ASQ CQA – 2. Audit Process

11. 2B3 Opening meeting

Let’s look at the purpose of an opening meeting. The key purpose of an opening meeting is to confirm the agreement of all participants, the auditor and audit, to the audit plan. So in the opening meeting, both auditor and audit teams agree to the audit plan which have been issued to them earlier. Another important thing, what is done in the opening meeting? Introducing the auditor and audit team. We will talk about the participants of the opening meeting later on. But let’s understand that in the opening meeting, both the auditor and audit team assemble and attend this meeting. This makes sure that all the planned audit activities which were in the audit plan could be effectively performed. So this is the purpose of the opening meeting. Now let’s look at the participants of an opening meeting. Participants of an opening meeting would be the representative from the auditor and audit. From the audit side, you are expecting the senior management of audit to attend the opening meeting. And you also want all the responsible person for areas or functions to be audited to attend the opening meeting.

So let’s say if the scope of this audit is production design and dispatch, then the people who are responsible for these functions should participate in the opening meeting. Other participants from the audit side who need to attend the opening meeting are observers. So if there are any observers planned for the audit, they should attend that all the guides which are expected to guide the audit team, they should attend the meeting. And in some cases, if this audit is done in a different language, then the interpreter also should be the part of the opening meeting. So these were from the audit side. Now, coming to the auditor side, all the audit team members should attend this meeting. So if the audit team consists of more than one auditor, all of them should attend the opening meeting. This opening meeting is chaired by the lead auditor or the audit team leader. One of the important thing which the audit team leader needs to make sure is to keep the record of attendance.

So keeping attendance of all the participants will help the audit team in identifying the people who they need to talk to during the audit process and will also help them in the audit report. So at the end of this audit, when they prepare the audit report, then you need to list down all the participants who were in the opening and closing meeting. So this was about the participants in the opening meeting. Now, coming to the agenda, what’s included in the opening meeting. So here are some of the items which are included. And on the next slide, there are few optional items which could be included in the opening meeting agenda. And once again, the purpose of the opening meeting is to have alignment between auditor and auditor on the scope of the audit. So first thing which is covered here is the audit objective, scope and criteria.

So, since this meeting is led by the lead auditor, so the lead auditor specifies the objective, scope and criteria of the audit. In addition, the lead auditor will talk about the date time of the closing meeting. So let’s say if this audit is to go for two days or three days, then the auditor and auditor need to reach an agreement that when is the expected time for closing meeting, so that the proper notification could be sent to all the participants. Because some of the participants in the closing meeting are senior management, so you might not get them on a short call. So at this stage, the auditor and audit agree on the closing meeting time and place. In addition, the auditor and audit might agree on the interim meetings which needs to be conducted within the audit team or between auditor and audit. The next item in the list is language to be used in the audit.

So if you are doing an audit in a different language, then you need to specify that what will be the language of the audit. The lead auditor need to confirm that the audit will be kept informed of the audit process during the audit. As the audit happens, audit will know that what are the shortcomings or what are the strengths or what are the results of the audit as the audit happens, rather than just waiting for the closing meeting. So, as the audit progresses, audit need to know the progress of the audit. Another thing which is discussed in the opening meeting is availability of the resources and the facility needed for the audit team. So, if the audit team needs a place or a conference room to discuss the findings, or a place where they can sit and do interviews, that is identified in the opening meeting itself. Another important thing which the lead auditor need to emphasize is that the findings or the things which they see in the audit will be kept confidential. And in addition to that, if there are other things related to informational, security or confidentiality that needs to be discussed in the opening meeting, in the opening meeting, things related to access, health and safety, security, emergency exit and other arrangements are also discussed with the audit team.

So if there is a place if there is a facility where the audit team doesn’t have a direct access, that needs to be discussed. If there is an assembly point in case of emergency, that needs to be informed. To the audit team if there are any security concerns or something that needs to be discussed in the opening meeting and in case if there are some activities which could impact the conduct of an audit, that also needs to be discussed. So let’s say if there was a major milestone or major activity or major function which is happening parallely in the organization, which could impact the audit, that also needs to be discussed with the audit team. In addition to these, some other things which could be discussed in the opening meetings are method of reporting, audit finding and criteria for grading. So as the audit team does the audit, they make some findings.

