CQI NCR Training Presentation

8/10/2019 CQI NCR Training Presentation

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Non-conformance Reporting

Jim Kirk FCQI CQP

Quality Manager


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Annex 24


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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?

TriviaA 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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6

There is a Procedure

For Non-conformance!

Area 4> Area 4 Document Centre

> Procedure Documents
http://portal.bbmmjv.com/http://portal.bbmmjv.com/A4Documentshttp://portal.bbmmjv.com/A4Documents/Procedures/Forms/AllItems.aspx?View={EE28A527-FE80-47BE-A5D0-879D1E8EBF76}&FilterField1=ReportOwner&FilterValue1=Barry%20Tophamhttp://portal.bbmmjv.com/A4Documents/Procedures/Forms/AllItems.aspx?View={EE28A527-FE80-47BE-A5D0-879D1E8EBF76}&FilterField1=ReportOwner&FilterValue1=Barry%20Tophamhttp://portal.bbmmjv.com/A4Documentshttp://portal.bbmmjv.com/


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On-line NCR System

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Raising NCRs

Copy from one of these

1. Copy from the process,

procedure, form, template orother 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 isreally a non-conformance?

Activity:

To the Activity box on the NCR form


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Parts 2 & 3

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Fix the problemComplete the form

correctlySign 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 therequirement 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


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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 toprevent 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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There is a Procedure for

Corrective Action!

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Area 4> Area 4 Document Centre

> Procedure Documents
http://portal.bbmmjv.com/http://portal.bbmmjv.com/A4Documentshttp://portal.bbmmjv.com/A4Documents/Procedures/Forms/AllItems.aspx?View={EE28A527-FE80-47BE-A5D0-879D1E8EBF76}&FilterField1=ReportOwner&FilterValue1=Barry%20Tophamhttp://portal.bbmmjv.com/A4Documents/Procedures/Forms/AllItems.aspx?View={EE28A527-FE80-47BE-A5D0-879D1E8EBF76}&FilterField1=ReportOwner&FilterValue1=Barry%20Tophamhttp://portal.bbmmjv.com/A4Documentshttp://portal.bbmmjv.com/


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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.


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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 lost8. Why was the nail of the shoe lost?

.............................?

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Notes on Root Cause Analysis

Difficulties in tracking down the root causesWhere do you draw the line?

At the Joint Venture?

At the Parent Company?

At the Client?

At the Regulator?At the Big Bangcreation 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 exercisecontrol

A sad story will help to illustrate this point

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Chernobyl

Academician Valeri Legasov was the principle investigator of the Chernobylreactor disaster. He was also the Soviet Unions chief spokesman at the

international conference on this accident. At this meeting Legasov put theblame 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 conclusionthat the accident was ... the summit of all the incorrectrunning of the economy which had been going on in ourcountry for many years.2

1 Managing the Risks of Organisational AccidentsJames 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 inPravda shortly after Legasovsdeath.

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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

________________________

________________________

________________________________________________

________________________

________________________


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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 1.3Probable 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 6.2Underlying cause 4.1.1 Underlying cause 4.2.1

Underlying cause 6.2.1


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Worked example of fishbone analysis

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Employees

rude tocustomer

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.


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Acceptance

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I will not accept

inadequately

completed forms,

missing information etc

If I think 2 & 3 are

reasonably ok, I willput further guidelines

in the comments box

Rejected forms will

return to Parts 2

and 3.

At that point thenames of the

actionees can be

changed if needed


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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 (theymay move or be deleted)

Highlight the word for example Click Here

Press Ctrl K

Paste the web address into the pop-up

menu
http://localhost/var/www/apps/conversion/tmp/scratch_2/Root%20Cause%20Analysis.pptxhttp://localhost/var/www/apps/conversion/tmp/scratch_2/Root%20Cause%20Analysis.pptx


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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 inthe 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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CQI NCR Training Presentation

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Transcript of CQI NCR Training Presentation