Es10 c groups

 Whether you work in a public area or a place
of business, when something unusual occurs
most businesses and insurance companies
require an incident report to be filed. An
incident report is simply a written statement of
the events and how they occurred. It isn’t hard
to write an incident report, but there are a few
things you should know that will help you to
write a good one.

1. Write the incident report in complete sentences and
use simple language. Because you do not know if a
third-party may be reviewing your incident
report, keep the explanation of the events easy to
understand and avoid using expertise language that
could confuse the examiner who reads your report.
2. State what happened in chronological order. Begin
with what was happening just prior to the incident (if it
is relevant), then list details of the event in the sequence
they occurred.

3. Notate whether you were the witness of the
event or if the details were reported to you. If
you did not see the incident or did not arrive
until after it occurred, explain in your report
who informed you about the incident and
what steps you took after you were notified.
4. List all witnesses and parties involved. Since
the person that reviews the incident report
may have further questions, include contact
information for everyone that was involved
and remember to notate any fire, ambulance or
police units that responded, as well as when
they arrived.

 Incident reports should be written as soon as
possible after an event occurs. This will ensure
that important details are reported accurately
while they are still fresh in your mind.

 The process of reacting to an
existing product
problem, customer complaint
or other nonconformity and
fixing it.

A process for detecting
potential problems or
nonconformance’s and
eliminating them.

 Regulatory Requirements
 Both FDA and ISO require an active CAPA program
as an essential element of a quality system.
 Customer Satisfaction
 The ability to correct existing problems or implement
controls to prevent potential problems is essential for
continued customer satisfaction
 Good Business Practice
 Quality problems can have a significant financial
impact on a company.

 Implementing an effective and fully
compliant Corrective / Preventive action
program is a seven step process.
 Each step must be thoroughly
documented!
 Properly documented actions provide important
historical data for a continuous quality improvement
plan and are essential for any product that must
meet the regulatory requirements demanded by
FDA and ISO.

1. Identification – clearly define the problem
2. Evaluation – appraise the magnitude and impact
3. Investigation – make a plan to research the problem
4. Analysis – perform a thorough assessment
5. Action Plan – create a list of required tasks
6. Implementation – execute the action plan
7. Follow Up – verify and assess the effectiveness

 The initial step in the process is to clearly
define the problem or potential problem.
 This should include:
 the source of the information,
 a detailed explanation of the
problem,
 Documentation of the available
evidence that a problem exists.

 The specific source of the information is
documented. There are many possible sources:
Service requests Customer complaints
Internal quality audits Staff observations
Trend data QA inspections
Process monitoring Risk analysis
 This information is important for the
investigation and action plan, but also useful
for effectiveness evaluation and
communicating the resolution of the problem.

 A description of the problem is written
that is concise - but complete.
 The description must contain enough
information so that the specific
problem can be easily understood.

 List the specific
information, documents, or data
available that demonstrates that the
problem does exist.
 This information will be very important
during the investigation into the problem.

1. Identification – clearly define the problem
2. Evaluation – appraise the magnitude and impact
3. Investigation – make a plan to research the
problem
4. Analysis – perform a thorough assessment
5. Action Plan – create a list of required tasks
6. Implementation – execute the action plan
7. Follow Up – verify and assess the effectiveness

 The situation must be evaluated to determine
both the need for action and then, the level of
action required.
 An evaluation should include:
 Potential Impact of the problem.
 Risk to the company or its customers
 Remedial Action that may be required

 Determine and document
specifically why the problem is a
concern and what the impact to
the company and/or customers
may be.
 Concerns may include
costs, function, product
quality, safety, reliability, and/or
customer satisfaction.

 Based on the result of the impact
evaluation, the seriousness of the problem is
assessed.
 The level of risk that is associated with the
problem will affect the actions that are taken
and the priority assigned to the situation.

 The potential impact and risk assessment
may indicate a need for some immediate
action to remedy the situation until a
permanent solution can be implemented.
 In some cases the remedial action may be
adequate. If so, the CAPA can then be
closed, after documenting the rationale
for this decision and completing
appropriate follow up.

 A written procedure for doing an investigation
into the problem is created.
 This procedure should include:
 The objectives for the action
 An investigation strategy
 Assignment of responsibility and
required resources

 The objective is a statement of the
desired outcome(s) of the
corrective or preventive action.
 The action will be complete when
all aspects of the objective have
been met and verified.

