Non-conformity, RCA & reporting an audit

Non-Conformity and CauseAnalysis
8
1
Issue: 01.01. 2010 MMC/INTAS- EMS Internal Auditor TrainingCourse
Chapter 8
Non-conformity, RCA &
reporting an audit

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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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3
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.

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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

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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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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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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

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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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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

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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.

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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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•Area
•Problem
•Attribution
•Grading
•Reference to internal
Requirement(s), if
necessary
•Sign

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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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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?

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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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Auditor Auditee
Prepare NCR
Review
effectiveness
Explain Cause/Propose
Corrective Action
Agreement
Prepare NCR
Acknowledge
& investigate
Identify, note
& communicate Agreement
Implement,
verify & notify
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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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Example:
Non-conformance and
Corrective Action
Request Form
Note area for corrective
action review. What
should be entered here?
By who?

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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
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EXAMPLE OF CAR FORM
IQATRAINING
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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:

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

8
Observation/Area of Improvement
 An observation is essentially an OPINION.
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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
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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
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Root cause methods : ISHIKAWA
Example
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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
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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)

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Group exercise – nonconformity
26

Non-conformity, RCA & reporting an audit

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