Objective evidence exists showing that:
a requirement has not been addressed
(intent)
practice differs from the defined system (implementation)
the practice is not effective
(effectiveness)
2. Non-Conformity and CauseAnalysis
8
What is a Nonconformance?
ISO 9000
“Non-fulfillment of a requirement”
Objective evidence exists showing that:
• a requirement has not been addressed
(intent)
• practice differs from the defined system
(implementation)
• the practice is not effective
(effectiveness)
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Issue: 01.01. 2010 MMC/INTAS- EMS Internal Auditor TrainingCourse
3. Non-Conformity and CauseAnalysis
8
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Issue: 01.01. 2010 MMC/INTAS- EMS Internal Auditor TrainingCourse
Communicating Findings of Nonconformance
D o not view nonconformance in a negative
way. This is NOT like a traffic ticket. It is NOT a
punishment.
Uncovering nonconformance presents
a previously undiscovered opportunity
for improvement.
B e positive, be professional, be precise.
4. Non-Conformity and CauseAnalysis
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Issue: 01.01. 2010 MMC/INTAS- EMS Internal Auditor TrainingCourse
Nonconformity Report
N o set rules; however all have these two parts:
• The requirement (what was supposed to be)
• The evidence (what actually is)
Different organizations have different formats
• Use the format chosen by your client or firm
5. Non-Conformity and CauseAnalysis
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A Nonconformance Must Also Be...
Factual
Precise
Objective
Traceable
Concise
Will someone else be able to trace back and find the
same evidence you found, based on what you wrote?
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Issue: 01.01. 2010 MMC/INTAS- EMS Internal Auditor TrainingCourse
6. Non-Conformity and CauseAnalysis
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Major Nonconformance Definition
• A failure of the clients system to address a specified
requirement of the standard.
• A frequent or purposeful failure to follow specified
requirement written within the organization system.
• A failure to achieve the fundamental aim of a system
requirement.
• A failure to achieve legal or statutory requirements.
• Multiple minor nonconformities within the same
requirement of the standard or organization system.
• A purposeful failure of the organization to correct
nonconformities.
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Issue: 01.01. 2010 MMC/INTAS- EMS Internal Auditor TrainingCourse
7. Non-Conformity and CauseAnalysis
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Issue: 01.01. 2010 MMC/INTAS- EMS Internal Auditor TrainingCourse
Major Nonconformance Definition
Directly related to significant aspect.
Failure to meet legislative requirements or
to report a legal non-compliance.
Failure to meet improvement criteria
towards objectives and targets without
identifying.
Failure to identify an environmental aspect.
Failure to correctly evaluate significance
8. Non-Conformity and CauseAnalysis
8
What is a Minor Nonconformance?
• Minor indicates the issue is not significant
• The system is not threatened
• “Noise in the system”
• Isolated instance where a requirement has not been fulfilled
• If it is not a MAJOR NC then it is a Minor NC.
Only 21
minor NCR!
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Issue: 01.01. 2010 MMC/INTAS- EMS Internal Auditor TrainingCourse
9. Non-Conformity and CauseAnalysis
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Issue: 01.01. 2010 MMC/INTAS- EMS Internal Auditor TrainingCourse
Examples of Objective Evidence
Factual evidence of differences between the
Environmental Manual and associated procedures
Factual evidence of differences between procedures
and working practices
Lack of evidence to support implementation of
various standard clauses
Lack of evidence to show continuous
implementation of various parts of the system
10. Non-Conformity and CauseAnalysis
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Issue: 01.01. 2010 MMC/INTAS- EMS Internal Auditor TrainingCourse
Scenario:
Engineering department,
Acetylene gas delivered but left in unsecuredarea.
W I 9-01, clause 3, requires that on delivery all
flammable gases must be immediately stored in
secure storage area.
11. Non-Conformity and CauseAnalysis
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ENVIRONMENTAL AUDITS Incident Number
…....................
NONCONFORMITY REPORT
Organizationy under Audit: XYZplc
.............................
Note NumberSW/01
Area under review:
……………………………………….
I
S
(
O
X
1
X
4
X
0
0
X
1Clause Number
…………………………
Category MAJOR* MINOR* * delete one
Deficiency
Evidence was available that ACETYLENE
GAS was left in a non-secure area
Refer to WI 9-01, clause 3
Auditor Richard Simon
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Issue: 01.01. 2010 MMC/INTAS- EMS Internal Auditor TrainingCourse
•Area
•Problem
•Attribution
•Grading
•Reference to internal
Requirement(s), if
necessary
•Sign
12. Non-Conformity and CauseAnalysis
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A word of Caution
B e cautious, do not not be
over conclusive!
