NOE Human Error Reduction:

Schering Plough (Brinny )

Donal O’Callaghan & Julie Wade
Agenda
► Definition of Human Error

► Human Error Data from Brinny

► Types of Human Error

► Error Reduction Hierarchy

► The HEAT Tool

► The results to date…..next steps

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What are Human Errors ?

“An inappropriate action or

response by a person resulting in
an undesired outcome”

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4
 NOE Data 2008
180
% Hum an Error NOEs vs. Total per Month 2008
33 % of NOEs 50%

160
Root Cause was
Human Error
40%
140

120
Number of NOEs

30%
100

80
20%
60 50 53
40
40 30 31 30
28 26 10%

20

0 0%
May Jun Jul Aug Sept Oct Nov Dec

Total NOEs H.E. NOEs % H.E. vs. Total NOEs

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What did the data tell us?
► Human Error NOEs consistently accounted for 33% of total
NOEs

► Training Common Response – Investigate & Train

– Many errors not due to lack of skill or knowledge.

► Number of Human Errors were not reducing

► Similar issues re-occurred over and over again  re-training is

NOT working.

► Training can only solve a Human Error when the cause is lack of
skill or knowledge
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Human Error Factors

Training 18 %

???

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Human Error Factors

Training

Physical or
Recognition mental
capacity?
Support? Clarity of
instruction?
Clarity of Working
expectations? conditions? Feedback

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 Brinny : Human Error Categories* on Trackwise
 Learning Gap – don’t know or don’t understand – no training or poor quality
training

 Memory Gap – know, but don’t remember – after break, after holidays, long
absence – after recent change not reinforced

 Application – know, but did not use correctly – over burden - stressed

(*Source Talsico ; www. Talsico.com )

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 Brinny : Human Error Categories* on Trackwise

 Attention-
Attention know but distracted by other factors – wrong position – visual
inspection units wrong place

 Omission – know, but missed a step – overburden, pressure

 Decision – incorrect decision is made – decisions are emotional why was

wrong one made?

 Procedure – inconsistent performance due to poorly documented procedure

(*Source Talsico ; www. Talsico.com )

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HUMAN ERROR ANALYSIS TOOL ( HEAT )
HEAT Tool is a combination of

5 Whys
– Method for getting people to think about true root cause

– Prevents the investigation team from being satisfied with superficial

solutions that won’t fix the problem in the long run

– Gets to real Human Error Category

Recommended Actions V’s Talsico Human Error Category’s

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Human Error (HE) Investigation Ref. TRID No.:

Meeting held with (including personnel involved with HE):

Meeting Date:
Include all names in the space below.

Attendees:

Problem statement (Clear and

precise):

1. Why?

2. Why?

3. Why?

4. Why?

5. Why?

Type of HE identified:

Conclusions / CAPA based on type of HE:

Prepared by (Chair of Meeting):

Print Name:

Date:

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 Human Error Investigations
Learning Gap: Employee didn’t know – lack of skill or knowledge.
Was employee trained and qualified on the applicable task or procedure(s)? Is this the first time the employee
performed the task? Does the employee know the importance of using the correct method and the consequences of
deviations? Did the employee perform the task as trained? Length of timeframe from previous execution of task?
Quality of instruction or training material?
Ensure colleague is trained. Update training material. Update training methods e.g. use brain friendly/adult learning
Solutions
techniques. Use coaching, team pairing, scenarios.
Decision: Employee made wrong decision given situation/info. – Inappropriate decisions and/or behaviour, or
insufficient understanding of consequence.
Was this a new situation? Did the employee have to make a decision? Was the supervisor informed? Was the event or
circumstance covered in the procedure or initial training? Was this a normal activity or troubleshooting? Was dilution of
responsibility/turning a blind eye a factor? Was employee aware of the consequences?
Solutions Ensure individuals are aware of their own responsibilities and correct feedback channels – avoid dilution of
responsibilities. Change the balance of consequences. Provide more training if necessary.
Memory Gap: Employee knew but didn’t remember – unable to use skill or knowledge at time/situation required e.g.
one new change in a step/sequence forgotten.
Does the employee perform this task on a regular basis? Length of time from previous execution of task or frequency?
Has the employee performed the task(s) previously free of error? Did the employee forget the step(s) to perform the
task? Was the procedure or job aids available to and used by the employee?
Reduce interruptions. Ensure working environment is suitable. Ensure procedures or job aids are readily available and
Solutions changes highlighted. Engineering solutions e.g. if a sequence of steps has been updated to ‘press button B’ instead of
‘press button A’ – deactivate button A. Visual e.g. put a label on Button A as a reminder not to press that button.
Application: Employee knew but applied incorrect action/info e.g. slips, wrong outcomes, transcription errors,
mistakes.
Were several tasks involved simultaneously i.e. too many things happening at once? Was this task possible with the
resources that were available at the time of the event? Was the environment disorganized? Were health issues a factor?
Was poor design of documentation or equipment a factor? Does the employee know the task, but applied the incorrect
action/steps e.g. perceived a colour check incorrectly? Did the employee have to move around to obtain items to
perform the task?
Reduce/balance cognitive load e.g. if too many things are happening at the start of a shift, re-order or re-assign tasks.
Provide symbols/signs/colour standards/written descriptions in documentation and job aids. Ensure correct items are
Solutions
to hand before task begins. Error-proof the system e.g. change connections so that only correct hosing can physically
be attached. Make sure employee is physically fit and has the resources to do the task.
Attention: Employee believed they did task correctly but end result was variable or not desired outcome.
Was employee relying on recall rather than recognition? Were there distractions? Were there competing priorities at
the time?
Minimise disruptions and pressure, isolate or rotate task, separate in sequence tasks of a similar nature and of similar
Solutions priority. Provide recognition aids rather than relying on recall. Use colours/sounds/lights.

