GLOBAL STANDARDS

UNDERSTANDING
PREVENTIVE
ACTION AND
ROOT CAUSE
ANALYSIS
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UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS 1

CONTENTS
UNDERSTANDING PREVENTIVE
ACTION AND ROOT CAUSE
ANALYSIS
1. WHAT IS PREVENTIVE ACTION? 3
2. WHAT IS ROOT CAUSE ANALYSIS? 4
3. HOW TO COMPLETE A
ROOT CAUSE ANALYSIS? 6
4. METHODS OF ROOT CAUSE ANALYSIS 8
4.1 The ‘5 whys’ 8
4.2 Fishbone diagrams 10

5. COMMON MISTAKES 13
5.1 Unmanageable conclusions 13
5.2 Duplication of the immediate corrective action 14
5.3 People 14
5.4 Preventive action plan doesn’t prevent recurrence 15
5.5 Extra checks 17

6. ADDITIONAL DOCUMENTATION 18

APPENDIX A INCLUSION OF ROOT CAUSE

ANALYSIS IN THE AUDIT REPORT 19
GLOSSARY 21

2 UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS

PART 1
WHAT IS PREVENTIVE
ACTION?
When a non-conformity is identified, either during an audit or as the result of a non-conforming
product, good practice is to ensure that two separate sets of action are completed:

• correction (sometimes referred to as immediate corrective action), which involves management

of the immediate issue or non-conformity
• preventive action, which is action to ensure that recurrence of the non-conformity is prevented.
In order to complete effective preventive action and therefore prevent recurrence of a non-
conformity, it is important to understand the fundamental or underlying reason why the non-
conformity occurred, which is often referred to as the root cause. Identification of this underlying
cause is usually achieved by root cause analysis (see section 2).

Preventive action may require the identification and management of processes, procedures,
activities (or lack of), behaviours or conditions. It is usually applied to the same system(s) implicated
by the non-conformity but, on some occasions, the underlying cause may indicate other systems
or processes that are susceptible to the same failure. In these situations it is good practice to
complete preventive action on all the implicated systems.

UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS 3

PART 2
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. The aim of the root cause analysis is to enable the
investigators to look beyond the solution to the immediate problem and understand the
fundamental or underlying causes of the situation so that preventive action can be taken.

Root cause analysis is a completely separate process from incident management and immediate
corrective action (correction), although they are often conducted in close proximity. The benefits of
a comprehensive root cause analysis include:

• identification of permanent solutions

• prevention of recurring failures
• introduction of a logical problem-solving process that can be applied to issues and non-
conformities of all sizes.

2.1 TAKING EFFECTIVE PREVENTIVE ACTION

Figure 1 shows a summary of the typical steps involved in taking effective preventive action, from a
non-conformity occurring, through root cause analysis, to implementing action and monitoring its
effectiveness.

STEP 1
DEFINE THE NON-CONFORMITY

STEP 2
INVESTIGATE THE ROOT CAUSE

STEP 3
CREATE PREVENTIVE ACTION PLAN & DEFINE TIMESCALES

STEP 4
IMPLEMENT PREVENTIVE ACTION

STEP 5
VERIFICATION & MONITORING OF EFFECTIVENESS

Each of the main steps in Figure 1 requires a number of actions to be completed. While the exact
actions will vary depending on the nature and magnitude of the non-conformity, an example of the
actions for Step 1 could be as follows:

4 UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS

• establish a root cause team to investigate the issue
• describe the event or non-conformity (i.e. provide a summary of what went wrong)
• confirm the sequence of events (e.g. if a customer illness led to a product analysis, which
subsequently led to a raw material investigation, then the dates and results of each step could
provide useful information)
• compile a list of dates and times (e.g. when the non-conformity was discovered and when the
last acceptable monitoring result of the implicated process was obtained)
• compile a list of implicated products/ingredients (raw materials) or processes
• provide a summary of any incident management or immediate corrective action that has been
completed to manage the issue
• summarise any other relevant data or information (e.g. records, test results, information from staff
in the relevant area or complaints)
• collate all the available information
• investigate possible scenarios and collate this information (e.g. this may include product or
environmental testing or liaison with technical experts and regulatory authorities).

