Company LOGO Quality Improvement Consulting, LLC Risk Management
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Company
LOGO
Quality Improvement Consulting LLC
Risk Management
What Is Risk
bull Risk may be defined as the possibility of suffering damage or loss
Possibility
The possibility is characterized by three factors
bull probability or likelihood that loss or damage will occur
bull The expected time of occurrence
bull The magnitude of the negative impact that can result from its occurrence
What Is Risk Management
bull A Determination of the probability of
occurrence of a process failure amp the
negative effect or impact if it does
bull Putting in place preventive actions to
mitigate those risks that are determined to
be most likely to happen and will have a
server impact to the process
What Is Acceptable Risk
A decision process thatbull Specifies the objectives to measure
the desirability or lack thereofbull Defines possible options including
no actionbull Identifies the consequences of each
option and likelihood of occurrencebull Specifying the desirability of
consequencesbull Analyzing the options and selecting
the ldquomost acceptablerdquo option
The Seriousness of a Risk
This can be determined by multiplying the probability of the event actually occurring by the potential negative impact to cost schedule or performance
Risk Severity = Probability of Occurrence x Potential Negative Impact
Potential Risk Scenarios
bull Scenario 1 Probability of occurrence is high and the potential impact is very low
bull Scenario 2 Probability of occurrence is low and the potential impact is very high
bull Scenario 3 Probability of occurrence is low and the potential impact is very low
bull Scenario 4 Probability of occurrence is high and the potential impact is very high
Ways to Deal With Risk
bull Proactive approach Risk Managementndash Analyzes future project events and past
projectsndash Identify potential risksndash Taking measures to reduce their probability
and or impactbull Reactive approach Crisis Management
ndash Resource-intensivendash Available options constrained or restricted by
events
Systems of Feedback
bull Design feedbackbull Management Reviewbull Risk Management
bull Customer Complaintsbull CAPA Escalationbull Acceptable Risk
Proactive
Reactive
Balance
Risk
Benefit
Why Risk as Part of CAPA System
bull What is the impact of risk to the CAPA
system
bull What hurdles will you encounter
CAPA Connecting RiskManagement and Trending
Critical questions that drive into the CAPA process and determine the depth of investigationpriority of CAPAndash Is this a new or unknown problemndash Has the severity increased Decreasedndash Has the frequency of occurrence
increasedndash Have the causes of the problem been
confirmedndash Are there new causes of the problem
that have inadequate or no mitigation
Key Definitions
Nonconformance (NC)bull Any noncompliance with the requirements of the Quality
System (product and non-product)Correctionbull Repair rework or adjustment related to the disposition of an
existingnonconformity Corrections are typically one-time fixesCorrective Action (CA)bull Action taken to eliminate the causes of an existing
nonconformity defect or other undesirable situation in order to prevent recurrence
Preventive Action (PA)bull Action taken to eliminate the cause of a potential
nonconformity defect or other undesirable situation in order to prevent occurrence and improve quality trends
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
What Is Risk
bull Risk may be defined as the possibility of suffering damage or loss
Possibility
The possibility is characterized by three factors
bull probability or likelihood that loss or damage will occur
bull The expected time of occurrence
bull The magnitude of the negative impact that can result from its occurrence
What Is Risk Management
bull A Determination of the probability of
occurrence of a process failure amp the
negative effect or impact if it does
bull Putting in place preventive actions to
mitigate those risks that are determined to
be most likely to happen and will have a
server impact to the process
What Is Acceptable Risk
A decision process thatbull Specifies the objectives to measure
the desirability or lack thereofbull Defines possible options including
no actionbull Identifies the consequences of each
option and likelihood of occurrencebull Specifying the desirability of
consequencesbull Analyzing the options and selecting
the ldquomost acceptablerdquo option
The Seriousness of a Risk
This can be determined by multiplying the probability of the event actually occurring by the potential negative impact to cost schedule or performance
Risk Severity = Probability of Occurrence x Potential Negative Impact
Potential Risk Scenarios
bull Scenario 1 Probability of occurrence is high and the potential impact is very low
