Quality Management
Workshop
August 2012
This project has been funded in whole or in part with Federal funds from the Division of AIDS (DAIDS), National Institute of Allergy and Infectious
Diseases (NIAID), National Institutes of Health, Department of Health and Human Services, under contract No. HHSN272201200009C, entitled
NIAID HIV and Other Infectious Diseases Clinical Research Support Services (CRSS).
Reminders and Helpful Hints
 Review of presentation materials
 Please turn off or silence mobile phones
 Exits
 Restrooms
 Assistance
2
Audience Response System (ARS)
 Respond to Questions
 Change an Answer
 Responses are Anonymous
 Question cue is a
on preceding slide
 Ensure remote is on by
pressing and holding the
“On/Off” button
 Please leave remotes on the
tables
3
Choose
your
answer
Send or
change
your
answer
Audience Response System
(cont’d)
Good documentation practices
include following the principles
of:
A. Electronic Record
Management
B. “ALCOA”
Choose
your
answer
C. Electronic Signatures
Send or
change
your
answer
4
Audience Response System
(cont’d)
Name one of the words that is
applied within the acronym
“ALCOA”.
Choose
your
answer
Send or
change
your
answer
5
Quality Management Workshop
Quality Management
Quality Assurance
CQMP Policy
Quality Control
Activity 1: Key Indicators
QA and QC Activities
Activity 2: Detecting and assessing trends/issues
Activity 3: SMR Review
Corrective and Preventive Action
Activity 4: Root cause analysis
Activity 6: Implementation Plan
Activity 5: Develop a CAPA Plan
Review, evaluate and create a culture
of Quality Management
Activity 7 : CQMP Review
6
Objectives
 Differentiate between Quality Assurance (QA) and Quality
Control (QC)
 Discuss the roles and responsibilities associated with
maintaining a Quality Program at the site
 Apply the DAIDS Clinical Quality Management Plan (CQMP)
Policy for the development, implementation, evaluation, and
adaptability of a site CQMP
 Determine corrective and preventive actions (CAPA) based on
scenarios of common findings
 Discuss clinical site monitoring and how monitoring and data
management queries can influence quality at the site
 Discuss actions a site can take to implement a quality
management culture at the site
7
Additional QM Resources
 DAIDS Learning Management System (DLMS):
https://daidslms.plateau.com/learning/user/login.do
 Orientation to Quality Management eLearning - Course 676
 Quality Management Roles and Responsibilities eLearning Course 991
 CAPA for Clinical Staff eLearning - Course 950
 CAPA for Laboratory Staff eLearning - Course 990
 CAPA for Pharmacy Staff - Course 970
 CQMP Plan Policy, Session 1 - Webinar
 Clinical Quality Management Plans - Policy eLearning
 Clinical Quality Management Webinars - Courses 267, 287,
and 288
 Clinical Quality Quick Reference Card
 DAIDS Clinical Research Policies
 CQMP Annual Summary Report
8
Pre-Assessment Question #1
The clinical site has had three site monitoring visits since the first
subject enrolled in the study. Each subsequent site monitoring visit
report has reflected a 50% decrease in site issues. The site diligently
reviews its site monitoring report (SMR) to clearly identify the issues
listed and adjust its CQMP accordingly to ensure the amount of queries
generated during monitoring visits and by the data management center
has significantly decreased.
Based on the findings in the SMR what step has the site taken to
decrease the number of monitoring findings and data management
queries?
A. Developed corrective action plans to address the monitoring
findings
B. Submitted the SMR to the Institutional Review Board/Ethics
Committee (IRB/EC)
C. Filed the SMR in the regulatory files
9
Pre-Assessment Question #2
Once a CQMP is developed, how often should the Plan be
reviewed?
A. Every two years
B. Annually
C. Per policy
10
Pre-Assessment Question #3
Which of the following individuals is ultimately responsible
for the quality management activities at a research site?
A.
B.
C.
D.
11
The Investigator
The Study Coordinator
The Pharmacist
The Research Participant
Pre-Assessment Question #4
Which quality management activity is conducted in
real-time?
A. Quality control
B. Quality assurance
12
Pre-Assessment Question #5
The corrective action component of Corrective and
Preventive Action (CAPA) is defined as the action
taken to remove or improve a process to prevent
potential future occurrences of a nonconformance.
A. Yes
B. No
13
Pre-Assessment Question #6
What actions can site staff take to implement a
quality management culture at their site?
