Module 1 RCA
Module 1 RCA
Module 1 RCA
Nonconformity (Problem)-
10.1 General
10.1 General
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
Nonconformities
- Identified.
- Problems are recognized.
Correction
- Immediate action taken to correct the NC.
- Solving 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
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.
Tree Diagram/Analysis
Brainstorming
Ishikawa Diagram
D7 • Standardization
D8 • Closure
Risk Management
Risk Management
likelihood of occurrence
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
Method/system/process
Man
Machine
Materials
Environment
• Data Gathering
DO
DO
D1 Procedure
D1 Example
D1 Example
D2 PROCEDURE:
D2 Example:
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:
Objective:
Effectively and efficiently determine the root
cause(s) of the nonconformity or the problem.
D4 PROCEDURE:
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).
Factors in RCA?
3) Approach – effective RCA and corrective
actions must be carried out systematically
though a defined plan of action
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.
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
2
Machine is leaking
3
Oil coupling is leaking
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
Charact
eristic
(Result)
Method Environment Effect
Cause
• Root-cause Analysis
D4
D4
Ishikawa Diagram
1. Controllable or uncontrollable
2. Investigate causes through brainstorming.
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
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
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
Manpower Method
Ishikawa Diagram
4. Determine controllable and uncontrollable root
causes.
Material Equipment
Manpower Method
• Determination of Corrective Action
D5
D5
• Solutions Formulation
Matrix
• Gantt Chart
• Tree Diagram
• Determination of Corrective Action
D5
D5
Consensus Decision-Making
Gantt Chart
ACTIVITIES
WEEK
1 2 3 4 5 6 7 8 9 1 1 1
0 1 2
1. Draw up current process
9. Pilot Test
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.
D7 PROCEDURE:
D7 PROCEDURE:
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.
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.