ASQ CQA – 2. Audit Process Part 5

20. 2D2 Review of corrective and preventive action (CAPA) plan

So here are steps related to corrective action plan. The step number one is audit team identifies the nonconformity during the audit. We have talked about that. Then the audit team proposes the corrective action. We have talked about that as well in the previous lecture. Now, coming to the step of corrective action plan review, this plan is reviewed either by the client who has requested for the audit or this plan is reviewed by the audit program manager which in general terms could be the quality director, quality manager of the company in regards to internal audit.

Or this plan is reviewed by the lead auditor or the audit team leader. So what are the components of review? We will talk about that later. But now let’s stick to the steps related to corrective action plan. So, once this plan is reviewed by either the client or the audit program manager or the lead auditor, the next step is the audit completes the necessary action. So whatever actions were proposed by audit in the plan, those are taken by the audit. Then the next step is the lead auditor verifies the completion and the effectiveness of the corrective action. Not just the completion, but also the effectiveness of the corrective action. And the next step after that will be follow up on ineffective corrective action.

So if during this verification some of the corrective actions were found to be ineffective, then follow up is done on those as well. And once this is done, the audit gets completed. So this is basically the road map related to corrective action plan. Now, coming back to what happens in the review of corrective action. So, as I earlier told, the corrective action could be reviewed by the client, the audit program manager or the lead auditor. Let’s say this review is done by the lead auditor.

Either the lead auditor will accept the plan which was given to the lead auditor or the lead auditor could ask for more clarification or the lead auditor could reject the plan. These are some of the things could happen when it comes to corrective action plan. Now, what are things which needs to be seen in the corrective action plan? Let’s see that on the next slide which is here. So this slide basically tells that what are the reasons, what are the things to be looked into corrective action plan which could lead to the corrective action plan getting rejected?

The first and the most important thing here is that many times the audit does not understand the difference between the correction and the corrective action. And I am again going back to that simple example of one bolt being loose in the assembly. Now, if this is the non conformity which you have issued as a lead auditor, that the boat in that assembly was loose. And if you get the corrective action plan which tells you that the board has been tightened, this basically tells that the audit does not understand the difference between the correction and the corrective action. So what audit has done is correction. Audit has not taken the corrective action.

So this is the first thing which you will be seeing when you look at the corrective action plan submitted by the audit, whether the audit understands the difference between correction and corrective action or not. And the next thing which you need to see in the corrective action plan is whether the root causes of the problems have been identified and have been addressed or not. So here I am talking about the root cause, not just the symptoms. This is another mistake or this is the another problem in the corrective action plan, that the corrective action plan might just be addressing the symptoms, only might not be addressing the root cause behind that.

So this is something which you need to look in the corrective action plan. And now when it comes to the causes of the problem, and let’s again go back to the same old example of the volt being loose, let’s say if they have done a root cause analysis. And in the root cause analysis, audit has identified that the bolt was loose because of human error. Now, human error is not a root cause. Human error is not something which you can address. So there need to be some system, some processes in place. So as an auditor, I will not accept human error as the root cause of a problem. So you need to look at things like that as well. And another thing many times I have seen is that, okay, in this particular case, there was a procedure. There was a procedure that operator will check the boat tightness, but operator has just ignored that and has not followed the procedure.

So this is also I will not accept as a root cause. So as a lead auditor, I will be asking audit to go deeper into that and find out why did that particular thing happen, why that boat was loose, this boat was not lose just because of a human error or just because the person did not follow the procedure. So these are the type of things which you need to consider when you look at the corrective action plan, whether the audit has actually gone into the root of that, whether they have discussed this problem, whether they have done that.

Five y analysis. Five y basically tells them why this has happened, why the bolt was loose. Bolt was loose because operator did not check that. Why operator did not check that. Operator did not check that because the bolt was not accessible, why this was not accessible, because this wasn’t design issue or something. So you go deeper into that and you find out that this board was not lose just because the operator forget this board was loose because of, let’s say, design issue or even deeper than that. So this is something which you see as a part of corrective action plan review.

21. 2D3 Verification of corrective and preventive action (CAPA)

So even though the audit did something to address the problem, to address the nonconformity, but this particular action which was taken by audit did not help, did not remove the problem from the root. So if that is the case, then we will say that the corrective action was ineffective. Now, what are the options in case of ineffective corrective actions? To understand what are the actions which could be taken in case of ineffective corrective actions, let’s understand what does effectiveness means? Effectiveness means that the corrective actions has actually met the desired objective.

Let’s take the case of assembly which we were talking earlier. In that assembly, one bolt was loose. And for that, let’s say the audit took some corrective actions. They made some arrangement to avoid that the bolts are not loose. But when the auditor did the follow up activity, auditor still found some of the assemblies having loose bolts.

So that means whatever actions were taken by auditor were not actually effective. They might have helped to some extent, but these were not effective to remove the problem from the bottom, from the root. So what are the options in that case? In that case, what auditor could do is auditor could reissue another corrective action request, ask the auditor to relook at what corrective actions they have taken and resubmit the corrective action plan.

So this is one option. Another option could be to do a reorder re audit and look at the whole system once again to make sure that this particular type of problem do not occur. Or the auditor might consider to escalate the issue, escalate the issue to the higher management of the audit, or escalate the issue to the client of the audit. So these are some of the options which auditor can take if the corrective action is ineffective. And here, as an auditor, you need to understand that what all type of actions could be taken? What are the tools available to find out the root cause?