A. Identify a Quality Manager who is responsible for
monitoring and addressing trends identified in site
monitoring reports
B. Create a site CAPA plan
C. Engage stakeholders in implementing the site’s CAPA
D. All of the above
14
Your Mission…
15
work
Quality Management Workshop
Quality Management
Quality Assurance
CQMP Policy
Quality Control
Activity 1: Key Indicators
QA and QC Activities
Activity 2: Detecting and assessing trends/issues
Activity 3: SMR Review
Corrective and Preventive Action
Activity 4: Root cause analysis
Activity 6: Implementation Plan
Activity 5: Develop a CAPA Plan
Review, evaluate and create a culture
of Quality Management
Activity 7 : CQMP Review
16
Quality Management Activities
Quality
Management
Quality
Control
17
Quality
Assurance
Quality Control
Quality Control is the real time, ongoing (day-to-day)
operational techniques and activities that are undertaken
to verify requirements for quality trial-related activities.
Example:
Verification that all headers, required fields, and
dates are completed correctly on case report forms
(CRFs) prior to data entry.
18
Quality Assurance
Quality Assurance is a retrospective, objective,
systematic, and periodic review of trial-related activities to
ensure that the trial is performed and the data are
generated, documented and reported in compliance with
Good Clinical Practice and any applicable regulatory
requirements.
Example:
Staff may evaluate key elements of source
documentation and compare them to completed
CRFs for agreement on a weekly basis.
19
Clinical Quality Management Plan (CQMP)
 According to the DAIDS Policy on “Requirements for
Clinical Quality Management Plans (CQMP)”, all clinical
research sites conducting or participating in NIAID
DAIDS supported and/or sponsored clinical research
must have a CQMP.
 CQMP Clinical Site or Screen Shot
20
Why is implementation of a CQMP important?
21
VOICE Enrolled versus Monitored
Quality Roles and Responsibilities
22
Develop and Implement a CQMP
Collaborate with team members to:
 Identify areas of performance to monitor
 Identify measurable components to record
 Communicate plan
 Measure performance at established
intervals
 Document all CQMP activities
 Report performance measurements
to appropriate members of the team
23
CQMP Documentation
 Name of the reviewer
 Date of the review
 Research participant
identification number
 Specific items that were
reviewed
 Time period covered by the
review
 Findings/results of the review
24
Key Indicators
What are Key Indicators?
Established measures to determine how
well an organization is meeting its
regulatory and operational expectations
25
Key Indicators (cont’d)
Informed Consent Form
and process
Concomitant/prohibited
medications
Eligibility criteria
Study product
administration/dosing
Scheduled tests and
procedures
Missed visits, tests, or
procedures
26
Clinical endpoint
identification
Identification and reporting
of SAEs, EAEs, and AEs
Key Indicators
Activity 1
27
Key Indicators (cont’d)
Scenario
 A large Phase IIB randomized trial of a vaccine to
prevent HIV-1 acquisition is being conducted at three
sites in South Africa.
 Sites were selected, in part, for estimated enrollment of
500-750 volunteers per site.
 There is a strong interest in this trial within the
communities.
 A large number of volunteers are illiterate.
 Many volunteers may have health issues related to poor
nutrition and crowded living conditions.
28
Group Discussion
Define Quality Indicators
 Name quality performance goals for documenting
eligibility.
Measure Quality Indicators
 Name some measurable indicators for eligibility
verification.
Process Evaluation and Improvement
 Analyze results
 Improve processes
 Control processes
29
Define Key Indicators
Choose one or more quality performance goals for
documenting informed consent.
100% of enrolled research participants will have:
A. Signed/dated informed consent on file
B. Source documentation in the clinic/medical record
C. Informed consent obtained prior to collection of any
research-specific data
D. All of the above
30
Measure Key Indicators
Choose the measurable indicator(s) for the informed
consent process:
A. The percent of research participants who have signed
informed consent
B. The percent of research participants who have
documentation in the clinic/medical record of informed
consent process
C. The percent of research participants who signed
informed consent prior to collection of any researchspecific data
D. All of the above
31
Group Discussion: Key Indicators
Let’s discuss ideas for evaluating informed consent
performance for a site enrolling 500-750 research
participants in a Phase IIB/III trial.
What would you consider as you develop this aspect of
your CQMP?
