Root Cause Corrective Action

Root Cause Corrective Action Your Instructor: Romains Bos Contain Solve D R C R R

Root Cause Corrective Action 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 you’re drowning in problems? Cause Analysis & Mistake proofing can rescue you!

Don’t Mess With It! YES NO YES YOU IDIOT! NO Will it Blow Up In Your Hands? NO Look The Other Way Anyone Else Knows? You’re DONE! YES YES NO Hide It Can You Blame Someone Else ? NO NO PROBLEM! Yes Is It Working? Did You Mess With It? Traditional Problem Solving

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

Overview (Continued) RCCA will strictly enforce the requirements for corrective action Don’t 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

Overview (Continued) 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. Updated ISO 9001: 2000

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. Updated ISO 9001: 2000

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 Loop Back NO YES! EVENT Form Team Identify Problem Gather & Verify Data Determine Causes Determine Corrective Actions (Specific & Preventative) Solution Acceptable? Mistake Proofing Implement & Follow up DONE Contributing Direct Root

Containment and Problem Identification Loop Back NO YES! EVENT Form Team Identify Problem Gather & Verify Data Determine Causes Determine Corrective Actions (Specific & Preventative) Solution Acceptable? Mistake Proofing Implement & Follow up DONE Contributing Direct Root

Of particular interest to the supplier Logical order or progression Format must be used Requires clear and concise descriptions NCR Response Format Effectivity Date: Objective Evidence Attached: Action Taken to Prevent Recurrence: Impact of all Identified Causes and the Root Cause: Root Cause of Nonconformances: Immediate Corrective Action Taken (Containment Actions):

Loop Back NO YES! EVENT Form Team Identify Problem Gather & Verify Data Determine Causes Determine Corrective Actions (Specific & Preventative) Solution Acceptable? Mistake Proofing Implement & Follow up DONE The Event Contributing Direct Root

Event An all inclusive term for any of the following: Product Failure Audit Finding Special Cause (SPC) Accident Customer Complaint Pleasant Surprise Failure Mode (FEMA)

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 Effectivity Date: Objective Evidence Attached: Action Taken to Prevent Recurrence: Impact of all Identified Causes and the Root Cause: Root Cause of Nonconformances: 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).

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: You’ve contained the event and stopped the problem from occurring Now it’s time to begin corrective action!

Loop Back NO YES! EVENT Form Team Identify Problem Gather & Verify Data Determine Causes Determine Corrective Actions (Specific & Preventative) Solution Acceptable? Mistake Proofing Implement & Follow up DONE Form Team Natural Team Qualified Team Contributing Direct Root

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

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 Effectivity Date: Objective Evidence Attached: Action Taken to Prevent Recurrence: Impact of all Identified Causes and the Root Cause: Root Cause of Nonconformances: THE PROBLEM 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).

Loop Back NO YES! EVENT Form Team Identify Problem Gather & Verify Data Determine Causes Determine Corrective Actions (Specific & Preventative) Solution Acceptable? Mistake Proofing Implement & Follow up DONE Identify Problem Contributing Direct Root

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:

Loop Back NO YES! EVENT Form Team Identify Problem Gather & Verify Data Determine Causes Determine Corrective Actions (Specific & Preventative) Solution Acceptable? Mistake Proofing Implement & Follow up DONE Gather and Verify Data Problem (event question) has been identified. Time to gather data Contributing Direct Root

Data Collection You can’t 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 Location Names of Personnel Date and Time Operational Conditions Environmental Conditions Communications Sequence of Events Equipment Physical evidence Recent Changes Training Other Events Look for:

Data Collection Performed by Team Members 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 data would you look for with NCR #001:

Loop Back NO YES! EVENT Form Team Identify Problem Gather & Verify Data Determine Causes Contributing Determine Corrective Actions (Specific & Preventative) Solution Acceptable? Direct Root Mistake Proofing Implement & Follow up DONE Analysis Direct Cause Contributing Cause(s) Root Cause

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

Typically, when there is a problem, those who are closely involved tend to believe they can quickly identify the solution. This tends to lead to the ‘band-aid’ approach to correcting the problem…and provides less than satisfactory results! Caution: I wonder how long it will take them to figure out I’m unplugged I’m busted! I bet someone spilled coffee in it! The board must be fried! The switch must be bad!

