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Lead Investigator Overview DMAIC

DMAIC: “A structured improvement method that leads logically from a definition of the problem to implementing solutions that address underlying causes.

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114 views7 pages

Lead Investigator Overview DMAIC

DMAIC: “A structured improvement method that leads logically from a definition of the problem to implementing solutions that address underlying causes.

Uploaded by

Anonymous CsDebVi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as PDF, TXT or read online on Scribd
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Lead Investigator Overview: DMAIC

Problem Solving
DMAIC: A structured improvement method that leads logically
from a definition of the problem to implementing solutions that
address underlying causes. Michael L. George, Lean Six Sigma

D
M
A
I
C
1

Define

Define the what, when, where, and extent of problem as well


as the scope of the initiative.

Measure

Measure the processs current performance to requirements.

Analyze

Get to root cause. Analyze the data to characterize the nature


of the process and why the problem is occurring.
Determine and Implement optimal solutions that eliminate
defects and variance.
Monitor the process performance in order to confirm the
improvement and ensure the system can sustain.

Improve
Control

DEFINE
STEP

Description &
Impacted
Requirements

Historical Check

Initial
Impact Assessment

Interim
Containment

Did we fail to meet a


RQ? If so, what RQ?

What initiated the


CAPA/Investigation?

What products or processes


are impacted?

How is the problem


described?

Plant history?
Complaint History?
Issue Trending?
Validation data?
Related CAPA Issues?
Risk/pFMEAs?

Are there other RQ that


should be considered?

What product
containment has
occurred/ is
necessary?

Example data sources:


ERs, LIRs, Complaints,
Audits, Supplier

Consider all potentially affected


sites
Address clinical use, impact to
patient safety , likelihood of
hazardous events
Are there similar sites, product
lines, or materials

NOTES

QUESTIONS

What is the
problem?

OUTPUT

Define Phase: Define the what, when, where, and extent of


problem as well as the scope of the initiative.

What, When, Where,


Extent?
Affected product,
process, equipment,
validation, or object
How was it discovered?
When in life cycle/
process?
Lead Investigator Problem Solving v3

What is the
background?

What is the
initial scope?

Immediate
Actions?

List affected product or


materials and
distribution chain
Internal and external
specifications
List potentially affected
quality systems

MEASURE
Collect Data?

Can I trust my
data?

Updated
IS/ IS NOT
Using the background
and initial IS/ IS NOT,
what data needs to be
collected and how?
What does the data tell
us?
Are there other
variables that should be
considered?

NOTES

QUESTIONS

OUTPUT

STEP

Measure Phase: Measure the processs current performance


to requirements.

Lead Investigator Problem Solving v3

What is the scope of each data


set? (included/ not included)
Are there any obvious errors/
typos in the data set?
Is the data valid, stable,
capable?

What is the
updated
scope?

What is the final


problem
definition?

Impact Assessment

Updated Problem
Definition

What products or
processes are
impacted?

Did we fail to meet a RQ?


If so, what RQ?

Are there other RQ


that should be
considered?

How much measurement


variation is there?
During Define we begin to
ask the questions for
scope.
Measure: as data
becomes available we
update the scope as
necessary

How is the problem


described?
What, When, Where,
Extent?
During Define we begin
questions for problem
definition
During Measure, as data
becomes available we update
the problem definition as
necessary

ANALYZE

NOTES

QUESTIONS

OUTPUT

STEP

Analyze Phase: Get to root cause- Analyze the data to characterize the
nature of the process and why the problem is occurring.
Identify
Potential
Causes

Organize
Potential
Causes

Eliminate
Potential
Causes

Brainstormed
Potential
Causes

Fish Bones
Fault Tree
Cause Maps

Contradiction
Matrix
Fact List

See IS/IS NOT

5 Whys?

See Fish Bone

What are the


connections?

What potential
causes are
eliminated by the
data?

Collect &
Refine
Data

Summary

What further data


needs to be
collected?

Lead Investigator Problem Solving v3

Clear logical
description of
each possible
cause

Screen potential causes,


test hypothesis, eliminate
Explain how causes
were eliminated

What was the root


cause(s)?
What are the
recommended
actions?

