Dataplate Training Introduction to Root Cause Corrective Action

Dataplate Training Introduction to Root Cause Corrective Action and the 5 Why Process Konrad Burgoyne www. dataplate. co. uk

Introduction x. Aim - To understand the concepts of cause analysis and to be able to apply those concepts to prevent or eliminate errors and defects x. Reason - This is a requirement of the aerospace industry x. Incentive – RCCA is a fundamental and valued skill used within many areas of business. © 2014 Dataplate 2

What is Root Cause Corrective Action? An effective process for finding the causes of an event and facilitating effective corrective actions to prevent recurrence. © 2014 Dataplate 3

RCCA for Non Conformances x. A requirement of the aerospace industry for many years. x. A process of determining the causes that led to a nonconformance or event. x. An effective method for implementing corrective actions to prevent recurrence. x. Requirements are not new, but they may not have been aggressively enforced in the past. © 2014 Dataplate 4

Event An all inclusive term for any of the following: Product Failure Non Conformance Audit finding Special Cause (SPC) Accident Customer complaint Failure Mode (FMEA) © 2014 Dataplate 5

The Traditional Approach to an Event • • © 2014 Dataplate Event (Problem) Containment Establish Team Identify Problem Gather & Analyze Data Find the Root Cause Determine Corrective Action Implement Corrective Action Review Corrective Action Fix it 6

Traditional Problem Solving Don't Mess With It! Yes Did You Mess With It? No Does It Work? No Yes No Does Anyone Know You Messed With It? Yes You Could Be In Trouble! Will You Be Blamed For It Anyway? No No Yes Uh - Oh ! Hide It Or Throw Away The Evidence! Can It Be Fixed Before Your Boss Finds Out? Yes Can You Transfer Blame To Someone Else? Yes No L PROBLEM! J NO PROBLEM ! © 2014 Dataplate 7

The Requirement - AS 9100 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. © 2014 Dataplate 8

The RCCA Approach to an Event (Problem) • • © 2014 Dataplate Containment Establish Team Identify Problem Gather & Analyze Data Find Root Cause Determine Corrective Action Implement Corrective Action Review Corrective Action 9

Containment Immediate Corrective Action x. Put out the fire x. STOP producing bad product x. Evaluate product impact x. Inform customer if shipped product impact is suspected – A legal requirement. © 2014 Dataplate 10

Establish Teams Natural Team Assignment of wrong personnel a common problem. Common to assign to Quality – did quality make the error? x. Who owns the problem? x. Who has a stake in the outcome and the solution to the problem? x. Who are the vested owners of both the problem and the solution? x. Who knows the process – have data and experience? x. Who will have to implement and live with the corrective action? Without the full buy-in and support of the stakeholders, long-term solutions are not likely. © 2014 Dataplate 11

Establish Teams Qualified Team The Natural team plus other individuals who can provide necessary resources to understand the problem further. x. Those who can provide additional information x. Those who have technical expertise – Subject Matter Experts (SME) x. Those who may need to act as advisors x. Those providing management support © 2014 Dataplate 12

Remember Take action: x. To a degree appropriate to the magnitude of the problem. x. Proportionate with the risks encountered. © 2014 Dataplate 13

Identify Problem • You must understand the problem. • Is there more than one problem? • You must know what you don’t know, to be able to find out. • Keep it simple © 2014 Dataplate 14

The Problem x. Must be clearly and appropriately defined. x. The nonconformance identified may not be the real problem – only a symptom of the problem. x. Asking questions is helpful. x. What is the scope of the problem? x. How many problems are there? x. What is affected by the problem? x. What is the impact on the company? x. How often does the problem occur? x. Addressing appropriate questions will assist in clarifying and defining the problem(s). © 2014 Dataplate 15

Caution If you cannot say it simply, you do not understand the problem! © 2014 Dataplate 16

Gather & Analyse Data Performed by Team Members Look for: § Location. § Names of Personnel. § Date and Time. § Operational Conditions. § Environmental Conditions. § Communications. © 2014 Dataplate § § § Sequence of Events. Equipment. Physical Evidence. Recent Changes. Training. Other Events. 17