bull Scenario 2 Probability of occurrence is low and the potential impact is very high
bull Scenario 3 Probability of occurrence is low and the potential impact is very low
bull Scenario 4 Probability of occurrence is high and the potential impact is very high
Ways to Deal With Risk
bull Proactive approach Risk Managementndash Analyzes future project events and past
projectsndash Identify potential risksndash Taking measures to reduce their probability
and or impactbull Reactive approach Crisis Management
ndash Resource-intensivendash Available options constrained or restricted by
events
Systems of Feedback
bull Design feedbackbull Management Reviewbull Risk Management
bull Customer Complaintsbull CAPA Escalationbull Acceptable Risk
Proactive
Reactive
Balance
Risk
Benefit
Why Risk as Part of CAPA System
bull What is the impact of risk to the CAPA
system
bull What hurdles will you encounter
CAPA Connecting RiskManagement and Trending
Critical questions that drive into the CAPA process and determine the depth of investigationpriority of CAPAndash Is this a new or unknown problemndash Has the severity increased Decreasedndash Has the frequency of occurrence
increasedndash Have the causes of the problem been
confirmedndash Are there new causes of the problem
that have inadequate or no mitigation
Key Definitions
Nonconformance (NC)bull Any noncompliance with the requirements of the Quality
System (product and non-product)Correctionbull Repair rework or adjustment related to the disposition of an
existingnonconformity Corrections are typically one-time fixesCorrective Action (CA)bull Action taken to eliminate the causes of an existing
nonconformity defect or other undesirable situation in order to prevent recurrence
Preventive Action (PA)bull Action taken to eliminate the cause of a potential
nonconformity defect or other undesirable situation in order to prevent occurrence and improve quality trends
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Possibility
The possibility is characterized by three factors
bull probability or likelihood that loss or damage will occur
bull The expected time of occurrence
bull The magnitude of the negative impact that can result from its occurrence
What Is Risk Management
bull A Determination of the probability of
occurrence of a process failure amp the
negative effect or impact if it does
bull Putting in place preventive actions to
mitigate those risks that are determined to
be most likely to happen and will have a
server impact to the process
What Is Acceptable Risk
A decision process thatbull Specifies the objectives to measure
the desirability or lack thereofbull Defines possible options including
no actionbull Identifies the consequences of each
option and likelihood of occurrencebull Specifying the desirability of
consequencesbull Analyzing the options and selecting
the ldquomost acceptablerdquo option
The Seriousness of a Risk
This can be determined by multiplying the probability of the event actually occurring by the potential negative impact to cost schedule or performance
Risk Severity = Probability of Occurrence x Potential Negative Impact
Potential Risk Scenarios
bull Scenario 1 Probability of occurrence is high and the potential impact is very low
bull Scenario 2 Probability of occurrence is low and the potential impact is very high
bull Scenario 3 Probability of occurrence is low and the potential impact is very low
bull Scenario 4 Probability of occurrence is high and the potential impact is very high
Ways to Deal With Risk
bull Proactive approach Risk Managementndash Analyzes future project events and past
projectsndash Identify potential risksndash Taking measures to reduce their probability
and or impactbull Reactive approach Crisis Management
ndash Resource-intensivendash Available options constrained or restricted by
events
Systems of Feedback
bull Design feedbackbull Management Reviewbull Risk Management
bull Customer Complaintsbull CAPA Escalationbull Acceptable Risk
Proactive
Reactive
Balance
Risk
Benefit
Why Risk as Part of CAPA System
bull What is the impact of risk to the CAPA
system
bull What hurdles will you encounter
CAPA Connecting RiskManagement and Trending
Critical questions that drive into the CAPA process and determine the depth of investigationpriority of CAPAndash Is this a new or unknown problemndash Has the severity increased Decreasedndash Has the frequency of occurrence
increasedndash Have the causes of the problem been
confirmedndash Are there new causes of the problem
that have inadequate or no mitigation
Key Definitions
Nonconformance (NC)bull Any noncompliance with the requirements of the Quality
System (product and non-product)Correctionbull Repair rework or adjustment related to the disposition of an
