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

1. 2A-1 Basic elements

You have successfully completed the section one of ASQ CQE exam preparation course. And now we are in section two of this course. So section two is the quality system. From this section you will get 16 questions in your exam. Let’s see what we have in this section. Let’s start with quality system which is the first part of this section which is basic elements of the quality system. Earlier when we talked about quality gurus, we talked about one quality guru which was Dr. Juron. Dr. Juron proposed Juron tree logic. And here you see the picture of Juron tree logic. And this is how Geron explained that how organizations can achieve quality. Quality can be achieved in three steps. One is quality planning, then quality control and quality improvement. Before you do anything you need to plan. You need to plan how you want to achieve quality, what systems, procedures, controls, what you want to put to achieve the quality. That is quality planning part.

Once you have done quality planning then you control your process. You control your process within certain range, within certain limits, within the specification limit. And this is what is shown here in the middle section of this diagram which shows that the original zone of quality control. So your process is controlled within certain boundary. Once in a while you will see that your process goes out of that range and then you take necessary steps to bring this process back to control. And that’s what you see here as a spike which has been brought back into the control limit. So this is the quality control part. Then you go for quality improvement.

So once your process is in control then only you need to go for quality improvement. Once you do some quality improvement, what quality improvement will do is that will bring your quality to a better range. So now here you see that the new zone of quality control has lesser defects. So if you read this vertical axis as number of defects, number of problems, then you see that the new band of quality control has come down. That means defect rate has come down. Also you would see that this band is a narrow so you are in a narrow band the lower level of problems.

So that’s how you have achieved quality improvement. In quality improvement also you go for control. You attempt to control your process in this new zone of quality control. So this is the process of quality improvement in the organization and as you do improvement you learn something out of that and put that learning back to your design phase or the planning phase of the quality. So this was Duran’s trilogy for achieving quality. Few more things which we’ll learn in this section is we will learn about few definitions and those definitions will be related to system management system, quality management system and these three terms which we have shown here which are quality planning, quality control, quality improvement.

We will look at the formal definition of these six terms in next two slides. Let’s see that. So here on this slide we have three definitions definitions related to System management system and Quality Management System. To understand the definition of quality management system we need to understand what’s the management system and then before that we need to understand what is the system. Let’s go one by one. The definition of system is that system is a set of interrelated or interacting elements. So if you have number of elements which are interacting together which are interrelated, that is called a system.

System could be something in your home, system could be something in your organization, how things work, how you make a product, how you sell a product, how you get up in the morning and get ready for your office all these things are system which have number of interrelated or interacting elements. So if this was a system, then what is management system? Management system would be something related to organization which you can obviously guess that management system is set of interrelated or interacting elements of an organization to establish policies, objectives and processes to achieve these objectives. Coming to the next definition which is quality management System. Quality management System is that part of management system which is related to quality. So these are the three definitions we learned in the slide. Let’s move on to the next slide and learn three more definitions which are related to Duran’s Trilogy which we learned earlier.

2. 2A-2 Design

In the quality system section. Previously we looked at the basic elements of a quality system. We talked about quality planning, control and quality improvement. And we also looked at Duran’s trilogy which was connecting these three elements. The basic elements of quality system, the planning, the control and the improvement. Now coming to designing a quality system. So when you want to design your quality system, you need to understand that quality system will consist of number of processes. So number of processes together will make a quality system.

The basic thing which we need to understand in a process is that in the process chain you have an input, then you have the process and then you have the output. So there’s nothing new about that input process output. One thing which we need to understand here is that output of one process could be an input for another process, the next process.

So if you have machine number one, two, three running in a sequence, then the output of machine number one will be the input for the machine number two and so on. So there’s a chain. Other way to look at that is let’s say you have a sales department. Your sales department will work with your clients to get an order. Once they get that order and the order is the output of the sales department, that’s what sales department does, gets the order. So the output of the sales department which is the order, will be an input for the production planning group. So all these processes are interrelated. That’s another thing which you need to understand.

All these processes, once you put together, will form a quality system. These need to be aligned with the strategic plan of the organization. Strategic plan of the organization what your organization wants to do. So that’s something which you need to understand when it comes to designing a quality system in the organization. We talked about processes that there are number of processes which are interrelated input, process output and output of one process becomes input for another process. So that’s something which we talked earlier. But then when we look at number of processes, there are some processes which are cold processes.