It should be noted that Figure 1 is a simplified process flow which is typical of that required by BRC
Global Standards for the majority of situations. 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 may require considerable time to
complete.

UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS 5

PART 3
HOW TO COMPLETE A
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;
consequently many tools and methods have been published (two popular methods are highlighted
below). The choice of method for root cause analysis may be a matter of personal choice, company
policy or depend on the type of issue/non-conformity being investigated. Some companies find
different tools work better for different types of situation (e.g. according to 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
• which products/processes were implicated
• what, if any, immediate corrective action (correction) was completed.
Throughout the process the key question that root cause analysis is seeking to answer must be
borne in mind: What system or process failed so that this problem was able to occur?

On some occasions the answer is straightforward:

• ‘The documented policy didn’t include the requirement’ or

• ‘The staff weren’t trained in the procedure’.
In these situations the subsequent steps of the investigation and necessary action can be planned
immediately. On other occasions the cause is not immediately clear and investigative steps will be
required. For example:

• Did the operator understand the procedure?

• Did the method as laid out in the policy work if followed precisely?
• Did 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 (e.g. on raw materials, final product,
factory environment or the process).

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

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

An important final step of an effective root cause analysis is to undertake monitoring or verification
activity. This is necessary to ensure that the changes to the procedures or the introduction of any

6 UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS

new activities are fully operational, that they are effective in managing the root cause and that they
do not inadvertently introduce any additional problems. Examples of verification activity 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 the changes or new activities are fully embedded and effective, a
review can consider whether the additional monitoring is still required or whether it can be reduced
to a lower frequency.

UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS 7

PART 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-and-effect relationships underlying the problem. The
investigator keeps asking the question ‘Why?’ until meaningful conclusions are reached (Figure 2).

WHY? WHY? WHY? WHY? WHY? ROOT

CAUSE

This method suggests 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 drawing 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?’, try asking ‘Why
was the operator not trained?’, ‘Why did the training process fail?’ or ‘Why was the training process
not effective on this occasion?’

4.1.1  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 uses ingredient B instead.

An immediate reaction will probably suggest that this non-conformity was caused by an operator
error. While this may be accurate, it does not establish the reason why the error occurred or prevent
it from happening in future. The root cause analysis must ask a series of ‘Why?’ questions (and
obtain answers). Figure 3 illustrates how the 5 whys technique gets to the root cause of the
problem.

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 (i.e. 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 that should be taken.

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 the training procedure to ensure sign-off (and 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 a check of
the labels

8 UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS

• ensure an individual (e.g. 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) to a fully operational state
• amend line start-up checks to confirm that all activities have been completed.
5 WHYS
An operator should have weighed out ingredient A on line 2.
However inadvertently used ingredient B. Why is this happening?

1. Why did the operator make the error?

Operator unfamiliar with procedure

Why is that?

2. O
 perator trained but no supervison or sign
off to confirm training was satisfactory

Why is that?

3. Why was the training not satisfactory?

Both ingredients look identical and were
not labelled
Why is that?

4. Labels were removed during last clean and

not replaced

Why is that?

5. Cleaning staff didn’t consider potential for error

and checking labels not part of anyone’s duties

UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS 9

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 sized
pieces or where there is a lot of data that needs to be trended.

One of the key aspects of this type of root cause analysis is to visually lay out the causes of the
problem. Therefore, the fishbone starts with the problem or non-conformity on the right and builds
across the page moving left as more information is obtained (as shown in Figure 4).

Further causes
(Secondary cause)

Problem or
Initial information
non-conformity
(Primary cause)
being investigated

Further causes
(Secondary cause)

The arrows in the diagram indicate how the causes flow through various steps towards the
non-conformity that occurred.

To provide further clarity to the diagram, the various causes are grouped into categories (such as
equipment, materials or processes) so that solutions for each category can be individually
assessed (i.e. each identified root cause is considered by category within the preventive action
plan), as shown in Figure 5.