32
Performance Metrics: Use Available Data
Use available data and reports to monitor and
measure trends in performance:
 Site monitoring reports
 Data quality management reports
33
Create Your Own Tools
Tracking timelines
 Set reminders for EC/IRB due dates:
 Protocol continuing review
 Record submission dates:
 Safety reports to EC/IRB
Protocol-specific checklists
 Source documentation tools to ensure
compliance with:
 Informed consent process
 Confirming eligibility criteria
34
Tools
The CQMP includes tools or checklists to be used
in the QA and QC processes. Examples include:






35
Visit reminder checklist
Data entry reports
Query reports
Error reports
Site monitoring reports
Chart review tools
Sponsor Quality Oversight
Sponsor
Clinical Site
Oversight
Clinical Site
Monitoring
Regulatory Affairs
Protocol
Registration
Safety Reporting
36
Statistical and Data
Management
Edit checks,
queries,
delinquency reports
Pharmaceutical
Affairs
Clinical Research
Product
Management
Your Mission…
37
work
Quality Management Workshop
Quality Management
Quality Assurance
CQMP Policy
Quality Control
Activity 1: Key Indicators
QA and QC Activities
Activity 2: Detecting and assessing trends/issues
Activity 3: SMR Review
Corrective and Preventive Action
Activity 4: Root cause analysis
Activity 6: Implementation Plan
Activity 5: Develop a CAPA Plan
Review, evaluate and create a culture
of Quality Management
Activity 7 : CQMP Review
Quality Control and Assurance
Activity 2
39
Quality Control and Assurance Activity
1. Review the scenario
2. Review the documents
included in the scenario
packet for issues
3. Complete the
Issue/Trend Worksheet
for each issue/trend
identified
4. Worksheets are labeled
for Quality Control and
Quality Assurance
40
Documents You Need For This Activity
 Clinical Quality
Management Plan
(CQMP) Training Protocol
and Site Information –
Reagan’s Research Clinic
 Protocol Summary
 Letter of Amendment
March 2010
 Clinical Site Monitoring
Group Site Monitoring
Report
 Protocol MTN-003 Line
Check Error Log
41
Documents You Need For This Activity
(cont’d)
 Clinical Laboratory
Report PID 555100101
 Clinical Laboratory
Report PID 555100095
 Queries Report
 Quality Management
Chart Review
 Site Investigational
Product Accountability
Record - Tablets
 Site Investigational
Product Accountability
Record – Tubes
42
Documents You Need For This Activity
(cont’d)
Subject I.P Accountability
Record – Subject 101
Subject I.P. Accountability
Record – Subject 95
Subject I.P Accountability
Record – Subject 96
Delegation of
Responsibility
Log/Signature List
Document to Note
Information:
 Quality Control (QC) Issue
and Trend Worksheet
43
Quality Control and Assurance
Reagan’s Research Clinic is located at:
63847 Capitol Hill Boulevard
Durban, KwaZulu-Natal
Scenario
The Research Team
44
Investigator
Dr. Dominick Reagan
Sub-Investigator
Dr. Phillip Dole
Study Coordinator
Cecilia Cooper
Pharmacist
Olivia Seagull
Counselor
Kevin Jones
Quality Control and Assurance
(cont’d)
Scenario
The site has had numerous audit findings identified during
monitoring visits and during internal quality management
review activities over the course of the year.
The Investigator is holding a staff meeting to review audit
findings from quality management activities over the past
year.
45
Quality Control and Assurance
(cont’d)
Scenario
During the meeting Dr. Reagan has asked all the research
team members to review the following documents to identify
trends:
QC Log
Letter of Amendment (LOA)
QM Chart Review Tool
Queries Report
Site Monitoring Report (SMR)
Pharmacy Logs
CQMP Annual Report
46
Quality Control and Assurance Activity
FEEDBACK
47
Quality Control and Assurance
Activity 3
48
Document You Need For This Activity
Clinical Site Monitoring
Group Site Monitoring
Report (28-Sep-2010)
49
What Can You Do?
Next Monitoring Visit: October
 Work with the participants at your table to review the
Site Monitoring Visit Report (SMR)
 Rank issues/trends according to number of times the
issue is found and priority
 Identify the trends
50
Next Monitoring Visit: October (cont’d)
 Why is it important to note issues/trends?
 What can happen if these issues are left unresolved?
 What do these issues mean at the site?
 What are your practices on site when you identify an
issue?
