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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

CHANGEMGMT

DOC CONTROL / TRAINING

[I love CAPA!]

For more than 5 minutes…

EtQ’s Blog on Corrective Actionblog.etq.com

Webcasts on EtQ’s Corrective Action systemwww.etq.com/webinars

www.etq.cominfo@etq.com516.293.0946