MANAGEMENT MATERIALS PROCESS

Further cases
(Secondary cause)

Initial information
(Primary cause)

Problem or
non-conformity

Further cases
(Secondary cause)

Initial information
(Primary cause)

ENVIRONMENT EQUIPMENT PEOPLE

10 UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS

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 (e.g. production line, facilities, computers and/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 (e.g. metal detection records, check weights or final product analysis)
• Materials Any information relating to raw materials or final products (e.g. raw material
specifications or goods-in receipt checks for a specific batch of ingredients)
• Environment The location, time, temperature, standards of cleanliness or available time for an
activity
• People Any role involved in the implicated process.
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 of this cause are
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 was this allowed to happen? Staff shortages
• So what (i.e. 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’ technique, it is important to initially investigate the cause and then examine the
cause of the cause to ensure that the root cause has been correctly identified (fishbone diagrams
sometimes refer to this as examining primary and secondary causes).

4.2.1  AN 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’, but inadvertently uses ingredient B. The causes would be set out as
shown in Figure 6 and the proposed action plan developed.

MANAGEMENT MATERIALS PROCESS

Potential for error not Checking labels did not Labels were removed
considered in cleaning form part of anyones’s during cleaning and
procedures duties not replaced

Both ingredients look

identical and not An operator should
labelled
have weighed out
ingredient A, however,
inadvertently used
Operator trained but ingredient B
not signed off

Incomplete training
procedure for cleaning
staff

ENVIRONMENT EQUIPMENT PEOPLE

Figure 6 An example of root cause analysis using a fishbone diagram

UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS 11

Again this diagram shows the various elements leading to the non-conformity – the wrong
materials were weighed out because materials that look similar were not labelled. Further
investigation showed that the labels had been removed and not replaced, and the significance of
this action had not previously been considered. Therefore the failure to replace labels after cleaning
had not been addressed in procedures or verification activities such as line start-up checks.

12 UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS

PART 5

PART 6 COMMON MISTAKES

COMMON MISTAKES
To help users avoid a number of common mistakes, which are known to hinder the formation of
quality preventive action plans, an explanation of each mistake is given below. This explanation
includes an example of the incorrect approach (indicated by a ‘ ’), which is immediately
followed by the same non-conformity being accurately investigated, leading to a better
preventive 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 beyond 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 by asking specific questions such as, ‘Why
did the process fail?’ or ‘What system allowed the mistake to be made?’

Table 1 highlights that in practice there may be more than one cause (e.g. no deputies, out-of-date
policy, lack of training) and therefore the proposed preventive action plan may require multiple actions.

Table 1 Example of a preventive action plan to progress beyond an ‘unmanageable’ conclusion

DETAILS OF IMMEDIATE CORRECTIVE ROOT CAUSE ANALYSIS AND PREVENTIVE

NON-CONFORMITY ACTION (CORRECTION) TAKEN ACTION PLAN (PAP)

Internal audit of supplier
management systems
scheduled for January had
not been carried out
Audit completed Root cause Lack of resource in technical
department because of long-term sickness
All scheduled audits completed and
up to date PAP Resource issues to be 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 staff were absent on long-term
sickness

PAP 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

UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS 13

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 preventive 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 preventive action plan can focus on ensuring
that the system or process is amended so that the fault cannot occur in future. Therefore this action
plan must not be a repeat of the immediate corrective action/correction (see an example of the
correct approach in Table 2).

Table 2 Example of a preventive action plan to avoid duplication of immediate corrective action

DETAILS OF IMMEDIATE CORRECTIVE ROOT CAUSE ANALYSIS AND PREVENTIVE

NON-CONFORMITY ACTION (CORRECTION) TAKEN ACTION PLAN (PAP)

Acceptance and rejection
criteria have not been
defined for calibrated
devices. Therefore the
actions to take if the device
is incorrect or out of the
calibration range were not
defined
Acceptance and rejection criteria
defined and documented
Actions in case of an out-of-
calibration device documented
Root cause Requirement not documented
PAP Calibration procedure has been updated
and information added
Root cause Neither HACCP procedures,
calibration procedure nor installation policies
documented the need to define these criteria
before use of new equipment

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’, ‘Misunderstood’ 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.