Which potential
causes are supported
by the data?
Document:
Tools used & why
Team

Confirm

All outside results


and summaries are
clear and linked into
summary

Have clear and logical


investigation scope
Clearly support root
cause(s) with data
Root cause(s) align
with Investigational
Analysis

IMPROVE
STEP

Inputs:
Outputs

Risk &
Feasibility

Targets &
Tolerances

Verification
& Validation

Plan Actions and


Execute

Plan for
Immediate
Corrections/
Permanent

What is the
rationale/
justification
for why this
solution will
address the
problem?

What is the best


solution? Why?
What were risk and
feasibility
considerations?

What is the impact of


the change?
Design? Process?
Documentation? Other
Sites/ Systems?

Is the change
feasible? What
are the roll out
considerations?
Is it safe,
efficacious, &
does not
adversely
impact release?

What is the approach?


Are immediate
corrections needed?
What is the
plan/timing?
Show traceability of
cause: solution

How do we
determine if root
cause was
reached? How
do we prevent
re-occurence/
sustain the
change?

Objective
Evidence

Risk/Benefit Matrix
Selection Matrix
Decision Tools

Document updates:
Design & Operational
(e.g. pFMEA,
Procedures)

Protocols &
Objective
Evidence

Timelines
Gantt
Final Impact

DocumentsSustainability
(e.g. Metrics,
Training,
Preventative
Maintenance

NOTES

QUESTIONS

Solutions
Address
Causes

OUTPUT

Improve Phase: Determine and Implement optimal solutions that


eliminate defects and variance.
Choose
Best
Solution

Lead Investigator Problem Solving v3

Refine
Selected
Solution

Pilot

Implement

Plan for
Effectivity
& Control

Control

STEP

Control Plan

OUTP
UT

Control Phase: Monitor the process performance in order to


confirm the improvement and ensure the system can sustain.

Define where controls


reside

Results/
Dissemination

Plan for Closure

Provide Objective
Evidence

Has the risk documentation


been updated? (e.g. pFMEA
where applicable)

Data sources required to ensure effectiveness?


Considerations from Risk/ Impact Assessments?
Who owns the data?
How will it be obtained/analyzed?
When/Frequency?
Is this action the responsibility of another
function? Are they aware?
Is the Effectiveness Check traceable to investigational
findings?
What is the acceptance criterion and is it statistically
justifiable?
Who owns/reviews the Effectiveness Check?
Is there agreement with functional management
on commitments/responsibilities

How do the results compare


to the acceptance criteria?
Are the implemented actions
effective? If no, what
alternative actions are
required?
Who should the information
be Disseminated to?
What similar products/
processes could have
similar failure modes?
How should info be
disseminated, and document
dissemination.

List of Updated Documents/


Controls, including tolerances
where applicable

Monitoring Plan

Objective Evidence

QUESTIONS
NOTES

Effectiveness and
Control Planning

Lead Investigator Problem Solving v3

How DMAIC maps to the Regulations


DMAIC

Define

21 CFR 820.100
820.100 (a) (1)- Detecting Problems

13485
8.2.1 Feedback

Measure

820.100 (b)- All activities Documented


820.100 (a) (1)-Detecting Problems (and Assessment)

8.2.3 Monitoring and Measurement of Processes

820.100 (b)- All activities Documented

8.2.4 Monitoring and Measurement of Product


8.3 Control of Nonconforming Product
8.4 Analysis of data

Analyze

Improve

820.100 (a) (2)-Investigating (Root Cause Determination)

8.4 Analysis of data

820.100 (a) (6)-Dissemination

8.5.2 Corrective Action

820.100 (a) (7)- Submit for Mgmt Review

8.5.3 Preventative Action

820.100 (b)- All activities Documented


820.100 (a) (3)- Identifying Action

8.5 Improvement

820.100 (a) (4)- Verifying/Validating

8.5.2 Corrective Action

820.100 (a) (5)- Implementing

8.5.3 Preventative Action

820.100 (a) (6)- Dissemination


820.100 (a) (7)- Submit for Management Review

Control

820.100 (b)- All activities Documented


Effectiveness Checks

8.5.2 f. Corrective Action- effectiveness

820.100 (a) (6)- Dissemination

8.5.3 e. Preventative Action- effectiveness

820.100 (a) (7)- Submit for Management Review


820.100 (b)- All activities Documented
7

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