51
Quality Control and Assurance
FEEDBACK
52
PID(s)
Obse
Visit Observation rvatio
n
Code
Date
Code
555100095
M04 30/Sep/2010 A23
Missed Visit Adequate Source Documentation: The study participant did not return to the
research clinic for their scheduled M04 study visit. The subject took a holiday and was away
during the visit window.
555100095
M05 30/Sep/2010 A17
Transcription Error: The following laboratory values were not transcribed from the source to
the CRF: Sodium, Total Bilirubin, ALT (SGPT) and AST (SGOT).
555100095
M05 30/Sep/2010 A72
Procedural Inadequate Source Documentation: The fax copy of the chemistry laboratory
results was not certified per the DAIDS Source Documentation requirements by the
research clinician who received the document.
*555100096 M04 01/Oct/2010 A17
*555100096 M05 01/Oct/2010 A23
555100101
M00 28/Sep/2010 A1A
Observation Description
A1A:
Inadequate
Missed
Visit
A72: Inadequate
A17:Adequate
Inadequate
Source
Missed Visit Adequate Source Documentation: Source
The study participant did not return to the
research clinic for her scheduled M05Documentation
study visit.
The study coordinator contacted the
Source
Documentation
participant on the following dates without success: 16/Sep/2010, 21/Sep/2010,
Documentation
23/Sep/2010, 27/Sep/2010, 28/Sep/2010
29/Sep/2010. The participant’s visit was
IsIs
ititaand
atrend?
trend?
Documentation
scheduled to occur 13/Sep/2010. Messages were left on the participant’s voicemail to
Is it a trend?
Transcription Error: The participant’s systolic blood pressure reading was incorrectly
transcribed from the source to the CRF.
contact the clinician to reschedule the study visit before the protocol window closed. The
IsWhat
it a can
trend?
What
happen
if this
finding is
could
happen
if this
window closed and the site still had not heard from the participant.
What
could
happen
if this
unresolved?
left
unresolved?
Informed Consent Violation Level left
1:finding
Pages
5 and
6 were
missing from the Enrollment
What
could
happen if this
finding
left unresolved?
Informed Consent Form, V1.0, dated
02/Nov/2009,
signed on 07/Sep/2010. Action was
corrected during the monitoring visit.
What
finding
left this
unresolved?
Whatdoes
does
thisfinding
findingmean
meanfor
for
What
does this finding mean for
the site?
555100101
555100101
M00 28/Sep/2010 A17
M01 28/Sep/2010 A72
the
Transcription Error: The participant’s
yearsite?
of
birth isthis
incorrectly
transcribed
from
the
What
does
finding
mean
for
the
site?
Demographic source document to the Demographic CRF. Action was corrected by the
What
are
the
site?
What
areyour
yourpractices
practiceson
onsite
site
research clinician during the monitoring
visit.
What
are
practices
on site
when
you
identify
an
whenare
youyour
identify
anissue?
issue?
What
your
practices
on
when you identify an issue?site
Procedural Inadequate Source Documentation:
to verify
source documents the
when youUnable
identify
anin issue?
pregnancy test results entered on the CRF.
53
Quality Management Workshop
Quality Management
Quality Assurance
CQMP Policy
Quality Control
Activity 1: Key Indicators
QA and QC Activities
Activity 2: Detecting and assessing trends/issues
Activity 3: SMR Review
Corrective and Preventive Action
Activity 4: Root cause analysis
Activity 6: Implementation Plan
Activity 5: Develop a CAPA Plan
Review, evaluate and create a culture
of Quality Management
Activity 7 : CQMP Review
Corrective and Preventive Action (CAPA)
PA
CA
CAPA
Corrective
Action
55
Preventive
Action
Corrective and Preventive Action (CAPA)
Process of identifying the root cause of a problem,
nonconformity, or undesirable situation.
The root cause is the most basic reason for the effect,
which if eliminated or corrected, can prevent the event
from existing or reoccurring.
56
Corrective and Preventive Action Plans
Develop CAPA Plans
 Perform root cause analysis
 Identify and implement corrective actions
 Propose and implement preventive actions
 Continue measuring performance at established
intervals
 Compile and report performance measurements within
the team
57
Corrective and Preventive Action
(CAPA)
Root Cause Analysis
Activity 4
58
Document You Need For This Activity
 Root Cause Analysis
Worksheet
59
Corrective and Preventive Action (CAPA)
Root Cause Analysis
Using the trends identified, complete the root cause
analysis worksheet.
