S For ISO Team uggestion FOR WRITING-RESPONSE to Corrective Action Requests Somrudee Krumsiri Docume nt Controller Tainee
Hi ! ISO Team If you have a problem Don't worry, problem meant to be solved Snehal Sahay Let's open The E-Handbook and solve it step by step!
Contents Understand the topic 1 Objectives of the E-Handbook 1 Why ISO team have to improve CAR skills? 2 Why I choose topic about CAR? 3 Understand the Corrective Action Request 5 What is Corrective Action Requests? 5 Which activities use the Corrective Action Requests? 6 What are the details of Corrective Action Requests Form? 7 Which part is easy to have a problem? 11 Suggestion of writing CAR issue 13 By 4W1H 7 Steps to respond CAR 15 16 Step 1 Define the problem 16 Step 2 Let’s see the problem 17 Step 3 Make a Correction
Step 4 Identify the Root Cause 17 18 Step 5 Plan a Corrective Action 19 19 Step 6 Implement the Corrective Action 21 Step 7 Follow up 22 Anaslysis Tools Suggestion 27 Why Why Analysis Fishbone Analysis 33 Summarization 34 References
1 Understand the Topic
1 Understand the Topic Purpose of E-Handbook Why ISO team have to improve CAR skills? Why I choose topic about CAR Purpose of 1 E-Handbook Purpose of the project \"Suggestion for Writing-Responding to a Corrective Action Request (CAR) E-Handbook\" is: To help ISO team improve CAR writing-responding skills To close the comment of auditor in ISO external audit To help the ISO team improve analysis skills To suggest how to write-respond CAR in the easy way for ISO team easy to understand To help ISO team get ready in writing-responding CAR that can sent in Internal audit & External audit on next year To help ISO team get ready to respond CAR of \"Customer Complaint\"
2 CAR skills Why ISO team have to 2improve CAR skills? Because CAR skills is important for our team ,that it very useful for audit of business system, like : INTERNAL AUDIT EXTERNAL AUDIT CUSTOMER SOLVE COMPLAINT EVERYDAY PROBLEM
3 Why I choose 3 topic about CAR If you take a look at our working processes, document controlling ,correcting data or others, we can see that they are ISOvery complete as we have just gotten 9001 certification from TÜV SÜD. However, if we look deeply into one process that is very important that CARwe still have a mistake with, it is “”. According to the comment of auditors of the first ISO External audit from TÜV SÜD, she said that some of our CAR's responded on internal audit were not completed and had some mistakes, like the part that should link, they were not linked, the root causes still didn't analyzed correctly, seems like we’re lack some skills of CAR writing and responding. I can say it wasn’t that bad since she didn’t gave us any observe, but at that time she suggested that it would be great if we know the right way to write-respond CAR, because it not only show how good we can solve and analyze the problem but the customer or auditor who sent CAR will know the way we care about their problem and the way we try to solve it , and yes more trust to continued business with our company.
