ASQ CQE Certified Quality Engineer – Section II – The Quality System (16 Questions) Part 3

9. 2C-5 ISO 9001:2015 Key Changes

Earlier we talked about that why there was a need to revise the standard. Now let’s look at what are the key changes in ISO 9001 from version 2008 to 2015. There are a few terms which have changed in this new standard. Earlier, ISO 9001 2008 called the term products and in the revised version now it’s products and services. So even though earlier this was understood that product means product and services.

But then in this recent version this has been clearly mentioned that ISO 9001 applies to both products as well as services. Earlier there was a term document and a term called records. Document was something which you read, which you follow and record were evidence of implementing the quality management system. But now both of these terms have been combined together as documented information. Earlier there was a term called work environment. Now the term is environment for the operation of processes, not a big deal.

Earlier we called purchased products and now we called as externally provided products and services. This could be services as well. So that also has been included. Specifically in 2015 version, suppliers are called as external providers. Suppliers could be some organization which is supplying a product. Now this includes the organization which provides services as well. So the common term for that is external providers coming to the next slide, which is that in this new version there is no exclusion clause. In the previous version there was a clause which organization could use to exclude a part of their operation. But now that clause has been removed.

So now the organization cannot take any part of the organization which basically affects the kind satisfaction or the customer satisfaction. For example, let’s say if you are doing the design and the production of a component and earlier what you could have done is you could have taken design out of the scope of this certification and you could have got your company certified for the manufacturing of the production only. Now that is not possible because design and production both needs to be included in ISO 9001 certification because together these help in getting client satisfaction. So now there’s a restriction on excluding some of the requirements from your certification.

Next one is that there is no quality manual, that in this new standard there is no need to have a specific quality manual. You might have it, you might not have it. You might have this in the form of a table, in the form of a chart, or if you want, you don’t need quality manual. That’s a new change. In the ISO 9001 2015 standard there is no need to have a management representative which was required earlier. This new standard puts a lot of emphasis on the involvement of the top management. And with that there was no need to have a specific requirement to have a management representative appointed in the organization. New standard focuses on process approach. So there is a specific requirement to follow a process approach and process approach is having input, doing some processes and having output. So that is very specifically written in the 2015 version of the standard to have a process approach implemented there is no preventive action.

So earlier, if you remember, in the previous standard there used to be two main things corrective action and preventive action. Corrective action still is there, but there is no need to have preventive action because new standard assumes that implementing the quality management system is a preventive action in itself. So there is no need to have a specific requirement to issue or have preventive actions in the organization. So this requirement has been deleted from the standard to have a preventive action. A new term has been implemented which is risk based thinking. So anything which you do, you need to think about what are the risks involved in that.

So that term has been implemented in the new standard so there is no need to have a formal risk management implemented in the organization but you need to have risk based thinking in whatever things you do in your organization. So that was a quick overview of changes what has happened from 2008 to 2015. Now the next thing what we need to do is quickly look at the clauses or the requirements of ISO 9001 standard. There are ten clauses so in the next video we will be looking at each of these clauses one by one at a very high level. We just quickly need to look at these clauses and that’s what is required for the CQE exam. Let’s see that in the next video.

10. 2C-6 ISO 9001 Clauses Explained

We looked at this slide in the previous lecture as well when we were talking about the changes in ISO 9001 from 2008 version to 215 version. These are the clauses in the latest version of ISO 9001. One, two, three, clause number one which is scope, clause number two which is normative references and clause number three which is terms and definitions. So these are basically some sort of introductory clauses, but the real meet or the real action clauses are clause number four to clause number ten. Clause number four which is context of the organization, number five is leadership, number six is planning, number seven is support, number eight is operation, number nine is performance evaluation and number ten is improvement.

So these are the main clauses of the standard. In quality management we have a PDCA cycle which is plan, do, check and act. These clauses are also based on that PDCA cycle. So let’s look at the PDCA cycle in the next slide which is here. So you plan first, you do, you check and you act. Let’s see that how these clauses which are clause number four to clause number ten fit into these parts of the PDCA cycle. So this is the diagram, the diagram you see below is from the standard itself. So looking at the clause number four which is here, clause number four is the context of the organization. Context of the organization is the whole envelope of this. So this is the circle which shows that organization and its context, that’s overall organization. And then if you look at the clause number five which is the leadership, leadership is in the center of this PDA cycle which is here.

