Root_Cause_Corrective_Action.ppt

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Registration Management Committee (RMC)

Auditor Training and Workshop

Minneapolis, MN

July 30-31, 2009

WELCOME!Americas Aerospace Quality Group

AAQG

Registration Management CommitteeRMC

Auditor Training and Workshop Session

Minneapolis, MN

July 30-31, 2009

Value Added Aerospace Auditing





Minneapolis, MN

July 30-31, 2009

Who is R. Darrell Taylor?• Raytheon Corporate AS9100 QMS Auditor

• 27 years experience in the quality field (inspector,

engineer, teacher, director)

• RABQSA certified Lead QMS auditor, AIEA

• ASQ – CQA, CMQ/OE, CQPA

• 6 s Master Black Belt, certified Black Belt,Raytheon 6 s Specialist





Minneapolis, MN

July 30-31, 2009

Root Cause & Corrective Action

Analysis Training – Why Needed?

At a recent IAAR (Independent Association of AccreditedRegistrars) meeting the question was asked, why are OEMs, ABs

and ICOP all focused on correction, root cause analysis andcorrective action?

Simply stated, CBs and suppliers are not delivering to theAviation, Space and Defense (aerospace) industries expectations!

It is essential all CBs and auditors support industry in its quest toimprove these activities within the CB community, its auditor baseand throughout the supply chain. We can make a difference!

Reg Blake – Primary IAAR Rep to AAQG RMC and Americas CB Rep to IAQG OPMT





Minneapolis, MN

July 30-31, 2009

Root Cause & Corrective ActionAnalysis

The scope of this workshop is to explore howwe, as auditors, can analyze auditee correctiveaction and root cause for accuracy, relevancy,

and completeness for the purpose of improving the auditee’s system and have apositive impact on the aerospace industry.





Minneapolis, MN

July 30-31, 2009

“It is not necessary to change.

Survival is not mandatory.”

Quote from : Dr. William Edwards Deming





Minneapolis, MN

July 30-31, 2009

What is the Auditors Role?

• Identify Requirements

• Verify Conformance to the

Requirements

• Verify the effectiveness of the

process





Minneapolis, MN

July 30-31, 2009

Topics

• Process

• Corrective Action Initiation

• Root Cause Analysis

• Corrective Action

• Verification & Validation





Minneapolis, MN

July 30-31, 2009

Questions to Explore

What constitutes real root cause analysis?

How is root cause analysis documented?

Who should be involved?

How do we determine if corrective action is

effective?

Who should do this?





Minneapolis, MN

July 30-31, 2009

AS9100 -8.5.2 Corrective Action

• The organization shall take action to eliminate the causes of nonconformitiesin order to prevent recurrence. Corrective actions shall be appropriate to theeffects of the nonconformities encountered. A documented procedure shall beestablished 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 notrecur,

– d) determining and implementing action needed,

– e) records of the results of action taken (see 4.2.4),

– f) reviewing the effectiveness of the corrective action taken,

– g) flowing down corrective action requirements to a supplier when it isdetermined that the supplier is responsible for the nonconformity,

– h) specific actions where timely and/or effective corrective actions are not achieved, and

– i) determining if additional nonconforming product exists based on thecauses of the nonconformities and

– taking further action when required.





Minneapolis, MN

July 30-31, 2009

Process

Conduct

Verification &Validation

What We Control

What the Auditee Controls

Identify aNonconformity

Initiate Corrective

Action

ApproveCorrective

Action

Implement

Corrective Action

Containment

Root Cause

Corrective Action





Minneapolis, MN

July 30-31, 2009

What do you like?

What can be done better?





Minneapolis, MN

July 30-31, 2009

Sample Finding - Observation

Despite the procedures in place, a certain amount of undocumented equipment swapping and borrowingoccurs. Training should be conducted to ensure that

equipment such swapping/borrowing is approved bythe assigned owner of the equipment. Otherwise,there is the danger of equipment not being availableto the owner when needed, since verbal agreements,as demonstrated above, are easily forgotten.

Convincing evidence was given showing that therewas no chance of an Out of Tolerance item beingused for testing, which is why this is an Observationand not a finding. Further findings of this sort wouldlead to a minor nonconformance.

