Root Cause Corrective Action: Solve

Root Cause Corrective Action
Your Instructor: Solve Romains Bos

R
Contain

Your Instructor: Romains Bos
Agenda
Introduction NCR Response Format Containment Problem Identification Collect Data and Determine Causes Corrective Action Planning Mistake Proofing Implementation and Validation NCR Examples Resources
Introductions
Name Company Location Position / Role Task Group Interest Expectations Why am I here?
Cause Analysis Process

An effective process for finding the causes of an event and facilitating effective corrective actions to prevent recurrence.
Goal
To understand the concepts of cause analysis and to be able to apply those concepts to prevent or eliminate errors and defects.
Feel like youre drowning in problems?

Cause Analysis & Mistake proofing can rescue you!
Traditional Problem Solving

YES NO
Is It Working? Dont Mess With It!

YES
Did You Mess With It?
YOU IDIOT!
NO
Anyone Else Knows?
YES
Youre DONE!
YES
Will it Blow Up In Your Hands?
NO NO
NO
Hide It
Can You Blame Someone Else?
Look The Other Way
Yes
NO PROBLEM!
The Traditional Way

Event (Problem)
Form Team Identify Problem Gather Data Analyze Data Determine Causes Determine Corrective Action
Implement (fix It)
Overview
RCCA for Nonconformances
A requirement of the Aerospace industry for many years A process of determining the causes that led to a nonconformance or event An effective method for implementing corrective actions to prevent recurrence Requirements are not new, but they may not have been aggressively enforced in the past
Overview (Continued)
RCCA for Nonconformances
Presentation of tools for NCR corrective action and response Guidance documents and on-line tutorial A full and complete NCR response to criteria will aid in acceptance of NCR corrective action, shorten cycle time, and provide a continuous improvement tool There is nothing unique about expectations for corrective action
RCCA will strictly enforce the requirements for corrective action Dont look at cause analysis only as a way to get through the NCR response portion of an audit Can be applied to all aspects of business for problem solving and process improvement Approach varies based on differences in the organization and size of businesses
Multiple uses of the process that go beyond response to NCRs Effective tool for problem solving The process described here is a process for identifying the information required as well as meeting corrective action requirements Steps described here encompass essential elements of any corrective action system The steps may be accomplished with different tools or called by different names
The Requirement
8.5.2 Corrective Action: The organization shall 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. A documented procedure shall be established to define requirements for: a) reviewing nonconformities (including customer complaints), b) determining the causes of nonconformities, c) evaluating the need for action to ensure that nonconformities do not occur, d) determining and implementing action needed, e) records of the results of action taken, f) reviewing corrective action taken, g) flow down of the corrective action requirement to a supplier, when it is determined that the supplier is responsible for root cause, and h) specific actions where timely and/or effective corrective actions are not achieved.
Updated ISO 9001: 2000
The Requirement (Continued)

8.5.3 Preventive Action: The organization shall 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. A documented procedure shall be established to define requirements for: a) determining potential nonconformities and their causes, b) evaluating the need for action to prevent occurrence of nonconformities, c) determining and implementing action needed, d) records of results of action taken, and e) reviewing preventative action taken.
The Requirement (Continued)

8.3 Control of Nonconforming Product: The organization shall ensure that product which does not conform to product requirements is identified and controlled to prevent its unintended use or delivery. The controls and related responsibilities and authorities for dealing with nonconforming product shall be defined in a documented procedure.
Key Components: Corrective Action

Establish and maintain documented procedures. Take action:
To a degree appropriate to the magnitude of the problems Commensurate with the risks encountered
Implement and record any changes Effective handling Investigating of the cause and recording the results Determination of action needed to eliminate the cause Controls to ensure that action taken is effective
Key Components Nonconforming Product