Then how these findings are graded? Graded as an observation, minor, nonconformity major, nonconformity. So what is the basis of that? That also could be discussed in the opening meeting. If the auditor or auditor is aware of any condition under which the audit might be terminated, then that also needs to be discussed. The example of this could be non availability of access to certain area during the audit if something happens that needs to be discussed. In addition to this, the auditor and audit also might want to discuss how to deal with possible findings during the audit. So let’s say during the audit, if one of the auditor finds one gauge which was not calibrated, one paper which was not signed, how to deal with this, would it be okay just to calibrate that equipment or just to sign that paper which was not signed? Will that make everything okay or not? That also is discussed in the opening meeting audit.

12. 2B4 Audit data collection and analysis

When it comes to data collection. During the audit, data could be collected in these ways, which are listed here on the slide, which includes Interviews, observations and Measurements, document and Record Review and Corroboration. And you will see that I have kept corroboration as a separate item. Let’s focus on three things which are interview, Observations and Document and Record Review. Let’s start with interviews. Now, as a part of audit, the auditor will interview audit. So if I’m doing audit of materials management, I will go and meet materials manager and talk to the materials manager how things are done in his or her scope of work. How does this department receives material requisitions? How? They select suppliers, how they issue the purchase order, how they make sure that the items being produced are right or wrong, how does the receiving inspection works, and so on. So, what I will be doing is I will be interviewing the manager or the person responsible for these activities. When you do an interview as an auditor, the first and foremost thing is that you need to make a good climate and environment where you could comfortably talk with the audit. Don’t make things very tense because of auditor audit relationship. Just make the environment relaxed so that you could comfortably talk about the processes. When you do an audit, you have a checklist to follow. Now, one approach could be you open your checklist and start talking about point number one, how you receive material requisition, how you select the supplier.

Point number three is how you issue the purchase order. This is one way of doing that. So rather than looking at the checklist, talking about those checkpoints, you need to make sure that you make this conversation in a friendly manner, rather than just reading the question and getting the answers. So you need to arrange your questions in a general conversational way. So as you interview the responsible person or the audit, you need to make sure that you keep on taking notes. This is important because in the discussion you might just forget about taking notes. And when you are taking notes, you need to make sure that you take specific notes as well. So if there was any reference to a specific purchase order, make sure that you note down the purchase order number. If you were talking about a specific piece which was received in the receiving inspection area, note down that the piece number and the type or whatever description of that piece is.

And this is the type of mistake which I have made in early part of my career where I did interviews and I thought that I will remember everything. But during the audit, you get so much of information that it’s really not possible to retain all that information in the mind. So it’s much better to keep taking notes as you do the audit interviews. So in the audit interview, your questions should yield the relevant information. So you need to ask your question in such a way or your questions should be such that those questions yield the relevant information because it is much easier for the audit interview to get sidetracked and you will forget about what is the main theme here, what are the main objectives of the audit. So make sure that whatever questions you are putting that should give you the relevant information. And obviously when you ask a question, don’t suggest an answer and what does that mean is so don’t say that when you are receiving these components you definitely inspect them.

Don’t tell them that they inspect them, let them, let the audit tell that they do the inspection. And always, always, always focus the audit interview on the object or the process, not on the person. So don’t make it emotional, don’t make it personal. That’s another important thing which you need to keep in mind when you are interviewing auditing. So now when you are doing audit and you are asking questions, your questions could fall in three types of categories. Question could be open question, your question could be a closed question or this could be a clarifying question. Let’s understand these and that will help us in putting the right question when you’re doing the audit interview. Let’s start with open questions. Open questions start with what? Why, where, who, when, how? For example, how do you receive material, who receives this material? Where this material gets placed?

