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CONFIDENTIAL: This document contains information that is confidential and proprietary to EtQ, Inc. Disclosure, copying, distribution
or use without the express permission of EtQ is prohibited. Copyright 2013 EtQ, Inc. All rights reserved.
5 minutes on…
5 Things to Look for in
Corrective Action Software Solutions
Tim Lozier, EtQ, Inc.
Corrective Actions – Central to Compliance
• Central to the Quality, EHS, Compliance Management
Systems
• Need to correct Systemic Issues
• Technology is evolving; more automation drives
efficient process management
• Here are 5 ways you can streamline Corrective Action
1. Workflows for Many C/A Types
• Workflow is central to compliance
• You may have different workflows for different
Corrective Action types
– External/Internal Audit | Customer Concern | Safety Incident
• Workflows need to be flexible for many C/A types
– Each type can have it’s own dedicated workflow
– Multiple routing options – intelligence in the workflow
• Flexible workflow is a cornerstone of process efficiency
2. Not Everything needs to be a C/A
• Often common to create a Corrective Action for every
adverse event
– Challenge: End up with too many Corrective Actions
– Not all are necessary
• Corrective Action: Process for systemic events
– Some issues are not systemic; can be corrected immediately
– Correct minor issues at the source
• Corrective Action Determination/Investigation
– Like a “Pre-Corrective Action” – initial assessment on the nature
of the adverse event
– Asks, “Can this be immediately corrected?” If not, then maybe a
Corrective Action
3. Filter Your Corrective Actions
• Don’t use what’s “most overdue”
– You may miss critical events that just happened
– Key is to address most critical first
• Filtering events as they come in can enable better
prioritization
– Decision Trees
– Risk Assessments
– Team Reviews
• Use Criticality/Risk as a metric for handling C/A
ACTION PLAN
4. Corrective Action Plans
• Corrective Action can be an involved Process
– Many roles/deliverables/tasks to complete the process
– Corrective Action can have a level of Project Management
• Action Plans
– Automatically schedules deliverables by roles
– Sets due dates with business rules
– Helps to organize and prioritize actions from the C/A
• Project Management = efficiency in handling C/A
Root cause
Corrective
Action
Verification
5. Traceability and Reporting
• Reporting is key to any business system
– Helps to make sense of the data
– Provides visibility into the “health” of your Corrective Action program
• Look for robust reporting to look into the C/A system
– Ad-hoc, template, scheduled reports
– Uncover trends, issues, opportunities for improvement
• Traceability
– Ability to look at the entire history of an event – from source to
corrective action to resulting change management
– Corrective Action History Report – generate reports on the entire
“story”
Corrective Action – The “Heart”
• Is the central process from which events filter through
• Is how we ensure that Compliance is kept and
maintained
• Each company handles C/A differently
– Key is to find a process that works for your business
– Maintain compliance and good business practices
– Simple or complex – technology will help you to streamline and
automate these processes
CAPA
SOURCE
EVENTS
SOURCE
EVENTS
SOURCE
EVENTS
REPORTS
CHANGE
MGMT
DOC
CONTROL /
TRAINING
[I love CAPA!]
For more than 5 minutes…
EtQ’s Blog on Corrective
Action
blog.etq.com
Webcasts on EtQ’s
Corrective Action system
www.etq.com/webinars
www.etq.com
info@etq.com
516.293.0946

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5 Things to Look for in Corrective Action Software Solutions

  • 1. CONFIDENTIAL: This document contains information that is confidential and proprietary to EtQ, Inc. Disclosure, copying, distribution or use without the express permission of EtQ is prohibited. Copyright 2013 EtQ, Inc. All rights reserved. 5 minutes on… 5 Things to Look for in Corrective Action Software Solutions Tim Lozier, EtQ, Inc.
  • 2. Corrective Actions – Central to Compliance • Central to the Quality, EHS, Compliance Management Systems • Need to correct Systemic Issues • Technology is evolving; more automation drives efficient process management • Here are 5 ways you can streamline Corrective Action
  • 3. 1. Workflows for Many C/A Types • Workflow is central to compliance • You may have different workflows for different Corrective Action types – External/Internal Audit | Customer Concern | Safety Incident • Workflows need to be flexible for many C/A types – Each type can have it’s own dedicated workflow – Multiple routing options – intelligence in the workflow • Flexible workflow is a cornerstone of process efficiency
  • 4. 2. Not Everything needs to be a C/A • Often common to create a Corrective Action for every adverse event – Challenge: End up with too many Corrective Actions – Not all are necessary • Corrective Action: Process for systemic events – Some issues are not systemic; can be corrected immediately – Correct minor issues at the source • Corrective Action Determination/Investigation – Like a “Pre-Corrective Action” – initial assessment on the nature of the adverse event – Asks, “Can this be immediately corrected?” If not, then maybe a Corrective Action
  • 5. 3. Filter Your Corrective Actions • Don’t use what’s “most overdue” – You may miss critical events that just happened – Key is to address most critical first • Filtering events as they come in can enable better prioritization – Decision Trees – Risk Assessments – Team Reviews • Use Criticality/Risk as a metric for handling C/A
  • 6. ACTION PLAN 4. Corrective Action Plans • Corrective Action can be an involved Process – Many roles/deliverables/tasks to complete the process – Corrective Action can have a level of Project Management • Action Plans – Automatically schedules deliverables by roles – Sets due dates with business rules – Helps to organize and prioritize actions from the C/A • Project Management = efficiency in handling C/A Root cause Corrective Action Verification
  • 7. 5. Traceability and Reporting • Reporting is key to any business system – Helps to make sense of the data – Provides visibility into the “health” of your Corrective Action program • Look for robust reporting to look into the C/A system – Ad-hoc, template, scheduled reports – Uncover trends, issues, opportunities for improvement • Traceability – Ability to look at the entire history of an event – from source to corrective action to resulting change management – Corrective Action History Report – generate reports on the entire “story”
  • 8. Corrective Action – The “Heart” • Is the central process from which events filter through • Is how we ensure that Compliance is kept and maintained • Each company handles C/A differently – Key is to find a process that works for your business – Maintain compliance and good business practices – Simple or complex – technology will help you to streamline and automate these processes CAPA SOURCE EVENTS SOURCE EVENTS SOURCE EVENTS REPORTS CHANGE MGMT DOC CONTROL / TRAINING [I love CAPA!]
  • 9. For more than 5 minutes… EtQ’s Blog on Corrective Action blog.etq.com Webcasts on EtQ’s Corrective Action system www.etq.com/webinars www.etq.com info@etq.com 516.293.0946