Presented By

Ken Peterson

Partner Quality and

Compliance Consulting

Advancing beyond CAPA

compliance using innovation

for growth

ASQ

October 9, 2018

Now that CAPA is working…

What are the next steps to drive successful improvements?

CAPA

Innovate

Design

Investigate

Root Cause

Solve

Organizations should be

looking to innovate.

Why do we not have more innovation?

Logic &

Reason

Innovative &

Creative

Has our

investigative

mindset taken over,

or influenced our

innovative mind?

Is QEM in opposition to innovation?

CAPAInvestigate

Find Root Cause

Solve

INNOVATEDesign

Invent

Exploit

Compliance Versus Improvement…

What should we do?

• Understand the processes

- CAPA… origin is past

- Innovate… origin is future

5

QEM and CAPA… Lessons Learned

6

First Wave…

CAPAPoor

RiskManagement

Faulty

Exit

System

Faulty

Action

Selection

QEM… Lessons Learned

First Wave… CAPA

Poor Risk Management

CAPA Overload

Faulty Exit System

Faulty Action Selection

Second Wave…CQI is not Deviation

Management

Poor Gain Management

Work outside CAPA System

Faulty Exit System

Faulty Action Selection

7

VarianceSupplier Deviation

Out-of-Spec

Non-Conformance

Audit Finding

DeviationCustomer Complaint

Risk-Based

Issue Review

Tracking &

Trending

Inputs

CAPA

RequiredInvestigation

Corrective/

Preventive

Actions

CAPA

Initiation

CAPA

Not Required

Effectiveness

ChecksClose

Incident

CAPA

QEM Process

Quality Events

Decisions

Methodology

MarketDemandsAuditsSuccessesProblems

ThreatsChangesPotential Problem

Tracking &

Trending

Improvement

Required Improve /

Innovate

Facilitative/

Exploitive

Actions

Opportunity

Improvement

Not Required

Effectiveness

ChecksClose

Improvement

Improvement Process

Opportunities

Benefit-Based

Issue ReviewInnovate

Inputs

Decisions

Methodology

QEM… Sourcing Your Entrance…

Knowing Your Finish!

1

0

ComplianceImprovement

Past• Correction• Corrective• Preventive

(CAPA)

Future• Preventive (CQI)• Facilitative• Exploitive

Risk Benefit

Future Oriented Actions

• Preventive = Decrease the probability of

occurrence

• Facilitative = Increase the probability of

occurrence

• Exploitive = Take advantage/leverage new

solution (occurrence)

1

1

Future

Prevention and Opportunity

Decrease

Probability

And Impact

Increase

Probability

And Impact

Impact

Risk / Gain

Potential

Problem

Preventive

Action

Opportunity

Facilitative

Action

F x I = Opportunity Score

Impact (Benefit) Scale

Negligible Minor Important Critical

1 3 5 10

Continually 5 5 15 25 50

Frequently 3 3 9 15 30

Occasionally 2 2 6 10 20

Rarely 1 1 3 5 10

Undesirable (1 to 3) Desirable (5 to 10) Significant (15 to 50)

Fre

qu

en

cy

Sc

ale

Solution Deployment

Increase/Leverage Benefit of Solution

Exploitive Action

Solution

High Impact Conversion

InnovationPrevent Breakthrough

Improvement…

Actions to get it done!

Potential Problem

Analysis

Study Groups, Lean

Techniques, etc.

Creativity, Innovation

Techniques,

Solution Development

Research and

Development, Design

• Potential Problems

• Creation

• New Ideas

• Invention

Improvements

• Incremental

• Enhance

Examples:

1

6

1. Increase the throughput of line one 20% Improvement

2. Redesign lab bench to accept new piece of equipment

Innovate

3. Prevent label failure on line due to planned increase in run

speed Prevention

4. Increase doctor satisfaction of in service instructions for

new dental x-ray gun Improvement

5. Invent new component to transfer energy through pediatric

bed during surgery Innovate/Invention

Innovation Steps

Sell

Refine

Improve

Requirements

Scope

Opportunity

Original Steps Courtesy PathWise

Opportunity

• Identify… find

• Enhance market, operations,

product, processes, use

• Look at trends, threats,

changes, successes

Understand the Opportunity

Innovation Step

Improvement Step

Scope

• DO…consider the scope to provide

direction and add focus to your

solution.

• DON’T…allow scope to overcome

innovative thought and new ideas.

Know the Scope

Improvement Step

Scope

Know the Scope

• “What will the solution look like?”

• “How will this make things better?”

• “What will change as a result of…?”

Develop an improvement scope by visualizing the

end result. Consider questions as:

Improvement Step

Scope

Know the Scope

A good improvement scope should state…

• What you will accomplish

• Where it will be done

• When you expect to finish

You need not show “how”.

Only create a clear vision of intent.

Improvement Step

Requirements

Why?

1- Provide focus

2- To refine solutions

later

Determine Key Solution Requirements

Improve

Improve and Innovate

Innovation Steps

Convert your scope into an objective or

objectives you can move to improve…

Keep objectives open and unbiased…

How best to _____________…

Improve

Improve and Innovate

• Where do we find new solutions?

• How do the ideas come forward?

Innovation Steps Consider:

Creativity Is Learned…

“Creativity does not depend on

intelligence, it depends on how

well you have trained your

mind to be creative.”