60
60
Root Cause Analysis
Feedback Session
1. Why is this issue
occurring?
2. Why is this issue
occurring?
3. Why is this issue
occurring?
4. Why is this issue
occurring?
5. Why is this issue
occurring?
61
Corrective and Preventive Action
(CAPA)
Developing a CAPA Plan
Activity 5
62
Corrective and Preventive Action (CAPA)
Develop a CAPA Plan
 Using the CAPA Worksheet,
develop a CAPA Plan using
your noted trends
 Be prepared to discuss this
as a group
63
Root Cause Analysis
Feedback Session
Proposed Corrective Action:
Who is involved in this Corrective Action?
What resources are needed to complete this Corrective Action?
What is the timeline for completing this Corrective Action?
How will the effectiveness of this Corrective Action be
measured?
What other areas could this Corrective Action impact?
What are the risks and benefits for implementing the proposed
Corrective Action to the affected areas?
What strategies could you employ to minimize risks to the
affected areas?
64
Root Cause Analysis
Feedback Session
Proposed Preventive Action:
Who is involved in this Preventive Action?
What resources are needed to complete this Preventive Action?
What is the timeline for completing this Preventive Action?
What are the risks and benefits for implementing the proposed
Preventive Action to the affected areas?
What strategies could you employ to minimize risks to the
affected areas?
65
Corrective and Preventive Action
(CAPA)
Implementation
Activity 6
66
Document You Need For This Activity
 CAPA Worksheet
67
Corrective and Preventive Action (CAPA)
Implementation Plan Worksheet
 Using the Implementation Plan Worksheet, develop an
Implementation Plan for your CAPA
 Outline roles and responsibilities at the site
68
Corrective and Preventive Action (CAPA)
Implementation Plan
Feedback Session
CAPA
69
How you will accomplish this?
Quality Management Workshop
Quality Management
Quality Assurance
CQMP Policy
Quality Control
Activity 1: Key Indicators
QA and QC Activities
Activity 2: Detecting and assessing trends/issues
Activity 3: SMR Review
Corrective and Preventive Action
Activity 4: Root cause analysis
Activity 6: Implementation Plan
Activity 5: Develop a CAPA Plan
Review, evaluate and create a culture
of Quality Management
Activity 7 : CQMP Review
Reminder: CQMP Review
 Proactively review your CQMP to assess the
effectiveness of your current plan
 Make sure it adequately reflects all necessary QM
activities
 Review your CQMP after a monitoring visit to
determine if changes need to be made to the CQMP
to address recent findings
71
What Can You Do?
 Become a change agent
 Motivate site staff to implement the change
 Communicate the change effectively
 Ensure you have stakeholder buy-in
 Allow for adequate time to implement the change
 Recognize site/staff improvements
 Maintain realistic expectations
72
CQMP Review
Activity 7
73
Documents You Need For This Activity
Clinical Quality
Management Plan
(CQMP)
Clinical Quality
Management Plan
Summary Report
74
Activity: Update CQMP
 Review the completed
sample CQMP
 Update the plan to reflect
corrective actions
determined in the CAPA
Plan
75
CQMP Evaluation and Reporting – Be Ready!
 Required annual review and submission of Annual
Summary Report
 Submit CQMP to Program Officer on an annual basis, if
there have been any changes
 Program Officers may ask to review plan based on
findings at the site
CQMP Annual Summary Report
76
Implement a Quality Management Culture
Basic and ongoing training:
 Provide and reinforce rationale for quality
 Protect the safety, welfare, privacy and
confidentiality of research participants
 Generate complete, accurate and timely
data to promote the safety of research
participants and future consumers
 Establish efficient and streamlined
processes
 Document and train on work processes
 Evaluate and revise processes as
needed
77
Engage Team Members in CQMP Processes
Build QC steps into processes
 Promote rapid, selfidentification and correction of
errors
Perform root cause analysis
activities
 Applicable team members to gather input
 Share perspectives in an open (non-blaming) manner
Share results of QA activities
 Acknowledge and celebrate performance improvements
78
ALCOA
ttributable: Is it obvious who wrote it?
egible: Can it be read?
ontemporaneous: Is the information current?
Is it in the correct time frame?
riginal: Is it a copy? Has it been altered?
ccurate: Is conflicting data recorded elsewhere?
From DAIDS Policy on “Requirements for Source Documentation in
DAIDS Funded and/or Sponsored Clinical Trials”
79
Enforce Excellence in Source
Documentation
 “If it isn’t written down, it didn’t happen”
 Good documentation practices:
 Use pens. No pencils! No white out!
