This document discusses elements of an effective deviation management program. It begins by defining deviation as any departure from standard operating procedures or quality requirements. An effective deviation management program includes risk management, root cause analysis, corrective and preventive action procedures, and data collection to assess effectiveness. Root cause analysis identifies underlying systemic causes of problems rather than just direct causes. Establishing the right corrective and preventive actions is important to eliminate or mitigate future risks of deviations. Managing deviations effectively supports quality, continuous improvement, and achieving organizational objectives.

1. ELEMENTS OF
AN EFFECTIVE
DEVIATION
MANAGEMENT
PROGRAM

2. What is
Deviation?o It is a departure or divergence from an anticipated
result or outcome
o WHO characterizes deviation as any departure from
an established SOP, a validated process or other
quality related requirement
o Other terms for deviation:
o Nonconformity
o Incident/Accident
o Event
o Error or Mistake

3. Deviation Management
o It is the process of dealing with and controlling
deviation
o Deviation Management is an essential element in any
well-established Quality Management System
o Deviation Management plays a key role in:
o Ensuring the quality of service
o The continuous improvement of work processes
o There is a direct relation between deviation
management and continuous improvement

4. COMMO
N
FALLACIE
S

5. o We have all the policies, processes and procedures in
place; therefore there are going to be no mistake!
o We invest so much in the training of our employees so
as to achieve perfect performance
o Most mistakes are due to human error
• To prevent errors from happening you need to:
• Look at systems and processes
• Go upstream (high level) in the process and
make sure that any risk of a deviation is
eliminated before it goes downstream to
produce an event or error
o We will check mistakes out of the system
o Introduce another level of checks and balances to
ensure that no mistakes happen
o If a mistake happens we will council our employees
and retrain them

6. What is an effective
Deviation
Management Program?
o A deviation management program should include a
mechanism to differentiate deviations or
nonconformities based on their relevance or risk
o A deviation management program has to distinguish
between nonconformities that will affect the quality of
service and those that will have little impact on the
established norms
o Risk management has always been a part of an
analysis process linked to the handling of deviations or
nonconformities

7. What is an effective
Deviation Management
Program? (Cont’d)
o A deviation management program should include a root cause
analysis component that will determine the systemic cause of an
event or nonconformity
o Root cause analysis helps focus resources on performing a good
quality investigation to determine the actual cause of an
nonconformity
o Root cause analysis enables problem solvers to distinguish the
“vital few” from the “trivial many” causes of a problem

8. What is an effective
Deviation Management
Program? (Cont’d)
o An effective deviation management program
should include a mechanism to determine the
corrective/preventive actions (CAPA) to be taken
in order to eliminate causes or potential causes
of nonconformities
o A corrective/preventive action procedure
implements corrective or preventive measures
that are appropriate to the significance of the risk
or potential risk for a deviation event
o A deviation handling program should include a
mechanism to collect data and evaluate the
effectiveness of the corrective/preventive action
taken

9. Elements of an Effective
Deviation Management
Program
o Risk Management
o Root Cause Analysis
o Corrective/Preventive Action Procedure
o Data Collective to assess effectiveness

10. Risk
Manageme
nt

11. What is Risk?
o Uncertain event
o Always in the
future
o Has a cause and
effect (Impact)
o Has the potential
to impact
(negatively)
objectives or
outcomes

12. Risks: Known and Unknown
o Known Risks:
o Are predictable to a degree
o Can be identified, analyzed and
proactively managed
o Unknown Risk:
o A potential hazard that is completely
unknown
o In the context of risk management it is
any risk that is not identified and
managed

13. Hazard vs Risk
o In order to quantify risk there should precede a
measure of identifying and creating a hazard
inventory
o Risk frequency and severity is a function of the
measure of hazards identified in a process and
/or procedure
o Risk and hazard has to be considered in two
consecutive phases
o Risk Assessment: is the phase of
identification and categorization of hazards
o Risk Control: is the phase of risk reduction or
(acceptance)

14. Hazard Risk

15. Risk
o Risk can be mathematically expressed
in terms of two parameters:
o Severity (S)
o Frequency (F)
o Risk = SxF
o Risk evaluation is an answer to the
double question
o What probability?
o Which consequences?