D o n ’ t judge on facevalue!
M a k e sure you have completeevidence!
M a k e sure your evidence isobjective!
W h e n in doubt, investigate!
Identify the leads for furtherinvestigation.
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13. Non-Conformity and CauseAnalysis
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Company: Audit Date:
STANDARD REFERENCE or
ENVIRONMENTALMANUAL
REFERENCE or
SUBJECT REFERENCE
Departments
T
o
t
a
l
TOTALS
FINALTOTALS MAJOR MINOR
COMMENTS
NAME SIGNED DATE:
Matrix or cluster
analysis
Is the system
fundamentally sound?
Are there any problem
areas?
Are there weak
elements in the
system?
14. Non-Conformity and CauseAnalysis
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Corrective Action
“Action to eliminate the
cause of a detected
nonconformity or other
undesirable situation”
Same as ISO 9000
Don’t cure symptoms only!
Hit the cause!
Effective Corrective/RiskAction
Preventive Action
“Action to eliminate the
cause of a potential
nonconformity”
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16. Non-Conformity and CauseAnalysis
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Corrective Action Request
Company: Date: NCR
Number:
Auditor: Auditee:
Standard & Clause Major: Minor
Auditors Report: of non-conformance (requirement & evidence)
Signed:
Date:
Cause & Proposed Corrective Action:
Proposed Completion Date:
Date: Signature
Corrective Action Review:
Signed:
Date:
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Issue: 01.01. 2010 MMC/INTAS- EMS Internal Auditor TrainingCourse
Example:
Non-conformance and
Corrective Action
Request Form
Note area for corrective
action review. What
should be entered here?
By who?
17. 17
Non-Conformity and CauseAnalysis
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REPORTING NON CONFORMITIES
Non conformity reports should include:
Date of audit
Site/area/location
Auditors signature
Audi tees acceptance signature
Details of the deficiency
IQATRAINING
17
18. 18
Non-Conformity and CauseAnalysis
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EXAMPLE OF CAR FORM
IQATRAINING
18
FOR TRAINING PURPOSES ONLY MMC/INTAS
Corrective Action Request (CAR)
organization: Audit date: CAR Number:
Department: Process:
Auditor: Auditee:
Standard: Major: Minor:
Clause:
Nonconformity report:
Signed: Date:
Root cause analysis:
Proposed Corrective Action's):
Proposed Completion Date:
Signed: Actual Completion Date:
Corrective Action Review (state effectiveness of action)
Signed: Date:
Management Review Meeting comment's)
Date:
19. Non-Conformity and CauseAnalysis
8 CAUTION!!
Be cautious, do not be over conclusive!
Don’t judge on face value!
Make sure you have
complete evidence!
Make sure your evidence
is objective!
When in doubt, investigate!
Identify the leads for further investigation
IQATRAINING
19 19
21. Non-Conformity and CauseAnalysis
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What is root cause analysis?
a class of problem solving methods aimed a
t
identifying the root causes of problems or
events
21
22. Non-Conformity and CauseAnalysis
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nd all the factors that have impa
Root cause methods : ISHIKAWA
are causal diagrams that show the causes ofa
specific event
an analyzing instrument which helps to identify, or
de
r
and print possible causes of a specific problem or a
quality characteristic
graphical representation of the relation between a
result a ct
22
24. Non-Conformity and CauseAnalysis
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Root cause methods : 5 Why
The 5 Whys is a question-asking technique
used to explore the cause-and-effect
relationships underlying a particular
problem
24
25. Non-Conformity and CauseAnalysis
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25
Root cause methods : 5 Why
The vehicle will not start. (the problem)
• Why? - The battery is dead. (first why)
• Why? - The alternator is not functioning. (second why)
• Why? - The alternator belt has broken. (third why)
• Why? - The alternator belt was well beyond its useful service
life and not replaced. (fourth why)
• Why? - The vehicle was not maintained according to the
recommended service schedule. (fifth why, a root cause)
• Why? - Replacement parts are not available because of the
extreme age of the vehicle. (sixth why, optional footnote)
Start maintaining the vehicle according to the recommended service
schedule. (possible 5th Why solution)
Purchase a different vehicle that is maintainable. (possible 6th W
h
y
solution)