4 CAR
2 Understand Corrective Action Request
5 Understand Corrective Action Request What is Corrective Action Request? Which activities use the Corrective Action Requests? The details of Corrective Action Request? Which are the part that easy to have a problem? 1 What is Corrective Action Request If we search the word “Corrective Action Request or CAR” on the internet, there are many definitions about it, but the good one is from defenseacq.com. They defined CAR as “A formal notice from the Supplier Quality Control that often provided during an audit of the business system and requesting the removal of an item, product, process, or non-compliance to create a remedy” The definition above is correct, but let me explain it to be easier to understand. CAR is a requirement from an auditor during audit of the business system like internal & external audit, customer audit and others audit that request us to remedy, to solve the process, and product that non-compliance. Moreover, this requirement demand the root cause of non- compliance of product and process to be removed to prevent recurrence
6 2 Which activities use the Corrective Action Requests? 1 CUSTOMER COMPLAINTS/ STAKEHOLDER COMPLAINTS 2 PRODUCTS, PROCESS NON-CONFORMITIES 3 AUDIT FINDING INTERNAL AUDIT EXTERNAL AUDIT YOU CAN GET \"CAR\" BY THIS ACTIVITIES 4 MANAGEMENT REVIEW 5 EMPLOYEE REPORTS OF PROBLEMS EQUIPMENT PROCEDURES PROCESSES BUILDINGS INFRASTRUCTURE 6 EMPLOYEE SUGGESTIONS FOR IMPROVEMENT 7 ANY OTHER REPORTED PROBLEM OR SUGGESTION (NO MATTER THE SOURCE)
7 3 The details of Corrective Action Requests form This is CAR Form (FP-MRD-03-01) Rev 00 of \" Wuerth (Thailand) co, ltd \" It has separated into 4 parts 1 ISSUE 2 PERSON IN CHARGE 3 AUDITOR 4 QMR 1 2 3 4
8 1 ISSUE 1 1 \"CAR NUMBER\" 2 We are set Car number as follow : A-BB-CC A C= Corrective Action: BB = 2 digits showed in A.D. : in 2021, BB = 21 3 CC = The figure showed the CAR number from 01-99 For example: C-21-01 is Car number 1 of 2021 4 2 “MANAGEMENT SYSTEM” & “CAR TYPE” In the ISSUE part we will see Management system and CAR Type firstly. This step is not hard, because we just have to check on the system and type of CAR, but be careful that your check is correct. 3 “NONCONFORMITY” Here is one of the difficult point, because in \"nonconformity\" we have to write the nonconformity of CAR. The problem or nonconformity can't write in any way we want, but it should write in the right way, not too narrow or too wide. You can see the suggestion of writing nonconformity of CAR in the part 3 of E- Handbook. 4 “REQUIREMENT NUMBER” In this part you have to write the requirement number that shows on the requirement table part of the Management Manual. It is a part that shows which document and requirement that relate in each department. So you just check the CAR issue you write that is relate with which department, then check the requirement number to write (On the last block of the table name “ISO 9001 2015” to fill in on this part). 5 “REFERENCE” You can check the reference on requirement table part of Management Manual too, that the CAR issue you write is refer to which form or procedure of each department.
9 IMPORTANT! 2 PERSON IN CHARGE 1 2 3 1 “CAUSE” This part we have to write the cause of the problem and it should be the root cause of the problem that we can find it by analysis tools like Why Why analysis, Fishbone and so on (you can find the suggestion of using analysis tools on part 5 of the E-Handbook) Tip: Cause should be the part that connect with Corrective Action, after we found the root cause, then we will do the corrective action of the root- cause we found to prevent recurrence 2 “CORRECTION” Correction is mean a change made to something in order to correct or improve it, so in this part we have to remedy and solve the problem to control the problem immediately, to stop the factor that made a problem, not make it affect customer or others process Tip: Correction is linked with Nonconformity (CAR Issue), after we get a CAR we have to define it and do the correction to stop the Nonconformity immediately, to keep it in control and not affect customer or other processes while we analyze the root cause
10 3 “CORRECTIVE ACTION \" This is the part where we have to write corrective action. After we found the root cause , the corrective action is the action we do next to prevent the recurrence Tip: Corrective Action is linked with Cause (root-cause), because corrective action is make to solve and prevent the recurrence of root cause of problem , so be careful when write car, make sure the answer are linked 3 AUDITOR \"AUDITOR\" This is a part of Auditor to check all answer of responder and decide the result of CAR by select ACCEPT or NOT ACCEPT 4 QMR \"QMR\" After the auditor checked and selected the result, this is part of QMR to CLOSE or NO CLOSE the CAR. On this part it depends on the answer and result of the auditor too, if the auditor does not accept the CAR, then QMR is unable to close the CAR as well.
