Quality Systems: Quality Systems: Managing Human Error Managing Human Error and CAPA Effectivenessand CAPA Effectiveness
John Shaeffer
May 2008
Objectives
Why is "Not following SOPs" a top issue for the pharmaceutical industry
How to know if your CAPA will be effective
How to manage human error within
systems
Top 10 Drug Observations (FDA) 2008
Total # of Citations Citation Text1. 734 – Responsibilities and procedures in QC not in writing/ followed2. 629 – Written production & process control procedures not followed3. 532 – Control procedures not established which monitor/validate
manufacturing4. 457 – Lab controls do not include appropriate test procedures5. 451 – No written procedures for production and process controls6. 423 – Testing and release do not include appropriate lab results7. 422 – Failure to fully review discrepancies to determine whether or
not the batch has been thoroughly distributed8. 401 – Employees are not given training in operations/procedures
being conducted9. 400 – Batch production and records do not include complete
information10. 344 – Written procedures not established/followed for the cleaning
and maintenance of equipment (including utensils)
As of 02/11/2008
Revision Process: Routine Violations
Undefined procedure structure/usage rules
+
No “on the spot correction” process
+
Slow normal revision cycle
times+
High frequency of internal
revisions=
ROUTINE VIOLATIONS
Execution Excellence Goals
Prevent EVENTSIncrease SOP adherence
Increase CAPA effectiveness
Increase efficienciesImprove product cycle times
Decrease inadvertent errors
Addressing Events - CAPAs
Typical Organizational Progression
Blind Eye Awareness Accountability
Shared Responsibility
Typical CAPAs for Personnel Events
Retrain
Counsel
Isolated incident - no action required
Increased supervision
Disciplinary action up to dismissal
Typical CAPAs for Procedural Events
Fix the procedure Add a note or caution
Add another step to specifically address the event
Fix the person Counsel
Retrain
No action
Increased supervision
Disciplinary action
Underlying PrinciplesPeople:
Are FALLIBLE Achieve high levels of performance based largely on the
ENCOURAGEMENT and REINFORCEMENT received from leaders, peers and subordinates
Will exhibit behaviors that are influenced by ORGANIZATION PROCESSES and VALUES
Error likely situations are: Predictable Manageable Preventable
Events can be prevented: Understanding the reasons mistakes occur Applying the lessons from past events
Human Performance = Results + Behaviors
AutomobileManufacturer
OrganizationalIssues
Flawed Defenses
Initiating Action
Error Precursors
James Reason Ph. D., 1990
ORGANIZATIONAL CULTURE
RESPONSE to inefficiency and error is related to organizational culture.
An organization's culture is reflected by what it does: Practices
Procedures
Processes
An organization's culture is NOT what it claims to espouse or believe in.
ORGANIZATIONAL CULTURE3 Types:
1. PATHOLOGIC; the organization says “We don't make errors, and we don't tolerate people who do.” likely to shoot the messenger
2. BUREAUCRATIC:
write a new rule
3. LEARNING ORGANIZATION
seeks to understand the broader implications of error
Ron Westrum Ph. D., 1984
Time
Typical Procedure Progression - Bureaucratic
Actions allowed by plant procedures
Actions requiredto perform the job
Non Compliance
Compliant Operations
Events
LEARNING ORGANIZATION
Actively seek flaws in systems Messengers are trained and rewarded Responsibility is shared Failures lead to far-reaching reforms New ideas are welcomed
Creating an organizational culture that supports OPEN
DISCUSSION of errors & near misses is perhaps the
SINGLE MOST EFFECTIVE INTERVENTION.
As such a culture is created,THE ERROR RATE WILL
INCREASE, not because more are made, but because
MORE ARE REPORTED.
Errors & Organizational Culture
Human Performance = Results + Behaviors
AutomobileManufacturer
OrganizationalIssues
Flawed Defenses
Initiating Action
Error Precursors
James Reason Ph. D., 1990
Defenses
Physical barriers to control the processExamples:
- Policies, Procedures and Job Aids
- Alarms, Warning signs, Labels and Floor Markings
Flaws in defenses Promotes errors
Creates error likely situations
i cdnuolt blveiee taht I cluod aulaclty uesdnatnrd waht I was rdanieg. The phaonmneal pweor of the hmuan mnid; aoccdrnig to a rscheearch at camabrigde Uinervtisy, it dseno't mtaetr in waht oerdr the ltteres in a wrod are, the olny iproamtnt tihng is taht the frsit and lsat ltteer be in the rghit pclae.