16. What is an Acceptable
Risk?o The risk is sufficiently low in frequency and minimal in its impact
that it is not considered cost effective to control
o There is not yet a treatment or control of such risk
o The benefits outweigh any perceived risk

17. Quality Risk Management
(QRM)
o QRM is a process for the identification, assessment and
prioritization* of risk followed by;
o A coordinated and economic deployment of resources to
minimize or eliminate, if possible, the probability and/or
negative impact of a deviation or nonconformity
o QRM has become a mandatory requirement in the
manufacturing and service sector including healthcare

19. QRM Process

20. Prerequisites
o In order to implement a risk management program
effectively it is vital that a risk management
culture be developed
o Risk management culture would support the
vision, mission and objectives of an organization
o Limits and boundaries should be established and
communicated concerning what are acceptable
risk practices and outcomes

22. Establish the Context
o QRM enables an organization:
• To understand the environment in which the
organization operates
• The external environment
• The internal culture
o To undertake a number of environmental analyses:
• Review of regulatory requirements
• Review of codes and standards
• Review of industry guidelines

23. Identify Risk
o When, where, how and why are
risks are likely to occur when
you implement a certain process
or procedure
o What risks are there when we
achieve our priorities
o What risks are there when we
forgo our priorities

24. Risk Analysis
o Consideration of the sources of risk
• Identification of the sources of risk is the most critical stage
of risk assessment
• The better understanding of the sources of risk the better
outcome of risk assessment process and the more
meaningful and effective the management of risk will be
o The likelihood (frequency) and impact (severity) of risks
o Identification and evaluation of controls
• Estimation of their effectiveness
• Level of risk (residual risk) after controls are put in place

26. o Promotes the safety, security and well being of staff
members, patients and the community at large
o Enables a better understanding of work processes and
procedures
o Provides an opportunity for continuous improvement of
work processes and procedures

27. ROOT
CAUSE
ANALYSI
S

28. What is Root Cause
Analysis?
o Is a problem solving approach for identifying
underlying causes of problems so that the
most effective solutions can be determined
and implemented
o Goes beyond the obvious (proximate,
immediate, direct) cause of a problem and
investigates deeper underlying causes
o Requires logical thinking about cause-effect
relationships
o Is a paradigm shift in the way problems are
identified and resolved

29. Machine is
producing defective
parts
A device on the
machine is
damaged
Hit by a forklift
The yellow
lines that
guide the
driver of the
forklift around
the machine
have worn off
There is no
policy/process
for reviewing
the status of
these lines and
repainting
them when
needed
Why?
Why?
Why?
Why?
Problem
Root Cause

30. Think System and
Process
Toast is burned
Toaster did
not eject
bread on time
Bread crumps
build-up
interfered
with
mechanism
No
policy/process
for cleaning
toaster regularly
Direct
Cause
System or
Root Cause
Symptom
or Problem

31. Root Cause
Analysis
o It is a skill that can be applied to nearly any
problem
 People become proficient over time and
from repeated experience
o Only systemic causes are considered root
causes
• It is the policy, process, or procedure that
needs to be changed or modified to
prevent future recurrence

32. When to Use Root
Cause Analysis?
o There is high frequency of failure
o There is a significant negative impact on
established objective and outcomes
o There is a significant negative impact on
others
o There is high cost associated with such
failure

33. Root Cause Analysis
Steps
o Define the problem
o Understand the process
o Identify possible causes
o Collect data
o Analyze the data
o Identify and select the best solution
o Implement, evaluate and
institutionalize

34. Define the Problem
o A problem well stated is a problem half
solved
o A good problem definition can help make
the diagnosis more focused
o Components of a good problem statement
include the following:
 What: description of what happened
 Where: description of where the
problem was found
 Who: if the problem affects individuals
or groups
 When: the problem was first identified
 How much: frequency and/or
magnitude

35. Trending
15
20
18
20
23 22
25
30
35
40
50
60
0
5
10
15
20
25
30
35
40
45
50
55
60
65
Jan Feb Mar Apr May Jun Jul Aug Sep Oct Nov Dec
minutes Patient Wait Time

36. 18
21 22 23
17
30
40
60
25
20
18
22
0
10
20
30
40
50
60
70
Jan Feb Mar Apri May Jun Jul Aug Sep Oct Nov Dec
Patient Wait Time

37. Auto Mechanic Shop
Problem
o How much did it increase (>tolerance
limits)?
o What was the average before and what
is it now?
o Was is it sudden or gradual increase
(trending)?
o Is there a specific kind of work done on
those cars that were not ready for pick
up?

38. Combination of Causes:
Convenience Store Example
o Takes too long to fill gas
o Goods bought from the store
damaged
o Store not clean
o Prices too high
o Too much trash around
o Should management take all these
complaints together and starts working
on them?
o Should management focus on those
complaints that have the highest impact?