11 4 Which part often has a mistake? ISSUE WRITING ISSUE CAUSE In issue part people often have a mistake in writing the Nonconformity (CAR issue), like unclear, too wide or too narrow and not specific. (You can learn how to write on part 3) MISUNDERSTANDING ABOUT CAUSE The responders often misunderstands that the CAR issue that the auditor sent to them is the Cause of the problem. For example, the issue is “After audit the procedure and forms of X Department, didn’t find using FP-00-00 in X process” and responder wrote the cause as “Didn’t use FP-00-00”. In this way is just repeat the issue, the responder didn’t analyze the problem. Cause isn’t the point that explains or repeat the issue, cause is the point that you have to find the root cause by analysis tools, to meet the root cause of the problem and fix it. Tip: Every time you got CAR, try to change the CAR issue a bit by put WHY“ ” in front of the problem, like a simple issue is “After audit the procedure and forms of X Department, didn’t find using FP-00-00 in X process” , the let’s put WHY in the issue “After audit the procedure and forms of X Department, why didn’t find using FP-00-00 in X process” This is why you will understand the issue more and respond in a better way. HUMAN ERROR In the cause part, people often answer like “overlook”, “oversight”, “lack of awareness” or others about human error. If ask that it can or can’t answer like this, I can say that it can but deeper than lack of awareness, it can be lack of communication in team, lack of training team member, so be careful with your answer, think deeper to find the root cause!
12 ADD MORE INFORMATION OF PROBLEM INSTEAD OF EXPLAIN THE CAUSE People often answer by adding more information or explaining the problem, instead of explaining the cause in the cause part. For example “Why X department didn’t use the FP-00-00”, “Because used the wrong form”. In this case the answer should be explained like lack of communication in the team or lack of member training about using that form before work. CORRECTION THE DIFFERENCE OF CORRECTION & & CORRECTIVE ACTION CORRECTIVE ACTION correctionSomeone may don’t know the difference of and corrective action, because people often have a mistake when answer 2 of them, like answer them in the same way, so let see the meaning of them: Correction is the action to remedy, to stop and control problem immediately or manage it to not affect other processes. Corrective Action is the action to protect, to prevent the recurrence in the future. **You can see that the meaning are different, so be careful when answer** WRITE THE CORRECTIVE ACTION ISN’T LINK WITH THE ROOT-CAUSE THEY FOUND Like the problem occur by human, but take an action with the document or the problem is about system, but solve by meeting or training WRITE THE CORRECTIVE ACTION ISN’T COVER THE ROOT CAUSE Like the root cause of problem is about human and equipment humanbut solve only the problem with
3 Principle of writing CAR issue (Nonconformity)
13 Suggestion of writing CAR issue (Nonconformity) By 4M1H Note fstoNpdoobrWoeiotfuynhcfrotiiceicstfuwoirpiunscnterlgtoifcta.eoiinwtafrNmigascroPiyi,tlnietletycoo,tioanoptrsonolrtefsoihugoohenrwhmemdtrrlieieeidiNkgttreeyiohsam,lttnyrateeicwsononosdaw'ntotyofnrmoiitadstroeermifrwqmfotiniituwrcpyaoiiutstkteel,et,
14 BY : \"4W1H\" WHAT WHAT IS THE PROBLEM + WHERE'S IT OCCUR WHERE WHEN'S THE PROBLEM OCCUR +4W WHO OR TEAM THAT TOOK RESPONSIBILITY WHEN + (CAN MENTION OR NOT MENTION) WHO HOW MANY TIMES IT OCCUR +1H OR HOW'S IT OCCUR HOW 4W1H is a tool for you to write the CAR issue or Nonconformity easier and better It is because 4W1H is consist of : WHAT, WHERE, WHEN ,WHO and HOW, that are important information of the problem, so if use this tool your Nonconformity will be complete and make responder easy to understand and they can solve problem in the right point
4 7 Steps ot respond Correctiv Action Request
15 7 Steps to respond Corrective Action Request Step 1 Define the problem Step 2 Let’s see the problem Step 3 Make a Correction Step 4 Identify the Root Cause Step 5 Plan a Corrective Action Step 6 Implement a Corrective Action Step 7 Follow up
Steps 1 16 Define the problem When we get CAR, the first thing we should do is define the problem. Let’s describe and check the problem we got with the team that it is fact and isn’t an observed or misunderstand. Then, let’s assemble all the people who relate with the problem, to explain who, what, when, where and why the problem occurs clearly before doing other steps. Steps 2 Let’s see the problem After we make sure that CAR we got is fact and already assembled all people who are related with the problem. Then let’s go to see the problem where it occurs, to see and observe the factor that created the problem. This step you should observe and note as much as you can, because the data you get will be useful for correction, searching for a root cause and corrective action parts.