existingnonconformity Corrections are typically one-time fixesCorrective Action (CA)bull Action taken to eliminate the causes of an existing
nonconformity defect or other undesirable situation in order to prevent recurrence
Preventive Action (PA)bull Action taken to eliminate the cause of a potential
nonconformity defect or other undesirable situation in order to prevent occurrence and improve quality trends
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
What Is Risk Management
bull A Determination of the probability of
occurrence of a process failure amp the
negative effect or impact if it does
bull Putting in place preventive actions to
mitigate those risks that are determined to
be most likely to happen and will have a
server impact to the process
What Is Acceptable Risk
A decision process thatbull Specifies the objectives to measure
the desirability or lack thereofbull Defines possible options including
no actionbull Identifies the consequences of each
option and likelihood of occurrencebull Specifying the desirability of
consequencesbull Analyzing the options and selecting
the ldquomost acceptablerdquo option
The Seriousness of a Risk
This can be determined by multiplying the probability of the event actually occurring by the potential negative impact to cost schedule or performance
Risk Severity = Probability of Occurrence x Potential Negative Impact
Potential Risk Scenarios
bull Scenario 1 Probability of occurrence is high and the potential impact is very low
bull Scenario 2 Probability of occurrence is low and the potential impact is very high
bull Scenario 3 Probability of occurrence is low and the potential impact is very low
bull Scenario 4 Probability of occurrence is high and the potential impact is very high
Ways to Deal With Risk
bull Proactive approach Risk Managementndash Analyzes future project events and past
projectsndash Identify potential risksndash Taking measures to reduce their probability
and or impactbull Reactive approach Crisis Management
ndash Resource-intensivendash Available options constrained or restricted by
events
Systems of Feedback
bull Design feedbackbull Management Reviewbull Risk Management
bull Customer Complaintsbull CAPA Escalationbull Acceptable Risk
Proactive
Reactive
Balance
Risk
Benefit
Why Risk as Part of CAPA System
bull What is the impact of risk to the CAPA
system
bull What hurdles will you encounter
CAPA Connecting RiskManagement and Trending
Critical questions that drive into the CAPA process and determine the depth of investigationpriority of CAPAndash Is this a new or unknown problemndash Has the severity increased Decreasedndash Has the frequency of occurrence
increasedndash Have the causes of the problem been
confirmedndash Are there new causes of the problem
that have inadequate or no mitigation
Key Definitions
Nonconformance (NC)bull Any noncompliance with the requirements of the Quality
System (product and non-product)Correctionbull Repair rework or adjustment related to the disposition of an
existingnonconformity Corrections are typically one-time fixesCorrective Action (CA)bull Action taken to eliminate the causes of an existing
nonconformity defect or other undesirable situation in order to prevent recurrence
Preventive Action (PA)bull Action taken to eliminate the cause of a potential
nonconformity defect or other undesirable situation in order to prevent occurrence and improve quality trends
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
What Is Acceptable Risk
A decision process thatbull Specifies the objectives to measure
the desirability or lack thereofbull Defines possible options including
no actionbull Identifies the consequences of each
option and likelihood of occurrencebull Specifying the desirability of
consequencesbull Analyzing the options and selecting
the ldquomost acceptablerdquo option
The Seriousness of a Risk
This can be determined by multiplying the probability of the event actually occurring by the potential negative impact to cost schedule or performance
Risk Severity = Probability of Occurrence x Potential Negative Impact
Potential Risk Scenarios
bull Scenario 1 Probability of occurrence is high and the potential impact is very low
bull Scenario 2 Probability of occurrence is low and the potential impact is very high
bull Scenario 3 Probability of occurrence is low and the potential impact is very low
bull Scenario 4 Probability of occurrence is high and the potential impact is very high
Ways to Deal With Risk
bull Proactive approach Risk Managementndash Analyzes future project events and past
projectsndash Identify potential risksndash Taking measures to reduce their probability
and or impactbull Reactive approach Crisis Management
ndash Resource-intensivendash Available options constrained or restricted by
events
Systems of Feedback
bull Design feedbackbull Management Reviewbull Risk Management
