ISO 9001 - Clause 10.2: Corrective Action Explained [with Procedure] (2024)

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 until lasting corrective actions involve it.

Establish An Investigation Team, with:

• 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

Select an Interim Containment Action

An interim containment corrective action request is kept in place until a verified permanent corrective action can be implemented. In some cases, the interim containment corrective corrective and preventive action definition may be the same as or similar to the emergency response corrective action grew.

However, an emergency response action is implemented with minimal supporting data. An interim containment action provides more opportunity for investigation.

Verify the Interim Containment Action

Any interim containment or corrective action plan you initiate 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 more than one interim containment action to fully protect the customer.

An interim containment action can be any corrective action that protects the customer from the problem. However, before you initiate 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
• Assurance that the interim containment action did not introduce a new problem

Conduct trial runs whenever possible. However, in some situations, your verification may simply be a matter of common sense.

For example, if an employee or interim employee or containment action involves stopping the shipment of all products, you can be sure that customers and employees will stop experiencing the problem.

You and your team must consider all of the trade-offs connected to your interim containment action. An important part of implementing an interim containment and action plan is planning how you will implement the cost effective action.

To deploy an interim containment action, follow up this management cycle:

• Plan (Re-plan)
• Do (Implement)
• Check (Monitor)
• Act (Evaluate)

Identify the Cause of the Problem

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).

Complete a Comparative Analysis

The problem description should describe the problems in terms of what, where, when, and how big. The description should contain facts; essential information such as observations and documentary documentation as evidence and not assumptions. All information must be gathered before formal process of identifying the 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 other team member may have gathered since completing the initial problem description.

Once you have reviewed the problem description, begin a comparative risk analysis first. 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 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 evaluation 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.

Develop Root-cause Theories

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.

Verify the Root-Cause

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

Determine and Verify the Escape Point

As part of the root-cause analysis process, you need to determine the escape point of the problem for the corrective action process. An escape point is the point closest to the cause at which the problem could have been detected but was not.

A control system is a system deployed to monitor the product/process and ensure compliance to the organization's processes and quality management requirements. A control system consists of responsibilities, procedures, and resources.

A control point is a location within the control system at which the product/process is checked forcompliance to the quality and performance standards used.

A product or process may have more than one control point within the system. When you can identify problems at the escape point, you can work to improve or establish a system to ensure that if problems occur, they will not go undetected.

To understand how the problem escaped and to identify the escape point:

• Review the process; focus on the part of the process where the problem occurred
• Determine if a control system exists to detect the problem

If none exists, the development of a new control system must be considered as part of the whole problem solving and solution. If a control system currently exists:

• Identify the control point closest to the cause
• Determine if the control point is capable of detecting the problem

If the control system is not capable, the development of an improved system must be part of corrective action process for the problem solving solution. If the control point is capable of detecting the next problem solving itself, then the control point is the verified escape point. Choose and verify permanent corrective actions for the and the escape point.

Select the best permanent corrective action to remove or eliminate the cause and select the best permanent corrective action to eliminate the escape point. Verify that both decisions will be successful when implemented without causing undesirable effects.

Steps for permanent corrective actions (PCA) selection:

• Establish decision criteria, e.g. what is feasible
• Identify possible actions
• Choose the most appropriate permanent corrective action (PCA)
• Test and verify the permanent corrective action
• Re-evaluate the ICA & PCA for the escape point

Corrective Action Plan - Prevent Recurrence

Modify the necessary systems, policies, federal regulations, which require corrective actions and preventive actions, practices and procedures to prevent recurrence of this problem and similar ones.

Implement & Validate Permanent Corrective Actions

Plan and deploy selected permanent, corrective measures and actions. Remove the interim containment action and monitor the long-term results of implementing corrective action. Steps for implementing permanent corrective actions:

• Develop an action plan for the permanent corrective actions
• Implement the permanent corrective action plan
• Remove the interim containment action
• Evaluate the permanent corrective action for the escape point
• Perform validation
• 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
• Undertake root cause analysis
• 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 corrective and preventive actions and their effectiveness
• Develop action plan
• Implement preventive action
• Present systemic preventive action recommendations to the process owner.

Serious consequences may occur when the underlying symptoms are not addressed, when the quick fix is accepted as a final, permanent solution. Excessive reliance on containment or emergency response action will create a repeating cycle. Problem containment is an addiction that will only get worse until root-causes of unacceptable behavior or performance are found and addressed.

Related Information You Might Find Useful

• 10.2 Nonconformity in ISO 9001
• 10.2 What is Non-conformance?
• ISO 45001 — 10.2 Nonconformity and Corrective Action
• Video — ISO 9001:2015 Clause 10.2 Corrective Action Reporting Simplified

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