and regulations. A lot of (inter)national standards help companies to uniformly operate. Some great standards are FDA, API, and CE. They serve as a guide for companies when they want to operate in certain markets. Most of the time, customers demand compliance to certain standards as a mandatory requirement in order to do business with them. 

5. Consequences of Failure (Risks) Associated with the Potential of Failure Due to the Nature of the Products and Services

A properly performed risk analysis will help the company to tackle this last point. The company should be aware of all the consequences the products or services can have—not only on the company itself but any other stakeholder. Take time to think thoroughly about these risks. This will help the company to plan out the best mitigation plan possible.

These are the basic inputs required for a functioning Design and Development Process. Next post will dive deeper into the output of the process. Don’t forget to subscribe to stay up-to-date!


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Toolbox Meetings: Stop Wasting Time

Toolbox meetings are an important tool to inform the employees about everything related to safety. The topics can vary from just general safety to project-specific risks. Getting the employees together and talking about these topics is really important to keep the safety culture alive. Despite the importance of the toolbox meetings, they do come with some pitfalls. We will touch upon them and give you some simple tips on how to prevent them.

The Planning

Planning toolbox meetings can be already quite a big deal. Figuring out who is available at which particular time isn’t all that easy. We have seen professionals trying to be everybody’s friend and taking all the agendas of the employees into account. Please don’t do this, it’s not feasible. Make your own plan, it’s best to just plan the meeting and don’t give people the room to renegotiate the time and date. When you agree to this, you will never be able to plan anything as they will constantly be moved about to suit everyone’s needs.

Attendance List

Related to the planning is managing attendees of these toolbox meetings. It is crucial that every employee has had access to the information discussed during the meeting. To guarantee this happens properly, an attendance list can help. It is then easy to see who attended the toolbox meeting and what was discussed. Regardless of the importance of the attendance list, creating clear overviews of who attended which toolbox meetings in any given year isn’t that straightforward. Big Excel sheets are often to guide the process. This is where Qooling steps in and helps you manage this process with just a couple of mouse clicks.

Missing Toolbox Meeting

When the overviews of the attendees have been created, you need to start to fill in the blanks. Employees can be sick, on holiday or at a different location for work. Despite the reasons, it is your responsibility to make sure every employee has had all the information that was shared. Filling in the missing pieces can be a big pain because you need to invite these people again for a retake of the toolbox meeting. Which means that you end up doing the toolbox meeting at least 2 times, and maybe even more. The digital toolbox meetings of Qooling allow you to simply distribute the toolbox meeting digitally and add some additional questions. This way the employee can check the toolbox meeting whenever they have the time within a fixed time period. Plus they always have all the historical toolbox meetings right at his/her fingertips. Want to try out the digital toolbox meetings? Click here Published by:

CAPA Management and how to structure this

Corrective and preventive actions (CAPA) have been subject to changes the last years due to some modifications to several standards. These recent changes made a lot of companies choose to get rid of the preventive actions. Regardless of the changes, the struggles of managing these tasks is still present. There are still multiple actions pending per employee, regardless of the wording.

Origin of the Task

The different tasks can originate from a number of different sources. Activities like a management walk, incident, customer complaint or an audit. These tasks are then stored in Excel documents or similar, which leads to long lists of actions with different due dates and statuses. Tracking the origin of the task is not only crucial for analyzing the data, but also to track the progress. One incident can hold multiple tasks, these origins show exactly which tasks need to be done to finish the incident report.

Manage the Sheet

The Excel doc that holds all the tasks (CAPA) quickly holds hundreds of records. To organize the data, multiple tabs get introduced and more columns are added to allow better shifting of data. The concept behind this Excel document is that every employee checks his/her tasks in the document and changes the data when something has been done. This sounds great in theory, but it is not so good in practice.

Some things that happen to the file are:
● Employees don’t close the file and therefore “keep it occupied”.
● People start to add a bunch of fields to keep in the data or don’t know where to store it.
● Employees cannot find the document.

The list is pretty long, which is why this method breaks pretty quickly when you some employees. In order to solve this, companies make the Quality Manager responsible for managing the list. This method is undoable and requires a lot of time and effort.

Automate CAPA

Picking a proper solution for managing the tasks will give instant structure. The employees will not be able to change the sheet whenever they see fit. Everyone will get notified when tasks are due and they can access it from anywhere in the world. The integration with other parts of the management system makes it very easy to track why a certain task was started. This makes task management on certain incidents fairly easy because it is simple to filter which tasks are pending on the incident.