Core processes are the one which basically make or break the organization. So these processes have a significant impact on the success of the organization. Those are the core processes. Let’s look at an example of Amazon. Amazon core process would be taking order, shipping the product. These are probably the core processes. They really cannot compromise on those core processes because these have significant impact on the success of the organization. So you need to give more emphasis to the core process and see that these core processes are aligned with the strategic direction of the organization. So this was basically a brief overview of how to design your quality system. This is something which you need to keep in your mind when you are designing the quality system for your organization.

3. 2B-1 Document components

The quality system. Initially we talked about some basic definition, basic elements of a quality system. Then we talked about the philosophy behind it designing a quality system. Now let’s talk about documenting the quality system and why do you want to document the quality system? You want to document to make sure that everyone has the same understanding of the quality system. Everyone follows use the same system. That’s the reason you want to document your quality system. So we will be talking about two main things here document components and document control. In document components we will talk about what all will constitute the quality system, what all components will be there in the quality system.

And when it comes to document control, we will see that. How do you control your documents? Let’s start with document components first here, when it comes to document components, you can have a number of layers of documents. The generally used structure for quality system documentation is that at the top you have a quality manual and even before quality manual you could have quality policy. So quality policy at the top, then you have in the actual form of documentation, you have a quality manual as the top level document. Then you have all the procedures where you give details related to specific procedures, your core processes, and then you have work instructions.

Work instructions are the detailed step by step instructions and then you have forms which keep the record of whatever activities you have carried out. So this is a generally used structure for quality system. With the recent release of ISO 9001, 2015 quality manual is not a mandatory document. Earlier this used to be a mandatory document in ISO 9001 system as well, but now in 2015 version it’s not mandatory. But still I’ve seen that many organizations still keep a quality manual as the top level document. So this is the broadly the structure of quality system documentation.

Let’s quickly look at each of these components starting with the quality manual. And as I earlier said, that 2015 version doesn’t require quality manual, but you can still have that, it doesn’t stop you from having a quality manual. Many organizations have this quality manual based on ISO 9001 clauses. So clause by clause they match what they do and to demonstrate that how they meet ISO 9001 requirements. Here, when you are creating a quality manual, either you can follow the structure of ISO 9001 which many companies do, or you can change the structure of the quality manual based on how do you do your own work. So if you structure your quality manual based on your own work processes, that is going to be a good help for your employees. But if you structure your quality manual based on ISO 9001 clauses, then this will be a good help to the external auditor.

Now it’s your choice to decide whether you want to align your quality manual to facilitate the external auditors work. Or your own employees. I would suggest that you structure your quality manual based on how you do your own work. And then on top of that, you can have a separate matrix which tells that how the elements of this quality manual match with ISO 9001 requirements. So this was the top level document, which was the quality manual. And the next one is procedures. In procedures you give high level overview of processes, how these processes are carried out. The procedures do not include the detailed how component, step by step components of the processes that’s not included in procedures. So if there are some processes for which you need to give STEPBYSTEP instructions for that, the right document is a work instruction which we will be covering the next. And then procedures are generally multidisciplined, let’s say sales procedure, which will tell that how sales will interact with the client, how sales will interact with the design, production, see what capacity we have, what design we can do. So all these procedures, what you have will normally be multidisciplinary procedures. Now coming to the next step, or the next level of documentation, which is work instructions. So, as we earlier said, work instructions are step by step detail instructions on how to do a job. Step number one, do this. Step number two, do that. That’s work instruction.

Next level in documentation is forms. Forms are basically records of compliance. These are documentary evidence that activities have been done. So this, this is proof of activity being done when you have an empty form, empty form is a document. And once you fill in, this becomes record. So earlier in ISO 9001, there used to be two things, documents and records. But now with 2015 that has been removed. Now both documents and records are called as documented information.

That’s another thing which you might want to know, that earlier we had document. Documents will tell what to do, records will be evidence of doing that. But now both of these terms have been clubbed together with the name documented information in ISO 9001 2015. So these were four elements of a quality system, starting with quality manual procedures. Then you have work instructions and forms. You can have more or less of this structure, depending on the complexity. More complex organizations might have more four layers of documentation. A very small one person organization might even just have a quality manual and some form. So it all depends on the complexity of the processes and the organization. But generally you have these four layers of documentation.

4. 2B-2 Document control

So previously we talked about documentation components, what all constitute the quality system, we talked about quality manual, we talked about procedures, work instructions and forms. In this section we will talk about document control. How much do you need and how do you control those documents? And in this section, I have taken ISO 9000 and 121 five clauses to to explain concepts behind document control. So in document control, the first question is how much to document? What’s the level of documentation you need? Some organizations might have documentation of, let’s say, 20 pages, constituting a few flowcharts, and some other complex organizations might have tens of thousands of documents.