So leadership is the core of this PDCA cycle. And then section number six is planning which is here, which is the planning part of PDCA cycle. So this is P and then the do part of that is in clause number seven and eight which is support and operation. So this is the D part of PDCA cycle and then check part is in the performance evaluation. So this is the C part of that and x part is in improvement which is the clause number ten. So now if you look at this, the standard is based on PDCA with the P in the clause number six with a D in clause number seven and eight with a C which is checked in clause number nine and x in clause number ten which is improvement. So this is how standard fits into the PDCA loop of improvement. In this lecture we will have an overview of ISO 9001 2015 clauses. So one thing which we need to remember is that we are not going into details of each of these clauses because that itself is a big course.

So I have a separate course on Udemy which covers ISO 9001 2015 clause by clause explanation, but probably you don’t need that for your CQE exam preparation. Let’s focus on the high level overview of ISO 9001 2015 clauses. So, we have ten clauses, as we said earlier, from section number one, which is scope, to section number ten, which is improvement. Let’s quickly look at each of these, starting with section number one, which is the scope. So this section tells that when does organization need to implement ISO 9001 requirements? When the organization wants to demonstrate its ability to provide good quality product to its client. So that’s when the organization needs to implement ISO 9001 or when the organization wants to enhance customer satisfaction through application of a system. And this standard, which is ISO 9001, provides generic requirements. That means this standard is applicable to any type of industry, any product, any services you provide, you could use this standard. So this is which is covered in clause number one, coming to the clause number two, which is normative references. This tells that what all you need to have when you are implementing ISO 9001.

So it refers to ISO 9000 standard which provides the vocabulary and the definition of the terms being used in this standard. So when you implement 9001, you need to have 9000 to understand the terms being used in 9001. So this is clause number two. Clause number three is terms and definitions. So here, instead of listing all the terms and definitions, this particular clause refers to 9000, that you go and refer to 9000 for any clarification on the terms being used. So all terms and all vocabulary is provided in ISO 9000, coming to the clause number four, which is the context of the organization. Here, what standard wants is that before you start implementing or setting up the quality management system, you need to understand the organization, understand what is the context of the organization, what is happening inside, what’s happening outside.

Then you need to understand the needs and expectations of interested parties, not only clients, not only your employees, but all the interested parties. You need to understand before you set up the quality management system, then you need to determine the scope of the quality management system which will tell what are the boundaries of your quality management system. So you need to establish that, and then you need to establish your processes, your systems and processes. So this is clause number four. Clause number five is focused on leadership and commitment.

It also covers policy, the quality policy, and it also asks organization to establish roles, responsibilities and authorities. So this is clause number five, which is the leadership. Clause number six is on planning. And as we earlier said, that in PDCA cycle P is for planning. So that’s where this clause fits into that. Organization need to have proper planning and for that the organization is required to establish what actions they need to take to address the risks and opportunities. So as I earlier talked that in this new standard the term risk has been introduced, the specific term is risk based thinking. So you need to establish what actions organization need to take to address the risks and opportunities, quality objectives and planning to achieve them is also part of planning section and planning for change.

So any change needs to be a planned change rather than random change. So that’s clause number six which is planning, coming to clause number seven which is support. So here we are looking at all the supports which are needed to make something or to provide the service, to produce a product or to provide a service. Whatever supports we are needing that are included in this section, which is support. Here Standard talks about the resources. Here Standard talks about the competence of people doing the job, awareness, the communication and the documented information. And if you remember earlier that in the previous standard, the previous version of the standard we had two things documents and records. Those two terms have been combined together in this new standard and we call them as documented information.

