8d

Effective Corrective Action (C/
A) Program
Presented by David Barber, General
Manager of Omnex Canada
for ASQ, Toronto, January 10, 2007

Copyright 2007 Omnex. All rights reserved
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Omnex provides training, consulting and software to the
international market with offices in the USA, Canada, Mexico,
China (PRC), Germany, India, the Middle East and Thailand.
Omnex offers over 55 training courses in business, quality,
environmental, and health & safety management systems
worldwide.
Internet email: info@omnex.com
Web: www.omnex.com

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David A. Barber, CQE (ASQ)
• Mr. Barber is the General Manager and Senior Quality Consultant /
Trainer for Omnex Canada Inc. He has been a full time consultant since
1998, and estimates a total of 7,000 hours of in-class instructional
training and 4,000 hours of client consultation since that time.
• Mr. Barber has over 22 years experience in the Quality profession with
the majority of this time being spent in Quality Director / Manager and
Quality Engineering roles. He has a diverse background with
experience in the automotive, medical devices, consumer electronic,
telecommunications, plastics, machining, and stamping industries. Mr.
Barber has assisted companies in the development and implementation
of cohesive quality systems that have resulted in the achievement of
ISO 9001:1994, QS-9000, TS16949:1999, ISO 9001:2000,
TS16949:2002, TL9000, ISO/IEC 17025 and Six Sigma projects.
• Mr. Barber is a fifteen-year senior member of the American Society for
Quality (ASQ) and is a Certified Quality Engineer. He received his
Quality Assurance Certificate (accredited by the ASQ) from Centennial
College of Applied Arts and Technology, has a diploma in Electronics
from Radio College of Canada.

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Presentation Overview
• What is a C/A Program?
– Elements of a C/A Program
• Background of Corrective Action
Requirements
– Forced Requirements to Expand the C/A Activities
into a Program
• Team Problem Solving Basics
• The Ultimate C/A Program

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Program Management
• Application of knowledge, skills, tools and techniques to
project activities to meet project requirements
• Manages Competing Demands:
– Scope - Time - Quality
– Cost - Risk - Value
• Manages Competing Stakeholder Expectations:
– Customers & End Users
– Management & Employees
– Pressure Groups, Local Communities
– Regulatory Entities (Safety, Environment)
– Supplier Organizations
– Stockholders (Owners & Investors)

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Simplified Understanding
of the C/A Program?
• A process? – Best Practice
• A system? – Interacting sub-processes
• Management of various of inputs?
• These inputs may have different:
– Priorities / Importance to the supplier or customer
• Cost / Waste – Cost of Poor Quality
• Complexity of the Issue
– Communication levels
– Tasks / Sub-processes which are triggered
• Team involvement
• Detailed Problem Solving

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Simplified Understanding
of the C/A Program?
• Various expected outputs or outcomes?
• Improve the Business
– Which other process(s) should have prevented
this issue (or input to the C/A program) from
occurring in the first place?
– Lessons Learned
– Change!

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Process Characteristics
• A process can be identified by a series of
unique, but consistent, characteristics. There
are six characteristics of a process that are
mandatory for effective quality management.
– A process owner exists
– The process is defined
– The process is documented
– The linkages of the process are established
– The process is monitored and improved
– Records are maintained

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Inputs to the C/A Program
Suggestion Programs?
OH&S Issues
Environmental Non-conformance / Spills
Internal & External
Audits
Poor Quality Objective Indicators
Reliability Data
High Scrap, Material Review Boards
Production or Service Rejects / Defects / Defectives
Supplier Issues
Customer Complaints / Feedback
Others – Many more
Compliance Issues Improvement Programs

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Managing the Inputs
Two Paths Minimum (MUST BE LINKED)
1. Information Flow (Management Process)
• High-level Management Process? – Best Practice
• Manage the program, various type of Inputs
• Assign resources (people & money)
• Provide training – i.e., Team Problem Solving
• Communicating the progress and results
• Support the team
2. Detailed Problem Solving (Support Process)
• Your preferred Best Practice Method
– 5 why, 8D, 7 step, 5P, Drill Down, Red X, etc.
– Team Based
– Use Proven Tools for a give situation
– BE DISCIPLINED

Background of Corrective
Action Requirements

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8.5.2 Corrective Action
• Requirements
– Take action to eliminate the cause of
nonconformities in order to prevent recurrence
– Corrective actions shall be appropriate to the
effects of the nonconformities encountered

