Module Objective
At the end of this module you will be able to:
• Define Root Cause Analysis;
• Identify the different tools used to conduct Root Cause
Analysis;
• Apply Root Cause Analysis to Non conformities;
• Complete a Corrective Action Request Form;
• Define Corrective Action Plan follow up;
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Audit Conclusion
The conclusions of the audit can, depending on the audit
objectives, indicate the need for corrections, or for
corrective, preventive or improvement actions.
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Corrective Action Requests
Auditor Action - Raising a Corrective Action Request Form
Record the following details:
Where was the problem found, e.g. area, department,
machine, etc.
What was found, i.e. the details of the non-conformity;
Why a Corrective Action is required, i.e. give a justification
for raising the non-conformity;
Quote the criteria against which the non conformity was
raised.
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Root Cause Analysis
Evaluation of a Non-conformity
• The term “corrective action” has a specific meaning that
relates to the action taken to eliminate the underlying or
root cause of a problem or system weakness.
• Identify the “root cause” of the problem that has resulted in
the non-conformity
• 10.2.1 When a nonconformity occurs, including any arising
from complaints, the organization shall:
b) evaluate the need for action to eliminate the cause(s) of
the nonconformity, in order that it does not recur or occur
elsewhere, by:
• reviewing and analysing the nonconformity;
• determining the causes of the nonconformity; (ISO 9001:2015)
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Perform a Root Cause Analysis if…
Corrective Action FINDING
Required
There is an Everything
issue is in order
Regulatory non- Management Good Local attention
Compliance System non- Management item
compliance
practice
observation
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Root Cause Analysis
• RCA is a method of problem solving used for identifying the
causes of faults or problems to prevent the final undesirable
outcome from recurring.
• Root cause involves 3 steps
• Define and describe properly the event or problem (NC)
• Establish a timeline from normal situation until the final crisis or
failure. (Correction)
• Distinguish between root causes and causal factor.
A casual factor is one that affects an event’s outcome, but is not the root
cause. Though removing a casual factor can benefit an outcome, it does
not prevent its recurrence with certainty.
• Once implemented (and with constant execution), RCA is
transformed into a method of problem prediction.
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Root Cause Analysis Process
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Root Cause Analysis Brainstorming
When collecting data for RCA, you may use the 5W1H tool:
• WHAT
• WHEN
• WHERE
• WHO
• WHY
• HOW
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Effectiveness of RCA
• Effective problem statements and event descriptions (as failures,
for example) are helpful and usually required to ensure the
execution of appropriate analysis.
• MUST be performed systematically, usually as part of an
investigation, with conclusions and root causes that are
identified backed up by documented evidence. A team effort is
typically required.
• If there are alternatives that are equally effective, then the
simplest or lowest cost approach is preferred.
• Should establish a sequence of events or timeline for
understanding the relationships between contributory (causal)
factors, root cause(s) and the defined problem or event to be
prevented.
• Threats to cultures are often met with resistance. A "non-
punitive" policy toward problem identifiers may be required.
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Root Cause Analysis
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Root Cause Analysis
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Root Cause Analysis
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RCA Tools
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RCA Tools
5 WHYS?
CAR WON’T ROOT CAUSE CORRECTIVE ACTION
START
MAITENANCE NOT SCHEDULE
PERFORMED PREVENTIVE
MAINTENANCE
• WHY? BATTERY WHY?
• WHY? DEAD
ALTERNATOR
NOT
WORKING
• WHY? BELT
BROKEN
• WHY? BELT
BEYOND LIFE
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RCA Tools
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RCA Tools
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RCA Tools
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RCA Tools
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RCA Tools
• The defect is shown as the fish's head, facing to the right,
with the causes extending to the left as fishbones; the ribs
branch off the backbone for major causes, with sub-
branches for root-causes, to as many levels as required
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RCA Tools
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RCA Tools
• Agree on the problem statement (also referred to as the
effect). This is written at the mouth of the “fish.” Be as clear
and specific as you can about the problem. Beware of
defining the problem in terms of a solution (e.g., we need
more of something).