 A set of specific instructions for determining
the contributing and root causes of the
problem is written.
 This procedure directs a comprehensive
review of all circumstances related to the
problem and must consider:
- equipment - materials
- personnel - procedures
- design - training
- software - external factors

 It is important to assign someone the
responsibility for each aspect of the
investigation.
 Any additional resources
(financial, equipment, etc) should be
identified and documented.

 The investigation procedure is used to conduct
the investigation into the cause of the problem.
 Every possible cause is identified and
appropriate data collected.
 The results of the data collection are documented
and organized.
 Everything related to the problem must be
identified, but the primary goal must be to find
the root cause.

 A list of all possible causes is created which
then form the basis for collecting relevant
information, test data, etc.
 The necessary data and other information is
collected that will be used to determine the
primary cause of the problem.

 Data may come from a variety of sources: testing
results and/or a review of records, processes,
service information, design controls, operations,
and any other information that may lead to a
determination of the fundamental cause of the
problem.
 The data collected is organized into a useable form.
 The resulting documentation should address all of
the possible causes previously determined. This
information is used to determine the root cause of
the problem. The effectiveness of the analysis will
depend on the quality and thoroughness of the
information available.

 Use the data to complete a Root Cause Analysis
 This involves finding the actual cause of the
problem rather than simply dealing with the
symptoms.
 Finding the primary cause is essential for
determining appropriate corrective and/or
preventive actions.

 Using the results from the analysis, the best
method(s) for correcting the situation (or
preventing a future occurrence) is determined.
 All of the tasks required to correct the problem
and prevent a recurrence are identified and
incorporated into an action plan.
 The plan includes changes that must be made
and assigns responsibility for the tasks.

 List all activities and tasks that must be
accomplished to correct the existing problem or
eliminate a potential problem, and prevent a
recurrence.
 It is very important identify all actions
necessary to address everything that
contributed to or resulted from the situation.

 Needed changes to
documents, processes, procedures, or other
system modifications should be described.
 Enough detail must be included so it is clearly
understood what must be done and what the
outcome of the changes should be.

 Employee training is an essential part of any
change that is made and should be made part
of the action plan.
 To be effective, all modifications and changes
made must be communicated to all
persons, departments, suppliers, etc. that were
or will be affected.

 The Action Plan that has been
developed is executed and all
identified tasks and activities
completed.
 The actions that were taken are
summarized and all modifications to
documents, processes, etc. are listed.

 One of the most fundamental steps in the
CAPA process is completing an evaluation of
the actions that were taken.
 This evaluation must not only verify the
successful completion of the identified
tasks, but also assess the appropriateness and
effectiveness of the actions taken.

 Have all of the objectives been met? (Did the
actions correct or prevent the problem with
assurances that the same situation will not happen
again?)
 Have all recommended changes been completed
and verified?
 Has training and appropriate communications
been implemented to assure that all relevant
employees understand the situation and the
changes that have been made?
 Has an investigation demonstrated that that the
actions taken have not had any additional adverse
effect on the product or service?

 Make sure that appropriate information has
been recorded that provides proof that all
actions have been completed successfully.

 A validation of the action is done. This
must document that:
 The root cause of the problem has been solved,
 Any resulting secondary situations have been
corrected,
 Proper controls have been established to prevent a
future occurrence,
 The actions taken had no other adverse effects.
 Adequate monitoring of the situation is in place.

 When the Follow Up has been
finished, the CAPA is complete.
 It should be dated, and signed
by appropriate, authorized
personnel.

Presenter:
Ralph Williams, President

SEI Authorized
• CBA IPI Lead Assessor (CMM®)
• SCAMPI Lead AppraiserSM (CMMI®)

®CMM and CMMI is registered in the U.S. Patent and Trademark Office.
SMIDEAL is a service mark of Carnegie Mellon University.