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8.5.2 Corrective Action
• Requirements
– A documented procedure shall be established to
define requirements for:
• Reviewing nonconformities (including customer
complaints)
• Determining the causes of nonconformities
• Evaluating the need for action to ensure that
nonconformities do not recur
• Determining and implementing action needed
• Records of results of actions taken (see 4.2.4)
• Reviewing corrective action taken

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Management Review Topics
• Product realization and
support process efficiency
and effectiveness (5.1.1)
• QMS and its performance
trends (5.6.1.1)
• Quality Objectives (5.6.1.1)
• Cost of Poor Quality
(5.6.1.1)
• Objectives in business plan
(5.6.1.1)
• Customer Satisfaction with
product (5.6.1.1)
• Results of audits (5.6.2)
• Customer Feedback (5.6.2)
• Status of Corrective and
Preventive Actions (5.6.2)
• Follow up from previous
reviews (5.6.2)
• Business changes (5.6.2)
• Actual and potential field
failures and their impact
(5.6.2.1)
• Design and Development
measurements- risk, costs,
lead times… (7.3.4.1)

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Additional C/A Requirements
• 8.5.2.1 Problem Solving
– The organization shall have a defined process for problem
solving leading to root cause identification and elimination
– If a customer-prescribed problem solving format exists, the
organization shall use the prescribed format
• 8.5.2.2 Error-proofing
– The organization shall use error-proofing methods in their
corrective action process
• 8.5.2.3 Corrective Action Impact
– The organization shall apply to other similar processes and
products the corrective action, and controls implemented, to
eliminate the cause of a nonconformity

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8.5.3 Preventive Action
• Requirements
– Determine action to eliminate the causes of
potential nonconformities in order to prevent their
occurrence
– Preventive actions shall be appropriate to the
effects of the potential problems

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8.5.3 Preventive Action
• Requirements
– A documented procedure shall be established to
define requirements for:
• Determining potential nonconformities and their
causes
• Evaluating the need for action to prevent occurrence
of nonconformities
• Determining and implementing action needed
• Records of results of actions taken (see 4.2.4), and
• Reviewing preventive action taken

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Effective Problem Solving
• Uses a disciplined process based on facts,
but takes advantage of experience and
creativity
• Uses an effective team of the right people
with the right skills
• Uses quality analysis and problem solving
tools effectively
• Has meaningful management support

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Effective Problem Solving Tools
for Identifying and Understanding
• Check Sheets
– Help gather information
• Pareto Diagrams, Scatter Diagrams and Histograms
– Help to organize data
• Process Flow Diagrams
– Help identify the process and to see the interaction between
operations
• Cause and Effect Diagrams
– Help identify relationships within the data
• Five Whys
– Help explain effects vs. causes
• Is/Is Not Analysis (Problem Solving Worksheet)
– Helps to describe the problem in scientific terms

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Effective Problem Solving Tools for
Analyzing and Tracking Data
• Changes and Differences Analysis
– Helps to isolate causes
• Trend Charts
– Help to track and identify intermittent factors
• DOE (Design of Experiments)
– Used to analyze complex processes with multiple variables
• Paynter Charts
– Help to track interim actions and determine their
effectiveness
• Action Plans
– Action plans are used to document and track actions to
ensure that all data is gathered and all assignments are
completed as required

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Effective Problem Solving Tools
for Maintaining Improvements
• FMEA
– Document the most up to date methods used for controlling known
and suspected risks to the process – they ensure that future similar
products will have all of the current best practices applied at the
earliest opportunity
• SPC (Statistical Process Controls)
– Monitor on-going process variation to ensure that process capability
is maintained
• Control Plans
– Used to document controls needed to ensure that risks to the
process are effectively addressed through automated process
controls or inspection
• Quality Auditing
– Validates that changes have been fully implemented and monitors
processes once implemented to ensure that best practices are
maintained

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Inhibitors to Effective Problem
Solving
• Problem Described Incorrectly
– No clear, thorough description of the problem
– Too broad of a problem
– Too narrow of a problem
• Problem-Solving Effort Expedited
– Problem solving steps are skipped in order to obtain a quick
solution
• Poor Team Participation
– Some team members don’t participate effectively, tasks don’t get
completed, or the team drifts into inaction
• No Logical Thought Process
– The team lacks a disciplined system for analyzing problems, relies
on experience only or even someone’s best guess
• Lack of Technical Skills
– Team members are not adequately trained in problem solving tools
and skills

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Inhibitors to Effective Problem
Solving
• Management Impatience
– Management’s lack of understanding of the problem solving
process causes impatience with the process and a demand
to know exactly when a problem will be solved
• Potential Cause Misidentified as Root Cause
– Potential causes can quickly become identified as root
causes and the problem investigation is concluded.
• Permanent Corrective Actions not Implemented
– A root cause may be identified, but no action is taken to
implement permanent corrective actions
– Permanent actions are implemented but don’t take hold and
soon deteriorate
The Internal Audit is an excellent tool for making sure that
planned actions are fully and effectively implemented.

