Non-conformance Reporting

Jim Kirk FCQI CQP

Quality Manager

Annex 24

HA Network
Map

HA Area 4 Map

What is an NCR?

What isnt an NCR?

A report issued when a product, process

or procedure does not comply with the
set standards for a product, process or
procedure under inspection
An NCR is any significant deficiency
A means of tracking actions
A tool to put right things that are going
wrong
A means of stopping repeated errors
NCRs are used to record findings from
internal and external audits that require
addressing
NCRs are usually raised from within a
process team relating to their inputs
received as outputs
Accumulating data from across the
organisation and reporting in a consistent
way will enable you to identify nonconformance trends before they seriously
affect the business.
5

Trivia
A tool to get your own
back
Somebodys opinion as to
something going wrong when
it is not actually a
requirement

There is a
Procedure
For Nonconformance!

Area 4 >
Area 4 Document Centre >
Procedure Documents

On-line NCR System

Raising NCRs

ce
n
a
id
Gu

rm
Fo
ss
e
c
Pro

p la
m
Te

te

er
h
t
O
en
m
cu
Do t

1. Copy from the process,

procedure, form, template
or other document, the
instruction as to what
needs to be done
2. State what is wrong and
how it doesnt match what
is required
3. If you cannot find the
written requirement, ask
Activity:
yourself if this is really a
non-conformance?

Copy from one of these

To the Activity box on the NCR form

Parts 2 &
3 the
Fix
problem

Complete the
form correctly
Sign the form
Enter a realistic dateDecide who the correct person is and speak to him/her
Re-draw the Asbuilt
Close the
Ask
the 5 why
scheme
questions
Provide the
Enter the root cause after answering all these questions
missing
Why didnt
he do it?
document
Why didnt he know
Having worked out the root cause, the action to prevent recurrence is obviou
he was supposed to
do it
Enter a realistic date Decide who the correct person is and speak to him/her
Why wasnt he
trained
Why wasnt the
N.B. The
Quality
Action
Management
Owner should
requirement specified
Pointsdiscussed
have
awarded with
if thethe
working
Why9 wasnt there
enough resource to
day 7 deadline
actionee
beforemissed
approval.
- from
It is
do the work

BS EN ISO 9001:2008
Records of the audits and their results shall be maintained
(see 4.2.4).
The management responsible for the area being audited shall
ensure that any necessary corrections and corrective
actions are taken without undue delay to eliminate
detected nonconformities and their causes.

10

BS EN ISO 9001:2008
8.5.2 Corrective action
The organization shall take action to eliminate the causes of nonconformities
in order to prevent recurrence.
Corrective actions shall be appropriate to the effects of the nonconformities
encountered.
A documented procedure shall be established to define requirements for
a) reviewing nonconformities (including customer complaints),
b) determining the causes of nonconformities,
c) evaluating the need for action to ensure that nonconformities do not recur,
d) determining and implementing action needed,
e) records of the results of action taken (see 4.2.4), and
f) reviewing the effectiveness of the corrective action taken.

11

BS EN ISO 9001:2008
8.5.3 Preventive action
The organization shall determine action to eliminate the causes of
potential nonconformities in order to prevent their occurrence.
Preventive actions shall be appropriate to the effects of the potential
problems.
A documented procedure shall be established to define requirements for
a) determining potential nonconformities and their causes,
b) evaluating the need for action to prevent occurrence of
nonconformities,
c) determining and implementing action needed,
d) records of results of action taken (see 4.2.4), and
e) reviewing the effectiveness of the preventive action taken.

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There is a
Procedure for
Corrective Action!
Area 4 >
Area 4 Document Centre >
Procedure Documents

13

Benjamin Franklin's 5-Why Analysis

For want of a nail a shoe was lost,
for want of a shoe a horse was lost,
for want of a horse a rider was lost,
for want of a rider an army was lost,
for want of an army a battle was lost,
for want of a battle the war was lost,
for want of the war the kingdom was lost,

And all for the want of a little

horseshoe nail.

5 Why Questions
1.
2.
3.
4.
5.
6.
7.
8.

Why was the Kingdom lost?