Establish and maintain documented procedures including process nonconformity that may result in product nonconformity Prevent nonconformances from unintended use Review and disposition nonconforming product Timely reporting of nonconformities that may affect delivered product
Success depends on you. Participate actively!
RCCA Cause Analysis Flow Chart
EVENT
Form Team
Identify Problem
Gather & Verify Data
Determine Causes
Direct
Root
Contributing
Determine Corrective Actions (Specific & Preventative)
Mistake Proofing
Implement & Follow up
Loop Back NO
Solution Acceptable?
YES!
DONE
EVENT
Form Team
Identify Problem
Containment and Problem Identification

Direct
Determine Causes
Root
Contributing
Mistake Proofing
Loop Back NO
YES!
DONE
Immediate Corrective Action Taken (Containment Actions):
NCR Response Format

Of particular interest to the supplier Logical order or progression Format must be used Requires clear and concise descriptions
Root Cause of Nonconformances:
Impact of all Identified Causes and the Root Cause:
Action Taken to Prevent Recurrence:
Objective Evidence Attached:
Effectivity Date:
EVENT
The Event
Form Team
Identify Problem
Determine Causes
Direct
Root
Contributing
Mistake Proofing
Loop Back NO
YES!
DONE
Event
An all inclusive term for any of the following: Product Failure Special Cause (SPC) Customer Complaint Failure Mode (FEMA) Audit Finding Accident Pleasant Surprise
So, you have had an EVENT--
First, you react!
Containment
Put out the fire Assess the damage Contain all affects Notify as appropriate
Put Out the Fire

We all know how to do this We are all really good at firefighting
Just a Reminder
Stop producing bad product
Asses the Damage

How many parts were impacted? How much were they impacted? Any other damage?
Contain All Effects

Where are all the impacted parts? Segregate all impacted parts? Determine if impacted parts have been shipped
Notify
Notify affected customers
NCR Response Format
Immediate Corrective Action Taken (Containment Actions): Describe what was accomplished to stop producing nonconforming product, assess damage, contain all effects, and to notify customers (as applicable).
Effectivity Date:
Containment
NCR #001. Rockwell hardness tester, S/N C2350, was found to be in use after calibration period had expired. Calibration expired on 12/01/2005. The hardness machine was used for acceptance testing of production parts on 12/03/2005. Immediate Corrective Action
You have had an EVENT:

Youve contained the event and stopped the problem from occurring
Now its time to
begin corrective
action!
EVENT
Form Team
Identify Problem
Form Team
Natural Team Qualified Team

Direct
Determine Causes
Root
Contributing
Mistake Proofing
Loop Back NO
YES!
DONE
Natural Team
A Group of people having vested ownership of the problem to be solved
Natural Team: Vested Ownership

Assignment of wrong personnel a common problem Common to assign to Quality did quality make an error? Who owns the problem? Who has stake in the outcome and the solution to the problem? Who are the vested owners of both the problem and the solution? Who knows the process have data and experience? Without the full buy-in and support of the stakeholders, long-term solutions are not likely
The Qualified Team

The Natural Team, including other individuals who can provide necessary resources to understand the problem Those who can provide additional information Those who have particular technical expertise Those who may be needed to act as advisors Those providing management support
Team Composition
Stakeholders and qualified members may change as the team gains or information and data Clarifying the problem or additional problems may identify additional stakeholders or require additional expertise As the process evolves, continue to assure that the team includes stakeholders and necessary experts and resources
What is the team going to work on?

Logical order of progression Determine the root cause of the problem
THE PROBLEM
Effectivity Date:
EVENT
Form Team
Identify Problem
Identify Problem
Direct
Determine Causes
Root
Contributing
Mistake Proofing
Loop Back NO
YES!
DONE
Caution:
Know Your Problem!
You must understand the problem Is there more than one problem? Keep it simple!
The Problem
Must be clearly and appropriately defined.
The nonconformance identified may not be real problem only a symptom of the problem
Asking questions helpful

What is the scope of the problem? How many problems are there? What is affected by the problem? What is the impact on the company? How often does the problem occur?
Addressing appropriate questions will assist in clarifying and defining the problem(s)
Caution:
If you cannot say it simply, you do not understand the problem!
State the Problem as an Event question starting with:
Why?
An event question is short, concise, and focused on ONE problem It is a question starting with Why? It is the first Why in the process
An event question does not:

Tell what caused the event State what to do next Explain the event
Exploring the Event Question

NCR #001. Rockwell hardness tester, S/N C2350, was found to be in use after calibration period had expired. Calibration expired on 12/01/2005. The hardness machine was used for acceptance testing of production parts on 12/03/2005. What is the Event Question? Natural Team: Qualified Team:
EVENT
Gather and Verify Data
Form Team
Identify Problem
Problem (event question) has been identified. Time to gather data
Determine Causes
Direct
Root
Contributing
Mistake Proofing
Loop Back NO
YES!
DONE
Data Collection
You cant tell which way the train went by looking at the tracks!
Gather and Verify Data

Problem identified begin data collection May need to be collected several times The preliminary collection phase occurs now and will guide the analysis process Initial data gathering starts at the scene
Data has a shelf life Waiting makes it difficult to obtain good information. Go to the scene Note those present, what is in place, when the event occurred, and where the event happened
Data Collection
Performed by Team Members
Look for:
Location Names of Personnel Date and Time Operational Conditions Environmental Conditions Communications Sequence of Events Equipment Physical evidence Recent Changes Training Other Events
Data Collection
Performed by Team Members
What data would you look for with NCR #001:

NCR #001. Rockwell hardness tester, S/N C2350, was found to be in use after calibration period had expired. Calibration expired on 12/01/2005. The hardness machine was used for acceptance testing of production parts on 12/03/2005.
EVENT
Analysis
Form Team
Direct Cause Contributing Cause(s) Root Cause
Identify Problem
Determine Causes
Direct
Root
Contributing
Mistake Proofing
Loop Back NO
YES!
DONE
Analysis
The 5-Why process used as example The 5-Why method
Used to build a cause chain A natural logical progression for thinking through a problem The answer to the first Why is the direct cause The logical end of each chain is a root cause The causes in between are contributing causes
Caution:
Typically, when there is a problem, those who are closely involved tend to believe they can quickly identify the solution.
I wonder how long it will take them to figure out Im unplugged
I bet someone spilled coffee in it!
The board must be fried!
The switch must be bad!
Im busted!
This tends to lead to the band-aid approach to correcting the problemand provides less than satisfactory results!
Caution:
Complex problems, especially those where an entire process has been brought into question require a more thorough analysis.
Requirements & Design Process Planning & Materials
Equipment & Maintenance

Production Operations & Quality Assurance
Root Cause Analysis (RCA) is a systemic approach to determining all the contributors to a problem before attempting to implement a corrective action plan.
5 Why Analysis:
One tool that can be used to assist in performing a root cause is the 5-Why Analysis
Why? Why? Why? Why? Why?
Simply put, a 5-Why analysis adds discipline to the problem investigation to ensure that as many contributors as possible are reviewed up front. This makes it possible to create an action plan taking into account all the informationwhich should lead to much better results.
Consideration for Analysis: Act on Fact!

The process requires complete honesty and no predetermined assumptions! Follow the datadont make it up! Dont get personal! Its not a witch hunt! What we really want to know is... Ask, Why did it happen? Not Who did it?
Common Initial Consideration

Operator error (most common) Honest mistake Second shift did it We didnt include the requirement in our internal procedure We didnt know it was a requirement Not familiar with the specification
Caution: Operator Error

Yes, it happens, but Used as root cause much too often Used as an easy way out
Ask: If the operator was replaced, could the next person make the same mistake? If so, then you probably have not determined the Root Cause!
Caution: Is it really Operator Error?

You must ask these five questions: Proper Instructions? Proper Tools? Proper Training? Clear Expectations / Goals? Is the process Complex or Unusual?
Measuring Responsibility
Can the operator be partially responsible? Yes. Rarely are situations clearly all or nothing. You must weigh your answers to the five questions carefully.
Dont limit your search!