Omission: Employee knew, but forgot.

Does the employee know how to perform the task, but miss or did not verify the steps/actions or used wrong item?
Did the employee confuse items? Or leave a field blank? Were any distractions within the line of vision or casual
conversations? Were any interruptions present? Did the employee have a single or double check of
activity/information/results? On which shift did the error take place? Was the error at the beginning, middle, or end of
the shift? Which day of the week was the task was performed? Does the procedure allow enough time to perform the
task? Was the perceived pressure higher than usual? Was the employee concerned with something unusual (personally
or professionally)?

Attention Activators e.g. job aids, checklists, coloured labels/highlighting, auditory/visual alerts, symbols, signs, form
design (must be appropriate activators, strength and location, multiple activators). Reduce possibility for distractions.
Solutions
Change time that task is carried out or allow more time. Reduce pressure e.g. more personnel to help with that task.
Ensure items required are available to hand in the right order.
Documentation/PD Error: Quality of Documentation e.g. batch records, procedures, job aids.
Does the procedure reflect current practices? Does the procedure(s) include all steps and appropriate sequence? If the
procedure does not reflect current practices or include all the steps, was this a factor on the event? Are any
inconsistencies in the method or procedure clarity vs. practice? Are job aids available or further instructions required?
Is the procedure in a sequence or using terminology that make sense to the employee? Are the steps detailed in simple
and clear terms? Is the procedure perceived by employees as easy to work with?
Revise documentation. Consider writing a job aid with pictures to accompany the procedure, or include pictures in the
Solutions procedure. Get end-user’s help with wording of documentation 13 to ensure clarity. Simplify and reduce amount of
documentation. Eliminate duplication.
 N Learning Gap N

N N

Investigation Did the

Is the
Root Cause Is the person Is there proof Person
Y Y Y training
–Human trained? of training? understand the
effective?
Error training?

How long since

Did the
task last performed?
Memory person remember Omission
N Did the person remember Y N
Gap to complete the
HOW to perform the
task?
task?
Y

Are the
Steps 1. Ask more questions
Was it a wrong
Y N 2. Is this a Human Error?
Application Did the person Y understood and decision? 3. Different Root Cause?
/ Attention N follow the clear?
procedure?
N Y
Learning Gap or
Procedure14 Decision
 Corrective Action :Error Control Hierarchy
1. Mistake-Proof (Poka-Yoke control)
– eliminate potential for errors – Engineering Controls
e.g Machine won’t start unless door is locked

2. Error Prevention (Poka-Yoke warning)

– SPC, alarms, dress code signs, yellow lines
e.g Alarm sound if car lights left

3. Error Detection
– Ability to “catch” error before accident or batch release
e.g Batch Record review, visual inspection

4. Redundancy
– Duplication of effort
e.g. multiple checks
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The Data : 2009
% Human Error NOEs vs. Total per Month

Human Error Training

250 Introduction of HEAT Tool 40%

35%
200 Year to Date
30%
Human Error NOEs 24 %
150 25%

20%
100 15%

10%
50
5%

0 0%
Oct Nov Dec Jan Feb Mar Apr May June July Aug Sept Oct

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Success & Next Step
► Downward Trend
– Human Error NOE’s down from 33 % to 24% of total NOEs

► Inclusion
– Employees engagement & satisfaction

► Knowledge
– Better understanding of Human Factors and error

Next Steps
► Review effectiveness of CAPAs and quantify

► Is the 5 Whys best tool or do we need a more diagnostic tool for drill down

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