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Verification vs. Validation
• Verification and Validation are often not well
understood
– In 8D’s, Verification and Validation work together as
a sort of 'before' (Verification) and 'after'
(Validation) proof
• Verification provides 'insurance' at a point in time that the
action taken was in fact the action that was supposed to
have been taken.
• Validation provides measurable 'evidence' that the actions
taken had the effect or end results that were desired.

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8D Problem Solving
8D Problem Solving
D0 Prepare for the Problem Solving Process
D1 Establish the Team
D2 Describe the Problem
D3 Develop the Interim Containment Action
D4 Define and Verify Root Cause
D5 Choose and Verify Permanent Corrective Action
D6 Implement and Validate Permanent Corrective
Action
D7 Prevent Recurrence
D8 Team and Individual Recognition

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Example: Problem Solving Tools

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Corrective Action Check List
(Partial Example)
 Has corrective action been established?
 Does it meet the required givens?
 Have different alternatives been examined as
possible corrective actions?
 Have Poka-Yoke techniques been considered?
 Has each alternative been screened?
 Have the risks involved with the corrective action
been considered?
 Was the corrective action verified?
 Was the corrective action proven to eliminate the root
cause?

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Key Elements of C/A Program
Before
Corrective Action
• Problem Solving Steps (Partial)
• Describe the Problem
• Develop the Interim Containment Action
• Define and Verify Root Cause
• Choose and Verify Permanent Corrective Action
• Implement and Validate Permanent Corrective Action
After

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The Ultimate C/A Program
• We need to focus on the “Before” and “After”
when we are talking about a “Program”
Note, with a poor “Team Problem Solving”
process, there can be no Effective C/A
Program

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BEFORE
• Realize that C/A Program is a Process
– Minimum of two unique processes
– This is a Management Process
• Drive a Company-wide Problem Solving Process
– Make sure “Process Characteristics” are met?
• Communicate
– Consider a Enterprise-Wide Integrated Management System
Software (web)
– Monitor Time & Money – “Cost of Quality” still works
• Understand when to use “Team Problem Solving”
– Train & monitor competency
– Spend the time now, next time will be easier!
– Prevent! Prevent! Prevent!

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Company-wide Problem
Solving Process
• Maintain Data
– Create and maintain a database of external and internal quality
and process problems, and the result of previous corrective
action efforts
• Set Priorities
– Use customer satisfaction, current process performance to
identify, and select problems or improvement opportunities
• Manage the Process
– Use a defined process (PDSA) for:
• Identifying the need for corrective action
• Assigning teams, for tracking projects
• Analyzing the effectiveness of problem solving activities
• Implementing, verifying and validating the effectiveness of the
project

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Company Wide
Problem Solving
• All Continual Improvement
processes follow the PDSA
cycle
Success occurs when a company uses all four steps (Plan, Do, Study, Act)
in the PDSA cycle. Any breakdown in the cycle negatively effects the
outcome.
Fix weaknesses, prevent recurrence and add lessons learned to the
knowledge base of the company
Act
Study the effects of actions taken to see if anticipated results
occurred
Study
Finalize and implement the plan
Do
Gather Data in order to formulate a plan.
Plan
The Fundamental Cycle for Corrective Action or Process
Improvement

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Company-Wide Problem Solving
• A company-wide process incorporates multiple PDSA cycles. How
much a company improves depends upon how quickly and effectively
it has learned to spin these cycles.
• The continual improvement process incorporates both break-through
improvements and incremental improvements.
IMPROVEMENT
IMPROVEMENT

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AFTER
• Realize that C/A Program is a Process
– Improve this Process
• Communicate
– Track to the end
– Report “Cost of Quality” to support prevent actions
– Publish results and lessons learned
– Management must recognize team efforts
• Finish “Team Problem Solving”
– Always apply Preventive Actions
• Institutionalize
– Which other process(s) needs to be improved? CHANGE!

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Summary & Review
• What is a C/A Program?
– Elements of a C/A Program
• Background of Corrective Action Requirements
– Forced requirements to expand the C/A activities into a
program
• Team Problem Solving Basics
• The Ultimate C/A Program

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