bull Customer Complaintsbull CAPA Escalationbull Acceptable Risk
Proactive
Reactive
Balance
Risk
Benefit
Why Risk as Part of CAPA System
bull What is the impact of risk to the CAPA
system
bull What hurdles will you encounter
CAPA Connecting RiskManagement and Trending
Critical questions that drive into the CAPA process and determine the depth of investigationpriority of CAPAndash Is this a new or unknown problemndash Has the severity increased Decreasedndash Has the frequency of occurrence
increasedndash Have the causes of the problem been
confirmedndash Are there new causes of the problem
that have inadequate or no mitigation
Key Definitions
Nonconformance (NC)bull Any noncompliance with the requirements of the Quality
System (product and non-product)Correctionbull Repair rework or adjustment related to the disposition of an
existingnonconformity Corrections are typically one-time fixesCorrective Action (CA)bull Action taken to eliminate the causes of an existing
nonconformity defect or other undesirable situation in order to prevent recurrence
Preventive Action (PA)bull Action taken to eliminate the cause of a potential
nonconformity defect or other undesirable situation in order to prevent occurrence and improve quality trends
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
The Seriousness of a Risk
This can be determined by multiplying the probability of the event actually occurring by the potential negative impact to cost schedule or performance
Risk Severity = Probability of Occurrence x Potential Negative Impact
Potential Risk Scenarios
bull Scenario 1 Probability of occurrence is high and the potential impact is very low
bull Scenario 2 Probability of occurrence is low and the potential impact is very high
bull Scenario 3 Probability of occurrence is low and the potential impact is very low
bull Scenario 4 Probability of occurrence is high and the potential impact is very high
Ways to Deal With Risk
bull Proactive approach Risk Managementndash Analyzes future project events and past
projectsndash Identify potential risksndash Taking measures to reduce their probability
and or impactbull Reactive approach Crisis Management
ndash Resource-intensivendash Available options constrained or restricted by
events
Systems of Feedback
bull Design feedbackbull Management Reviewbull Risk Management
bull Customer Complaintsbull CAPA Escalationbull Acceptable Risk
Proactive
Reactive
Balance
Risk
Benefit
Why Risk as Part of CAPA System
bull What is the impact of risk to the CAPA
system
bull What hurdles will you encounter
CAPA Connecting RiskManagement and Trending
Critical questions that drive into the CAPA process and determine the depth of investigationpriority of CAPAndash Is this a new or unknown problemndash Has the severity increased Decreasedndash Has the frequency of occurrence
increasedndash Have the causes of the problem been
confirmedndash Are there new causes of the problem
that have inadequate or no mitigation
Key Definitions
Nonconformance (NC)bull Any noncompliance with the requirements of the Quality
System (product and non-product)Correctionbull Repair rework or adjustment related to the disposition of an
existingnonconformity Corrections are typically one-time fixesCorrective Action (CA)bull Action taken to eliminate the causes of an existing
nonconformity defect or other undesirable situation in order to prevent recurrence
Preventive Action (PA)bull Action taken to eliminate the cause of a potential
nonconformity defect or other undesirable situation in order to prevent occurrence and improve quality trends
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Potential Risk Scenarios
bull Scenario 1 Probability of occurrence is high and the potential impact is very low
bull Scenario 2 Probability of occurrence is low and the potential impact is very high
bull Scenario 3 Probability of occurrence is low and the potential impact is very low
bull Scenario 4 Probability of occurrence is high and the potential impact is very high
Ways to Deal With Risk
bull Proactive approach Risk Managementndash Analyzes future project events and past
projectsndash Identify potential risksndash Taking measures to reduce their probability
and or impactbull Reactive approach Crisis Management
ndash Resource-intensivendash Available options constrained or restricted by
events
Systems of Feedback
bull Design feedbackbull Management Reviewbull Risk Management
bull Customer Complaintsbull CAPA Escalationbull Acceptable Risk
Proactive
Reactive
Balance
Risk
Benefit
Why Risk as Part of CAPA System
bull What is the impact of risk to the CAPA
system
bull What hurdles will you encounter
CAPA Connecting RiskManagement and Trending
Critical questions that drive into the CAPA process and determine the depth of investigationpriority of CAPAndash Is this a new or unknown problemndash Has the severity increased Decreasedndash Has the frequency of occurrence