Because the war was lost.
Why was the war lost?
Because the battle was lost.
Why was the battle lost?
Because the army was lost.
Why was the army lost?
Because the rider was lost.
Why was the rider lost?
Because the horse was lost.
Why was the horse lost?
Because the shoe was lost.
Why was the shoe lost?
Because the nail was lost
Why was the nail of the shoe lost?

.............................?
15

Notes on Root Cause Analysis

Difficulties in tracking down the root causes
Where do you draw the line?
At the Joint Venture?
At the Parent Company?
At the Client?
At the Regulator?
At the Big Bang creation of the universe?
What are the stop rules?
There are no natural break-points, only artificially imposed ones.
The goal is to establish what happened and how to stop it happening again.
The logical stop point would seem to be where managers might reasonably be
expected to exercise control
A sad story will help to illustrate this point

16

Chernobyl
Academician Valeri Legasov was the principle investigator of the Chernobyl
reactor disaster. He was also the Soviet Unions chief spokesman at the
international conference on this accident. At this meeting Legasov put the
blame for the disaster squarely on the errors and violations of the
operators. Later he confided to friends, I told the truth at the conference,
but not the whole truth. Two years later he hanged himself after recording
his innermost feelings about the accident to a tape recorder. 1

After being at Chernobyl, I drew the unequivocal

conclusion that the accident was ... the summit of all the
incorrect running of the economy which had been going
on in our country for many years.2
1

Managing the Risks of Organisational Accidents James Reason, Ashgate Publishing ISBN 978-1-84014-105-4

This quotation is taken from the Legasov Tapes, a transcript prepared by the US Department of Energy in 1988. The original material
appeared in Pravda shortly after Legasovs death.

17

An alternative method of root cause

analysis

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What was supposed to

happen?
________________________
________________________
________________________
________________________
________________________
________________________

Why was there a

difference?
________________________
________________________
________________________
________________________
________________________
________________________

What actually happened?

(and did we get hurt?)
________________________
________________________
________________________
________________________
________________________
________________________

What have we learnt?

Plus actions
________________________
________________________
________________________
________________________
________________________
________________________

Fish-bone analysis to find root cause

Main Factor 2

Main Factor 1

Probable cause 1.2

Probable cause 2.1

Probable cause 1.3

Probable cause 1.1

Main Factor 3

Probable cause 2.2

Probable cause 3.1

Probable cause 3.2

Problem
Probable cause 4.1

Probable cause 4.2

Probable cause 6.1

Underlying cause 4.2.1

Underlying cause 4.1.1

Probable cause 5.2

Probable cause 6.2

Probable cause 5.1

Main Factor 4

19

Main Factor 5

Main Factor 6

Underlying cause 6.2.1

Worked example of fishbone analysis

Lack of recognition

Procedures

Employees
expected to
perform tasks that
reduce time spent
on customer
service

Management
not sensitive to
employee
concerns

Inadequate training

People

Low pay
Employees not motivated

Supervisor
assigns
unrealistic
workload

Employe
es rude
to
custome
Etc.
r

Provide quick service to customers

Equipment

Policies

Customer is always right

Bend the rules to satisfy customer
Etc.

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Etc.

Acceptance
I will not accept
inadequately
completed forms,
missing
information
etc
Rejected forms
will return to
Parts 2 and 3.
At that point
the names of
the actionees
can be changed
if needed
If I think 2 & 3 are
reasonably ok, I
will put further
guidelines in the
comments box
21

Closure
The Closure must be completed
in full
all the evidence must be
uploaded to the three sections
Include hyperlinks as a last
resort (they may move or be
deleted)
Highlight the word for example
Click Here
Press Ctrl K
Paste the web address into the
pop-up menu

22

Closure
Approval
I will
not close out
the NCR if the
evidence is not
provided or the action
to prevent recurrence
is not adequate
The Local Process
Owner is required to
sign off the NCR to
indicate that he / she
is satisfied that the
actions are suitable
and to understand
that the NCR may
need to be included
in the process review
input
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Further Training Available - 1

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Further Training Available - 2

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Any
Questions?
Comments?
Other
Concerns?
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