The rset can be a taotl mses and you can sitll raed it whotuit a pboerlm. Tihs is bcuseae the huamn mnid deos not raed ervey lteter by istlef, but the wrod as a wlohe. Azanmig huh? yaeh and I awlyas tghuhot slpeling was ipmorantt!
1Can you raed tihs?
1Cambridge University
Human Performance = Results + Behaviors
AutomobileManufacturer
OrganizationalIssues
Flawed Defenses
Initiating Action
Error Precursors
James Reason Ph. D., 1990
Task
Demands
Error PrecursorsTWIN Analysis
Work
Environment
Individual
Capabilities
Nature
(human nature)
complicated vs. simple
time constraints
multiple steps at the same time
lighting
noise
clothing requirements
space
first time evolution
training
how long since last performed
personal affects
shortcuts
egos
culture
time into shift
perceived pressures
Human Nature Effects
Take 1000 and Add 40 to it. Now add another 1000. Now add 30. Another 1000. Now add 20. Now add another 1000. Now add 10. What is the total?
Add these numbers (without a calculator!)
Answer
Did you get 5000? Great job! You probably followed the procedure usage rules
discussed earlier.
You are not alone! Did you get 4010 or 410? If you said 4100 great job!
However, chances are you violated the procedure usage rules discussed earlier.
The decimal sequence confuses our brain, which always jumps to the highest decimals (100s instead of 10s).
Human Nature Effects
Take 1000 and Add 40 to it. Now add another 1000. Now add 30. Another 1000. Now add 20. Now add another 1000. Now add 10. What is the total?
Human Performance = Results + Behaviors
AutomobileManufacturer
OrganizationalIssues
Flawed Defenses
Initiating Action
Error Precursors
James Reason Ph. D., 1990
Operational Modes (Initiating Action)
Attention
Low
High
Low High
Skill BasedER = 1 in 10,000
Rule BasedER = 1 in 1,000
Knowledge Based
NOTE: Error Rate (ER)
ER = 1 in 2
TaskDemands
Importance of Operation Modes
Determines corrective action
Dictates procedure usage rules
Identifies error likely situations
Determines efficiency of execution
Operational Modes (Initiating Action)
Attention
Low
High
Low High
Skill BasedER = 1 in 10,000
Rule BasedER = 1 in 1,000
Knowledge Based
NOTE: Error Rate (ER)
ER = 1 in 2
TaskDemands
Human Performance = Results + Behaviors
AutomobileManufacturer
OrganizationalIssues
Flawed Defenses
Initiating Action
Error Precursors
James Reason Ph. D., 1990
Performance Problem CAUSES26 Leading Organizations Surveyed
Airlines Delta Airlines Jet Blue
Automotive Lexus
Financial Services & Banking American Express Barclays Bank
Government Navy New York Fire Department Social Security Administration
Manufacturing Caterpillar Steelcase Molex Johnson Controls
Media BBC
Retail Coffee Ben & Tea Leaf Godiva SAB Miller
Pharmaceutical and Healthcare Becton Dickson Eli Lilly Humana Novartis
Industrial Agilent
Telecom and Technology Nextell IBM SAS SAP
Results: 24.3% Individual 75.7% Environmental
Tony O’Driscol Ph. D., 2006
Reliance on Employee vs. CA Effectiveness
HIGH
Low
HighLOWReliance on Employee
Effectiveness
Desired area for CAPA
CAPA Effectiveness: Targeting Human Performance Problems
100 events
75% of events are outside of individuals control
5 events
Assume corrective actions are 20% effective
Number of eventswith effective corrective actions
25 events
100 Total Events
Procedure Checklist: Procedure GMP-10052, Documentation Of GMP Practices
Step Performed By:
Checked By:
1 One action per step JS AP
2 Every step to successfully complete the task should be in the procedure JS AP
3 Procedure steps should be in the order that they are performed JS AP
4 Each procedure step should be 2 lines or less (exceptions allowed but rarely) JS
5 Only information critical for step implementation should be included within the step JS AP
6 Use note for location if a particular piece of equipment is hard to find AP
7 Use cautions to delineate steps that need to be done together in a rapid fashion or if time is critical
JS AP
8 Use bullets or numbering in accordance with site standards JS AP
9 Use specific nomenclature for identifying components to be manipulated when possible JS AP
10 Place visuals close to the relevant text
11 The range of acceptable values for an entry should be next to or below the entry JS AP
12 Critical steps should be identified JS AP
