“To err is human, but to edit is divine.”
This adage summarizes the corrective action process. It’s an activity that involves undertaking actions, processes, and procedures to fix and document problems. The purpose of a corrective action procedure is to define a problem, contain it, determine its cause, and take the appropriate action to prevent the same thing from happening again.
Companies must improve their practices to manage the issues that trigger the corrective action process effectively. Alongside, a built-in audit method should be included in the process. to ensure that the corrective measures are in place.
The action system is performing at its best. It’s crucial to keep track of data and evidence. As well as being a part of action management so that the organization may be sure that all nonconformity data is correct, Observed, measured, and, if necessary, corrected.
What is Corrective Action?
When an activity, process, product, or even a person’s conduct produces errors or deviates from an intended plan, corrective action is implemented. It’s a part of the quality management process implemented in an organization and initiated as a part of damage control.
The corrective actions undertaken in the process can be viewed as changes made to an organization to eliminate negative consequences. When the deliverables, whether tangible or intangible, deviate from the required output, corrective actions can be applied to the entire project.
Furthermore, the corrective action plan procedure also relates to individual employees and functions in the company. The human resources department can explain the corrective procedures to the employees to improve their aspects of attendance, undesirable behavior, or performance that need to be improved.
The methods undertaken in corrective action include identifying a problem and thoroughly documenting the resources and activities needed to alleviate the acute symptoms.
Hence, documentation is the core of a corrective action system procedure. Its primary purpose, however, is to identify and resolve the problem’s core cause.
Corrective action, in theory, should only be taken in response to severe difficulties and recurring issues, significant supply concerns, problems that jeopardize health or safety, or situations in which a client wants a modification in shape, fit, or function.
How is a Corrective Action Procedure Different from Preventive Action?
Corrective and Preventative Actions (CAPA) combine the processes and procedures for corrective action and preventive action. While disciplinary action is meant to help you fix the consequences of the problem, preventive action takes proactive steps to prevent potential problems.
The benefit of using CAPA is that you will be able to address all the same types of problems in every operation. For instance, if there’s an issue with the assembly line of one product, the same issue will be there in every product built using the same assembly line.
Generally, there are two categories of corrective actions are designated under the corrective action procedure and process.
Although the primary goal of developmental actions is the process or product improvement, we can consider them preventive in nature.
The goal or objective of the effort undertaken should be clearly defined in terms of corrective activities. Plus, the progress, monitoring, and results must be clearly documented.
For new projects, good documentation can help in communicating the goal to the team and capturing lessons gained for future attempts.
Recommended and Required Actions:
The actions that have been recommended can be examined and then adopted, refused, or postponed. A regulation, internal guideline, or policy is frequently the source of required actions. You must carry out specified steps or offer written justification if you cannot do so.
In the debate on the differences between corrective and preventive action plans, we often understand things with a common example of mixed parts.
Assuming that you are a company that builds small automotive parts for two large car manufacturers, GM and Toyota. Both companies use the same part that you are building with a 10 mm difference in diameter.
Due to some reason, you have sent the wrong part to either of the companies. In this situation, the corrective action is to replace the part with each company. The preventive action will help you point out such risks before they happen and make corrections prematurely.
In a preventive action plan, we follow risk-based thinking, also ISO-oriented thinking. So, instead of just reacting to the problems you face, a preventive action plan is about stopping those issues from happening.
Understanding the Corrective Action Plan Steps
Panicking after seeing a problem in the process is not the solution. The right way is to plan your further steps carefully with a focus on ensuring damage control. That said, here are the five steps you must take to implement a corrective action plan in your organization.
1. Identify the Non-Conformities
It is pivotal to describe all non-conformities that may have an influence on a company’s operations while adopting a corrective action process. Managers can establish processes and design activities that will address non-conformities if they thoroughly understand them.
But what is a non-conformity?
Divergence from a certain procedure, standard, declared process, or system requirement is classified as a non-conformity. As you identify and define the non-conformities, it is also essential to know the severity of the problem.
Because then the severity will dictate the further steps in your corrective action plan. Since the very purpose of corrective action solutions is based on a premise, we need first to identify the level of non-conformity.
