Module 1 RCA

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Disciplined Approach

to Problem Solving for


Continual Improvement
Rationale
The need for RCA stems from the fact that
the elimination of the symptoms of the
problem is not alone sufficient to address
the problem, it has to be addressed at the
source. Solving a problem on the root level,
it is highly probable that the recurrence or
occurrence of the problem can be
prevented.
What is Root Cause Analysis?

Nonconformity (Problem)-

Failure of a process, which when resolved


prevents its recurrence.
Factor that contributes to the occurrence of
a problem.
What is Root Cause Analysis?
Root Cause Analysis (RCA) is a set of
analytical and problem solving techniques
targeted at identifying the actual root
cause or the reason for the
nonconformity.
A method that is used to address a problem or
nonconformance to get to the root cause, for it to
be eliminated thus, preventing the problem/
nonconformance from RECURRING and a
potential problem from OCCURRING.
What is Root Cause Analysis?

Problem Solving is the communication


that analyzes the problem in detail before
decision making

Decision Making is the communication


that results in a choice
ISO 9001:2015 QMS
4 Context of the organization

4.1 Understanding the organization and its context

…shall determine internal and external issues that


are relevant to the purpose of the organization and
its strategic direction, issues that affect the
organization’s ability to achieve the intended
result(s) of its quality management system.

Monitor and review information about these


internal and external issues.
ISO 9001:2015 QMS
4 Context of the organization

4.2 Understanding interested parties by


determining, monitoring and reviewing their
needs and expectation
The organization shall determine the ff.:

a. Who are the interested parties relevant to the


QMS.
b. Requirements of interested parties that are
relevant to the QMS.
ISO 9001:2015 QMS
6 Planning

6.1 Actions to address risks and opportunities


When planning, the organization shall consider the
issues referred to 4.1 and the requirements referred
to in 4.2 and determine the risks and opportunities
that needs to be addressed to:

a. Give assurance that the QMS can achieve


intended results;
b. Enhance desirable effects;
c. Prevent or reduce undesired effects
d. Achieve improvement
ISO 9001:2015 QMS
10 Improvement

10.1 General

The organization shall determine and select


opportunities for improvement, and implement
necessary actions to meet customer requirements
and enhance customer satisfaction, this shall
include;

a. Improve products and services to meet


requirements as well as future needs and
expectations;
ISO 9001:2015 QMS
10 Improvement

10.1 General

…this shall include;

b. Correcting, preventing, or reducing undesired


effects;

c. Improving the performance of the quality


management system.
ISO 9001:2015 QMS
10 Improvement

10.2 Nonconformity and corrective action

When nonconformity occurs, including complaints,


the organization shall;

a. react to the nonconformity, and as applicable:


1) take action to control and correct it;
2) deal with the consequences;
ISO 9001:2015 QMS
10 Improvement

10.2 Nonconformity and corrective action

…the organization shall;

b. evaluate the need for action to eliminate the


cause(s) of the nonconformity in order to prevent
recurrence and occurrence elsewhere by:
1) reviewing and analyzing the nonconformity
2) determining the root causes
3) determining if the same nonconformities
exists, or could potentially occur;
ISO 9001:2015 QMS
10 Improvement

10.2 Nonconformity and corrective action

…the organization shall;

c. implement any actions needed;


d. review the effectiveness of the actions taken;
e. update risks and opportunities determined
during planning, if necessary;
f. make changes in the quality management
system, if necessary.
ISO 9001:2015 QMS
10 Improvement

10.3 Continual improvement

The organization shall continually improve the


suitability, adequacy, and effectiveness of the
quality management system.
General Requirements
POTENTIAL Nonconformity

 Determine action to eliminate the causes of


potential nonconformities
 Prevent occurrence of NC
 Take preventive actions appropriate to the
effects of the potential NC

1) Determine potential NCs


2) Evaluate the need for action to ensure NC do not
occur
3) Determine the potential root cause(s)
4) Determine and implement action(s) needed
5) Document actions taken
6) Review effectiveness of the corrective action
How to prevent occurrence of NC?
Potential Nonconformity
- Potential Nonconformities are identified.
- Possible problems are recognized.

