Non-conformance Reporting

Jim Kirk FCQI CQP

Quality Manager
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Annex 24
HA Network Map
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HA Area 4 Map
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What is an NCR?
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What isnt an NCR?
Trivia
A tool to get your own back
Somebodys opinion as to
something going wrong when it is
not actually a requirement

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 non-conformance trends before they
seriously affect the business.
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There is a Procedure
For Non-conformance!

Area 4 > Area 4 Document Centre
> Procedure Documents
On-line NCR System
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Raising NCRs
Copy from one of these
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 yourself if this is
really a non-conformance?
Activity:



To the Activity box on the NCR form
Parts 2 & 3
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Fix the problem
Complete the form
correctly
Sign the form
Re-draw the As-built
Close the scheme
Provide the missing
document
Ask the 5 why questions
Why didnt he do it?
Why didnt he know he
was supposed to do it
Why wasnt he trained
Why wasnt the
requirement specified
Why wasnt there
enough resource to do the
work
Enter the root cause after answering all these questions
Having worked out the root cause, the action to prevent recurrence is obvious
Enter a realistic date
Enter a realistic date
Decide who the correct person is and speak to him/her
Decide who the correct person is and speak to him/her
N.B. Quality Management Points awarded
if the working day 7 deadline missed - from
observation date not NCR raised date
N.B. The Action Owner should have
discussed with the actionee before
approval. It is difficult to change afterwards
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.
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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.
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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!

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Area 4 > Area 4 Document Centre
> Procedure Documents
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. Why was the Kingdom lost?
Because the war was lost.
2. Why was the war lost?
Because the battle was lost.
3. Why was the battle lost?
Because the army was lost.
4. Why was the army lost?
Because the rider was lost.
5. Why was the rider lost?
Because the horse was lost.
6. Why was the horse lost?
Because the shoe was lost.
7. Why was the shoe lost?
Because the nail was lost
8. Why was the nail of the shoe lost?
.............................?
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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

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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
2 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.

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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
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Problem
Main Factor 1 Main Factor 2 Main Factor 3
Main Factor 4 Main Factor 5 Main Factor 6
Probable cause 1.2
Probable cause 1.3
Probable cause 1.1
Probable cause 2.1
Probable cause 2.2
Probable cause 3.1
Probable cause 3.2
Probable cause 4.1
Probable cause 4.2
Probable cause 5.1
Probable cause 5.2
Probable cause 6.1
Probable cause 6.2
Underlying cause 4.1.1
Underlying cause 4.2.1
Underlying cause 6.2.1
Worked example of fishbone analysis
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Employees
rude to
customer
Procedures People
Equipment Policies
Employees expected
to perform tasks that
reduce time spent on
customer service
Low pay
Employees not motivated
Provide quick service to customers
Customer is always right
Inadequate training
Lack of recognition
Supervisor assigns
unrealistic workload
Management not
sensitive to
employee concerns
Bend the rules to satisfy customer
Etc.
Etc.
Etc.
Acceptance
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I will not accept
inadequately
completed forms,
missing information etc
If I think 2 & 3 are
reasonably ok, I will
put further guidelines
in the comments box

Rejected forms will
return to Parts 2
and 3.
At that point the
names of the
actionees can be
changed if needed
Closure
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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
Closure Approval
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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
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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