13 One series of signoffs per step (performed by, checked by, verified by) JS
14 Batch record signatures, checked by and verified by should be aligned in separate columns AP
15 Any cautions or important notes should be in the procedure before the information is required to be used
JS AP
16 Write the WARNING: statement to the person using the SOP JS AP
17 Align the second line of the warning statement with the text and not the word JS AP
Performed By: _____John Shaeffer__________________________ Date:________09/24/06____ Checked By: _____Amy Peterson____________________________ Date:________ 09/24/06____
Procedure Checklist: Procedure GMP-10052, Documentation Of GMP Practices
Step Performed By:
Checked By:
1 One action per step JS AP
2 Every step to successfully complete the task should be in the procedure JS AP
3 Procedure steps should be in the order that they are performed JS AP
4 Each procedure step should be 2 lines or less (exceptions allowed but rarely) JS
5 Only information critical for step implementation should be included within the step JS AP
6 Use note for location if a particular piece of equipment is hard to find AP
7 Use cautions to delineate steps that need to be done together in a rapid fashion or if time is critical JS AP
8 Use bullets or numbering in accordance with site standards JS AP
9 Use specific nomenclature for identifying components to be manipulated when possible JS AP
10 Place visuals close to the relevant text
11 The range of acceptable values for an entry should be next to or below the entry JS AP
12 Critical steps should be identified JS AP
13 One series of signoffs per step (performed by, checked by, verified by) JS
14 Batch record signatures, checked by and verified by should be aligned in separate columns AP
15 Any cautions or important notes should be in the procedure before the information is required to be used JS AP
16 Write the WARNING: statement to the person using the SOP JS AP
17 Align the second line of the warning statement with the text and not the word JS AP
Performed By: _____John Shaeffer__________________________ Date:________09/24/06____
Checked By: _____Amy Peterson____________________________ Date:________ 09/24/06____
Procedure Checklist: Procedure GMP-10052, Documentation Of GMP Practices
Step Performed By:
Checked By:
1 One action per step JS AP
2 Every step to successfully complete the task should be in the procedure JS AP
3 Procedure steps should be in the order that they are performed JS AP
4 Each procedure step should be 2 lines or less (exceptions allowed but rarely) JS
5 Only information critical for step implementation should be included within the step JS AP
6 Use note for location if a particular piece of equipment is hard to find AP
7 Use cautions to delineate steps that need to be done together in a rapid fashion or if time is critical JS AP
8 Use bullets or numbering in accordance with site standards JS AP
9 Use specific nomenclature for identifying components to be manipulated when possible JS AP
10 Place visuals close to the relevant text
11 The range of acceptable values for an entry should be next to or below the entry JS AP
12 Critical steps should be identified JS AP
13 One series of signoffs per step (performed by, checked by, verified by) JS
14 Batch record signatures, checked by and verified by should be aligned in separate columns AP
15 Any cautions or important notes should be in the procedure before the information is required to be used JS AP
16 Write the WARNING: statement to the person using the SOP JS AP
17 Align the second line of the warning statement with the text and not the word JS AP
Performed By: _____John Shaeffer__________________________ Date:________09/24/06____
Checked By: _____Amy Peterson____________________________ Date:________ 09/24/06____
Procedure Checklist: Procedure GMP-10052, Documentation Of GMP Practices
