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Root Cause Analysis (RCA)
Root Cause Analysis (RCA)
Root Cause Analysis (RCA)
information session
&
Investigation Training
Our Protocol
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3
The Need for RCA
• There is a significant misunderstanding of the RCA and in many instances it would either be
incorrectly prepared or not prepared at all.
• Identifying, for example, “lack of documentation” as the root cause without getting to the real
answer as to WHY the documentation was deficient is not enough.
• As per the 2016 IRBA Public Inspections report, the highest root cause allocation was “human
error”, without drilling down to exactly WHY the issue existed or resulted in a finding (root cause
vs. symptoms).
• Those auditors that effectively identified the underlying root causes and implemented real
proactive action plans demonstrated significant improvement during follow-up inspections.
4
RCA Introduction & Background
(cont …)
Brief history on RCA:
•Developed by Sakichi Toyoda who later founded Toyota Motor Company.
•RCA was first used during the development of Toyota’s manufacturing processes in 1958.
Definitions:
•Root Cause: The original event, action and/or condition generating an actual or potential undesirable
condition, situation, nonconformity or failure.
•RCA is a technique for identifying the underlying key cause (or causes) behind review findings,
whether specific to one audit or firm wide, so that an appropriate and achievable action (or actions) can
be taken to prevent the recurrence of negative outcomes and promote the recurrence of positive ones.
5
RCA Introduction & Background (cont …)
6
RCA Introduction & Background (cont …)
Visible
Not visible
7
Audit
Quality
Improvement
Process
9
Principles of RCA
The RCA cycle
10
Principles of RCA (cont …)
The following are examples of possible causes, but they do NOT drill down to the true
ROOT cause:
- Human error
- Misunderstood the requirement
- Misunderstood the standards
- Documentation
- System error/Audit methodology
- Elaborating on the finding
- Expanding on symptoms
- The consultant messed up
- It was an oversight
- Audit procedures/software not updated, etc.
- We have not set criteria about what makes an acceptable corrective action plan (firms to implement
RCA and RAP Policies and Procedures).
- We continue to accept bad answers.
- People (internal and external) do not have the Root Cause Analysis culture; don’t know any process or
are not effectively trained.
- We are addressing the symptoms and not the true root of the issue.
Using the 5 Cs
1) Criteria:
The law, regulation, contractual obligation, policy, procedure or best practice that is
expected to be followed.
2) Condition:
The factual analysis of the process as it exists.
3) Consequence/Effect:
Why the issue is important and noteworthy from a compliance, financial, or operational
standpoint.
4) Cause:
The root cause that allowed the condition to not emulate the criteria.
5) Corrective Action/Recommendation:
Change that will address the root cause – action plan.
13
Principles of RCA (cont …)
It is important to get your mind into an investigative mode (refer to principle of professional
scepticism).
The audit partner did not provide training/guidance and did Fifth why
not apply his time to supervise the manager.
21
Principles of RCA (cont …)
Keep environmental matters in mind (most root causes can be traced back to decisions,
actions or inactions by one or more engagement team members):
Resource issues:
• Issues arising from the firm’s policies and procedures – are they well framed; are
there gaps; are they well understood and complied with?
• Does on-the-job mentoring and reviewing happen in the way they should?
• Poor project management, incl. leaving issues to the end of the audit.
25
Principles of RCA (cont …)
Leadership issues
•Can the firm be fairly expected to serve its client base? (Consider:
competence, resources and specialities.)
•Are review findings rooted in difficulties with client interaction? For
example, fee pressure, an unreasonable client-imposed deadline to complete
the audit, poor quality or information arriving late from the client.
26
Principles of RCA (cont …)
Link to ISQC 1 Para. 26: “The firm shall establish policies and procedures for the acceptance
and continuance of client relationships and specific engagements, designed to provide the firm
with reasonable assurance that it will only undertake or continue relationships and engagements
where the firm:
(a) Is competent to perform the engagement and has the capabilities, including time and
resources, to do so; (Ref: Para. A18, A23)
(b) Can comply with relevant ethical requirements; and
(c) Has considered the integrity of the client, and does not have information that would lead it to
conclude that the client lacks integrity. (Ref: Para. A19-A20, A23)”
•
27
Principles of RCA (cont …)
Remedial Action Plan (RAP) examples
When root causes are identified correctly, it is easy
to develop and implement an action
plan as follows:
•Reviewing of resourcing.
