ANSI National Accreditation Board

Cause Analysis and Corrective Action

WebinarAugust 28, 2019

Key Takeaways

Definition of cause analysis

Understanding the changes in ISO/IEC 17025 from 2005 to 2017

Understanding the corrective action process

Understanding the difference between correction and corrective action

How to evaluate the significance of nonconforming work

“Laboratories that conform to this document (17025) will also operate generally in accordance with the principles of ISO 9001.”

ISO/IEC 17025:2017 DOES include requirements of

ISO 9001:2015

ISO 9001:2015 & ISO/IEC 17025:2017

ISO 9001:2015 & ISO/IEC 17025:2017

Option A

Option B

• Address management system requirements (Clause 8)

• Establish and maintain a management system in accordance with requirements of ISO 9001

• Capable of supporting and demonstrating fulfillment of requirements in Clauses 4 to 7, and 8.2 to 8.9 in ISO/IEC 17025

Much less prescriptive…

React to nonconformity

Evaluate the need for action

Implement actions, as needed

Update risks and opportunities

Maintain records

Effective cause analysis

Key to determining corrective actions

that yield long-lasting results

Address the cause, not

the symptoms

CorrectionCorrective actionPreventive action

The laboratory should identify and implement the corrective action(s) most likely to:

Correct the problem Prevent recurrence

The suitability of a corrective action cannot be determined without an identified cause

Definition of Cause Analysis

Determination of a potential problem’s underlying cause or causes

Process of identifying all causes that have or may have resulted in an undesirable condition, situation, nonconformity, or failure

Analytical technique used to determine the basic underlying reason that causes a variance, defect, or risk

Potential Causes Related to

Inputs Customer requirements

People skills Training

Planning Design

Equipment Standards

Policies Methods, procedures

Consumables Materials

Outputs Reports, records

Common Techniques

Ishikawa (fishbone) diagram

5 why’s

Failure mode and effects

analysis (FMEA)

Pareto chart

Ishikawa (fishbone) Diagram

6 M’s 4 S’s 8 P’s

Machine Systems Price

Method Skills Promotion

Materials Surroundings People

Maintenance Suppliers Processes

Man Place

Mother Nature Plant

Policies

Product

Ishikawa diagram category examples

Five Whys

The first response is usually a symptom

• Keep asking “Why?” until you get to a real cause

• You may get to a cause before asking “Why?” five times

• If you keep asking, you may identify additional causes

5 Why Example

I fell downWhy did I hurt my arm?

5 Why Example

I tripped backwards

over the dog

Why did I fall down?

The dog was behind me trying to see what

was in the shower

Why did I trip backwards over

the dog?

5 Why Example

5 Why Example

There was a bat in the shower

Why was the dog trying to see what

was in the shower?

5 Why Example

The fireplace screen is broken

Why was there a bat in the

shower?

I hurt my arm…

I fell down

Why?

I tripped backwards over

the dog

Why?The dog was

behind me trying to see what was

in the shower

Why?

There was a bat in the shower

Why?The fireplace

screen is broken

Why?

ISO/IEC 17025 Changes17025:2017• 8.7.1 When a nonconformity occurs, lab shall:

a) React as applicable:• Take action to control and correct it• Address consequences

b) Evaluate need to eliminate cause• Review and analyze nonconformity• Determine cause(s)• Determine if similar issues exist or could occur

c) Implement any action needed

17025:2005• 4.11

• 4.11.1

• 4.11.2 Root Cause Analysis

• 4.11.3 & 4.11.5

17025:2017• 8.7.1 (cont.)

d) Review effectiveness of corrective actionse) NEW: Update risks and opportunitiesf) Make changes to management system, if

necessary

17025:2005

• 4.11.4

• NEW

• 4.11.3

ISO/IEC 17025 Changes

17025:2017• 8.7.2 Corrective actions shall be appropriate

• NEW• 8.7.3 Shall retain records:

• Nonconformities, cause(s) and actions• Results of corrective actions

Related to 4.13.1.1

17025:2005• 4.11.3

ISO/IEC 17025 Changes

React to the nonconformity

Control and correct it

Address consequences

Evaluate need for action to

eliminate cause(s)

Implement action

Review effectiveness

Update risks and

opportunities

Make changes to

management system

Retain records

Corrective Action Process

Corrective Action vs. Correction

Corrective Action• Treats the cause• Comprehensive

actions

Correction

• Treats the symptoms

• Individual actions

Evaluating the Significance of Nonconforming Work

Impact analysis on previous results

Controls, reference standards, reference materials

Acceptability of nonconforming

work

Wrap-up

There are many ways to perform cause analysis and arrive at the cause

of a nonconformity

Select the analysis method that suites your

organization and the specific nonconformity

being addressed

Effective cause analysis

Saves time and money by solving a problem onceEnsures that nonconformity does not recur

Training OfferingsIntroduction to ISO/IEC 17025:2017

Approaches to Risk-based Thinking in Laboratories

Internal Auditing to ISO/IEC 17025

Fundamentals of Measurement Uncertainty

Introduction to Data Validation

And more…

www.anab.org/training

Coming Soon!

ANSI National Accreditation Board

Thank youMelanie Ross

Training Products Specialist414-501-5345

training@anab.org