how did this happen? - american society for quality 2013 rccm... · how did this happen? ......

12/12/13

1

How Did This Happen? Getting to the Root of Process &

Product Problems

12/12/13 VT-ASQ Jeff Berliner & Tim King 1

Presenters •  Jeff Berliner; CQE, CQA

– VTASQ Past President •  CAD CUT, Inc. •  [email protected]

•  Tim King; CMQ/OE, CQA – VTASQ Education Chair

•  Tupelo Group, LLC •  [email protected]


12/12/13

2

Agenda 1. Prerequisite Concepts

2. The RCCM and 8D CAPA Process

3. Hands On Exercise (time permitting)

Process performance gaps cost the company money and resources that, over time, must be significantly reduced in order to provide customers with exceptional product and/or service quality… it’s a competitive requirement.


The Systems Thinking Concept •  Analysis means to break something into its constituent

parts for examination, in a sensible way. •  Systems Thinking focuses on the interactions between

system parts or process steps, not just the individual step or “part” itself. –  The whole is the sum of the parts

•  So many important problems that plague us are complex, involve multiple actors and are at least partly the result of past actions we took to alleviate them.

•  Plan-Do-Check-Act: learn and improve; you can not always do it right the first time but you can get it right the next time!

A Pesticide story…


12/12/13

3

QA, QC or QI ?

Quality Management System Governance

Quality Assurance & Planning Practices

Quality Control

Practices

Quality Improvement

Practices


Special vs. Common Cause •  Common cause variation is inherent in a process. For example, chatter in a vertical machining center may be inherent in the process.

•  Special Cause occurs when the magnitude of variation is unexpected. There must have been some unexpected, or special that caused this difference.

•  Common or Special Cause? –  The wind is blowing 12 mph SSE –  The 1st big blizzard of the year causes an accident –  Your car won’t start –  A CNC machine is holding +/-.005” versus +/-.002 yesterday


12/12/13

4

Some Definitions •  Non-conformance: a process, product or service outcome that does not meet the

specification or standards set for “acceptance.”

•  Containment: Stopping the bleeding by instituting short term checks and balances until the root cause can be identified and a CAPA plan can be developed and implemented. (Service Recovery)

•  Root cause: the underlying cause(s) to the symptoms of a process or product/

service that are assessed to be non-conforming. •  Corrective action (CA): Actions that correct and prevent the problem from occurring

again. •  Preventive action (PA): Actions that prevent similar nonconformities or situations

that do not yet exist. (similar parts, similar processes, similar machines...) Prevention requires “risk prevention” thinking.

Root Cause and Countermeasures (RCCM)


The CAPA Cycle

Detect

Isolate RCCM

Improve

Plan to Analyze

Do & Prevent

Check

Act- contain

Starts here!


12/12/13

5

Various CAPA Methodologies (tools matter!)

•  8D as a CAPA process

•  5-Why; fishbone; fault tree; DOEs

•  Kepner-Tregoe (is – is not)

•  Other QC tools (Memory Jogger 2)


Creating a Robust Team and Solution Methodology

•  A proper problem statement •  A team approach •  Finding process or system inadequacies that caused the non-

conformance •  Root cause analysis & verification •  Prescribing proper corrective countermeasures •  Data collection and analysis •  Seeking the insights of SMEs (subject matter experts, including

process operators) •  Process analysis (flow charting, GEMBA, procedure checks) •  Ensuring sustained improvement by monitoring countermeasures

and preventive solutions; and…adjusting as required.

Think P-D-C-A!


12/12/13

6

D7 Prevent recurrence

D8 Congratulate the team

D5 Choose / verify permanent corrective action

D3 Develop interim containment action

D1 Establish the team

D2 Describe the Problem

D4 Define and verify Root Cause

D6 Implement corrective action plan

Close out corrective

action

Detect

Counter- measure

Isolate Improve

Gate Check

Gate Check

Gate Check

Gate Check

Verification

The 8D Problem Solving Method


The Problem Statement •  Should be divided into “Should Be” and “Is” so we know

the basis of the rejection. •  Must be factual, specific, measurable, actionable,

relevant, and time based. •  Include Who, What, Where, and When as relevant

–  Avoid over-writing it; the details can be put in back-up documentation

•  Do not include opinion or analysis •  Do not define the problem as a solution

–  Object + (Standard vs. Finding) gap is the problem!