Root Cause Analysis


- Analyze and identify the cause of potential
nonconformity
- Analyzing the cause of the possible problem.

Preventive Action
- Action taken to prevent occurrence of
potential
nonconformity
- Preventing the problem from happening.

Evidence of Effectiveness
- Records of effectiveness of actions taken.
General Requirements
ACTUAL Nonconformity
 Take action to eliminate the causes of
nonconformity
 Prevent recurrence of NC
 Take actions appropriate to the effects of the
nonconformity encountered

1) Take action to control and correct the NC, and


deal with the consequences
2) Evaluate the need for action to ensure NC do not
recur
3) Determine and implement action needed
4) Document actions taken
5) Review effectiveness of the corrective action
How to prevent recurrence of NC?

Nonconformities
- Identified.
- Problems are recognized.

Correction
- Immediate action taken to correct the NC.
- Solving the problem.

Root Cause Analysis


- Analyze and identify the closest possible cause
- Analyzing the cause of the problem.

Corrective Action
- Action taken to address the root cause of
nonconformity.
- Preventing the problem from recurring.

Evidence of Effectiveness
- Records of effectiveness of actions taken.
Tools and Techniques
for Problem Solving
Tools and Techniques for Problem Solving

• Selecting the right root cause analysis


tools to solve a problem is paramount to
not only ensure the analysis is effective
and efficient, but also that the real root
cause is in fact identified.

• Identifying the root cause doesn’t require


complex tools.
Tools and Techniques for Problem Solving

Pareto Analysis
The Pareto principle also known as the 80-20
rule derived from the Italian economist Vilfredo
Pareto’s observations about the factor of sparsity
which states that 80% of the effects are coming
from 20% of the causes.

This also holds true to the


business’ rule of thumb
that 80% of the sales are
contributed by only 20% of
the customers.
Tools and Techniques for Problem Solving

Tree Diagram/Analysis

Fault tree analysis


is a top-down,
deductive failure
analysis in which an
undesired state of a
system is analyzed
using Boolean logic
to combine a series
of lower-level
events.
Tools and Techniques for Problem Solving

Brainstorming

Technique used to solicit ideas from a


group of people on a given subject, it is a
creative and systematic way of stimulating
and generating large number of ideas.
Tools and Techniques for Problem Solving

5 WHY ( Why – Why Analysis)


Tools and Techniques for Problem Solving

Ishikawa Diagram

A schematic diagram that shows the


systematic relationship between a
problem or effect and its causes
Tools and Techniques for Problem Solving

Eight Disciplined (8Ds) Approach to


problem solving is a method developed at
Ford Motor Company used to approach and
to resolve problems, typically employed by
engineers or other professionals. Focused
on product and process improvement, its
purpose is to identify, correct, and eliminate
recurring problems.
Disciplined Problem Solving Approach
D0 • Data gathering 8D
D1 • Team Identification
• Problem Description (Actual and
D2 Potential)
D3 • Develop Interim/Correction Action
• Root-cause Analysis (Actual and
D4 Potential)
D5 • Determination of Corrective Action

D6 • Implementation Corrective Action

D7 • Standardization

D8 • Closure
Risk Management
Risk Management

Potential impact to the process, product and


service, office, organization and the customer

The magnitude or severity of the problem

likelihood of occurrence

Capability of the existing system to detect the


problem before or during occurrence

The likelihood to be the root cause(s) of a problem,


its controllability

Necessary actions to prevent the occurrence of the


identified problem
Practice Problem Solving
• Data Gathering
DO
DO

Objective: To identify and gather relevant


information necessary to the
identification of the problem.

