Asq toronto10 jan2007effectcorraction

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 reserved2

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: [email protected]

Web: www.omnex.com


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.


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

What is a C/A Program?


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)


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


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!


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


Inputs to the C/A Program

Suggestion Programs?

OH&S Issues

Environmental Non-conformance / Spills

Internal & External Audits

Poor Quality Objective IndicatorsReliability Data

High Scrap, Material Review Boards

Production or Service Rejects / Defects / Defectives

Supplier Issues

Customer Complaints / Feedback

Others – Many more

Compliance Issues Improvement Programs


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


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


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


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)


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


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


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

Team Problem Solving Basics


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


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


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


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


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


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.


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.


8D Problem Solving

8D Problem SolvingD0 Prepare for the Problem Solving ProcessD1 Establish the TeamD2 Describe the ProblemD3 Develop the Interim Containment ActionD4 Define and Verify Root CauseD5 Choose and Verify Permanent Corrective ActionD6 Implement and Validate Permanent Corrective

ActionD7 Prevent RecurrenceD8 Team and Individual Recognition


Example: Problem Solving Tools


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?

The Ultimate C/A Program


Key Elements of C/A ProgramBeforeBefore

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

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

AfterAfter



• 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



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!


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


Company Wide Problem Solving

• All Continual Improvement processes follow the PDSA cycle

The Fundamental Cycle for Corrective Action or Process Improvement

Plan Gather Data in order to formulate a plan.

Do Finalize and implement the plan

Study Study the effects of actions taken to see if anticipated results occurred

Act Fix weaknesses, prevent recurrence and add lessons learned to the knowledge base of the company

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.


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



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!


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

Thank You!Q & A!