39. Pareto Principle (80/20
Law)
o Named after the Italian economist Vilfredo Pareto
o Principle was based on an observation
that Pareto made in his garden
o He observed that 80% of his peas are
produced by 20% of the peapods
o Pareto principle is now used in
different disciplines:
 Economics
 Management
 Business
 Sports
 Occupational Health & Safety
o Pareto used this information to show
that 80% of wealth in Italy at his time
was owned by 20% of the population

40. Complaints # of complaints
Non food items
damaged 102
Prices too high 65
Take too long to fill gas 162
Food items damaged 84
Too much trash around 31
Refrigerator looks dirty 16
Other 47
Complaints # of complaints
Take too long to fill
gas 162
Non food items
damaged 102
Food items
damaged 84
Prices too high 65
Other 47
Too much trash
around 31
Refrigerator looks
dirty 16
Complaints
# of
complaints
Cumulativ
e
%
cumulative
Too long to fill gas 162 162 32%
Non food items
damaged 102 264 52%
Food items damaged 84 348 69%
Prices too high 65 413 81%
Other 47 460 91%
Too much trash
around 31 491 97%
Fridge looks dirty 16 507 100%
Pareto Analysis
Convenience store
example

41. 0%
20%
40%
60%
80%
100%
120%
0
20
40
60
80
100
120
140
160
180
Too long to fill
gas
Non food items
damaged
Food items
damaged
Prices too high Other Too much trash
around
Fridge looks
dirty
Customer Complaints
# of complaints % cumulative

42. 0%
20%
40%
60%
80%
100%
120%
0
10
20
30
40
50
60
70
80
Schedule of test Staff Service Instructions Laboratory Location Delayed Delivery of
Results
Waiting Time Laboratory Cleanliness Other
Patient Complaints
# of Complaints % Cumulative

43. Understand the Process
o It is all about stepping back and taking a broad view of the
problem before jumping to possible causes
o This is achieved by mapping out the process by constructing
a flowchart
Define
Policy
Communic
ate policy
Impleme
nt policy
Monitor
complian
ce
Provide
feedbac
k

45. Cytotech places
order in System
Test labels are
generated
Tech assistant
dates a blank
sheet and affixes
one label on it
Tech assistant
affixes the other
label on sample
vial
Disoposes of
remaining vials
once all cases are
verified
Cytotech places the
labels in the prep
area
Tech assistant
makes a copy of
sheet and keeps
original on file
Tech assistant
submits vials and
sheet to micro at the
end of each day
Ordering HPV DNA Testing
The Problem:
One day a physician called
complaining that there is no
HPV result for her patient
even though final report
indicated that an HPV DNA
test has been ordered.
Note: One month passed
before this physician
contacted our lab

46. Cytotech places
order in System
Test labels are
generated
Cytotech dates a
blank sheet and
affixes one label
on it
Cytotech affixes
the other label on
sample vial
Disoposes of
remaining vials
once the cases are
verified
Cytotech places the
labels in the prep
area
Tech assistant makes a
copy of sheet and
keeps the original on
file
Tech assistant
submits vials and
sheet to micro at the
end of each day
Ordering HPV DNA Testing
Cytotech collects
vials and places them
in a designated
location along with
the sheet for the tech
assistant to pick up
Before disposing of
vials tech assistant
checks age on vial
and makes a list of
all samples with ages
30-65
Tech assistant
submits the list to
cytotech to
investigate

47. CORRECTIVE &
PREVENTIVE
ACTION
(CAPA)

48. Corrective & Preventive
Action
o Correction:
o Corrective
Action:
o Preventive
Action:
Is an action taken to address a
particular instance of
noncompliance (deviation)
Is an action take to prevent the
recurrence in the future of a
noncompliance that has been
found
• Is an action taken to prevent a
noncompliance in the firs place
• If the preventive action had been in
place the problem would not have
occurred

49. The Problem
o Customers who bought the newly
released model complained that the
seat belt is not fastening properly
o The company should launch an
investigation to collect as much
information as possible so as to state
the problem properly and clearly
• What?
• Where?
• When?
• How often?
• How serious?

50. Immediate/Direct Cause
o Investigation has shown that the
seatbelt clip was faulty and it was not
aligning properly
Problem Containment
(Correction)o Company contacts all customers who
complained and replaces the defective
seatbelt
o Company recalls all released model
and replaces sea belt
Prevent this deviation from recurring
(Corrective Action)
o Root Cause Analysis to determine the
systemic or process cause of the problem
o Investigate other hazards in the process
(risk management) that could cause such a
problem in the future and to mitigate their
effect or even eliminate them
Preventive Action

51. Putting It All
Together
Deviation/
nonconformance/e
rror

52. Final Word
“It is not enough to do your
best; you must know what
to do and then do your
best”
Edward
Deming
(Quality Guru)