Gather & Analyse Data x. Problem identified – begin data collection. x. May need to be collected several times. x. The preliminary collection phase occurs now and will guide the analysis process. x. Initial data gathering starts at the scene. x. Data has a shelf life. x. Waiting makes it difficult to obtain good information. x. Go to the scene. x. Note those present, what is in place, when the event occurred, and where the event happened. © 2014 Dataplate 18

Remember Take action: x. To a degree appropriate to the magnitude of the problem. x. Proportionate with the risks encountered. © 2014 Dataplate 19

Find The Root Cause The Cause Chain Direct>Contributing>Root The direct cause is the cause that immediately caused the problem • Causes in-between are contributing causes • A root cause is the last cause in the cause chain • © 2014 Dataplate 20

Find The Root Cause An Important Thing to Remember About “Root Cause. ” x. It’s not always the most significant cause in the chain. . . x. Just focus on the fact that it is the cause in the chain. . . © 2014 Dataplate LAST 21

The 5 -Why Process The ‘ 5 why’ is one method that can be used to find: xthe cause chain. x. A natural logical progression for thinking through a problem. x. The direct cause. x. The root cause. x. The contributing causes. © 2014 Dataplate 22

Why? 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. © 2014 Dataplate 23

Common Initial Considerations x. Operator error (most common). x. Honest mistake. x. Second shift did it. x. We didn’t include the requirement in our internal procedure. x. We didn’t know it was a requirement. x. Not familiar with the specification. © 2014 Dataplate 24

Caution : Operator Error Yes, it does happen, but. . . x. Used as “root cause” much too often. x. Used as an easy way out. Ask: If the operator was replaced, could the next person make the same mistake? If so, then you have not determined the Root Cause! © 2014 Dataplate 25

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? © 2014 Dataplate 26

How many whys? Do not believe that the 5 Why process restricts you to asking why 5 times A root cause may be found with 3 Whys or it may take 7 Whys © 2014 Dataplate 27

How many whys? Times asked why © 2014 Dataplate 28

Remember Take action: x. To a degree appropriate to the magnitude of the problem. x. Proportionate with the risks encountered. © 2014 Dataplate 29

No Big Secret Simple Question Simple Answer © 2014 Dataplate Simple Answer 30

Don’t fall into the trap CAUTION Cause chain under construction. No corrective actions allowed! © 2014 Dataplate 31

The cause chain Event Direct Cause Contr. Cause Root Cause How many root causes are you allowed? © 2014 Dataplate 32

The cause chain Event Problem #1 Direct Cause CC CC Root Cause Problem #2 Direct Cause CC CC Root Cause Two or more, if you have multiple branches. © 2014 Dataplate 33

Fishbone Diagram A fishbone diagram is a graphic methodology to identify “Whys. ” To make a Fishbone Diagram, start with your 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. © 2014 Dataplate 34

5 Why Example The Problem Nadcap Audit 54345 NCR 5 For job 6 (OEM Prime, job no. B 140898), drawing DX 667 -039 required "stress relieve at 525 +/-5°C for 30 min to KPS 425” It was found that the data card, DC 2488, required 538 +/-13. 9°C for 20 - 25 min. Although this is in line with the requirement of KPS 425, there was no customer or delegated approval on the data card to show that this deviation from the drawing was acceptable. It was determined by OEM Prime that a Drawing Clarification Form should have been raised in the first instance. Drawing Clarification Forms were not formalised or understood throughout the company © 2014 Dataplate 35

