CAPA Process (Corrective Action & Preventative Action) · The CAPA Process Ti Hi Preventive...

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

3

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

4

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

5

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








Adjust and Improve7

The CAPA Process








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


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

9

The CAPA Process








Adjust and Improve10

Structured Problem Solving

Traditional approach vs. Structured

Solving

approach

ProblemProblem

Solution

Solution

Solution(quick fix)

(prevent recurrence)

11

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

12

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

4

5Traditional Lean methodology and data-based decisions

2

32. Problem and Loss Awareness –Basic Methods and Tools

1

1. Firefighting

13

Structured Problem SolvingSolving

14

Getting Started – Forming the Team

MeaningfulMeaningfulpurpose

Smallnumbers &

Clearperformance

clear rolesperformance

goalsTeam

BASICS

Mutualaccountability

Well definedworking

approachComplimentary

skills

15

1. Define the Problem

16

1. Define the Problem

What?, When?, Where?, How?, Who?

17

2. Analyze the Problem

18

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

19

O OPINIONSG - GUESSES

2. GEMBA

Walk the Line / Area

• Look for potential causes

• Observe inputsp

• Take pictures

20

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

24

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

27

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.

28

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

29

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

30

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)

32

3. Brainstorm Solutions

Root Cause Root Cause Root Cause

33

4. Select the Solution(s)Solution(s)

34

4. Prioritize Solutions

Large Do nowPlan now

Impact

Do laterDon’t do

S llSmallEasyDifficult

E f I l t tiEase of Implementation

35

The CAPA Process









5. Implement the SolutionsSolutions

37

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?

40

6. Evaluate the Result

41

6. Validation

Did theDid the SolutionSolution work?

42

The CAPA Process









7. Standardize

44

Standardize

45

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

46

Q & A

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CAPA Process (Corrective Action & Preventative Action) · The CAPA Process Ti Hi Preventive...

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