Understanding Root Cause Analysis

BRC Global Standards

6/1/2012
Contents
1. What is Root Cause Analysis? ................................................................................................... 1
2. Where in the Standard is RCA Required?................................................................................ 3
3. How to Complete Root Cause Analysis?.................................................................................. 3
4. Methods of Root Cause Analysis ............................................................................................... 5
4.1 The ‘5 Whys’:.............................................................................................................................. 5
4.2 Fishbone Diagrams: .................................................................................................................. 7
5. Common Mistakes ....................................................................................................................... 9
5.1 Unmanageable Conclusions .................................................................................................... 9
5.2 Duplication of the Immediate Corrective Action .................................................................. 10
5.3 People ....................................................................................................................................... 11
5.4 Proposed Action Plan Doesn’t Prevent Re-occurrence ..................................................... 12
5.5 Extra Checks ............................................................................................................................ 14
6. Preventative Action .................................................................................................................... 14
7. Additional Documentation ......................................................................................................... 15
8. Glossary of Terms ...................................................................................................................... 15
9. Appendices .................................................................................................................................. 16
9.1 Inclusion of Root Cause Analysis in the Audit Report ....................................................... 16
9.2 ‘5 Whys’ Route Cause Analysis Template ........................................................................... 18
9.3 Fishbone Diagram Template.................................................................................................. 19

1. What is Root Cause Analysis?

Root cause analysis is a problem solving process for conducting an investigation into an
identified incident, problem, concern or non-conformity. Root cause analysis is a completely
separate process to incident management and immediate corrective action, although they are
often completed in close proximity.

Root cause analysis (RCA) requires the investigator(s) 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 or
conditions.

The benefits of comprehensive root cause analysis include:

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

Steps to Root Cause Analysis

Step 1
Define the Non-Conformity

Step 2
Investigate the Root Cause

Step 3
Create Proposed Action Plan & Define Timescales

Step 4
Implement Proposed Action

Step 5
Verification & Monitoring of Effectiveness

It should be noted that this is a simplified process flow, which is typical of the majority of
situations required by the BRC Standards. However, for a complex non-conformity, such as a
serious incident involving a microbiological outbreak, root cause analysis will become
proportionally more detailed, require extra activities and can require considerable time. For
example, some or all of the following steps may be required:

 Establish a root cause team to investigate the issue

 Compilation of a summary of the event or non-conformity (ie a summary of what was
wrong)
 Confirmation of the sequence of events (for example if a customer illness, led to
product analysis, which subsequently led to a raw material investigation then the
dates and results of each step may provide useful information)
 List of dates/times (for example when the non-conformity was discovered and when
the last acceptable monitoring result of the implicated process was obtained)
 A list of implicated products/ingredients (raw materials) or processes
 A summary of any incident management or immediate corrective action that has
been completed
 Any other relevant data or information (for example records, test results, information
from staff in the relevant area or complaints)

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  Collation of all available information
 Investigation of possible scenarios & collation of information (for example this may
include product or environmental testing or liaison with technical experts and
regulatory authorities).

2. Where in the Standard is RCA Required?

An important part of any non-conformity management is the identification of the root cause
and the implementation of suitable action. There are a number of requirements in the BRC
Standards for root cause analysis:

Food Standard Issue 6:

Clause Requirement
Senior management to ensure the root cause of audit non-
1.1.10 conformities have been effectively addressed to prevent
recurrence.
Identification of the root cause of non-conforming products and
3.7.1
implementation of any necessary corrective action.
Root cause analysis and associated actions relating to customer
3.10.1
complaints.
Audit
Following an audit, the root cause of non-conformities shall be
Protocol
identified and an action plan to correct this, including timescales,
9.2 &
must be provided to the Certification Body.
9.2.2
Consumer Products Standard Issue 3
Review of risk assessment and evaluation of complaints /
2.4.2
incidents
3.7.4 Corrective actions and prevention of re-occurrence
3.12.4 Analysis of complaint data
Packaging Standard (Issue 4)
There are no requirements for root cause analysis in the
Packaging Standard, but sites are required to state “corrective
action taken (with consideration of root cause)” in the audit
report.

3. How to 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, many
tools and methods have therefore been published (two popular methods are highlighted
below). The choice of root cause methodology may be a matter of personal choice, company
policy or dependent on the type of issue/non-conformity being investigated. Some companies

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find different tools work better for different types situations, for example based on the size or
complexity of the incident or the type/source of data.