increasedndash Have the causes of the problem been
confirmedndash Are there new causes of the problem
that have inadequate or no mitigation
Key Definitions
Nonconformance (NC)bull Any noncompliance with the requirements of the Quality
System (product and non-product)Correctionbull Repair rework or adjustment related to the disposition of an
existingnonconformity Corrections are typically one-time fixesCorrective Action (CA)bull Action taken to eliminate the causes of an existing
nonconformity defect or other undesirable situation in order to prevent recurrence
Preventive Action (PA)bull Action taken to eliminate the cause of a potential
nonconformity defect or other undesirable situation in order to prevent occurrence and improve quality trends
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Ways to Deal With Risk
bull Proactive approach Risk Managementndash Analyzes future project events and past
projectsndash Identify potential risksndash Taking measures to reduce their probability
and or impactbull Reactive approach Crisis Management
ndash Resource-intensivendash Available options constrained or restricted by
events
Systems of Feedback
bull Design feedbackbull Management Reviewbull Risk Management
bull Customer Complaintsbull CAPA Escalationbull Acceptable Risk
Proactive
Reactive
Balance
Risk
Benefit
Why Risk as Part of CAPA System
bull What is the impact of risk to the CAPA
system
bull What hurdles will you encounter
CAPA Connecting RiskManagement and Trending
Critical questions that drive into the CAPA process and determine the depth of investigationpriority of CAPAndash Is this a new or unknown problemndash Has the severity increased Decreasedndash Has the frequency of occurrence
increasedndash Have the causes of the problem been
confirmedndash Are there new causes of the problem
that have inadequate or no mitigation
Key Definitions
Nonconformance (NC)bull Any noncompliance with the requirements of the Quality
System (product and non-product)Correctionbull Repair rework or adjustment related to the disposition of an
existingnonconformity Corrections are typically one-time fixesCorrective Action (CA)bull Action taken to eliminate the causes of an existing
nonconformity defect or other undesirable situation in order to prevent recurrence
Preventive Action (PA)bull Action taken to eliminate the cause of a potential
nonconformity defect or other undesirable situation in order to prevent occurrence and improve quality trends
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Systems of Feedback
bull Design feedbackbull Management Reviewbull Risk Management
bull Customer Complaintsbull CAPA Escalationbull Acceptable Risk
Proactive
Reactive
Balance
Risk
Benefit
Why Risk as Part of CAPA System
bull What is the impact of risk to the CAPA
system
bull What hurdles will you encounter
CAPA Connecting RiskManagement and Trending
Critical questions that drive into the CAPA process and determine the depth of investigationpriority of CAPAndash Is this a new or unknown problemndash Has the severity increased Decreasedndash Has the frequency of occurrence
increasedndash Have the causes of the problem been
confirmedndash Are there new causes of the problem
that have inadequate or no mitigation
Key Definitions
Nonconformance (NC)bull Any noncompliance with the requirements of the Quality
System (product and non-product)Correctionbull Repair rework or adjustment related to the disposition of an
existingnonconformity Corrections are typically one-time fixesCorrective Action (CA)bull Action taken to eliminate the causes of an existing
nonconformity defect or other undesirable situation in order to prevent recurrence
Preventive Action (PA)bull Action taken to eliminate the cause of a potential
nonconformity defect or other undesirable situation in order to prevent occurrence and improve quality trends
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Balance
Risk
Benefit
Why Risk as Part of CAPA System
bull What is the impact of risk to the CAPA
system
bull What hurdles will you encounter
CAPA Connecting RiskManagement and Trending
Critical questions that drive into the CAPA process and determine the depth of investigationpriority of CAPAndash Is this a new or unknown problemndash Has the severity increased Decreasedndash Has the frequency of occurrence
increasedndash Have the causes of the problem been
confirmedndash Are there new causes of the problem
that have inadequate or no mitigation
Key Definitions
Nonconformance (NC)bull Any noncompliance with the requirements of the Quality
System (product and non-product)Correctionbull Repair rework or adjustment related to the disposition of an
existingnonconformity Corrections are typically one-time fixesCorrective Action (CA)bull Action taken to eliminate the causes of an existing