A major non-conformity, for example, could be an actual or potential issue with the existing system and can give a fatal blow to the management system. A less severe non-conformity could be an isolated situation and not have that much of an impact on other systems.
Some of the most common reasons for non-conformities in any organization are;
- Improper documentation
- Failure to communicate the processes, changes, and procedures effectively.
- Insufficient training material leads to operational issues.
- Obsolete action plans and processes.
- Missing data and information.
While identifying the issues, you must also note that not every problem necessitates a solution. The goal of creating a corrective action plan is to identify and rectify systemic problems that put a company’s quality management system in jeopardy.
2. Define the Scope of the Problem
Continuing ahead from the tasks completed in the first step, you need to define the scope of the problem. In short, you must identify its level. We have touched on this aspect in the previous point, but here are some details on the same.
For the scope of the issue ailing your existing operations and processes, it is pivotal to give context to the size of the problem. Do you see the same issue happening every day? Does it happen with one particular product, service, or type of customer?
Identifying the scope is essential because not every non-conformity needs correction. Creating a corrective action procedure for every small problem will be cumbersome as the employees will be entirely focused on solving the problem, becoming ignorant of the main process.
It hinders their day-to-day responsibilities and leads to a chaotic situation leaving no room for continuous improvement. The same is dictated by ISO 9001:2008 standards.
These standards specify that suitable remedial action must be taken. It continues by stating that when managers are determining what is appropriate, they should think about their behavior. The type and scope of surveillance or they intend to conduct a measurement.
3. Problem Evaluation
With the scope of the issue identified, set up a team that will look at the problem in more detail and responds with an explanation to build a quality corrective action plan.
Members of the team should think about where the information and data came from. They must also obtain or write down a full description of the situation.
Taking action is essential when assessing the situation. We need to think about the ramifications of the difficulty in terms of the company’s risk and its clients and any current threats and a course of action that may be required.
4. What’s the Root Cause?
Next up, we need to understand and identify where the problem first arises. What’s the reason that the assembly line is not functioning as intended why wrong parts were sent to the client, or why did an employee see wrong figures in the datasheet?
Specificity is the keyword here. Whatever the perceived problem, maybe we need to find out the underlying cause. This is similar to a doctor taking different sorts of tests to identify the root cause of abdominal pain.
Identifying the root cause starts with dictating the problem statement, which means you need to describe the issue clearly. That’s why the previous two steps are essential.
The description must be detailed enough to understand the problem precisely and comprehend the underlying cause. Furthermore, the data that backs up the claim must also be simple to understand.
The problem statement may need to be evaluated numerous times before the entire team understands and agrees on the task at hand. The team must then conduct a thorough study into the conditions that led to the problem, known as root cause analysis.
The only way to prevent the problem from reoccurring is to eliminate the main cause. This stage of the process is aided by a variety of problem-solving strategies.
The most common strategy here is creating a corrective action process map, which can be done in either of the two ways;
- Fish Bone
Fish Bone Strategy
The Fishbone diagram follows a holistic approach to conducting the root cause analysis. The diagram has five M’s that are used to categorize the issues and participants of the nonconformity. These 5 MS are;
We can use cause-and-effect diagrams to illustrate essential links between variables and the possible causes. You can conduct brainstorming sessions to figure out the different causes of these categories.
You can set different categories, if required, to complete the fishbone diagram, but these categories will likely fall under the five headings you see above. Some problems might be unique, and for them, you can always set different categories. We can use these causes and reverse engineer them to reach the source of the problem, hence, the root cause.
The 5 Whys strategy can take different roles and be used for troubleshooting, problem-solving, quality control, and improvement. Its usage is limited because the 5 Whys strategy has limited use cases, and it can only help you tackle a linear track of problems.
To implement this methodology in the corrective action plan procedure, start by making a list of the issues you are dealing with or the non-conformities. Writing the problem down at the start of the diagram helps everyone understand the issue.
The first WHY is “Why does the problem occur?” Write the answer below the problem. If the answer you just gave doesn’t identify the root cause of the problem you wrote down, cover the next WHY, but it must be aligned with the first response.