5 Why Example The “Drawing Clarification Form” was known as a “query form” and came into use in September 2013. There is no identified formal process or procedure in place in obtaining clarification from the OEM Prime. Why is there no formal process for implementing the Drawing Clarification Form (Query form)? This form was a new form that was sent to a specific engineer in January 2014 for project G 053 XX 016 -103, G 053 XX 038 -103 and G 053 XX 048 -101 queries. Why was this form not put in general use for OEM Prime queries? There was no other information or instruction flowed down from OEM Prime in relation to this form Why was there no other information requested? It was understood that this form was an informal document specific to project G 053 XX Why was this form understood to be an informal document? It was created with no process or instruction document and showed no document ID number and it is not referenced in the OEM Prime Q 700 Requirements for Suppliers document? Root cause: Inadequate control of documentation Containment: The Drawing Clarification Form has now been completed for drawing DX 667 -039 and sent to OEM Prime (See attached) Corrective Action Quality Alert OEM 11 has been raised and distributed throughout. (See attached) © 2014 Dataplate 36

5 Why Example Quality Alert – OEM 11– Control of Documents Aim – The aim of this quality alert is to put in place corrective action and initiate preventative action for similar situations. Reason – Control of Documents is a requirement of AS 9100 Incentive – A well understood standardised quality system will improve efficiency, productivity and profitability throughout the business. Issue A recent Nadcap audit NCR response led to a discovery of a document (issued by a customer) used without a formal process or written procedure. Action With immediate effect, all users of documents both internally generated and externally provided shall ensure there is a formal process to follow that is referenced in the Quality Management System (QMS). In the event a document is identified having no formal process please refer to P-Q-2 -11 Document Control & Control of Records Procedure for the process to follow. © 2014 Dataplate 37

Caution Complex problems, especially those where an entire process has been brought into question require a more thorough analysis. Requirements & Design Equipment & Maintenance Process Planning & Materials Production Operations & Quality Assurance Root Cause Analysis (RCA) is a systematic approach to determining all the contributors to a problem before attempting to implement a corrective action plan. © 2014 Dataplate 38

Corrective Action A set of planned activities (actions) implemented for the sole purpose of permanently resolving the problem. © 2014 Dataplate 39

Types of Corrective Action x. Specific corrective action changes only the direct cause or the effect. Action(s) taken to correct the direct cause and/or the effect. x. Sustaining corrective action changes contributing and root causes. Actions taken to prevent recurrence of the event © 2014 Dataplate 40

Sustaining Corrective Action x. Sustaining corrective actions focus on changing root cause(s) and contributing cause(s). x. If you have only identified one cause, you probably won’t get a 100% effective fix. x. Remember – today’s contributing cause is tomorrow's root cause. © 2014 Dataplate 41

Corrective Action – What, Who & When The three W’s x. What, Who, When. x. What is the corrective action? x. Who is responsible for doing it? x. When is it going to be done? © 2014 Dataplate 42

Corrective Action Establish the most effective corrective action to put in place. x. Must correct the root cause x. Must correct contributing causes x. Must be workable x. Must have a effectivity date x. Must be sustainable x. Must not be the cause of other unforeseen nonconformances x. Must be reviewed © 2014 Dataplate 43

Remember Take action: x. To a degree appropriate to the magnitude of the problem. x. Proportionate with the risks encountered. © 2014 Dataplate 44

Corrective Action - Review x. The corrective action can have a working review to ensure it is effective x. Adjustments to the corrective action can be made and documented x. A formal review is required to document effectivity © 2014 Dataplate 45

Summary EVENT Containment Form Team Identify Problem Gather & Verify Data Determine Causes Direct Root Contributing Determine Corrective Actions (Specific & Preventive) Mistake Proofing Implement & Follow up No © 2014 Dataplate Solution Acceptable? Yes! Done 46

Documentation EVENT Containment Form Team Identify Problem Minutes Team Meetings Gather & Verify Data Document Causes Determine Causes Document Corrective Action Direct Root Contributing Determine Corrective Actions (Specific & Preventive) Document Follow-up Mistake Proofing Implement & Follow up No Solution Acceptable? Yes! Done Write Final Report © 2014 Dataplate 47

Remember Take action: x. To a degree appropriate to the magnitude of the problem. x. Proportionate with the risks encountered. © 2014 Dataplate 48

Questions? © 2014 Dataplate 49