Quick Contact : 408-458-8343
Select Page
FacebookGoogle BookmarksTwitterLinkedInPinterestEmail

Unless you live in an alternate universe, as a business leader you are bound to encounter problems, issues, or challenges. These are a drain on resources, cost money, and sometimes can even cause damage to your organization’s reputation. They could get you into trouble with regulators too.

Taking corrective action is one step, but it should be followed by implementing preventive measures to mitigate the risk of the problem recurring in the future. To be able to understand the risk and identify the best corrective and preventive action, root cause analysis becomes very important. Only when the causative factor is correctly identified and addressed can future occurrences be prevented.

In this blog, we share highlights from a webinar we conducted in partnership with ASQ. Leslie Pemberton, Head of OE & Quality at Kennametal, shares with us tips and tricks of using the Countermeasure Ladder for Effective Root Cause & Preventive Actions.

Using “Percentage of Repeats” as a Metric:

Some of the frequently occurring challenges can be complaints about quality from customers, productivity downtime, or safety-related incidents. Typically, the number of incidents is measured against the cost of the problem. For instance, suppose ‘Plant X’ receives 19 complaints in a given month, and out of these, 7 are issues that have already occurred before within the rolling 12 months, you can get a “Percentage of Repeats” metric. To overcome this issue companies can set targets for improvement, with the ultimate target being zero. As is often said, what gets measured, gets fixed.

Using the Countermeasure Ladder to improve Preventive Actions

Countermeasure Ladder is a methodology taken from TPM (Total Productive Maintenance). Historically, the technique has been used to assess countermeasures for machine down-time. It is usually listed down as a set of six countermeasures.

Using the same tool for Quality CAPAs has been extremely effective.

Now, let’s talk about six levels of Countermeasure Ladder to improve CAPA.

LevelStepExample
Level 1Remind operators of the way to do the check correctlyOPL (one-point lesson), retraining, accountability/ follow-up
Level 2Double-check that the person has remembered to do it the correct wayPerform a Gemba or an audit
Level 3Constantly remind ‘at a glance’ – the correct way to do an action/taskVisual controls — gauge marking, signage, floor markings
Level 4Make it difficult to do it the incorrect wayFoolproof or Poka-yoke
Level 5Eliminate the human elementMechanize the operation/step
Level 6Eliminate the operationDesign out the need to do the step

Examples of Level 4, 5 & 6 Countermeasure for a Complaint:

Let’s discuss a few examples of Level 4, 5 & 6 Countermeasures along with issues for better understanding.

Issue: Operators are entering incorrect data for part weights due to keying (manual) error.

  • CAPA: Install scales with auto feed to SPC charts (Poka-yoke — Level 4)

Issue: Operators continuously measure parts incorrectly due to poor R&R on gauges.

  • CAPA: Install in-line laser measurement system to measure parts and auto-enter into SPC charts (Mechanize the process — Level 5)

Issue: Operators fail to remove flash from parts after they are molded

  • CAPA: Install automatic deburring right in the mold (Eliminate the step — Level 6)

Typical CAPAs in Manufacturing

Some of the common corrective actions in the manufacturing industry based on root cause analysis include:

  1. Retraining operators
  2. Issuing a new procedure
  3. Disciplining the operator who ran the parts

Scoring CAPAs by Countermeasure Level

Scoring CAPAs by Countermeasure level is called an Input Metric or a Leading Indicator.

Input metric = scoring system using Countermeasure Ladder

The team’s CAPAs are measured with scores and feedback provided helps move it further up in the ladder. The examples shared in the six levels of Countermeasure Ladder with typical CAPAs are at Level 1. An improvement target for this metric would be:

% CAPAs rated 4 or above on the Countermeasure Ladder

The lagging indicator vs percent repeating issues and input metric and percentage CAPA at level 4 or above are highly correlated when running a statistical analysis.

Scorecard metric = % Repeating issues – drive to zero!

Proactive input metric = % CAPAs at level 4 or above – drive to at least 75%

% CAPA at level 4 or above can be used for complaints, safety incidents, downtime, scrap, or any other improvement opportunities that require a countermeasure for failure.

ComplianceQuest’s CAPA Management Solution is an easy-to-use system designed to effectively manage the corrective action/preventive action workflow. It is a next-generation solution with the following features and capabilities:

  1. Automation of workflows for not only investigation and taking preventive action, but also for ensuring the effectiveness of action taken
  2. AI-enabled features that can spot trends and patterns, to efficiently identify the root cause of the problem
  3. Continuous improvement (CI) through a collaborative, connected, data-driven system
  4. Ease of customization and interoperability ensures that any methodology or approach – including the countermeasure ladder approach can be done using this system

For a more detailed overview of the features of our CAPA product, visit here: https://www.compliancequest.com/webinar/using-the-countermeasure-ladder-for-effective-root-cause-preventive-actions/

If you’d like to see the demo of our solutions, schedule here: https://www.compliancequest.com/online-demo/

Webinars
x
Upcoming
FDA’s Response to COVID-19: Fundamentals of Obtaining Emergency Use Authorizations

Register

   January 27, 2021   |   01:30 - 02.15 PM EST

Follow Us