C ( C)





Minneapolis, MN

July 30-31, 2009

Corrective Action Initiation

NOTE: Use AS9101 form or equivalent

R i t ti M t C itt (RMC)





Minneapolis, MN

July 30-31, 2009

Definitions

• ASQ (The Quality Audit Handbook)

– Finding - A conclusion of importance

based on observation (s).

• Audit Standards (Willborn)

– Audit Findings – are the significant

conclusions and information needed bythe client or audit user for attaining theplanned audit objectives.






Minneapolis, MN

July 30-31, 2009

Problem Definition - Simple Approach

• Four Elements:

– Source of the Requirement

– Requirement

– Source of the Finding

– Finding

Fundamentals of Quality Auditing






Minneapolis, MN

July 30-31, 2009

Example

AS9100, paragraph 8.2.2 “Internal

Audit” states “The organization shallconduct audits at planned

intervals…”

At XYZ company there is no audit plan.

Requirement Source

Nonconformance Source Nonconformance

Requirement






Minneapolis, MN

July 30-31, 2009

Problem Definition

• 4W: – What was affected

– Where did the problem take place

– When was the problem discovered – Who Discovered the problem

• 2H: – How much was affected

– How often has the problem occurred

• 1C: – What is the consequence

Correct, Prevent, Improve






Minneapolis, MN

July 30-31, 2009

Complete Problem Definition

• What is the problem?

• When did it happen?

• Where did it happen?

• What is the significance of the problem?

Apollo Root Cause Analysis






Minneapolis, MN

July 30-31, 2009

Corrective Action Initiation Requirements

• Write complete sentences – The problem description needs to be written clearly

– Stick to the facts. Don’t make it a story.

– Be precise in defining the requirement and deficiency – Avoid abbreviations, acronyms…

• Noncompliance issues (Major, Minor) need to“violate” some requirement or they may

document the absence of a process – Program plan, procedure, standard (AS9100), etc.

– Always include the violated requirement in the problemdescription






Minneapolis, MN

July 30-31, 2009

Problem Description Requirements

(cont.)

• Problem Description Sufficiency – Identify What, Where, When, as appropriate

– Reference the Evidence

– The responsible assignee needs to have enoughinformation from the problem statement to conduct rootcause analysis and identify corrective action

• Self-check the problem description

– Is the statement complete and self-sufficient? – Ask yourself … So What?

– Where does it say that I have to?






Minneapolis, MN

July 30-31, 2009

“A problem well defined is a problem

half solved”

(anonymous)






Minneapolis, MN

July 30-31, 2009

CASE STUDY 1

WRITING A PROBLEM DESCRIPTION






Minneapolis, MN

July 30-31, 2009

Levels of Nonconformities






Minneapolis, MN

July 30-31, 2009

AS9101 - DRAFT

Major

Minor

NOTE: An observation is not a nonconformity






Minneapolis, MN

July 30-31, 2009

AS9101 - DRAFT• 3.2 Major Nonconformity

• A non-fulfillment of a requirement which, is likely to

result in the failure of the quality management system

or reduce its ability to assure controlled processes or

products; it can be one or more of the following: – a nonconformity where the effect is judged to be detrimental to

the integrity of the product, or service;

– the absence of, or total breakdown of a system to meet a 9100-

series standard requirement, an organization procedure, or

customer quality management system requirement;

– any nonconformity that would result in the probable shipment

of nonconforming product; and

– a condition that could result in the failure or reduce the

usability of the product or service and its intended purpose.






Minneapolis, MN

July 30-31, 2009

AS9101 - DRAFT

• 3.3 Minor Nonconformity

• A non-fulfillment of a requirement which is not likely toresult in the failure of the quality management system or reduce its ability to assure controlled processes or

products; it can be one of the following: – a single system failure or lapse in conformance with a9100-series standard or customer quality managementsystem requirement; or

– a single system failure or lapse in conformance with aprocedure associated to the organization's qualitymanagement system.

• NOTE: A number of minor nonconformities against onerequirement, e.g. on different sites, can represent a totalbreakdown of the system, and thus be considered a major nonconformity.