Complex problems, especially those where an entire process has been brought into question require a more thorough analysis. Root Cause Analysis (RCA) is a systemic approach to determining all the contributors to a problem before attempting to implement a corrective action plan. Caution: Requirements & Design Production Operations & Quality Assurance Equipment & Maintenance Process Planning & Materials

One tool that can be used to assist in performing a root cause is the “5-Why” Analysis 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 information…which should lead to much better results. “ 5 Why” Analysis: Why? Why? Why? Why? Why?

Consideration for Analysis: Act on Fact! The process requires complete honesty and no predetermined assumptions! Don’t get personal! It’s not a witch hunt! What we really want to know is... Ask, ” Why did it happen?” Not “ Who did it ?” Follow the data…don’t make it up!

Common Initial Consideration Operator error (most common) Honest mistake Second shift did it We didn’t include the requirement in our internal procedure We didn’t know it was a requirement Not familiar with the specification

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: Operator Error

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.

Don’t limit your search! What role did management system play? Don’t be afraid to look beyond the area in which you work!

Just Keep Asking “Why?” Event: Didn’t get to work on time. EQ: Why were you late? Car wouldn’t start. Why didn’t 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 wasn’t watching them!

A’5 Why’ analysis is simple to create…as 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 Starting too detailed may lead you to only a partial answer. Why is that atom over there? Why do we make airplane parts?

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 wasn’t 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 wouldn’t start. Did that cause…? Event: Didn’t get to work on time.

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.” It’s 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 How many root causes are you allowed? Root Cause

How many Root Causes can you have? C C Event Problem #1 Direct. Cause How many root causes are you allowed? Root Cause Problem #2 Direct. Cause Root Cause C C C C C C

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? 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? C C Event Cont. Cause One or more, if you have multiple branches Root Cause Cont. Cause Root Cause C C C C C C Direct. Cause Root Cause C C C C

Review of the Analysis Process: Start with the event question Use the “ Why-Why ” process Take small steps – don’t skip causes Write down each cause (and the Why) No corrective action allowed! Test chain by working backwards

Ignorance Silly Workable Times asked “why” Unworkable

NCR #001, Problem 2. E: Used hardness tester that was out of calibration . Inspector didn’t look at the calibration date. He wasn’t trained to check the date. I didn’t train him to do that. Not enough time. To many customer specs to review. Job responsibility. It’s 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 didn’t the aluminum parts harden to required strength? Parts did not respond to H/T Material Problem Time/Temp Cycle Temperature Uniformity Quench Delay 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 didn’t the aluminum parts harden to required strength? Parts did not respond to H/T Material Problem Time/Temp Cycle Temperature Uniformity Quench Delay However, we will not be too eager to eliminate early on. There should be data or sound reasoning to indicate that it doesn’t 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 Procedures Incorrect Technician Training Temperature Distribution Controller T/C Problem Be sure to keep your questions in line with the original issue. Otherwise, you can stray into unrelated areas and waste time. Material Problem Time/Temp Cycle Temperature Uniformity Quench Delay

The resultant of questions and answers should lead to a comprehensive picture of POTENTIAL causes for the problem. Continuing Analysis Don’t 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. Temperature Distribution Damaged Baffles Burned Out Heater Elements Door Air Leak Deteriorated Insulation 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. Temperature Distribution 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. 5 Why Matrix Block RCA Discussion Document 3.2.1.1.1

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 Look for patterns in the findings. Understanding patterns will help when it comes time to develop the Corrective Action Plan. 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.

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. Fishbone Diagrams 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 Other Important to analyze with a method for determination of: 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) Effectivity Date: Objective Evidence Attached: Action Taken to Prevent Recurrence: Impact of all Identified Causes and the Root Cause: Root Cause of Nonconformances: Identify the root cause(s) of the nonconformance as determined by the team(s). 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).

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 Effectivity Date: Objective Evidence Attached: Action Taken to Prevent Recurrence: 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? Root Cause of Nonconformances: Identify the root cause(s) of the nonconformance as determined by the team(s). 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).

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?

Loop Back NO YES! EVENT Form Team Identify Problem Gather & Verify Data Determine Causes Contributing Determine Corrective Actions (Specific & Preventative) Solution Acceptable? Direct Root Mistake Proofing Implement & Follow up DONE Determine C/A Specific Preventative

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.