What role did management system play? Dont be afraid to look beyond the area in which you work!
Just Keep Asking Why?

Event: Didnt get to work on time.
EQ: Why were you late?
Car wouldnt start.

Why didnt the car start?
Battery was dead.

Why was the battery dead?
Dome light on all night.

Why was the light on?
Kids played in the car, left door ajar!

Why were the kids playing in the car?
Babysitter wasnt watching them!
A5 Why analysis is simple to createas long as you know the right question to ask Identify the basic question will guide your whole analysis Starting too broad will waste effort, money, and time Why do we
make airplane parts? Why is that atom over there?
Starting too detailed may lead you to only a partial answer.
No Big Secret!
Simple Question
Simple Answer
Simple Question
Simple Question
Simple Answer
Simple Answer
Simple Answer
CAUTION
Cause chain under construction. No corrective actions allowed!
Test it! Does it hold up backwards?

Babysitter wasnt watching them!
Did that cause?
Kids played in the car, left door ajar!

Did that cause?
Dome light on all night.

Did that cause?
Battery was dead.

Did that cause?
Car wouldnt start.

Did that cause?
Event: Didnt get to work on time.

Your Instructor: Solve Romains Bos
R
Contain
Direct Cause:
The cause that directly resulted in an event. (The first cause in the cause chain.)
Event
Direct Cause
Contributing Cause:
The cause that contributed to an event, but by itself, would not have caused the event. (The causes after the direct cause.)
Event
Direct Cause
Contr. Cause
Also referred to as conditions.
A true Statement?
Root Cause: The fundamental reason for an event, which if corrected, would prevent recurrence.
A true Statement!
Root Cause: The fundamental reason for an event, which if corrected, would prevent recurrence.
The last cause on the cause chain.
An important Thing to Remember About Root Cause.

Its not always the most significant cause in the cause chain Just focus on the fact that it is the LAST cause in the cause chain
Cherry picking will not lead to success!
Use the cause chain!
The Complete Cause Chain:
Event
Direct Cause
Contr. Cause
Root Cause
How many root causes are you allowed?
How many Root Causes can you have?

Problem #1 Direct. Cause Direct. Cause C C C C C C C C Root Cause Root Cause
Event
Problem #2
How many root causes are you allowed?
Example: Multiple Problems

NCR #001. Rockwell hardness tester, S/N C2350, was found to be in use after calibration period had expired. Calibration expired on 12/01/2005. The hardness machine was used for acceptance testing of production parts on 12/03/2005. What is the Event Question? 1) Why was the hardness tester out of calibration?
2) Why did the worker operate the hardness tester while out of calibration?
How many Root Causes can you have?

Event Direct. Cause Cont. Cause Cont. Cause C C C C C C C C Root Cause Root Cause Root Cause
One or more, if you have multiple branches
C C C C
Review of the Analysis Process:

Start with the event question Use the Why-Why process Take small steps dont skip causes Write down each cause (and the Why) No corrective action allowed! Test chain by working backwards
Ignorance
Silly
Unworkable
Workable
Times asked why
NCR #001, Problem 2.