nonconformity defect or other undesirable situation in order to prevent recurrence
Preventive Action (PA)bull Action taken to eliminate the cause of a potential
nonconformity defect or other undesirable situation in order to prevent occurrence and improve quality trends
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Why Risk as Part of CAPA System
bull What is the impact of risk to the CAPA
system
bull What hurdles will you encounter
CAPA Connecting RiskManagement and Trending
Critical questions that drive into the CAPA process and determine the depth of investigationpriority of CAPAndash Is this a new or unknown problemndash Has the severity increased Decreasedndash Has the frequency of occurrence
increasedndash Have the causes of the problem been
confirmedndash Are there new causes of the problem
that have inadequate or no mitigation
Key Definitions
Nonconformance (NC)bull Any noncompliance with the requirements of the Quality
System (product and non-product)Correctionbull Repair rework or adjustment related to the disposition of an
existingnonconformity Corrections are typically one-time fixesCorrective Action (CA)bull Action taken to eliminate the causes of an existing
nonconformity defect or other undesirable situation in order to prevent recurrence
Preventive Action (PA)bull Action taken to eliminate the cause of a potential
nonconformity defect or other undesirable situation in order to prevent occurrence and improve quality trends
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
CAPA Connecting RiskManagement and Trending
Critical questions that drive into the CAPA process and determine the depth of investigationpriority of CAPAndash Is this a new or unknown problemndash Has the severity increased Decreasedndash Has the frequency of occurrence
increasedndash Have the causes of the problem been
confirmedndash Are there new causes of the problem
that have inadequate or no mitigation
Key Definitions
Nonconformance (NC)bull Any noncompliance with the requirements of the Quality
System (product and non-product)Correctionbull Repair rework or adjustment related to the disposition of an
existingnonconformity Corrections are typically one-time fixesCorrective Action (CA)bull Action taken to eliminate the causes of an existing
nonconformity defect or other undesirable situation in order to prevent recurrence
Preventive Action (PA)bull Action taken to eliminate the cause of a potential
nonconformity defect or other undesirable situation in order to prevent occurrence and improve quality trends
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Key Definitions
Nonconformance (NC)bull Any noncompliance with the requirements of the Quality
System (product and non-product)Correctionbull Repair rework or adjustment related to the disposition of an
existingnonconformity Corrections are typically one-time fixesCorrective Action (CA)bull Action taken to eliminate the causes of an existing
nonconformity defect or other undesirable situation in order to prevent recurrence
Preventive Action (PA)bull Action taken to eliminate the cause of a potential
nonconformity defect or other undesirable situation in order to prevent occurrence and improve quality trends
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
CAPA Process
Failure Investigation(Root Cause Analysis)
CAPA Plan
Approval andDissemination
Implementation(Change Control)
Follow-up for Effectiveness
Problem Identification (Risk Assessment)
Closure
Not EffectiveEffective
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Inputs and Triggers -Internal
bull Acceptance activitiesbull Calibration and Maintenance recordsbull Design Control systembull Management ReviewsAnnual Product Reviewsbull Nonconformances (product and non-product)bull Packaging and Labeling materialsbull Quality Auditsbull Returned productsbull Risk Management documentsbull Service and Installation recordsbull Six SigmaProcess Excellence programsbull SPC monitoringbull And morehellip
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Inputs and Triggers-External
bull Customer complaintsbull Customer feedbackbull External Quality Audit reportsbull ISOAS 9100 feedbackbull Product warrantybull Recallsfield actionsbull Identification of any other conditionissue that
does not comply withbull Your own Quality System andorbull ISOAS standards (eg ISO 9001 AS 9100 etc)bull And morehellip
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Inputs and Triggers- Issues
bull Inputs not clearly defined or established
bull Trigger thresholds not establishedbull Focus on reactive metrics
(Nonconformances Complaints Audit
Observations)bull Data not easily retrievablebull Data not easy to analyze for trends
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Root Cause Analysis-Issues