In a similar manner, you need to write down different responses until the final WHY or the root cause is reached. It can take less than or more than five responses to reach the desired conclusion.
Here’s an example.
Problem: The client refused to pay for the order because it arrived late and at that moment it was unusable. The order was delivery of puddings for a wedding.
- WHY was there a delay in the delivery?
Because it took more time than expected to prepare the puddings.
- WHY did it take more time than usual to prepare the puddings?
Because we lacked the main ingredient and it had to be arranged.
- WHY was there a shortage of the main ingredient?
Because it had to be used on another last-minute order.
- Why didn’t we have enough stock of the main ingredient to prepare the last-minute orders?
Now, this is the root cause (lack of enough stock). So, from here on, the team needs to stock enough quantities of the main ingredient to ensure continuity in preparation and order delivery.
Correction action: A preventative action plan would be to contact vendors and suppliers who can fulfill the last-minute stock requirements and keep enough stock of not only the main ingredient but every type of raw material. This way, you will be covered for any challenge in the process.
These two methods are popular ways to identify the root cause. While implementing them, completing the flowcharts with a process workflow solution that further automates the response gathering from different participants will make it convenient and speed up the analysis process.
5. Identify the Escape Point
This is an additional point, and it is not integrated by every organization working on the corrective action process. The point closest to the root cause where the problem could have been noticed is known as an escape point.
In addition to this, you should also know about a control system and a control point. The control system represents the set of procedures used to monitor a product or process and guarantee that it meets quality standards. That said, different types of responsibilities, processes, and resources make up a control system.
Moreover, a control point is a point in the control system where the product/process is examined for quality standards compliance. Within a system, a product or process may have multiple control points.
When you’ve identified the escape route, you can improve or set up a system to ensure that problems don’t go unnoticed. To figure out how the problem got away and where it went, follow these steps.
- Examine the entire process while paying special attention to the point where you have found the root cause.
- Determine if there is a control system already in place to detect the issue.
If there is no control point or system set in place, you need to build a new one from scratch and integrate it into the problem-solving process.
On the other hand, if a control system is already in place, you need to determine which control point is closest to the source of the problem. Secondly, check if that control point was able to identify the problem.
6. Build a Team to Work on the Solution
With the root cause analysis complete, you will know exactly the reason for the nonconformity. The next step is to build a team to work on the solution and rectify the issues and implement damage control measures.
Identifying the root causes and their consequences can aid in the formulation of the best corrective action or actions. There are two important steps in a corrective action plan.
- The first one is the “correction” recommendation itself which will help you eradicate the identified non-conformity immediately.
- The second is the corrective action that helps improve the entire process.
Aside from the nonconformity and the recommended corrective action, detailed data such as the implementation timetable, relevant personnel and signatories, and costs should be supplied or decided before implementing the corrective action plan.
The digital corrective action plan can be shared with relevant persons to standardize information once it has been prepared and evaluated.
You might expect to visualize the impact of the corrective action plan even before it is implemented, but determining the possible impact of an action plan is not easy.
However, a pre-programmed tool with a comprehensive search function can help speed up the discovery process and guarantee that all affected regions are identified, evaluated, and treated.
Once the long-term permanent solution is in place, the team must document all actions completed. It must also have a plan in place to monitor, verify, and assess the efficiency of the solution it has adopted after a certain amount of time has passed.
The team should also take preventative actions (which can be a part of the Corrective and Preventive action plan), such as changing management systems and operations.
The preventive part involves implementing the systems, techniques, and methods to avoid a repeat of this non-conformity and all other difficulties of a similar nature.
7. Following Up on the Implementation Plan
Monitoring and following up on the implementation plan is pivotal to creating a quality corrective action process. Besides the necessity of the same, even the ISO 9001:2015 standards dictate that every corrective action plan must be constantly monitored and evaluated.
The process and quality teams should wait a reasonable period of time after the installation to undertake follow-up reviews. Dedicated personnel can enter comments in the required fields digitally, which are visible to the entire implementation team, and these comments can be used to iterate the action plan further.
A better way would be to use QMS software features like attaching photographs to authenticate further the points and share clearer evidence on the consequences of the actions taken in the corrective plan.