E: Used hardness tester that was out of calibration. Inspector didnt look at the calibration date. He wasnt trained to check the date. I didnt train him to do that. Not enough time. To many customer specs to review. Job responsibility. Its in my job description. Because we build aircraft parts.
Why do I even work here?
Guideline for ending the chain:. Is the last cause within your control? Do you have ownership?
Event: Aluminum parts did not properly respond to solution heat treatment.
EQ: Why didnt the aluminum parts harden to required strength?
Material Problem Time/Temp Cycle Quench Delay Temperature Uniformity
Parts did not respond to H/T
We will brainstorm consider all areas of the process, not just the ones that we know are involved.
For our purposes, we are going to say that we have data indicating that our material is not the issue. Therefore, we can eliminate that as a path to follow.
EQ: Why didnt the aluminum parts harden to required strength?
Material Problem Time/Temp Cycle Quench Delay Temperature Uniformity
Parts did not respond to H/T
However, we will not be too eager to eliminate early on. There should be data or sound reasoning to indicate that it doesnt apply. Better to leave it, and eliminate it later.
The process of questioning the answer is continued at least 4 more times (i.e., 5 Why) for each Why.
Parts did not respond to H/T Material Problem Time/Temp Cycle Quench Delay Temperature Uniformity Procedures Incorrect Technician Training Controller T/C Problem Temperature Distribution
Be sure to keep your questions in line with the original issue. Otherwise, you can stray into unrelated areas and waste time.
The resultant of questions and answers should lead to a comprehensive picture of POTENTIAL causes for the problem.
Continuing Analysis
Dont be surprised if more than one path leads to similar causes.
Once the tree is complete, a detailed review of each of the potential causes can be performed. Compare it with facts gathered to determine if it is a demonstrated contributor.
Damaged Baffles
Temperature Distribution
Burned Out Heater Elements Deteriorated Insulation Door Air Leak
Continued fact finding into each potential cause may be required to determine the overall contribution of each item.
The next step is to document findings in detail. A discussion of the potential cause and findings should be provided.
3.2.1.1.1
Temperature Distribution
5 Why Matrix Block
3.12 Temperature Uniformity 3.1.2.1 Door Air Leak 3.2.1.1.1 Preventative Maintenance
Discussion: A worn door seal allowed air leaks that influenced temperature patterns within the furnace work zone.
RCA Finding: Preventative maintenance procedures should be revised to include inspection of door seals.
RCA Discussion Document
When detail discussion of the 5 Why analysis is complete, individual root cause findings can collected and analyzed to identify those with the most impact to the process.
3.2.1.1.1 Preventative Maintenance 3.2.1.1.1 Preventative Maintenance 3.2.1.1.1 Preventative Maintenance Discussion: A worn door seal allowed air leaks that influenced temperature patterns within the furnace work zone. RCA Finding: Preventative maintenance procedures should be revised to include inspection of door seals.
Look for patterns in the findings. Understanding patterns will help when it comes time to develop the Corrective Action Plan.
Fishbone Diagrams
A fish bone diagram is a graphic methodology to identify Whys. To make a Fishbone Diagram, start with you problem or event and brainstorm ideas about why that problem/event is happening. Each one of these ideas (or causes) becomes a bone that shoots off the main one. Then, brainstorm ideas that might have caused those bones. Eventually, it will look like a skeleton of a fish. The key bones from our example (and an acceptable response) are shown. In actual practice, there may be many additional bones.
Analysis Method Your Decision

The 5-Why decision tree Fishbone (Ishikawa diagram) TQM Six-sigma Important to analyze with a method for determination of: Other 1) direct cause(s),
2) contributing cause(s), 3) true root cause(s), and 4) a cause chain.
The cause chain is your bridge between the event and the solution. Trust it!
RC Entry.
Root cause is now identified by teams List root cause(s)
Root Cause of Nonconformances: Identify the root cause(s) of the nonconformance as determined by the team(s).
Effectivity Date:
Impact.
A part of the team(s) effort Not an action item on the RCCA flow chart What is the impact of the root cause and all identified causes? Identify
Impact of all Identified Causes and the Root Cause: Detail the impact of all identified causes and the root cause. Was there product impact? Verify how product impact was determined?
Effectivity Date:
Root Cause and Impact

NCR #001. Rockwell hardness tester, S/N C2350, was found to be in use after calibration period had expired. Calibration expired on 12/01/2005. The hardness machine was used for acceptance testing of production parts on 12/03/2005. Root Cause? Impact?
EVENT
Form Team
Identify Problem
Determine C/A
Specific Preventative
Direct
Determine Causes
Root
Contributing
Mistake Proofing
Loop Back NO
YES!
DONE
A set of planned activities (actions) implemented for the sole purpose of permanently resolving the problem.
Specific corrective action changes only the direct cause or the effect Sustaining corrective action changes contributing and root causes
Action(s) taken to correct the direct cause and/or the effect.
Action(s) taken to prevent recurrence of the event.
Rememberwe want to break the Cause Chain.

