capa process (corrective action & preventative action) · the capa process ti hi preventive...
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CAPA ProcessCAPA Process
(Corrective (Corrective Action & Preventative Action)Action)Bill Greenwood Director, Quality Technology ProgramsDirector, Quality Technology ProgramsKellogg Company
Objectives
1 U d d h CAPA P1. Understand the CAPA Process2. Ability to apply Structured Problem Solving Tools and Techniques to
Food Safety Incidentsood Sa e y c de s
2
What is CAPA?
1. Part of the Preventative Control Process that Supports a Food Safety PlanPlan
2. Provides a systematic approach to identify, solve, and prevent re-occurrence of food safety incidents
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Why do we need to f ll th CAPA follow the CAPA Process?1. FDA Food Modernization Act requires that Preventative and
Corrective Action be taken for Food Safety IncidentsCorrective Action be taken for Food Safety Incidents2. Identifies Root Cause of Food Safety Incidents3. Identifies Solutions for Food Safety Incidents3 de es So u o s o ood Sa e y c de s4. Reduces the chances of having re-occurring Food Safety Incidents
through Verification and Validation
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AGENDA
1. Overview of CAPA Process2 Wh S d P bl S l i2. When to use Structured Problem Solving3. Structured Problem Solving Tools and Techniques4 Implementation Validation and Verification4. Implementation, Validation, and Verification5. Wrap Up
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The CAPA Process
T i HiPreventive C Trigger HitControls in Place
Determine Problem Solving Path
ImplementationVerification
Knowledge Management
RCA Investigation & Problem Verification
ValidationManagement Process
& Problem Solving Tools
Adjust and Improve6
The CAPA Process
T i HiPreventive C Trigger HitControls in Place
Determine Problem Solving Path
ImplementationVerification
Knowledge Management
RCA Investigation & Problem Verification
ValidationManagement Process
& Problem Solving Tools
Adjust and Improve7
The CAPA Process
T i HiPreventive C Trigger HitControls in Place
Determine Problem Solving Path
ImplementationVerification
Knowledge Management
RCA Investigation & Problem Verification
ValidationManagement Process
& Problem Solving Tools
Adjust and Improve8
When to use Structured Problem SolvingProblem Solving
iWhich of 2 paths should be followed?
It depends on….Determine Problem
Needed NotNeeded
Severity Complexity
Determine Problem Solving Path
Complexity Trend R ImplementationRCA Investigation Recurrence If HACCP CCP pre-determined
ti ti did t dd
ImplementationVerificationValidation
RCA Investigation & Problem
Solving Tools
corrective action did not addressroot cause
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The CAPA Process
T i HiPreventive C Trigger HitControls in Place
Determine Problem Solving Path
ImplementationVerification
Knowledge Management
RCA Investigation & Problem Verification
ValidationManagement Process
& Problem Solving Tools
Adjust and Improve10
Structured Problem Solving
Traditional approach vs. Structured
Solving
approach
ProblemProblem
Solution
Solution
Solution(quick fix)
(prevent recurrence)
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Traditional Approach to Problem Solving
Typical reasons for treating
Treat symptoms
Problem Solving
Short-term focus on “getting production
symptoms
Situation
Metal found
symptoms
“getting production out”
Initial
Metal found in food
Inconsistent role modeling from management
finding
A part broke and management
Cultural issues –
broke and fell into foodTypical response Cultural issues
fire fighters gain a “hero” status and are repeatedly
Fix the part
yp p
p yasked to fix fires rather than find root cause
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Problem Solving Tools Phased Approach for
5. Proactive Improvement - Six Sigma Advanced Problem Solving
Phased Approach for Capability
Advanced Problem Solving
4. Problem and Waste Elimination - Advanced
3. Problem and Waste mitigation –Traditional Lean
problem solving methods and tools and statistics-based decisions
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5Traditional Lean methodology and data-based decisions
2
32. Problem and Loss Awareness –Basic Methods and Tools
1
1. Firefighting
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Structured Problem SolvingSolving
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Getting Started – Forming the Team
MeaningfulMeaningfulpurpose
Smallnumbers &
Clearperformance
clear rolesperformance
goalsTeam
BASICS
Mutualaccountability
Well definedworking
approachComplimentary
skills
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1. Define the Problem
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1. Define the Problem
What?, When?, Where?, How?, Who?
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2. Analyze the Problem
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2. What do we Know?