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 may include:

 What the non-conformity is

 When it occurred and when it was discovered
 Implicated products/processes
 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 trained to 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 operator understand the procedure?

 Does the method laid out in the policy work if followed precisely?
 Does the specified time/temperature achieve the expected outcome?

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

 Talk to the operator to establish the level of understanding

 Take the method into the appropriate factory area and follow it through precisely as
written
 Review the original shelf life or processing data
 Where appropriate complete new or additional tests (for example on raw materials,
final product, factory environment or the process)

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

Once the underlying cause has been established, the next stage of the process is to
establish a proposed action plan, indicating the action that will be taken to prevent the non-
conformity recurring. The action plan should include a defined timescale in which the action
will be completed and define who is responsible for completion.

An important final step of an effective root cause analysis is to consider monitoring or

verification activity. This is necessary to ensure that the changes to (or new) activity or

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procedures is fully operational, that it is effective in managing the root cause and that it does
not inadvertently introduce any additional problems. Example activities could include:

 Internal audits covering the new process

 Check sheets to be completed at the time of the changed process
 Line start up checks
 Investment in new technology
 End of production/shift countersigning by production or line manager

Once it is demonstrated that an action is fully embedded and effective, a review can
consider whether the additional monitoring is still required or can be reduced to a lower
frequency.

4. Methods of Root Cause Analysis

4.1 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 underlying the
problem. The investigator keeps asking the question ‘Why?’ until meaningful conclusions are
reached.

Root
Why? Why? Why? Why? Why? Cause

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 operator not trained?’ or ‘why did the training process fail?’ or ‘why was the
training process not effective on this occasion?’

An example of root cause analysis using the ‘5 Whys’:

An operator is instructed to perform a simple action ‘weigh out ingredient A’, however the
operator inadvertently used ingredient B instead.

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An immediate reaction will probably suggest this was caused by an operator error. Whilst this
may be accurate, it does not establish the reason why the error occurred or prevent it
happening in future. The root cause analysis must ask a series of ‘Why?’ questions (and
obtain answers), for example:

In this example it would be easy for the investigator to stop the analysis part way through
thinking that all the conclusions had been reached (ie that this was purely a training issue),
however, the further questions reveal useful information about the nature of the cause and
therefore the appropriate action.

The issue actually had a number of causes that contributed to the incident:

 Incomplete training procedure

 A faulty cleaning process
 Lack of post-cleaning check procedures

Proposed action can now be planned, for example:

 Update training procedure to ensure sign off (& possibly a supervision step)
 Replace ingredient labels – if practical with ones that cannot be removed.
 If labels must occasionally be removed, ensure that post cleaning line checks include

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 a check of labels.
 Ensure an individual (eg the production manager) is authorised and responsible for
post-cleaning line sign off.
 Ensure cleaning staff fully understand and are trained in the need to return labelling
(and all equipment) in a fully operational state.

4.2 Fishbone Diagrams:

A second commonly used method of root cause analysis, is the use of fishbone diagrams
(sometimes referred to a Ishikawa models or Herringbone diagrams). They are most useful
when the ‘5 whys’ is too basic, for example, where a complex issue needs to be considered
in bite size pieces or where there is a lot of data that needs to be trended.

In the diagram, the various causes are grouped into categories (such as equipment,
materials or processes) and the arrows in the image indicate how the causes cascade or flow
toward the non-conformity.

The categories are not pre-defined but common ones include:

 Equipment – this should include consideration of all equipment that could have a role
in the non-conformity, for example, production line, facilities, computers or tools
 Processes or Methods – how work is performed, policies, procedures, rules or work
instructions
 Measurements – any data collection or measurement, either from a process or
subsequent to the non-conformity, for example metal detection records, check
weights or final product analysis
 Materials – any information relating to raw materials or final products, for example raw
material specification or goods receipt checks for a specific batch of ingredient.
 Environment – The location, time, temperature, culture, standards of cleanliness or
available time, for an activity.
 People – Any role involved in the implicated process.

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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 each of the group categories.

For example:

 What happened? - Procedure was not followed correctly

 Why? - Staff member was untrained in the procedure
 When? - Monday morning
 Where? - Line 2
 How? - Staff shortages
 So what? (ie is this important) - The safety of the product could be implicated if the
procedure is not followed correctly. Training processes have not been followed
correctly.