Root Cause Contrib. Cause
Event Direct Cause
Sustaining corrective actions focus on changing root cause(s) and contributing cause(s) If you have only identified one cause, you probably wont get a 100% effective fix Remember todays contributing cause is tomorrows root cause
Corrective Action
NCR #001. Rockwell hardness tester, S/N C2350, was found to be in use after calibration period had expired. Calibration expired on 12/01/2005. The hardness machine was used for acceptance testing of production parts on 12/03/2005. Specific C/A. Sustaining C/A:
Means making judgment calls based on facts Three questions need to be asked 1) What is the cost of the event in terms of:
Personal & environmental safety? Lost time? Lost product? Customer dissatisfaction?
2) How likely is the event to recur if not fixed? 3) Can you accept the consequences of a recurrence?
Means preventing recurrence everywhere There may be multiple occurrences and far reaching effects outside the boundaries of the original event. The team must take responsibility for extending the corrective actions How does the cause chain affect other areas and how widespread is it? How severe is the event? How many times has it happened before?
Applying preventive corrective actions plant-wide is a quality system requirement and a management expectation.
Expand the team, create a second team, pass it up to management, do whatever it takes just dont ignore the problem if its a plantwide issue.
Fix the Problem

Review all potential areas of impact and fix the problem everywhere Otherwise, problems will keep popping up Learn to fix BEFORE there is an event
Sustaining Action Test

Test each sustaining action by asking: 1. Do the sustaining corrective actions lower the risk of the event reoccurring to an acceptable level? 2. Are there adverse effects caused by implementing the corrective actions that make them undesirable?
What, Who, When.

What is the corrective action? Who is responsible for doing it? When is it going to be done?
AVOID: Assigning corrective actions to someone who is not on the team? No vested interest!
RCCA
Got a problem?
Select A Matic
Give it a spin!
Doing the same thing over and over and expecting different results!
Trained Operators? Revised Procedures?
Procedures are the scar tissue of past mistakes.
Dont write yourself into a corner (audit trap). Say exactly what you mean and then do it! Beware when using words like training or everyone.
Action.
Follows determination of direct, contributing and root causes What has been implemented to provide long term correction of the problem?
Action Taken to Prevent Recurrence: Cannot be determined until the direct, contributing, and root causes have been identified. What has been implemented to correct the process from a long term perspective. Objective Evidence Attached:
Effectivity Date:
Evidence.
Verification that C/A procedures are in place and are effective Training evidence Applicable pages from revised procedures Required for all NCRs on initial, major NCRs on reaccreditation
Action Taken to Prevent Recurrence: Cannot be determined until the direct, contributing, and root causes have been identified. What has been implemented to correct the process from a long term perspective. Objective Evidence Attached: Evidence that C/A procedures are in place. Effectivity Date:
Effectivity.
When was the C/A effective? Typically needs to be implemented prior to closing the NCR
Action Taken to Prevent Recurrence: Cannot be determined until the direct, contributing, and root causes have been identified. What has been implemented to correct the process from a long term perspective. Objective Evidence Attached: Evidence that C/A procedures are in place. Effectivity Date: Date C/A effective.
EVENT
Form Team
Identify Problem
Determine Causes
Mistake Proofing
Direct
Root
Contributing
Mistake Proofing
Loop Back NO
YES!
DONE
Consider:
Mistake Proofing!
Mistake proofing a process which provides a structure for designing a failure mode out of a product or process.
Preventive Corrective Action Connection
Mistake proofing devices and techniques are highly effective in breaking cause chains. They tend to be simple, inexpensive devices that prevent errors from occurring or detect errors that have occurred.
Demand Vigilance: There is no mistake; there has been no mistake; and there shall be no mistake. (Arthur Wellesley, 1st Duke of Wellington.) Mistake-proof: Eliminate the error before it becomes an event Defects are never found until after the final inspection. (Murphys law of business.)
Remember Operator Error?

