8d presentation

7/28/2019 8D Presentation

1/22

8D- Eight Disciplines of Problem Resolution

Uzair Rajput

Quality Engineering Manager

LifeNet Health


2/22

OBJECTIVES:

UNDERSTANDING OF 8D PROCESS


3/22

WHY USE a FORMAL8D?


4/22

8D ensures a comprehensive resolution of anissue

8D contains all aspects of other methodse.g. DMAIC and A3

8D will help to build a common understanding ofthe PROCESS of Problem Resolution

Why re-invent the wheel

Exceptions: adjustments allowed without cuttingout any steps


5/22

So, what is 8D?


6/22

8D is formal Problem Resolution Process

Was devised in automotive industry

Has been utilized by Aerospace Industry

Is being Increasingly adopted byMedical Devices and Healthcare

Industry


7/22

8 Disciplines

D1: DefineTeam

D2: DefineProblem

D3: ICA and/or

Countermeasures

D4: Root CauseAnalysis

D5: Choose andVerify PCA

D6: Implement &Validate PCA

D7: PreventiveAction/Prevent

RecurrenceD8: Thank Team


8/22

So, How to Conduct an8D?


9/22

Team to :

1.Meet in 8D Work Out Sessions

2.Update Management during scheduled reviewsor as needed

3.Attach to CAPA upon completion


10/22

D1: Define TeamWHY:

1. Multiple people bring multiple perspectives

2. Allows for objective Reviews

HOW:Essentials:

One Champion: Person with authority

Responsible to reprioritize required resources remove road blocks as needed

One Lead: Sr. Engineer or a Value Stream Manager

responsible for administering this process

accountable for progress ensures the pace of progress

Reaches out to Champion if help is needed.

One Objective Reviewer / Coach: Usually a QS person

One Engineer: Could be from outside of area in question


11/22

D2: Define Problem

WHY:1. A well defined problem is half resolved problem

2. To avoid any waste-full application of resources

3. Symptom may not be THE problem

HOW:1. DO NOT assume you know the problem, make it measureable

2. What internal or external customer REQUIREMENT was not met?

3. How many products are affected?4. When did the problem start?

5. Basically, use 5W2H approach i.e. (Who, What, When, Where, Why, How

and How many)

6. Map out the process as much as possible


12/22

D3: INTERIM CONTAINMENT ACTION

And/or COUNTERMEASURESWHY:1. It is all about protecting the customer

2. And off course, QSR and ISO require Control of NC Product

HOW:1. Urgently Identify suspect product i.e. BOOKEND the product

Take Action to avoid continual shipping to customer e.g. Hold or

extra-ordinary inspection, etc.

2. Identify suspect process i.e. labeling, assembly, etc.

apply Controls to avoid continual production of

suspect product


13/22

D4: ROOT CAUSE ANALYSISWHY:

To ensure effective Corrective Actions

HOW:1. Never assume, use a method and identify contribution

2. Always analyze why it was not detected

3. Some Methods are:

5-Why: Team to use the judgment when to stop, generally, asking

5 times would reveal THE Root Cause, more explanation in latter

slides

Other Methods:a.Ishikawa Diagram, also know as Fish Bone Diagram

b.Is or Is Not analysis, etc. etc.


14/22

LETS TALK ABOUT ONE OF RCA Techniques

5-WHY


15/22

1st Degree 5-WHY (1 RC)

Why 5

Why 4th Why Occurred Why Not Detected

Why 4

Why 3rd Why Occurred Why Not Detected

Why 3

Why 2nd Why Occurred Why Not Detected

Why 2

Why 1st Why Occurred Why Not Detected

Why 1

Why Failure Mode Occurred Why Not Detected


16/22

2nd Degree 5-WHY (>1 RCs)

Why 1

Why 2

Why 3

Why 4 Why 4.1 Why 4.2 Why 4.3 Why 4.4Root Cause

1

Why 4aWhy

4.1a

Why

4.2a

Why

4.3a

Why

4.4a

Root Cause

2

Why 4b and So on


17/22

Estimated contribution of a root

cause towards the issue

Root Cause from

Methodical Analysis

Capture here a failure of

detectability

Excerpt from a sample 8D Form


18/22

D5: Permanent Corrective Actions

CHOOSE AND VERIFYWHY:1. To ensure PCAs will be effective if implemented

2. Will provide confidence on % Effectiveness

HOW:

1. For the most part Reversing the Root Cause would yield adirection for PCA

2. Brainstorming and List all PCAs

3. Verify against a specific Root Cause, If Action does not

ELIMINATE a Root Cause, it is not 100% effective, IF AT ALL

4. Not all potential CAs identified may need implementation. Choose

the ones that are sufficient to eliminate root cause. Dont over do!


19/22

D6: Permanent Corrective Actions

IMPLEMENT AND VERIFYWHY:1. To ensure RCs have been removed - Implement

2. PCAs are implemented as intended Verify

HOW:

1. Plan out the implementation

2. Give yourself reasonable time for stress free implementation

3. Setup some metrics to Verify long term effectiveness


20/22

D7: PREVENTIVE or PREVENT

RECURRENCE ACTION

WHY:

1. Improve overall organization Use Lessons Learnt

HOW:

1. Identify similar processes where this issue might occur

2. Implement Actions in other processes to avoid similar problem3. Implement process performance metrics/KPIs and review as

leaders standardized work


21/22

D8: THANK YOU TEAM


22/22

QUESTIONS:

[email protected]

8d presentation

Documents