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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
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