- Michael Michalko

Author

Improve: Creation

Range

Depth

Channeling the Mind

Improve: Creation Slide Courtesy PathWise

Think of Some Bird Names

Improve: Creation Slide Courtesy PathWise

Bird Names

Improve: Creation Slide Courtesy PathWise

Innovation Steps

Improve

• Brainstorming

• Channeling

• Idea Builder Tools

Improvement Techniques

Idea Generation: Tools

Creative Tools –

“Getting Un-stuck” Tools –

Organizing Tool –

Communication Tool -

Improve: Creation

• Analogy, Inverse, SCAMPER, and Incubation

• Random Input, Imaging, Ideatoons, and Criteria Smashing

• Mind Mapping

• eChain and Graffiti Chart

Slide Courtesy PathWise

Idea GeneratorsTechnique Description When?

Imaging/

Idea toons

Use visual images as icons with special

meaning.

To get ideas flowing. Get

unstuck

Criteria Smashing Smash all rules that would restrict

innovation.

Throughout process. Can

combine with other technique.

Mind map Write central focus in middle of page then

connect each thought.

Organize ideas and thoughts

together.

eChain An email that goes to each group member.

Write ideas and forward.

Group is not available to

meet.

Graffiti Chart A chart posted in a central location that

group can write ideas on.

Group is not available to

meet.

Improve: Creation Slide Courtesy PathWise

Technique Description When?

Incubation Let ideas sit, go on to other things. Don’t

think about it, then return.

Throughout entire process.

Analogy A statement with the same goal, but

different content.

Situation calls for unique

ideas.

Inverse A statement with the opposite meaning. Situation calls for unique

ideas.

SCAMPER Substitute? Combine? Adapt? Modify? Put

to other use? Eliminate? Rearrange? Reverse?

Creation of new products or

services.

Random Input Use random words as triggers for new

ideas.

To get ideas flowing. Get

unstuck.

Improve: Creation

Idea Generators

Slide Courtesy PathWise

Analogy

Improve: Creation

Similar in process but very different in content.

Goal: Improve dental x-ray gun productivity

How to improve productivity of an apple orchard…

1. Prune dead wood

2. Shake trees

3. Cross pollinate

4. Fertilize

5. Chemically enhanced bees

Analogy Transfer

1- Prune dead wood

2- Shake trees

3- Cross pollinate

4- Fertilize

Improve: Creation

Improve dental x-ray gun productivity.

Incorporate digital

technology with Bluetooth

links…

Remove waste, target young

dentists, change sales process

Lock tight screws

Stimulate growth….

Technique Description When?

Incubation Let ideas sit, go on to other things. Don’t

think about it, then return.

Throughout entire process.

Analogy A statement with the same goal, but

different content.

Situation calls for unique

ideas.

Inverse A statement with the opposite meaning. Situation calls for unique

ideas.

SCAMPER Substitute? Combine? Adapt? Modify? Put

to other use? Eliminate? Rearrange? Reverse?

Creation of new products or

services.

Random Input Use random words as triggers for new

ideas.

To get ideas flowing. Get

unstuck.

Improve: Creation

Idea Generators

Slide Courtesy PathWise

Inverse

Improve: Creation

Try to destroy the innovative objective!!!

Goal: Improve dental x-ray gun productivity

How to destroy or make certain our x-ray

gun will fail…

1. Be condescending to dentists

2. Instructions difficult to understand

3. Difficult to use

4. Launch with technical problems

5. Use custom parts

Inverse Transfer

1-Be condescending to

dentists

2- Instructions difficult to

understand

Improve: Creation

Improve dental x-ray gun productivity.

Plan in-service that engages

and compliments, respect

them as experts.

Build Solutions

1. Generate Solution

2. Refine Solution

Improve: Creation

The solution step in the

process is comprised of

two intertwined steps:

Categorize and combine ideas together

for complete solutions

Theme

Theme

Theme

IdeaIdeaIdea

Solution

Improve: Creation

Refine

Refine your Solution

Innovation Step

Do you have earlier design requirements that are

absolutely necessary for success?

If so you MUST find a way to re-engineer your

solution or it is very likely to fail.

Bring in other experts to help you refine your

solution!

Refine

1. Evaluate the feasibility of your

Generated Solution; refine as

needed.

2. Evaluate the performance of your

solution; refine as needed.

3. Evaluate the risk of your solution;

refine as needed.

Refine your Solution

Re-examine your solution against

the earlier requirements you

established:

Innovation Step

Refine

Refine your Solution

Innovation Step

What potential problems or risks are inherent in your solution?

Debug them now before you present the solution to management!

Build these risk actions into your deployment plan.

Prevention Actions

Refine & Plan…

Innovation Step

Build an Action Plan

Plan your implementation and

consider these actions:

Preventive = Decrease the probability of occurrence

Facilitative = Increase the probability of occurrence

Exploitive = Take advantage of new solution

Pre-sale… This may be a detailed draft

Sell

Selling your

solution can be as important

as constructing it!

Sell the Solution to Management

Innovation Steps

Know the basics:

• Who is buying this?

• Who must accept?

• Who will fund it?

• Who has influence with the buyer?

• Who would make the best presentation?

• What hot buttons need I press?

Sell the Solution to Management

Innovation Steps

Review Sell

Refine

Improve

Requirements

Scope

Opportunity

1. Implement a step-by-step process to

transform ideas into practical and

business focused solutions.

2. Have good tools that work for your

environment and products.

3. Sell your solutions and obtain

commitment and buy-in to implement

them.

To Succeed

CAPA

Innovate

Design

Investigate

Root Cause

Solve

Growth… remember you may just learn more through your efforts even if failing occasionally than if you succeeded initially.

Are you ready to move into the future with innovation?

Not every solution needs a problem!

Exploit

Invent

Thank you