Remember…we want to break the “Cause Chain.” Preventive C/A Specific C/A Root Cause Contrib. Cause Direct Cause Event

Sustaining corrective actions focus on changing root cause(s ) and contributing cause(s) If you have only identified one cause, you probably won’t get a 100 % effective fix Remember – today’s contributing cause is tomorrow’s 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 What is the cost of the event in terms of: Personal & environmental safety? Lost time? Lost product? Customer dissatisfaction? How likely is the event to recur if not fixed? 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 don’t ignore the problem if it’s a plant-wide 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: Do the sustaining corrective actions lower the risk of the event reoccurring to an acceptable level? 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!

Select A Matic Got a problem? Give it a spin! RCCA Lack of Management Support (Not allowed Spin again.) Unknown (Spin again and don’t tell anyone Lack of Discipline (Send employee to obedience school.) Lack of Training (Add unrelated classes to training record.) Lack of System (Make another procedure.) Bad Procedure (Make procedure longer.) Not a Finding ( Recalibrate the auditor.) Lack of Time (Get employee a new watch.)

Doing the same thing over and over and expecting different results! Insanity

Trained Operators? Revised Procedures? How many times have you...

Procedures are the scar tissue of past mistakes.

Don’t 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? Effectivity Date: Objective Evidence Attached: 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. 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? Root Cause of Nonconformances: Identify the root cause(s) of the nonconformance as determined by the team(s). 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).

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 Effectivity Date: Objective Evidence Attached: Evidence that C/A procedures are in place. 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. 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? Root Cause of Nonconformances: Identify the root cause(s) of the nonconformance as determined by the team(s). 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. When was the C/A effective? Typically needs to be implemented prior to closing the NCR Effectivity Date: Date C/A effective. Objective Evidence Attached: Evidence that C/A procedures are in place. 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. 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? Root Cause of Nonconformances: Identify the root cause(s) of the nonconformance as determined by the team(s). 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).

Loop Back NO YES! EVENT Form Team Identify Problem Gather & Verify Data Determine Causes Contributing Determine Corrective Actions (Specific & Preventative) Solution Acceptable? Direct Root Mistake Proofing Implement & Follow up DONE Mistake Proofing

Mistake proofing – a process which provides a structure for designing a failure mode out of a product or process. 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. Preventive Corrective Action Connection

Demand Vigilance: “There is no mistake; there has been no mistake; and there shall be no mistake.” ( Arthur Wellesley, 1 st Duke of Wellington.) Mistake-proof: Eliminate the error before it becomes an event Defects are never found until after the final inspection. (Murphy’s 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 brain’s 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.” It’s 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 won’t 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 – won’t start until you are on sensor pad Kitting…seven 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? 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! Look for the error point(s).

Loop Back NO YES! EVENT Form Team Identify Problem Gather & Verify Data Determine Causes Contributing Determine Corrective Actions (Specific & Preventative) Solution Acceptable? Direct Root Mistake Proofing Implement & Follow up DONE Implement & Follow Up

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. Updated ISO 9001: 2000

Who Performs Follow-Up? Who Performs Assessment? When is Assessment Performed? How do you Assess?

Loop Back NO YES! EVENT Form Team Identify Problem Gather & Verify Data Determine Causes Contributing Determine Corrective Actions (Specific & Preventative) Solution Acceptable? Direct Root Mistake Proofing Implement & Follow up DONE Is the Solution Acceptable? Effectiveness measurement Did C/A Work? Report

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 RCCA Will Verify

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

Did Corrective Actions Work? Follow-up Reevaluate cause chain and Corrective Action? Was C/A Accomplished as Stated? Done! Yes! No!

The Job Isn’t Done Until the Paper Work Is Finished! Document Work Write Report Make Distribution

Loop Back NO YES! EVENT Form Team Identify Problem Gather & Verify Data Determine Causes Contributing Determine Corrective Actions (Specific & Preventative) Solution Acceptable? Direct Root Mistake Proofing Implement & Follow up DONE Complete Final Report

Loop Back NO YES! EVENT Form Team Identify Problem Gather & Verify Data Determine Causes Contributing Determine Corrective Actions (Specific & Preventative) Solution Acceptable? Direct Root Mistake Proofing Implement & Follow up DONE Document Follow-up Write final Report Document C/A Document Causes Minutes Team Mtgs Document Team(s)

The Report Isn’t 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 isn’t 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

Root Cause Corrective Action

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