 Sign, credential and date
 Follow ALCOA standards
 Train staff on DAIDS source documentation
requirements
 Build internal review and feedback of source
documentation practices into CQMP
80
Activity – ALCOA Practices
 Discuss source documentation at your CRS
 Identify methods used to ensure clinic notes are:
Attributable
Legible
Contemporaneous
Original
Accurate
 Share your best practices and lessons learned!
81
Communication Pathways
Staff has clear understanding
of roles and responsibilities
Creates a
positive quality
culture
Benefits
Increases teamwork,
establishes common
goals, promotes staff
unity
82
Promotes an
integrated Quality
Management
Program
Increases efficiencies
and decreases
redundancy
Remember your mission…
work
83
Quality Management Workshop
Quality Management
Quality Assurance
CQMP Policy
Quality Control
Activity 1: Key Indicators
QA and QC Activities
Activity 2: Detecting and assessing trends/issues
Activity 3: SMR Review
Corrective and Preventive Action
Activity 4: Root cause analysis
Activity 6: Implementation Plan
Activity 5: Develop a CAPA Plan
Review, evaluate and create a culture
of Quality Management
Activity 7 : CQMP Review
Summary
 Differentiate between QA and QC
 Discuss the roles and responsibilities associated with
maintaining a quality program at the site
 Apply the DAIDS Clinical Quality Management Plan Policy for
the development, implementation, evaluation, and adaptability of
a site CQMP
 Determine corrective and preventive actions based on scenarios
of common findings
 Discuss clinical site monitoring and how monitoring and data
management queries can influence quality at the site
 Discuss methods to implement a Quality Management culture at
the site
85
Remember Your Additional QM Resources
 DAIDS Learning Management System (DLMS):
https://daidslms.plateau.com/learning/user/login.do
 Orientation to Quality Management eLearning - Course 676
 Quality Management Roles and Responsibilities eLearning Course 991
 CAPA for Clinical Staff eLearning - Course 950
 CAPA for Laboratory Staff eLearning - Course 990
 CAPA for Pharmacy Staff - Course 970
 CQMP Plan Policy, Session 1 - Webinar
 Clinical Quality Management Plans - Policy eLearning
 Clinical Quality Management Webinars - Courses 267, 287,
and 288
 Clinical Quality Quick Reference Card
 DAIDS Clinical Research Policies
 CQMP Annual Summary Report
86
Post-Assessment Question #1
The clinical site has had three site monitoring visits since the first
subject has enrolled in the study. Each subsequent site monitoring visit
report has reflected a 50% decrease in site issues and trends. The site
diligently reviews their site monitoring report (SMR)to clearly identify
the issues listed and adjust their CQMP accordingly to ensure the
amount of queries generated during monitoring visits and by the data
management center has significantly decreased.
Based on the findings in the SMR what step has the site taken to
decrease the number of audit findings and data management queries?
A. Developed corrective action plans to address the audit findings
B. Submitted the site monitoring report to the Institutional Review
Board/Ethics Committee (IRB/EC)
C. Filed the site monitoring report in the regulatory files
87
Post-Assessment Question #2
Once a CQMP is developed, how often should the Plan be
reviewed?
A. Every two years
B. Annually
C. Per policy
88
Post-Assessment Question #3
Which of the following individuals is ultimately responsible
for the quality management activities at a research site?
A.
B.
C.
D.
89
The Investigator
The Study Coordinator
The Pharmacist
The Research Participant
Post-Assessment Question #4
Which quality management activity is conducted in realtime?
A. Quality control
B. Quality assurance
90
Post-Assessment Question #5
The corrective action component of Corrective and
Preventive Action (CAPA) is defined as the action
taken to remove or improve a process to prevent
potential future occurrences of a nonconformance.
A. Yes
B. No
91
Post - Assessment Question #6
What actions can site staff take to implement a quality
management culture at their site?
A. Identify a Quality Manager who is responsible for
monitoring and addressing trends identified in site
monitoring reports
B. Create a site CAPA plan
C. Engage stakeholders in implementing the site’s CAPA
D. All of the above
92
Quality Management Workshop
Culture of
Quality
Management
Quality
Management
Corrective
and
Preventive
Action
QA and QC
Activities
THANK YOU
94
Return
to Slide
95
Return
to Slide
Return
96