Special permission to reproduce and adapt portions of:
• Software Engineering Process Group Guide, CMU/SEI-90-TR-
024, (c) 1990 by Carnegie Mellon University

• Capability Maturity Model® Integration (CMMI®), Version 1.1 (CMMISM-
SE/SW/IPPD/SS, V1.1) Continuous Representation,
CMU/SEI-2002-TR-011, (c) 2002 by Carnegie Mellon University

• Capability Maturity Model® Integration (CMMI®), Version 1.1 (CMMISM-
SE/SW/IPPD/SS, V1.1) Staged Representation, CMU/SEI-2002-TR-
012, (c) 2002 by Carnegie Mellon University

• Standard CMMISM Assessment Method for Process Improvement: Method
Definition, Version 1.1 (SCAMPISM, V1.1),
CMU/SEI-2001-HB-2001, (c) 2001 by Carnegie Mellon University
is granted by the Software Engineering Institute.

®CMMI, CMM and Capability Maturity Model are registered in the U.S. Patent and Trademark Office.
SMIDEAL and SCAMPI are service marks of Carnegie Mellon University.

The mission of Cooliemon, LLC is:

“helping organizations achieve
excellence through process improvement”

Our goal is to focus your process improvement efforts to:

 improve quality and productivity
 reduce operating costs
(i.e., reduce rework, waste and duplicate effort)
 capture the market with high quality products and services
 help you become the industry standard by which your competitors
measure themselves

Purpose:
To identify causes of defects and other
problems and take action to prevent
them from occurring in the future. — CMMI
V1.1
SG 1: Determine Causes of Defects
Root causes of defects and other problems
are systematically determined.

SG 2: Address Causes of Defects
Root causes of defects and other problems
are systematically addressed to prevent their
future occurrence.
SG = Specific Goal

 Describe how CAR can be used to build Senior
Management commitment for Quality.

 Overview of Juran’s Quality Improvement
Process - a practical example of the CAR a
CMMI® Process Area (PA).

 When to use Quality Tools (e.g., Pareto, Cause
& Effect diagrams, Brainstorming, etc.)

 Answer any of your questions.

 Proof of the Need

 Selecting a Strategy, Problem & PAT

 Determine Causes of Defects

 Address Causes of Defects

 Holding The Gains

 Summary

The cost of poor quality (COPQ):

• “COPQ is the sum of all costs that would
disappear if there were no quality
problems.” - Juran

• “You can easily spend 15 - 20% of your sales
dollars on the COPQ.” - Crosby

• “In most companies the costs of poor quality
runs at 20 - 40%.” - Juran

Compile a list of improvement opportunities.
Example sources:

• Accounting data on COPQ
• Benchmarking reports
• External customer complaints
• Internal customer complaints
• Process improvement suggestions
• Surveys
• Simply talk to people
• etc.

QC PAT(s) Organization

Select: Review/Verify
Strategy,Problem to Charter, Mission &
be solved & PAT Team Membership

PATs Report Status:
Process
Understand,
Support, Execute Process
Direct & Recognize
Team QC Updates

Phase Out Team Implement Solution &
Recognize Team Controls

Lessons Learned Monitor Solution to Hold the Gains
• Adapted from Juran, “Leadership for Quality”, 1989

Discover Root Causes (Diagnostic Journey):
1. analyze the symptoms
2. formulate theories
3. test theories
4. identify root causes

Develop Solutions & Controls (Remedial Journey):
5. consider alternative solutions
6. design solutions and controls
7. address resistance to change
8. implement solutions and controls

Holding the gains
9. design effective quality controls
10. audit the controls • Adapted from Juran, “Leadership for Quality”, 1989

Selection Criteria to be considered:

• Chronic (a continuing problem)
• Vital Few (significant impact on company)
• Size (manageable problem <12 months)
• Measurable (impact must be measured)
• Urgency (how urgent is the problem to the organization?)
• Risk (what are the risks?)
• Resistance to Change (how high is resistance to change?)

Example: Selection Criteria

PROBLEM A B C
CRITERIA SCALE
Strategic Goal 5 = Most Supportive
Points = 25 1 = Least Supportive
Return on Investment (ROI) 5 = Most Significant
Points = 20 1 = Least Significant
Frequency of Occurrence 5 = Most Chronic
Points = 15 1 = Least Chronic
Urgency 5 = Most Urgent
Points = 15 1 = Least Urgent
Measure of Potential Impact 5 = Most Impact
Points = 8 1 = Least Impact
Risk Management 5 = Least Risk
Points = 7 1 = Most Risk
Size 5 = Most Manageable
Points = 5 1 = Least Manageable
Change Management 5 = Least Resistance
Points = 5 1 = Most Resistance



PATs Report Status:
Discover Root
Understand,
Causes
Support,
Direct & Recognize Develop Solutions
Team & Controls


• Adapted from Juran, “Leadership for Quality”, 1989

Charters can include the following information:

• name of team
• mission statement and desired results
• activities and functions
• deliverables
• authorization (QC - signatures)
• team members
• estimated return on investment
• start date and end date
• team ground-rules

Juran's Quality
Improvement Process

3. test theories

Holding the gains:
10. audit the controls

Discover Root Causes - 1

Definitions:

Symptom: A symptom is the outward observable evidence of a
problem. — Juran Institute, Inc.