DO Procedure
1. Review the nonconformity report, identify
the specific product or service reported; the
nature of the complaint or the
nonconformity and the details such as the
date, time, area of service, stages of the
process and the responsible employee.
• Data Gathering
DO
DO

2. The verification of the current operation


shall be a priority.

 Method/system/process
 Man
 Machine
 Materials
 Environment
• Data Gathering
DO
DO

3. Re-visit process records such as monitoring


report (including digital files) and other
historical records relative to the processing
of the reported product or service.
4. If applicable, retrieve the affected product
or service or at least a sample from the
customer.
5. Ensure all necessary information are
available.

OUTPUT : INITIAL FINDINGS


• Team Identification
D1
D1

Objective: To gather credible and reliable


information necessary to solve
reported nonconformity.

 Relative to the reported nonconforming


product/service, establish a cross-functional
team, with identified authority, skills,
product/service knowledge and required
discipline, to analyze the reported problem.
 The appropriate correction and corrective
action shall be formulated by the people
composing the team. Identify a group leader
(champion).
• Team Identification
D1
D1

D1 Procedure

1. Identify Team Leader and secretary.


2. Establish responsibilities of members.
3. Set target dates for the achievement of set
goals or activities.
4. Schedule meetings.

OUTPUT : TEAM ESTABLISHED


D1 • Team Identification

D1 Example

Champion : Name – ASO


Secretary : Name – Mktg. Personnel (OD)
Members : Name – C&A Dept AM
Name – COD
Name – Security Officer
Name – Unitility Personnel
D1 • Team Identification

D1 Example

Champion : Name – HR Supervisor


Secretary : Name – HR Assistant
Members : Name – Finance Staff
Name – Accounting Staff
Name – Payroll Officer
D2
D2 • Problem Description

Objective: Establish a clear description of the


reported nonconformity aimed to
define appropriate actions to
provide effective solutions.

1. Clearly define the problem. Using the


report (CAR, analysis) as reference, the
team needs to evaluate the following:

• Nature of the problem


• Requirements
• Processes and personnel involved
• Impact
D2
D2 • Problem Description

2. Analyze process documents and records


relative to the reported nonconformity.
• process history
• environment
• process condition
• action plans

Describe the problem using all indicators to


identify the degree and magnitude.

3. Define controllability of the problem.


D2
D2 • Problem Description

Describe the problem in customer’s perspective


against operation or management’s perspective.

Identify in quantifiable term, the who, what,


when, where, why, how and how many for the
problem.
D2
D2 • Problem Description

D2 PROCEDURE:

1. State the problem as claimed by the


Customer
2. Describe the problem in the point of view of
the organization
3. Establish the affected batch, date, coding,
etc.
4. Document items 1 – 3.

OUTPUT : PROBLEM DESCRIBED


D2 • Problem Description

D2 Example:

Payroll Release : 06-0630-101 Div. A


Nature of NC : Unpaid OT,
Sept. 25 - 26
8AM – 10AM (5 hrs)
Service Rqmt. : No unpaid OT,
HRD Procedure (DP08-A
V4)
Sec. 14.
• Develop Interim/Correction Action
D3
D3

Objective: To effectively and efficiently contain


problem.

 Identify interim, correction or containment


actions appropriate to the nature of the
nonconformity reported.

 Consider defining the impact of the problem


to the affected customer and other possible
complainant, whether internal or external.
• Develop Interim/Correction Action
D3
D3

 Products and services on process

 Other similar processes.

Contain the effects problem and isolate other


external or internal customer from the
nonconformity.

Firewalls (additional verification and validation)


are the usual action.
• Develop Interim/Correction Action
D3
D3

D3 PROCEDURE:
1. Establish correction action to arrest the
problem and prevent it from reaching
the customers
• Trace other affected outputs
• Disseminate information, if needed
2. Monitor result of ICA (rejection rate)
3. Release waiver, notices to concerned
process(es)
4. Update affected inspection criteria and
standards.
OUTPUT : ICAs ESTABLISHED
• Develop Interim/Correction Action
D3
D3

D3 Example:

• Inform other members of the validity of the


MID and advise the correct ID.
Responsible: Mktg. COD
• Provide concerned processes of the corrected
data.
Responsible: QA Engineer
• Pull out affected materials from the work area.
Responsible: COD
• Conduct 100 % sorting / re-inspection. Define
inspection criteria and instruction
Responsible: Dept. Manager
• Root-cause Analysis
D4
D4

Objective:
Effectively and efficiently determine the root
cause(s) of the nonconformity or the problem.