Minneapolis, MN

July 30-31, 2009

What do you like?





eg st at o a age e t Co ttee ( C)


Minneapolis, MN

July 30-31, 2009

EXAMPLE

• Nonconformance Description: – Some departments are not included in the distribution list of

relevant quality procedures such as Engineering was notincluded on the distribution list for Procedure XYZ, Control of Nonconforming Material, although Engineering is involved in

the disposition decisions.

• Root Cause: – Inadequate review of procedure needs.

• Corrective Action: – Company A will issue Procedure XYZ to Engineering by12/31/200X.

– Company A will then post Quality Procedures on its intranetwith access available to all departments.




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Minneapolis, MN

July 30-31, 2009

Containment Action

• Containment addresses the immediate issue.

– For example, you have a car that will not start.

Containment gets it started.

– If we have a controlled process to keep measuring

equipment calibrated and someone finds un-calibratedor delinquent calibration dates, the containment would be

to get the equipment calibrated.

• During development of Containment, the auditeewill determine how big is this issue.

Stop the bleeding!!!




g g ( )


Minneapolis, MN

July 30-31, 2009

Root Cause Analysis




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Minneapolis, MN

July 30-31, 2009

Root Cause• DEFINITIONS:• Root Cause (s): The original event (s), action (s), and/or condition (s)

generating (directly or in cascade) an actual or potential undesirablecondition, situation, nonconformity or failure.*

• Note : There are often several root causes for one problem*

• Contributing Causes: Contributing causes are causes that taken alonewould not cause the problem but can increase the risk of the issue tohappen. Analysis for these causes generally require taking small steps (or a finer look) to be identified and fixed.*

• Root Cause Analysis: The process of identifying all the causes (root

causes and contributing causes) that have or may have generated anundesirable condition, situation, nonconformity or failure.*

• Examples of traditional root causes tend to focus on lack of, or currencyof a procedure, training of stakeholders in applicable policy/procedures,lack of an effective tool to perform a task, etc.

*IAQG - SCMH




g g ( )


Minneapolis, MN

July 30-31, 2009

Example

• AS9100, paragraph 8.2.2 “Internal

Audit” states “The organization shall

conduct audits at plannedintervals…”

• At XYZ company there is no audit

plan.

Requirement Source

Nonconformance SourceNonconformance

Requirement





Minneapolis, MN

July 30-31, 2009

Root Cause Analysis

5 Why’s

Apollo

Fishbone

DMAIC

Process Maps

Process FMEA

DOE

5 Why’s

Design FMEAControl Charts

Pie Charts

Histograms

Control Plans Pareto Charts

Force Field Analysis

Affinity Diagrams

Interrelationship Digraph

Scatter Diagram

BrainstormingFlowcharts

Run Charts

Barrier Analysis

Change Analysis

Tree Diagrams

Process Capability

Events & Causal Analysis

Risk Tree Analysis





Minneapolis, MN

July 30-31, 2009

Response

• Containment – N/A

• Root Cause Analysis – Did not

understand the requirement

• Corrective Action – Write plan

COMMENTS?





Minneapolis, MN

July 30-31, 2009

Why do we have poor root causeanalysis?





Minneapolis, MN

July 30-31, 2009

Reasons

– We have not set criteria about what makes an acceptable

corrective action plan (we are satisfied when we don’t

receive any more defective parts and stop here)

– We continue to accept bad answers (even if say we will

not, reality of life makes us accepting )

– People (internal and external) have not the Root Cause

Analysis culture, don’t know any process or are not effectively trained

*IAQG - SCMH





Minneapolis, MN

July 30-31, 2009

Investigation Checklist

• Describe the fast fix that was taken, Is it working?

• Identify owner and those involved.

• Gather information:

– Data

– Employee Input

– Flowcharts of the process

– Procedures

– Records – (quantitative data)

• Has the problem occurred in the past?

• Identify Root Cause.

Book: Correct! Prevent! Improve!


A di T i i d W k h




Minneapolis, MN

July 30-31, 2009

Rules of Investigation

• Use proven root cause analysis tools

• Think “out – of – the – box”

• Take the time needed

• Put a plan together Book: Correct! Prevent! Improve!


A dit T i i d W k h




Minneapolis, MN

July 30-31, 2009

Actions and Conditions

Oxygen

Oily Rags

Match

Match

Strike

TIME

Apollo: Root Cause Analysis


A dit T i i d W k h




Minneapolis, MN

July 30-31, 2009

Apollo• There is no such thing as a single root cause!!

