Quality

Management
System Guidance
Root-cause Analysis & Corrective Action
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Quality Management System Guidance
Root-cause Analysis & Corrective Action

Table of Contents
1 Root-Cause Analysis & Corrective Action ............................................................................................. 2

1.4.2.1 Root-causes .................................................................................................................................. 8

1.4.2.2 Immediate Causes .................................................................................................................... 10
1.4.2.3 Contributing Causes .................................................................................................................. 10
1.4.2.4 Peripheral Causes ...................................................................................................................... 10
1.4.2.5 Systemic Cause .......................................................................................................................... 10

1.4.3.1 Essential Elements of the 5-Whys ............................................................................................. 10

1.4.3.2 How to Use the 5-Whys.............................................................................................................. 11
1.4.3.3 Mastering the 5-Whys ................................................................................................................ 11

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Quality Management System Guidance
Root-cause Analysis & Corrective Action

1 Root-Cause Analysis & Corrective Action

There is a clear link between ISO 9001:2015 Clause 8.7 Non-conforming Outputs and Clause 10.2 Non-
conformity and Corrective Action, this guidance document provides a 6-step methodology for meeting the
requirements in each of these clauses. These clauses state the requirements for the occurrence of a non-
conformity and include actions to prevent a similar non-conformity or problems occurring.

Your organization is required to take whatever

Identify the
action is necessary to control and correct the problem
non-conformity, and to deal with any resulting
impact by determining what caused the non-
conformity and considering whether the Monitor
Define the
effectiveness
problem
potential for a similar problem remains. of actions

This is done by considering whether any further Root-cause

action is required to prevent a similar non-
Analysis
conformity arising at the same place or
Process
occurring somewhere else, at some point in the
future and by determining if similar non- Implement
Understand
conformities have occurred elsewhere; and Corrective
the problem
Actions
consequently, whether it needs to take similar
corrective action.
Identify the
Taking appropriate action to address the root-cause
effects of the problem may require a simple
correction by the process owner or operator where it was discovered, or, if a major failure or defect exists, more
significant levels of resource would be needed for problem solving and corrective action.

There may be instances where it is impossible to completely eliminate the cause of the non-conformity, so in
these instances, the best you can do is to reduce the likelihood or the consequences of a similar problem
happening again in order to reduce the risk to an acceptable level.

Any non-conformities and subsequent actions to prevent their reoccurrence and the effectiveness of the
corrective action(s), should be duly documented and retained. Therefore, consideration should be given to the
development and use of the Corrective Action Log to capture this information.

The following guidelines are for completing root-cause analysis and corrective action responses to audit non-
conformity reports (NCRs). However, these guidelines should also be applied to corrective action responses
from other sources (customer complaints, internal defects, etc.)

Identify the Problem

Once a problem has been identified through inspection, customer complaints, or audit results, it should be
captured using non-conformity reports (NCRs) or corrective action reports (CARs) in order to identify who is
affected by the problem and what the impact is. Considering the following:

1. What are the operations, products, materials, defects, malfunctions that may characterise the
problem? What is it about?

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Quality Management System Guidance
Root-cause Analysis & Corrective Action

2. Who is concerned with the problem? Who is reporting the problem? Who is rectifying the problem?
Who is the problem affecting?
3. Where are all the places where the event takes place; shop floor, services, machine, process step?
4. Where is it seen? Where does it originate?
5. When does the event appear (time, date, when does it start, how long does it last, how often)
6. When is the problem reported defective? When is the problem repaired?
7. Has it occurred before? If yes, what is the history?
8. How do we know there’s a problem (how is it detected)?
9. How does the event appear, how does it stop?
10. How frequently is the problem experienced?
11. How is the effect of the problem being measured (costs, delays, scrap rate, customer complaints,
return rate, concessions, reliability rate, etc)?
12. How is the problem currently addressed? How is it corrected?
This step helps to fully describe a situation, precisely analyse all its elements and gain a common understanding
of them, allowing the definition of an action plan. Ensure that all team members agree about the definition of
the issue and resulting impact.

Define the Problem

Generate a Problem Description
The problem description should describe the problems in terms of what, where, when, and how big. On a flip
chart, presentation board, or even paper; write out a description of what you know about the problem. Try to
document the problem and describe it as completely as possible.

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.

Describe the 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.

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:

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

2. Continue to ask the question until all possible theories are developed;
3. List at least one theory for each change;
4. List each theory individually on a worksheet;
5. List every possibility, no matter how strange or unlikely;
6. Don't reject or qualify any theory;
7. Start with the simplest single change theory first, then work up to more complex theories.
Note: Be specific; don't use generalities such as ‘poor quality’ or ‘doesn't work’.

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Quality Management System Guidance
Root-cause Analysis & Corrective Action

Establish a Response Team

Identify representatives from functions that may have an influence on the corrective action process, including
the identification of the root causes. Remember to assign responsibilities and objectives to the team members.
Remember, those performing the job, such as operators, inspectors, drivers, etc., are the best people to help
identify the real causes, don’t leave them out of the team!
The size and composition of the team should depend on the complexity and the impact of the problem. The
composition of the team is not fixed forever and may evolve depending on the analysis results and the required
actions. New team members should join the team if analysis shows they are identified as being in the scope,
some others will leave if their area is definitely identified as out of the scope.
However, consideration should be made that expending the size of the core team over 6 to 8 members
generally results in less efficiency. When more members or special skills are required, sub teams should be
considered. Don’t forget, root-cause analysis must not be used for assigning blame or transferring
responsibility. In summary, you should establish an investigation team with:
1. Process and/or product knowledge;
2. Allocated time and resources;
3. Authority to solve the problem and implement corrective actions;
4. Skill in the required technical disciplines;
5. A designated Team Leader.
Brainstorming sessions should be used to identify potential causes to investigate each potential cause.
Coordinate parallel activities with different team members to help expedite the process of verification.

Effective Communication
Continual communication between all team members is mandatory, for instance trough regular reviews until
root-cause are clearly identified and agreed by all. Inside the organization where the problem originated,
between all actors of the supply chain to ensure effective root-cause analysis and definitive corrective action
implementation.

A team leader needs to know that he has been chosen and why he has been assigned this role, along with a
description of the team’s objectives and constraints, while each team member needs to understand his role
and objectives. The line managers of each team member need to know each members’ level of involvement,
e.g. their time, duration, and role. All stake-holders must be informed of the team’s composition and objectives.

Root-causes must be communicated to all stake-holders and agreed, especially by the customer when he is
impacted. Communication internally and between various tier levels and between the supplier and customer
to immediately stop the problem getting worse, ensure full understanding of the problem and verify that
implemented solutions are satisfactory.

Understand the Problem

Comparative Analysis
Once you have reviewed the problem description, you can undertake 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:

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