12/12/13

7

Containment •  Short term actions to contain the issue

within the supply chain, inventory, WIP, final goods and fielded units.

•  Could include: –  Temporarily stopping the production lines –  Inspecting and sorting material in house –  Recall of fielded product –  Containing on other lines & shifts –  Temporary work instructions –  Elevated QC


Root Cause is What: •  Is inherent in the process: design, equipment,

documentation, etc. (the 6Ms) • People: knowledge & skills (not attitude or traits)

•  Can be identified in terms of process or procedural terms

•  Can be controlled through typical process controls and/or proper training

•  Can be counter-measured with a prevention strategy, that will result in indisputable improvement to achieving a “quality in” process


12/12/13

8

Root Cause Tools and Tips •  Simple 5-Why •  Analyze gap data to develop Pareto chart •  Run Charts and SPC Data •  DOE Results revisited •  Fault Tree Analysis (Great for Complex Problems!) •  FMEA •  Ishikawa Diagram using 6Ms •  ANOVA, Correlation and Regression Analysis •  Prioritization Matrices •  Differentiate between Symptoms and Systems •  Check your logic and eliminate items that are not causes. •  Evaluate special vs. common causes

Your Child has a Fever, Is this a symptom or a cause?


5-Why Classic Example The cleaning crews at the Jefferson Memorial had to remove a lot of pigeon-

waste. So there was a 5-Why study done in order to find out see why. •  Why was there so much pigeon-waste at the Memorial? •  – Because there were a lot of pigeons sticking around •  Why were there so many pigeons sticking around? •  - Because they found a lot of spiders which are an excellent food-

source •  Why were there so many spiders at the memorial? •  - Because their favorite food: bugs were flying around •  Why were there so many bugs flying around the memorial? •  – Because the memorial was always lit shortly before sunset. The light

disturbed the bugs from falling asleep who they gathered around the light sources.

Prevention: Light the memorial shortly after sunset when the bugs are already

asleep. Then they won’t be disturbed and buzzing around the memorial.


12/12/13

9

Fault Tree Analysis Semiconductor Lithography Equipment Failure

Mechanical Electrical Software Chemical

Robot

Module 1

Module 2

Power Supply

Servo motor

•  Evaluate probability of failure at each level as is relevant to the problem at hand

•  Focus on the most likely levels to help you drive to Root Cause


Ishikawa Diagram


12/12/13

10

Analyzing the Gap Data (Where you are now vs. Where you need to be

or want to be)

•  What has changed? •  What has not changed? •  Identify facts surrounding the undesired outcome •  When did the undesired outcome occur? •  Where in the process did it occur? •  What conditions were present prior to its occurrence? •  What controls or barriers could have prevented its occurrence but

did not? •  What are all the potential causes? (Fault Tree Analysis)


Corrective and Preventive Actions


12/12/13

11

•  In the Short-Term –  These are corrective actions around Symptoms. –  Develop actions to quickly get back on target –  Not to be confused with Containment (“stop the

bleeding”) •  In the Long-Term

–  These are corrective actions around Systems. –  Needed when the short-term countermeasure is not

sustainable –  Tend to address & resolve systemic issues

Think short term and long term


Verification and Closure


12/12/13

12

Verification of CAPA actions for effectiveness

•  Monitor the applicable metrics that you base-lined for the process before the CAPA actions were implemented. – Has the performance improved? – Has the nonconformity recurred? – Are updated procedures being followed


Don’t make these mistakes


12/12/13

13

Common Mistakes Reviewed •  Properly problem definition: problems statements must

describe: the service or product (object) + the requirement (standard) + the actual result (the result, finding) –  Common errors: defining the problem as the solution; or it

being too vague

•  Analyze what event/factors led to producing the non-

conformance –  Common error: Hard to “trace” how the steps taken led to an

objective series of findings; conclusions lack validity; or jumping to “blaming the operator” as the root cause


More Common Mistakes Reviewed •  Identify what events/factors contributed the most

to the problem –  Common errors: fixing the wrong cause, focusing

on trivial root cause; fixing symptoms not root causes.

•  Implement preventive actions and monitor for sustained effectiveness –  Common errors: short-term validation then forget to

ensure long-term sustainability; lack of ownership for the improved process methods or standards


12/12/13

14

Hands on Case Study

Wind Power


Questions and Answers


how did this happen? - american society for quality 2013 rccm... · how did this happen? ......

Documents