•Improving the project management.
•Increased focus on joiners or leavers.
•Coaching and guidance on related initiatives.
•Improving the integration of internal experts.
•Real-time monitoring/support teams.
•Methodology enhancements.
•Guidance and communications.
•Training (technical and soft skills).
•Supervision and review.
•Software, procedures and technical updates.
Introduction & Overview
Learning Outcomes
• Outline and discuss RCA Investigation
Over 1 million
Complexity of Healthcare
January 2010
Complexity of Healthcare
?
Patient safety - A global issue
- True scale still unknown
Patient Safety
Incidents/
Events
Hospital blunders 'kill 90,000 patients‘
Rebecca Smith: Daily Telegraph - 29.11.07
Analysis Tools
In nearly 1 in 5 operations:-
the equipment was faulty, missing or used incorrectly
– or staff did not know where it was or how to use it.
Analysis of these system failures and true causes enables targeted and,
where possible, failsafe actions
to be developed and implemented which demonstrate significantly reduced
likelihood of recurrence
Taylor-Adams (2011)
Basic elements of RCA investigation
Implementing Solutions
To err is Human
To cover up is unforgivable
To fail to learn is inexcusable
Sir Liam Donaldson
Tihs is bcuseae the huamn mnid deos not raed ervey lteter by istlef,
but the wrod as a wlohe.
?
The Perfection Myth
- if we try hard enough we will not
make any errors
Failed defences
Patient Safety
Incident
Service Delivery Problem (SDP)
• Latent failure
• Distant from direct patient care
• Arise from weaknesses in the organisation or environment
• Active failure
• Arises in process of direct patient care
• Act or omission by member of staff
Novel task
Knowledge
Error Wisdom
Predict ‘what can go wrong today’
3
2
1 3
2
1 3
SELF 2
1
CONTEXT
T ASK
Three bucket model of error likelihood – James Reason 2004
ERROR TYPES
– based on the work of Reason, adapted by NPSA
Unintended Lapses
actions
Skill based errors
Slips Attentional failures
Def: Human Factors
The study of how humans behave physically and psychologically
in relation to particular environments, people, or procedures.
Lessons from Human Factors Research
Example outcomes :
Perceptual and contextual problems ……….
Perception
Contextual clues leading to error
(Bum steers)
Error is normal
• Humans are bad at routine but good at compensation/recovery
• We need to use this wisdom to identify the true causes of incidents ... and
the most effective solutions
Gathering and Mapping
the Information
The RCA Process
Getting Started
Implementing Solutions
60% of the time should be Only once all Develop targeted failsafe
spent on gathering data facts have been solutions/
gathered recommendations
Paradigms
Documentation
People
What
information
to Equipment Site
collect?
Documentation
1. Incident report
2. Medical records
3. Local & national guidelines, policy, procedure (in operation at time of incident)
4. Local and national data on previous related incidents
5. Relevant integrated care pathways
6. Relevant audit data (clinical, risk management, H&S)
7. List of key staff involved and their informal statements/reports
8. Staff rotas
9. Training and supervision records
10.Medical equipment maintenance records
etc
People
Personnel directly involved in the incident & other witnesses
• Clinical staff
• Patient/family
• Porters
• Healthcare assistants
• Ward clerks
• Members of the public
etc
How to retrieve information from people
• Interrupting interviewees
• Stress - can affect the quantity of information stored, but not the quality.
• Selective Attention – witnesses remember what they think are the most
important aspects of the event.
Summary Phase 6
Return to safe topic and thank interviewee Closure Phase 7
• This only needs to change if the aim / terms of reference change i.e. if an investigation
becomes a formal HR or Criminal case.
• If coroners or independent investigators require signed statements for other reasons, terms
of reference should change to reflect this.
Equipment
Identify and retain any equipment involved
• CTG machine
• Shower curtain
• Anaesthetic machine
• Infusion pump
• Drug delivery system
etc
Site
Consider the following:
21 September 2000
Seven days later the supplier came to repair the motor.
The chair seemed to be working better again and disruption was minimal over the following
three weeks.