How much is the right amount? How many documents is the right amount? That will depend. And when it comes to ISO 9001 2015, ISO 9000 2015 tells that the extent of documented information can differ from one organization to another organization due to the size of the organization and type of activities. Bigger organizations might have more documentation, organizations with complex products or services would have more number of documents. And the another component of the level of documentation is the competency of people. So if the people are competent, then they don’t need specific work instructions where they are described step by step way to do a job.

So if you got a skilled level of people, highly skilled people who don’t need detailed instructions, then you don’t need to make work processes for those particular processes. So it will depend on these things, the size of the organization, the complexity and the competence of the people. So these are something which will decide what should be the right level of documentation. Now, coming to the next question that why do we need to control documents? Why can’t we just leave it open? Anyone to take it? Anyone to change it? We need to control document to make sure that these are available and suitable for use where and when it is needed. So you need to have right document at the right place. That’s something which is important. And then you need to make sure that your documents are adequately protected, protected from loss of confidentiality, improper use and loss of integrity. So these are the reasons for which you need to control your documentation.

Coming to the first case here, let’s say, which says that documents are available and suitable for use where and when it is needed. It really doesn’t make sense that at the workplace, if the worker who is doing the job has an obsolete document, obsolete means a new revision of that has come, work process has changed, but this worker is still working with the previous version of the document.

You really don’t want that. For that, you need to control your document. Looking at the second one where you might have confidentiality agreement with your client, you have some client documents, you have signed a confidentiality agreement. You don’t want to lose those documents because that will be the violation of your confidentiality agreement with the client. So you need to maintain those documents tightly. You need to issue these documents to the right people only, don’t keep it open.

So these are some of the reasons we tell that why do you need a document control system in place. Now, ISO 9001 2015 gives in clause number 7. 5. 3 control of Documented information. What all is required to control the documented information? Let’s go back and talk about document and Record, which we did earlier also.

So as I said that before 2015 version of ISO 9001, this documented information was called as documents and records, two different things. But now in 2015 version, this is called as documented information. In the earlier version of ISO 9001, we had control of documents and control of records. Here we just have control of documented information. So here we are looking at both things, the documents and records. Without going into details of this, what do you want to control when it comes to documents? Documents are basically instructions on how to do a job. You want to make sure that there is a right revision of the document at the right place.

So you need to have a right revision control. You need to make sure that whatever instructions or the documents you are giving those are properly readable, people cannot change that because those are the instructions. That’s something which you want. In a layman terms, when you want to control your documents and when you want to control your records, records are evidence of things being done. What you want to do there is you want to make sure that people cannot just change those records, because records are history.

That’s a history you don’t want to change. Second thing, in records, in a layman terms, what you want to do is you want to maintain those. You don’t want to lose that. You don’t want to put them in a water or a humid room where these gets deteriorated over time. Some of the records you might have to keep for ten years, 20 years. So you need to make sure that these are properly protected generally without going into ISO clauses. That’s generally what you would want when it comes to controlling the documented information, documents and Records both. Now, let’s come back to this clause where it says that for control of documented information, the organization shall address following activities as applicable.

So both in case of documents and records, you need to ensure that there is a proper distribution. You need to maintain the distribution because you want to make sure that when the next revision comes, you give that revised copy to those people. You need to maintain the access, retrieval and use of these documents. Not everyone should be able to access everything, whatever is appropriate to them, they should have access to that coming to storage and preservation.

You need to make sure both in case of Documents and records that these are properly stored and preserved. Control of Changes we did talk about the version control because the new revision comes, you need to give the new revision to the right people at the right time. And then you need to make sure that you retain some of the records, as I told, that you might need to keep for 15 years, 20 years. So you need to have a proper process of retaining these documents. Next is disposition. After ten years, 15 years of retention, you need to have a process of dispositioning. Those how to destroy those, because now you don’t need those documents after 15 years.

So you need to have processes for all these things. Here, ISO 9000 even talks about external documents, documents of external origin. These are something like your client drawings, client documents. Those also need to be maintained. So the documented information of external origin also shall be identified and controlled. And the last bullet here is for records that these should not be altered. As I talked earlier that you need to make sure that the records which are the proof of things being done should not be altered. Unauthorized means not everyone should be able to change the records. That these are some of the controls which are required by ISO 9001 for documents.

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