So these are open question. The answer to open question will not be in the form of yes or no. The answer of open question will be in the form of some information. And that’s what you want as a part of audit, to get some information. But the limitation of open question is that your discussion might become much longer or your discussion even might get side tracked. So make sure that you keep focus on the audit objective and if things go out of control, then make sure that you bring the discussion back to the original topic. And one of the tools which auditors use during the interview is show me. So let’s say you are doing the audit of receiving inspection. And then the audit tells you that when they receive equipment or instrument or items which they receive, then they check as per the checklist. And then your question will be, okay, can you show me the checklist which you use when you receive this particular piece of item? So Show me is a good tool to have some objective evidences during the audit process. Coming to the next type of questions which are closed questions. The answer to closed questions will be in terms of yes or no. Open question had answer in terms of few words but closed question will give answer in form of yes or no. The example of open question will be did you do the inspection when you received this particular piece? The answer to that will be in the form of yes or no. This is closed question. In open question you get more information, but in closed question you get very specific information. So this is something which you need to keep in mind and balance your interview with both open questions and closed questions. Now, what are the disadvantages of closed questions? Closed questions do not bring out much information, but they do help in getting some confirmation. They do help us in getting very specific information, but having too many closed questions. And closed questions are those which have answers in terms of yes or no. So having too much of these closed questions might give an impression to the audit that oddity is being cross questioned.

So make sure that you don’t make that sort of impression, that you are basically investigating the oddity. You need to make environment friendly where you talk about things and there you need to have a mixture of open and closed questions. Now coming to the third type of questions which are clarifying questions here the intention is to clarify and get more information and to avoid any misunderstanding. So when the audit responded to you in terms of how they do a certain process, then you might want to reconfirm that with the audit. So ask that audit that okay, as I understand from your discussion, this is how you do this process. So you do step number one and then you check it, then you do step number two and so on. So what you are doing is basically reconfirming or clarifying. So you can use clarifying questions once in a while where you think that there might be some misunderstanding. So every time if you are clarifying, that gives an impression that you are not listening when the audit was initially telling you something. So use these type of questions whenever needed, whenever you need to confirm things. And obviously there is a time limit for the audit.

So if you have too many clarifying questions, basically every clarifying question will take some additional time, so time will be lost. So make sure that you listen to the auditing in the first instance itself. So these were three types of interview questions, open questions, closed questions and clarifying questions. Now here are some tips related to interviewing. The first tip here is you generally use open questions. There you ask how you do that, why you do that, where you keep it. Those sort of questions you ask more. And once in a while you ask closed questions which are in terms of yes or no. Most of that will be generally to reconfirm whatever you discussed. And then another important thing is, and this is very important that your audit interview should focus on the process, not on the person.

So don’t give a feeling that this is a personal problem when you are doing audit, you are doing the audit of a process, not you are investigating the person. That’s something you should always keep in mind. So let’s say if I’m getting audited and the auditor is asking such a question, that that gives me a feeling that I’m personally being blamed for all these mistakes, for all these process problems, then I might not be open to share information. So make sure that your focus is on the process, not on the person. And once again, and I don’t know how many times I say that, whatever number of times I say that, that would be less. But keep taking notes. When you’re doing interviews, when you look at a drawing, when the audit was showing you a drawing, note down the drawing number and the revision number and date of issue of the drawing. When the audit was showing you a piece of item, then note down what was the part number, what was the batch number, whatever it is, keep on noting down all the information, because you will not be able to find that later on. Later on when you make a report, and then when you have to prove something that which drawing had a problem. And if you don’t have the drawing number, revision number, you might not be able to go back and look at that drawing, look at that piece.

So keep taking notes. Another important thing in audit interview, which is my personal favorite, is that whenever you do interview, you talk to the person, you look at the document. But before you leave that place, before you leave that audit interview, make sure that you tell the auditing, the person whom you are interviewing, that what all could be the potential problem in that area. So give all the potential findings to the audit, because later on, when you will compile the report, when you will issue a nonconformity or observation, you might see that audit doesn’t agree to what you are saying. You can very well avoid that by having a very clear discussion at the end of the interview. That okay. In this area, what I have observed is that there is a deficiency in filling the checklist. When you receive a component, some of the items which you check does not have a checklist. For example, item number, this, there was no checklist available. So keep that level of details when you leave the interview and get the agreement from the audit, because later on this will be very difficult. Later on it might not be possible to find out that piece of item, that component, that drawing where you found the problem. So this was about audit interviews.

So in the data collection, we have talked about interviews, the next thing is observations and measurements which you make during the audit. So observation is something where you observe some work being done, how the inspector inspects the item which are being received, how the inspector takes the measurement of the item being produced, and so on. So here you are actually observing the things being done in the process of observing things, make sure that you follow the safety requirements. For example, let’s say if there is welding being done and you are observing the welding being done, that make sure that you have the welding glasses which are required to observe the welding. If you are doing the observation of a machine there, you need to have eyeglasses or something. So make sure that you use eyeglasses. So whatever safety requirements are there for the process, you follow that in the observation. Some places you might want to take a picture, but then make sure that you have already taken the permission to take pictures during the audit.