Through the – Standard Timeline
www.npsa.nhs.uk/rca
Time-person grid
10.25 10.15 10.05 Staff
Nurses st With pt 3 With pt 1 Snr Nurse A
With pt 2 ? ? Dr 1
Group work
During care/treatment
□ Via clinical assessment/observations - staff identifying a change in patient's condition e.g.
□ By a review
□ By Incident trend
www.npsa.nhs.uk/rca
Key Points – Gathering & Mapping
• Plan with care how you can best collect information from people and who you
need to interview (time management)
for
لحوادثJJياJJJلة فJJاJعJJJتحقيقاتفJJلجذريلJJلسبباJJحليلاJJJت
• Introduction
Outline
• What is Root Cause Analysis (RCA)?
• How does RCA work?
• Tips to make your RCA more effective
• Interviewing techniques
1. المقدمة
2. ما هو تحليل السبب الجذري
3. كيف يعمل تحليل السبب الجذري ؟
4. نصائح لجعل تحليل السبب الجذري الخاص بك أكثر فعالية.
5. تقنيات المقابلة
What is Root Cause Analysis (RCA)?
• كاف لتحديد العالقات بين مختلف األحداث والقضايا التي قد تكون مجتمعة إلنتاج حدث
ٍ طريقة مباشرة مهيكلة بشكل
How Does RCA Work?
ي
لجذر ؟JJلسبباJJحليلاJJJعملتJJيفيJJك
• Employee fell downلموظفJJقط اJJس
Symptoms vs. Roots
ً لموظفJJاناJك
• Employee was careless مهمال
• Employee under time pressureلوقتJJغط اJJحتضJJJموظفت
• Under time pressure because of overlapping delivery
dates خلةJلمتداJJ اJلتسليمJJواريخ اJJJسببتJJJلوقتبJJغط اJJحتضJJJت
• Delivery dates overlap because of poor communication
between teams
تتداخل تواريخ التسليم بسبب ضعف التواصل بين الفرق
106
The Root لجذرJJا
أو العوامل التي قد تسببت (وحدها) أو ساهمت (باالقتران مع الظروف األخرى) في/ تحديد ما هي الظروف واألحداث و
) لماذا؟، ) (أي1( هذه هي عواملك األساسية.الحادث
3- Determine conditions/events/factors that may have caused or contributed to the
primary factors. These are your secondary (2o) factors (i.e., Why?)
هذه هي عواملك الثانوية. العوامل التي ربما تكون قد سببت أو ساهمت في العوامل األساسية/ األحداث/ تحديد الشروط
) لماذا؟، ) (أي2(
109
Examples of RCA Documentation
Methods
Machines
Written checklist did not
New valve access
include warnings re safe
requires ladder
ladder use
No Mgt of No hazard
Change analysis analysis of
Ladder legs uneven procedure
Lack of
Maintenance
No Trng Operator
Mgt broke wrist on
System fall from
Operator not trained ladder
Steps wet and slippery
Operator did not heed ladder Lack of
warning label Housekeeping
Root
it was manually added to
exposure
tank
"OR" "OR"
JلعلىرسمJJمثا
omitted
assessment Procedure unclear Deviations
not
considered
important
لجذرىJJلسبباJJا
No PPE inventory
management system
No procedural HAZOP
PPE performed
PPE was Change review
hinders
not didn't consider PPE
work
considered issues
progress
important 4o
No Ma na g e me nt o f
Cha ng e p ro c e s s in p la c e 5o
Lo w a c c o unta b ility fo r
s a fe ty is s u e s
PPE assessment
poor/omitted
KEY:
"AND" "Root"
Example
Root
Cause
Diagram
JلعلىرسمJJمثا
لجذرىJJلسبباJJا
Chronology of an Incident Investigation
لحوادثJJياJJJلتحقيقفJJلزمنيلJJلتسلسلاJJا
1. Event occursحدثJJدثيJح
2. Collect information from the scene of the eventلحادثJJوماتمنمكاناJلمعلJJ اJجمع
3. Gather more information (witnesses, system information, etc.) )لىذلكJJ وما إ، JلنظامJJ ومعلوماتا، ودJلشهJJلمعلومات(اJJلمزيد مناJJ اJجمع
4. Conduct detailed RCAلجذريJJسبباJJتمفصلة لJجراءاJإ
5. Write an Action Planكتبخطة عملJا
6. Implement the Action PlanلعملJJنفيذ خطة اJJJت
7. Review results لنتائجJJة اJجعJمرا
8. Modify Action Plan as necessary لضرورةJJلعملحسباJJديلخطة اJعJJJت
Tips For More Effective RCAs
• Speculation is clearly identified as such لنحوJJ علىهذا اJضحJشكلواJJJلمضاربة بJJحديد اJJJ تJتمJJي
• Actionable items are clearly defined وضوحJJJلتنفيذ بJJابلة لJلقJJلعناصر اJJحديد اJJJ تJتمJJي
• Conduct analysis as soon as possible after data have been gatheredلبياناتkk اkمعkد جkعkkتممكنبkقربوقkيأkkkلتحليل فkkجراء اkإ
120
Examples Of Questions To Ask - اJطرحهJJسئلة لJمثلة علىأJأ
• Were operating conditions leading up to the incident recorded (e.g., strip charts, process control system
print outs, instrumentation )?