So that’s also part of support coming to the clause number eight, which is the operation. This is the key clause of the standard. Here we are talking of whatever product or service we are producing. So for that you need to have planning and control in place which is covered in 8. 1. And then requirements for product and service needs to be established. Then comes the design, then comes the purchasing part in 8. 4 where you are looking at all the external providers, whether you are buying something as a product or whether you are buying a service that gets covered in 8. 4. So we covered engineering, we covered the purchasing and then in 8. 5 we are covering the actual production or the service provision. So whatever we are producing or whatever service we are providing that is covered in 8. 5.

Once everything is done, once a product is produced, then comes the release of product and service. So what all are the requirements related to releasing of a product or service that’s covered in 8. 6? And if there is any non conforming output that is covered in 8. 7, which is control of non conforming output. This is a very big clause, very extensive clause, which is clause number eight, operations clause number nine is Performance Evaluation. So in PDCA cycle this comes under the C, which is the check. That’s where we check whether we are doing things right or not. So here we are talking about monitoring, measurement, analysis and evaluation. The standard also covers internal auditing in this and the Management Review.

Management Review is biannual or annual review conducted by management. Standard has specific numbers of inputs and outputs for management Review. So those are covered in clause number 9. 3. So this was performance evaluation. Clause number ten is improvement. So here we are looking at that, whatever nonconformities we had, whatever corrective actions we had, how do we improve our process so that we don’t repeat the same mistakes again that is covered here under nonconformity and corrective action. I just want to highlight here that when you have a problem or when you have a non conformity, you take two actions. One is the correction. Correction is to correct the situation and then you take corrective action. Corrective action is to avoid the recurrence of that particular problem. Again, there is a good chance that you might get a question from this section where the examiner might want to test whether you know the difference between the correction and the corrective action. Correction is to correct the situation.

Whatever has gone wrong, how do you correct that? Corrective action is to avoid the recurrence of that thing happening again. And what is preventive action? Even though preventive action is not part of this standard. But you still need to understand that preventive action is to avoid the occurrence of a problem even before that problem has occurred. So the difference between the corrective action and preventive action is corrective action happens when you have a problem. Then you want to avoid that happening again. That’s corrective action. Preventive action is even though the problem has not happened yet, but based on the risk assessment, based on other factors, you are taking some action to prevent that problem from happening in the first place itself.

That’s something which you need to remember here and then coming to 10. 3, which is continual improvement. How do you improve on ongoing basis? So these are ten clauses in ISO 9000 and 120 15. I know that I have gone very fast on this. This could have been a six hour session in itself, which is already covered in one of my Udemy courses. So I have a Udemy course which covers ISO 9001 2015. But that’s not something which you need for your CQE exam preparation. You just need to have some high level overview and that’s what we have covered in this lecture.

11. 2C-7 Quality Awards – MBNQA

Section two C of the CQE body of knowledge is quality standards and other guidelines in that there are two broad requirements. The first one is to have the key points of ISO 9000 series of standards. So we have already talked about that. So that was one part of this section two C. The second part of this section, section two C is Malcolm Elbridge National Quality Award. There are three main quality awards and of course there are a number of these. Every country has their own quality awards. Even the states in the country have quality awards. But globally, there are three awards which are well recognized. And these are deeming Award, EFQM European Foundation for Quality Management and Malcolm Belgian National Quality Award. Deming Award was introduced in 1051 in Japan, european foundation for Quality Management and Malcolm Baldrige National Quality Award.

Both of these are introduced in 1988, EFQM in Europe and Malcolm Baldridge National Quality Award in the USA. Let’s keep our focus on Malcolm Baldridge National Quality Award as one of the examples. Many of these things might be similar in these awards, but let’s keep focus on Malcolm Balkridge National Quality Award. Let’s look at the history of that first. As you see here that in mid 1980s there was a realization to have a quality award to promote quality. In July 1987, the Malcolm Baldridge National Quality Award was set up in the name of Malcolm Belgridge who was the Secretary of Commerce in the USA.

Next year. In 1988, the first Malcolm Baldrige National Quality Award was given. So the main award was for the companies which are for profit organizations, and then later on this award was extended to include education organization award, the one award for educational organizations, and award for nonprofit or the government organizations. So if we look here on this slide, there are three main awards in Malcolm Balkridge National Quality Award.