bull Poorlack of technical skills to conduct root cause analysis
bull Poorlack of writing skills in documenting root cause analysis
bull Poorlittle business knowledge in conducting root cause analysis across processes systems product lines and Quality Systems
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Preventive Actions- Issues
bull When everything is corrective how can the organization assign resources to address Preventive Action
bull Risk assessment may not be designed to address elevation to CAPA for a potential issue or improvement (Preventive Action)
bull CAPA metrics tend to focus on closure rates cycle time number of open CAPAs etc Preventive Actions are in most cases longer-term solutions across processes systems product lines and Quality Systems and will take more time to close
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
From Corrective to Preventive
bull Clearly define inputs and establish thresholds
bull Implement predictive metricsindicators
bull Routinely review and act on sources of product and quality data
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
From Corrective to Preventive
Risk Managementbull Establish elevation mechanisms to CAPAbull Use a risk assessment process to allow
prioritization of CAPAs and elevation to Management
bull Use a risk assessment process that allows CAPAs for Preventive Action
bull Link CAPA to Risk Management documentation (eg Design Control documents)
bull Make data reporting available and easy to users and management
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
From Corrective to Preventive
Root Cause Analysisbull Establish clear roles and responsibilities
for conducting investigationbull Increase technical skills on root cause
analysis toolsbull Improve writing skillsbull Use team approach to conduct
investigation to increase business and technical knowledge
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
From Corrective to Preventive
Preventive Actionbull Implement predictive metricsindicatorsbull Routinely review and act on sources of product
and quality databull Use a risk assessment process that allows CAPAs
for Preventive Actionbull Improve linkage between CAPA into Design
Controlsbull Take a holistic view of issuesbull Can it link to other Quality Systems product lines
systems andor processes
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
From Corrective to Preventive
Management Support and Oversightbull Ensure Management oversight and
commitmentbull Align CAPA with company departmental
and individual goals and objectivesbull Create rewards and recognition programsbull Establish joint partnership between
businesssystem owner and Information Technology for continuous improvement efforts
bull Align metrics from departmental to corporate level
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Annual Product Review - Requirements
Written records subject to this review include but are not limited to the following
1048713 Manufacturing and quality records from lots or batches of products manufactured within the previous year including
bull ndash receiving inspectionbull ndash in-processbull ndash final release testing resultsbull ndash deviationsbull ndash investigationsbull ndash change control recordsbull ndash quality system trends
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Annual Product Review - Requirements
Post market quality records such as
ndash Customer complaintsndash Adverse eventsndash Field actionsndash Product correctionsndash Regulatory submissionsndash Returned or salvaged products
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
Conclusions - Annual Product Review
bull Covers the product cradle to grave Presents management a view of product and process behavior over time
bull Is influenced by all aspects of the Quality System - including in process and release testing
bull Supports decisions related to design control process validation and control as well as user drift
bull Identifies trendsopportunities across mfg lines or sites
- Slide 1
- What Is Risk
- Possibility
- What Is Risk Management
- What Is Acceptable Risk
- The Seriousness of a Risk
- Potential Risk Scenarios
- Ways to Deal With Risk
- Systems of Feedback
- Balance
- Why Risk as Part of CAPA System
- CAPA Connecting Risk Management and Trending
- Key Definitions
- CAPA Process
- Inputs and Triggers -Internal
- Inputs and Triggers-External
- Inputs and Triggers- Issues
- Root Cause Analysis-Issues
- Preventive Actions- Issues
- From Corrective to Preventive
- From Corrective to Preventive (2)
- From Corrective to Preventive (3)
- From Corrective to Preventive (4)
- From Corrective to Preventive (5)
- Annual Product Review - Requirements
- Annual Product Review - Requirements (2)
- Conclusions - Annual Product Review
-
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