To sum it up, the corrective action procedure ISO 9001:2015 will help the managers and responsible personnel receive feedback on necessary process adjustments as a result of the corrective action process.
As a result, they are able to improve how they address and prevent non-conformities continuously. A planned and meticulous approach to evaluating the effectiveness of a corrective action procedure is required. Data from corrective actions must be simple to access and analyze, with a continuous feedback loop.
Automation of forms-based processes, such as corrective action, promotes compliance and saves time and money for businesses; with automation, regulators, auditors, and other stakeholders’ complaints may be addressed quickly.
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Implementing Corrective and Preventive Action (CAPA) Plan
The CAPA goes one notch higher in the machinery of corrective action processes and helps organizations prevent any sort of problems from happening by addressing all the potential issues in advance.
Implementing the CAPA plan is similar to CAP, with the only difference being that in the former, the preparations and systems take a proactive approach. Any non-conformity that the CAP plan has addressed should not occur again in any part of the organization.
The plan you set to correct the existing problem is widened enough to cover every angle and prevent future occurrences.
CAPA is usually used to address systemic concerns where the same complaint is reported repeatedly. While there is no set rule for when a problem becomes CAPA-worthy, the length of time between complaints and the circumstances surrounding them must be taken into account.
Unless there is a significant danger, a single complaint rarely necessitates a CAPA response. For example, if a customer is gravely harmed, it’s critical to treat the complaint seriously to ensure public safety.
The two most important elements in determining the need for a CAPA are quantity and severity. A severe problem that is only reported once and a minor one that is reported frequently are like two pieces cut from the same cloth, and they don’t require CAPA attention.
How Does Process Tracking Play a Role in Corrective Action Procedure?
Action tracking is integral to completing the corrective action procedure. However, suppose you are using excel sheets or diaries to tell whether all relevant data has been captured—or whether essential action items have been overlooked. In that case, things will get much more complicated before you realize it.
Hence, using a process tracking system is the right way to move forward. A corrective action tracking software solution provides the responsible person with real-time visibility and capabilities to manage actions effectively.
Furthermore, it can substitute for a number of other aspects required to implement the required corrective action. Besides helping implement the corrective action plan, a process tracking system can also help with;
- Drive closure related to audit compliance assurance
- Incident management
- Change management
- Quality management
- Responsible sourcing
- Security management
So, with a process tracking system embedded into the CAP or CAPA, organizations can streamline the workflow and ensure accurate implementation of the required tasks.
An ISO 9001:2015 Certified Corrective Action Plan Template
While building an action plan for corrective measures, the organization needs to work according to the guidelines set by the global ISO standard. The format below will highlight the main elements of the action plan that you must include in the process.
|Introduction||It explains the entire project while naming the stakeholders and parties and the components included in the project.|
|Project Overview||This section highlights the specific details of the project with a focus on daily tasks.|
|Corrective Action Plan – Details||
|Corrective Action Plan – Activities||This section will highlight all the activities and processes undertaken per the plan. So, from reviewing the existing documents to understanding the non-conformities and procedural actions, review, evaluation, and other related activities are elaborated on.|
|Reviewing the Corrective Action Plan||Once the entire solution is implemented, its impact must be measured and recorded. This will help us make the required changes and iterate the plan until we have the intended result.|
|Preventive Steps||The last step in the corrective action process map is about implementing the preventive steps. These steps are required to ensure that the non-conformity for which the plan was created does not manifest again.|
Implementing a corrective action plan can be costly, no doubt about that. But the cost of inaction is much higher than implementing the action plan. In order to minimize unforeseen outcomes that could lead to non-conformities, preventative activities, in particular, must be thoroughly explored and justified, both at the time of implementation and on a regular basis going forward.
The corrective action process is a formal, documented method of solving issues and problems. However, keep in mind that effective, long-term corrective actions necessitate more than just filling out a template; they also necessitate a disciplined, practical execution of the process.
Hence, it would always be in your best interest to build a corrective and preventive action plan for the reason that it covers more ground and has a better chance of making a tangible impact on the organization’s processes.
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