Action

Condition

Condition

Action

Condition

Condition

Action

Condition

Condition

Action

Condition

Condition

STOP

Beyond your

area of

control


A dit T i i d W k h




Minneapolis, MN

July 30-31, 2009

FREQUENCY

I M P A C T

Modified from IAQG - SCMH

OBSERVATION MINOR MAJOR

5 WHY’s APOLLO

Understandthe severity

of the

problem

Root Cause Requirement?






Minneapolis, MN

July 30-31, 2009

What Makes a Good Root Cause?

• Document the primary cause (s) of thenonconformance – Understand the problem statement

– Don’t assume that people know or understand the problem well

enough to determine root cause – Data collection and analysis

• Involve people who have an understanding of theproblem

• Use the cause and effect principle

• Facilitate the Root Cause Analysis – Provide the knowledge of RCA tools

• When solved, the problem will not recur






Minneapolis, MN

July 30-31, 2009

Analyzing a Root Cause

• How does an auditor evaluate a root cause?

– CONNECT THE DOTS!!

• Does the root cause fit the problem statement?• Does the root cause fit the containment?

• Is there any indication of the use of “tools”?

– Is this a repetitive root cause?

– Is this a point analysis, or a system

analysis?






Minneapolis, MN

July 30-31, 2009

What do you like?







Minneapolis, MN

July 30-31, 2009

Example

• Corrective Action Subject

– Residue on contact causing intermittent

electrical connection.

• Problem Description:

– Found 2 units of XYZ which has intermittent electrical

connection. Contact pieces are found with glue residue.

This is nonconforming to note 3 of assembly drawingXYZ rev G.






Minneapolis, MN

July 30-31, 2009


– After investigation it was discovered that the adhesivepermabond did not have a regulating component torestrict the amount of flow that was being applied. This

caused an overflow of glue into the area and the timingof the subsequent assembly did not allow for thedetection of the contamination. None of thedocumentation identified the need for this regulationdevice. This was indicated during the initial buildhowever the documentation did not reflect what wasconsidered a common practice.






Minneapolis, MN

July 30-31, 2009

• Corrective Action Short Term(immediate action for existing material)

– Amend work instructions to emphasize that board anddomes must be thoroughly cleaned and domes are notto be installed for eight hours after board installation.

• Corrective Action Long Term(long term preventive action)

– The bottle that contains the adhesive was modified witha regulator to control the flow of the glue and to limit theexpansion of the glue once pressure is added. Also theImmediate Corrective Action will be a secondary actionapplied to further safe guard

Registration Management Committee (RMC)Auditor Training and Workshop




Minneapolis, MN

July 30-31, 2009

Evaluating Corrective Actions

Definition – Action taken to

eliminate the causes of an existing

nonconformity, defect, or other undesirable situation in order to

prevent recurrence – ASQ Audit Handbook





Minneapolis, MN

July 30-31, 2009

Corrective Action

• This is the specific action (s) you take to address the rootcause of a problem.

• They will only be effective if you have identified the true

root cause of the problem.

– For example, cleaning battery terminals or replacing a batteryin your car will not resolve the problem of a car that will notstart if the root cause of the problem is a bad alternator.

• Corrective action includes the changes in policy, procedureand training to affected stakeholders with assignments tospecific individuals and scheduled dates for taskcompletion.





Minneapolis, MN

July 30-31, 2009

Elements of a Corrective Action

• Containment – Stop the Bleeding


• Design, Implement Corrective Action Plan

• Verify Corrective Action Plan is Implemented

• Validate the effectiveness of the Corrective

Action Plan





Minneapolis, MN

July 30-31, 2009

Traditional vs. Apollo

Match

Strike

Operator

Unaware of

the

Requirements

Train

Operator

Oxygen

Oily Rags

MatchPut in locked fireproof container on

the North side of the building

Put in fireproof container on the

South side of the building, empty

daily

Nothing – too costly

ROOT CAUSE

CONDITIONS





Minneapolis, MN

July 30-31, 2009

Point SolutionSystem Solution

ROBUST!!!!