Process flow
Location
Frequencyq y
Other actions taken
Other studies
Who was involved
Time (Day, Shift…)Time (Day, Shift…)
AVOID THE “FOG”
F – FACTSO – OPINIONS
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O OPINIONSG - GUESSES
2. GEMBA
Walk the Line / Area
• Look for potential causes
• Observe inputsp
• Take pictures
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2. Fishbone –Categorization
Cat. 1 Cat. 2 Cat. 3 Cat. 4 Cat. 5Machine Methods Mother Nature
g(Taking a large volume of data and bucketing it into manageable slices)
Problem
Materials MeasurementManpower
21ORGANIZED BRAINSTORMING SEEING THE TREES FROM THE FOREST
2. Prioritize Categories(Highest probability of being the cause)
Cat. 2 Cat. 5 Cat. 4 Cat. 1 Cat. 3
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2. Narrowing in on the Cause
Test Cause Categories – Prove or Disprove
Cause
• Process of Elimination (follow up detective work)
– Field Investigation
– Testing
– Data Analysis
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2. The Cause –But not the “Root” Cause
Cat. 2 Cat. 5 Cat. 4 Cat. 1 Cat. 3
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2. 5 Why’s? – The “Root” Cause(s)
Why? Why? Why?Why? Why?R t C
Sub CauseRoot Cause
Sub Cause
Root Cause
Root Cause
Cause 1
Sub Cause
Sub Cause
Sub Cause
Sub Cause
Sub Cause
Sub Cause
Sub Cause
Root Cause
R C
Root Cause
ProblemCause 2
Cause 3
Sub Cause
Sub Cause
Sub Cause
Sub Cause Sub CauseRoot Cause
Sub Cause
Root Cause
Root Cause
Cause 4
Cause 5
Sub Cause
Sub Cause
Root Cause
Sub Cause Root Cause
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2. 5 Why’s? – The “Root” Cause(s)
Why? Why? Why?Why? Why?R t C
Sub CauseRoot Cause
Sub Cause
Root Cause
Root Cause
If you solve for this, the problem will most likely reoccur
Cause 1
Sub Cause
Sub Cause
Sub Cause
Sub Cause
Sub Cause
Sub Cause
Sub Cause
Root Cause
R C
Root Cause
ProblemCause 2
Cause 3
Sub Cause
Sub Cause
Sub Cause
Sub Cause Sub CauseRoot Cause
Sub Cause
Root Cause
Root Cause
Cause 4
Cause 5
Sub Cause
Sub Cause
Root Cause
Sub Cause Root Cause
Solve for these
Nov 2012 26
these
THE POWER OF “WHY?”
• The most powerful question a problem solver can ask is:
WHY?WHY?WHY?WHY?… ask enough times and you will uncover the
root cause.root cause
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WHAT ARE THE 5 WHYS?
• The Root Cause is the key element of the problem, which when resolved will prevent re-occurrencep
• The tool used to identify the Root Cause is the “5 Whys?”• In theory this appears to be the simplest of techniques, but in
reality it takes some practice to master
UnworkableIgnorance Silly
Why?1 Why?9
reality it takes some practice to master
Why?2
Why?3Why?7
Why?8
Workable
y 3
Why?4
Why?5
Why?6
Workable
• The questioning for this example could be taken further to a sixth, seventh, or higher level: the "five" in 5 Whys is not gospel, but five iterations of asking why is generally sufficient to get to a root cause.
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EXAMPLE – 5 WHYS
The Jefferson Memorial:A Study in Root Cause Analysis
The National Park Service askedThe National Park Service asked
the “5 why’s” to attack a crumbling stone bl f hiproblem from washing
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EXAMPLE – 5 WHYS
The Jefferson Memorial
WHY d th t d l hi ?WHY does the stone need regular washing?
Because a large amount of bird droppings on the stone WHY?the stone. WHY?
Because of the large number of birds inside the memorial WHY?the memorial. WHY?
Because there is a large food supply (spiders) inside the memorial. WHY?inside the memorial. WHY?
Because there are a large number of flying insects inside and around the memorial. WHY?insects inside and around the memorial WHY?
Because the lights that illuminate the memorial attract flying insects at dusk. WHY?y g
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EXAMPLE – 5 WHYS
The Jefferson Memorial –The Conclusion
• The memorial lights were not needed at dusk
• There was still enough light to see th i l th d l d t the memorial, so they were delayed to turn on instead at 1 hour after dusk
• The result was a 90% reduction in flying insects, fewer spiders, fewer y g pbirds, and far fewer washings
F hi lt i l t • Fewer washings result in less stone crumbling 31
3. Generate Solutions (Brainstorm)(Brainstorm)
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3. Brainstorm Solutions
Root Cause Root Cause Root Cause
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4. Select the Solution(s)Solution(s)
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4. Prioritize Solutions
Large Do nowPlan now
Impact
Do laterDon’t do
S llSmallEasyDifficult
E f I l t tiEase of Implementation
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The CAPA Process
T i HiPreventive C Trigger HitControls in Place
Determine Problem Solving Path
ImplementationVerification
Knowledge Management
RCA Investigation & Problem Verification
ValidationManagement Process
& Problem Solving Tools
Adjust and Improve36
5. Implement the SolutionsSolutions
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5. Implement the SolutionsSolutions
Solutions TimelineP0 P1 P2 P3
0 30 days 60 days 90 days
5. Timeline / Schedule
Action LogAction Log or
P j t S h d l39
Project Schedule
5. Verification
Did the Solution getDid the Solution get implemented?
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6. Evaluate the Result
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6. Validation
Did theDid the SolutionSolution work?
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The CAPA Process
T i HiPreventive C Trigger HitControls in Place
Determine Problem Solving Path
ImplementationVerification
Knowledge Management
RCA Investigation & Problem Verification
ValidationManagement Process
& Problem Solving Tools
Adjust and Improve43
7. Standardize
44
Standardize
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Problem Solving Template(Basic A3)
Problem:
1. Define the problem and determine the objective
4. Select the solution(s) and plan the fix
Objective:
2. Analyze the problemy p5. Implement the solution(s)
Why?
6. Evaluate the result
Why?Why?Why?Why?Why?
3. Generate potential solutions
Why?
7. Standardize and maintain control
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Q & A
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