17 Steps 3 Make a Correction Making a Correction is a step that we have to control the problem immediately, to stop the factor that created the problem and to control it before it affects the customer or others working processes. You have to bring the data you corrected on step 2 to make a correction like make a short- term fix to stop the problem, this is an immediate action to stop the problem while we are searching for the root cause as well Steps 4 Identify the Root Cause Identifying the root cause is not always easy because it depends on how big, important the problem is and how much it affects other processes. Of-cause that the NC we had gotten were both big and small, but even it is a small problem doesn’t mean we can answer the Cause part as the way we like, because if it can’t solve the root cause and even the small problem, if it occur many and many times, it can become the big problem.
18 Problem Why Why As a result, when we search for the cause it’s not just a surface of the problem, but try to Fishbone identify the underlying problem, and find the root cause by using analysis tools. For example, a basic one is Why Why analysis or more difficult one by Fishbone (You can learn about analysis tools in “Root Cause Analysis Tools Suggestion” on part4) Steps5 Plan a Corrective Action After we found the root cause of the problem, then let’s move to planning a Corrective Action step. As I said that Cause and Corrective action parts are linked, so after we find the root cause, we can think about corrective action easily. The planning corrective action is a step that we have to think about the action to block, protect and prevent recurrence, so let’s list the action we will do to prevent the problem in the future and consult with team because sometimes it may require cost or have to make a big change but it depend on the size of the problem.
19 Steps 6 Implement a Corrective Action Implementing the corrective action step is a step that you will take with your corrective action plan. It can be as simple as setting a new procedure for some processes in the department or making changes to the documents. Or it can be an investment in new equipment for some working process, it’s depend on what’s is the root cause that we should make an action with Steps 7 Follow up Final step is Follow Up. This step is the last step to make sure that your plan was effective. Close out all the process with a meeting with the team, present what was done and inform the team about changes. Give a suitable amount of time to see that the problem doesn’t recur. If it does, you need to question if you got the actual root cause.
20 Follow up is one of the important steps, and we can have trouble if we do not care about it. Often, people want to close out the paperwork quickly, but proper follow-up is essential too, so our company has a CAR follow up process to correct, check the information and ensure that you didn't forget any steps. In case of \"Amendment results and correction is complied with the requirement with satisfaction\", shall record the details / reference evidence to the objectives specified in CAR to close CAR, and deliver to QMR for approval. On the other hand if not, the checker will issue the new CAR to you The goal of corrective actions is to correct the root of the problem, so the failure does not recur
5 Root Cause Analysis Tools Suggestion
21 Root Cause Analysis Tools Suggestion Why Why Analysis Fishbone Diagram
22 Why Why Analysis Why Why or 5 Why Analysis is a method of searching for and finding the root causes of the problem. The name of the method comes from the main question asked during the analysis: Why? ,found with real causes prevents the problem from happening again. HOW TO CREATE WHY WHY ANALYSIS TOOL FORM A TEAM Try to assemble a team of people who are relevant and familiar with the process of the 1 problem, or involve the people from different departments who are familiar with the process on the team as well. Because forming a cross-functional team you are going to receive unique points of view. This will help you collect enough information to make an informed decision DEFINE THE PROBLEM Discuss the problem with the team and make 2 a clear problem statement. It will help you define the scope of the issue you are going to investigate.