Tasks management is a crucial part of the improvement plan. Make sure you structure this properly in order to keep track of the improvement plan in the best way possible.

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How to design a good nonconformity report

A good nonconformity report has all the information that is needed, and is easy to understand by others in the organization. This sounds trivial and easy to do, however in practice it can be a lot harder to put together. The report is actually a way to communicate what went wrong somewhere in the company with everybody in the organization. Clear sentences and proper detailed descriptions are crucial. A lot of confusion can be prevented by having an easy to use NC form, so it is vital that it is done correctly.

Keep It Simple

More often than not we see quite complex nonconformity reports. The form has a ton of questions which people in the field don’t feel like filling in. Their jobs are to build and produce, not to fill in forms. So it is important to keep the form simple. Make sure that the people in the field only have to fill in just a couple of questions which holds the bare minimum of information for the manager to create the report.

Reduce Freedom

In order to analyze properly, make sure you use pre-defined fields in your nonconformity form. This way you will have consistent information to analyze. Also ensure that the person filling in the nonconformity doesn’t have the option to come up with a whole story that is hard to understand. These predefined selections make life a lot easier both for the quality department and the person that fills in the form.

Photos

Always add pictures to the nonconformity report. Pictures say more than thousands words and are much easier to interpret by someone else. He or she simply looks at the image and sees what went wrong. All mobile phones these days allow you to take a photo or two of the situation and add it to the report. With the latest quality platforms you now have mobile apps that integrate directly with your quality management system for even faster reports. Check out how Qooling allows you to do this.

Root Cause

Support some kind of root cause analysis for the nonconformities. There are more than enough options to use. Just make sure you pick one and follow through. Some options are:

The root-cause analysis really allows the company to find out why things went wrong. Finding the root cause is important for setting up the right actions to prevent this from happening in the future. Coming up with a solution to just one cause will not lead to the desired results and still leaves room for the same kind of mistakes.

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Problem Solving Approach (8D) Method

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

D1: Use a Team

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

D2: Define and Describe the Problem

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

D3: Develop an Interim Containment Plan

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

D4: Determine and Verify Root Causes

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

D5: Verify Permanent Corrections (PCs)

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

D6: Implement and Validate Corrective Actions

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

D7: Prevent Recurrence / System Problems

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

D8: Congratulate Your Team!

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

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

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8 Tips for How to Approach the ‘internal context’ in relation to ISO9001: 2015

One of the bottlenecks that I encountered when my customers developed their quality management system to comply with ISO9001: 2015 is the concept of “internal context”.

1 Employee engagement

The engagement of employees is fundamental to the success of every business operation. Reducing turnover also reduces costs associated with recruitment such as agency fees, preparation of contracts and training and inductions.  Engagement with the quality management system is integral to its effectiveness. Everyone at every level should know how they contribute to quality.

2 Training and development

Whether your employees undertake formal external training, an internal development program (such as a graduate scheme or accelerated promotion scheme) or informal sharing of knowledge through a buddy or mentor system, training and development is key to managing a skilled workforce.   A quality management system can help you to identify training needs and maintain appropriate records.

3 Skills and competence

Consider how your quality management system can help you to identify and address skills gaps and ensure you always have the right skills to satisfy your customer requirements.  How will you measure competence to ensure the effectiveness of any training you provide or any specific skills you recruit?

4 Physical resources

Ensuring you have the right physical resources to deliver your promise to customers is essential.  A quality management system can help you get to grips with what you need, where and when you need it and what the potential impact might be if you don’t.

5 Management methodology

ISO 9001:2015 promotes leadership at all levels.  It talks about top management empowering and encouraging leadership to promote the quality management system.  Do all your managers sing from the same hymn sheet? Are your management team clear on the vision, values and goals of the company?

6 Policies

Having robust policies in place to support your business strategy is essential.  Not only do they set out your stance internally for staff members, they can also provide a source of information externally for your customers and suppliers.

7 Mission and values

This is essentially your reason for being in business along with the principles which matter to you in running your business.  These are an important element of a quality management system as they feed in to the policies and management methodology mentioned above.

8 Supplier / partner management

Is your business entirely self-sufficient?  Chances are you rely on at least one key supplier or partner in order to deliver your products or services.  Try categorising them in order of how critical they are to your operations. The ones that you absolutely can’t function without should be your priority to manage.