• واألجهزة)؟، وطبعات نظام مراقبة العمليات، الرسوم البيانية الشريطية، هل سُجلت ظروف التشغيل السابقة للحادث (على سبيل المثال
• Were any reactants changed just prior to the incident (e.g., new chemical used, change in chemical
concentration, change in chemical vendor)?
• تغير في بائع المواد، تغير في التركيز الكيميائي، مادة كيميائية جديدة مستخدمة، هل تغيرت أي مواد تفاعالت قبل وقوع الحادث (على سبيل المثال
الكيميائية)؟
• Employee Interaction -لموظفJJاعلاJفJJJت
• Was the employee involved in the incident interacting with the process equipment at the time (e.g.,
adjusting valves, performing a manual procedure, servicing, troubleshooting, calibrating)?لموظفJJاناJهلك
ستكشافJ ا، لصيانةJJ ا،دويJJجراء يJجراء إJ إ،لصماماتJJبط اJJ ض،لJJلمثاJJبيلاJJلوقت(علىسJJيذلك اJJJلجة فJJاJلمعJJتاJداJ معJتفاعلمعJJلحادثيJJياJJJلمتورط فJJا
ايرة)؟JلمعJJ ا، اJصالحهJألخطاء وإJJا
• Was the employee involved in the incident using support equipment at the time (e.g., ladder, extension
cord, lift devices, portable pumps for maintenance)?لوقت(مثلJJيذلك اJJJ فJلدعمJJتاJداJ معJستخدمJJلحادثيJJاJJJلمعنيبJJلموظفاJJاناJهلك
لصيانة)؟JJ مضخاتمحمولة ل، Jزة رفعJجهJ أ، مديدJJJلك تJJ س، JلمJJس
Examples Of Questions To Ask - اJطرحهJJسئلة لJمثلة علىأJأ
• DocumentationلمعلوماتJJوثيقاJJJت
• Do written procedures exist for the operation/activity performed at the time of the incident? وجدJJJهلت
حادث
ل ؟JJيوقتوقوع اJJJ فJنفيذهJJJ تJمJJJلذيتJJلنشاط اJJ ا/ لعمليةJJتمكتوبة لJجراءاJإ
• Do written maintenance procedures exist for the equipment involved in the incident?
• هل توجد إجراءات صيانة مكتوبة للمعدات المعنية بالحادث؟
• Was maintenance performed on the equipment involved in the incident?
• ء الصيانة على المعدات المعنية بالحادث؟Jهل تم إجرا
• Did clearly-written procedures exist for all tasks required for this process/equipment?
• المعدات؟/ لعمليةJهل توجد إجراءات مكتوبة بوضوح لجميع المهام المطلوبة لهذه ا
• Do written procedures describe the potential consequences of deviations?
• هل تصف اإلجراءات المكتوبة العواقب المحتملة لالنحرافات؟
• Do written procedures describe the PPE required?