As with the ‘5 Whys’ it is important to initially investigate the cause and then examine the
cause of the cause to ensure the root cause has been correctly identified (fishbone diagrams
sometimes refer to this as examining primary and secondary causes).

Example of root cause analysis using the Fishbone Diagram:

Using the same scenario as for the ‘5 Whys?’ in which an operator is instructed to perform a
simple action ‘weigh out ingredient A’, however inadvertently uses ingredient B. The causes
would be tabulated as discovered and proposed action developed:

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 5. Common Mistakes

To help users avoid a number of common mistakes, which are known to hinder the formation
of quality proposed action plans, an explanation of each mistake given below. This
explanation includes an example of the incorrect approach (indicated by an ‘X’), which is
immediately followed by the same non-conformity being accurately investigated, leading to a
better proposed action plan (indicated by a ‘’).

5.1 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:

Corrective action Root cause analysis and

Details of Non-conformity
taken proposed action plan (PAP)
Root Cause: Lack of resource in
Internal audit of supplier Audit completed.
technical department due to long
 management systems scheduled
for January had not been carried
All scheduled audits
completed and up to
term sickness.
out. date.
PAP: Resource issues to be
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 discussed in monthly management
review.
Root Cause: Procedures didn’t
recognise the need for deputies
and therefore no alternative staff
had the appropriate
qualifications/training when key
Internal audit of supplier Audit completed. staff were on long term sickness.
management systems scheduled All scheduled audits

for January had not been carried completed and up to PAP: Internal audit process/policy
out. date. 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.

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.

5.2 Duplication of the Immediate Corrective Action

It is important that immediate action is taken to correct a non-conformity. However, this is

separate from the root cause analysis and proposed action plan. The purpose of root cause
analysis is to look beyond the immediate non-conformity, to investigate what system or
process allowed the non-conformity to occur. Once this is established, the proposed action
plan can focus on ensuring that the system or process is amended such that the fault cannot
occur in future. Therefore the proposed action plan should not be a repeat of the immediate
corrective action.

For example:

Corrective action Root cause analysis and

Details of Non-conformity
taken proposed action plan (PAP)
Acceptance and rejection criteria
Acceptance and
have not been defined for Root Cause: Requirement not
rejection criteria defined
calibrated devices. documented.
and documented.
 Therefore the actions to take, if
Actions in case of an
Action Plan: Calibration procedure
the device is incorrect or out of has been updated and information
out of calibration device
calibration range were not added.
documented.
defined.
Acceptance and rejection criteria Acceptance and Root Cause: Neither HACCP
have not been defined for rejection criteria defined procedures, calibration procedure

 calibrated devices.

Therefore the actions to take, if

and documented.

Actions in case of an
nor installation policies
documented the need to define
these criteria before use of new
the device is incorrect or out of out of calibration device equipment.
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 calibration range were not documented.
defined. PAP: HACCP procedures reviewed
and updated to ensure that all
steps are documented and the
requirement to validate any
changes to CCPs is documented in
the policy.
Policies regarding the purchase
and installation of new equipment
also updated to reflect requirement.
All relevant staff (HACCP team and
production managers) trained in
new requirements

5.3 People

It is sometimes tempting to reach a conclusion such as; ‘oversight’, ‘mis-understood’, or

‘forgot’, however people are rarely the true root cause and the investigator will need to
establish what system, policy or process allowed the human error to occur.

For example:

Corrective action Root cause analysis and

Details of Non-conformity
taken proposed action plan (PAP)
Training completed on
CCP control records were not Root Cause: Inexperience
 signed by the person completing
the monitoring.
the correct completion
of monitoring sheets
PAP: Raise staff awareness.
and their importance.
Root Cause: Effectiveness of
training for newest members of
staff was not assessed. CCP
worksheets were not checked by
either technical team or internal
audits. (The reason for this should
also be subject to root cause
Re-training designed
analysis)
using a number of
worksheets where staff
PAP: Examples of correctly
CCP control records were not were asked to identify
 signed by the person completing
the monitoring.
‘good and bad’ records
(ie those that were
completed, annotated CCP
worksheet included in work
instructions (copies of which are
completed correctly and
available in production areas).
those that had missing
Specific checks on CCP monitoring
information)
added to the internal audit
schedule.

Verification: Line or production

manager to countersign CCP
record sheets at end of
shift/production.