Individual Management

CULTURE SHIFT

Now Future




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Minneapolis, MN

July 30-31, 2009

Pitfalls

• Binary Thinking – Understand there are grades of solutions

• Incomplete or Faulty Information – Accepting facts to betrue when they are not

• Desire to Believe – Self prophesies

• Failure to Develop alternative Hypothesis – Options

• Making the pieces fit the puzzle – focus on preferredsolution

Root Cause Analysis




g p

Minneapolis, MN

July 30-31, 2009

Pitfalls

• Correlation vs. Causation – look at different paths

• Technical Terminology – cloudy solution

• Words vs. Meaning – buzz words, acronyms…

• Not checking thinking and opinions – accepting the first

solution

Root Cause Analysis




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Minneapolis, MN

July 30-31, 2009

Analyzing a Corrective Action

• How does an auditor evaluate a correctiveaction?

– CONNECT THE DOTS!!

• Does the corrective action fit the: – problem statement?

– the containment?

– the root cause?

– Does the Problem Statement connect to the

Containment to the Root Cause to the

Corrective Action Plan?




g p

Minneapolis, MN

July 30-31, 2009

Analyzing a Corrective Action (cont.)

– Is this a repetitive corrective action plan?

– Is this a point solution, or a system solution?

– Is the corrective action plan realistic?




Minneapolis, MN

July 30-31, 2009

CASE STUDY 2

Analyzing a Root Cause and Corrective Action




Minneapolis, MN

July 30-31, 2009

Verification & Validation




Minneapolis, MN

July 30-31, 2009

Definitions

• Verification – Confirmation by examination and

provision of objective evidence that specified

requirements have been fulfilled

• Validation - Confirmation by examination and

provision of objective evidence that the particular

requirements for a specified intended use arefulfilled




Minneapolis, MN

July 30-31, 2009

Verification

• Verify that the actions have been completed and

are effective

• What does this mean?

– We must see evidence that the containment actions and

corrective actions are completed

– Example - documentation released, training completedwith attendance sheets




Minneapolis, MN

July 30-31, 2009

Validation – Effectiveness

• We are getting the desired results from our process

• Implementation of the actions noted on a corrective action

• Look at the process to ensure that the problem

documented on the corrective action has been eliminated

– Good to have a couple of examples of the new process

being implemented




Minneapolis, MN

July 30-31, 2009

What do you like?



Mi li MN



Minneapolis, MN

July 30-31, 2009

Example• Problem Description:

– Found that pump assembly p/n 12345 cannot function properly. Uponinvestigation, we found rubber flashing within the pump tubes isprohibiting air flow. Tubes p/n 2323, 2424, 2525 and 2626 are allaffected. Units from lotcode XYZ are affected.

• Immediate Corrective Action:

– Determined Scope of problem by reviewing WIP and Finished Goodsfor the described defect.

– Found defect in parts and developed repair method to eliminate

– Eliminated defect from in house WIP and Finished Goods Parts


Mi li MN



Minneapolis, MN

July 30-31, 2009

• Root Cause Type

– Vendor Supplied Part was incorrect

– Operator Failed to perform process as designed•

• Root Cause Corrective Action

– Issued Corrective Action to Vendor for Flashing left in the unit.

– Verified process in place to check for flashing .

– Reviewed Process with all assigned personnel to ensurecorrect process would be performed

– Added requirement for QA Inspector to randomly check for

Flashing in the material and record results on RovingInspection Sheet.

– Added requirement for the Lead to perform the same randomcheck and record results on the Roving Inspection Sheet.


Mi li MN



Minneapolis, MN

July 30-31, 2009

Questions???


Mi li MN



Minneapolis, MN

July 30-31, 2009

Bibliography

• Correct, Prevent, Improve – Jeanne Ketola & Kathy Roberts,ASQ 2009

• Apollo Root Cause Analysis, Dean L. Gano, ApollianPublications 2003

• Fundamentals of Quality Auditing, B. Scott Parsowith, ASQ1995

• Root Cause Analysis: A Tool for Total Quality Management,Anderson, Gaylord F.; Dell, Larry D.; Wilson, Paul F.; 1993

• The ASQ Auditing Handbook, Third Edition - J.P. Russell,editing director; 2006

• Websites: – IAQG Supply Chain Management Handbook;

www.sae.org/scmh

Root_Cause_Corrective_Action.ppt

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