Some places it might be okay, some places it might not be okay. Some of the companies which are doing something which are proprietary in nature, which are confidential in nature, they might be doing another project, another equipment they might be making, which is for the country defense, you might not have the permission to take picture. So for that, before taking any picture at the observation stage or measurement stage, make sure that you have all the permissions required to take those pictures. And once again, keep notes, keep notes of whatever you are observing. Whatever piece number you saw, whatever equipment being checked you saw, keep a note of that. So in audit data collection, we have talked about interviews and we have talked about observations and measurement. The third thing which you do in audit data collection is look at some of the documents.

You review some documents, and as I was telling earlier, that when you do audit interview, you ask audit to show the documents, to show the proof, to show the evidences. So here, if you are asking audit to show the document, to show the checklist, then keep a record of that. We will be talking about sampling concepts later on. But when you are doing document review, when you are making observations, then make sure that you use random sampling for selecting the documents or the items which you want to review. So let’s say if you want to look at records of welding, and then you have thousands and thousands of these being stored, and in the audit, you cannot look at all those thousands of records of welding. What you will be doing is you will be drawing some samples from that and you will be looking at the Weld inspection report of some of those Welds. So out of those thousands of records, you just might want to see five documents, five reports. So you can ask auditing to give you report number five, report number 357, report number 507, and so on. So you randomly ask that and that will cover the whole population.

The sample which you are picking will give you a good idea about how everything is being managed. And in document review, we need to understand that the document could be in any form, document could be a hard copy, or document could be an electronic document. When we are talking of reviewing documents, let’s quickly review the requirements of ISO 9001 2015 in regards to documented information. Before ISO 9001 2015 version was issued earlier, there used to be two terms documents and records. Document will tell how things to be done and record will be the proof of that. But with the issue of 9000 and 121 five, both of these terms have been combined. Now, the term is Documented information and documented information consists of both documents and records. So these are some of the questions you might want to ask when you are reviewing documents. The first question here is is it available and suitable for use where and when it is needed? So the document which is available at the workplace needs to be suitable for the work.

And what you will be looking here is that the drawing or the instructions, whatever are available at the workplace are relevant and are the latest one. You might want to check that at the shop floor, the drawing which you saw was revision number two. But once you go back and look at the document register and you find out that the revision number three is the latest revision, that means there’s a problem. The piece which is being made in the shop floor is with the rev two, whereas the latest one is revision three. So the first checkpoint here is that make sure that the document which is available at the workplace is suitable. Another thing which you might want to look in document review is whether the documents are adequately protected. Protected from the loss of confidentiality, from improper use, or loss of integrity. So make sure that your documents are properly stored. Some of the contractual documents are needed to be kept for 40 years. So whether the documents are stored in such a way or not. So if you see that documents are stored in a humid, wet place where these are getting deteriorated, then that is a problem. So this is another thing which you might want to look when you’re doing document review. Another thing is to preserve the legibility, whether you can read those documents or not. Most of the time problem comes in scanning of these documents. So documents are being produced and these are scanned and the electronic copy is kept.

But the scanning is not good that you cannot even read the document number of times. You have very complex drawings, big drawings which are made on a smaller paper and once you scan them, you really cannot read them. So if you cannot read them, then definitely you would not be able to implement them. So this is another thing which you might want to see when you are doing the audit of documents. Next important thing is the change control. And I have already talked about change control when I was talking about the drawing revision which is available at the shop floor. And which is available in the document register. So that also needs to be checked whether there is a proper change control or not, if there is a change in the design, how that change is conveyed to the production or to the client. So this is something which you might want to check when you’re doing the audit of documents.

And then you need to check whether the documents are protected from unintended alteration. So that means the work instructions are not issued to people in Microsoft Word format where anyone can make changes to that, or people are not just hand marking the instructions and changing the instructions. So what you want to make sure is the documents or the instructions, instructions which people are following are controlled, are authorized. So if someone has authorized to use certain instructions, then people should not be free to make.