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

Where re-training is considered to be a necessary part of the proposed action plan, thought should
be given to the format of the training. If the initial training was not effective, then just repeating the
same training is unlikely to achieve the desired result. Consider, for example, the use of:

• workshops
• an example-based activity
• a pilot plant (where available)
• work-based training (such as observing an experienced colleague)
• external training providers.
The language in which the training is provided must also be considered.

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 recurrence. Table
3 provides an example of a preventive action plan to correct the procedure that gave rise to human
error.

14 UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS

Table 3 Example of a preventive action plan to establish which policy or process led to the non-conformity

DETAILS OF IMMEDIATE CORRECTIVE ROOT CAUSE ANALYSIS AND PREVENTIVE

NON-CONFORMITY ACTION (CORRECTION) TAKEN ACTION PLAN (PAP)

CCP control records were Training carried out on the correct Root cause Inexperience
not signed by the person completion of control records and
completing the monitoring their importance PAP Raise staff awareness

Re-training designed using a number Root cause Effectiveness of training for

of control records where staff
were asked to identify ‘good’ and
‘bad’ records (i.e. those that were
completed correctly and those that
had missing information)
newest members of staff was not assessed.
CCP control records were not checked by either
technical team or internal audits (the reason
for this should also be subject to root cause
analysis)

PAP Examples of correctly completed,

annotated CCP control records included in work
instructions (copies of which were available
in production areas). Specific checks on CCP
monitoring added to the internal audit schedule

Verification Line or production manager to

countersign CCP control records at end of shift/
production

5.4 PREVENTIVE ACTION PLAN DOESN’T PREVENT

RECURRENCE
Occasionally, despite root cause analysis and the implementation of a preventive 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 (i.e. the true root cause was not established)
• multiple root causes (the preventive action plan needs to manage every root cause)
• preventive action plan not fully implemented.
In these situations it may be necessary to revisit the root cause analysis to identify any additional
causes and appropriate controls. Tables 4 and 5 provide examples of where the original preventive
action plan has been revisited.

UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS 15

Table 4 Preventive action plan revisited: example 1

DETAILS OF IMMEDIATE CORRECTIVE ROOT CAUSE ANALYSIS AND PREVENTIVE

NON-CONFORMITY ACTION (CORRECTION) TAKEN ACTION PLAN (PAP)

The company procedure Procedure changed to monthly Root cause Weekly meeting not sustainable
states that weekly meetings
production meetings PAP Change to monthly meetings
are held to verify the
effectiveness of the
HACCP plan. However,
there is no evidence
available to demonstrate
that these meetings are
being held

There is no evidence
available to demonstrate
that these meetings are
being held on a monthly
basis
A meeting was held Root cause Meetings occurred on an ad hoc
basis but didn’t have an agenda or minutes
PAP Formalise meetings with agenda and
minutes. Identify team member responsible for
agenda and minutes. Schedule meetings for
the year ahead and put the dates/times and
locations into the team members’ diaries

Table 5 Preventive action plan revisited: example 2

INCIDENT DETAILS OF CORRECTION ROOT CAUSE ANALYSIS AND

NON-CONFORMITY ACTION TAKEN PREVENTIVE ACTION PLAN (PAP)

Product released with Dairy dessert was Product withdrawn and Root cause: Multiple sets of packaging
incorrect allergen packed into non- customers notified are retained in the vicinity of the
information dairy packaging and packing line
released to customers PAP: All packaging (except that
(dairy dessert contains currently in use) to be kept in the
milk which could cause storage area until needed
a reaction in an allergic Verification: Manual checks of packed
individual) product at regular intervals during
packing operations.
Manual checks on Product mis-packed. Implicated product Root cause: Several products have
packed products The previous root captured and corrected similar packaging artwork and are
indicate that mis-packs cause analysis has not before it left the therefore not visually distinct. Unused
still occur prevented recurrence packing line part-packs of similar packaging are all
of the non-conformity stored together
PAP: Redesign storage areas to
ensure similar packaging has separate
areas. Ensure new procedures are
documented and trained. Investigate
opportunities to redesign some
products (or discuss options with brand
owners)
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

