Corrective action response

Definitions

Corrective Action: A solution meant to reduce

or eliminate an identified problem.
Correction: Action to eliminate a detected
nonconformity. (Immediate fix) (Example:
Rework, Regrade)
Preventive Action: Action taken to remove or
improve a process to prevent potential future
occurrences of a nonconformance.
Nonconformity: The non-fulfillment of a
specified requirement.
Root Cause: A factor that caused a
nonconformance and should be permanently
eliminated through process improvement.
 Non confirming work
When one or more characteristics of a product fail to
meet specified requirements, we have a non-
confirming work.
Number one rule: If you cannot express the
nonconformity in the words of the management
system standard, the appropriate test or calibration
method, laboratories own policies and procedures -
Then you do not have a non-conformity.
Corrective action requires:
a) A specific requirement
b) Evidence that the requirement has not been met
) If you dont have either of them, then you dont have
a Nonconformity and you dont have to initiate
corrective action!!
 Corrections - containment

Stopping work
Evaluating significance of the problem
Taking immediate Correction the immediate fix
Notifying customers if necessary
Resuming work
Root cause analysis (RCA)
RCA is the key and sometimes the most
difficult part in the corrective action
procedure.
Often the root cause is not obvious and
thus a careful analysis of all potential
causes of the problem is required.
Potential causes could include customer
requirements, the samples, sample
specifications, methods and procedures,
staff skills and training, consumables, or
equipment and its calibration.
 Principles of RCA

Must be performed systematically as an

investigation.

Not a blame game

Not looking for the immediate fix
Dig deeper
Establish a sequence of events or timeline
Understand the relationships between the contributing factors
 General process for performing a rca

Define the problem.

Gather data/evidence.
Ask why and identify the true root cause associated
with the defined problem.
Identify corrective action(s) that will prevent
recurrence of the problem.
Implement the corrective action(s).
Observe the corrective actions to ensure
effectiveness.
If necessary, reexamine the RCA.
 Tools and techniques for rca

Flow charts
Records
Documents
Interviews
Five whys
Cause and effect
Diagramming
Checklist
 Root cause analysis
Ask questions to define the problem:
What is the problem? (this is the issue that
we want to stop from happening again)
When did it happen? (when did the
primary effect occur)
Where did it happen? (the location of the
primary effect)

WE WONT ASK THE QUESTION

WHO? this is not the place for blame!!
 Root cause analysis

Root Cause Analysis encourages brainstorming by ALL who

are involved
There is no judgement and no wrong answers
We are encouraged to find multiple root causes, and pick
the most appropriate
We are encouraged to find multiple corrective actions and
pick the most appropriate
 WHY?
Roof shingles are missing
WHY?
Rain thru hole in garage roof
WHY?
Box got wet
WHY?
Box of nails on shelf split open
WHY?
Nails on garage floor
Problem or primary effect: Flat Tire
Example - Five whys
Fishbone/cause and effect diagram
Example - Cause and effect diagram
 Root cause analysis

Unacceptable root causes

Human error
Mistakes

Distraction

Unacceptable Corrective Actions

Reminded employees

Retraining
Instructed to pay more attention
A2LA explanation on rca
 Its time to practice!

Problem Kitchen destroyed by fire

It was 5 p.m. Mary was frying chicken. Her friend
Jane stopped by on her way home from the doctor,
and she was very upset. Mary invited her into the
living room so we could talk. After about 10
minutes, the smoke detector near the kitchen came
on. Mary ran into the kitchen and found a fire on
the stove. Mary reached for the fire extinguisher
and pulled the plug. Nothing happened. The fire
extinguisher was not charged. In desperation, Mary
threw water on the fire. The fire spread throughout
the kitchen. Mary called the fire department, but the
 Pan
Pan Burner
Aluminium Arcing heats
bottom of Electric
Jane melts forming
aluminium burner
hole in pan
Jane comes pan shorts out
to the door CF
Conclusion

Grease ignites
Jane when it hits the Assumption Mary Mary
burner
Fire Fire
Jane rings Mary sees fire
generates extinguisher
the doorbell on stove
smoke not charged

Fire starts on
Mary Mary the stove Mary Mary Mary

Mary begins Mary leaves Mary runs Mary tries to Fire extinguisher
Smoke alarm
frying frying chicken into the use the fire does not operate
Jane, Mary sounds
chicken alone kitchen extinguisher when Mary tries it
17:00 CF Mary chats About 17:10
CF
with Jane
Mary Mary
Mary uses 10 minutes
Mary pulls the
an
plug on fire
aluminium Mary, pan extinguisher
pan
Fire was a
grease fire

Mary Kitchen, Mary Mary, FB FB

Mary throws Fire spreads Mary calls Kitchen

Fire brigade Fire brigade
water on the throughout the fire destroyed by
arrives puts out fire
fire the kitchen brigade fire
CF
 Root cause summary table
Causal Factor 1
Description: Mary leaves the frying
chicken unattended
Recommendations
Implement a policy that hot oil is never left
unattended on the cooker
Determine whether policies are required for
other types of hazards

Causal Factor 2 Recommendations

Description: Electric burner element
fails (burns out)
Replace all burners on cookers
Develop a preventative maintenance
strategy to periodically replace burner
elements
Consider alternative, less hazardous
methods for preparing chicken
 Root cause summary table
Causal Factor 3
Description: Fire extinguisher does
not operate when Mary tries to use it
Causal Factor 4
Description: Mary throws water on
fire
Recommendations
Refill fire extinguisher
Inspect all fire extinguishers in the building
to make sure they are full
Ensure a safety equipment audit is properly
in place
Recommendations
Provide practical training on the use of fire
extinguishers
Review overall training plan
Thank You