23 ASK WHY The team leader will ask the questions and try to WHY WHY keep the team focused. The answers should be based on facts and real data, rather than on WHY WHY emotional opinions. WHY WHY 3 The facilitator should ask “Why” as many times as WHY needed until the team can identify the root cause of the initial problem. (Normally 5 times) Tip : Don’t ask too many \"Whys\". If you keep going, you may end up receiving tons of unreasonable suggestions and complaints, which is not the purpose. TAKE ACTION After the team detects the root cause, it is time to take corrective actions. All members should be involved in a discussion to find and apply the best solution that will protect your process from recurring problems. 4 When the decision is made, one of the team members should be responsible for applying the right actions and observing the whole process. After a certain period of time, the team needs to meet again and check if their actions actually had a positive impact. If not, the process should be repeated.
Why Why Analysis 24 PROBLEM The last reason is a root cause ........................ that use WHY? for making corrective action REASON Most problems WHY? can be resolved within around 5 REASON times of why WHY? questioning., but some ask only 3 REASON times, it's depend on each problem WHY? REASON WHY? REASON
25 Example of Why Why Analysis PROBLEM 1 PROBLEM WHY? REASON WHY? REASON WHY? REASON WHY? REASON WHY? REASON ROOT CAUSE
26 These are example of Why Why Analysis By leanopedia.com that show analyzing 2 problem : \"Failure to comply to Aerospace legislation\" and \"On time delivery isn't ,meeting the target \" PROBLEM 2 PROBLEM WHY? REASON WHY? REASON WHY? REASON WHY? REASON WHY? REASON ROOT CAUSE
27 Fishbone Diagram IcsahAuiksFaeiswsh.abodniaegrdaiamg,rIatmis uissecdalliendoradecar utoseidaenndtifeyffaepcrtodbilaegmra’smr,oootr mcTyoapmpicbtaienllmyespultashteeed. pfroarctricoeotofcabursaeinsatnoarmlysinisg, waitfhishabtoynpee doifagmrainmd It should be efficient as a test case technique to determine cause and effect. A fishbone diagram is useful in product development and troubleshooting processes When we should use Fishbone diagram 1 Wprhoebnlemwethawtarnetlevtaontfiwndithtmheanryofoatctcoarsusoer coafustehse 2 pWrhoebnlemwewitwhatnetamtomfeinmdbetrhsebyrobortaincsatuosrem of the
28 Advantages \"WFliEkisahehsyby5soWttnooheUdysDsrieilaal\"ndgdorawBmnratisionesataorsorymottoincgua,usesaenadqsuwoictohkrelkyrswaenllawlyisthis tthoeol5s EASY TO USE cBts\"Hhoaeeeuciltsappeuhrssoseiebdelpleaoensftmiteltyiafhoymenpdtrtheooesbsilgheenemeaotdafhnatedhncidscoatcnuoansoueelsscertiessolaoffitnsitohhtnbhesoehpnbierpoo\"tnbhelaeotmfshfaiosnhwd, EESSUUAACC MMEELLBBOORRPP EESSUUAACC ESUAC ESUAC Helps prioritize relevant causes, allowing you to address underlying root causes Helps develop brainstorming skills Disadvantages \"tmmTIhhraareeekkleecebavuuruassasneicnetrosscgntaoatfuhurinmsaseetaisndilgrocartaennopldefrcvowcaacaauneusststseseewcsoioit,nfhnatnfitfmudhisseesihoobnpmo\"rnoeebolefdmtiha,egsmroamciat nccbaanne tba\"tBhorraeaapstinretosedhvtneoeodrcnrmeeadousinupsgelitbnstiiyso\"hn:ejMuy\"rVsaavotntothyotineeptgriiimns\"tihtoehasnfenrtoohremefavatimdlbcetereanmaaucinmbsesee;triot,mrnimteeicmenadgbnsep'ttrre,opscrtobeinvsugest Fhiasvhebotoneusdeiaogthraemr tocoanls'ttosohlevelptshoelvpinrgobpleromblbemy itself, so it