16 UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS

Table 5 highlights that once actions have been implemented, best practice is to introduce
monitoring or verification activity to demonstrate that the action has effectively prevented
recurrence of the non-conformity. (It should be noted that section 1 of each of the Global Standards
requires site managers to ensure that the root causes have been effectively addressed; monitoring
and verification activity can then be used as evidence, not only for the site’s management, but also
for the auditor.)

5.5 EXTRA CHECKS

While extra checks are often required for verification or monitoring (see section 3), it is preferable
that the preventive action plan is not viewed solely as an extra check. The reason for this is twofold:

• While it should prevent a problem from becoming a non-conformity or an incident recurring, it is

only monitoring the situation; it is not fixing or preventing it from occurring.
• Extra monitoring requires ongoing investment, in terms of time (and therefore cost), whereas
preventive action plans may require an initial investment, but should not require continuous
ongoing investment.

Table 6 shows a preventive action plan which doesn’t rely solely on ongoing monitoring.

Table 6 Example of a preventive action plan that reduces the need for ongoing monitoringon

DETAILS OF IMMEDIATE CORRECTIVE ROOT CAUSE ANALYSIS AND PREVENTIVE

NON-CONFORMITY ACTION (CORRECTION) TAKEN ACTION PLAN (PAP)

Water used for hand-
washing in the production
area was cold
Check for hot water introduced Root cause Boiler turned on too late for first
(completed by QA at start of day) shift
PAP Turning on the boiler 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 first person arriving
to switch on the boiler. It is not one particular
colleague’s responsibility

PAP Company to 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)

UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS 17

PART 6
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 and/or any other factors implicated
• details of any immediate corrective action (correction) (e.g. withdrawal of product, laboratory
analysis, stopping of production etc.)
• time when non-conformity occurred and when the root cause analysis commenced/concluded
• conclusions reached
• preventive action plan with expected completion dates
• consideration of preventive action
• verification and/or monitoring.

18 UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS

APPENDIX A
INCLUSION OF ROOT
CAUSE ANALYSIS IN THE
AUDIT REPORT
Following a BRC Global Standard audit, in addition to undertaking any necessary immediate
corrective actions, the site must conduct a root cause analysis to identify the fundamental cause(s)
of each non-conformity. Figures 7 and 8 provide templates for undertaking such an analysis.

The site shall provide the certification body with a preventive action plan to correct the root causes.
This proposed action plan, including timescales for completion, will be included in the audit report.

5 WHYS’ ROOT CAUSE ANALYSIS TEMPLATE

Enter details of the problem that needs resolving here.

Why is that?

Why is that?

Why is that?

Why is that?

Why is that?

If your last answer is something you cannot control, go back up to the previous answer.

UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS 19

FISHBONE DIAGRAM TEMPLATE

MATERIALS
PEOPLE

METHODS
EQUIPMENT

INFORMATION
ENVIRONMENT

DETAILS OF
PROBLEM

Figure 8 Fishbone diagram template

20 UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS

GLOSSARY

PART 9 APPENDICES
Correction (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).

Preventive action: The action taken to ensure that recurrence of the non-conformity is prevented.

Preventive action plan: Following root cause analysis, the site must develop a preventive action
plan to correct each of the root causes, so that recurrence of the non-conformity is prevented.

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

Root cause analysis: A systematic investigation to identify the fundamental or underlying

cause(s) (root causes) of a problem or incident. There are a wide range of tools and techniques that
can be used to aid the process.

UNDERSTANDING PREVENTIVE ACTION AND ROOT CAUSE ANALYSIS 21

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