Root cause analysis

Root cause analysis is a problem solving process for conducting an investigation into an identified non-conformity.

What is root cause analysis

Root cause analysis requires the Management Representative to look beyond the solution to the immediate problem and understand the fundamental or underlying cause(s) of the situation and put them right, thereby preventing re-occurrence of the same issue.

This may involve the identification and management of processes, procedures, activities, inactivity, behaviours and/or conditions.

The benefits of comprehensive root cause analysis include:

Identification of permanent solutions
Prevention of recurring failures
Introduction of a logical problem solving process applicable to issues and non-conformities of all sizes

Note

Root cause analysis is a completely separate process to incident management and immediate corrective action, although they are often completed in close proximity.

For example:

You are issued with a Corrective Action Request by Trading Standards which states the sealing arrangements of an instrument are incorrect. It is tempting to jump to the conclusion that the Accredited Person should be retrained. But what led to this happening in the first place? Has the Accredited Person:

Been given the relevant training?
Been kept up to date regarding the sealing requirements of instruments?
Followed your procedures?
Access to the correct Certificate of Approval for the instrument?
Sufficient time to carry out his duties?

Complete root cause analysis

There is no single prescribed method of conducting root cause analysis and any structured approach to identifying the factors that resulted in the non-conformity could be used. Some organisations find different tools work better for different types of situations, for example based on the size or complexity of the incident.

Whichever method of root cause analysis is used it is usually necessary to commence with, and record, the known facts. Depending on the situation these could be listed on Corrective Action Request Part 1 and may include, but not limited to:

What the non-conformity is
When it occurred and when it was discovered
Implicated instrument/processes or equipment, and
Any immediate corrective action completed.

Throughout the process it should be remembered that the key question that root cause analysis is seeking to answer is: What system or process failed so that this problem could occur?

On some occasions the reason is straightforward - ‘Why did this occur?’

‘The documented policy didn’t include the requirement’ or
‘The procedure wasn’t disseminated to the staff’.

In these situations, the subsequent steps of the investigation and action can be planned immediately.

On other occasions the cause is not immediately clear and investigative steps will be required, for example:

Does the Accredited Person understand the procedure?
Does the method laid out in the procedure work if followed precisely?
Does the specified procedure achieve the expected outcome?

In these situations, it is necessary to gather and collate evidence, for example:

Talk to the Accredited Person to establish the level of understanding
Review the method by following it through precisely as written, and
Where appropriate complete new or additional checks to test the process.

Once this information is gathered, it should be possible to draw conclusions or to establish the areas where further focus/questions are required.

Methods of root cause analysis

The ‘5 Whys’

The ‘5 Whys’ is the simplest method for structured root cause analysis.

It is a question asking method used to explore the cause/effect relationships to identify the underlying problem. The Management Representative keeps asking the question ‘Why?’ until a meaningful conclusion(s) is reached.

It is generally suggested that a minimum of five questions need to be asked, although sometimes additional questions are required or useful, as it is important to ensure that the questions continue to be asked until the real cause is identified rather than a partial conclusion.

As previously mentioned it is usually necessary to obtain information or objective evidence at each stage of the process, it is also sometimes necessary to re-phrase a question or make it more specific to obtain meaningful data, for example, instead of simply asking ‘why?’, ask ‘why was the Accredited Person not trained?’ or ‘why did the training process fail?’ or ‘why was the training process not effective on this occasion?’

An alternative is a basic investigation

This type of root cause analysis is a causal process, it seeks to understand the possible causes by asking ‘what actually happened?’, ‘When?’, ‘Where?’ ‘Why?’, ‘How?’ and ‘So-what?’ in other words a possible cause is identified, and the consequences and significance is investigated.

For example:

What happened? - Procedure was not followed correctly
Why? - Accredited Person was untrained in the procedure
When? - Monday morning
Where? - Remote site
How? - Staff shortages
So what? (i.e. is this important?) - The incorrect approval could be referenced if the procedure is not followed correctly. Training processes have not been followed correctly.

Unmanageable conclusions

The root cause should be something that can be managed or changed, which means that it normally relates to a system or process and occasionally an alterable behaviour. For example, it is often tempting to reach a conclusion, such as ‘they forgot’, ‘not enough time’, ‘not enough money’, ‘not enough staff’, ‘staff sickness’ or ‘made a mistake’, these answers may be true, but in most cases they are out of our control, whereas root cause analysis should lead to controllable, manageable or adjustable processes. If these answers are evident, it is worth going back into the process to establish whether there is any other cause, for example by asking specific questions such as, ‘Why did the process fail?’ or ‘What system allowed the mistake to be made?’

For example:

Find below an ‘incorrect’ and ‘correct’ method of assessing when an internal audit of an Accredited Person scheduled for January had not been carried out. The details of the non-conformity, the corrective action taken, the root cause analysis and proposed action plan, are shown in the table below.

Examples	For example: Details of Non-conformity	Corrective action taken	Root cause analysis and Proposed Action Plan
Incorrect	Internal audit of Accredited Person scheduled for January had not been carried out.	Audit completed. All scheduled audits completed and up to date.	Root Cause: Lack of resource in technical department due to long term sickness. Proposed Action Plan: Resource issues to be discussed in monthly management review.
Correct	Internal audit of Accredited Person scheduled for January had not been carried out.	Audit completed. All scheduled audits completed and up to date.	Root Cause: Procedures didn’t recognise the need for deputies and therefore no alternative staff had the appropriate qualifications/training when key staff were on long term sickness. Proposed Action Plan: Internal audit process/policy updated to incorporate deputies. The size of the internal audit team will be increased to include sufficient deputies. These staff will be trained, as appropriate, for the systems to be audited. The Quality Management System will be updated to reflect these changes.

Examples

For example: Details of Non-conformity

Corrective action taken

Root cause analysis and Proposed Action Plan

Incorrect

Internal audit of Accredited Person scheduled for January had not been carried out.

Audit completed.

All scheduled audits completed and up to date.

Root Cause: Lack of resource in technical department due to long term sickness.

Proposed Action Plan: Resource issues to be discussed in monthly management review.

Correct

Internal audit of Accredited Person scheduled for January had not been carried out.

Audit completed.

All scheduled audits completed and up to date.

Root Cause: Procedures didn’t recognise the need for deputies and therefore no alternative staff had the appropriate qualifications/training when key staff were on long term sickness.

Proposed Action Plan: Internal audit process/policy updated to incorporate deputies. The size of the internal audit team will be increased to include sufficient deputies. These staff will be trained, as appropriate, for the systems to be audited. The Quality Management System will be updated to reflect these changes.

This example again highlights that in practice there may be more than one cause (no deputies, out of date policy and a lack of training) and therefore the proposed corrective action plan may require multiple actions.

Where the root causes are identified, the organisation will decide what actions will be implemented to solve the non-compliance(s) and avoid reoccurrence. The detail of each action and timeline must be recorded on the Corrective Action Request Part 2.

Once the corrective action plan and a timeline of compliance is agreed with Client Manager, remedy the cause of the non-compliance by ensuring that corrective action is taken and is effective.

The Management Representative must follow up and record that the Corrective Action Request was actioned and effective on the organisation corrective action form for each action implemented.

Note

The organisation corrective action form has been created by the accredited organisation, as part of the Quality Management System.

Once the organisation corrective action form has been completed and monitored, the completed documentation is sent to the Client Manager.