Corrective Action

Corrective actions (CARs) are a way to make the problem go away. In addition, they can also teach your company how to improve your manufacturing processes. In that way, they are at the heart of a continuous improvement program.

As ISO 9001:2015 made clear, the priority is to prevent problems, but if that fails, corrective action is the next best thing. Corrective action is defined as “action to eliminate the cause of a nonconformity and to prevent its recurrence,” according to ISO.  While the terminology has changed in the ISO 9001:2015 standard—preventive action is now known as risks and opportunities—the idea has not.

Though the ISO 9001:2015 version did make changes regarding corrective and preventive action, the requirements have not disappeared. Despite these changes, the theory behind them holds true. If it’s not possible to prevent a problem—always the ideal method—then at least the solution should address how to avoid it in the future.

A nonconformity, as stated by ISO, would be any failure to meet a requirement. This could be a requirement from a customer, regulatory body, ISO, or your organization. Audits, whether internal or external, will uncover these issues. Keep in mind that audits are there to improve an organization and lead the way to a better version of the company, so addressing any nonconformities is a necessary step on the road to improvement.

React to the nonconformity and take action to control and correct it; deal with the consequences?

 Evaluate the need for action to eliminate the causes of the non-conformity so that it does not recur or occur elsewhere by: reviewing and analyzing the nonconformity; determining the causes of the nonconformity; determining if similar nonconformities exist or could potentially occur?

• Implement any action needed?

• Review the effectiveness of corrective action taken?

• Update risks and opportunities determined during planning?

• Make changes to the QMS?”

Ultimately, corrective actions should be a satisfying way to get something out of a problem. Knowing that you won’t have to face the same issue again—or at least that’s the idea—should be a relief. To ensure that your corrective action process is robust, ISO requires organizations to review the effectiveness of actions taken. For example, this could take the form of a meeting or just a follow-up with those involved. Continual improvement takes work, and it also takes corrective action.

The following steps will help you create a corrective action process:

• Define the Problem

• Establish an investigation team

• Select an Interim Containment Action

• Verify the Interim Containment Action

• Identify the Root-Cause

• Complete a Comparative Analysis

• Develop Root-cause Theories

• Verify the Root-Cause

• Determine and Verify the Escape Point

• Implement & Validate Permanent Corrective Actions

• Preventing Recurrence

• Define the Problem

Describe the internal/external customer problem by identifying what is wrong and detail the problem in quantifiable terms Define, verify and implement the interim containment action to isolate the effects of the problem from any internal/external customer until permanent corrective actions (PCA) are implemented. Validate the effectiveness of the containment actions.

 · Process and/or product knowledge

· Allocated time

· Authority to solve the problem and implement corrective actions

· Skill in the required technical disciplines

· A designated Team Leader

· Contain The Problem

  An interim containment action is kept in place until a verified permanent corrective action can be implemented. In some cases, the interim containment action may be the same as or similar to the emergency response action. However, an emergency response action is implemented with minimal supporting data. An interim containment action provides more opportunity for investigation. 

  Any interim containment action you implement must protect the customer from the problem without the introduction any new problems. Also, a single interim containment action may not be enough. You may need to implement more than one interim containment action to fully protect the customer. An interim containment action can be any action that protects the customer from the problem. However, before you implement an interim containment action, you need to verify that the interim containment action will work. To verify the interim containment action:· Prove before implementation it protects the customer from the problem· Provide a before-and-after comparison· Prove that the interim containment action will not introduce any new problems. Methods of verification may include:· A test to determine the desired performance level· A demonstration that changes eliminated the issue without creating a new problem· A comparison between the interim containment action and similar proven actions· A review to evaluate whether the interim containment action was effective to implement an interim containment action, follow this management cycle:

Plan (Re-plan)

Do (Implement)

Check (Monitor)

Act (Evaluate)’ 

  Isolate and verify the root-cause by testing each possible cause against the problem description and test data. Also isolate and verify the place in the process where the effect of the root-cause should have been detected and contained (escape point).