Demming Study on Errors: 94% of Errors are Process Related. 6% are People Related
There are operator errors, then there are processes that cause operator errors. The key is keeping all errors, process & operator, from becoming defects.
Usable Design
Warning labels and large instruction manuals are signs of failures, attempts to patch up problems that should have been avoided by proper design in the first place.
*Source: The Design of Everyday Things, by D.A. Norman, 1988, Doubleday
A New Attitude Toward Preventing Errors

The human brains default mode of operation is pattern recognition and autopilot execution. If the pattern is familiar, a behavior that has been successful in the past is" launched. Its only when feedback suggests that things are not going as planned that more in-depth thought is called up.
*Source: The Design of Everyday Things, by D.A. Norman, 1988, Doubleday
We keep on making errors until something tells us to stop.

A robust process will take into account varying degrees of operator experience and be designed accordingly.
Make errors more difficult to commit Make it possible to reverse errors to undo them Make it easier to discover the errors that do occur Make the process more forgiving of errors
Examples of Mistake Proofing

Asymmetric prongs on electrical connectors only fit one way or only fit in correct socket Beeper on ATMs so that you wont forget card Car lights that turn on and off automatically Active switch on lawn mowers and treadmills Picture on money changer for correct insertion Position sensor in car wash wont start until you are on sensor pad Kittingseven day medicine/pill dispensers. Bevel on floppy disks Lock-out fields and tab control on electronic forms
How do you apply mistake proofing to the cause chain?

Look for the error point(s).
Error points are causes where someone failed to do something correctly a point at which a mistake was made.
Find those causes and attack them first!
EVENT
Form Team
Identify Problem
Determine Causes
Direct
Root
Contributing
Implement & Follow Up

Loop Back NO
Mistake Proofing
YES!
Solution Acceptable? DONE
A review done by a team member to insure all corrective actions were implemented as stated
An independent review to determine if the corrective actions have been effective in preventing recurrence
The Requirement
8.5.2Corrective Action: The organization shall 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. A documented procedure shall be established to define requirements for: a) reviewing nonconformities (including customer complaints), b) determining the causes of nonconformities, c) evaluating the need for action to ensure that nonconformities do not occur, d) determining and implementing action needed, e) records of the results of action taken, f) reviewing corrective action taken, g) flowdown of the corrective action requirement to a supplier, when it is determined that the supplier is responsible for root cause, and h) Specific actions where timely and/or effective corrective actions are not achieved.
Who Performs Follow-Up? Who Performs Assessment? When is Assessment Performed? How do you Assess?
The team must decide!
EVENT
Form Team
Identify Problem
Is the Solution Acceptable? Effectiveness measurement Did C/A Work? Report
Determine Causes
Direct
Root
Contributing
Mistake Proofing
Loop Back NO
YES!
DONE
The criteria used to evaluate if the corrective actions achieved the desired outcome Plan your measurements. How are you going to prove your corrective actions worked?
Measure attributes for correctness or completeness Measure quantities (how many right or wrong) Measure frequencies and rates (how often per period)
Do Test Cases Review Data Use Experts
RCCA will verify the effectiveness of your corrective actions on subsequent audits Ineffective or nonsustaining action is cause for removal from the Supplier Merit Program
Did Corrective Actions Work?

Follow-up
Was C/A Accomplishe d as Stated?
Yes!
Time to Assess
No!
A New Corrective Action?
Did Corrective Actions Work?

Follow-up
Was C/A Accomplishe d as Stated?
Yes!
Done!
No!
Reevaluate cause chain and Corrective Action?
The Job Isnt Done Until the Paper Work Is Finished!
Document Work Write Report Make Distribution
EVENT
Form Team
Identify Problem
Determine Causes
Direct
Root
Contributing
Mistake Proofing
Complete Final Report
Loop Back NO
YES!
DONE
EVENT
Document Team(s) Minutes Team Mtgs Document Causes Document C/A Document Follow-up
Direct
Form Team
Identify Problem
Determine Causes
Root
Contributing
Mistake Proofing
Write final Report
Loop Back NO
YES!
DONE
The Report Isnt Just for Your Team

You did an excellent job of analysis and corrective action, now its time to tell everyone
Your boss Your colleagues Your customer(s) Your Auditors

Customer Registrar
Use the Report to Open a Dialog with Management

This is the place to tell management:
What your real problems are The real cost of those problems How often those problems are really happening What is really going on
Build a Corrective Action System that Works for You!!!