• هل توضح اإلجراءات المكتوبة أن معدات الحماية الشخصية مطلوبة؟
• Systems Review JلنظامJJضاJراJستعJا
• Was the appropriate PPE available and worn? لمناسبة متوفرة؟JJلشخصية اJJلحماية اJJتاJداJانتمعJهلك
• Have you received training on this process and equipment? تJ
دا ؟JلمعJJلعملية واJJ اJلتدريبعلىهذهJJلقيتاJJJهلت
Focusing the Analysis -لتحليلJJلتركيز علىاJJا
• Consider the likelihood and magnitude of impact of each potential cause, and assess
most deeply (i.e., spend the most time on) those which are most likely or which may
contribute most of the impact. Although the team may brainstorm 20+ potential
causes, they vary in their placement along the continuum…
• وتقييمها بعمق (أي قضاء معظم الوقت على) تلك، النظر في احتمالية وحجم تأثير كل قضية محتملة
على الرغم من أن الفريق قد يقوم بعصف.التي من المرجح أو التي يمكن أن تسهم في معظم التأثير
إال أنه يختلف في موضعه على طول السلسلة المستمرة، سببًا محتماًل20 ذهني ألكثر من...
123
Summary -ملخص
• Use Root Cause Analysis for actual or near miss incidents, to prevent
recurrence كرارهاJJJ تJمنعJJ ل، ريبةJJ قJعلية أوJJJحوادثفJJلجذريلJJلسبباJJحليلاJJJ تJمJستخداJا
124
Root Cause Analysis
To
Deliver Value Added Results
A Brief History Behind Root Cause Analysis (RCA)
لجذريJJلسبباJJحليلاJJJاريخ موجز وراء تJJJ ت-
• Developed by Sakichi Toyoda who later founded Toyota Motor
Company.
• الذي أسس الحقا ً شركة تويوتا..... تم تطويره بواسطة تاويودو.
• Process circumstances and other influencing items that led the person or
persons to make the decisions
• ظروف العملية والعناصر المؤثرة األخرى التي قادت الشخص أو األشخاص إلى اتخاذ القرارات
• Decision-making authority of the person or persons involved.
Techniques قنياتJJJت
Output 2 Input 2
Process Step
2
• Criteria اييرJلمعJJا
• Condition رطJJش
• Consequence/Effect أثيرJJJ ت/ تيجةJJن
• CauseببJJس
• Corrective Action/Recommendation لتصحيحيةJJلتوصية اJJ ا/لعملJJا
Five Cs
• Criteria اييرJلمعJJا
• The law, regulation, contractual obligation, policy, procedure, or best
practice that is expected to be followed
• Condition رطJJش
• The factual analysis of the process as it exists
• Consequence/Effect
• Why the issue is important and noteworthy from a compliance, financial, or
operational standpoint.
Five
• Cause Cs
• The root cause which allowed the condition to not emulate the criteria.لسببJJا
اييرJلمعJJ محاكاة اJدمJعJJJلة بJJلحاJJ لJمحJJلذيسJJلجذرياJJا.
• Corrective Action/Recommendation لتصحيحيةJJلتوصية اJJ ا/لعملJJا
• Change that will address the root cause, allow the current condition to
mirror best practice or other criteria and does not cost more in relation to
its effect.
• يسمح للشرط الحالي بأن يعكس أفضل الممارسات أو المعايير األخرى، التغيير الذي سيعالج السبب الجذري
وال يكلف أكثر فيما يتعلق بتأثيره.
• Factsحقائق
Situation 1 - Wire
• Wire was released for $2,828,282,828.28
• Why was it released? Use 5 why’s
• حقائق
• دفع الموظفون عمولة
• سجالت مزورة
• RCA can be used in consulting opportunities requested by Management, the Audit Committee,
by circumstances resulting from an audit, from many situations.
Adding Value - Opportunities
• I have received these opportunities from:
• Hotline calls
• H.R. requests
• Legal requests
• Line of Business requests
• Audit Committee requests
• من العديد من، حسب الظروف الناتجة عن المراجعة، لجنة التدقيق، يمكن استخدامها في الفرص االستشارية التي تطلبها اإلدارة
المواقف.
• لقد تلقيت هذه الفرص من:
• مكالمات الخط الساخن
• طلباتH.R.
• طلبات قانونية
• طلبات خط العمل
• طلبات لجنة التدقيق
Adding Value – HowيفJJلقيمة – كJJا اJمضيف