29 HOW TO CREATE FISHBONE DIAGRAM Fishbone diagrams are typically made during a team meeting and drawn on a flipchart or whiteboard using brainstorming in a team to find the root cause. The following are the step to create fishbone diagram : IDENTIFY THE PROBLEM The first step in creating a fishbone diagram is agreeing upon and writing down the exact problem you’re facing. Have your team figure out who’s involved, what the problem is and when and where it occurs. 1 Next, on a whiteboard, write the problem PROBLEM statement in a box on the right-hand side and draw a horizontal line protruding left from the problem statement. The problem statement resembles the head of the fish and the horizontal line resembles the spine, giving you room to develop ideas. BRAINSTORM THE MAJOR CATEGORIES OF CAUSES Step two is deciding how to categorize the causes of the problem, think about the factors that may be part of the problem. These factors could be as following : 2 6Ms 4Ss In a manufacturing setting, they usually use (SERVICE BUSINESS) the 6 Ms or 5M1E. SURROUNDING SUPPLIER Methods SYSTEM Manpower SKILL Machine Materials 4Ps Mother Nature (Environment) (MARKETING) Measurements PRODUT PRICE PLACE PROMOTION
30 After you identify each cause, draw a ENVIRONMENT METHOD MAN line off the bone of the fish and add PROBLEM each factor that might contribute to the problem. MATERIAL MACHINE IDENTIFY POSSIBLE CAUSES ENVIRONMENT METHOD MAN Step three is brainstorming the possible PROBLEM causes of the problem that may be MATERIAL MACHINE 3 related with each factor you add. Let's visualize the possible causes by drawing shorter lines off of the “bones” of the factors. ANALYZE THE DIAGRAM On step 4 you will have a full fishbone diagram showing all possible causes of the problem. Let's use tools like the 5 Whys, investigations and surveys, you can now investigate the problem and test to see 4 which of these potential causes is in fact contributing to the problem. A helpful tip for this step is to write all possible causes of the problem on sticky notes, so you can group similar ones together on the whiteboard without having to erase and rewrite so much.
31 Fishbone Diagram STRUCTURE This is a example of Fishbone diagram structure that separated causes into 6 categories by 5M1E (6Ms) : Methods Manpower Machine Materials Measurement Environment
32 Example of Fishbone Diagram This is the example of Fishbone Diagram By Vasogen that show analyzing \"Late Deliveries\" problem It's separated the causes into 4 points: Processes, People, Systems and Data and add the possible causes that contribute to the problem in each factor. Processes : Delivery, Pricing, Order Entry People : Lack of Training, Unrealistic Promises Systems : No Customer Required, Availability, Functionality Data : Wrong Product Code, Inaccurate Order Due Dates
33 Summarization To sum up, this e-handbook was especially created to help the ISO team at Wuerth (Thailand) Company Limited, to improve skills that are needed in the ISO system and business system. For example, CAR writing and responding skills, analysis skills and problems solving skills . The E-handbook consisted of 5 main parts : Understand the topic, Understand the corrective action, Suggestion for writing Nonconformity, 7 steps to respond CAR and root cause analysis tools suggestion. All of these parts collected the important information about CAR that I tried to make it in the way that ISO team easy to understand. All information was corrected mainly from: online article about CAR and analysis tools the CARs responded of ISO internal audit 2021 the procedure 03 corrective action of MRD the comment of auditor on ISO external audit the opinion of me and manager As a result, I would like to apologize first if the e-handbook has any mistake or I presented wrong information or I misunderstand in some point, because I am not know well about CAR but I tried to collected data and understand them as much as I can, then make them into the simple information that all of our team or others can understand CAR easily Finally, If you have a problem or you get CAR, don't forget to use this E- Handbook to help you solve the problem. I hope it can help your problem and your work easier. Thank you
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