• Agree on the major categories of causes of the problem
(written as branches from the main arrow).
• Major categories often include: equipment or supply
factors, environmental factors, rules/policy/procedure
factors, and people/staff factors.
• Brainstorm all the possible causes of the problem. Ask “
Why does this happen?” As each idea is given, the facilitator
writes the causal factor as a branch from the appropriate
category (places it on the fishbone diagram). Causes can be
written in several places if they relate to several categories.
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RCA Tools
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RCA Tools
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RCA Tools
Cause and Effect Tool
The 5 Ms (used in manufacturing)
• Originating with lean manufacturing and the 5 Ms is one of
the most common frameworks for root-cause analysis:
• Machine (equipment, technology)
• Method (process)
• Material (includes raw material, consumables, and information)
• Man / mind power (physical or knowledge work, includes:
• Measurement / medium (inspection, environment)
• These have been expanded by some to include an additional
three, and are referred to as the 8 Ms:
• Mission / mother nature (purpose, environment)
• Management / money power (leadership)
• Maintenance
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Cause and Effect - The 5 Ms
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Exercise on RCA and CAP
MODULE 4 EXERCISE.docx
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MODULE 4 EXERCISE
• ROOT CAUSE ANALYSIS
• Indicate TRUE or FALSE as appropriate.
1. The goal of root cause analysis is to prevent recurrence of
a nonconformance.
2. Root cause analysis takes place immediately after a
nonconformance is identified, before any corrections or
corrective actions take place.
3. The root cause is often the first reason that comes to
mind.
4. The correction is what you do to address one instance of a
nonconformance. The corrective action is what you do to
address the root cause of a nonconformance.
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MODULE 4 EXERCISE
5. You are not required to monitor a corrective action for
effectiveness.
• *Tick the correct answer
6. An appropriate corrective action is
• A. The action you think is most likely to eliminate the
problem
• B. The action you think is most likely to prevent the
problem from recurring
• C. Appropriate to the magnitude and risk of the problem
• D. A, B and C
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MODULE 4 EXERCISE
7. Who should work on a root cause analysis?
• A. Only area supervisor(s)
• B. Only the supervisor and the Quality Manager
• C. The people who are closest to the work on a daily basis
• D. Only the person who identified a nonconformity
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Corrective Action &
Follow up
Corrective Actions
Decided and undertaken by the auditee within the
agreed timeframe.
Auditee should keep the person managing the audit
programme and the audit team informed of the status
of these actions.
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Correction and Corrective Action
• CORRECTION
• These are immediate set of actions performed to stop or to reduce
the impact of a non-conformity on any management system.
• CORRECTIVE ACTION
• Action to eliminate the cause of a detected non-conformity or
other undesirable situation.
• Auditors when checking corrective actions should look for
objective evidence from:
• samples of non conformities and corrective actions
• effectiveness of corrective and preventive actions, possibly by
samples
• root cause analysis
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Auditor Responsibilities
Investigate findings thoroughly
Clearly define findings on corrective action forms;
Summarise findings in summary audit report
Do not accept immediate corrective action at face value.
Verify!!
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Risk-based approach to Corrective Action
• The concept of risk-based thinking is underscored as
preventive action to eliminate potential nonconformities,
analyze any nonconformities that do occur.
• The organization should analyze the causes of potential
nonconformities (use of cause and effect)
• There should be clear definitions of the responsibilities for
the identification, evaluation, implementation and review of
preventive actions.
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Risk-based approach to Corrective Action
• In a risk based approach to defining and implementing an
effective Corrective Action, the auditee will have to analyse
the probability of an accident/incident or failure occurring
as a result of the non conformance against the impact to
the organization should it happen.
What is the risk to the organization?
• Based on this, the auditee will act accordingly and this
should be reflected in the Corrective Action Plan provided.