The problem description should describe the problems in terms of what, where, when, and how big. The description should contain facts; such as observations and documentary evidence and not assumptions. All information must be gathered before identifying the root-cause can begin. Make sure both of the above factors are true before you move to the next step. Consider any new information that the team may have gathered since completing the initial problem description.

Once you have reviewed the problem description, you can begin a comparative analysis. A comparative analysis will help you identify relevant changes in a change-induced situation. Then you can reduce the number of possibilities that you must consider to determine root-cause.

To complete a comparative analysis:

· Ask yourself; what is unique, peculiar, different, or unusual about the symptoms?

· Consider features such as people, processes, materials, machines and the environment

· List all facts without prejudice as to the possible cause

· Consider each difference you listed, and look for changes, ask yourself:

· What has changed to give rise to this difference?

· Keep in mind that each difference may not have a corresponding change

· List the changes next to the difference

· Look at the dates each change occurred

· Eliminate some changes if they occurred after the problem started

· Consider categories of people, machines, processes or measurements

If the problem is change-induced, the root-cause must be the result of a change relative to one or more of the identified changes. It is important to remember that you have not yet moved from the ‘observations’ phase of the process. Any information you develop during the comparative analysis must be fact based, not opinion based and must be true only for the symptoms information. Do not rule out any facts that might be valid answers. If it is a fact and it answers the question, write it down.

  Now that you have narrowed down the possible root-causes, you need to develop theories about how the problem occurred. Theories are statements that describe how a change may have created the problem. To develop root-cause theories

· Use brainstorming techniques to generate ideas

· Ask: ‘how could this change have caused the problem?’

· Continue to ask the question until all possible theories are developed

· List at least one theory for each change

· List each theory individually on a worksheet

· List every possibility, no matter how strange or unlikely

· Don't reject or qualify any theory

· Start with the simplest single change theory first

· Then work up to more complex theories

· Be specific; don't use generalities such as ‘poor quality’ or ‘doesn't work’

· Test the Theories

· Ask, ‘Does this theory explain the symptoms and data, if so how?’

· Test the theory against each individual condition

If a theory explains the problem, but lacks information necessary to explain why it happened, gather more data:

· Gather more data to prove or disprove these theories

· Test simple (single change) theories first

· Test highly complex or interactive theories last.

The root-cause must explain all known data. Any theories that pass the trial run are the most likely causes. If only one theory passes the trial run then verify this theory as the root-cause. However, more than one theory may pass the trial run. In those cases (and when practical and feasible), collect and analyze any missing data for uncertain theories and re-examine information to resolve uncertainties.

If additional information reveals that a theory cannot fully explain why the problem happened eliminate it from consideration. If it is not feasible to gather and evaluate additional information, try to verify each remaining theory. Start verification with the theory that best explains the symptoms.

Once you have determined the most likely cause(s), verify that it actually causes the problem. Verification is the proof you need to confirm that you have identified the root-cause. Verification is done passively and actively. Passive verification is done by observation:

• Look for the presence of the root-cause without changing anything

• If you cannot prove root-cause, then the identified cause is not the root-cause

• Active verification is done by manipulating the root-cause variable:

• Implement and remove the root-cause variable to make the problem ‘come and go’

• Both ‘coming’ and ‘going’ are essential tests to confirm the root-cause

• There can be more than one verified root-cause

• Implement & Validate Permanent Corrective Actions

Plan and implement selected permanent corrective actions. Remove the interim containment action and monitor the long-term results. 

Confirm with the customer that the symptom has been eliminated

Make recommendations for systemic improvements as necessary:

• Review the history of the problem

• Analyze how the problem occurred and escaped

• Identify affected parties

• Identify opportunities for similar problems to occur and escape

• Identify practices and procedures that allowed the problem to occur

• Identify practices/procedures that allowed the problem to escape to the customer

• Analyze how similar problems could be addressed

• Identify and choose appropriate preventive actions

• Verify preventive action and its effectiveness

• Develop action plan

• Implement preventive actions

• Present systemic preventive recommendations to the process owner.