• Specify the root cause by evaluating all


possible causes against the problem
description and processing date.

• Also, verify and isolate the area in the


operation where the effect of the root cause
should have been detected and contained
(escape point).
• Root-cause Analysis
D4
D4

D4 PROCEDURE:

1. Review and update the problem description.


2. Conduct a scientific approach to determine
the root causes of the reported
nonconformity and its outflow (escape point).
3. List the potential root causes.
4. Identify the real root cause(s).

OUTPUT : VERIFIED REAL ROOT CAUSE List


• Root-cause Analysis
D4
D4

Factors in RCA?
1) Focus – corrective actions are more
effective if focused on addressing the root
causes than merely treating the symptoms
(or just doing remedial action).

2) Factual basis – effective RCA and


corrective actions are based on factual
information, or evidence-based.
• Root-cause Analysis
D4
D4

Factors in RCA?
3) Approach – effective RCA and corrective
actions must be carried out systematically
though a defined plan of action

4) Multiplicity – there can be more than one


root-cause for a given problem or
nonconformity
• Root-cause Analysis
D4
D4

Finding the Root Cause


This will provide the “why” (cause) and possibly
lead to the “how” (the solution)

Finding the root Cause should:


- Use a disciplined approach (or technique)
- Address the system problem
- Be a team effort
- Be verified
- Not stop at “Staff Error”
• Root-cause Analysis
D4
D4

Finding the Root Cause


• Brainstorm for possible causes
• Show relationship among
causes
• Validate causes
• Identify and classify root causes
according to controllability
• Select major root causes
• Root-cause Analysis
D4
D4

Brainstorming
• Technique used to solicit ideas
from a group of people on a given
subject, it is a creative and
systematic way of stimulating and
generating large number of ideas
• Root-cause Analysis
D4
D4

Brainstorming Rules
1. Topic to be brainstormed should be
defined clearly
2. Each member is asked for ideas
3. A member can offer one idea each time
4. Member says “pass” when he has no idea
5. Criticisms are not allowed
6. Free-wheeling is welcome
7. Large number of ideas is desirable
8. Combine ideas for improvement
9. Make sure all members contribute ideas
10. Record all ideas
• Root-cause Analysis
D4
D4

Tools

 Why-why Analysis

 Ishikawa Diagram
• Root-cause Analysis
D4
D4

Why-why Analysis
A question-asking method to determine cause
and effect relationship in a particular problem
in a stair-stepping fashion.

 Root Cause may become obvious after 3, 4,


or 5 Whys.
 The Root Cause should be described at the
system level.
• Root-cause Analysis
D4
D4

Why-why Analysis
» Subsequent Corrective Action should
address and eliminate the Root Cause
identified.
» Verification should ensure that the system
is more robust and recurrence is unlikely
or impossible.
» Implementation and verification must be
supported by objective evidence.
• Root-cause Analysis
D4
D4

Why-why Analysis SLIPPERY and


UNSAFE FLOOR

2
Machine is leaking
3
Oil coupling is leaking

1 4 Rubber lining inside oil


coupling is worn out
Oil on Floor
5
Wear and tear
• Root-cause Analysis
D4
D4

Why-why Analysis Frequent


delays in the
submission of
reports

2 Frequent computer
breakdown
3
No regular maintenance

1 4
No preventive
maintenance schedule
Machine/
Equipment 5 No office is in-charge
of computer
maintenance
• Root-cause Analysis
D4
D4

Ishikawa Diagram

A schematic
diagram that
shows the
systematic
relationship
between a
problem or effect
and its causes
• Root-cause Analysis
D4
D4

Ishikawa Diagram
Possible or Corrective Correction
Detected or Actions
Preventive

Man Machine Material

Charact
eristic
(Result)
Method Environment Effect

Cause
• Root-cause Analysis
D4
D4

Ishikawa Diagram
1. Controllable or uncontrollable
2. Investigate causes through brainstorming.