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 In a few situations where individuals are the root cause, for example, a site new to
certification could, during its first audit, discover it has mis-understood a clause of the
Standard, there will often be a need for additional training or methods to gain experience or
competence (for example attending additional training, using an experienced consultant, etc)

Where re-training is considered to be a necessary part of the proposed action plan,

consideration should be given to the format of the training. If the initial training was not
effective then just repeating the same ineffective training, is unlikely to achieve the desired
effects. Consider for example; the use of workshop or example based activity, use of pilot
plant (where available), work-based training such as observing an experienced colleague,
use of external training providers, language in which the training is provided, etc.

Throughout the process it must be noted that root cause analysis is not designed to
establish who is to blame for a non-conformity, but to correct the underlying cause and
prevent re-occurrence.

5.4 Proposed Action Plan Doesn’t Prevent Re-occurrence

Occasionally, despite root cause analysis and the implementation of a proposed action plan
the non-conformity re-occurs. There are a number of potential reasons why this might
happen, including:

 Incomplete initial root cause analysis

 Incorrect root cause conclusions (ie the true root cause was not established)
 Multiple root causes (the proposed action plan needs to manage every root cause)
 Proposed action plan not fully implemented or trained to staff

In these situations it may be necessary to re-visit the root cause analysis and identify
additional causes and appropriate controls.

Example 1:

Corrective action Root cause analysis and

Details of Non-conformity
taken proposed action plan (PAP)
The company procedure states
that weekly production meetings
Root Cause: Weekly meeting not
are held to verify the
 effectiveness of the HACCP plan.
However, there is no evidence
Procedure changed to
monthly meetings.
sustainable

PAP: Change to monthly meetings

available to demonstrate that
these meetings are being held.
Root Cause: Meetings occurred on
an ad hoc basis but didn’t have
There is no evidence available to agenda or minutes.

 demonstrate that these meetings

are being held on a weekly or
monthly basis.
A meeting was carried
out. PAP: Formalise meetings with
agenda and minutes. Identify team
member responsible for agenda
and minutes. Schedule meetings for
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 the year ahead and put the
dates/times and locations into the
team members diaries.

Example 2:

Details of Non- Corrective action Root cause analysis and

Incident
conformity taken proposed action plan (PAP)
Root Cause: Multiple sets of
Dairy dessert was packaging are retained in the
packed into non-dairy vicinity of the packing line.
Product
packaging and
released
released to customers Product withdrawn PAP: All packaging (except that
 with
incorrect
(Non-dairy dessert
does not contain milk
and customers
notified.
currently in use) to be kept in the
storage area until needed.
allergen
which could cause a
information
reaction in an allergic Verification: Manual checks of
individual) packed product at regular intervals
during packing operations.
Root Cause: Several products
have similar packaging artwork and
are therefore not visually distinct.
Unused part packs of similar
packaging are all stored together.

PAP: Re-design storage areas to

Manual
ensure similar packaging has
checks on Product mis-packed.
separate areas. Ensure new
packed The previous root Implicated product
procedures are documented and
 products
indicate
that mis-
cause analysis has
not prevented re-
occurrence of the
captured and
corrected before it
left the packing line.
trained. Investigate opportunities to
redesign some products (or discuss
options with brand owners).
packs still non-conformity.
occur.
Verification: Introduce additional
packaging checks at line start up
and when changing packaging on
the line. Maintain system of manual
checks of packed product, but also
investigate options for automatic
bar code scanners.

This example again highlights that once actions have been implemented best practice is to
introduce monitoring or verification activity to demonstrate that the action has effectively
prevented re-occurrence of the non-conformity. (It should be noted that clause 1.10.1 of the
Food Standard requires senior managers to ensure that the root causes have been
effectively addressed, monitoring and verification activity can be used as evidence, not only
to the site’s management, but also for the auditor).

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 5.5 Extra Checks

Whilst extra checks are often required for verification or monitoring (refer to section 3), it is
preferable that the proposed action plan is not solely an extra check(s). The reason for this is
twofold:

 Whilst it should prevent a re-occurrence, a check is only monitoring the non-

conformity; it is not addressing the true cause of the problem.
 Extra monitoring requires on-going investment, in terms of time (and therefore cost),
whereas proposed action plans may require an initial investment, but should not
require continuous on-going investment.