One action per step JS AP Every step to successfully complete the task should be in the procedure JS AP Procedure steps should be in the order that they are performed JS AP Each procedure step should be 2 lines or less (exceptions allowed but rarely) JS ___ Only information critical for step implementation should be included within the step JS __ Use note for location if a particular piece of equipment is hard to find.___ AP Use cautions to delineate steps that need to be done together in a rapid fashion, if time is critical, or an error likely situation JS AP Use bullets or numbering in accordance with site standards JS AP Use specific nomenclature for identifying components to be manipulated when possible JS AP Place visuals close to the relevant text The range of acceptable values for an entry should be next to or below the entry JS AP Critical steps should be identified JS AP One series of signoffs per step (performed by, checked by, verified by) JS __ Batch record signatures, checked by and verified by should be aligned in separate columns ___ AP Any cautions or important notes should be in the procedure before the information is required to be used JS __ Write the WARNING: statement to the person using the SOP JS AP Align the second line of the warning statement with the text and not the word JS AP Performed By: John Shaeffer Date: 09/24/06 Checked By: Amy Peterson Date: 09/24/06
Procedure Checklist: Procedure GMP-10052, Documentation Of GMP Practices
One action per step JS AP Every step to successfully complete the task should be in the procedure JS AP Procedure steps should be in the order that they are performed JS AP Each procedure step should be 2 lines or less (exceptions allowed but rarely) JS ___ Only information critical for step implementation should be included within the step JS __ Use note for location if a particular piece of equipment is hard to find.___ AP Use cautions to delineate steps that need to be done together in a rapid fashion, if time is critical, or an error likely situation JS AP Use bullets or numbering in accordance with site standards JS AP Use specific nomenclature for identifying components to be manipulated when possible JS AP Place visuals close to the relevant text The range of acceptable values for an entry should be next to or below the entry JS AP Critical steps should be identified JS AP One series of signoffs per step (performed by, checked by, verified by) JS __ Batch record signatures, checked by and verified by should be aligned in separate columns ___ AP Any cautions or important notes should be in the procedure before the information is required to be used JS __ Write the WARNING: statement to the person using the SOP JS AP Align the second line of the warning statement with the text and not the word JS AP Performed By: John Shaeffer Date: 09/24/06 Checked By: Amy Peterson Date: 09/24/06
Operational Modes (Initiating Action)
Attention
Low
High
Low High
Skill BasedER = 1 in 10,000
Rule BasedER = 1 in 1,000
Knowledge Based
NOTE: Error Rate (ER)
ER = 1 in 2
TaskDemands
Predicted Results
First documentSpeed – 7 seconds average
Success rate – over 85%
Second documentSpeed – doubled in time (15 seconds)
Success rate – reduced significantly (under 10%)
OrganizationalIssues
Flawed Defenses
Operation Modes- Skill- Rule- Knowledge
Error Precursors
James Reason Ph. D., 1990, modified
Performance Model
Procedure PolicyJob Aid LabelAlarm Sign
Task Demands
Work Environment
Individual Capabilities
Nature (human nature)
Initiating Action
Process & valuesSystem alignmentCommunicationBehavior (Culture)
20% Individual
80% Organizational
CA 5% CA 95%
CA – Corrective Action
“Defense in Depth Model” : Anatomy of Events
HumanFallibility
Flawed Defenses
OrganizationalBarriers
ManagementBarriers
InitiatingAction
Modified from Managing the Risks of Organizational Accidents, James Reason, Pd. D. 1997.
ACTIVE ERRORS
- Weak Skills- Failed or Non- existent Barriers
LATENT ERRORS
Organizational issues:- Poorly Written Procedures- Failed or Nonexistent Programmatic Barriers - Ineffective Management
Event
Corrective Actions Effectiveness
ELIMINATE: Organizational Issues
ELIMINATE: Flawed Defenses & Error
Precursors
PROVIDE: Preventative Actions for the
individual who initiates the
action
More
Less
Execution Excellence
Nine different components1. HPM Basic Concepts
2. HPM Based Investigations
3. Human Factoring Records
4. Human Factoring Processes
5. Error Prevention Techniques
6. Preventive Actions
7. Behavior Modification
8. Organizational Issues
9. Procedure Usage
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