What are the tools which can help in having an effective corrective action? So let’s look at list of some of those tools on the next slide. So these are the tools which should be used by the audit. But as an auditor, you need to understand that. What are the options available with audit? So here on this slide, I have a list of commonly used tools which can help in having effective corrective actions. So these are tools for finding out the root cause and having an effective corrective actions. So, let’s look at first two things which are five YS and fish bone diagram. These are the common tools which are used for root cause analysis. So let me put it RCA. So when you do root cause analysis, find out the root cause of the problems.

Then these are two tools which you could use five whys? Where you will look at the situation and ask five times why this has happened, why the bolts are loose. Bolts are loose because operator did not see that. Why operator did not see that. Operator did not see that because this was in a hidden area. Why this was in a hidden area because this is a design problem and so on. So you investigate the problem and ask the question why this has happened multiple times. So this is one tool. Second tool here is Fishbone diagram which looks at all the causes which could have contributed to this problem. So this tool is called as fishbone diagram. This tool is called as ishikawa diagram and this tool is also called as Cause and Effect diagram. We will be talking about most of these tools as we go further into this course. Another tool. Could be pareto. Chart. Pareto chart helps us in finding out what are the key causes which contribute to this problem. So this is basically based on 80 20 principles. So there are small number of causes which contribute to a large number of problems.

So that’s where you could use Pareto chart and we will talk about Pareto chart also in detail as we go further. Another tool is control charts. Control chart basically helps in seeing whether the process is in control or not. And similar to control Chart is the process capability index. So these two things generally go together. So here you might want to find out that what is the capability of the process? So if you are making a piece whose dimensions are going out of the specification limit then you might want to find out that what is the process capability? Whether your process is capable to meet that requirement or not, that specification or not. We will talk about these things also as we go further into this course. Another thing which the audit could consider is mistake proofing. Mistake proofing is a tool, this is also called as Pokai UK which helps in avoiding problem from happening at all. So some of the common examples of mistake proofing is that you cannot start your car when your car is standing in the gear or you cannot put the USB in the computer upside down. So there is only one way the USB can go into the USB slot. And another tool here is FMEA failure mode and effects analysis. That also you can use even at the design stage. That what all things could go wrong and what will be the effect of that. And based on that you identify that what are the critical issues and you take necessary action on that. We will be talking about FMEA also as we go further into.

22. 2D4 Follow-up on ineffective corrective and preventive action (CAPA)

Previously we talked about review of corrective action. So if we relook at the audit process here the audit was done, then audit proposed the corrective action. This corrective action was reviewed by the client or the audit program manager or the lead auditor. Once they agree on the corrective action, this was sent back to audit to take necessary action and audit took all the necessary actions. Now comes the time for verification of those corrective actions. And this is what we will be discussing in this video, which is verification of corrective actions.

Now, in verification of corrective action, the purpose is to ensure the implementation and effectiveness of corrective actions which were proposed by audit. So audit did a root cause analysis and proposed number of actions to address the nonconformities which were identified in the audit. Now, what we want to do is we want to verify whether those have been completed and also if these are effective or not. And when I say effective, effectiveness means whether those corrective actions actually achieve the desired objective.

And here once again, I will talk about the difference between correction and corrective action. Correction was something which was done to address the problem. Corrective action was to make sure that this problem is not repeated again. So this is what we want to verify as a part of verification of corrective action. So one option is to do a follow up audit. Sometimes it is possible to do follow up audit, sometimes it becomes too much cost ineffective to do a follow up audit. Let’s say if you have to do a follow up audit in a different country. So this might require a lot of time, a lot of traveling, a lot of cost related to traveling. So here you might want to look at some of the alternate options. And alternate options could be looking at the documents which are provided by audit. So audit has taken some actions, then audit will provide all the supporting documentation to auditor, look at that and based on that also the corrective action could be verified.

These are some things to save time and money. Other option could be to do a remote audit. Now, remote audit is an option which has been identified in ISO 19,011 that you can do a remote audit as well. Here you might do a webex or a web meeting or share documents and do some face to face interviews as well. So there are options where you can do a remote audit rather than actually traveling. Because now you know specific problem, now you know what specific corrective action you are looking at. So this could be done through a remote audit as well. Other option could be combining this with a subsequent audit. Let’s say if you have a plan to do next audit, let’s say you are doing audit every six months or you are doing audit every year. So rather than having a separate follow up audit to check the corrective actions. What you could do is you can address that in the subsequent audit. So these are some of the approaches which you could use for verification of corrective actions.

23. 2D5 Audit closure

Section two A we talked about audit profession and planning. There we looked at the planning part of the audit. Then in section two B, we looked at audit performance and this was related to on site audit. There we talked about opening meeting, audit interviews, document reviews, closing meetings, ETCA. So this was audit performance which was two B. In two C, we talked about audit reporting. There we looked at what are the the components of report and how can we make our report effective. So this was two C. In section 2D, we talked about audit follow up and closure. There we talked about number of things and these are listed here. Here we looked at the element of corrective actions. We talked about reviewing the corrective action by the audit team leader or the client. And then we talked about verification of corrective action where the auditor or the lead auditor will go and verify whether the corrective action has been taken and whether that corrective action is effective or not. Effective means this has actually met the need. This has actually avoided the problem.

So this was verification of corrective action. Then we talked about follow up on ineffective corrective action. If the corrective action is ineffective, then what could be done? So let’s assume that at this stage, a corrective action plan was prepared for all the non conformities which were identified in the audit. Those corrective actions were effective and these were verified by the auditor. So with that, everything is done. Now it’s time to close the audit. So the requirement for audit closure is that when all the corrective actions have been taken, then the audit can be closed. So this is as simple as that. So if there were five nonconformities identified, for those five nonconformities, a number of corrective actions were identified. All corrective actions have been taken. Those are effective. The auditor is happy with that. Because these are effective, the problems are not reoccurring. So with this, the audit can be closed.