Logic – logical proof


Reality Verification – by observation or interview
(observe where the problem
was noted)
Results Verification – testing, checking,
experimenting, simulation or
taking actions and evaluating
the results
• Root-cause Analysis
D4
D4

Ishikawa Diagram
3. Write results of action taken in verifying
cause.
4. Make a remark whether it is the most
probable cause or not.
Categories of Causes D4
Causes arising out of the
Manpower actions SOPs are not followed
or performance of person

Causes arising out of the


systems Too many signatories
Method or procedures in doing the
work

Causes arising out of the Shortage of internet


Material items facilities
needed to deliver the service

Causes arising out of the Frequent breakdown


Machine eqp’t. of computer
used to deliver the service

Causes arising out of the Lay-out, room


Environment condition temperature,
in which the work is carried out facilities
Ishikawa Diagram
1. Write the effect on the right-most part and connect
it into the spine.

Man Machine Material

Increasing Customer
Complaints on Long
Waiting Time

Method Environment
Ishikawa Diagram
2. Identify the major causes or groups of causes.
Write them into the large bones.

Material Equipment

Slow processing of computers


Shortage of forms
Computer virus
No computer
maintenance Increasing
Customer
Complaints on
Ineffective frontline Long Waiting
staff Long cycle SOPs not followed
Varied interpretation of rule
Time
Too much workload Too many
signatories Proper orientation not provided
Poor planning

Manpower Method
Ishikawa Diagram
3. Identify the causes under each major cause or
group of causes by asking “why” at most five times.
Write each cause into the middle & small bones.

Material Equipment

Slow processing of computers


Shortage of forms
Computer virus
No computer
maintenance Increasing
Customer
Complaints on
Ineffective frontline Long Waiting
staff Long cycle SOPs not followed
Varied interpretation of rule
Time
Too much workload Too many
signatories Proper orientation not provided
Poor planning

Manpower Method
Ishikawa Diagram
4. Determine controllable and uncontrollable root
causes.

Material Equipment

Slow processing of computers


Shortage of forms
Computer virus
No computer
maintenance
Increasing
Customer
Complaints on
Ineffective frontline Long Waiting
staff Long cycle SOPs not followed
Varied interpretation of rule
Time
Too much workload Too many
signatories Proper orientation not provided
Poor planning

Manpower Method
• Determination of Corrective Action
D5
D5

Should focus on:

 Addressing the system problem


 Eliminating the Root Cause
 Implementing CA or PA planned in a timely manner
 Include a detailed Action Plan if it will take
considerable time
 For identified NCs, implementing correction action
controls while CA is being implemented is necessary
 Be commensurate with the risk involved
 Risk to the customer, employee, organization,
public, etc.
• Determination of Corrective Action
D5
D5

• Refer to the objectives of CA and PA


• For NONCONFORMITIES, generate
alternative solutions per root cause
• Choose best solution
• For POTENTIAL NONCONFORMITIES, do
a Potential Problem Analysis
• Detail out implementation of solution
(Action Plan)
• Determination of Corrective Action
D5
D5

CA/PA Tools and Techniques

• Solutions Formulation
Matrix
• Gantt Chart
• Tree Diagram
• Determination of Corrective Action
D5
D5

Solutions Formulation Matrix


Target Date
Controllable
CA/PA
Root Causes Responsible Resources
Solutions or
Potential Person Needed
Activity Start Finish
Root Causes

Identify the controllable root causes.