Fix your procedure to require cause analysis
All events should have some root cause analysis be selective
Some events require a full-blown root cause analysis Some events require something less
Insure that your procedure accommodates the need
Build a Corrective Action System (Continued)

Put White or Chalk Boards throughout your facility communicate and enforce the expectation Require measures of effectiveness and assessments for all corrective actions Do not allow closure of bad corrective action
Establish a review that requires and enforces the process established Have champions who work with groups for remedial training
Build a Corrective Action System (Continued)

Recognize that this isnt easy and it takes time
Allow time to accomplish the process Allow time to develop the skill You will be more proficient and effective at this with practice and on-going assessment
Post Script Resources Available

www.pri-network.org
Supplier Information
RCCA Tutorial CA Response Guidelines Nonconformance Reporting Guidelines eAuditNet Instructions
Post Script Resources Available

(Continued)
www.eauditnet.com
Public Documents
Organized by task group and subject Numerous files for assistance
Task group Specific NCR Guidelines

Attached to NCR #1 of each audit report Contact your Staff Engineer
Success depends on you. Participate actively!

Root Cause Corrective Action: Solve

Загружено:

Сведения о документе

Исходное описание:

Оригинальное название

Авторское право

Доступные форматы

Поделиться этим документом

Поделиться или встроить документ

Параметры публикации

Этот документ был вам полезен?

Это неприемлемый материал?

Авторское право:

Доступные форматы

Root Cause Corrective Action: Solve

Загружено:

Авторское право:

Доступные форматы

Root Cause Corrective Action

Your Instructor: Solve Romains Bos

Root Cause Corrective Action

Cause Analysis Process

Feel like youre drowning in problems?

Traditional Problem Solving

Is It Working? Dont Mess With It!

Did You Mess With It?

Anyone Else Knows?

Will it Blow Up In Your Hands?

Can You Blame Someone Else?

Look The Other Way

The Traditional Way

Implement (fix It)

Updated ISO 9001: 2000

The Requirement (Continued)

Updated ISO 9001: 2000

The Requirement (Continued)

Key Components: Corrective Action

Key Components Nonconforming Product

Success depends on you. Participate actively!

RCCA Cause Analysis Flow Chart

Gather & Verify Data

Determine Corrective Actions (Specific & Preventative)

Implement & Follow up

Containment and Problem Identification

Gather & Verify Data

Determine Corrective Actions (Specific & Preventative)

Implement & Follow up

Immediate Corrective Action Taken (Containment Actions):

NCR Response Format

Root Cause of Nonconformances:

Impact of all Identified Causes and the Root Cause:

Action Taken to Prevent Recurrence:

Objective Evidence Attached:

Gather & Verify Data

Determine Corrective Actions (Specific & Preventative)

Implement & Follow up

So, you have had an EVENT--

First, you react!

Put Out the Fire

Asses the Damage

Contain All Effects

NCR Response Format

Root Cause of Nonconformances:

Impact of all Identified Causes and the Root Cause:

Action Taken to Prevent Recurrence:

Objective Evidence Attached:

You have had an EVENT:

Now its time to

Natural Team Qualified Team

Determine Corrective Actions (Specific & Preventative)

Implement & Follow up

A Group of people having vested ownership of the problem to be solved

Natural Team: Vested Ownership

The Qualified Team

What is the team going to work on?

Root Cause of Nonconformances:

Action Taken to Prevent Recurrence:

Objective Evidence Attached:

Gather & Verify Data

Determine Corrective Actions (Specific & Preventative)