 

This article has been written by Lucy Payne of valeqms.co.uk

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Why data is important in Quality Management.

At the center of all quality management systems is the concept of continuous improvement. This implies that you have the ability to prove that there has been some kind of improvement. It may sound straightforward, but it isn’t always that easy to do. Many times there is limited data or even no data to even come up any results. In order to prove progress, it is important to have the consistent data to back it up.

Collecting Data

Data is a main ingredient to show how the company improves on certain KPI’s. However, collecting the data is more often that not a very labor intensive task, mainly done by the quality department. In order to make it easy for the organization to share the required data, it should be fairly easy for employees to do this. A mobile app helps in this process. Having all the important forms at your fingertips makes it so much easier to share this information, which allows the quality department to focus on analyzing the data instead of pushing people to provide it. Also having an open IT infrastructure which allows for sharing data between systems is key in order to pull the data from different sources.

Analysing Data

When the data is gathered it should be analyzed properly. This is not just drawing graphs but also interpreting the changes of the data over time. Different time frames could show interesting effects. Furthermore, mapping out different root causes will give more insight on how to improve the company. It is important to play around with the data and not only focus on the predefined KPI’s. Playing around and plotting different variables against each other can give completely new insights. A great technique to check out where this goes wrong is by using the “Pareto” plot of the data.

 Showing Results

Maybe the most important aspect of using data to improve quality management is communicating the results. Not only to top management, but to the employees within the company. Every employee helps by providing the data. When you involve them in the results of the analysis, they see the impact they had on the company instantly. Which then makes them more willing to share again in the future.

 Pitfalls

The biggest pitfall with analysis data is the inconsistency in the data. It is very important the data is clean and usable. This can be easily checked simply by plotting the data and looking for weird spikes. Also during the setup, it is required to predefine certain choices. When you give employees the option such as “I don’t know” or “general”, they will most likely choose that. This will lead to a lot of data with that option, which completely ruins the possibility to analyze it, so try to prevent these options.

 

Qooling makes collecting information and analyzing it a lot easier by a simple to use mobile app and the straightforward interface of its platform.

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How to apply the PDCA-cycle to improve your business!

The PDCA (plan-do-check-act) cycle is a four-step approach which is used in business for the control and continual improvement of processes and products. By consistently testing out possible solutions, comparing the results and implementing those that are successful, there is the potential for steady improvement in all areas. Therefore, the PDCA cycle fits exactly to the elements and requirements of the quality management system.

Planning

The PDCA cycle starts with planning, in which your problems or opportunities are identified and understood. Collect as much relevant data as possible and find the cause of the problem. The data can be collected from your recalls, quality issues, safety problems or any other register in which data is accumulated. After the data is gathered, it is important to make a plan according to the mission, vision and values of the company. This allows the company to stay close to what is important for it. Set goals and determine the best way to meet them.

Execution

In the ‘do’ phase, all planned activities of the process take place. Use the approved plan from the previous phase as a starting point. Set a clear goal that you want to achieve and measure the results along the way. Involve the employees while executing the plan – this helps with gaining trust and allows them to contribute to improving the company. It is crucial that data is collected to see what happens over a period of time.

Check

Once the data of the execution phase is collected, it is essential to make it understandable. When the data is known, it is important to benchmark this data against the data that was identified in the planning phase. The initial data was collected to spot certain areas to improve. Now check the new data against your initial goals while at the same time benchmarking it against the old data. According to the results, you can then go to the next step – act.

Act

On the basis of the analysis and results from the previous phases, decisions can be made on whether previous measures and plans need to be adjusted. If necessary, adjust the plan and start again with planning phase. When the results show no consequences, it is important to make the decision to stop the project. This will prevent the company from spending resources on projects which have a low likelihood of adding value.

How PDCA Is Covered in Qooling

Qooling allows for easy gathering of information throughout the company. This data can be used to identify improvement projects and plan ahead for them. During the execution phase you can assign tasks to employees and again allow them to share information fairly easily. The information can then be used to check the results and benchmark against the situation which occurred months ago. This way the results can be found by the a few simple clicks.

Conclusion

The PDCA-cycle is a great way to improve the operations, but similar to most management practices it is important to gather the data to check the progress. Gathering this information isn’t always easy or straightforward, so it is important to use the proper solutions to get accurate results.

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