One for the business which covers manufacturing services, small businesses, and then there is another one for education, and then there is a third one for healthcare. There is a separate criteria for these. So there is a slight difference in the criteria for these three main categories of awards. If we look at the criteria of the Malcolm Balkrish National Quality Award, this consists of 1000 marks. So each organization is evaluated and marks are awarded on certain criteria and out of 1000 marks, whichever gets the highest. So there are a number of steps being done in this process, but let’s quickly look at the high level overview of this. So in that there are certain categories and these categories include leadership, strategy, customers, workforce, operation and results, and then integration.

And then the basis or the foundation of that is measurement, analysis and knowledge management. So these are high level clauses in this award. Organizations are awarded based on the evaluation done by themselves and then done by some external auditors who look into the organization and go through how these particular criterias are implemented in the organization. And each of these criteria, let’s say leadership, strategy, customer, each of these criteria is evaluated on four dimensions and these dimensions are approach, what approach organization is taking, the deployment, how consistently this particular requirement has been implemented across the whole organization and then the learning and the integration.

So these are the four dimensions on which each of these points are evaluated. So those four dimensions which we talked earlier were related to all other criterias except results. When it comes to results, results are evaluated based on these four criterias, which are level trend, what’s the trend of this, whether the profits are going up, whether the customer satisfaction is going up or down. And then comparison, how does this organization compares with the competitors and other organizations and then the integration, how well this is integrated.

So these are the four dimensions for results. So, this was a brief overview of Malcolm Belgian National Quality Award. Other awards which are Deming Award or European Foundation for Quality Management EFQM Award, those are also based on similar sort of criteria, not exactly the same criteria, but on a similar trend. The organizations are evaluated and based on the evaluation, awards are given to these organizations.

So, coming back to the Malcolm Balgis National Quality Award, as we said that in 1987 this was first introduced and 1988, the first organization which got Malcolm Baldrige National Quality Award was Motorola. And that was the time when Motorola introduced the Six Sigma concept. So with this we finished section two C of the Body of Knowledge, which was quality standards and other guidelines. Let’s move to section 2D, which is quality audits. Let’s see that in the next video.

12. 2D1-1 Types of audits Product Process System

Section two D of the Body of knowledge of CQE is quality audits. In this section we will talk about types of audits, roles and responsibilities in audit, audit planning and implementation, and audit reporting and follow up. So these are four broad topics which we will be discussing in this section, which is quality audits. Let’s start with the type of audits first. So when we classify audits, audits could be classified either as this what you see here on the screen, which is System product or the process Audit. Or you could classify audits as first party, second party and third party audits. Or you could classify audits as internal and external audits.

So there are various ways you can classify audits. Let’s start with this first classification which is here. Audits could be System Audit, audit could be Product Audit or the process audit. So if you see here on this diagram the narrowest or the smallest focused area is the product audit. Then the broader than that is the process audit. And then you have the system audit, which is the overall audit of the system. Let’s understand each of these three in next three slides starting with the product audit. When we say product audit, the focus is on the product. So whatever product you are auditing here, your focus is to see whether that product is fit for use or not, whether the product meets design requirements or not.

So your focus is just on the product, the output. The next level of audit is the process audit. Here what you’re doing is you are auditing a process, a particular activity, a particular step. The process audit, let’s say, could be audit of manufacturing process or the audit of sales process or the audit of design process, one specific process. You are focusing on one process, one activity or one function. And then what you do here is you compare the actual process with the documented requirements. So if your documented requirements are related to design, says that these are the steps you will be following when you do the design. And then what you do is you audit the actual design process against that documented requirement. So this is the process audit.

The next level of audit would be the system audit. Here it’s a comprehensive audit of multiple processes. So you are not just focusing on one process of sales, one process of design, one process of production, you are covering the overall system audit. So this includes all the processes and also in addition to processing is what you are doing is you are looking at the interaction between these processes as well. How does sale and the production interact with each other. That sort of thing also is covered in the system audit. So this was one way of classifying audits, auditing the product, auditing the process or auditing the system.

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