For example:

Corrective action Root cause analysis and

Details of Non-conformity
taken proposed action plan (PAP)
Root Cause: Boiler turned on too
Check for hot water late for first shift.
 Water used for hand washing,
in the production area, was cold
introduced (completed
by QA at start of day) PAP: Added as part of start- up
checks.
Root Cause: Switching the boiler
on was forgotten on the day of the
audit.
Investigation has demonstrated
that the boiler must be on by 7am
to be sufficiently hot for the first
shift.
The current system relies on the
Check for hot water first person arriving to switch on
 Water used for hand washing,
in the production area, was cold
introduced (completed
by QA at start of day)
the boiler. It is not one particular
colleague’s responsibility.

PAP: Company will invest in an

automatic time control for switching
on boiler. In the meantime the QA
manager will be responsible for
switching on boiler by 7am. (This
has been documented in the policy
on QA start-up checks).

6. Preventative Action
Although not specifically required by the BRC Standards, good practice is to ensure that once
a root cause and proposed action plan is identified, consideration is given to whether any
other systems, processes or procedures are susceptible to the same failure. Where
appropriate, this provides an opportunity to introduce preventative action on these other
systems before a non-conformity actually occurs.

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 7. Additional Documentation

When documenting the root cause investigation and output good practice is to include:

 A summary of the non-conformity

 Details of products/ingredients/etc implicated
 Details of any immediate corrective action eg withdrawal of product, laboratory
analysis, stopping of production, etc.
 Time of non-conformity and when the root cause analysis commenced/concluded
 Conclusions reached
 Proposed action plan with expected completion dates
 Consideration of preventative action
 Verification or monitoring

8. Glossary of Terms

Root Cause: The underlying cause of the problem which, if adequately addressed, will
prevent a recurrence of that problem.

Corrective Action (Immediate Corrective Action): Action taken to manage a non-

conformity (the non-conformity may originate from any source, for example, a product
incident, site audit or product testing). Corrective action should be completed as soon after
detecting the non-conformity as possible (this is particularly important where the non-
conformity could affect product safety, integrity or quality).

Corrective Action Plan: Following an audit, sites in the Enrolment Programme are required
to develop a Corrective Action Plan which outlines the non-conformities observed during the
audit and the action that has/will be taken to address the non-conformity.

Proposed Action Plan: Following root cause analysis, the site must develop a proposed
action plan to correct each of the root causes, such that they prevent recurrence of the non-
conformity.

Preventative Action: On some occasions, root cause analysis will identify an underlying
cause that indicates systems or processes other than that with the current non-conformity,
are susceptible to the same failure. In these situations, in additional to the normal proposed
action plan, it is good practice to complete preventative action on the implicated systems
before a non-conformity actually occurs.

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 9. Appendices

9.1 Inclusion of Root Cause Analysis in the Audit Report

Following an audit the relevant information must be included in the audit report. For the Food
Standard this will include a summary of the root cause analysis and proposed action plan.
An example of the completed non-conformity section of the food audit report, complete with
root cause analysis and proposed action plan is show below:

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Minor

Evidence provided
No Requireme Details of non- Corrective action document, Date
nt ref.
Root cause analysis and proposed action plan Reviewed by
. conformity taken photograph, reviewed
visit/other
1 3.4.1 Internal audit of Audit now Root Cause: Copy of audit reports 2012-08-06 M Oliver
supplier completed as Procedures didn’t recognize the need for deputies
management have audits and therefore no alternative staff had the
systems scheduled for appropriate qualifications/ training when key staff
scheduled for October, were on long term sickness.
January had not November and
been carried out. December. Proposed Action:
Internal audit procedures updated to incorporate
deputies. The size of the internal audit team will be
increased to include sufficient members. These staff
will be trained, as appropriate, for the systems to be
audited.

2 3.11.2 Incident Procedure Root Cause: Copy of new 2012-08-06 M Oliver

management reviewed and fully 1) Procedures didn’t recognize the need for procedure
procedure was updated. deputies and therefore not reviewed to schedule
not up to date, due to the previously mentioned long term
included J Read sickness. (NB This is the second non-conformity
and R Smith with a similar root cause which implies a wider
who have left the issue may exist that should be investigated and
company. managed).
2) The incident procedure is written in such a way
that it need frequent updating (ie every time a
staff member leaves or changes role)

Proposed Action:
1) procedures updated to incorporate deputies. The
size of the internal audit team will be increased
to include sufficient members. These staff will be
trained.
2) Review format of Incident procedure to facilitate
less frequent or easier updates. For example, by
including roles (& deputies) in the main
procedure and appending a spreadsheet with
names, contact details etc.

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9.2 ‘5 Whys’ Route Cause Analysis Template

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9.3 Fishbone
Diagram
Template

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