Determine the timelines, person responsible, and


needed resources.
• Determination of Corrective Action
D5
D5

Solutions Formulation Matrix


Why is prioritizing corrective/preventive action
important?

1. To ensure that actions are implemented with


undue delay
2. To ensure undivided attention and full
concentration in ensuring that the problem does
not recur/occur
3. To show the seriousness and degree of
importance of implementing a corrective action
over other actions
• Determination of Corrective Action
D5
D5

Consensus Decision-Making

 Finding an idea or proposal acceptable enough


that all members can support it
 Having a free and open exchange of ideas which
continue until agreement is reached
 Each individual’s concerns are heard and
understood
 Conclusion may not reflect exact
wishes of each person but does
not violate the deep concerns of
everyone
• Determination of Corrective Action
D5
D5

Guidelines for Consensus Decision-Making

1. Avoid arguing for your own individual


judgements. Approach the task on the basis
of logic.
2. Avoid changing your mind only in order to
reach agreement and avoid conflict.
3. Avoid “conflict-reducing” techniques such as
majority vote, averaging, or trading
in reaching your decision.
• Determination of Corrective Action
D5
D5

Guidelines for Consensus Decision-Making

4. View differences of opinion as helpful rather


than as a hindrance in decision-making.

5. Settle on something that you can “live with


but not necessarily die for.”
• Implementation Corrective Action
D6
D6

Gantt Chart
ACTIVITIES
WEEK
1 2 3 4 5 6 7 8 9 1 1 1
0 1 2
1. Draw up current process

2. Remove non-value adding


operations
3. Determine preliminary improvement

4. Determine resource requirements

5. Make a skills inventory

6. Formalize responsibility matrix

7. Implement training plan

8. Update skills inventory

9. Pilot Test

10. Determine Results (positive/


negative)
11. Standardize
D6
D6 • Implementation Corrective Action

 Based on the planned Action Plan


 Ensure designated functions
 With necessary resources
 On or before agreed timeliness

NOTE:
 An un-implemented, or partially
implemented, Corrective or Preventive Action
will definitely not eliminate nor prevent the
recurrence or occurrence of the NC.
 A fully implemented planned Corrective
Action may still not effectively prevent
recurrence.
• Standardization
D7
D7

Objective:
Ensure the prevention of the recurrence or
occurrence of identified NCs and/or Potential NCs.

Modify the existing systems by


incorporating the formulated
corrective/preventive action. Modification
includes policies, practices, and
procedures to prevent recurrence of this
problem and similar ones. Make
recommendations for systematic
improvements as necessary.
• Standardization
D7
D7

D7 PROCEDURE:

1. Review and analyze D4. How did the problem


occurred and flow out?
2. Identify gaps in the system’s policies,
practices and procedures that allowed this
problem to
occur and escape to the customer.
3. Analyze how similar problems can be
addressed.
• Standardization
D7
D7

D7 PROCEDURE:

4. Develop preventive actions that will address


the problem and similar problems in other
areas.
5. Incorporate and document preventive actions
on the applicable control plans, Process flow,
process specification and other systems.

OUTPUT : STANDARDIZED COUNTERMEASURES


• Closure
D8
D8

Objective:
Ascertain the resolution and elimination of the
reported nonconformity in the system

Verification of Effectiveness
Often confused with verification of implementation,
the completion of corrective action tasks the
monitoring and measurement of the process to
verify the effectiveness of the actions taken.

Poor results often indicate wrong Root Cause or


wrong Corrective Action(s). Consider performing
audits as a verification tool.
• Closure
D8
D8

D8 PROCEDURE:
1. Verify the documentation and implementation
of the TEAM’s preventive actions.
2. Review the internal / external data to validate
if the symptom as defined by the customer has
been eliminated.
3. Congratulate the TEAM if there is no incident
of the symptom as defined by the customer
after 6 consecutive weeks.
4. Indicate the date the G8D has been closed.

OUTPUT : G8D COMPLETED

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