Root Cause: A root cause is the source of the problem, which, when
removed, will sharply reduce or eliminate the deficiency. — Juran
Institute, Inc.

A root cause is an antecedent source of a defect such that if it is
removed, the defect is decreased or removed itself. — CMMI V1.02


1. Analyze the Symptoms: understand fully the nature and extent of
the problem to be solved.

Tools: Flow Diagram, Data Collection, Pareto Analysis

2. Formulate Theories: a PAT should speculate about the cause of the
problem versus jumping to a solution.

Tools: Brainstorming, Cause-Effect

Purpose:

Role Role Role

SUPPLIER(S)

Input(s)

The process The process
begins with . . . ends with . . .

CUSTOMER(S)

Output


3. Test Theories: Before accepting any theory as true, a PAT should
systematically test it with data.

Tools: Data Collection, Graph/Charts, Histogram,
Pareto Analysis, Scatter Diagram, Stratification

4. Identify Root Cause(s): Does the data help determine the root cause
of the problem?

Tools: Data Collection, Graph/Charts, Histogram,
Pareto Analysis, Scatter Diagram, Stratification

 1. Formulate good questions
 2. Consider appropriate data analysis tool
 3. Define data collection points
 4. Select unbiased collector
 5. Understand data collectors & their environment
 6. Design data collection forms
 7. Document instructions
 8. Pilot/test forms and instructions
 9. Train data collectors
 10. Audit the collection process & validate results



PATs Report Status:
Discover Root
Understand,
Causes
Support,
Direct & Recognize Develop Solutions
Team & Controls



Juran's Quality
Improvement Process

3. test theories


Holding the gains:

Develop Solutions & Controls - 1

5. Consider Alternative Solutions: identify possible remedies
and evaluate each alternative solution in terms of impact on the
problem.

Tools: Brainstorming, Data Collection, Selection Matrix

6. Design Solutions & Controls: design the remedy which will
entail documentation of the solution (e.g., process, procedures,
standards) and controls.

Tools: Control Spreadsheet, Control Chart

Control How Where Who Who What is
Variable Measured Measured Standard Analyzes Acts done

• Juran Institute

Develop Solutions & Controls - 2

7. Address Resistance to Change: identify likely sources of resistance
(barriers) and support (aids). Identify counter measures to the vital few
barriers.

Tools: Barriers/Aids, Brainstorming

8. Implement Solutions & Controls: implementing a change includes:
developing a plan - involving relevant stakeholders, training and explaining
“why” the change.

Tools: Planning Matrix, Tree Diagram

3. test theories


Holding the gains:

9. Design Effective Quality Controls: determine how actual performance
will be compared to the standard (i.e., record data) in order to evaluate the effect
of the change.

Tools: Control Chart, Control Spreadsheet, Flow Diagram

10. Audit The Controls: develop systems for reporting results.

Tools: Control Chart, Control Spreadsheet, Data Collection,
Graphs/Charts, Pareto, Stop Light Charts

The Language of Senior Management is $money$ - CAR
can be used to “grab” management's attention.

A practical example of CAR Process Area is the Jurans
Quality Improvement Process:
• Discover Root Causes (CAR SG 1)
• Develop Solution & Controls (CAR SG 2)
• Holding the Gains (CAR SG 2)

Look for “low hanging fruit” for the first few problems to
solve.

Know when to use the appropriate tool in the Quality
Improvement journey.

“The competitor to be feared is one
who never bothers about you at
all, but goes on making his own
business better all the time.”

Es10 c groups

Recommended

Recommended

More Related Content

What's hot

What's hot (20)

Similar to Es10 c groups

Similar to Es10 c groups (20)

Recently uploaded

Recently uploaded (20)

Es10 c groups