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5X5 Safety Risk Tolerability Matrix
Severity
Likelihood Catastrophic Hazardous Major Minor Negligible
A B C DE
Frequent 5 5C 5D 5E
Likely 4 5A 5B 4C 4D 4E
4A 4B 3C 3D 3E
2C 2D 2E
Possible 3 3A 3B 1C 1D 1E
Unlikely 2 2A 2B
Rare 1 1A 1B
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Risk Acceptability Table
• STOP: Unacceptable under the
existing circumstances. Immediate Action
Severe • Do not permit any operation until • max 24 hours
High sufficient control measures have Corrective Action
Moderate
Low been implemented to reduce risk to • max 7 days
an acceptable level.
• Senior Management notification
• Management attention and approval
of risk control/mitigation actions Corrective Action
• max. 30 days
required.
• Departmental management
notification
• Acceptable risk after review of the Corrective Action
• max 60 days
operation
• Acceptable risk with monitoring Corrective Action
• max 90 days
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Developing a Corrective Action Plan
• Corrective action can be;
• Immediate
• Taken immediately upon identification of the audit finding to remove an
immediate threat to aviation safety.
• Short term
• To correct a non-conformance that does not pose an immediate threat
to aviation safety
• Ensures that conformance is established quickly until, if necessary, long
term action is completed.
• Normally implemented within 30 days
• Long- term;- has two components
• System change: Identifying the cause of the problem and indicating the
measures the company will take to prevent a recurrence.
• Implantation: A timetable for implementation, normally within twelve
months.
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Developing a Corrective Action Plan
• Long term beyond 12 months
• Risk Assessment to determine acceptability
• If acceptable, an exemption might be required to permit
operations to continue for extended period of time pending
implementation.
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Corrective Actions Supporting Documents
• Long and short term correction action should be
accompanied by supporting documents for review
• Logbook entries
• Purchase orders
• Memoranda or revised inspection procedure cards
Important to verify supporting documentation during follow-
up inspections
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SUMMARY
USING PDCA IN ROOT CAUSE AND CORRECTIVE ACTION PLAN
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Monitoring Corrective Action
• This focuses on the corrective action to findings issued
during an audit
• Includes acceptance of the organization’s corrective action
plan
• Verifies full implementation of that plan and formal closure
of the audit by the convening authority
• Audit follow up is complete when:
• The auditor has accepted all audit finding corrective action
• Corrective action status has been recorded in the audit file
• Convening authority has been advised and
• Letter informs the auditee that the audit is closed.
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Reviewing Effectiveness of Corrective Actions
• The conclusions of the audit can, depending on the audit
objectives, indicate the need for corrections, or for
corrective, or improvement actions.
• Such actions are usually decided and undertaken by the
auditee within an agreed timeframe.
• The audit team and the audited party shall jointly conduct
post-audit/inspection reviews with the following objectives:
• To monitor the progress on the implementation of a CAP, and
• To verify the effectiveness of the corrective actions.
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Verification of Effectiveness
• The completion and effectiveness of the CAP
should be verified.
• This verification may be part of a subsequent
audit.
• Such reviews should be reported to the senior
management of the respective Divisions and
properly documented.
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Verification of Effectiveness
If corrective action is not considered effective, either;
Leave the Corrective Action Request Open;
Issue a new Corrective Action Request;
Consider escalation to Senior Management.
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Why can Corrective Action be Ineffective?
Common Causes:
• The problem is not investigated thoroughly by the auditors;
• The problem is not communicated effectively to the auditee;
• The corrective action process is not understood by the
auditee;
• The corrective action process does not address the root
cause;
• The auditee does not understand the auditor’s role in the
corrective action process;
• The problem does not exist!! This is common when the
auditor misinterprets the standard or regulation under
audit.
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Audit Closure
Conducting audit follow -up
Audit Corrective, or Verify
Conclusions improvement completion and
effectiveness of
actions actions taken
Verification may be
part of a subsequent
audit
Audit/Inspection Closure
• As a rule, the CAP should aim at having all corrective action
in place within 90 days of acceptance by the applicable
Auditor or other assigned person.
• However, it is not always possible to meet these deadlines
and special consideration may be required to ensure Audit
closure in a timely fashion.
Closure
• The lead auditor will confirm that all follow-up actions have
been completed entered in the functional database and will
so advise the CEO of auditing firm who in turn will then
forward a letter to the auditee informing them that the
Audit is closed.
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